    [Senate Hearing 108-745]
    [From the U.S. Government Publishing Office]

                                                            S. Hrg. 108-745

                                                            Senate Hearings

                                     Before the Committee on Appropriations

    _______________________________________________________________________

    Departments of Labor,

    Health and Human Services,

    and Education, and Related

    Agencies Appropriations

                                                                Fiscal Year
                                                                       2005

                                              108th CONGRESS, SECOND SESSION

                                                           H.R. 5006/S. 2810

            DEPARTMENT OF EDUCATION
            DEPARTMENT OF HEALTH AND HUMAN SERVICES
            NONDEPARTMENTAL WITNESSES

                                                            S. Hrg. 108-745

      DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
              RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2005

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

                                    HEARINGS

                                    before a

                              SUBCOMMITTEE OF THE

                COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                          ONE HUNDRED EIGHTH CONGRESS

                                 SECOND SESSION

                                       on

                               H.R. 5006/S. 2810

     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, 2005, AND FOR OTHER PURPOSES

                                   __________

                            Department of Education
                    Department of Health and Human Services
                           Nondepartmental witnesses
                                   __________

             Printed for the use of the Committee on Appropriations

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

                                   __________

                        U.S. GOVERNMENT PRINTING OFFICE
    92-155                      WASHINGTON : 2004
    ____________________________________________________________________________

                          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
    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
    MIKE DeWINE, Ohio                    TIM JOHNSON, South Dakota
    SAM BROWNBACK, Kansas                MARY L. LANDRIEU, Louisiana
                        James W. Morhard, Staff Director
                     Lisa Sutherland, Deputy Staff Director
                  Terrence E. Sauvain, 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
    JUDD GREGG, New Hampshire            ERNEST F. HOLLINGS, South Carolina
    LARRY CRAIG, Idaho                   DANIEL K. INOUYE, Hawaii
    KAY BAILEY HUTCHISON, Texas          HARRY REID, Nevada
    TED STEVENS, Alaska                  HERB KOHL, Wisconsin
    MIKE DeWINE, Ohio                    PATTY MURRAY, Washington
    RICHARD C. SHELBY, Alabama           MARY L. LANDRIEU, Louisiana
                                         ROBERT C. BYRD, West Virginia (Ex
                                             officio)
                               Professional Staff
                                Bettilou Taylor
                                  Jim Sourwine
                                  Mark Laisch
                             Sudip Shrikant Parikh
                                 Candice Rogers
                            Ellen Murray (Minority)
                             Erik Fatemi (Minority)
                          Adrienne Hallett (Minority)

                             Administrative Support
                                 Carole Geagley

                                C O N T E N T S

                                  ----------

                            Thursday, March 4, 2004

                                                                       Page

    Department of Education: Office of the Secretary.................     1

                            Thursday, March 25, 2004

    Department of Health and Human Services: Office of the Secretary.    75

                             Tuesday, April 1, 2004

    Department of Health and Human Services: National Institutes of
      Health.........................................................   107

                           Nondepartmental Witnesses

    Department of Labor..............................................   255
    Department of Health and Human Services..........................   271
    National Institutes of Health....................................   345
    Department of Education..........................................   429
    Related Agencies...........................................448
    Miscellaneous..................................................??? deg.

      DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
              RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2005

                                  ----------

                            THURSDAY, MARCH 4, 2004

                                           U.S. Senate,
               Subcommittee of the Committee on Appropriations,
                                                        Washington, DC.
        The subcommittee met at 9:40 a.m., in room SD-192, Dirksen
    Senate Office Building, Hon. Arlen Specter (chairman)
    presiding.
        Present: Senators Specter, Hutchison, Stevens, Harkin,
    Kohl, Murray, and Landrieu.

                            DEPARTMENT OF EDUCATION

                            Office of the Secretary

    STATEMENT OF HON. RODERICK PAIGE, SECRETARY
    ACCOMPANIED BY:
            C. TODD JONES, ASSOCIATE DEPUTY SECRETARY FOR BUDGET AND
                STRATEGIC ACCOUNTABILITY
            THOMAS SKELLY, DIRECTOR, BUDGET SERVICES

                   OPENING STATEMENT OF SENATOR ARLEN SPECTER

        Senator Specter. The hearing of the Appropriations
    Subcommittee on Labor, Health, Human Services, and Education
    will now proceed. I regret being a few minutes late. They have
    Constitution Avenue blocked off. How did you make it Mr.
    Secretary?
        Secretary Paige. I know some shortcuts.
        Senator Specter. You must have more clout than a chairman,
    Mr. Secretary.
        Secretary Paige. I doubt that.
        Senator Specter. We never know what's going to happen
    around the Capitol from one day to the next, but Constitution
    Avenue is blocked off as we came up. They publicized recently
    that the Capitol is an armed camp but at least the streets were
    clear, but this morning even the streets are not clear.
        Well, on to the business of the subcommittee. We have the
    distinguished Secretary of Education with us today, came to the
    administration with an outstanding reputation as the
    superintendent of the Houston Independent School District. He
    served as dean of education and athletic director prior to that
    at Texas Southern University. He takes on a gigantic job, has
    taken on a gigantic job in the Department of Education, and
    with the President on a bipartisan basis has led to the
    enactment of legislation on Leave No Child Behind, which was
    widely heralded in 2001 when enacted.
        The President made a special trip to Massachusetts with
    Senator Kennedy to show the bipartisan support. Since that
    time, there have been some growing pains, which we will be
    exploring in today's hearing, a call for greater flexibility
    where the Department has responded so far, at least in part,
    concerns about adequacy of funding, where we are trying to move
    ahead with more funding.

                   FISCAL YEAR 2005 EDUCATION BUDGET REQUEST

        The budget for the Department as asked for by the
    administration is in excess of $57 billion, an increase of
    $1.68 billion over last year for a 3 percent increase, and the
    administration has recommended additions in very important
    lines, a billion in title I, a billion in special education.
    But that is possible by eliminating quite a few programs,
    which, Mr. Secretary, are very popular with members, and the
    Constitution gives the Congress the appropriation power,
    subject, of course, to the President's signature.
        So we have always worked it out in the past. We're facing a
    very difficult year on discretionary spending with one half of
    1 percent overall on discretionary spending. We're facing a
    budget deficit in the range of $500 billion, but in Winston
    Churchill's famous words, we'll muddle through, and by working
    together and the relationship the Secretary has had with this
    subcommittee and with the Congress in general has been
    excellent and on a cooperative basis.
        A group of school leaders had a meeting in southeastern
    Pennsylvania earlier this week where there were many concerns
    expressed about the No Child Left Behind Act, and on a last
    minute basis we've invited some of the people party to that
    meeting and some other Pennsylvanians to come to the hearing.
    The chairman is exercising his prerogative as chairman to look
    to the home State. That's not unusual in Washington, D.C., but
    it's representative of a national picture.
        I talked to Secretary Paige last yesterday afternoon. He
    has other commitments, but we struck a time agreement, out no
    later than 11:00, and we appreciate his flexibility. Mr.
    Secretary, the floor is yours. We have a 5-minute rule, but it
    is waived for people who can get by the Constitution Avenue
    blockade.

                    SUMMARY STATEMENT OF HON. RODERICK PAIGE

        Secretary Paige. Thank you, Mr. Chairman. I would like to
    submit material for the record. I'll just provide a summary and
    try to get it in in 5 minutes.
        Senator Specter. Well, that's wonderful, Mr. Secretary.

                            NO CHILD LEFT BEHIND ACT

        Secretary Paige. Thank you. Let me summarize the statement
    for you. With this request, President Bush has reaffirmed his
    longstanding commitment to our Nation's children. Mr. Chairman,
    in the time since the No Child Left Behind Act became law, we
    have made tremendous progress in building a solid foundation
    for educational achievement.
        From day one we've been working to provide guidance on
    implementation of this comprehensive and complicated law. The
    States will tell you that we've done so at a record pace. We've
    entered into a historic partnership with the States. In the
    first year, we hosted meetings with nearly every State to
    support the development of our accountability plan. Our Teacher
    Assistance Corps has visited 49 States to date, working to help
    States meet the law's provisions regarding highly qualified
    teachers.
        We continue to provide regulatory flexibility on the law's
    implementation, including the recent announcement that benefits
    students learning the English language for the first time, and
    also greater flexibility in testing students with disabilities.
    As we continue to assess the law's impact, we must always keep
    in mind what is right for the child, but also be fair to the
    school.

                   FISCAL YEAR 2005 EDUCATION BUDGET REQUEST

        Despite this important progress, we still have much work to
    do. My message to you this year, Mr. Chairman, is no less
    urgent than it was in years past. Federal Reserve Chairman Alan
    Greenspan noted recently, and I quote: ``We need to be forward-
    looking in order to adapt our educational system to the
    evolving needs of the economy and the realities of a changing
    society. . . . It is an effort that should not be postponed.''
        The President's budget proposes $57.3 billion in
    discretionary appropriation for the Department of Education for
    fiscal year 2005. This represents an increase of $1.7 billion,
    or 3 percent, over the 2004 levels, and an increase of $15.1
    billion, or 36 percent, since President Bush took office in
    2001. This budget request reflects the historic bipartisan
    commitment of President Bush and the Congress to increase
    flexibility and accountability in the use of these funds.

                            KEY BUDGET YEAR FOR NCLB

        The 2005 appropriation will fund the 2005-2006 school year,
    a critical year that will witness two significant milestones
    under the No Child Left Behind law. The first, States and
    school districts will begin testing all students in grades 3
    through 8 in reading and mathematics in 2005-2006. With the
    information provided by these annual assessments, teachers will
    have the data they need to teach each student effectively and
    parents will be empowered to make informed choices for their
    children's education--for their educational future. The
    President is proposing $410 million in 2005 to support the
    assessment system developed by each State.
        The second milestone is that all teachers must become
    highly qualified by the end of the school year of 2005-2006.
    There is no better way to improve education than putting a
    highly qualified teacher in every classroom. The No Child Left
    Behind Act recognizes this fact and we will continue to work
    hard with States to make this a reality. The President's Budget
    proposes $5.1 billion to support teachers through training,
    recruitment incentives, loan forgiveness, tax relief. This is
    up from $4.4 billion in 2004 and this is a historic number.

                  TITLE I GRANTS TO LOCAL EDUCATIONAL AGENCIES

        For students who most need our help, the President has
    again proposed a billion dollar increase in title I, which
    brings it up to $13.3 billion. Many of these children are on
    the wrong side of a staggering achievement gap with their more
    advantaged peers, often struggling in school and also in life.
    We know that this problem can't be solved in Washington. Local
    communities know best what to do in order to remedy these
    conditions.

                  HISTORIC LEVELS OF RESOURCES AND FLEXIBILITY

        So to help schools and districts better meet the needs of
    these students, we're providing resources that are historic in
    their scope and also in their flexibility, and we're asking for
    annual progress assessments in return for this historic
    investment.
        In conclusion, when the President said in his State of the
    Union address: ``We've not come all this way . . . only to
    falter and leave our work unfinished.'' I took that message to
    heart. In the last 3 years, we've witnessed some of the most
    important milestones yet in education reform, and I believe
    that one day we're going to look back at this year and see it
    as a turning point in the educational culture in our country.

                               PREPARED STATEMENT

        Fifty years ago, the historic Brown v. Board of Education
    decision began to break down the barriers that prevented some
    of us from attending classrooms--certain classrooms. But we
    know now access was not enough. We still have a long way to go
    to ensure achievement. We believe that today, at the start of
    the third year of the No Child Left Behind Act, we are closer
    to making that goal a reality than ever before.
        Mr. Chairman, thank you, and I'd be pleased to respond to
    any questions that you might have.
        [The statement follows:]

                   Prepared Statement of Hon. Roderick Paige

        Mr. Chairman and Members of the Subcommittee: Thank you for this
    opportunity to testify on behalf of President Bush's 2005 discretionary
    request for the Department of Education. As all of you know, the effort
    to control spending while fighting a war on terrorism and ensuring
    homeland security forced the President to make some tough decisions in
    his 2005 budget. The significant overall increase requested for the
    Department of Education shows that the President remains committed to
    the vision of No Child Left Behind--that all children can learn, and
    all children deserve the opportunity for a quality education.

                      A KEY YEAR FOR NO CHILD LEFT BEHIND

        Fiscal year 2005 is a critical year for No Child Left Behind. The
    2005 appropriation will fund the 2005-2006 school year, a year that
    will witness two significant milestones under the new law. First,
    States and school districts will begin testing all students in grades
    3-8 in reading and mathematics. This is a necessary step toward giving
    teachers the data they need to teach effectively and parents the
    information they need to assess the progress of their children's
    education.
        Second, all teachers must be highly qualified--as defined by States
    in accordance with the law--by the end of the 2005-2006 school year.
    Research tells us there is no better single way of improving education
    than by putting a highly qualified teacher in every classroom. The No
    Child Left Behind Act recognized this fact, and we'll be working hard
    with States to make it a reality.
        We also continue to explore ways to provide the additional
    flexibility that States and school districts need to effectively
    implement No Child Left Behind. In December, the Department published a
    new regulation giving States greater flexibility in testing students
    with disabilities. Two weeks ago, I announced two new policies
    governing the treatment of limited English proficient students in the
    State accountability systems required by No Child Left Behind. And we
    are working on some clarifications regarding the law's requirement that
    all teachers be highly qualified.
        In these and other instances, we believe the law is sufficiently
    flexible to accommodate the legitimate concerns of State and local
    educators, without undermining the core goal that all students and all
    student groups must reach proficiency in reading and mathematics.

                            MAJOR PROGRAM INCREASES

        The President's budget proposes $57.3 billion in discretionary
    appropriations for the Department of Education in fiscal year 2005.
    This represents an increase of $1.7 billion, or 3 percent, over the
    2004 level, and an increase of $15.1 billion, or 36 percent, since
    President Bush took office in 2001.
        As was the case in the President's previous education budgets, most
    new resources are dedicated to three major programs that form the
    cornerstone of the Federal role in education. For the Title I Grants to
    Local Educational Agencies program--the key driver of No Child Left
    Behind reforms in the areas of accountability and parental options--the
    President is seeking $13.3 billion, an increase of $1 billion over the
    2004 level.
        Title I helps the children who are most in need of extra
    educational assistance, who are most in danger of falling further
    behind, on the wrong side of the staggering achievement gap between
    poor and minority students and their more advantaged peers. Our
    determination to help these students--which I know is shared by the
    Members of this Committee--is reflected in a request that would result
    in a total increase of $4.6 billion, or 52 percent, in Title I funding
    since the passage of the No Child Left Behind Act.
        The President also is asking for his fourth consecutive $1 billion
    increase for the Special Education Part B Grants to States program.
    Under the request, funding for Part B Grants to States would rise by
    $4.7 billion, or 75 percent, since 2001. The 2005 request would
    increase the Federal contribution to about 20 percent of the national
    average per-pupil expenditures for all children--the highest level of
    Federal support ever provided for children with disabilities.
        And for the need-based Pell Grants program, the budget includes an
    increase of $856 million, for a total of $12.9 billion. This level
    would fully fund the cost of maintaining a $4,050 maximum award and
    providing grants to an estimated 5.3 million postsecondary students.
    More than 1 million additional students are now receiving Pell Grants
    than when the President took office.

                           JOBS FOR THE 21ST CENTURY

        In addition to these major programs, another priority in the
    Department's request is a package of proposals, totaling $333 million
    in new resources, which play a key role in President Bush's Jobs for
    the 21st Century initiative. These proposals would help ensure that
    middle- and high-school students are better prepared to succeed in
    postsecondary education and the workforce. They focus on improving
    instruction to ensure students are performing on grade level in reading
    and mathematics and on increasing the rigor of secondary school
    curricula.
        A key proposal, for example, is $33 million for new Enhanced Pell
    Grants for State Scholars, which is included in the overall request for
    Pell Grants. We know students who complete a rigorous curriculum are
    more likely to pursue and succeed in postsecondary education, so this
    proposal would provide an additional $1,000 for postsecondary freshmen
    who took challenging courses in high school.
        The Jobs for the 21st Century initiative also includes $100 million
    in new funds to help struggling readers at risk of dropping out of
    secondary school and $120 million to improve the math skills of
    secondary school students who are performing below grade level. Another
    $28 million in new funds is provided to help expand Advanced Placement
    courses for low-income students, and $40 million is set aside for
    Adjunct Teacher Corps to bring professionals with sought after
    knowledge into the classroom.
        The request for Vocational Education complements Jobs for the 21st
    Century by proposing a $1 billion Secondary and Technical Education
    State Grants program that would promote local partnerships between
    community colleges and high schools to improve academic achievement and
    transitions to the workforce. This request includes $12 million to help
    those States that do not currently have State Scholars programs to
    establish such programs.
        Jobs for the 21st Century also emphasizes research-based
    approaches, the importance of which is reflected in our $185 million
    request for Research, Development, and Dissemination. This is an
    increase of $19 million, or nearly 12 percent, to fund research on
    reading comprehension, mathematics and science education, and teacher
    quality.

                                OTHER PRIORITIES

        The 2005 request provides new funding in other ongoing priority
    areas, such as reading, expanding choice options, and support for
    postsecondary institutions serving large percentages of minority
    students.
        Funding for Reading First would grow by $139 million, or more than
    12 percent. Reading first offers children in grades K-3 the benefits of
    research-based, comprehensive reading instruction designed to help meet
    the President's goal that all children read on grade level by the end
    of third grade. The request includes $1.1 billion for Reading First
    State Grants, an increase of $101 million or 10 percent over last year,
    as well as $132 million for Early Reading First, an increase of $38
    million or 40 percent.
        Our budget also reflects President Bush's determination to extend
    educational options to all parents and students--not just those who can
    afford this freedom. No Child Left Behind has greatly expanded the
    choices available to students in low-performing schools, including both
    the option to transfer to a better school and to obtain supplemental
    educational services from a private-sector provider. And this fall we
    will for the first time provide federally funded opportunity
    scholarships to low-income students in the District of Columbia.
        The President's 2005 budget would build on these achievements by
    investing an additional $113 million in expanding choices for students
    and parents. This total includes $50 million for a Choice Incentive
    Fund that would support new transfer options, including private school
    options, and a $63 million increase for the Credit Enhancement for
    Charter School Facilities program, which encourages greater private
    sector lending to finance academic facilities for charter schools.
        Finally, our request reflects the President's ongoing commitment to
    postsecondary institutions that serve large numbers and percentages of
    minority students. We are asking for a total of $515 million for these
    institutions, an increase of almost $21 million, or 4 percent, over the
    2004 level. The total includes $241 million for Strengthening
    Historically Black Colleges and Universities, $59 million for
    Historically Black Graduate Institutions, and $96 million for Hispanic-
    Serving Institutions.

                            MANAGEMENT IMPROVEMENTS

        Another thing that I am proud of is the very real improvement we
    have made in managing the Department and its programs. I knew when I
    came to the Department that if we were going to demand stronger
    accountability from States, school districts, and schools as part of No
    Child Left Behind, we would have to demand that same kind of
    accountability from ourselves. This has been a major priority for me
    and my senior officers for the past three years, and I am pleased to
    report that thanks to a lot of hard work and discipline, taxpayers can
    rest assured that their hard-earned tax dollars are managed responsibly
    at the Department of Education.
        Fiscal year 2003 marked the second consecutive year that the
    Department received an unqualified ``clean'' opinion from its financial
    auditors. That may not seem like something worth celebrating, unless
    you know that the 2003 opinion was only the third ``clean'' audit in
    the Department's 24-year history.
        We also are continuing to make progress in all areas of the
    President's Management Agenda. Earlier this year, the Office of
    Management and Budget announced that the Department received a major
    upgrade on financial performance--moving from a RED to GREEN status
    score. Our performance is ranked in the top one-third of all government
    agencies, and reflects our continued determination to inject
    accountability into everything we do here at the Department of
    Education.

                                   CONCLUSION

        The President's 2005 budget request for the Department of Education
    demonstrates his ongoing commitment to investing in educational
    excellence and achievement. But it also reaffirms that the Federal role
    in education is not just about money, but more importantly about
    leadership based on high standards, accountability, and the use of
    proven educational methods. Only in combination with this leadership--
    exemplified by the No Child Left Behind Act--will the resources
    provided by the Congress have the impact we have all hoped for over the
    past four decades.
        We still have a long way to go before we ensure equal educational
    opportunity for disadvantaged children, but I believe we are witnessing
    the turning point. With your help, we'll keep turning in the right
    direction.
        Thank you, and I will be happy to take any questions you may have.

                    NEW FLEXIBILITY UNDER NCLB REQUIREMENTS

        Senator Specter. Well, thank you very much, Mr. Secretary.
    There have already been some significant changes made in the
    Leave No Child Behind program according to media reports.
    Secretary Paige, could you tell us a little bit about those
    changes which have already been made to add flexibility and the
    reasons for those changes?
        Secretary Paige. Yes. Let's kind of put this in
    perspective. It's been about 8 months since school systems
    began to really exercise the tenets of the No Child Left Behind
    law, so we can see the impact of it. The first began in
    September and October just after the accountability plans were
    approved in June. Accountability programs were approved in
    June; in September, October, and November, we began to see the
    impact of these plans.
        In October, late October, we assessed what had happened in
    September and October. We were particularly interested in where
    the hot spots were or the areas of difficulties that could be
    found. We began then to assess those difficulties and say, for
    which of these difficulties do we have regulatory ability to
    provide more flexibility?
        The first was special education because we found it was
    having--giving us the most heartburn at that point. And so in
    December we announced some new flexibility, new flexibility
    with special education. The next one was LEP--limited English
    proficient students. Our policy people and our legal people
    studied the LEP issues, they conferred with Congress, they
    conferred with the White House, and we found ways that we could
    agree that we could provide more flexibility for LEP students,
    and so in February we announced new flexibility in
    accountability requirements for LEP students.
        The third challenge was the highly qualified teacher
    requirement, and the progress is ongoing now in developing some
    new latitude in the highly qualified teacher requirement; all
    of this within the confines of the law. And we hope in the next
    10 days or so to be able to announce some new flexibility with
    the highly qualified teacher requirements.
        Following that, we hope that we'll be able to take a good--
    we are in the process now of taking a good look at the 95
    percent participation requirement to see if there's any way
    there that we can find new flexibility in the law.
        So there's been a constant march towards providing
    flexibility to the people who really are going to have to get
    this done, and those are the people who are at the schools and
    in the superintendent's office and in the classrooms.

        REGULATORY FLEXIBILITY FOR SPECIAL EDUCATION AND LEP ASSESSMENTS

        Senator Specter. Mr. Secretary, let me shift focus just a
    little bit on the issue of No Child Left Behind. Earlier this
    week, last Monday, more than 100 school superintendents from 14
    Pennsylvania counties met to discuss the No Child Left Behind
    law and they signed a petition supporting changes, including
    flexibility in testing requirements for special education and
    limited English proficient students, and also full funding for
    the No Child Left Behind Act. Would you direct your attention
    to the issues of increased flexibility for special education
    and limited English proficient students?
        Secretary Paige. Yes, thank you, Mr. Chairman. Let's start
    with the point of view that the philosophy of the No Child Left
    Behind Act is that every student is a concern to us and the law
    should provide the same kind of protection for every single
    student. There are some students who bring different challenges
    to us. Students with disabilities are one of those groups of
    students. We want to make sure that students with disabilities
    are assessed just like the other students. The law, in fact,
    requires it.
        What we did in December was to announce an initiative that
    provided a little flexibility there, but yet kept the spirit of
    the law that Congress had in mind, Congress' intent, which was
    that every student is assessed. And so we announced some
    flexibility such that students with the most significant
    cognitive disabilities could be assessed against alternate
    achievement standards. That would be limited to 1 percent of
    the students tested, which could be 8, 9, 10, 11 percent of the
    students with disabilities overall.
        We also indicated that if a particular school district
    finds that that 1 percent cap is too tight for them, and
    they've got a way that they can justify a need for it to be
    expanded, a process is put in place so that it can be expanded.
    So the special ed regulations we think are going to provide the
    kind of flexibility that school districts need in order to get
    the job done.
        Senator Specter. Do you think that would be enough to
    account for students who are not proficient in English and also
    those who need special education, Mr. Secretary?
        Secretary Paige. Especially in special education. Now about
    those students that have limited proficiency in English, we
    indicated that the test that they're measured with would be a
    test to measure where they are in that progress to English
    proficiency, not a content test. Now, that's the law, but many
    States have different laws that require different kinds of
    approaches to that.

                              SINGLE SEX EDUCATION

        Senator Specter. Mr. Secretary, I notice in this morning's
    media reports a shift in policy by your Department on single
    sex education and it is in the formative stage. And there was a
    comment by Superintendent Vallas of the Philadelphia School
    District, which we will be inquiring into when he testifies
    later, that there's going to be a very careful examination of
    community response on that issue.
        But I'd be interested in your professional judgment as to
    the advantages and disadvantages, and before you start to
    answer the question, let me say that that's my last question,
    because I want to stay within the 5-minute rule because we have
    so many witnesses later. But I'd be interested in your
    professional judgment on that issue.
        Secretary Paige. We would like to provide broad flexibility
    in the kind of systems that we have in schools for the
    education of children. There's no coercion here. What we're
    trying to do is to provide options for parents and for those
    who administer schools. If they decide that a single-sex school
    or a single-sex classroom brings the kind of advantages that
    they need in order to accomplish their educational goals, we
    don't want to restrict that. And so what we are attempting to
    do now is to provide that kind of flexibility.
        We were in New York at the Young Women's Leadership School.
    I had a chance to talk to girls who felt and expressed that the
    school that they were attending now gave them a really real new
    lease on life. This kind of environment they thought was very
    special and met their needs. They weren't required to attend
    that kind of classroom, but if this is the kind of classroom
    that they feel is needed there, then the ability to adapt the
    structure of the delivery system should be available to the
    person on the scene, and that's what we're trying to get
    accomplished.
        Senator Specter. Thank you very much, Mr. Secretary. I'll
    turn now to, in order of arrival, Senator Landrieu.

                     STATEMENT OF SENATOR MARY L. LANDRIEU

        Senator Landrieu. Thank you, Mr. Chairman. I have a longer
    statement I'll submit to the record and, welcome, Secretary
    Paige. Just for the--briefly though this morning, just say
    after looking and studying very closely at this budget, Mr.
    Secretary, I must say, and to the administration, that this
    budget is wholly inadequate to support the education reform
    efforts that are underway in this country at our own urging.
        Together we set out on a path to help our States and help
    our cities and help our communities identify the schools and
    the systems that weren't working, and then when they looked to
    us to help to provide the resources to hire better qualified
    teachers, to make smaller classroom sizes, to provide early
    childhood education, to provide for after-school care, the
    resources are not there.
        Mr. Chairman, I have to say just my general comment about
    this budget is that it is wholly inadequate to meet the
    challenges of reform and to strengthen what we understand is a
    weak economy in the United States at this time, and the only
    way this economy is going to be strengthened is if we can
    increase the human capacity and invest in human talent and
    skill.
        Senator Specter. Senator Landrieu----
        Senator Landrieu. So with that----
        Senator Specter. Senator Landrieu, may I interrupt you for
    just a moment? While this hearing is going on, there is an
    executive session of the Judiciary Committee and they need me
    there for a quorum. I'm going to excuse myself for a few
    minutes. When you finish your round, Senator Murray will
    proceed, and if somebody else comes, they may proceed, and I
    will return momentarily.
        Senator Landrieu [presiding]. Thank you, Mr. Chairman, and
    I'm going to be brief because I'll--Senator Murray will have an
    opening statement and then I'll get back to questions, but you
    know, Mr. Secretary, I have to go on record as saying I don't
    know where to begin. And let me just end with one very
    specific. We called our schools and some around the country
    just on one specific, so I can just express and give some real
    meat to the general statement I just made.
        As you know, in New Orleans and Louisiana, we're 5 years
    into a very strong accountability program in which we used in
    some measure as a model for the Nation. But unlike the Nation,
    Louisiana stepped up and tried to fund those reforms. Last
    year, 35,000 children were identified in failing schools, 1,100
    applied for transfers, yet only 400 were transferred because
    the rest were denied because of lack of space in higher
    performing schools.
        So the plan that we've put in place can't work unless we
    provide the resources to give them opportunities to move to
    schools that are performing but they either don't have the
    teachers or don't have the classrooms, yet every time we've
    asked this administration for help, for classrooms, for school
    construction, we've been told no, no, and no.
        In Chicago, 125,000 students were eligible for transfer,
    yet there was only space for 3,000 to transfer to higher public
    schools. In Baltimore--I mean, in Los Angeles, 230,000 children
    were eligible, yet only 100 could transfer because there's no
    space. And yet in the same budget, you all provide space to
    transfer to private schools, but won't help children transfer
    to higher performing public schools, and the bias is clear and
    it is, in my opinion, not right.

                               PREPARED STATEMENT

        I could go on for 3 hours, but I will not. That's just one
    example, and Senator Murray will have an opportunity for an
    opening statement now, or questions.
        [The statement follows:]
                 Prepared Statement of Senator Mary L. Landrieu
        Mr. Chairman, again let me take the opportunity to thank you for
    your leadership in this area. I am pleased to have the opportunity
    today to hear from the Secretary of Education, Secretary Paige, about
    the President's Budget request for Education. As I know you agree,
    there are few greater investments that can be made in the future of
    this great country than the investment we make in our children's
    education. For this reason, I remain committed in my support of a
    budget that not only reflects national priorities in education, but
    also invests in them. I am sad to find that the budget that has been
    put forward by the President does neither. I hope that this committee
    can work together, as we have in the past, to address the many
    shortfalls left by this budget and fully invest in our promise to leave
    no child behind.
        As all of us know, our nation is faced with one of the largest
    federal deficits in our history. While we may disagree as to how we
    have come to be in this position, there is not a member of the United
    States Senate who is not aware of the need to enact fiscally
    responsible policies aimed at restoring balance in the federal budget.
    Most experts agree that a sound fiscal policy in times of deficit
    requires limited spending in key priority areas that both increase
    revenue and spur economic growth. Strategic investments in education
    not only allow us to develop a strong and competitive workforce but
    also help citizens to move from a life of dependence on government
    support to one of individual productivity.
        This is not just my opinion, these are the facts. Let me read you a
    few of the most recent statistics on this point.
        According to the Employment & Training Administration, a person
    with a bachelor's degree earns a million dollars more over a lifetime
    than a person with a high school diploma and a person with an
    associate's degree will earn an average of a half million dollars more
    than a person with high school diploma.
        According to the Current Population Survey, those with a bachelor's
    degree had less than half the unemployment rate of people with only a
    high school diploma during 2000.
        According to the U.S. Department of Labor, occupations requiring at
    least a bachelor's degree are expected to grow 21.6 percent and those
    requiring an associate's degree are projected to grow 32 percent.
        Recognizing the national importance of investing in the education
    of our young people, I, along with other members of this committee,
    have continued to push for a federal education budget that reflects the
    needs our schools have in educating our future workforce. Year in and
    year out, these efforts have been met with great resistance by the
    Administration. Despite this fact, this President continues to claim
    education as a priority and takes credit for record increases in
    education spending. Again, let the facts speak for themselves.
        In the three years that Bush has been in office, discretionary
    education spending has increased by a total of 14 percent. In just the
    last two years of the Clinton Administration, discretionary education
    spending rose by 40 percent. At the same time, since the passage of the
    No Child Left Behind Act, increases in spending have been going down
    while federal expectations for performance have been going up. What
    this indicates to me is that this President is only committed to
    investing in education reform when it is politically expedient for him
    to do so. Unfortunately, Mr. Secretary, that type of leadership is not
    what we need. We need a President whose promises last beyond the press
    conferences and photo opportunities.
        This administration also claims that any cuts that are made in
    education programs are part of a overall, ``better, more efficient
    government'' economic strategy. In fact, on page two of your budget
    summary, Mr. Secretary, you state, that the Department of Education
    supports ``the elimination of categorical programs and low-priority
    activities in favor of funding through flexible State grant programs
    created by the NCLB Act.'' As you may know, I was one of the 13 members
    who voted in favor of an education reform bill called ``The Three
    R's,'' from which President Bush derived much of his education
    platform. One of the main principles of this bill was that federal
    resources in education needed to be consolidated into flexible state
    grant programs that reflected key national priorities. Consolidation is
    something I support.
        But, once again, your actions do not match your rhetoric, Secretary
    Paige. Your budget does in fact call for the elimination of 38
    categorical programs, such as Art in Education, Even Start, Education
    Research Labs, and Drop Out prevention, but you do not, as you indicate
    is your policy, shift these resources toward increases in the state
    grant programs created by No Child Left Behind. Instead, for the second
    year in a row, you flat fund two out of the largest, most important
    NCLB state grant programs, Teacher Quality and Innovation in Education,
    and recommend a level of funding for the 21st Century After School
    State Grant Program that is below the level it was in fiscal year 2002.
    It seems to me that the funds recouped from the elimination of these
    programs went instead to create 7 new programs that are more in line
    with the President's personal preferences and political agenda, such as
    the Choice Incentive Fund and Striving Readers program.
        Finally, Mr. Secretary, I am sad to see that despite my stated
    concerns on the utility of education savings accounts for private
    elementary and secondary school tuition that they are again included in
    your budget. As I said last year, a $150 tax savings does not help a
    single mother of two who makes $30,000 a year to afford $15,000 in
    school tuition. In your testimony last year, you conceded this point.
    If we are sincere about helping low-income children trapped in failing
    schools, then we would be better to invest the $2.0 billion reserved
    for ESAs in serving disadvantaged students, teacher quality and smaller
    classes.
        In summary, I am very disappointed by this budget. It is wholly
    inadequate to support the reforms that are underway in every state in
    the Nation at our request. We made a promise to our schools that if
    they went the distance and identified failure, we would be there to
    help them reform. This budget does not fulfill that promise.

                       STATEMENT OF SENATOR PATTY MURRAY

        Senator Murray. Well, thank you, Mr. Secretary and Senator
    Landrieu. I share the concerns of Senator Landrieu certainly as
    I look at this budget, and I just have a few minutes because
    Budget is meeting right now. I'm on that committee. But the
    overall funding levels in the 2005 budget request just don't
    meet the needs in our States as our States are struggling to
    try and meet the mandates of No Child Left Behind that I put on
    them.
        I will submit my statement for the record, but I just want
    to echo what Senator Landrieu said. We are really shortchanging
    our students at a time when we need to invest in their
    education because we know that, as all of us worry about where
    the jobs are of the future, if our kids aren't educated, we're
    just not going to make it.

                       SINGLE SEX EDUCATION AND TITLE IX

        So I'll submit my statement, but I do have a number of
    questions that I want to ask the Secretary while I have a few
    minutes here. And the first one, during the passage of No Child
    Left Behind, you will remember that we reached a bipartisan
    agreement on single-sex education, and in that we said that
    schools may provide single-sex programs as long as they are
    consistent with applicable law, title IX and the U.S.
    Constitution, and requires the Department of Education to
    provide guidance on that applicable law.
        That law does not direct the Department of Education to
    change the title IX regulations, but yesterday you released the
    new proposal to amend 30-year-old title IX regulations on
    single-sex education. Current law single-sex programs allow
    such programs when appropriate, but contain protections against
    sex discrimination. The proposed regulations would dispense
    with meaningful, anti-discrimination protections and authorize
    schools to provide alternatives for girls that fall far short
    of equality. In fact, I believe that the No Child Left Behind
    would prohibit the adoption of the Department's new proposals.
        In the press release announcing the change, you even admit
    that research on students' performance in single-sex education
    programs is inconclusive. It seems to me this is deja vu all
    over again. In 2002 and 2003, the Department of Education spent
    hundreds of thousands of dollars to form a commission to look
    at title IX athletics regulations, and when it was all said and
    done, thankfully no changes were made to the law due to a
    strong, bipartisan, and grassroots effort to support title IX.
        It seems to me that spending money and efforts on the
    Department--by the Department of Education helping States
    implement No Child Left Behind to close the achievement gap
    would be a much higher priority than throwing out longstanding
    anti-discrimination laws potentially broadening the achievement
    gap for our Nation's girls and boys.
        Mr. Secretary, wouldn't you agree with me that the
    Department's efforts should be somewhere where we really need
    them to focus on right now?
        Secretary Paige. Senator, with all due respect, I
    completely disagree with you. May I say first that the
    administration's position on title IX was brought together
    based on what the administration thought is best for the
    country, not because of pressure from any group. We studied the
    issue, we listened to the Nation speak, we considered all the
    information that they brought up, we considered their point of
    view and what we were trying to accomplish. We have great
    respect for title IX and what it has brought to our Nation, and
    we want to only build on that and make matters better.
        So I don't want it to be viewed that the administration's
    output on the title IX issue resulted from pressure groups
    bringing pressure for one point of view or another.
        Senator Murray. Oh, I don't think--I didn't imply that at
    all. But there was strong bipartisan support to--at that time,
    grassroots support that the commission listened to and ended up
    supporting title IX.
        Secretary Paige. Well, that's----
        Senator Murray. I don't call that outside pressure groups.
    I call it this country.
        Secretary Paige. That was our goal, to listen to the
    country, and that's why we had an outstanding panel go around
    the United States and conduct hearings and listen to the
    country and take that into consideration. So our listening and
    taking into consideration is what brought us to the conclusion
    that we came to.

                 NO CHILD LEFT BEHIND AND SINGLE SEX EDUCATION

        With respect to single-sex schools and single-sex
    classrooms, our view is that it expands opportunities for the
    development and achievement of No Child Left Behind as a goal.
    Many young girls--I met many of them in New York when I
    attended the Young Women's Leadership School, who felt that
    they were being left behind, and only were able to catch up
    because of the existence of that school.
        So we are, without coercion, simply trying to expand
    opportunities for communities and systems who choose----

                         ``SUBSTANTIALLY EQUAL'' CLAUSE

        Senator Murray. Mr. Secretary----
        Secretary Paige [continuing]. To have an environment like
    that.
        Senator Murray [continuing]. Let me just say that my
    concern is that under your proposal you use substantially equal
    rather than the protections that we have under title IX under
    No Child Left Behind. The term, substantially equal, concerns
    me a great deal.
        Mr. Jones. Senator, the provisions in No Child Left Behind
    were obviously to reaffirm the protections of the Constitution,
    and the protections of the title IX statute itself, but also to
    recognize that the regulations under title IX are something at
    the discretion of the implementation or the implementers of the
    law within the public notice and comment process.
        When those regulations were originally put in place, the
    limit of what was known about single-sex education was somewhat
    more narrow than it is today, but it----
        Senator Murray. Well, but you even in your report say that
    the research is inconclusive. Mr. Secretary, I have a few other
    questions. Let me just say I am deeply opposed to your
    proposal.
        Secretary Paige. Thank you. We would----
        Senator Murray. The words, substantially equal, to any one
    of us who have been through this process for a lifetime----
        Secretary Paige. Senator----
        Senator Murray [continuing]. Leaves us with great concern--
    --
        Secretary Paige. We would----
        Senator Murray [continuing]. For what the future's going to
    bring.
        Secretary Paige. We would invite continued discussions with
    you around your concern.
        Senator Murray. Okay. And I would, I'd love to have you
    come in and talk with me about this, but we will have further
    discussions. I think the term, substantially equal, leaves many
    of us very concerned.
        Secretary Paige. We would welcome continued discussions.

                          EDUCATIONAL VOUCHER PROGRAMS

        Senator Murray. All right. Let me ask you too, because the
    President's budget includes funding for vouchers, which were
    rejected when we had our long debates and battles throughout No
    Child Left Behind. At the end of the day, No Child Left Behind
    rejected vouchers, but the Bush budget again includes $50
    million for the Choice Incentive Fund and $14 million for the
    D.C. voucher program, when even the Senate never voted on these
    programs.
        I just don't understand how you can repeatedly abandon
    public education by giving just 1,700 students $7,500 to attend
    schools that are unaccountable to students and their families
    and the Department of Education, and meanwhile we can't even
    increase Pell grants for low-income students to help them,
    especially at a time when we know that getting education at a
    higher level is important.
        It seems to me that we keep focusing on a narrow program,
    just as a matter of principle rather than trying to look at
    where we can put our dollars in a substantial way to help a
    number of students who are struggling today. And I know you and
    I disagree philosophically, but I remind you that when we
    debated the No Child Left Behind Act and passed that, the
    voucher discussion was an essential part of that, it was
    rejected at the end of the day, Congress said no, yet we keep
    seeing the Bush administration put money forward for it.
        Secretary Paige. Senator, it's because we believe that it
    adds to the possibility of authentic school reform. We think
    that the proposals we put forth are to benefit public schools,
    not to detract from public schools. We think public schools,
    when bound in the kind of monopolistic organizational
    structures that they operate in now, that this penalizes them
    and constrains innovation and constrains creativity. And that
    is why we keep pushing for broader choice. We think in an
    environment with broad choice, public schools will prosper.
        Senator Murray. Mr. Secretary----
        Senator Specter [presiding]. Senator Murray, you're about
    3\1/2\ minutes over now.
        Senator Murray. Okay.
        Senator Specter. How much longer would you like?

                               PREPARED STATEMENT

        Senator Murray. Well, I have questions, a number of
    questions. I'll submit my questions for the record. I would
    just say that it seems to me when we have our debates within
    the No Child Left Behind Act, at the end of the day we agree on
    it, and then we keep seeing the budgets come back outside of
    what we all agreed on, for No Child Left Behind. It leaves all
    of us disconcerted.
        Thank you, Mr. Chairman. I apologize for going over my
    time. I will submit my questions for the record.
        [The statement follows:]

                   Prepared Statement of Senator Patty Murray

        Mr. Secretary, thank you for coming to talk with us today about the
    President's fiscal year 2005 education budget request. I am concerned
    about overall funding levels for education. Instead of providing real
    funding for critical education programs, the President robs Peter to
    pay Paul by cutting funding from some programs and adding it others,
    expecting it to count as an increase. Further, the President continues
    to fund unproven private school voucher schemes, but cannot seem to
    fund after school programs or provide increases for Impact Aid.
        In fact, the President's budget only increases NCLB programs by
    $1.8 percent over the fiscal year 2004 Omnibus Appropriations bill--
    shortchanging the reforms included in the bill by over $9.4 billion.
    The level of Title I funding in the President's budget leaves more than
    4.5 million low-income children behind. In Washington State alone, the
    difference between the President's request and the promise of NCLB
    means that over 27,000 low-income students will be left behind.
    Currently, secondary schools only receive 15 percent of Title I funds
    so we are shortchanging education at all levels when we shortchange
    Title I. I was pleased that the President wants to provide funding for
    math gains in secondary education, but we need to be putting real
    funding into our high schools. Our high schools need increase funding
    for literacy and counseling to ensure that our students have the skills
    and knowledge for true access to higher education and training.
        The President's budget eliminates 38 programs including dropout
    prevention, elementary and secondary school counseling, smaller
    learning communities, and important literacy programs like Even Start.
    The President's budget request also freezes critical education
    programs, which is actually a cut in funding with increasing
    enrollments and other costs to run schools and programs. The President
    froze funding for Impact Aid, after-school, Teacher Quality, migrant
    education, and rural education. At a time when thousands of soldiers
    and reservists from Washington State--more than a 130,000 from around
    the country--are serving in Iraq and Afghanistan, I am shocked that
    this President would level fund Impact Aid instead of increasing
    funding to make sure their families are well cared for in our
    communities and schools. Further, funding after school at the
    President's request will mean 1.4 million students will be without a
    safe, adult-supervised environment after school.
        The President's budget does not fully fund our share of special
    education costs, failing yet again to fulfill that commitment to our
    communities, our schools and our disabled students.
        Under the President's budget funding for higher education programs
    continue to stagnate. The President should not punish students for
    increasing college costs by not increasing Pell grants.
        We know what the needs are out there. We know what works to help
    our children succeed. That's why I'm so disappointed that the
    President's budget shortchanges America's students, and shortchanges
    our country in the long run.

        Senator Specter. Thank you very much, Senator Murray.
    Senator Landrieu, I understand you have 2 minutes left.

                          PUBLIC SCHOOL CHOICE FUNDING

        Senator Landrieu. Thank you. I'm going to try to get in two
    questions if I can. Mr. Secretary, to follow-up on my original
    comments, in your budget you make mention of the fact that
    there are 2.5 million children eligible for transfer to higher
    performing schools, yet the budget only reflects a $27 million
    figure for public school choice.
        There is an additional $50 million for public school choice
    and private school choice, but only $27 million for public
    school choice. Just putting the pencil to it, at $10,000 a
    student, which in some areas may be too high, some areas may be
    too low, my math would say that we'd need to come up with $25
    billion. So how did you all come up with the $27 million figure
    to help 2.5 million children who to date have been identified
    as eligible? How did we arrive at that figure?
        Secretary Paige. Well, the $27 million you refer to is over
    and above the dollars available under the title I allocations,
    which each district has. So that is not limited to $27 million.
        Senator Landrieu. But our title I, based on just the basic,
    is short $160 million, just the title I under Leave No Child
    Behind, and now in addition we have just in our State 35,000--
    --
        Secretary Paige. Is short? What do you mean by short?
        Senator Landrieu. Shorted based on the commitment that this
    administration made to fund No Child Left Behind.
        Secretary Paige. Please explain. I'm not sure I understand.
        Senator Landrieu. Well, the Leave No Child Behind Act is
    about $9 billion short based on the agreement that was made, if
    reforms were put in, the resources would be there.

                             TEACHER CERTIFICATION

        But let me ask my second question. Again on teachers, one
    of the points of No Child Left Behind that the White House
    insisted on, and I actually agreed to with some hesitation, was
    that all teachers would be certified by 2005. Now, I had 40
    percent of my teachers uncertified, but I was willing to say,
    okay, in 3 years we'll get them certified, and the White House
    said, we'll help you do it.
        I look at this budget and title II, teacher quality, is
    flat-funded. So what should I tell the 40 percent of my
    teachers that need to get certified?
        Secretary Paige. You may say to them that this budget----
        Senator Specter. Mr. Secretary----
        Senator Landrieu. Could he answer the question?
        Senator Specter. The time is expired, but you may answer
    the question.
        Secretary Paige. You may say to them that, this budget has
    $5.1 billion in it to support teachers, and if the States
    decide to use those dollars for certification purposes, the
    flexibility is there to provide opportunities for them to do
    that, and the $5.1 billion to support teachers is historic in
    its level.
        Senator Specter. Thank you, Senator Landrieu. Senator
    Hutchison.

                   STATEMENT OF SENATOR KAY BAILEY HUTCHISON

        Senator Hutchison. Thank you, Mr. Chairman. Mr. Secretary,
    I applaud that you are coming forward with the regulations on
    single-sex schools as an option for public schools to be able
    to meet the needs of individual children in school districts.
    This is not a mandate. This is another option. If a school
    district, because of input from parents or principals or
    teachers, believes that they have behavioral problems or
    specific problems that single-sex classes or schools would
    address, they would have the option to do it.

                              SINGLE SEX EDUCATION

        In the Washington Post this morning, there is the picture
    of Moton Elementary School that on its own decided to go to
    single-sex classes in 2001--2000 or 2001--and they are now--
    they were at the bottom of the achievement measures in the
    District of Columbia and now they're at the top, and they
    credit the opportunity to have single-sex classes for doing
    that. It was 2001 that they started this program.
        So yesterday you did come out with the regulations and you
    will have public comment, and I know, maybe there's a
    disagreement on the specific language, substantially equal, but
    the purpose was to assure that you could offer classes that are
    tailored to boys or girls and not have a requirement of
    equality when that would defeat the purpose of offering
    specialized courses.
        So I applaud the effort that you are making, and this is
    the language in your regulations that are proposed: Single-sex
    classes will be permitted as long as they are part of an even-
    handed effort to provide a range of diverse educational options
    for male and female students, or if they are designed to meet
    particular identified educational needs.
        So, Mr. Secretary, I hope you are going to pursue this. You
    have a 45-day comment period, which is expedited because if a
    school district wants to offer this option, they will be able
    to plan for the next school year. My question to you is this.
    Are you going to have funding under the title that allows for
    funding creative programs to help some of these schools
    implement these single-sex schools and classes?
        Let me go further and just say that Houston is already
    offering in their public schools a boys school. Dallas is on
    the brink of offering a girls school and the headmistress of
    the finest girls school in North Texas, Hockaday School, has
    said that when she retires in July of this year, she is going
    to volunteer her time to create a girls school in the public
    school district, Dallas Independent School District.
        So I am so happy that they are going to have this chance,
    and I would like to know if there will be grants available for
    people who are trying to be creative and offer these options to
    the people that attend public schools throughout America?
        Secretary Paige. Thank you, Senator, and we are going to
    move forward with this. We are now awaiting the 45-day comment
    period. As soon as we receive those comments we're going to
    move faster, for the issues involve other agencies. The Justice
    Department was involved as well. But now it's in our court, so
    you can expect that we're going to move with dispatch with
    this.
        Senator Hutchison. Will there also be grants available?
        Secretary Paige. The answer is yes.
        Mr. Skelly. Senator, money is available under the State
    grants for innovative programs budget, a continuing grant
    program of approximately $297 million.
        Senator Hutchison. Well, thank you, because, you know, so
    many schools--Secretary Paige, you visited the Young Women's
    Leadership School in Harlem with me, and that school is in a
    part of New York that has a very low rate of graduation and
    college attendance, and in fact, since that school was created,
    every graduate, every graduate has gone to college, every one.
    And 60 Minutes has interviewed those girls and they have
    applauded the opportunity that they have, so I just am very
    pleased that you are moving forward and it can't be fast
    enough.
        I would say to my colleagues who are concerned about the
    language, why not try it? We have had failing schools for 25
    years in this country and we have had people throwing up road
    blocks to innovation and creativity, so let's try and see if we
    can work with this language. Nobody wants schools or classes to
    be inferior for boys or girls. This is America, so let's be
    creative, and I applaud your efforts in what you're doing.
        It appears that my time is up, but I hope that we will
    finalize those regulations so school districts will have the
    option, not the mandate, to go forward with hopefully creative
    grants that will give us more knowledge about the benefits that
    can be given--gotten from creativity in our public schools.
        Thank you, Mr. Chairman.
        Senator Specter. Thank you, Senator Hutchison. Senator
    Kohl.

                         STATEMENT OF SENATOR HERB KOHL

        Senator Kohl. Thank you, Mr. Chairman. Secretary Paige,
    like many of my colleagues, I am also troubled by the funding
    levels in the President's budget for No Child Left Behind. We
    voted for that legislation because we believed it would provide
    a real chance for real reform. As you know, for the first time
    schools in States would be held accountable for results and the
    Federal Government promised that they would provide the dollars
    necessary to help them meet the new requirements.

                      NO CHILD LEFT BEHIND FUNDING LEVELS

        Both the President and the Congress agreed to this and
    parents, teachers, principals, and administrators all expected
    that we would live up to our word. But now for the third year
    in a row, the President's budget falls short of the promise.
    His fiscal year 2005 budget request, as you know, is $9.4
    billion short of what was discussed and we believe promised
    when the No Child Left Behind law was enacted.
        You and the administration have stated that schools have
    plenty of money to implement the laws. Let me tell you just a
    little about what's happening in my own State of Wisconsin. In
    2003, Mr. Secretary, Milwaukee public schools received an $8
    million increase in title I funds, but the new requirements for
    supplemental services and transportation for students to better
    performing schools cost over $10 million. In other words, the
    new mandates cost $2 million more than the total increase the
    Milwaukee Public Schools received, and they had to make up the
    difference. To cover the costs, they were forced to eliminate
    their popular summer school program, which had served 17,000
    students.
        This is only one example. Across Wisconsin, school
    districts are being forced to cut staff and increase class
    sizes, cut music, art, foreign language education, and cut
    textbook purchases. Some have even had to keep their schools
    colder, believe it or not, to cut down on their heating bills,
    or restrict how many pages students can print from their
    computers. These are clearly not the results that we all want.
        Problems exist also at the State level in Wisconsin. Our
    State Department of Public Instruction is working hard to
    implement the new law, but they believe they'll need more
    funding to create new data systems to meet new data collection
    and reporting requirements. They'll also need more funding for
    technical assistance teams to help schools and districts in
    need of improvement.
        In a recent Washington Post op-ed, you argued that studies
    show that No Child Left Behind funding is sufficient. Many
    researchers, however, argue that you are underestimating the
    huge new cost that schools are facing. The President himself
    agreed to higher funding levels when he signed No Child Left
    Behind. He agreed that those authorized funding levels were
    needed to help schools succeed.
        So I have a problem with people in my State who wonder what
    you would say in response to the statement that I just made.

                AUTHORIZATION VS. APPROPRIATION LEVELS FOR NCLB

        Secretary Paige. Senator, I'm confused by the word
    ``promise,'' and I've asked clarification on that on many
    occasions, and some have pointed out that they view the
    authorizing level as a promise. And when I look up what that
    really means, I found that it means that you can spend no more,
    but it does not say that you must spend that much as a promise.
    In fact, I've been able to identify without much effort lots of
    examples where there's a difference between the appropriated
    level and the authorized level, and I have found that it has
    been consistent throughout various administrations, both
    Democrats and Republicans, where this delta appears. And this
    is the first time that I've been able to understand it being
    characterized as a promise.
        The second point would be that my experience as a
    superintendent tells me that all these schools are under
    extreme pressure as far as funding is concerned. I know what
    the superintendent is doing now in Houston without even talking
    to her. She is preparing their budget, and she is wrestling
    with how they're going to take care of their health care costs
    or how they're going to take care of the transportation cost
    that is increasing.
        We empathize with all of that. But that has nothing to do
    with the requirements of the No Child Left Behind Act. There
    was one State that even indicated that in order to meet the
    requirements of the No Child Left Behind Act that they would
    have to have a laptop computer for every student. I would be
    pleased to have a laptop computer for every student, but it has
    nothing to do with the requirements of the No Child Left Behind
    Act.
        The budget that the President has proposed has ample
    dollars in it to meet the needs and the requirements of the No
    Child Left Behind Act, and as you know, the Act has language in
    it that says, if it isn't funded, it isn't required. That would
    be my response to it, but I don't want to be perceived as not
    being empathetic to the fact that all of these schools are
    under real tight budget constraints now, and we empathize with
    that. But compliance with the No Child Left Behind Act is not
    responsible for many of those cost elements.
        Senator Kohl. Well, the President's budget in 2005 is
    $24.91 billion. The authorized--and we can debate what that
    meant--the authorized level was $34.32 billion. The difference
    there is almost $9\1/2\ billion. Now, I would agree with you
    the authorized level was not something that was legally put in
    that had to be met, but the implication was very clear to those
    of us who engaged in putting together the law and signing it.
    You don't put a number in there unless you have some intention
    or some hope of seeing that number fulfilled.
        As you know, yes, there's no legal requirement and we
    understand that and you're pointing that out. But clearly there
    is a perception out there, which I'm sure you can understand--
    --
        Secretary Paige. Absolutely.
        Senator Kohl [continuing]. That we're being shortchanged,
    because that was the number that we put into that law.

                  RELATIONSHIP BETWEEN FUNDING AND ACHIEVEMENT

        Secretary Paige. Could I just briefly say----
        Senator Specter. Mr. Secretary, Senator Kohl's time has
    expired, but you may finish your answer.
        Secretary Paige. I would just like to say very briefly that
    the assumption that there is a tight link between spending and
    student achievement has not been established. In fact, I can
    point out very easily many places where there is a very high
    average per-pupil expenditure and very low performance.
    Washington, D.C. public schools would be one example. I have
    examples here that I could provide for anyone who wants to have
    this information. There simply does not exist this tight
    correlation between those two variables.
        In fact, I would go further and even say in some cases the
    argument about money may even be a destructive element in that
    it masks some of the real challenges that need to be discussed
    and looked at, and I have evidence of that in many places. But
    I don't want to be perceived as not wanting more money. I know
    the school systems want more money, and that's not my argument
    at all. I would like for them to have more money. My argument
    is that the requirements of the No Child Left Behind Act are
    sufficiently and amply funded in order to get those things
    carried out.
        Senator Kohl. Thank you, Mr. Chairman.
        Senator Specter. We've been joined by the distinguished
    ranking member, Senator Harkin.

                        STATEMENT OF SENATOR TOM HARKIN

        Senator Harkin. Thank you, Mr. Chairman. I apologize for
    being late.

                    WASHINGTON POST OP-ED BY SECRETARY PAIGE

        I would just say, Mr. Secretary, that this budget, if
    enacted, will enact in the smallest increase for education in 9
    years, shortchanges title I by over $7 billion, underfunds No
    Child Left Behind by $9.4 billion and eliminates programs like
    school counselors, arts and education, and drop-out prevention.
        There's a lot more I want to say, but just a couple of
    statements I want to make here before I ask a question. You
    wrote an op-ed in the Washington Post that talked about Members
    of Congress: ``. . . who voted for the law and support its
    ideals but now see opposition as being to their political
    advantage.'' That was your statement in an op-ed piece in the
    Washington Post.
        Well, I hope you weren't referring to me, Mr. Secretary. I
    voted for the law, I was involved in the negotiations that led
    up to it as a member of the authorizing committee, but I do
    have concerns about how the Department is implementing it and
    how it's funding it, and these concerns come from dozens of
    conversations I've had with parents and teachers from Iowa. You
    visited Iowa recently. You heard the same concerns I did. Just
    because I'm trying to address them doesn't mean I'm, quote,
    seeking political advantage. I'm trying to represent my
    constituents. That, Mr. Secretary, is what they elected me to
    do.
        Now, you and I have always gotten along well, Mr.
    Secretary, and I respect you personally. Believe it or not, you
    and the White House don't always have all the answers to all
    these questions. You might learn something from people in
    Congress on both sides of the aisle and sometimes from our
    constituents, even those who disagree with you.

                        UNSPENT FEDERAL EDUCATION FUNDS

        Here's one bit of advice I'll give you, Mr. Secretary. Stop
    making claims that States have billions of dollars for No Child
    Left Behind at their disposal that they aren't bothering to
    spend. You and I both know from your own Department statistics
    the States are spending the money that they get from the
    Federal Government as fast as they can, and yet you wrote that
    States are not fully utilizing the Federal education funds
    available to them in a timely manner, allowing billions of
    dollars to remain in the Federal Treasury instead of improving
    the education of our children.
        You know full well, Mr. Secretary, the States don't spend
    Federal money as soon as it's appropriated. It takes time. It's
    like the situation where you put an addition on your house. It
    costs $10,000, you don't pay for it all up front. You pay
    $1,000 and you may pay a little bit later on, then you pay
    something at the end of the time when it's over with. Schools
    work the same way. They agree to contracts but they don't write
    the checks until the services are provided. You know that, and
    yet you're accusing States of sitting on their money.
        Our chief school officer in Iowa, Ted Stilwill, responded
    in a letter to you in January and said: ``the implication that
    we have let huge sums of Federal money languish, that the funds
    are at our disposal to use at our discretion, or that we have
    not been good stewards of the public's money is not only
    unfair, but patently insulting.''

                             RATE OF STATE SPENDING

        According to the data from your own Department, States are
    actually spending their Federal money faster than expected. I
    have a chart from your Department showing that as of February
    20, using normal spending rates, States should still be waiting
    to spend about 7 percent of their money from fiscal years 2000
    and 2002. As a matter of fact, States have spent all but 6
    percent.
        So, Mr. Secretary, if you know that States are spending the
    money faster than your own Department expects them to, why are
    you criticizing them for not spending it fast enough?
        Secretary Paige. Senator, I hope that I can explain that,
    that's not characterized as a criticism. It is a statement of
    fact that I asked our office early in December to give me a
    report, and early in December they did give me a report, about
    December 12 or somewhere nearby. The report they gave me
    indicated that there was better than $6 billion available that
    had been appropriated for various educational purposes that
    went all the way back to the year 2000. In fact, there are
    examples of some States who had money lapse that had been on
    the table so long that it was no longer available to them. So I
    was making that as a statement of fact, not as a statement of
    criticism.
        Senator Harkin. Well, facts are facts. They're stubborn
    things. This is from your own Department, Mr. Secretary, from
    your own Department.
        Senator Specter. Senator Harkin, how much more time do you
    think you will need?
        Senator Harkin. Well, do we have another round?
        Senator Specter. The Secretary has to leave at 11 a.m. and
    we have six people here, some superintendents who I would like
    to have him hear their testimony, but I don't want to cut you
    short.
        Senator Harkin. Well, I appreciate that, Mr. Chairman. This
    is very, very important because the allegation has been made by
    the Secretary, and I have the figures right here from your own
    Department, I have these figures. Now, yes, there is $6
    billion, but as I said, Mr. Secretary, they don't spend this
    money as soon as they get it. They have 27 months in which to
    spend this money, 27 months. Obviously they haven't obligated
    yet. They're spending it as it goes out.

               SPENDING RATE BY STATES OF FEDERAL EDUCATION FUNDS

        Your Department expected, as I said, that 7 percent would
    still be unspent. They now have 6 percent left of the total
    amount of money, so they're spending it even faster than your
    own Department anticipated, and yet you say, and I'm only
    saying what you wrote, that they're not utilizing these Federal
    education funds available to them. I don't know how you explain
    this. I don't know how you explain it, Mr. Secretary. Whoever
    you asked for this gave you some very, very bad advice.
        Senator Specter. Senator Harkin, would it be sufficient if
    the Secretary responded for the record?
        Senator Harkin. Yes, I would appreciate that, and as long
    as you're responding for the record, I would like to have the
    Secretary respond to the fact that there is $1.5 billion cut in
    the President's budget from fiscal year 2005 to fiscal year
    2006, and I'd like to know where you're going to find that $1.5
    billion.
        Senator Specter. Will you respond for the record, Mr.
    Secretary?
        Secretary Paige. Yes. I'll have Todd respond to the first
    point.
        Senator Specter. Anything further?
        Mr. Jones. Senator Harkin, the issue of draw-down----
        Senator Specter. I want the response--I'm sorry, Mr.
    Jones--for the record because we're very short of time so we
    can honor our commitment to the Secretary to leave at 11.
        [The information follows:]

                                 Unspent Funds

        President Bush and the Congress have provided unprecedented levels
    of funding to implement the No Child Left Behind Act (NCLB Act). In
    fiscal year 2002--the first year of implementation--funding for the
    Elementary and Secondary Education Act programs reauthorized by the
    NCLB Act increased by $4.6 billion, or almost 27 percent. Subsequent
    increases in fiscal years 2003 and 2004 have raised the total increase
    to $6.9 billion, or 40 percent, since the NCLB Act was signed into law.
    Nevertheless, many critics continue to insist that the new law is
    underfunded, and even cite this alleged underfunding as an excuse for
    not fully meeting the law's requirements.
        In this context, the Administration and the Department believed it
    was appropriate to point out that States and school districts have not
    yet spent very significant portions of already appropriated Federal
    education funds. Our intention in publicizing the facts about these
    unspent funds was not to imply any wrongdoing or negligence on the part
    of State or local officials, but simply to show that there is a great
    deal of money in the pipeline, with about $6 billion remaining from
    2000 through 2002 and billions more available from the 2003 and 2004
    appropriations. The point is especially important because these
    balances contrast with the claims from some State and local officials
    about the inadequacy of these record Federal appropriations increases.
        The availability of this very substantial, multi-year funding for
    the NCLB Act is important, because major provisions of the law are
    being phased in over time. For example, States were not required to
    implement the new reading and mathematics assessments in grades 3-8
    until the 2005-2006 school year. Similarly, veteran teachers have until
    the end of the 2005-2006 school year to demonstrate that they are
    highly qualified. In this context, data showing that States and school
    districts are still drawing down 2002 funds simply provides another
    perspective that we believe helps demonstrate that the law is
    adequately funded.
        As for the Senator's concern about 2006 funding levels for Federal
    education programs, I would note that outyear figures in the
    President's budget are primarily for planning purposes. The Department
    will begin developing its 2006 request later this spring, and that
    process will provide another opportunity to address concerns about the
    appropriate level of funding for fiscal year 2006.

        Senator Specter. We've been joined by the distinguished
    chairman of the full committee, Senator Stevens.

                        STATEMENT OF SENATOR TED STEVENS

        Senator Stevens. Mr. Secretary, I'm very pleased to be able
    to get here today so I can express my appreciation to you for
    what you're doing and I think you're doing a marvelous job.
        Secretary Paige. Thank you, Senator.

                         ALASKA'S EDUCATION CHALLENGES

        Senator Stevens. Your visits to Alaska have been really a
    breath of fresh air to deal with the challenges that we face in
    Alaska. We have one-fifth of all the land mass of the United
    States and we have over 750,000 people. We are committed to
    making No Child Left Behind work in Alaska, and thanks to you
    and what you've done, I think we'll be able to achieve that
    goal.
        Our schools want to meet the high standards set forth in No
    Child Left Behind legislation and we're looking forward to
    working with you even more to find ways to bring that about.
    Unfortunately, as you found out, in too many of our schools
    English is the second language, and also, we have too many
    schools where we don't have any teachers right now because of
    the lack of teachers that are willing to go to the rural areas.
    Thankfully, you came up and looked and found, along with my
    colleague, Senator Murkowski, Lisa, who really deserves a lot
    of credit for what the two of you have done really in finding
    out one of the reasons they weren't staying was because they
    didn't have adequate housing. I think you found one teacher
    living in a broom closet.
        Secretary Paige. In a closet, yes, I did.

                       ALASKA NATIVE EDUCATION EQUITY ACT

        Senator Stevens. Now, we're anxious to work with you and
    I'm pleased that your budget contains funding for the Alaskan
    Native Education Equity Act. Those programs will bring
    opportunities to these native students who are out in rural
    Alaska, and we will meet the requirements of this bill by tele-
    education, by utilizing Internet and direct access. All of
    these schools are hooked up to the Internet now. We can have
    live presentations from qualified teachers with master's
    degrees and Ph.D.s in our Alaska universities throughout the
    State.

                   CAROL M. WHITE PHYSICAL EDUCATION PROGRAM

        But your budget also contains continued funding for the
    Carol White physical education program, that is named after my
    former chief of staff who's now the longest living person after
    a brain tumor operation in the world. So we are delighted. This
    program really is a great joy to her to read about and I want
    to thank you for that.

                         PHYSICAL EDUCATION AND OBESITY

        One of the things I would like to ask you about--as I try
    to move around the country and particularly around my State,
    we're moving forward in education, we're moving backward in
    obesity. Have you thought about doing anything more to bring
    the concepts of physical education and discipline to our
    schools to try to teach our children when they're younger about
    the basic essentials of exercise and diet?
        I read--we all read every day more and more stories about
    how we are exceeding the world in obesity. I would hope it
    would be part of the educational program that you foster as you
    develop this No Child Left Behind to deal with the obesity
    factors that do affect the outcome of the education that we're
    seeking to give our children.

             INCREASED NCLB FLEXIBILITY FOR RURAL AND SMALL SCHOOLS

        Secretary Paige. Senator, thank you for inviting me to
    Alaska. We learned much there, and especially about the need to
    have more flexibility under the highly qualified teacher
    elements of the No Child Left Behind Act. We have provided some
    flexibility already, but you can expect in the next 10 days an
    additional announcement that will provide additional
    flexibility that is aimed primarily at helping rural and small
    schools meet the No Child Left Behind Act requirements.

                              EPIDEMIC OF OBESITY

        With respect to obesity, we're very concerned about that.
    There's an epidemic of obesity, even in our young people. My
    colleague, Tommy Thompson, and I are in the process of
    discussing ways that we can be helpful. We are collaborating in
    developing some strategies and some ways that we can try to
    stem what we think is a very dangerous, very dangerous trend
    that's going on now.
        Senator Stevens. Well, if you need any additional
    flexibility under existing law to deal with that, I hope you'll
    talk to the chairman or to me, because I think that one of the
    keys to the success of the No Child Left Behind Act is to
    develop children that are capable of retaining their education,
    and they can't do it if they're suffering from obesity, in my
    opinion.
        Last, I want to go on record and invite you to come back,
    as a matter of fact. I was out in some villages and they told
    me to stay home and send you and Lisa back.
        Secretary Paige. We'd enjoy it. We enjoyed our stay there
    and would enjoy going back again sometime.
        Senator Stevens. Well, I'm serious. There's some other
    things we'd like to work with you on to make sure this law
    works. I went to the State legislature this year. We have a
    strange procedure in Alaska. We speak to a joint session of the
    State legislature. And I told them: ``We do not need your
    request to modify this law, we need your cooperation to work
    with Secretary Paige to make it work.'' So we--again, we thank
    you. I think you're doing a marvelous job, Mr. Secretary.
        Secretary Paige. Thank you.
        Senator Stevens. Thank you, Mr. Chairman.

               INCREASES IN THE FISCAL YEAR 2005 EDUCATION BUDGET

        Senator Specter. Thank you very much, Senator Stevens.
    Senator Hutchison asked me to point out for the record that the
    President's proposal of $13.3 billion for title I grants to
    local education agencies is an increase of $1 billion, or 8
    percent, over last year. The proposal of $11.1 billion for
    individuals with disabilities is an increase of $1 billion, or
    9 percent, over last year. And the President's proposal of $73
    billion for postsecondary student aid is an increase of $4.4
    billion, or 6 percent over last year. And also that
    historically black colleges and universities have had an
    increase of 30 percent by 2005, nine such colleges in her State
    of Texas, and that for Hispanic-serving institutions, in fiscal
    year 2005 the request is $96 million, which is a significant
    increase.

                                  TEEN SUICIDE

        Mr. Secretary, I'd like you to answer one more question for
    the record and that is on the issue of teen suicide. In a
    small, rural Pennsylvania county, Potter County, there were
    three teenage boys who committed suicide and they did not
    appear to be linked in any way except that they were troubled
    youth who needed counseling.
        In our committee report last year, we urged you to make
    availability screening programs more widely known and to
    encourage school districts to implement similar teenage
    programs. We have received a report, one page, which is, I
    think fairly stated, not adequate in response to that request
    or that issue and I would appreciate it if you would supplement
    that for the record.
        [The information follows:]

                        Screening Programs for Teenagers

        The Department is taking several steps to make school districts,
    juvenile justice facilities, and community-based organizations aware of
    and encourage them to use screening tests to detect depression, risk of
    suicide, and other mental health disorders in teenagers.

                     RAISING AWARENESS OF EXISTING PROGRAMS

        The Department's Office of Safe and Drug-Free Schools (OSDFS) has
    worked with the Columbia University ``Teen Screen'' program
    (www.teenscreen.org) to make school districts more aware of tools that
    are available to screen students for depression, suicide ideation, and
    other mental disorders. The Columbia Teen Screen program was developed
    in 1999 by Columbia University and a range of national and community
    partners to identify youth who are at risk for suicide and/or suffering
    from undiagnosed mental illness, and to help them obtain appropriate
    treatment. The ultimate goal of the program is to ensure that all youth
    are offered a mental health check-up before graduating from high
    school.
        In October 2003, staff from the Columbia University Teen Screen
    program made a presentation at the OSDFS National Conference. The
    presentation provided conference participants with an overview of the
    problem of youth mental illness; information about why it is necessary
    to screen for youth mental illness; information about the Columbia Teen
    Screen program, including how it has been implemented in schools and
    the results; and how participants can bring this program to their own
    schools. Several school representatives contacted the Columbia program
    after hearing about it through the OSDFS conference.
        The Department will feature the Columbia Teen Screen program on the
    agenda for the April 2004 Safe Schools/Healthy Students Conference
    (scheduled for April 26-30, 2004) to promote the screening program. The
    Safe Schools/Healthy Students initiative is a discretionary grant
    program that is jointly sponsored and funded by the Departments of
    Education (ED), Health and Human Services (HHS), and Justice (DOJ), and
    supports local educational agencies and communities in developing and
    implementing comprehensive programs that create safe, disciplined, and
    drug-free learning environments and promote healthy childhood
    development.
        In fiscal year 2003, ED and HHS awarded more than $161 million to
    89 Safe Schools/Healthy Students grantees in communities across the
    Nation. These funds support locally developed comprehensive plans that
    address the following elements: (1) Safe School Environment, (2)
    Alcohol and Other Drugs Violence Prevention and Early Intervention, (3)
    School and Community Mental Health Preventive and Treatment
    Intervention Services, (4) Early Childhood Psychosocial and Emotional
    Development Services, (5) Educational Reform, and (6) Safe Schools
    Policies. The mental health element of the Safe Schools/Healthy
    Students comprehensive plan has a dual purpose: (1) to provide metal
    health preventive services early to reduce the risk of onset or delay
    the onset of emotional and behavioral problems for some children; and
    (2) to identify those children who already have serious emotional
    disturbance and ensure that they receive appropriate referral,
    treatment, and follow-up services.
        At the Safe Schools/Healthy Students Conference on April 24, 2004,
    Columbia Teen Screen will present a session called ``Suicide
    Prevention: Who's At Risk?'' This workshop will offer an opportunity
    for Safe Schools/Healthy Students grantees and for grantees from the
    HHS Youth Violence Prevention and Mental Health Targeted Capacity
    Expansion Grants programs to learn more about the Columbia Teen Screen
    tool. This information may be particularly helpful to any grant site
    that has not already adopted a suicide risk screening tool, or is
    interested in learning more about other existing screening tools.
        In addition to the specific workshop about the Columbia Teen Screen
    program, several of the other 232 workshops offered throughout the 3-
    day Safe Schools/Healthy Students conference will address the
    prevention of mental health issues in young people. For example, in
    another workshop that will be offered multiple times throughout the
    conference, the National Suicide Prevention Resource Center will
    address current issues in the prevention of youth suicide. The Rhode
    Island Department of Children Youth and Families will offer a session
    about youth with mental health issues who are transitioning out of the
    juvenile justice system. The National Mental Health Association will
    present a session about training communities around the language of
    mental health. These are just a few examples of the mental health
    disorder screening and prevention issues training opportunities that
    will occur at this spring's Safe Schools/Healthy Students Conference.

                  IDENTIFYING DISTRICTS FOR SCREENING PROGRAMS

        The Department will also work with the Teen Screen program to
    identify school district sites where this type of program has a
    likelihood of success. Because resources are limited and as not all
    communities have to have the ability to provide mental health services
    to those who need them (which is a requirement of the screening
    program), advocacy for such screening tests needs to be targeted
    appropriately if it is to have the greatest possible effect. By way of
    example, the Columbia University Teen Screen program will provide
    assistance to applicants for Project SERV (School Emergency Response to
    Violence) grants. Project SERV provides education-related services to
    local educational agencies in which the learning environment has been
    disrupted due to a violent or traumatic crisis.
        Since the beginning of the 2003-2004 school year, the Department
    has received requests for Project SERV funding from four school
    districts in response to student suicides: Three of the four districts
    experienced multiple suicides within a calendar year; the fourth
    district experienced a student suicide on campus during school hours.
    In each instance, the learning environment was severely impacted.
    Requested services for responding to each incident consisted primarily
    of student mental health screening; grief and suicide prevention
    counseling; and information sessions for parents, students, and
    teachers regarding suicide prevention. Columbia Teen Screen program
    staff members are in contact with three of these school districts about
    how their program services can help with some of the recovery efforts.
    OSDFS will continue to work with Columbia Teen Screen to identify other
    school districts that may be able to benefit from the program's
    resources.

         HIGHLIGHTING SCREENING PROGRAMS IN GRANT APPLICATION PACKAGES

        The OSDFS is reviewing relevant announcements for upcoming
    Department of Education grant competitions so that language about
    screening programs can be included in grant application packages where
    appropriate. For example, the Safe Schools/Healthy Students Initiative
    (discussed earlier) published a Notice of Proposed Priority for the
    fiscal year 2004 grant competition in the Federal Register on March 18,
    2004. Under the proposed priority, grantees would be required to
    provide for school and community mental health preventive and treatment
    intervention services, which could include screening programs to detect
    depression and other mental health disorders. In addition, one of the
    proposed requirements for the competition is that grantees and their
    local public mental health authority sign a memorandum of agreement in
    which the local public mental health authority must agree to provide
    administrative control and/or oversight of the delivery of mental
    health services. This agreement also must state procedures to be used
    for referral, treatment, and follow-up for children and adolescents
    with serious mental health problems. Accordingly, we will include
    guidance in the application package to urge applicants to consider
    including screening for depression and other mental health disorders in
    their overall comprehensive plan.

                                ADDITIONAL STEPS

        Over the next few months, we will pursue additional steps in this
    area. For example, we have discussed coordinating the Department's
    efforts on mental health screening with the HHS Center for Mental
    Health Services (CMHS). We understand that CMHS plans to support mental
    health screening activities with its own funds, and there is an
    opportunity to work collaboratively with them on this effort.
        We will also make our Safe and Drug-Free Schools and Communities
    State coordinators more aware of what mental health screenings are, how
    they can be used, and the positive benefits they can have for youth so
    that they can disseminate this information to school districts and
    communities in their States. Toward that end, we intend to allocate a
    small amount of Safe and Drug-Free Schools and Communities National
    Programs funds this year to develop a short publication on mental
    health screening strategies that we would publicize and make available,
    for example, on the Department's world wide web site over the Internet
    as well as in print.

        Senator Specter. We now have a second panel and five of our
    witnesses are going to be talking about the No Child Left
    Behind Act, so, Mr. Secretary, if you and your two colleagues
    would come up and sit on the panel here with us, it would be a
    good vantage point to listen to the witnesses, and it is my
    request, as you know, for you to hear what they have to say.

    STATEMENT OF JAMES WEAVER, PRESIDENT, PENNSYLVANIA
                STATE EDUCATION ASSOCIATION
        Senator Specter. I want to move now to the introduction of
    the first witness, Mr. Weaver, president of the Pennsylvania
    State Education Association, coordinator for the Social Studies
    Department at the State College Area School District, bachelor
    of science from Lockhaven College and master's from
    Pennsylvania State University. Mr. Weaver, your 5 minutes begin
    right now.
        Let me ask Dr. Melissa Jamula, Dr. Jim Scanlon, Dr. Marie
    Slobojan, Dr. Paul Vallas, Mr. Sam Evans, and Dr. C. Delores
    Tucker also to take seats at the witness table. Thank you for
    joining us.
        Mr. Weaver, I wanted the Secretary to hear what your
    concerns are about the No Child Left Behind Act.
        Mr. Weaver. Thank you, Senator Specter. I appreciate the
    invitation to be here this morning to share some thoughts
    regarding No Child Left Behind. I do especially want to thank
    you for inviting those of us from Pennsylvania who have been
    working back home in Pennsylvania to do our best to make every
    school a good school and provide quality education for
    everyone.
        Senator Specter. This hearing responds to a meeting which
    was held earlier this week in southeastern Pennsylvania, so I
    called the Secretary and he graciously agreed to stay on to
    hear your concerns. Nothing like having the Secretary's ear,
    Mr. Weaver.
        Mr. Weaver. That's correct. Well, what I'd like to share
    with you really is not so much from the perspective of being
    president of the Pennsylvania State Education Association but
    really being a teacher and being a teacher who represents other
    education support personnel folks and other teachers.

                            NO CHILD LEFT BEHIND ACT

        Really it deals with the frustration that educators have
    with the law, and quite frankly that frustration often brings
    my colleagues to tears when they see what is happening not only
    to their students in terms of the testing requirements but also
    to the quality curriculum that they feel is being abandoned as
    a result of the law.
        There are a number of things wrong with the law and we
    believe many of the issues can be corrected, but the problem of
    a one-size-fits-all kind of approach for not only how students
    learn and how they can be assessed in terms of their
    proficiency, that is a fundamental flaw of the law and it's
    fundamentally wrong in what the impact is on the programs that
    are being taught back in our school.
        Every child can learn, but also every parent and every
    teacher knows that every child does not learn at the same rate,
    does not achieve at the same rate, nor in the same way. I've
    had teachers tell me that the pressure on their schools to meet
    adequate yearly progress both in math and reading is so strong
    that they're pressured really to teach little else but what is
    going to be taught on the test.
        We recently gathered a group of our members along with some
    administrators back in Harrisburg together to discuss the law.
    During the course of the discussion, several of the comments
    that were made I think are revealing. One teacher said the PSSA
    test is dominating my classroom. Each year as the stakes get
    higher I spend more time on how to take tests than teaching my
    curriculum, and for those that may not be familiar, PSSA is the
    State-prescribed test in Pennsylvania that we use to
    demonstrate adequate yearly progress.
        Another teacher said, and this is--well, it's just
    shocking--we have a gun at our heads. We must meet the
    requirements but we don't have the tools or the funding to
    offer the interventions that are proven to help children. Even
    our vocational technical school educators point out that
    they're not teaching all the important skills in many of their
    programs, their vocational skills, because they're now working
    to ensure that their students pass the math and reading test,
    and they believe they're sending out their students with less
    skills in their technology areas now than before the law was
    enacted.
        Probably most important is a special education student--or
    teacher--said, important life skills curricula that are being
    sacrificed to teach to a test that really doesn't measure the
    identified goals of the IEP. But probably the most resounding
    and discouraging, disheartening statement that I hear a lot
    from my members is that they feel they're being set up for
    failure by No Child Left Behind.

                               PREPARED STATEMENT

        I'm mindful of my time, so I'll say that educators don't
    object and do not fear accountability, but they do understand
    that trying to boil down the complicated process of educating a
    child to a specific test score is at best problematic, if not
    downright impossible. We believe that we need to remove the
    threat of No Child Left Behind and replace it with a helping
    hand, replace it with things like fully-funded programs that
    work, replace it with the encouragement of our teachers and our
    school support professionals and our administrators----
        Senator Specter. Ten seconds left, Mr. Weaver.
        Mr. Weaver [continuing]. And our parents. Let's replace
    that, the threat of No Child Behind, with the encouragement of
    all those stakeholders in the education process.
        [The statement follows:]

                     Prepared Statement of James R. Weaver

        Good morning Senator Specter and members of the committee. Thank
    you for inviting me here this morning. I especially commend Senator
    Specter for inviting those of us from Pennsylvania who are doing our
    best to make every public school a great one for our children. We have
    worked with Senator Specter for many years, and we know that you, Mr.
    Chairman, want what is best for our children.
        I also commend the group of superintendents who showed great
    professional leadership by holding a news conference back in
    Pennsylvania this past Monday to draw attention to the failings of the
    No Child Left Behind Act.
        Rather than repeat what I said at the news conference Monday, I'd
    like to spend my time focusing on what I'm hearing from the teachers
    and school support professionals about their frustrations with the Act.
        And frankly, Senators, that frustration brings many of my members
    to tears when they see what is happening to their students and to the
    quality curriculum that is being abandoned as a result of this law.
        There are a number of things wrong with this law--some of which can
    be corrected--but because it is focused on a one-size-fits-all approach
    for learning and for demonstrating proficiency, it is fundamentally
    flawed and it is fundamentally wrong in what it is doing to the
    programs in our schools. Every child can learn, but parents and
    teachers know that all children do not achieve at the same rate and in
    the same way.
        I have had teachers tell me the pressure on schools to meet
    Adequate Yearly Progress in math and reading is so strong that they are
    forced to abandon teaching anything other than what is to be tested.
        We recently gathered together several of our members, along with
    school administrators to discuss this law. During the course of our
    discussion, one teacher said, ``The PSSA test is dominating my
    classroom. Each year as the stakes get higher, I spend more time
    teaching how to take tests than teaching my curriculum.'' The PSSA is
    the state-prescribed test in Pennsylvania for demonstrating Adequate
    Yearly Progress.
        Another teacher said, ``We have a gun at our heads. We must meet
    the requirements, but we don't have the tools or the funding to offer
    the interventions that are proven to help children succeed.''
        Our vocational-technical school educators point out that they are
    not teaching all the important skills in many of their programs because
    they are working to ensure that their students pass the math and
    reading tests. They believe this law is causing them to send their
    graduates into the work force with fewer skills now than before this
    law was enacted.
        A special education teacher had this to say: ``Important life
    skills curricula are being sacrificed to teach to a test that does not
    measure the identified goals of the IEP.''
        The most resounding message that I receive from my members is that
    they have been set up for failure by NCLB. And that is very
    disheartening. Educators do not object to accountability. But they do
    understand that reducing the complicated process of educating a child
    to a specific test score is at best problematic, if not impossible.
        Our National Education Association lobbyists have circulated to
    this subcommittee our recommendations specific to the education budget.
    I want to highlight briefly these points:
      --Funds for Title I and special education must be funded at their
            promised levels, and
      --The programs that work to improve student learning--many of which
            are eliminated by the proposed budget, must be continued and
            fully funded. These include Dropout Prevention, Gifted and
            Talented programs, School Counseling and Smaller Learning
            Communities. They all have a track record of success.
        Before I end my remarks, I must mention the sanctions portion of
    the Act. Secretary Paige and his staff continually assert that the NCLB
    is based upon research.
        One of the remedies for schools not making AYP is to convert them
    to charter schools. The law also allows for privatization of school
    services.
        Where is the evidence that charter schools, that for-profit
    schools, that cyber schools, that private education services succeed in
    improving student performance? The evidence of the success of these so-
    called ``remedies'' does not exist. Yet these are the ``remedies'' for
    schools not making AYP.
        We believe that if this Administration were interested in improving
    public schools for all children, if it were interested in making Great
    Public Schools for Every Child, it would focus less on punishment and
    more on what actually works.
        It would provide the funds to reduce class size--especially in our
    schools which serve the most-difficult to reach students. It would
    provide initiatives for full-day kindergarten, and it would fully fund
    Head Start.
        There is indisputable evidence that these programs make a
    difference in students' long-term success.
        Frankly, Mr. Chairman and members of the subcommittee, I don't
    believe that the No Child Left Behind Act can be ``fixed'' as long as
    it is focused on punishment and abandonment and not on what will make
    our schools better for every child.
        Our educators want a fair opportunity to show progress in their
    efforts. We need to remove the threat of No Child Left Behind and
    replace it with a helping hand. Replace it with fully-funded programs
    that work, and replace it with the encouragement our teachers, our
    school support professionals, our administrators, our students and
    their parents need to make our public schools great for every child.
        Again, thank you for this opportunity to share my thoughts.

    STATEMENT OF DR. MELISSA JAMULA, SUPERINTENDENT,
                READING SCHOOL DISTRICT
        Senator Specter. We have to turn now to Dr. Melissa Jamula,
    superintendent of schools for the Reading School District.
    We'll put your impressive curriculum vitae and statement in the
    record. Dr. Jamula, you have 5 minutes.
        Dr. Jamula. Thank you, Senator Specter, and thank you for
    the opportunity to speak with you today about No Child Left
    Behind. I would request that the testimony be submitted for the
    record.
        As superintendent of a large urban school district, I
    strongly support the tenets that No Child Left Behind was
    created to support. I absolutely believe that all children can
    succeed and that public schools should be held accountable for
    that success. I believe that every child has the right to be
    taught by highly qualified teachers in a safe environment.
        Those beliefs, as stated in No Child Left Behind, without
    question should be the hallmarks that drive our public
    education. But I also believe that there are specific mandates
    within the law that undermine the spirit of No Child Left
    Behind and truly discriminate against poor minority children
    and the schools that serve them, and I believe that Congress'
    willingness to address these mandates will be fundamental to
    whether or not No Child Left Behind goes down in history as a
    piece of legislation that significantly helped to improve the
    quality of education by all of America's children, or as
    legislation that derailed public schools.

                            READING SCHOOL DISTRICT

        Today I would like to provide you with what I think to be a
    vivid example of how one school district is struggling without
    success to comply with the mandates of No Child Left Behind.
    I'm the superintendent of the Reading School District in
    Reading, Pennsylvania. Of the 501 school districts in
    Pennsylvania, we are the fifth largest. We have a diverse
    student body, 64 percent of our children are Hispanic, 19
    percent are white, 15 percent are African-American, 2 percent
    are Asian or other nationalities. Of our student population, 12
    percent are formally identified as students in the English
    language acquisition program and another 12 percent are
    formally identified as special education students.
        About 3 years ago, the Pennsylvania Department of Education
    hired Standard & Poor's to compare data on the 501 school
    districts in Pennsylvania. In order for you to understand my
    grave concerns as they exist in No Child Left Behind, I need to
    have you please consider these facts about the Reading School
    District. Compared to the other 500 school districts in
    Pennsylvania, the Reading School District ranks in the 98th
    percentile for the percentage of students who are at or below
    the poverty line. We rank in the 99th percentile for children
    who have English as their second language. We are in the 100th
    percentile for mobility.
        Last year, the Reading School District had 16,280 students.
    From the time we opened our doors in September until May 1,
    over 8,000 students either enrolled or disenrolled from one of
    our schools. We rank in the 100th percentile for our dropout
    rank. We rank only in the 1st percentile for adults in the
    community with a high school diploma, and conversely, in the
    99th percentile for single-parent households.
        We have a very needy student and community population, but
    although we are a poor community, we place high value on our
    children's education. The citizens of Reading make the highest
    local tax effort in Berks County and are in the top 15 percent
    in the State of Pennsylvania, yet we're able to spend $2,000
    less per student than the average. We have a $106 million
    general fund budget. If we could spend only the average of the
    State's spending per child, we could increase that budget by
    over $33 million. In truth, if we could spend what our
    neighbors directly to the north of us spend, we could increase
    that budget by $70 million.
        To me it is unconscionable that in this country the quality
    of a child's education is determined by his zip code. For those
    who argue otherwise, I would ask you to consider these facts.
    Again, as compared to the other 500 school districts in
    Pennsylvania, the Reading School District is in the 93rd
    percentile for the number of students per teacher, the 92nd for
    classrooms with 30 or more children. We're in the 99th
    percentile for the number of students who need to share one
    computer. We're in the 99th percentile for students per
    administrator and the 88th percentile for our professional
    turnover rate.
        We have many children with many needs, and as our teachers
    and our children are working so hard every day to close the
    educational gaps, these children have--when they enter our
    schools, they're being told by No Child Left Behind that
    they're failures.
        Members of Congress, we know exactly what needs to be done
    to give these children the same opportunities as other children
    across the Nation.
        Senator Specter. Dr. Jamula, you have 30 seconds.

                               PREPARED STATEMENT

        Dr. Jamula. Yes, thank you. But these initiatives will take
    tens of millions of dollars, dollars that we don't have. I urge
    Congress to fully fund the mandates of No Child Left Behind. I
    urge Congress to reconsider the mandates for the current method
    of evaluating and testing special education students. I urge
    Congress to reconsider the timelines established for the
    evaluation of children who are limited English proficient, and
    I urge Congress to consider to hold us accountable by
    instituting value-added evaluations for special education and
    limited education students.
        [The statement follows:]

                    Prepared Statement of Dr. Melissa Jamula

        Members of Congress: Thank you for the opportunity to speak to you
    today about No Child Left Behind.
        As superintendent of a large urban school district, I strongly
    support the tenets upon which No Child Left Behind was created: I
    believe that all children can succeed; that public schools should be
    held accountable for their success; that we should focus special
    attention on children who have traditionally been underserved; and,
    that all children deserve to be taught by qualified teachers in a safe
    environment. Those beliefs, as stated in No Child Left Behind, without
    question, should be the hallmarks that drive our public education
    system.
        But I also believe that there are specific mandates within No Child
    Left Behind that undermine the spirit of the law and truly discriminate
    against poor, minority children and the schools that serve them. I
    believe that Congress' willingness to address these mandates will be
    fundamental to whether No Child Left Behind goes down in history as a
    piece of legislation that helped to significantly improve the quality
    of education received by all of America's children, or as legislation
    that de-railed the public school system.
        Today, I would like to provide you with a vivid example of how one
    school district is struggling, without success, to comply with No Child
    Left Behind.
        I am the superintendent of the Reading School District in Reading,
    Pennsylvania. Of the 501 school districts in Pennsylvania, we are the
    fifth largest, with approximately 16,700 students. We have a diverse
    student body: 64 percent of our students are Hispanic; 19 percent are
    white; 15 percent are African American; and 2 percent are Asian or
    other nationalities. Of our student population, 12 percent of the
    children are in a formal English Language Acquisition Program and
    another 17 percent are formally identified as special education
    students.
        About three years ago, the Pennsylvania Department of Education
    hired Standard and Poors to analyze annually thousands of pieces of
    data, comparing the 501 school districts in the state. This analysis
    ranges from academic performance to finances to demographic data. In
    order for you to understand my grave concerns about meeting the
    mandates of No Child Left Behind, consider these facts about the
    Reading School District. Compared to the other 500 school districts in
    Pennsylvania, Reading School District ranks in the:
      --98th percentile for the percentage of students at or below the
            poverty line
      --99th percentile for the percentage of children who have English as
            their second language
      --100th percentile for mobility (Last year, the Reading School
            District had 16,280 students. From the time we opened our doors
            in September, until May 1, we had over 8,000 children either
            move into or from one of our schools!)
      --100th percentile for our drop out rate
      --1st percentile for adults in the community with at least a high
            school diploma
      --99th percentile for single parent households
        As you can see, indicators suggest we have a needy student
    population. Although we are a very poor community, our community places
    a high value on our children's education: The citizens of Reading make
    the highest local tax effort of the 18 school districts in Berks County
    and rank 75th, or in the top 15 percent, in Pennsylvania. Yet, we are
    able to spend $2,000 less per student than either our county or the
    state average. We have a $106 million general fund budget. If we could
    spend the average of what our peers spend, we could increase that
    budget by over $33 million! In truth, if we could spend what our
    neighboring school district directly to the north spends, we could
    increase our budget by $70 million. To me, it is unconscionable that,
    in this country, the quality of a child's education is determined by
    his zip code. For those who would argue otherwise, I would ask you to
    consider these facts. Again, compared to the other 500 school districts
    in Pennsylvania, the Reading School District ranks in the:
      --93rd percentile for the number of students per teacher
      --92nd percentile for classrooms with 30 or more children
      --99th percentile for the number of students per computer
      --99.8th for students per administrator (meaning, of course that we
            have one of the leanest administrative staffs in the state)
      --88th percentile for our professional turnover rate (Our starting
            teacher salaries are approximately $10,000 below both our
            county and state averages.)
        In spite of these numbers, I believe we have an excellent school
    district. I say that not only as the superintendent, but as a parent
    whose child is thriving as a junior at Yale, due largely to the
    educational foundation she received in the Reading School District.
        But we have many children with many needs. And, as our teachers and
    our children are working so hard to close the educational gaps these
    children have when they enter school, they are now being told that they
    are failures according to No Child Left Behind.
        Members of Congress, we know exactly what needs to be done to give
    our children the same educational opportunity to succeed as other
    children across this nation. Given the resources, we would increase the
    length of the school day and the school year, we would institute all
    day kindergarten, we would significantly reduce our class size at every
    level for all children and would assure that children who have English
    as their second language are in classrooms with not more than 15
    children, and are taught by teachers and assisted by aides who both are
    truly bilingual, so that these children learn English, but not at the
    expense of their education. We would provide smaller class sizes, more
    intense interventions and year round school for our special education
    students. We would use technology as an effective educational tool to
    meet the varied needs of our students. And that's just the beginning.
        Our schools that have been placed in Year One of School Improvement
    under No Child Left Behind have complied with a mandate under this law
    and have written school improvement plans. They have written these
    initiatives into their plans.
        But these initiatives will take tens of millions of dollars; money
    we don't have; money that has not been provided through the enactment
    of No Child Left Behind. Although our federal funds have grown by about
    $6 million since 1999, given our growth in student population, which
    consistently is between 300 and 350 students a year for the past 15
    years, and, given the profile of the children who are entering our
    school district, we actually are able to spend two dollars less per
    eligible child using federal funds than in 1999!
        I urge Congress to fully fund the mandates of No Child Left Behind,
    so that our children, all of our children, are given the educational
    opportunities they deserve.
        I urge Congress to reconsider the mandates for the current method
    of testing special education children and I urge Congress to require
    that No Child Left Behind mandates are consistent with the mandates of
    IDEA.
        I urge Congress to reconsider the timelines established for the
    evaluation of children who are limited English proficient and develop
    evaluation methods for these children that are consistent with bodies
    of research that speak to the number of years it takes for a child,
    particularly for a child of poverty, to adequately develop academic
    vocabulary.
        I urge Congress to continue to hold public schools accountable for
    the achievement of both special education children and children who are
    limited English proficient by requiring value-added testing, designed
    to show the academic growth that each of these children makes each
    year.
        Members of Congress, while I speak from the point of view of a
    superintendent in an urban school district, it is important for you to
    know that many of my concerns are shared by superintendents of some of
    the wealthiest, most academically successful school districts in
    Pennsylvania. Recently, 138 superintendents, from a 14 county region in
    Pennsylvania, signed their name to a position paper relative to No
    Child Left Behind, which I have included with my testimony.
        I thank you for your time today and I urge you to honor the intent
    of the No Child Left Behind law by addressing the mandates within this
    law that will surely undermine its effectiveness.

        Senator Specter. Thank you, Dr. Jamula.

    STATEMENT OF DR. JAMES SCANLON, SUPERINTENDENT OF
                SCHOOLS, QUAKERTOWN COMMUNITY SCHOOL
                DISTRICT
        Senator Specter. Dr. Jim Scanlon, superintendent of schools
    with the Quakertown Community School District. We'll put your
    impressive curriculum vitae in the record.
        Dr. Scanlon. Yes, thank you very much. I'm here speaking on
    behalf of the superintendents from 138 school districts
    representing 14 counties in Pennsylvania, including those
    suburban counties around Philadelphia and near our capital of
    Harrisburg.

                            NO CHILD LEFT BEHIND ACT

        It's extremely rare that an issue has the power to
    galvanize and unite districts so solidly. In fact, I've never
    known one issue to arouse so much concern and unity. These
    districts are committed to educational excellence, quality
    instruction, and accountability for results, all qualities that
    No Child Left Behind Act strives to promote.
        Each of us supports the concepts of high standards, using
    data for decision-making, creating school profiles and giving
    information to parents in parent-friendly language, again all
    goals of the Act. But there are three major concerns we have
    about this law. One, it's inherently unfair to special
    education students and conflicts with the Federal law, IDEA,
    Individuals With Disabilities Education Act. Two, it disregards
    the needs of students who demonstrate limited English
    proficiency. And three, it disregards the amount of time,
    funding, and resources to meet the requirements in the law.
        Children with disabilities have to participate in their
    respective State testing programs. They're not designed for
    children who have disabilities. Therefore, these tests do not
    accurately reflect their academic progress.

                       NO CHILD LEFT BEHIND ACT AND IDEA

        No Child Left Behind and IDEA are two laws that are
    polarized. That is, IDEA says special education students are
    entitled to progress at different rates. No Child Left Behind
    says all students must progress at the same rate. IDEA says
    special education data sources tailored to a student's
    capabilities must be used to assess his or her progress, while
    No Child Left Behind says standardized test data must be used
    to assess progress. IDEA measures student progress against
    standards based on current levels of performance. No Child Left
    Behind measures progress against universal grade-level
    standards.
        Basically, No Child Left Behind has no consideration for
    the special learning needs of special education students. We're
    being asked to answer to two completely contradictory Federal
    laws and our special needs students are caught in the middle.

                       LIMITED ENGLISH SPEAKING STUDENTS

        No Child Left Behind requires non-English-speaking students
    to be assessed during their first year of attendance in school
    in the United States. In effect, these limited-English-speaking
    students are being forced to take a test many of them don't
    even understand. Research shows it takes 5 to 7 years for
    students to learn the language proficiently.

                       COSTS OF NO CHILD LEFT BEHING ACT

        Many of our school district budgets receive between 1 and 2
    percent of Federal money. Most of it comes in the form of title
    I funds, which is targeted for early childhood reading and
    math. No Child Left Behind forces us to spread the title I
    funds across our entire district, and although title I funds
    have increased, they have not increased in proportion to the
    number of children those funds are now supposed to cover. It's
    like giving someone a queen-sized comforter instead of a sofa
    throw but now asking them to keep 10 people warm with it
    instead of two. Someone's going to be left out in the cold.
        Districts will also have to incur other costs because of No
    Child Left Behind. They include hiring and training
    professionals to meet highly qualified provisions,
    transportation costs for families exercising school choice
    options, additional infrastructure and staff for analyzing test
    scores, the cost of additional teachers and aides to provide
    remediation. The list goes on and on.

                     FLEXIBILITY FOR IDEA AND LEP STUDENTS

        We're asking you to do the following to help us better
    educate and change what we firmly believe is destructive rather
    than constructive legislation. One, allow special education
    students' progress to be measured by the assessments in their
    individual education plans protected under the Federal law,
    IDEA. Essentially, allow IDEA to drive the evaluation of
    special education students.
        Two, provide sufficient time and accommodations for
    assessing limited-English-speaking students, and I know
    Secretary Paige has addressed some of that recently. However,
    we believe one year is not quite enough. Give them more time to
    learn the language before they're tested.

                               PREPARED STATEMENT

        Fully fund No Child Left Behind to support schools and
    districts. Study, analyze, collect data, and learn how much
    this law and its changes will really cost us, and then
    adequately fund it so that we can fulfill the requirements.
        We'll continue to work to provide the best learning
    environments possible for our students and staff. It's our duty
    to point out the flaws in this law, and I hope you will work
    with us, not against us, toward the common goal of educating
    our children. Thank you for listening and learning with us.
        [The statement follows:]

                   Prepared Statement of Dr. James R. Scanlon

        I am here speaking on behalf of the superintendents from 138 school
    districts, representing 14 counties in Pennsylvania, including those in
    suburban Philadelphia and near our capital of Harrisburg.
        It is extremely rare that an issue has the power to galvanize and
    unite districts so solidly--in fact, I've never known one issue to
    arouse so much concern and unity.
        These districts are committed to educational excellence, quality
    instruction and accountability for results, all qualities that the No
    Child Left Behind Act strives to promote. Each of us supports the
    concepts of high standards, using data for decision-making, creating
    school profiles and giving information to parents in parent-friendly
    language--again, all goals of the Act. BUT--there are three major
    concerns we have about this law:
        1. It's inherently unfair to special education students and
    conflicts with the federal law, IDEA (Individuals with Disabilities in
    Education Act).
        2. It disregards the needs of students who demonstrate limited
    English proficiency.
        3. It disregards the amount of time, funding and resources to meet
    the requirements in the law.
        Children with disabilities have to participate in their respective
    state testing programs--that are NOT designed for children who have
    disabilities--therefore these tests do not accurately reflect their
    academic progress.
        No Child Left Behind and IDEA are two laws that are polarized--that
    is, IDEA says special education students are entitled to progress at
    different rates. No Child Left Behind says all students must progress
    at the same rate. IDEA says specialized data sources tailored to a
    student's capabilities must be used to assess his or her progress. No
    Child Left Behind says standardized data sources must be used to assess
    progress. IDEA measures student progress against standards based on
    current levels of performance. No Child Left Behind measures progress
    against universal grade level standards. Basically, No Child Left
    Behind has no consideration for the special learning needs of special
    education students. We are being asked to answer to two completely
    contradictory federal laws, and our special needs students are caught
    in the middle.
        No Child Left Behind requires non-English speaking students to be
    assessed during their first year of attendance in school in the United
    States. In effect, these limited English speaking students are being
    forced to take a test many of them don't even understand. Research
    shows it takes five to seven years for students to learn the language
    proficiently.
        Many of our school district budgets receive between one and two
    percent in federal money--most of it comes in the form of Title One
    funds, which is targeted for early childhood reading and math. No Child
    Left Behind forces us to spread the Title One funds across our entire
    district--and although Title One funds have increased, they have not
    increased in proportion to the increase in the number of children those
    funds are now supposed to cover. It's like giving someone a queen-size
    comforter instead of a sofa throw but now asking them to keep 10 people
    warm with it instead of two. Someone's going to be left out in the
    cold.
        Districts will also have to incur other costs because of No Child
    Left Behind. They include: hiring and training paraprofessionals to
    meet ``highly qualified'' provisions; transportation costs for families
    exercising school choice options; additional infrastructure and staff
    for analyzing test scores; the cost of additional teachers and aides to
    provide remediation. The list goes on and on.
        We are asking you to do the following to help us better educate our
    children and change what we FIRMLY believe is destructive, rather than
    constructive legislation:
        1. Allow special education students' progress to be measured by the
    assessments in their individualized education plans, protected under
    the federal law, IDEA. Essentially, allow IDEA to drive the evaluation
    of special education students.
        2. Provide sufficient time and accommodations for assessing limited
    English speaking students--essentially, give them more time to learn
    the language before they are tested.
        3. Fully fund No Child Left Behind to support schools and
    districts--study, analyze, collect data, and learn how much this law
    and its changes will really cost us--and then adequately fund it--so
    that we can fulfill the requirements.
        We will continue to work to provide the best learning environments
    possible for our students and staff. It is our duty to point out the
    flaws in this law, and hope you will work with us, not against us,
    toward the common goal of educating our children.
        Thank you for listening, and learning with us!

        Senator Specter. Thank you very much, Dr. Scanlon. As I
    said earlier, Secretary Paige has to leave at this point, but
    he's very graciously agreed to meet with all of you at 2 p.m.
    this afternoon in his office. I want to announce that there are
    others who have come from Pennsylvania--Dr. Jacob Dailey, who's
    the director of legal and external relations at the Chester
    County Intermediate Unit; Dr. Mary Lou Folts from the
    Tredyffrin/Easttown School District; Dr. Melody Wilt from the
    Chester County Intermediate Unit; and Dr. Mark Dietz from the
    Wyomissing Area School District. And those folks may be
    included as well, Secretary Paige.
        I'll have one of my staffers take you over. Secretary Paige
    has to leave at this point, and we're going to interrupt the
    hearing for just a few minutes and we'll resume with the
    balance of the witnesses in just a few minutes.
        Secretary Paige. Can we say thank you very much for your
    leadership and the opportunity to come and testify before you.
        Senator Specter. You're very welcome, Mr. Secretary. The
    issues here are very important and I appreciate your open ear.
    It's good to have the Secretary's ear and even better to have
    the Secretary's pen, but you start with his ear. And what we're
    always doing around here, and you saw a number of Senators
    wanted to ask more questions, but we have so much time and so
    many commitments. But you have provided the very good safety
    valve, Mr. Secretary, by being willing to meet this afternoon,
    and for the record here, we'll continue to hear from the
    witnesses after a very brief recess.
        I regret the interruption, but I had to address a veterans
    convention in Harrisburg. There's a great problem when somebody
    is selected to the Senate and he or she is not twins or
    triplets.

    STATEMENT OF DR. MARIE SLOBOJAN, DIRECTOR OF
                INSTRUCTION, TREDYFFRIN/EASTTOWN SCHOOL
                DISTRICT
        Senator Specter. I return now to Dr. Marie Slobojan,
    director of instruction, staff development, and planning at the
    Tredyffrin/Easttown School District. I'm sorry that you don't
    have the Secretary here, but you have--would you identify
    yourself for the record?
        Mr. Simon. Yes, I'm Ray Simon. I'm Assistant Secretary for
    Elementary and Secondary Education.
        Senator Specter. And this gentleman is right in line with
    the issues, but you'll have the Secretary's ear, as I said
    earlier, at 2 p.m. Dr. Slobojan, thank you for joining us and
    we look forward to your testimony.
        Dr. Slobojan. Thank you for inviting us to discuss the
    impact of the reauthorization of the Elementary and Secondary
    Act in the Tredyffrin/Easttown School District. As you can see
    from the district profile that we submitted, Tredyffrin/
    Easttown School District is a high-performing K-12 district as
    determined by multiple measures of performance, including
    scholastic aptitude tests, educational record tests, and
    advanced placement standardized tests.
        We consider the SAT a particularly informative measure of
    our performance, because typically 100 percent of our students
    participate in this test. Our average daily attendance is 96.6
    percent and we graduate 99.9 percent of our students. We take
    our responsibility to educate every child very seriously by
    setting and enforcing strong standards of accountability for
    our district.
        The Pennsylvania School System of Assessment is the single
    academic measure of performance that defines the district's
    adequate yearly progress. Students must perform at the
    proficient or above-proficient level.

                      TREDYFFRIN/EASTTOWN SCHOOL DISTRICT

        The 2002-03 Standard & Poor's report for our district
    states the following: Statewide, none of Pennsylvania's school
    districts report a greater proportion of test scores that meet
    or exceed State standards. Statewide, none of Pennsylvania's
    school districts report higher proportions of scores in the
    advanced performance level. Across the State, none of
    Pennsylvania's districts report a smaller proportion of scores
    in the below-basic performance level.
        In spite of such an extraordinary record of meeting the
    needs of children, strongly supported by our community, the
    current version of the Elementary and Secondary Education Act
    has endangered the public school students in our district.
        Point one, all students in our school district are
    currently experiencing a skewed educational program designed to
    ensure their success on the Pennsylvania assessments in
    mathematics and reading. Placing this emphasis on a single
    high-stakes test detracts from the rich curriculum and creative
    environment that promotes self-directed, lifelong learning that
    students in our district have come to expect.
        Teachers within the district feel constrained by the narrow
    parameters suggested in the State curriculum. We believe that
    our compliance with this initiative results in our providing a
    regressive educational experience for our students.
        Second, our district receives no title I funds. Therefore,
    any compliance action we take is funded from our local
    resources. This means that we redirect our funds from existing
    programs with demonstrated success.
        Point three, in the 2002-03 school year, we were audited in
    our special education program and identified as having
    exemplary practices for the State of Pennsylvania. This year,
    we anticipate that we will placed on the warning list for this
    special education subgroup. We believe that this will start our
    6-year march to privatization in the Tredyffrin/Easttown School
    District.

               NCLB ACT AND THE INDIVIDUALS WITH DISABILITIES ACT

        We believe the principles of the No Child Left Behind
    legislation violate the instructionally sound framework of the
    Individuals with Disabilities Act. Principle one, children
    learn at different rates. Principle two, valid student
    assessment involves multiple data sets. Principle three,
    effective instruction and assessment is delivered at the
    student's instructional level. The result is that these
    students are experiencing stress, fear, and they risk being
    ostracized due to their inclusion in a federally labeled
    subgroup.

                NCLB ACT AND LIMITED ENGLISH PROFICIENT STUDENTS

        Point four, we currently have 111 English language learners
    speaking 29 different languages. The Federal requirements for
    testing are inconsistent with the research, which suggests it
    takes approximately 7 years for non-native speakers of English
    to acquire proficiency to perform on standardized tests.
        During the testing period, students demonstrate anger and
    frustration. Students who are about to take this test feel as
    though they are forced to show that they will fail. The sense
    of failure has made it difficult to encourage students to learn
    English and to improve their proficiency. In effect, the law is
    having the exact opposite effect it was designed to promote.
        Senator Specter. Thirty seconds left.

                               PREPARED STATEMENT

        Dr. Slobojan. I'll just skip to my concluding remarks. In
    order to effectively assess the progress of our students for
    the purposes of adequate yearly progress, please include
    multiple assessments, factor subgroups into an equation that
    weights their proportion within the school population as a
    whole, develop appropriate assessments and have comparable
    tests and standards across all States.
        We ask you to amend the legislation to fairly assess the
    multiple dimensions of human intelligence and to respect the
    dignity of every student.
        [The statement follows:]

                    Prepared Statement of Dr. Marie Slobojan

        Honorable Senators: Thank you for inviting us to discuss the impact
    of the reauthorization of the Elementary and Secondary Education Act in
    Tredyffrin/Easttown School District.
        As you can see from the District profile, Tredyffrin/Easttown is a
    high-performing K-12 school district, as determined by multiple
    measures of performance including Scholastic Achievement Tests,
    Educational Records Bureau tests and Advanced Placement standardized
    tests. We consider the SAT a particularly informative measure of our
    performance because typically 100 percent of our students participate
    in this test. Our average daily attendance is 96.6 percent and we
    graduate 99.9 percent of our students. We take our responsibility to
    educate every child very seriously by setting and enforcing strong
    standards of accountability for our district.
        The Pennsylvania School System of Assessment, or PSSA, is the
    single academic performance measure that defines the district's
    Adequate Yearly Progress where students must perform at the proficient
    or above proficient level. The 2002-03 Standard & Poor's report for our
    District states the following:
      --Statewide, none of Pennsylvania's school districts report a greater
            proportion of test scores that meet or exceed state standards.
      --Statewide, none of Pennsylvania's school districts report higher
            proportions of scores in the Advance performance level.
      --Across the state, none of Pennsylvania's districts report a smaller
            proportion of scores in the Below Basic performance level than
            this district.
        In spite of such an extraordinary record, of meeting the needs of
    every child, strongly supported by our community, the current version
    of the Elementary and Secondary Education Act has endangered the public
    school students in our district.

                                    POINT 1

        All students in our school district are currently experiencing a
    skewed educational program designed to ensure their success on the
    Pennsylvania assessments in mathematics and reading. Placing this
    emphasis on a single high-stakes test detracts from the rich curriculum
    and creative environment that promotes the self-directed life-long
    learning that students in our district have come to expect. Teachers
    within our district feel constrained by the narrow parameters suggested
    in the state curriculum. We believe that our compliance with this
    initiative results in our providing a regressive educational program
    for our students.

                                    POINT 2

        Our District receives no Title I funds. Therefore, any compliance
    action we take is funded from local resources. This means that we
    redirect funds from existing programs with demonstrated success to
    programs that provide remediation for state testing.

                                    POINT 3

        The 2002-03 school year audit of our Special Education Program
    identified our District as having exemplary practices. In 2003-04, we
    anticipate that we will be placed on the warning list for this special
    education sub-group, thus starting the six-year march to privatization
    for the Tredyffrin/Easttown School District.
        We believe the principles embodied in the No Child Left Behind
    legislation violate the instructionally sound framework of the
    Individuals with Disabilities Act.
        Principle 1.--Children learn at different rates.
        Principle 2.--Valid student assessment involves multiple data sets.
        Principle 3.--Effective instruction and assessment is delivered at
    the student's instructional level.
        The result is that these children are experiencing stress and fear
    and risk being ostracized due to their inclusion in a federally labeled
    sub-group.

                                    POINT 4

        Currently we have 111 students in our English Language Learners
    program, speaking 29 different languages. The federal law requires that
    these students be tested in English following three years of tutoring
    in English. Research indicates that it takes a minimum of 7 years for a
    nonnative speaker of English to gain the proficiency level that
    translates into successful performance on most standardized tests.
        During the test, students taking the assessment have demonstrated
    anger and frustration. Going through a test where only the directions
    were translated made the students feel as though they were forced to
    demonstrate what they did not know. Currently students who are about to
    take this test feel that they are forced to participate in an
    assessment they will fail. This sense of failure has made it difficult
    to encourage students to learn English and to improve their
    proficiency. In practice, this law is having the exact opposite effect
    it was designed to promote.

                                    POINT 5

        Pennsylvania's calculation of Adequate Yearly Progress places
    students in our Commonwealth at a disadvantage to students in other
    states. This disadvantage occurs because the proficiency in standards
    across the United States punish students in states where the standards
    are high. For school districts such as ours, that already meet the
    state's annual requirements, this concept is regressive. While other
    school districts have until the year 2014 to meet these goals, the high
    achievement of our district's students places us on the warning list if
    we marginally drop from the high standards that we currently achieve.
        In order to effectively assess the progress of our students for the
    purposes of Adequate Yearly Progress we recommend the following
    changes.
        1. Include multiple assessments of academic performance in the
    Adequate Yearly Progress formula.
        2. Factor sub-groups into an equation that weights their proportion
    within the school population as a whole. In this way sub-groups would
    not carry the same weight as the entire school population.
        3. Develop assessments that are appropriate for students with
    special needs and those who are English Language Learners. Use those
    assessments in the Adequate Yearly Progress calculation.
        4. Have comparable tests and standards across all states for the
    calculation of Adequate Yearly Progress.
        The Tredyffrin/Easttown community is proud of the public education
    that it provides for its students. We have always accepted
    responsibility and demonstrated accountability for the performance
    results of every student that we serve. We respectfully request
    amendments to the legislation to fairly assess the multiple dimensions
    of human intelligence and to respect the dignity of every student that
    is educated in public school districts across this nation. Thank you
    for your attention.

        Senator Specter. Dr. Slobojan, we have your point and we
    thank you very much. Moving right down the table in sequence,
    sitting next to Dr. Slobojan is Mr. Samuel Evans. Mr. Evans is
    the founder of the American Foundation for Negro Affairs, a
    long list of accomplishments, being appointed by President
    Roosevelt. Was that Franklin or Theodore, Mr. Evans?
        Appointed by President Roosevelt, I know it was FDR, as the
    coordinator of the U.S. Division of Physical Fitness. President
    Johnson appointed him as czar of the war on poverty. He's the
    founder of Youth City, the cooperative education extension
    service and the family of leaders.
        Mr. Evans celebrated his 101st birthday last November. Sam
    Evans was older than Strom by a full month. Sam Evans is about
    the only man in America who could--who did refer to Strom
    Thurmond as one of the young guys.

    STATEMENT OF SAMUEL LONDON EVANS, FOUNDER, AMERICAN
                FOUNDATION FOR NEGRO AFFAIRS
        Senator Specter. Mr. Evans, we're honored to have you here,
    and you have wanted to meet with Superintendent Paige for some
    time. We're going to put your testimony in the record and this
    afternoon you're going to have a chance to meet with Secretary
    Paige. It's an honor to have you here, Mr. Evans.
        Mr. Evans. Thank you, Mr. Chairman. Let me say right away
    that I was up this morning around 3:30, 4:00 to be sure I get
    here because when Senator Specter calls me, I have to go. Let
    me say right away that I asked President Carter, when he was
    running for office, to set up the Department of Education.
    Everywhere I go I hear people talking about education. Nations
    of the world are rated on three things: what percent of that
    nation is educated; number two, what percent is economic
    secure; and number three, what is their behavior pattern and
    sense of values?
        It is right here our behavior pattern and sense of values
    in education that is destroying America's democracy. America
    ranked 22 among the nations in science, mathematics, and
    education. It means then that the United States--21 nations in
    the world are greater educated than we are. It's because our
    behavior pattern and sense of values about education is
    contaminated with colonial concepts.
        Every step of the way it is preventive rather than
    encouraging. Let's take one instance. When you put a power in
    the hand of an individual today, the success of a student on
    any level is no further than the pen or pencil of his professor
    teacher. He has that power. But that awesome power is the
    control numbers. If you take up the philosophy of education,
    take it up and study it, you'd be amazed at the--how many
    individuals understand the American--you see, for instance,
    goal from K to graduate school, you come out, they will believe
    in six things, six, and those six will aid the controlling
    power and harm the other group.
        Number one, they believe in war, w-a-r, war. You keep the
    guns. Now you got population to deal with, we got to cut them
    up, cut them up into pieces, so therefore, number two, you
    believe in getting ahead of others rather than getting rid of
    the others. And number three, you believe in class distinction.
        Senator Specter. Mr. Evans, you have 1 minute left.

                               PREPARED STATEMENT

        Mr. Evans. Number four, you believe in authority. I'm sorry
    that I come here today, but I'd be glad to talk to anyone. I
    want to end by saying this, that the American educational
    system must be purified. Thank you.
        [The statement follows:]

                   Prepared Statement of Samuel London Evans

        The Frontiers Of Knowledge In: Integrated Concepts Of Science,
    Philosophy And Education Is Eliminated From The Established Schools Of
    Learning That Propagates Specialization. Therefore, The Curriculum Is
    Limited To Only ``One'' Of The Following Subjects:
        1. Philosophy Of Education
        2. Basic Concepts And Modern Physic
        3. Theory Of Values
        4. Nature Of Mathematics
        5. Anthropology
        6. Astronomy
        7. Paleontology
        8. Stars And Nebulae
        9. The World Of Crystal
        10. Direct Implicit In The Structure Of Earth
        11. Gestalt Psychology
        12. The Nature Of Aesthetics
        13. Signs Symbols And Personalities
        14. Laws Of Density
        15. The Nature Of Meteorology
        16. The Nature Of Etiquette
        In This Connection, Students Who Are Limited To: ``Only One,'' Of
    The Above Subjects, Are Recognized As ``Educated Models,'' However, The
    AFNA Program Serves In Two Or More Capacities:
        ONE.--``The AFNA Plan,'' Prepares The Student To Meet The Academic
    Requirements Of The School He Or She Attends, In Order That They May
    Pursue Professional Careers In: Medicine, Law, Computer Science,
    Business And Commerce, To The Humanities.
        TWO.--Beyond This, ``AFNA Students'' Are Privileged To Learn And
    Study The Entire Basic Structure Of: The Frontiers Of Knowledge, In
    Integrated Concepts Of: Science, Philosophy And Education.
        THREE.--Professors And Educators, Will Lecture In: One Of The Above
    Subjects . . . In This Connection, The Students Will Receive A Copy Of
    Each Lecture And Required To Take It Home For Study And Review . . .
    Students Then, Are Required To: Rewrite The Lecture, With The
    Cooperation Of Their Parents And Qualified Neighbors, All Assisting The
    Student . . . ``He'' Or ``She'' Will Then Bring A Copy Back To Their
    Class For Evaluation . . .
        Students Will Receive:
      --Ten Points For Completion
      --Ten Points For Spelling
      --Ten Points For Neatness
      --Ten Points For Format
      --Ten Points For Clarity And Etc.
        Means, The Total Experience Will Bring Academic Surroundings Back
    Into The Home And Made Available To Family And Community, For Study And
    Review . . . With The Desire To Expand The Concept Of Academic
    Scholarly Learning in The Home And Community Level.
        FOUR.--In This Connection, Students Are Required To Keep Copies Of
    Each Lecture For Their Files . . . For It Is Hoped That Each Student
    Will Complete Written Studies Of: ``The Sixteen Subjects, From 7th
    Grade, Through High, College And Graduate School . . .'' Indeed, Such
    An Achievement; Would Place Students On That High Rarefied Academic
    Platform, That Holds Less Than 7 percent of The World's Scholars.
        FIVE.--AFNA Is Not A School, College Or University. AFNA, Is A
    Supplementary Schooling Institute . . . Working And Preparing Students
    To Meet Their Academic Qualifications, In Cooperation With Academic
    Schools Of Learning. Together, AFNA, Universities, And Colleges, Work
    To Obtain The Needed Funds From: Federal, State, City And
    Philanthropists; To Eliminate The Dismissal Of Students For Tuition
    Deficiencies.
        The Need To Eliminate, ``BAR AND BOARD'S FAILURES,'' Based On
    Academic Deficiencies, Of Which The Students Have Already Obtained And
    Qualified Through Their Graduate Schools Of Learning.
        SIX.--Beyond This, AFNA; Requires That Each Student Be Given A Copy
    Of: ``The Declaration Of Independence,'' For Each To Study, Learn, And
    Recite . . . For It Represents The Basic Roots And Meaning Of: ``The
    American Form Of Government'' . . . Which Has Been Largely Eliminated
    In Schools Of Learning.
        Today, At This Writing 2004; 5th Of January, Humanity Is Divided
    Into A Multitude Warring Camps . . . With Each Group Fighting For Their
    Individual Advancement, Based On The Concept Of The Fastest Draw.
        Yet, Humanity Is 99.9 percent The Same, The 1 percent Difference Is
    Environment, Culture And Ethnicity . . . However, ``The AFNA Plan,'' Is
    Based On The Concept:
        ``One God And One Humanity'' . . .
        ``Seek Not Advantage Over Others, Seek Equality And Justice For
    All''
        ``Therefore, Democracy Is The Key, That Provides For Individuals,
    Or Groups, To Work Out Their Own Way Of Life, Without Fear, Or Without
    Hindrances And Without Destructive Attitudes Towards Others.''
        Therefore, No Race, Political Ideology, Religion, Commercial
    Enterprise Are Worth Saving, If It Destroys The Democratic Process Of
    Government.
        ``The AFNA Model,'' Students Learning In Cooperation With Parents,
    Guardians, Relatives, And Friends, Will Join The Other AFNA Graduates .
    . .
      --750 Medical Doctors
      --550 Lawyers
      --96 PhD's
      --4,500 College Graduates
        And Many Other Para-Professionals In The Health Fields.
                                   Evaluation

    [Mithras Group Ltd., Aaron N. Katcher, M.D., Chairman And Director, Of
        The Division Of Behavioral Sciences, University Of Pennsylvania]

        Indeed, In Evaluating The AFNA Plan: We List Below The Following
    From: The Mithras Group Ltd., Aaron N. Katcher, M.D., Chairman And
    Director, Of The Division Of Behavioral Sciences, University Of
    Pennsylvania.
                    excerpts of the evaluation (mgl) process
        In This Connection, We Know; Doubt Comes From The Thought That You
    Could Be Doing Better. Well-intended, Even Satisfying Effort Is Not
    Always Effective . . . Are The Courses In AFNA The Right Ones, Should
    The AFNA Students Be Spending Their Time In A Laboratory, And Are They
    The Right Students For The Program?
        The Above And The Following Doubts, Are Doubts About ``The Model''
    . . . ``The Plan'' . . . Is It The Best Mode For A Supplementary
    Minority Education Program? In Describing, ``The Model,'' We Also
    Described How We Displayed That Mode To A Succession Of Audiences In
    Pursuit Of Critical Commentary . . . The Meetings Of The American
    Association Of Medical Colleges, The Conferences Of Educators With
    Interest In Minority Problems, Convened In Philadelphia And New
    Orleans. The Discussions, With Faculties Of The Participating Medical
    Colleges, And The Paper Presented To The Association For Higher
    Education In Chicago.
        One.--In All Of These Meetings, ``The Model''; Was Exposed For
    Evaluation, Amendment And Revision. No Substantive Suggestion For
    Change Were Offered. If There Were Anything Better Or More: The
    Participants In The Program Should Be Doing, Those Who Should Know,
    Were Silent About Describing What That ``More'' Might Be . . .
        Two.--The Next Doubt, Was A Question About The Outcome Of The
    Program . . . That Goes Beyond The Know/edge Of Personall Success Of
    The Students We Have Known In The Program; The Kind Of Description Of
    Outcome That Goes Beyond Individuals, To The Abstraction Of Numbers.
        The Numbers And Findings Have Been Gathered:
        (A) 98 percent Of Those Completing The High School Phase Of The
    Program Go On To College . . .
        (B) College Retention Rate Over All Four Years is 83 percent . . .
        (C) 57 percent Of The Students Entering College, Graduate . . .
        AND THE IMPORTANT BOTTOM LINE,
        (D) 25 percent Of The Students Who Enter College, Go On To
    Graduate, Or To Medical School . . .
        An Evaluation Of The Program Conducted In Cooperation With The
    Educational Testing Service Of Princeton, Demonstrated, The Program's
    High Retention And Graduation Rates From High School . . . This Record
    Was Achieved With Students, Whose SAT Scores Were Well Below The
    Average Goals For Students In College They Attended.
        Therefore, The Evaluation Of ``The Model'' Presented Herein Has Met
    Every Test And Goes Over And Beyond The Usual And Previous Analytical
    Problems Of Leaders. Indeed, ``The Model'' Has Accomplished Its
    Purposes.
        So In Conclusion, When The AFNA Students Have Reached The
    Requirement Of Their Profession, They Will First Direct Their Knowledge
    In:
        ``Building Security Of: The Family, Mother, Father, Guardian, And
    Country . . . The Very Roots Of Your Living And Being, To Meet Their
    Needs In The Sunset Of Their Life.''
        Indeed, Brothers And Sisters, Under This United Conviction, We:
        ``WOULD RATHER RIDE IN AN OX-CART, OR A COVERED WAGON IN A
    DEMOCRACY . . . THAN IN A ROLLS ROYCE, DRIVEN UNDER A DICTATOR.''

        Senator Specter. Thank you very much, Mr. Evans. Thank you
    for your profound statement.

    STATEMENT OF C. DELORES TUCKER, FOUNDER, PHILADELPHIA
                MARTIN LUTHER KING, JR. ASSOCIATION FOR
                NON-VIOLENT CHANGE
        Senator Specter. We turn now to Dr. C. Delores Tucker,
    founder and national chair of the National Congress of Black
    Women, also founder and president of the Bethune-DuBois
    Institute and the Philadelphia Martin Luther--Dr. Martin Luther
    King, Jr. Association for Non-Violent Change. She served as
    Pennsylvania's Secretary of State, attended Temple University
    and the Wharton School of the University of Pennsylvania. Thank
    you for joining us, Dr. Tucker, and I might add to your regular
    resume your leadership on education at Cheyney and other
    educational institutions.
        Dr. Tucker. Thank you so much. I can't say much about you
    because of the 5-minute rule, but nevertheless, to leave a
    child behind is to leave a child behind forever. We as a Nation
    can ill afford to allow ourselves to slip into a second-rate
    position in any area of global competition. The No Child Left
    Behind Act must be more than a slogan. It must be a reality.
        Outsourcing is one of the problems that we're facing
    because we have not met up to that position of that child being
    educated. I'm going to say all of this to get to my time. There
    is a wealth of undeveloped talent languishing in the urban
    centers of America, but we have the will and the vision to
    really tap into what this Nation needs, a tap into the brain
    pool of wealth. America would be assured of achieving
    educational superiority over all nations in this century.

                           COLLEGE FOR TEENS PROGRAM

        The National Congress of Black Women, the Philadelphia
    Martin Luther King Association, of which you serve on our board
    with our mayor, Senator Specter, we have tapped into this brain
    pool of wealth with our College for Teens program, which grew
    out of our College for Kids program, 9 to 12 years of age,
    which began at the University of Pennsylvania 10 years ago, and
    parents said you can't drop them at 12 years of age, that's
    from 9 to 12. And so I said, what can we do? College for Teens.
    We approached you, and you recognized the need for training our
    young people early.
        Thirteen months after I met with the president of Cheyney
    University, we cut the ribbon for 200 students to live on
    Cheyney's campus in the summer learning the work that they're
    going to have in the fall and being taught by the Princeton
    Review national organization, training them to learn the work
    that they're going to have in the fall, but also geared toward
    enhancing their SAT scores.

                STUDENT PARTICIPANT OF COLLEGE FOR TEENS PROGRAM

        I have one of the young persons here now that was a part of
    the second College for Teens program. We had 246 young people
    living on campus at Cheyney University this past fall--summer
    rather. And she's here today, and I want you to stand right
    here for a minute, quickly please, and tell him what your
    scores increased to when you went into the school and when you
    came out of the school.
        Ms. Dursey. When I started I had----
        Senator Specter. Would you step forward and speak into the
    microphone? First, if you would identify yourself, please.
        Dr. Tucker. You have 5 minutes too, right? Yeah, 2\1/2\,
    2\1/2\. I'll let the child speak.
        Ms. Dursey. Hi, my name is Nakeisha Dursey. I'm a
    Philadelphia student at the Philadelphia High School for Girls.
    When I first started the program my score was 1,140. When I
    left it was 1,400.
        Dr. Tucker. It was 1,100?
        Ms. Dursey. It was 1,140 when I started.
        Dr. Tucker. And then when you left?
        Ms. Dursey. It was 1,400.
        Dr. Tucker. 1,400. That's what we do. Her parents are here,
    her mother is here, and we have others that have come, but we
    just wanted to have a child speak with you today. The first
    year the Princeton Review provided SAT preparation classes for
    all program participants whose student achievement--well, I
    skipped so many pages I'm up to page 6--but the Martin Luther
    King Association for teens exemplifies your program, Senator
    Specter, your zeal for student achievement. One hundred percent
    of all graduating high school seniors from the 202--the 2002
    MLK program successfully completed the college application
    process and were accepted into college. And this last class,
    the 246th, we didn't have the money for it but we reached out
    to do it anyhow.
        I'm saying as I close, I got so far down here I'm at the
    end--with the outsourcing of jobs overseas, education is no
    longer a domestic issue. It is now a global issue. No Child
    Left Behind must become the catalyst for success for all of
    America's students. The law meant to deliver on President
    Bush's campaign promise to improve public school education with
    specific regard to the substandard educational opportunities
    that have been historically offered to poor and minority
    students.

                       AFTER SCHOOL AND SATURDAY PROGRAMS

        Clearly, Senator Specter, you have maximized the funding
    opportunities that we needed because this isn't just the summer
    program. We have an after-school program coupled with this
    where we make sure they stay ahead and they keep ahead of the
    courses and they have--they're great students when they go into
    school and they just say that we're bored now, we don't have
    everything, everybody wants to tell us--want us to tell them
    how to do things.
        Well, we also have a Saturday program where they come in
    and enhance their computer skills and we give them a free
    computer, so we help them in every way, and we just want you to
    know that this year we hope to have 300 students on that campus
    and we've started another College for Teens at Capital College,
    which is right here in Maryland, and the Justice Department has
    said this is one of the model programs that they have seen in
    this country. Nowhere else is this program done, but it's a
    vision that I had because I've been raising and working for
    children all my life.

                             CHILDREN WITHOUT HOMES

        When I was Secretary of State, I went up to school to get
    the kids registered. I got the voting age reduced from 21 to
    18. I saw the gang coming into the high school. I said why do
    you travel with gangs? And you know what they said to me? And
    this is what I want to leave with you. They said, Dr. Tucker,
    you have to understand, the gang is our family and the street
    is our home. We wanted Gerard College, because where these
    children don't have homes, and too many don't, that's where the
    problem is, that's where the problem is. Those who do not have
    parents, like the little 6-year-old boy that was living with
    his mother, she was on drugs, father in jail, mother on drugs,
    Flint, Michigan, and they took him, put that boy into a home
    with his relative and that was a crack house. So he went to
    school one day in Flint, Michigan and killed a student who was
    6 years old.

                               prepared statement

        So we need to deal with the children who do not have homes,
    like Gerard College, and I would like to invite the Senate for
    you to bring a team up there. That's what Steven Gerard did in
    the 1800s. He was an orphan, and he said, in order to take
    these children and train them and make them the best that they
    are--and when I gave the graduation address there the other
    day, I cried, because I've never seen so many males walking in
    a graduation class, because 15 to 24, 60 percent of that age
    are in what I call the three-P: prison, parole, probation.
        The last point that you always hear, this is a cost. It is
    not a cost. It is an investment. It's an investment that will
    take care of itself, and either we are going to educate or the
    other choice is incarcerate, and that's the cost.
        [The statement follows:]

                  Prepared Statement of Dr. C. Delores Tucker

        To leave a child behind now is to leave a child behind forever! We,
    as a nation, can ill-afford to allow ourselves to slip into a second
    rate position in any area of global competition. The No Child Left
    Behind Act must be more than a slogan; it must be a REALITY, if America
    is to maintain her position of influence and respect in the global
    community. The greatest power that America can amass at this juncture
    in history is BRAIN POWER!!! Even as we deliberate here today, many of
    our blue chip companies are OUTSOURCING jobs that require critical
    thinking and analytical skills as well as high-tech jobs because it is
    said that not enough students who graduate from our high schools,
    colleges, and universities have the academic prowess to perform
    efficiently and competitively. This is a sad commentary on the most
    powerful country in the world!
        Every day and every week we are reading reports where America is
    losing its advantage because of a perceived lack of Brain Power on the
    part of our youth. Conversely, an excellent commentary on the world's
    leading nation is that congressional appropriations support public
    schools as well as comprehensive youth development programs that
    prepare students to succeed in any aspect of the American workforce,
    that is, congressional appropriations reinforce America's greatness!
        I am here today to applaud and praise the Congress for the progress
    you have made in recognizing how important youth development programs
    are in maintaining educational excellence in our great nation. There is
    a wealth of under developed talent languishing in the urban centers of
    America. If we have the will and vision to really tap into this ``Brain
    Pool of Wealth'', America would be assured of achieving educational
    superiority over all nations, in this century.
        The National Congress of Black Women and The Philadelphia Martin
    Luther King, Jr. Association for Nonviolence have begun, what we
    believe to be, a very unique program, in Philadelphia, Pennsylvania, to
    tap into this Brain Pool of Wealth. It is our College For Teens
    Program, which began in 2001 at Cheyney University, in Pennsylvania. It
    allowed low-income, first generation, minority students to experience
    the rigors of a college environment for six weeks. It features a three
    (3) pronged approach to student achievement:
        1. An After-School Tutorial Program that focuses on direct
    instruction in language arts and mathematics;
        2. Saturday Computer classes that bridge the digital divide; and
        3. Summer College Residency Program that features a six to eight
    week college preparation program, where students live on the college
    campus and prepare for the SAT, receiving academic preparation from The
    Princeton Review professionals.
        Longitudinal data reveal that The SUCCESSES of those students are
    phenomenal!
        The first year The Princeton Review provided SAT preparation
    classes for all program participants, whose grades represented eighth
    through twelfth. THE AVERAGE GAIN IN PRE and POST SAT RESULTS WERE 140
    points, as measured by The Princeton Review. This success was a direct
    result of the investment Senator Arlen Specter made in the public
    school children of Philadelphia.
        In 2002, TWO HUNDRED STUDENTS participated in the Philadelphia
    Martin Luther King, Jr. Association for Nonviolence's College For Teens
    Program because Senator Specter is committed to early intervention for
    student success and he wants to close the achievement gap that
    presently exists between urban and non-urban student populations.
    Senator Specter is to be commended for raising the level of
    expectations for all of America's students so that America will bridge
    the digital divide and the student achievement gap. He has done this by
    thoroughly examining the tenets of all appropriation requests, ensuring
    that America's dollars will yield American success.
        The MLK Association's College For Teens Program exemplifies Senator
    Specter's zeal for student achievement.
        Examples:
      --100 percent of all graduating high school seniors from the 2002 MLK
            program successfully completed the college application process
            and were accepted into college;
      --School attendance in the targeted middle and high schools
            increased;
      --Parent participation in school activities increased; and
      --SAT scores measured average gains of 160 points.
        Examples:
      --In 2003--246 students were enrolled in the College For Teens
            Program representing grades seven through twelve;
      --80 percent of the student population represented returning
            students; and
      --SAT Scores soared an average of 200 points!
        One high school sophomore, who is with me today, increased her 2003
    SAT Score by almost 400 points!
        Her mother and grandmother comprise 50 percent of the executive
    committee of her high school PTA, and she has maintained a 3. GPA
    throughout high school, and until today has a nearly perfect attendance
    record for the first two years of her high school career.
        With the OUT-Sourcing of jobs overseas, education is no longer a
    domestic issue . . . it is now a global issue! No Child Left Behind
    must become the catalyst for success for all of America's students! The
    law was meant to deliver on President Bush's campaign promise to
    improve public school education, with specific regard to the
    substandard educational opportunities that have been historically
    offered to poor and minority children. Clearly, Senator Arlen Specter
    has maximized his funding resources to advance public education and
    community development in limited communities in Philadelphia.
        In closing, Senators, I say to you, think for a moment what it
    would mean to America's future to have one million inner-city children
    involved in a program like this one. We must remember that education is
    not a cost but a lifetime investment.
        Thank you.

        Senator Specter. Thank you very much, Dr. Tucker.

                     AMERICAN FOUNDATION FOR NEGRO AFFAIRS

        Mr. Evans. Mr. Chairman, would you permit me to just have
    read--just mention a word about the AFNA program. I just want
    Dr. Cooper to come up and read about what AFNA is all about.
        Senator Specter. Mr. Evans, we're running very late, but
    how much time would you need?
        Mr. Evans. Well, how much time do you think these kids are
    worth? What I'm saying is I took my time to come down here.
        Senator Specter. Go ahead, Mr. Evans.
        Mr. Evans. Well, I'm saying. Wait a minute--where are you
    at, Cooper? Will you come up here? Are you here? Come over
    here? Okay, sit down there, Cooper. Let me say this, I want to
    say this. We are never going to solve a program in a colonial
    system where you don't permit to present what you're doing.
    Now, I put in some 75, 80 years in this work and real sincere,
    and I'm 100 years old and you're going to give me 5 minutes to
    explain my work.
        So let me come here now and say this. I'm a resident of
    America, I'm an American, and I want to see America work. Now I
    want Dr. Cooper just to read just what AFNA's doing, read this.
        Senator Specter. Would you identify yourself for the record
    at the start please?
        Mr. Cooper. Reverend Jason Jerome Cooper, member of the
    AFNA staff. AFNA national education and research fund, AFNA is
    and AFNA is not----
        Mr. Evans. Louder.

                   AFNA NATIONAL EDUCATION AND RESEARCH FUND

        Mr. Cooper. AFNA is a scholarship--is not a scholarship or
    loan-granting organization, a job placement agency, an
    organization that pays students for participation, a guarantee
    of admission to college and other professional schools set up
    to provide students with summer jobs. AFNA is a non-profit
    organization, national in scope with national headquarters in
    Philadelphia.
        Mr. Evans. You're reading the wrong thing, Reverend.
        Mr. Cooper. Designed to assist students in pursuing
    professional careers in medicine, law, engineering, computer
    science, business through the humanities, through advanced
    academic tutorials and apprenticeships directed and supervised
    by the professionals. AFNA is working in conjunction with
    parochial----
        Mr. Evans. Reverend, will you just hold that? You're
    reading the wrong paper. Read the other paper, the paper about
    14 things. You're reading the wrong paper.
        Senator Specter. Mr. Evans, in another minute or two you'll
    want to chair this hearing.
        Mr. Evans. Well, I'm just saying that----
        Senator Specter. You may have him read the other paper if
    you promise not to run for the Senate, Sam.
        Mr. Evans. We have turned out some 800 medical doctors, 700
    lawyers.
        Senator Specter. Go ahead, sir.
        Mr. Cooper. Mr. Chairman, the paper that he's----
        Mr. Evans. You were reading the----
        Mr. Cooper. I'm sorry. AFNA national education and research
    fund is beyond the concepts of specialization and the frontiers
    of knowledge: integrated concepts, science, philosophy, and
    education, by Samuel London Evans. The frontiers of knowledge
    in integrated concepts of science, philosophy, and education is
    eliminated from the established schools of learning that
    propagates specialization. Therefore, the curriculum is limited
    to only one of the following subjects: (1) philosophy of
    education; (2) basic concepts of modern physics; (3) theory of
    values; (4) nature of mathematics; (5) anthropology; (6)
    astronomy; (7) paleontology; (8) stars and nebulae; (9) the
    world of crystal; (10) direct implicit in the structure of
    earth; (11) gestalt psychology; (12) the nature of aesthetics;
    (13) signs, symbols, and personalities; (14) laws of density;
    (15) the nature of meteorology.
        In this connection, Mr. Chairman, students are limited only
    to one of the above subjects that are recognized as educated
    models. However, AFNA program serves in two or more capacities.
    One, the AFNA plan prepares the student to meet the academic
    requirements of the school he or she attends in order that they
    may pursue professional careers in medicine, law, computer
    science, business and commerce, to the humanities.
        Two, beyond this AFNA students are privileged to learn and
    study the entire basic structure of the frontiers of knowledge
    in integrated concepts of science, philosophy, and education.
        Three, professors and educators will lecture on one of the
    15 subjects before mentioned, and in this connection the
    student will receive a copy of each lecture and be required to
    take it home for study and review. Students then are required
    to rewrite the lecture with the cooperation of their parents
    and qualified neighbors all assisting the student. He or she
    will then bring copies back to class for evaluation in
    completion, spelling neatness, and so on.
        This means, Mr. Chairman, the total experience will bring
    academic surroundings back into the home and made available to
    the family and the community for study and review with the
    desire to expand the concept of academic scholarly learning in
    the home and on the community level.
        Four, in this connection, students are required to keep
    copies of each of the 15 lectures for it is hoped that each
    student will complete written studies of the 15 subjects from
    7th grade through high, college, and graduate school. Indeed,
    such an achievement would place the students on the high
    rarefied academic platform that holds less than 7 percent of
    the world's scholars.
        Five, AFNA is not a school----
        Senator Specter. You now have 1 minute left on the time
    allocated by Chairman Evans.

                               EVALUATION OF AFNA

        Mr. Cooper. Let me then go to evaluation of the program by
    Dr.--by Dr. Katcher, The Mithras Group, Aaron N. Katcher,
    University of Pennsylvania. In this connection, we know no
    doubt--doubt comes from the thought that you could be doing
    better. Well intended, even satisfying efforts is not always
    effective. Are the courses in AFNA the right ones? Should AFNA
    students be spending their time in the laboratory or are they--
    are they right for the student? Is it the best model for the
    supplementary minority education program?
        In describing the model, we also describe how we displayed
    that model to a succession of audiences in pursuit of critical
    commentary. The conference of educators with interest in
    minority problems convened in Philadelphia and New Orleans, and
    the Association for Higher Education in Chicago. They
    discovered at all of these meetings the model was exposed for
    evaluation. If there were anything better to be added from
    these various organizations the participants in the program
    should be doing, none present were able to----
        Senator Specter. Reverend Jason Cooper, we have to move on.
    Thank you very, very much.

    STATEMENT OF PAUL G. VALLAS, CHIEF EXECUTIVE OFFICER,
                SCHOOL DISTRICT OF PHILADELPHIA
        Senator Specter. Dr. Paul Vallas, will you resume your
    place at the table? Thank you very much. We turn now to the
    distinguished chief executive officer of the School District of
    Philadelphia, Mr. Paul Vallas.
        Prior to coming to Philadelphia, he was the chief executive
    officer for the Chicago public schools, and we were very lucky
    to kidnap him from Chicago. He received his undergraduate and
    master's degree from Western Illinois University, was in the
    Philadelphia Inquirer just this morning on the issue of single
    sex education separating young men and young women, and said he
    wasn't going to adopt it until he found community support, so
    that's a sage approach. Mr. Vallas, you've waited a long time.
    Now the floor is yours.
        Mr. Vallas. It's always a pleasure to follow my colleagues
    and, of course, the great Dr. Evans and the great Dr. Tucker.
    I'll be very quick because we've really covered just about the
    same territory. First of all, I'm a strong supporter of No
    Child Left Behind. I think No Child Left Behind is bringing the
    accountability measures that are long overdue, and I'm not
    afraid to test and I'm not afraid to disaggregate the data,
    because I think the disaggregation of data, while it's created
    a great degree of consternation among many, it's long overdue
    because it really identifies the underachievement that exists,
    not only in large urban schools but in rural districts and
    suburban districts and even some of the more affluent
    districts. And I think by focusing attention on those who are
    being underserved, I think it forces us to be held accountable.

                              NO CHILD LEFT BEHIND

        You know, No Child Left Behind has four objectives. One is
    to provide children with more choices if they're in
    underperforming schools--oh, sorry about that. Should I start
    over? Just joking. Two, to provide supplemental education
    services for children who can have no choices other than their
    neighborhood school. Three, to reorganize those schools that
    are consistently academically failing. And four, to make sure
    you've got certified teachers.
        Now, clearly, while all of these goals pose in many
    respects much greater challenges for smaller districts,
    particularly districts with only one to two school districts,
    these goals, at least among the larger districts, are
    achievable, and rather than to go into how we've worked to
    comply with those goals, I'll just refer you to my written
    testimony that I've submitted with the attached materials to
    the committee.

                       STANDARDS, CURRICULUM, AND TESTING

        I will tell you this, though. In terms of testing and
    holding children to standards, I've always felt that if you
    understand what the standards are and your curriculum and
    instruction is aligned with those standards and the test that
    you subject your children to, are testing children to those
    standards, then every day that you deliver quality curriculum
    instruction, you are in fact teaching to the test.
        So, you know, the--our move towards obviously embracing not
    only standardized tests but our own turnover test in our
    revamping of our curriculum and our aligning of our curriculum
    and instructional models to the State standards are increasing
    the amount of time on tests spent helping children learn to
    those standards providing supplemental services.
        In our data-driven instruction, in which case we evaluate
    our children's progress every 6 weeks and then we make
    adjustments in that instruction so that we can do what we need
    to do to bring them to those standards. You know, I'm very
    comfortable with that. It certainly is creating a lot of
    consternation and a lot of anxiety, but, you know, that's good,
    because for far too long, at least in our school district,
    there has been so much underachievement and there has been a
    great degree of neglect.

                    NCLB ACT AND CHILDREN WITH DISABILITIES

        I will say this. Like my colleagues, I share with them the
    concern over funding. Let me point out that there has been a 36
    percent increase in funding, particularly, I believe, title I
    funding, and our district alone has received over $35 million
    in additional funding over the past couple of years. Clearly,
    the mandates--we need to be doing a better job to fully fund
    the mandates. We clearly need to be doing a better job to fully
    fund the special education mandate and I certainly think that
    some modifications are in order when it comes to the students
    with English language deficiencies, as well as with special
    education students, because I also agree with my colleagues
    that IDEA and No Child Left Behind seem to be in conflict, and
    I think the evaluation of special education children should
    really be driven by their individualized education plan.

                               PREPARED STATEMENT

        But that said and done, you know, I think the--I think the
    act is a tool that sets clear, definable objectives, and I
    think it's an act that demands accountability. Certainly
    funding is an issue. Funding is always going to be an issue.
    Obviously that's where I will continue to focus my attentions
    on, but I do want to thank you for this opportunity to speak
    and to follow my distinguished colleagues. Thank you so much.
        [The statement follows:]

                      Prepared Statement of Paul G. Vallas

        Good morning. Thank you Chairman Specter, Ranking Member Harkin,
    and other distinguished members of the subcommittee for this
    opportunity to appear before you today. When Senator Specter asked me
    to testify here today on Philadelphia's implementation of the No Child
    Left Behind Act, I was both honored and humbled to appear. And given
    Senator Specter's unyielding support of the School District of
    Philadelphia and of education in general, I was delighted to accept his
    offer.
        Like any broad and sweeping reform of its nature, the No Child Left
    Behind Act has certainly drawn a great deal of attention recently.
    Passionate advocates both for and against the Act have filled the
    airwaves, the newspapers, and sometimes their own backyards with
    rhetoric espousing its virtues or deriding its failures. While there is
    certainly room for debate on the pros and cons of the Act, there can be
    little debate about this fact: there is simply no time to waste when it
    comes to setting high expectations for our children, providing the
    needed resources for children to meet these expectations, and holding
    adults accountable for achieving these expectations. As the head of
    America's sixth largest school district, it is my belief that the No
    Child Left Behind Act lays the groundwork for accomplishing these
    objectives, and I have made every effort to accomplish its mandates.
        The chief objective of the Act is closing the achievement gap
    between majority groups and minority groups. The greatest tool that
    NCLB provides to achieve this objective--and, I suspect, the greatest
    object of consternation of some of my colleagues--is the disaggregation
    of test scores by subgroup. For the first time, we are able to shine a
    spotlight on groups that have been historically underserved. With this
    recognition comes our obligation to provide whatever resources we have
    to correct this historic imbalance, and the structure of the Act
    provides districts with the opportunity to do so.
        The School District of Philadelphia has aggressively implemented
    all four phases of No Child Left Behind over the past two years. Those
    four phases are ``Expanding Comprehensive School Choice Options,''
    providing ``Intensive Supplementary Education Services in Low
    Performing Schools,'' ``Implementing a Rigorous Corrective Action Plan
    for Schools Not Making Adequate Yearly Progress,'' and ``Aggressively
    Recruiting Highly Qualified Teachers.'' The handout you have been
    given, entitled ``School District of Philadelphia: Programming to
    Implement No Child Left Behind Legislation'' details what we have
    accomplished under each of these phases, but I would like to draw your
    attention to a few highlights.
        Under ``Expanding Comprehensive School Choice Options,'' you will
    note that the District has 176 out of our 263 schools identified as low
    performing schools. With that, over 45,000 students chose to enroll
    this year in schools outside of their neighborhood schools. But the
    District went beyond the limits of ``choice'' as a decision to be made
    between your neighborhood school and a ``higher performing school.'' In
    addition to meeting the choice mandates of No Child Left Behind, we
    have also formed innovative new school-by-school partnerships with
    universities, museums, private managers, and even companies like
    Microsoft to manage and assist our lowest performing schools. We have
    also seeded our schools with magnet programs, International
    Baccalaureate programs, honors classes, dual credit offerings, and
    advanced placement courses to provide real choice to our parents. The
    School District has enacted a 300 percent increase in the number of
    honors and advanced placement courses, because we believe that closing
    the ``high achievement'' gap is just as critical as closing the
    ``remedial'' gap for our children.
        Under the provision calling for ``Intensive Supplementary Education
    Services in Low Performing Schools,'' the District has targeted
    assistance for over 40,000 Grade 1-9 students performing below grade
    level in reading and mathematics through the implementation of a
    comprehensive extended day academic program in all district elementary,
    middle, and comprehensive high schools during the 2003-2004 school
    year. The District has also implemented a comprehensive mandatory six-
    week summer school academic program in reading and mathematics for over
    58,000 Grade 3-10 students not meeting promotion requirements or
    performing below grade level. The District has contracted with Voyager,
    Princeton Review, and Kaplan to provide the curriculum and the
    professional development for these programs.
        The second part of your handout deals specifically with
    Supplemental Education Services, and I feel it is important to draw
    your attention to one problematic provision of NCLB here. As the
    briefing indicates, Pennsylvania has approved, and the School District
    of Philadelphia has contracted with, 20 providers of Supplemental
    Education Services. The District's Intermediate Unit (Pennsylvania's
    version of ``Education Service Agencies'') has also been approved as a
    provider, so services to low-achieving students through Voyager and
    Princeton Review can also receive funding under this provision. I
    cannot argue with the spirit of a provision that calls for parents to
    be able to choose between different providers for tutoring and support
    for their child, and I certainly support a free-market model that has
    these providers compete to provide the best services. But as the law
    stands, the price is in essence ``fixed'' as a percentage of a
    district's Title I budget, so very little can be done in terms of
    achieving the most amount of service for the most economical model. To
    put it simply, I as a superintendent was faced with the prospect of
    serving 12,000 students for 36 hours of instruction at $1,800 per child
    or serving 40,000 children for 160 hours of instruction at $300 per
    child. Wanting to serve the largest number of children, our District
    pursued the IU-provider model, and given that some of the providers in
    the Philadelphia area are making 60-70 percent profit on their
    services, I felt this to be the most prudent course of action.
        Under ``Implementing a Rigorous Corrective Action Plan for Schools
    Not Making Adequate Yearly Progress,'' the District has developed a
    mandatory, rigorous, and uniform K-12 standards-based curriculum,
    instructional delivery models, instructional materials, and aligned
    professional development system for low-performing schools. We have
    also implemented a uniform district-wide assessment system to
    complement the results from our state assessment to provide yearly
    benchmarks for district and school accountability. As your handout
    indicates, we have provided a number of additional resources to provide
    support for our schools lagging behind in AYP. This includes changes in
    the management, structure, and organization of low performing schools
    that cannot demonstrate improved performance; 49 failing schools in
    Philadelphia were restructured with private and charter school
    management, 22 comprehensive high schools have implemented 9th grade
    academies designed to narrow the achievement gaps of students below
    grade level in reading and mathematics, and a number of failing middle
    schools have been converted into neighborhood K-8 magnet and high
    school programs.
        Finally, the District has wholeheartedly embraced the provisions
    requiring the ``Aggressive Recruitment and Retention of Highly
    Qualified Teachers.'' Under our Campaign for Human Capital, the
    District hired over 1200 new teachers this year working with programs
    like Troops for Teachers, Teach for America, our retired teacher
    program, and aggressive recruitment and retention practices. Even in
    spite of a substantive class-size reduction in grades K-3, which
    necessitated the hiring of an additional 400 teachers, we met our
    hiring objectives and opened the school year with almost no teacher
    vacancies.
        The School District of Philadelphia has chosen to aggressively
    implement the No Child Left Behind Act because its tenets are sound and
    its goals are clear: we must do all that we can to ensure that all of
    our children are reaching their full potential. There is certainly room
    for improvement, however. While no one should deny that meaningful
    increases in federal education funding have been achieved under No
    Child Left Behind (a 36 percent increase since 2001), providing more
    Title I resources, which can be used rather flexibly to support proven
    successful practices like reduced class size and after school
    assistance, should be a priority. Providing transportation resources
    for choice programs, which for Philadelphia has meant more than $7
    million in additional costs, would be a welcome assistance. Moving
    closer to a 40 percent funding of special education versus the current
    18 percent funding is critical as disaggregated data shows how woefully
    inadequate our special education resources are. And complementing a
    standards and accountability movement such as the No Child Left Behind
    Act with a desperately needed school construction assistance program
    would be a smart investment in districts like Philadelphia whose walls
    have sometimes fallen faster than our test scores in past years.
        While we can't shortchange our children by failing to fund reforms,
    neither can we hold their futures hostage by waiting for a never-ending
    funding debate to resolve itself. The School District of Philadelphia
    has demonstrated that substantial education reform can be attained by
    using existing resources to fund education priorities. In short, our
    philosophy is about sending all available dollars into the classroom.
    We will continue to use the tools provided us under the No Child Left
    Behind Act to accomplish this, and we will not allow excuses to get in
    the way of achievement. Thank you again for the opportunity to provide
    comment here today, and I welcome any questions you may have.
    School District of Philadelphia Programming to Implement No Child Left

                               Behind Legislation

                 EXPANDING COMPREHENSIVE SCHOOL CHOICE OPTIONS

    Expand the opportunities for students attending the 176 identified low
            performing schools (total number of district schools is 263) to
            transfer to higher performing schools
        Over 45,000 students choose to enroll in schools outside of their
    neighborhood schools:
      --Sent 2003-2004 School Choice notifications to families of 127,499
            students via mail; as well as posted information on the
            district web site, press releases, and public notices to the
            media.
      --Over 3,000 students will transfer from the district's lowest
            performing, highest poverty schools for the 2003-2004 school
            year.
      --Over 1,000 students transferred as part of a Regional Program for
            School Choice from the 10 lowest performing/highest poverty
            elementary schools during the 2002-2003 school year.
      --Over 11,000 students participate in the district's voluntary
            transfer program from 132 racially isolated low performing
            schools.
      --Over 11,000 students are enrolled in district magnet programs in 13
            high performing middle and high schools (over the next five
            years a significant number of magnet programs will be
            introduced with as many as 15 added during the 2003-2004 school
            year).
      --Over 19,000 students are enrolled in 46 charter schools (four new
            charter schools have been approved for 2003-2004, and an
            additional three new charters will open in 2004-2005).
        Over 20,000 students are enrolled in the 70 identified new
    partnership schools (45 privately managed, 21 restructured by the
    district, and 4 new district charters) as part of the school reform
    process (over the next five years the number of partnership schools
    will continue to increase, with 10 additional schools added in 2003-
    2004).
        Within the next five years, 11 new magnet high schools will be
    constructed (one in each academic region); 14 large middle schools will
    be converted to small neighborhood magnet high schools (during 2003-
    2004, 6 middle schools will begin conversions).
      --Formed partnerships with universities (Drexel, Eastern, Holy
            Family, St. Joseph's, and Temple Medical School) to develop new
            management structures for low performing high schools.
      --Formed partnerships with private and public institutions to enroll
            high school juniors and seniors in high performing college
            preparatory and school-to-career programs.
        Within the next five years, 30 low performing smaller middle
    schools will be converted into neighborhood K-8 schools with open
    enrollment for students living in that region.

      INTENSIVE SUPPLEMENTARY EDUCATION SERVICES IN LOW PERFORMING SCHOOLS

    Expand the opportunities for students attending low performing schools
            to receive intensified supplementary education services to
            significantly improve academic achievement
        Implemented aggressively a school readiness campaign (Healthy Kids,
    Healthy Minds) for screening and health care support services for
    students prior to enrolling in the district's full-day Kindergarten
    program, and at appropriate grade levels in compliance with
    Commonwealth of Pennsylvania mandates (during 2002-2003, 75 percent of
    students screened for vision, 2003-2004 projection: 95 percent; during
    2002-2003, 12 percent of students screened for dental, 2003-2004
    projection: 75 percent).
        Targeted physical and behavioral health care support and case
    management services for elementary school students who are performing
    below grade level, i.e., establishment/verification of insurance
    coverage, medical and dental care homes, behavioral health linkages as
    needed, and timely resolution of identified health problems (during
    2002-2003, 72 percent of students had documented insurance, 2003-2004
    projection: 95 percent).
        Implemented a rigorous district-wide promotion/graduation policy as
    a means of identifying and supporting students performing below grade
    level.
        Targeted assistance for approximately 30,000 Grade 3-9 students
    performing below grade level in reading and mathematics through the
    implementation of a comprehensive extended school day academic program
    in all district elementary, middle, and comprehensive high schools
    during the 2002-2003 school year.
        Contracting with PDE approved providers to administer extended
    school day and summer programs including Voyager, Princeton Review and
    Kaplan Learning, 21 community based organizations in 11 Beacon School
    sites (serving over 1,300 students with 8 new sites in development),
    and 17 private providers (offering tutoring services to 4,538
    students).
        Implementing a comprehensive mandatory six-week summer school
    academic program in reading and mathematics for over 58,000 Grade 3-10
    students not meeting promotion requirements or performing below grade
    level (12,000 students participated in 2002).
      --Providing summer programs for over 5,000 English Language Learners
            and Special Education students.

     IMPLEMENTING A RIGOROUS CORRECTIVE ACTION PLAN FOR SCHOOLS NOT MAKING
                            ADEQUATE YEARLY PROGRESS

    Develop and implement a rigorous accountability system that ensures
            academic improvement and sustained growth through a system of
            evaluating, monitoring, and providing assistance to low
            performing schools
        Developed a mandatory, rigorous, and uniform K-12 standards-based
    curriculum, instructional delivery models, instructional materials, and
    aligned professional development system for low performing schools.
        Implemented a uniform district-wide assessment system to complement
    the results from the state assessment system (Grades 3, 5, 8, 11 in
    reading, writing, and mathematics) and provide yearly benchmarks for
    district and school accountability.
      --Over 128,000 Grade 3-10 students were assessed using the TerraNova
            in reading, mathematics, and science in the fall 2002 to set
            district, school, and individual student baselines for academic
            performance.
      --Over 157,000 Grade 1-10 students were assessed using the TerraNova
            in reading, mathematics, and science in the spring 2003 to
            measure district, school, and individual student progress for
            academic performance from the fall 2002 baseline.
      --Over 58,000 Grade K-3 students were assessed quarterly using the
            Dynamic Indicators of Basic Early Literacy Skills to measure
            and track individual student progress in fluency, phonics, and
            phonemic awareness.
      --Over 58,000 Grade K-3 students were assessed quarterly using the
            Diagnostic Reading Assessment to measure and track individual
            student progress using running records.
        Developed a rigorous district-wide school performance index to
    complement the state NCLB Accountability Plan by tracking school
    progress using a variety of indicators including the PSSA, the
    TerraNova, student mobility (the district average is 35 percent
    annually for each school), student, attendance, teacher attendance,
    persistence rates (the percentage of students who do not drop out of
    school before graduation), and promotion and graduation rates.
        Implemented a rigorous school quality review process to evaluate
    the performance of the district's 85 identified lowest performing
    schools.
        Wrote corrective action plans with mandated timelines and
    implementation strategies for the district's 85 identified lowest
    performing schools (this includes privatized, charter, and district
    restructured school models).
        Designed and implemented a uniform process for school improvement
    planning for the 2002-2003 school year for all the district's 263
    schools, based on the findings from the school quality review process.
        Developed procedures for changes in the management, structure, and
    organization of low performing schools that cannot demonstrate improved
    performance.
        Pre qualified up to 5 new private companies to manage additional
    low performing district schools.
        Restructured 49 failing schools by implementing proven privatized
    and charter school models (over the next five years the number of
    privatized and charter schools will continue to increase, with 14
    additional schools added in 2003-2004).
        Restructuring failing middle schools by converting schools into
    neighborhood magnet K-8 and high school programs (during 2003-2004, 3
    middle schools begin conversions).
        Restructuring failing high schools by implementing a rigorous
    reform movement that includes converting schools that do not
    demonstrate improved performance into neighborhood magnet programs
    (during 2003-2004, 22 comprehensive high schools will implement 9th
    grade academies designed to narrow the achievement gaps of students
    below grade level in reading and mathematics).
        Facilitated the implementation of the Accountability Review Council
    in cooperation with the School Reform Commission to meet the
    requirements of the district reform partnership agreement between the
    city and state governments (the ARC will certify the district's reform
    results and produce annual report cards measuring the progress of
    reform).

              AGGRESSIVE RECRUITMENT OF HIGHLY QUALIFIED TEACHERS

    Institute the Campaign for Human Capital, a blueprint for the
            recruitment, retention, and renewal of a highly qualified
            teaching staff
        Utilizing alternative recruitment strategies including Teach
    America and Troops to Teachers (resulting in the hiring of 145 new
    qualified teachers).
        Implementing an aggressive strategy to recruit qualified
    mathematics and science teachers through partnerships with local
    universities such as Drexel University and the Transition to Teaching
    Program.
        Expanding the Reduced Class Size model from K-2 to K-3 classrooms
    to increase the district's pool of highly qualified elementary school
    teachers.
        Preparing emergency certified teachers for the Praxis examination
    by offering classes at Holy Family, Temple, or using an on-line Praxis
    preparation course.
        Expanding the district's pool of highly qualified elementary school
    teachers by assigning former literacy interns who have become certified
    to serve as stand alone teachers (it is anticipated that 250 new
    teachers will come from this pool).
        Developing a competency profile made up of characteristics commonly
    possessed by the highest quality teachers as found by a variety of
    research methods, including surveys, focus groups, interviews, etc.
        Implementing an aggressive marketing campaign to target segmented
    groups of high need teacher candidates (African-Americans, males,
    critical needs subject area candidates).
        Implementing a training program to build the capacity of the
    recruitment team by exposing them best practices.
        Designing ``Leadership for Retention and Renewal'' professional
    development program--that will equip them with the skills and
    strategies necessary to support all teachers (rookie, novice and
    veteran) in their schools.
        Implementing a tuition reimbursement program for teachers beginning
    their second year in the district to continue professional development,
    thus providing an incentive for ongoing professional growth.
        Implementing a comprehensive mandated pre-service training program
    all new teachers must attend to ensure their preparedness for entering
    our classrooms.
        Establishing the position of New Teacher Coach to support newly
    hired at teachers at a 10:1 ratio.
        Expanding the district's current incentive programs to attract
    highly qualified teachers to include a Teacher Ambassador Program
    called ``Every Teacher, an Ambassador'' which will provide a monetary
    incentive for identifying certified teachers and teachers in hard to
    staff positions.
        Increasing the number of student teachers by offering a series of
    incentives to the student teacher as well as to the cooperating
    teacher.
        Creating for the 2003-2004 recruitment season a ``Roll Out the Red
    Carpet Campaign'' strategy that will attract college juniors and
    seniors from our regional colleges and universities to learn about the
    benefits of teaching in our schools and living in Philadelphia.
        Testing of all instructional paraprofessionals has begun and will
    continue until all paraprofessionals meet the requirements of the
    statute.

                                 SES PROVIDERS

        No Child Left Behind guarantees that students from low income
    families who are attending low performing schools will have access to
    tutoring services paid for by the School District of Philadelphia. The
    Intermediate Unit's program was recently approved by the State as one
    of these supplemental providers.

    ----------------------------------------------------------------------------------------------------------------
                                               Number of hours                Cost               Students served
    ----------------------------------------------------------------------------------------------------------------
    SES Providers (47 approved by state).  36-40 hours total......  $1,815 per student.....  12,500
    Extended Day (using state approved     160 hours..............  $300 per student.......  Upwards of 40,000
     providers).
    ----------------------------------------------------------------------------------------------------------------

        The District, as required by law, notified parents that they could
    choose to use the services of an SES provider by letter on October 24.
    The letter included a list of all the SES providers--as well as their
    phone numbers--that had submitted their paperwork to the District.
        This letter followed up and reinforced an aggressive advertising
    program launched by the SES providers themselves back in August.
        The SES advertising has been ongoing from August until today.
        17,000 students improved their performance between the beginning of
    last year and the beginning of this year so that they have moved out of
    the bottom quartile, as measured by the Terra Nova. However, these
    students are still encouraged to take advantage of the District's
    Extended Day program.
        Extended Day is being modified from last year to include an hour of
    instruction as well as an hour of enrichment activities Monday through
    Thursday. The curriculum for instruction aligns with state standards
    and directly supports the new standardized curriculum being taught in
    all classrooms throughout the District. The second hour, provided in
    conjunction with community based organizations, is optional.
        There are 30,500 3rd through 8th graders in the District that can
    take advantage of the Extended Day program. In fact, the first hour of
    Extended Day is mandatory for students in grades 3, 8 or 11 who are
    scoring in the bottom quartile, as measured by the Terra Nova.
        The objective of the District's Extended Day program is to provide
    high quality supplemental educational services to all the District's
    children.
        To ensure that parents know about that they have this choice, the
    School District is sending letters home with students in 192 schools.
    Pursuant to federal law, low income families at the 192 schools qualify
    for supplemental services.
        State approved providers have partnered with the District in order
    to provide the high quality Extended Day program. The providers include
    Voyager, Princeton Review and Kaplan.
        Extended Day--which began October 17 for grades 3-8 and will begin
    on December 2 for grades 1, 2 and 9--is able to provide more hours of
    instruction and enrichment to more students than supplemental service
    providers can because they cost significantly less. For example, the
    average cost of Extended Day is about $300 per student for the 20 week
    program (up to 160 hours), while the law authorizes comparable
    supplemental services for $1,815 per student.
        While the District supports the spirit and intent of the federal No
    Child Left Behind law, it intends to enforce academic and fiscal
    accountability. This will ensure that as many children as possible can
    have access to services.
        Educational choice for parents and students is actually reduced
    when private companies are allowed to make unreasonable profits at the
    expense of students. Fewer students can be served and the quality of
    the program invariably diminishes.

        Senator Specter. Thank you very much, Mr. Vallas. When you
    said the thing has already been said, that was a commentary of
    a very famous Congressman, Mo Udall, a Democrat from Arizona.
    He stood at a speech once after many speakers presented
    themselves and he said, everything has been said, but not by
    everybody. And on Capitol Hill, it doesn't matter that
    everything has been said until everything has been said by
    everybody.
        This has been a very informative hearing and I want to
    thank you for coming from Pennsylvania on short notice. When I
    saw the meeting which you had on March 1, just on Monday, it
    seemed to me that really ought to attract the attention of the
    Secretary and his expert in the field, Mr. Ray Simon. And the
    Secretary will meet with you at 2 p.m. and you'll have a little
    more time.
        Everything that's been said has been transcribed in the
    record, and although the Senators come and go because they have
    many other committee assignments, the transcript will be read
    by staff and your words will be weighed, and I believe that
    there will be changes to No Child Left Behind. There will be
    modifications made as we go through the learning curve, and
    there will be more funding as well.
        We have a very tight budget this year, which you all know,
    but there are many of us here who, as you said, Dr. Tucker,
    consider education an investment. It is not an expenditure, and
    when Mr. Evans outlines what he has done for AFNA, we have
    recognized that on the Federal funding for many, many years, as
    we have recognized what you have done, Dr. Tucker, and what you
    are all doing.
        So thank you very much for coming. There is no higher
    priority on the budget than education and this subcommittee
    will pursue it with great diligence.
        Dr. Tucker. Thank you, Senator, too, for having us here.

                       STATEMENT OF SENATOR THAD COCHRAN

        Senator Specter. We have received the prepared statement of
    Senator Thad Cochran which will be placed in the record.
        [The statement follows:]

                   Prepared Statement of Senator Thad Cochran

        Mr. Chairman, I want to welcome the Secretary and thank him for
    coming to testify before the subcommittee today, and for his
    outstanding service to our nation as Secretary of Education.
        I appreciate the Secretary's attention to my state of Mississippi,
    which is also his home state. He has honored us with several personal
    visits.
        I've visited with our State School Superintendent, and a good
    number of teachers, principals and parents since the passage of the No
    Child Left Behind Act. My impression is that our State has embraced the
    concept of accountability and is utilizing the new flexibility that is
    built into the programs.
        I'm pleased to see the budget proposal for the Department of
    Education suggests increases of $1 Billion each for title I grants and
    Special Education grants to states. And, I'm pleased that continued
    funding is suggested for Ready to Learn Television, Civic Education,
    Character Education and other areas of importance. There are some areas
    in the budget proposal that eliminate programs that have been important
    to individual schools, teachers and assisted the State's efforts in
    meeting the requirements of No Child Left Behind. In particular,
    proposed elimination for the National Writing Project, Arts in
    Education, Gifted Education, STAR Schools, and Foreign Language
    programs for K-12 schools draw my attention. I'm concerned about those
    areas, and I know we'll work through the appropriations process and try
    to meet the needs and interests in my state and across the nation.

                         ADDITIONAL COMMITTEE QUESTIONS

        Senator Specter. 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

                          PENNSYLVANIA TITLE I FUNDING

        Question. In Pennsylvania 233 of 500 school districts who receive
    Title I grants will receive less funding in fiscal year 2004 than they
    did in fiscal year 2001, the year before the No Child Left Behind Act
    was passed. As a former superintendent, what advice related to carrying
    out this important law do you have for the 233 districts in
    Pennsylvania that will receive fewer Title I funds in fiscal year 2004
    than they did in fiscal year 2001?
        Answer. My advice would be that as important as Title I funding is
    to local school districts, it is typically a small fraction of overall
    funding, and that the reforms in No Child Left Behind are specifically
    designed to leverage education spending from all sources, Federal,
    State, and local. So the question is not what can or cannot be done
    with a Title I allocation, which may be smaller or larger than it was
    the year before, but how can we better allocate all our funding to help
    ensure that all our students reach challenging State standards.

                  BUDGET REQUEST AND HIGHLY QUALIFIED TEACHERS

        Question. Is the President's budget request for fiscal year 2005
    sufficient to meet the requirements of the No Child Left Behind Act,
    such as to attract, train and retain ``highly qualified'' teachers,
    implement additional testing requirements, and provide more public
    school choice and after-school tutoring, in light of the reduction in
    Federal funding for these districts?
        Answer. We believe Federal funding is more than adequate to meet
    the requirements of No Child Left Behind programs. As I mentioned
    earlier, success in meeting those requirements depends not primarily on
    a particular level of Federal support, but on making better decisions
    in the use of combined education funding from Federal, State, and local
    sources. I would add that when it comes to testing, the development and
    implementation of the additional assessments required by No Child Left
    Behind is separately funded through a State grant program, and the
    amount of this funding has been going up every year. In addition, not
    all districts are required to provide public school choice and
    supplemental educational services, just those in which schools have
    been identified for improvement, corrective action, or restructuring.

     STUDENTS TRANSFERRING TO SCHOOLS NOT IDENTIFIED FOR IMPROVEMENT UNDER
                            NO CHILD LEFT BEHIND ACT

        Question. Based on available information and pending analysis of
    consolidated State applications and other State-reported data, the
    Department has reported that 5,000 schools have been identified for
    improvement and an estimated 2.5 million students are available to
    transfer to a public school that is not identified for improvement. How
    many of these students have in fact transferred?
        Answer. These data will be included in the Department's forthcoming
    report on the implementation of key provisions in No Child Left Behind,
    which is scheduled for completion and submission to the Congress in
    late spring of this year.

                             TITLE I SCHOOL CHOICE

        Question. What is known about whether eligible students and their
    parents are choosing to stay in their current school?
        Answer. We do not have comprehensive data on this issue, but
    preliminary studies carried out by education organizations, as well as
    news reports, suggest that the great majority of students eligible to
    transfer to another public school do indeed stay in their current
    school. Sometimes this is because parents and students are more
    comfortable in their neighborhood schools; in other cases it may be
    that parents are encouraged by improvement efforts or other special
    programs at their current school. In still others, it may be that local
    school officials have not done enough to inform parents about available
    choices or have not provided that information early enough in the year.
        I would add that I see nothing wrong with parents choosing not to
    move their children, so long as they receive sufficient information on
    the available choices. The point of the public school choice
    requirement is that parents and students have options if they are not
    happy with their current school, and that no student is forced to
    remain in a poorly performing school if there is a better alternative.

                           BARRIERS TO SCHOOL CHOICE

        Question. To what extent do real and perceived barriers prevent
    students from exercising the choice option required by No Child Left
    Behind?
        Answer. I believe it is too early to determine the extent of this
    problem. Certainly in the first couple of years of implementing No
    Child Left Behind many districts did not aggressively inform parents of
    available choice options, and in many cases the fact that options were
    made available only after the school year had already started
    discouraged students from transferring. We expect, and have already
    seen, that such problems diminish over time, as States and districts
    improve their procedures and more parents become aware of choice
    options.
        Question. What specifically does the fiscal year 2005 budget
    propose to address these issues?
        Answer. Effective implementation of public school choice under No
    Child Left Behind is not really a budget issue, and our budget does not
    include any specific proposals in this area. As I mentioned earlier, I
    believe this is a problem that is being addressed over time. And of
    course the Department continues to provide guidance and technical
    assistance on public school choice, and to examine choice
    implementation as part of its regular Title I monitoring efforts.

                         REPORT ON NCLB IMPLEMENTATION

        Question. The subcommittee understands the Department's report to
    Congress, including State and local performance related to No Child
    Left Behind, is expected to be available in late spring of 2004. As
    soon as it is available, please provide the subcommittee with a copy of
    the report.
        Answer. We expect that the report will be completed and submitted
    to the Congress in late spring of this year.

              COSTS OF SCHOOL IMPROVEMENT AND CHOICE REQUIREMENTS

        Question. Based on information derived from State reporting and/or
    other reliable and appropriate data, what is the Department's estimate
    of the funding required to meet all of the requirements related to
    school improvement status--public school choice, supplemental services,
    school restructuring, etc.--which must be taken with respect to schools
    that fail to meet adequate yearly progress standards for 2 or more
    consecutive years?
        Answer. There is no reliable way to estimate such costs, primarily
    because States and districts have great flexibility in developing
    school improvement plans, and because costs will vary greatly from
    district to district depending on the extent of the problems that are
    preventing schools from meeting adequate yearly progress (AYP)
    standards. Also, it is not necessarily the case that school improvement
    or restructuring requires additional funding. More often, districts
    will obtain improved results through better use of existing funding
    from all sources--Federal, State, and local--rather than merely adding
    new spending or initiatives that tend to ignore problems in core
    instructional areas.
        Question. Does the fiscal year 2005 budget request provide
    sufficient funds to pay the costs of such activities?
        Answer. We believe the President's budget request, combined with
    funding made available in earlier years as well as State and local
    resources, is sufficient to pay for the school improvement requirements
    of the No Child Left Behind Act.

                          FUNDS FOR SCHOOL IMPROVEMENT

        Question. Mr. Secretary, the Pennsylvania Department of Education
    has indicated that under the No Child Left Behind law, they will have
    fewer funds available at the State level for school improvement than
    they did in fiscal year 2001, while they have almost three times as
    many schools identified as in need of improvement. How will the
    Department provide these schools with the additional assistance they
    need to improve the academic achievement of students, with fewer
    resources?
        Answer. It is possible that State-level resources for school
    improvement are somewhat lower than under the earlier law, but overall
    funding for school improvement efforts, which under No Child Left
    Behind is targeted to the district level, greatly exceeds the funding
    available for such activities prior to reauthorization. This is because
    under the old law, States were permitted, but not required, to reserve
    up to one-half of one percent of their Title I allocations for school
    improvement efforts. Under No Child Left Behind, beginning in fiscal
    year 2004, States are required to reserve 4 percent of their
    allocations for school improvement, and to distribute 95 percent of
    such reservations to those school districts with the greatest need for
    such funds.
        To put this change in dollar terms, in fiscal year 2001, States
    might have reserved as much as $44 million for school improvement. In
    fiscal year 2005, under the President's request for Title I, they will
    be required to reserve more than $500 million for this purpose.
        Congress did provide, in appropriations language, separate funding
    for school improvement, including the provision of public school choice
    options, in fiscal years 2000 and 2001. Even these amounts--$134
    million in 2001 and $225 million in 2002--were significantly below the
    levels provided under No Child Left Behind.
        Question. What other resources are proposed in the fiscal year 2005
    budget to assist schools trying to improve the academic achievement of
    all students, particularly those schools identified as in need of
    improvement or on watch lists?
        Answer. There are no specific proposals for additional school
    improvement-related funding in our budget, both because we believe the
    Title I reservation is sufficient and because, in a larger sense, all
    of our programs provide funding that is intended to help schools
    improve the academic achievement of all students.

                         SUPPLEMENTAL SERVICE PROVIDERS

        Question. Has the Department compiled any evidence that third-party
    supplemental services providers are more successful than their regular
    public schools in providing Title I services?
        Answer. No, we do not yet have any performance data on supplemental
    service providers. What we do know is that Title I, as operated by
    regular public schools over the past four decades, has largely failed
    to improve achievement for participating students. No Child Left Behind
    is trying to change this rather unimpressive record, and we believe
    third-party providers will be able to make a contribution in this
    effort, particularly for low-income students in schools that
    consistently do not make adequate yearly progress.

                        CHOICE AND SUPPLEMENTAL SERVICES

        Question. What information is available about the timeliness and
    effectiveness of communication to parents of affected pupils eligible
    for public school choice and supplemental services options?
        Answer. Preliminary studies and other early evidence suggests a
    mixed record by districts in communicating No Child Left Behind choice
    and supplemental service options to parents. In part this reflects the
    usual difficulties encountered in doing something new, and we have seen
    districts improve over time. And, unfortunately, it also reflects at
    least occasional reluctance by districts to fully comply with the
    requirements or spirit of the new law.
        Question. Are parents typically being offered a substantial range
    of choices?
        Answer. Based on the limited information we have, most districts
    are complying with the law, which requires a choice of more than one
    school. This is not the same as a ``substantial range of choices,'' but
    the law and our regulations do give districts some flexibility in this
    area, in order to take into account geographic limitations and allow
    LEAs to make efficient use of transportation resources.
        Question. Have any localities received waivers from the requirement
    to provide supplemental services; if so, how many have been provided?
        Answer. Such waivers may be approved by State educational agencies
    only if there are no available service providers and the school
    district itself is unable to provide services. We do not have data on
    waivers that SEAs may have granted.

                      MATHEMATICS AND SCIENCE PARTNERSHIPS

        Question. The fiscal year 2005 budget proposes to override the No
    Child Left Behind Act authorization for the Math and Science
    Partnerships program in order to administer a new competitive grant
    competition focusing solely on math instruction for secondary education
    students. How is this proposal consistent with Goal 2 and objectives
    2.2 and 2.3 identified in the Department's fiscal year 2005 Performance
    Plan related to math and science achievement, when additional funds may
    only be used for math instruction in secondary schools?
        Answer. The Administration believes that it is critical to fund
    efforts specifically to accelerate mathematics learning at the
    secondary level by helping secondary students master challenging
    curricula and by increasing the learning of students who have fallen
    behind in mathematics. Research indicates that many students who drop
    out of school lack basic skills in mathematics, and our Nation needs to
    support these students so that they can catch up to their peers and
    stay in school.
        Question. Where does the Department find any congressional intent
    for it to run a separate $120 million grant program focusing only on
    math instruction and reduce State flexibility to target funds to areas
    of greatest need?
        Answer. It is not at all unusual for a President to identify
    critical educational needs and, in between the periodic congressional
    reauthorizations of major education laws, propose either modifications
    to existing programs or even entirely new programs to address such
    needs. It also is not unusual for both the President and the Congress
    to emphasize one part of a law over another. In the case at hand, the
    President believes there is good reason to give priority to improving
    math instruction. Moreover, he is proposing to use new money to pursue
    this priority, thus preserving State flexibility in the use of existing
    funding.

                         STUDENTS' SCIENCE ACHIEVEMENT

        Question. Since annual science assessments will be required under
    NCLB beginning in the 2007-2008 school year, won't this new grant
    program designed only to improve math achievement curtail efforts to
    improve science achievement?
        Answer. Since we are proposing to use new money for the President's
    proposal to improve math instruction, I do not see how this would
    ``curtail'' current efforts to improve science achievement. In
    addition, since mastery of basic mathematics is often a prerequisite
    for learning most sciences, I believe it is reasonable to argue that
    the President's proposal may well have the additional benefit of
    contributing to improved science achievement.

                 FUNDS FOR ASSESSMENTS REQUIRED BY THE NCLB ACT

        Question. To date, the Congress has appropriated more than $1,161
    million to assist States with the development and implementation of
    additional assessments required by the No Child Left Behind Act and the
    fiscal year 2005 budget request includes $410 million for such
    authorized activities. The General Accounting Office, National
    Association of the State Boards of Education and other organizations
    have developed different estimates for the costs associated with the
    additional assessment requirements of No Child Left Behind. Is the
    Department confident that funding provided at the proposed fiscal year
    2005 level--in addition to funds already appropriated--would be
    sufficient to meet the additional assessment requirements of the No
    Child Left Behind Act? If so, please provide the subcommittee with the
    specific evidence used by the Department to reach this conclusion.
        Answer. We believe that the funding provided under the State
    Assessment Grant program, in addition to being fully consistent with
    the congressional authorization level and the ``trigger amounts'' in
    the law, is sufficient to pay for the costs of developing and
    implementing the new assessments required by No Child Left Behind.
        These costs vary considerably, of course, depending on such factors
    as the grades covered by a State's existing assessment system, the
    number of students tested, and the types of assessments used. This is
    why the cost estimates developed by differing organizations also vary
    considerably. Under these circumstances, and particularly in view of
    the fact that such costs were not separately funded under the previous
    law, we believe that No Child Left Behind funding for assessments
    reflects a reasonable and responsible approach to paying for the new
    assessments.

                        GRANTS FOR ENHANCED ASSESSMENTS

        Question. Within the amount provided for assessments, more than $21
    million has been used for activities authorized under the Grants for
    Enhanced Assessments Instruments program. Specifically, what projects
    have been funded to assist States with meeting the challenge of
    developing and implementing appropriate alternate assessments for
    students with disabilities and for developing and implementing
    assessments for English language learners?
        Answer. So far the Department has made nine grants under this
    program using approximately $17 million from fiscal year 2002 funds. A
    competition to award $4 million from fiscal year 2003 closed on April
    5, 2004. The Department estimates that it will make 6 grant awards from
    these funds.

    ENHANCEMENT OF ASSESSMENT PROJECTS FOCUS ON STUDENTS WITH DISABILITIES
                 AND STUDENTS WITH LIMITED ENGLISH PROFICIENCY

        The nine current projects, which are awarded to States or consortia
    of States, focus on enhancement of assessments for students with
    disabilities and students with limited English proficiency. Four
    projects focus on the assessment of English proficiency, two focus on
    appropriate test design and accommodations for LEP students, one
    project examines appropriate accommodations for special education
    students, one aims to improve the technical quality of alternate
    assessments for students with severe disabilities, and one project will
    enhance State capacity to evaluate and document the alignment between
    State standards and State assessments.
        Below is a short summary of each Grants for Enhanced Assessments
    project:
        Lead State: Utah Collaborators: Montana, Idaho, New Mexico,
    Colorado, Oregon, Wyoming, and North Dakota
        Grant amount: $1,842,893
        Summary: The project aims to develop a series of assessments of
    English language proficiency at four levels (K-3; 4-6; 7-9; 10-12) to
    enable teachers to diagnose the proficiency level of English language
    learners (ELLs).
        Lead State: Rhode Island
        Collaborators: Maine, New Hampshire, and Vermont
        Grant amount: $1,788,356
        Summary: The project will build upon an existing collaboration
    among Maine, New Hampshire, Rhode Island and Vermont and will help
    compare progress across States and combine resources to develop the
    highest quality assessments. States will examine the impact of
    computer-based testing accommodations on the validity of test scores
    for students with and without special needs, and train teachers to
    create and use the assessments.
        Lead State: South Carolina
        Collaborators: American Association for the Advancement of Science,
    Austin (Texas) Independent School District, The Council of Chief State
    School Officers, District of Columbia Public Schools, Maryland, and
    North Carolina
        Grant amount: $1,719,821
        Summary: The project will help gather valid information about ELLs'
    academic knowledge and skills, and matching ELL students with the
    proper accommodations based on their testing needs.
        Lead State: Oklahoma
        Collaborators: Alabama, California, Delaware, Kansas, Louisiana,
    Massachusetts, Minnesota, New Jersey, North Carolina, Pennsylvania,
    South Carolina, Texas, Wyoming, West Virginia, and Wisconsin
        Grant amount: $1,442,453
        Summary: The project will work to expand and automate a process for
    judging the alignment of assessments with content standards, serve
    students with disabilities and help link assessments across grades. The
    alignment process system will be available on a CD-ROM that can be
    readily distributed to States to increase the use of the alignment tool
    in assessment development and verification.
        Lead State: Nevada
        Collaborators: Indiana, Iowa, Kentucky, Louisiana, Massachusetts,
    Michigan, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, South
    Carolina, Texas, and West Virginia
        Grant amount: $2,266,506
        Summary: The project will help States implement assessments to
    measure the annual growth of English language development in speaking,
    listening, reading and writing. The project will produce test forms and
    an item bank from which States can draw to create test forms that
    reflect local needs and characteristics, and will help States predict
    ELLs' readiness for English language assessment.
        Lead State: Pennsylvania
        Collaborators: Maryland, Michigan, and Tennessee
        Grant amount: $1,810,567
        Summary: This project is designed to help States assess ELLs by
    analyzing State standards, establishing content benchmarks and
    developing standards-based assessments drawn from scientific research.
    The resulting assessments are to be shared with interested States and
    districts.
        Lead State: Colorado
        Collaborators: Iowa, Oregon, Illinois, Missouri, South Carolina,
    West Virginia, and Wyoming
        Grant amount: $1,746,023
        Summary: The project will help improve alternative assessments for
    students with complex disabilities, and the assessment methods will be
    developed, pilot tested and analyzed during the course of this project.
        Lead State: Wisconsin
        Collaborators: Alaska, Delaware and Center for Applied Linguistics,
    Center for Equity and Excellence in Education, Second Language
    Acquisition, University of Wisconsin, and University of Illinois
        Grant amount: $2,338,169
        Summary: This project will develop and enhance assessment
    instruments specially designed to measure ELLs' performance and
    progress in English proficiency and literacy skills based on State
    standards on reading, writing and language arts and alternate
    assessments to measure their performance in other academic content
    areas.
        Lead State: Minnesota
        Collaborators: Nevada, North Carolina, and Wyoming
        Grant amount: $2,013,503
        Summary: This project will develop new tools to measure the
    progress of ELLs using technology to pilot language assessment, develop
    new methods to organize, collect and score student assessment data and
    combine data from multiple measures to improve the evaluation of
    student progress over time. Staff development will help teachers use
    assessment results to improve instruction and the methods will be
    available to other States.

                  EFFECTIVENESS OF ASSESSMENTS BEING DEVELOPED

        Question. Has the Department disseminated information about the
    best practices and innovative approaches to high-quality, appropriate
    assessment tools developed through this funding stream?
        Answer. The first awards under this program were made a little over
    a year ago, and it is too early to assess the effectiveness of the
    assessments that are under development by the various grantees.

                      STATEWIDE LONGITUDINAL DATA SYSTEMS

        Question. Mr. Secretary, section 208(e) of Public Law 107-279
    requires you to ``make publicly available a report on the
    implementation and effectiveness of Federal, State, and local efforts
    related to the goals of this section, including--identifying and
    analyzing State practices regarding the development and use of
    statewide, longitudinal data systems . . .'' as well as other required
    elements, not later than one year after the enactment of the Education
    Technical Assistance Act of 2002. What is the status of this report?
        Answer. The Department currently is not preparing the specific
    report referenced in section 208(e), but has been pursuing similar
    efforts--including the analysis of existing State data systems, the
    identification of weaknesses, and highlighting best practices--as part
    of our Performance Based Data Management Initiative.

            STATEWIDE LONGITUDINAL DATA SYSTEMS NOT REQUIRED BY NCLB

        Question. Given the importance of high quality and timely student
    achievement data as relates to implementation of No Child Left Behind,
    don't you agree with the critical need to assess State systems and
    provide evidence of best practices with regard to such statewide
    systems?
        Answer. I agree that reliable student and school performance data
    are essential to reaching the goals of No Child Left Behind, and we are
    working with States and school districts on this issue through our
    Performance Based Data Management Initiative. This initiative is
    focused on the performance data required by No Child Left Behind, and
    will consolidate data collection from States, districts, and schools to
    both improve data quality and reduce paperwork burdens.
        However, the reporting requirements of No Child Left Behind are
    almost exclusively concerned with groups of students, rather than
    individual students. For this reason, although statewide longitudinal
    data systems may be very desirable as a tool to support educational
    reform, they are not required to successfully implement the No Child
    Left Behind Act.
        Moreover, most of the data that would be collected by such
    longitudinal systems--such as enrollment, annual assessment results for
    individual students, course completion, and SAT and ACT results--is
    required for State purposes and not for meeting Federal reporting
    requirements.
        For these reasons, while I applaud efforts to develop statewide
    longitudinal data systems, I believe such systems are primarily a State
    and local responsibility.

      EDUCATION PROGRAM FUNDS THAT CAN BE USED FOR STATEWIDE LONGITUDINAL
                              STUDENT DATA SYSTEMS

        Question. How does the fiscal year 2005 budget request specifically
    support the goal of ensuring that States and school districts have the
    knowledge and resources to develop and implement such systems?
        Answer. As indicated previously, longitudinal student data systems
    are not required by the No Child Left Behind Act, and thus have not
    been targeted for specific support in our fiscal year 2005 budget
    request. States are free to use Title V, Part A State Grants for
    Innovative Programs for this purpose, as well as State Assessment Grant
    funding once they have implemented the full range of assessments
    required by No Child Left Behind. In addition, the Department is
    providing $10 million annually to support the integration of statewide
    data systems as part of our Performance Based Data Management
    Initiative.
        Question. Mr. Secretary, I am informed by the Pennsylvania
    Department of Education that it needs $12 million over 3 years to
    implement the required system in Pennsylvania and an additional $1
    million per year to maintain it. What Federal funding is available for
    the Commonwealth to develop the statewide data system required to
    support effective implementation of the No Child Left Behind Act?
        Answer. Again, while Pennsylvania deserves praise for undertaking
    the development of a statewide longitudinal student data system, such a
    system goes beyond the data-collection requirements of the No Child
    Left Behind Act. And since this system would primarily serve the needs
    of Pennsylvania's school districts and schools, finding $12 million
    over three years should not be overly daunting for a State that spends
    more than $16 billion annually on public elementary and secondary
    education.
        However, as I mentioned earlier, Pennsylvania could use Title V,
    Part A State Grants for Innovative Programs funding, as well as State
    Assessment Grant funding once it has implemented the assessments
    required by No Child Left Behind, to support the development and
    implementation of its statewide longitudinal student data system.

                               PELL GRANT MAXIMUM

        Question. The President's fiscal year 2005 budget proposes to
    establish $4,050 for the Pell Grant maximum award, the same as fiscal
    year 2003 and fiscal year 2004. If adopted, this would mean three
    years, consecutive years at this maximum grant level. According to the
    College Board, tuition for 4-year private colleges has gone up more
    than 5 percent for the third year in a row; and for public 4-year
    universities, tuition has increased by more than 13 percent this year.
    I would also note that research has demonstrated that low-income
    students are not as successful in completing their postsecondary
    education because they often attend school part time, work long hours,
    and borrow heavily.
        Mr. Secretary, doesn't your proposal to maintain the current
    maximum Pell Grant at $4,050 for fiscal year 2005 mean that students
    served by the program will lose ground relative to the price of
    postsecondary education?
        Answer. We share your concern about the increasing cost of higher
    education. Our primary goal, however, must be to secure the financial
    stability of the Pell Grant program, the cornerstone of Federal student
    aid. Raising the maximum award without adequate funding would
    exacerbate the program's funding shortfall, currently estimated at $3.7
    billion by the end of award year 2004-05. The Administration's 2005
    budget would increase Pell Grant funding by over $800 million to fully
    fund the cost of maintaining the current $4,050 maximum award. The
    Administration is committed to working with Congress to eliminate the
    shortfall and place the program on a firm financial footing.

                             COLLEGE ENROLLMENT GAP

        Question. What other support is proposed in the President's budget
    to reverse the increasing college enrollment gap between low- and high-
    income students?
        Answer. The Administration's Enhanced Pell Grants for State
    Scholars proposal is one way the President's budget addresses this
    issue. Research consistently shows students who complete a rigorous
    high school curriculum are more successful in pursuing and completing
    postsecondary education. The Administration's proposal will encourage
    additional States and their local governments to participate in the
    State Scholars program, encouraging low-income students to successfully
    complete these programs.
        The Administration also supports strong academic preparation for
    postsecondary education and training through the Federal TRIO and GEAR
    UP programs. The Administration is proposing in fiscal year 2005 to
    spend $1.13 billion dollars for these two programs. In addition, the
    Administration is doubling support for the Advanced Placement Program.
    Low-income students who participate in Advanced Placement programs,
    which give students the opportunity to take college-level courses in
    high school, are much more likely to enroll and be successful in
    college than their peers. These programs also serve as a mechanism for
    upgrading the entire high school curriculum for all students. The
    Administration is proposing a $28 million increase for the Advanced
    Placement program authorized in the No Child Left Behind Act, bringing
    spending on it to nearly $52 million a year.

                 LEVERAGING EDUCATIONAL ASSISTANCE PARTNERSHIPS

        Question. Why does the fiscal year 2005 budget propose to eliminate
    the $66.2 million in funding for the Leveraging Educational Assistance
    Partnerships program--which helps States establish and expand need-
    based student aid programs--despite the fact that it is the only
    Federal program designed to expand the amount of need-based student aid
    provided by States?
        Answer. When the Leveraging Educational Assistance Partnerships
    (LEAP) program was first authorized as the SSIG program in 1972, 28
    States had undergraduate need-based grant programs. Today all but two
    States have need-based student grant programs. State grant levels have
    expanded greatly over the years, and most States significantly exceed
    the statutory matching requirements. For academic year 2002-2003, for
    example, estimated State matching funds totaled nearly $1 billion. This
    is more than $950 million over the level generated by a dollar-for-
    dollar match, and far more than would be required even under the 2-for-
    1 match under Special LEAP. This suggests a considerable level of State
    commitment, regardless of Federal expenditures.

                           PELL GRANT COST ESTIMATES

        Question. The Administration has proposed a budget process reform
    that would change budget scoring with respect to the Pell Grant
    program. For the last three fiscal years, what was the difference
    between program costs (displayed by academic year) for the Pell Grant
    program as estimated in the President's Budget, and at the time of the
    Mid-Session Review?
        Answer. The requested information is shown in the following table.

    ----------------------------------------------------------------------------------------------------------------
                                                               Est. program cost  Est. program cost
              Fiscal year             Award year   Max award      President's        mid-session        Difference
                                                    proposed         budget             review
    ----------------------------------------------------------------------------------------------------------------
    2002...........................      2002-03       $3,850     $9,582,000,000     $9,531,000,000    ($51,000,000)
    2003...........................      2003-04        4,000     10,863,000,000     11,442,000,000     579,000,000
    2004...........................      2004-05        4,000     11,410,000,000     12,133,000,000     723,000,000
    ----------------------------------------------------------------------------------------------------------------

           MID-SESSION REVIEW REESTIMATES OF PELL GRANT PROGRAM COSTS

        Question. For the same period, what were the differences between
    the assumptions used in the President's budget and those available at
    release of the Mid-Session Review?
        Answer. In general, the Administration revises its applicant growth
    assumptions for Mid-Session Review in June based on updated operational
    data, including actual information for the current academic year. For
    the last three years, the Administration adjusted its applicant growth
    assumptions for Mid-Session Review to account for unanticipated
    increases in Pell applicants, increasing estimated costs over the
    President's Budget level. Other technical assumptions used to estimate
    program cost--such as changes in Federal tax provisions, mandatory
    updates to the Need Methodology Tables, and proposals to verify
    applicants' income data with the IRS--were either revised or introduced
    during this update period. In addition, government-wide economic
    assumptions used for Mid-Session Review typically differed from those
    used in the President's Budget.

                 ACCURACY OF DEPARTMENT'S PELL GRANT COST MODEL

        Question. Has the Department ever accurately estimated the program
    cost of the Pell Grant program?
        Answer. Historically, the Department's Pell Grant cost model has
    been a reasonably accurate predictor of program costs. Over the last 10
    years (academic years 1994-95 through 2003-04), the model's estimates
    were within an average of 4.6 percent of actual costs. A review of
    annual data indicate the forecasting model is particularly reliable
    during times of economic stability and less so during other periods.
    Estimation in this area is particularly challenging due to the lead
    time necessary to produce the President's budget--up to two full years
    before the beginning of the funded academic year--and the economic
    changes occurring during that period.
        Question. What actions has the Department taken to improve its
    ability to more accurately forecast the cost of the Pell Grant program?
        Answer. Since one of the key components in forecasting the cost of
    the Pell Grant program is projecting applicant growth in future years,
    the Department is working to build better and more robust tools for
    forecasting applicant growth. Over the past three years, the Department
    has made ongoing improvements to its primary Pell Grant cost model by
    expanding the sample sizes of applicants and recipients, incorporating
    real-time disbursement data, and by auditing key technical parameters.

                     INTERNAL REVENUE SERVICE DATA MATCHING

        Question. The Administration has again proposed to allow the IRS to
    match income tax return data against student aid applications, in order
    to reduce the number of erroneous student aid payments. According to
    the U.S. Department of Education, this proposal would save the Federal
    Government $50 million in erroneous payments during the 2005-2006
    academic year and substantially more in subsequent years. What is the
    status of efforts to enact authorizing legislation?
        Answer. We have worked closely with the Treasury Department and the
    Office of Management and Budget in developing this proposal. The
    Administration's unambiguous support is clearly shown in the August 9,
    2002, letter signed by Secretaries Paige and O'Neill and OMB Director
    Daniels transmitting the proposed legislation to the Congress.
        Recently Congressman Johnson introduced H.R. 3613 the ``Student Aid
    Streamlined Disclosure Act of 2003,'' which was referred to the
    Subcommittee on Oversight of the Ways and Means Committee. There is
    general support for the concept, and we are currently working to
    address specific operational concerns.
     steps taken to reduce erroneous federal student aid education payments
        Question. What other steps is the Department taking to reduce and
    eliminate erroneous Federal education payments?
        Answer. The Department has implemented a multi-year effort to
    research the causes of, and to suggest solutions to, incorrect student
    payments. We have substantially increased the number of student aid
    applications submitted using FAFSA on the Web. The online student aid
    application substantially reduces errors and improves services to
    students. The Department retargeted the verification selection criteria
    to focus on the Pell Grant program and is encouraging schools to verify
    all selected applicants. To ensure that verification occurs, the
    Department is conducting a series of community outreach sessions on
    student aid application verification processes. Finally, we have taken
    steps for improving the Department's compliance and monitoring
    techniques in the Federal Student Aid and Office of Postsecondary
    Education programs.

                    NEW PROGRAMS VERSUS PROGRAM ELIMINATIONS

        Question. Mr. Secretary, in response to a question I submitted last
    year, you stated, ``the Administration believes it is more effective to
    deliver scarce Federal education resources to States and school
    districts through large, flexible formula grant programs rather than
    small, categorical grant programs mandating particular approaches to
    educational improvement.'' I agree with this general proposition.
    However, I note that you have proposed in the fiscal year 2005 budget,
    6 new programs that would provide separate funding through categorical
    grant programs that support a narrow purpose. At the same time, the
    fiscal year 2005 budget request proposes to eliminate 38 categorical
    grant programs funded at more than $1.4 billion last year, ranging from
    the Smaller Learning Communities program to Arts in Education, because
    your Department believes that in many instances these programs have a
    narrow or limited effect.
        Will you explain your rationale for requesting funds for new
    programs proposed in the fiscal year 2005 budget, which have a very
    narrow purpose, but not those you propose to eliminate because of their
    limited objectives?
        Answer. The Administration does not oppose all categorical grant
    programs, nor have we proposed to eliminate funding for all of them. We
    recognize that such programs often serve an important purpose, such as
    calling attention to unmet needs, stimulating innovation, or
    demonstrating specific educational strategies. What we have objected
    to, particularly in the current budget environment, is the continued
    funding of such programs long after they have achieved their
    objectives, when they duplicate other funded activities, or when it has
    become clear that the funded strategies are not an effective use of
    taxpayer funds.
        I believe our 2005 request is entirely consistent with this
    approach, as reflected in our budget documents, which clearly identify
    the rationale for a handful of new categorical programs while proposing
    to terminate separate funding for a much larger number of similar
    programs that have largely achieved their original purposes. I would
    add that, in most cases, these latter programs may be funded under
    broader, more flexible State grant authorities if desired by States and
    local school districts.

              CENTER FOR CIVIC EDUCATION'S WE THE PEOPLE PROGRAMS

        Question. Mr. Secretary, the fiscal year 2005 budget proposes
    funding for the Center for Civic Education's We the People (WTP)
    programs. These programs have been very effective through the years in
    providing students with the knowledge, skills, and attitudes they need
    to be effective citizens, and evaluations continue to testify to the
    success of these programs. Would you agree the WTP programs can be an
    antidote to the cynicism and apathy toward politics and government that
    persists among young people today?
        Answer. We agree that civic education programs can play a critical
    role in equipping young people with the knowledge and skills necessary
    for effective citizenship. Civic Education is a clear Administration
    priority. Although the Department has not conducted any evaluations of
    the Center for Civic Education's We the People programs, recent studies
    suggest that quality civic education programs may prompt students to
    understand, care about, and act on core citizenship values. Quality
    civic education programs can also help schools and communities maintain
    safe and inclusive learning environments that foster increased social
    responsibility and tolerance.

             INCREASE FOR RESEARCH, DEVELOPMENT, AND DISSEMINATION

        Question. The fiscal year 2005 President's budget acknowledges the
    importance of evidence-based decision making in education, yet proposes
    to eliminate funding for many of the programs that provide this
    information to SEAs, LEAs and teachers themselves. On the one hand you
    ask for an increase in Research, Development and Dissemination. At the
    same time the fiscal year 2005 budget proposes to eliminate funding for
    the Regional Educational Labs, the Eisenhower Math and Science
    Clearinghouse and the Regional Technology in Education Consortia. Can
    you please comment on these proposals?
        Answer. The requested increase for Research, Development, and
    Dissemination is not an indication that the Administration proposes to
    shift funds from technical assistance to research. Instead, the
    Administration recognizes the fact that although the No Child Left
    Behind Act mentioned scientifically based research 111 times, there are
    significant gaps in our scientific knowledge in many of the areas in
    which Congress instructed that funding decisions and practice should
    adhere to scientifically based research, including math, science,
    school-wide reform models, early literacy programs in preschools, and
    professional development of teachers. Our request for increased funding
    would support rigorous research to give education practitioners the
    information they need to ground their decisions and practices in strong
    evidence of what works.
        In the conference report accompanying the Consolidated
    Appropriations Act of 2004, the conferees strongly urged the Department
    to hold a competition for the new comprehensive centers authorized
    under sections 203 and 205 of the Education Sciences Reform Act of 2002
    (ESRA). In the budget request for fiscal year 2005, the Administration
    requested funding under the School Improvement account to support a
    competition for the new comprehensive centers. The new comprehensive
    centers would provide much-needed training, technical assistance, and
    professional development in reading, mathematics, and technology to
    States, local educational agencies, and school in order to improve the
    academic progress of disadvantaged students, boost teacher quality, and
    improve English fluency among students with limited English
    proficiency.
        Under section 205 of the Educational Technical Assistance Act of
    2002, the Comprehensive Regional Assistance Centers, the Regional
    Technology in Education Consortia, and the Eisenhower Regional
    Mathematics and Science Consortia were only authorized to continue
    until the comprehensive centers authorized under section 203 are
    established. Since the Department plans to hold a competition for the
    new comprehensive centers in 2005, there would be no authority under
    which to request funds to continue awards to the existing technical
    assistance providers.

                   REGIONAL EDUCATIONAL LABORATORIES PROGRAM

        The Administration did not request funds for the Regional
    Educational Laboratories program because there is no evidence that the
    laboratories consistently provide quality research and development
    products or evidence-based training and technical assistance. Although
    the Education Sciences Reform Act of 2002 reauthorized the program, the
    current authority does not enable IES to ensure that all of the
    laboratories adhere to standards of scientific quality needed to
    produce evidence with which to inform decisions.

                               ARTS IN EDUCATION

        Question. The No Child Left Behind Act recognizes the arts as a
    core subject of learning. Studies show that the arts are proven to help
    close the achievement gap and improve essential academic skills. If
    arts have been proven to be essential to the learning process, why does
    the fiscal year 2005 budget propose to eliminate the arts in education
    program?
        Answer. The Administration's fiscal year 2005 budget eliminates 38
    small categorical programs that have narrow or limited effect,
    including the Arts in Education program, to help increase resources for
    high-priority programs. Districts seeking to implement arts education
    activities can use funds provided under other Federal programs. For
    example, districts can use the funds they receive through the State
    Grants for Innovative Programs to implement arts programs.
        In addition, under the Improving Teacher Quality State Grants
    program, districts may use their funds to implement professional
    development activities that improve the knowledge of teachers and
    principals in core academic subjects, including the arts. Also,
    districts are able to supplement the amount of funding they receive for
    these two programs by exercising their options under the
    transferability authority of the State and Local Transferability Act.

                    21ST CENTURY COMMUNITY LEARNING CENTERS

        Question. The fiscal year 2005 President's budget proposes to
    freeze funding for the 21st Century Community Learning Centers Program.
    This is a program that enjoys public and bi-partisan congressional
    support. These programs help working families, provide vital additional
    academic support to students and provide safe, supervised environments
    for kids after school. Is there a reason the Department's fiscal year
    2005 budget does not support expanding this program beyond its current
    funding level?
        Answer. The Administration is proposing to maintain strong support
    for the 21st Century Community Learning Centers program by requesting
    $999.1 million in the 2005 budget. The request recognizes that the
    program provides a significant opportunity to improve the quality of an
    estimated 1,800 after-school programs that the program is able to
    support. At the same time, we need to ensure that the weaknesses in the
    previous program are not carried into the State-administered program.
    Preliminary findings from the evaluation of the antecedent program show
    a need to focus the program on providing more academic content and
    developing a knowledge base about successful academic interventions.
        The request also recognizes that the new grantees funded by States
    need some time to achieve better outcomes for students, and that
    national evaluation and technical assistance activities can play a key
    role in successful implementation. The Department continues to provide
    technical assistance and intensive outreach to help grantees focus on
    program improvement. We also continue to fund rigorous evaluation
    activities that will yield program performance information and assist
    us in developing new interventions.

                        NCLB TRANSFERABILITY PROVISIONS

        Question. Under the State and Local Transferability Act enacted as
    part of the No Child Left Behind Act, States and local school districts
    are provided with additional flexibility to target certain Federal
    funds to Federal programs that most effectively address the unique
    needs of States and localities and to transfer Federal funds allocated
    to certain State grant activities to allocations for certain activities
    authorized under Title I. How did the Department consider this
    authority in making its fiscal year 2005 budget request?
        Answer. Our 2005 request maintains high levels of funding for the
    programs that are included in the transferability authority (Improving
    Teacher Quality State Grants, Educational Technology State Grants,
    State Grants for Innovative Programs, and Safe and Drug-Free Schools
    and Communities State Grants programs) to ensure that States and school
    districts have meaningful flexibility to use Federal funds to address
    their own priorities. In addition, the flexibility provided by the
    transferability provisions supported the Administration's proposals to
    reduce or eliminate funding for small categorical programs, since the
    transferability provisions make it easier for States or districts to
    identify alternate sources of funding for such programs, should they
    wish to continue them.
        Question. How will the authority be considered in assessing the
    relationship between Federal funding provided and the performance
    outcomes achieved with such funds?
        Answer. The Department plans to collect information, through
    program performance reports and a study of resource allocation, on the
    amount of funds transferred among programs under the transferability
    authority. As for the relationship between Federal funding and
    performance outcomes, we believe that it is often not possible to
    isolate the separate impact of many Federal programs on student
    outcomes, due to the fact that federal programs frequently seek to
    leverage broader State and local improvements in education programs.
    However, we will also continue to collect and report information on
    trends in student outcomes in order to assess the overall impact of
    Federal, State, and local reform efforts on student achievement.
        Question. How will this authority shape decisions on future budget
    requests for affected programs?
        Answer. The transferability authority supports the Administration's
    emphasis on rationalizing and consolidating the delivery of Federal
    education resources to give States and school districts maximum
    flexibility in using these resources to meet local needs, and to
    improve student achievement while reducing administrative, paperwork,
    and regulatory burdens. As with the 2005 budget request, I expect that
    we will work to maintain or increase funding for the flexible State
    grant programs included in the transferability authority, while
    reducing budget support for smaller categorical programs with limited
    impact and more complex administrative requirements.
                                     ______

                  Questions Submitted by Senator Thad Cochran

            REPORT ON WRITING BY THE NATIONAL COMMISSION ON WRITING

        Question. Mr. Secretary, many teachers in my State, and I know in
    other States, have benefited from the very economical professional
    development provided by the network of National Writing Project
    institutes. Every State is benefiting from the relatively small Federal
    investment in the National Writing Project. Many schools report data
    that shows measurable improvement in student success in writing who
    have been taught by writing project teachers. This is a program that
    I've worked for more than a dozen years, to keep authorized and keep
    funded.
        This past year, the College Board--this is the organization that
    administers the college entrance examinations with which we are all
    familiar, such as the SAT, established the National Commission on
    Writing. It concluded that, ``Writing today is not a frill for the few
    but an essential skill for the many.'' Further, it has added to the
    college entrance examination a writing section, and it proposes a
    concerted effort on retraining teachers in the teaching of writing, and
    doing so by increasing the Federal investment in the National Writing
    Project. I find this recommendation compelling. These were
    professionals, college presidents, and academicians from all over the
    country, who looked at the state of student writing and how it was
    being taught, and concluded that the best thing the Federal Government
    could do to make a positive contribution to improving this condition,
    is to increase the funding of the National Writing Project.
        Are you aware of the report of the National Commission on Writing?
        Answer. Yes, I am familiar with the National Commission on Writing
    report, and the important recommendations included in this document. I
    agree that writing is an essential learning skill, and that the ability
    to write is foundational to other learning areas.
        When considering recommendations made in this report, however, it
    is important to keep in mind that Richard Sterling, the National
    Writing Project's (NWP) Executive Director, chaired the project's
    advisory panel. There is no reliable evidence that the NWP is any more
    or less effective than other professional development activities. No
    impact evaluations of the NWP have been conducted to date. In recent
    years, the NWP has sponsored several evaluations of activities
    supported under their project. Unfortunately, neither evaluation
    approach employed by NWP was sufficiently rigorous to yield reliable
    information on the effectiveness of interventions supported through the
    program. For example, NWP claimed that the latter evaluation shows
    statistically significant gains from baseline to follow-up for 3rd and
    4th grade student participants; however, because the study failed to
    used control groups or carefully matched comparison groups, it is not
    possible to draw any reliable conclusions regarding impact on student
    learning in NWP classrooms relative to other classrooms where writing
    skills are taught.

                               ARTS IN EDUCATION

        Question. The grants that have been available under the Arts in
    Education program have provided nationally recognized school reform in
    my State through the Mississippi Arts Commission's Whole School
    Program. The Commission received one of the first grants available
    under this program and this has been successful as well as provided
    arts in schools that otherwise would have none. The benefit of arts
    education has been widely reported over the last several years, and I
    think we need to continue to allow schools to have a resource that goes
    beyond what States and local governments can supply. The Federal funds
    that go to States simply do not stretch far enough to allow arts
    education to be a priority in schools of high poverty. School
    representatives regularly thank me for my support, and in the same
    breath, ask for continued funding. This is a difficult situation, but
    one I hope we can resolve.
        Answer. While the Department plays a significant role in certain
    areas of education, all specific decisions about curricula and other
    program offerings are made at the State and local levels. Because it is
    my understanding that most decisions to reduce or eliminate music and
    art programs are driven by budget concerns, I believe there is little
    the Department can do in this area, given our relatively small and
    necessarily focused contribution to overall education spending. New
    flexibility provisions in the No Child Left Behind Act made it easier
    for States and districts to support music and arts programs with
    Federal dollars, but we recognize that there are many needs competing
    for these resources. I do believe that as States and districts make
    progress in meeting their proficiency goals for reading and math, they
    will devote additional attention and resources to other core subjects
    such as music and art.

                FEDERAL SUPPORT FOR FOREIGN LANGUAGE INSTRUCTION

        Question. In the area of foreign language instruction, the evidence
    is that we need to be doing this beginning in elementary schools. It is
    my understanding that the small grant program we have to provide
    schools with support for this has many more times the applicants than
    it can approve. Most schools K-8 do not offer foreign language
    instruction, and in States where resources are overburdened, even high
    schools are not able to offer even common foreign languages such as
    Spanish or French. The point, Mr. Secretary, is that for these schools,
    the resource they need is direct access to a Federal grant program.
    These programs make a difference in whether or not certain subjects are
    taught, and whether or not students have the advantage of a competitive
    education.
        Answer. I share your view that, in general, foreign language
    instruction is important for students who will pursue careers in an
    increasingly multicultural world economy. However, both budget
    constraints and the limited Federal role in education dictate a focus
    on core priorities, and our core priority in elementary and secondary
    education lies in helping special populations, such as poor students
    and students with disabilities, to meet challenging State standards in
    reading, math, and science, as called for in the No Child Left Behind
    Act.
        I also think that the rebounding economy will permit greater State
    and local support for programs such as foreign language instruction--as
    well as art, music, and physical education--that suffered most during
    the recent recession. Finally, States and school districts may fund
    foreign language instruction under larger, more flexible Federal
    authorities like Title V State Grants for Innovative Programs.
                                     ______

                  Questions Submitted by Senator Patty Murray

                              SINGLE SEX EDUCATION

        Question. During passage of No Child Left Behind, we reached a bi-
    partisan agreement on single-sex education. NCLB says that schools may
    provide single-sex programs as long as they are consistent with
    ``applicable law,''--Title IX and the U.S. Constitution--and requires
    the Department of Education to provide guidance on that applicable law.
    The law does not direct the Department of Education to change the Title
    IX regulations. However, yesterday, you released new proposals to amend
    30-year-old Title IX regulations on single sex education.
        Current law allows single-sex programs when appropriate, but
    contains protections against sex discrimination. The proposed
    regulations would dispense with meaningful anti-discrimination
    protections and authorize schools to provide alternatives for girls
    that fall far short of equality. In the press release announcing this
    change, you even admit that research on students' performance in
    single-sex education programs is inconclusive.
        Shouldn't you be spending that funding and the efforts of the
    Department of Education on helping our States implement the No Child
    Left Behind Act to close the achievement gap instead of throwing out
    long-standing anti-discrimination laws, potentially broadening the
    achievement gap for our Nations' girls and boys?
        Answer. As required by the new law, we issued guidance on May 8,
    2002 on the Title IX requirements related to single-sex schools and
    classrooms. At the same time, the Department published a notice that
    the Secretary was planning to propose amendments to the existing Title
    IX regulations applicable to single-sex education.
        The No Child Left Behind Act brought a new emphasis on flexibility
    and choice in Federal education programs. Consistent with this
    emphasis, the proposed amendments to the Title IX regulations provide
    more flexibility to educators to establish single-sex schools and
    classrooms in elementary and secondary schools. Research indicates that
    single-sex programs may provide educational benefits to some students,
    and such programs also offer additional public school choice options to
    children and their families.
        The Department's proposed amendments continue to require school
    districts to afford substantially equal educational opportunities to
    both sexes when single-sex classes and schools are offered. Any effort
    to provide either sex with alternatives that are inferior to those
    provided the other sex would not be consistent with these amendments.
        In addition, the proposed amendments require school districts to
    ensure that single-sex classes do not rely on overly broad
    generalizations about the different talents or capacities of female and
    male students. While we acknowledge that there is a debate among
    researchers and educators regarding the effectiveness of single-sex
    education, we believe our proposal makes educational sense and protects
    both girls and boys from discrimination.

                         SCHOOL CHOICE AND PELL GRANTS

        Question. The President's budget yet again includes funding for
    vouchers, which were rejected during passage of No Child Left Behind.
    The Bush budget includes $50 million for the Choice Incentive Fund and
    another $14 million for the DC voucher program, which the Senate never
    even voted on.
        How can you justify repeatedly abandoning public education by
    giving just 1,700 students $7,500 to attend schools that are
    unaccountable to students, their families, or the Department of
    Education and may not be providing a quality education, when you are
    not increasing Pell grants for millions of low-income students past
    $4,050 to attend accredited institutions of higher education? This is
    especially troubling when so many people are going back to school,
    particularly community colleges, for education and training to compete
    in this workforce.
        Answer. The President's request would increase Pell Grant funding
    by over $800 million, to a record $12.8 billion. The Administration
    believes there is no contradiction between this strong support for the
    Pell Grant program and our proposed modest funding for educational
    innovations that expand choice for the parents of elementary and
    secondary school students. Both proposals are fully consistent with the
    Department's mission and goals; in fact, vouchers and other choice
    options are an effort to bring to elementary and secondary education
    the same accountability mechanism supported by the Pell Grant program:
    allowing students to attend the school of their choice.

                          STRIVING READERS INITIATIVE

        Question. Your budget proposes $100 million for a new program--
    Striving Readers--to help improve reading for middle and high school
    students. I support efforts to improve our high schools and additional
    resources for high schools, including through my Pathways for All
    Students to Succeed Act, which provides tools and resources to reform
    secondary education.
        Isn't it true that overall high schools will be net losers in
    funding? Your budget proposes to cut the Perkins Career and Technical
    Education program by $300 million, eliminate the $173 million Smaller
    Learning Communities program designed to provide more individualized
    attention to high school students, as well as eliminate the $34 school-
    counseling program. That seems to result in a net loss to high school
    students of some $300-400 million. What is the rationale behind that?
        Answer. I don't believe that it is correct to say that our budget
    results in a net loss of support for high school students. The
    Administration has chosen to target scarce resources on programs such
    as the Title I Grants to Local Educational Agencies (LEAs) and Special
    Education Grants to States, programs that benefit high school as well
    as elementary school students, rather than fund small categorical grant
    programs with narrow effect, such as the Smaller Learning Communities
    and School Counseling programs. Our fiscal year 2005 request would
    provide for an increase of 52 percent for Title I Grants to LEAs and 75
    percent for Special Education State Grants since President Bush took
    office; these programs support our Nation's secondary school students
    as well as elementary students.
        In addition, our proposal to strengthen and modernize the Federal
    investment in vocational education will help States and communities
    improve the academic performance of high school students by supporting
    effective career pathway programs that promote rigorous academic
    curriculum and build a stronger bridge between high schools and
    postsecondary and workforce preparation. Further, rather than funding
    general expenses like equipment purchases and hiring of staff that have
    little direct impact on student learning as we do now, the proposed
    ``Sec Tec'' program would target funds to partnerships between school
    districts and technical schools, community colleges, and other career
    pathways programs to ensure that students are being taught the academic
    and technical skills necessary for further education and training and
    success in the workforce.

                           FUNDING FOR NCLB PROGRAMS

        Question. Your budget for NCLB provides only a 1.8 percent overall
    increase. After factoring in inflation and continued enrollment growth
    that increase would actually result in a cut in funding for schools.
    Further, instead of providing real funding for programs, including
    Title I and IDEA, you cut 38 programs and level fund many more.
        Since States and schools have been complaining that they need
    significant additional resources to meet the many requirements of NCLB,
    do you think a cut in funding in real terms is the right approach?
        Answer. Over the past decade, overall spending on elementary and
    secondary education in the United States has grown from $300 billion to
    just over $500 billion. Funding for the Elementary and Secondary
    Education Act has more than kept pace with this increase, nearly
    tripling from $8.5 billion to $24 billion over the same period.
    Moreover, these increases occurred in an environment of historically
    low inflation, resulting in very substantial increases in real terms. I
    believe these funding levels, along with the President's budget
    request, are more than sufficient to pay for the changes called for in
    the No Child Left Behind Act.

                              SUBCOMMITTEE RECESS

        Senator Specter. Thank you all very much. The subcommittee
    will stand in recess to reconvene at 9:30 a.m., Thursday, March
    25, in room SD-192. At that time we will hear testimony from
    the Honorable Tommy Thompson, Secretary, Department of Health
    and Human Services.
        [Whereupon, at 11:55 a.m., Thursday, March 4, the
    subcommittee was recessed, to reconvene at 9:30 a.m., Thursday,
    March 25.]

      DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND
              RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2005

                                  ----------

                            THURSDAY, MARCH 25, 2004

                                           U.S. Senate,
               Subcommittee of the Committee on Appropriations,
                                                        Washington, DC.
        The subcommittee met at 9:35 a.m., in room SD-192, Dirksen
    Senate Office Building, Hon. Arlen Specter (chairman)
    presiding.

        Present: Senators Specter, Cochran, Stevens, and Harkin.

                    DEPARTMENT OF HEALTH AND HUMAN SERVICES

                            Office of the Secretary

    STATEMENT OF HON. TOMMY G. THOMPSON, SECRETARY

                   OPENING STATEMENT OF SENATOR ARLEN SPECTER

        Senator Specter. Good morning, ladies and gentlemen. The
    Appropriations Subcommittee for Labor, Health, Human Services,
    and Education will now proceed.
        Our witness today is the distinguished Secretary of Health
    and Human Services, Tommy Thompson. Secretary Thompson served
    as Governor of Wisconsin from 1987 to the year 2000, the
    longest tenure of a Governor in Wisconsin's State history, a
    national leader in welfare reform and expanding healthcare to
    low-income children and families, served as chairman of the
    National Governors Association, the Education Commission of the
    States, and Midwestern Governors Conference, bachelor of law
    degree from the University of Wisconsin in Madison.
        We focus today on the budget of the Department of Health
    and Human Services, which has been proposed by the
    administration at $62.9 billion, which is an increase of $974
    million over the fiscal year 2004 level, or 1.6 percent. And
    this is tough year on all accounts, as we know. This budget
    proposal has a great many question marks in it, one of which is
    the assumed savings of $767 million, all of which are within
    the jurisdiction of Finance Committee, but I'm sure Senator
    Thompson will drop a letter to the Finance Committee and tell
    them to proceed to save that money for us, right, Secretary?
        Secretary Thompson. That is correct, sir.
        Senator Specter. And the reduction and elimination of about
    a dozen programs, which have a lot of support in the Congress--
    Article 1 of the Constitution still has that cumbersome
    provision about congressional authority to appropriate, and
    some of our colleagues take that very seriously on programs
    which have been developed over the years. And I take a look at
    11 programs which are being zeroed out, and then major cuts.
        The Center for Disease Control has a reduction of $116
    million, which is a little hard to understand in light of their
    increased responsibilities. Every time we turn around, there's
    a major problem on SARS or AIDS or bioterrorist threats. And
    their building program is in midstream. I visited the Center
    for Disease Control several years ago, and was shocked to see
    what was going on down there. Your predecessor, Mr. Secretary,
    appeared here every year, and never once mentioned the need for
    capital improvements at the CDC, and it was in dire need. It's
    gone a fair distance on a billion-and-a-half dollar budget, and
    I don't know how we can stop it now, but, at the same time, I
    don't know how we can not stop it now.
        The NIH funding is totally inadequate to allow NIH to go
    forward. I know how important that is in your personal agenda.
    And I also know you're not the President or the director of
    OMB, and you don't structure all of the budgets.
        But it looks like a tough year ahead for us, Mr. Secretary.
        Secretary Thompson. It is.
        Senator Specter. I was hoping to finish before the
    distinguished ranking member came, so he missed his opening
    statement.
        Just kidding. Just kidding, Senator Harkin.
        We have established a unique partnership, I think, that the
    world knows about, to the detriment of both of us, personally.
    But when we have changed gavels from time to time, it has been
    seamless, and we have worked very, very closely together. And
    I'm delighted to yield to my distinguished colleague today, who
    has effectively tied up the Senate with an overtime issue on
    which I agree with his position.
        Senator Harkin.

                    OPENING STATEMENT OF SENATOR TOM HARKIN

        Senator Harkin. I wish it wouldn't tie up the Senate. I
    wish we would just vote, that would be the end of it.
        Thank you very much----
        Senator Specter. We--Senator Frist may let you do that.
    Then what are you going to do?
        Senator Harkin. We vote, and then we move on.
        Thank you very much, Mr. Chairman. And, again, I just echo
    the words that you've said. I've enjoyed our partnership, now
    going back 14 years, and the changing of the gavel back and
    forth has been seamless. And I have appreciated your
    willingness to work together and make this truly a bipartisan
    subcommittee, in every sense of the word. The issues we deal
    with, on health and education, medical research, biomedical
    research, are not really partisan issues at all, and I don't
    think either one of us have ever looked at them in that regard.
        Mr. Secretary, it's always a pleasure to have you appear
    before this subcommittee, and I look forward to working with
    you in this year's budget process. First, I want to commend you
    for your commitment to two important issues, issues that I know
    are a top priority for both of us.
        The first is the support for programs for persons with
    disabilities. I appreciate your continued support for the New
    Freedom Initiative and its goal of removing barriers to
    community living for people with disabilities. This is
    extremely important. Now let's work together to get the
    legislation enacted.
        Secretary Thompson. Please.
        Senator Harkin. I also want to thank you for including
    funding for the Real Choice System Change Grants in your fiscal
    year 2005 budget. I don't think those funds would be there
    without your personal intervention, and I appreciate that.
        Second, I congratulate you on your efforts to make wellness
    programs a priority. Obesity, lack of physical activity,
    smoking, and poor nutrition are a grave threat to our country;
    not just to individuals, but to all of us, as taxpayers. In
    this country, we spend a trillion dollars a year on healthcare,
    and the figures show that fully 75 percent of those are spent
    on chronic diseases, like heart disease, cancer, and diabetes.
    And what those diseases have in common is that often they're
    preventable.
        So, Mr. Secretary, I know you agree, because I've read your
    statements. In this country, we fail to make the necessary up-
    front investments in prevention. I'm absolutely convinced that
    prevention is an idea whose time has come. And the good news
    is, this can be and should be a bipartisan initiative. Senator
    Specter and I are working together on some wellness initiatives
    that we plan to include in this year's bill. I look forward to
    working with you on these initiatives.
        For one thing, CDC has promised to send me some more
    pedometers. Ah-ha, you beat me to it. All right, Mr. Secretary,
    tell you what I'll do. Unscripted, I tell you what, I may issue
    a challenge, and I'll issue one to my partner here. We'll all
    put pedometers on, and we'll see who takes the most steps this
    year.
        Secretary Thompson. Ten-thousand steps a day, Senator.
        Senator Harkin. How many?
        Secretary Thompson. Ten-thousand steps a day.
        Senator Harkin. Are you doing that?
        Secretary Thompson. Uh-huh.
        Senator Harkin. I may take back my challenge.
        Good for you. Well, that is a great example, because that's
    what we've got to be doing here.
        We're doing some other things. I've been working with
    Senator Frist on getting some signs put by the elevators----
        Secretary Thompson. Uh-huh.
        Senator Harkin [continuing]. Which they've done at NIH. I
    don't know if you've done your Department the same. If we just
    go over there a little bit, there's a stairs. If you climb the
    stairs, it's healthier, and there's a certain calorie type of
    thing for how many stairs you climb, and stuff like that, to
    get people climbing stairs. Well, that's just off the record.
        But we're going to get the pedometers, and we're going to
    try to get this thing moving here on the Hill. But, again, I
    just wanted to commend you for those things. The Freedom Grants
    Initiative, the money that you've requested for the Systems
    Change Grants--please work with us to get that bill through,
    the New Freedom Initiative. It's most important. And on all the
    stuff you're doing on wellness and obesity and things like
    that--I may differ with you slightly--I have this in my
    questions--in terms of whether or not it should be mandatory or
    permissive for restaurants and things like that, on the menus
    and stuff, and we'll have a dialogue with you on the questions
    on that.
        The one last thing that--on a less positive note, I
    suppose--I'm concerned about recent reports that the chief
    actuary for the Medicare program was told not to tell Members
    of Congress that his office had concluded that the Medicare
    Prescription Drug Program--that would cost upwards of $10
    billion more than previously reported. Again, I'll be asking
    you this during the question-and-answer period.
        Again, Mr. Secretary, I look forward to your testimony.
        Secretary Thompson. Thank you very much.
        Senator Specter. Thank you very much, Senator Harkin.
        Senator Cochran.

                   OPENING STATEMENT OF SENATOR THAD COCHRAN

        Senator Cochran. Mr. Chairman, thank you very much.
        Mr. Secretary, we appreciate very much your exemplary
    service as Secretary of the Department of Health and Human
    Services. We also note that you've made strong efforts to begin
    the implementation of the new Medicare Prescription Drug
    Initiative. I'm pleased to see, also, the aggressive effort in
    the budget to safeguard the country against bioterrorist
    threats--$5 million that's included in the budget to help
    prepare State and local governments to respond to these disease
    outbreaks is an important step forward.
        I also commend the efforts to identify threats before they
    reach our country, and to prevent the entry of microbes,
    diseases, adulterated drug products, and all other items that
    would threaten the safety of our citizens. The budget also
    provides funding to help improve the health of those who live
    in small towns and rural communities, such as in my State of
    Mississippi. Almost half of those served by small-town health
    centers are in rural areas. The increase of $219 million to
    provide for health centers and their sustainment was
    appreciated very much.
        It's my hope that special emphasis can also be placed on
    targeting research to areas of the country that suffer
    disproportionately from diseases like diabetes, cardiovascular
    disease, and obesity. Generally speaking, I think, under the
    pressures of trying to control spending and deal with the
    problems of the deficit, this is a budget that should encourage
    those of us who are interested in improving the health and
    safety of American citizens.
        Thank you very much.
        Secretary Thompson. Thank you, Senator.
        Senator Specter. Thank you, Senator Cochran.
        Just one note, to answer the question which may be on the
    minds of many, or at least some, about my Halloween mask. I
    came out of the restaurant in Philadelphia on Saturday night
    and tripped on a defect in the sidewalk, and landed squarely on
    my nose. And I'm pleased to report that my nose was not broken,
    but where my nose hit the sidewalk, the sidewalk was broken.
        Mr. Secretary, the floor is yours.
        Secretary Thompson. Mr. Chairman, Senator Harkin, Senator
    Cochran, thank you very much.
        I am very happy that the nose was not broken, and I'm glad
    that you are mending back in good shape. That could have been a
    very serious fall, and I'm very happy and appreciative that
    things are----
        Senator Specter. Mr. Secretary, my colleague in the
    Philadelphia city race, Tom Gola, a famous basketball star,
    lost his balance, slipped and hit his head, and he's been in
    very serious condition ever since, so there are repeated
    circumstances of people falling, and even fatalities, so I
    consider myself very fortunate.
        Having brought up the subject, I'm reminded there's a
    famous story, probably apocryphal, about Winston Churchill
    laying on a veranda one night, and a woman walked by and saw
    his condition and said, ``You're drunk.'' And he responded,
    ``You're ugly.''
        She recounted again, ``You're drunk.'' And he said,
    ``You're ugly.'' And then she said again, ``You're drunk.'' And
    he said, ``Yes, but I'll be sober in the morning.''
        Next week, I'll be back to my old appearance, however bad
    that may be.

                  SUMMARY STATEMENT OF HON. TOMMY G. THOMPSON

        Secretary Thompson. I want to thank you, Senator Specter,
    for inviting me, and Senator Harkin, for giving me this
    opportunity to discuss the President's fiscal year 2005 budget
    for the Department of Health and Human Services.
        In my first 3 years in the Department, I believe we have
    made tremendous progress in improving the health, the safety,
    and the independence of the American people. We continue to
    advance in providing healthcare to seniors and to low-income
    Americans, and in providing the welfare to children and
    strengthening families and protecting the homeland. We have re-
    energized the fight against AIDS at home and abroad. We've
    increased access to quality healthcare, especially for
    minorities, the uninsured, and the under-insured.
        We're helping smokers--and I know this is a very big
    concern of yours, Senator Harkin--free themselves of a
    debilitating habit through a national hotline. We have set it
    up in the Department, Senator Harkin, without asking the
    Congress for any money. It'll be up and running by the end of
    this year. And I want you to know that I pushed this, and I
    feel as passionate as you do that we've got to reduce the
    tobacco. And hopefully someday we'll be regulating it.
        With your help, 3 months ago President Bush signed the most
    comprehensive Medicare improvements since it was created,
    nearly four decades ago. There has been some controversy, and I
    know there'll be questions about it, and I'm going to answer
    those questions completely to this particular Committee.
        To expand on our achievements, the President proposes $580
    billion for HHS for fiscal year 2005, an increase of $32
    billion, or 6 percent, over fiscal year 2004. Our discretionary
    budget authority is $67 billion, an increase of $819 million,
    or 1.2 percent, over fiscal year 2004, and an increase of 26
    percent since 2001. And I understand, Senator Specter, that
    there are some gaps, and I want to work with you to see how we
    might be able to ameliorate the situation.
        Of this total, subcommittee is responsible for $63 billion,
    an increase of $659 million, or 1.1 percent, over fiscal year
    2004, or $974 million under current law. In order to strengthen
    our bioterrorism preparedness and public-health system, we have
    requested $4.1 billion, up from $300 million in 2001. And I
    would respectfully--humbly respect--and invite all of you
    Senators down to take a look at what we have done in the
    Department. And I think you'll find it very impressive and
    informative, what we have built, to be able to track diseases
    and bioterrorism activities all over the world. I've had a lot
    of people come down, and everybody that walks out of it feels
    very much relieved that we are very much there. And I would
    hope that you'd come down and see it.
        This investment will improve our preparedness for
    bioterrorism attack on any kind of bioterrorism attack or for
    any public-health emergency. We already have seen our
    investment pay off, in CDC's leadership in fighting the SARS
    outbreak last year in a coordinated a public-health response to
    the West Nile virus, and even helped to deal with a
    particularly hard flu season this past year.
        As you all know, I'm a very big proponent of information
    technology. That's why we will be providing a computer
    language, called SNOMED, to any proprietor that wants to, at no
    charge, starting, hopefully, by the 1st of May. We're leading
    the way in developing standards for electronic medical records.
    And last month, I announced an FDA rule to prevent medication
    errors by requiring bar codes on medicine and blood products.
        Community health centers, as you have mentioned, Senator
    Cochran, are absolutely a key element for increasing access to
    and availability of healthcare for helping the uninsured. We're
    proposing to provide $1.8 billion for health centers to provide
    healthcare services to 15 million Americans. I want to thank
    you, Senator Specter and Senator Harkin, for your leadership on
    this. We wouldn't be here today if it wouldn't have been for
    your great leadership.
        Through our New Freedom Initiative, Senator Harkin, we're
    working to help the elderly, the disabled, by promoting home
    and community-based centers. In my desire to reduce obesity and
    diabetes, we, along with the help of Congress last September,
    my Department announced 12 steps to HealthierUS grants totally
    more than $13 million to some more community initiatives to
    promote better health and prevent disease. This included 23
    communities, including one tribal organization, 15 small cities
    and rural communities, and seven large cities. These
    communities are doing some very exciting work in chronic
    disease prevention and health promotion. For example, in
    Washington State, health professionals are targeting Latino
    adults who have diabetes, asthma, or obesity, or have a high
    risk of getting those conditions.
        In Michigan, through the Intertribal Council of Michigan,
    public-health officials have created a resurgence of interest
    in passing on traditional wisdom in cultural practices,
    including consumption of highly nutritious traditional foods.
    We're delighted by these activities, and the Department will
    expand the program this year with the addition of $44 billion,
    and has requested $125 million for these programs in 2005.
        Later today, I'm going to unveil the Medicare improved
    drug-discount cards. I will also announce that a Pennsylvania
    company will be among our Medicare-approved drug-discount card
    sponsors. This company serves 265,000 Pennsylvania seniors,
    and, all together, Pennsylvania seniors will receive $486
    million this year and next.

                               PREPARED STATEMENT

        We look forward, ladies and gentlemen, to working with this
    committee, the medical community, and all Americans as we build
    upon our past accomplishments, implement the new Medicare law,
    and carry out the initiatives that President Bush is proposing
    to build a healthier, safer, and stronger America. And I want
    to thank you for your bipartisan support on health issues.
        Thank you, once again, for giving me this opportunity to
    appear in front of you.
        [The statement follows:]

                  Prepared Statement of Hon. Tommy G. Thompson

        Good morning, Chairman Specter and members of the Subcommittee. I
    am pleased to present to you the President's fiscal year 2005 budget
    for the Department of Health and Human Services (HHS). I am confident
    you will find our budget to be a positive solution to improving the
    health, safety, and well-being of our Nation's citizens. Before I
    discuss the fiscal year 2005 budget, I would like to thank the
    Subcommittee for its hard work and dedication to the programs within
    HHS. I am extremely proud of the manner in which we have worked
    together effectively, in a bipartisan effort, since I was appointed
    Secretary. This cooperation should be lauded and the tremendous results
    for the American people can be seen in our many accomplishments.
        This year's budget proposal builds upon past accomplishments in
    meeting several of the health and social well-being goals established
    at the beginning of the current Administration. I deeply appreciate the
    level of support I have received from the Subcommittee during the past
    on so many issues that have touched American's lives. For example, with
    your help, the Department has funded 614 new and expanded health
    centers. This has effectively increased access to health care for an
    additional 3 million people, of which 64 percent are minorities,
    increasing the overall number of patients served in health centers by
    almost 30 percent. In the past three years, your support for protecting
    our nation from bioterrorism has made the country better prepared and
    better protected.
        Your unwavering commitment in doubling the budget for the National
    Institutes of Health has supported work by more than 217,000 research
    personnel affiliated with 2,000 universities, hospitals, and other
    research facilities across our great nation. This support has led to a
    constant flow of new scientific discoveries. We have also established
    the Access to Recovery State Vouchers program, providing 50,000
    individuals with needed substance abuse treatment and recovery
    services. HHS initiated a new Mentoring Children of Prisoners program
    to provide one-to-one mentoring for approximately 30,000 children with
    an incarcerated parent and created education and training vouchers for
    foster care youth, securing funding to provide vouchers of up to $5,000
    to 17,400 eligible youth since 2001. Last year, we worked together with
    Congress to pass the Medicare Prescription Drug, Improvement, and
    Modernization Act of 2003 (MMA), adding prescription drug coverage for
    seniors and modernizing the Medicare program. While I thank you for
    your support in these and the many other accomplishments to improve the
    health, safety, and well-being of our citizens, there is still much to
    be done.
        For fiscal year 2005, the President proposes an HHS budget of $580
    billion in outlays to enable the Department to continue working with
    our State and local government partners, as well as with the private
    and volunteer sectors, to ensure the health, safety, and well-being of
    our nation. This proposal is a $32 billion increase in outlays over the
    comparable fiscal year 2004 budget, or an increase of about 6 percent.
    The mandatory programs in the HHS budget total $513 billion in outlays.
    Of this $513 billion, Medicare and Medicaid combine to equal about $474
    billion, an increase of approximately $29 billion or 6.5 percent over
    fiscal year 2004. The discretionary programs in the HHS budget totals
    $67 billion in budget authority. Of this total, this Subcommittee is
    responsible for approximately $63 billion in budget authority, an
    increase of approximately $659 million, or 1.1 percent over fiscal year
    2004 for proposed law, and an increase of approximately $974 million,
    or 1.6 percent over fiscal year 2004 for current law.
        For fiscal years 2004 and 2005, the MMA appropriated $1.0 billion
    in start-up funds so that the Centers for Medicare and Medicaid
    Services (CMS) would have funds available upon enactment to implement
    the enormous increase in new administrative responsibilities under the
    legislation. With rare exceptions, however, these administrative costs
    have typically been categorized in the budget as discretionary. Thus,
    this year the President's budget classifies the $1 billion for CMS
    implementation of the MMA as discretionary.
        In addition, the budget identifies approximately $500 million in
    mandatory program savings for this Subcommittee's consideration. These
    are four legislative proposals that I believe will lead to increased
    cost effectiveness and reduced waste in the Medicare and Medicaid
    programs. First, allowing beneficiaries to purchase durable medical
    equipment after 13 months instead of 15 months is a lower burden for
    our beneficiaries and a savings for Medicare, and it will improve
    access to these products while reducing rental payments. Second,
    requiring the Centers for Medicare and Medicaid Services (CMS) to use
    the Administration for Children and Family's (ACF) wage database will
    allow CMS to identify more quickly whether a beneficiary has employer-
    sponsored insurance and to determine whether Medicare should be the
    secondary payer, as opposed to the primary payer, to that other health
    coverage.
        Third, we are proposing to eliminate a windfall to the States by
    reducing Federal reimbursement for Medicaid administrative costs by
    about $300 million. Most states' TANF Block Grants were based on
    expenditures that included the costs of determining Medicaid
    eligibility, but they have also received Federal match for these
    expenditures through Medicaid since TANF's implementation. Our proposal
    seeks to eliminate this double payment for fiscal year 2005. Finally,
    we are proposing to change the enhanced matching rates for
    administrative activities toward systems' improvements, consistent with
    other enhanced rates.

                 EXPANDING ACCESS TO HEALTH CARE FOR AMERICANS

        One of the most important issues on which we can continue to work
    together, is expanding access to quality health care for all Americans.
    In 2002, the President launched an initiative to expand access to
    health care by creating 1,200 new or expanded health care sites and
    serving an additional 6 million people by 2006. Since the initiatives
    inception, with the strong bi-partisan support of this Subcommittee,
    the Health Centers program has significantly impacted more than 600
    communities, serving over 13 million patients, 3 million more than in
    2001, 40 percent of who have no health insurance coverage, and many
    others for whom coverage is inadequate. In addition, States use Health
    Insurance Flexibility and Accountability (HIFA) demonstrations to
    expand health care coverage. As of January 2004, HIFA demonstrations
    expanded coverage to 175,000 people and another 646,000 were made
    eligible.
        While we have made significant strides in this endeavor, there is
    still much work to be done. In fiscal year 2005, the President's budget
    request will continue to expand resources for Health Centers to a level
    of $1.8 billion, an increase of $219 million over fiscal year 2004.
    This increase will result in increased services for an additional 1.6
    million people in approximately 330 new and expanded sites. This level
    will provide access to comprehensive preventative and primary care
    services, at over 3,800 health sites nationwide, for a total of almost
    15 million uninsured and underserved individuals, nearly 7 million from
    rural areas.

                               ACCESS TO RECOVERY

        Mr. Chairman, the fiscal year 2005 budget represents the fourth
    year of the President's strong commitment in leading our nation's
    battle against addiction. With your support, we have made significant
    progress. Current use of illicit drugs among students has declined by
    11 percent between 2001 and 2003. However, there continues to be an
    unmet need for drug treatment services. The fiscal year 2005 budget
    will provide 100,000 individuals with drug and alcohol treatment
    benefits by doubling funding to $200 million for the Access to Recovery
    State Voucher Program. This program will allow individuals seeking
    clinical treatment and recovery support services choices among
    qualified community provider organizations, including those that are
    faith-based. The program's emphasis is on objective results and is
    measured by outcomes, including decreased or no substance use, no
    involvement with the criminal justice system, attainment of employment
    or enrollment in school, family and living conditions, and social
    support.

                DISEASE DETECTION AND BIOTERRORISM PREPAREDNESS

        In the past three years, your support for our bioterrorism efforts
    has been unwavering, and together we have made tremendous strides in
    protecting our nation from various threats. While we have made great
    strides, it is imperative that we remain steadfast in our commitment to
    protect our nation and the well-being of all its citizens. The fiscal
    year 2005 request for HHS bioterrorism activities is $4.1 billion, an
    increase of $155 million above fiscal year 2004, and $3.8 billion above
    the fiscal year 2001 level.
        This work will be coordinated with the Global Disease Detection
    Initiative at CDC. The Global Disease Detection Initiative (+$27.5
    million) will help the United States learn more rapidly about new
    disease threats that emerge in other Nations. CDC will recognize
    infectious disease outbreaks abroad faster, and help those nations
    identify and stop those diseases before they arrive in the United
    States. In order to accomplish this task, CDC will expand its presence
    internationally and collaborate with multinational organizations, such
    as the World Health Organization (WHO) to improve overall global
    disease detection, control, and surveillance. CDC will also invest an
    additional $10 million to expand quarantine efforts at ports-of-entry
    for international travelers.
        Funds will be directed to carry out a new interagency bio-
    surveillance initiative to prepare against a potential bio-terrorist
    attack. The Centers for Disease Control and Prevention (CDC), in
    coordination with the Food and Drug Administration (FDA), the
    Department of Homeland Security, and the Department of Agriculture,
    will be working to improve the response to bioterrorism through early
    detection with the BioSense Surveillance Initiative. Through this
    program, we will improve human health surveillance, strengthen the
    laboratory response network, and increase the numbers of boarder health
    and quarantine stations, which will allow us to identify and isolate
    potential disease outbreaks more rapidly.
        We also continue our work in building the Strategic National
    Stockpile of drugs, vaccines and medical supplies that can be shipped
    anywhere in the country on short notice, with a request for $400
    million in fiscal year 2005. The fiscal year 2005 budget returns the
    financing of the stockpile to HHS. DHS will continue to have the
    authority to order deployment of the stockpile in an emergency, along
    with HHS. The fiscal year 2005 budget includes a three-year financing
    plan to expand our antibiotic stockpile to be able to provide post-
    exposure anthrax treatment from 13 million to 60 million people. In
    fiscal year 2005, we have included a contingency provision that will
    allow us to transfer up to $70 million to the Stockpile from funds
    available for State and local preparedness, should the added funds be
    needed.
        Our nation's ability to detect and counter bioterrorism ultimately
    depends on the state of biomedical science, and the National Institutes
    of Health (NIH) will continue to ensure full coordination of research
    activities with other Federal agencies in this battle. The fiscal year
    2005 budget includes $1.74 billion for NIH biodefense research efforts,
    an increase of $120 million, or +7.4 percent. Included within this
    biodefense total is $150 million to support the construction of
    Biosafety laboratories for NIH to help develop medical protection from
    bioterrorism, and to back up State and Federal public health
    laboratories. Prior to fiscal year 2002, only a few laboratories in the
    United States were capable of conducting research on potential bio-
    terrorism agents. The $150 million investment in fiscal year 2005 will
    fund an additional 20 Biosafety Level 3 laboratories across the
    country.
        The ability to mitigate the health effects of radiation exposure in
    the potential event of the use of a limited nuclear or radiological
    device in a terrorist attack presents a critical challenge for which
    little progress has been made in the last forty years. For fiscal year
    2005, $47 million is requested in the budget for the Public Health and
    Social Services Emergency Fund, to be coordinated and managed by NIH.
    This new initiative will support targeted research activities needed to
    develop medical countermeasures to more rapidly and effectively treat
    nuclear or radiological injuries.
        Throughout my time as Secretary, many steps have been taken to
    allow for improved access to vaccines for those in need and better
    methods to combat the spread of influenza viruses. The average Medicare
    reimbursement rate to physicians for the administration of the flu
    vaccine increased from $3.98 per dose in CY 2002, to $7.72 in CY 2003,
    an increase of +94 percent. The payment increased again in 2004 to
    $8.25 per dose. In fiscal year 2004 and 2005, $40 million per year will
    be used for creating a stockpile of children's influenza vaccine to
    ensure this past year's shortages do not reoccur. While these previous
    measures have improved access to vaccines, we must also look toward
    future improvements. It is imperative that the United States develops
    the domestic capacity to produce rapidly the vaccine our nation would
    need in a pandemic. For that reason, the fiscal year 2005 budget seeks
    to double to $100 million our investment to ensure a year round
    production capacity for influenza vaccines to improve our preparedness
    for an influenza pandemic, as well as develop production technologies
    that could be scaled-up rapidly to provide surge capacity during a
    pandemic.

                               CHILDHOOD VACCINES

        The Budget includes two legislative proposals in Vaccines for
    Children that I believe should be strongly supported by the members of
    this Subcommittee. This legislation would enable any child who is
    entitled to receive VFC vaccines to receive them at State and local
    public health clinics. There are hundreds of thousands of children who
    are entitled to VFC vaccines, but can receive them only at Community
    Health Centers and other Federally Qualified Health Centers. The
    proposal ensures VFC coverage of childhood vaccines for VFC eligible
    children when they show up for services at a public health clinic.
    Given the rising cost of childhood vaccines, ensuring access to VFC
    vaccines for eligible children is especially important. Legislation is
    also needed to restore tetanus and diphtheria vaccines to the VFC
    program. The VFC authorization caps prices at such a low level that no
    manufacturer will bid on a VFC contract. As a result, the vaccines that
    are provided to VFC children through the public health system have to
    be financed with scarce discretionary resources. Enactment of the
    legislation the budget proposes would, at the same time, expand by $55
    million the vaccines that are available to children while reducing by
    $110 million the demand for vaccines financed with discretionary
    appropriations.
        CDC will continue to build a six-month, vendor-managed stockpile of
    all routinely recommended childhood vaccines. Between fiscal year 2004
    and fiscal year 2006, CDC will invest an additional $583 million to
    meet target quantities needed for a six-month stockpile. Vaccines from
    the stockpile can be distributed in the event of a disease outbreak and
    will mitigate the effect of any potential manufacturing supply
    disruption.

                       COMPLETION OF THE DOUBLING OF NIH

        I commend you, Mr. Chairman, and this Subcommittee, for your
    commitment in doubling the budget for the National Institutes of
    Health, consistent with the President's request. Building on the
    momentum generated by the fulfillment of the President's commitment to
    complete the five-year doubling of the NIH budget, the fiscal year 2005
    request provides $28.8 billion for NIH. This is an increase of $764
    million, or +2.7 percent, over the fiscal year 2004 level. In fiscal
    year 2005, over $24 billion of the funds requested for NIH will flow
    out to the extramural community, which supports work by more than
    217,000 research personnel affiliated with 2,000 university, hospital,
    and other research facilities across our great nation. These funds will
    support a record total of nearly 40,000 research project grants in
    fiscal year 2005, including an estimated 10,393 new and competing
    awards.
        NIH remains the world's largest and most distinguished organization
    dedicated to maintaining and improving health through the use of
    medical science. Major advances in scientific knowledge, including the
    sequencing of the human genome, are opening dramatic new opportunities
    for biomedical research and providing the foundation for un-imagined
    results in preventing, treating, and curing disease and disability.
    Investment in biomedical research by NIH has driven these advances in
    health care and the quality of life for all Americans, and the fiscal
    year 2005 budget request seeks to capitalize on the resulting
    opportunities to improve the health of the nation.
        In an effort to target gaps and opportunities that no single NIH
    institute could solve alone, the fiscal year 2005 budget allocates $237
    million for the Roadmap for Medical Research initiative, an increase of
    $109 million (or +85 percent) over fiscal year 2004. This initiative
    consists of three core themes of establishing new pathways to
    discovery, inventing the research teams of the future, and re-
    engineering the clinical research enterprise.

                     COMMUNITY AND FAITH-BASED INITIATIVES

        In support of the President's Community and Faith-Based Initiative,
    the fiscal year 2005 budget maintains a commitment toward programs that
    link community and faith-based organizations with State, local
    governments, and Federal partners programs. The initiative creates
    results by empowering those at the community level, who can best
    identify the social and health related problems. Those at the community
    level can then act to produce positive results and be agents of change
    in the lives of the most needy.
        The President's budget requests a total of $100 million for the
    Compassion Capital Fund, doubling the fiscal year 2004 level. Initiated
    in fiscal year 2002, the Compassion Capital Fund awards grants to
    organizations which provide technical assistance to help faith-based
    and community organizations access funding sources, operate and manage
    their programs, develop and train staff, expand the reach of programs
    into the community, and replicate promising programs.
        As our nation's prison population continues to rise, another
    important program that reaches our most vulnerable children is the
    Mentoring Children of Prisoners program. Studies indicate that children
    with incarcerated parents have a seven times greater chance of becoming
    incarcerated themselves and are more likely to succumb to substance
    abuse, gangs, early childbearing, and delinquency. This budget request
    includes $50 million, maintaining the fiscal year 2004 level, to
    provide grants to enable public and private organizations to establish
    or expand projects that provide mentoring for children of incarcerated
    parents and those recently released from prison. This activity will
    give 30,000 adolescent children of prisoners a beacon of hope in their
    world of despair.
        The President's budget includes $10 million for Maternity Groups
    Homes as part of the Transitional Living program. This will provide
    pregnant and parenting youth who cannot live safely with their own
    families access to adult-supervised community-based group homes, and a
    range of coordinated services including childcare, job training, and
    counseling.

                               HEAD START PROGRAM

        One of the most fundamental truths in our society today is the
    necessity for a solid educational background to allow all children the
    opportunity to succeed. The initial educational experience is the
    bedrock of our children's healthy growth and development. Mr. Chairman,
    with the generous support of this Subcommittee, we have made a
    significant difference in this beginning stage of our children's growth
    and development. This commitment towards meeting the needs of our most
    vulnerable citizens is unwavering and remains stronger than ever with
    the 2005 President's budget request of $6.9 billion for Head Start.
    This is an increase of $169 million over the fiscal year 2004 level. In
    fiscal year 2005, 919,000 children will receive Head Start services
    including 62,000 children in the Early Head Start program.
        In fiscal year 2005, we will continue to emphasize the goals of the
    President's Good Start, Grow Smart Initiative to strengthen Head Start
    by partnering with States, by providing information on child
    development and early learning to teachers, caregivers, parents, and
    grandparents, and close the gap between research and practice in early
    education. The fiscal year 2005 request includes $45 million to support
    the President's initiative to improve Head Start by funding nine State
    pilot projects coordinating State preschool programs, Federal child
    care grants, and Head Start into a comprehensive system of early
    childhood programs for low income children. The budget also includes
    $124 million to maintain competitive salaries for Head Start teachers
    and to support program enhancements in early literacy and cognitive
    development.

                             PREVENTION INITIATIVES

        More than 1.7 million Americans die of chronic diseases--such as
    heart disease, cancer, and diabetes--each year, accounting for 79
    percent of all U.S. deaths. Although chronic diseases are among the
    most common and costly health problems, they are also among the most
    preventable. The budget includes $915 million for CDC's Chronic Disease
    Prevention and Health Promotion program, an increase of $62 million
    over fiscal year 2004.
        Within this request is $125 million, an increase of $81 million,
    for the Steps To A Healthier U.S. Initiative. This increase will fund
    the State and community grant program initiated this past September to
    reduce the prevalence of diabetes, obesity, and asthma-related
    complications, targeting those at high risk. Last year these funds
    reached 23 communities, including seven large cities, one Tribal
    consortium, and 15 smaller cities and rural areas, and more areas will
    benefit during the upcoming year. Also a total of $10 million will be
    used to expand the Diabetes Detection Initiative, which targets at-risk
    populations. The aim of this initiative is to reach these populations
    where they live, work, and play through a customized, tailored approach
    with the aim of identifying undiagnosed diabetes.
        The fiscal year 2005 budget request for the CDC National Breast and
    Cervical Cancer Early Detection Program (NBCCEDP) is $220 million, an
    increase of $10 million over fiscal year 2004. This program has helped
    to increase mammography use by women aged 50 and older by 18 percent
    since the program's inception in 1991. Efforts are targeted toward low-
    income women with little or no health insurance and have helped to
    reduce disparities in screening for women from racial and ethnic
    minorities. With the requested increase, an additional 32,000
    diagnostic and screening services will be provided to women who are
    hard-to-reach and have never been screened for these cancers.

                            MENTAL HEALTH TREATMENT

        In meeting the President's goal of transforming the mental health
    system and increasing access to mental health services for some of our
    most vulnerable citizens, the fiscal year 2005 budget includes $913
    million in discretionary funding for mental health services, an
    increase of $51 million over fiscal year 2004, or +6 percent. As an
    important step in reshaping this delivery system, the budget proposes
    $44 million for State Incentive Grants for Transformation. These new
    grants will support the development of comprehensive State mental
    health plans to reduce system fragmentation and increase services
    available to people living with mental illness.
        Recent studies have found that 20 percent of individuals
    experiencing chronic homelessness also have a serious mental illness.
    This request proposes $10 million for the Samaritan Initiative, an
    Administration-wide initiative to reduce chronic homelessness, jointly
    administered with the Departments of Housing and Urban Development and
    Veterans Affairs. Through this initiative, States and localities will
    develop processes to better enable access to the full range of services
    that chronically homeless people need, including housing, outreach, and
    support services such as mental health services, substance abuse
    treatment, and primary health care.

                               FIGHTING HIV /AIDS

        HIV is one of the most serious and destructive challenges facing
    humanity in our world today. No country, whether large or small, rich
    or poor, can escape the devastation it brings. All have citizens whose
    lives have been destroyed by this horrible disease, and our commitment
    to ending this pandemic is both strong and unwavering. No nation in
    history has ever committed the time, energy, and fiscal resources that
    the United States has invested in this effort. The fiscal year 2005
    total HHS budget will continue this emphasis with the request for HIV/
    AIDS funding of $15 billion, or +31 percent over fiscal year 2001 for
    both domestic and global HIV/AIDS prevention, care, treatment, and
    research activities.
        Specifically, the fiscal year 2005 budget includes $784 million for
    States to purchase medications for persons living with HIV/AIDS. At
    this level, monthly AIDS Drug Assistance Programs will increase from
    93,800 clients in fiscal year 2004 to 100,000 clients in fiscal year
    2005. Also included is $53 million for the HIV/AIDS in Minority
    Communities activities to support innovative approaches to HIV/AIDS
    prevention and treatment in minority communities.

                    MARRIAGE AND HEALTHY FAMILY DEVELOPMENT

        The President announced an expanded initiative to build on research
    that there are life-long benefits of growing up in married-parent
    families. This initiative, comprised of new and existing programs, has
    four elements: (1) supporting marriage and families; (2) providing
    tools to parents; (3) teaching values to children; and (4) encouraging
    community and faith-based organizations to support families.
        Within this initiative is $273 million to help parents and
    communities provide teens with the tools to make responsible choices
    and abstain from early sexual activity. The budget includes $50 million
    to support a new program that will assist non-custodial fathers in
    becoming more involved in their children's lives, and $107 million to
    nearly double funding for State child abuse programs to reduce the
    incidence of child abuse and neglect and increase services to those who
    are victims.

                       HEALTH CARE INFORMATION TECHNOLOGY

        Improvements in the safety, effectiveness, and efficiency of health
    care, as well as in public health preparedness, can best be achieved by
    the accelerated use of health information technology (IT). Therefore,
    the fiscal year 2005 budget requests $50 million in new funding for a
    Health Care IT initiative. This amount, by funding demonstrations and
    investing in private sector and public program partnerships, will
    accelerate the development and utilization of modern IT in both health
    care and public health. These investments will assist development by
    the private sector of needed standards, examine ways the use of IT can
    be encouraged, coordinate actions across all agencies, and ensure that
    this investment will further the national health information
    infrastructure.
        These resources will be made available to local, regional, tribal
    and State data exchange networks and organizations, to provide the
    infrastructure necessary for exchange of a patient's health information
    within that area, and with other such organizations nationally. In
    addition, technical assistance and resources to these networks and
    information infrastructures will be available. These investments will
    complement and build upon the Agency for Healthcare Research and
    Quality's (AHRQ) demonstration grants and other activities to evaluate
    the effects of IT on the safety and quality of health care--a critical
    component of assuring that IT's positive benefits are adopted broadly.

                      MODERNIZATION AND REFORM INITIATIVES

        With the enactment of Medicare Prescription Drug, Improvement, and
    Modernization Act of 2003, the Department faces many challenges in the
    coming fiscal year. A top priority for CMS, and all Operating Divisions
    within HHS, will be the timely implementation of the sweeping changes
    in the law. As the most significant reform of Medicare since its
    inception in 1965, the law expands health choices for beneficiaries and
    adds a prescription drug benefit. MMA will strengthen and improve
    Medicare, while providing beneficiaries with new benefits and the
    option of retaining their traditional coverage.
        Along with Medicare reform, the President remains fully committed
    to strengthening and empowering America's families through legislation
    supporting welfare reform, modernization of Medicaid and SCHIP,
    increased child support enforcement, and reform of the child welfare
    system.

                            MANAGEMENT IMPROVEMENTS

        Finally, I would like to update the subcommittee on the
    Department's efforts to use our resources and the taxpayer's dollars in
    the most efficient manner. To this end, HHS remains committed to
    setting measurable performance goals for all HHS programs and holding
    managers accountable for achieving results. I am pleased to report that
    HHS is making steady progress. We have made significant strides in
    streamlining and making performance reporting more relevant to both
    decision makers and customers. As a result, the Department is better
    able to use performance results to manage and to improve programs. By
    raising our standards of success, we will continue to improve
    efficiency and increase our ability to improve the health of every
    American citizen.

           IMPROVING THE HEALTH, SAFETY, AND WELL-BEING OF OUR NATION

        Chairman Specter and members of the Subcommittee, I would like to
    thank you once again for your passion and support in working with us in
    this fight to improve the health, safety, and well-being of all
    Americans. The budget I bring before you contains proposals from many
    different areas. These programs, from enhancing the building blocks for
    our youngest and most vulnerable with Head Start, to expanding Health
    Centers to increase the access to quality health care for minorities,
    to protecting our nation from the threat of bio-terrorism, all meet
    vital needs within our communities. All of these proposals, which vary
    greatly in substance, are put forth with one simple overarching goal of
    ensuring the health, safety, and well-being of all Americans. I know
    that this goal is one that we share together, and I look forward to
    your continued support as we move toward turning our passionate
    commitment into positive results for the American people.

        Senator Specter. Thank you very much, Mr. Secretary.
        We will now proceed with our customary 5-minute rounds.

                      PRESCRIPTION DRUG BENEFIT ESTIMATES

        Mr. Secretary, the morning news reports are filled with the
    testimony of Mr. Richard Foster before a House committee
    yesterday, where he, in his capacity as the Medicare programs
    chief actuary, told House Members that he gave an analysis last
    June to the White House and the President's Budget Office which
    was not shared with the Congress, predicting that prescription
    drug benefits being drafted on Capitol Hill would cost about
    $150 billion more than President Bush said he wanted to spend.
    And he further reported that unnamed administration officials,
    or perhaps they are named, threatened to fire him.
        I have two questions for you on that. Do you have any
    personal knowledge that the cost estimate of $150 billion was
    concealed? And, second, do you have any personal knowledge
    about the alleged threats?
        Secretary Thompson. Senator, let me quickly respond, as
    accurately as I possibly can. Number one, I read in the paper,
    after the alleged threat by the Administrator of CMS--I had my
    chief of staff immediately----
        Senator Specter. The first you knew about it was reading
    about it in the newspaper?
        Secretary Thompson. No, no. This was way back in June when
    this took place. I read about it in the newspaper, I heard
    about it, and I had my chief of staff call----
        Senator Specter. And my question is: The first time it came
    to your attention was when you heard news reports?
        Secretary Thompson. That is correct. Last June.
        Senator Specter. Okay.
        Secretary Thompson. And then I had my chief of staff
    contact Mr. Foster and tell him, directly from me, that his job
    was not in jeopardy.
        Now, the actuary's assumptions, based upon that, was only
    for the first section of Senate bill 1, and that was $550
    billion. I did not know of that figure. I did know of the
    assumptions that Rick Foster had projected that we would be
    having more people participate in Medicare, by 94 percent
    versus CBO's number of 87 percent that was publicized. The
    Congress knew about that. The administration knew about that.
    And that was the big difference.
        The second difference on the cost estimates was based upon
    how much is going to be used by low-income seniors. We assumed
    that it's going to be a lot more than CBO. CBO scores it at 87
    percent. We score it at 94 percent. That is a difference of
    about a $100 billion of the $134 billion difference between CBO
    and our actuary. That's based upon assumptions. Those figures
    were known--not the exact figures. The fact is, is that we knew
    that they were going to be more, and we made that to be known
    to the Congress.
        Senator Specter. Well, focus specifically on what Mr.
    Foster----
        Secretary Thompson. Okay.
        Senator Specter [continuing]. Has said. And that is that he
    had a figure of $154 billion more than the President's figure,
    and he did not tell Congress about that $150 billion more.
        Secretary Thompson. Senator, that was based upon an earlier
    bill. That was Senate bill 1 that was introduced--that was the
    chairman's score from the Finance Committee. That was not the
    bill that was debated on the floor of the Senate or the House
    of Representatives. Those figures didn't come out until
    December of this past year, after the bill passed.
        Senator Specter. So are you saying that his allegation is
    factually incorrect, that he did not have information about
    $150 billion excess beyond what the President wanted to spend,
    and that he did not conceal that from the Congress?
        Secretary Thompson. I'm saying that the $150 billion
    difference is based upon an earlier version of the bill, and
    the final version is $134 billion, and that didn't come out
    until December 13. And the $150 billion was based upon only the
    first section of the bill. And there was no--to the best of our
    knowledge, and we have looked through all the records--there
    has not been any written record where any Member of Congress
    has asked for the earlier assumptions or the earlier figures.
    And that's why I've asked the inspector general of my
    Department to get all the facts so that we can report it to
    Congress. I have asked the inspector--have asked the Inspector
    General to make a detailed report to me and to Congress.
        Senator Specter. My red light just went on, and I want to
    observe the time limits, so I'll turn now to Senator Harkin.
        Senator Harkin. Mr. Secretary, I think the record will show
    here that you might have made a little bit of a misstatement,
    because I made a note on this. You said you read about this
    last June in the news reports. You did not read about it last
    June.
        Secretary Thompson. Yes, I did.
        Senator Harkin. There was a news report last June----
        Secretary Thompson. Yes, there was.
        Senator Harkin [continuing]. In the newspapers----
        Secretary Thompson. Absolutely.
        Senator Harkin [continuing]. Saying that there was this
    higher estimate?
        Secretary Thompson. No. No, there was a--the newspaper
    article that was last June was--is that--it came out, it was
    reported by AP, that Mr. Foster had been threatened that he was
    going to lose his job if he didn't send up--and what was
    requested was the score on the benefits of the particular bill,
    on premium support.
        Senator Harkin. Premium support, that's----
        Secretary Thompson. Premium support. And that was what was
    requested. That was what Tom Scully had told Rick Foster not to
    send up. That's what was said.
        Senator Harkin. Okay.
        Secretary Thompson. Then Tom Scully says, ``Somebody made
    the allegation that you're going to get fired if you send it
    up.'' When I heard that, I asked my chief of staff to call--
    which he did--call Mr. Foster and say, ``Your job is not in
    jeopardy at all.'' Mr. Foster has testified to that.
        Senator Harkin. Okay, then, I still wonder why we were not
    given those numbers.
        Secretary Thompson. We've looked at it, Senator Harkin, and
    we do not believe there has ever been a written request from
    any Member of Congress--neither the Senate or the House had
    ever requested for those figures. Those figures were
    preliminary figures on Senator Grassley's bill, and it was only
    on the benefit portion, on the drug portion, not the total
    bill. And that figure was $551 billion. And the last figure
    that deals with the bill that was passed was $534 billion.
        Senator Harkin. Uh-huh.
        Secretary Thompson. That's $17 billion difference, and
    that's--and Rick Foster testified yesterday that the final
    figures did not come out until the latter part of December,
    after the bill passed.
        Senator Harkin. That's right. But on June 3, Foster made
    his higher estimate. That's one. That was $150 billion.
        Secretary Thompson. That is--but that was on a different
    bill. That was on----
        Senator Harkin. That was on S. 1.
        Secretary Thompson [continuing]. S. 1. But that was--that
    was the chairman's mark, and that was only on the drug benefit.
    It wasn't on the other seven provisions of the bill, the other
    seven chapters.
        Senator Harkin. Okay. So then the bill passed in November,
    but the bill that passed--it was somewhat different than S. 1,
    obviously.
        Secretary Thompson. Completely different.
        Senator Harkin. Well, I don't know that it was completely
    different; it was somewhat different. But are you saying that
    it made no difference whether or not we knew there was $150
    billion more, or what the estimates were by the time the bill
    passed?
        I guess it just seems to me that, you know, who knew what,
    when, and how they knew it, and all that kind of stuff. It just
    seems to me that we have a fundamental question here. Do you
    think it should be the policy of the administration, any
    administration, that the actuaries officers at CMS provide
    technical assistance to Members of Congress, as I understand
    the practice was before this year? Now, I could be mistaken on
    that. But I understand the practice was that the actuaries
    office at CMS provided information to the relevant committees.
        Secretary Thompson. We have looked at that, and that was
    not the practice, and that's why there was some report language
    put in, in the Balanced Budget Act, because members of the
    Republicans were not able to get it from the actuary under the
    previous administration.
        But to answer your question, Senator Harkin, I think that
    that information should be made available, and I have testified
    to that previously.
        Senator Harkin. I agree with you, because obviously it was
    collected at taxpayers' expense. I mean----
        Secretary Thompson. Yes, sir.
        Senator Harkin [continuing]. This is not some private
    entity doing this, and that--those figures ought to be
    available for policymakers. I don't know what the end result is
    going to be, but I hope it is that we have access to these kind
    of figures in the future, I hope.
        Secretary Thompson. I think you should. I think you will.
    The CBO numbers are the ones that are--and those are the ones--
    the CBO still says it's $395 billion, not the $534 billion. And
    there's a logical explanation that I could go into if you would
    want me to, Senator Harkin.
        Senator Harkin. My time is up. I hope we get a second
    round, because I did want to ask you about the Wellness
    Program.
        Senator Specter. There will be a second round, Senator.
        Senator Harkin. Thank you, Mr. Chairman.
        Senator Specter. Senator Cochran.

                               DRUG REIMPORTATION

        Senator Cochran. Mr. Secretary, we've had some debates and
    votes on amendments here in the Senate relating to importation
    of pharmaceutical products from other countries. Are there
    sufficient funds in this budget request to deal with the
    problem of counterfeit or unsafe pharmaceutical products that
    may enter the United States from other countries?
        Secretary Thompson. I don't think so, Senator. I think it's
    a growing problem, and I think that we are doing the best job
    possible. As you know, I requested this Congress, early on when
    I came on, to get enough inspectors to deal with some things
    with food. We have increased it. But, overall, I still think
    that there is a good chance of having counterfeit drugs. And we
    see that every time we stop. We had, as you know, some
    inspections at the border not too long ago, one in July and one
    in September and October of this year, and about 87 percent of
    the drugs that came in were either mislabeled, mis-packaged--
    some were counterfeit, some were not certified by FDA, or
    approved by FDA. So a lot of drugs that come into America are
    not regulated by the FDA.
        Senator Cochran. Are you making an effort to bring this to
    the attention of our friends around the world, and try to get
    help there in those countries?
        Secretary Thompson. We are. We have a very strong,
    aggressive outreach program to other countries, especially to
    Canada. But Canada has pretty much indicated that it's not
    their problem, and it's our problem, and that we should address
    it ourselves. We have started hearings. Last Friday was the
    first hearing. I set up a commission, headed up by Surgeon
    General Carmona, to take a look at reimportation, importation,
    as well as ways in which we can develop it.
        We've also set up a task force on counterfeit drugs, and we
    announced that a couple of weeks ago. We're working with the
    Federal Trade Commission and the Department of Justice in
    regards to that.
        We're quite aggressive, but your question was, are there
    enough resources? I don't think there are, because FDA is very
    strapped with all of its demands. And this is a huge problem,
    and if, in fact, we are going to have reimportation, we're
    going to have more resources in order to make sure that this
    reimportation of drugs are safe.

                                    VACCINES

        Senator Cochran. In connection with the availability of
    vaccines to deal with threats to the public health----
        Secretary Thompson. Yes.
        Senator Cochran [continuing]. There seems to be a gap
    between what we should have and what we do have in the way of
    an inventory of vaccines, being able to locate them, and then
    mobilize our resources to deliver them where they may be needed
    in case of an outbreak of a disease or illness. Is there any
    effort in the budget to deal with that problem by providing
    funding to the Centers for Disease Control or other agencies
    that could help move us in the direction to deal with that more
    effectively?
        Secretary Thompson. Absolutely, there is, and you've
    already done a great deal, and I wish you could just come down
    and see how we track this. We have got the country split up
    into 12--in 10 regions, but we have 12 strategic locations
    where we have 600 tons of medical supplies, antibiotics,
    vaccines that we can strategically deploy to any city in
    America within 7 hours. It takes nine semi-truck loads or a KC-
    135 in order to do so. And we track that.
        We also have got, at the present time, enough smallpox
    vaccine, 400 million doses, to vaccinate every man, woman, and
    child in America. We have enough doxycycline and Cipro, as far
    as anthrax is concerned, to treat 14 million people in America
    for 60 days. We have money in here to go to 20 million, which
    is a huge increase of supplies that we're going to have to put
    in the supplies depots, but we're going to do that.
        We are asking for a BioShield, which is still tied up in
    Congress, and this is going to allow us to reach out to the
    pharmaceutical and biological companies to develop new vaccines
    for tularemia, for the plague, and for hemorrhagic
    superviruses, and so on.
        We're doing a lot, but we can always do more. I'm very
    satisfied with where we are, but I know that we can improve,
    and that's what we intend to do.
        Senator Cochran. Thank you very much for your efforts in
    this area. It's so important to homeland security and the
    health and safety of our American citizens.
        Secretary Thompson. I would hope you'd come down and see
    us, Senator.
        Senator Cochran. I'll do that. I need to go to the Center
    for Disease Control, too. I've never gone down there to take a
    tour around. I've seen photographs of some of the buildings
    that need upgrading----
        Secretary Thompson. Senator Specter's been down there. I'd
    like you to come down there. It's worth your time to do it.
    We're only a block away. If you come down, I can get you
    through in a half an hour, 45 minutes, and I can show you
    exactly how we track diseases and storms and whatever we've got
    to face. It's really an educational type of thing, and it's
    really--I invite you. I'd love to have you come down and host
    you and get a chance to see it.
        Senator Cochran. I accept your invitation, with pleasure.
        Secretary Thompson. Thank you.

                                    ORASURE

        Senator Specter. Mr. Secretary, a Pennsylvania company,
    Orasure Technologies, Incorporated, in Bethlehem, has developed
    a 20-minute HIV test, and I know you're familiar with it.
        Secretary Thompson. I'm very excited about it, Senator.
        Senator Specter. On March 10, Orasure met with HHS
    officials regarding additional purchases through the Substance
    Abuse and Mental Health Administration, and was led to believe
    that SAMHSA had committed to a $13 million purchase order;
    however, SAMHSA has now told staff that no such commitment has
    been made, and any potential purchase will be less than $5
    million. You and I have exchanged correspondence on it. I would
    be interested to know whether there was any commitment for a
    $13 million purchase, and what you anticipate by way of a
    purchase in light of the remarkable technology at hand and the
    tremendous need for determining, in Africa and other places,
    whether the people have HIV/AIDS?
        Secretary Thompson. I can't answer you specifically as to
    what was committed by SAMHSA, or if there was a
    misunderstanding, but I will get an answer to you very quickly.
    I'm sorry about that, that I don't have it at the top of my
    head, Senator Specter.
        [The information follows:]

                                    Orasure

        We are committed to using new technology to identify undiagnosed
    HIV-positive individuals, help them reduce risk of transmission, and
    refer them to care. In fiscal year 2003 CDC bulk-purchased $2 million
    of rapid tests (250,000 kits), and has placed an additional $2 million
    order for fiscal year 2004. We have also encouraged our international
    partners to consider the OraQuick tests in their efforts to identify
    individuals with HIV/AIDS. The Global Assistance Program countries
    frequently use OraQuick as a tie breaker when two less expensive tests
    give different results.
        SAMHSA submitted a request to the HIV/AIDS in Minority Communities
    Fund to purchase HIV rapid test kits for its HIV/AIDS grantees. At this
    time, no final decision has been made about the level of funding
    available for this request. The HIV/AIDS in Minority Communities Fund
    supports innovative approaches to HIV/AIDS prevention and treatment in
    communities of color. Each year HHS agencies/offices submit proposals
    for activities to reduce the disproportionate impact of HIV/AIDS on
    racial and ethnic minorities. In fiscal year 2003, a total of eight
    agencies/offices received dollars from this fund. It is our hope to
    reach final decisions on these dollars very shortly.

                GLOBAL FUNDS FOR AIDS, MALARIA, AND TUBERCULOSIS

        Secretary Thompson. In regards to Africa, as you know, I'm
    chairman of the Global Fund for fighting AIDS, malaria, and
    tuberculosis. I advised--we just came back from Geneva this
    past--we had our seventh board meeting, and I advised the board
    of this new, innovative idea that Orasure has come up with. The
    problem we have in the Global Fund is that it will use Orasure
    to be the arbitrator. They don't use it for the basics. I mean,
    they have a cheaper product. And if there's some question as to
    the accuracy, then they bring in Orasure to determine for sure.
    When they came out with this new quick test, I'm hoping to be
    able to push through the Global Fund to be able to be a bigger
    user of Orasure's product, because I'm very sold on it, and I'm
    very--I think the company is doing a tremendous job, and I
    think it could help save us money in the future.
        Senator Specter. Well, thank you for that answer and for
    your assurances that you will take a look to see what
    commitments----
        Secretary Thompson. I will.
        Senator Specter [continuing]. Have been made by SAMHSA or
    others in your Department.

                              CDC AND NIH BUDGETS

        A two-part question, Mr. Secretary. Your budget document
    states there is a growing concern that the next public-health
    emergency could overwhelm current capacities to respond, and
    would likely overwhelm CDC's current capabilities. How can we
    realistically cut the CDC budget by $116 million on their
    overall budget, and almost 180 million on their buildings and
    facilities, in the light of their mission and the tremendous
    threats?
        The second question I have for you relates to the budget of
    the National Institutes of Health, where we are facing a
    situation with the administration request to lead to a drastic
    curtailment of NIH awards.
        If you would respond to those two questions, I would
    appreciate it.
        Secretary Thompson. Thank you. And let me quickly respond
    so I can get to both of them.
        In regards to CDC, let me say that I let you down, Senator.
    I did not sell as effective as I thought I should have been
    able to, to get a little more money into buildings. That is the
    big difference in the reduction at CDC. As you all know, and
    you've been the leader in this, we're trying to get $250
    million a year down there, and we came in with a budget of $82
    million, of which $40-some million is going to Fort Collins.
    That is the big difference. A reduction in the VERB program was
    the other. I gave Director Gerberding, Assistant Secretary
    Julie Gerberding, an allotment of what she could do. She came
    in with the best budget she could. I think it's quite good.
        In regards to overwhelming the resources, the biggest thing
    I'm concerned about right now is a pandemic flu, and we have
    put some additional money in there, $50 million in the CDC,
    I've got $50 million into my accounts, in order to try and make
    sure that we are prepared to try and move companies from the
    egg culture to the cell culture, especially with avian flu that
    may come or may not come. I am very concerned about that. And
    avian flu could have the potential for destroying some of the
    egg stock because it affects chickens, and so we're trying to
    do something.
        In regards to NIH, we still, under our budget, are going to
    be able to give out more grants. Where we saved the dollars was
    reducing what was called the cost of increase to the cost of
    inflation over the 4-year grants, and we reduced that
    approximately from about 3.3 percent down to about 1.3 percent.
    But next year, even if our budget--if Congress doesn't put more
    money into it, there will be more grants out there than there
    has been before. And since I've been Secretary, thanks to you,
    the Congress leadership in giving us the dollars, we have gone
    up by 30 percent in grant applications, in grant requests, in
    grant approvals, and 42 percent increase in the amount of
    dollars that those grants have been able to receive.
        Senator Specter. My red light went on in the middle of your
    answer, Mr. Secretary. And we will be submitting more detailed
    questions on NIH----
        Secretary Thompson. Thank you.
        Senator Specter [continuing]. For the record.
        Secretary Thompson. I would be more than happy to answer
    them, sir.
        Senator Specter. We've been joined by the distinguished
    chairman of the full committee.
        Senator Stevens.

                              HEALTHCARE DELIVERY

        Senator Stevens. Thank you, Mr. Chairman. I do have three
    other areas to stop by--I stopped by here, Mr. Chairman,
    because I don't think any person in history has brought more
    hope to the Alaska native people in the area of healthcare
    delivery than Secretary Thompson, and I'm----
        Secretary Thompson. Thank you.
        Senator Stevens [continuing]. Here to thank you very much
    and, what's more, to invite you back again. Your annual visits
    really bring great hope to our people.

                           ALASKA DENTAL ASSOCIATION

        You may be interested to know that yesterday, for the first
    time, the American Dental Association, the Alaska Dental
    Association, approached me with the idea of trying to interface
    some dental care into the village health clinics. That has been
    a total gap, in terms of the care----
        Secretary Thompson. Huge gap.
        Senator Stevens [continuing]. Of Alaska natives. It's
    really great news. They came forward on their own, and I look
    forward to working with you and with your people on trying to
    partnership with them. They're willing to take on part of the
    cost. It's a very interesting thing.

                          POSITRON EMISSION TOMOGRAPHY

        I also am grateful to you for what you've done to help us
    try to move CMS forward to bring about the favorable coverage
    decision for PET, positron emission tomography. I do believe,
    Mr. Chairman, that there's no system that holds more hope for
    dealing with the baby-boom generation than PET, in terms of
    trying to get a handle on Alzheimer's and those diseases
    related to dementia. And, clearly, if we follow through in that
    generation with the amount of Alzheimer's we've had in my
    generation, the cost is going to be overwhelming. We must find
    some way to deal with it, and at least PET will give us a
    chance for our medical researchers going ahead to try and find
    a cure to slow it down and to provide the opportunity, through
    the prescription drugs already on the scene, to deal with
    severe symptoms and to give those seniors with Alzheimer's a
    chance to have a fairly decent life as they can--into that
    terminal period. I can't thank you enough for that.
        I do have a couple of questions that I would like to submit
    for the record, if I may, Mr. Chairman. And I thank you for
    your courtesy.

                                    OBESITY

        My last comment would be, keep up the battle against
    obesity.
        Secretary Thompson. Thank you.
        Senator Stevens. You know, we're just back on a journey
    through the Middle East, Mr. Secretary--Jordan, Iraq, Kuwait,
    Pakistan, Afghanistan, and even into France. We're the only
    nation that really has this terrible, terrible addiction to
    obesity, that I saw on that whole trip. Not our military men
    and women, thank God. They get the discipline when they're
    fairly young, and I hope it carries through for them. But for
    our community at large, I think obesity is becoming a number-
    one challenge to our survival. So I would hope we would all
    join with him and help him as much as possible.
        Thank you for your courtesy.
        Secretary Thompson. Thank you very much, Senator Stevens,
    and let me just thank you for your leadership. And, yes, I will
    be back in Alaska. I told you I'd go back to Alaska every year
    as long as I'm Secretary, and we've made some progress; not as
    much as you or I would like, but we're making some, and we'll
    be back there, and we've still got to work on the water and
    sewer for Alaska natives, because that is still--it's a huge
    problem, and I know you're the leader in that that, and I
    applaud you.

                               PREPARED STATEMENT

        Senator Stevens. Well, when your nearest neighbor is 500
    miles away in every direction, and you have a hundred people,
    hope is a great thing.
        Secretary Thompson. Yes, sir.
        Senator Stevens. And you've brought hope to those people,
    and I want to help you continue that.
        Secretary Thompson. Thank you very much.
        Senator Stevens. Mr. Chairman.
        [The statement follows:]

                   Prepared Statement of Senator Ted Stevens

        Thank you Mr. Chairman. Secretary Thompson, it's a pleasure to see
    you here today. Once again I want to express my appreciation for your
    leadership on a host of issues that are of vital importance to all
    Americans. I especially want to thank you for all that you have done
    for Alaska. We are looking forward to having you visit us again this
    summer.
        I am also very grateful to you for helping get C.M.S. moving
    forward to a favorable coverage decision for PET scans to help diagnose
    Alzheimer's disease in Medicare patients at an earlier time than any
    other diagnostic test. That coverage will give many seniors who
    discover they have Alzheimer's a chance to slow the progress of the
    disease with medication before its incapacitating symptoms appear.
        Mr. Secretary, I believe we will be facing a crisis of huge
    proportions when Alzheimer's begins to strike the baby boom generation.
    I hope our investment in medical research at NIH will produce a cure
    before that time. But, in the meantime, early diagnosis of Alzheimer's
    disease, through pet, coupled with currently available prescription
    drugs begun at a stage before the most severe symptoms appear, will
    help many seniors continue to lead productive and reasonably healthy
    lives.
        I'm also pleased that you were finally successful in including
    funding in your fiscal year 2005 budget for the Denali Commission.
    While it is less than our fiscal year 2004 number, I know that you have
    worked hard to have those funds included in your budget because you
    have seen first hand many of the infrastructure projects the commission
    has funded in remote parts of Alaska.
        I am concerned that several programs that fund rural health
    activities, like the Rural Outreach grants and Rural Hospital
    Flexibility grants have been eliminated. Both of these programs, while
    relatively small ones, have benefited remote communities in Alaska and
    other rural States that need special help to provide needed health
    services. I know this is a very tight budget, but I urge you to work
    with the subcommittee to restore funding for these programs.
        Another matter of concern to me is our Nation's growing epidemic of
    obesity. Mr. Secretary, you are to be applauded for your personal
    leadership in this area, beginning with your putting the Department on
    a diet and encouraging physical activity. I hope you will continue to
    push forward, because yours is a message we must heed. A recent report
    from the CDC tells us that obesity will soon overtake smoking as the
    Nation's leading cause of preventable death. I will be pleased to work
    together with you in your efforts to make us a healthier Nation.
        Mr. Secretary, again I thank you for your tireless efforts to
    improve the health and well being of Alaskans and other Americans.

        Senator Specter. Thank you, Senator Stevens.
        Senator Harkin.
        Senator Harkin. Thank you, Mr. Chairman.

                      MONEY FOLLOWS THE PERSON INITIATIVE

        Mr. Secretary, as I said in my opening statement, I know
    you've long supported the right of people with disabilities to
    choose to live in their neighborhoods and communities, rather
    than nursing homes and institutions. Along with Senators
    Specter and Smith, we introduced a bill last summer to get the
    Money Follows the Person Initiative, as it's called, enacted
    last summer. As I said earlier, you included funds for this
    initiative in your fiscal year 2005 budget, for which we're
    very appreciative. I understand the Finance Committee is going
    to hold hearings on this issue on April 7. Again, these are all
    good first steps, but we really need your support to get this
    bill moving through Congress and signed into law.
        I haven't really heard of any real opposition to it. It's
    just, sort of, we've got to get it moving. You know, we hear a
    lot of talk about the New Freedom Initiative and everything,
    and we're all very supportive, but nothing seems to happen. I
    guess I'm just asking if you could really help with the
    administration and getting this thing moving through Congress
    this year. That's all I'm asking.
        Secretary Thompson. Absolutely. I am as passionate about
    it, hopefully, as you are, Senator. And I want to see it done,
    because I'm not going to be here next year, and I want to make
    sure that we get it through before I leave, and then I'm--I
    have talked to Senator Grassley on it, and he's going to hold a
    hearing on it. I'm hoping he'll get the bill introduced quickly
    so we can start getting co-authors on it and start getting
    bipartisan support. I don't think there's that much--any
    opposition to it. I think we've just got to get the time to get
    it through the committee and on the floor and through both
    houses. And I know the President's going to sign it. So let's
    work together on a bipartisan basis and make sure it gets
    completed this year.
        Senator Harkin. Well, I appreciate that, and I just--
    whatever we can do to help, but you can also be very
    influential in----
        Secretary Thompson. Thank you.
        Senator Harkin [continuing]. Move it through. And I know
    you're passionate about it. And I agree with you, we've got to
    get it through this year.

                                 FOOD LABELING

        The second part of my question is, I had--I said I'm--
    again, I'm really appreciative of all that you're doing
    personally, and, through you, your Department, on this issue of
    obesity and wellness, and personal wellness as, sort of, a
    thing that we've got to be focusing on. I am somewhat puzzled,
    however, by the fact that many of the recommendations
    pertaining to the food industry and the labeling of foods,
    especially restaurant foods, are voluntary rather than
    mandatory.
        As the FDA report notes, food consumed away from the home
    has increased from 33 percent of consumers' food budgets in
    1970 to 47 percent in 2002. Over the same period, total
    calories consumed from food purchased outside the home
    increased from 18 percent to 32 percent. I guess my question is
    this: Why, then, despite FDA's own assertion that the food
    labeling required under the original National Labeling
    Education Act has been helpful to the consumers, and despite
    the fact that your focus groups show that consumers would like
    more labeling in restaurants, why do does the report recommend,
    quote, ``urge'' the restaurant industry to launch a nationwide,
    quote, ``voluntary'' and point-of-sale information campaign for
    customers, rather than some sort of mandatory labeling
    requirement? I guess that's the essence of my question. Why
    voluntary? Why not have some mandatory labeling requirement for
    that information?
        Secretary Thompson. It's a different way to approach the
    problem. I'm not saying one approach is that much better over
    the other one. Every month I sit down with a different group of
    people. I've met with the Restaurant Association now three
    times. I have asked them to put more information on their
    menus. Most of them are complying. It was a tough sell in the
    first meeting. Every meeting since then has been getting
    better, Senator. And the last one was a very friendly meeting
    in which they were volunteering many more menu items that are
    going to be heart-healthy and low carbs and better, and they're
    going to be more informative.
        Number two, I have met with the health insurance companies
    many times. I met the health insurance, health companies,
    medical companies, and so on. I do this on a monthly basis. I
    bring in a different group to talk about prevention. And we
    continue to do that. We're holding a summit, I believe, next
    week, in Baltimore, on prevention, and we're having, I believe,
    1,200 people that have signed up already to do it. So I'm using
    the bully pulpit because I believe, like you do, of $1.5
    trillion, 75 percent is for chronic illnesses--$155 billion for
    tobacco-related diseases, 442,000 people die; $135 billion for
    diabetes, 200 million Americans die; $117 billion on obesity.
    And I think we can do a lot better job. And I just think right
    now we can do it by pushing rather than hammering them.
        Senator Harkin. Well, Mr. Secretary, I was here when we
    pushed through the labeling for packaged goods in grocery
    stores. We had the same arguments then from the grocery people.
    The grocery manufacturers--oh, my gosh--``We changed the
    contents of boxes. We can't be doing this. And it's just going
    to be awful. It's just going to cost so much money.'' We went
    ahead and did it, and, you know, not even a blip. And yet
    people rely on that today. They go to grocery stores--it's
    taken some years, but now you look, I think the figures are
    over 60-some percent in surveys--people go to grocery stores,
    look at those labels to find out what they're buying.
        Now, Ruby Tuesday, I don't know anybody--I don't know Ruby
    Tuesday--who owns it or who runs it, but I have a feeling they
    had a lot to do with these people now being more willing to put
    things on their menus, because Ruby Tuesday voluntarily said
    they're going to put it all in.
        Let me just show--where's my chart? They were saying how
    onerous it was going to be. Here's a typical menu. And all they
    did is, they put the calories, the saturated fat, and sodium
    for each item. It's not a big deal.
        Secretary Thompson. It is not.
        Senator Harkin. It's not a big deal.
        Secretary Thompson. And it's very enlightening. And that's
    what we've got. We're changing the labeling out at FDA. We set
    up a committee. We're going to have some new labels with more
    information as to calories, portion size. And that's coming to
    FDA.
        Senator Harkin. But, again--and I know my time is up--I'm
    all for volunteerism, but FDA is also in the business of
    regulation and mandating, and we've been through this before,
    because it is such a health crisis. I, again, urge you to get
    the FDA involved in setting down a mandatory--there's
    legislation here, as you know, to do that, pending in the
    Senate and the House, to get the FDA to set down regulations on
    information of fat, calories, sodium on menus in restaurants.
    Rather than urging them--and you can urge and urge and urge.
    Some will do it, but not all of them will.
        Secretary Thompson. I think you're going to see a lot of
    that kind of information on the labels when we come out later
    on this summer, Senator.
        Senator Harkin. Well, I hope so.
        Secretary Thompson. I think you'll be very happy with it.
        Senator Harkin. But, again, I guess my rhetorical response
    might be, well, should we undo the regulations on the labeling
    regarding packaged good, and just make that voluntary?
        Secretary Thompson. No.
        Senator Harkin. Of course not. Of course not. So I think
    this is, sort of, the next step in that, and I still believe
    that--I hope voluntarily everybody does it, but then you're
    going to have--maybe one will voluntarily put this information,
    someone will put this information.
        Secretary Thompson. No, we're going to have uniform
    standards, and I'm going to be rolling those out this summer.
        Senator Harkin. But they'll be voluntary.
        Secretary Thompson. Most of them will be at this point.
        Senator Harkin. So I won't have to abide by it. I'll put
    whatever I want to on it. Rather than putting the total
    calories and what that double-cheese, double-whatever-it-is,
    and these fries, I might put it on for a 6-ounce portion.
        Secretary Thompson. I think we're going to be much more
    successful than you think, Senator.
        Senator Harkin. Well----
        Secretary Thompson. I hope, anyway.
        Senator Harkin. Well, we can hope. We can hope. But it
    seems to me they've got to be pretty stringent and
    straightforward. But if it's voluntarily, you'll get a mismatch
    of all kinds of different information on stuff, and they will
    try to confuse people, because we've seen that happen in the
    past without the kind of things we have on the packaged goods.
    And we have a problem there, too, a little bit, as you know,
    because they use different sizes. And the FDA is getting ready
    to address that, and I applaud that.
        Secretary Thompson. Yes, we are.
        Senator Harkin. Thank you, Mr. Chairman, for letting me go
    over my time.
        Senator Specter. Thank you, Senator Harkin.

                               HEALTH PROFESSIONS

        Mr. Secretary, there are three questions that I would like
    to state now, and ask you to respond to for the record.
        With respect to health professionals, Mr. Secretary, I
    would like you to answer, for the record, how we can
    realistically cut the $300 million reduction on those programs
    in light of the urgent shortage of health professionals,
    especially in rural areas. Your budget justifies that by an
    additional $25 million to the National Health Service Corps,
    which, frankly, I don't see the relationship. But if you would
    respond for the record, we would appreciate it.

                              ABSTINENCE EDUCATION

        Number two, on the abstinence initiative, this is a program
    that I think is very meritorious, abstinence education, and we
    would like a response on the evaluation that your Department is
    having as to how well these programs are working.

                               STEM CELL RESEARCH

        And, third, as to stem cells, this continues to be a highly
    controversial subject. Those who oppose embryonic stem-cell
    research seek to tar those who favor it with the accusation
    that human cloning is supported, which, of course, is factually
    untrue. It's totally different, nuclear transplantation. But we
    would like you to respond as to your evaluation as to the
    availability of the 63 lines the President referred to on his
    famous declaration, back on August 9, 2001 in his 9 o'clock
    speech--the line was expanded to 70--and what has happened
    there, and how many of those are really usable, untainted with
    mouse feeder, and what is happening elsewhere. We hear periodic
    reports, but you are the central figure in the Federal
    Government. Give us the specifics on what's going on in South
    Korea or other places, or what Harvard is doing with reported
    $100 million program, another report about things going on in
    Minnesota. And I see these periodically in the press, but we
    really ought to collate all of this in one central repository
    so we know what is happening on this very important subject,
    which is the cutting edge of real opportunity to make inroads
    against the most dreaded maladies of the era. I know your
    personal thinking on the subject, and I know that--the
    complexities of the issue, but, at the minimum, as of this
    time, we ought to have the facts before us as to what is
    happening there to make a judgement.
        Well, thank you very much for coming in, Mr. Secretary.
        Secretary Thompson. Thank you, Senator.
        Senator Specter. I'd like to meet with you privately for a
    moment or two after the hearing.

                         ADDITIONAL COMMITTEE QUESTIONS

        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

                               HEALTH PROFESSIONS

        Question. With respect to health professionals, Mr. Secretary, I
    would like you to answer, for the record, how we can realistically cut
    the $300 million reduction on those programs in light of the urgent
    shortage of health professionals, especially in rural areas?
        Answer. Over the past two decades, we have invested over $6 billion
    on general health professions training grants. However, as we shape
    future spending, we will concentrate on directly supporting efforts
    that improve health professions shortages, focus on emerging workforce
    demands, and meet the needs of the underserved.
        The President's budget makes a substantial investment in expanding
    access to health care to underserved communities through the Health
    Centers program and the National Health Services Corps. In fiscal year
    2005, the Health Centers program is on-track to meet the President's
    five-year goal to increase access to health care in 1,200 communities
    with new and significantly expanded health center sites and increase
    the number of people served by over 6 million. Further, the President's
    budget supports approximately 2,750 loan repayments and scholarships
    for health care professionals in the neediest communities through the
    National Health Services Corps program.
        The new rural health care investments created by the Medicare
    Prescription Drug, Improvement and Modernization Act (MMA) will mean
    greater access to hospitals, health professionals and other medical
    services for rural seniors. It is estimated that the major rural
    provisions of the MMA will increase Medicare spending in rural America
    by $20 billion over 10 years. In addition to substantially increasing
    Medicare reimbursement for rural hospitals, a focal point for health
    care in rural communities, the MMA will also increase reimbursement for
    physicians, and other health care providers, in rural areas. For
    example, the Act establishes a new 5 percent incentive payment for
    physicians practicing in physician scarcity areas which include many
    rural communities.

                                   ABSTINENCE

        Question. On the abstinence initiative, this is a program that I
    think is very meritorious, abstinence education, and we would like a
    response on the evaluation that your Department is having as to how
    well these programs are working.
        Answer. The Department is currently funding two independent,
    rigorous, longitudinal evaluations of abstinence education programs.
    The first is an on-going evaluation of a select number of State Section
    510 abstinence education programs. It is being conducted by Mathematica
    Policy Research (MPR). The second evaluation effort is currently in
    design phase. It will examine the effectiveness of community-based
    abstinence education programs and other approaches to teen pregnancy
    and STD prevention. Both of these evaluation efforts are overseen by
    the Office of the Assistant Secretary for Planning and Evaluation
    (ASPE).
        An implementation report from the ongoing MPR evaluation was issued
    in April 2002. It documented a wide range of abstinence education
    programs that have been well received. They are innovative in their
    approach to promoting abstinence as the healthiest choice for youth.
    These programs incorporate activities that have been shown to be
    effective: an emphasis on goal setting; developing decision-making
    skills; getting parents, schools, and communities involved in
    supporting the healthy development of youth.
        The programs are diverse, creative, and offer youth much more than
    a single message of abstinence. Youth responded positively to program
    staff who showed a strong and unambiguous commitment to the program
    message, and programs that used an intensive set of youth development
    services to enhance and support the abstinence message were very well
    received. The report showed that addressing peer pressure is difficult,
    and many programs have struggled to address these issues and engage
    parents in this process. This report also offered a description of the
    ways in which programs have partnered with local schools to provide
    abstinence education, highlighting some of the challenges to creating
    and sustaining these partnerships.
        The MPR evaluation has an end date of September 30, 2006. The
    original time frame in the statute under which the evaluation project
    is operating was through September 2001. However, the contractor and
    others have recognized the need for a longer-term follow-up period in
    which to examine the program effects on youth. As a result, the
    contract period has been extended through September 2006.
        ASPE is also in the process of designing an evaluation of
    community-based abstinence education activities and other approaches to
    teen pregnancy and STD prevention. ASPE contracted Abt Associates to
    develop evaluation designs for a longitudinal, rigorous impact study,
    which will help best answer some of the original policy questions that
    were the impetus for this study. The study will follow adolescents
    through high school, and will measure the impact of these programs on
    behavioral outcomes, including the reduction and prevention of out-of-
    wedlock pregnancies and sexually transmitted diseases (both viral and
    bacterial). Other key outcome variables of interest include age at
    first sexual activity and intercourse, frequency of sexual activity and
    intercourse, and number of individuals who postpone sexual activity or
    intercourse through adolescence.

                               STEM CELL RESEARCH

        Question.What is the status of the human embryonic stem cell (hESC)
    derivations listed on the NIH Stem Cell Registry? How many are in
    private hands? How many have been grown on mouse feeder layers? How
    many are viable?
        Answer. All of the derivations listed on the NIH Human Embryonic
    Stem Cell Registry are privately owned by 15 different companies or
    academic institutions. The providers indicated by an asterisk (*) below
    are recipients of the NIH Infrastructure award to develop, characterize
    and distribute cell lines.
        BresaGen, Inc., Athens, Georgia*
        --4 derivations
        --3 lines available
        --The cells in derivation BG04/hESBGN-04 failed to expand into
                undifferentiated cell cultures.
        Cell & Gene Therapy Research Institute (Pochon CHA University),
    Seoul Korea
        --2 derivations
        --0 lines available
        Cellartis (formerly Cell Therapeutics Scandinavia), Goteborg,
    Sweden*
        --3 derivations
        --2 lines available
        --Cell line SA03/Salgrenska 3 was withdrawn by donor.
        CyThera, Inc., San Diego, California*
        --9 derivations
        --0 lines available
        --The cells failed to expand into undifferentiated cell cultures.
        ES Cell International, Melbourne, Australia*
        --6 derivations
        --6 lines available
        Geron Corporation, Menlo Park, California
        --7 derivations, all duplicates of Wisconsin Alumni Research Fdn.
                derivations
        Goteborg University, Goteborg, Sweden
        --16 derivations, reported to have not been exposed to mouse feeder
                layers
        --0 lines available
        Karolinska Institute, Stockholm, Sweden*
        --6 derivations
        --0 lines available
        --The cells failed to expand into undifferentiated cell cultures.
        Maria Biotech Co. Ltd.--Maria Infertility Hospital Medical
    Institute, Seoul, Korea
        --3 derivations
        --0 lines available
        MizMedi Hospital--Seoul National University, Seoul, Korea*
        --1 derivation
        --1 line available
        National Centre for Biological Science/Tata Institute of
    Fundamental Research, Bangalore, India
        --3 derivations
        --0 lines available
        Reliance Life Sciences, Mumbai, India
        --7 derivations
        --0 lines available
        Technion-Israel Institute of Technology, Haifa, Israel*
        --4 derivations
        --2 lines available
        University of California, San Francisco, California*
        --2 derivations
        --2 lines available
        Wisconsin Alumni Research Foundation, Madison, Wisconsin*
        --5 derivations
        --5 lines available
        Of the 78 entries on the Registry, 71 are from independent embryos
    and 7 are duplicates located at both WiCell (Wisconsin Alumni Research
    Fdn.) and Geron. The Geron cell lines are not being widely distributed
    to the research community.
        Of the 71 independent derivations:
      --16 have failed to expand into self renewing, pluripotent cell lines
            (9 at CyThera, 1 at BresaGen, 6 at Karolinska), and 1 line was
            withdrawn by the donor at Cellartis (formerly Cell Therapeutics
            Scandinavia, CTS). NIH provided Infrastructure support in
            failed attempts to expand these 16 derivations into
            distribution-quality cell lines.
      --Of the remaining 54 independent derivations, 21 are available for
            shipment, after expansion and characterization using NIH
            Infrastructure grant awards. The 21 that are currently
            available are:
                    BresaGen, Inc.--BG01, BG02, BG03
                    Cellartis--SA01, SA02
                    ES Cell International--ES01, ES02, ES03, ES04, ES05,
                    ES06 4
                    MizMedi Hospital--MI01
        4Technion-Israel--TE03, TE06
                    UCSF--UC01, UC06
                    WiCell--WA01, WA07, WA09, WA13, WA14
      --Of the remaining 33 independent derivations, 2 more are at
            institutions with NIH Infrastructure awards. If these 2 were
            developed into distribution quality cell lines ready for
            shipment, there would be 23 independent cell lines available to
            the research community. The 2 cell lines under development are:
                    Technion-Israel--TE04, TE07
      --The remaining 31 independent derivations are all at institutions
            located outside of the United States that have not applied for
            NIH Infrastructure awards to develop their cell lines. Any
            plans to develop these derivations into cell lines that are
            available to the research community are unclear at this time.
            The 31 derivations at institutions that do not have
            Infrastructure awards are:
                    Pochon CHA (Korea)--2 derivations
                    Goteborg Univ. (Sweden)--16 derivations
                    Maria Biotech (Korea)--3 derivations
                    National Centre for Biological Sciences (India)--3
                    derivations
                    Reliance Life Sciences (India)--7 derivations
        As far as we know, all derivations have been exposed to mouse
    feeder cells, with the exception of the 16 derivations at Goteborg
    University (Sweden).
        Information on the detailed characteristics of each of the
    derivations is available on the NIH Human Embryonic Stem Cell Registry,
    http://escr.nih.gov.
        Question. What is Happening at Harvard University?
        Answer. On March 25, 2004, Harvard University announced the
    derivation of 17 hESC lines in an article published in the New England
    Journal of Medicine. Funding for the derivations and distribution of
    these lines is being provided by the Howard Hughes Medical Institute,
    Juvenile Diabetes Research Foundation and Harvard University.
        On April 23, Harvard University announced the establishment of the
    Harvard Stem Cell Institute. According to Harvard, the Institute will
    encourage adult and embryonic stem cell research using both animal and
    human stem cells. The Institute has two co-directors: Harvard Medical
    School Professor David Scadden, who also directs Massachusetts General
    Hospital's Center for Regenerative Medicine and Technology, and Douglas
    Melton, the Thomas Dudley Cabot Professor of the Natural Sciences and a
    Howard Hughes Medical Institute investigator.
        Research at the Institute will be focused on five areas of disease
    for which stem cell therapy seems most promising. The diseases all
    result from some sort of organ or tissue failure and include: diabetes,
    neurodegenerative diseases, blood diseases, immune diseases,
    cardiovascular disease, and musculoskeletal diseases.
        Although research on the 17 new human embryonic stem cell (hESC)
    derivations are not eligible for Federal funding, NIH is currently
    supporting several scientists at Harvard University whose hESC research
    use lines eligible for Federal funding. Dr. Doug Melton is working to
    identify the genes involved in hESC self-renewal and differentiation.
    Dr. George Daley is studying hematopoietic development from hESCs. Dr.
    Howard Green is working to develop the culture conditions to coax hESCs
    to become the keratinocytes that make up human skin's epidermis. Dr.
    Jeffrey Harper is analyzing the signals that control hESC division.
        Question. What is Happening in South Korea? What is Happening in
    Other Countries?
        Answer. On February 12, 2004, South Korean researchers published
    the first scientifically credible report of the creation of a cloned
    human embryo in the laboratory by means of somatic cell nuclear
    transfer (SCNT) (Science 303: 1669-1674.) These scientists, supported
    by the South Korean government, then used these cloned embryos to
    establish a human embryonic stem cell line. They combined the DNA of a
    woman's ovary cell with her donated egg, from which the nucleus had
    been removed, and then stimulated the newly combined cell to divide.
    The resulting very early embryo was then allowed to develop to the
    blastocyst stage (five to nine days), at which point it was
    disaggregated and the highly potent stem cells of the inner cell mass
    were removed. These stem cells were then treated to produce a stem cell
    line to be used for various kinds of biomedical research. Subsequent to
    the publication of the SCNT study, the South Korean government voted to
    ban the creation of cloned human embryos, but might allow cloning for
    biomedical research on a case-by-case for medical treatment subject to
    approval by a National Bioethics Advisory Commission. Scientists will
    be permitted to use spare frozen embryos, left over from infertility
    treatments and kept in laboratories for at least five years, for
    limited stem cell research into treatments for hard-to-cure diseases.
    The regulations banning human cloning are expected to come into effect
    after President Roh Moo-hyun signs the bill. The regulations on stem
    cell research will go into effect in 2005.

    Other International Stem Cell Efforts
                International Society for Stem Cell Research (ISSCR)
        The International Society for Stem Cell Research is an independent,
    nonprofit organization established to promote and foster the exchange
    and dissemination of information and ideas relating to stem cells, to
    encourage the general field of research involving stem cells and to
    promote professional and public education in all areas of stem cell
    research and application. Opinions on the legitimacy of experiments
    using human embryos vary among members of the European Union (EU)
    according to the different ethical, philosophical and religious
    principles in which they are grounded. EU member states have taken very
    different positions on the regulation of human embryonic stem cell
    research and cloning for biomedical research. More information about
    the regulations and policies of EU members can be found on the website
    of the ISSCR at the following link: http://www.isscr.org/scientists/
    legislative.htm.

                The International Stem Cell Forum (ISCF)
        The ISCF was founded in January 2003 to encourage international
    collaboration and funding support for stem cell research, with the
    overall aim of promoting global good practice and accelerating progress
    in this vitally important area of biomedical science. The Forum's long-
    term aim is to help stem cell scientists achieve a range of
    revolutionary medical advances that will benefit people throughout the
    world. The ISCF is led by the United Kingdom's Medical Research Council
    and consists of 14 leading supporters of stem cell research from around
    the world. Member organizations are based in the United States,
    Finland, Australia, Canada, Germany, France, Israel, Netherlands,
    Japan, Singapore, Sweden, Switzerland, and the United Kingdom. Within
    ISCF, the United States is represented by the NIH. The Juvenile
    Diabetes Research Foundation International (JDRF) is also a member of
    the ISCF. One short term goal of the ISCF is to compare different stem
    cell lines from the member organizations. As part of this goal, NIH's
    federally approved stem cell lines will be compared to those of other
    member organizations. Information about the stem cell research efforts
    of the member organizations can be found on the website: http://
    mrc.live.tmg.co.uk/.

                          PREPARED STATEMENT RECEIVED

        Senator Specter. We have received the prepared statement of
    Senator Mary L. Landrieu. The statement will be placed in the
    hearing record.
        [The statement follows:]

                 Prepared Statement of Senator Mary L. Landrieu

        With the release of the 2005 budget, President Bush emphasized his
    commitment to reducing the deficit, most of which has been created by
    his fiscally irresponsible policies, within five years. The overall
    budget proposed by the President cuts domestic discretionary spending
    outside of homeland security by $49 billion by 2009, a 12 percent cut
    in spending. A large portion of the domestic discretionary spending
    that the Administration proposes to cut from 2005-2009 is administered
    by the Department of Health and Human Services and provides services
    such as child care, child welfare, and health care to our poorest
    children, families, and seniors.
        Because it is an election year, the Administration has attempted to
    hide their lack of support for domestic spending by playing a shell
    game. When questioned about their commitment to important social
    issues, the Administration touts its minor increases in some programs
    in the 2005 budget as evidence of their ``compassionate conservatism.''
    Yet, if you look closely enough you will see that after this year,
    these ``increases'' continue to shrink until they sink below current
    funding levels by 2009.
        Although I am supportive of almost any policy aimed at bringing the
    economy back into an era of surpluses, as we enjoyed during the Clinton
    years, I believe the President's method for trying to achieve a
    reduction in deficits through cuts in spending on our most vulnerable
    populations is at best, flawed. Because domestic discretionary spending
    outside of homeland security only accounts for one-sixth of the overall
    budget, the President's proposed cuts would not significantly reduce
    the deficit. What they will do, however, is increase financial burdens
    on states at a time when they are experiencing the worst fiscal crises
    since WW II. estimates show that states will face deficits of $40
    billion or more in 2005. It is predicated that my own state of
    Louisiana will face a deficit of $500 million this year. Under the
    decreased federal funding in the President's new budget, Louisiana and
    other states will be forced to impose deeper cuts on programs such as
    government subsidized health insurance and child care subsidies for the
    poor.
        In his budget, President Bush does not limit his cuts to
    discretionary spending but also proposes cuts in entitlement spending
    for many of these programs. It is unbelievable to me that in a time of
    a recession, this President proposes to cut support for TANF, child
    care, child welfare, and other social services by over $2.8 billion.
        While his TANF re-authorization calls for increases in the number
    of hours that fathers and mothers must work, the budget flat funds
    child care assistance to these families. Over the last year 100,000
    children have lost assistance and predictions indicate that at least an
    additional 200,000 children will lose assistance by 2009 under the
    current budget proposal. The TANF entitlements funds are also flat-
    funded, though 8.2 million people are unemployed and more families are
    at risk of reliance on the welfare system. And although President
    Bush's policies have contributed greatly to the dire situation many of
    these families face, he continues to turn his back on them by refusing
    to provide adequate funding to the government programs that will allow
    them to survive these difficult times.
         The Administration's proposal for health care reflects an equal
    lack of compassion towards these low-income families. Our country's
    problem of the uninsured has reached a crisis level, with almost 44
    million individuals who are not insured. Predictions show this problem
    is getting even worse. Yet, the Administration is proposing further
    cuts in aid to low-income individuals through Medicaid, calling for a
    reduction in funding for Medicaid by nearly $1 billion in 2005 and by
    nearly $16 billion over the next ten years. And the President is
    attempting to unload this crisis onto states by pushing for turning
    Medicaid into a block grant. The result would be a cap on the amount of
    money the federal government would spend on this program and a shift of
    costs to the states, preventing them from being able to respond to the
    dynamic health care needs of their residents.
        President Bush is proposing a similar funding structure for foster
    care payments to states. Under this proposal, states would be given the
    option to receive block grants in place of entitlement funding that is
    typically provided for services to foster children. These block grants
    would freeze funding to states at a specific level for five years,
    meaning that the funds would no longer be based on need or the number
    of eligible children. This cost neutral proposal does not increase
    funding to a foster care system that is already under-funded. In fact,
    many programs that have been block-granted in the past have ended up
    with less funding over time. Although I do support a federal funding
    structure for child welfare services that allows states the flexibility
    to be innovative in meeting the challenges of families involved in this
    system, the President's proposal of block granting will ultimately
    result in states having less resources to provide necessary services.
        Understanding that these families face complex and varying
    challenges, I support the President's budget proposal that would
    increase funding for Promoting Safe and Stable Families to $505
    million. This program offers flexible funding to states for a range of
    community-based family support and adoption services. This money can be
    used for prevention and family preservation services that help to keep
    children with their biological families and out of the child welfare
    system. Although I am happy to see that the Administration has
    recognized the importance of this program by proposing increased
    funding, I hope that it will modify proposals for other child welfare
    programs to provide adequate funding to assist families.
        Investments in programs that focus on prevention, such as those
    provided through the Promoting Safe and Stable Families funding, are
    cost-saving. By investing in these primary services, our government
    avoids investment in solving problems that could have been prevented.
    Unfortunately, the President's budget proposal for substance abuse
    services under the Substance Abuse and Mental Health Administration
    does not reflect this idea, with over 2\1/2\ times the amount of
    funding proposed for prevention services dedicated to treatment
    services. I support the increases that President Bush is proposing for
    these treatment services, for this funding will aid in the healing of
    individuals and families who suffer from substance abuse issues.
    However, I further support increases in funding for prevention
    services, so that we can help families avoid the problems associated
    with substance abuse.
        As lawmakers and appropriators, we have the responsibility to act
    on the idea that we can always do more to help the people we represent.
    We cannot be complacent with this budget. Much more can be done for
    some of our most vulnerable populations that are served through the
    Department of Health and Human Services than what is outlined in the
    President's budget. Using my seat on the Appropriations committee, I am
    committed to seeing valuable programs proposed to receive cuts by the
    Administration receive the funding that is necessary to meet the needs
    of those they are intended to serve.

                              SUBCOMMITTEE RECESS

        Senator Specter. Thank you all very much. The subcommittee
    will stand in recess to reconvene at 9:30 a.m., Thursday, April
    1, in room SH-216. At that time we will hear testimony from the
    Honorable Elias Zerhouni, Director, National Institutes of
    Health.
        [Whereupon, at 10:35 a.m., Thursday, March 25, the
    subcommittee was recessed, to reconvene at 9:30 a.m., Thursday,
    April 1.]

    DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED
                  AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2005

                                  ----------

                            THURSDAY, APRIL 1, 2004

                                           U.S. Senate,
               Subcommittee of the Committee on Appropriations,
                                                        Washington, DC.
        The subcommittee met at 9:30 a.m., in room SH-216, Hart
    Senate Office Building, Hon. Arlen Specter (chairman)
    presiding.
        Present: Senators Specter, Cochran, Stevens, and Harkin.

                    DEPARTMENT OF HEALTH AND HUMAN SERVICES

                         National Institutes of Health

    STATEMENT OF ELIAS A. ZERHOUNI, M.D., DIRECTOR
    ACCOMPANIED BY:
            RAYNARD KINGTON, M.D., Ph.D., DEPUTY DIRECTOR, OFFICE OF THE
                DIRECTOR
            WILLIAM R. BELDON, DEPUTY ASSISTANT SECRETARY FOR BUDGET
            DUANE ALEXANDER, M.D., DIRECTOR, NATIONAL INSTITUTE OF CHILD
                HEALTH AND HUMAN DEVELOPMENT
            BARBARA ALVING, M.D., ACTING DIRECTOR, NATIONAL HEART, LUNG,
                AND BLOOD INSTITUTE
            JAMES F. BATTEY, JR., M.D., Ph.D., NATIONAL INSTITUTE ON
                DEAFNESS AND OTHER COMMUNICATION DISORDERS
            JEREMY M. BERG, DIRECTOR, NATIONAL INSTITUTE OF GENERAL MEDICAL
                SCIENCES
            FRANCIS S. COLLINS, M.D., Ph.D., DIRECTOR, NATIONAL HUMAN
                GENOME RESEARCH INSTITUTE
            ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY
                AND INFECTIOUS DISEASES
            PATRICIA A. GRADY, Ph.D., DIRECTOR, NATIONAL INSTITUTE OF
                NURSING RESEARCH
            RICHARD J. HODES, M.D., NATIONAL INSTITUTE OF AGING
            SHARON H. HRYNKOW, ACTING DIRECTOR, FOGARTY INTERNATIONAL
                CENTER
            THOMAS R. INSEL, M.D., DIRECTOR, NATIONAL INSTITUTE OF MENTAL
                HEALTH
            STEPHEN I. KATZ, M.D., Ph.D., DIRECTOR, NATIONAL INSTITUTE OF
                ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
            STORY C. LANDIS, Ph.D., DIRECTOR, NATIONAL INSTITUTE OF
                NEUROLOGICAL DISORDERS AND STROKE
            TING-KAI LI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALCOHOL
                ABUSE AND ALCOHOLISM
            DONALD A.B. LINDBERG, M.D., DIRECTOR, NATIONAL LIBRARY OF
                MEDICINE
            KENNETH OLDEN, Ph.D., S.C.D., L.H.D., DIRECTOR, NATIONAL
                INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
            RODERIC I. PETTIGREW, Ph.D., M.D., DIRECTOR, NATIONAL INSTITUTE
                OF BIOMEDICAL IMAGING AND BIOENGINEERING
            JOHN RUFFIN, Ph.D., DIRECTOR, NATIONAL CENTER ON MINORITY
                HEALTH AND HEALTH DISPARITIES
            PAUL A. SIEVING, M.D., Ph.D., DIRECTOR, NATIONAL EYE INSTITUTE
            ALLEN M. SPIEGEL, M.D., DIRECTOR, NATIONAL INSTITUTE OF
                DIABETES AND DIGESTIVE AND KIDNEY DISEASES
            STEPHEN E. STRAUS, M.D., NATIONAL CENTER FOR COMPLEMENTARY AND
                ALTERNATIVE MEDICINE
            LAWRENCE A. TABAK, D.D.S., Ph.D., NATIONAL INSTITUTE OF DENTAL
                AND CRANIOFACIAL DISEASES
            JUDITH L. VAITUKAITIS, M.D., DIRECTOR, NATIONAL CENTER FOR
                RESEARCH RESOURCES
            NORA D. VOLKOW, M.D., DIRECTOR, NATIONAL INSTITUTE ON DRUG
                ABUSE
            ANDREW C. VON ESCHENBACH, M.D., DIRECTOR, NATIONAL CANCER
                INSTITUTE
            JACK WHITESCARVER, Ph.D., DIRECTOR, OFFICE OF AIDS RESEARCH

                   OPENING STATEMENT OF SENATOR ARLEN SPECTER

        Senator Specter. Good morning, ladies and gentlemen. The
    time is precisely 9:30, which is our starting time, and the
    Appropriations Subcommittee on Labor, Health, Human Services,
    and Education will now proceed.
        Today we will consider the appropriations process as it
    applies to the National Institutes of Health. And as I have
    stated on many occasions, I consider NIH the crown jewel of the
    Federal Government. It may be the only jewel of the Federal
    Government.
        But medical science and humanity is deeply indebted to the
    extraordinary work which has come out of medical research from
    the National Institutes of Health.
        The budget process is always complicated and a goal was
    established to double NIH funding, which we have more than met.
    When asked what would happen after doubling, as you know, my
    response was instantaneous and obvious, and it was tripling. It
    would be too hard to quadruple it before you triple it.
        When I took over the chairmanship of this subcommittee in
    January 1995, I took a look at the priorities and thought this
    was none higher, really at the top of the list. And Senator
    Harkin, the ranking member, agrees. We know around here if you
    want to get something done, you have to cross party lines.
    Sometimes it gets you into trouble if you have a primary
    election campaign. My opponent thinks I should not talk to
    Democrats. But Senator Harkin and I, when we have changed the
    gavel, it has been seamless and we have proceeded to give
    tremendous support to NIH.
        We have a very tight discretionary budget this year. It is
    up one-half of 1 percent, and that is very, very, very
    difficult. The administration has put in a figure of $729
    million over the $28.5 billion budget, and as I am sure you
    know, we offered an amendment to increase it by $1.3 billion
    and we were successful, 72 to 24.
        But there were some strenuous arguments raised by my
    colleagues in the Senate that NIH was getting too much funding
    compared to other important research Departments in the Federal
    Government. And when one of my colleagues made an impassioned
    plea, I agreed with him that the other Departments were not
    getting adequate funding. But that did not bear on not
    adequately funding NIH. And what it takes is the subcommittee
    chairmen to pick up those important research projects and take
    the lead and get them funded.
        We have a Federal budget of $2,400,000,000,000. Do you know
    how much money that is? Well, nobody else does either.
        They say if you took a room this size, it would be
    insufficient to stuff $10,000 bills into it.
        We can afford money for research. That is the best
    investment that we are making beyond any question. But it is a
    fight.
        NIH has its own problems which you know about, challenges
    on conflicts of interest, which we have addressed in a separate
    hearing and we will talk about today, the issues about
    compensation, an issue which I know is being addressed.
        NIH is being attacked on an ideological level. The November
    28, 2003 edition of Science had an editorial marked Don't Let
    Ideology Trump Science. An amendment was offered in the House
    of Representatives to strike four NIH grants because sex was
    mentioned in the title, peer-reviewed. One of them involved a
    question of spread of venereal disease at truck stops where
    truckers are highly vulnerable, long stops, fatigue, away from
    home, places frequented understandably by prostitutes, and NIH
    wanted to make a study. And that and three other of your
    projects were challenged because if you have sex in the title,
    it makes a good 30-second commercial, if you voted for it, to
    defeat you. The surprising thing was that in the House of
    Representatives the amendment almost passed: 212 to 210.
        Now, it just happens that the amendment was offered by the
    fellow who wants to take my seat on the U.S. Senate who has
    voted against every domestic spending bill, voted against Head
    Start, voted against Medicare reform, voted against the budget
    for Labor, Health and Human Services, voted against the budget
    for NIH. So in this town you have to be prepared to defend
    yourself against attacks. So if you have one or two, Dr.
    Zerhouni, do not think you are being discriminated against.
        It goes with the territory. I think it is within your pay
    grade to defend yourself, Dr. Zerhouni, and to prevail, and I
    think it is within my pay grade to prevail also. But it is a
    battle.
        So much for an opening statement. I read it just like Betty
    Lou wrote it for me.
        Super Senator Taylor. She is not just a regular Senator.
    She is a super Senator.
        Dr. Elias Adam Zerhouni began his tenure as the 15th
    Director of NIH on May 20, 2000. He had a very distinguished
    career prior to coming to NIH: executive vice dean of Johns
    Hopkins University School of Medicine, Chair of the Department
    of Radiology; Martin Donner Professor of Radiology; medical
    degree from the University of Algiers School of Medicine; and
    residency in diagnostic radiology at Johns Hopkins. Thank you
    for joining us, Dr. Zerhouni, and we look forward to your
    testimony.

                    SUMMARY STATEMENT OF DR. ELIAS ZERHOUNI

        Dr. Zerhouni. Thank you, Mr. Chairman. It is our pleasure
    to be here with the 27 institute and center directors of NIH to
    present our budget, but also to express our thanks and
    appreciation for your strong leadership on behalf of research
    and medical research and NIH.

                    INTRODUCTION OF NEW INSTITUTE DIRECTORS

        I would like to start by introducing three of our new
    directors, and I will ask them to stand up to be introduced to
    you, Mr. Chairman.
        Dr. Story Landis is now the Director of the National
    Institute of Neurological Diseases. She has been appointed in
    the past year and has done an outstanding job already working
    with all aspects of neurological disorders, including
    collaboration with patient groups in trying to find the best
    approaches to rising threats of neurological degenerative
    diseases.
        Dr. Nora Volkow is the new Director of the National
    Institute of Drug Abuse. She has joined us from the Brookhaven
    National Laboratory in Stony Brook University. She is a leader
    in imaging of drug addiction and has already changed the
    strategy of her institute in many appropriate ways.
        Dr. Jeremy Berg is the new Director of the National
    Institute of General Medical Sciences. Dr. Jeremy Berg joined
    us from Johns Hopkins where he was the Chair of the Basic
    Science Institute at Johns Hopkins and Chair of the Department
    of Biophysics.
        I also would like to mention two acting Directors, Dr.
    Barbara Alving, who is the acting Director of NHLBI, and Dr.
    Sharon Hrynkow, who is the acting Director of the Fogarty
    International Center.

                           BREAKTHROUGHS AND ADVANCES

        Mr. Chairman, members of the committee, it is my pleasure
    to actually summarize the written testimony that we submitted
    to you. What I would like to do is go right away and tell you
    how important your investment has been in terms of specific
    breakthroughs and advances between last year and this year.
        NIH developed a completely new Ebola vaccine that can
    protect the population in less than a month. This a real
    breakthrough in biodefense.
        Just 2 days ago, NIAID announced that a new SARS
    experimental vaccine has been successful in animal experiments
    and will enter human trials as soon as we can do so. This is
    less than a year after the SARS epidemics which we knew not the
    cause of and it took us several weeks to find the cause. A year
    later, we are ready to fight this disease if it reappears.
        We discovered in 2003 several genes, for the first time,
    associated with schizophrenia. This was ranked as the number
    two advanced scientific advance of 2003, following the
    discovery of dark matter in the universe.
        We identified just 3 weeks ago a new master switch gene
    relating to type 2 diabetes. This is a very important discovery
    that will help us in discovering how type 2 diabetes develops.
        We have changed the practice paradigm of long-term hormone
    replacement therapy for women because of the landmark studies
    of the Women's Health Initiative.
        Today on the cover of Nature magazine, we are announcing
    the completion of the rat genome, a very important advance. As
    you know, by 2005 we were hoping to only have the human genome
    available to us. We now have the mouse, the rat, and the human
    genome, and we will be able to do comparative analysis that
    will advance our understanding of biology and disease.

                        NIH ROADMAP FOR MEDICAL RESEARCH

        All throughout the past 2 years, we have also taken into
    account the need for new science strategies, and this is what
    we call the NIH roadmap for medical research. The roadmap is
    essentially our effort to find ways to accelerate basic
    research discoveries and speed the translation of those
    discoveries into clinical practice. It is a dedicated effort to
    explicitly address roadblocks that slow the pace of medical
    research in improving the health of the American people.
        The major driver for this approach is exemplified on this
    slide in front of you, and that is that we need to transform
    medical research in the 21st century. In the 20th century, we
    treated disease when symptoms appeared and normal function had
    been lost. Why was that? Because for the past 5,000 years and
    the 20th century included, we did not understand the molecular
    and cellular events that led to disease. So we had to wait
    until the disease was explicit. And this is very expensive in
    both financial and disability costs.
        The paradigm of the 21st century is that we will intervene
    before symptoms appear and preserve normal function for as long
    as possible because we do understand much better the genetic
    events that lead to disease.
        We have come up with very bold initiatives. We will
    integrate all clinical research networks that are under NIH
    throughout the country and link them to community physicians to
    form new communities of research that will translate much
    quicker, much more efficiently than we have in the past the
    benefits of our fundamental understanding of research.
        A good example is juvenile rheumatic diseases, a disease
    set that affects only 300,000 children in the country. To do
    good research and have enough understanding of what happens, we
    need to recruit patients across the Nation, and this will be
    facilitated by a project of the roadmap called National
    Clinical Research Networks with trained community physicians in
    every community linked to academic centers.
        We continue to invest across NIH in a combined and
    coordinated fashion to advance medical research as fast as we
    can. This year we are requesting $237 million for the roadmap.

                                  STEWARDSHIP

        We have continued also to focus on management excellence
    and stewardship of our resources. Let me point out two very
    simple statistics. Our funding went up by 141 percent in the
    past 10 years, almost 2 and a half times, 2.4 times. Our FTE's,
    the number of people, at NIH needed to manage this portfolio
    has only increased by 16 percent. Why? Because we have
    aggressively used modern methods of management using
    information systems to prevent the need for us to increase our
    FTE numbers. Our Research Management and Support budget has
    gone from 4 percent of our budget to 3.5 percent of our budget.
    So we are doing what you are asking us to do and being very
    good stewards.
        As you said, we will have on May 6 a final meeting of the
    Advisory Committee to the Director to finalize the
    recommendations of the Blue Ribbon Panel for conflict of
    interest and will report back to you as soon as we have that.

                        FISCAL YEAR 2005 BUDGET REQUEST

        Mr. Chairman, we are requesting a budget of $28.607 billion
    which is $28.527 billion from this committee, and a 2.6 percent
    increase over 2004. We also have at our program level $47
    million for nuclear and radiological countermeasures which are
    housed in the Public Health Service emergency fund.

                               PREPARED STATEMENT

        We are pleased to be here and will answer any of your
    questions. Again, we would like to thank the bipartisan support
    of this committee over the years. Thank you, Mr. Chairman.
        [The statements follow:]

                  Prepared Statement of Dr. Elias A. Zerhouni

        Good morning, Mr. Chairman and members of the Committee. Let me
    begin by expressing my deepest appreciation to the Congress, Secretary
    Thompson, President Bush, and the American people for their generous
    and bipartisan support of the NIH's efforts to help improve the health
    of all our citizens. I respect the extraordinary effort of this
    committee and, Mr. Chairman, your leadership as well. I thank you for
    it.
        The year 2004 marks a sea change for the NIH and its Roadmap for
    Medical Research. We are refining our basic and clinical research
    programs to ensure that new discoveries rapidly lead to new and
    improved diagnostics, treatments and prevention strategies that extend
    the length and improve the quality of human life.
        In my testimony today, I want to cover four areas: first, highlight
    several key research advances that took place in the last year which
    represent the critical contributions of NIH intramural researchers and
    grantees; second, give examples of how the NIH Roadmap effort will help
    shape our approach to patient-oriented research; third, offer examples
    of our stewardship; and fourth, present an overview of our budget. In
    the course of my testimony, I will mention emerging priorities and our
    plans for responding to the health challenges ahead.

                            BREAKTHROUGHS & ADVANCES

        Each year, the public investment in research yields critical
    scientific advances. The four I highlight here are just a sample of the
    many that represent the development of new and improved treatments,
    diagnostics, or prevention strategies that will affect the health of
    the entire nation.
        Few viruses are feared more than the Ebola, a deadly microbe that
    causes outbreaks in Africa and Asia and kills up to 90 percent of those
    it infects. Scientists at the NIH National Institute of Allergy and
    Infectious Diseases Vaccine Research Center developed a single dose,
    fast-acting, experimental Ebola vaccine that successfully protects
    monkeys after just one month, and human trials are now under way.
        This year NIH research further elucidated the role of widely used
    hormone replacement therapies. The NIH halted the estrogen alone study
    of the Women's Health Initiative on March 1, 2004 after 5.6 years of
    follow-up, due to increased risk of stroke. You will recall that NIH,
    in 2002, stopped the combination hormone trial arm of the Women's
    Health Initiative early due to an increased risk of invasive breast
    cancer, coronary heart disease, stroke, and pulmonary embolism in study
    participants on estrogen plus progestin compared to women taking
    placebo. It indicated that healthy postmenopausal women taking
    combination hormone therapy also suffered twice the rate of dementia as
    those taking a placebo. Together, the results of these clinical studies
    changed conventional dogma, and provided important new evidenced-based
    information to women who are deciding whether to begin or how long to
    continue menopausal hormone therapy. These trials clearly are having a
    major impact on the health of people we know and love--our wives, our
    sisters, our daughters and our mothers.
        The third advance was the discovery of genes associated with
    schizophrenia, which is a profoundly disabling disorder that affects
    one percent of the adult population. It is marked by hallucinations,
    delusions, social withdrawal, flattened emotions, and loss of social
    and personal care skills.
        Research like this on the genetics of mental illness was named the
    Number 2 scientific ``breakthrough of the year'' for 2003 by the
    prestigious peer-reviewed journal, Science. Most of this work was
    funded by NIH and included discoveries of candidate genes for
    schizophrenia, depression, anxiety and bipolar disorders. These
    discoveries bring us closer to developing new diagnostic tests,
    strategies for prevention, and targets for the treatment of
    schizophrenia and other mental disorders.
        The fourth advance came only three weeks ago, when NIH announced a
    major new discovery, the identification of a common variation of a
    pancreatic ``master switch'' gene that increases the risk of type 2
    diabetes by 30 percent. Type 2 diabetes now affects 17 million people
    in the United States, and is responsible for enormous health care
    costs. This gene discovery opens the door to the development of new and
    more effective methods of prevention and treatment.

                                  NIH ROADMAP

        Let me now turn your attention to the NIH Roadmap for Medical
    Research. I want to tell you why the Roadmap is so important to the
    future of medical research and to innovations in improving people's
    health. I also want to give you some examples of how we at NIH expect
    the Roadmap to change the way we do research and the practice of
    medicine.
        One of the questions we face is how do we successfully do our part
    in the battle to contain health costs? We need to address the following
    issues: What are the roadblocks? What are the major challenges? How can
    we most effectively invest the funds that the American taxpayers
    entrust to us to fashion the fastest track to discovery as well as
    translate those discoveries to the patient's bedside or the doctor's
    office?
        In seeking answers to these questions, one thing becomes clear. The
    traditional paradigm of medical care--when practitioners waited for the
    disease to cause the patient the loss of some function--must be
    replaced by a paradigm where health professionals act before the
    individual loses any function. This has become even more critical since
    chronic diseases now consume about 75 percent of our fast-growing
    health care expenditures.
        Let me present four examples of how the NIH Roadmap will transform
    our approach to biomedical research in specific disease areas.
        The first example is schizophrenia, a disorder that--as I mentioned
    earlier--affects one percent of the U.S. population. The peak onset
    occurs between the ages of 18 and 25. Schizophrenia has the hallmarks
    of both a neurodevelopmental and a neurodegenerative disease. But after
    100 years of neuropathological study, we still lack knowledge of the
    precise cause of the disorder.
        Today, schizophrenia is the fifth leading cause of years lost due
    to disability among Americans from ages 15-44. Although we can treat
    the so-called ``positive'' symptoms, such as hallucinations and
    delusions, we do not yet have treatments for the ``negative'' symptoms,
    like withdrawal and cognitive deficits. And these are the largest
    source of disability.
        Less than 30 percent of people with this illness are currently
    employed. And people with schizophrenia represent one of the largest
    groups on atypical antipsychotics as the treatment of choice. In 2001,
    Medicaid paid for more than 50 percent of the total spending on
    atypical antipsychotics, amounting to $2.7 billion, a figure which has
    been growing at roughly 25 percent a year for the past 3 years.
        Today, we lack a diagnostic test or a strategy for preventing
    schizophrenia. This situation is similar to cardiovascular disease 30
    years ago in that we see schizophrenic patients only after their first
    ``heart attack,'' that is, episode, and we do not have the equivalent
    of cholesterol as an identifiable risk factor.
        However, what we have done recently--and what holds great promise
    for those who are suffering--is identify 12 genes associated with risk.
    Our challenge now is to move from the discovery of those genes--most of
    which have no known function--to understand the role these genes play
    in the onset and progression of this brain disease--and do something
    about it.
        Our hope is to use these genes to identify what is abnormal in the
    brains of schizophrenics, identify it early and thus provide the
    psychiatric equivalent of serum cholesterol. To accomplish this, we
    must study the protein products of these genes by using molecular tools
    that can make their function transparent.
        It is precisely here that the NIH Roadmap will help accelerate the
    effort to study protein products through so-called molecular
    libraries--databases of information on small molecule compounds like
    aspirin and antihistamines. These libraries will let researchers screen
    hundreds of thousands of small molecules to yield these tools.
        For example, we know that a variation in the neuregulin gene is
    associated with an increased risk for schizophrenia. To understand how
    this gene confers risk, we need to find chemicals that mimic or inhibit
    the gene's function. This would give us a precise description of how
    alterations in the gene change the activity of brain cells. Molecular
    libraries will not only yield the tools to study the neuregulin gene
    but also provide a test for vulnerability to schizophrenia. With such
    tools and tests, doctors could approach risk for schizophrenia the way
    we currently approach risk for heart disease.
        A second example where the NIH Roadmap offers promise is in
    pediatric diseases, through the creation of clinical research networks.
        Uncommon disorders like the juvenile forms of rheumatic diseases,
    such as arthritis, lupus and dermatomyositis, affect 300,000 children
    in the United States. Not one of these diseases is common enough to be
    studied intensively at any one academic health center. Thus, many such
    centers as well as community-based pediatricians are needed to collect
    a sufficient group of patients who can participate in these studies to
    gather meaningful results.
        The development of clinical research networks that focus on chronic
    childhood diseases--like those already established for childhood
    cancers--and the potential to include community physicians trained in
    clinical research methodology in the research process will enable
    clinical trials to be more efficient and effective.
        Using the NIH Roadmap clinical research networks concept, this
    could occur without building a new, and often very expensive,
    infrastructure for every new trial. Including community-based
    pediatricians as full partners in the research will allow us to
    overcome some of the limitations of patient recruitment that we
    currently experience and enable more children to participate in these
    trials, and accelerate the development of new treatments.
        The third example is Alzheimer's Disease (AD). We have made
    considerable progress in understanding Alzheimer's Disease. Fifteen
    years ago, we knew none of the genes that cause AD and we had only a
    limited understanding of the biological pathways involved in the
    development of brain pathology. Ten years ago, we could not model the
    disease in animals. Five years ago, we were not funding any prevention
    trials and had no way of identifying persons at high risk for the
    disease. And, as recently as one year ago, we had no way of imaging
    AD's characteristic amyloid plaques in a living person.
        Today, we can do all of these things. And we are poised to make the
    discoveries that will transform our understanding of the basic and
    clinical aspects of AD and enable us to effectively prevent, diagnose,
    and treat it using several NIH Roadmap initiatives.
        Through basic research in Alzheimer's disease, we identified a
    number of brain pathways that are potential targets for preventive
    interventions. These range from dysfunction and death of specific
    neurons to loss of the connections between neurons. Roadmap efforts to
    improve imaging of small molecules will let us visualize the effects of
    treatments more rapidly and accurately, which could make effective AD
    clinical trials smaller, faster and more affordable.
        My fourth and final example is cardiovascular disease. One of the
    greatest public health success stories of the last half century is the
    dramatic reductions in mortality from cardiovascular diseases. Studies
    initiated by the NIH--the Framingham Heart Study and the Lipid Research
    Clinics Coronary Primary Prevention Trial--have been key to that
    success. They helped not only to identify risk factors that contribute
    to the development of cardiovascular diseases, but also to demonstrate
    the efficacy of therapeutic interventions to control them.
        Even so, cardiovascular disease remains an enormous health burden,
    accounting for 38 percent of all deaths in the United States in 2001.
    Progress in reducing that burden will require continued efforts to
    refine our understanding of risk factors, such as obesity and high
    cholesterol, and to identify and evaluate new prevention approaches.
    This means that large scale population-based studies will remain a
    critical component of our research effort.
        The NIH Roadmap will help fashion the interactive network and
    involvement of many community-based practitioners. For example, we can
    make better use of large-scale organizations set up for single studies,
    such as the recently completed Antihypertensive and Lipid-Lowering
    Treatment to Prevent Heart Attack Trial (ALLHAT). Instead of disbanding
    it, we can involve many or all of the investigators in other trials
    addressing not only cardiovascular disease but also other diseases. The
    National Electronic Clinical Trials and Research (NECTAR) initiative--a
    critical part of the Roadmap effort to re-engineer clinical research--
    will enable data sharing and enhance comparison and aggregation of
    results from multiple trials by using standard definitions of outcomes
    and adverse events. In the future, patients will know directly from
    their own community doctors, who will be equipped with the new web-
    based NECTAR, what medical research can do for them in terms of
    participation in studies, the best available therapies, and nearby
    advanced research centers.

                                  STEWARDSHIP

        We realize that to advance the NIH scientific agenda, our
    management and administration must be effective, efficient and
    productive. By introducing new information technology and business
    systems and streamlining governance structures, we are placing
    continuous improvement of management and administrative functions at
    the forefront of our agency priorities. Let me highlight a few of our
    efforts.
        NIH is making rapid progress to modernize its business and
    financial systems. An agency-wide information technology system, known
    as the New Business System (NBS), is integrating such processes as
    acquisitions, travel, property, and financial management. This effort
    will reduce the cost and complexity of doing business, enhance the
    level of service, and improve management controls.
        NIH is also improving its peer review system, which is recognized
    as the cornerstone of NIH's success. The NIH Center for Scientific
    Review (CSR), the focal point of the NIH peer review system, reviews
    about 70 percent of the grant applications submitted to NIH. In fiscal
    year 2003, CSR received a record-breaking 66,000 grant applications.
        CSR is in the final stages of crafting new and more flexible review
    panels organized into 24 scientifically-related clusters. NIH is also
    incorporating new technologies into the review process through the
    electronic Research Administration (eRA). The goal is to implement an
    end-to-end electronic grants administration for NIH research award
    mechanisms that could reduce the waiting period from submission of an
    application to a grant award by more than two months--from 9 to 10
    months down to 7 months.
        Remarkably, because of improvements in productivity over the past
    ten years, NIH funding has grown 141 percent, while our FTEs have
    increased by only 16 percent.
        The NIH also realizes the need for a more efficient means of trans-
    NIH coordination. To streamline decision making, we reduced the
    plethora of NIH administrative committees down to a trans-NIH Steering
    Committee and 5 working groups. Additionally, as we discussed when I
    met with the subcommittee in January, all our conflict of interest
    policies and procedures are under review both to ensure that they meet
    the highest standards and, most importantly, to preserve the public's
    trust in the NIH. I will soon receive the report of a Blue Ribbon Panel
    I created to advise NIH on what changes they think we should make. I
    will inform you about their conclusions, and mine, once they complete
    their work next month.

                                     BUDGET

        The discretionary fiscal year 2005 budget request for the NIH is
    $28,607 million ($28,527 million from this subcommittee and $80 million
    from the VA/HUD subcommittee), an increase of $729 million or 2.6
    percent over the fiscal year 2004 Enacted Level. In addition, $47.4
    million is included in the budget authority request of the Public
    Health and Social Services Emergency Fund (PHSSEF), for NIH research in
    radiological/nuclear countermeasures, and $150 million in mandatory
    funds was previously appropriated for the Special Type 1 Diabetes
    Initiative, bringing NIH's program level total to $28,805 million, or a
    2.7 percent increase. The budget increases funding for the NIH Roadmap
    (+$109 million), obesity research (+$40 million), which will thus grow
    by 10 percent from $400 million in 2004, and biodefense research (+$74
    million), an increase of 4.5 percent over fiscal year 2004.

                                   CONCLUSION

        In conclusion, I want to reemphasize the NIH commitment to help
    improve the health of the American people. Although we have had great
    success in changing acute lethal diseases like AIDS and many cancers
    and childhood diseases into chronic manageable diseases, there are many
    challenges ahead. Life expectancy has increased and the diseases of
    aging and the aging population have become major priorities.
        With a shift from acute to chronic diseases, health disparities and
    pediatric diseases also present challenges, as do emerging and re-
    emerging diseases, such as SARS. We are confident, as the committee has
    shown it is, that medical research will make a critical difference in
    the lives of all Americans.
        As the NIH director, I fully understand and embrace my role as the
    steward of our Nation's investment in medical discovery. And I remain
    vigilant to ensure that these precious resources--including over
    212,000 scientists working at 2,800 institutions in the United States
    and overseas and the 5,000 scientists at the NIH itself--are used
    wisely and efficiently and produce not only new knowledge but also
    tangible benefits that touch the lives of every individual who reaches
    out for our help.

                        BUILDINGS AND FACILITIES PROGRAM

        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's budget request for the Buildings and Facilities (B&F)
    Program for fiscal year 2005, a sum of $99,500,000.

                          ROLE IN THE RESEARCH MISSION

        State-of-the-science research and support facilities are a vital
    part of the research enterprise. The National Institutes of Health's
    (NIH) Buildings and Facilities (B&F) program designs, constructs,
    repairs and improves the agency's portfolio of laboratory, clinical,
    animal, administrative and support facilities at its six installations
    in three states. These facilities house researchers from the NIH
    Institutes' and Centers' (ICs) intramural basic, translational, and
    clinical research programs; the NIH leadership, and various programs
    that support agency operations. The fiscal year 2005 B&F budget request
    supports critically needed and timely investments to keep the agency's
    facilities and supporting physical infrastructure healthy, safe,
    secure, and research ready.
        The B&F budget request is the product of a comprehensive, corporate
    capital facilities planning process. This process begins with extensive
    consultation across the research community and the NIH's professional
    facilities staff. It works through the Facilities Working Group, an
    advisory committee to the NIH Steering Committee and the HHS Capital
    Investment Review Board. The budget request is the current year plan in
    a rolling five-year facilities plan. Through this process, the real and
    insistent program demand for more effective and efficient facilities
    designed to support current and emerging investigative techniques,
    technologies, and tools is integrated with, and balanced against, the
    need to repair, renovate, and improve the existing building stock to
    keep it in service and to optimize its utility.
        The fiscal year 2005 request provides the necessary funding support
    for the ongoing safety, renovation and repair, and related projects
    that are vital to proper stewardship of the entire portfolio. It
    provides funds to continue the functional integration of the clinical
    research components of the existing Building 10 with the new Mark O.
    Hatfield Clinical Research Center (CRC). Additionally, the request
    includes funds to: complete the design of the Animal Research Center
    (ARC) on the Bethesda campus; complete the creation of a security
    buffer around the Rocky Mountain Laboratories (RML), in Hamilton, MT;
    and to add another chiller to the NIH's Bethesda campus central utility
    system that is needed to meet current and anticipated cooling demands.
        The fiscal year 2005 B&F budget request is organized among five
    broad Program Activities: Construction, Essential Safety and Regulatory
    Compliance, Repairs and Improvements, Renovations, and Equipment/
    Systems. The fiscal year 2005 request provides funds for specific
    projects in each of the program areas. The projects and programs
    enumerated are the end result of the aforementioned NIH facilities
    planning process and are the NIH's capital facility priorities for
    fiscal year 2005.

                        FISCAL YEAR 2005 BUDGET SUMMARY

        The fiscal year 2005 budget request for Buildings and Facilities is
    $99.5 million. The B&F request contains $16.5 million for Construction,
    including $5 million to complete the design of an Animal Research
    Center; $9.5 million to complete the creation of a security buffer
    around the Rocky Mountain Laboratories (RML) in Hamilton, MT; and $2
    million for concept development studies of projects proposed in the
    facilities plan.
        There is a total of $6 million for Essential Safety and Regulatory
    Compliance programs composed of $0.5 million for the phased removal of
    asbestos from NIH buildings; $2 million for the continuing upgrade of
    fire and life safety deficiencies of NIH buildings; $1 million to
    systematically remove existing barriers to persons with disabilities
    from the interior of NIH buildings; $0.5 million to address indoor air
    quality concerns and requirements at NIH facilities; and $2 million for
    the continued support of the rehabilitation of animal research
    facilities. In addition, the fiscal year 2005 request includes $59.2
    million in Repairs and Improvements for the continuing program of
    repairs, improvements, and maintenance that is the vital means of
    maintaining the complex research facilities infrastructure of the NIH.
    The request includes $10.8 million in Renovations to complete the
    Building 10 Transition Program. Finally, the request includes $7
    million in Equipment/Systems for the Chiller 27 project.
        My colleagues and I will be happy to respond to any questions you
    may have.
                                     ______

                   Prepared Statement of Dr. Paul A. Sieving

        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's budget request for the National Eye Institute (NEI) for
    fiscal year 2005. This budget includes $671.6 million, an increase of
    $18.8 million over the fiscal year 2004 enacted level of $652.7 million
    comparable for transfers proposed in the President's request. As the
    Director of the NEI, it is my privilege to report on the progress
    laboratory and clinical scientists are making in combating blindness
    and visual impairment and about the unique opportunities that exist in
    the field of vision research.

                                RETINAL DISEASES

        Retinal diseases are a diverse set of sight-threatening conditions
    that include age-related macular degeneration, diabetic retinopathy,
    retinopathy of prematurity, retinitis pigmentosa, Usher's syndrome,
    ocular albinism, retinal detachment, uveitis (inflammation), and cancer
    (choroidal melanoma and retinoblastoma). One of the most tragic retinal
    diseases, retinopathy of prematurity (ROP), causes severe vision loss
    in premature, low-birthweight infants. ROP is characterized by
    excessive growth of abnormal blood vessels in the back of the eye that
    often hemorrhage and scar the retina. This year, results from an NEI-
    funded clinical trial, called the Early Treatment of Retinopathy of
    Prematurity (ETROP), established that early treatment, based on newly
    developed diagnostic criteria, improves visual outcomes in infants at
    the greatest risk of developing ROP. The ETROP study also found that
    these new diagnostic criteria were helpful in select patient subgroups
    that may not ultimately develop ROP. For these infants, careful
    observation was found to be the best approach. Results from ETROP will
    greatly improve visual outcomes for children with ROP.
        Age-related macular degeneration (AMD) is a leading cause of
    blindness in patients over age 60 in the United States and is a major
    health problem in most other developed countries. More than 9 million
    Americans have some degree of AMD (Archives of Ophthalmology, In
    Press). Based on the results of an NEI-funded clinical trial, the Age-
    Related Eye Diseases Study (AREDS), 1.3 million of these people would
    develop advanced AMD if no treatment were given to reduce their risk.
    If these people at risk for development of advanced AMD received the
    supplements (vitamins C, E, beta-carotene, and zinc) used in AREDS,
    more than 300,000 of them would avoid advanced AMD and any associated
    vision loss over the next five years. Delaying the advance of a disease
    in older-age populations is an essential strategy to reduce the burden
    and incidence of disease.
        Uveitis is an autoimmune inflammatory disease of the eye that
    accounts for up to 10 percent of blindness in the United States
    (Ophthalmology 2004; 111:491-500). In collaboration with researchers at
    the National Cancer Institute, NEI intramural scientists have reported
    promising results with the use of a monoclonal antibody (daclizumab) in
    the long term treatment of patients with uveitis. This new therapy
    seems to have many fewer side effects than existing immunosuppressive
    therapies, leading to an improved quality of life. Planning is underway
    to begin a Phase III study to evaluate the full potential of this
    therapy.

                                CORNEAL DISEASES

        The cornea is the transparent tissue at the front of the eye.
    Corneal disease and injuries are the leading cause of visits to eyecare
    clinicians, and are some of the most painful ocular disorders. In
    addition, approximately 25 percent of Americans have a refractive error
    known as myopia or nearsightedness that requires correction to achieve
    sharp vision; many others are far-sighted or have astigmatism.
        NEI intramural scientists found that serum albumin represents up to
    13 percent of the total water-soluble protein of the mouse cornea.
    Humans also have abundant serum albumin in the corneal stroma. Because
    the serum albumin accumulates in the corneal stroma by diffusion from
    the blood supply surrounding the cornea, it may provide an improved
    route of drug delivery to the cornea. Conjugating serum albumin to the
    drug of choice and injecting the conjugate into the blood stream will
    not only direct the drug within the cornea, but extend its half-life
    within this tissue. Future research will evaluate the usefulness of
    serum albumin as a drug carrier to treat corneal disorders.
        NEI intramural scientists recently identified an enzyme called CDK5
    that regulates corneal epithelial cell adhesion and migration. Using a
    model wound healing system, these researchers found that the rate of
    wound closure was significantly retarded in cells with too much CDK5
    and accelerated in cells in which the CDK5 was inactivated.
    Continuation of this line of research may provide the means to promote
    rapid healing of corneal tissues that have been damaged by disease or
    injury.

                                    CATARACT

        Cataract, an opacity of the lens of the eye, interferes with vision
    and is the leading cause of blindness in developing countries. In the
    United States, cataract is also a major public health problem. The
    economic burden of cataract will worsen significantly in coming decades
    as the American population ages.
        Age-related cataract formation is believed to result from the
    complex effects of aging on normal physiological processes. It has long
    been recognized that lens transparency is a function of a very high
    concentration of soluble proteins, the crystallins, within the
    specialized lens fiber cell. In the lens, a-crystallin has a dual
    function: it accumulates in fiber cells in high concentrations to
    produce the high refractive index needed for transparency, and it
    functions as a molecular chaperone to protect against clouding of the
    lens due to protein aggregation. For some time, scientists have
    attempted to understand how a-crystallin can continue to perform its
    chaperone functions over a range of stress conditions encountered by
    the lens during a lifetime. New data suggest that under low stress, a-
    crystallin is maintained in a multi-subunit complex. Under conditions
    of high stress, a-crystallin breaks into smaller sub-units that can
    protect the clarity of the lens from protein aggregation. It has been
    hypothesized that this chaperone function decreases with age and leaves
    the lens more vulnerable to stressful conditions. Improving our
    understanding of this protective role of a-crystallin may one day lead
    to the means to prevent cataract.

                        GLAUCOMA AND OPTIC NEUROPATHIES

        Glaucoma is a group of eye disorders that share a distinct type of
    optic nerve damage, which can lead to blindness. Elevated intraocular
    pressure (IOP) is frequently, but not always, associated with glaucoma.
    Glaucoma is a major public health problem and is a leading cause of
    blindness in African Americans (Archives of Ophthalmology, In Press).
        A hallmark of glaucoma is the death of retinal ganglion cells (RGC)
    in the retina, which can lead to catastrophic vision loss. Previous NEI
    studies have found evidence that elevated IOP deprives RGCs of brain-
    derived neurotrophic factor (BDNF), an endogenous protein that is
    crucial to RGC survival. Ocular injections of BDNF in rodent models of
    glaucoma have improved RGC survival. However, due to the relatively
    short half-life of this protein, the need for frequent ocular
    injections would not bode well in treating a chronic disease like
    glaucoma. To overcome this hurdle, NEI-supported researchers recently
    used gene therapy in rodent models of glaucoma to transfect RGCs with
    the gene that encodes BDNF, providing a lasting and direct supply of
    this essential protein. Ongoing NEI-supported laboratory work is
    evaluating whether gene therapy with BDNF provides long-term benefit
    and whether gene delivery with other neurotrophic agents, alone or in
    combination with BDNF, improves RGC survival.

                  STRABISMUS, AMBLYOPIA AND VISUAL PROCESSING

        Developmental disorders such as strabismus (misalignment of the
    eyes) and amblyopia (commonly known as ``lazy eye'') are among the most
    common eye conditions that affect the vision of children. In addition,
    more than three million Americans suffer from visual processing
    disorders not correctable by glasses or contact lenses (Archives of
    Ophthalmology 1990; 108:286-290).
        Patching the stronger eye has been a mainstay of amblyopia therapy.
    Unfortunately, there is no specific patching regimen that is widely
    accepted for treating the disease. To address the clinical issue of the
    optimal number of patching hours for moderate amblyopia, an NEI-
    supported clinical trial compared daily patching of two hours versus
    six hours for children with moderate amblyopia. Results from this
    clinical trial revealed that patching the unaffected eye of children
    with moderate amblyopia for only two hours daily is as effective as
    patching the eye for six hours. This finding should improve treatment
    compliance as patching can be a socially stigmatizing and uncomfortable
    practice for young children.

                           TECHNOLOGICAL INNOVATIONS

        The marriage of computer technology and medical science is creating
    advances in treating even the most intractable diseases. In one such
    union, specially designed computer chips implanted in the eye may one
    day make it possible to partially restore visual function to the blind.
    Ocular neuro-degenerative diseases such as retinitis pigmentosa (RP)
    and macular degeneration damage and destroy the light-sensitive
    photoreceptor cells in the retina. The microelectronic retinal
    prosthesis, a device developed by NEI-supported researchers, mimics the
    function of photoreceptor nerve cells by turning light into electric
    signals. In a recently published study, a 74 year-old patient blind
    with RP was able to see spots of light, detect motion, and recognize
    simple shapes. Although preliminary, these results are a promising
    first step in realizing a prosthetic device that can restore ambulatory
    vision to patients with retinal degenerative diseases, which are a
    major cause of vision loss in this country.

                              PROGRAM INITIATIVES

        The rapid progress in areas of gene discovery and bioinformatics
    has created the need for enhanced cooperation and coordination among
    groups that provide genetic diagnostic information to the clinician and
    patient, store and provide DNA specimens to researchers, and maintain
    data banks of genotype-phenotype information. Such groups are
    underrepresented in the area of human ocular disease. The purpose of
    this initiative is to explore the establishment of a national central
    registry and molecular database of securely coded information from a
    large number of people with ocular diseases caused by genetic
    mutations. Information will be provided through a network of
    cooperating groups who provide genetic and diagnostic services to
    patients and clinicians. Such a registry and database will be of great
    value in advancing research for these important diseases.
        Clinician scientists will play a major role in translating
    laboratory findings into safe and effective therapies. However, the
    vision research community has raised concerns about the future of
    clinician scientists. Declining clinical revenues are making it
    increasingly difficult for clinicians to find time away from the
    examination room to get the training they need. However, many of the
    investigational therapies now being contemplated will be translated by
    the next generation of clinician scientists. We need to make sure that
    current clinician scientists have a capable next generation to pass the
    torch to.
        In addition to its existing extramural training and career
    development grant programs, the NEI is working to increase the ranks of
    the clinician scientist through a new intramural clinician scientist
    training program at the NEI. The Clinician Scientist Development
    Program is designed for board eligible/certified clinicians who seek to
    develop an independent research program that integrates the field of
    vision research with the clinical study of patients with ocular disease
    or disorders.
        The NEI recently published its forward looking National Plan for
    Eye and Vision Research. The NEI's ongoing planning process involves
    the assessment of important areas of progress in eye and vision
    research and the development of new goals and objectives that address
    outstanding needs and opportunities for additional progress. The
    National Plan can be accessed through the NEI website at: http://
    www.nei.nih.gov/strategicplanning.

                                  NIH ROADMAP

        The NIH Roadmap provides a framework for the priorities the NIH as
    a whole must address in order to optimize its entire research
    portfolio. The NEI is committed to the initiatives of the Roadmap and
    is working to meet its goals. I would like to highlight NEI's
    involvement in two Roadmap Initiatives: ``Nanomedicine'' and ``Re-
    Engineering the Clinical Research Enterprise.''
        The NEI and the National Human Genome Research Institute are
    heading an NIH committee charged with implementing the Nanomedicine
    Roadmap Initiative. Nanotechnology originated in the fields of
    engineering and physics and refers to the research and development of
    materials and devices at the atomic, molecular or macromolecular
    levels. Nanomedicine integrates nanotechnology with biomolecular
    processes. The long-term goal of the Nanomedicine Roadmap Initiative is
    the development of therapeutic nanotechnology interventions for medical
    diagnosis and the treatment of disease. To meet these goals we are
    establishing a process to solicit ideas and concepts germane to the
    development of Nanomedicine Development Centers.
        Nanomedicine Development Centers will be designed to achieve an
    understanding of biological systems at the nanomolecular level.
        Over the past decade NEI-supported laboratory research has given
    rise to an unprecedented number of promising, pre-clinical therapies
    for eye disease. NEI's continued success depends on building the
    clinical infrastructure for translational medicine. Consonant with the
    NIH Roadmap initiative ``Re-engineering the Clinical Research
    Enterprise'' the NEI is creating cooperative clinical research groups
    that will enhance and expand clinical trial infrastructure. Over the
    last year, the NEI implemented the Diabetic Retinopathy Clinical
    Research Network. More than 70 clinical centers with the capability to
    participate in the clinical trials network have been identified. This
    network joins the highly effective Pediatric Eye Disease Investigator
    Group as models for future clinical networks the NEI plans to build.
        Mr. Chairman that concludes my prepared statement. I would be
    pleased to respond to any questions you or other members of the
    committee may have.
                                     ______

                     Prepared Statement of Dr. John Ruffin

        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's budget request for the National Center on Minority
    Health and Health Disparities (NCMHD) for fiscal year 2005, a sum of
    $196,780,000, which represents an increase of $5,324,000 over the
    comparable fiscal year 2004 appropriation.

              A STRATEGIC APPROACH TO ELIMINATE HEALTH DISPARITIES

        Unprecedented scientific advances in biomedical research over the
    last several decades dramatically improved public health. However,
    racial and ethnic minorities and other populations that experience
    disparities in health status have not benefitted equally from our
    Nation's progress in scientific discovery.
        The NIH supports a comprehensive research program to better
    understand why a broad spectrum of diseases disproportionately impact
    racial and ethnic minorities and the urban and rural poor. No other
    scientific area so thoroughly transcends so many diverse areas of
    science and involves all of the NIH Institutes and Centers (ICs).
        The NCMHD plays a key role in framing the NIH health disparities
    research agenda by conducting and supporting basic, clinical, social
    sciences, and behavioral health disparities research; developing
    research infrastructure and training programs; reaching out to and
    disseminating health information to minority and other health disparity
    populations; stimulating scientific programs within the NIH ICs to
    uncover the causes of health disparities and eliminate their impact on
    society; and developing and updating the NIH Health Disparities
    Strategic Plan.
        This past year, the NCMHD, in collaboration with the NIH Director,
    every NIH IC, and the National Advisory Council on Minority Health and
    Health Disparities, completed the first comprehensive NIH Health
    Disparities Strategic Plan, based on scientific priorities and
    opportunities that will lead to new therapies and prevention strategies
    that will ultimately eliminate health disparities in America. This
    evolving plan will guide future NIH health disparities research
    efforts.

                INNOVATIVE EFFORTS TO COMBAT HEALTH DISPARITIES

        The NCMHD has accomplished much since its creation. Today, the
    NCMHD has 60 Health Disparities Centers of Excellence spread across the
    nation. These Centers of Excellence, now located in 23 states, the
    District of Columbia, and Puerto Rico, support health disparities
    research, research training, and community involvement to identify
    factors that contribute to health disparities and to develop and
    implement new diagnostic, treatment, and prevention strategies.
        The NCMHD addresses the national need to develop a diverse, strong,
    and a culturally competent scientific workforce by eliminating barriers
    that prevent racial and ethnic minority students and students from
    disadvantaged backgrounds from pursuing research careers. Currently,
    the NCMHD supports about 300 researchers from 38 states through its two
    Loan Repayment Programs, which help to level the playing field and make
    it possible for under represented individuals to enter the scientific,
    technological, and engineering workforce. These ``Health Disparities
    Ambassadors'' are key to creating the culturally competent health
    disparities and clinical research workforce of the future.
        The NCMHD has also created a one-of-a-kind Research Endowment
    Program. Unique at the NIH, this program addresses the national need to
    build research and training capacity in institutions that make
    significant investments in the education and training of minority and
    disadvantaged individuals. This program is making it possible for 13
    institutions located in 11 states and Puerto Rico to establish health
    disparities endowed chairs and programs, enhance student recruitment
    efforts, provide merit-based scholarships, recruit and retain faculty,
    develop innovative instruction delivery systems in minority and health
    disparities research areas, and access emerging technologies.
        The NCMHD Research Infrastructure in Minority Institutions Program,
    born out of a partnership between the National Center of Research
    Resources and the Office of Research on Minority Health, (the
    predecessor to the NCMHD) is making it possible for institutions to
    target research efforts on health disparities that exist in the
    Southwest Border States; in rural communities, such as the Appalachia
    Region, the Mississippi Delta, and the Frontier States; and in urban
    centers of the nation. Currently, 11 institutions in eight states
    benefit from this program.
        In addition to using its core programs, the NCMHD strategy to
    eliminate health disparities also includes leveraging NIH dollars and
    expertise by creating partnerships with the NIH ICs and other agencies
    within the Department of Health and Human Services to fund health
    disparities research, training, and outreach programs. Over the past
    two years alone, the NCMHD forged many new partnerships, supporting
    more than 400 research projects to combat health disparities in our
    nation.

                        CLOSING THE HEALTH DISPARITY GAP

        Racial and ethnic minorities and other health disparity populations
    experience a disproportionate burden of illness, disability, and
    premature death due to cancer, cardiovascular disease and stroke,
    diabetes, HIV/AIDS, infectious diseases, infant mortality, and other
    diseases. The Department of Health and Human Services, through its
    ``Closing the Gap Initiative,'' designates these areas as major
    research priorities. NCMHD programs focus on these priorities and many
    others. The following initiatives represent a small sampling of the
    richness and diversity of NCMHD activities.
    Cancer
        Cancer deaths vary by gender, race, and ethnicity. Certain racial
    and ethnic groups have lower survival rates than whites for most
    cancers. Colorectal cancer rates among Alaska Natives are higher than
    the national average and Asian Americans suffer disproportionately from
    stomach and liver cancers. African American men have the highest rates
    of colon, rectum, prostate, and lung cancers (Healthy People 2010).
        NCMHD Health Disparities Centers of Excellence in 12 states across
    the nation are bringing to bear their state-of-the-art research and
    outreach programs to eliminate the impact of cancer on diverse
    populations. These efforts take place in Alabama, Arizona, California,
    Colorado, Georgia, Maryland, Mississippi, New York, Pennsylvania,
    Tennessee, Texas, and Virginia. One example of this intense effort is
    the American Indian and Alaska Native Health Disparities Center in
    Colorado, which conducts cancer research to address the needs of Native
    American and Alaska Native populations.
        The NCMHD Research Infrastructure in Minority Institutions program,
    which focuses on building research capacity at minority serving
    institutions, also addresses cancer health disparities. The Charles R.
    Drew University is working to improve the detection and
    characterization of brain tumors, and researchers at San Francisco
    University are examining the impact of social support, spirituality,
    and depression on quality of life among breast cancer survivors from
    diverse populations.
        Forty-five Health Disparities Ambassadors supported by our Loan
    Repayment programs have also set their sights on combating cancer
    health disparities in 17 states including Alabama, California,
    Colorado, Georgia, Illinois, Kansas, Massachusetts, Maryland, Michigan,
    Minnesota, North Carolina, New York, Pennsylvania, Tennessee, Texas,
    Virginia, Wisconsin, and in the District of Columbia. Some of the
    exciting work taking place under this program includes a community-
    based health promotion project to prevent cervical cancer in
    Vietnamese-American women; research studies on racial differences and
    barriers in obtaining breast, cervical, and colon cancer screening; and
    a population-based study that examines the variation in outcomes of
    colorectal cancer between African Americans and whites.
        Collaboration with the other NIH Institutes and Centers has allowed
    the NCMHD to extend the reach of its scientific expertise to tackle
    cancer health disparities in rural populations. For example, the
    Appalachia Cancer Network, cosponsored by the NCMHD and the National
    Cancer Institute, addresses cancer in rural and medically underserved
    Appalachian populations in West Virginia, Kentucky, Tennessee,
    Virginia, Ohio, Pennsylvania, Maryland, and New York. The goal of this
    network is to reduce cancer incidence and mortality and to prevent
    future increases; to increase cancer survival; and to stimulate greater
    coordination and participation among regional, state, and community
    cancer control networks throughout Appalachia.
    Cardiovascular Disease & Stroke
        Cardiovascular disease takes a heavy toll on certain populations.
    Heart disease rates have been consistently higher in the African
    American population than in whites (Healthy People 2010). Data on
    stroke risk factors are sparse for most racial and ethnic populations,
    except for African Americans whose stroke deaths, when adjusted for
    age, are almost 80 percent higher than in whites (Healthy People 2010).
        Today, 13 NCMHD Health Disparities Centers of Excellence, located
    in nine states across the nation including California, Georgia, Hawaii,
    Maryland, Mississippi, North Carolina, New York, Pennsylvania, and
    Texas focus on eliminating disparities due to cardiovascular disease.
    Three Health Disparities Centers of Excellence in Georgia, Mississippi,
    and New York focus on stroke research. The NCMHD also supports 20
    Health Disparities Ambassadors spread across 11 states, including
    California, Florida, Illinois, Indiana, Massachusetts, Michigan, New
    Hampshire, New Jersey, New York, Ohio, and Texas, who have set their
    sights on eliminating health disparities due to cardiovascular disease.
        The NCMHD Health Disparities Center of Excellence at Jackson State
    University in Jackson, Mississippi is built on a partnership with the
    University of Mississippi Medical Center, the University of Pittsburgh,
    and the Jackson Medical Mall Foundation. This Center's research agenda
    focuses on cardiovascular disease, stroke, and cancer in the African
    American population in Mississippi.
        The NCMHD also partners with its fellow NIH ICs, in the battle
    against cardiovascular disease and stroke disparities. The NCMHD
    partners with the National Heart, Lung, and Blood Institute to support
    the Jackson Heart Study. This study evaluates the environmental and
    genetic factors contributing to the disproportionate incidence of
    cardiovascular disease in African American men and women living in
    Mississippi. To date, almost 5,000 participants have benefitted from
    the program by visiting the clinic, with an average of 25 participants
    per week.
        The NCMHD and the National Institute of Neurological Disorders and
    Stroke partner to support two Specialized Neuroscience Research
    Programs at the Morehouse School of Medicine and at the University of
    Texas at San Antonio. This funding allows institutions to develop
    state-of-the-art neuroscience research programs; strengthen
    collaborations and resource-sharing between minority medical and
    graduate schools, community-based organizations, and leading
    neuroscience laboratories; expand training opportunities for minority
    students to access and prepare for careers in neuroscience research;
    and build new stroke research capacity.
    Diabetes
        Certain communities, including Hispanics, American Indians, African
    Americans, and certain Pacific Islanders and Asian populations, as well
    as economically disadvantaged and older people suffer
    disproportionately from diabetes (Healthy People 2010). Diabetes is the
    target of 27 Health Disparities Centers of Excellence in 17 states
    including Alabama, Arizona, California, Colorado, Georgia, Hawaii,
    Illinois, New York, North Carolina, North Dakota, Maryland,
    Mississippi, Oklahoma, Pennsylvania, South Carolina, Texas, and
    Wisconsin, as well as the District of Columbia. These programs include
    the University of Hawaii at Manoa, where efforts are underway to reduce
    and eliminate the major complications of diabetes in Pacific Islanders.
    The University of Pennsylvania is developing behavioral strategies for
    reducing obesity, a major factor contributing to diabetes in Latino and
    African American communities.
        The NCMHD has also deployed 15 Health Disparities Ambassadors to 10
    states, including Alabama, California, Florida, Georgia, Illinois,
    Massachusetts, New Hampshire, New York, Texas, and Virginia in the
    effort to eliminate diabetes-related health disparities. These
    individuals are conducting several important projects including
    reducing obesity in diabetic African American women in the state of
    Georgia and conducting educational interventions to prevent type 2
    diabetes in middle school children in Alabama. Under the NCMHD Research
    Endowment program, Xavier University of Louisiana is increasing the
    diabetes research capability of its College of Pharmacy, promoting
    health disparities research, and increasing the pool of well educated
    under represented minorities who pursue advanced education in
    biomedical and behavioral research.
        New NCMHD partnerships are also playing a significant role in
    eliminating diabetes health disparities. The NCMHD and the Indian
    Health Service recently formed a partnership to develop the Tribal
    Epidemiology Centers Program to address and eliminate health
    disparities, including diabetes disparities, experienced by American
    Indians and Alaska Natives. Recent NCMHD support enabled the creation
    of a new Northern Plains Tribal Epidemiology Center in Rapid City,
    South Dakota, continued funding for the other six existing EpiCenters,
    and the development of a summer training institute for Indian Health
    professionals. The funding will assist the EpiCenters to carry out
    their training program for local health staff, and expand their
    outreach activities to include a community-based research training
    program.

    HIV/AIDS
        The disproportionate impact of HIV/AIDS on certain populations
    underscores the importance of sustained research and prevention
    efforts. In 2002, the AIDS diagnosis rate among African Americans was
    almost 11 times the rate among whites. African American women had a 23-
    times greater diagnosis rate than white women. African American men had
    almost a nine-times greater rate of AIDS diagnosis than white men.
    (Centers for Disease Control and Prevention Division of HIV/AIDS
    Prevention 2003). In 2000, the AIDS incidence among Hispanics was 22.5
    per 100,000 population, more then three times the rate for whites
    (Centers for Disease Control and Prevention Division of HIV/AIDS
    Prevention 2002:1).
        In its fight against HIV/AIDS health disparities, the NCMHD
    partners with the Centers for Disease Control and Prevention to support
    the Racial and Ethnic Approaches to Community Health (REACH) Program.
    REACH serves African American, Asian American, Pacific Islander,
    Hispanic American, American Indian, and Alaskan Native populations at
    increased risk for HIV/AIDS, cardiovascular disease, breast and
    cervical cancer, diabetes and infant mortality. REACH develops,
    implements, and evaluates innovative community level intervention
    demonstrations that could be effective in eliminating health
    disparities by 2010.
        With the Agency for Healthcare Research and Quality, the NCMHD
    supports the EXCEED Program to examine the underlying causes and
    contributing factors for racial and ethnic disparities in health care
    and to identify and implement strategies for reducing and eliminating
    those disparities. Under this initiative, the Medical University of
    South Carolina is examining strategies to address HIV/AIDS disparities
    in health status between African Americans and whites, and the Baylor
    College of Medicine is assessing the extent to which problems in
    doctor-patient communication contribute to racial and ethnic
    disparities in health care use.

    Infant Mortality
        In recent years, infant mortality rates in the United States have
    steadily declined; yet the rate of Sudden Infant Death Syndrome among
    African Americans is still twice that of whites. African American women
    continue to be three to four times more likely than white women to die
    of pregnancy-related complications. Hispanic women are less likely than
    whites to enter into early prenatal care. Fetal Alcohol Syndrome
    disproportionately impacts American Indian, Alaska Native, and African
    American babies. (Healthy People 2010).
        The NCMHD has Health Disparities Centers of Excellence in six
    states including Alabama, Florida, Georgia, Texas, Iowa, and Wisconsin
    that focus their efforts to improve the health of mothers and their
    infants. One of these, the ``Mexican-American Women's Health Project
    Center'' at the University of Texas, El Paso, partners with established
    Hispanic health disparities researchers at the University of Arizona.
    Their research efforts focus on modifying behaviors of Mexican-American
    women relating to alcohol use; maternal health and nutrition; smoking
    cessation; and the pursuit of recommended Pap and HPV screening tests.
    Another Center at the University of Northern Iowa focuses on maternal
    and child health disparities to address the special health needs of
    Iowa's minority groups, which include urban African Americans, members
    of the Meskwaki Indian Tribe, rural families, growing populations of
    Latino and East African immigrants, and refugees from Bosnia and the
    former Soviet Union.
        The NCMHD also supports six Health Disparities Ambassadors through
    its Loan Repayment Programs, who are focusing their attention on infant
    mortality health disparities. These efforts is take place in Florida,
    Maryland, Michigan, Missouri, North Carolina, and Pennsylvania. Ongoing
    efforts include evaluating the link between sexually transmitted
    diseases and infant mortality; determining leading health indicators
    for women and girls; and creating logic models for maternal, child, and
    family health programs.

                                  RURAL HEALTH

        Another top priority of the NCMHD is improving rural health across
    the nation. In pursuit of this goal, the NCMHD established an
    innovative Health Disparities Center of Excellence partnership between
    Clemson University and Voorhees College, a Historically Black
    Institution in South Carolina. This partnership will build capacity for
    research, training, and outreach to address health disparities in rural
    Hispanic and African American communities in South Carolina. The
    Tuskegee University and the University of Alabama, Tuscaloosa Health
    Disparities Center of Excellence partnership, in conjunction with the
    University of Alabama Institute for Rural Health Research and community
    organizations, focuses on adult immunization, infant mortality, cancer,
    and diabetes.
        Over the past year, the NCMHD also created opportunities to include
    the expertise of other NIH ICs in addressing the needs of rural
    communities, forming 16 new rural health partnerships with the NCI,
    NHLBI, NIAAA, NIDA, NIEHS, NIMH, and the NINR. Examples of these new
    projects include the Appalachia Cancer Network; the Deep South Network
    for Cancer Control; the Rural Caregiver Telehealth Intervention Trial;
    and studies on the effects of alcohol and violence on rural women;
    coronary artery disease in Alaska Natives; migrant worker health and
    the environment; mental health treatment for rural Mexican Americans,
    African Americans, women, and the poor; cardiovascular health training
    and outreach in Latino communities; and substance abuse among Ojibwe
    children and youth.

                                   CONCLUSION

        The diversity of the American population is one of the greatest
    assets of the nation. One of the greatest challenges facing the nation
    is reducing and eliminating the profound disparity in health status
    that exists for many of its populations. Without decisive action now,
    the health challenges of the 21st century will expand along with the
    increasing number of racial and ethnic minorities, inhabitants of rural
    areas, and low socioeconomic populations.
        The NCMHD will continue to combat health disparities through our
    flagship programs. We will explore new opportunities to support
    academic development for the health disparity researchers of tomorrow.
    We will seek to create innovative programs to serve as a bridge between
    NCMHD capacity building programs and an investigator's first
    independent research effort. Cognizant of the value of engaging
    communities in the elimination of health disparities, we will lead
    efforts to conduct effective community-based outreach and research to
    our numerous constituents. We will continue our legacy of creating and
    nurturing partnerships to further increase the reach of our activities
    to eliminate health disparities and we will encourage our fellow NIH
    ICs to join the core health disparities programs of the NCMHD. The NIH
    Roadmap Initiative should also provide opportunities for the NCMHD
    constituent populations and research community to participate in
    interdisciplinary research, clinical research, and technology.
        Our vision of the future is a collective one that is embodied in
    the NIH Health Disparities Strategic Plan. With leadership, commitment,
    and strong scientific partnerships the NIH can advance scientific
    discovery to ensure the health of all Americans. Working together, we
    can turn the vision of an America where all citizens have an equal
    opportunity to live long, healthy, and productive lives into reality.
                                     ______

                Prepared Statement of Dr. Judith L. Vaitukaitis

        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's budget request for the National Center for Research
    Resources (NCRR) for fiscal year 2005, a sum of $1,094,141,000,
    including support for AIDS research, which reflects a net decrease of
    $84,815,000 over the comparable fiscal year 2004 appropriation, due
    entirely to the phasing out of extramural construction projects for
    fiscal year 2005.
        It is a pleasure once again to have the opportunity to present the
    accomplishments of NCRR-supported investigators and the future
    directions for NCRR programs. As a component of the National Institutes
    of Health, NCRR enables all lines of health-related discovery by
    supporting the creation and development of critical research resources
    and technologies. Because significant discoveries can be made at a
    variety of levels--from molecules to patients, or even patient
    populations NCRR supports a wide range of research resources across
    several disciplines. These resources include state-of-the-art clinical
    research environments, such as the nationwide network of General
    Clinical Research Centers. The GCRCs facilitate clinical research and
    protect the safety of participants in research. Each year more than
    10,500 NIH-supported investigators conduct nearly 8,000 research
    projects at the GCRCs, predominantly through more than a half million
    outpatient research visits.
        NCRR also supports research resources that develop and enhance
    scientific access to advanced technologies, nonhuman models for the
    study of human diseases, and career development and training. Because
    of its trans-NIH focus, NCRR is well-positioned to facilitate research
    by promoting the sharing of research tools and technologies as well as
    providing the tools for research collaborations so that research teams
    may address more complex research problems.

                         TECHNOLOGY AND INSTRUMENTATION

        NCRR strives to ensure that neither the lack of research resources
    nor technology development becomes rate-limiting for research. Two
    Nobel Prize winners in 2003 can vouch for the importance of having
    ready access to NCRR-supported resources. Dr. Roderick MacKinnon of
    Rockefeller University, co-recipient of the Nobel Prize in Chemistry,
    was honored for his groundbreaking studies of the structures and
    functions of ion channels, which control the movement of electrically
    charged atoms across cell membranes. Ion channel malfunctions can
    trigger a host of human disorders, including irregular heart rhythms
    and seizure disorders. Dr. MacKinnon noted that his award-winning
    discoveries depended on having access to the scientific expertise and
    advanced research instrumentation available at NCRR-supported resources
    that specialize in mass spectrometry and crystallography of complex
    molecules.
        The challenge for NCRR is to keep pace with the biomedical
    community's changing needs for research tools and to ensure that
    tomorrow's research queries have tomorrow's critical instrumentation
    and technologies in hand. The research resources and tools needed for
    scientific investigations change dramatically over time as more complex
    research queries are posed and require new technologies. Many research
    tools now considered critical to understanding the cause of disease and
    protecting the health of Americans were unheard of just a few years
    ago. For instance, the Magnetic Resonance Imagers, or MRIs, now found
    in hospitals and medical centers across the country were rare and
    experimental less than 20 years ago. Dr. Paul Lauterbur of the
    University of Illinois, Urbana-Champaign, depended on NCRR for many of
    his investigations into magnetic resonance imaging. Dr. Lauterbur was
    co-recipient of the Nobel Prize in Physiology or Medicine for his
    studies that led to the development of MRI. From 1990 to 2000, Dr.
    Lauterbur headed an NCRR-funded magnetic resonance research center,
    which helped to facilitate the evolution of MRI into the invaluable
    diagnostic and clinical research tool that it is today.

                          CLINICAL RESEARCH RESOURCES

        Just as NCRR technology and instrumentation resources laid the
    foundation for critical discovery in the basic and applied sciences,
    NCRR also catalyzes clinical and patient-oriented research through the
    network of GCRCs. In addition, NCRR develops and supplies investigators
    with clinical-grade biomaterials, such as vectors for gene therapy and
    human pancreatic islets for transplantation into patients with type 1
    diabetes.
        Research on rare diseases is one area where the GCRCs are ideally
    positioned to catalyze clinical research. Rare disease research is
    challenging in part because few patients with a particular rare disease
    can be recruited from any one clinical center. The nationally
    distributed network of the GCRCs makes them well-suited for enabling
    multicenter studies of rare conditions. Therefore, NCRR has partnered
    with the NIH Office of Rare Diseases and other groups to launch a
    network of Rare Diseases Clinical Research Centers. The network
    provides researchers with access to sufficient numbers of affected
    patients for statistically meaningful studies. The network also
    facilitates collaborations among scientists from multiple disciplines
    and institutions.
        To ensure the safety of human subjects participating in clinical
    research projects, clinical investigators must adhere to Federal, state
    and local regulations, policies, and guidelines. Yet these necessary
    responsibilities place heavy demands on the time of already-busy
    clinician investigators. To address this issue, NCRR established a new
    GCRC staff position known as the Research Subject Advocate (RSA). The
    RSA assists GCRC investigators, nurses, and staff to underscore the
    safe and ethical conduct of clinical studies and represents the
    interests of research participants. NCRR plans to extend and strengthen
    the role of RSA in an approach that complements that undertaken by the
    host institution.

                               HEALTH DISPARITIES

        NCRR also supports clinical research studies on health disparities,
    or diseases that disproportionately affect racial and ethnic minority
    populations. NCRR has joined with the National Institute of Mental
    Health to establish three Comprehensive Centers on Health Disparities.
    These Centers will further develop the capacity of Research Centers in
    Minority Institutions' (RCMI) medical schools to conduct basic and
    clinical research in type 2 diabetes and cardiovascular disease, both
    of which disproportionately affect minority populations. The Centers
    will provide support to further develop the requisite research
    infrastructure, recruit magnet clinical investigators, recruit and
    develop promising junior faculty, and facilitate substantial
    collaboration between the RCMI grantee institutions and more research-
    intensive universities. NCRR also supports a Stroke Prevention and
    Intervention Research Program that focuses on minorities, as well as a
    mentored clinical research career development program to provide
    clinical research training for doctoral and postdoctoral candidates in
    minority institutions.

                      BIOINFORMATICS AND COMPUTER NETWORKS

        Whether studying clinical manifestations of disease or the basic
    biology of cells and tissues, today's biomedical researchers generate
    vast data sets. This data deluge has increased scientific demand for
    access to scaleable computation and modern management tools. A related
    and equally important trend is the fact that biomedical research
    projects are becoming broader in scope. For example, neuroscientists
    now want to correlate brain images with events at cellular and
    molecular levels, including gene expression. These broad research
    projects require large multidisciplinary teams, gathered from
    scientists distributed across the country.
        To meet the challenges associated with these trends, NCRR supports
    the development of bioinformatics tools, including the software
    programs or algorithms that help scientists manage and analyze their
    data. NCRR also is instrumental in the creation of high-performance
    computer networks that link laboratories throughout the United States.
    A few years ago, NCRR joined with the National Science Foundation,
    Internet2, and investigators from several universities to establish the
    Biomedical Informatics Research Network (BIRN). The BIRN provides the
    tools for researchers to pool their data and to use federated databases
    so that they can oversee the integrity of their data, use
    bioinformatics tools for data mining, and visualize their data. In
    fiscal year 2004, NCRR began expanding the number of BIRN sites in
    order to establish a national infrastructure of bioinformatics tools
    and provide access to scaleable computing that, in turn, is linked to a
    nationally distributed network of modern imaging capabilities for
    studies of degenerative brain disorders.
        Other components of the BIRN network will link underserved
    institutions, such as doctoral degree-granting minority institutions
    and institutions in states that have received limited NIH research
    funding because they include very few research trained investigators,
    otherwise known as Institutional Development Award (IDeA) states. The
    networks will foster collaborative research and help investigators
    create a virtual critical mass of investigators. The BIRN also will
    foster collaborations across institutions located at remote sites. NCRR
    plans to establish a network for institutions with medical schools that
    are associated with NCRR's Research Centers in Minority Institutions
    (RCMI) Program. This electronic network will facilitate their
    participation in large clinical trials and other research studies and
    help define the factors contributing to health disparities among
    minority populations and ways to overcome those factors.
        In concert with other NIH components, NCRR participates in many NIH
    Roadmap initiatives for example, development of a National Electronic
    Clinical Trials and Research (NECTAR) network, which will form the
    backbone for all clinical research networks. An important component of
    NECTAR will be the standardization of patient data collection and
    storage procedures, which will facilitate data sharing by
    investigators. NCRR also supports other trans NIH Roadmap initiatives,
    including the National Centers for Biomedical Computing, Exploratory
    Centers for Interdisciplinary Research, and National Technology Centers
    for Networks and Pathways.

                                   PROTEOMICS

        The availability of complete genomes for a variety of organisms
    provides an important first step in understanding many complicated
    biological questions, including the molecular basis for disease. The
    next step in this process will be to develop technologies to quantitate
    spatiotemporal differences in the levels of gene expression, assess
    post-translational modifications of proteins, and characterize protein-
    protein interactions in both healthy and diseased cells.
        NCRR will support the development of the necessary technology and
    infrastructure to advance the science of proteomics. An advanced
    proteomics center will focus on multiple technologies, including
    techniques for protein purification, structural techniques, mass
    spectrometry, and DNA microarray instrumentation along with the
    necessary bioinformatics.

                                   CONCLUSION

        I have today noted two important trends in biomedical research the
    rapid accumulation of data and the broadening scope of research
    studies. To these, I must add a third trend namely, the increasingly
    collaborative nature of biomedical science. Some of today's most
    pressing questions in biomedical science are so complex, so
    multifaceted, that they cannot be addressed by a single investigator or
    even a single research laboratory. In many cases, teams of scientists
    with diverse skills and backgrounds are needed to get the job done.
        It is my belief that this emphasis on interdisciplinary
    collaborations, as evidenced by the multiple NIH Roadmap initiatives
    related to this area, will bring about unprecedented gains in
    biomedical science, and ultimately lead to improved health of all U.S.
    citizens. Finally, as the research paradigm evolves toward greater
    complexity, the infrastructure required to support that research must
    evolve too.
        I will be happy to respond to any questions you may have.
                                     ______

                   Prepared Statement of Dr. Duane Alexander

        Mr. Chairman and Members of the Committee: I am pleased to present
    the fiscal year 2005 President's budget request for the National
    Institute of Child Health and Human Development (NICHD). The fiscal
    year 2005 budget includes $1,280.9 million, an increase of $39.1
    million over the comparable fiscal year 2004 appropriation of $1,241.8
    million.
        The NIH Roadmap provides the schema to guide the NICHD in achieving
    its programmatic and research goals.
        Today I would like to share with you how the research supported by
    this committee is improving the lives of children, mothers, adults and
    families, and helping to reduce health disparities. The NICHD is
    participating in the trans-NIH obesity initiative identifying how
    primary care physicians can help children maintain a healthy weight.

                       ENCOURAGING HEALTHY BIRTH OUTCOMES

        Preeclampsia is a condition that affects five out of every hundred
    women who become pregnant. Preeclampsia can occur suddenly, and without
    warning, causing women to develop dangerously high blood pressure. In
    some cases, the condition may progress to eclampsia in which women
    experience potentially fatal seizures. Infants born to mothers with
    preeclampsia may be extremely small for their age or may be born
    prematurely, putting them at risk for a variety of other birth
    complications. Although a woman's high blood pressure and seizures can
    be treated, the only cure for preeclampsia is delivery of the baby. In
    a significant step toward treating preeclampsia, researchers have
    identified substances in the blood that have the potential to predict
    who will develop preeclampsia. This knowledge may help us treat women
    before preeclampsia becomes a serious problem, for them and their
    infant.
        We have also intensified our research in the area of stillbirth, a
    devastating occurrence that affects far too many families. Health care
    providers use the term stillbirth to describe the loss of a fetus after
    the 20th week of pregnancy. Stillbirth can occur before delivery or as
    a result of complications during labor and delivery. In at least half
    of all cases, researchers can find no cause for the pregnancy loss. We
    hope to change that. The NICHD has established the Stillbirth
    Collaborative Network, which consists of research centers in Texas,
    Utah, Rhode Island, and Georgia. In each center, a team of specialists,
    including obstetricians, nurses, statisticians, and even grief
    counselors will seek to understand the causes of stillbirth and
    eventually find ways to prevent these deaths.
        One way to increase the chances of a healthy pregnancy and healthy
    birth outcome is to avoid alcohol during pregnancy. Infants born to
    mothers who drink heavily during pregnancy are known to be at risk for
    mental retardation and birth defects. They are also at increased risk
    for Sudden Infant Death Syndrome (SIDS). NICHD researchers have now
    identified another reason that women should not consume alcohol during
    pregnancy: exposure to alcohol before birth affects the developing
    nervous system in the arms and legs.
        Recently, scientists in NICHD's Maternal-Fetal Medicine Units
    Network reported a breakthrough in reducing a major cause of infant
    mortality and the subsequent long term health problems associated with
    prematurity. The scientists, working collaboratively in 14 academic
    health centers across the United States, demonstrated that progesterone
    administered to women at risk for premature birth could significantly
    reduce the likelihood of early delivery. This was a very significant
    discovery and we were delighted that others recognized its importance.
    A few weeks ago, Parade magazine identified this discovery as one of
    the ten most significant health advances of the past year.

               NEW FRAGILE X CENTERS TO DEVELOP TREATMENT OPTIONS

        In 2003, the NICHD funded three new Fragile X research centers.
    Teams of researchers at each of the centers located in North Carolina,
    Texas, and Washington state are developing new ways to diagnose both
    the mild and severe forms of the condition, as well as new treatments.
    Fragile X syndrome is the most common genetically-inherited form of
    mental retardation currently known. It occurs in 1 out of every 2,000
    males and in 1 in 4,000 females. The syndrome is caused by a mutation
    in a specific gene, known as FMR1, on the X chromosome. In its fully-
    mutated form, the FMR1 gene interferes with normal development,
    resulting in mental retardation. In a partially mutated form, the FMR1
    gene can cause fragile X syndrome in the children of a parent who is a
    carrier. Until recently, it was thought that carriers did not have any
    symptoms. Researchers have learned that some people with a form of
    fragile X have mild cognitive and emotional problems. In addition, some
    female carriers are likely to undergo premature menopause. In older
    male carriers, the fragile X is associated with a neurological
    degenerative syndrome. Identifying a means to predict which carriers
    will develop the symptoms could be a first step toward developing new
    treatments for these often overlooked symptoms. The Fragile X Research
    Centers are focusing their research on how the fragile X affects the
    developing brain and nervous system, how the disorder progresses
    throughout an individual's life span, and treatments that can improve
    the behavior and mental functioning of people with fragile X syndrome.

                IMPROVING TREATMENT FOR CRITICALLY ILL CHILDREN

        Critical care medicine for children is an emerging field where, in
    general, physicians continue to rely upon adult treatments that have
    not yet been tested for effectiveness in a young population. To change
    this situation, the NICHD will help establish a national pediatric
    critical care research network to develop and evaluate treatments for
    children with disabling conditions. The initiative will foster
    collaborations among scientists in many different fields and will
    support research such as the best approach to care for children with
    brain injury, the most effective way to transition a critically ill
    child from an acute care to a rehabilitation setting, and the care of
    critically ill children in the event of a bioterrorism attack.

                 CUTTING OBESITY THROUGH RESEARCH AND PROGRAMS

        The increase in overweight and obesity among adults and children is
    a major public health concern. In fact, in a recent analysis of
    international data, NICHD researchers documented that U.S. teenagers
    were more overweight than youth in 14 other developed countries. Like
    many other health conditions that affect adults, the antecedents of
    adult obesity can be found in childhood. Young children who are
    overweight are likely to be overweight as adults. There is no single
    explanation for the increase in childhood overweight and there is no
    single solution. However, we know we must devise successful
    interventions that help children maintain a healthy weight. As part of
    the trans-NIH initiative, the NICHD will lead a major effort to
    determine whether a weight control program for children and youth led
    by primary care physicians as part of a comprehensive community-based
    effort can be successful. Currently, most weight management programs
    are administered through specialty clinics. However, there is strong
    evidence that an appropriate intervention by a physician can have a
    significant impact on personal behaviors such as tobacco use. Effective
    weight management programs in a primary care setting would be
    accessible to large numbers of children and would minimize the
    geographic, social, and economic barriers that commercial weight
    management programs can impose.
        We are also developing an exciting research-based program that
    helps to teach young children the fundamentals of good nutrition and
    physical activity as well as how to make sense of the messages that
    appear in the media. Three years ago, this committee provided funds to
    the NICHD and other health agencies to develop programs that encourage
    young people to engage in healthy behaviors. In response to this
    directive, the NICHD has developed ``Media Smart Youth,'' an after
    school program for children between nine and 13 years of age. The
    program focuses on good nutrition and physical activity. But it also
    provides skills to young children to interpret the messages about food
    and snacks they see on television, in magazines, and on the Internet.
    As part of their activity, the children who take part in Media Smart
    Youth develop messages about the importance of good nutrition and
    physical activity for their peers. The program has been tested with
    youth groups around the country. In fact, the children at P.S. 127 in
    the Bronx who took part in this program developed a message about
    physical activity for young people that appeared for 30 minutes on the
    Panasonic ``jumbotron'' screen in Times Square.

                   HELPING YOUNG CHILDREN PREPARE FOR SCHOOL

        The preschool years are crucial for learning language, social
    skills, and developing the intellectual capabilities that set the stage
    for later success in school. Yet, comparatively little is known about
    how to help young children obtain the greatest benefit possible from
    the preschool experience. In December 2003, NICHD joined with two other
    HHS agencies and the Department of Education, and launched a five year
    research initiative to find the best ways to help preschoolers at risk
    for failure in school acquire the skills they need for school success.
    The initiative provided $7.4 million in funding for the first year.
    Eight projects were funded to test research-based approaches to
    preschool curricula, Internet based approaches to training preschool
    teachers, and the importance of parental involvement for preparing
    children to enter school. Funds requested for fiscal year 2005 will
    allow us to expand this effort by funding academic researchers and
    small businesses to develop and produce more effective measurements of
    outcomes from preschool interventions.

                    SIDS RESEARCH SUPPORTS PROGRAM OUTREACH

        We have known for more than 10 years that placing infants on their
    backs to sleep reduces their risk of Sudden Infant Death Syndrome
    (SIDS). In fact, since the NICHD launched the Back to Sleep SIDS risk
    reduction campaign in 1994, the rate of SIDS in the United States has
    declined by more than 50 percent. The NICHD continues a vigorous
    research program to learn more about the causes and prevention of SIDS.
    For instance, a team of NICHD-funded researchers in Ohio recently
    discovered that infants who were placed to sleep on their backs were
    less likely to develop fevers, get stuffy noses or develop ear
    infection. Ear infections alone cost the health care system an
    estimated $5 billion a year. So this simple behavior of placing infants
    on their backs to sleep not only saves lives, it can save the health
    care system large sums money by reducing the use of antibiotics to
    treat ear infections. We also learned that infants who are normally
    placed to sleep on their backs are at greatly increased risk of SIDS
    when they are occasionally placed to sleep on their stomachs. New
    research on SIDS continues to shape our SIDS risk reduction outreach
    campaign. More recently, a major focus of the campaign has been
    reducing the risks of SIDS in African American communities.
        SIDS rates for African American babies have declined significantly
    since the NICHD initiated its Back to Sleep campaign ten years ago.
    Yet, the SIDS rate for African American infants is more than twice that
    of white infants. To address this health disparity, the NICHD joined
    forces with three national African American organizations in a unique
    collaboration to reduce the risks of SIDS in African American
    communities. The Alpha Kappa Alpha Sorority, the National Coalition of
    100 Black Women, and the Women in the NAACP, sponsored three regional
    summit meetings to raise SIDS awareness and train community leaders to
    be resources and spokespersons for SIDS risk reduction in their
    communities. The summit meetings were held in Tuskegee Alabama, Detroit
    Michigan, and Los Angeles California, and they helped build an
    infrastructure to involve faith-based, community, and service
    organizations in reducing the risks of SIDS and in promoting the health
    of infants. In Detroit, for instance, the summit ended with a ``SIDS
    Sunday,'' which was held at Hartford Memorial Baptist Church on the
    Sunday following that summit. Afterwards, other churches across the
    region held a ``SIDS Sunday,'' where pastors shared SIDS information
    from their pulpits, in their church bulletins, and with nurses and care
    givers in their childcare centers and nurseries. The successful
    collaboration of researchers, government officials, and the community
    will create a strong foundation for launching other interventions to
    eliminate health disparities.

             MOTHERS LEAVING WELFARE HAD NO EFFECT ON PRESCHOOLERS

        A study that received much of its funding from the NICHD
    demonstrated that when a mother leaves welfare to enter the labor
    force, it does not seem to have any negative effects on preschoolers or
    young adolescents. The study was undertaken in response to the Personal
    Responsibility and Work Opportunity Reconciliation Act of 1996, which
    mandated stricter welfare requirements for all welfare recipients. The
    researchers theorize that the positive and negative effects of going
    off welfare and getting a job may cancel each other out. For example,
    the increase in family income that comes with leaving welfare thought
    to relieve the stress on a family may make up for the decreased amount
    of time that mothers spend with their young children. In addition,
    mother's transition to work had a slightly positive effect on teens,
    reducing the teens' levels of anxiety. Conversely, teens whose mothers
    left the job market and went on welfare developed increased anxiety
    levels.

         MICROBICIDES THAT CAN PREVENT SEXUALLY TRANSMITTED INFECTIONS

        The NICHD is funding a number of projects to develop microbicidal
    compounds to prevent the spread of sexually transmitted infections and
    HIV. These compounds not only have the potential to prevent the spread
    of disease-causing bacteria and viruses, but may also be effective in
    preventing pregnancy. One project is a large scale test of the
    contraceptive effectiveness of Buffergel, a compound that kills the
    microorganisms that cause sexually transmitted diseases, and shows
    promise as a contraceptive. Another project is studying a microbicidal
    spermicide, C31G. The compound's effectiveness will be compared to that
    of a conventional spermicide preparation. Working with the National
    Institute of Allergy and Infectious Diseases, the NICHD has funded a
    new system to test the quality of potential microbicides to determine
    if they warrant further testing in human beings.

                       SAFER DRUGS FOR USE WITH CHILDREN

        In January 2002, President Bush signed into law the Best
    Pharmaceuticals for Children Act (BPCA). The law recognizes that drugs
    may have different effects in children than they do in adults, and
    seeks testing for drugs given to children. For roughly 75 percent of
    the drugs approved by the U.S. Food and Drug Administration (FDA) for
    adults, there is inadequate information available to ensure the safety
    and effectiveness of the drugs in children. Moreover, there is little
    or no data to guide physicians in prescribing dosages of these drugs
    for children. Working in close collaboration, the NICHD and the FDA, as
    directed by the BPCA, identified several high priority drugs to be
    tested. The NICHD is currently establishing partnerships with pediatric
    drug study networks in other NIH Institutes to expedite the study of
    other clinically important drugs.
        Drugs prescribed to pregnant women are also a concern. Although
    nearly two-thirds of all pregnant women take at least four to five
    drugs during pregnancy and labor, the effects of these drugs on a
    pregnant woman and her fetus remain largely unstudied. In addition,
    little is known about how pregnancy-related changes in cardiac output,
    blood volume, intestinal absorption, and kidney function may influence
    drug absorption, distribution, utilization, and elimination. Therefore,
    the NICHD will establish a new network of Obstetric-Fetal Pharmacology
    Research Units that will allow investigators to conduct key
    pharmacologic studies of drug disposition and effect during normal and
    abnormal pregnancies.

                           NATIONAL CHILDREN'S STUDY

        In a few short years, The National Children's Study has evolved
    from a concept to an exciting research collaboration poised to answer
    critical questions about child development. The fiscal year 2005 budget
    request continues planning dollars for this important project, but does
    not reflect funding to launch the study itself, since it is still being
    developed. The National Children's Study plans to examine the effects
    of environmental influences on the health and development of more than
    100,000 children across the United States, following them from before
    birth until age 21. The NICHD serves as the lead agency on this
    ambitious project, working closely with the National Institute of
    Environmental Health Sciences, the Centers for Disease Control and
    Prevention, and the U.S. Environmental Protection Agency. The
    collaboration involves government agencies, the research community,
    industry, and community groups.

                       NIH ROADMAP AND CLINICAL RESEARCH

        To ensure that the necessary clinical research workforce is
    available to translate laboratory findings to improved treatments for
    patients, the NIH Roadmap is strengthening several stages in the career
    path for these researchers. One new program will provide clinical
    research experience and didactic training during medical and dental
    school. Another will train doctorate-level professionals in multi
    disciplinary collaborative clinical research settings that reflect the
    diversity of today's clinical research team. To attract community
    practitioners to clinical research, the NIH plans to create a cadre of
    National Clinical Research Associates, community practitioners trained
    in clinical research who will refer patients to large clinical trials
    to enhance patient recruitment and more rapidly test potential
    therapies. The NIH is also identifying ways to improve peer review of
    clinical research grant applications and to enhance promotion and
    tenure policies in academia for clinical researchers.
                                     ______

                   Prepared Statement of Dr. Allen M. Spiegel

        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's budget request for the National Institute of Diabetes
    and Digestive and Kidney Diseases (NIDDK) for fiscal year 2005, a sum
    of $1,876,196,000, which includes $150 million for the Special
    Appropriation for Research on Type 1 Diabetes through Sec. 330B of the
    Public Health Service Act. The NIDDK transfers some of these funds to
    other institutes of the NIH and to the Centers for Disease Control and
    Prevention (CDC). Adjusted for mandatory funds, this is an increase of
    $54,956,000 over the fiscal year 2004 enacted level of $1,821,240,000
    comparable for transfers proposed in the President's request.

                       HIGHLIGHTS OF PROGRAM ENHANCEMENTS

        I appreciate the opportunity to testify on behalf of the NIDDK's
    efforts to combat the wide range of debilitating, chronic health
    problems within our research mission, many of which are caused directly
    or indirectly by obesity. Last year, I reported the creation of an
    NIDDK Office of Obesity Research to intensify the fight against this
    major public health problem, which is harmful both in its own right and
    as a driver of type 2 diabetes, especially in minorities and the young.
    Obesity can also be a contributing factor to nonalcoholic fatty liver
    disease, gallstones, end-stage kidney disease, and urinary
    incontinence. According to the CDC, approximately 64 percent of adults
    and 15 percent of children and teens are considered either overweight
    or obese. Disturbingly, these rates reflect skyrocketing trends over
    the past two decades. To accelerate research to combat this epidemic,
    the NIH Director established the NIH Obesity Research Task Force in
    April 2003, with co-chairmanship by the Directors of the NIDDK and the
    National Heart, Lung, and Blood Institute (NHLBI). I am pleased to
    report that the Task Force has completed a draft Strategic Plan for NIH
    Obesity Research, with input from external scientific and lay experts.
    This Plan is posted on a newly established Web site that will alert
    investigators to NIH obesity research funding opportunities, and also
    inform the public about NIH efforts. Both the Plan and the Web site are
    dynamic, and will evolve with changes in science and public health
    needs. Acting alone, the NIH cannot halt or reverse obesity; however,
    by generating and disseminating new research knowledge, we can lend a
    vital scientific dimension to what must truly be a multifaceted
    national effort.
        The Strategic Plan will contribute to the prevention and treatment
    of obesity by bolstering research in three major avenues: (1)
    behavioral and environmental approaches to modify lifestyle; (2)
    pharmacologic, surgical, or other biological/medical approaches; and
    (3) ways to break the link between obesity and its associated health
    conditions, known as co-morbidities. Within the goals and strategies
    outlined in the Plan, the NIDDK will have a major role in three trans-
    NIH initiatives.
        The first is an effort to combat pediatric obesity in site-specific
    ways--both in primary-care settings, and in other community settings,
    such as the home, day-care, pre-school, school, and other venues.
    Researchers will explore effective methods for the primary prevention
    of inappropriate weight gain among children and adolescents who are not
    overweight; secondary approaches to prevent further weight gain among
    those already overweight or obese; and tertiary efforts to prevent co-
    morbidities. We will build on studies the NIDDK is already pursuing to
    evaluate the effects of so-called ``natural experiments'' in which
    States or localities are changing the food and lifestyle choices and
    cues that students encounter in school settings. We will also build on
    studies to determine the effects of modifying the home environment,
    such as the influence of T.V.-watching on obesity, eating behavior, and
    physical activity. Our children are precious, and we should do all we
    can to spare them the serious health problems that can attend a
    lifelong struggle with obesity.
        A second trans-NIH initiative will focus on the neurobiological
    basis of obesity, which includes the intricate brain-gut circuits that
    signal hunger and fullness, and thus are crucial to maintaining the
    body's energy balance between calories consumed as food and expended in
    physical activity. I previously reported on several hormones that
    mediate energy-related signals, such as leptin, adiponectin, and
    ghrelin. By exploiting these and other findings through innovative
    collaborations between biomedical and behavioral researchers, we will
    delineate the many pathways that modulate the control of eating
    behavior in humans.
        In a third trans-NIH initiative, the NIDDK will take the leadership
    role in creation of an Intramural Obesity Clinical Research Program to
    capitalize on the unique, collaborative infrastructure of the NIH
    Clinical Research Center. This Program will foster multidisciplinary
    approaches to obesity research in areas such as metabolism,
    endocrinology, nutrition, cardiovascular biology, liver and other
    digestive diseases, genetics, and the behavioral sciences. A ``magnet''
    approach will draw upon the extensive expertise and resources of the
    NIH intramural program to frame state-of-the-art clinical investigative
    strategies and harness emerging technologies.
        In addition to these trans-NIH initiatives, the NIDDK will support
    a range of research, including ancillary studies to maximize the
    resources already invested in ongoing clinical trials. We will pursue
    challenging questions about obesity. What factors control where fat is
    deposited, and the relationship between its location and differences in
    metabolism, fat-cell regeneration, cell signaling, and associated co-
    morbidities of obesity? What is the relationship between obesity and
    abnormal levels of circulating and stored lipids, which are a hallmark
    of metabolic problems? Can we identify biomarkers of change brought on
    by the obese state? What genetic abnormalities underlie the co-
    morbidities of obesity? What steps can people take to achieve long-term
    maintenance of weight loss?
        As obesity is escalating in the United States, so is type 2
    diabetes. New estimates from the CDC place the number of people with
    diabetes at 18.2 million, and about 90-95 percent of them have this
    form of the disease. Disturbingly, about 5.2 million of those affected
    are unaware. Millions of adults also have a condition called ``pre-
    diabetes,'' in which glucose levels are elevated, but not as high as in
    full-blown diabetes. Because clinical trials have demonstrated that
    lifestyle and medical interventions can significantly delay or prevent
    disease onset in those at high risk, it is critical to identify these
    individuals and underscore the preventive actions they can take. The
    NIDDK is taking vigorous steps to foster the generation of new
    laboratory tests to improve diabetes detection, as well as to promote
    the development of more cost-effective strategies to pinpoint those at
    risk who can benefit most from early intervention. We are also
    supporting studies to translate important advances from clinical trials
    in diabetes prevention and care into medical practice. For example, for
    a low-income Latino population, we are supporting a clinical trial to
    compare current translation efforts for type 2 diabetes prevention with
    a method that incorporates culturally-sensitive strategies. We are also
    studying an interactive video conferencing system to enable
    communication between health professionals at a large medical center
    and diabetes patients in a rural state, with limited access to health
    care providers. Interventions that are successful in these trials could
    pave the way to widespread use by communities throughout the country.
        Once considered an ``adult-onset'' disease, type 2 diabetes is
    being increasingly diagnosed in children and adolescents, especially in
    minority populations. We are launching a multi-center, school-based
    trial (STOPP-T2D) to find ways to prevent the development of risk
    factors for type 2 diabetes in middle-school children. The trial will
    include school-based programs targeting nutrition, physical activity,
    and behavior modification. Another multicenter trial (Treatment Options
    for Type 2 Diabetes in Adolescents and Youth TODAY) will seek the best
    treatment strategies.
        Diabetes can lead to serious complications, such as blindness,
    irreversible kidney failure, lower limb amputation, and heart disease.
    We have established an NIDDK Diabetes Complications Working Group,
    which is charged with seamless integration of these activities across
    the Institute. The NIDDK also recently convened an international group
    of clinical and basic researchers to brainstorm research approaches to
    the urologic complications of diabetes. Because complications can
    affect many organs, we collaborate with other components of NIH and the
    Department to benefit from their expertise. For example, studies have
    shown that the process of new blood vessel formation, called
    ``angiogenesis''--traditionally studied in relation to cancer--is also
    critically important to vascular changes in diabetes, such as the
    dangerous proliferation of blood vessels in the eye that can lead to
    blindness. Angiogenesis will be the central theme of a new research
    collaboration involving multiple NIH institutes.
        In an aggressive research program on type 1 diabetes, we have
    established unique, innovative, and collaborative research groups,
    clinical trial networks, and consortia, with an overarching group to
    standardize and coordinate their efforts. We are also working to
    overcome barriers that currently prevent widespread clinical research
    on islet transplantation to restore normal insulin-producing capacity
    to patients. In collaboration with the National Institute of Allergy
    and Infectious Diseases (NIAID), we are establishing a national
    consortium to step up progress toward general clinical applicability of
    islet transplantation.
        To spur research in digestive diseases, the NIDDK recently
    established a new Liver Disease Branch within its Division of Digestive
    Diseases and Nutrition. With expert external input, this Branch is now
    spearheading the development of a Liver Disease Research Action Plan
    under the auspices of the Digestive Diseases Interagency Coordinating
    Committee. As requested by the Congress, the NIDDK is submitting a
    report on actions taken by the NIH and other HHS components in response
    to recommendations from a Consensus Conference on hepatitis C. In other
    research, broad approaches are providing insights into the inflammatory
    bowel diseases--Crohn's disease and ulcerative colitis. Fundamental
    studies are shedding light on the development of pathways that control
    gut motility; integration of pain, motility and behavioral neural
    circuits; and gut inflammation.
        For polycystic kidney disease (PKD), a research consortium has
    established the value of Magnetic Resonance Imaging for measuring
    kidney size. This advance portends dramatic improvements in assessing
    disease progression--a critical step in developing and evaluating new
    treatments. The HALT-PKD Network is testing a regimen designed to lower
    blood pressure and slow disease progression--the first of several
    clinical studies envisioned. A workshop on oxalosis and primary
    hyperoxaluria--an inherited cause of kidney stone disease--has
    identified future clinical research directions, which will apply
    emerging knowledge about underlying metabolic and genetic
    abnormalities. We have also launched or expanded initiatives on
    interstitial cystitis, urinary incontinence, and urinary tract
    infections, consistent with the scientific recommendations of the
    Strategic Plan of the Bladder Progress Review Group. A recently formed
    Interstitial Cystitis (IC) Epidemiology Task Force is guiding efforts
    in that area, as described in a requested report to the Congress.

                    TRANSLATION RESEARCH AND ROADMAP EFFORTS

        Underpinning our disease-focused programs is an emphasis on
    ``translation'' research, which benefits patients directly by bringing
    the fruits of laboratory discoveries into the arena of clinical
    research, and by propelling the positive results of clinical trials
    into medical practice. In one promising pilot effort to speed the
    development of therapies for type 1 diabetes, we are building on an
    innovative mechanism established by the NCI called ``Rapid Access to
    Intervention Development.'' We are also pursuing several translational
    efforts related to the NIH Roadmap for Biomedical Research. These
    include development of non-invasive methods for diagnosing and
    monitoring the progression of diabetes, kidney and digestive diseases;
    harnessing new technologies such as proteomics the study of proteins
    and their functions; as well as studying stem cells during human
    development and tissue repair. We are leading an NIH Roadmap initiative
    in ``New Pathways to Discovery'' by enhancing metabolomics--the study
    of networks within the cell, and constituents of the cell, such as
    carbohydrates, lipids, and amino acids. We are also playing a major
    role in Roadmap efforts to build ``Research Teams of the Future'' by
    spurring interdisciplinary research training. These efforts can benefit
    programs within the NIDDK mission by bridging scientific disciplines
    and catalyzing partnerships, such as collaborations between biomedical
    and behavioral researchers, which are so important to moving obesity
    research forward.
        Today, I have presented a cameo of our many and diverse research
    efforts and plans. Our research momentum has never been greater, and
    our commitment to improving health remains clear and strong.
                                     ______

                  Prepared Statement of Dr. Sharon H. Hrynkow

        Mr. Chairman and Members of the Committee, I am pleased to present
    the President's Budget for the Fogarty International Center for fiscal
    year 2005, a sum of $67,182,000, which reflects an increase of
    $1,838,000 over the comparable fiscal year 2004 appropriation.
        I welcome this opportunity to relate Fogarty's progress over the
    past year and proposed plans for fiscal year 2005. Programs at Fogarty,
    developed with the support and guidance of the Administration and this
    Committee, reflect our nation's enduring commitment to achieve ``a
    healthy America, in a healthier world.'' These were the words of the
    late Congressman John E. Fogarty, Chairman of the House Appropriations
    Subcommittee from 1951 until 1967, and for whom the center is named. He
    championed research as the one truly global effort in which all nations
    can and will join as real partners.
        The health challenges facing the United States are many. Among the
    communicable diseases, AIDS and tuberculosis continue to challenge even
    the most sophisticated public health interventions. SARS emerged in
    Asia and washed upon our shores, as did West Nile Virus several years
    ago. And the emergence of avian flu in Asia and the United States is a
    compelling tale that is a harbinger of probable Asian flu pandemics yet
    to come. All told, the infectious threats cost our economy dearly. And
    as chronic disease such as cancer, cardiovascular disease, and mental
    health disorders increase year after year in the United States and
    world-wide, both treatment and prevention efforts must be applied.
    These challenges are shared with communities around the world.
        To address these challenges, Fogarty supports a broad range of
    research and training programs, each designed to tackle particular
    health problems shared by United States and foreign populations. Our
    particular focus is on improving the capacity of communities in poor
    settings to address health challenges. Accordingly, our emphasis has
    been on working with scientists and health professionals in low- and
    middle-income nations on shared health problems. Our programs identify
    research opportunities best addressed through international
    cooperation. Fogarty's efforts are multidisciplinary, embracing
    clinical, epidemiological, basic biomedical and social science
    research. They are multi-sectoral, closely coordinated with our sister
    institutes at NIH, the Centers for Disease Control and Prevention, and
    international organizations with health and development missions,
    including The World Bank and the World Health Organization. Moreover,
    the programs enhance foreign relations with governments and communities
    alike, and advance the historic humanitarian role of our nation. And
    importantly, our programs promote a global culture of science, founded
    on equal partnerships between scientists working across borders, in a
    culture of sharing of scientific information, peer review and sound
    management policies. Fogarty supports over twenty research and training
    programs in more than 100 countries, involving more than 5,000
    scientists in the United States and abroad.
        What follows is a selective summary of ongoing and planned Fogarty
    activities to support NIH international objectives and realize
    Congressman Fogarty's vision.

                             THE HIV/AIDS EMERGENCY

        HIV/AIDS has exacted a profound human toll in the United States and
    abroad, reversed gains in child survival in many nations, and
    threatened the economic stability of emerging markets by reducing the
    number of working men and women. Reducing the impact of HIV/AIDS in
    resource-poor countries, which bear the disproportionate burden of this
    disease, requires a strong national commitment on their part and
    international research cooperation to develop effective prevention and
    control strategies. The Fogarty AIDS International Training and
    Research Program (AITRP), now in its 16th year of operation, has been a
    major source of support for training a cadre of foreign medical
    scientists from developing countries needed to combat the global HIV/
    AIDS pandemic. Working through U.S. universities, Fogarty has supported
    Masters level, Ph.D., and post-doctoral training for young scientists
    in countries most affected by the pandemic. These scientists are
    testing HIV/AIDS vaccines abroad, developing effective public health
    strategies to reduce transmission, and acquiring new knowledge for
    treatment for those already infected.
        Through the Fogarty AIDS Program, nearly 2,000 foreign researchers
    from over 100 countries have been trained in the United States, many at
    senior levels, and over 50,000 have trained in cutting-edge laboratory
    methodologies through workshops and courses conducted in those
    countries where HIV/AIDS is most devastating. This large international
    cadre of trained scientists has facilitated the implementation of new
    programs such as the Pediatric AIDS Foundation Call-To-Action, the
    President's initiative on prevention of maternal-to-infant transmission
    of HIV, and the President's Emergency Plan for AIDS Relief (PEPFAR). In
    addition, health scientists trained under the program have played vital
    roles in helping approximately 20 countries receive awards from the
    Global Fund for AIDS, TB and Malaria. As we work in partnership with
    colleagues around the world, the benefits of the Fogarty AIDS program
    accrue also in the United States. Interventions and strategies
    developed and tested abroad may have direct relevance to communities in
    the United States.
        Among research accomplishments in the past fiscal year, scientists
    at the University of North Carolina and the University of Malawi have
    identified a new and effective means to minimize postpartum
    transmission of HIV through implementation of an inexpensive two-drug
    antiretroviral regimen. This is of significance because low-income
    women in sub-Saharan Africa typically do not obtain medical attention
    during pregnancy and are usually uninformed of their HIV status until
    delivery. Effectively deployed, this intervention will mean that more
    newborn infants will have a chance to grow to be healthy adults, even
    where the lack of resources and other obstacles to extending medical
    care limit prenatal care and interventions.

                           CHANGING MICROBIAL THREATS

        HIV/AIDS is a cautionary example. The rapid emergence of new
    pathogens and re-emergence of infectious disease, believed to have been
    controlled or contained, presents a disturbing new chapter in the grim
    evolutionary battle between humans and microbes. This is the result of
    social and demographic trends, including increases in international
    travel and trading across borders, and changes in the genetic structure
    of microbes that increase virulence and transmission, and weaken the
    efficacy of existing drugs. Among major disease pathogens, malaria has
    resurged due to resistance of the parasite to available drugs and
    resistance of mosquitoes to insecticides. Malaria accounts for an
    estimated 2 million deaths per year with increasing mortality due to
    drug resistance and HIV-contaminated blood transfusions related to
    malaria-induced anemia.
        Building on the success of the AIDS training program, Fogarty
    launched in 1996 the International Training and Research in Emerging
    Infectious Diseases, a training program which builds expertise in
    microbiology, epidemiology, and laboratory methods as part of a broad
    effort to combat new and emerging diseases worldwide. Today, that
    program has been expanded to include other infectious diseases as the
    Global Infectious Disease Research Training Program, linking U.S.
    universities with counterparts around the world to advance research
    projects (through 27 Fogarty awards) and, importantly, to build the
    next generation of scientists able to combat emerging infections, such
    as SARS and West Nile Virus. Through this program, Fogarty is helping
    to address the infectious disease challenges of today while preparing
    for new pathogens yet to emerge tomorrow, as surely they will.
        A powerful new tool for malariologists and other infectious disease
    researchers concerns the use of sophisticated mathematics to predict
    the course of an epidemic. Such mathematics, sometimes termed models,
    can be used to chart the benefits of prevention and control measures.
    Most recently, mathematical models were used to project the course of
    the SARS epidemic in Asia, and to develop strategies to limit the
    spread of the disease. Several years ago, Fogarty established a unit at
    NIH concerned with the use of mathematical models for control and
    prevention of several diseases, including malaria. The elements of a
    malaria prevention program include reducing the population of
    mosquitoes, treatment of malaria patients, and use of personal
    protection such as bed nets to prevent mosquito bites. In addition,
    there is a major effort underway to develop a malaria vaccine. The
    Fogarty epidemiologists have used mathematical models to determine the
    best strategy to employ such a vaccine, when it becomes available,
    along with existing methods of malaria control and prevention. All this
    must be done within the various complex ecological settings in which
    malaria occurs. The use of such advanced mathematics in devising the
    most effective strategies in the study of infectious diseases will
    surely bring unexpected benefits to human kind. Importantly, through a
    network of in-house research experts and extramural scientists, Fogarty
    also employs mathematical models to assist biomedical research and
    public health policy-makers prepare for and respond to bioterrorism
    events. In coordination with DHHS, Fogarty has mobilized experts in
    epidemiology, terrorism-response and public health policy in the
    context of category A agents including plague, tularemia smallpox and
    anthrax.

                   THE EMERGING EPIDEMICS OF CHRONIC DISEASE

        By the year 2020, chronic disease is expected to contribute 60
    percent of the global disease burden. The toll in the United States is
    already enormous: for example, obesity has more than doubled from 15
    percent during 1976-1980 to 31 percent in 1999-2000, and 65 percent of
    adults ages 20 to 74 were overweight to obese in 1999-2000. As
    populations age, and risk exposures shift due to environmental and
    dietary factors, non-communicable diseases are estimated to become a
    leading source of disability and premature death in developing nations
    as well. Tobacco-caused disease and death is a major concern in the
    United States and globally. In the United States, while picking up the
    habit of smoking is on the decline in most groups, in young girls it is
    on the rise (The World Bank). In low- and middle-income nations, as
    wealth increases in urban settings, smoking commencement in youth, and
    particularly in girls, is rising at alarming rates (The World Bank). To
    address this challenge, Fogarty launched in 2002 its International
    Tobacco and Health Research and Capacity Building Program. While in its
    early stages, our expectation is that research will lead to new
    interventions that will benefit U.S. communities as well as those
    around the world.
        There is a growing awareness of the burden on health inflicted by
    trauma and injury both in the United States and worldwide. The numbers
    are startling: more than 1.2 million people are killed in traffic
    accidents annually, and millions more are injured or disabled. Deaths
    from all types of injuries, including war and domestic violence, are
    projected to rise from 5.1 million in 1990 to 8.4 million in 2020, with
    road traffic injuries as a major cause for this increase, with millions
    more sustaining injury that results in life-long disability. In
    response to the growing epidemic of trauma, Fogarty is initiating a new
    research and training program. Among the features of the program will
    be training across the range of basic to applied sciences, the
    epidemiology of risk factors, acute care and survival, rehabilitation,
    and the long-term mental health consequences. Possible research areas
    will include development of low-cost synthetic blood products and
    diagnostic imaging tools, identification of behavioral intervention
    strategies, particularly in youth and other high-risk groups, and
    health services research to determine cost-effective measures for
    emergency care in low-income settings. The new knowledge from the
    program will benefit not only developing countries but, as low-cost and
    effective strategies are identified, communities in the United States.

         PREPARING THE NEXT GENERATION OF U.S. GLOBAL HEALTH LEADERSHIP

        While Fogarty works to build capacity and train young scientists in
    the developing world, critical steps have been taken to ensure that
    U.S. investigators at a formative stage in their careers also have
    opportunities to engage in international research projects. The Center
    will enhance and expand two programs to bring the next generation of
    U.S. scientists more fully into the global culture of science. The
    first of these, the International Research Scientist Development Award
    (IRSDA) program, provides post-doctoral training for four years, two of
    which must be spent conducting research in a developing country. Nearly
    20 U.S. scientists are now being supported as IRSDA trainees.
    Addressing an earlier step in the career path, Fogarty has recently
    teamed with the Ellison Medical Foundation to create a second program,
    the new pre-doctoral clinical research training program for U.S.
    medical and public health students. Under this program, students will
    spend a year in a developing country conducting NIH-sponsored clinical
    research under the mentorship of an experienced foreign investigator
    and a collaborating research team. The first students to be selected
    will begin the program this summer.

                  ENHANCING OPPORTUNITIES FOR WOMEN IN SCIENCE

        NIH's goal to bolster the nation's intellectual capital includes
    attracting more women to careers in science, both to build a new
    generation of talented scientists and to ensure that research issues
    germane to women's health are addressed. Fogarty has extended this
    important goal to international programs. At an October 2003 colloquium
    on career path issues facing women in the life sciences, including
    women in the developing world, Fogarty and its co-sponsors, the NIH
    Office of Research on Women's Health and the National Institute of
    Environmental Health Sciences, invited perspectives on opportunities in
    advancing career issues for women in the life sciences from a community
    of scientists, administrators and science funding agencies. To follow
    up on the recommendations, Fogarty and its partners have agreed to:
    collect data on developing country women in science and their career
    paths; support workshops to develop skill sets for women scientists in
    the developing world that will better enable them to take on leadership
    roles within health research and/or policy settings; and develop and
    implement strategies to effectively use the Internet and other
    information technologies to support networking and mentorship.

                 ADVANCING THE NIH ROADMAP: GLOBAL POSITIONING

        Fogarty supports programs linked to each of the three main Roadmap
    themes--New Pathways to Discovery, Research Teams of the Future, and
    Re-Engineering the Clinical Research Enterprise. In particular, to
    improve the clinical research enterprise, Fogarty supports two new
    programs aimed at training developing country professionals in
    clinical, operational and health services research. These programs
    represent a new approach to enhance clinical research, and pave the way
    for new partners, namely those in low- and middle-income nations, to
    work more closely on mental health, and on AIDS and TB with U.S.
    counterparts. In support of Roadmap themes of new approaches and new
    pathways to discovery, Fogarty is also supporting studies to identify
    the impact of environmental degradation on economic development and
    human health. These programs link social scientists, including
    mathematicians and economists, with clinicians and medical researchers
    to provide new insights and strategies to tackle urgent global health
    challenges.

                                   CONCLUSION

        Mr. Chairman, global challenges require a global response.
    Collective action is not only an economically rational approach to
    global health research challenges, but a scientific and humanitarian
    imperative. With the continued support of this Committee, Fogarty will
    accelerate both research discoveries and applications through
    international cooperative action to the benefit of the United States
    and to global communities. ``A healthy America in a healthier world''
    has never been as important as it is today. Thank you.
                                     ______

                 Prepared Statement of Dr. Roderic I. Pettigrew

        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's budget request for the National Institute of Biomedical
    Imaging and Bioengineering (NIBIB) of the National Institutes of Health
    (NIH). The fiscal year 2005 budget includes $297,647,000, an increase
    of $8,817,000 over the fiscal year 2004 enacted level of $288,830,000
    over the comparable fiscal year 2004 appropriation.
        The NIBIB's mission is to improve human health by leading the
    development and accelerating the application of biomedical
    technologies. The Institute is committed to integrating the physical
    and engineering sciences with the life sciences to advance basic
    research and health care. Our vision is to profoundly change healthcare
    by pushing the frontiers of technology to make the possible a reality.

                            PROGRESS TOWARDS SUCCESS

        Established by law in December 2000, the NIBIB has already
    demonstrated an impressive track record as a conscientious steward of
    public funds and has achieved significant milestones. In fiscal year
    2003 the NIBIB funded approximately 750 awards, including 300 new
    awards that received outstanding scores in a highly competitive peer
    review system. Consistent with our mission, approximately one-third of
    our new awards were for innovative, high-impact, though high-risk,
    exploratory studies. These studies addressed the feasibility of a novel
    avenue of investigation and/or breakthroughs in biomedical imaging and
    bioengineering within a specific area. The Institute has also been
    effective at reaching segments of the scientific community that
    traditionally have not been supported by the NIH, especially those from
    the engineering and quantitative sciences. Between the first and second
    years of our grant-making authority, proposals to the NIBIB from first-
    time NIH applicants increased significantly. In fiscal year 2003,
    approximately 50 percent of respondents to requests for targeted
    applications identified themselves as first-time NIH applicants.
        The Institute has built a solid research infrastructure through the
    issuance of numerous basic and applied research solicitations in
    promising areas of scientific investigation. Responses to the
    Institute's targeted initiatives far exceeded even the most optimistic
    estimates based on prior NIH experience. Coupling this to the
    successful outreach to new applicants and to the science community, it
    is clear that NIBIB is filling an important need with regard to
    catalyzing interdisciplinary science and supporting engineering
    research aimed at translating scientific discoveries to practical
    applications.
        The NIBIB continues to foster successful linkages and
    collaborations with other NIH Institutes and Centers, Federal agencies,
    academic institutions, and private industry. We regard input from
    industry as critical for helping to identify research needs that will
    result in significant healthcare improvements as well as for
    translating technologies and research results to patient applications.
    As a first step in establishing collaboration with the biomedical
    industry, the NIBIB sponsored a workshop on ``Biomedical Industry
    Research and Training Opportunities'' in December 2003. Recommendations
    from this meeting will be considered in the planning and development of
    future NIBIB programs.

                    ADVANCING TOMORROW'S TECHNOLOGIES TODAY

        Biomedical imaging and bioengineering are interdisciplinary fields
    requiring collaborations not only among imagers and engineers, but also
    with biologists, chemists, mathematicians, computer scientists, and
    clinicians of all specialties. Today, the imaging and engineering
    sciences are essential for improved understanding of biological
    systems, detecting and treating disease, and improving human health.
    Recent advances in these fields have enabled the diagnosis and
    treatment of various diseases using increasingly less invasive
    procedures. Benefits associated with minimally invasive imaging
    applications include quicker and more accurate diagnoses leading to
    improved patient outcomes at reduced costs. Minimally invasive image-
    guided interventions now serve as powerful tools in the operating room
    and can be applied to surgical procedures in urology, oncology,
    neurosurgery, ophthalmology, orthopedics, and cardiology.
        The quest for faster and more effective minimally invasive surgical
    interventions has resulted in the introduction of computer-assisted
    robotic technology, whereby the surgeon works with small tools through
    small incisions. However, current instrumentation prohibits the surgeon
    from actually feeling the forces exerted when manipulating tissue. This
    lack of sensory control can be particularly detrimental in surgery,
    where the forces applied to sutures are critical in creating knots that
    are strong enough to hold, but do not damage the tissue. To overcome
    this problem, NIBIB investigators are developing instruments with
    three-dimensional sensors designed to give the surgeon a feeling
    comparable to that of performing the task manually. This research has
    additional applications as well, including expert-assisted surgery in
    remote locations.
        Magnetic resonance imaging (MRI) has been used successfully for
    over 15 years to generate soft tissue images of the human body.
    However, a number of diagnostic MRI applications require further
    improvements in both imaging speed and spatial resolution. For example,
    accurate abdominal imaging generally requires a complete image obtained
    during a single ``breath-hold'' period, which can take up to 30
    seconds. Many patients, especially those with respiratory illnesses,
    cannot tolerate long breatholds. The NIBIB supports an active research
    program on optimizing MRI speed and spatial resolution. One new
    approach under study, called parallel imaging, collects MRI signals
    from a number of independent coil shaped antennas. The appropriate
    combination of these signals can provide an order of magnitude
    improvement in imaging speed or resolution. Enhancements such as this
    hold promise for greatly enhancing the non-invasive diagnosis and
    treatment of abdominal and neurological diseases.
        Functional magnetic resonance imaging (fMRI) is a relatively new
    technique that builds on the basic properties of MRI to measure quick
    and tiny blood flow related metabolic changes that take place in the
    active brain. Thus, fMRI studies are capable of providing not only an
    anatomical view of the brain, but a minute-to-minute recording of
    actual brain activity. This technology is now being used by NIBIB
    researchers to precisely map functional areas of the normal, diseased,
    and injured brain and to assess risks associated with surgery or other
    invasive treatments. Functional MRI can help physicians determine
    exactly which parts of the brain are responsible for specific crucial
    functions such as thought, speech, movement, and sensation. This
    information allows physicians to better plan surgeries and radiation
    therapies and to guide interventional strategies for a variety of brain
    disorders.
        Molecular imaging provides a way to monitor cellular activities in
    normal and diseased states. The development of novel imaging
    technologies, combined with new or enhanced probes that bind to and
    ``highlight'' defined cellular targets, will allow this technique to be
    more broadly applied to biomolecules that are known indicators of a
    diseased state. For example, NIBIB researchers have developed nanometer
    sized fluorescent crystals, called quantum dots, that glow and can act
    as markers for specific cells when bound to certain targeting agents
    such as cancer cell antibodies. These agents can more precisely
    pinpoint the location of the sentinel lymph node in breast cancer
    patients. The sentinel node (SN) is the first node in the body to come
    into contact with cancer cells as they leave the breast and begin to
    spread to the rest of the body. Testing for metastatic cancer cells in
    the SN allows for accurate staging using information from a single
    lymph node, rather than 10 to 15 axillary nodes, and allows patients to
    avoid many of the complications and side effects associated with a
    traditional axillary lymph node dissection.
        Advances in bioinformatics have been identified as having great
    potential for positively impacting medical science and health care.
    NIBIB researchers are developing and evaluating several innovative
    technologies designed to help solve the information management problems
    faced by today's doctors. Concepts enveloped in this system include a
    medical record architecture designed for portability; a mechanism for
    linking laboratory findings with medical problems; and a real-time,
    context-sensitive visualization of the medical record. Taken together,
    these concepts form a comprehensive system for facilitating evidence-
    based medicine in a real-world setting.

                    NEW BIOMATERIALS FOR TISSUE ENGINEERING

        Tissue engineering holds the promise to repair and/or replace
    damaged organs using biologic materials. For success in this area, a
    number of scientific and bioengineering challenges must first be met.
    For example, we must learn to produce, manipulate, and deliver
    collections of cells not only as building blocks for tissues and organ
    systems, but as models for studying drug development. Toward this goal,
    NIBIB researchers have successfully transformed adult rat engineered
    tissue cells into cells that form cartilage and bone. The two cell
    types were integrated into separate layers, encapsulated in a gel-like
    biocompatible material, and shaped into the ball structure of a human
    jaw joint. Although more work is needed before this tissue-engineered
    joint can be used in humans, it holds great potential for treating
    patients with temporomandibular disorders, osteoarthritis, and
    rheumatoid arthritis. These procedures could also be further refined
    and adapted for developing artificial knee and hip joints.
        Coronary stents are small devices that serve as a scaffold to prop
    open the inside of an artery and provide vessel support. They are
    commonly made of stainless steel or nylon mesh and therefore remain as
    a permanent implant in a blood vessel. Although stents have
    revolutionized the treatment of coronary artery disease, limitations
    include an inflammatory reaction and the development of stent closure
    due to blood clots forming within the device, a process termed
    restenosis. To address this problem, NIBIB researchers have recently
    developed a mechanically strong, hemocompatible, and X-ray visible
    polymer as a noninflammatory fully-degradable coronary stent. While
    designed as a stent, work continues to refine the device to serve
    additionally as a drug-delivery vehicle. This may also have application
    as a drug-delivery mechanism for other diseases, such as cancer.

                              SENSORS FOR MEDICINE

        Biosensors are nanoscale or microscale devices that detect,
    monitor, and transmit information about a physiological change, or
    indicate the presence of various chemicals, gases, or biological
    materials. Laboratory diagnostics used in hematology, clinical
    chemistry, pathology, and microbiology already employ sensor
    technologies to perform simultaneous measurements for many substances
    in urine, blood, saliva, sweat, and interstitial fluids. The Institute
    has an active research program in sensor technologies and continues to
    expand this important area. For example, NIBIB researchers are
    engineering recombinant antibody fragments (recAbs) that will increase
    the sensitivity and specificity of a type of biosensor called a
    piezoimmunosensor. Piezoimmunosensors have been proposed for almost 20
    years; however, there has been no procedure for providing a sensing
    layer that is uniform, chemically stable during the measurement
    process, and contains high numbers of binding sites. By creating
    tightly packed monolayers of recAbs that will bind to the surface of
    the sensing unit, researchers are solving this problem while also
    preventing non-specific interactions with molecules, and thus improving
    specificity.
        Other researchers are focusing on the design and fabrication of
    miniaturized implantable responsive drug delivery devices that
    integrate a smart drug delivery system with a biosensor. These drug
    delivery systems are aimed at providing individualized therapies that
    monitor the patient's body chemistry and control drug flow as needed.

                                  NIH ROADMAP

        To transform the Nation's medical research capabilities and to
    speed the movement of research discoveries from the bench to the
    bedside and into medical practice, the NIH has laid out a series of
    far-reaching initiatives known collectively as the NIH Roadmap for
    Medical Research. The NIH Roadmap focuses on the most compelling
    opportunities in three main areas: new pathways to discovery, research
    teams of the future, and re-engineering the clinical research
    enterprise.
        The NIBIB mission also strongly supports the NIH Roadmap
    initiative, since the Roadmap goal is to facilitate the development of
    innovative, novel and multidisciplinary science and technology that has
    the potential to further advances in health care. For example, the
    NIBIB is participating in an initiative that will facilitate the
    formation of collaborative research teams capable of generating novel
    probes for molecular and cellular imaging. The overall goal is to
    establish programs to create complete tool sets for the detection of
    single molecule events in living cells and to generate new strategies
    for dramatically increasing the imaging resolution of dynamic cellular
    processes.
        Other areas of immediate interest to and supported by the NIBIB
    include the development of nanomedicine technologies, new tools for the
    study of proteomics and metabolic pathways, data and techniques for
    computational biology, and advances in bioinformatics. The NIBIB also
    strongly supports the NIH Roadmap theme on research teams of the future
    through sponsoring multidisciplinary research and interdisciplinary
    training.

                        MULTIDISCIPLINARY RESEARCH TEAMS

        The value of collaboration among disciplines and organizations has
    long been recognized as important for developing novel approaches to
    problems in biology and medicine, and for effectively translating
    research results to patient applications. We are pleased to report that
    there have already been some successful ``NIBIB partnerships'' between
    biomedical engineers and imaging scientists that have had significant
    impacts on healthcare. For example, an ongoing Bioengineering Research
    Partnership team is using fMRI to integrate information on the
    suspected location of brain seizures with information about surrounding
    brain function in order to improve surgical outcome and reduce or
    eliminate seizures. In one early phase study, surgery employing fMRI
    strategies was used to almost eliminate seizures in a patient who had
    been suffering from as many as 100 seizures daily.
        In conclusion, the NIBIB is dedicated to promoting the development
    of emerging technologies and interdisciplinary collaborations that
    drive healthcare advances. I would be pleased to respond to any
    questions that the Committee may have.
                                     ______

                  Prepared Statement of Dr. Jack Whitescarver

        Mr. Chairman and Members of the Committee, I am pleased to present
    the President's budget request for the AIDS research programs of the
    NIH for fiscal year 2005, a sum of $2,930,397,000 an increase of 5,000
    above the comparable fiscal year 2004 appropriation.
        The NIH represents the largest and most significant public
    investment in AIDS research in the world a comprehensive program of
    basic, clinical, and behavioral research on HIV infection and its
    associated opportunistic infections and malignancies. Perhaps no other
    disease so thoroughly transcends every area of clinical medicine and
    scientific investigation, crossing the boundaries of the NIH
    institutes. The Office of AIDS Research (OAR) plays a unique role at
    the NIH. OAR coordinates the scientific, budgetary, and policy elements
    of the NIH AIDS program, supported by nearly every Institute and
    Center; prepares an annual comprehensive trans-NIH plan and budget for
    all NIH-sponsored AIDS research; facilitates NIH involvement in
    international AIDS research activities; and identifies and facilitates
    scientific programs for multi-institute participation in priority areas
    of research.

                               WORLDWIDE PANDEMIC

        AIDS is the deadliest epidemic of our time. More than 22 million
    people have already died of AIDS--3 million of them in 2003 alone--the
    largest number ever. HIV has already infected more than 60 million
    people around the world, and AIDS has surpassed tuberculosis and
    malaria as the leading infectious cause of death worldwide.\1\
    ---------------------------------------------------------------------------
        \1\ ``Report on the Global HIV/AIDS Epidemic: July 2002,'' (UNAIDS/
    WHO, Geneva, Switzerland, 2002).
    ---------------------------------------------------------------------------
        The United Nations General Assembly's Declaration of Commitment on
    HIV/AIDS states ``. . . the global HIV/AIDS epidemic, through its
    devastating scale and impact, constitutes a global emergency and one of
    the most formidable challenges to human life and dignity, as well as to
    the effective enjoyment of human rights, which undermines social and
    economic development throughout the world and affects all levels of
    society national, community, family, and individual.'' \2\ According to
    a U.N. report, ``The epidemic has not only killed people; it has
    imposed a heavy burden on families, communities and economies. The
    misery and devastation already caused by HIV/AIDS is enormous, but it
    is likely that the future impact will be even greater . . . The HIV/
    AIDS epidemic has erased decades of progress in combating mortality and
    has seriously compromised the living conditions of current and future
    generations. The disease has such a staggering impact because it
    weakens and kills many people in their young adulthood, the most
    productive years for income generation and family caregiving. It
    destroys families, eliminating a whole generation crucial for the
    survival of the younger and older persons in society.'' The report also
    highlights ``the long-term damage accruing to human capital, as
    children's education, nutrition and health suffer directly and
    indirectly as a consequence of HIV/AIDS. The effects of lowered
    investment in the human capital of the younger generation will affect
    economic performance for decades to come, well beyond the timeframe of
    most economic analysis.'' \3\ Another dimension to the epidemic in
    Africa was cited in the New York Times: ``As a result of HIV, the
    worst-hit African countries have undergone a social breakdown that is
    now reaching a new level: African societies' capacity to resist famine
    is fast eroding. Hunger and disease have begun reinforcing each
    other.'' \4\
    ---------------------------------------------------------------------------
        \2\ ``The Impact of AIDS'' (Department of Economic and Social
    Affairs, United Nations, 2003).
        \3\ Ibid.
        \4\ A. de Waal, ``What AIDS Means in a Famine,'' New York Times,
    11/19/02.
    ---------------------------------------------------------------------------
        A recent CIA report estimated that by 2010, five countries of
    strategic importance to the United States--Nigeria, Ethiopia, Russia,
    India, and China--collectively will have the largest number of HIV/AIDS
    cases on earth.\5\ Foreign Affairs magazine stated: ``The spread of
    HIV/AIDS through Eurasia, in short, will assuredly qualify as a
    humanitarian tragedy--but it will be much more than that. The pandemic
    there stands to affect, and alter, the economic potential--and by
    extension, the military power--of the region's major states . . . Over
    the decades ahead, in other words, HIV/AIDS is set to be a factor in
    the very balance of power within Eurasia--and thus in the relationship
    between Eurasian states and the rest of the world.'' \6\ Dramatic
    increases in HIV infection also are occurring in Eastern Europe,
    Central Asia, Latin America, and the Caribbean.
    ---------------------------------------------------------------------------
        \5\ ``Intelligence Community Assessment: The Next Wave of HIV/AIDS:
    Nigeria, Ethiopia, Russia, India, and China.'' (CIA, 2002).
        \6\ ``The Future of AIDS,'' Foreign Affairs, November/December
    2002.
    ---------------------------------------------------------------------------
                               THE U.S. EPIDEMIC

        According to CDC, the decline in death rates observed in the late
    1990s, due largely to expanded use of new antiretroviral therapies
    (ART) that prevent progression of HIV infection to AIDS, has now
    leveled off; and AIDS incidence increased 2 percent in 2002 (over
    2001). This means that the overall epidemic is continuing to expand.\7\
    \8\ \9\ In addition, use of ART has now been associated with a series
    of side effects and long-term complications that may have a negative
    impact on mortality rates. HIV infection rates are continuing to climb
    among women, racial and ethnic minorities, young homosexual men,
    individuals with addictive disorders, and people over 50 years of
    age.\10\ The appearance of multi-drug resistant strains of HIV presents
    an additional serious public health concern.\11\ \12\ \13\ \14\ \15\
    According to CDC reports, approximately one quarter of the HIV-infected
    population in the United States also is infected with hepatitis C virus
    (HCV). HIV/HCV co-infection is found in 50 to 90 percent of injecting
    drug users (IDUs). HCV progresses more rapidly to liver damage in HIV-
    infected persons and may also impact the course and management of HIV
    infection, as HIV may change the natural history and treatment of
    HCV.\16\ This expanding and evolving U.S. epidemic presents new and
    complex scientific challenges.
    ---------------------------------------------------------------------------
        \7\ CDC Year-End HIV/AIDS Surveillance Report for 2002 (CDC, 2003).
        \8\ ``Centers for Disease Control and Prevention HIV Prevention
    Strategic Plan Through 2005,'' (CDC, 2001).
        \9\ ``HIV/AIDS Update--A Glance at the HIV Epidemic,'' (CDC, 2001).
        \10\ ``U.S. HIV and AIDS Cases Reported Through June 2000,'' CDC
    HIV/AIDS Surveillance Report, Vol. 12 (2002).
        \11\ N. Loder, Nature 407, 120 (2000).
        \12\ H. Salomon et al., AIDS 14, 17 (2000).
        \13\ Y.K. Chow et al., Nature 361, 650 (1993).
        \14\ M. Waldholz, ``Drug Resistant HIV Becomes More Widespread,''
    Wall Street Journal, 2/5/99.
        \15\ ``World Health Report on Infectious Diseases: Overcoming
    Antimicrobial Resistance,'' (WHO, Geneva, 2000).
        \16\ ``Frequently Asked Questions and Answers About Coinfection
    with HIV and Hepatitis C Virus'' (CDC, 2002).
    ---------------------------------------------------------------------------
                  COMPREHENSIVE AIDS RESEARCH PLAN AND BUDGET

        To address these compelling scientific questions, the OAR develops
    an annual comprehensive trans-NIH AIDS research plan and budget, based
    on the scientific priorities and opportunities that will lead to better
    therapies and prevention strategies for HIV infection and AIDS. The
    planning process is inclusive and collaborative, involving the NIH
    Institutes, as well as eminent non-government experts from academia,
    industry, foundations, and AIDS community representatives. The Plan
    serves as the framework for developing the annual AIDS research budget
    for each Institute and Center, for determining the use of AIDS-
    designated dollars, and for tracking and monitoring those expenditures.
    The planning process also serves to monitor and assess scientific
    progress on an annual basis.
        The Plan establishes the NIH AIDS scientific agenda in the areas
    of: Natural History and Epidemiology; Etiology and Pathogenesis;
    Therapeutics; Vaccines; and Behavioral and Social Science. In addition,
    the plan addresses the cross-cutting areas of: Microbicides; Racial and
    Ethnic Minorities; Women and Girls; Prevention Science; International
    Research; Training, Infrastructure, and Capacity Building; and
    Information Dissemination. In consultation with the Director of NIH,
    the OAR determines the total annual AIDS research budget. Within that
    total, the OAR establishes the AIDS research budgets for each NIH
    Institute and Center, in accordance with the priorities and objectives
    of the Plan, at each step of the budget development process up to the
    Conference Committee. To accomplish this, OAR consults regularly with
    the Institute and Center Directors. This process allows the OAR to
    ensure that NIH AIDS research funds will be provided to the most
    compelling scientific opportunities, rather than a distribution based
    solely on a formula.
        OAR plays a crucial role in identifying scientific areas that
    require focused attention and facilitating multi-Institute activities
    to address those needs. OAR fosters this research through a number of
    mechanisms, such as designating funds and supplements to jump-start or
    pilot program areas, sponsoring workshops or conferences to highlight a
    particular research topic, and sponsoring reviews or evaluations of
    research program areas to identify research needs.
        The overarching priorities that continue to frame the NIH AIDS
    research agenda are: prevention research to reduce HIV transmission,
    including development of vaccines, microbicides, and behavioral
    interventions; therapeutics research to develop simpler, less toxic,
    and cheaper drugs and drug regimens to treat HIV infection and its
    associated illnesses, malignancies, and other complications;
    international research, particularly to address the critical needs in
    developing countries; and research targeting the disproportionate
    impact of AIDS on minority populations in the United States. All of
    these efforts require a strong foundation of basic science, the bedrock
    of our research endeavor.

                        VACCINES AND PREVENTION RESEARCH

        Vaccine research remains a critical priority. As a result of
    increased NIH funding, many new approaches to HIV vaccines are being
    pursued. Although production of candidate vaccines for clinical study
    has proceeded slowly, approximately 14 new candidate vaccines will
    enter Phase I trials in the next 2 years. Several new combinations of
    products, which are expected to provide better immune responses, also
    will be tested in Phase I or II trials. The Dale and Betty Bumpers
    Vaccine Research Center, located on the NIH campus, recently launched
    the first Phase I clinical trial of a multi-clade, multi-gene vaccine
    candidate. The development of vaccine candidates also requires
    sufficient quantities of non-human primates for preclinical testing.
        In addition to vaccines, our biomedical prevention research
    priorities include the development topical microbicides; strategies to
    prevent mother-to-child transmission, including a better understanding
    of risk associated with breast-feeding; and management of sexually
    transmitted diseases (STDs). NIH also supports behavioral research
    strategies, including interventions related to drug and alcohol use.
    Efforts continue to identify the most appropriate intervention
    strategies for different populations and sub-epidemics in the United
    States and around the world.

                    NEW CHALLENGES IN THERAPEUTICS RESEARCH

        While multiple ART drug combinations continue to successfully
    reduce viral load and restore immune responses in many HIV-infected
    individuals, these regimens also can result in serious toxicities and
    side effects, single- and multiple drug-resistance, and other
    complications that make them unacceptable for some individuals. These
    side effects and complications appear to be increasing as HIV-infected
    individuals continue on drug regimens. More deaths occurring from liver
    failure, kidney disease, and cardiovascular complications are being
    observed in this patient population. NIH-sponsored research efforts
    continue to develop better antiretroviral drugs and treatment regimens
    that demonstrate less toxicity, activity in viral and cellular
    reservoirs, reduced development of drug resistant virus, improved
    pharmacodynamics and pharmacokinetics, easier compliance, and lower
    cost.
        While the incidence of certain opportunistic infections (OIs) and
    malignancies has decreased with the advent of ART, the number of cases
    of TB, multiple drug resistant TB, and other coinfections such as
    Hepatitis B virus and Hepatitis C virus has increased. The development
    of practical and affordable treatment regimens against HIV coinfections
    and endemic diseases in developed and developing nations is an NIH
    priority.

                             INTERNATIONAL RESEARCH

        NIH bears a unique responsibility to address the urgency of the
    global AIDS epidemic. To meet that need, the OAR established an
    initiative and strategic plan for global research on HIV/AIDS and has
    significantly increased research efforts in the past several years to
    benefit resource- and infrastructure-poor nations. NIH supports a
    growing portfolio of research conducted in collaboration with
    investigators in developing countries. Results of this research benefit
    the people in the country where the research is conducted, as well as
    people affected by HIV/AIDS worldwide. Critical to the success of these
    international studies are foreign scientists who are full and equal
    partners in the design and conduct of collaborative studies. To that
    end, NIH also supports international training programs and initiatives
    that help build infrastructure and laboratory capacity in developing
    countries where the research is conducted.

                              WOMEN AND MINORITIES

        Women experience HIV/AIDS differently from men. NIH research has
    demonstrated that women progress to AIDS at lower viral load levels and
    higher CD4 counts than men. Women also experience different clinical
    manifestations and complications of HIV disease. These findings may
    have implications for care and treatment of HIV-infected women,
    particularly with ART. There are many research questions that remain
    unanswered about specific characteristics of women and girls that might
    play a role in transmission, acquisition, or resistance to HIV
    infection during different stages of the life course.
        In many U.S. urban centers, HIV seroprevalence rates mimic those
    found in some developing nations. These findings, along with the
    resurgence of STDs and associated high-risk behaviors, demonstrate the
    need for comprehensive strategies to decrease HIV transmission in
    affected vulnerable populations, and improve treatment options and
    treatment outcomes. OAR is directing increased resources toward
    research to develop new interventions that will have significant impact
    on these groups. These include interventions that address the 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
    will continue to ensure the participation of minorities in AIDS
    clinical trials, as well as in natural history, epidemiologic, and
    prevention studies.

                                    SUMMARY

        The human and economic toll of the AIDS pandemic is profound,
    demanding a unique response that is complex, comprehensive, multi-
    disciplinary, and global. The NIH role in this response is fundamental
    and unprecedented. The nation's investment in AIDS research is reaping
    even greater dividends, as AIDS-related research is unraveling the
    mysteries surrounding many other infectious, malignant, neurologic,
    autoimmune, and metabolic diseases. The authorities of the OAR allow
    NIH to pursue a united research front against the global AIDS epidemic.
    We are deeply grateful for the continued support the Administration and
    this Committee have provided to our efforts.
                                     ______

                  Prepared Statement of Dr. Francis S. Collins

        Mr. Chairman, I am pleased to present the President's budget
    request for the National Human Genome Research Institute for fiscal
    year 2005, a sum of $492,670,000, which reflects an increase of
    $13,842,000 over the fiscal year 2004 Final Conference appropriation.
        Following the completion of the Human Genome Project last year, the
    National Human Genome Research Institute (NHGRI) of the National
    Institutes of Health announced an ambitious plan for applying genomics
    to human health benefits. A Vision for the Future of Genomics Research,
    the outcome of almost two years of intense discussions with over 600
    scientists and members of the public, has three major areas of focus:
    Genomics to Biology, Genomics to Health, and Genomics to Society.
    Several ambitious projects are already underway to help achieve this
    vision including the International Haplotype (HapMap) Project, the
    Encyclopedia of DNA Elements (ENCODE), the NIH Roadmap initiative on
    Molecular Libraries, and a new Ethical, Legal and Social Implications
    (ELSI) Center initiative. As we enter the genomic era, the continued
    support of biomedical research in this area is more vital than ever.

                           ONGOING NHGRI INITIATIVES

    International HapMap Project
        To study genetic variation more effectively across the human
    genome, the NHGRI and a team of partners has launched the International
    HapMap Project. The goal of the project is to determine the common
    patterns of DNA sequence variation in the human genome, and to make
    this information freely available in the public domain. This
    international consortium is developing a map of these patterns across
    the genome by determining the genotypes of one million or more sequence
    variants in DNA samples from populations with ancestry from Africa,
    Asia, and Europe. When complete, the HapMap will enable the discovery
    of sequence variants that affect common disease, the development of
    diagnostic tools, and the ability to choose targets for therapeutic
    intervention. Detailed information about the HapMap project was
    published in a landmark article in Nature, and updated details can be
    found on the web at www.hapmap.org.

    Comparative Genomics to Understand the Human Genome
        One of the most powerful approaches for unlocking the secrets of
    the human genome is comparative genomics. While the completed sequence
    of the human genome represents a milestone of historic proportions, a
    daunting challenge that still lies ahead is to interpret its biological
    meaning and function. Recently sequenced genomes of the mouse, rat, and
    a wide variety of other organisms--from yeast to chimpanzees--prove
    that the genomes of other species are amongst the most powerful tools
    in advancing understanding of the human genome. The current NHGRI-
    supported, large-scale sequencing centers have built a prodigious
    capacity for, and expertise in, sequencing entire genomes. The combined
    capacity of these centers is expected to yield the equivalent of about
    20 additional draft vertebrate genomes in just the next three years.
    These additional species sequences will provide exciting new insights
    into the function of the human genome, and will assist genome
    scientists in translating the basic findings of the Human Genome
    Project into tangible applications, including the diagnosis,
    prevention, and treatment of disease.

    ENCODE--ENCyclopedia Of DNA Elements
        To understand the meaning of the human instruction book, the
    genome, the identities and precise locations of all functional elements
    must be determined. Thus, the NHGRI has launched the ENCyclopedia Of
    DNA Elements (ENCODE) project to identify these elements
    comprehensively. The ENCODE project seeks to characterize the tools
    needed for exploring genomic sequence, improve those tools when
    necessary, and define a clear path for the determination of all of the
    functional elements in the entire human genome. On October 9, 2003, the
    NHGRI announced the first ENCODE grants in a three-year, $36 million
    project (www.genome.gov). ENCODE begins as a pilot effort to evaluate
    methods for the exhaustive identification and verification of
    functional sequence elements in a carefully selected 30 million base
    pairs, or about one percent, of human genomic DNA. This will require
    access to information, resources, ideas, expertise, and technology
    beyond the capabilities of any single group. Therefore, a consortium of
    investigators with diverse backgrounds and expertise will work
    cooperatively to carry out this project to: (1) evaluate rigorously the
    relative merits of a varied set of computational and experimental
    techniques, technologies, and strategies for identifying the functional
    elements in human genomic sequence, and (2) test the capabilities of
    such methods to scale up efficiently to allow, ultimately, analysis of
    all the functional elements encoded in the entire human genome
    sequence.

    Centers Of Excellence In Genomic Science (CEGS)
        The NHGRI Centers Of Excellence In Genomic Science (CEGS) program
    has been in place for four years. This program is a centerpiece of the
    Institute's effort to stimulate new interdisciplinary approaches to
    genomic research and technology development. A total of about 10 CEGS
    grants are ultimately expected to be funded. These will generally be
    five-year awards of up to $3 million per year. Seven awards have been
    made to date; each involves multiple investigators and disciplines, and
    several cut across departments and institutions. A grantee meeting in
    October 2003 stimulated new collaborations and identified ways to share
    CEGS grant data and resources with the larger research community.
    Clinical Research Activities in the NHGRI Intramural Program
        Research efforts of NHGRI Division of Intramural Research (DIR)
    investigators are aimed at deciphering the genetic contributions to
    common disorders, to provide a better understanding of diseases such as
    cancer, diabetes, and heart disease, as well as to a number of less
    common but equally debilitating afflictions. DIR investigators have
    been at the forefront of scientific innovation, developing a variety of
    research approaches that accelerate the understanding of the molecular
    basis of disease. These include the development of DNA microarray
    technologies for large-scale molecular analyses, innovative computer
    software to study fundamental biological problems, animal models
    critical to the study of human inherited disorders, and the clinical
    testing of new therapeutic approaches for genetic disease. Three
    examples of gene discoveries within the past year include the gene
    responsible for Hutchinson-Gilford progeria syndrome, the disease
    causative gene for Charcot-Marie-Tooth disease type 2D, and a gene
    variant that contributes to the risk of type 2 diabetes. These and
    other advances should ultimately lead to improved diagnostic,
    prevention, and treatment strategies having a direct impact on human
    health.

                                NEW INITIATIVES

        The NHGRI is very enthusiastic about the initiatives included in
    the NIH Roadmap and is deeply involved in implementation plans for
    several of the projects embodied in the ``New Pathways to Discovery''
    theme.

    Molecular Libraries
        As part of its Vision for the Future of Genomics Research, and in
    partnership with many other NIH Institutes as part of NIH's new Roadmap
    for Medical Research, the NHGRI is taking a lead role in providing
    access to high throughput screens for small organic molecules to public
    sector researchers. These small molecules can be used as chemical
    probes to study cellular pathways in great depth and will broadly
    enable public and private biomedical research into basic biology and
    accelerate the validation of new therapeutic targets, and thus the
    discovery of new drugs. For this effort to provide maximal benefits,
    the library of small molecules must contain a sufficient number of
    compounds. To build such a library, a network of six national centers
    will establish a common collection of 500,000 or more chemically
    diverse small molecules, of both known and unknown activities.
    Investigators who develop assays suitable for high throughput screening
    will apply for access to these centers. After peer review, suitable
    assays will be run through a screen of 500,000 or more compounds, and
    the positives subjected to a first pass of chemical optimization to
    generate useful compounds. We anticipate that this new resource will
    catalyze a genuine paradigm shift, because it will give academic
    investigators a new and powerful research tool not previously at their
    disposal.

    $1,000 Genome Sequence
        Current sequencing costs are too high to collect the quantity and
    quality of soome sequences optimal for research and clinical
    applications. Completely sequencing the genomes of many individuals
    would greatly advance understanding of the role of DNA sequence
    variation in human health, but using DNA sequence information for care
    of individuals is not possible at current costs. Thus, NHGRI has
    launched an aggressive program to develop technologies to lower the
    cost of DNA sequencing dramatically. The goal for the first five years
    of this program is to develop the capability to produce a high quality
    draft sequence for a large, complex (e.g., mammalian) genome for
    $100,000. The goal of the second phase, which is estimated to take ten
    years, is producing a genome sequence for $1,000. Once achieved, a
    $1,000 genome analysis would be of great use to correlate DNA
    information with health outcomes. This includes determining genes in
    each individual that predispose that individual to specific diseases,
    and assessing which drugs are likely to elicit adverse reactions in
    each individual, so that drugs can be used more effectively and with
    fewer side effects.

    Centers for Excellence in ELSI Research
        The NHGRI Ethical Legal and Social Implications (ELSI) research
    program recently released a Request for Applications inviting proposals
    for the development of Centers of Excellence in ELSI Research (CEER).
    The CEER program is designed to support the development of groups that
    will pursue research questions best approached through intensive and
    extended collaboration among investigators from multiple disciplines,
    using diverse methodologies. CEER investigators are encouraged to
    consider new ways to explore these questions, design innovative and
    efficient research projects, propose and disseminate health or social
    policy options based on Center research, and, when feasible, facilitate
    policy development pertinent to a specific issue. Center applicants are
    particularly encouraged to identify cutting edge research topics and
    approaches that may lead to high payoff solutions to important ELSI
    problems.

    Intramural Social and Behavioral Research Branch
        The NHGRI has formed a new Social and Behavioral Genetics Research
    Branch within its intramural research program. The main focus of the
    Branch is to conduct research on the social and behavioral aspects of
    translating genomic discoveries into improved health. The Branch will
    also: (1) study innovative ways of applying genetic discoveries to
    promote health and well-being; (2) apply social, behavioral, and
    communication theories to understand how to communicate genetic risk
    effectively; (3) develop and refine evidence-based methods of
    communicating genetic risk to individuals, families, communities, and
    populations; (4) seek to understand how social factors influence
    genetic discoveries and research; and (5) investigate the ethical and
    public policy implications of genetic research and the use of genetics
    in clinical practice.

                       OTHER AREAS OF INTEREST FOR NHGRI

    Genetic Discrimination
        The NHGRI remains concerned about the risk of genetic
    discrimination and supports the President's call for federal
    legislation. Many Americans are worried that insurers and employers may
    use genetic information to deny, limit, or cancel their health
    insurance or to discriminate against them in the workplace. A total of
    41 States have enacted legislation on discrimination in health
    insurance and 31 have enacted legislation on workplace genetic
    discrimination. However, only comprehensive federal legislation can
    guarantee everyone in the United States protection from genetic
    discrimination. Last October, the full U.S. Senate voted unanimously
    (95-0) in favor of the ``Genetic Information Nondiscrimination Act of
    2003'' (S. 1053), which would address this problem. It is hoped that
    the House will soon take similar steps.

    Intellectual Property Rights in Genetics and Genomics Research
        NHGRI has long worked on issues of intellectual property related to
    genetic and genomic data. The NHGRI ELSI program plans soon to issue a
    new initiative to encourage studies of the role of intellectual
    property rights in genetics and genomics research, as well as the
    impact of exclusivity on progress in these fields. The initiative will
    support legal, economic, political science, and statistical analyses
    and empirical investigations of theories and practices of rights
    holders, stakeholders, and researchers in genetics and genomics
    research and development, with the specific goal of helping build the
    research base necessary to inform the rational development of future
    policy options regarding intellectual property in genetics, and
    genomics.
        The NHGRI, with several other NIH Institutes, has recently provided
    funds for a National Academy of Sciences' study, ``Intellectual
    Property in Genomic and Protein Research and Innovation.'' This 18-
    month study, involving experts from law, public policy and genomics,
    will address such important questions as: What is the impact of
    intellectual property and licensing on genetic and proteomic research?
    What policy options should be considered in this area? How have other
    regions of the world addressed these issues? It is hoped that this
    study will provide insights on how to address the thorny issues
    surrounding the interface of intellectual property, biomedical
    research, and patient care.

    Direct-to-Consumer Marketing of Genetic Tests
        Marketing of products or services that promise to provide consumers
    with genetic insights into personal health has proliferated
    dramatically in recent years. NHGRI's intramural Division of Bioethics
    has systematically studied this issue. So far, researchers have found
    that many direct-to-consumer (DTC) advertisements exaggerate the
    scientific basis of claims made and/or fail to communicate effectively
    the current limitations of the specific genetic knowledge discussed. In
    particular, the Internet has provided a powerful medium for the
    construction of ``informational'' resources through which DNA analysis
    is often linked to a claim to individualize consumer profiles for
    specific products available through the website. Additionally, the
    first example of a multi-media DTC advertising campaign for a genetic
    test, the BRCA1/2 test, was piloted in two metropolitan areas in the
    last year. The NHGRI recently held a workshop to assess DTC marketing
    of genetic tests, and considered the scope of the practice and possible
    policy options. The NHGRI will work with the Secretary's Advisory
    Committee on Genetics Health and Society on this issue.

    Trans-NIH Obesity Initiative
        The NHGRI Deputy Director represents the Institute on the trans-NIH
    obesity working group. We believe that this initiative is vitally
    important, and that the genomic tools produced by the Human Genome
    Project can be of considerable utility in discerning the role of genes
    and environment in causing obesity, and in predicting which obese
    individuals will develop which diseases.

                                   CONCLUSION

        With the completion of the human genome sequence, we have fully
    entered the genomic era. The NHGRI has now spearheaded many specific
    and innovative initiatives to understand how genetics affects human
    health, the ultimate motivation for the Human Genome Project. The most
    interesting and important applications of genomics lie not behind us,
    but ahead of us. Continued investment by the Congress in genetic/
    genomic research is vital to our efforts to enhance the health of all.
                                     ______

                   Prepared Statement of Dr. Richard J. Hodes

        Mr. Chairman and Members of the Committee: The NIA is requesting an
    fiscal year 2005 budget of $1,055,666,000, an increase of $31,068,000
    or 3 percent over the comparable fiscal year 2004 appropriation.
        Thank you for this opportunity to participate in today's hearing. I
    am Dr. Richard Hodes, Director of the NIA, and I am pleased to be here
    today to tell you about our progress making and communicating
    scientific discoveries that will improve the health and well-being of
    older Americans.
        There are today approximately 35 million Americans ages 65 and
    over, according to the U.S. Bureau of the Census. Thanks to
    improvements in health care, nutrition, and the overall standard of
    living, these men and women are more likely than ever before to be
    healthy, vigorous, and productive: Studies confirm that disability
    among America's elders has declined steadily over the past decade. More
    older Americans are able to participate in ``instrumental activities of
    daily living,'' such as performing household chores and managing their
    own medications, while fewer are experiencing limitations in basic
    physical tasks such as walking or climbing stairs.
        At the same time, diseases of aging continue to affect many older
    men and women, seriously compromising the quality of their lives. For
    example, more than half of all Americans over age 65 show evidence of
    osteoarthritis in at least one joint. Over half of Americans over age
    50 have osteoporosis or low bone mass. Cardiovascular disease, cancer,
    and diabetes remain common among older Americans. And as many as 4.5
    million Americans suffer from Alzheimer's disease (AD), the most common
    cause of dementia among older persons.
        The mission of the National Institute on Aging is to improve the
    health and well-being of older Americans through research. In support
    of this mission, the Institute conducts and supports an extensive
    program of research on all aspects of aging, from the basic cellular
    and molecular changes that occur as we age, to the prevention and
    treatment of common age-related conditions, to the behavioral and
    social aspects of growing older, including the demographic and economic
    implications of an aging society. In addition, the NIA is the lead
    federal agency on Alzheimer's disease research; our activities in that
    area encompass prevention, detection, clinical trials, and caregiver
    issues. Finally, our education and outreach programs provide vital
    information to older people across the United States on a wide variety
    of topics, including living with chronic conditions such as arthritis
    or diabetes, caring for a loved one with Alzheimer's disease, and
    maintaining optimal health through exercise.
        The NIA works to rapidly translate research findings into practical
    interventions and information that will benefit older Americans. This
    may involve enhancing our methods of communicating important research
    findings to physicians or the public; creating opportunities for
    patients to benefit from groundbreaking research through participation
    in clinical trials; or even recognizing the potential of a very basic
    finding in a mouse, a worm, or a molecule to eventually have a powerful
    impact on the public health.
        For example, recent findings in C. elegans, a tiny worm that is
    frequently used for genetic studies, are providing important insights
    about fat regulation and storage that may lead to improved
    understanding of overweight and obesity in humans. NIH-supported
    researchers used RNA interference (RNAi), a technique in which genes
    are inactivated one at a time to determine their function, to screen
    the worm's genome and found some 417 genes involved with fat regulation
    and storage. Many of the genes they found have human counterparts, a
    number of which had not been previously implicated in the regulation of
    fat storage. Overweight and obesity are widespread in the United States
    and are associated with an array of health problems, including heart
    disease, stroke, osteoarthritis, adult-onset diabetes, and certain
    types of cancer; the genes identified in C. elegans may ultimately
    suggest new targets for treating human obesity and its associated
    diseases.
        Another recent basic discovery, this one in mice, may have profound
    implications on the field of reproductive biology. Since the 1950s,
    scientists have believed that women are born with all the oocytes
    (eggs) they will ever have, and that these eggs die off as a woman
    ages, with fertility diminishing and, at menopause, disappearing as a
    result. However, NIH-supported researchers recently found that oocyte-
    containing follicles continue to develop in the ovaries of adult mice.
    If this finding is confirmed--and extended to humans--it could lead not
    only to new treatments for premature ovarian failure (which affects
    some 250,000 American women under age 40, according to the National
    Institute of Child Health and Human Development), but also to
    interventions to delay menopause and extend fertility.
        NIA-supported investigators in all fifty states are conducting
    research that is changing the way we prevent, diagnose, and treat the
    diseases of aging. NIA also supports networks of centers that focus on
    specific topics, including demography and the basic biology of aging.
    There are currently 29 NIA-supported Alzheimer's Disease Centers
    (ADCs), at which investigators are working to translate research
    advances into improved care and diagnosis for AD patients while
    focusing on the program's long-term goal--finding ways to treat and
    possibly prevent AD. Many ADCs have satellite facilities that offer
    diagnostic and treatment services and collect research data in
    underserved, rural, and minority communities. Another type of Center,
    the Edward R. Roybal Centers for Research on Applied Gerontology,
    translates behavioral and social research findings into practical
    outcomes for older adults. Each of the six Roybal Centers addresses one
    or more central themes (e.g., cognitive influences on physician/patient
    interaction affecting medical compliance; safe driving behavior; social
    role adjustment upon retirement).
        The NIA also supports a variety of clinical trials, frequently in
    collaboration with one or more NIH Institutes or other organizations.
    For example, NIA is currently supporting 25 AD clinical trials, seven
    of which are large-scale prevention studies. These trials are testing
    agents such as anti-inflammatory drugs and anti-oxidants for their
    effects on slowing progress of the disease, delaying AD's onset, or
    preventing the disease altogether. Other intervention trials are
    assessing the effects of various compounds on the behavioral symptoms
    (agitation, aggression, and sleep disorders) of people with AD. In
    addition to AD, NIA supports clinical trials for a number of other
    conditions, including cardiovascular disease, Parkinson's disease, and
    certain types of cancer.
        A major clinical trial in which NIA-supported researchers took part
    is the Diabetes Prevention Program, a multi-institutional study that
    was initiated by the National Institute on Diabetes and Digestive and
    Kidney Diseases and was designed to identify interventions that could
    prevent or delay the development of type 2 diabetes. The researchers
    found that people who are at high risk for diabetes can sharply reduce
    their risk by adopting a low-fat diet and moderate exercise regimen.
    This effect was most pronounced among study participants age 60 and
    over. Treatment with the drug metformin (Glucophage) also reduced
    diabetes risk among study participants, but for unknown reasons was
    less effective among older participants. With other participating NIH
    Institutes, we are continuing to follow the study participants to
    determine long-term effectiveness of these interventions.
        The NIA also has a number of ongoing or planned special initiatives
    on diverse research topics. These include:
        Health Disparities.--The NIA's Healthy Aging in Neighborhoods of
    Diversity Across the Lifespan (HANDLS) project is a community-based
    study of health disparities among different racial, ethnic, and
    socioeconomic groups in Baltimore. The purpose of HANDLS is to
    disentangle the effects of race and socioeconomic status on risk
    factors for morbidity and mortality, incidence and progression of pre-
    clinical disease, development and persistence of health disparities,
    longitudinal health status, and health risks. The pilot phase of the
    study was completed in December 2001, and the full-scope study is now
    being planned for implementation in 2004-2005. Unique to the HANDLS
    study is the use of two fully-equipped mobile research laboratories
    that enable investigators to collect data directly in the neighborhoods
    under study, establishing links with the community and increasing both
    the interest of potential participants and the retention rate.
        Neuroimaging.--The NIA is developing an Alzheimer's Disease
    Neuroimaging Initiative, a longitudinal, prospective, natural history
    study of normal aging, mild cognitive impairment, and early AD to
    evaluate neuroimaging techniques such as magnetic resonance imaging
    (MRI) and positron emission tomography (PET). The study objectives are
    to:
      --Identify the best markers for early diagnosis of AD
      --Identify markers for following disease progression and monitoring
            treatment response
      --Develop surrogate endpoints for clinical trials
      --Decrease time and expense of drug development
      --Establish methods for the collection, processing, and distribution
            of neuroimaging data in conjunction with other biological,
            clinical, and neuropsychological data
        The initiative is planned as a partnership among the NIA/NIH,
    academic investigators, the pharmaceutical and imaging equipment
    industries, the Food and Drug Administration, the Centers for Medicare
    and Medicaid Services, and the NIH Foundation, with participation from
    the Alzheimer's Association and the Institute for the Study of Aging.
    The clinical, imaging, and biological data and samples will be made
    available, with appropriate safeguards to ensure participant privacy,
    to scientific investigators in the academic and industrial research
    communities.
        Testosterone replacement in men.--Levels of circulating
    testosterone decline as men age, and this decline may be related to
    decrements in physical and cognitive functioning--for example, recent
    research suggests that older men with lower levels of free, or unbound,
    testosterone circulating in their bloodstreams could be at increased
    risk of developing Alzheimer's disease (AD). Increasingly, middle-aged
    and older men are turning to testosterone replacement therapy (TRT) to
    forestall these symptoms: In 2002, over 800,000 men received some form
    of testosterone replacement. However, as with the use of hormone
    replacement therapy among women prior to the release of the Women's
    Health Initiative results demonstrating serious HRT-related risks, men
    are using TRT in the absence of clear scientific data supporting its
    use. A multi-disciplinary panel, led by the Institute of Medicine and
    supported by the NIA and the National Cancer Institute, recently
    evaluated the pros and cons of conducting clinical trials of
    testosterone replacement therapy in older men to answer many of the
    lingering questions about the effects of this hormone in the aging
    body. The NIA is considering the IOM recommendations very carefully and
    will act on the recommendations to begin clinical trials to determine
    the efficacy of testosterone in treating symptomatic older men with low
    testosterone levels.
        Genetics.--The NIA has established a new AD Genetics Initiative, a
    program to accelerate the pace of AD genetics research by creating a
    large repository of DNA and cell lines from families with multiple AD
    cases. The goal of this initiative is to develop strategies for
    identifying the remaining late-onset AD (LOAD) risk factor genes,
    associated environmental factors, and the interactions of genes and the
    environment. The NIA's AD Genetics Initiative will intensify sample
    collection and encourage data sharing by providing access to the
    repository to qualified investigators. To date, several well-integrated
    components of the Genetics Initiative have been launched. Mechanisms to
    efficiently identify and share large numbers of samples for AD genetic
    analysis have been developed through the recently-enlarged National
    Cell Repository for AD (NCRAD), and eighteen of the NIA's Alzheimer's
    Disease Centers have received supplemental funding to recruit new
    family members participation. Uniform standards for sample collection
    have also been developed. As of late January, over 200 families have
    been evaluated and enrolled, and over 800 blood samples have been
    logged at NCRAD. A clinical task force has been established which is
    helping to determine the correct phenotypic data to be included with
    the biological samples. A major goal is the long-term follow-up of
    individuals participating in the study.
        In order to publicize the initiative, the NIA Office of
    Communications and Public Liaison, together with its Alzheimer's
    Disease Education and Referral Center, Columbia University, and NCRAD,
    partnered with the Alzheimer's Association to conduct focus groups and
    develop publicity materials to help recruiting efforts. These publicity
    materials, including a workbook, CD ROM, fact sheet, and brochure were
    distributed at the a recent meeting of the ADCs and will now be sent to
    ADCs and Alzheimer's Association chapters to help recruiting efforts.
        Longevity.--The NIA has formed a Longevity Consortium to help
    identify and understand genetic and other factors that predispose to
    human longevity or protect against multiple age-related conditions, a
    major goal in aging research. The Consortium is an innovative system
    for expeditious generation, review, and funding of new projects as
    opportunities arise, and includes epidemiologists, geneticists,
    population biologists, statisticians, and others with an interest in
    the genetic and molecular basis for longevity. Participants can draw on
    the study populations of 15 of the largest human aging studies,
    including the Cardiovascular Health Study, the Women's Health
    Initiative, Health ABC, the Study of Osteoporotic Fractures, the
    Rotterdam Study, the Honolulu Heart Study, and the New England
    Centenarian Study. Altogether, Consortium researchers will have access
    to data on some 200,000 study subjects.
        Demography.--As the percentage of Americans over age 65 increases,
    profound societal changes will likely occur. NIA-supported researchers
    are exploring the changing demographic, social, and economic
    characteristics of the older population. Research embraces topics such
    as: trends in the age-structure of populations; changes in levels of
    disease and disability; economic costs of disability; cost-
    effectiveness of interventions; migration and geographic concentrations
    of the elderly; decision-making about retirement; pensions and savings;
    the relationship between health and economic status; and health
    disparities by gender and race. The results of this research often have
    important implications for public policy. Such research often involves
    large datasets that are frequently co-sponsored by NIA and other
    government agencies in the United States and overseas. These include:
      --Health and Retirement Study, a biennial survey of more than 22,000
            Americans over age 50, which provides data for researchers,
            policy analysts, and program planners who are making major
            policy decisions that affect retirement, health insurance,
            saving and economic well-being.
      --National Long-Term Care Study, which explores trends in the
            prevalence of self-rated old age disability and physical,
            cognitive, and sensory limitations.
      --Longitudinal Study of Aging, a long-term study in which the NIA
            participates with the National Center for Health Statistics.
      --Panel Study of Income Dynamics, begun in 1968 and conducted by the
            National Science Foundation, is a nationally representative
            longitudinal study that collects information on U.S.
            households. Notably, the PSID contains information on
            approximately 5,000 heads of households and spouses who are
            baby boomers (born 1945-1964)--a cohort not yet represented in
            the Health and Retirement Study (HRS). Continued data from the
            PSID will shed light on individual household saving behavior of
            the baby boom generation and its neighboring age cohorts.
        Health Communication.--Communication of research-based health
    information is another key activity of the NIA, and the Institute uses
    both traditional and innovative means to disseminate information. In
    2003, the Pew Internet and American Life survey found that 22 percent
    of Americans age 65 or older have access to the Internet, and that 58
    percent of these ``wired seniors'' had used the Internet to look for
    information about a specific disease. However, NIA-supported research
    has demonstrated that with age come changes in cognition (such as
    working memory, perceptual speed, text comprehension) and vision
    (including loss of ability to detect fine details, less light reaching
    the retina, and loss of contrast sensitivity) that could hinder the
    older person's ability to use the Internet easily and effectively. To
    respond to the unique needs of Internet users over 60, the NIH launched
    NIHSeniorHealth.gov on October 23, 2003. Developed by the NIA and the
    National Library of Medicine, and featuring content developed in
    collaboration with several other NIH Institutes, this web site is easy
    for older adults to read, understand, remember, and navigate. For
    example, the site features large print and short, easy-to-read segments
    of information repeated in a variety of formats--such as open-captioned
    videos and short quizzes--to increase the likelihood it will be
    remembered. Consistent page layout and prompts help users move from one
    place to another on the site without feeling lost or overwhelmed. The
    site also has a ``talking'' function, which allows users the option of
    reading the text or listening to it as it is read to them.
        The risk of many diseases increases with age, so the site focuses
    on health topics or specific diseases that are of particular interest
    to older people, including Alzheimer's disease, Alzheimer's disease
    caregiving, arthritis, balance problems, breast cancer, colorectal
    cancer, exercise for older adults, hearing loss, lung cancer, and
    prostate cancer. Upcoming and planned topics include complementary and
    alternative medicine, diabetes, falls, shingles, vision changes, and
    others. Each topic provides general background information, quizzes,
    frequently asked questions (FAQs), open-captioned video clips,
    transcripts for the videos, and photos and illustrations with captions.
    From its launch in October 2003 through late January,
    NIHSeniorHealth.gov has received over a million page views and been
    visited by nearly 118,000 unique visitors.
        The NIA also maintains a large selection of lay-language Age Pages,
    which cover an array of topics relevant to older people and include
    information on a number of diseases and conditions, suggestions for
    coping with these conditions, and information on other resources. Most
    of the Age Pages have been translated into Spanish.
        At a March 2002 hearing of this Committee entitled ``Bench to
    Bedside,'' Chairman Regula recommended that NIA and the Administration
    on Aging (AoA) work together to disseminate research-based consumer
    education to the thousands of seniors who participate in the Meals-on-
    Wheels program across the Nation. In response, NIA staff, with the
    participation of AoA, have conducted focus groups of program managers
    from the Meals on Wheels Association of America (MOWAA) to determine
    the types of information of greatest interest to MOW's clients, as well
    as the best ways to deliver such information (e.g., meal tray liners
    printed with key health messages, articles for MOWAA newsletters, or
    specially crafted Age Pages.) Based on focus group feedback, NIA is
    currently revising Age Pages on diabetes, alcohol, and depression;
    these materials will be tested at the upcoming MOWAA meeting in
    September 2004, and we anticipate that distribution to MOWAA clients
    will begin shortly thereafter.
        The Alzheimer's Disease Education and Referral (ADEAR) Center has
    been compiling and disseminating information about AD for health
    professionals, persons with AD and their families, and the public since
    1990. NIA is also working to translate research findings into action
    through its highly successful campaign to encourage older people to
    exercise. In the last four years, NIA has distributed over 611,000
    copies of its exercise guide and 93,000 copies of its companion video
    to the public. A Spanish-language version of the guide was published in
    January 2002, and over 33,500 copies have been distributed to date. The
    NIA's efforts to promote exercise and strength training are conducted
    in support of the President's ``HealthierUS'' and the Department of
    Health and Human Services' ``Steps to a HealthierUS'' initiatives.
                                     ______

               Prepared Statement of Dr. Andrew C. von Eschenbach

                                BUDGET STATEMENT

        The fiscal year fiscal year 2005 budget includes $4,870,025,000, an
    increase of $134,052,000 over the fiscal year 2004 enacted level of
    $4,735,973,000 comparable for transfers proposed in the President's
    request.

                              2015 CHALLENGE GOAL

        The Nation's unwavering support of cancer research has enabled the
    National Cancer Institute (NCI) and our many partners throughout the
    cancer research community to make enormous strides over the past three
    decades. Our understanding of cancer as a disease process, and the
    associated opportunities to prevent, detect early and successfully
    treat it has improved dramatically. However, even in the face of this
    progress, the magnitude of the cancer burden means that the disease
    still affects nearly every family in America. This year, approximately
    1.4 million of our citizens will face a cancer diagnosis, and over
    560,000 of our citizens--about 1,540 each day--will die from their
    disease. Furthermore, the fact that cancer occurs primarily in
    individuals over the age of 50 means that more of our citizens will
    suffer the terrible burden of this disease in the next 10-20 years due
    to the aging and changing demographics of our population.
        Fortunately, the convergence of science and advanced technologies
    is changing our perceptions of what is possible. In fact, we are
    entering a period in biomedical research where progress in cancer
    research can be exponential--an inflection point. Last year I informed
    this committee that ``our nation's investment in basic research has
    fueled the engine of discovery, which is rapidly illuminating the
    cumulative genetic changes and associated molecular mechanisms that
    ultimately produce cancer.'' As I said then and I reiterate now ``for
    the first time, we have within our grasp the ability to design target-
    specific interventions to preempt this process.'' Based on the current
    astounding pace of progress in cancer research and the transformational
    effects of advanced biomedical technologies, I am even more fervent in
    my belief that we can achieve this vision.
        To capitalize on this inflection point, I have set forth an
    ambitious challenge goal for the NCI, and for the entire cancer
    research and care community: to eliminate suffering and death from
    cancer by 2015. This ``stretch goal'' is intended to unify and focus
    our thinking, strategies, and actions in new ways that will optimize
    the use of our resources and accelerate progress against cancer. This
    challenge also presents new opportunities for the NCI to provide
    leadership for our Nation's effort to conquer cancer, especially in the
    development of the new synergies and partnerships needed to achieve
    this bold vision.
        Recent progress across nearly all of biomedical research has set
    the stage for unimagined progress in biomedicine early in the 21st
    century. Thanks to research, we now understand that cancer is a disease
    process--where normal cells are transformed into cancer cells through a
    series of defined steps that begin with a simple change in the genetic
    material. If left unchecked, these transformed cells can progress and
    spread to cause the suffering and death that we recognize as the
    horrific burden of cancer. Thankfully, our growing understanding of
    this process has revealed multiple opportunities to intervene. These
    new intervention strategies include preventing initiation of the
    process; detecting it early when it is most amenable to elimination;
    and arresting the process to stop the spread (metastasis), which is the
    primary reason that patients suffer unduly and die from their disease.
    In short, we are rapidly learning how to ``preempt'' the cancer disease
    process. We believe in the next few years that new intervention
    strategies will allow us to prevent and/or eliminate many cancers--and
    ultimately transform cancer into chronic, manageable diseases that
    patients live with--not die from.
        Scientific advances and major discoveries from areas such as
    genomics, nanotechnology, proteomics, immunology, and bioinformatics
    allow us to envision a not too distant future when a patient's genetic,
    lifestyle, and environmental risk for cancer can be combined with
    effective prevention and early intervention strategies especially for
    those at high risk. Serum genomic and proteomic patterns, and advanced
    imaging technologies, will be employed to detect cancers at the
    earliest stages. Precise molecular diagnosis and patient-specific
    prognostic profiling will allow physicians to predict response to
    specific interventions and provide a rational basis for tailoring
    therapies. The result will be more efficacious and less toxic, targeted
    agents delivered to patients. Achieving these outcomes will result in
    the preemption of a great deal of cancer. I believe that this is no
    longer a dream but an achievable reality.
        To achieve the 2015 challenge we must take the steps necessary to
    accelerate the pace of progress across the entire cancer research
    continuum. The basic research which is aimed at discovering the
    pathways that lead to cancer represents the beginning of a continuum
    that proceeds through development of new agents and technologies and
    ultimately to the delivery of these new interventions to patients.
    Using our ever increasing knowledge of the molecular defects in cancer
    cells and the biomarkers that define the cancer process will enable the
    development of the new targeted interventions we need to prevent,
    detect, and treat cancer.
        To achieve this acceleration the NCI has identified six ``mission-
    critical'' research areas that we believe will offer significant
    potential for near term progress against cancer. These include:
    harnessing the power of the newly emerging science of molecular
    epidemiology to better identify risk populations; developing an
    integrative understanding of cancer (systems) biology to discover key
    biomarkers and targets; facilitating the development of ``strategic''
    cancer interventions for targeted prevention, early detection, and
    treatment; creating a national integrated clinical trials system to
    more effectively test these interventions; overcoming health
    disparities to deliver these advances to those in greatest need; and
    developing a bioinformatics network to connect the cancer research
    community and optimize the collection, analysis, and use of the
    enormous amount of data and knowledge that must be managed and shared.

                   CANCER BIOMEDICAL INFORMATICS GRID (CABIG)

        In this past year's Appropriations Committee Report, NCI was
    requested to explore ways in which information could be better shared
    among researchers and cancer care deliverers. In early 2004, the NCI
    responded by launching an unprecedented program to connect cancer
    researchers through an advanced technology platform called the Cancer
    Biomedical Informatics Grid (caBIG). This pilot initiative has the
    potential to transform the pace of cancer research by providing the
    tools needed to share information and data. caBIG will be developed by
    connecting 50 of our NCI-designated cancer centers through an NCI-
    developed open source system which will in effect become the ``World
    Wide Web'' of cancer research. This platform which integrates with the
    NIH Roadmap informatics initiative will link individual cancer
    researchers and research institutions across the nation, and around the
    world, in an open source, federated network that will enable
    researchers to share tools, standards, data, computing applications,
    and technologies. This unprecedented bioinformatics system will
    facilitate the collection, storing, searching, analysis,
    classification, management, and archiving and retrieval of research
    data. caBIG will improve the quality of data, provide unimagined access
    to heretofore limited databases, increase the pace of cancer research
    and enhance the effectiveness of our investments in cancer research.
    caBIG has the capability to virtualize cancer research.
        caBIG leverages the unique resources and capabilities of NCI's
    cancer centers to meet the needs of the broad cancer research and care
    communities. The cancer centers, along with NCI's platforms for
    translational research, the Specialized Programs of Research Excellence
    (SPORES), are our partners in this strategic effort to ensure that the
    fruits of fundamental scientific research can be rapidly captured for
    the benefit of cancer patients. This is an example of how the future
    can be transformed if we can successfully integrate advanced
    technologies across the discovery, development, and delivery research
    continuum. In this instance the whole will be a great deal more than
    the sum of the parts.

               NATIONAL ADVANCED BIOMEDICAL TECHNOLOGY INITIATIVE

        In developing strategies to optimize progress in NCI's high
    priority research areas, it became clear that we must proactively
    identify, develop, and deploy advanced biomedical technologies, such as
    bioinformatics, across the entire cancer research continuum. This
    concept represents a critical new element of our overall strategy to
    achieve the 2015 challenge goal; however, there is clearly a gap
    between our current level of capabilities in advanced technologies and
    what is needed. I believe that we now have the opportunity to address
    this gap through the creation of an unprecedented national advanced
    biomedical technology initiative that will be transformational for
    cancer and other diseases.
        Achieving our challenge goal will require that we fully integrate
    advanced ``enabling'' technologies with the cancer research and care
    enterprise. Advanced technologies represent those new tools and
    approaches that enable new approaches to the challenging problems of
    detecting, controlling, and preventing cancer. Advanced technologies
    allow cancer researchers to generate, collect, and analyze vast amounts
    of data, and to pursue innovative approaches that could not be
    accomplished without these sophisticated tools. As illustrated by our
    efforts in bioinformatics, the NCI is providing leadership in the
    development and integration of advanced technologies and we are also
    building the cross-disciplinary teams needed to implement these new
    strategies.
        Providing advanced technology platforms to scientists working in
    cancer research is one of our highest priorities at the NCI; and to
    that end, we have undertaken a cancer-enterprise wide planning effort
    to develop a national advanced technology initiative for cancer. In
    planning for this initiative, the NCI has identified (in addition to
    bioinformatics) multiple areas of advanced technology development that
    will be crucial in building this national resource. Examples of cross-
    cutting capabilities, which will support the range of strategic
    research priorities that we have identified as pivotal areas for
    progress, include: advanced imaging; biomarkers and proteomics;
    nanotechnology; and development capabilities such as scale-up for new
    cancer therapies and prototyping for new diagnostics devices.
        We have made significant progress in cancer diagnosis and treatment
    based on static imaging of the body's organs provided by x-ray, CT,
    PET, and MRI. The new generation of advanced imaging technologies will
    target specific molecules and cells. We will be able monitor cellular
    processes to assess the effectiveness of experimental treatments and to
    define cancer cells at their earliest stages. Nanotechnology will
    provide opportunities to develop biosensors that have the capability of
    detecting changes in cells at the earliest stages of cancer and
    ``report'' back on them. This breakthrough technology will also
    facilitate the design of new technologies to probe cell functions,
    measure cellular events with unimagined precision, and specifically
    deliver molecular entities to attack cancer. The combination of
    advanced imaging and nanotechnology offers the promise of realizing
    these advances to achieve the exponential progress that is possible at
    the current inflection point.
        The post-genomics era in cancer research has produced vast amounts
    of information aout the genetic basis of cancer, but perhaps of more
    importance, we are learning that the functioning of normal and tumor
    cells is controlled by the proteins that are transcribed from these
    abnormal genomes. These proteins, along with genes and other indicators
    of the processes and pathways that distinguish cancer, are called
    biomarkers. Through the use of advanced technologies NCI is developing
    innovative strategies to discover and validate biomarkers for use in
    clinical applications. Biomarkers, along with advanced imaging,
    nanotechnology, and other advanced technology platforms, will comprise
    an unprecedented National Advanced Biomedical Technology Initiative for
    Cancer (NABTIc).
        This initiative is a major element of our strategy to achieve NCI's
    challenge goal to eliminate suffering and death due to cancer by 2015.
    The NABTIc would leverage and align the capabilities and resources in
    advanced technology development across the nation--and gain strength
    from all sectors. Through a network of technology ``nodes'' it would
    capitalize on capabilities in our cancer centers and SPORES and
    optimize the deployment of NCI's existing strengths in advanced
    technologies that currently exist at our Frederick campus. This
    initiative is currently being refined and further developed with the
    aid of our advisors and partners in the extramural community, and a
    plan to purse this concept is under development.

                             STRATEGIC PARTNERSHIPS

        Finally, to implement many elements of our strategic plan, we will
    partner broadly With all of the sectors that comprise the cancer
    community, including other federal agencies and private industry. The
    NCI is an active partner with many federal agencies, including the
    Department of Defense, the Veterans Administration, the Centers for
    Disease Control and Prevention, the Agency on Healthcare Research and
    Quality, and the Centers for Medicare and Medicaid Services. One
    partnership that is critically important to optimizing the pace at
    which laboratory discoveries progress to become new interventions for
    cancer is our alliance the Food and Drug Administration (FDA). Early
    last year we created the NCI/FDA Interagency Oncology Task Force to
    leverage the expertise of both agencies for the expressed purpose of
    streamlining and accelerating the development of preventive,
    diagnostic, and therapeutic interventions for cancer. Considerable
    progress has already been made in the areas of joint training and
    fellowships, developing markers of clinical benefit, improvement in the
    overall process of oncology drug development, and creation of a common
    bioinformatics platform (caBIG) to improve the organization and
    reporting of data from oncology clinical trials. These partnerships are
    critical. Each agency, along with the other sectors involved in the
    development, commercialization, and delivery of the new inventions we
    desperately need to preempt cancer, is a valued partner who can unite
    with us to facilitate and speed the overall process.
        Last year, I closed by telling members of this committee that we
    stand at a pivotal crossroads--a defining moment in this nation's
    effort to prevent and cure cancer. Over the past 12 months we charted
    the future course forward--through the creation and implementation of
    innovative strategies--and have undertaken initiatives that will allow
    us to move rapidly toward a day when cancer will become a chronic
    disease. What was once a vision is becoming reality through the
    combined efforts of researchers and leaders from all sectors, patients
    and their families--and so many others. I believe that together we will
    realize the economic and human benefits of eliminating the suffering
    and death due to cancer, and in this quest, inform our efforts to
    transform our overall health care system.
                                     ______

                   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) of the National Institutes of Health
    (NIH). The fiscal year 2005 budget of $4,425,507,000 includes an
    increase of $122,467,000 over the fiscal year 2004 enacted level of
    $4,303,040,000, comparable for transfers proposed in the President's
    request.
        NIAID conducts and supports research studies to understand, treat,
    and prevent infectious diseases such as HIV/AIDS and other sexually
    transmitted infections, influenza, tuberculosis, malaria, and illness
    from potential agents of bioterrorism. In addition, the Institute
    supports research on transplantation and immune-related illnesses,
    including autoimmune disorders, asthma and allergies. For 56 years,
    NIAID-sponsored research has led to new therapies, vaccines, diagnostic
    tests, and other technologies that have improved the health of millions
    of people worldwide. Historically, NIAID has accomplished its mission
    with a strong commitment to basic and targeted research in immunology,
    microbiology, and infectious disease, disciplines that are related and
    complementary. The new initiatives of the NIH Roadmap, and the
    information, reagents and infrastructure they will produce, will
    further promote the efficient and effective movement of NIAID
    discoveries from the laboratory bench to the bedsides of patients.
           the niaid research response to the threat of bioterrorism
        The use of deadly pathogens such as smallpox or anthrax as agents
    of bioterrorism is a serious threat to the citizens of our nation and
    the world, and biodefense research to mitigate this threat is a key
    focus of NIAID research. Since the anthrax attacks of 2001, NIAID has
    significantly strengthened, accelerated, and expanded our biodefense
    research program. NIAID-supported biodefense research includes: (a)
    basic studies of the structure, ecology, and disease-causing mechanisms
    of microbes that could be used by bioterrorists; (b) the response of
    the immune system to these pathogens, and; (c) the translation of this
    knowledge into safe and effective countermeasures--treatments,
    diagnostics, and vaccines. To achieve our biodefense research goals,
    NIAID works closely with partners in academia, industry, and other
    private and public-sector agencies. Research on potential agents of
    bioterror promises to enhance not only our preparedness for
    bioterrorism, but also for naturally occurring endemic and emerging
    infectious diseases.
        Progress in biodefense research has been swift and substantial.
    More than 50 major NIAID initiatives involving intramural, academic and
    industrial partners have been undertaken. As part of this effort, the
    Institute has greatly increased biodefense research capacity. For
    example, NIAID recently funded eight Regional Centers of Excellence for
    Biodefense and Emerging Infectious Diseases Research. This nationwide
    network of multidisciplinary academic centers will conduct wide-ranging
    research on infectious diseases and the development of diagnostics,
    therapeutics and vaccines. In addition, NIAID is supporting the
    construction of two National Biocontainment Laboratories (NBLs) and
    nine Regional Biocontainment Laboratories (RBLs). These high-level
    biosafety facilities promise to speed the development of effective
    therapies, vaccines and diagnostics for diseases caused by agents of
    bioterror as well as for naturally occurring emerging diseases such as
    SARS and avian influenza.
        In addition, NIAID has developed and expanded contracts to screen
    new drugs; develop new animal models and establish a reagent and
    specimen repository. NIAID also has made a significant investment in
    determining the genetic sequences of the genomes of a range of
    pathogens, which has helped to illuminate the workings of all classes
    of microorganisms. NIAID-supported researchers and their international
    colleagues have sequenced genomes representative of all bacteria
    considered bioterror threats (including multiple strains of the anthrax
    bacterium), as well as at least one strain of every potential viral and
    protozoan bioterror pathogen. NIAID also is funding research to better
    understand the body's own protective mechanisms. A new NIAID program,
    the Cooperative Centers for Translational Research on Human Immunology
    and Biodefense, will conduct research to better understand the human
    immune response to potential agents of bioterror, with the objective of
    developing new bioterror countermeasures. Another large-scale program
    is funding sophisticated studies of the human innate system, comprised
    of the cells that are the ``first responders'' to infection. Boosting
    innate immunity holds great promise for developing fast-acting
    countermeasures to mitigate the effects of bioterror pathogens or
    toxins.
        The ultimate goal of all NIAID biodefense research is the
    development of medical countermeasures. NIAID-supported scientists have
    identified: (a) antivirals that may play a role in treating smallpox or
    the complications of smallpox vaccination; (b) several approaches to
    blocking the toxins of the anthrax bacterium; as well as (c)
    antibiotics, antivirals and antitoxins against other major bioterror
    threats. New and improved vaccines against smallpox, anthrax and other
    potential agents also are being developed, with the objective of adding
    them to the Strategic National Stockpile (SNS). For example, NIAID has
    sponsored the development of a next-generation anthrax vaccine known as
    rPA, with the goal of adding 75 million doses to the SNS to protect
    U.S. citizens. Clinical trials of rPA are ongoing; results to date
    build on similar findings in animal studies and suggest that the
    vaccine is safe and capable of evoking a robust immune response.
    Researchers also will test whether the currently recommended course of
    antibiotic therapy for individuals exposed to anthrax spores can be
    reduced by vaccinating exposed subjects with rPA.
        NIAID-supported researchers also are testing several new smallpox
    vaccines that may prove at least as effective as the current smallpox
    vaccine, but with fewer side effects. One of these, modified vaccinia
    Ankara (MVA), is based on a strain of the vaccinia virus that
    replicates less robustly than the traditional Dryvax vaccinia virus,
    and is known to cause fewer side effects than the latter. Human trials
    of MVA vaccines are underway at NIH and elsewhere. Encouragingly,
    recent studies by NIAID intramural scientists and their colleagues have
    shown that MVA protects monkeys and mice from smallpox-like viruses.
    NIH also has launched the first human trial of a vaccine designed to
    prevent infection with Ebola virus. The trial vaccine, a type called a
    DNA vaccine, is similar to other investigational vaccines that hold
    promise for controlling such diseases as AIDS, influenza, malaria and
    hepatitis.

                               HIV/AIDS RESEARCH

        Most recent estimates on the scope of the HIV/AIDS pandemic are
    profoundly sobering. Approximately 40 million people worldwide are
    living with HIV/AIDS. In 2003 alone, 5 million people worldwide were
    newly infected with HIV--about 14,000 each day, more than 95 percent of
    whom live in low and middle income countries. In 2003, 3 million people
    worldwide with HIV/AIDS died. In the United States, nearly one million
    people are living with HIV/AIDS, and by the end of 2002, more than
    500,000 people with HIV/AIDS had died. As shocking as these numbers
    are, they do not begin to adequately reflect the physical and emotional
    devastation to individuals, families, and communities coping with HIV/
    AIDS, nor do they capture the huge deleterious impact of HIV/AIDS on
    the economies and security of nations, and indeed entire regions. Even
    as the burden of HIV/AIDS continues to grow, recent developments
    provide some measure of optimism. For example four new antiretroviral
    drugs were licensed in 2003 by the U.S. Food and Drug Administration
    (FDA), each of which built on NIAID-sponsored research and/or has been
    tested in NIAID clinical trials networks. Many other ``next-
    generation'' anti-HIV drugs are in clinical trials.
        A vaccine that prevents HIV infection--or at least slows the
    progression of disease--is a critical NIAID priority. Vaccine
    developers face formidable obstacles, including the genetic diversity
    of the virus and the lack of a clear understanding of the immune
    responses that might protect against HIV infection. Nonetheless, NIAID
    and our academic, industrial, international and philanthropic partners
    have made significant progress. Numerous HIV vaccine candidates are in
    various stages of preclinical and clinical development. The new
    Partnership for AIDS Vaccine Evaluation (PAVE) promises to optimize
    these efforts. PAVE is a coordinated HIV vaccine research effort that
    includes the three government agencies most involved in this activity--
    NIH, the Centers for Disease Control and Prevention (CDC), and the
    Department of Defense. These agencies will work together to ensure that
    research protocols, standards, and measures are developed in a
    coordinated and harmonized manner so that outcomes can be compared
    across trials in the most cost effective and scientifically efficient
    manner. International non-government organizations (NGOs) and companies
    also have expressed interest in joining the partnership. Concurrently,
    novel approaches to HIV prevention are being studied and validated,
    including topically applied microbicides that individuals could use to
    protect themselves from HIV and other sexually transmitted pathogens.
    As discussed in the new NIAID Strategic Plan for Topical Microbicides,
    more than 50 candidate agents have shown laboratory activity against
    HIV and other STDs, and several of these agents have demonstrated
    safety and efficacy in animal models. In small human studies, several
    products have proven safe; later this year, NIAID's HIV Prevention
    Trials Network (HPTN), in conjunction with the National Institute of
    Child Health and Human Development, will launch a large international
    study to test two promising products in more than 3,000 women at high
    risk of acquiring HIV in the United States, five African countries, and
    India.

          RESEARCH ON OTHER EMERGING AND EMERGING INFECTIOUS DISEASES

        Infectious diseases have always afflicted humanity, and they will
    continue to confront us as long as man and microbes co-exist.
    Unfortunately, the viruses, bacteria, and parasites that cause
    infectious diseases do not remain static, but continually and
    dramatically change over time as new pathogens (such as HIV and the
    SARS coronavirus) emerge and as familiar ones (such as influenza virus
    and West Nile virus) re-emerge with new properties or in unfamiliar
    settings.
        West Nile virus (WNV) first appeared in the western hemisphere in
    1999, and by 2003 had spread to 45 states in the United States. NIAID
    has moved quickly to address this threat with basic research on the
    virus and its maintenance in nature, the development of vaccines and
    treatments, and the provision of reagents and other resources to the
    research community. NIAID also is supporting the development of three
    types of vaccines, as well as the screening and testing of WNV
    therapies. For example, the NIAID-sponsored Collaborative Antiviral
    Study Group is assessing the safety and efficacy of WNV immunoglobulins
    in patients with, or at high risk of serious brain diseases caused by
    WNV.
        Severe acute respiratory syndrome (SARS) is a new infectious
    disease first identified in humans in early 2003. The prompt
    recognition that SARS is caused by a new type of coronavirus, and the
    rapid progress in SARS research reflect the dedication of and
    collaboration by the world's medical researchers and public health
    experts, including NIAID-sponsored scientists in the United States and
    abroad. NIAID supports research to understand the epidemiology and
    biology of the SARS virus and how it spreads, and to develop SARS
    countermeasures. Several approaches to SARS countermeasures are being
    pursued by the NIAID Laboratory of Infectious Diseases, the NIAID
    Vaccine Research Center, and by our contractors and grantees. For
    example, NIAID is participating in a project to screen up to 100,000
    antiviral drugs and other compounds for activity against the SARS
    virus, and will test the most promising in animal models and human
    clinical trials. A number of compounds have shown promise in the test
    tube, including alpha interferon, a drug already approved by the FDA
    for the treatment of hepatitis B and C infections.
        NIAID scientists and grantees are pursuing several parallel
    approaches in the search for a SARS vaccine. Once these experimental
    vaccines are ready, NIAID plans to test them in human clinical trials
    in our network of Vaccine and Treatment Evaluation Units. New research
    suggests that a SARS vaccine is within reach: NIAID intramural
    scientists have demonstrated that the mouse immune system develops
    antibodies capable of single-handedly neutralizing the SARS virus. This
    discovery affirms that researchers developing vaccines that trigger
    antibodies to the SARS virus are heading in the right direction. These
    findings also indicate that drug researchers can use laboratory mice as
    a model to evaluate whether a drug blocks the SARS virus. Both findings
    could help lessen the time it takes to develop an effective vaccine or
    antiviral drugs for SARS.
        Influenza is a classic example of a re-emerging disease; it is not
    a new disease, but it continually changes. Because the replication
    machinery of the influenza virus is error prone, as the virus
    multiplies it can mutate to a slightly different form; this is referred
    to an ``antigenic drift.'' Such viruses might require a slight
    modification of the yearly influenza vaccine to accommodate these
    changes. In addition, non-human influenza viruses such as avian
    influenza, can emerge that may be able to jump species into domestic
    poultry, farm animals such as pigs, and humans. This type of
    significant change in the antigenic makeup of the virus is referred to
    as ``antigenic shift.'' Deadly pandemics associated with antigenic
    shifts are known to have occurred in 1918, 1957, and 1968. The pandemic
    that occurred in 1918-1919 after an antigenic shift killed 20-40
    million people worldwide, including more than half a million in the
    United States. This recent history explains the current high level of
    concern about the appearance of new forms of virulent H5N1 avian
    influenza viruses in Asia that can adapt themselves by mutation to
    infect humans as has been the case already in dozens of individuals in
    Viet Nam and Thailand. Of even greater concern is the possibility that
    this avian virus can combine or reassort its genes with a human
    influenza virus and acquire the capability of readily spreading from
    person to person resulting in a new pandemic. Given the poor condition
    of public health systems in many underdeveloped regions and the speed
    of modern air travel, the consequences of such an event, should it
    result in an influenza pandemic, would be severe.
        To address this threat, NIAID supports a broad program to develop
    more effective approaches to controlling influenza virus infections.
    Research includes programs to understand the pathogenesis,
    transmissibility, evolution, epidemiology, and the immune response to
    influenza viruses, as well as to develop new diagnostics, antiviral
    drugs and vaccines. NIAID currently supports several research projects
    to develop vaccines that could be manufactured more rapidly, are more
    broadly cross-protective, and are more effective than current influenza
    vaccines. The use of reverse genetics--a tool developed by NIAID
    grantees--holds the promise for more rapid generation of vaccine
    candidates that match the anticipated strain expected to circulate
    during the influenza season. Reverse genetics also can be used to turn
    highly pathogenic influenza viruses into vaccine candidates more
    suitable for vaccine manufacturing by removing or modifying certain
    virulence genes; laboratories around the world are using the technique
    to prepare vaccine candidates against the H5N1 viruses emerging in
    Asia. NIAID also is funding the development of new influenza vaccine
    technologies. Recently, NIAID supported a Phase II clinical trial of a
    new influenza vaccine produced in a cell culture system as an
    alternative to manufacturing the vaccine in eggs. Because NIAID has had
    remarkable success in the past with groundbreaking vaccine research--
    including advances that led to hepatitis B, Haemophilus influenzae b,
    pneumoccocal pneumonia, and acellular pertussis vaccines--we are
    confident that one of the approaches that we are pursuing also will
    lead to a useful, ``next-generation'' influenza vaccine that can
    readily be adapted to emerging influenza strains.

                      RESEARCH ON IMMUNE-MEDIATED DISEASES

        Immune-mediated diseases such as autoimmune diseases, allergic
    diseases, and asthma are important health challenges in the United
    States and abroad. Autoimmune diseases afflict 5 to 8 percent of the
    U.S. population; asthma and allergic diseases combined represent the
    sixth leading cause of chronic illness and disability in the United
    States, and the leading cause among children. The past two decades of
    fundamental research in immunology have resulted in a wealth of new
    information and extraordinary growth in our conceptual understanding of
    the immune system and the pathogenesis of immune-mediated diseases,
    which has led to the development of many useful therapies. For
    instance, we now have powerful treatments that selectively target
    several of the immune system molecules that cause inflammation, a
    hallmark of many autoimmune diseases. NIAID-sponsored researchers are
    now developing novel ways of selectively blocking inappropriate or
    destructive immune responses, while leaving protective immune responses
    intact, an area of research known as tolerance induction. In the Immune
    Tolerance Network, a consortium of basic and clinical scientists,
    promising studies are underway using tolerance induction to treat
    autoimmune diseases, such as rheumatoid arthritis, type 1 diabetes, and
    multiple sclerosis; asthma and allergic diseases; and the rejection of
    transplanted organs, tissues, and cells. So-called ``tolerogenic''
    therapies would replace current lifelong non-specific immunosuppressive
    regimens (and their often debilitating side-effects) with short-term
    specific regimens that hold the promise of being curative.
        Other important research is being conducted by the recently
    expanded Autoimmunity Centers of Excellence. The nine centers that make
    up this program conduct basic research and clinical trials on new
    immune-based therapies for diseases that collectively afflict between
    14 and 22 million Americans. The Institute and our collaborators also
    have significantly bolstered the study of primary immunodeficiency
    diseases--disorders caused by inherited flaws in the immune system that
    increase susceptibility to infections--with funding of the Primary
    Immunodeficiency Research Consortium (PIRC), a coalition of the world's
    most prominent researchers in the field of primary immunodeficiency
    diseases.
        Another important NIAID research focus is the development of new
    interventions to reduce the burden of asthma, a significant and growing
    public health problem in the United States and many nations worldwide.
    NIAID has long been at the forefront of discoveries leading to the
    characterization of asthma and allergic diseases and is now vigorously
    pursing the translation of basic knowledge into more effective
    treatment and prevention strategies. To develop interventions to
    prevent the onset of asthma, more information is needed on the events
    that induce asthma. NIAID's Inner-City Asthma Consortium (ICAC) will
    soon launch a large study to define and analyze immunological and
    environmental influences upon the development of childhood asthma in a
    cohort of urban children followed from birth.

                                   CONCLUSION

        With a strong research base, talented investigators in the United
    States and abroad, and the availability of powerful new research tools,
    NIAID anticipates that our basic and applied research programs will
    provide the countermeasures to improve our defenses against those who
    would attempt to harm us with bioterrorism, will develop new tools in
    the fights against HIV/AIDS and other infectious diseases, and will
    improve therapies and management of immune-mediated diseases.
                                     ______

                    Prepared Statement of Dr. Nora D. Volkow

        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's budget request for the National Institute on Drug
    Abuse. The fiscal year 2005 budget includes $1.019 billion, an increase
    of $28.273 million over fiscal year 2004 conference level of $990.787
    million comparable for transfers proposed in the President's request.

                          NIDA: 30 YEARS OF DISCOVERY

        As the National Institute on Drug Abuse (NIDA) prepares to
    celebrate its 30th anniversary this year, I am honored to have this
    opportunity to tell you about some of our remarkable scientific
    accomplishments and how these advances are setting the course for a
    better future. A tomorrow that will bring us even better prevention
    interventions to deter the initial use of drugs by those at risk before
    they become one of the more than 180 million people around the world
    who currently abuse illegal drugs. A future that will also bring us
    better treatment interventions to help those who have already become
    addicted, and who may suffer from some of the myriad consequences of
    drug abuse including HIV/AIDS and comorbid mental illnesses. Research
    supported by NIDA, the world's largest supporter of research on the
    health aspects of drug abuse and addiction, may even bring us
    innovative and improved ways to deal with other major health epidemics
    impacting our society, such as chronic pain and obesity.

            ADDICTION AND OBESITY: COMMON NEUROBIOLOGICAL MECHANISMS

        Obesity and addiction are serious National health problems that may
    have much in common. Both addiction and some forms of obesity represent
    problems resulting from excessive behaviors and lack of impulse
    control. Knowledge derived from addiction research shows that the brain
    circuits involved in compulsive eating and impulse regulation are part
    of the same brain systems involved in addiction, with the
    neurotransmitter dopamine playing a prominent role. (See Figure 1.) A
    better understanding of the role of the dopamine and other systems in
    the motivation for and salience of food may lead us to the development
    of better medications and behavioral interventions for obesity, as well
    as addiction. In addition, medications being developed for obesity may
    also help to reduce drug use. Because of the commonalities between
    these disorders, we are able to share knowledge of brain and behavior
    and combine efforts across institutes to forge new insights and
    approaches that may result in improved health for all. NIDA is pleased
    to be a key participant in a trans-NIH initiative that is looking at
    all aspects of this chronic health problem, from its neurobiological
    underpinnings to helping people establish healthy behaviors.

                 THE INTEGRATION OF BRAIN, BEHAVIOR AND HEALTH

        Understanding the connections between brain, behavior, and health
    will be critical to improving the health of ALL Americans. Science is
    at a point where all the elements of the human brain (genes, proteins,
    circuits) and its development can now be mapped out.
        We did it with the Human Genome and I am confident we can do it
    with the brain. We are already beginning to unravel how various genes,
    proteins, brain circuits and pathways interact with each other and the
    environment to affect all aspects of human behavior. This overarching
    approach is necessary if we are to make progress in improving the
    quality of life for individuals who suffer from complex disorders, such
    as drug addiction, which can start at a young age and continue across
    the lifespan. Now that advances in medical sciences have increased the
    lifespan of humans, a major challenge becomes to improve the quality of
    life of individuals, which hinges on our ability to understand the
    neurobiological underpinnings of human behavior and the impact and
    malleability the environment can have on it. This pertains not only to
    problems such as addiction, but other health problems such as obesity,
    adherence to medical regimens and with establishing and maintaining
    healthy life styles.

               ADOLESCENCE, THE DEVELOPING BRAIN, AND PREVENTION

        Collaborating with other Institutes to map out structural and
    functional aspects of the brain and how it changes throughout
    development will help us better understand human behavior, and how we
    can modify it to improve and extend human life. In particular,
    understanding the developing adolescent brain will be useful in drug
    abuse prevention efforts. Research indicates that exposure to drugs of
    abuse in adolescence, when many changes are occurring in the brain, may
    be a period of significantly increased vulnerability to drugs' effects.
    Fortunately, advances in science and NIH-funded studies have now
    brought us to a point where our researchers can use new animal models,
    new brain imaging technology and other neurobehavioral assessment tools
    to probe the development of brain and behavior interactions. These new
    directions in adolescent research will help to inform us on important
    aspects of cognition, decision-making, emotional regulation, and risk
    perception during adolescence, and will help us determine how these
    play a role in the use and consequences of illicit drugs. Armed with
    new knowledge about how adolescents make decisions, NIDA will be poised
    to design interventions that can reduce drug experimentation and
    addiction. We are making progress in this regard through our National
    Prevention Research Initiative and through our science education
    activities like ``NIDA Goes Back to School Campaign'' where science-
    based materials were disseminated to teachers and students all across
    America.

                       EXCELLENT NEWS: DRUG USE DECLINES

        Some of the best news to a NIDA Director came in December 2003 when
    we released the latest data on teen drug use trends. NIDA's long-
    standing Monitoring the Future Survey showed an approximately 11
    percent decline in illicit drug use over the last 2 years by students
    in the eighth, tenth, and twelfth grades combined. (See Figure 2.) The
    use of MDMA or Ecstasy decreased by almost fifty percent for the three
    grades combined in that same time period Also encouraging was the fact
    that tobacco use among this population was the lowest in the 28 year
    history of the survey.

              NEWS FOR CONCERN: PRESCRIPTION DRUG ABUSE CONTINUES

        There was also some disturbing news last year about youth drug use,
    showing very high rates of abuse of prescription pain killers (e.g.,
    Vicodin and OxyContin). Remarkably, 1 in 10 twelfth graders reported
    abusing Vicodin last year, making it the second most widely abused
    illicit substance after marijuana in this population. Hospitals are
    also seeing more patients coming to emergency rooms for prescription
    drug abuse. According to data from SAMHSA, between 1994 and 2001 the
    number of emergency room mentions for hydrocodone and oxycodone
    increased 131 percent and 352 percent respectively. When used as
    prescribed, medications like Vicodin can be very effective, but when
    used improperly they can have very serious adverse health consequences
    including death from overdose. More research is needed to prevent,
    educate, and treat prescription drug abuse. Developing new medications
    that have no abuse or diversion potential is a high priority for NIDA.
        Researchers are making progress in this area. Just last year,
    researchers developed a compound to selectively affect a cannabinoid
    receptor that is involved in regulating pain. Unlike many other
    receptors, this one is not found in the brain. When the compound
    (AM1241) was given to animals, they were less sensitive to several
    forms of painful stimulation. Not only does this research open up a new
    arena for pain medication development, but it also sets the stage for
    developing new medications that are less likely to be abused. Also,
    NIDA's investment in the development of buprenorphine/naloxone for
    treating opioid addiction, for example, provides an alternative
    medication for pain that has less diversion potential than that of
    other opiate analgesics, and exemplifies how science can help alleviate
    our Nation's problems.

     RESEARCH ON THE CONSEQUENCES OF MARIJUANA, AND THE DEVELOPMENT OF NEW
                                  MEDICATIONS

        Research continues to shed new light on the deleterious
    consequences of marijuana, the most abused illegal drug in the United
    States. Early exposure to marijuana, for example, has been found to
    increase the likelihood of a lifetime of subsequent drug problems. A
    recent study, published in the Journal of the American Medical
    Association of over 300 fraternal and identical twin pairs, who
    differed on whether or not they used marijuana before the age of 17,
    found that those who had used marijuana early had elevated rates of
    other drug use and drug problems later on, compared to their twin who
    did not use marijuana before age 17. This study re-emphasizes the
    importance of primary prevention by showing us that early drug
    initiation is associated with increased risk of later drug problems,
    and it provides more evidence for why preventing marijuana
    experimentation during adolescence could have a big impact in
    preventing addiction.
        We are also finding that a lifetime of heavy cannabis use can
    result in an overall dissatisfaction with oneself and with life for
    most users. Last year, researchers published data on the impact of
    long-term cannabis use on life achievement such as educational
    attainment and income. Significantly fewer of the heavy cannabis users
    completed college and more had household incomes of less than $30,000
    compared to individuals who used marijuana minimally.
        It is clear, more research is needed to curtail use of this drug.
    Although the number of marijuana treatment admissions has increased
    from 92,414 in 1992 to 255,394 in 2001, there are relatively few
    treatments that have been shown to be effective specifically for
    marijuana addiction. NIDA is encouraging researchers, as well as the
    pharmaceutical industry, to become more active in finding new
    medications for marijuana and for other drugs of abuse. With the fairly
    recent discovery of an endogenous cannabinoid system with specific
    receptors and endogenous ligands, the likelihood of finding new targets
    for medications development is increased. One form of a cannabinoid
    receptor antagonist (CB1-receptor) has already been developed by
    several pharmaceutical companies and is undergoing clinical
    investigation for the treatment of alcoholism and nicotine addition, as
    well as obesity. Moreover, preliminary data in humans has shown that it
    can block the effects of marijuana.

        ACCELERATING RESEARCH DISCOVERIES BENCH TO BEDSIDE: BEDSIDE TO
                  COMMUNITY NIH ROADMAP AND OTHER INITIATIVES

        For science to be useful in preventing and treating addiction this
    knowledge has to reach the communities. This is an area where NIDA
    continues to excel. Over the past few years, NIDA has established and
    strengthened strong collaborative relationships with a number of
    government agencies, including the Substance Abuse and Mental Health
    Services Administration (SAMHSA) to build national infrastructures that
    can facilitate the flow of research into community practice. NIDA's
    National Drug Abuse Treatment Clinical Trials Network (CTN), which now
    serves 27 states plus the District of Columbia and Puerto Rico, and the
    more newly established National Criminal Justice Drug Abuse Treatment
    Study (CJ-DATS) exemplify NIDA's commitment to bringing science out of
    the laboratory and to the community. These initiatives parallel and
    complement those proposed as part of the NIH Roadmap, including the
    promotion of interdisciplincary research and the development of
    improved infrastructures for clinical research, which aim to accelerate
    the advancement of research discoveries from the bench to the bedside
    and to the community.

    GETTING THE MEDICAL COMMUNITY MORE INVOLVED IN SCREENING AND ADDRESSING
                   HIV/AIDS AND OTHER DRUG ABUSE CONSEQUENCES

        Because drug abuse begins in youth and most pediatricians and
    family physicians typically do not ask questions about drug use, NIDA
    has launched a Primary Care Outreach Initiative to educate
    pediatricians and other primary care physicians about the importance of
    early detection and treatment. The medical community is also being
    reminded of the need to recognize substance abuse and addiction as
    disorders that will affect the course of other diseases, including
    mental illness, cancer, cardiovascular and pulmonary diseases, trauma
    and infectious diseases. Injection drug use has directly and indirectly
    accounted for more than one-third (36 percent) of AIDS cases in the
    United States. Data show that drug abuse treatment can reduce
    activities related to drug use that increase the risk of getting or
    transmitting HIV. Also the fact that the health and social consequences
    of drug abuse, including HIV/AIDS, disproportionately affect racial and
    ethnic minority populations; for example almost half of HIV/AIDS cases
    occur in African Americans even though they constitute only 11 percent
    of the population according to the latest Census data, which highlights
    the urgency to conduct research that can benefit all populations. (See
    Figure 3.)
        Using our established networks (CTN and CJ-DATS), NIDA is
    strengthening its commitment to attend to associated health problems
    like HIV/AIDS, hepatitis and co-morbidity that often accompany
    substance use. The CTN, for example has a number of treatment protocols
    underway that address HIV/AIDS and hepatitis. Also, because data
    suggest that the prevalence of HIV and other infectious diseases is
    high among drug users in the criminal justice system, with HIV
    seropositivity rates estimated to be 8-10 times higher than in the
    general population, NIDA is encouraging more research to prevent and
    treat the spread of HIV/AIDS and other diseases among individuals in
    the criminal justice system with substance abuse related problems.

                                   CONCLUSION

        Our Nation's investment in drug abuse research is showing
    reductions in drug abuse rates and its deleterious consequences at the
    individual, family, and community level. A continued commitment to
    medical research, and to working with other agencies and sectors, will
    lead to new advances, technologies and innovations that will result in
    a healthier population.

                    Prepared Statement of Dr. Jeremy M. Berg

        Mr. Chairman and Members of the Committee, good morning. I am
    pleased to present the President's budget request for the National
    Institute of General Medical Sciences (NIGMS). The fiscal year 2005
    budget includes a sum of approximately $1,960 million which reflects an
    increase of $55 million over the fiscal year 2004 enacted level of
    $1,905 million.

                    CROSS-CUTTING AND CUTTING-EDGE RESEARCH

        Both before joining NIGMS as its new director last November and
    since then, I have been tremendously impressed by the Institute's
    leadership in supporting basic biomedical research--that is, scientific
    studies into the most fundamental biological processes that govern
    human health. The kinds of research that we fund are both cross-cutting
    and cutting-edge. NIGMS-supported studies have shed light on everything
    from the three-dimensional structures of individual proteins--life's
    building blocks--to the complex interactions between molecules inside
    cells. More importantly, by uncovering the previously hidden workings
    of this cellular machinery, not only do we gain a better understanding
    of the very basis of human health, but we also gain valuable clues to
    fixing this machinery when it goes awry. Those clues are essential in
    helping scientists develop better methods to diagnose, treat, and even
    prevent a wide range of human diseases.
        NIGMS has a successful track record of supporting the nation's
    brightest minds in basic biomedical science. Perhaps the highest
    recognition of that success can be seen in the number of Nobel Prizes
    that NIGMS grantees have won over the past four decades: a remarkable
    55 to date. This past year was no exception. Roderick MacKinnon, M.D.,
    a biophysicist at the Rockefeller University and a long-time NIGMS
    grantee, won the 2003 Nobel Prize in chemistry for discovering the
    structure and function of membrane ion channels--the ``gatekeepers''
    that control what essential molecules move in and out of cells.
    MacKinnon's breakthrough provides direct visualization of the basis for
    the electric circuits that are responsible for the functioning of our
    brains and the beating of our hearts. The detailed structural
    information is revealing how local anesthetics work and why some drugs
    have life-threatening cardiac side effects. The work of literally
    thousands of other researchers has been redirected in response to his
    discoveries.
        NIGMS' impressive return on investment in basic biomedical research
    is also evidenced by the many other prestigious awards honoring our
    grantees. In 2003, Rockefeller researcher C. David Allis, Ph.D., won
    the third annual Wiley Prize in the Biomedical Sciences for his work on
    chromatin, the complex of DNA with proteins that packages genetic
    information inside each cell nucleus. The structure of chromatin is
    largely responsible for why one cell is a nerve cell while another cell
    is a muscle cell, even though they contain exactly the same DNA
    sequence. Allis' studies of the chemical modifications that regulate
    chromatin hold promise for learning how to control genes that suppress
    and inhibit the growth of tumors in cancer. The previous year, two
    other NIGMS grantees--Andrew Z. Fire, Ph.D., of the Stanford University
    School of Medicine, and Craig C. Mello, Ph.D., of the University of
    Massachusetts Medical School--were among the winners of the second
    annual Wiley Prize for their groundbreaking discovery of gene silencing
    by a mechanism called RNA interference. The phenomenon of RNA
    interference is the subject of upcoming meetings at both the National
    Academy of Sciences and NIH because of its potential impact for both
    basic research and for entirely novel approaches to preventing and
    treating disease.
        Even greater advances in biomedical science are possible in the
    years to come. Through forward-thinking programs designed to foster
    innovative research and train the next generation of pioneering
    scientists, NIGMS is playing a leading role in the NIH Roadmap for
    Medical Research--the exciting new vision of the future recently
    launched by NIH director Elias Zerhouni, M.D. I would like to share
    with you some of the key strategies we have developed to help realize
    this important vision.

                      BLAZING A TRAIL FOR THE NIH ROADMAP

        Throughout its history, NIGMS has helped push back the frontiers of
    medical knowledge primarily by funding the most promising research
    grant applications submitted by both new and established scientists.
    This so-called investigator-initiated research--supported through the
    NIH's R01 grant mechanism continues to be the most important instrument
    NIGMS has to promote experimentally based, hypothesis-driven research--
    the heart of our nation's scientific mission.
        In recent years, NIGMS launched a number of larger, targeted
    initiatives to address both significant opportunities and critical gaps
    in biomedical research today. In many ways, programs such as NIGMS'
    Protein Structure Initiative (PSI), its large-scale collaborative
    ``glue grants,'' and its new Center for Bioinformatics and
    Computational Biology have blazed a trail for the NIH Roadmap. Today,
    NIGMS is well positioned to participate with other NIH institutes in
    transforming the nation's biomedical research capabilities and
    accelerating the translation of scientific discoveries from the bench
    to the bedside.
        Structural biology is part of the Roadmap's New Pathways to
    Discovery theme, and NIGMS is playing a key role in this area. One
    major activity is the PSI, an ambitious 10-year project launched in
    2000. The aim of the PSI is to solve the three-dimensional structures
    of thousands of proteins experimentally and ultimately produce
    computer-based tools for modeling the 3-D structure of any protein from
    its genetic spelling, or sequence. Knowing the structures of proteins
    helps scientists understand how these molecules function in health and
    disease and aids in the development of new medicines.
        Results from the nine pilot centers set up in the first phase of
    the PSI are promising, demonstrating that automated protein production
    ``factories'' are feasible and are yielding high-resolution data that
    is already being used by scientists around the world. This year, NIGMS
    plans to ramp up the PSI in its second phase, with the funding of
    large-scale centers that will dramatically reduce the time and cost of
    solving protein structures, as well as specialized centers that will
    tackle challenging problems such as membrane proteins and protein
    complexes.
        NIGMS is also contributing substantially to Roadmap-related
    initiatives through its support of research aimed at unraveling the
    complexities of living systems. In 2003, the Institute awarded its
    fifth glue grant, bringing together a diverse team of scientists to
    assemble a complete picture of lipids--fats and oils--inside cells, and
    the role they play in heart disease, arthritis, and other major
    illnesses. Other ongoing glue grants awarded since the program started
    in 2000 include projects aimed at understanding cellular signaling and
    communication, cell movement, and inflammation and the way the body
    responds to injury.
        Last year, NIGMS also added two new Centers of Excellence in
    Complex Biomedical Systems Research. At these centers,
    interdisciplinary teams of researchers from both the biological and
    physical sciences will focus on the emerging field of ``systems
    biology,'' which seeks to find hidden patterns of biological
    interactions at all levels, from individual proteins to entire
    organisms. The new centers join two others launched the previous year
    with NIGMS funding.

               COMPUTER-BASED SOLUTIONS TO BIOMEDICAL CHALLENGES

        Harnessing the power of computers to solve complex problems in
    biology is another major theme in both the NIH Roadmap and NIGMS'
    research mission. In 2003, the Institute's recently created Center for
    Bioinformatics and Computational Biology welcomed its first director,
    Eric Jakobsson, Ph.D., a leading researcher in the field from the
    University of Illinois at Urbana-Champaign. Dr. Jakobsson has been
    instrumental in launching one of the first Roadmap initiatives, a
    program to fund the creation of NIH National Centers for Biomedical
    Computing. The centers will bring together computer scientists,
    biomedical researchers, and experts from the experimental, clinical,
    and behavioral sciences to tackle such challenges as developing
    computer simulations that will accurately model the complex inner
    workings of the human brain and other vital systems.
        One of the most exciting prospects for computational biology is the
    promise of turning the vast amounts of data generated by the Human
    Genome Project into promising new medical treatments that are tailored
    to the individual. As Allen D. Roses, M.D., senior vice-president of
    genetics research at GlaxoSmithKline, recently observed, ``The vast
    majority of drugs--more than 90 percent--only work in 30 to 50 percent
    of the people.'' NIGMS is addressing this critical issue through the
    Pharmacogenetics Research Network, a nationwide collaboration of
    scientists from academia, government, and industry that the Institute
    spearheaded in 2000, with additional funding from five other NIH
    institutes. The network has already produced a key computer-based
    resource that scientists are now actively using: the Pharmacogenetics
    and Pharmacogenomics Knowledge Base (PharmGKB). With this and other
    tools at their disposal, scientists will be able to study the effect of
    genes on people's responses to a wide variety of medicines including
    antidepressants, chemotherapy, drugs for asthma and heart disease, and
    many others. The ultimate goal of pharmacogenetics research is to help
    tailor medicines to people's unique genetic make-ups, thus making
    medicines safer and more effective for everyone.
        Computational biology is also at the heart of another NIGMS
    initiative: the Models of Infectious Disease Agent Study (MIDAS). An
    integral component of the overall NIH biodefense plan, MIDAS is a
    network of scientists who will produce user-friendly computational
    models for policymakers, public health workers, and other researchers
    to assist them in making better-informed decisions about emerging
    infectious diseases. The first centers funded through the MIDAS
    initiative will launch this year and are expected to contribute
    significantly to our ability to prevent, detect, and respond to new
    infectious diseases, either natural or human-made.
        Other NIH Roadmap-related initiatives include NIGMS' program to
    establish high-quality chemical libraries that provide scientists with
    powerful tools for discovering potential new drugs, and a portfolio of
    grants designed to stimulate the development of new molecular imaging
    technologies that can be harnessed to visualize the actions of
    individual molecules over time in living cells. The effort to create,
    distribute, and apply these tools will be tremendously enhanced by
    initiatives that are part of the Roadmap.

                  TEAM SCIENCE AND INTERDISCIPLINARY TRAINING

        The increasingly complex nature of biomedical research today
    demands new approaches to carrying out the scientific enterprise. NIGMS
    has been at the forefront of addressing this issue, especially in its
    support for ``team science''--interdisciplinary research that seeks to
    combine the skills and expertise of scientists from diverse fields and
    backgrounds. And now as part of another major theme in the NIH
    Roadmap--Research Teams of the Future--NIGMS is bringing its own
    experience to the table to help build successful synergies in large-
    scale research collaborations, and to help prepare the next generation
    of biomedical scientists trained in multiple disciplines.
        For example, NIGMS has led the way in supporting cross-disciplinary
    research and training through its Medical Scientist Training Program--
    which leads to the combined M.D.-Ph.D. degree and produces
    investigators who can bridge the gap between basic and clinical
    research. Other NIGMS programs support training in the cellular,
    biochemical, and molecular sciences; systems and integrative biology;
    the pharmacological sciences; genetics; molecular biophysics;
    biotechnology; the chemistry-biology interface; and bioinformatics and
    computational biology.
        Many NIGMS research and training programs combine both the
    biological sciences--cellular and molecular biology, genetics--and the
    quantitative sciences--physics, chemistry, engineering, mathematics.
    Indeed, bringing together these two scientific cultures is essential if
    we are to continue to make important advances in biomedical research in
    the 21st century. That growing realization has spurred a flurry of
    activity in recent years. For example, NIGMS joined forces with the
    National Science Foundation in 2002 to launch an initiative to
    encourage the use of mathematical tools and approaches to study
    biology. NIGMS is also partnering with the NIH Office of Science
    Education on a program to transform undergraduate biology education by
    incorporating examples and perspectives from the quantitative sciences
    into biology courses. This program responds to the National Research
    Council's Bio2010 report.
        NIGMS also has a long-standing commitment to increasing the number
    of underrepresented minorities engaged in biomedical research. Through
    our Division of Minority Opportunities in Research, NIGMS takes a
    leading role at NIH to encourage and prepare minority students to
    pursue training for scientific careers and to enhance the science
    curricula and faculty research capabilities at institutions with
    substantial minority enrollments. Both these programs and the efforts
    to train and recruit more scientists from the physical sciences into
    biomedical research are essential if we are going to have the
    biomedical workforce necessary to solve the challenging problems that
    lead to human disease and drive up the costs of providing health care.

                    BALANCING LARGE- AND SMALL-SCALE SCIENCE

        As promising and worthwhile as these major initiatives are, we must
    not lose sight of NIGMS' mainstay over the past four decades:
    investigator-initiated research. By encouraging the best and brightest
    basic scientists to pursue new directions in their fields, NIGMS has
    made tremendous contributions to advancing biomedical science. It is
    often a single investigator, supported by a single grant, who discovers
    something that turns out to be the tip of a very important iceberg. And
    we must continue to support these creative minds in order to sow the
    seeds for tomorrow's advances.
        At the same time, we must recognize the need to invest
    strategically in targeted, larger-scale research to meet the critical
    needs of ensuring the nation's health and well-being, its technological
    competence and competitiveness, and its security. In short, we need to
    balance small- and large-scale science in a way that both catalyzes and
    capitalizes on innovation. With our experience in managing thousands of
    individual research grants every year along with a growing number of
    multi-institutional, multidisciplinary research efforts, NIGMS can
    strike that balance while leaving open the door to future directions
    that are still beyond our powers of prediction.
        Thank you, Mr. Chairman. I would be pleased to answer any questions
    that you may have.
                                     ______

                   Prepared Statement of Dr. Story C. Landis

        Mr. Chairman and Members of the Committee, I am Story Landis,
    Director of the National Institute of Neurological Disorders and Stroke
    (NINDS). I am pleased to present the President's budget request for
    NINDS for fiscal year 2005. The fiscal year 2005 budget includes
    $1,546,623,000, an increase of $44.9 million over the fiscal year 2004
    enacted level of $1,500,693,000 comparable for transfers proposed in
    the President's request.
        The mission of the NINDS is to reduce the burden of neurological
    disorders by finding ways to prevent or to treat these diseases. When I
    began as Director about six months ago, one of my first priorities was
    to meet with voluntary groups representing patients and their families.
    So far, I have met with more than 40 groups, and this remarkable
    experience has educated me about the extraordinary range of diseases
    within the NINDS mission, the power of their impact, and the urgency of
    finding ways to prevent or treat these disorders. These discussions
    also reinforce the importance of increasing public-private
    partnerships, which is a goal of our Institute, as well as a major
    focus of the NIH Roadmap process.
        My own research has focused on fundamental questions about how the
    nervous system develops how genes help wire up connections in the
    brain, how cells choose to become a particular type, and whether there
    is any ``plasticity'' in this process. Issues such as these, long
    central to basic neuroscience research, are now at the crux of efforts
    to devise treatments for neurological diseases. I am encouraged by the
    prevention and treatment strategies emerging from the investment in
    basic research drugs to home in on the molecules that cause disease,
    stem cells to repair the damaged nervous system, natural neurotrophic
    factors to promote survival and growth of brain cells, ``vaccines'' to
    prevent stroke, implantable stimulation devices to compensate for brain
    circuits unbalanced by disease, therapies to turn off, repair or
    replace defective genes, neural prostheses to read control signals
    directly from the brain, and behavioral and drug interventions to
    encourage the ``plasticity'' of the brain and spinal cord to compensate
    for damage. The NINDS must continue to support basic research. We must
    also re-energize our efforts to translate opportunities into practical
    therapies. Today I will highlight a few of the ways we are working to
    bring people and resources together to accomplish that.

                                   STEM CELLS

        Neural stem cell biology is one area in which basic science and
    clinical promise are so closely intertwined that it is easy to forget
    the origins of our understanding of neural stem cells in very basic
    research. The generation of new neurons in the adult brain was
    discovered when a basic scientist sought to understand how male
    canaries learn a new song each spring. This year, NINDS researchers
    have contributed to advances in identifying and isolating adult neural
    stem cells, in understanding the signals that control embryonic and
    adult neural stem cells, and in developing stem cell therapies in
    animal models that show promise for Parkinson's disease, demyelinating
    diseases, such as Canavan, Krabbe, or Tay-Sachs, and many other
    disorders. The NINDS has helped foster research on embryonic and adult
    stem cells through several initiatives, including training programs in
    the use of approved human embryonic stem cells, grant supplements to
    compare these to cells from other sources, and scientific workshops. An
    NINDS intramural researcher also leads a new NIH facility that is
    characterizing the approved human embryonic stem cell lines. For the
    coming year, an initiative targeting collaborative research in stem
    cell biology, designed to bring together teams of experts from several
    areas of stem cell biology, is a high priority.

                          GENES AND THE NERVOUS SYSTEM

        Genetics is another neuroscience research area that has made
    astonishing progress. Overall, researchers have identified more than
    200 genes that can cause neurological disorders. Gene findings in the
    past year are relevant to diseases such as Parkinson's disease,
    Charcot-Marie-Tooth disorder, and cerebral cavernous malformations,
    which can predispose people to strokes. Discoveries such as these lead
    to improved diagnosis, development of animal models, and the first
    clues to what underlies disease processes and how to stop them.
        Several NINDS efforts bring people and resources together in
    genetics. Some are simple, but important, such as programs to promote
    sharing of transgenic mice that are essential models of human diseases.
    Others are more ambitious, such as the Gene Expression Nervous System
    Atlas (GENSAT) project, which will map the activity of thousands of
    genes in the brain and provide genetically engineered mouse strains
    that allow scientists to study how these genes contribute to health and
    disease. Microarray screening centers make another new technology and
    the data arising from it widely available. Microarrays allow scientists
    to simultaneously monitor the activity of virtually all genes, with
    wide potential applications to basic and clinical neuroscience; for
    example, recent studies show micrarrays may predict which patients will
    respond to approved drugs for multiple sclerosis. The NINDS Human
    Genetics Resource Center, established this year, makes DNA samples,
    immortalized cell lines, and accompanying clinical and pedigree data
    available to all qualified researchers. The repository currently
    contains samples related to stroke, epilepsy, Parkinson's disease, and
    motor neuron diseases, including amyotrophic lateral sclerosis (ALS)
    and spinal muscular atrophy (SMA).

                             TRANSLATIONAL RESEARCH

        ``Translational research'' encompasses the many steps that are
    needed to move from basic research insights to a therapy that is ready
    for human testing in clinical trials, and the NINDS has a long history
    of programs in this arena. For example, over three decades, the Neural
    Prosthesis program has supported research on electronic and mechanical
    devices that help compensate for abilities lost through disease or
    injury, including pioneering research on direct brain control of
    prostheses, which has recently become a focus of such forward thinking
    agencies as the Defense Advanced Research Projects Agency (DARPA). The
    NINDS has responded to increasing opportunities by developing a
    comprehensive translational research program that fosters cooperative
    efforts, provides peer review criteria tailored to the needs of
    translational research, and utilizes milestone driven funding, which is
    common in industry. In fiscal year 2003, the Institute funded the first
    projects in this program, focused on gene and stem cell therapies for
    Parkinson's disease, neuroprotectants for stroke and trauma, treatments
    for brain tumor, and drugs for epilepsy, ALS and Huntington's disease.

                  DRUG DEVELOPMENT FOR NEUROLOGICAL DISORDERS

        New and expanding efforts to develop drugs complement the broad
    translational program. The NINDS has awarded a contract for a high
    throughput screening (HTS) facility, and solicited proposals for the
    development of disease-related screening tests. HTS uses robotics to
    rapidly test large numbers of chemicals to find lead compounds for drug
    development and use as research tools. Ongoing screening efforts focus
    on ataxia telangiectasia, ALS, and Parkinson's disease. Several NIH
    institutes are working together to develop chemical libraries focused
    on the brain, and the NIH Roadmap ``Molecular Libraries'' component
    will directly facilitate screening efforts such as these.
        Another NINDS drug development effort is a longstanding public-
    private partnership. Since 1975, the NINDS Anticonvulsant Screening
    Project has worked with more than 140 companies and 230 academic
    institutions to test more than 20,000 compounds for anti-convulsant
    properties, including several drugs now in clinical use. Guided by the
    epilepsy benchmarks planning process, the Institute is expanding this
    program with increased focus on preventing the development of epilepsy
    and on treatment-resistant epilepsy. The NIH Roadmap ``Structural
    Biology'' goals to improve our understanding of membrane proteins, such
    as ion channels that are implicated in some types of epilepsy and
    neurotransmitter receptors that are often the targets for drugs, will
    have an important impact on future efforts to develop drugs for this
    and many other neurological disorders.
        Some drugs developed for epilepsy have shown promise for other
    diseases, such as chronic pain. To take advantage of that kind of
    crossover, observed in many areas of medicine, the NINDS worked closely
    with academia and voluntary disease organizations to develop a
    consortium of 26 laboratories to screen a set of 1,040 known drugs,
    mostly approved by the U.S. Food and Drug Administration (FDA) for
    other uses, for potential use against neurodegenerative diseases. The
    Consortium is sharing data on 29 laboratory screening tests based on
    molecules, cells in culture, or simple organisms. Several promising
    drugs have moved to further testing in animals, and a few may move soon
    to clinical trials.

             PROGRAM TO ACCELERATE THERAPEUTIC DEVELOPMENT FOR SMA

        Valproic acid is one example of a drug, now used for the treatment
    of epilepsy, that in the past year has shown promise in cell culture
    for a different disease, spinal muscular atrophy (SMA). SMA is the most
    common single gene cause of infant mortality. In recent years,
    scientists have discovered the gene defects that cause SMA, developed
    animal models that mimic essential aspects of the human disease, and
    devised plausible strategies for developing therapies. Because of the
    impact of SMA and the state of the science, the NINDS chose this
    disease as the focus of an innovative approach, initiated in fiscal
    year 2003, to expedite the development of therapies. The performance-
    based contract mechanism accelerates all steps from recognition of a
    research need, through solicitation and review, to funding of targeted
    research subprojects, with guidance by an expert steering committee
    that takes a very active role in driving the process. If successful,
    this approach might be applied to other diseases.

                    MUSCULAR DYSTROPHY AND CENTERS PROGRAMS

        The muscular dystrophies are another group of inherited disorders
    that are a high priority for NIH. Researchers, beginning more than a
    decade ago, have identified defects in several genes that can cause the
    various kinds of muscular dystrophy. These findings have brought
    improved understanding of what causes these diseases, better animal
    models to develop therapies, and some practical benefits for example, a
    new diagnostic test for Duchenne muscular dystrophy will eliminate the
    need for painful muscle biopsy in many children, and help identify
    female carriers of the disease before they pass it on to their sons.
    Therapies to slow or stop muscular dystrophies have been elusive, but
    there have been encouraging results recently in animals using drugs,
    stem cells, and gene therapy approaches. To expedite progress against
    the muscular dystrophies, the NIH has funded three Senator Paul D.
    Wellstone Muscular Dystrophy Cooperative Research Centers, with the
    expectation that up to three more will be funded competitively in
    fiscal year 2005. The NIH is also working together with the broadly
    representative interagency Muscular Dystrophy Coordinating Committee
    (MDCC) on developing a muscular dystrophy research and education plan
    for NIH.
        The NINDS, often working with other components of NIH, has several
    centers programs, such as the Morris K. Udall Parkinson's Disease
    Centers of Excellence, the Specialized Programs of Translational
    Research in Acute Stroke (SPOTRIAS), the Studies to Advance Autism
    Research and Treatment (STAART), and the Specialized Neuroscience
    Research Program (SNRP), which encourages minority scientists and
    addresses health disparities in neurological disorders. Other centers
    focus on disorders such as brain tumor, spinal cord injury, and head
    trauma.

                                CLINICAL TRIALS

        The NINDS continues to set standards of quality and innovation in
    clinical trials that evaluate whether potential treatments or
    preventive measures are safe and effective. One recent example, the
    Neuroprotection Exploratory Trials in PD (NET-PD), was launched in
    April 2003 to evaluate drug therapies that might slow the progression
    of Parkinson's disease. The project rigorously selected candidate drugs
    from a broad array of potential compounds identified by working with
    clinicians and researchers throughout academia and industry. The 42
    clinical sites have recruited individuals with early, untreated
    Parkinson's, and early phase trials of four drugs will be completed in
    early 2005. In the coming year, the NINDS clinical trials program is
    also working to train researchers to conduct clinical trials and to
    develop a broad clinical trials network that will encompass the greater
    community of neurologists. Clinical trials for neurological disorders
    is another area in which the cross-cutting NIH Roadmap efforts for
    ``Re-engineering the Clinical Research Enterprise'' are likely to have
    a major impact.

                              INTRAMURAL PROGRAMS

        Before becoming the director of NINDS, I led the Institute's
    intramural program on the NIH campus in Bethesda, MD, which is one of
    the largest basic and clinical neuroscience programs in the world. In
    addition to recruiting superb individual scientists in fields such as
    ion channels, genetic diseases of the nervous system, brain tumors, and
    stroke, a central focus of the program has been to bring researchers
    together from disparate fields of science. To this end, the Porter
    Neuroscience Research Center, opening its first phase in 2004, brings
    together scientists from eight institutes to ``put the brain back
    together'' by overcoming artificial disciplinary boundaries within and
    across institutes and by setting the standard for collaborative
    research in neuroscience.

                           FUTURE COOPERATIVE EFFORTS

        I have mentioned a few areas in which the NIH Roadmap efforts will
    facilitate our efforts against neurological diseases, but the same can
    be said of virtually every major effort within the Roadmap. Driven by
    the science, several NIH components that have a major focus on the
    brain are also increasingly working together to form a ``blueprint for
    the brain,'' in which cooperative efforts across Institutes can
    expedite progress. These Institutes already cooperate extensively in
    areas such as training of researchers, genetics, autism, muscular
    dystrophy, health disparities, brain tumors, stroke, and pediatric
    neuroimaging, to name a few examples. I hope to report to you in the
    future about progress in forming other cooperative ventures aimed at
    our common goal of finding better ways to prevent or to treat all
    disorders that affect the brain and other parts of the nervous system.
        Thank you, and I would be pleased to answer questions.
                                     ______

                  Prepared Statement of Dr. Stephen E. Straus

        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's fiscal year 2005 budget request for the National Center
    for Complementary and Alternative Medicine. The fiscal year 2005 budget
    includes $121.1 million, an increase of $4.2 million over the
    comparable fiscal year 2004 appropriation of $116.9 million.

                                  INTRODUCTION

        Five years ago, recognizing the increasing public health
    opportunities of complementary and alternative medicine (CAM) and the
    challenges to research in this area, Congress elevated the NIH Office
    of Alternative Medicine to the National Center for Complementary and
    Alternative Medicine (NCCAM). Several months later, as NCCAM's first
    Director, I articulated a set of priorities for the Center that
    emphasized growth in the portfolio of rigorous research project grants,
    enhanced investments in research training and careers awards to build
    an effective CAM research collective, creation of an intramural
    research program (IRP), and commitment of stable funding for research
    centers. As we embark on planning our second 5 years of work, I am
    pleased to report that NCCAM has achieved these and many other critical
    objectives.
        NCCAM's success to date is evident in some of its vital statistics:
      --Under the President's proposed fiscal year 2005 budget, NCCAM's
            investment in research project grants will have increased from
            approximately $10 million in 1999 to almost $76 million, while
            funding for research training and career awards will have
            increased from under $1 million in 1999 to approximately $8.8
            million.
      --In collaboration with other NIH Institutes and Centers (ICs), NCCAM
            has launched nine multi-center Phase III clinical trials of
            popular CAM interventions for chronic illnesses that affect so
            many Americans, including osteoarthritis, dementia, cancer, and
            coronary artery disease.
      --NCCAM established an intramural research program in 2001, which
            studies CAM approaches to diseases of aging, including
            arthritis, depression, muscle wasting, cancer, pain, and
            diabetes.
      --Based on a comprehensive external review, NCCAM refined its
            research centers program to support rigorous investigations at
            both traditionally research-intensive and CAM institutions. In
            2003, NCCAM made its first round of revised center awards in
            three categories: Centers of Excellence for Research on
            Complementary and Alternative Medicine, Developmental Centers
            for Research on Complementary and Alternative Medicine, and
            Planning Grants for International Centers for Research on
            Complementary and Alternative Medicine. NCCAM's Centers program
            will foster capacity in CAM research, catalyze more effective
            and essential partnerships between CAM institutions and
            research-intensive universities, and facilitate the integration
            of effective CAM therapies with conventional medical
            approaches.
        Already, the nearly 800 projects that NCCAM has supported since
    1999 have yelded over 700 scientific publications, including some that
    were published in the most prestigious journals--Journal of the
    American Medical Association, New England Journal of Medicine, and
    Proceedings of the National Academy of Sciences. Complementing these
    research and research training activities are extensive efforts to
    communicate research results and other critical information about CAM
    to the public and practitioners. NCCAM's award-winning Web site is
    visited over 1.5 million times each year for its 90 fact sheets,
    consumer alerts, news releases, and announcements of new research
    initiatives. In a partnership with the National Library of Medicine,
    NCCAM helped create a CAM subset on the reference database PubMed that
    now hosts nearly 400,000 reports about CAM studies, which are available
    to anyone with Internet access. In the aggregate, the investments made
    in NCCAM's first 5 years are already informing the health care
    decisions Americans make at home and in consultation with their
    practitioners.
        In its first 5 successful years, NCCAM has become fully integrated
    within the NIH, developing a research agenda that is responsive to its
    mission, fiscally accountable, and supportive of rigorous CAM research.
    NCCAM's research priorities today encompass six thematic areas in which
    CAM can have a public health impact: obesity, botanicals, brain-body
    interactions, acupuncture, neurodegenerative diseases, and HIV/AIDS.
    The next section highlights some of the advances and activities in
    three of these priority areas.

                        ADDRESSING THE OBESITY EPIDEMIC

        An alarming 65 percent of American adults,\1\ 16 percent of
    adolescents, and 10 percent of American children are now overweight.\2\
    Obesity results from complex interactions among human biology,
    behavior, and the environment and, therefore, requires a
    multidisciplinary approach to prevent and treat it. NCCAM is
    contributing to the trans-NIH strategy to address this epidemic by
    supporting studies of the safety and efficacy of popular, but
    unsubstantiated, dietary approaches to obesity and its many
    complications. One of the most popular approaches today is the diet
    plan championed by the late Dr. Robert Atkins, which emphasizes a low-
    carbohydrate, high-fat, high-protein regimen.
    ---------------------------------------------------------------------------
        \1\ Journal of the American Medical Association, 288 (14): 1723-
    1727, Flegal et al, ``Prevalence and trends in obesity among U.S.
    adults, 1999-2000''
        \2\ Journal of the American Medical Association, 288 (14): 1728-
    1732, Ogden et al, ``Prevalence and trends in overweight among U.S.
    children and adolescents, 1999-2000''
    ---------------------------------------------------------------------------
        In fiscal year 2003, NCCAM-sponsored researchers reported in the
    New England Journal of Medicine on a ground breaking 1-year, multi-
    center trial about the effects of the Atkins diet on weight loss and
    risk factors for cardiovascular disease. At 6 months, those on the low-
    carbohydrate diet had lost more weight and had reduced levels of blood
    lipids more than those on the conventional diet. At the end of 1 year,
    however, the differences between the two groups of dieters lessened,
    leading investigators to call for larger and longer-term studies. NCCAM
    is working with its NIH partners to support a larger and more
    definitive study.
        In its intramural program, NCCAM researchers are testing whether
    the dietary supplement glucosamine, used by over 4 percent of older
    Americans for degenerative arthritis, causes resistance to insulin, a
    condition that predisposes one to diabetes--a disease linked to
    obesity. Other IRP studies are evaluating carnitine, a nutrient
    essential for the normal metabolism of fats, to see whether it can
    reduce abdominal fat content, stimulate weight loss, and improve
    glucose utilization.
        In fiscal year 2005, as part of the overall trans-NIH focus on
    obesity, NCCAM will cosponsor two major initiatives in obesity
    research, Neurobehavioral Basis of Obesity and Prevention and Treatment
    of Pediatric Obesity in Primary Care Settings. The first seeks to
    bridge the gap between understanding the molecular and genetic
    regulation of food intake and behavioral influences on obesity. The
    pediatric initiative will evaluate preventive and therapeutic
    strategies for obesity that could be recommended for children and
    adolescents in primary care settings, such as a physician's office,
    primary care clinic, or HMO.

          EXAMINING THE SAFETY AND EFFECTIVENESS OF BOTANICAL PRODUCTS

        Approximately 14 percent of Americans use herbal supplements to
    prevent disease, maintain wellness, or treat illness or pain.\3\ Many
    of these people also take prescription drugs. NCCAM-supported research
    is identifying herbal products that interact with drugs and the
    underlying biochemical mechanisms of these interactions. For example,
    studies have shown how St. John's wort and PC SPES (a botanical mixture
    that had been used to treat advanced prostate cancer) induce the
    activity of a key liver enzyme that is responsible for the metabolism
    of some 80 percent of all drugs. This finding shows how herbal
    supplements have the potential to either enhance a drug's toxicity or
    reduce a drug's effectiveness when a patient takes both dietary
    supplements and prescription medication.
    ---------------------------------------------------------------------------
        \3\ Journal of the American Medical Association, 287 (3); 337-344;
    Kaufman et al., ``Recent patterns of medication use in the ambulatory
    adult population of the United States: the Slone survey.''
    ---------------------------------------------------------------------------
        Each year in the United States, an estimated 70,000 people are
    diagnosed with head and neck cancers, which are typically resistant to
    multi-drug chemotherapy. In fiscal year 2003, NCCAM-sponsored
    researchers examined extracts from the root of Scutellaria baicalensis,
    a Chinese herb, for activity against head and neck cancers. The new
    study is promising because it shows that the herbal extracts strongly
    inhibit the growth of human head and neck cancer cells in vitro as well
    as in mice with tumors composed of human cells. Future studies will
    determine the herb's effects on regulating the cell replication cycle
    and whether it can be translated into a safe and effective intervention
    for head and neck cancer patients.
        While some research studies confirmed the promise of certain
    botanicals, others have found herbs that do not deliver on their
    claims. One example is guggulipid, a botanical extracted from the resin
    of the mukul myrrh tree, that is marketed in the United States as a
    dietary supplement to help control blood cholesterol levels and
    maintain a ``healthy heart.'' In an 8-week placebo-controlled study
    involving over 100 subjects, NCCAM-funded scientists found that neither
    the standard or even higher doses of guggulipid significantly lowered
    the levels of the key low-density lipoprotein (LDL) form of cholesterol
    in people with high blood cholesterol. This study highlights the need
    to study popular botanicals that the public is using so that
    individuals can make informed decisions regarding their own care.
        In fiscal year 2005, NCCAM will co-sponsor three important
    initiatives on the use of botanicals as dietary supplements. Through a
    newly refined Botanical Research Centers Program being mounted with the
    NIH Office of Dietary Supplements and the National Institute of
    Environmental Health Sciences, NCCAM will support interdisciplinary
    studies of botanicals to generate evidence regarding their safety and
    potential public health benefits. NCCAM also plans to establish a Phase
    I Resource Center (PRC) to define the pharmacology and optimal dosing
    of botanical products and functional foods. Finally, in fiscal year
    2005, NCCAM plans to initiate in vitro, animal, and preliminary
    clinical studies of Silybum marianum (milk thistle) and its derivative
    silymarin as a treatment for chronic hepatitis and cirrhosis of the
    liver, conditions that affect millions of Americans for whom, to date,
    there is no effective treatment.
        Through these programs, NCCAM thoughtfully is investing in programs
    of basic research to discover natural products and food supplements
    that could open new avenues for prevention and treatment of conditions
    that affect the health, well being, productivity, and quality of life
    of millions of Americans.

                     INVESTIGATING BRAIN-BODY INTERACTIONS

        NCCAM scientists are exploring ancient practices such as
    meditation, Tai Chi, hypnosis, and yoga to understand their abilities
    to harness the healing effects of the mind on the body. For example,
    NCCAM grantees are conducting pilot studies of yoga as a behavioral
    intervention for the management of chronic obstructive lung disease,
    insomnia, and chronic low back pain, as well as investigating whether
    one's spirituality and religiosity have a significant influence on
    immune system functioning.
        In 2003, NCCAM-funded researchers reported that a traditional
    Chinese meditative exercise regimen, Tai Chi, could enhance physical
    performance and immune responses in older people. As people age,
    immunity to the virus that causes chicken pox wanes until the infection
    can reactivate from its dormant state in nerves and develop into the
    painful condition shingles. The study concluded that older adults who
    participated in a form of Tai Chi for 15 weeks experienced
    statistically significant increases both in ellular immune responses to
    the virus and in physical performance. This is the first scientific
    study to show that a CAM approach is responsible both for improvements
    in physical function and in virus-specific immunity and provides the
    basis for a larger study of Tai Chi currently being supported by NIH.
        To further stimulate research in the field of brain-body
    interactions, NCCAM is a cosponsor of several NIH research initiatives.
    The first effort, entitled Mind-Body Interactions and Health:
    Exploratory/Developmental Research Program, will foster program
    development at institutions that have high potential for advancing
    mind-body and health research. The second initiative, Research on Mind-
    Body Interactions and Health, will support interdisciplinary
    collaborations and innovations to understanding the underlying
    processes of mind-body interactions and health and translating basic
    knowledge into interventions and clinical practices.

                                LOOKING FORWARD

        Five years ago, the discipline of rigorous CAM research was in its
    infancy. Absent precedents for the field, NCCAM's initial efforts led
    to supporting an array of studies spanning numerous CAM practices and
    health conditions. In these first years, NCCAM found that to better
    ensure that its funds yield compelling results, it needed to encourage
    studies on mechanisms of action of CAM approaches, well-developed Phase
    I and II clinical trials as a foundation for future definitive studies,
    and collaborations between CAM and research-intensive institutions. In
    the coming years, the Center will refine its research priorities even
    more, to emphasize those areas and conditions for which CAM can have
    the greatest health impact. To this end, in 2004, NCCAM began a formal
    process to seek input from its many stakeholders, including the
    scientific community, health professionals, and the public to further
    target its research, training, and communication goals and to craft a
    long-term plan to guide the way toward its tenth anniversary.
        Complementing this strategic planning process are the trans-NIH
    Roadmap for Medical Research activities in which NCCAM leadership has a
    significant role. Core themes of the Roadmap resonate strongly with
    NCCAM because they promise to provide NCCAM grantees access to more
    sensitive technologies, richer environments for learning and conducting
    interdisciplinary research, and a re-engineered platform for clinical
    trials, all in ways that small institutes and centers could never
    achieve on their own.
        In the coming months and years, I look forward to sharing with
    members of the Committee, the scientific community, practitioners, and
    the public our second strategic plan and the results of the research
    and training investments that we have made. Thank you for your interest
    in NCCAM's progress and plans. I would be pleased to answer any of your
    questions.
                                     ______

                    Prepared Statement of Dr. Kenneth Olden

        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's budget for the National Institute of Environmental
    Health Sciences (NIEHS). The fiscal year 2005 budget is $650,027,000,
    an increase of $18,964,000 over the comparable fiscal year 2004
    appropriation.

                                  INTRODUCTION

        Most complex diseases arise from the interplay between biology,
    environment and behavior. It is the NIEHS' mission to understand this
    interplay as it translates into increased disease risk. Thanks to the
    rare confluence of technology breakthroughs in analysis of genes and
    proteins and their recent application to the environmental health
    sciences, gene-environment interactions can now be investigated with
    more rigor and specificity. Our new opportunities within the framework
    of the NIH Roadmap also offer promise for a more rapid understanding
    and translation of this knowledge into improved public health. I will
    outline several of the NIEHS' most important efforts.

                             GENES AND ENVIRONMENT

        There are two principal avenues for exploration of the complex
    interplay between genes and environment. One is to look at the
    variations of genes themselves, and the other is to examine how genes
    respond to environmental stressors. In the case of the first approach,
    NIEHS is conducting the Environmental Genome Project (EGP) an effort to
    resequence 544 ``environmentally responsive'' genes--genes which are
    thought to be involved in an individual's susceptibility to
    environmental exposures--and to identify alleles or genetic variants
    associated with these genes. The key objective of the EGP is to
    discover and characterize these alleles or genetic variants, called
    polymorphisms, and to define their roles in the pathways by which
    environmental agents exert their effects on human health and disease.
        Last April, the EGP completed the first phase, publishing a catalog
    of variation in over 200 genes responsible for detoxifying
    environmental compounds such as pesticides, as well as metabolizing
    natural biological components such as hormones. Over 17,000 single
    nucleotide polymorphisms (SNPs) were identified, with more than 1,000
    in coding sequences. This information is already being used to make
    significant scientific discoveries. For example, it was found that
    people suffering from benzene-induced leukemia lack a certain SNP in
    the gene responsible for utilizing a vitamin B, folate, that healthy
    people have. Thus, the ability to metabolize folate might relate to the
    relative risk of developing leukemia among benzene workers.
        To aid in the functional characterization of SNPs in both coding
    and regulatory sequences of specific genes, NIEHS initiated the Mouse
    Genetic Variation Mapping Initiative. The mouse is the most widely used
    mammalian model system for the study of human health and disease for
    several reasons, including the fact that the genomes of mice and other
    mammals are highly conserved. Most human genes have counterparts in the
    mouse genome; thus, cloning of a gene in one species often leads to
    cloning of the corresponding gene in the other. The mouse also offers
    well developed toxicological and pathology databases and molecular
    genetic techniques for construction of gene knockout strains. Data
    generated using rodent models have been used widely in preparation of
    environmental regulatory policy and by the pharmaceutical industry.
        One of the greatest challenges for comparative toxicogenomics is
    the integration of the vast amount of genomic information being
    generated for a variety of model organisms. At present, there are
    several disparate but complementary databases on genomic sequences.
    Most of these databases provide data on gene and genome sequences for
    individual animal species. These databases do not provide a means to
    link the genome data to specific environmental chemicals or to
    toxicological and biological endpoints. They also do not enable
    researchers to compare information about potentially similar genes and
    biological responses across multiple species.
        Integrating the large number of disparate data sets is the goal of
    the Comparative Toxicogenomics Database (CTD). The CTD was developed
    through a collaboration of five NIEHS-funded Marine and Freshwater
    Biomedical Sciences Centers. The goal of the CTD is to develop a
    comparative database that links sequence information for genes that are
    relevant to toxicology to information about gene expression, toxicology
    and biological processes. The primary focus of the CTD is on marine and
    aquatic organisms as model systems for human diseases. The initial
    focus is also on genes that have been identified through the NIEHS' EGP
    as important for toxicology in these model systems. However, the
    database will eventually merge all gene sequence information generated
    on all vertebrates and invertebrates, including aquatic organisms,
    worms, flies, rodents, and people. The CTD provides information about
    gene curation and annotation (gene synonyms, sets and functions) and
    links between gene sequence and toxicity data published in the
    scientific literature. These aspects of the database represent an
    important advancement for comparative toxicogenomics. Understanding
    these mechanisms will allow more informed assessment of human risk by
    extrapolating toxicity data from animal models to people and will
    provide a mechanism by which members of the research community can
    share their data and promote fruitful avenues for future toxicological
    research.
        At present, the CTD is the only fully curated, publicly available
    database of its kind in the world. However, it serves as a prototype
    database and data resource for more comprehensive efforts ongoing at
    the NIEHS. The centerpiece for these discoveries is the NIEHS' National
    Center for Toxicogenomics (NCT), which uses a multidisciplinary
    approach to identify genes and proteins affected by specific
    environmental exposures. When a person is exposed to a chemical,
    physical, or biological agent, cells in the body may respond by
    switching on some genes and switching off others, potentially changing
    the proteins that are produced by the cells. The on/off pattern of
    various genes is different for each specific exposure, creating a
    characteristic pattern or ``signature,'' which scientists hope will be
    useful in classifying chemicals by their effects on various cellular
    processes. By constructing and populating a database of chemical
    effects on biological systems, the NCT is assisting the field of
    environmental health research to evolve into an information science in
    which gene and protein expression datasets are compiled and made
    readily available to the scientific community. By building on the data
    infrastructure being developed through the CTD and other databases,
    NIEHS scientists are developing the sequence-driven and context-
    documents Chemical Effects in Biological Systems (CEBS) knowledge base.
    CEBS is planned as a public toxicogenomics knowledge base that combines
    and integrates scientific data from a multitude of public domain data
    sources. These data sources include studies of genetic polymorphisms,
    gene expression and proteomics, metabolism and toxicology. Once
    sufficient high quality data have been accumulated and assimilated, it
    will become possible to characterize an unknown environmental exposure
    by comparing its gene and/or protein expression profile to compendia of
    expression profiles in the database. Ultimately, the NCT will develop
    the capacity to use gene expression signatures and other data to
    facilitate characterization of toxicants and their biological effects.
    Through the predictive capabilities expected from toxicogenomics,
    adverse toxicity in clinical trials will be reduced and the efficiency
    of bringing new therapeutics to the public will be increased; adverse
    effects from long-term use or from combinations of therapeutic agents
    will be better understood and reduced. The final payoff for investing
    in CTD and CEBS will be more rational environmental health policy and
    an improved understanding of gene-environment contributions to the
    major causes of human death and disease.

                            OBESITY AND ENVIRONMENT

        Environment and behavior intersect in fundamental ways,
    intersecting with our biology but also with each other. In no area of
    public health is this more apparent than with the problem of obesity.
    There is a growing body of literature that illustrates the negative
    physical and mental health effects of unregulated and poor urban,
    rural, and suburban development and planning. These studies have
    documented increased rates of obesity, diabetes, depression, anxiety,
    and heart disease in these poorly developed areas. For example, in
    sprawling communities, higher dependence on motor vehicles has resulted
    in polluting the atmosphere with ground-level ozone and particulate
    matter, contributing to human health problems such as lung and
    cardiovascular disease. People most affected by air pollution include
    older adults with pre-existing diseases; children, especially those
    with asthma; persons with inadequate health care; and even healthy
    individuals who work and exercise outdoors. Lack of safe sidewalks in
    growing urban areas has resulted in a reduction in the number of
    children walking or biking to schools. Today, only 10 percent of
    children walk or bicycle to school--a 40 percent reduction over the
    last 20 years (according to researchers in Urban Land). Research
    suggests that inadequate urban planning, such as a lack of bike paths
    and sidewalks, results in a more sedentary lifestyle of children,
    which, in turn, may be a factor in the growing rates of childhood
    obesity. All of these examples demonstrate how the physical or built
    environment influences choices that ultimately affect health.
        The NIEHS is designing a program as part of the trans-NIH obesity
    initiative which is designed to examine how the built environment
    affects obesity and the effectiveness of changes in community planning,
    design, and development in reducing the extent of obesity and
    associated comorbidities. These intervention research projects will
    develop tools to characterize and measure individual and population-
    level indicators of healthful communities--and of residents' lifestyles
    and behaviors--that prevent or reduce obesity. We hope that not only
    will studies of interaction between parameters of the built environment
    and individual lifestyle choices and behaviors help delineate factors
    that can prevent or reduce obesity, but also that this work will point
    the way towards new, cost-effective intervention strategies that
    promote healthful environments and behaviors.
        In a related initiative, NIEHS is partnering with the Robert Wood
    Johnson Foundation to support a program called Active Living by Design,
    which will provide support to 25 communities across the country to
    implement active living programs, policies, and communication
    strategies to improve community development and promote more healthy
    lifestyles. The NIEHS is providing an evaluation component to the
    program to determine the efficacy of various policies and promotions in
    reducing obesity.
        It is critical to delineate the role and impact of community
    design, planning, and development on individual and population health
    by understanding the contribution of urban/rural planning (i.e., land
    use decisions), housing structure, transportation issues, and the
    availability of public and green spaces as determinants of mental
    health, physical activity, nutrition, and access to healthy foods. In
    turn, modifying such parameters may reduce the prevalence of obesity in
    adults and children. This research effort will require integrated,
    interdisciplinary research teams, including biomedical scientists,
    behavioral scientists, social scientists, clinicians, epidemiologists,
    urban planners, developers, and architects, as well as active
    participation of community members. It is expected that such research
    will result in a greater understanding of the health benefits of living
    in communities that promote healthful environments and behaviors and
    may also impact policy for land use and public health.

                TOXICOLOGICAL EVALUATION OF NANOSCALE MATERIALS

        Nanoscale materials are a broadly defined set of substances where
    at least one critical dimension is less than 100 nm. Ultrafine
    particulate matter, e.g. the very smallest particles of soot from such
    sources as diesel exhaust, is a well-known example of ambient
    nanoparticles; however, this initiative will initially focus on
    manufactured nanomaterials of current or projected commercial
    importance. Nanoscale materials can in theory be engineered from nearly
    any chemical substance; semiconductor nanocrystals, organic dendrimers,
    and carbon fullerenes and carbon nanotubes are a few of the many
    examples. Nanoscale materials are already appearing in commerce as
    industrial and consumer products and as novel drug delivery
    formulations. Commercial applications and resultant opportunities for
    human exposure may differ substantially for nanoscale vs. ``bulk''
    materials.
        Currently there is very little research focus on the toxicology of
    manufactured nanomaterials. Studies from the ultrafine particle
    inhalation toxicology literature hint at the complexity of the topic
    and suggest that nanoparticle size can impact toxicity equally if not
    more so than chemical composition. There are indications in the
    literature that manufactured nanomaterials may distribute in the body
    in unpredictable ways and that certain nanoparticles have been observed
    to preferentially accumulate in particular organelles. Surface
    properties can be changed by coating nanoparticles with different
    materials, but surface chemistry also is influenced by the size of the
    particle. This interaction of surface area and particle composition in
    eliciting biological responses adds an extra dimension of complexity in
    evaluating potential adverse events that may result from exposure to
    these materials.
        The National Toxicology Program (NTP) is developing a broad-based
    research program to address potential human health hazards associated
    with the manufacture and use of nanoscale materials. The intent of the
    NTP/NIEHS research program is to evaluate the toxicological properties
    of major nanomaterials classes which represent a cross-section of
    composition, size, surface coatings, and physico-chemical properties,
    and use these as model systems to investigate fundamental questions
    concerning if and how nanomaterials can interact with biological
    systems. Some of these fundamental questions include: What are the
    appropriate methods for detection and quantification of nanoscale
    particles in tissues? How are nanoparticles absorbed, distributed in
    the body and taken up by cells? Are there novel toxicological
    interactions?
        Discussion and review of efforts in this area has highlighted the
    need for studies of nanoscale materials that not only apply existing
    toxicology testing methodologies, but also explore the development of
    appropriate novel toxicological methods to adequately assess potential
    human health effects. The NIEHS is looking ahead to be able to
    supplement our critically inadequate knowledge of this rapidly emerging
    technology.
                                     ______

                   Prepared Statement of Dr. Thomas R. Insel

        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 2005, a sum of $1,421 million, which
    reflects an increase of $39 million over the comparable fiscal year
    2004 appropriation.
        In my statement, I will call to your attention the immense burden
    on our Nation of mental and behavioral disorders. In addition, in the
    context of a brief review of our research activities and
    accomplishments, I will describe some of our efforts, in collaboration
    with trans-NIH initiatives, to bring new treatments from the laboratory
    to the clinical research arena and ultimately to widespread practice in
    the community.

                            BURDEN OF MENTAL ILLNESS

        The National Institute of Mental Health faces an enormous
    challenge: to reduce the burden of mental and behavioral disorders
    through research on mind, brain, and behavior. Mental disorders are
    real illnesses that can be diagnosed and in many cases, treated
    effectively. The need is vast: 450 million people worldwide suffer from
    a mental disorder. Mental illnesses account for four of the top six
    causes of disability among 15-44 year olds in the Western world. By
    2020, psychiatric and neurological conditions will have likely
    increased their share of the total global burden by almost half, from
    10.5 percent to 15 percent.
        In addition to morbidity, mental illnesses are a substantial source
    of mortality. Of the 30,000 Americans who die by suicide each year, 90
    percent have a mental illness. Deaths from suicide outnumber deaths
    from homicide (18,000) as well as deaths from AIDS and most forms of
    cancer. Suicide is high among several ethnic minority groups, though
    remains highest in older white males. Between 1952 and 1992, the
    incidence of suicide among adolescents and young adults nearly tripled;
    currently it is the third leading cause of death in adolescents.
        In addition to the emotional costs, the economic costs of mental
    illness are staggering. According to the recent report from the
    President's New Freedom Commission on Mental Health, the cost in the
    United States from both direct (treatment-related) and indirect
    (productivity loss) expenses may exceed $150 billion per year with
    rapid annual increases, especially in the drug treatment area. Adding
    to that, more than three million people are receiving disability
    benefits due to mental disorders. They constitute nearly 28 percent of
    disabled workers in the Social Security Disability Insurance Program,
    and more than 35 percent of people with disabilities receiving
    Supplemental Security Income. Together they accounted for an estimated
    $25 billion dollars in cash benefits in 2001.

                               SCIENCE TO SERVICE

        For many mental disorders, there is some form of treatment, but
    there is no cure. The report from the President's New Freedom
    Commission on Mental Health describes the need for transforming the
    delivery of evidence-based treatment and services to communities where
    they can directly benefit people with mental illness. To achieve this
    goal, NIMH recognizes the need for the research enterprise to partner
    with other organizations such as the Substance Abuse and Mental Health
    Services Administration (SAMHSA), state governments, and advocacy
    groups. In one such example, NIMH and SAMHSA recently funded nine one-
    year grants to state mental health agencies to support planning
    activities toward the implementation of evidence-based practices.
    Proposed science to service research activities include devising
    evidence-based group-focused activities for specific ages (child,
    adult); managing medication for those with schizophrenia; and providing
    cognitive behavioral therapy for people with depression. Each grant is
    expected to result in future research and service development
    initiatives. Translating scientific breakthroughs into far-ranging
    clinical care, we believe, is an urgent and achievable task.

                              PROGRESS IN GENETICS

        In addition to applying what we already know, we must continue the
    scientific efforts required to develop better treatments to bring us
    closer to our ultimate goals of curing or preventing severe mental
    health disorders. To attain these ambitious goals, we will need a much
    larger variety of medications and behavioral therapies than are
    currently available--treatments that can be tailored to work for all
    those who need them, not just a small subset. As an initial first step,
    we must discover how genes and the environment interact to produce the
    biological variations that can signal vulnerability to disease. This
    year has been remarkable in its wealth of discoveries of genes as well
    as gene-environment interactions. In depression, for example, NIH-
    sponsored researchers found that a variation in the gene that regulates
    serotonin transmission can make a person more vulnerable to depression
    when faced with stressful life experiences. Those without the gene
    variation had no such vulnerability, and appeared to be resilient even
    in the face of many life stresses. Those with the gene variation were
    not depressed until and unless they faced major life stressors. This
    suggests that some of the environmental contributors to illness may
    only be detected by first identifying variations in genetic risk.
    Future research could help us apply this information to identify those
    most at risk, and develop treatments that either target genes or the
    environment, or both. It also suggests a new model with which to test
    genetic vulnerability and environmental stresses in other major
    diseases, such as schizophrenia, anxiety disorders, or eating
    disorders.
        This year we have also seen exceptional progress in research on
    schizophrenia. Several genes have been found which appear to
    significantly contribute to the development of schizophrenia, providing
    at least a partial blueprint for the genetic risk architecture of the
    disease. While we still need to learn more about how they work, this
    group of genes should bring us closer to diagnostic tests for early
    detection, new targets for treatment, and even new strategies for
    prevention. In other studies, genes have been found which are thought
    to play a role in obsessive-compulsive disorder, panic disorder, and
    autism. NIMH researchers have also identified genes involved in memory
    and information processing, both of which are impaired in schizophrenia
    and various other disorders. These studies were among those named
    collectively as the number two scientific ``breakthrough of the year''
    by the prestigious journal Science in December. Most of the studies
    listed were conducted by intramural or NIMH-funded investigators.
    Studies this year have also provided new insight into the neural
    circuitry of anxiety and fear processing, suggesting new targets for
    drug development to treat anxiety, post-traumatic stress disorder, and
    various phobia disorders.

                       SCHIZOPHRENIA TREATMENT INITIATIVE

        While the news on schizophrenia has been exciting, we recognize
    that the road from gene discovery to prevention and treatment is
    neither simple nor rapid. To accelerate this process, we created a new
    initiative on schizophrenia research. A primary component is a new
    intramural interdisciplinary team, ranging from molecular to clinical
    scientists, who will lead a broad effort to understand how different
    gene variations alter neural networks and disrupt brain activity,
    leading to cognitive impairment and psychosis. The team will work to
    identify the role of these vulnerability genes, including their
    individual contributions to risk, severity of the disease, and drug
    response.
        A second component of the initiative is a program that targets
    cognitive problems for people with schizophrenia. Cognitive deficits,
    such as trouble with memory, attention, and executive function
    (capacity to make judgments and control impulses) are major
    determinants and predictors of long-term disability in schizophrenia.
    They remain a significant barrier to a productive life for people with
    the disease, yet the medications currently available provide no relief
    for cognitive problems. There has been a lack of scientific consensus
    on which cognitive impairments should be targeted and which tools are
    best for measuring them. As a result, the FDA has not been able to
    recognize cognition in schizophrenia as a valid treatment endpoint for
    drug registration. To address these issues, NIMH launched the
    Measurement and Treatment Research to Improve Cognition in
    Schizophrenia (MATRICS) program. It brings together representatives
    from academia, industry, and regulatory agencies to develop a
    comprehensive assessment tool to measure cognitive functioning in
    people with schizophrenia. The second phase is to develop and test
    novel compounds designed to enhance cognition.

                                    ROADMAP

        For most of our recent genetic discoveries, we lack the molecular
    tools needed to link the genes to new treatments. The search for new
    molecular tools for schizophrenia and other mental disorders will be
    aided greatly by one of the NIH Roadmap initiatives that will establish
    a repository of diverse organic chemicals. Organic chemicals, commonly
    referred to as ``small molecules,'' have proven to be extremely
    important to researchers exploring the functions of the cell at the
    molecular level. In fact, most medicines, from aspirin to
    antihistamines, are small molecule compounds. This new ``molecular
    library'' will offer researchers access to hundreds of thousands of
    small organic molecules that can be used as chemical probes to study
    cellular pathways. These compounds will help validate new targets for
    drug therapy more rapidly, and will enable other researchers to move
    them into the drug-development pipeline.

                                     AUTISM

        NIMH plays a major role in a broad-based NIH effort to create a
    network of autism research centers focusing on the biomedical and
    behavioral aspects of the disease. Five institutes at NIH are
    coordinating their research efforts in an initiative called the Studies
    to Advance Autism Research and Treatment (STAART) Centers program. This
    year, the institutes awarded grants to support six new autism research
    centers, in addition to the two that were funded last year. NIH expects
    to spend $65 million over five years for the eight centers.
        NIMH is the lead agency for the Interagency Autism Coordinating
    Committee (IACC), a group charged with coordinating research and other
    efforts on autism within the Department of Health and Human Services
    (HHS). NIMH took the lead in organizing the ``Autism Summit Conference:
    Developing a National Agenda,'' a joint effort of the HHS and the
    Department of Education, held in November 2003. About 650 people
    attended the meeting to address three major areas of emphasis:
    biomedical research, implementing early screening and diagnosis, and
    improving the accessibility and coordination of services. A key focus
    of the meeting was the introduction of a 10-year national research
    agenda, developed by an IACC-appointed expert panel. The research
    agenda identified roadblocks hindering progress in understanding
    autism's causes and developing treatment, and provided goals and
    strategies for the next 10 years to overcome these challenges. These
    research efforts will be carried out through the centers of excellence
    within the STAART network.

                           PRACTICAL CLINICAL TRIALS

        To improve human health, scientific discoveries must be translated
    into practical applications. Such discoveries typically begin at ``the
    bench'' with basic research where scientists study the mechanisms and
    pathogenesis of a disease at a molecular or cellular level--then
    progress to the clinical level, or the patient's ``bedside.'' Equally
    important is the translation from bedside to practice. Moving new drugs
    and therapies more quickly and smoothly out of the research environment
    and into the hands of clinicians is a key feature of the NIH Roadmap.
    To achieve this, NIH will promote the creation of better integrated
    networks of academic centers that work jointly on clinical trials and
    which include community-based physicians who care for large groups of
    patients. Implementing this vision will require new ways of organizing
    the methods in which clinical research information is recorded,
    defining new standards for clinical research protocols, and creating
    new models of cooperation between NIH and patient advocacy alliances.
        For its part, NIMH is finishing up four large-scale, longitudinal
    research studies to compare therapeutic approaches for serious mental
    illnesses, including schizophrenia, Alzheimer's disease, major
    depression, and bipolar disorder. These are different than most
    clinical trials, which are usually of short duration and limited to
    assessment of clinical symptoms. The NIMH studies are testing the
    various treatment options currently available for these disorders in
    diverse community populations, recruiting people from a variety of
    ``real world'' practice settings, and expanding outcome measures to
    include functional status and economic costs. The clinical populations
    currently enrolled in these NIMH treatment trials are among the largest
    and best characterized populations with bipolar disorder,
    schizophrenia, and depression ever studied through clinical trials in
    mental health. These trials will answer urgent questions about the
    treatment of adolescents with depression, the use of atypical anti-
    psychotics in people with schizophrenia and Alzheimer's, and the
    optimal long-term medication for bipolar patients. When the studies are
    over within the next two years, we hope to be able to continue
    utilizing this valuable clinical infrastructure--made up of staff,
    investigators, federal and state agencies, industry, patients, and
    patient advocacy groups--to answer other critical public health
    questions in diverse populations.

                                PRIORITY-SETTING

        Over the past five years, we have witnessed unparalleled advances
    in the basic sciences relevant to mental health. Genomics, imaging, and
    many areas of neurobiology are beginning to reveal a new understanding
    of normal and abnormal behavior. Against this backdrop of scientific
    progress, we continue to face extraordinary challenges for our patients
    with mental disorders. Science now yields opportunities that promise to
    deliver for each of these challenges. To realize this promise, we must
    define areas of high priority. To assist us, workgroups of our National
    Advisory Mental Health Council are reviewing the NIMH portfolio
    initially in two key research areas: clinical trials and basic science.
    Both workgroups plan to deliver reports by May 2004 and both will
    define priority areas using the criteria of relevance, traction, and
    innovation. Both workgroups have done an impressive job in reviewing
    the hundreds of relevant grants in the portfolio. We look forward to
    their recommendations, as well as to those of our Outreach Partners in
    every state, the mental health advocacy community, and the public. We
    rely on these groups to help us meet our ultimate goal of relieving the
    profound misery suffered daily by patients and families affected by
    mental disorders.
                                     ______

                   Prepared Statement of Dr. Raynard Kington

        Mr. Chairman, members of the Committee: I am pleased to present the
    President's budget request for the Office of the Director (OD) for
    fiscal year 2005, a sum of $359,645,000, which reflects an increase of
    $32,556,000 over the comparable fiscal year 2004 appropriation. The OD
    provides leadership, coordination, and guidance in the formulation of
    policy and procedures related to biomedical research and research
    training programs. The OD also is responsible for a number of special
    programs and for management of centralized support services to the
    operations of the entire NIH.
        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.
        In addition, 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 request for the OD in greater
    detail.

                                  NIH ROADMAP

        As part of the NIH Roadmap for Medical Research, the NIH has
    launched initiatives in fiscal year 2004 critical to addressing the
    roadblocks to the acceleration of science conduct and transfer to the
    public. These initiatives promise to yield far-reaching dividends in
    medical knowledge and improved health for the public. Under the theme
    of New Pathways to Discovery, initiatives are aimed at quantifying and
    cataloging complex biological systems and in developing a better ``tool
    box'' for today's researchers, for research teams of the future, and
    for re-engineering the clinical research enterprise. Examples of
    initiatives include the creation of an accessible public library
    database for chemically diverse small molecules, centers that will
    create new tools to describe the dynamics of protein interactions,
    development of novel technologies to study cellular metabolites,
    creation of national software engineering system that can facilitate
    the ability of scientists to tap into supercomputing networks and share
    and analyze complex data, and the early conceptual development of
    nanomedicine. The NIH Roadmap initiatives also have taken steps to
    prepare Research Teams of the Future, the second theme, by encouraging
    scientists and research institutions, including the NIH, to test
    alternative models for conducting research that take advantage of the
    scientific advances and complexities. A major focus has been placed on
    planning and research workforce training for the conduct of
    interdisciplinary research, that research that spawns new disciplines
    of science. In addition, a new award--the NIH Director's Pioneer
    Award--will support a select group of investigators who have the
    potential for ground-breading discoveries. Ultimately findings from the
    laboratory must reach the public, and the initiatives under the third
    them--Re-engineering the Clinical Research Enterprise--are geared to
    address the roadblocks to the conduct of clinical research and its
    translation to patients. These initiatives include the exploration of
    the ability to create and enhance interoperability among clinical trial
    networks, the testing the feasibility of establishing a National
    Clinical Research Associations program where community-based clinicians
    are trained to participate in studies and play a role in augmenting the
    transfer of research to their patients, and the assessment of patient-
    reported chronic disease outcomes. Critical work continues in the area
    of research policy analysis and coordination with an emphasis on
    harmonization and standardization of policies and requirements
    pertaining to clinical research. In addition, extension and expansions
    of clinical research training programs extramurally and intramurally
    have been initiated.

                          THE OFFICE OF AIDS RESEARCH

        The Office of AIDS Research (OAR) coordinates the scientific,
    budgetary, legislative, and policy elements of the NIH AIDS research
    program. Our response to the epidemic requires a unique and complex
    multi-institute, multi-disciplinary, global research program. Perhaps
    no other disease so thoroughly transcends every area of clinical
    medicine and basic scientific investigation, crossing the boundaries of
    the NIH Institutes and Centers. This diverse research portfolio demands
    an unprecedented level of scientific coordination and management of
    research funds to identify the highest priority areas of scientific
    opportunity, enhance collaboration, minimize duplication, and ensure
    that precious research dollars are invested effectively and
    efficiently, allowing NIH to pursue a united research front against the
    global AIDS epidemic. Each year, OAR oversees the development of the
    comprehensive NIH AIDS-related research plan and budget, based on
    scientific consensus about the most compelling scientific priorities
    and opportunities that will lead to better therapies and prevention
    strategies for HIV disease. The Plan serves as the framework for
    developing the annual AIDS research budget for each Institute and
    Center; for determining the use of AIDS-designated dollars; and for
    tracking and monitoring those expenditures. OAR identifies scientific
    areas that require focused attention and facilitates multi-institute
    activities to address those needs. OAR coordinates, monitors and
    fosters plans for NIH involvement in international AIDS research and
    training activities. OAR supports a number of initiatives to enhance
    dissemination of research findings to researchers, physicians, patients
    and communities. The fiscal year 2005 budget request for OAR is
    $61,435,000.

                    THE OFFICE OF RESEARCH ON WOMEN'S HEALTH

        The Office of Research on Women's Health (ORWH), the focal point
    for women's health research for the Office of the Director,
    strengthens, enhances and supports research related to diseases,
    disorders, and conditions that affect women, and sex/gender studies on
    differences/similarities between men and women; ensures that women are
    appropriately represented in biomedical and biobehavioral research
    studies supported by the NIH; and, develops opportunities for the
    advancement of women in biomedical careers and investigators in women's
    health research. The report, An Agenda for Research on Women's Health
    for the 21st Century, provides a framework for the ORWH to collaborate
    with the scientific and advocacy communities to address gaps in
    knowledge about women's health and sex and gender factors in health and
    disease. The fiscal year 2005 budget request of $41,577,000 includes an
    increase of $626,000 over the fiscal year 2004 appropriation.
        Research priorities for women's health emphasize the importance of
    interdisciplinary research with collaboration and integration of
    knowledge from multiple areas of scientific expertise; lifespan issues
    and the continuum from intrauterine life into elderly years; health
    disparities/differences and diversity among different populations or
    subpopulations of women; and, sex/gender differences in health and
    disease and therapeutic interventions at genetic, molecular, cellular,
    and functional levels. Areas of research interest for 2005 include:
    pathogenesis of diseases including prevalence/validation of sex
    differences in diagnosis/treatment of disorders/diseases; clinical
    trial methodology; mental health studies; new agents for management of
    menopausal symptoms; treatments/interventions for diseases that show
    enhanced clinical features in women; and other specific areas such as
    CFS, and benign gynecologic disorders including uterine fibroids.
    Special emphasis areas for women's health research include genetics/
    pharmacogenomics, and the genetic, molecular and cellular bases for
    action of pharmacologic agents known to have differential effects in
    females; and, prevention and treatment, from basic biological factors
    to effects of risk behaviors or interventions. There is expansion of
    new research in the ORWH specialized centers of interdisciplinary
    research in women's health and sex and gender factors, and the unique
    ORWH interdisciplinary career development program in women's health
    research that fosters the mentored development of junior faculty and
    assists them in bridging advanced training towards a goal of research
    independence. In addition, the ORWH has now implemented a new
    Intramural Program on Research on Women's Health to focus on NIH
    intramural women's health and sex and gender comparison research. The
    ORWH continues to partner with Institutes and Centers to ensure
    compliance with NIH policies for the inclusion of women and minorities
    in clinical research, and that analyses by sex/gender are addressed by
    investigators funded by the NIH.

             THE OFFICE OF BEHAVIORAL AND SOCIAL SCIENCES RESEARCH

        The NIH has a long history of funding health-related behavioral and
    social sciences research, and the results of this work have contributed
    significantly to our understanding, treatment, and prevention of
    disease. The Office of Behavioral and Social Sciences Research (OBSSR)
    furthers NIH's ability to capitalize on the scientific opportunities
    that exist in behavioral and social sciences research by providing
    leadership in identifying and implementing research programs in
    behavioral and social sciences that are likely to improve our
    understanding of the processes underlying health and disease and
    provide directions for intervention. OBSSR works to integrate a
    behavioral and social science approach across the programs of the NIH.
    The fiscal year 2005 OD budget includes $26,321,000 for OBSSR, an
    increase of $415,000 over the fiscal year 2004 appropriation.
        Many exciting scientific developments are occurring at the
    intersection of behavioral and social science research and biomedical
    research. It has become apparent that increasingly, scientific advances
    are being made at the interfaces of traditional disciplines, and that
    approaches to science are becoming more integrative. OBSSR has begun
    development of a program to provide interdisciplinary training to
    postdoctoral fellows in NIH intramural laboratories. This program would
    provide a mechanism hereby an individual with a PhD in a behavioral or
    social science discipline might acquire interdisciplinary training that
    included biomedical research. Alternatively, someone trained in a more
    traditional biomedical field would receive postdoctoral training that
    included a behavioral or social science component. In addition to the
    benefits to be realized by the individual trainees, this program would
    also show NIH leading, by example, our Roadmap efforts to build
    interdisciplinary Research Teams of the Future.
        OBSSR is also developing an initiative to advance discovery of
    scientific knowledge about eHealth technologies for health behavior
    change and chronic disease management. Consumers, patients, and
    providers are increasingly using eHealth applications, particularly the
    Internet, to seek health information for themselves or family and
    friends, communicate with others who have a similar disease or illness,
    and to communicate with their health care providers. These technologies
    offer people the ability to obtain health information at relatively low
    cost, including those with limited or no access to health care
    professionals or services, and historically underserved populations.
    While the use of eHealth interventions is becoming widespread, these
    techniques have yet to receive much rigorous evaluation. This
    initiative's goal is to bring together components of NIH, the Robert
    Wood Johnson Foundation and other public agencies and private
    foundations in a ``meeting of the minds'' about the state of eHealth
    evaluation research for health behavior change and chronic disease
    management, future directions in the field, and the role of NIH and
    others in developing a research agenda for this area.
        Behavioral and social factors contribute significantly to racial
    and ethnic health disparities. Consequently, OBSSR is committed to
    developing better knowledge of specific pathways to health disparities
    and to finding solutions. In February 2003, OBSSR published in the
    American Journal of Public Health a set of papers presenting scientific
    evidence of the effects of racial/ethnic bias on health and identifying
    areas for future research to further explicate the relationship. The
    papers were the product of an OBSSR meeting of approximately 100
    leading scientists held in April 2002. Currently, OBSSR is convening
    discussions among ICs regarding the role of social and behavioral
    science in their health disparities research activities and avenues for
    coordinated initiatives.
        An effective way to ensure that results of behavioral and social
    science improve our society's health involves incorporating these in
    clinical practice. In order to start this process at an early stage in
    the training of the next generation of physicians, OBSSR funded the IOM
    to determine how to improve medical education. The results of this
    study [April 2004] will inform a training initiative that OBSSR with
    several ICs will launch this year.

                        THE OFFICE OF DISEASE PREVENTION

        The primary mission of the Office of Disease Prevention (ODP) is to
    stimulate disease prevention research across the NIH and to coordinate
    and collaborate on related activities with other federal agencies as
    well as the private sector. There are several other offices within the
    ODP organizational structure.
        The Office of Medical Applications of Research (OMAR) has as its
    mission to work with NIH Institutes, Centers, and Offices to assess,
    translate and disseminate the results of biomedical research that can
    be used in the delivery of important health services to the public. 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 2005, the Office of Dietary Supplements (ODS) within
    ODP requests a budget of $26,218,000, an increase of $414,000 over the
    fiscal year 2004 appropriation. In fiscal year 2004, ODS published its
    5-year Strategic Plan for 2004-2009, a major component of which is to
    significantly expand efforts to address the role of dietary supplements
    in reducing the risk for chronic diseases. It will continue to promote
    the scientific study of the use of dietary supplements by supporting
    investigator-initiated research in conjunction with other ICs at NIH
    and stimulating research through conduct of conferences and through
    presentations at national and international meetings.
        ODS, in collaboration with the National Heart, Lung, and Blood
    Institute and other NIH ICs, has sponsored a systematic review of the
    relationship between omega-3 fatty acids and a series of clinical
    indications, particularly coronary heart disease. Several reports will
    be published in fiscal year 2004 based upon this review, which will
    serve as the basis for planning further NIH research on omega-3 fatty
    acids. Congressional language in recent appropriation reports directed
    ODS to enhance an ongoing collaboration for the development,
    validation, and dissemination of analytical methods and reference
    materials for botanical dietary supplements. ODS works with other
    partners in the public and private sectors to meet this objective. ODS
    supports the National Health and Nutrition Examination Survey (NHANES),
    conducted by the National Center for Health Statistics at the Centers
    for Disease Control and Prevention, in order to provide more
    information about dietary supplement use in the U.S. population.
        This will inform future research about potentially important target
    populations, such as children, women, and the elderly. Funding is used
    to create and populate a database of dietary supplements, as well as to
    support the measurement of blood levels of key metabolites associated
    with dietary supplement use. ODS collaborates with USDA to develop an
    analytically-based database of dietary supplement ingredients. ODS
    collaborates with other federal agencies to develop an approach to
    assessment of the health effects of bioactive factors in foods and
    dietary supplements. In its continuing efforts to inform the public
    about the benefits and risks of dietary supplements, ODS collaborates
    with USDA on the International Bibliographic Information on Dietary
    Supplements (IBIDS) database, which now includes a consumer-oriented
    search strategy. It has also disseminated a database devoted to federal
    funding of dietary supplement research, called CARDS, which is
    currently populated with data about the NIH investment from fiscal year
    1999-2002. ODS publishes Fact Sheets about vitamin and mineral dietary
    supplements in collaboration with the NIH Clinical Center, as well as
    Fact Sheets about botanical supplements.
        Another component of ODP, the Office of Rare Diseases (ORD) was
    formally established through the Rare Diseases Act of 2002, Public Law
    107-280. The purpose of this Act is to increase the national investment
    in the development of diagnostics and treatments for approximately 25
    million patients with more than 6,000 rare diseases. A rare disease is
    defined as one where fewer than 200,000 persons are affected in the
    United States. The fiscal year 2005 budget request for ORD is
    $15,787,600, an increase of $253,000 above the fiscal year 2004
    appropriation.
        Through its Extramural Research Program, the ORD supports a Rare
    Diseases Clinical Research Network with NIH Institutes and Centers
    (ICs). The major goals for the network include the systematic
    collection of clinical information to develop biomarkers and new
    approaches to diagnosis, treatment, and prevention of rare diseases,
    and to promote training of new clinical research investigators in rare
    diseases. ORD funded seven Rare Diseases Clinical Research Consortia
    and one Data and Technology Resources Coordinating Center. The
    consortia focus on urea cycle disorders, inborn errors of metabolism,
    rare neurological channelopathies, idiopathic bone marrow failure
    states and cytopenias, vasculitides, and defects in steroidogenesis.
    The patient support organizations are closely integrated into the
    consortia and the network.
        The ORD Intramural Research Program promotes training in the areas
    of clinical and basic research into rare diseases and in biochemical
    genetics, fosters protocol-based initiatives into rare diseases not
    currently investigated in the intramural program, assists in the
    investigation of select, unique disorders of unknown etiology, provides
    overall research support for diagnostics and therapeutics of rare
    disorders, and supports five Bench-to-Bedside grants.
        In its Scientific Conferences Program, in fiscal year 2004, the ORD
    will cosponsor more than 70 scientific conferences on rare diseases.
    The 460 conferences sponsored to date since 1995 have been shown to be
    excellent venues to establish a research agenda for specific rare
    diseases, take advantage of scientific opportunities, or eliminate
    barriers to dvancing research.
        To provide more comprehensive information, ORD, together with the
    National Human Genome Research Institute (NHGRI), established the
    Genetic and Rare Diseases Information Center to respond to requests for
    information about genetic and/or rare disorders. In its third year of
    operation, the information center broadened its language base to
    include Spanish in addition to English.
        In fiscal year 2004, ORD plans to establish a Trans-NIH Rare
    Diseases Working Group to encourage collaborative research activities,
    provide opportunities for input as new rare diseases research programs
    unfold, and gather information about the rare disease research programs
    supported by the ICs and Offices for mandated annual and biennial
    reports.

                        THE OFFICE OF SCIENCE EDUCATION

        The Office of Science Education (OSE) plans, develops, and
    coordinates science education programs to strengthen and enhance
    efforts of the NIH to attract young people to biomedical and behavioral
    science careers and to improve science literacy in both adults and
    children. The office's mission is to help people understand and use new
    knowledge uncovered by the NIH in pursuit of better health for
    everyone. The OSE works toward this mission by: creating programs to
    improve science education in schools (the NIH Curriculum Supplement
    Series); creating programs that stimulate interest in health and
    medical science careers (the new LifeWorks Web site); creating programs
    to advance public understanding of medical science, research, and
    careers; promoting NIH educational resources and programs; and advising
    NIH leadership about science education issues. All office programs
    target diverse populations including under-served communities, women,
    and minorities, with a special emphasis on the teachers of students
    from Kindergarten through grade 12. The OSE works closely with NIH
    institutes, centers, and offices on science education issues, and
    maintains the OSE Web site as a source of information about available
    resources and programs. http://science.education.nih.gov.
        The NIH Curriculum Supplements series are National Science
    Education Standards-based lesson plans that are distributed free to K-
    12 teachers across the country. They incorporate the best of both
    science and education communities, and are intended to update science
    content and allow the teacher to incorporate the latest NIH research
    into classroom instructions. Life Works is a new OSE Web site created
    as a source of career information for students, teachers, counselors,
    and parents. The site will allow exploration of the educational
    requirements, knowledge, skills, and abilities required for over 100
    health and medical science careers. The fiscal year 2005 Budget request
    for OSE is $3,899,000.

                     LOAN REPAYMENT AND SCHOLARSHIP PROGRAM

        The NIH, through the Office of Loan Repayment and Scholarship
    (OLRS), administers the Loan Repayment and Undergraduate Scholarship
    Programs. The NIH Loan Repayment Programs (LRPs) seek to recruit and
    retain highly qualified physicians, dentists, and other health
    professionals with doctoral-level degrees to biomedical and behavioral
    research careers by countering the growing economic disincentives to
    embark on such careers, using as an incentive the repayment of
    educational loans. There are loan repayment programs designed to
    attract individuals to clinical research, pediatric research, health
    disparities research, and contraception and infertility research, and
    to attract individuals from disadvantaged backgrounds into clinical
    research. The AIDS, Clinical, and General Research Loan Repayment
    Programs are designed to attract investigators and physicians to the
    NIH's intramural research and research training programs. The NIH
    Undergraduate Scholarship Program (UGSP) is a scholarship program
    designed to support the training of undergraduate students from
    disadvantaged backgrounds in biomedical research careers and employment
    at the NIH. The fiscal year 2005 Budget request for OLRS is $7,250,000.
        Thank you for giving me the opportunity to present this statement;
    I will be pleased to answer questions.
                                     ______

                  Prepared Statement of Dr. Patricia A. Grady

        Mr. Chairman and Members of the Committee: The fiscal year 2005
    budget includes $139.198 million, an increase of $4.497 million over
    the comparable fiscal year 2004 appropriation level.
        I am pleased to be here today to discuss the activities of the
    National Institute of Nursing Research (NINR). NINR supports research
    that converges well with NIH's top priorities and activities. Our
    research emphases are also reflected in the NIH Roadmap, the strategy
    to accelerate scientific discoveries and take new approaches to make
    them more rapidly available to patients. NINR's scientific community is
    excited about the opportunities within the current and future NIH
    Roadmap initiatives. NINR is already supporting important
    interdisciplinary research training and interdisciplinary research,
    including community-based research. NINR's scientific community has
    been alerted to the procedural changes that need to take place in order
    to capitalize on the NIH Roadmap initiatives; their enthusiasm predicts
    a high level of support for the Roadmap.
        From its inception, NINR has emphasized interdisciplinary research
    teamwork and clinical and translational research, which are prominently
    featured in the Roadmap agenda. Our studies address national health
    problems head on. We have moved from an acute to a chronic disease
    focus, with emphasis on older people, who are living longer with
    illness and want the highest quality of life possible. We promote
    ethnically and culturally sensitive research and are aggressively
    pursuing research on health disparities, devoting about 20 percent of
    our budget to this area of science.
    control of high blood pressure in young inner-city african-american men
        A good example of a program of research that improves health care
    disparities in a vulnerable African-American population is located a
    short distance from here--East Baltimore. The number of people with
    hypertension nationally is 40 percent higher for African-Americans than
    for Caucasians, and there is more severe disease impact among African-
    Americans that can include heart enlargement and kidney dysfunction.
    The Johns Hopkins School of Nursing conducted this unique hypertension
    study, targeting a high-risk population of hypertensive young African-
    American men between 21 and 54 years of age who are generally
    considered underserved by the healthcare system. At the study's start,
    only 17 percent had control of their blood pressure, but after three
    years, 44 percent of the men receiving the intensive form of a
    carefully designed community-based intervention attained control of
    their blood pressure. In some cases, the study represented the first
    time the study participants experienced formal healthcare. Of special
    significance is that 90 percent of the young men were retained in the
    study for the entire three-year period. A key to this success was the
    culturally appropriate, multidisciplinary research team approach that
    involved nurse practitioners, community health workers, and physicians.
    Among the lessons learned from this research is the need to modify
    healthcare for vulnerable populations like this one in Baltimore--
    health care that involves home visits that offer educational and
    behavioral counseling to supplement visits to the clinics, and
    addresses factors beyond the disease itself, such as reducing substance
    abuse and obesity.

     HEALTH OF MINORITY, INNER CITY NEWBORNS IMPROVED BY NURSE HOME VISITS

        Another example of a health disparity is infant mortality, with
    rates for African-Americans twice those of Caucasians. Researchers
    tested a carefully designed intervention tailored to the risks of the
    populations studied to help close this health disparity gap. Findings
    after one year of the project indicate that the health outcomes of both
    mother and infant were improved, and costly health care was avoided.
    The intervention involved focusing on low-income, pregnant African-
    American and Mexican-American mothers from the inner city, who received
    a program of planned prenatal care and post-natal monitoring with
    teaching and counseling at each encounter. Home visits made by a team
    of trained community residents and led by a nurse were an important
    feature, and the mothers received monthly phone calls for a year after
    their babies were delivered. The effects of the program varied by race
    and ethnicity. For African-Americans, findings indicated that mothers
    had more realistic expectations of their parenting role and were able
    to document the immunization of their infants. Their infants' mental
    development scores were higher than the control group. Mexican-American
    mothers showed improved skills in dealing with everyday life and in
    playing with their infants. This research and previous studies indicate
    that home visits by a nurse-health advocate team are among the most
    successful interventions in improving maternal and infant health--even
    for-inner city, low-income minority families. The key is to implement
    culturally sensitive interventions that are intensive and adequately
    staffed and funded.

                  WOMEN'S EARLY WARNING SIGNS OF HEART ATTACK

        Although heart disease is the number one cause of death in both
    genders, far less is known by physicians and by women themselves about
    how women experience the disease. Research focusing on women's symptoms
    prior to heart attack found that women have different early warnings of
    heart attach than men have. Of note is that most clinicians consider
    chest pain as the most significant symptom for both sexes. Yet in this
    study the most prevalent symptom was reported to be unusual fatigue (70
    percent), followed by sleep disturbance (48 percent), and shortness of
    breath (42 percent). Fewer than a third of the women reported chest
    pain or discomfort. Even during the heart attack, 43 percent did not
    experience chest pain. Clearly, women's symptoms appear to be different
    from men's. This underscores the importance of women and clinicians,
    both, recognizing early warning signs of impending heart attack in
    women, so that they can prevent it or ease its effects.

                  CHOLERA REDUCED BY LOW TECH WATER FILTRATION

        A growing global problem faced by developing nations is the
    availability of healthy drinking water, a most basic need for life and
    health. Cholera is carried by untreated surface water and kills
    thousands of people around the world by causing severe vomiting and
    diarrhea. The World Health Organization reports that the number of
    countries with cholera is increasing. In our own hemisphere, cholera
    incidence is now increasing in 16 Latin American nations. Researchers
    in Bangladesh have found a simple preventive technique that works and
    may be transferable to other countries. Inexpensive and widely
    available cotton sari cloth, when folded four to eight times, creates a
    filter small enough to remove most plankton, where cholera bacteria
    often live. In 65 villages with 133,000 inhabitants, the number of
    cholera cases was almost cut in half when people filtered their water
    with the sari cloth. Cultural barriers were not an issue, and about 90
    percent of the rural study participants followed the filtering
    procedure. When cholera did occur, those villagers had drunk unfiltered
    water at villages not participating in the study. The sari filtering
    technique could work just as well using other types of inexpensive
    cloth filters if replicated in countries where cholera is widespread.

                        THE NINR ROLE IN THE NIH ROADMAP

        Last year, NINR developed what we call Research Themes for the
    Future, which represent NINR priorities over the next five plus years.
    These themes blend well with the NIH Roadmap overall, especially in two
    areas--Interdisciplinary Research Teams of the Future, and Re-
    engineering the Clinical Research Enterprise. In the first area, NINR
    has considerable experience carrying out interdisciplinary team
    research projects. In fiscal year 2003, more than half of NINR
    investigator publications appeared in non-nursing journals. This
    underscores the promise of future successful interdisciplinary research
    and practice collaborations. It also indicates that many other
    disciplines value nursing research findings. In the area of improving
    the clinical research enterprise, most of NINR's research is clinical
    in nature and can bring research questions to the laboratory from the
    clinical researcher's perspective. Investigators also translate
    research findings into the clinical practice of healthcare providers
    and develop partnerships with communities to speed new scientific
    knowledge into mainstream health regimens. Late last year, NINR
    supported a national conference to promote research-intensive
    environments in clinical settings, including academic medical centers
    and those that are nontraditional as far as research is concerned, such
    as nursing homes and community-level health enterprises. The goal was
    to create partnerships between academic researchers and potential
    investigators in these settings to develop resources and ease barriers
    to innovative research.
        To make the Roadmap a reality for nurse researchers, since the
    Roadmap will not be business as usual, but business as usual plus, NINR
    recently convened an implementation meeting with interdisciplinary
    experts from across the country. The meeting addressed ways to
    intersect NINR's themes and priorities with those of the Roadmap, as
    well as suggestions for new Roadmap directions that reflect the
    expertise of nursing research. Since NINR has always stressed
    interdisciplinary research, we look forward to increased participation
    in the Roadmap.

                                  INITIATIVES

        Looking ahead to our fiscal year 2005 initiatives, reduction of
    obesity, a major public health issue, is certainly on the NINR agenda.
    Pediatric and adolescent obesity is particularly disturbing in and of
    itself, because it forewarns of future poor health. We plan to target
    minority populations at risk for obesity and children who are
    underserved--for example, those in rural areas. Research will address
    biological, behavioral and social science factors leading to or
    perpetuating obesity.
        Our genetics initiative is novel for NINR, since it involves
    incorporating behavioral, biological and molecular science into nursing
    research. Our focus will be on the interactions between genes,
    environment and behavior, including health promotion behavior. We will
    also assess the results of genetic education and counseling, and the
    effects of genetic testing on health, including lifestyle changes and
    the reduction of risks for disease.
        Increased attention is required to build the knowledge base for
    effective end of life care. NINR is the lead Institute at NIH for end-
    of-life research. The research agenda we have identified for better
    healthcare management at this final stage of people's lives includes
    improved methodology, instruments, communication, and interventions
    that helped making choices. Previously published NINR-funded research
    findings on symptom management are already being integrated into
    standards of care. Further study is taking place to develop new
    behavioral approaches to improve the lives of patients and their
    caregivers and to devise new techniques to improve management of pain.
        Self-management has become the most basic way people can improve
    their lives when they are living with long-lasting, incurable chronic
    illness. Successful self-management interventions tested in mainstream
    populations, such as how to improve coping skills and how to maintain
    and improve cognitive functioning, will be tested in populations with
    special needs: the unemployed, homeless, very old, impoverished,
    disabled, or geographically isolated.
        Another initiative involves symptom management. Traditionally,
    clinical practice treats symptoms one symptom at a time. Yet symptoms
    rarely occur alone they occur in clusters. NINR plans to support
    research that will identify and describe groups of symptoms in HIV/AIDS
    and cancer patients by determining these clusters' effects on the
    patient, and developing interventions to manage the multiple symptoms.
    In addition to assisting how one symptom impacts the others in a
    cluster, we will consider the effects of age, treatment, gender, and
    type and stage of disease.
        NINR will expand on past and current research initiatives that
    focus on minority and underserved women's health, such as health
    disparities and reduction of low birth weight among minority women. The
    new initiative will focus on other aspects of women's health outside of
    reproduction, which in the past was frequently the central focus of
    women's health research by investigators of many disciplines.

                  INCREASING THE NUMBER OF NURSE INVESTIGATORS

        The well documented and current shortage of nurses was preceded by
    a significant shortage of nurse researchers. The shortage of nurse
    researchers also means fewer nursing faculty to train future nurses and
    to conduct research that provides the scientific base for healthcare
    practice. In confronting this issue, NINR continues to collaborate with
    universities nationwide to rapidly develop baccalaureate-to-doctoral
    fast-track programs. This is in response to one of the recommendations
    of the National Research Council four years ago, which urged
    preparation of more nurse researchers more quickly. NINR revised the
    predoctoral training mechanism to enable nurses to enroll in the many
    fast-track doctoral programs in nursing which accept baccalaureate-to-
    doctoral students. NINR has been responsive to the National Research
    Council's recommendation, and the nursing community has also responded
    by rapidly developing these baccalaureate-to-doctoral programs all over
    the nation.
        NINR supports Developmental and Core Centers to stimulate research
    and research training opportunities. Creating partnerships and
    leveraging funds is a hallmark of those Centers. We also initiated 17
    Nursing Partnership Centers to Reduce Health Disparities, in
    collaboration with the National Center on Minority Health and Health
    Disparities. These Centers partner eight research-intensive
    universities with nine minority-serving institutions. As a result of
    this program, we expect health disparities research to expand and the
    number of minority nurse investigators to increase.
        NINR will continue to offer career development awards, and we will
    make a special effort to train minority investigators through mentored
    research scientist awards and research supplemental awards. NINR's
    small but growing intramural research program is initiating a graduate
    partnership program with universities across the country this year and
    continues to support postdoctoral training opportunities on the NIH
    campus.
        In closing, the upcoming year contains new opportunities to
    configure scientific research in new ways. NINR and the nursing
    research community look forward to participation in the NIH Roadmap
    initiative and in other research that directly impacts the improvement
    of people's health.
        Thank you, Mr. Chairman. I will be pleased to answer any questions
    the Committee might have.
                                     ______

                    Prepared Statement of Dr. Barbara Alving

        I am pleased to present testimony before this Committee on behalf
    of the National Heart, Lung, and Blood Institute (NHLBI).
        The NHLBI leads a national program directed at alleviating the
    burdens of diseases of the heart, blood vessels, lungs, and blood. The
    Institute also is responsible for research on the clinical uses of
    blood and its products and the management of blood resources. For more
    than a decade, the National Center on Sleep Disorders Research has been
    part of the NHLBI and, since fiscal year 1998, the NIH Women's Health
    Initiative has been administered by the Institute. Our diseases and the
    burdens associated with them touch the lives of all Americans.

                     BASIC AND CLINICAL RESEARCH APPROACHES

        The ultimate goal of the NHLBI is to improve the public health
    through discovery of effective methods to prevent and treat disease.
    Progress toward this goal depends on the existence of a coordinated
    program that focuses on clinical investigation as the culmination of
    basic research to unravel the fundamental processes that govern health
    and disease. The Institute has fostered and sustained a longstanding
    commitment to laboratory investigations of relevance to its mandate.
    Moreover, in recent years it has allocated a significant share of the
    generous budget increases provided to it to aggressive pursuit of
    promising, cutting-edge opportunities in such disciplines as genomics,
    proteomics, and nanotechnology. Advances in these areas promise to
    enable, among other things, more specific approaches to health
    promotion based on detailed assessment of individual characteristics
    rather than on general observations about what does or does not foster
    good health. Our optimism about the probable yield of these new
    endeavors cannot be overstated.
        However, the health-related outcomes of these basic science
    endeavors depend greatly on the extent to which laboratory discoveries
    are translated into approaches applicable to ``real-life'' health
    problems. And that, in turn, depends on clinical research. Being a
    disease-oriented agency, the NHLBI has for many years placed strong
    emphasis on developing and maintaining a robust clinical research
    portfolio. Particularly with regard to clinical trials, the Institute
    has worked to design efficient, less costly research approaches to
    evaluating therapeutic and preventive strategies. As part of this
    effort, the NHLBI has developed and refined the ``clinical research
    network'' concept and successfully applied it to evaluate new
    therapeutic approaches to conditions such as pediatric cardiovascular
    disease, asthma, acute respiratory distress syndrome, and Cooley's
    anemia. The networks provide an infrastructure that enables rapid and
    cost-effective testing of new therapies as they come to light.

                       THE NIH ROADMAP--CLINICAL RESEARCH

        It naturally follows that the NHLBI is an enthusiastic participant
    in the NIH Roadmap initiative titled Re-Engineering the Clinical
    Research Enterprise: Feasibility of Integrating and Expanding Clinical
    Research Networks. This new solicitation seeks to identify ways in
    which clinical research networks can collaborate to conduct clinical
    trials and other multicenter clinical research studies more efficiently
    than the current system allows. We at the NHLBI believe that
    application of lessons learned from this Roadmap initiative will better
    position the Institute to accelerate the pace of research and to reduce
    barriers that prevent research advances from becoming incorporated into
    clinical practice.

                         POSTMENOPAUSAL HORMONE THERAPY

        Major unexpected findings from the NIH Women's Health Initiative
    (WHI) illustrate the critical importance of the randomized, controlled
    clinical trial in determining the risks and benefits of preventive
    strategies. The study, which assessed the role of estrogen therapy,
    with or without added progestin, in preventing major causes of death
    and disability among postmenopausal women, was predicated on strongly
    suggestive evidence from basic research, observational studies, and
    smaller clinical trials that often measured so-called surrogate end
    points (e.g., changes in heart disease risk factors or subclinical
    manifestations), rather than events such as heart attacks or deaths
    from coronary disease. Indeed, at the outset of the WHI, much doubt
    existed regarding the feasibility and ethics of conducting the trial,
    because ``everybody'' already ``knew'' that hormone therapy helped
    women remain youthful and ``feminine forever,'' by not only relieving
    troublesome menopausal symptoms but also improving general health. Much
    to the surprise of researchers, practicing physicians, and women
    themselves, the trial of estrogen plus progestin last year was halted
    when it found increased risks of heart attack, stroke, invasive breast
    cancer, and blood clots among women assigned to take hormones. And
    quite recently, the estrogen-alone part of the study was discontinued
    because the hormone did not appear to have the hoped-for beneficial
    effect on heart disease (or, on the other hand, the feared unfavorable
    effect on breast cancer), but it did increase risk of stroke. These
    findings have major public health significance: the conclusion is that
    postmenopausal hormones, once ranking among the most-prescribed
    preparations in the United States, should generally be used only for
    short-term alleviation of menopausal symptoms.

                      LUNG-VOLUME-REDUCTION SURGERY (LVRS)

        Another trial of great practical importance was a rigorous
    assessment of LVRS, a procedure that was first used to treat emphysema
    during the 1950s. Although some patients seemed to benefit from this
    radical and invasive procedure, high mortality and morbidity
    discouraged its widespread use until the early 1990s, when some
    surgeons began performing LVRS again and insurance reimbursement became
    one of several issues demanding resolution. The National Emphysema
    Treatment Trial (NETT) clarified the short-and long-term risks and
    benefits of LVRS and identified the characteristics of patients who may
    be most likely to benefit from LVRS, as well as those who are at
    greater risk of death and complications from the procedure. The NETT
    reflects a unique relationship in which the NIH funded and administered
    the study and the Centers for Medicare and Medicaid Services (CMS),
    which sought evidence regarding the advisability of providing Medicare
    reimbursement for LVRS, supported participants' care costs.
    Additionally, the Agency for Healthcare Research and Quality
    contributed support for analysis of the cost-effectiveness of LVRS. The
    study results have provided a scientific basis for reassessment of
    Medicare coverage for LVRS.

                 TRIALS OF HYPERTENSION CONTROL AND PREVENTION

        Last year, we reported results from the ALLHAT (Antihypertensive
    and Lipid-Lowering Treatment to Prevent Heart Attack Trial), which
    found persuasive evidence that traditional diuretics should be the
    initial treatment of choice for lowering high blood pressure. This is a
    study that only the NIH would likely have undertaken, as the comparison
    drugs--a calcium channel blocker and an ACE (angiotensin-converting
    enzyme) inhibitor--were already established as blood-pressure-lowering
    agents; it further illustrates the unique role played by the NIH in
    addressing issues of public health importance. Of additional interest
    is the observation that blood pressure control rates among ALLHAT
    participants increased from 25 percent at the beginning of the ALLHAT
    to 66 percent after five years of followup. These gains were achieved
    in a variety of clinical practice settings and in subgroups of people
    known to experience difficulty with blood-pressure control, such as
    blacks, the elderly, and diabetic patients. These results offer
    encouragement that blood pressure control is obtainable, and they
    challenge us to pursue this goal vigorously.
        The ALLHAT findings, in combination with evidence from other
    research studies, prompted issuance of an updated set of guidelines for
    hypertension management--the so-called JNC 7, or Seventh Report of the
    Joint National Committee on Prevention, Detection, Evaluation, and
    Treatment, of High Blood Pressure. An important feature of the
    guidelines is a reclassification of blood pressure levels that includes
    the new category ``prehypertension'' (120 to 139 mm Hg systolic and/or
    80 to 89 mm Hg diastolic blood pressure). Individuals with
    prehypertension are strongly encouraged to pursue lifestyle changes--
    losing excess weight, eating a heart-healthy diet, increasing physical
    activity, quitting smoking--to forestall development of overt
    hypertension. To date, most behavioral interventions have focused on
    only one or two lifestyle changes at a time. However, findings from a
    recent clinical trial indicate that an all-in-one approach to lifestyle
    changes is feasible and effective in lowering blood pressure. Trial
    participants who addressed many elements of a healthy lifestyle
    simultaneously also significantly reduced their weight and became more
    fit providing even more incentive to undertake such changes.

                  HYDROXYUREA THERAPY FOR SICKLE CELL DISEASE

        A breakthrough for patients occurred in 1995 when the NHLBI
    announced the results of a major trial of the first treatment for
    adults with sickle cell disease. The study found that use of the drug
    hydroxyurea slashed rates of painful crises and acute chest syndrome,
    and sharply reduced the need for blood transfusions and
    hospitalizations. A followup study of the trial participants recently
    reported that hydroxyurea not only protects patients from episodes of
    severe illness associated with their disease, but also prolongs their
    lives. Even the sickest patients--those who suffered three or more
    painful crises a year--benefitted. These results have important
    implications both for improving patient care and for decreasing health
    care costs associated with sickle cell disease.

                IMPROVING SURVIVAL FOR VICTIMS OF CARDIAC ARREST

        Cardiac arrest--in which the heart stops beating effectively, blood
    does not circulate, no pulse can be felt, and the victim collapses into
    unconsciousness--is a frequent occurrence in this country. Despite
    several decades of efforts to train members of the public to perform
    CPR (cardiopulmonary resuscitation), few victims of out-of-hospital
    cardiac arrest survive the experience. The NHLBI Public Access
    Defibrillation trial trained volunteer rescuers to use an automated
    external defibrillator, a device that shocks the heart back into normal
    rhythm. It found that use of CPR plus the defibrillator, compared with
    use of CPR alone, markedly increased survival of people who suffered
    cardiac arrest in various community settings, and caused no major
    injuries or serious safety problems. An important next step, currently
    under way with NHLBI support, is to determine the safety and
    effectiveness of providing defibrillators to families of heart attack
    patients for use when a cardiac arrest occurs at home. In addition, the
    Institute is establishing a research consortium of investigators,
    hospitals, emergency medical services, and local communities to
    investigate promising experimental strategies to resuscitate patients
    who experience out-of-hospital cardiac arrest.

                         COMBATING THE OBESITY EPIDEMIC

        Obesity is a problem of great concern to the NHLBI, as it strongly
    influences the risk for developing diseases and conditions such as
    coronary heart disease, hypertension, and diabetes. Thus, the Institute
    is strongly involved in the overall NIH effort to reverse the U.S
    obesity epidemic, and I have been especially pleased to serve as
    cochair of the NIH Obesity Research Task Force.
        The NHLBI recently launched a major study that addresses one of the
    most challenging aspects of weight control--keeping lost pounds off.
    The Weight Loss Maintenance Trial will initially assist overweight or
    obese adults participants in making lifestyle changes to reduce their
    weight and, subsequently, it will test various strategies to help the
    participants maintain their weight loss over the next several years.
    The trial focuses on persons who are being treated for high blood
    pressure or high blood cholesterol and, consequently, have particularly
    strong reasons to achieve and maintain a healthy weight.
        Another new initiative will assess the effectiveness of worksite
    interventions for preventing or controlling overweight and obesity in
    adults. Strategies to be considered include implementing environmental
    and policy changes to increase employees' physical activity (e.g.,
    flextime or fitness-center discounts), offering healthful food choices
    in cafeterias and vending machines, providing information about
    nutrient and calorie content of foods at the point of purchase, and
    enhancing social support from fellow workers to encourage improved diet
    and physical activity.
        A third NHLBI initiative will explore the potential use of
    bioengineering approaches to address problems of obesity. For example,
    new methods for imaging body fat content may enable more specific
    identification of who needs to lose weight and their success in doing
    so. Bioengineering techniques may also offer a solution to the
    difficult technical challenge of obtaining precise measurements of
    energy intake and expenditure. One can envision development of a
    wristwatch-like gadget from which the wearer could easily determine
    whether an energy intake goal has been exceeded or an energy
    expenditure has been met. New approaches might provide accurate,
    convenient, easily understood, and inexpensive devices that would
    foster research, improve clinical management of adults and children,
    and help the public eat less and exercise more.

                                   CONCLUSION

        These examples illustrate the extraordinary potential of clinical
    research, and particularly clinical trials, to address issues of major
    importance to the public health. The NHLBI will continue its commitment
    to stimulate and support clinical research, and to ensure that the
    knowledge thereby gained is rapidly, efficiently, and fully applied to
    disease treatment and prevention.

                                BUDGET STATEMENT

        The fiscal year 2005 budget includes $2,963.9 million, an increase
    of $172.1 million over the fiscal year 2004 enacted level of $2,791.8
    million.
        I would be pleased to answer any questions that the Committee 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 budget request for the National Institute on Deafness
    and Other Communication Disorders (NIDCD). The fiscal year 2005 budget
    includes $393,507,000 which reflects an increase of $11,561,000 and a 3
    percent increase over the fiscal year 2004 final conference level.
    Disorders of human communication exact a significant economic, social,
    and personal cost for many individuals. The NIDCD supports research and
    research training in the normal and disordered processes of hearing,
    balance, smell, taste, voice, speech, and language. NIDCD's mission
    includes the support of research to create assistive devices which
    substitute for lost and impaired sensory and communication function.
    Equally important to the NIDCD mission has been the discovery of
    genetic mutations that affect communication disorders. This work would
    not have been possible without the completion of the Human Genome
    project, supported in part by the National Institutes of Health.
    Enabled by this landmark accomplishment, scientists supported by the
    NIDCD have been studying the genes responsible for non-syndromic (not
    associated with any other problem) hereditary hearing impairment.
    Within the last 8 years, 54 genes have been identified, largely due to
    the contributions of NIDCD. Scientists are now focusing their efforts
    on identifying more genes, learning what role the genes have in
    deafness, and determining which genes affect certain populations of
    individuals. For example, recent studies have demonstrated that
    particular ethnic groups carry specific genetic mutations. Studying the
    genes that cause non-syndromic hereditary deafness will also permit
    early and more accurate genetic testing and foster the development of
    innovative intervention and prevention strategies, and more effective
    treatment methods for individuals with deafness and other communication
    disorders. My testimony today will primarily focus on the many genetic
    discoveries that have allowed NIDCD-supported scientists to learn more
    about the causes of communication disorders, a first step in prevention
    and treatment.

                 NEW WAY TO IDENTIFY USHER SYNDROME IN CHILDREN

        Usher syndrome Type 1 is an inherited disorder. Children born with
    this disorder are deaf, suffer balance problems, and gradually lose
    their vision. Although Usher syndrome affects individuals of other
    racial and ethnic backgrounds, scientists have recently identified a
    clear pattern of its inheritance in Ashkenazi Jews, who are descendants
    of Jews from Germany, Austria and Eastern Europe. In 2003, a NIDCD-
    supported scientist identified a mutation within the gene known to be
    responsible for Usher syndrome. The particular mutation seems to be
    responsible for most of the Usher syndrome seen in Ashkenazi Jews.
    Because scientists now know which mutation is responsible for this type
    of Usher syndrome, they can develop genetic tests to detect the
    mutation in Ashkenazi Jewish children who are born deaf. By identifying
    children destined to lose their sight, parents and doctors can help
    them learn to communicate and prepare them for blindness. Some of these
    children will be appropriate candidates to receive a cochlear implant.
    Cochlear implants are small electronic devices that enable individuals
    who are deaf or have severe hearing loss to detect sound. This research
    will now enable doctors to provide important quality of life
    improvements for children with Usher syndrome.

              GENE REPLACEMENT THERAPY CAN GENERATE NEW HAIR CELLS

        The sensory hair cells of the inner ear play an important role in
    detecting sound. People who lose hair cells due to excess noise,
    infections, or accidents often lose some or all of their ability to
    hear. Scientists have determined that many forms of inherited deafness
    are also due to problems with hair cells. The hair cells of the inner
    ear act like miniature amplifiers. Sound waves that enter the inner ear
    are converted into a series of chemical and electrical signals within
    the cells. These signals are ultimately transmitted to the brain via
    the auditory nerve and interpreted as sound. In the past, only birds or
    reptiles were thought to be capable of generating new hair cells. Now,
    NIDCD-supported scientists have discovered a way to use gene therapy to
    generate new hair cells in the ears of adult mammals. Scientists used a
    virus to transfer a gene called Math1 into the ears of guinea pigs.
    Math1 is expressed in developing hair cells, and its expression is
    thought to cause the cells to become hair cells, rather than becoming
    another cell type within the ear. The virus infects cells of the ear
    and causes them to produce the Math1 protein. Early experiments suggest
    that when the virus infects cells that do not normally express Math1,
    some of these cells become hair cells. In addition, the new hair cells
    also attract fibers of the auditory nerve, suggesting that the new
    cells may also be able to establish a link to the part of the brain
    that interprets sound--the auditory cortex. If this work can be
    duplicated in human beings, it may be the first step towards enabling
    scientists to use gene therapy to restore hearing to those who have
    lost it, or to enable deaf individuals to hear.

     NEW SHORT ELECTRODE WILL ALLOW GREATER BENEFIT FROM COCHLEAR IMPLANTS

        Cochlear implants are commercially available miniature hearing
    prostheses capable of assisting those who are profoundly deaf or
    severely hearing impaired. Approximately 60,000 individuals all over
    the world have received cochlear implants. The implant bypasses damaged
    or missing hair cells to send electrical signals through an array of
    electrodes within the cochlea (inner ear). Current cochlear implants
    send sound information that covers the entire frequency range. In order
    to send both high and low frequency information, the electrodes of the
    cochlear implant are inserted as far into the cochlea as possible.
    Unfortunately, inserting the electrodes into the cochlea compromises
    any residual (remaining) hearing the individual may have had prior to
    implantation. Consequently, scientists developed a new shorter
    electrode to help an additional population of individuals with hearing
    loss. These individuals have a considerable amount of residual hearing
    and their primary hearing loss is in sounds in the high frequency
    range. They are also experienced, yet unsuccessful, adult hearing aid
    users with severe-to-profound hearing impairment who would not have
    been conventional cochlear implant candidates. The short electrode is
    inserted into the base (or bottom) of the cochlea to restore hearing at
    high frequencies, while preserving low frequency hearing, or residual
    hearing, in the apex (or top) of the implanted ear.
        The preliminary data demonstrates residual hearing can be preserved
    with this short electrode, and provides evidence that this is most
    beneficial for understanding speech in a noisy background. Furthermore,
    the innovative short electrode may be an ideal treatment for those with
    presbycusis, which is the loss of hearing that gradually occurs in most
    individuals as they grow older. This new electrode design allows many
    more people with some degree of hearing loss to benefit from cochlear
    implant technology.

               IDENTIFYING GENES IMPORTANT FOR THE SENSE OF TASTE

        The worldwide obesity epidemic is causing health professionals to
    focus their attention on how people choose which foods to eat. Because
    taste plays an important role in food choice, scientists are interested
    in figuring out how taste buds tell the brain that they have tasted
    something, and which taste genes are responsible for sensing different
    food flavors. Vegetables such as broccoli, cauliflower, cabbage, and
    brussels sprouts contain compounds related to phenylthiocarbamide
    (PTC). For more than 50 years, scientists thought that the ability to
    taste PTC and similar compounds was determined by a single gene. If an
    individual inherited the PTC-tasting version of the gene, then they
    detected its bitter taste. If the tasting version of the gene was not
    inherited, the compound had no taste to that individual. Now NIDCD
    scientists, in collaboration with scientists in California and Utah,
    have identified a gene that regulates a person's sensitivity to the
    bitter taste of PTC. This explains why people seem to demonstrate a
    range of sensitivity to PTC's taste and may even influence whether or
    not an individual likes to eat broccoli and other vegetables containing
    PTC-like compounds. Because they determine an individual's sensitivity
    to a particular taste, inherited genes probably influence food choices.
    In the future, doctors may now be able to use this knowledge as part of
    a strategy to prevent and treat obesity and to overcome poor nutrition
    due to poor food choices. Increased knowledge about how taste cells
    tell the brain that they have detected a particular flavor may also
    help doctors restore the sense of taste to those who have lost it due
    to injury, disease or aging.

                              VOCAL FOLD PARALYSIS

        Vocal fold paralysis is a genetic disorder that can be inherited.
    The vocal folds are two bands of smooth muscle tissue that lie opposite
    each other and are located in the larynx or voice box. When at rest,
    the vocal folds are open to allow an individual to breathe. Voice is
    produced by vibration of the vocal folds. To produce voice, air from
    the lungs passes through the folds, causing vibration and thus making
    sound. The sound from this vibration then travels through the throat,
    nose, and mouth (resonating cavities). The size and shape of these
    cavities, along with the size and shape of the vocal folds, help to
    determine voice quality. Paralysis of the vocal folds impacts voice
    quality and inhibits an individual's ability to communicate. This
    disorder can also cause life-threatening breathing difficulties in
    affected newborn infants.
        Intramural scientists at the NIDCD and the National Institute of
    Neurological Disorders and Stroke are studying a family in which this
    disorder occurs and have found that vocal fold paralysis is due to
    degeneration of the nerves involved in movement. Weakness in the
    muscles of the arms and legs can also accompany this disorder. In the
    study, genetic analyses were used to locate the site of the causative
    gene to a section on chromosome 2. Further studies revealed that
    mutations in the dynactin gene, which resides at this location, are
    responsible for this disorder. Dynactin is a molecule that helps
    transport materials within nerve cells, and this research finding
    suggests that dynactin transport is essential for health and
    maintenance of at least some motor nerve cells.
        This finding allows for a genetic tool for diagnosing vocal fold
    paralysis, which can aid in the clinical and neonatal management of
    this disorder. In addition, these findings provide better understanding
    of motor nerve cells and the molecular mechanisms that cause motor
    nerve degeneration.

                                  NIH ROADMAP

        The NIH Roadmap initiative to support interdisciplinary research
    and research training will advance the NIDCD mission because it
    encourages collaboration of scientists from seemingly unrelated
    disciplines. Interdisciplinary collaborations from a variety of
    scientific disciplines are necessary for developing assistive
    communications devices such as hearing aids and cochlear implants. The
    success of the development of the cochlear implant is a good example of
    successful interdisciplinary research as it involved the effort of
    physicists, chemists, material scientists, psychologists
    otolaryngologists, audiologists, speech-language pathologists,
    electrical engineers, and biomedical engineers We look forward to
    expanding upon that type of research in the coming years.
        Finally Mr. Chairman, I would like to thank you and Members of this
    Committee for giving me the opportunity today to speak to you about the
    exciting recent discoveries from the NIDCD. I am pleased to answer any
    questions that you have.
                                     ______

                 Prepared Statement of Dr. Donald A.B. Lindberg

        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's budget request for the National Library of Medicine
    (NLM) for fiscal year 2005, a sum of $325,147,000, which reflects an
    increase of $16,671,000 over the comparable fiscal year 2004
    appropriation.
        The National Library of Medicine continues to be the premier source
    of science-based medical information. Just 10 years ago the Library
    introduced its Web site one of the very first in the federal government
    and so began a decade of amazing growth in the amount and variety of
    medical information it made available. Today the Library's Web service
    not only provides free access to Medline/PubMed, the largest and most
    reliable database of scientific medical information in the world, but
    NLM has created information products designed specifically for
    patients, families, and the public.
        Despite its recent successes, NLM believes that the surface has
    barely been scratched and that the future holds the promise of many
    more valuable information products for the professions and the public.
    The Library's communications experts are at the cutting edge of new
    technology and, as more and more users have access to ever more
    powerful networks, the Library will put in place sophisticated yet easy
    to use information services that allow users free access to the world's
    burgeoning base of science-based health information. For scientists
    this means access not only to the growing published journal literature,
    but also electronically to scientific monographs and textbooks and to a
    variety of genomic information resources through NLM's National Center
    for Biotechnology Information (NCBI). For the general public, this
    means making even more consumer health information--from the National
    Institutes of Health and other reliable sources--available from the
    NLM's Web site.
        The new NIH Roadmap Initiative has the potential to have a profound
    and positive impact on how American medical research is conducted. The
    NLM sees itself has having an important role in the Initiative in three
    areas. Because the Roadmap recognizes that one of the most powerful and
    unifying concepts of 21st century biology is that of bioinformatics,
    the computerized bioinformatics databases and analysis tools of the
    NCBI will become even more central to the research enterprise. Second
    is the Roadmap's requirement to ``re-engineer the national clinical
    research enterprise.'' NLM's leadership role in working with biomedical
    vocabularies the Unified Medical Language System, the recently
    announced arrangement with the SNOMED clinical vocabulary, and NLM's
    expanding the NIH clinical trials database are all key aspects of
    improving clinical research. Finally, the Roadmap articulates NIH's
    responsibility to communicate research results to improve the quality
    of life for all people. The Library has a central role in collecting
    and communicating these results through Web-based information services
    and online databases. These are described in what follows.

                 TOOLS FOR SCIENTISTS AND HEALTH PROFESSIONALS

        The NLM's Medline/PubMed is the most-used database of peer-reviewed
    medical information in the world. It contains more than 12 million
    references and abstracts to the world's medical literature published
    since the 1960s; an ancillary ``OldMedline'' extends the coverage back
    to the early 1950s. Each year millions of scientists and health
    professionals connect to Medline/PubMed (no registration or fee is
    required) and search for information they can use in the research or
    practice. More than a half billion such searches are done every year.
    The newest system, introduced in 1997, is constantly being improved.
    Several years ago NLM introduced links between Medline/PubMed
    references and publisher websites so users could retrieve the full text
    of articles. Today, more than 4,000 of the database's 4,600
    publications have such links.
        Another heavily used database is GenBank, the repository of all
    publicly available DNA sequences sent to the NLM from laboratories
    around the world. GenBank, and an increasing array of other valuable
    data resources, is the responsibility of the National Center for
    Biotechnology Information. The Center, which was created by the
    Congress in 1988 with the mandate to manage and disseminate genetic
    data, coordinates closely with the NIH Human Genome Project. GenBank
    today contains more than 27 million sequence entries totaling 33
    billion base pairs from over 130,000 species. NLM, through the Web
    operations of the NCBI, receives more than a quarter million visitors a
    day seeking molecular biology information ranging from DNA sequences
    and protein structures to the related research literature.
        A repository for chemical structure and assay data has been
    suggested as one aspect of NLM's involvement with the NIH Roadmap
    Initiative on ``small molecules'' to enhance research and develop new
    therapies. The NCBI is working on such a repository--called PubChem--
    which will integrate into one open database, information from existing
    chemical structure databases at various NIH institutes as well as data
    supplied from industry and academic centers. By providing chemical
    structure validation and structure-structure matching and by linking to
    descriptions of the compounds in journal articles, PubChem will play an
    invaluable role in making this information useful to scientists.
        PubMedCentral, a digital archive, is an important component of the
    infrastructure needed to enhance access to the life sciences
    literature. Publishers electronically submit peer-reviewed research
    articles, essays, and editorials. NLM guarantees free access to the
    material; copyright remains with the publisher or the author. Access to
    PubMedCentral is free and unrestricted. The full text of more than 100
    life science journals, some going back decades, is now available, and
    more are added as they sign on to the system. Digitally archiving the
    scientific literature and guaranteeing access for future generations is
    an important NLM responsibility.

                      INFORMATION SERVICES FOR THE PUBLIC

        The National Library of Medicine has become a favorite destination
    of seekers of health-related information on the Web--people looking for
    answers to questions about their health or the health of their loved
    ones. MedlinePlus, the largest of NLM's Web offerings for the general
    public, now receives about 4 million unique visitors a month.
    Increasingly, they also find their way on the NLM Web site to other
    services created specifically for them--NIHSeniorHealth.gov,
    ClinicalTrials.gov, Genetics Home Reference, Household Products
    Database, and Tox Town are all recent examples. These Web sites contain
    or point to information created by NIH components and other reliable
    noncommercial sources. They require NLM librarians and information
    specialists to work closely with a wide variety of outside
    organizations. MedlinePlus, launched in November 1998, today is one of
    the most heavily trafficked Web sites containing health information for
    the public. It has more than 650 ``health topics,'' containing, for
    example, overview information, pertinent clinical trials, alternative
    medicine, prevention, management, therapies, the latest research, and
    the latest news from the print media. There are even links to the
    scientific literature through Medline/PubMed. In addition to the 650
    health topics, there are medical dictionaries, encyclopedias,
    directories of hospitals and providers, and interactive ``tutorials''
    with images and sound. MedlinePlus en espanol was introduced in 2002
    and has grown to virtual parity with the English version. Both scored
    the highest marks of any Federal Web site in a recent outside
    evaluation. A new aspect of MedlinePlus is its plan to ``Go Local,''
    that is, to link users with community helping services near them. North
    Carolina is the first MedlinePlus partner to go local.
        The National Library of Medicine is collaborating with the American
    College of Physicians in a unique ``Information Rx'' project that seeks
    to encourage practicing physicians who are members of the College to
    ``prescribe'' MedlinePlus to their patients who need further
    information on a medical subject. After test runs in Georgia, Iowa,
    Virginia, and Florida, the Information Rx program will go nationwide
    later in 2004.
        MedlinePlus is not the only NLM information service directed at the
    consumer. Another very popular resource is ClinicalTrials.gov, which
    integrates previously fragmented information on human studies for
    different conditions into a single, coherent system, providing the
    public with an easy-to-use and convenient ``one-stop'' site for
    comprehensive information on clinical trials. The site, which is used
    not only by the public but by their health care providers, currently
    includes information on approximately 8,800 trials for hundreds of
    diseases and conditions conducted in about 90 countries.
    ClinicalTrials.gov receives approximately 16,000 visitors daily and
    over 3 million page views monthly.
        Late in 2003 another service for the public was launched:
    NIHSeniorHealth.gov. This site contains information in a format that is
    especially usable by seniors. For example, the site features large
    print and easy-to-read segments of information repeated in a variety of
    formats--such as open-captioned videos and short quizzes to increase
    the likelihood it will be remembered. NIHSeniorHealth.gov has a
    ``talking'' function, which allows users the option of reading the text
    or listening to it as it is read to them. Another new NLM consumer
    service is the Household Products Database. This is a guide that
    provides easy-to-understand information on the potential health effects
    of more than 2,000 ingredients contained in more than 4,000 common
    household products. The database provides information on many of these
    substances and their potential health effects, in consumer-friendly
    language. For more technical information, users can launch a search for
    a product or ingredient from the product's page into NLM's TOXNET, a
    cluster of databases on toxicology, hazardous chemicals, and related
    areas.
        Another consumer health information resource introduced in 2003 is
    the Genetics Home Reference. Genetics is a complex subject, and much of
    the primary data and literature are difficult to understand without
    formal training. The Genetics Home Reference Website augments
    MedlinePlus with summaries of genetics information and an overview of
    the fundamentals of genetic science. The user can browse by a specific
    disease/condition or by gene. It also has a geographic list of genetic
    counselors and information for care-givers. The database has more than
    100 condition summaries and 80 gene summaries and new content is being
    added continuously.
        The Library launched Tox Town late in 2002. Tox Town looks at an
    ordinary town and points out many environmental hazards that might
    exist there. Users can click on a town location, like the school, and
    see a colorful dollhouse-style cutaway view of that building. Toxic
    chemicals that might be found in the school are listed, along with
    links to selected Internet resources about school environments. There
    are similar cutaways for offices, factories, parks, and other
    locations. NLM has plans to add new scenes, such as an urban community
    and a farming region.

                          SERVING SPECIAL COMMUNITIES

        With all these unique information resources, it becomes more and
    more important for the Library to engage in outreach to let citizens
    know what is available. The 5,100-member National Network of Libraries
    of Medicine is an important partner in these outreach endeavors. Many
    of the programs are directed at minority populations. For example,
    there are programs to assist in remedying the disparity in health
    opportunities experienced by African Americans, Latinos, Native
    Americans, senior citizens, and rural populations. A new NLM database
    introduced in 2003 has health information aimed at Asian Americans;
    2004 will see a similar database with information about the health
    concerns of Native Americans.
        Under a program with the Historically Black Colleges and
    Universities (HBCUs), NLM is helping to train people to use information
    resources in dealing with environmental and chemical hazards. The
    latest aspect of this outreach effort is NLM's collaboration with the
    United Negro College Fund Special Programs Corporation to work with the
    HBCUs in the area of consumer health to encourage the use of reliable
    electronic health information (such as that provided by the NLM) by the
    public.
        NLM also has been instrumental in reaching out to other countries
    around the world to help improve their access to scientific medical
    information. The oldest such program is that involving formal
    partnerships with major institutions in 20 countries. The NLM helps
    them obtain computerized access to the literature; the countries in
    turn help NLM receive the medical literature from that part of the
    world. The Library is also a key player in the Multilateral Initiative
    on Malaria, the multiagency effort to improve malaria research in
    African nations. NLM's role is to establish and maintain the first
    malaria research communications network, MIMCOM. There are now 19
    research sites in 9 countries participating, with full access to the
    Internet.

                                SCIENCE ADVANCES

        Many scientists believe that molecular biology is the primary
    driver of medical advances in the 21st century. The rapidly increasing
    volume of molecular data and the need to decipher its cryptic and
    subtle patterns has created demanding requirements for computerized
    databases and analysis tools, special curatorial expertise, and unique
    physical facilities. The National Center for Biotechnology Information
    is a key player in ensuring that the outpouring of data from molecular
    biology laboratories around the world is turned to life-enhancing
    purposes. GenBank, as noted above, is growing rapidly with
    contributions received from scientists around the world. Scientists
    also avail themselves of sophisticated computational tools, such as the
    BLAST suite of programs, which lets scientists search enormous
    quantities of data for sequence similarities that will identify genes
    and genetic features. Another tool, Entrez, allows users to search DNA
    sequences and literature information with techniques that are fast and
    easy to use. The newest tool is the ``Reference Sequence Collection,''
    which provides a centralized, integrated, non-redundant set of
    sequences that is integrated with other information for all major
    research organisms. Using the Reference Sequence Collection, time once
    spent on having to identify, gather, and analyze data can now be spent
    effectively on research.
        The Center is now also conducting research using the human genome
    sequence to begin exploring the history of human populations. NCBI
    researchers, working with other collaborators, first assembled a set of
    500,000 high-confidence variations and then compared the distribution
    of these variations on the genome to that predicted by several models
    of population history. They found that the data best fit a model in
    which the human population shrank dramatically about 40,000 years ago,
    a time when modern humans first appeared in Europe. The model suggests
    that the population subsequently grew about 30,000 years ago,
    consistent with archaeological evidence of a population expansion
    during that period. The results indicate that databases of genetic
    variation constructed alongside the human genome project can provide a
    unique insight into the history of human populations. This insight may
    also explain how these populations may respond differently to selective
    pressures such as infectious diseases.
        NLM's Lister Hill National Center for Biomedical Communications
    sponsors high-technology communications research projects in such areas
    as high quality imagery, medical language processing, high-speed access
    to biomedical information, developing intelligent database systems,
    multimedia visualization, data mining, and machine-assisted indexing.
    One prominent area of research has been the Visible Human Project. The
    project consists of two enormous (50 gigabytes) data sets, one male and
    one female, of anatomical MRI, CT, and photographic cryosection images.
    These data sets are available through a free license agreement to 1,800
    individuals and institutions in 47 countries where they are being used
    in a wide range of educational, diagnostic, treatment planning, virtual
    reality, artistic, and industrial applications. An ``Insight Toolkit''
    has been developed and makes available a variety of open source image
    processing algorithms for computing segmentation and registration of
    medical data. The Visible Human Web site is one of the most popular of
    all NLM's Web offerings.
        NLM's Extramural Programs for more than 20 years has supported the
    training of medical informaticians at universities across the nation.
    In the early years the program focused on training of informaticians
    for clinical care. Today the training programs have added opportunities
    for training in bioinformatics, the field of biomedical computing for
    the large datasets characteristic of modern research. At present, NLM
    provides 18 grants to biomedical informatics training at 26
    universities, supporting 250 trainees. NLM also participates in the NIH
    Roadmap activities, almost all of which have major emphasis on
    biomedical computing. For example, training is an important requirement
    of the National Centers for Biomedical Computing, an initiative for
    which NLM is one of the key leaders. Training as embedded in Roadmap
    activities is expected to become a significant complement to NLM's
    traditional support of informatics training.

                                   THE FUTURE

        In its role as the world's largest medical library, the NLM will
    continue to provide free access to the enormous literature of the
    health sciences, including even priceless historical treasures dating
    to the 11th century. As to the 21st century, the Library is making
    major contributions to the NIH Roadmap and is also applying its
    unparalleled collections and talents to ``BIOSHIELD,'' the Department
    of Health and Human Services' effort to combat bioterrorism. The
    ability to apply medical knowledge to make our citizens healthy and
    safe is to repay the investment of the nation in medical research. In
    this, the National Library of Medicine can be of great help.
                                     ______

                     Prepared Statement of Dr. Ting-Kai Li

        I am pleased to present the President's budget request for the
    National Institute on Alcohol Abuse and Alcoholism (NIAAA) for fiscal
    year 2005, a sum of $441,911,000, which reflects an increase of
    $13,486,000 over the comparable fiscal year 2004 appropriation.
        As the recent NIAAA National Epidemiologic Survey on Alcohol and
    Related Conditions (NESARC) has shown, most cases of alcoholism are
    established by age 25, beginning as early as age 18.\1\ These new
    results, which are corroborated by studies not yet published, call for
    a major refocusing of research on youth as the most important target
    for preventing alcohol abuse and alcoholism on a public-health scale.
    We now know that youth and adolescence are the critical window of
    opportunity. The earlier one drinks in adolescence, the greater the
    likelihood that he or she will develop alcoholism.
    ---------------------------------------------------------------------------
        \1\ NIAAA National Epidemiologic Survey on Alcohol and Related
    Conditions, 2003, and unpublished data from the Collaborative Studies
    on the Genetics of Alcoholism.
    ---------------------------------------------------------------------------
        The public-health implications of preventing alcoholism before it
    becomes established in youth are large, given the magnitude of alcohol
    misuse and its consequences. The 2002 report of the World Health
    Organization ranks alcohol third as a preventable risk factor for
    premature death in developed nations. Only tobacco and cholesterol are
    greater risk factors.
        In the United States, almost 18 million American adults met the
    clinical diagnostic criteria for alcohol abuse or alcohol dependence in
    2002.\2\ Annual costs to U.S. society of the consequences of alcohol
    misuse are about $185 billion.\3\
    ---------------------------------------------------------------------------
        \2\ Grant BF, Dawson DA, Stinson FS, Chou SP, Dufour MC, Pickering
    RP. The 12-month prevalence and trends in DSM-IV alcohol abuse and
    dependence: United States, 1991-1992 and 2001-2002. Drug and Alcohol
    Dependence, in press, 2004.
        \3\ Harwood, H.; Fountain, D.; and Livermore, G. (2000). The
    Economic Costs of Alcohol and Drug Abuse in the United States 1992
    (updated for 1998). Report prepared for the National Institute on Drug
    Abuse and the National Institute on Alcohol Abuse and Alcoholism,
    National Institutes of Health, Department of Health and Human Services.
    NIH Publication No. 98-4327. Rockville, MD: National Institutes of
    Health.
    ---------------------------------------------------------------------------
        Heavy alcohol use in the American military is on the rise, with
    more than 19 percent of male personnel and more than 5 percent of
    female personnel reporting heavy use.\4\ (The Department of Defense
    defined heavy drinking as five or more drinks on one occasion, at least
    once a week, in its survey). This pattern of drinking is hazardous to
    the health and welfare of the individual, the family, and society. In
    the general population of the United States, alcohol-related illness
    and injury account for at least 8 percent of all emergency-room
    visits.\5\
    ---------------------------------------------------------------------------
        \4\ The 2002 Department of Defense Survey of Health Related
    Behaviors Among Military Personnel.
        \5\ McDonald III AJ, Wang N, Camargo Jr CA. U.S. Emergency
    Department Visits for Alcohol-Related Diseases and Injuries Between
    1992 and 2000, Archives of Internal Medicine, 2004;164:531-537.
    ---------------------------------------------------------------------------
                              ALCOHOL USE BY YOUTH

        Alcohol is the primary psychoactive substance of abuse by American
    children. As the NIAAA fiscal year 2005 Congressional Budget
    Justification notes, 78 percent of 12th graders, 67 percent of 10th
    graders, and 47 percent of 8th graders have used alcohol.
        The same source of those statistics, the National Institute on Drug
    Abuse's Monitoring the Future survey, also indicates that youth who
    report having been drunk at least once include 62 percent of 12th
    graders, 44 percent of 10th graders, and 21 percent of 8th graders.
    Roughly half of those percentages say that they drank heavily five or
    more drinks in a row in the past 2 weeks.
        The NESARC data show that most cases of addiction, not only to
    alcohol, but also to other drugs of abuse, first occur in youth, after
    which new cases drop off sharply. The same research shows that, by
    comparison, new cases of depression do not follow this trajectory,
    instead continuing to rise after adulthood.

                            REFOCUSING THE RESEARCH

        The new finding that youth is the stage of life during which
    alcoholism is most likely to begin calls for a shift in the emphasis of
    our research. By focusing even more strongly than we currently do on
    developing strategies to prevent the onset of alcoholism in this
    population, we have the potential to dramatically reduce, overall, the
    occurrence of this common disease.
        Likewise, shifting the focus of our medication development program
    to the early stages of the disease stands to improve the effectiveness
    of treatment. As with most diseases, early treatment for alcoholism
    could prevent a host of problems, including the medical sequelae of
    heavy alcohol use, which are estimated to cost $18.9 billion annually.
        Studies show that a combination of factors underlie drinking
    behaviors. Environmental factors--family and peers, for example--are
    the dominating influences on whether or not an individual first uses
    alcohol. Personality and temperament also influence the decision to
    begin drinking. These factors have a profound effect on youth.
        Whether or not drinking continues also is influenced by
    differences, from individual to individual, in the pharmacological
    effects (activities of genes, proteins, and metabolic products) that
    come into play once drinking has begun. When drinking progresses to
    alcoholism, alcohol's pharmacological effects will have become the
    dominant influence on drinking behavior.
        Identifying the pharmacological effects of alcohol is essential to
    our ability to design effective prevention and treatment strategies for
    youth. In childhood and adolescence, the pharmacological effects of
    alcohol are occurring at a time of rapid structural and physiological
    change in the brain. One of the major questions before us is how
    alcohol's pharmacological effects work in ways that specifically
    promote alcoholism during this vulnerable time of life. Two NIH Roadmap
    initiatives will be particularly informative in this regard, as
    follows.
        The Roadmap Metabolomics Technology Development Initiative will
    enhance our ability to identify metabolic processes that contribute to
    alcohol dependence (and alcohol-related organ damage). People have
    differences in the genes that regulate their cellular mechanisms,
    including the enzymes responsible for alcohol metabolism. These
    differences result in variations in how people respond to alcohol; for
    example, the choice to drink and the amount of alcohol consumed.
        Proteins, such as the receptors and transporters for
    neurotransmitters, play roles in virtually every step of alcohol's
    actions in the brain and other organs. Another Roadmap initiative, the
    National Technology Centers for Networks and Pathways, will remove
    barriers to defining how these proteins behave in the complex
    biological systems in which they interact. Such proteins are potential
    targets for medications, but efforts to alter the actions of proteins
    with potential medication compounds have thus far met with limited
    success in preventing and treating alcohol-use disorders in adults.
    This Roadmap initiative will provide much-needed tools that will help
    us track the interactions of specific proteins at specific points in
    time and cellular space an ability that will enable us to develop more
    precise targets for medications to treat the early stages of
    alcoholism.

                                ACTIONS UNDERWAY

        Our current research on drinking by youth includes studies of the
    neurobiological mechanisms of adolescent alcohol abuse; an initiative
    on preventing alcohol-related problems among college students; expanded
    testing of preventive interventions, from rural children to children in
    urban, diverse neighborhoods; and an initiative that is examining risk
    factors and testing community-based, longitudinal prevention programs
    among children in rural and small urban areas, in response to fiscal
    year 2004 House Appropriations Report language.
        Included in NIAAA's fiscal year 2005 Congressional Budget
    Justification is an expansion of the latter initiative among youth in
    rural and small urban communities, both of whom have high rates of
    alcohol use. Both biological and environmental studies, as well as
    studies of prevention strategies, will be included. The Substance Abuse
    and Mental Health Services Administration, the National Institute on
    Drug Abuse, the National Institute of Child Health and Human
    Development, the National Institute of Mental Health, and other NIH
    Institutes, as well as the Department of Education and other Federal
    agencies, will be invited to collaborate in this initiative.
        In addition to our research, we conduct outreach programs for
    youth. The Leadership to Keep Children Alcohol-Free has recruited 33
    Governors' spouses to spearhead a national prevention campaign. The
    Task Force on College Drinking has brought together university
    presidents and researchers, and is making headway in efforts to reduce
    drinking by college students and in evaluating those efforts.

                               THE LARGER PICTURE

        Alcohol abuse and alcoholism often result in behavioral outcomes
    such as property damage, legal problems, disrupted family lives, and
    derailed academic pursuits and professional careers. But its
    consequences also include medical sequelae. With prolonged, heavy use,
    it can act as a toxin, damaging virtually any organ in the body. For
    example, alcohol is a leading cause of liver cirrhosis and contributes
    to some kinds of cancer. Approximately 77 percent of the annual $185
    billion cost of alcohol misuse is health-related, generated by medical
    consequences and lost productivity associated with illness or death.
        Research leading to effective strategies for preventing and
    treating alcoholism early in life, when it is most likely to begin, can
    help avert many other costly problems. While we will increase our
    research on drinking by youth, we will continue our studies of the many
    other facets of alcohol use, such as fetal alcohol syndrome, as well as
    our research on the apparent protective effect of moderate drinking
    against certain chronic diseases.

                             CONNECTION TO OBESITY

        We will also conduct research on alcohol's role in the national
    obesity epidemic. In addition to acting as a drug, alcohol is a food--a
    highly caloric food. It has more calories per gram than do
    carbohydrates or proteins.
        In addition, alcohol acts on some of the same neurotransmitter
    systems that regulate appetite. Some medications that work to reduce
    appetite may also reduce alcohol intake. One of the highest priorities
    that NIH lists in its Government Performance and Results Act goals is
    human testing of the compound rimonabant for its potential to reduce
    alcohol use.
        Among the many neurotransmitter receptors that alcohol affects is
    the one receptor to which the active ingredient in marijuana binds.
    Stimulation of this receptor promotes appetite, and NIAAA animal
    studies show that blocking the receptor with rimonabant has the
    potential to reduce drinking in humans. NIAAA is preparing a human
    trial of rimonabant for treatment of alcoholism. Rimonabant made news
    in March of this year, when a French company announced the medication's
    effectiveness in reducing both weight and smoking.
        The anticonvulsant topiramate also is being tested for its
    effectiveness in reducing both obesity and alcohol use, through actions
    on another neurotransmitter system. The neurotransmitter gamma-
    aminobutyric acid (GABA), among many others, is known to be an
    important intermediary of alcohol's actions in the brain.
        Obesity and alcohol are linked in yet another way, recent studies
    show. The livers of obese rats undergo more cell death and sustain more
    injury from heavy, periodic alcohol use than do those of their slimmer
    counterparts. In humans, liver damage is one of the most prevalent
    medical consequences of chronic drinking.\6\
    ---------------------------------------------------------------------------
        \6\ Carmiel-Haggai M, Cederbaum AI, Nieto N. Binge ethanol exposure
    increases liver injury in obese rats. Gastroenterology, 125(6):1818-33.
    Dec. 2003.
    ---------------------------------------------------------------------------
                                  IMPLICATIONS

        On a large scale, epidemiology tells scientists where the action
    is. That is the case with our new findings on the stage of life when
    alcoholism is most likely to develop; that is, by age 25. We are
    beginning to take steps to greatly increase our focus on this period--
    on how variations in genetic, biological, and environmental factors
    unfold to promote establishment of alcoholism during development.
    Meanwhile, the NIH Roadmap initiatives on metabolomics and proteomics
    are developing tools that can significantly accelerate our research.
                                     ______

                  Prepared Statement of Dr. Lawrence A. Tabak

        Mr. Chairman and Members of the Committee: I am pleased to present
    the President's budget request for the National Institute of Dental and
    Craniofacial Research (NIDCR) for fiscal year 2005. The fiscal year
    2005 budget includes $394,080,000, an increase of $11,032,000 over the
    fiscal year 2004 level of $383,048,000 comparable for transfers
    proposed in the President's Request.

                  DELIVERING ON THE PROMISE OF BASIC RESEARCH

        Although highly technical in nature, basic research provides the
    detailed molecular clues that scientists and clinicians can use to
    develop new strategies that more effectively prevent or treat disease.
    This year, I would like to highlight how NIDCR's investment in the
    basic sciences continues to yield important advances in oral and public
    health. I also would like to mention how NIDCR stands to benefit from
    the recently launched NIH Roadmap which has the potential to catalyze
    virtually all areas of oral health research and, most importantly,
    hasten the development of novel treatments that could greatly improve
    American oral health.

                     GENE TRANSFER AND THE SALIVARY GLANDS

        A prime example of basic research creating new clinical
    opportunities is the transfer of replacement genes into the salivary
    glands for therapeutic purposes. In the early 1990s, a team of NIDCR
    scientists published their initial paper on the technical feasibility
    of this approach. Thereafter, they began a unique long-term research
    interest in transferring replacement genes into the salivary glands of
    persons with Sjogren's syndrome and cancer patients whose salivary
    glands were damaged during radiation treatment. The hope was that the
    replacement genes would increase the production of saliva and eliminate
    the chronic parched sensation that plagues people with dry mouth
    conditions.
        The NIDCR scientists also began to apply their gene transfer
    studies to a third and seemingly less obvious therapeutic area: single-
    protein disorders, such as type I diabetes, human growth hormone
    deficiency, and erythropoietin-responsive deficiencies. Frequently
    overlooked in the medical literature, salivary glands not only release
    saliva into the mouth, they routinely secrete digestive enzymes and
    other proteins into the circulatory system. As the scientists later
    would demonstrate, the salivary glands readily accept gene-carrying
    vehicles, or vectors. Thereafter, with minimal coaxing, the salivary
    glands act as natural protein factories, dutifully manufacturing the
    encoded replacement protein and pumping it at steady levels into the
    circulation. The approach has some built in advantages over gene
    therapy in other parts of the body, such as the liver. Salivary glands
    are easily accessible and any potential adverse effects would be non-
    life threatening. Moreover, salivary gland cells are encapsulated to
    prevent leakage of the vector into the circulation and to other
    tissues.
        Recently, the group developed a new version of gene-carrying vector
    that entered the salivary glands of mice and produced the human protein
    erythropoietin for at least one year, a major step forward in the
    research. Just as importantly, the vector--a stripped down,
    bioengineered version of the harmless adeno-associated virus--did not
    trigger a sustained immune response, a common setback in gene therapy
    experiments.
        Building on this strong basic research base, NIDCR has developed a
    new initiative to evaluate the safety and efficacy of salivary gland
    gene transfer techniques in people with systemic single-protein
    deficiencies. The initiative will consist of three Phase I/II clinical
    trials. The first clinical trial will involve a prototype systemic
    single-protein deficiency disorder, adult growth hormone deficiency. As
    currently proposed, 21 patients will be enrolled in the study, which
    will be completed in four years. If successful, a second clinical trial
    will be conducted to treat people with erythropoietin-responsive
    deficiencies and ultimately a third clinical trial for those with
    Sjogren's syndrome and/or cancer patients with dry mouth.

                     PERIODONTAL DISEASE AND PRETERM BIRTH

        Another outstanding example of basic research creating new clinical
    opportunities is in the area of preterm pregnancy. In the United
    States, about one in eight babies is born prematurely,\1\ which is
    defined as a birth that occurs three or more weeks earlier than the
    expected due date. As all too many parents have tragically experienced,
    extremely preterm babies can be so small and underdeveloped that they
    must remain hospitalized for months and, if they survive, spend years
    battling chronic health problems.
    ---------------------------------------------------------------------------
        \1\ March of Dimes Defects Foundation. http://
    peristats.modimes.org. Access on March 15, 2003.
    ---------------------------------------------------------------------------
        This serious and common problem has spurred scientists to identify
    ``risk factors'' associated with premature births. These risk factors--
    which now include smoking, low-income status, hypertension, diabetes,
    alcohol use, genitourinary tract infections--allow doctors to identify
    women who are more likely to deliver prematurely and thereby tailor
    their prenatal care to control or eliminate the risk factors.
        However, the list of risk factors remains a work in progress. An
    estimated one in four preterm births occur without any known
    explanation, and that has left scientists searching for additional
    susceptibility factors to help more mothers and reduce the estimated
    $13.6 billion per year spent in the United States on hospital stays for
    infants with a diagnosis of prematurity.\2\
    ---------------------------------------------------------------------------
        \2\ March of Dimes, PeriStats.
    ---------------------------------------------------------------------------
        In the mid 1980s, scientists began to suspect that periodontal
    disease might be one of these elusive risk factors. These NIDCR
    grantees and colleagues monitored women with more serious periodontal
    disease and found they were more likely to deliver early than those
    with mild or non-existent disease. They also have developed a plausible
    biological explanation to explain the possible association. Based on
    animal studies, the scientists hypothesized that certain bacteria from
    severe periodontal infections, most notably Porphyroma gingivalis,
    enter the bloodstream and eventually circulate to the womb. There, the
    oral pathogens colonize and irritate the uterine wall. This causes
    inflammation of the uterus and a rise in prostaglandins and other
    infection-signaling chemicals, which can induce early contractions and
    trigger premature labor.
        Left unanswered is whether treating women for periodontal disease
    during pregnancy will help them give birth to full term babies. The
    NIDCR recently launched two large randomized clinical trials to answer
    this important public health question. These national studies, which
    merge the disciplines of dentistry and obstetrics, will involve over
    2,600 women of various racial, ethnic, and economic backgrounds. What
    is unique about these clinical trials is there will be a yes-or-no
    outcome for each woman within 37 to 40 weeks, or the completion of the
    pregnancy. Women will not need to be tracked at great expense for 10 or
    20 years to get the final answer, as is often the case in clinical
    research. Once all the data are compiled and analyzed, which could take
    an estimated five years to assemble and analyze, researchers anticipate
    that they will have sufficient clinical data to offer sound scientific
    advice one way or the other on this critical public health issue.

                                 PAIN RESEARCH

        In another example of the potential payoff from basic research,
    scientists are mapping in greater detail the multiple routes, or
    pathways, that sensory signals travel en route to the spinal cord and
    brain. This work has resulted in several new leads in how to more
    effectively manage pain. One of the most promising new leads stems from
    work conducted at the NIDCR. Our scientists found that an ultrapotent
    compound selectively eliminated an entire class of pain-sensing neurons
    from the peripheral nervous system of a living organism. The compound,
    called resiniferatoxin (RTX), killed the neurons, blocking inflammatory
    pain, thermal pain sensation, and reducing hypersensitivity to pain.
    Importantly, the animals maintained their ability to sense pain, in
    this case from a pinch, and they remained well coordinated, an
    indication that RTX did not affect sensory nerves in the muscles and
    joints. Since these initial reports, the investigators have assembled
    additional preclinical data and are moving rapidly toward evaluating
    RTX in human clinical trials.
        In order to seed additional discoveries in pain research and to
    help more Americans effectively manage pain, the NIDCR will begin an
    initiative to define the proteins and protein networks involved in
    processing pain-signal information in the orofacial region. This
    initiative encourages interdisciplinary studies that employ genomic and
    proteomic approaches, imaging technology, and computational biology to
    clarify the molecular events involved in chronic orofacial pain
    disorders.

                         PUTTING RESEARCH INTO PRACTICE

        To achieve our goal of improved oral health for all people, NIDCR
    must ensure that research advances are translated and adopted into
    clinical practice. Many of the unique questions faced by dental health
    professionals on a daily basis are most appropriately addressed in
    dental practice settings, among unselected patient populations.
    Practice-based research networks can generate important and timely
    information to guide the delivery of health care and improve patient
    outcomes. The NIDCR will launch an initiative to create dental
    Practice-Based Research Networks (PBRNs) to conduct clinical research.
    In time, linking the oral health practice-based research networks with
    existing medical networks will provide additional patients,
    professional expertise, and integration of resources for conducting
    research across a broad spectrum of health care specialties. By
    connecting practitioners with experienced clinical investigators, PBRNs
    will enhance clinical research supported by the NIDCR and produce
    findings that are immediately relevant to practitioners and their
    patients. The networks can support a variety of clinical studies with
    clear and easily defined outcome measures, and they typically draw on
    the experience and insight of practicing clinicians to help identify
    and frame the questions. Because research is conducted in the real-
    world environment of dental practice, the results are more likely to be
    readily adopted by practitioners.

                                  NIH ROADMAP

        The NIH Roadmap provides several additional opportunities to the
    oral-health research community. For example the goals of the initiative
    Building Blocks, Biological Pathways and Networks--are closely linked
    to NIDCR's molecular anatomy efforts to identify the full complement of
    genes, proteins and protein networks that are expressed in both oral
    cancer and periodontal disease. Advances in proteomic analysis
    platforms will be crucial for NIDCR to achieve its goal of defining the
    salivary proteome--a critical step in the Institute's long-term goal to
    exploit the salivary secretions for diagnostic purposes. The Molecular
    Libraries and Molecular Imaging initiative holds great promise for
    accelerating NIDCR's progress in defining the molecular pathways of
    pain reception and in elucidating new therapeutic targets to manage
    chronic pain. In addition, the initiative Research Teams of the Future
    will enable NIDCR's ongoing inter- and multi-disciplinary efforts to
    further expand and develop new ways to approach research questions.
    Finally, the integration of dentists into the new clinical research
    infrastructure that will be created by the Roadmap is key given that
    overall health and oral health are interrelated and that certain
    systemic conditions such as diabetes, Sjogren's syndrome, HIV/AIDS and
    osteoporosis have important oral symptoms, manifestations or
    complications.
        NIDCR envisions a clear path ahead for oral and craniofacial
    research. Many exciting new leads that have been reported in recent
    years makes it easy to imagine that the next wave of research advances
    will have a more profound and far reaching effect on oral health than
    ever before.

        Senator Specter. Thank you very much, Dr. Zerhouni.
        We have been joined by two members of the Appropriations
    Committee. Let me turn first to the distinguished chairman of
    the full committee, Senator Stevens.
        Senator Stevens. Well, Mr. Chairman, I am late. So I will
    just ask to put my statement in the record. I do greet our
    friends at the table and look forward to the comments and
    questions.
        Senator Specter. Without objection, the statement will be
    made a part of the record.
        [The statement follows:]

                   Prepared Statement of Senator Ted Stevens

        Thank you Mr. Chairman. It's a pleasure to welcome Dr. Zerhouni and
    his distinguished colleagues who head up the Institutes at NIH here
    today.
        I'd also like to thank Dr. Andy von Eschenbach. Andy, I understand
    from my good friend Dr. Mike Phelps that you gave an excellent speech
    this past Sunday to the Academy of Molecular Imaging meeting in
    Orlando. As you know, PET and Molecular Imaging are special interests
    of mine.
        I must be brief since I have three other hearings where I must make
    an appearance. However, I want to commend Dr. Zerhouni for his efforts
    to develop the ``Roadmap'' initiative.
        That initiative aims to focus NIH's resources on several broad
    categories of medical research and to bring together different
    disciplines to make real, rapid and visible progress to determine the
    true basis of many diseases and then to treat them. The Roadmap, with
    its focus in the Director's office is important because no single NIH
    Institute can address these problems alone.
        I'm particularly pleased that you have chosen to focus early
    efforts of the Roadmap on the integration of nanotechnology, systems
    biology, and molecular imaging. By combining these three disciplines we
    hope to discover the molecular basis of diseases like cancers and then
    to develop targeted molecular therapies to arrest the progress of the
    disease and cure it.
        In the fiscal year 2004 appropriations legislation I sponsored an
    amendment to give the Director of NIH new authority to put together
    innovative collaborative approaches to medical research to help speed
    up the process. I hope that you, Dr. Zerhouni, will use that authority
    to take bold and visionary steps to help us find these cures.
        I've been a longtime supporter of large increases in funding for
    medical research. I continue that support, but I must warn you that it
    will be more and more difficult to sustain increases for medical
    research unless you do pursue bold new approaches such as nanosystems
    biology that have the potential to show real results that the American
    taxpayer can see. We must begin to show a return on our investment in
    order to continue it.
        Once again, I commend Dr. Zerhouni and the directors of the NIH
    Institutes for their leadership and efforts on behalf of all people.

        Senator Specter. Senator Cochran, do you have an opening
    statement?

                   OPENING STATEMENT OF SENATOR THAD COCHRAN

        Senator Cochran. Mr. Chairman, thank you very much. I have
    submitted a statement as well and hope it will be included in
    the record.
        I want to commend the Director and his associates who are
    here today for the fine work that you are doing. I am
    particularly impressed with the work in health disparities and
    some of the research that is being undertaken now and funded by
    the National Institutes of Health.

                               PREPARED STATEMENT

        I notice an increase in the budget request for the National
    Center for Minority Health and Health Disparities. I think that
    is the entity that is supporting the Jackson Heart Study in my
    State where very meaningful work is being done in conjunction
    with the University of Mississippi Medical Center and Jackson
    State University and other educational institutions in our
    State to try to get at the bottom of some of the questions of
    why there is such a disparity in some kinds of heart diseases.
    This is being done in conjunction with the National Heart,
    Lung, and Blood Institute as well. But I think the need for
    more research, conducted in the places where we are
    experiencing health disparities or high incidences of chronic
    diseases, is something that is overdue, and I congratulate you
    for taking this initiative.
        [The statement follows:]

                   Prepared Statement of Senator Thad Cochran

        Dr. Zerhouni, thank you for joining us today to discuss the budget
    for the National Institutes of Health. We have had great success in
    increasing NIH funding. It is my hope that we continue to support high
    quality research, and focus this research on the most pressing health
    issues of our country. Our goal should be to make sure NIH research
    benefits all Americans.
        I know you are familiar with the Jackson Heart Study, which looks
    at the reasons why African-Americans suffer disproportionately from
    heart disease. I hope the NIH will continue to take an active role in
    making sure research like this reaches underserved areas of our
    country. This relatively small investment has made a tremendous impact
    on my state. I am encouraged by the progress made by institutes, like
    the National Center for Minority Health and Health Disparities. I am
    pleased to support NIH in these efforts.

        Senator Specter. Thank you, Senator Cochran.
        We will now proceed with 5-minute rounds of questioning, as
    is the custom of the subcommittee.

                        FISCAL YEAR 2005 BUDGET REQUEST

        Dr. Zerhouni, your proposed budget will permit grant
    increases by only 1.3 percent instead of the inflationary
    increase of 3.5 percent. If NIH applied its usual policy of
    providing an average grant increase equal to the rate of
    inflation, it is my understanding that about 640 fewer
    competing grants would be funded than in 2004.
        First of all, is that accurate?
        Dr. Zerhouni. That is accurate, Senator.
        Senator Specter. After the increases which we have provided
    over the last 5 years, do you think the proposed budget is
    sufficient to maintain the momentum and bring discoveries from
    the laboratory to the doctor's office?
        A subset of that is, how much additional funding would be
    required to restore the usual NIH average cost policy, assuming
    the same number of grants which are now in the budget?
        Dr. Zerhouni. Ideally, Mr. Chairman, you would like to be
    sure not to fall behind inflation. However, this year, because
    of the very difficult budget environment, we had to make some
    difficult choices. We elected to maintain the number of grants
    to be able to provide as many scientists the opportunity to
    succeed in applying and made some sacrifices on the cost
    increases.
        If we had $220 million more--the number is $220 million--we
    could satisfy both conditions: have enough grants and
    inflationary increases.
        Senator Specter. If the Congress is willing to appropriate
    the additional $1.3 billion, what new research initiatives
    would NIH be able to conduct with these additional funds?
        Dr. Zerhouni. As you know, because of the doubling and the
    opportunities offered by the doubling, many of our institutes,
    if not all of them, have opportunities in translation in
    clinical research. This is the area of research generally that
    is difficult to undertake in a budget that is the budget that
    we are requesting.
        So when you look at the priorities that we would have to
    fulfill, if we had more resources, the first one would be to
    keep up with inflation. The second would be to continue our
    analysis and the framework for the Roadmap for medical
    research, accelerate that. We have some programs like the
    extramural construction programs, the IDeA program, that we
    would like to enhance over time, including training stipends.
    But the most important report from all the institutes is that
    there are some clinical trials in translational research that
    will have to be slowed down.
        Senator Specter. Well, I would like to have a more detailed
    answer for the record on what the impact will be on the
    administration's request contrasted with what the impact would
    be on an additional $1.3 billion. So we have specific
    information as to how many grants there would be, what will
    happen to the clinical programs.
        Let me turn now to the issue of stem cell research. You and
    I have discussed this at some length and the President made his
    famous statement back on August 9th of 2001 about certain stem
    cell lines being added. Some of those stem cell lines are
    contaminated with mouse feeder cells. Some of those stem cell
    lines are owned other places. We see Harvard with a $100
    million allocation, which is wonderful but nothing compared to
    the $28 billion you have. We see South Korea taking the lead.
    We see scientists leaving the United States because ideology is
    conflicting with medical research.
        [The information follows:]

          Research That NIH Could Fund With an Additional $1.3 Billion

        The fiscal year 2005 President's Budget requests an additional $764
    million for NIH, a significant increase to the program level given the
    competing priorities within the Federal budget. An additional $1.3
    billion over the request would provide $30.057 billion, an increase of
    7.2 percent over fiscal year 2004. With this additional funding, NIH
    would fund a larger share of the great research ideas that scientists
    submit to us. We would be able to fund about 700 more research project
    grants, increasing chances of a scientist's application being funded
    and increasing the currently expected ``success rate'' from the 27
    percent in the President's Budget to 29 percent. Additional priorities
    would include:
      --Accelerating implementation of Roadmap initiatives;
      --Implementing an interdisciplinary approach to neuroscience research
            by completing the phase 2 of the Porter Neurosciences Building;
      --Providing average cost increases equal to biomedical inflation and
            finance the committed levels for competing continuation grants;
      --Increasing support for research training awards; and
      --Increasing the amounts NIH pays on career awards.
        Examples of the new research initiatives and significant expansions
    of ongoing programs that NIH would conduct with these additional funds
    follow:
        transdisciplinary research on energetics and cancer (trec) (nci)
      --Novel initiative involving scientists from multiple disciplines and
            encompassing projects spanning the biology and genetics of
            energy balance to behavioral, sociocultural, and environmental
            influences upon nutrition, physical activity, weight, energy
            balance and energetics.
      --The TREC Centers would foster collaboration among transdisciplinary
            teams of scientists with the goal of accelerating progress
            towards reducing cancer incidence, morbidity and mortality
            associated with obesity, low levels of physical activity and
            poor diet.
      --Centers would also provide training opportunities for new and
            established scientists who can carry out integrative research
            on energetics, energy balance and its consequences.
                cancer biomedical informatics grid (cabig) (nci)
      --Cancer research platform with common standards to expedite progress
            by creating a network that links organizations, institutions,
            and individuals to enable the sharing of cancer research
            infrastructure, data, and tools.
      --All cancer researchers would have access to a common research
            infrastructure that creates a plethora of opportunities to not
            only make important new findings but to do so more quickly and
            efficiently than ever before.
      --This new system would offer a library of tools and resources--from
            clinical trial management systems to tissue bank and pathology
            tools--that are all built to common standards and are
            interoperable with other existing systems.
      --Study population data would be far more robust and researchers will
            be able to mine data in a way that simply isn't possible at the
            moment.
      --Joins the various fields of cancer research--from etiologic
            research to prevention, early detection and treatment.
                  understudied cancers of high lethality (nci)
      --A key element to the elimination of death from cancer by 2015 would
            be to focus on malignancies which are highly fatal, such as
            pancreatic, esophageal, and liver cancers.
      --When these cancers are found, relatively little prolonging of life
            or quality of life follows.
      --Understanding gene-environment interactions is important in
            learning who is at elevated risk, and how that risk is
            regulated.
      --Discoveries in these areas would lead to more accurate and cost-
            effective public health interventions aimed at eliminating
            mortality.
      patient navigation research program: eliminating barriers to timely
           delivery of cancer diagnosis and treatment services (nci)
      --A major disconnect or gap exists between cancer Discovery and
            Development research and Delivery for many Americans. Discovery
            and Development research results in beneficial procedures for
            cancer prevention, early detection, diagnosis, and treatment
            that are intended for all Americans. Health disparities arise
            when the Delivery system does not provide access to timely,
            standard cancer care to everyone in the nation. NCI has
            established the goal of eliminating suffering and death due to
            cancer by 2015.
      --The NCI is challenging principal investigators to develop effective
            patient navigation interventions. These interventions would
            address access barriers to quality, standard cancer care. The
            purpose of the Patient Navigation Research Program (PNRP) would
            be to develop interventions to reduce the time to delivery of
            standard cancer care services after identifying a cancer-
            related abnormal finding.
      --The patient navigator could assist patients and their families
            through the cancer care continuum.
      --The research hypotheses are that navigated patients would: (1)
            receive timelier, definitive diagnosis following screening and
            abnormal finding; (2) receive more timely treatment following
            positive diagnosis; (3) improve their satisfaction with the
            health care system experience.

      STUDY TO IDENTIFY RISK FACTORS FOR CORONARY HEART DISEASE (CHD) IN
                          HISPANIC POPULATIONS (NHLBI)

      --The nation's largest minority group.
      --Involve four community-based cohorts of adults, one each of
            majority Cuban, Puerto Rican, Mexican American, and Central
            American origin.
      --Examine the role of acculturation in the development of risk
            factors and determine if any play a uniquely harmful role in
            the development of CHD in Hispanics.
      --Include a closely integrated community and professional education
            component to return the benefits of research results to the
            participating communities.

     FIVE-YEAR RANDOMIZED CLINICAL TRIAL OF CHRONIC OXYGEN USE IN MODERATE
    TO SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) PATIENTS (NHLBI)

      --COPD is the fourth most common cause of death in the United States.
      --Oxygen therapy is known to extend the life of patients with severe
            COPD and hypoxemia.
      --Billions of dollars are spent in the United States each year to
            provide oxygen for patients with moderate or severe COPD
            without good evidence as to who benefits.
      --The trial would determine the effects of oxygen therapy on life
            expectancy, hospitalization rates, independent living, and
            quality of life.

     MULTI-CENTER CLINICAL TRIAL TO EVALUATE NEW TREATMENT APPROACHES FOR
                              SARCOIDOSIS (NHLBI)

      --Sacroidosis is a multisystem disease that usually affects the
            lungs, and is more common in black Americans.
      --Current treatment, which is based mainly on corticosteroids and
            cytotoxic agents, is non-specific and has many dangerous side
            effects.
      --An NHLBI Sarcoidosis Research Working Group and several patient
            advocacy groups recommended support for a trial to test new
            agents for sarcoidosis.

     IDENTIFY AND TEST APPROACHES TO REDUCING CARDIOVASCULAR DISEASE THAT
     ARE SPECIFIC TO AMERICAN INDIAN AND ALASKA NATIVE POPULATIONS (NHLBI)

      --Such an initiative would test approaches to reducing cardiovascular
            disease (CVD) risk factors in American Indian/Alaska Native
            (AI/AN) populations that can be incorporated into clinical
            programs of community health care systems or delivered through
            other public health approaches in native communities.
      --Many AI/AN communities bear a heavy burden of CVD and modifiable
            CVD risk factors.
      --AI/AN communities are concerned that few intervention studies have
            been launched to test possible solutions.
         practice based research networks of dental specialists (nidcr)
      --NIDCR's Practice Based Research Networks (PBRN) initiative would
            otherwise be limited to networks of general dental
            practitioners.
      --Networks provide an infrastructure for conducting multiple,
            collaborative clinical trials and observational studies
            relating to dental practice and oral health care.
      --Linkage of the oral health PBRNs with existing medical PBRNs would
            provide additional patients, professional expertise, and
            integration of resources for conducting clinical research
            across a broad spectrum of health care specialties.

                      REGENERATIVE DENTAL MEDICINE (NIDCR)

      --Diseases and injuries that damage orofacial tissues have a serious
            impact on quality of life.
      --Human stem cells would be utilized in combination with new bio-
            inspired materials to regenerate the complex structures of the
            orofacial system.
      --Researchers would develop and test a number of stem cells and
            biomaterial structures that mimic the multi-dimensional
            architecture/function of tooth structures.
         prospective studies on craniofacial pain & dysfunction (nidcr)
      --Participants enrolled in this study would be followed over time to
            identify risk factors associated with or predictive of the
            onset of craniofacial pain and dysfunction.
      --Temporomandibular joint (TMJ) dysfunction is a condition of
            particular interest.

                       CLINICAL RESEARCH TRAINING (NIDCR)

      --In the ``post-genomic era,'' translational and clinical research
            plays an important role in bringing laboratory observations
            into the clinical setting.
      --NIDCR's new program announcement would foster clinical research
            training in multidisciplinary research settings for all members
            of the clinical research team.

    FULL-SCALE CLINICAL TRIAL OF PRIMARY INTERVENTIONS TO PREVENT OR DELAY
              TYPE 2 DIABETES IN CHILDREN AND ADOLESCENTS (NIDDK)

      --Cases of type 2 diabetes are increasing in the pediatric
            population, especially among adolescents and in certain
            minority groups.
      --A school-based intervention approach may be an effective way to
            prevent risk factors for type 2 diabetes in children and
            adolescents.
      --Pilot studies for a multi-site, multi-component, school-based
            intervention trial employing both environmental and behavioral
            changes are under way; could launch the trial in fiscal year
            2005.

      IMPROVE CLINICAL TRIALS FOR TREATMENT OF INFLAMMATORY BOWEL DISEASE
                                 (IBD) (NIDDK)

      --The conduct of new clinical trials in IBD is hampered by the
            current need to rely on indirect diagnostic tests and
            nonspecific clinical features.
      --The conduct of clinical trials and development of safer, more
            effective treatments would be accelerated by research in
            proteomics, to discover new biomarkers, and in molecular
            imaging, to discover new non-invasive diagnostic imaging tests.

     STUDY THE ROLE OF THE INTRAUTERINE AND POSTNATAL ENVIRONMENTS IN THE
                         DEVELOPMENT OF OBESITY (NIDDK)

      --A better understanding of aspects of the intrauterine environment
            and a mother's medical status that contribute to future
            overweight and obesity in offspring could lead to more
            effective interventions before, during, or shortly after
            pregnancy.
      --Strategies to prevent or treat obesity could also greatly benefit
            from research on the impact of diet and other environmental
            factors on the early development of brain pathways regulating
            calorie intake and energy expenditure, and the permanence of
            these effects in adulthood.
      --Tools are available to conduct these studies in appropriate animal
            models, including primates.

    EXPAND FEASIBILITY TRIAL OF DAILY DIALYSIS TO DETERMINE EFFECTS OF NEW,
      MORE INTENSIVE DIALYSIS MODALITIES ON MORTALITY AND CARDIOVASCULAR
                                DISEASE (NIDDK)

      --Clinical studies are needed to determine whether life expectancy of
            persons with end-stage renal disease (ESRD), or chronic kidney
            failure, can be improved by modifying standard dialysis
            regimens.
      --Clinical centers have been established to test the feasibility of a
            randomized clinical trial of more frequent dialysis.
      --The current frequent dialysis trial is limited by size and design
            to measuring intermediate outcomes, such as blood pressure,
            anemia, and quality-of-life.
      --An expansion of the trial could enable assessment of the effect(s)
            of any change in dialysis regimen on hospitalization rate and
            mortality, and on cardiovascular events--e.g., stroke,
            myocardial infarction and heart failure--which often complicate
            ESRD.

       INITIATE THE VERY LARGE PHASE III CLINICAL TRIALS FOR PARKINSON'S
                                DISEASE (NINDS)

      --Necessary to adequately test one or more of the neuroprotective
            drugs for Parkinson's disease (minocycline, creatine, coenzyme
            Q10 and GPI-1485) that are being tested in pilot trials.

     CONDUCT A PHASE III CLINICAL TRIAL OF CEPHALOSPORIN FOR THE TREATMENT
                     OF ALS (LOU GEHRIG'S DISEASE) (NINDS)

      --A screen of 1,040 drugs for potential use against neurodegenerative
            diseases revealed one that may be particularly helpful for
            ALS--the antibiotic cephalosporin.

       LAUNCH CHEMICAL COUNTERTERRORISM RESEARCH TO COMBAT NERVE AGENTS
                                    (NINDS)

      --A number of chemical agents and toxins that have served or could
            serve as terrorist weapons that target the nervous system.
      --Research initiatives would focus on ameliorating the acute
            neurologic responses to these chemical weapons as well as
            alleviating any chronic neurodegenerative effects.

      EXPAND THE SPECIALIZED PROGRAMS OF TRANSLATIONAL RESEARCH IN ACUTE
                           STROKE (SPOTRIAS) (NINDS)

      --From four to eight centers.
      --Would accelerate translation of basic research findings into

            CLINICAL PRACTICE IN ACUTE ISCHEMIC AND HEMORRHAGIC STROKE.
                   INITIATIVE FOR PANDEMIC INFLUENZA (NIAID)

      --Accelerate the development of next generation influenza antiviral
            drugs and the production and clinical testing of up to four
            pilot lots of candidate vaccines by up to one year or more.
      --Influenza routinely causes 36,000 deaths per year in the United
            States; however, the ability of flu viruses to occasionally
            jump from animals to humans poses an imminent threat of a
            pandemic affecting millions of people--over 20 million people
            worldwide is estimated to have died during the flu pandemic of
            1918.
      --Research would also expand surveillance of emerging flu strains in
            Asian animals to support development of new vaccines against
            influenza strains with pandemic potential.
             clinical trials of hiv/aids vaccine candidates (niaid)
      --Expand clinical trials to accelerate by one or more years clinical
            evaluation of six promising HIV vaccine candidates.
      --Forty million people were estimated to have HIV/AIDS as of December
            2003, with five million new infections occurring in 2003.
            Another three million people died of the AIDS pandemic in 2003,
            including 500,000 children, with a total of 70 million people
            projected to die of the disease by 2020 if the current trends
            continue.
      --As with other pandemic infectious diseases, a key component to
            preventing the spread of HIV/AIDS, and to mitigating the long-
            range impact of the AIDS pandemic, is the development of an
            effective HIV/AIDS vaccine. Critical challenges to developing
            an effective vaccine include the need to clinically evaluate a
            large number of promising HIV vaccine candidates in humans as
            rapidly as possible to determine the toxicity and effectiveness
            of the vaccine candidates. Factors contributing to the need to
            clinically evaluate a large number of the most promising
            vaccine candidates include the multitude of different HIV/AID
            virus strains in existence and the frequency at which the virus
            mutates and the fact that the virus infects and destroys the
            immune system.

                CLINICAL TRIALS IN ORGAN TRANSPLANTATION (NIAID)

      --Expand and accelerate clinical trials to develop therapeutic
            strategies to reduce the immune-mediated morbidity and
            mortality of organ transplantation.
      --Over 25,000 people receive organ transplants each year. Although
            the one-year survival for single-organ transplantation has
            improved over the last 15 years to a level approaching or
            exceeding 90 percent, there has been little success in
            reversing the decline in long-term graft-vs-host disease and
            patient survival (13 percent to 55 percent at 10 years,
            dependant upon organ).
      --Studies would support both children and adults and will address the
            barriers to short- and long-term success of transplant
            procedures, including incompatibility between donor and
            recipient, acute and chronic rejection, and complications of
            long-term pharmacologic immune suppression.
                clinical trials of topical microbicides (niaid)
      --Expand existing support of clinical trials to accelerate the
            clinical evaluation of four promising microbicide candidates
            that have unique mechanisms of action to potentially protect
            against sexually transmitted diseases (STD), including HIV/
            AIDS.
      --Topical microbicides are creams, gels or foams that can be applied
            to the vagina or rectum and prevent STD-causing microbes,
            including HIV, from invading the host. Pharmaceutical companies
            have been reluctant to invest in research on microbicides
            primarily because not enough data has been gathered through
            large clinical studies in humans to provide a ``proof of
            concept'' of any microbicide product.
      --A partially effective microbicide could avert more than 2 million
            HIV infections over a 3-year span; also, microbicides could
            play a critical role in reducing STD transmission from mother
            to infant during childbirth.
           determine three-dimensional structures of proteins (nigms)
      --Partner with other Institutes.
      --Includes those related to cancer and emerging infectious diseases.
      --Would be useful for the design of new antibiotics or anti-cancer
            agents.

       RESEARCH RELATED TO DETERMINING WHY DIFFERENT INDIVIDUALS RESPOND
             DIFFERENTLY UPON TREATMENT WITH THE SAME DRUGS (NIGMS)

      --Would help physicians customize treatment to individual patients
            and may guide the development of new drugs that are more
            predictively effective in most people.

         DEVELOPMENT OF TOOLS FOR INVESTIGATING MODEL ORGANISMS (NIGMS)

      --Model organisms such as fruit flies, mice, and roundworms have
            provided great insights into fundamental biological mechanisms
            and into human disease.

                INNOVATIVE METHODS OF NEWBORN SCREENING (NICHD)

      --While ensuring protection of privacy and providing ethical
            safeguards, the NIH could proceed with efforts to identify, at
            birth, hundreds of genetic defects associated with mental
            retardation, primary immunodeficiency diseases, and other
            potentially disabling and fatal conditions.
      --Technologies generated by the Human Genome Project are available to
            screen for hundreds of genetic diseases in newborns.
      --A database in rare genetic diseases could be developed to enable
            scientists to identify unrecognized genetic defects in
            newborns, to study currently untreatable disorders, and to
            develop new therapeutics.
      --New screening techniques could allow clinical and preventive
            interventions for currently treatable genetic disorders, such
            as Severe Combined Immunodeficiency Disease (SCID), in time to
            prevent or mitigate risks of early death or life-long
            disability.

          GENOMIC AND PROTEOMIC RESOURCES FOR PREMATURE BIRTH (NICHD)

      --The NIH could establish a major consortium to create high-quality
            data on human gene and protein expression, and to make this
            information available on a publicly-accessible database that
            will be dedicated to prematurity research. Investigators could
            mine the database to advance their own research into the causes
            of and ways to prevent premature birth.
      --Premature birth causes almost 70 percent of neonatal deaths and
            reducing prematurity would reduce wide racial disparities in
            infant mortality.
      --The depth and accessibility of the new genomic and proteomic
            database could enable scientists to discover biomarkers for
            premature birth and ultimately to develop early diagnostic and
            effective treatment interventions.

     RESEARCH BASE TO ASSESS EARLY CHILDHOOD LEARNING AND SCHOOL READINESS
                                    (NICHD)

      --The NIH could develop, refine, validate, and scale-up tests to
            assess how well preschool programs help young children--
            especially those at risk of school failure--to achieve ``school
            readiness,'' cognitively, socially, and behaviorally.
      --Significant academic, public, and political attention is focused on
            the educational achievement of all children, beginning with
            preschoolers, with certain federal funds tied to school
            systems' performance.
      --Preschool programs need scientifically-based tests to measure
            accurately how well they prepare young children for later
            school success. The programs especially need tests to measure
            their performance with non-English speaking, ethnically
            diverse, and educationally at-risk preschoolers. For the most
            part, such tests do not exist, leaving preschool programs
            unable to measure their performance for purposes of federal
            funding.
      --The NIH is the primary research agency with the basic and applied
            scientific expertise to produce these tests, which are now
            lacking.

                     THE NATIONAL CHILDREN'S STUDY (NICHD)

      --The first two vanguard centers could be established for this
            ground-breaking, congressionally-authorized, longitudinal study
            of children's health and development. (There would be
            significantly larger out-year costs.)
      --Extensive planning and selected feasibility studies enable vanguard
            centers, for this large and complex research effort, to
            investigate how environmental factors, broadly defined, may
            influence children's health and development.
      --Primary care pediatric practices and other types of clinical sites
            could become vanguard sites.
            new interventions to improve pregnancy outcomes (nichd)
      --The NIH could proceed with clinical trials and related studies to
            prevent preterm births and improve neonatal outcomes.
      --An NIH research network recently discovered the first effective
            intervention--progesterone treatment of high-risk women during
            pregnancy--to prevent recurrent preterm birth. The new
            treatment cannot be approved by the FDA until researchers study
            children of mothers who received the experimental treatment to
            detect any later-emerging adverse effect in the children.
      --A clinical trial is needed to affirm preliminary findings that a
            nutritional supplement during pregnancy (an Omega-3 (n-3)
            polyunsaturated fatty acid) is particularly efficacious in
            preventing recurrent preterm birth in African American women,
            for whom the experimental progesterone treatment was less
            effective.
      --A clinical trial is needed to affirm preliminary findings that a
            single, simple injection of tin mesoporphyrin can successfully
            prevent complications of hyperbilirubinemia that can result in
            severe, life-long disabilities. If not diagnosed and treated,
            hyperbilirubinemia can lead to jaundice, brain injury and
            kernicterus (a condition of severe neural symptoms, associated
            with high levels of bilirubin in the blood).

       CLINICAL TRIAL FOR THE TREATMENT OF INFLAMMATORY EYE DISEASE (NEI)

      --Would be able to begin a clinical trial to evaluate a treatment for
            uveitis that will greatly enhance patients' quality of life.
      --Uveitis is a group of ocular inflammatory disorders that represent
            a major cause of vision loss and blindness in the United
            States.
      --This new monoclonal antibody therapy could mean fewer side effects
            than current therapies that require systemic, immuno-
            suppressive drugs, leading to an improved quality of life.

       CLINICAL TRIALS NETWORK FOR THE TREATMENT OF AGE RELATED MACULAR
                            DEGENERATION (AMD) (NEI)

      --Could launch a clinical trials network to test promising new
            therapies for age-related macular degeneration.
      --A clinical trials network is needed to test a variety of new
            treatment approaches targeting the full range of disease forms
            and levels of severity of age-related macular degeneration.
      --Age-related macular degeneration is the leading cause of vision
            loss among Americans over 65 years of age, the fastest growing
            segment of the U.S. population.

       ROBUST PROGRAM TO EVALUATE THE TOXICOLOGY OF NANOSCALE MATERIALS
                                    (NIEHS)

      --Nanoscale materials are already appearing in commerce as industrial
            and consumer products and as novel drug delivery formulations.
            Commercial applications and resultant opportunities for human
            exposure may differ substantially for nanoscale vs. ``bulk''
            materials.
      --Currently there is very little research focus on the toxicology of
            manufactured nanomaterials. There are indications in the
            literature that manufactured nanomaterials may distribute in
            the body in unpredictable ways and that certain nanoparticles
            have been observed to preferentially accumulate in particular
            organelles.
      --The NTP/NIEHS research program would evaluate the toxicological
            properties of major nanomaterials classes which represent a
            cross-section of composition, size, surface coatings, and
            physico-chemical properties, and use these as model systems to
            investigate fundamental questions concerning if and how
            nanomaterials can interact with biological systems.

    USE OF METABOLOMICS TECHNOLOGIES FOR PREDICTING TOXICOLOGICAL RESPONSES
                                    (NIEHS)

      --Assessment of exposure and of risks from exposure could be greatly
            improved by using metabolic indicators such as changes in gene,
            protein or metabolite expression.
      --Research supported by this initiative would focus on the
            application of metabolomics technologies to identify predictive
            markers of exposure, toxicity and disease in animal and human
            populations; link metabolic profiles with biological pathways
            and mechanisms of environmentally-related exposures and
            diseases; and develop computational and modeling approaches for
            assessment and integration of metabolomics data in predictive
            toxicology research.
      --This program would be a critically important application of the
            basic methodology development work being undertaken as part of
            the NIH Roadmap initiative on Metabolomics Technology
            Development.

      PREVENTION TRIALS TO ASSESS THE POTENTIAL ABILITY OF NON-STEROIDAL
      ANTI-INFLAMMATORY DRUGS AND A COMBINATION OF ANTI-OXIDANT VITAMINS
                                     (NIA)

      --Prevent Alzheimer's disease and age-associated cognitive decline.
               development of a clinical trials consortium (nia)
      --Test testosterone therapy for older men with low testosterone
            levels who experience weakness, frailty, or a specific
            disability that may be related to low testosterone.

       NEW INTERVENTIONS FOR PREVENTION AND CONTROL OF HEART FAILURE IN
                        PERSONS AGED 65 AND OLDER (NIA)

      --Fully develop and validate new interventions through clinical
            trials.

        MULTIDISCIPLINARY IMAGING RESEARCH PARTNERSHIPS FOR ADDRESSING
     IMPORTANT BIOLOGICAL OR MEDICAL RESEARCH PROBLEMS OF SKELETAL MUSCLE
                       AND ASSOCIATED SOFT TISSUE (NIAMS)

      --Improved imaging techniques provide a non-invasive way to monitor
            changes in muscle (including muscular dystrophy and other
            muscle diseases) and soft tissue.
      --Multidisciplinary imaging research partnerships would stimulate the
            development of novel imaging technologies that will help us
            understand the genetic and molecular bases of musculoskeletal
            soft tissue function, disease, and injury processes.
      --Improved visualization of skeletal muscle and associated soft
            tissue would enable researchers to more accurately measure
            change during treatment or recovery from injury.

     PURSUE THE RESEARCH NEEDS AND OPPORTUNITIES IDENTIFIED AT THE RECENT
     NIH CONSENSUS DEVELOPMENT CONFERENCE ON TOTAL KNEE REPLACEMENT (NIAMS)

      --Approximately 300,000 total knee replacements are performed each
            year in the United States for end-stage arthritis of the knee
            joint, and the rate of total knee replacement procedures
            increases each year.
      --While these replacements have shown outstanding success,
            controversies still exist regarding implant designs and
            treatment. Research studies suggest that there are particular
            challenges that must be addressed in patients with Parkinson's
            disease, rheumatoid arthritis, and diabetes mellitus, as well
            as total knee replacements in younger patients.

    INCREASE SUPPORT FOR TRANSLATIONAL RESEARCH--MAXIMIZING THE RESULTS OF
                BASIC RESEARCH TO IMPROVE PUBLIC HEALTH (NIAMS)

      --To enhance and expand translational research, a new centers program
            is currently being or would be created called centers of
            research translation.
      --These centers would pair basic and clinical projects in
            investigator-initiated and directed research that is centered
            around particular diseases. Different diseases might require
            different translation mechanisms and strategies.
      --The goal of the centers is the application of powerful tools and
            knowledge from basic research to clinical research to improve
            human health.

       ADDITIONAL STUDIES ON INNOVATIVE THERAPIES FOR RHEUMATIC AND SKIN
                                DISEASES (NIAMS)

      --Would expand a successful program that the NIAMS instituted in
            fiscal year 1999.
      --Would solicit investigator-initiated proposals for clinical trials
            of innovative therapies or approaches for the treatment of
            rheumatic and skin disease.
      --The previous program has produced a number of ongoing clinical
            trials that form the cornerstone of NIAMS-funded trials in
            rheumatic diseases.
      --It is anticipated that the trials may identify new therapies for
            rheumatic and skin diseases.

                              OTITIS MEDIA (NIDCD)

      --Would initiate Phase One trials of vaccine candidates.
              initiate a definitive epidemiological study (nidcd)
      --Would establish the role of prenatal exposure to cytomegalovirus in
            progressive hearing loss during childhood.

                        COMMUNICATION DISORDERS (NIDCD)

      --Would expand research to identify the hereditary basis.
        hair cell degeneration and regeneration in the inner ear (nidcd)
      --Would initiate new research to define the molecular basis.

     ENHANCE CAPACITY FOR DISASTER/TERRORISM MENTAL HEALTH RESEARCH (NIMH)

      --Could enlarge this currently small program to establish emergency
            research protocols in conjunction with local public health
            authorities and develop critically needed measures for use in
            emergency/disaster research studies.

     RESEARCH INITIATIVE ON PEDIATRIC BRAIN-BEHAVIOR DEVELOPMENT VITAL TO
             DIAGNOSING AND TREATING CHILD MENTAL DISORDERS (NIMH)

      --This initiative would result in the first-ever identification of
            neuroimaging markers of specific child mental disorders which
            will lead to improved diagnostics and potential for new
            treatments in pediatric mental illnesses.

     USE NIMH CLINICAL TRIAL NETWORKS TO LAUNCH TRIALS ON SIMULTANEOUS USE
       OF MULTIPLE PSYCHIATRIC MEDICATIONS FOR THE SEVERELY MENTALLY ILL
                                     (NIMH)

      --Multiple medications is a widespread practice, but there is limited
            scientific data about its health effects and implications.

                          ANOREXIA AND BULIMIA (NIMH)

      --Would expand research on understanding eating disorders.
              more research using brain imaging techniques (nida)
      --Would study how exposure to drugs of abuse can affect the
            developing human brain.
      --Understanding precisely how brain changes relate to behavior,
            especially during childhood and adolescence, is critical to
            designing effective strategies for reducing drug use in the
            United States.
      --Better treatment strategies targeting children and adolescents
            would be developed through these efforts.

    COLLABORATIONS OF ESTABLISHED CLINICAL TRIALS NETWORK (CTN) WITH OTHER
                       ESTABLISHED NETWORKS AT NIH (NIDA)

      --NIDA CTN staff and staff from NCI's Community Clinical Oncology
            Program have discussed the possibility of jointly supporting a
            smoking cessation study. This study would bring these two NIH
            clinical research networks together in a synergistic
            collaboration and test the networks' interoperability.
      --CTN has also had discussions with NICHD to link the CTN to a
            Network at NICHD that is studying adolescents and comorbidity.

      ENHANCE OUR UNDERSTANDING OF THE GENETIC OR HERITABLE RISK FACTORS
     ASSOCIATED WITH DRUG ABUSE USING THE CTN AS A VALUABLE RESOURCE (NIDA)

      --The CTN could serve as a resource to acquire genetic information on
            participants in clinical trials and to better characterize
            different phenotypes associated with addiction.
      --As gene variants are identified in association with drug addiction,
            research could be conducted to determine how this genetic
            information can be used to tailor medications to an
            individual's genetic needs. This knowledge could be
            incorporated into ongoing medications trials in the CTN.

     EXPAND RESEARCH ON PREVENTING DRINKING BY YOUTH IN RURAL/SMALL URBAN
                                 AREAS (NIAAA)

      --Note: Partnerships have been formed with academic health centers,
            abbreviated ``AHC,'' to conduct this research. AHC have in
            place the disciplines required, as well as extensive service
            networks in rural and small urban regions.
      --Would expand the number of AHC sites that would conduct the
            research.
      --Would collect data on psychological and physical development, and
            environmental/community circumstances, that are not routinely
            collected in medical settings. A variety of biomedical,
            psychosocial, and environmental factors act in concert to lead
            to adverse outcomes, such as alcohol-related problems. We must
            understand what all of these factors are and how they interact,
            if we are to make real advances in preventing and treating
            adverse outcomes of alcohol use among youth.

     EXPAND RESEARCH AIMED AT DEVELOPING MEDICATIONS FOR ALCOHOLISM (NIAAA)

      --Would develop animal models of response to alcohol that closely
            predict efficacy of compounds to be tested in humans.
      --Would create a clinical-trials network for early Phase II human
            trials. These trials could yield relatively quick results and
            can indicate which compounds are worth the resources required
            for IND approval and Phase III trials. Partnerships would be
            sought with pharmaceutical companies interested in compounds
            found to be successful in NIAAA early Phase II human trials.

                 EXPAND RESEARCH ON ALCOHOL METABOLISM (NIAAA)

      --Alcohol metabolism plays a crucial role in alcohol dependence and
            in alcohol-induced organ damage.
      --Would form a bioinformatics data base, including data on gene
            expression, proteomics, and metabolomics involved in alcohol
            metabolism. This would be very important to our understanding
            of which genes and proteins are involved in addictive behavior
            and alcohol-induced organ damage, including cancer.
      --In human clinical studies, use metabolomics and proteomics to
            generate information on biomarkers of early/late tissue damage,
            and identify targets for medication development.
      --Using imaging technology, would determine if alcohol metabolism
            occurs in the brain and, if so, determine what enzymes are
            involved.
      --Would identify all adducts (especially those that promote
            autoimmune reactions) that result from alcohol metabolism, and
            their roles in addictive behavior and organ damage.
      --Would understand the interactions of alcohol metabolism with
            comorbid conditions, such as obesity and diabetes.

                 TISSUE ENGINEERED HUMAN MODEL SYSTEMS (NIBIB)

      --Would stimulate research and development in three-dimensional human
            tissue model systems; engineered tissues for drug development;
            and cell-based sensors for clinical diagnosis and treatment.
      --Tissue engineering holds the promise to repair and/or replace
            damaged organs.
      --Tissue engineering strategies focusing on cell-based therapies, or
            treatment modalities that rely on cells as the agents for the
            treatment of diseases, have the potential to revolutionize
            human therapeutics in the 21st century.

                MINIMALLY-INVASIVE, IMAGE-GUIDED SURGERY (NIBIB)

      --Would support research needed to rapidly develop computer-assisted,
            image-guided microsurgery, which could replace traditional
            surgery.
      --Image-guided, minimally-invasive surgical procedures involve less
            patient risk and pain and result in reduced hospital stays and
            shorter recovery periods.
      --Advances in surgical robots and microsurgical techniques could
            enhance a surgeon's ability to perform complex tasks that
            cannot be performed by hand.
      --Could support: integration of existing technologies and development
            of new technologies to navigate human anatomy, obtain
            diagnostic tissues, localize and treat human disease and
            injury, and monitor responses to surgical interventions.
            chemistry of imaging agents and molecular probes (nibib)
      --Could support exploratory projects for the synthesis, physical
            characterization, and initial demonstration of feasibility for
            clinical imaging agents for physiological, anatomical, and
            molecular imaging.
      --The ability to image molecular processes and cell function in vivo
            provides an opportunity to understand biological processes as
            they occur in their environment.
      --Knowledge gained may be used to advance early-stage disease
            detection and individually-tailored therapeutic interventions.
      --The development of new clinical imaging agents requires focused
            efforts by chemists and molecular biologists to discover new
            compounds and materials suitable for in vivo imaging.

                     BRAIN-COMMUNICATION INTERFACE (NIBIB)

      --Could develop technologies to create a more functional and
            convenient system for restoring movement to paralyzed
            individuals.
      --Investigators have been successful in making Function Electrical
            Stimulation (FES) a practical solution for restoring some
            movement to paralyzed individuals.
      --Current systems allow individuals with spinal cord injuries to
            stand and breathe, and can restore functional hand grasp and
            arm movement to some individuals with severe spinal cord
            injuries.
      --Recent developments in the technology of microelectrode design and
            neurophysiological signal analysis open the possibility of
            restoring greater control of motor function naturally--by
            thinking about moving, a technique referred to as direct brain-
            communication interface.

    SUPPORT PLANNING GRANTS TO DEVELOP AND OPTIMIZE MODELS FOR DEPARTMENTS
             OF CLINICAL RESEARCH WITHIN SCHOOLS OF MEDICINE (NCRR)

      --Would provide tools to develop and test models.

     RESTORE THE EXTRAMURAL RESEARCH FACILITIES IMPROVEMENT PROGRAM (RFIP)
                                  FUNDS (NCRR)

      --Would support construction and renovation projects at National
            Primate Research Centers, animal research facilities and for
            modem research laboratories at smaller institutions and
            institutions within IDeA states.

       ADDRESS THE SHORTAGE OF ADVANCED INSTRUMENTATION NEEDED TO PURSUE
                    CUTTING-EDGE BIOMEDICAL RESEARCH (NCRR)

      --The High End Instrumentation program is the only NIH program that
            provides support for research equipment that costs at least
            $750,000; awards may be up to $2 million.

       INTEGRATE TECHNOLOGY DEVELOPED THROUGH THE BIOMEDICAL INFORMATICS
     RESEARCH NETWORK (BIRN) INTO CLINICAL RESEARCH AND OTHER NEW DOMAINS
                         OUTSIDE OF NEUROSCIENCE (NCRR)

      --Some BIRN bioinformatics tools would be distributed and other tools
            developed; hands-on workshops to inform investigators how to
            use the tools for their research.
      --Information technologies would be critical for scientific
            discovery.
             ncmhd could strengthen and expand its programs (ncmhd)
      --Loan Repayment Program
      --Centers of Excellence Program
      --Research Endowment Program

     NCMHD COULD FULLY LAUNCH ITS COMMUNITY-BASED RESEARCH PROGRAM (NCMHD)

      --Would fulfill this Congressional requirement.

                            TRAUMA AND INJURY (FIC)

      --Would initiate a new program to support research training to
            address the growing global burden of morbidity and mortality
            due to trauma and injury related to road traffic accidents,
            suicide and drowning, mental health consequences of war and
            civil disorders, lack of emergency care and blood products and
            other related conditions.
      --Training supported by the new program would lead to prevention
            strategies and interventions in wound healing, development of
            synthetic blood products, development of low-cost imaging
            technologies, mental health strategies, and epidemiology to
            assess risk factors as well as other activities to reduce the
            impact of trauma and injury to individuals, families and
            communities.
      --Would support the establishment of a global network of highly
            meritorious research training centers to mitigate the impact of
            trauma and injury.

     BRAIN DISORDERS IN THE DEVELOPING WORLD: RESEARCH ACROSS THE LIFESPAN
                                     (FIC)

      --This program was begun through short term planning grants in fiscal
            year 2003 with the intention to grow to full research project
            grants in fiscal year 2005.
      --The program supports collaborative research and capacity building
            projects on brain disorders throughout life relevant to low-
            and middle-income nations. Brain disorders represent a fast
            growing proportion of the global burden of disease.

         DEVELOP THE NEXT GENERATION OF INTERNATIONAL RESEACHERS (FIC)

      --It is imperative that the U.S. scientific community be prepared to
            tackle new threats while at the same time be positioned to work
            in partnership with colleagues around the world on shared
            problems.
      --Would increase support to train U.S. medical students, graduate
            students and post-doctoral students in methodologies needed to
            tackle global health challenges.
      --Would extend and intensify efforts in resource-limited nations to
            provide clinically appropriate, cost-effective, and sustainable
            care of direct health and economic benefits for the global
            community and mitigate the threat of disease crossing borders
            to affect the U.S. population.

        COULD SIGNIFICANTLY EXPAND CAPABILITY TO ANALYZE, ANNOTATE, AND
     CLASSIFY MASSIVE AMOUNTS OF RAW SEQUENCE AND PROTEIN DATA TO MAKE IT
                      READILY USABLE BY RESEARCHERS (NLM)

      --Molecular biology is generating an unprecedented amount of genomic
            data that have the potential to overwhelm researchers by sheer
            volume.
      --The protein classification project provides a valuable method to
            deduce the function of newly discovered proteins, greatly
            accelerating research in the molecular basis of disease and
            therapy.
      --The unique and comprehensive Reference Sequence Collection would
            assist in studying the function of single genes and performing
            large-scale comparative analyses of genes across multiple
            organisms.

      COULD ACCELERATE PROGRESS TOWARD DEVELOPMENT AND IMPLEMENTATION OF
     CLINICAL VOCABULARY STANDARDS THAT ARE CRITICAL TO RE-ENGINEERING THE
                       CLINICAL RESEARCH ENTERPRISE (NLM)

      --The inability to share clinical data across systems impedes
            clinical research and is responsible for a significant number
            of medical errors.
      --An interlocking set of clinical vocabulary standards must be
            developed that incorporate robust mappings between multiple
            vocabularies used in clinical research and health care.
      --Research, testing, and demonstration projects would help to
            determine best practices for incorporating vocabulary standards
            into clinical research, health care, and public health.

        COULD WORK WITH OTHERS TO DEVELOP COMMON SOFTWARE PLATFORMS FOR
    ADVANCED CLINICAL AND EDUCATIONAL APPLICATIONS OF THE VISIBLE HUMAN AND
                          OTHER IMAGE DATA SETS (NLM)

      --Investments in building a Visible Human Functional Atlas of the
            Head and Neck and associated public software tools establish a
            strong foundation for developing applications software,
            including simulation and modeling, useful in medical training
            and treatment.
      --Further research and testing would fully integrate the data,
            software, and other technology in the teaching of embryology
            and anatomy courses.

     DEVELOP AND SUPPORT WOMEN'S HEALTH INTERDISCIPLINARY RESEARCH CENTERS
     ESPECIALLY IN THE AREAS OF: (OD--OFFICE OF RESEARCH ON WOMEN'S HEALTH)

      --Pharmacogenetic research that focuses on sex differences in drug
            metabolism and biological pathways involved in the treatment of
            diseases such as cancer, cardiovascular disease to provide the
            much needed information to improve clinical outcomes, including
            a better understanding of the impact of pregnancy or depression
            on pharmacokinetics, pharmacodynamics, drug efficacy and
            adverse effects of therapeutic agents.

      DEVELOP AND SUPPORT A CLINICAL TRIAL TO TEST A PROMISING INNOVATIVE
    TECHNIQUE THAT COULD REDUCE THE SIZE OF UTERINE FIBROIDS (OD--OFFICE OF
                          RESEARCH ON WOMEN'S HEALTH)

      --Could result in less morbidity for the women who face potential
            surgery or infertility as a result of this condition.

    LAUNCH A TRANS-NIH INITIATIVE TO LEARN WHETHER EHEALTH TECHNOLOGIES ARE
       EFFECTIVE IN ENHANCING HEALTH BEHAVIOR CHANGE AND CHRONIC DISEASE
       MANAGEMENT (OD--OFFICE OF BEHAVIORAL AND SOCIAL SCIENCES RESEARCH)

      --Consumers, patients and providers are increasingly using eHealth
            applications for making health care decisions, and for
            obtaining and dispensing services.
      --These technologies offer a potentially low cost health delivery
            system for underserved populations, as well as a means of
            supporting provider adherence to evidence-based care.

        Senator Specter. I want to finish this question before my
    red light goes on to stay within the time limits. What is the
    status and availability and adequacy of stem cell lines for
    adequate stem cell research?

                               STEM CELL RESEARCH

        Dr. Zerhouni. We have 17 cell lines now available. As you
    know, we have worked aggressively in providing infrastructure
    funding to all the sources that we knew were eligible for
    Federal funding. NIH has done every effort to expand the
    availability of lines. We have spent intramurally dollars to
    create a characterization lab. We have gone from one laboratory
    2 years ago to nine laboratories doing research. So we are also
    realizing that training of scientists in these very difficult
    methods is very important. So we are doing everything we can to
    advance the field. So 17 lines are available to date, Senator.
        Senator Specter. Well, I am going to violate the red light
    for just one question. That is not enough, is it? Those are not
    enough, are they? It is a leading question.
        Are they?
        Dr. Zerhouni. Well, we have a Stem Cell Task Force and Dr.
    Battey really works very hard with the entire community to look
    at what is the impact of what we need to do today of the number
    of cell lines. The reports that we have is that we are learning
    tremendously at a very high pace what are the advantages and
    limitations. We are looking, for example, at these issues of
    genetic stability and genetic diversity.
        The Stem Cell Task Force at this point feels that we can do
    a lot of research with what we have. Can we do all of the
    research that will need to be done over the entire future of
    stem cell research? No one can say that that would be the case.
        Senator Specter. Well, I will pursue that with Dr. Battey.
    I do not consider that an adequate answer, Dr. Zerhouni. It is
    not often where I say your answer is not adequate, but I do not
    believe that is an adequate answer.
        We have been joined by the distinguished ranking member,
    and I will yield to him at this time for 5 minutes for an
    opening statement or questions or however he chooses to use his
    time.
        Senator Harkin. Mr. Chairman, thank you very much.
        Senator Specter. We will have second rounds, but we have
    Senator Stevens and Senator Cochran who are here.

                        STATEMENT OF SENATOR TOM HARKIN

        Senator Harkin. Well, thank you very much, Mr. Chairman. I
    apologize for being late. Some mornings you have to leave about
    5:00 in the morning to get here because of the traffic.
        It has been a privilege, Mr. Chairman, to work with you
    over the last 14, almost 15 years, on behalf of supporting, as
    you have said so many times, the crown jewel of our Federal
    Government, which is the National Institutes of Health. I want
    to thank you again for that working relationship, and I want to
    thank you for your great leadership, Mr. Chairman, in doubling
    the funding for NIH over that short period of time. It was a
    pleasure to work with you to do that and to continue to work
    with you on these crucial issues that impact the health and
    welfare of all of our people.
        Now, unfortunately, the budget we have submitted this year
    is a far cry from the doubling years. I am concerned what it
    means for the future health of NIH. We did not double the
    funding for NIH to then fall off a cliff. But that is a real
    possibility if we continue on with this kind of budget that we
    have.
        I want to welcome Dr. Zerhouni and the dozens of other NIH
    leaders who have joined us. I do not always get the time to
    hear from each of you, but I appreciate your being here and all
    the work that you do.
        All of you were involved in developing the NIH Roadmap. I
    want to commend you for that effort. The initiative should help
    break down the walls between the institutes and unite everybody
    at NIH behind common goals. And, Dr. Zerhouni, I thank you for
    your leadership in encouraging that and also for your
    leadership in encouraging more risk-taking in the kind of
    applications that NIH funds. We always have to be open to new
    ideas. To the extent that I can, I hope to back you up. People
    may say, well, why are you funding some of these far-out
    things? Well, because sometimes we want to take a look at them.
    And I really applaud you for doing that.
        I just got here to hear a little bit about the stem cell
    issue. We have discussed that many times before here. We know
    that this research offers enormous potential to help ease the
    suffering of people with Parkinson's and juvenile diabetes,
    ALS, Alzheimer's.
        I just had the occasion last evening to meet an old friend
    of mine who I had not seen in several years. I found out that
    he has Lou Gehrig's disease. It was just a startling thing for
    me to see that last evening. His words to me were, you have got
    to put more research into the stem cell research and find out
    what is going on here. To see someone that you have known for a
    long time and then you lost contact with him and then you see
    him and you know they are not going to be around very much
    longer and they are in middle stages of Lou Gehrig's disease,
    it is a tough thing to see.
        I am just concerned that the restrictive policies in this
    research are delaying the day when these diseases could be
    cured. Under the President's guidelines only those cell lines
    generated before the arbitrary date of August 9, 2001 at 9
    p.m.--not 9:30, not 8:45, but at 9 p.m., very arbitrary--can be
    approved for federally approved research. The President said
    then there were more than 60 eligible lines. Later we heard
    there were 78. Now I just think I heard from you there were 17
    that are available to researchers. Well, I will ask some
    questions about this during my period of time.
        These 17 were also grown on mouse feeder cells, all of
    them, which raises questions whether or not they can ever be
    used for any kind of human therapies.
        Meanwhile, scientists in other countries are moving ahead,
    but we cannot fund those. We cannot fund any of that kind of
    research because those lines were developed after August 9,
    2001 at 9 p.m. So again, I will get into that in my question
    and answer period.
        I thank you for letting me make my opening statement, and
    whenever I can get a chance to ask questions, I will----
        Senator Specter. Thank you, Senator Harkin. We will come
    back to another round.
        Senator Stevens.
        Senator Stevens. Thank you very much.
        Dr. Zerhouni, it is nice to see you here. I do not think we
    have ever had an opportunity to put visuals on all of these
    people that you have brought here with you today. So I want to
    thank you for coming and apologize to them for taking their
    time. I do not know of another group that is more important to
    the future of our country than maybe now the intelligence
    community might be that would have a similar impact in the long
    range, but this long-range impact of you and your colleagues is
    just staggering.
        I heard the comments of my friend, Senator Harkin. Senator
    Connie Mack came to me and urged me to support a concept of
    doubling the NIH budget, and we have done that, Senator. So the
    real question I think we have to do one of these days is
    analyze what have we achieved with that money. I do think that
    that is something that you and your assembled colleagues could
    help us on. We are currently looking to increase other areas
    now, the National Science Foundation for one and the
    intelligence community for another. So the doubling of those
    budgets in the next 5 years will take precedence I think
    because of the circumstances that exist in the country.

                                PROSTATE CANCER

        I am glad to see Dr. von Eschenbach here. My good friend,
    Mike Phelps, reported you gave a tremendous speech at the
    molecular imaging meeting in Orlando. Several of you know my
    continuing interest in PET and its application to various areas
    of your institutes. I do hope that we can be able to be very
    aggressive in the use of that, the total molecular imaging
    concepts, to Alzheimer's, which I believe is becoming a great
    problem as the baby boom generation reaches retirement age.
        But I have one specific question. Prostate cancer is also a
    personal interest. I am a survivor now for 12 years. I would be
    interested if Dr. von Eschenbach would comment upon finasteride
    and what's going to happen to that clinical trial. I understand
    the clinical trial was canceled and there were some problems.
    Was the FDA a problem or was it that the high rate of tumor
    growth in those taking the drug? What happened, Doctor?
        Dr. von Eschenbach. Well, thank you, Senator, for that
    important question because I think it really underscores and
    points out not only the tremendous progress that we are making,
    but also how the investment that you have been responsible for
    in biomedical research is really now making it possible for us
    to solve problems that before we did not even understand.
        The issue with regard to the prevention trial of prostate
    cancer using finasteride demonstrated that in fact the drug did
    reduce the number of men who developed prostate cancer. So in
    that regard, we stopped the trial because the endpoint had been
    achieved. We in fact did get the answer and got the answer
    earlier than we had hoped or anticipated and demonstrated the
    protective effect of finasteride for a number of men who were
    susceptible to prostate cancer.
        What we also recognized in that trial was that although
    fewer men developed prostate cancer on finasteride, the kind of
    prostate cancer that they developed appeared to be more
    virulent and more aggressive, and perhaps could even increase
    their risk of progression or dying from prostate cancer.
        So in addition to demonstrating the protective effect, what
    we have now launched into is a subsequent set of studies to
    understand the mechanisms of action and to determine the impact
    on virulence. That is now an ongoing part of our research
    investigation.
        Senator Stevens. Thank you very much on that.
        Mr. Chairman, I do have, unfortunately, on the schedule
    several other subcommittees meeting. Again, I want to thank you
    for bringing all of the directors of these institutes here. I
    urge you to let them go quickly so they can go back to work.
        Senator Specter. That concludes the hearing.
        Senator Stevens. It concludes my time too. Thank you all
    very much.
        Senator Specter. Thank you very much, Senator Stevens.
        I am going to step out for a moment down the hall to the
    Judiciary Committee to see if I am needed for a quorum there. I
    hope to return within the time allotted to Senator Cochran, but
    if I do not, we will turn to Senator Harkin. Senator Cochran.
        Senator Cochran. Mr. Chairman, thank you.
        Dr. Zerhouni, we are very pleased with the fact that you
    are exploring research possibilities in areas that have
    previously been, I think, relegated to a fairly low priority.
    Fundamental challenges such as understanding obesity, its
    effect on health, what can be done to both treat those symptoms
    and, more importantly, prevent that condition should be the
    subject of research. I wonder what emphasis is placed in the
    budget request with regard to research in this area.

                                OBESITY RESEARCH

        Dr. Zerhouni. This is a very important topic to us.
    Actually I would like to point out that NIH has been working on
    obesity for over 10 years. I actually have a little graph here
    that you could see whereby our investments started in 1996
    because already at that time, NIH had predicted that the
    obesity crisis will hit, and it became one of the top 10 topics
    of research.
        However, as you know, the rate of increase of obesity is
    actually greater than what we expected, so we are increasing
    our funding at the same level. In fiscal year 1996, we had $86
    million. Next year we will have $440 million funding. Last year
    I established a trans-NIH Obesity Task Force, led by Dr. Allen
    Spiegel and Dr. Barbara Alving. They have come up with a new
    strategic research plan for obesity, and despite the difficult
    budget environment, we are going to increase our funding from
    $400 million to $440 million in obesity research by $10
    million. So we have almost quadrupled our investment in obesity
    research while the rest of the NIH doubled to show you our
    commitment to it and also our ability to see proactively where
    research needs to be.
        Senator Cochran. I hope you will take into account the
    importance of concentrating some of this funding in areas that
    suffer from this in a disproportionate way compared to the rest
    of the country.
        Dr. Zerhouni. Actually, Senator, this is one of the
    priorities of the new plan. We are going to focus on childhood
    obesity which affects rural areas and minority areas to a much
    greater degree than other communities. So we will have an
    implementation to be able to study that pattern early on in
    life.

     ROLE OF THE NATIONAL CENTER FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE

        Senator Cochran. One new phenomenon I know is the fact that
    millions of Americans are using dietary supplements and herbal
    products today. The National Center for Complementary and
    Alternative Medicine is playing a role in understanding the
    efficacy and the effects of these products. What are your plans
    for research with respect to these products?
        Dr. Zerhouni. If you allow me, I would like Dr. Stephen
    Straus, who is the Director of the National Center for
    Complementary and Alternative Medicine, to answer that. He has
    very definite plans and great strategies for that.
        Dr. Straus. Thank you. Mr. Cochran, our goal is to
    characterize the complementary and alternative medicine (CAM)
    products that Americans are using, understand why they have the
    activities they do, and then prove whether they are safe and
    effective. We are doing this in a multi-tiered approach, much
    of which is conducted in partnership with the other NIH
    Institutes and Centers because of their strong areas of
    thematic expertise.
        We are doing this with products that are used for
    neurodegeneration such as ginko biloba. In that regard, we have
    already enrolled, in partnership with the National Institute of
    Aging, the National Heart, Lung and Blood Institute and the
    National Institute of Neurological Disorders and Stroke, over
    3,000 patients in the largest study ever mounted of an herbal
    product, and at that time the largest preventative study
    conducted for dementia. The goal is to prevent the onset of
    Alzheimer's disease in otherwise healthy, aging Americans.
        At the same time we are studying mechanism, and in your own
    State, we have funded outstanding investigators at the
    University of Southern Mississippi who are showing us several
    different chemical constituents in ginko that prevent the death
    of neuronal cells in the brain. These are our strategies.
        Senator Cochran. Thank you very much.

        THE NATIONAL INSTITUTE FOR BIOMEDICAL IMAGING AND BIOENGINEERING

        I appreciate also the NIH's recognition of the role for new
    technologies in the detection and treatment of disease. The
    National Institute for Biomedical Imaging and Bioengineering
    was created specifically to enhance research in this area. Has
    this investment begun to show results, Dr. Zerhouni?
        Dr. Zerhouni. I think so. One of the most important
    meetings that the institute has had was actually organized at
    the University of Mississippi. It was a national strategic
    meeting to try to see where the direction of the field would
    go. Dr. Pettigrew is really a great leader and I would like him
    to comment, if you do not mind, Senator.
        Senator Cochran. Thank you.
        Dr. Pettigrew. Thank you, Senator, and I appreciate having
    the opportunity to respond to that question.
        There are many problems that physicians alone cannot solve.
    There are problems that also require the input of quantitative
    scientists. These would be scientists, which include not only
    imagers and physicists but also mathematicians and computer
    scientists.
        We have been very successful, I am pleased to report, in
    bringing physicians and quantitative scientists together to
    translate the fundamental discoveries from the technologically-
    based scientists into meaningful clinical applications for
    patients. That is certainly our goal and we work very hard to
    achieve that.
        The progress to date has been quite remarkable given our
    short history of only 2 years. I would like to tell you about
    two examples in this area.

                                NIBIB'S PROGRESS

        The first is the development of a new technology called
    quantum dots. These are small nano crystals that are able to
    identify specific cells of interest in the body, for example,
    cancer cells in lymphnodes. Quantum dots could also be used to
    identify the deposition of plaque in arteries.
        We have also seen progress in an area that many people in
    the audience might appreciate. No doubt people here have had
    MRI scans. This is a marvelous technology, in fact, the subject
    of the Nobel Prize in Medicine this year. But some of our
    researchers have tackled one of the problems, which is the
    speed with which these scans can be made. These researchers
    have improved the speed of acquisition of images 10-fold.
    Studies that used to take several minutes to acquire can now be
    acquired in a matter of seconds. The value of this is not only
    in improved patient comfort, but also in opening up additional
    applications such as image-guided surgery where speed would be
    very important.
        These are examples of some of the technological innovations
    that we have been pursuing and have begun to bring to fruition
    for the benefit of us all.
        Senator Cochran [presiding]. Thank you. Thank you very
    much, Mr. Chairman.
        Senator Harkin, do you have questions?
        Senator Harkin. If you want to have a follow-up.
        Senator Cochran. No. Go ahead. I am trying to carry out the
    chairman's 5-minute rule here. No, go ahead, please proceed.
        Senator Harkin. Okay, thanks.

                                STEM CELL LINES

        I would like to get back to the stem cell issue, if I
    could, and I would like to direct some questions to Dr. Battey.
    I believe you are heading the Stem Cell Task Force.
        Dr. Battey. That is correct.
        Senator Harkin. Correct me if I am wrong, but I think you
    have said that under the best case scenario, only 23 lines will
    be available to federally funded scientists. Is it 23 or is it
    17? I am a little confused there.
        Be that as it may, even if it is 23, my question basically
    is will 23 be enough to realize the full potential of stem cell
    research?
        Dr. Battey. Let me begin by addressing the numbers issue
    that you have raised.
        The number 17 refers to the number of cell lines that are
    available today for Federal funding that can be widely
    disseminated across the research community, cells that--if you
    had a laboratory--you could order and get in your laboratory
    for experiments. There are six additional derivations located
    at institutions that hold NIH infrastructure awards for the
    purpose of developing such cell lines, expanding them, getting
    them ready to be distributed, going from a derivation to a
    useful cell line that can be distributed. And we are hopeful
    that all six of these will become distribution quality cell
    lines. When you add 17 and 6, one arrives at the figure 23.
        Now, there are 31 derivations located in five institutions
    in Korea, India, and Sweden that are eligible for Federal
    funding that are on the registry, but they have not sought an
    NIH infrastructure award to develop such cell lines. So we do
    not know the status of these derivations. They are privately
    held and we are not privy to that information.
        Senator Harkin. Let me get to my question there, Dr.
    Battey. Will 23 or 17 be enough to realize the full potential
    of stem cell research?
        Dr. Battey. I do not know the answer to that question, but
    there are reasons to be concerned. For example, there was a
    published paper in December showing that when some of the cell
    lines, some of the 17, are grown in some people's hands and
    passaged for prolong periods of time, they develop karyotypic
    abnormalities, chromosomal abnormalities. These abnormalities
    are some of the same abnormalities that are seen on occasion in
    teratocarcinomas, which are tumors of cells like embryonic stem
    cells. That is an issue of great concern and will need to be
    followed very carefully.
        While I have to say I do not know whether or not we will be
    able to do everything possible with either 17 or 23 or 46 or 98
    or 321 cell lines, I do know that if there is additional
    functional diversity it is difficult to imagine that more cell
    lines would be detrimental to research progress.

                            MOUSE FEEDER CELL LINES

        Senator Harkin. Could any of these 23 lines ever be used in
    human therapy since they have all been developed on mouse
    feeder cells?
        Dr. Battey. We have discussed this issue at great length
    with the Food and Drug Administration, who would be the
    organization overseeing the safety and efficacy of any clinical
    studies that were done with these cells, were these cells to
    ever be returned to patients in transplantation in an effort to
    treat some of these awful disorders like ALS that you have
    spoken about. When we talk to the FDA about this, they say that
    the mouse feeder cell layer is an issue and the issue of
    whether or not a retrovirus or some other bad thing might have
    been transferred from the feeder cell layer to the human
    embryonic stem cells is an issue that must be explored.
        It is not, however, a prohibitive issue. It is one of many
    issues, including the history of the cells, where they have
    been cultured, what kind of medium they have been cultured in,
    if there have been any serum or other biological additives,
    what the state and purity of those are. So there is no question
    the feeder cell layer is a safety issue, but it is one of many
    safety issues and I do not think should necessarily be drawn
    out of that context.
        Would it be preferable to have cells that were not growing
    on mouse feeder cell layers? I think the answer to that
    question is yes. Would it be preferable to have cells that were
    grown in a medium that had nothing but completely defined
    substances, purified additives? Absolutely. That would be
    better. In fact, the NIH is funding investigators to try to
    develop better culture conditions for human embryonic stem
    cells with the goal of ultimately moving the cell lines into an
    environment that poses less questions about biological safety.

                           ACCESS TO ADDITIONAL LINES

        Senator Harkin. The other question I had was basically
    would federally funded scientists benefit from having access to
    additional lines. I think you basically answered that.
    Obviously, the more you have and the more involved, I would
    assume the better the research would be. You would have just
    more lines out there to look at.
        Dr. Battey. We will understand much better what the
    significance of number of cell lines is when we have explored
    to a greater degree what we can do with the cells that are
    available and widely distributed for Federal funding. But as I
    said before, it is difficult to argue that a greater number
    with more potential functional diversity would be detrimental
    to the research effort.
        Senator Harkin. If they had access to additional lines--
    lead me on. I just want to get a better understanding. How
    would this be not detrimental if they had more?
        Dr. Battey. Well, the problem here and the reason why I
    cannot be more specific in answering this question is that we
    are just at the beginning of exploring what we can do with the
    cell lines that are eligible for Federal funding. We are just
    beginning to learn the master switches that keep these cells in
    a pluripotent state and allow them to replicate indefinitely in
    the laboratory. We are just beginning to get our hands around
    the growth factors and gene expression profiles that are
    associated with differentiation towards a cell type that might
    be interesting for a therapeutic application such as a
    dopamine-producing neuron that might be lost in a patient with
    Parkinson's disease or a motor neuron that will be lost by your
    friend with ALS. We are only beginning to understand, and until
    we know more about what we can do with the cells we have, what
    their limitations are, what their possibilities are, it is hard
    for me as a scientist in a fact-based manner to give you a
    better answer than the one I have given, as much as I would
    like to do that.

                                STEM CELL POLICY

        Senator Harkin. Is it time to reevaluate the policy that
    has been in effect since August 2001?
        Dr. Battey. I think it is very important for there to be a
    continued dialogue between scientists, the National Institutes
    of Health, your subcommittee, and the administration about what
    the state of the science is. The decision to evaluate a
    presidential policy is a decision that is made at the level of
    the White House. Our role in this process, as I understand it,
    is to provide facts and information for the people who make
    policy, and we have a regular dialogue with individuals in the
    administration, as well as individuals on some of your staff
    about the state of the science in human embryonic stem cells.
    Just on a personal note, I am happy to come and talk to anybody
    who has questions or wants to know more about the state of the
    science in what I consider to be one of the most exciting areas
    of science for the future of biomedical research.
        Senator Harkin. Thank you very much, Dr. Battey.
        Senator Specter [presiding]. Thank you, Senator Harkin.
        Dr. Battey, the Congress also has a constitutional role in
    setting national policy and that starts with this subcommittee.
    Dr. Zerhouni and Dr. Battey, as the area of responsibility may
    fall, we would like to have a comprehensive report on what has
    happened to the original 60-some stem cell lines announced by
    the President back in August of 2001 and what has happened to
    them, how many are in private hands, how many of them are
    tainted with mouse feeders, how many of them can be used, what
    is happening at Harvard, what is happening in South Korea, what
    is happening in other countries so we can make an evaluation as
    to what the policy ought to be.
        [The information follows:]

                               Stem Cell Research

        Question. What is the status of human embryonic stem cell (hESC)
    derivations listed on the NIH Stem Cell Registry? How many are in
    private hands? How many have been grown on mouse feeder layers? How
    many are viable?
        Answer. All of the derivations listed on the NIH Human Embryonic
    Stem Cell Registry are privately owned by 15 different companies or
    academic institutions. The providers indicated by an asterisk (*) below
    are recipients of the NIH Infrastructure award to develop, characterize
    and distribute cell lines.
    BresaGen, Inc., Athens, Georgia*
        4 derivations
        3 lines available
        The cells in derivation BG04/hESBGN-04 failed to expand into
    undifferentiated cell cultures.
    Cell & Gene Therapy Research Institute (Pochon CHA University), Seoul
            Korea
        2 derivations
        0 lines available
    Cellartis (formerly Cell Therapeutics Scandinavia), Goteborg, Sweden*
        3 derivations
        2 lines available
        Cell line SA03/Salgrenska 3 was withdrawn by donor.
    CyThera, Inc., San Diego, California*
        9 derivations
        0 lines available
        The cells failed to expand into undifferentiated cell cultures.
    ES Cell International, Melbourne, Australia*
        6 derivations
        6 lines available
    Geron Corporation, Menlo Park, California
        7 derivations, all duplicates of Wisconsin Alumni Research Fdn.
    derivations
    Goteborg University, Goteborg, Sweden*
        16 derivations, reported to have not been exposed to mouse feeder
    layers
        0 lines available
    Karolinska Institute, Stockholm, Sweden*
        6 derivations
        0 lines available
        The cells failed to expand into undifferentiated cell cultures.
    Maria Biotech Co. Ltd.--Maria Infertility Hospital Medical Institute,
            Seoul, Korea
        3 derivations
        0 lines available
    MizMedi Hospital--Seoul National University, Seoul, Korea*
        1 derivation
        1 line available
    National Centre for Biological Science/Tata Institute of Fundamental
            Research, Bangalore, India
        3 derivations
        0 lines available
    Reliance Life Sciences, Mumbai, India
        7 derivations
        0 lines available
    Technion-Israel Institute of Technology, Haifa, Israel*
        4 derivations
        2 lines available
    University of California, San Francisco, California*
        2 derivations
        2 lines available
    Wisconsin Alumni Research Foundation, Madison, Wisconsin*
        5 derivations
        5 lines available

        Of the 78 entries on the Registry, 71 are from independent embryos
    and 7 are duplicates located at both WiCell (Wisconsin Alumni Research
    Fdn.) and Geron. The Geron cell lines are not being widely distributed
    to the research community.
        Of the 71 independent derivations:

      --16 have failed to expand into self renewing, pluripotent cell lines
            (9 at CyThera, 1 at BresaGen, 6 at Karolinska), and 1 line was
            withdrawn by the donor at Cellartis (formerly Cell Therapeutics
            Scandinavia, CTS). NIH provided Infrastructure support in
            failed attempts to expand these 16 derivations into
            distribution-quality cell lines.
      --Of the remaining 54 independent derivations, 21 are available for
            shipment, after expansion and characterization using NIH
            Infrastructure grant awards. The 21 that are currently
            available are:

        BresaGen, Inc.--BG01, BG02, BG03
        Cellartis--SA01, SA02
        ES Cell International--ES01, ES02, ES03, ES04, ES05, ES06
        MizMedi Hospital--MI01
        Technion-Israel--TE03, TE06
        UCSF--UC01, UC06
        WiCell--WA01, WA07, WA09, WA13, WA14

      --Of the remaining 33 independent derivations, 2 more are at
            institutions with NIH Infrastructure awards. If these 2 were
            developed into distribution quality cell lines ready for
            shipment, there would be 23 independent cell lines available to
            the research community. The 2 cell lines under development are:

        Technion-Israel--TE04, TE07

      --The remaining 31 independent derivations are all at institutions
            located outside of the United States that have not applied for
            NIH Infrastructure awards to develop their cell lines. Any
            plans to develop these derivations into cell lines that are
            available to the research community are unclear at this time.
            The 31 derivations at institutions that do not have
            Infrastructure awards are:

        Pochon CHA (Korea)--2 derivations
        Goteborg Univ. (Sweden)--16 derivations
        Maria Biotech (Korea)--3 derivations
        National Centre for Biological Sciences (India)--3 derivations
        Reliance Life Sciences (India)--7 derivations

        As far as we know, all derivations have been exposed to mouse
    feeder cells, with the exception of the 16 derivations at Goteborg
    University (Sweden).
        Information on the detailed characteristics of each of the
    derivations is available on the NIH Human Embryonic Stem Cell Registry,
    http://escr.nih.gov.
        Question. What is Happening at Harvard University?
        Answer. On March 25, 2004, Harvard University announced the
    derivation of 17 hESC lines in an article published in the New England
    Journal of Medicine. Funding for the derivations and distribution of
    these lines is being provided by the Howard Hughes Medical Institute,
    Juvenile Diabetes Research Foundation and Harvard University.
        On April 23, Harvard University announced the establishment of the
    Harvard Stem Cell Institute. According to Harvard, the Institute will
    encourage adult and embryonic stem cell research using both animal and
    human stem cells. The Institute has two co-directors: Harvard Medical
    School Professor David Scadden, who also directs Massachusetts General
    Hospital's Center for Regenerative Medicine and Technology, and Douglas
    Melton, the Thomas Dudley Cabot Professor of the Natural Sciences and a
    Howard Hughes Medical Institute investigator.
        Research at the Institute will be focused on five areas of disease
    for which stem cell therapy seems most promising. The diseases all
    result from some sort of organ or tissue failure and include: diabetes,
    neurodegenerative diseases, blood diseases, immune diseases,
    cardiovascular disease, and musculoskeletal diseases.
        Although research on the 17 new human embryonic stem cell (hESC)
    derivations are not eligible for Federal funding, NIH is currently
    supporting several scientists at Harvard University whose hESC research
    use lines eligible for Federal funding. Dr. Doug Melton is working to
    identify the genes involved in hESC self-renewal and differentiation.
    Dr. George Daley is studying hematopoietic development from hESCs. Dr.
    Howard Green is working to develop the culture conditions to coax hESCs
    to become the keratinocytes that make up human skin(s epidermis. Dr.
    Jeffrey Harper is analyzing the signals that control hESC division.
        Question. What is Happening in South Korea? What is Happening in
    Other Countries?
        Answer. On February 12, 2004, South Korean researchers published
    the first scientifically credible report of the creation of a cloned
    human embryo in the laboratory by means of somatic cell nuclear
    transfer (SCNT) (Science 303: 1669-1674.) These scientists, supported
    by the South Korean government, then used these cloned embryos to
    establish a human embryonic stem cell line. They combined the DNA of a
    woman's ovary cell with her donated egg, from which the nucleus had
    been removed, and then stimulated the newly combined cell to divide.
    The resulting very early embryo was then allowed to develop to the
    blastocyst stage (five to nine days), at which point it was
    disaggregated and the highly potent stem cells of the inner cell mass
    were removed. These stem cells were then treated to produce a stem cell
    line to be used for various kinds of biomedical research. Subsequent to
    the publication of the SCNT study, the South Korean government voted to
    ban the creation of cloned human embryos, but might allow cloning for
    biomedical research on a case-by-case for medical treatment subject to
    approval by a National Bioethics Advisory Commission. Scientists will
    be permitted to use spare frozen embryos, left over from infertility
    treatments and kept in laboratories for at least five years, for
    limited stem cell research into treatments for hard-to-cure diseases.
    The regulations banning human cloning are expected to come into effect
    after President Roh Moo-hyun signs the bill. The regulations on stem
    cell research will go into effect in 2005.

                     OTHER INTERNATIONAL STEM CELL EFFORTS

        International Society for Stem Cell Research (ISSCR).--The
    International Society for Stem Cell Research is an independent,
    nonprofit organization established to promote and foster the exchange
    and dissemination of information and ideas relating to stem cells, to
    encourage the general field of research involving stem cells and to
    promote professional and public education in all areas of stem cell
    research and application. Opinions on the legitimacy of experiments
    using human embryos vary among members of the European Union (EU)
    according to the different ethical, philosophical and religious
    principles in which they are grounded. EU member states have taken very
    different positions on the regulation of human embryonic stem cell
    research and cloning for biomedical research. More information about
    the regulations and policies of EU members can be found on the website
    of the ISSCR at the following link: http://www.isscr.org/scientists/
    legislative.htm.
        The International Stem Cell Forum (ISCF).--The ISCF was founded in
    January 2003 to encourage international collaboration and funding
    support for stem cell research, with the overall aim of promoting
    global good practice and accelerating progress in this vitally
    important area of biomedical science. The Forum's long-term aim is to
    help stem cell scientists achieve a range of revolutionary medical
    advances that will benefit people throughout the world. The ISCF is led
    by the United Kingdom's Medical Research Council and consists of 14
    leading supporters of stem cell research from around the world. Member
    organizations are based in the United States, Finland, Australia,
    Canada, Germany, France, Israel, Netherlands, Japan, Singapore, Sweden,
    Switzerland, and the United Kingdom. Within ISCF, the United States is
    represented by the NIH. The Juvenile Diabetes Research Foundation
    International (JDRF) is also a member of the ISCF. One short term goal
    of the ISCF is to compare different stem cell lines from the member
    organizations. As part of this goal, NIH's federally approved stem cell
    lines will be compared to those of other member organizations.
    Information about the stem cell research efforts of the member
    organizations can be found on the website: http://mrc.live.tmg.co.uk/.

        Senator Specter I have discussed it with the President and
    he has a view on it. The facts are very important in
    formulating all of our views. So let us proceed to bring all
    the facts to this subcommittee.
        Dr. Zerhouni. You have my commitment to do so, Senator.

                               BIODEFENSE AGENTS

        Senator Specter. Thank you very much.
        On the issue of biodefense, the concerns about another
    attack are with us imminently as we sit here. We have seen an
    acceleration of the venom and hatred from Wahabes and Islam
    fundamentalism and we have a long chronology of attacks going
    back to 1983 when 283 Marines were killed in Lebanon, what
    happened in Mogadishu, what happened in Africa in August 1998,
    what happened with the Cole, what happened on 9/11. We have to
    be prepared.
        Dr. Fauci, you and I have discussed this on other
    occasions. This year's request includes $1.7 billion toward
    biodefense research activities. What are the principal
    bioweapons that we are working to defend against?
        Dr. Fauci. The principal bioterror agents that we are
    involved in pursuing from the standpoint of developing
    countermeasures remain the category A agents that we have
    discussed before this committee on several occasions. High
    among those are still smallpox, anthrax, botulism toxin,
    tularemia plague, and the hemorrhagic fevers including Ebola.
    We are pleased to report, as Dr. Zerhouni mentioned in his
    opening statement, that over the past year with the resources
    that this committee has generously given us, we have made
    extraordinary progress in having available, either already in
    the stockpile or in contract on its way either in phase I/II or
    purchase, countermeasures in the form of vaccines for smallpox,
    anthrax, and soon Ebola.
        Senator Specter. If there was to be an attack on anthrax,
    how well prepared are we?
        Dr. Fauci. We are extraordinarily better prepared today
    than we were in the anthrax attacks in the fall of 2001 with
    the following issues. A, the stockpile of antibiotics right now
    to treat prophylactically for the entire 60-day period with
    ciprofloxacin or doxycycline is now able to meet a substantial
    attack, God forbid that were to occur. And also, we are now
    well into the development of the second generation of a
    recombinant protective antigen anthrax vaccine that could be
    used to vaccinate people who would go in to clean up, the
    hazmat people, health workers, and those who would be required
    to have an extended period of antibiotics. So the anthrax
    situation is dramatically different than it was in this
    building a year and a half, 2 years ago.
        Senator Specter. Adequate?
        Dr. Fauci. I believe adequate. I think we still have a ways
    to go on every issue, but the progress that is being made
    particularly in the arena of anthrax is striking.
        Senator Specter. My red light is about to go on. So I would
    like you to supplement in writing the details as to the other
    threats, what we have done, whether it is adequate, and what
    more needs to be done.
        Dr. Fauci. I would be happy to do that.
        Senator Specter. This is something we have to address
    forcefully and promptly.
        Dr. Fauci. Will do.
        [The information follows:]

       Research in Medical Countermeasures Against Category A Biological
                                     Agents

        The accompanying table provides a summary on the status of research
    and development of medical countermeasures for Category A biological
    agents. These biological agents and the countermeasures that are
    currently available for them are identified in the first two columns.
    Recent NIAID accomplishments are identified in column three (complete
    details of these and additional accomplishments can be found in the
    NIAID Biodefense Research Agenda for CDC Category A Agents Progress
    Report).\1\ Candidate countermeasures that are at an advanced research
    stage where rapid development of the countermeasures is scientifically
    feasible are identified in the fourth column. Finally, many of the
    countermeasures that are the focus of early research efforts are
    identified in the last column.
    ---------------------------------------------------------------------------
        \1\ See http://www2.niaid.nih.gov/Newsroom/Releases/
    biodefensereport2003.htm for a detailed report on research progress
    made to date for CDC Category A Agents.
    ---------------------------------------------------------------------------
        I would like to add that we continue to support a national,
    comprehensive biodefense research and development program. It includes
    the development of other biodefense countermeasures to combat
    Categories B and C biological agents, as well as a broad range of basic
    research activities.

        Senator Specter. Senator Harkin.
        Senator Harkin. Thank you, Mr. Chairman.

                           FUNDING OF RESEARCH GRANTS

        Dr. Zerhouni, our staff has brought to our attention this
    issue of the number of research grants that we are funding this
    year. It is a question we always ask. What are we doing in
    terms of the number of grants and the funding for these grants?
        I have found--and you correct me if I am wrong on this--
    that fiscal year 2004 marked the first time in 8 years that the
    number of new competing grants went down. It dropped from
    10,393 in fiscal year 2003 to 10,135 in fiscal year 2004. That
    is the bad news. We might say, well, but the good news is the
    President's 2005 budget calls for raising that number back to
    the 2003 level of 10,393. So I said, okay. How do we do that?
        As you know, when researchers get approved for NIH grants,
    for the second, third, fourth years, there is an automatic 3
    percent increase. Well, what I found out is that this
    longstanding commitment by NIH to these researchers is
    necessary so that they can pay their staff and give them their
    annual salary increases or get new equipment and so forth in
    the second, third, and fourth years. Now, that is 3 percent.
    And this year's budget calls for an increase of 1.9 percent to
    the second, third, and fourth year researchers. As a result,
    the researchers will receive less money than what NIH committed
    to providing them.
        I am wondering about the effect this is going to have.
    Could it force them to change the scope of their work in
    midstream?
        Now, again, I think that you and all of us are opposed to
    breaking NIH's commitment to its grantees. Once you make a
    commitment, you make a commitment. And I am concerned that this
    budget is changing this policy, and I am wondering why are we
    changing this policy. Why are we going to 1.9 percent rather
    than 3 percent?
        Dr. Zerhouni. These are very important questions and those
    are the questions we have grappled with in a very difficult
    budget environment and we had to make tough choices.
        But let me address your first question which was that a
    decrease between 2003 and 2004 and then recovery in 2005 in
    numbers of grants. Fiscal year 2003 was the last year of the
    doubling of the budget.
        Senator Harkin. Right.
        Dr. Zerhouni. We actually gave more grants in 2003 than we
    planned to do so that is why the number in 2003 was higher. In
    2004, we were planning on keeping that level or even go up a
    little bit, but certain budgetary events occurred.
        One, was the .59 percent cut across the board. That was in
    conference.
        Second was the reshifting of extramural construction, $119
    million we had not requested. It was then put back into the
    extramural construction.
        Last but not least was what we call the planning and
    evaluation tap, 2.2 percent of the NIH budget is used to fund
    AHRQ, for example. So all of these elements decreased the funds
    available for the grant pool in 2004.
        Now we come to this year and we have a budget envelope of
    2.6 percent. So we had to make tough choices.
        I agree with your policy principle. This is something that
    I have told all the Institute and center directors--that our
    word is our bond. We should really commit to maintaining
    research grants at least at an inflationary level so that they
    do not lose the ability to purchase research, if you will.

                                 SUCCESS RATES

        But on the other hand, we also have a marked increase in
    terms of applications and new scientists are coming to us
    asking for grants. So we had to make a tough decision. I have
    the information here to show you on the screen. If you looked
    at our success rate at the beginning of the doubling, our
    success rate was 32 percent here. The number of applications we
    received in 2001 was 28,000. Senator, the number of
    applications we are receiving is now 38,000. This year alone
    our Center for Scientific Review will receive 66,000
    applications for all types of grants for NIH as well as some
    from CDC, AHRQ, FDA, and SAMHSA.
        Senator Harkin. Excuse me, Dr. Zerhouni, but that 38,000
    and the 37,000 and the 34,000 I see, are those the ones that
    actually make it through the peer review process?
        Dr. Zerhouni. Those are the ones that are applied for. They
    are new and competing in that year. Only one-third of them will
    get funded.
        So, for example, if you go back to 2001, Senator, we had
    28,000 grants. Thirty-two percent of those were funded. Then we
    had 30,000 applicants. Thirty-one percent of those were funded.
    And then in 2003, we had 34,700 applications.
        So from my standpoint, as you look at the budget and you
    look at the number of scientists out there who are coming up
    with great ideas, we had to make a choice. Can we shave the
    cost increases to allow more of these increasing numbers of
    scientists to apply and be successful? So those are the
    tensions, Senator, that I had to deal with in making the tough
    decisions.
        Senator Harkin. Well, I understand the dilemma you were
    faced with. I guess under the budget we have got a choice,
    either increase the number of new grants and cut back on the
    increases for those that are already approved, or keep the
    increases in and not have new grants.
        Dr. Zerhouni. That's right.
        Senator Harkin. That seems to be the dilemma.
        Well, I do not know. Maybe we made the right decision, but
    I just think we all ought to be aware, Mr. Chairman, of the
    tradeoff that we have made with this budget. Now, I am
    preaching to the choir here because this person right next to
    me here keeps going on the floor trying to get our budget up
    for NIH and I have backed him every time we have tried to do
    that. But because of this budget, you have had to make almost a
    devil's choice here in terms of the tradeoff. As you say, you
    want to keep your word. You want to keep your commitment to
    these researchers. But then the President's budget--it is his
    budget--wants to have all these new starts, so then you have to
    trade that off. I think that is why we need to actually get
    this budget back up again so that that does not happen.

                          PROJECTING OUT-YEAR BUDGETS

        Now, I am particularly concerned, as I said in my opening
    statement, about the years ahead. According to OMB, NIH's
    budget is expected to drop in actual dollars by 2 percent in
    fiscal year 2006. If that goes through, do we have any idea
    what that is going to mean in the number of grants and this
    dilemma we are facing right now? What is that going to mean?
        Dr. Zerhouni. At this point I heard the same thing that you
    heard. So we queried and we asked are there decisions made in
    our out-year budgets. To this moment, I am not told of any
    formal decisions that were made by OMB that would imply those
    cuts in the NIH budget.
        Senator Harkin. I got it from OMB.
        Dr. Zerhouni. I understand. There were projections, but
    from the standpoint of our interactions with OMB, we are told
    that those are projections and estimates that were made, not
    policy decisions.
        Senator Harkin. Well, I know they are projections. This is
    what OMB is projecting. I have got the figures right here, a 2
    percent cut in fiscal year 2006. That is next year. That is
    what we are going to be confronting next year, and we are going
    to be here next year.
        So, again, I am just asking. We need some information. What
    would this mean if OMB's projection goes through and we have
    this 2 percent cut in fiscal year 2006 and we are confronting
    that, what does it mean for grants, commitments to researchers,
    size of grants? I mean, we need to know what the impact of that
    is going to be.
        Dr. Zerhouni. We definitely are willing to provide you with
    those projections from the standpoint of the agency, and I will
    provide that to you for the record.
        Senator Harkin. I do not need them right now, but we are
    going to need them sometime because we are going to start
    getting into this sometime this year. But we should have some
    handle on that as to what that might mean, so that we can at
    least, as we have been saying here, get the facts out as to
    what this would mean. Before the budget actually comes out is
    what I am saying, we ought to have this out there so people
    that are devising the budget know what it is going to mean.
        Dr. Zerhouni. But again, we checked and those figures are
    not decisional figures. They are not decisions made. They are
    projections.
        Senator Harkin. I understand that, but we have got to know
    what those projections mean in real terms if in fact they
    follow through on them.
        Dr. Zerhouni. Definitely.
        [The information follows:]

                     2 Percent Decrease in Fiscal Year 2006

        As indicated, while there are mechanically calculated numbers in
    the OMB computer system that reflect the Administration's overall
    budget targets in the outyears, no specific funding decisions have been
    made for NIH or most other domestic programs. In answer to your
    question, if the NIH budget were to decrease by 2 percent in fiscal
    year 2006 from the fiscal year 2005 Budget Request, the number of
    competing research projects grants (RPGs) would decrease by an
    estimated 2,000 to 2,500 depending on the average cost assumptions
    used.

        Senator Harkin. Thank you, Dr. Zerhouni. Thank you, Mr.
    Chairman.
        Senator Specter. Thank you, Senator Harkin.

                                OBESITY RESEARCH

        Dr. Zerhouni, the issue of obesity is one of enormous
    importance. In 15 years, obesity has increased by over 50
    percent among adults; in 20 years, 100 percent among children
    and adolescents. We would like a written response as to what
    can be done by NIH, how this subcommittee might be effective on
    diet or education. We have both Health and Human Services and
    Education to try to confront this growing problem.
        [The information follows:]

                                Obesity Research

        The NIH Obesity Research Task Force, which was established in April
    2003 to accelerate research on this escalating health problem, has
    developed a Strategic Plan for NIH Obesity Research in broad
    consultation with external scientific and lay experts. We believe that
    implementation of this Plan is the best way that the NIH can contribute
    to arresting the obesity epidemic. Combating obesity must be a broad
    national effort to which the NIH can contribute new and important
    scientific insights. As noted, the fiscal year 2005 President's Budget
    request for the NIH reflects a 10 percent increase for obesity
    research, which would bring total NIH funding for this area to $440
    million. The proposed 10 percent increase includes additional new
    funding to begin implementation of obesity research in specific areas
    identified in the Strategic Plan because of their scientific
    opportunity and public health challenge. With respect to your specific
    reference to diet and education, the NIH has also recently created a
    new obesity research website http://www.obesityresearch.nih.gov), which
    contains links to science-based information generated by many of the
    NIH Institutes and Centers for the public, patients, and providers. Two
    helpful programs are the NIDDK's Weight Control Information Network and
    the NHLBI's Obesity Education Initiative.

               MEDICATION TO LOWER PLASMA LIPOPROTEIN (A) [LP(A)]

        Senator Specter. Last year I asked Dr. Lenfant about
    research on medication to lower Lp(a). Dr. Alving of the Heart,
    Lung and Blood Institute, is there anything new that you can
    inform the subcommittee about on the status of research toward
    a medication to lower Lp(a)?
        Dr. Alving. Yes. Thank you very much.
        Since the past year, there has been no really new
    information on Lp(a). It is still defined as an emerging risk
    factor. But there has been certainly very new information on
    the importance of lowering LDL, even below the guidelines of
    less than 100 milligrams per deciliter.
        Senator Specter. We see the LDL research all the time on
    the front pages.
        Dr. Alving. Yes.
        Senator Specter. But how about Lp(a)? That has been
    identified as a very problemsome factor. We have asked you
    about it repeatedly. What efforts are you making to identify
    what can be done about it?
        Dr. Alving. The efforts to identify it have been in terms
    of our ATP III Guidelines Committee, which has been reviewing
    all of the literature and has been closely focused on the
    latest guidelines and the latest research.
        Senator Specter. Aside from reviewing literature, is there
    active research being undertaken in the field?
        Dr. Alving. There are R01 grants that include Lp(a), but it
    has not really been able to be classified as a true risk
    factor. But what I would like to do----
        Senator Specter. How many grants?
        Dr. Alving. What I would like to do is reply for the record
    with an actual listing of the R01 grants so that I can give you
    very specific information about all of our research.
        Senator Specter. That would be fine. We would appreciate it
    if you would specify the grants, what they are doing, what
    their success has been, what more you need to do.
        Dr. Alving. Yes. I will be happy to do that, Senator.
        [The information follows:]

                          Research Activities on Lp(a)

        The NHLBI supports a variety of grants and contracts related to the
    cardiovascular disease (CVD) risks associated with elevated
    concentrations of Lp(a), factors that influence Lp(a) levels,
    mechanisms by which Lp(a) may affect CVD, and Lp(a) metabolism.
    Beginning in 2005, the NHLBI will support measurement of Lp(a) in the
    next four years of the National Health and Nutrition Examination
    Survey.
        The NHLBI supports the following R01 grants related to Lp(a):
      --APEX: Adiposity Prevention by Exercise in Black Girls (Medical
            College of Georgia).
      --Biology of Proteolytic Derivatives of Lp(a) (University of
            Chicago).
      --Epidemiology of Coronary Artery Calcification (University of
            Michigan at Ann Arbor).
      --Genetic Determinants of Lp(a) Concentration (University of Texas
            Southwestern Medical Center).
      --Genetic Epidemiology of Blood Lipids and Obesity (University of
            Pittsburgh).
      --Lifestyle, Adiposity, and Cardiovascular Health in Youths (Medical
            College of Georgia).
      --Macronutrients and Cardiovascular Risk (Johns Hopkins).
      --Regulation of Lp(a) Metabolism in Humans (University of California-
            Davis).
        The Institute also supports a K08 clinical investigator development
    award for a project on Lp(a), Homocysteine, and Cardiovascular Risk in
    End-Stage Renal Disease (Johns Hopkins).
        Lp(a) is a subject in several epidemiologic studies supported
    through NHLBI contracts:
      --Atherosclerosis Risk in Communities Study (ARIC) (Baylor College of
            Medicine, Johns Hopkins, Mississippi Medical Center, University
            of Minnesota--Twin Cities, University of Texas Health Sciences
            Center, University of North Carolina at Chapel Hill).
      --Cardiovascular Health Study (CHS) (Johns Hopkins, University of
            Washington, University of Vermont, University of Pittsburgh,
            University of California--Davis, University of Wisconsin, Wake
            Forest University).
      --Coronary Artery Risk Development in Young Adults Study (CARDIA)
            (Harbor-UCLA Research and Education Institute, Kaiser
            Permanente Division of Research, Northwestern University,
            University of Minnesota--Twin Cities, University of Alabama at
            Birmingham, University of California--Irvine).
      --Framingham Heart Study (Boston University Medical Center).
      --Jackson Heart Study (Jackson State University, Mississippi Medical
            Center, Tougaloo College).
        Two NHLBI-supported cooperative agreements related to
    cardiovascular disease risk factors in Alaska Natives and Native
    Americans also include Lp(a) measurements:
      --Genetics of Coronary Artery Disease in Alaska Natives (GOCADAN)
            (MedStar Research Institute).
      --Strong Heart Study (MedStar Research Institute, Missouri Breaks
            Research Inc., Southwest Foundation for Biomedical Research,
            University of Oklahoma Health Sciences Center, Weill Medical
            College of Cornell University).
        In 1998, the NHLBI initiated a 4-year Lp(a) Standardization Program
    to enable accurate and consistent measurement that may help to
    reconcile various findings. Following completion of the program, a
    workshop was held to present the new results, evaluate current
    understanding of Lp(a) as a risk factor for CVD, and design future
    studies. The workshop report was published in the journal Clinical
    Chemistry in November 2003.
        In summary, the following statements can be made with respect to
    Lp(a).
      --In general, research has found only a modest association between
            Lp(a) levels and CVD risk.
      --Compared with plasma LDL, Lp(a) concentrations are relatively
            resistant to alteration by pharmacologic and lifestyle
            interventions.
      --Lp(a) is a complex and heterogeneous protein, and measurement
            challenges have created difficulties in comparing data from
            different sources or assessing the impact of findings on the
            severity of disease.
      --Measurement of Lp(a) is not currently recommended as part of CVD
            risk assessment in patients.

        Senator Specter. We are going to try to bring this hearing
    to a close, following Senator Stevens' admonition. We are
    keeping a lot of scientists away from their laboratories here
    and there is a lot of work to be done.

                            SPINAL MUSCULAR ATROPHY

        Dr. Landis, on the issue of spinal muscular atrophy
    therapeutics, could you bring us up to date on when that will
    be ready for clinical trials?
        Dr. Landis. We are actually running three pilot clinical
    trials right now based on previous data. This is a network that
    is set up by Susan Iannaccone. In addition, the new project
    looking at additional compounds is well underway. The advisory
    committee has created a flow plan, and the first set of awards
    to come up with an animal model that would be used for
    preclinical studies will be awarded in the next week or 2.
        In addition, two further solicitations have been put out,
    one that would that would look for cell culture models again
    being used to solicit better mechanisms to look at therapeutic
    molecules, and the second to come up with a satisfactory way to
    measure the protein that is missing. So I think, between what
    pilot trials are ongoing and this new therapeutics initiative,
    we are making significant progress.
        Senator Specter. Would you supplement your answer with a
    written report about how you project activities of NIH to
    proceed in this line looking toward some ultimate answer?
        Dr. Landis. I would absolutely be pleased to do so.
        [The information follows:]

                            Spinal Muscular Atrophy

        The NINDS has developed a new program, called the SMA Project, to
    accelerate the development of therapies for this disease. The SMA
    Project uses a performance-based, milestone driven, contract mechanism
    to shorten the cycle time from recognition of a need or opportunity for
    research to getting research underway on those issues and finding
    answers. We awarded the primary contract in September 2003. This is an
    extremely ambitious project in a very challenging area of medical
    science, and scientific progress is not predictable. However, we have
    explicitly designed the SMA Project to respond quickly to unanticipated
    obstacles and to emerging opportunities, in the hopes of achieving our
    goal of identifying a therapeutic candidate for SMA, and completing the
    required preclinical research and development by late 2007.
        One very important aspect of this program is that we are
    coordinating the research centrally, calling for targeted research
    projects to meet specific needs identified by an overall plan, and
    carefully monitoring progress. The program is guided by a superb
    Steering Committee, with scientists from academia, industry, the Food
    and Drug Administration, and the intramural and extramural programs at
    the NINDS. The Committee has already developed a plan and a sample
    timeline showing all of the steps necessary to meet the goal of
    bringing a candidate therapeutic to investigational new drug (IND)
    status that is necessary for clinical trials, within four years. The
    sample timeline and other detailed information about this program are
    available to the public on a website at http://smaproject.org.
        A crucial aspect of the SMA Project is the rapid turnaround from
    identifying a research opportunity or need, to solicitation for
    research proposals, to funding. The first targeted solicitation for
    research subprojects, focused on mouse models for testing therapies,
    was issued in December of 2003. These applications have been reviewed,
    and expect awards to be issued by June 1, 2004. Two further
    solicitations were issued in March, on cell culture models and on
    measuring the crucial protein that is lacking in SMA. Full length
    proposals are due in May, notification of subcontract awards is
    scheduled for June and funding for July. These initial proposals have
    been focused on generating the necessary research tools to identify a
    candidate treatment that has the highest probability of success in the
    clinic. Future solicitations will be aimed at stimulating new drug
    identification; the development of gene therapy; and establishing
    centralized testing facilities to conduct the activities required in
    the flow plan, such as evaluating compounds in animal and cellular
    models of SMA.
        In addition to the contract-based SMA therapeutics development
    project, we are currently supporting the short term, open label pilot
    clinical trials, being conducted by Dr. Iannaccone, of three drugs that
    have shown promise either in patients or in models of SMA. We will be
    looking to see if these results warrant larger trials. We are also
    planning a workshop on clinical trials for SMA to be held later this
    year. This workshop is intended to ready the SMA clinical community to
    test interventions that result from the SMA Project, by promoting
    collaboration and high quality trial design. In preparation, we are
    moving forward to work with the community on identifying and evaluating
    drugs now available that may slow the progression of SMA and be ready
    for testing in clinical trials.
        So, we are exploiting the best existing opportunities in the short
    term for slowing the disease, and at the same time we are developing
    the best possible treatments for the future through the SMA Project.
    Finally, I want to emphasize that the SMA Project is not replacing our
    traditional investigator-initiated grant programs and our intramural
    program on SMA; we are continuing to support this research as well. We
    also have extensive research programs in cross-cutting areas such as
    gene therapy, drug screening, and stem cells that may ultimately have
    an impact on SMA.

        Senator Specter. Thank you. Dr. Spiegel, in your field we
    had a high visibility attention-getter when NBA basketball star
    Alonzo Mourning was seeking a kidney transplant and was forced
    to retire early on glomerular disease that damages filters in
    the kidney that cleanse the blood. We were asked to hold a
    separate hearing which was just too much to do. Could you give
    us an update on where that stands?
        Dr. Spiegel. Yes, Senator, I would be happy to do that.
        The glomeruli are tiny units that cleanse the blood in the
    kidney and they are comprised of kidney membranes and small
    capillary blood vessels. There are really two types of injuries
    that occur. One is glomerulonephritis, which is caused by the
    immune system. Many institutes at NIH work together to direct
    attention to preventing kidney failure from glomerulonephritis.
        The form that you are referring to, focal segmental
    glomerulosclerosis, affects children, and as you implied in the
    case of Alonzo Mourning, can affect African Americans
    disproportionately. We have intensive research efforts together
    with patient advocacy groups such as the NephCure Foundation.
    In fact, we have launched a clinical trial directed at new and
    more effective therapies for this important disorder, and we
    are hopeful that from that trial, new, safer, and more
    effective medication will emerge. But at the same time, we are
    also reinforcing our basic research to understand the basis for
    the injury that occurs in glomerulosclerosis.
        Senator Specter. Thank you very much.

                     AGE-RELATED MACULAR DEGENERATION (AMD)

        Dr. Sieving, with respect to macular degeneration, how are
    you moving ahead on the clinical trial networks for advancing
    AMD research?
        Dr. Sieving. AMD is a leading cause of vision loss and, in
    fact, one of the leading causes of disability in the elderly.
    It is a neurodegenerative disease. A part of the mission of the
    institute is to form alliances, scientific alliances and
    communication related to other neurodegenerations, including
    Parkinson's and Alzheimer's disease, because there are some
    common features that mutually these two multiple areas can
    learn.
        Now, the AMD network specifically is going to tackle the
    opportunities presented by existing and new compounds to modify
    the effects of and the course of AMD. One such opportunity--it
    is not actually a network, but one recent success came from the
    finding reported about a year ago that antioxidant nutrients
    and zinc can decrease the risk of progressing to end-stage
    vision loss. That is a very important finding in the aggregate
    for the American population. Now it is our task to take that
    bedside finding back to the bench to help understand on a
    molecular and cell biological basis why this is happening.
        Back on the AMD networks, we are proceeding with that.
    Applications are coming in, will be reviewed, and we hope that
    we will be able to successfully fund this venture.

                                AUTISM RESEARCH

        Senator Specter. Dr. Insel, with respect to autism, could
    you bring us up to date on the research activities of your
    department and what success you have had and what your
    projection is for the future?
        Dr. Insel. I would be happy to, Senator.
        We have in the past year launched a total of eight STAART
    centers. These are interdisciplinary centers to bring both a
    research effort and an intervention effort to autism. This is a
    program that will go over the next 4 to 5 years. It involves
    five of the institutes that are here today. It is, we think, a
    great national effort that will, by coordinating efforts across
    many different sites, lead to some very new insights into this
    troubling and still very mysterious illness.
        Senator Specter. We have quite a number of questions for
    the record. We very much appreciate your coming. We appreciate
    even more the outstanding work you are doing. We are committed
    to doing our utmost to help you on the funding. When the other
    research entities come forward with their requests, it
    continues to be my view that it is a very, very solid capital
    investment for the United States and we will continue to push
    on all lines.
        Anything further, Senator?

                         SPINAL MUSCULAR ATROPHY (SMA)

        Senator Harkin. Yes, just one thing, Mr. Chairman.
        Dr. Landis, on the SMA issue and what you are sending up to
    us, I tried to listen to your answer, but would you also look
    ahead as to how soon we might be going to clinical trials, and
    what the--I hate to use the word ``Roadmap'' but what that time
    line might be?
        Dr. Landis. We would be pleased to do that. The projection
    is 4 years for this new initiative to come to fruition with
    optimally selected compounds, but I will certainly give you a
    detailed answer.
        Senator Harkin. I will take a look at that.

                          TRANS-NIH OBESITY TASK FORCE

        Back on the issue of obesity, I met with Dr. Gerberding
    last week at CDC. They have said that now it may be surpassing
    tobacco usage as the biggest health menace that we face as
    Americans. Again, I am wondering how, Dr. Zerhouni, you are
    approaching this in terms of NIH's role in looking at obesity.
        Again, it always seems to me that it is easier for people
    who have never been obese to not be obese than it is for
    someone who becomes obese to lose weight and hold it down. That
    is just the facts.
        So how do we prevent it in the first place? It seems to me
    that one of the links in child health, Dr. Alexander, as kids
    develop and as they learn and grow--it seems to me some
    research ought to be done on that, what hkids eat and how they
    develop. And there may be some genetic problems too. I do not
    know. Dr. Collins could be involved in that.
        I guess what I am getting at is this seems to lend itself
    to some kind of an inter-institute kind of task force to look
    at how we get to the prevention end of it, not just to the
    cure, but what are some of the forces that might go into
    preventing this in the first place.
        Dr. Zerhouni. You are absolutely correct, Senator. As I
    indicated to you in the past through this graph, NIH started
    investing in obesity 10 years ago. But more importantly is the
    relevancy of the question you are asking. Last year I asked
    that we form a trans-NIH Obesity Task Force that is led by Dr.
    Spiegel. This year we are going to increase funding in obesity
    research by 10 percent. Here on the screen I can actually show
    you what that 10 percent is going to be related to [see figure
    3]: $3.5 million will be the prevention and treatment of
    childhood obesity in primary care settings; $3.5 million will
    be site-specific approaches to prevent and treat pediatric
    obesity.

        In a nutshell, we are going to focus on the aspects of
    prevention and understanding the evidence that we need to, in
    fact, stop the leading edge of the epidemic which is, we agree,
    in childhood. The earlier we intervene, the more likely we are
    to dampen the epidemic as we see it. So we are focusing those
    efforts exactly on that. We are widening our portfolio. We have
    quadrupled our investment on obesity research because we knew
    already a while back that it would become a public health
    problem.
        In addition to that, the other part of the new plan, which
    is on the web site, is receiving public comment, which is
    related to exactly what you are asking, this trans-NIH view,
    the other end of the spectrum is most of the diseases that are
    developed because of obesity are what we call comorbidities,
    diabetes, hypertension. Those are the ones that really hit the
    patients hard. Those do not occur to the same degree at every
    level of overweight. They occur disproportionately in the very
    morbid, high obesity patient with a BMI index of 33, 34, 35. So
    the other component of our strategy is to look at the front
    end, children, and look at those who are very likely to develop
    the co-morbidities and understand how you stop obesity from
    giving diabetes to patients and what is the relationship there,
    what is the relationship with hypertension, and so on.
        Dr. Spiegel, who is leading the trans-NIH task force, will
    be happy to provide you more detailed information. But we agree
    with you. It is a multi-prong strategy that we need to
    implement across all Federal Departments and NIH needs to
    attack now the leading edge and the trailing edge of what we
    know are the most important points of action that we should
    take.
        Senator Harkin. Well, I appreciate it. From my own
    standpoint, it is the leading edge is where you ought to focus.
    I hope what I am not hearing, Mr. Chairman, is that somehow or
    other we are going to do research into finding out how you can
    be obese, but we can have some kind of blockers to keep you
    from getting diabetes. I think more research ought to be into
    the front end to keep you from getting obese in the first
    place. That is my unscientific statement on that.
        Thank you.
        Dr. Zerhouni. Thank you, Senator.
        Senator Specter. Thank you, Senator Harkin. Thank you all
    very much.

                          PREPARED STATEMENT RECEIVED

        We have received the prepared statement of Senator Mary L.
    Landrieu which will be placed in the record.
        [The statement follows:]

                 Prepared Statement of Senator Mary L. Landrieu

        Thank you, Mr. Chairman. Thank you, Dr. Zerhouni, for joining us
    today to discuss the National Institutes of Health (NIH) and its 2005
    budget, as proposed by the President. The National Institutes of Health
    are an integral component to our nation's health and safety. Within the
    twenty-seven Institutes and Centers at the National Institutes of
    Health, research is being conducted and studies are beginning to show,
    new and exciting ways to prevent, detect, diagnose, and treat the
    diseases and disabilities which plague our country and the world.
    Fostering communication and collaboration, the National Institutes of
    Health provide grant and research opportunities to universities,
    medical schools, hospitals, and other research institutes in addition
    to conducting their own federal research. Through these collaborations,
    the National Institutes of Health position themselves as the world's
    foremost medical research center and the focal point for domestic
    medical research.
        The President's fiscal year 2005 budget request provides $28.8
    billion for the National Institutes of Health. This number represents
    an increase of $764 million, or 2.7 percent, over fiscal year 2004
    levels. As a member of the Senate Appropriations Subcommittee on Labor,
    Health, Human Services and Education, I was proud to lend my support to
    doubling the National Institutes of Health budget in just five years.
    By steadfastly keeping the National Institutes of Health funding on
    track, my colleagues and I enabled the National Institutes of Health to
    support far more promising research than it was ever able to before,
    and to advance into new areas of science. While I am very proud of this
    aggressive increase and commitment to funding, we must not fall back on
    our commitment to medical research.
        Research at the National Institutes of Health has a real and direct
    impact on my state of Louisiana. The Centers for Disease Control and
    Prevention (CDC) reports that 9,306 people have been affected by the
    West Nile Virus in the United States this year. 240 of those infected
    have died. Of those cases, the state of Louisiana has reported 123
    cases and 8 deaths this year. Mosquito-borne diseases, such as the West
    Nile Virus, represent one of the most serious and preventable public
    health threats for many states. With the recent outbreak of the West
    Nile Virus in the United States, the National Institute of Allergy and
    Infectious Diseases at the National Institutes of Health have
    accelerated their research efforts into the West Nile Virus, possible
    vaccines, and treatment options. We have not yet developed a vaccine to
    combat the West Nile Virus but with the proper funding, researchers at
    NIH are committed to finding one.
        In addition to West Nile, Louisianians also find themselves
    battling another deadly epidemic, obesity. Currently in the United
    States there are 127 million adults that are overweight, 60 million of
    whom are obese, and 9 million who are severely obese. For children ages
    6-11, 30.3 percent are overweight and 15.3 percent are obese. These
    numbers have more than doubled in the last thirty years. This epidemic
    threatens the health of our Nation and increases the incidence of type
    2 diabetes, fatty liver disease, kidney failure, as well as many other
    diseases. I am pleased to learn that the fiscal year 2005 budget for
    the National Institutes of Health supports an expansion of $40 million
    to its obesity research portfolio but this is not nearly enough to
    reverse a trend of this magnitude. I hope that we can do more in the
    near future to end this epidemic. It is imperative that we work to
    understand the neurobiological, genetic, behavioral, and environmental
    basis of obesity and develop strategies to maintain healthy weight in
    adults and children.
        In conclusion, I would like to speak briefly about the flu epidemic
    that has recently taken a toll on our country and the global community.
    The CDC estimates that 10-20 percent of Americans come down with the
    flu each year. Of these numbers, more than 100,000 people are
    hospitalized and approximately 36,000 Americans die from the flu and
    its complications each year. While we have not experienced a flu
    pandemic since 1968, each fall and winter brings with it a new strain
    of the flu. Research institutions and health departments around the
    world are cooperating to track flu outbreaks and to determine the many
    different types, strains, and causes. The National Institute of Allergy
    and Infectious Diseases (NIAID) at NIH currently supports research into
    how the flu virus works and into developing better vaccines to prevent
    and treat the infection. By supporting this research at NIH we can hope
    to better track the development of flu strains and arm ourselves with
    the proper vaccines and treatments that will prevent deadly outbreaks.
        While these are but a few examples of the impact of NIH research on
    the state of Louisiana, I think they make it clear that the research
    being funded through the National Institutes of Health has a real and
    immediate impact on the citizens of our country. By wisely investing in
    medical research that advances the prevention and treatment of
    diseases, we in fact are saving money that would otherwise have to be
    used to diagnose and treat these diseases. I know that my colleagues
    agree that funding a cure is perhaps the best use of government
    resources there is. It is my hope that we will continue to increase the
    National Institutes of Health budget so that our children and
    grandchildren can truly benefit from the cures and medical advances
    made every day at NIH.

                         ADDITIONAL COMMITTEE QUESTIONS

        Senator Specter. 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 Herb Kohl

                                    OBESITY

        Question. Dr. Crawford, both USDA and FDA have recently announced
    new efforts to combat the increasing problem of obesity. FDA announced
    the ``Calories Count'' program, and USDA has money in several programs,
    including WIC, to help battle this problem. However, for all of the
    government's efforts, all of the money being put into this effort pales
    in comparison to the food industry's billions of dollars worth of
    advertising. How can the government successfully get its message out
    when, at first glance, its efforts appear to be dwarfed by the food
    industry? How do your agencies compete with that?
        Answer. In support of the President's Healthier U.S. initiative,
    the DHHS established a complementary initiative, Steps to a Healthier
    U.S., which emphasizes personal responsibility for the choices
    Americans make for healthy behaviors. One aspect of this initiative
    focuses on reducing the major health burden created by obesity and
    other chronic diseases. Following DHHS' July 2003 Roundtable on Obesity
    and Nutrition, on August 11, 2003, FDA established an Obesity Working
    Group, or OWG, to prepare a report that outlines an action plan to
    cover critical dimensions of the obesity problem from FDA's perspective
    and authorities. This report was released on March 12, 2004.
        There is no simple answer to the problem of obesity. Achieving
    success in reducing and avoiding obesity will occur only as a result of
    efforts over time by individuals as well as various sectors of our
    society. It should be noted, however, that most associations, agencies,
    and organizations believe that diet and physical activity should be
    addressed together in the fight against overweight and obesity.
        The OWG report provides a range of short and long-term
    recommendations to address the obesity epidemic with a focus on a
    ``calories count'' emphasis for FDA actions. These recommendations are
    based on sound science and address multiple facets of the obesity
    problem under FDA's purview, including developing appropriate and
    effective consumer messages to aid consumers in making wiser dietary
    choices; establishing educational strategies and partnerships to
    support appropriate messages and teach people, particularly children,
    how to lead healthier lives through better nutrition; developing
    initiatives to improve the labeling of packaged foods with respect to
    caloric and other nutrition information; encouraging and enlisting
    restaurants in efforts to combat obesity and provide nutrition
    information to consumers, including information on calories, at the
    point-of-sale; developing new therapeutics for the treatment of
    obesity; designing and conducting effective research in the fight
    against obesity; and continuing to involve stakeholders in the process.
        Regarding food labeling, the OWG report contains several
    recommendations based on sound science. I will provide these
    recommendations for the record.
        [The information follows:]
        Publish an advance notice of proposed rulemaking, or ANPRM, to seek
    comment on the following:
      --How to give more prominence to calories on the food label, for
            example, increasing the font size for calories, including a
            column in the Nutrition Facts panel of food labels for percent
            Daily Value for total calories, and eliminating the listing for
            calories from fat;
      --Whether to authorize health claims on certain foods that meet FDA's
            definition of ``reduced'' or ``low'' calorie. An example of a
            health claim for a ``reduced'' or ``low'' calorie food might
            be: ``Diets low in calories may reduce the risk of obesity,
            which is associated with type 2 diabetes, heart disease, and
            certain cancers.''
      --Whether to require additional columns on the Nutrition Facts panel
            to list quantitative amounts and percent Daily Value of an
            entire package on those products and package sizes that can
            reasonably be consumed at one eating occasion--or declare
            quantitative amounts and percent Daily Value of the whole
            package as a single serving if it can reasonably be consumed at
            a single eating occasion; and,
      --Which, if any, reference amounts customarily consumed of food
            categories appear to have changed the most over the past decade
            and hence require updating.
        In addition, FDA will file and respond in a timely way to petitions
    the agency has received that ask FDA to define terms such as ``low,''
    ``reduced,'' and ``free'' carbohydrate; and provide guidance for the
    use of the term ``net'' in relation to carbohydrate content of food--
    these petitions were filed on March 11, 2004.
        FDA will also encourage manufacturers to use dietary guidance
    statements, an example of which would be, ``To manage your weight,
    balance the calories you eat with your physical activity.'' In
    addition, the Agency will encourage manufacturers to take advantage of
    the flexibility in current regulations on serving sizes to label as a
    single-serving those food packages where the entire contents of the
    package can reasonably be consumed at a single eating occasion and
    encourage manufacturers to use appropriate comparative labeling
    statements that make it easier for consumers to make healthy
    substitutions.
        FDA believes that if the report's recommendations are implemented
    they will make a worthy contribution to confronting the nation's
    obesity epidemic and helping consumers' lead healthier lives through
    better nutrition.
        FDA also believes that the regulatory scheme for claims in food
    labeling, whether health claims, nutrient content claims, or other
    types of claims, are science based, and we continue to consider
    modifications to our regulations to keep up with recent scientific
    developments. A benefit of standardized, science-based terminology, as
    with other terms that FDA has defined that consumers may use to make
    health-based dietary choices--e.g., terminology concerning fat
    content--is that it allows consumers to compare across products and it
    encourages manufacturers to compete based on the nutritional value of
    the food. However, FDA does not regulate television and other media
    marketing of food products. Some of the modifications FDA is currently
    considering are described above in the list of topics to be covered by
    the ANPRM the agency intends to issue.
        With respect to conveying the report's messages to the public, FDA
    believes that all parties, including the packaged food industry,
    restaurants, academia, and other private and public sector
    organizations in addition to government agencies at all levels, have an
    essential role to play. On April 22, 2004, FDA's Science Board focused
    on specific recommendations from the OWG report. These recommendations
    call on FDA to work through a third-party facilitator to engage all
    involved stakeholders in a dialogue on how best to construct and convey
    obesity messages in the restaurant setting and in the area of pediatric
    obesity education.
        This approach is one example of how the Agency intends, by means of
    public and private partnerships, to leverage its ability to convey
    appropriate messages on obesity to the public with the goal of changing
    behavior and ultimately reversing obesity trends in the United States.

                               IMPORT INSPECTIONS

        Question. Dr. Crawford, the FDA budget this year includes a $7
    million increase to fund 97,000 food import examinations. This is a big
    increase in inspections over any previous year--still, however, less
    than one percent of all of the food imported into this country will be
    inspected. How would you respond to charges that you still aren't
    inspecting nearly enough imported food, especially in light of events
    during the past year where bad food has gotten in and people have died?
    How do we ensure consumers that their food is indeed safe?
        Answer. FDA is appreciative of the additional funding we have
    received for the inspection of domestic firms and for inspections of
    imported foods. FDA believes it is more effective to focus our
    resources in a risk-based manner than to focus simply on increasing the
    percentage of imported food shipments that are physically inspected. It
    is important to note that every shipment of FDA-regulated food which is
    entered through Customs and Border Protection as a consumption entry is
    electronically reviewed by FDA's Operational and Administrative System
    for Import Support to determine if it meets identified criteria for
    further evaluation by FDA reviewers and physical examination and/or
    sampling and analysis or refusal. This electronic screening allows FDA
    to concentrate its limited inspection resources on high-risk shipments
    while allowing low-risk shipments to proceed into commerce.
        Due to constantly changing environments of operation, e.g.,
    counterterrorism and BSE, our domestic inspection and import strategy
    cannot be defined in terms of a percentage of coverage through
    inspections, physical examinations and sample analyses. It needs to be
    a flexible blend of the use of people, technology, information and
    partnerships to help protect Americans from unsafe imported products.
    Accordingly, the Agency is developing and using strategies for
    mitigating risks prior to importation through partnerships and
    initiatives based on best practices and other science based factors
    relevant to the import life cycle, i.e., from foreign manufacturer to
    the U.S. consumer. Recently this principle has been applied in the
    ``Canadian Facility Voluntary Best Management Practices for Expediting
    Shipments of Canadian Grains, Oilseeds and Products to the United
    States'' implemented February 24, 2004, and designed to mitigate the
    potential of mammalian protein prohibited from being fed to cattle or
    other ruminants under BSE-prevention regulations promulgated by CFIA
    and FDA.
        Another piece of the long term solution to a higher level of
    confidence in the security and safety of food products lies in
    information technology that will merge information on products and
    producers with intelligence on anticipated risks to target products for
    physical and laboratory examination or refusal. This strategy would
    rely on data integrity activities that reduce the opportunity for
    products to be incorrectly identified at ports. It would also rely on
    cooperation from producers so that FDA can identify sources that are
    unlikely to need physical testing. However, even with such targeting,
    improvements are limited by the available methodologies for assessing
    threat agents and our ability to predict which tests ought to be used.
        We are ramping up our food inspections, but we recognize that we
    also need to inspect smarter, not just inspect more. That is why FDA is
    making significant investments in technology and information resources
    such as the development of the Mission Accomplishment and Regulatory
    Compliance Services System, MARCS. MARCS is a comprehensive redesign
    and reengineering of two core mission critical systems at FDA: FACTS
    and the Operational and Administrative System for Import Support,
    OASIS. OASIS supports the review and decision making process of
    products for which entry is sought into the United States. We are using
    funds to work to further improve targeting and using force multipliers
    such as IT.
        FDA also has a proof of concept project, called ``Predict,'' with
    New Mexico State University under a Department of Defencse contract
    which is being designed to enhance agency capability to rapidly assess
    and identify import entries based on risk using relevant information
    from various sources including regulated industry, trade, other
    federal, State, and local entities, and foreign industry and
    governments. This project, if successful, will greatly enhance FDA's
    capability to be smarter in directing field activities on products of
    greater risk to public health and safety. The proof of concept project
    is projected to be completed in the Fall of 2004. The relentless growth
    in the volume of domestic as well as imported food products, which are
    increasingly in ``ready for consumer sale packaging.'' Food imports are
    now growing at 19 percent per year. FDA needs to use all the potential
    tools available to improve its efficiency in food security and safety
    coverage.
        In addition, FDA has several strategic initiatives to enhance
    safety. One of these is ``Agency Initiatives to Improve Coverage,''
    which includes the creation of the Southwest Import District to better
    coordinate import activities on the southern border. Another is
    reciprocal FDA and U.S. Customs and Border Protection training to
    improve product integrity of goods offered for import and increase
    enforcement actions by Customs to deter willful violations of U.S. laws
    and regulations. While foreign inspections and border operations
    provide some assurance that imported foods are safe, the agency
    continues to work to foster international agreements and harmonize
    regulatory systems. For instance, we actively participate in the
    Canada/U.S./Mexico Compliance Information Group, which shares
    information on regulatory systems and the regulatory compliance status
    of international firms to protect and promote human health.
        It is very important that American consumers trust the safety of
    the food supply. FDA has made fundamental changes in how we implement
    our mission of protecting the food supply, so that all Americans can
    have confidence that their food has been handled under secure
    conditions that provide assurance of its safety.

                               FDA FOIA POLICIES

        Question. Dr. Crawford, my office has been working with a non-
    profit patient advocacy group, the TMJ Association, in their efforts to
    have two FOIA requests that are well over a year old responded to.
    Their original FOIA request was made on November 1, 2002 (request
    number 02017071), more than 17 months ago, and the subsequent request
    was made on March 25, 2003 (request number 03004361). They have not yet
    received the information requested, and have been unable to get a date
    commitment by FDA as to when the information will be provided. It is my
    understanding that they have been informed that FOIA requests are
    severely backlogged, and the FDA has no idea when they will be able to
    process their request. What is the current backlog for FOIA requests?
        Answer. As of April 28, 2004, FDA has 19,369 pending FOIA
    requests--17,555 have been pending more than 20 days and 1,814 have
    been pending 20 days or less. The Denver District Office is responsible
    for responding to the two requests from the TMJ Association. As of
    April 28, 2004, Denver District Office has 369 pending FOIA requests--
    357 requests have been pending more than 20 days, and 12 requests have
    been pending 20 days or less.
        Question. How many FDA staff are responsible for handling these
    requests? Is this their sole responsibility, or do they have other
    responsibilities as well?
        Answer. For fiscal year 2003 the total number of personnel
    responsible for processing FOIA requests was 91 FTE, 75 full time
    employees, and 16 FTE work years representing personnel with part-time
    FOIA duties in addition to other responsibilities.
        Question. Does FDA need additional staff or resources in order to
    process these requests on a timely basis?
        Answer. In some agency components FOIA is a collateral duty. For
    example, in most FDA field offices, Compliance Officers whose primary
    responsibilities are related to the Agency's regulatory enforcement
    activities also perform FOIA duties as permitted by time and regulatory
    workload. Additional staff devoted to FOIA could shorten the amount of
    time for processing requests.
        Question. What do you believe is a reasonable length of time for a
    group to wait for an information request to be processed and responded
    to?
        Answer. Requests are processed by the agency component that
    maintains the requested records. There are a number of factors that
    must be considered in order to predict a reasonable amount of time for
    a request to be processed. Those factors include the volume of requests
    received by the component, the complexity of requests received, the
    amount of time required to search for records, the amount of time
    require to review the records to determine whether information is
    releasable under FOIA, and the resources available to process requests.
        Question. What is the average length of time it takes to process a
    FOIA request? Can you please explain the severe delay in processing
    this specific one, which has taken over two years and apparently has no
    end in sight? Can you please provide me a timeframe within which the
    FDA will respond to these two particular FOIA requests?
        Answer. Under the Electronic Freedom of Act Amendments of 1996,
    agencies are permitted to establish multiple tracks for processing FOIA
    requests based on the complexity of the requests and the amount of work
    and time required to process requests. Some FDA components have
    established multiple processing tracks. Requests are processed on a
    first in, first out basis within each track. The median number of days
    to process requests in the simple processing track is 19 days. The
    median number of days to process requests in the complex processing
    track, for more complicated requests, is 363 days. For requests that
    are not processed in multiple processing tracks, the median number of
    days to process is 44 days.
        Due to a heavy load of regulatory cases in the Denver District
    Office that must be handled by the Compliance Officers in addition to
    staff shortages, FOIA work in the Denver District is being performed by
    one individual on a part-time basis. This has resulted in a significant
    backlog of FOIA requests. The Denver District Office expects to fill
    request 02-17071 from the TMJ Association in six months, and request
    03-4361 in one month.
        Question. What additional efforts can this group undertake in order
    to speed up their request?
        Answer. The Denver District Office expects to fill request 02-17071
    from the TMJ Association in six months, and request 03-4361 in one
    month.
        In addition, the Denver District is reviewing and evaluating its
    FOIA workload and will develop a strategy aimed at reducing the backlog
    of FOIA requests.
        Question. What is the FDA's policy on charging for FOIA requests
    made by non-profit patient advocacy groups?
        Answer. The FOIA sets forth criteria that agencies must follow with
    respect to charging for processing FOIA requests. Non-profit
    organizations are considered Category III requesters. Such requesters
    receive 100 pages of duplication and two hours of search at no charge.
    If the number of pages exceed 100 and/or if the amount of search time
    exceeds two hours, Category III requesters are charged based on the
    FOIA fee schedule of the Department of Health and Human Services. The
    fee for duplication is $.10 per page, and the fee for search is based
    on the grade level of the individual who processes the request. I will
    be happy to provide the current grade rates for the record.
        [The information follows:]

                              CURRENT GRADE RATES

        GS-1 through 8--$18.00 per hour
        GS-9 through 14--$36.00 per hour
        GS-15 and above--$64.00 per hour
        In addition, requesters may make a request for waiver or reduction
    of fees if their request meets the following criteria: disclosure of
    the information is in the public interest because it is likely to
    contribute significantly to public understanding of the operations or
    activities of the Government; and, disclosure is not primarily in the
    commercial interest of the requester.

                              IMPLICIT PRE-EMPTION

        Question. Adverse reactions to prescription drugs and other
    medicines take the lives of more than 100,000 Americans each year, and
    millions more are seriously injured. For many years, state tort laws
    have enabled some victims to receive compensation for their injuries.
    It has been brought to my attention that the Food and Drug
    Administration (FDA) has stepped in to protect drug companies from
    liability in some of these lawsuits, potentially robbing individuals of
    their only means of compensation. FDA's actions are even more troubling
    when you consider that these lawsuits have other important purposes,
    such as deterring future bad behavior and providing the American public
    with access to important health and safety information. How many times
    has the FDA interfered in lawsuits, arguing that implicit pre-emption
    prohibits a plaintiff from receiving compensation for their injuries?
    In how many of these cases has a court held that the plaintiff's tort
    claim was implicitly pre-empted by federal law?
        Answer. In the past several years, the Department of Justice (DOJ)
    has represented the United States in four cases involving state-law
    challenges to the adequacy of FDA-approved risk information
    disseminated for FDA-approved new drugs.\1\ In each case, DOJ contended
    that the state-law claim was preempted by federal law. In addition, in
    some cases, DOJ argued that the state-law claim was not properly before
    the court by operation of the doctrine of primary jurisdiction.\2\
    ---------------------------------------------------------------------------
        \1\ FDA also periodically becomes involved, through the Department
    of Justice, in cases involving preemption of state-law requirements
    under the medical device provisions of the FDCA, which include an
    express preemption provision, 21 U.S.C. 360k(a).
        \2\ Primary jurisdiction allows a court to refer a matter to an
    administrative agency for an initial determination where the matter
    involves technical questions of fact and policy within the agency's
    jurisdiction. See, e.g., Israel v. Baxter Labs., Inc., 466 F.2d 272,
    283 (D.C. Cir. 1972); see also 21 CFR 10.60.
    ---------------------------------------------------------------------------
        The legal basis for preemption in these cases is FDA's careful
    control over drug safety, effectiveness, and labeling according to the
    agency's comprehensive authority under the FDCA and FDA implementing
    regulations. If state authorities, including judges and juries applying
    state law, were permitted to reach conclusions about the safety and
    effectiveness information disseminated with respect to drugs for which
    FDA has already made a series of regulatory determinations based on its
    considerable institutional expertise and statutory mandate, the federal
    system for regulation of drugs would be disrupted. I will be happy to
    include information on the four cases for the record.
        [The information follows:]

    Bernhardt
        In 2000, two individual plaintiffs filed product liability actions
    in a New York court against Pfizer, Inc., seeking a court order
    requiring the company to send emergency notices to users of the
    prescription antihypertensive drug CARDURA (doxazosin mesylate) and
    their physicians. The notices would have described the results of a
    study by a component of the National Institutes of Health (NIH) that,
    the plaintiffs alleged, demonstrated that Cardura was less effective in
    preventing heart failure than a widely used diuretic. FDA had not
    invoked its authority to send ``Dear Doctor'' letters or otherwise
    disseminate information regarding a drug that the agency has determined
    creates an ``imminent danger to health or gross deception of the
    consumer.'' (21 U.S.C. 375(b).) The plaintiffs, nevertheless, filed a
    lawsuit under state common law seeking relief that, if awarded, would
    have pressured the sponsor to disseminate risk information that FDA
    itself had not disseminated pursuant to its statutory authority.
        FDA's views were submitted to the federal district court in the
    form of a Statement of Interest.\3\ The Statement relied on the
    doctrine of primary jurisdiction. The Statement also took the position
    that the plaintiffs' request for a court order requiring the
    dissemination of information about NIH study results to users and
    prescribers of CARDURA was impliedly preempted. According to the
    Statement, the court order ``would frustrate the FDA's ability
    effectively to regulate prescription drugs by having the Court
    substitute its judgment for the FDA's scientific expertise.'' The
    Statement also noted that, if the court granted the requested order, a
    direct conflict would be created between the information required to be
    disseminated by the court and the information required to be
    disseminated by FDA under the FDCA (in the form of the FDA-approved
    labeling).
    ---------------------------------------------------------------------------
        \3\ Statement of Interest of the United States; Preliminary
    Statement, Bernhardt v. Pfizer, Inc., Case No. 00 Civ. 4042 (LMM)
    (S.D.N.Y. filed Nov. 13, 2000).
    ---------------------------------------------------------------------------
        The Statement contended that state law could not provide a basis
    for requiring a drug manufacturer to issue drug information that FDA
    had authority to, but did not, require. Importantly, the submission did
    not argue that the state-law claim was preempted because FDA had
    reached a determination that directly conflicted with the plaintiff's
    view. Nor did it assert that FDA had specifically determined that the
    information on the NIH study requested by the plaintiffs was
    unsubstantiated, false, or misleading. In this sense, the Statement of
    Interest in Bernhardt was the most aggressive, from a legal
    perspective, than the three subsequent DOJ submissions on FDA's behalf
    in preemption cases made during the present Administration.
        The United States District Court for the Southern District of New
    York accepted the primary jurisdiction argument made on FDA's behalf.
    (Bernhardt v. Pfizer, Inc., 2000 U.S. Dist. LEXIS 16963, *9 (whether
    the additional warnings sought by the plaintiffs were appropriate ``is
    a decision that has been squarely placed within the FDA's informed
    expert discretion'')). It did not address the preemption issue. The
    case was voluntarily dismissed on April 22, 2003.

    Dowhal
        In 1998, an individual plaintiff in California asked that State's
    attorney general to initiate an enforcement action against SmithKline
    Beecham and other firms marketing OTC nicotine replacement therapy
    products in California. (These products are marketed pursuant to an
    approved new drug application.) The plaintiff contended that the FDA-
    approved warnings for the defendants' products did not meet the
    requirements of a state statute called the Safe Drinking Water and
    Toxic Enforcement Act (Cal. Health & Safety Code  25249.5 et seq.),
    also known as Proposition 65. From 1996 through 2001, FDA had
    repeatedly advised the defendants that they could be liable under the
    FDCA for selling misbranded products if they deviated from the FDA-
    approved warning labeling for their products. FDA also advised the
    state attorney general in writing in 1998 that the defendants' warning
    in the labeling clearly and accurately identified the risks associated
    with the products and, therefore, met FDA requirements under the FDCA.
    After receiving the letter, the attorney general declined to initiate
    enforcement action.
        Nevertheless, in 1999, the individual plaintiff initiated a lawsuit
    of his own in California state court under Proposition 65's ``bounty-
    hunter'' provision, which empowers individuals to file enforcement
    actions under that statute on behalf of the people of the State of
    California. The lawsuit asked the court to award civil money penalties
    and restitution, and to issue an injunction requiring the defendants to
    disseminate warnings for their products that differed from the warnings
    required by FDA. In 2000, the plaintiff filed a citizen petition with
    FDA requesting that the agency require the defendants to change their
    warnings to reflect the language sought by the plaintiff in the
    lawsuit. FDA rejected the proposed language, determining that it lacked
    sufficient support in scientific evidence and presented a risk of
    mischaracterizing the risk-benefit profile of the products in a way
    that threatened the public health. Although the trial court found for
    the defendant, the California Court of Appeal rejected the defendant's
    contention that the plaintiff's claim was preempted under the FDCA, and
    allowed the lawsuit to proceed. (Dowhal v. SmithKline Beecham Consumer
    Healthcare, 2002 Cal. App. LEXIS 4384 (Cal. Ct. App. 2002), argued,
    Case No. S-109306 (Cal. Feb. 9, 2004).)
        FDA's views were presented to the Court of Appeal of California in
    an amicus curiae (``friend of the court'') brief and to the Supreme
    Court of California in a letter brief and an amicus brief.\4\ All three
    documents explained that the warning language sought by the plaintiffs
    had been specifically considered and rejected by FDA as scientifically
    unsubstantiated and misleading. Including the language would,
    therefore, misbrand those products and cause the defendants to violate
    the FDCA. The documents explained, further, that principles of conflict
    preemption applied to the plaintiffs' claim because it was impossible
    for defendants to comply with both federal and state law and because
    the state law posed an obstacle to the accomplishment of the full
    purposes and objectives of the FDCA.
    ---------------------------------------------------------------------------
        \4\ Letter from Robert D. McCallum, Jr., Ass't Attorney General, et
    al., to Frederick K. Ohlrich, Supreme Court Clerk/Administrator, Dowhal
    v. SmithKline Beecham Consumer Healthcare LP, et al., Case No. S-109306
    (Cal. filed Sept. 12, 2002); Amicus Curiae Brief of the United States
    of America in Support of Defendants/Respondents SmithKline Beecham
    Consumer Healthcare LP, et al., Dowhal v. SmithKline Beecham, Case No.
    A094460 (Cal. Ct. App. filed Mar. 22, 2002); Amicus Curiae Brief of the
    United States of America in Support of Defendants/Appellants SmithKline
    Beecham Consumer Healthcare LP, et al., Dowhal v. SmithKline Beecham,
    Case No. S109306 (Cal. filed July 31, 2003).
    ---------------------------------------------------------------------------
        The California Court of Appeal rejected the preemption argument.
    (Dowhal v. SmithKline Beecham Consumer Healthcare, 2002 Cal. App. LEXIS
    4384, ***16-17 (Cal. Ct. App. 2002) (reversing trial court decision
    granting summary judgment for defendants on preemption grounds)). On
    April 15, 2004, the California Supreme Court reversed the appeals court
    decision, finding a direct conflict between FDA requirements and the
    state-law warning requirement advocated by the plaintiff. (Dowhal v.
    SmithKline Beecham Consumer Healthcare, 2004 Cal. LEXIS 3040.)

    Motus
        Also in 2000, an individual plaintiff sued Pfizer in a California
    court alleging, among other things, that the company had failed to
    fulfill its state common law duty to warn against the risk of suicide
    the plaintiff alleged was presented by ZOLOFT (sertraline HCl), an FDA-
    approved drug in the selective serotonin reuptake inhibitor (SSRI)
    class indicated to treat depression (among other things). On numerous
    occasions, FDA had specifically considered and rejected such language
    for SSRIs as scientifically unsupportable and inconsistent with FDA
    determinations as to the safety and effectiveness of the products.
        The United States District Court for the Central District of
    California (to which the case had been removed on the ground of
    diversity) rejected the defendant's preemption argument, allowing the
    lawsuit to proceed. (Motus v. Pfizer Inc., 127 F. Supp. 2d 1085 (C.D.
    Cal. 2000).) The court later granted the defendant's motion for summary
    judgment on non-preemption grounds (196 F. Supp. 2d 984, 986 (C.D. Cal.
    2001)), and the plaintiff appealed. DOJ submitted an amicus curiae
    brief to the United States Court of Appeals for the Ninth Circuit on
    FDA's behalf.\5\ The brief's arguments were essentially the same as the
    arguments advanced in Bernhardt. In contrast to the situation in
    Bernhardt, however, in Motus, FDA had specifically considered, and
    rejected, the language requested by the plaintiff under state law. The
    appeals court affirmed the trial court's decision earlier this year
    (2004 U.S. App. LEXIS 1944 (9th Cir. February 9, 2004)).
    ---------------------------------------------------------------------------
        \5\ Amicus Brief for the United States in Support of the Defendant-
    Appellee and Cross-Appellant, and in Favor of Reversal of the District
    Court's Order Denying Partial Summary Judgment to Defendant-Appellee
    and Cross-Appellant, Motus v. Pfizer, Case Nos. 02-55372 & 02-55498
    (9th Cir. filed Sept. 3, 2002).
    ---------------------------------------------------------------------------
    In re PAXIL
        In 2001, individuals filed suit in a California court on behalf of
    past or current users of PAXIL (paroxetine HCl) against the drug's
    manufacturer, GlaxoSmithKline (GSK), alleging that the company's
    direct-to-consumer (DTC) broadcast advertisements for the drug failed
    adequately to warn about the consequences of discontinuing the drug. In
    reviewing the new drug application for the drug, FDA had found no
    evidence that it was habit-forming and did not require GSK to address
    that risk in FDA-approved labeling. FDA did, however, require GSK to
    include in labeling statements regarding discontinuation syndrome, and
    the labeling consequently recommends that doctors gradually reduce
    dosages and monitor patients for syndrome symptoms. FDA reviewed
    proposed DTC advertisements GSK had submitted for Paxil that said that
    the drug was not habit-forming. The agency at no time determined that
    this statement was misleading. In August 2002, notwithstanding FDA's
    determination, the court issued a preliminary injunction prohibiting
    GSK from running DTC advertisements stating that Paxil is not habit-
    forming. (In re Paxil Litigation, 2002 U.S. Dist. LEXIS 16221 (C.D.
    Cal. Aug. 16, 2002))
        On reconsideration, the court declared that the preliminary
    injunction challenged only ``FDA's . . . determination that the public
    is not likely to equate the words not habit forming' as used in
    direct[-]to[-]consumer advertisements with no withdrawal symptoms.'''
    According to the court, ``The question of how members of the general
    public are likely to interpret (or misinterpret) a statement is within
    one of the courts' core competencies.'' Declaring itself ``unwilling to
    blindly accept FDA's ultimate determination here,'' the court rejected
    the defendants' preemption and primary jurisdiction arguments. It
    nevertheless denied the injunction on the ground that the plaintiff was
    not likely to succeed in demonstrating that ``non-habit forming''
    statement in the advertisement is misleading. Thus, although the court
    ultimately declined to award the injunctive relief sought by the
    plaintiff, it continued to distinguish between FDA's determinations as
    to the adequacy of drug warnings under federal law, and its own view of
    warnings adequacy under state common law. (In re Paxil Litigation, 2002
    U.S. Dist. LEXIS 24621 (C.D. Cal. Oct. 16, 2002).)
        DOJ submitted to the court a Statement of Interest and a brief
    asserting preemption.\6\ The Statement of Interest contended that a
    court order requiring GSK to remove the ``non-habit-forming'' claim
    from its advertisements for Paxil would be inconsistent with FDA's
    determination that the company's advertisements were proper and that
    Paxil is not, in fact, ``habit-forming.'' The brief contended that the
    court should find the plaintiff's state-law request for a court order
    preempted because it poses an obstacle to achievement of the full
    objectives of Congress ``by attempting to substitute th[e] Court's
    judgment for FDA's scientific expertise.'' As the brief pointed out,
    FDA had specifically reviewed the advertisements, made suggestions
    concerning the proper manner of presenting information relating to
    whether Paxil is ``habit-forming,'' and, in the exercise of its
    scientific and medical expertise, found the advertisements acceptable.
    The brief also included a primary jurisdiction argument. The court
    reversed its earlier award of an injunction prohibiting the
    manufacturer from running advertisements that had been reviewed and
    approved by FDA, but the reversal was based on a ground other than
    preemption. (In re Paxil Litigation, 2002 U.S. Dist. LEXIS 24621 (C.D.
    Cal. 2002).) \7\
    ---------------------------------------------------------------------------
        \6\ Statement of Interest of the United States of America, In re
    PAXIL Litigation, Case No. CV 01-07937 MRP (CWx) (C.D. Cal. filed
    August 20, 2002); Brief of the United States of America, In re PAXIL
    Litigation, Case No. CV 01-07937 MRP (CWx) (C.D. Cal. filed Sept. 4,
    2002).
        \7\ In December 2003 (296 F. Supp. 2d 1374), the litigation,
    consisting of twelve action in eleven federal judicial districts, was
    centralized for pretrial proceedings in the United States District
    Court for the Central District of California.
    ---------------------------------------------------------------------------
    Conclusion
        As these cases illustrate, courts entertaining lawsuits filed under
    state law do not always defer to FDA on matters that Congress has
    placed squarely within the agency's authority. In FDA regulatory areas
    characterized by comprehensive regulation and requiring a careful and
    expert evaluation of scientific data and public health issues, state
    coregulation can stand as an obstacle to or directly conflict with the
    agency's administration of its statutory mandate. Preemption is the
    constitutionally prescribed mechanism for resolving these conflicts.
        The practice of citing preemption and primary jurisdiction under
    the FDCA in litigation in which the United States is not a party is
    well-established and substantially predates the current Administration.
    DOJ and FDA participation in these cases is unusual. In the current
    Administration, DOJ has participated in private state-law actions on
    FDA's behalf only following a judicial finding that the action should
    proceed, and only to address a state-law finding that, left
    undisturbed, would undermine FDA's execution of its statutory mission
    or directly conflict with federal law. Responsibility for making final
    decisions whether to make submissions in private lawsuits, on
    preemption, primary jurisdiction, or any other issue, rests with the
    Department of Justice--not FDA itself.
        Question. These arguments conflict with long-standing FDA policy.
    The law appears to contradict what the FDA has argued. What motivated
    FDA to change its policy?
        Answer. The Government's participation in cases arising under
    state-law and presenting preemption issues is consistent with past FDA
    practice and with the pertinent law.
        The principal enabling statute of the Food and Drug Administration
    is the Federal Food, Drug, and Cosmetic Act, FDCA. Under this statute,
    FDA has broad authority to protect the public health by ensuring that
    foods are safe, wholesome, sanitary, and properly labeled, and that
    drugs and medical products are safe and effective. (See 21 U.S.C.
    393(b)(2)(A)-(C).) By operation of the Supremacy Clause of the United
    States Constitution (U.S. Const. Art. VI, clause 2), the FDCA nullifies
    conflicting requirements established by the States in legislation,
    regulations, or common law. (See Gibbons v. Ogden, 22 U.S. (9 Wheat.)
    1, 211 (1824) (Marshall, C.J.).)
        In the past, FDA has addressed conflicting state requirements in
    the context of rulemaking. In 1982, for example, FDA promulgated
    regulations requiring tamper-resistant packaging for over-the-counter
    drugs. In the preamble accompanying the regulations, FDA stated its
    intention that the regulations preempt any state or local requirements
    that were ``not identical to . . . [the rule] in all respects.'' (47 FR
    50442, 50447; Nov. 5, 1982.) Similarly, in 1986, FDA issued regulations
    requiring aspirin manufacturers to include in labeling a warning
    against use in treating chicken pox or flu symptoms in children due to
    the risk of Reye's Syndrome. In the accompanying preamble, FDA said the
    regulations preempted ``State and local packaging requirements that are
    not identical to it with respect to OTC aspirin-containing products for
    human use.'' (51 FR 8180, 8181; Mar. 7, 1986.) In 1994, FDA amended 21
    CFR 20.63 to preempt state requirements for the disclosure of adverse
    event-related information treated as confidential under FDA
    regulations. (59 FR 3944; Jan. 27, 1994.)
        In addition, for many years, conflicting state requirements have
    been addressed by FDA through case-by-case participation in selected
    lawsuits to which the United States has not been a party. Because FDA
    lacks independent litigating authority, this participation has been by
    the Department of Justice (DOJ) on FDA's behalf. The practice of
    addressing conflicting state requirements through participation in
    litigation dates back many years. For example, DOJ participated on
    FDA's behalf in favor of preemption in both Jones v. Rath Packing
    Company, 430 U.S. 519 (1977), and Grocery Manufacturers of America,
    Inc. v. Gerace, 755 F.2d 993 (2d Cir. 1985). In addition, as discussed
    in our response to the previous question on preemption, FDA has
    recently participated in several cases involving state-law requirements
    for the communication of risk information for prescription drugs. Of
    note, the first--and most aggressive, from a legal perspective--of
    these submissions occurred during the previous Administration--
    Bernhardt case included in materials for the record.

                                     NARMS

        Question. What is the total amount of funding for NARMS, and from
    what account does it come?
        Answer. The total amount of funding for NARMS in fiscal year 2004
    is $7.634 million. This funding is located in the Salaries and
    Expenses, or S&E, account.
        Question. How much is FDA giving to USDA and CDC in fiscal year
    2005? How does that compare to fiscal year 2004? Please describe what
    factors are used to determine the division of funds.
        Answer. At this time, FDA has not determined the exact funding for
    CDC and USDA for NARMS for fiscal year 2005 but plans to make decisions
    by Fall 2004. In fiscal year 2004, FDA funding on NARMS will be reduced
    due to government-wide rescissions. In fiscal year 2004, FDA provided
    funds of approximately $1.6 million to USDA and $2 million to CDC. It
    is important to point out that a large portion of the funds provided to
    CDC is given to the states for the collection, isolation and
    identification of bacterial isolates, which are then shipped to CDC and
    the Food and Drug Administration's Center for Veterinary Medicine--
    NARMS retail arm--for susceptibility testing. In determining the funds
    provided to CDC and USDA, we analyze the entire NARMS program,
    including the retail food arm of NARMS, and strive to fill in data gaps
    and avoid duplication of organisms to be tested.
        Question. How much NARMS money is currently being spent in foreign
    countries, specifically Mexico? How is this money being used?
        Answer. FDA is not spending any current year NARMS funding in
    Mexico or other foreign countries.
        Question. Does USDA or CDC spend any of their NARMS money in
    foreign countries?
        Answer. In fiscal year 2004 FDA is providing USDA and CDC, $1.6
    million and $2 million respectively. FDA does not keep detailed records
    of USDA and CDC funding for NARMS.

                               COUNTERFEIT DRUGS

        Question. In February, FDA released a report on combating
    counterfeit drugs. Several new technologies were mentioned that could
    be used to this effect, including Radiofrequency Identification
    tagging, color shifting inks, and holograms. Specifically regarding
    color shifting inks, which I understand are currently available, has
    FDA taken any action, or do you have any plans to pursue this option?
        Answer. It is true that color shifting ink technology is currently
    available for use on drug packaging and labeling. However, we heard
    uniformly from all stakeholders that this technology is expensive and
    requires significant investment of resources and time prior to
    implementation. Due to the wide variety of products, packaging, and
    labeling on the market, we heard from manufacturers, wholesalers, and
    retailers that the decision to use color shifting inks, or any other
    authentication technology, should be made by the manufacturer after a
    manufacturer initiated product risk assessment. Without such an
    analysis, use of color-shifting ink, or other authentication
    technology, could lead to an unnecessary increase in the cost of drugs
    to consumers. For example, we heard that color-shifting ink could be
    appropriate for use on a very expensive, high volume brand name drug
    product that is likely to be counterfeited, but not on a generic or low
    volume drug product that is less likely to be counterfeited.
        Based on our discussions with manufacturers, we estimate that it
    would take a minimum of six to twelve months to implement a technology
    such as color shifting ink from the time a decision is made to use the
    authentication technology on the packaging and/or labeling of a drug
    product. It could take longer if the technology, e.g., color-shifting
    ink, is used on the product itself because safety studies might have to
    be performed to ensure that the technology, e.g., the ink, does not
    affect the safety or stability of the product.

                            ANIMAL DRUG COMPOUNDING

        Question. Dr. Crawford, on February 10, I submitted a letter to Dr.
    McClellan regarding FDA's new Compliance Policy Guidelines, issued July
    14, 2003, regarding animal drug compounding. I received a response from
    FDA on March 31st, and I thank you for that. However, I do have a few
    more questions in light of the response.
        First, the letter stated that FDA issued the CPG for immediate
    implementation because of the ``urgent need to explain how it intended
    to exercise its enforcement discretion regarding compounded drugs for
    animal use in light of Thompson v. Western States Medical Center.''
    However, this case dealt only with compounding in human drugs, not
    animal drugs. How does this create an urgent need to deal with animal
    drugs?
        Answer. After the Western States decision, FDA revised its
    enforcement policy on pharmacy compounding of human drugs. FDA was
    concerned that without updated guidance regarding compounding of animal
    drugs, the public would remain uncertain about whether and how FDA
    would change its enforcement policy with respect to compounded animal
    drugs. In addition, agency staff would lack clear guidance on
    enforcement matters.
        As FDA stated in its letter, although prior public comment was not
    sought in this case, pursuant to the good guidance practices
    regulations the public was invited to comment on the CPG when it was
    issued and may comment on it at any time (68 FR 41591 (July 14, 2003)).
    FDA has been reviewing those comments and will revise the guidance as
    appropriate upon completion of our review.
        Question. Second, the response states that two federal appeals
    court decisions have held that ``the Federal Drug & Cosmetic Act does
    not permit veterinarians to compound unapproved finished drugs from
    bulk substances, unless the finished drug is not a new animal drug.
    These cases support FDA's position that new animal drugs that are
    compounded from bulk substances are adulterated under the FD&C Act and
    may be subject to regulatory action.'' I have been informed that the
    cases cited deal only with veterinarians compounding drugs, not
    pharmacists. Why do you limit pharmacists as well as veterinarians? Is
    this supported by any congressionally-enacted statutory authority,
    legislative history or case law?
        Answer. The principle established by the courts applies equally to
    compounding by pharmacists and veterinarians.
        Veterinary medicine has not traditionally utilized the services of
    compounding pharmacies to the extent that they have been utilized
    within human medicine. The increasing activities and presence of
    compounding pharmacies in veterinary medicine is a relatively recent
    development.
        The Federal Food Drug and Cosmetic Act, or ``the Act'', and its
    implementing regulations do not exempt veterinarians or pharmacists
    from the approval requirements in the new animal drug provisions of the
    Act, 21 U.S.C. Section 360b. In the absence of an approved new animal
    drug application, the compounding of a new animal drug from any
    unapproved drug or from bulk drug substances results in an adulterated
    new animal drug within the meaning of section 21 U.S.C. Section
    351(a)(5). The compounding of a new animal drug from an approved human
    or animal drug also results in an adulterated new animal drug within
    the meaning of 21 U.S.C. Section 351(a)(5), unless the conditions set
    forth in 21 CFR 530.13(b) relating to extralable use are met.
        FDA is concerned about veterinarians and pharmacists that are
    engaged in manufacturing and distributing unapproved new animal drugs
    in a manner that is clearly outside the bounds of traditional pharmacy
    practice and that violates the Act--such as compounding that is
    intended to circumvent the drug approval process and provide for the
    mass marketing of products that have been produced with little or no
    quality control or manufacturing standards to ensure the purity,
    potency, and stability of the product.
        Pharmacists and veterinarians who engage in activities analogous to
    manufacturing and distributing drugs for use in animals may be held to
    the same provisions of the Act as manufacturers.
        Question. Finally, the final paragraph of the FDA response states
    ``Accordingly, the regulations that implement AMDUCA provide that
    extralabel use by compounding applies only to compounding of a product
    from approved drugs, and that nothing in the regulations is to be
    construed as permitting compounding from bulk drugs.'' Is there in the
    agency's view anything in AMDUCA's regulations or the Act that is to be
    construed as not permitting compounding from bulk substances?
        Answer. As previously noted, under the Federal Food, Drug and
    Cosmetic Act, in the absence of an approved new animal drug
    application, the compounding of a new animal drug from a bulk substance
    results in a new animal drug that is adulterated as a matter of law.
    This has been FDA's longstanding position, which is supported by two
    federal appeals court decisions, United States v. Algon Chemical Inc.,
    879 F.2d 1154 (3d Cir. 1989) and United States v. 9/1 Kg. Containers,
    854 F.2d 173 (7th Cir. 1988).

                             CONCLUSION OF HEARINGS

        Senator Specter. Thank you all very much for being here.
    That concludes our hearings.
        [Whereupon, at 10:48 a.m., Thursday, April 1, 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 2005

                                  ----------

                                           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 LABOR

        Prepared Statement of the Association of Farmworker Opportunity
                                    Programs

        Good morning Chairman Specter and members of the subcommittee. My
    name is David Strauss and I represent the 50 nonprofit and public
    agencies that provide job training and related services to our nation's
    migrant and seasonal farmworkers.
        About 3 million people labor in the fields and farms of America,
    from Hawaii to Florida and Puerto Rico, from Maine to California.
    Estimates are that 85 percent of the fruits and vegetables we eat are
    hand harvested by farmworkers. The pay is extremely low: most
    farmworkers earn less than $12,000 per year. Few farmworkers receive
    the job-related benefits, such as health insurance and sick pay, which
    we all take for granted. In most states, agricultural workers are not
    even eligible for unemployment compensation. They live a tough life.
    Many workers travel hundreds, sometimes thousands of miles in search of
    work. They get paid only when they perform the work: if the weather is
    bad or the crop is not as plentiful as the farmer had hoped, they
    simply do not receive wages. They typically cannot afford decent
    housing. Their children have to struggle mightily to even complete
    their public school education. The dropout rate for farmworker youth,
    especially those who migrate with their parents, is enormous.
        For over 33 years the federal government has made and kept a
    commitment to these hardworking people. Special federal programs were
    created to recognize the reality that farmworkers often cross state
    lines to work and live. Thus, we have migrant head start, migrant
    health, migrant education, and the job training effort called the
    National Farmworker Jobs Program. These all are federally funded and
    have guidelines that acknowledge that Governors should not be placed in
    a position of deciding whether or not agricultural workers qualify for
    these services under state residency or other localized requirements.
        Today, I want to talk with you about the last program I mentioned:
    the National Farmworker Jobs Program, referred to in the budget as the
    migrant and seasonal farmworker job-training program. This program
    serves about 25,000 farmworkers each year, a very small percentage of
    the eligible total. Most of the customers are Hispanic; all must be
    American citizens or possess valid work authorization documents.
        It is an extraordinary program on several counts: it is the most
    successful program that the Department of Labor funds. In its most
    recent national report, this program outperformed all others, including
    the Job Corps, the Dislocated Workers program, the Older Americans
    program, and so on. The program is operated by nonprofit and public
    organizations that typically have to serve an entire state with ever-
    diminishing funds. In fact, they have to compete for the grants.
        Yet, they are able to hire staff who are bilingual, are culturally
    sensitive, and are skilled at serving people with significant barriers
    to career advancement. Characteristics such as low English proficiency,
    low education levels, and extreme poverty present significant
    challenges to case managers who must help farmworkers find a path to a
    more stable and better paying career. And they do. Staff of the
    National Farmworker Jobs Program reach out to farm laborers in camps,
    fields, churches, community centers: wherever necessary to meet the
    needs of these hardworking people. The hours they work and the
    locations in which they provide services must be flexible, for during a
    harvest, farmworkers may toil from sunup to after sundown.
        The results are excellent: over 83 percent of farmworkers who
    wanted training and a new job got one, and their average wage gains
    exceeded $4,400 per year. That data comes from the Department of Labor,
    not from our Association. Despite this excellent performance, despite
    the incredible efforts of dedicated staff and despite the commitment of
    program operators to achieve their goals with diminishing resources,
    the Department of Labor (DOL) seeks to eliminate this program in its
    budget request for 2005. DOL contends that the program is ineffective,
    that it duplicates the services available to farmworkers in the One
    Stop Career Centers, and that it spends too much time and money on
    supportive services. They are incorrect.
        Now, DOL stated the same rationale in its 2003 and the 2004 budget
    requests, and you rejected it. Instead, you funded the program at just
    under the 2002 level in those years. Members of the Association of
    Farmworker Opportunity Programs and I have met with Department leaders
    on several occasions to educate them on how the program works and to
    explain how effective it is. Now we have DOL's own report that
    illustrates that it is their best job-training program. Yet they
    continue to resist your instruction to maintain the National Farmworker
    Jobs Program.
        Since I can only speculate on why the Department persists in this
    stance, I will answer their three claims. First, as I said earlier the
    program is amazingly effective, especially when you also consider that
    many programs operate in counties with some of the highest unemployment
    rates in the country. I would like to submit relevant portions of the
    Workforce System Results as of September 30, 2003 issued in mid-January
    of this year as proof of our success.
        Secondly, this program does not duplicate services in the One Stop
    Career Centers. The One Stop system created in the Workforce Investment
    Act of 1998 represents an improvement in training and placement
    services for job seekers. In fact, NFJP agencies are mandated partners
    in that system. Labor Secretary Elaine Chao may not be aware that most
    of our members have memoranda of agreement with their state's workforce
    boards, and participate in the One Stop Centers. But many rural areas
    do not have One Stop centers that are easily accessible to those who
    work in the fields. Further, these centers seldom operate outside
    normal business hours, and they have no program of outreach to hard to
    serve agricultural workers. One Stops are held to program measures that
    work against serving people with less than 10th grade educations. And
    many rural One Stop Centers simply do not have staff who can converse
    in Spanish, Creole, Vietnamese or other languages that farmworkers in
    particular areas may speak. It would be a great mistake to assume that
    removing the NFJP agency from the One Stop partnership would improve
    services to farmworkers, as DOL has suggested. In fact, ending the NFJP
    would, I am certain, end job-training services to farmworkers in most
    of this nation. And that would be a great tragedy, for this program
    represents access to the American Dream for migrant and seasonal
    farmworkers. Whether they choose to build their careers in agriculture
    or in another industry, they deserve the opportunity to achieve a
    better life through training and job placement.
        Finally, DOL claims that our members spend too much time and money
    on what we call related assistance--services that help a farmworker
    prepare for training or stabilize their economic situation while they
    continue to work in agriculture. First, the data: last year, about 8.5
    percent of grant funds were spent on related assistance, while over 81
    percent went for job training and placement services. Now, it is true
    that a majority of the farmworkers nationwide who participated in our
    program received such assistance and no training. However, in states
    such as California, Texas, Washington, and Arizona you will find that a
    healthy majority of customers received job training and placement. In
    states to which farmworkers migrate and work for relatively brief
    periods, they tend to receive more life-sustaining services such as
    emergency shelter, car repair vouchers, or food. Again, I remind the
    committee that farmworkers do not have the same safety net as the rest
    of us: no unemployment insurance, for example. And when they migrate,
    they are often in places that have residency requirements for
    assistance.
        I dwell on this point because this seems to me to be a particularly
    cruel and insensitive criticism of our members' activities--they are
    charged by the Section 167 of the Workforce Investment Act with
    providing related assistance, and for good reason. And I think members
    of the agricultural industry would be unpleasantly surprised to learn
    that DOL thinks it is wrong to help a worker who plans to harvest a
    crop. Sometimes that help prevents homelessness. Sometimes the help
    consists of English language training so the farmworker can better
    understand the job he/she must perform. Sometimes it consists of
    pesticide safety training, which enables farmers to legally employ
    people who must be certified in such safety before they can work amidst
    dangerous chemicals.
        The Office of Management and Budget has issued an ``analysis'' of
    the NFJP that is as flawed as the Department of Labor's statements.
    Rather than going into it in detail today, I will instead ask you to
    accept our analysis and rebuttal of their Performance Assessment Rating
    Tool.
        In closing, I reiterate: the National Farmworker Jobs Program does
    an excellent job by the Department's own assessment. More importantly,
    the program operators are keeping faith with the charge that you gave
    them when you enacted the Workforce Investment Act in 1998. This
    program represents a path to the American Dream for our country's
    lowest paid and hardest working people. Please don't let them down.
    Maintain the National Farmworker Jobs Program in the appropriation for
    the Department of Labor for 2005. Thank you for this opportunity to
    present testimony today.
        For more information contact: David Strauss, AFOP, 4350 N. Fairfax
    Drive,
    Suite 410, Arlington, VA 22203 Telephone: 703-528-4141, ext. 101 email:
    strauss@afop.org
                                     ______

                 Prepared Statement of Rural Opportunities Inc.

        Honorable Chairman, Senator Arlen Specter, and Honorable Committee
    Members: I would like to sincerely thank you for this opportunity to
    present testimony to the Senate Appropriations Subcommittee for Labor,
    Health and Human Services, and Education.
        I am submitting this testimony on behalf of Rural Opportunities
    Inc., provider of the National Farmworker Jobs Program (NFJP) services
    to Migrant and Seasonal Farmworkers in Pennsylvania, New York, New
    Jersey and Ohio. NFJP is funded under Section 167 of the Workforce
    Investment Act (WIA). I am requesting that the Subcommittee recommend
    full restoration of funding for this initiative at $80 million for
    Federal fiscal year 2005.
        Historically, Congress has recognized the need for a nationally-
    administered program to serve Migrant and Seasonal Farmworkers. The
    mobility and unique socio-economic characteristics of these workers
    leave them unserved or under-served by any other workforce program
    convention. This fact is clearly evident, as each Congress since 1973
    has passed an Act designating specific programs to serve Farmworkers:
    the Comprehensive Employment and Training Act (CETA), the Job Training
    Partnership Act (JTPA) and most recently, the Workforce Investment Act
    (WIA). WIA was passed as a direct result of the work done by you and
    your colleagues, and we thank you.
        Today, although almost 6 years have passed since WIA was
    implemented, nothing has changed that should alter the intent
    demonstrated by the establishment and continuation of this program
    effort to serve the Farmworkers of this nation. Unfortunately, as
    grantees--and foremost as advocates--for Farmworkers and their needs,
    we have found ourselves continuously defending the Farmworker program
    and advocating for adequate funding. We also have recognized that,
    although Congress has clearly demonstrated its wishes in EVERY jobs
    program since 1973, the U.S. Department of Labor continues to zero out
    funding for this vital program, while at the same time hailing it as
    one of their most successful.\1\
    ---------------------------------------------------------------------------
        \1\ Workforce System Results, www.dol.gov, page 6.
    ---------------------------------------------------------------------------
        Although it may seem cliche in 2004, we are still forced to ask the
    question: ``Are Farmworkers better served today than they would be if
    no program existed?'' The answer is an unqualified ``Yes.'' NFJP
    nationally had an 84.6 percent successful placement rate (Entered
    Employment Rate) for Farmworkers who entered training in PY 2002 (July
    2002 to June 2003).\2\ According to USDOL statistics as of 30 September
    2003, ROI--across our entire service area--had a 100 percent success
    rate in placing Farmworkers in jobs after training.
    ---------------------------------------------------------------------------
        \2\ PY 2002 Preliminary Grantee performance for the NFJP,
    wdsc.doleta.gov/msfwPY02.
    ---------------------------------------------------------------------------
        Why does the Office of Management and Budget in their program
    analysis question the actions of Congress in establishing emergency and
    supportive services? We are directed by Section 167 of the Workforce
    Investment Act to provide emergency and supportive services to
    stabilize the agriculture workforce. Ensuring that our nation's
    agricultural employers continue to have access to a stable agricultural
    workforce required less than 9 percent of the total funds appropriated
    for the NFJP. Agricultural stabilization services that meet the short
    term emergency needs of Farmworkers enable them to be available for
    work in our nation's fields at peak harvest times.
        With regard to the impact of NFJP job placement, ROI statistics \3\
    for PY 2002 show an average wage gain of $5,611 in Pennsylvania, $4,372
    in New York, $6,519 in New Jersey and $3,925 in Ohio. The national
    average across all NFJP programs for the same wage measure is
    $4,413.\4\ Ironically, the average wage gain reported by the One Stop
    system for the same period was only $3,094,\5\ while serving a
    population confronted by far fewer barriers to employment.
    ---------------------------------------------------------------------------
        \3\ Rural Opportunities Inc. Management Information System, PY
    2002.
        \4\ Workforce System Results, www.dol.gov, page 6.
        \5\ Workforce System Results, www.dol.gov, page 7.
    ---------------------------------------------------------------------------
        As compelling as this economic information is, nothing speaks
    louder than the words of the participants, your constituents, who have
    begun to experience the American dream. I have requested and received
    permission from some of our participants to use their stories in this
    testimony.
        To set the background for these stories, let me describe the
    typical Farmworkers served in the NFJP programs Rural Opportunities
    Inc. operates. The average participant is a young Hispanic male or
    female. Of those served in PY 2002, 91.6 percent were Hispanic, 64.7
    percent were 21-44 years old, 71.5 percent had limited English speaking
    skills and 84.8 percent dropped out during or before high school. Most
    were members of families who had been working in agriculture since
    their birth. In fact, over 69 percent knew agriculture as their only
    work experience. These are the very characteristics that would preclude
    our program participants from being served by the local One Stop.
        Ofelia Carmona is an Hispanic woman aged 41. She was born into a
    Farmworker family. At age 6, she began working in the fields with her
    13 brothers and sisters. Married at age 14, Ofelia dropped out of
    school and began migrating with her husband, and soon children, to the
    fields and orchards of the Northeast. While pregnant with her 4th
    child, she and her husband decided they wanted more for their children.
    With the help of Rural Opportunities Inc., Ofelia pursued her GED. She
    attended GED class in the morning and work experience at a Migrant
    Health Clinic each afternoon. After completing her GED, Ofelia was
    hired full-time by the Clinic. But she was not through with her
    efforts; Ofelia returned to Community College and, while continuing her
    full-time employment, obtained a Nursing Assistant Associates Degree.
    Today, Ofelia is the Director of a Migrant Head Start Center and is
    working to achieve a Bachelors Degree in Early Childhood Education.
        Juan Luna's story is not unlike that of Ofelia; Juan is a 36-year-
    old Hispanic male. He dropped out prior to completing high school, had
    limited English speaking skills and no transportation, and his only
    work experience had been as a migrant following the crops. He was not
    in a position to enter the traditional job market. ROI began by helping
    Juan access English as a Second Language classes. Then, when his
    English skills had begun to improve, ROI assisted him in entering
    Occupational Skills Training at the Metal Working Institute, where he
    learned the skills to become a Machinist. Today, Juan is employed with
    the Hauser Corporation as a machine operator and will soon complete his
    second year on the job.
        Cipriano Rodriguez migrated from Mexico 12 years ago to pick
    apples. Discouraged by the poor pay, he finally left farm work after
    many years for a factory job, although his interest in agriculture
    remained strong. Learning of the services provided by Rural
    Opportunities, Inc., he established the goal of obtaining his
    Commercial Driver License and returning to agriculture--and his love
    for the land. He completed training and passed the required tests, and
    was able to obtain year-round employment at a large farm in the Hudson
    Valley, driving produce to processing and storage facilities. Four
    years ago, he became a United States citizen.
        Ofelia, Juan, Cipriano . . . these are not the customers of the
    traditional One Stop system. These are the customers of the National
    Farmworker Jobs Program grantees. They are not unlike the 328
    participants ROI assisted to gain full-time, year-around employment in
    PY 2002.\6\
    ---------------------------------------------------------------------------
        \6\ www.workforceatm.org
    ---------------------------------------------------------------------------
        NFJP program served 5,612 Farmworkers in PY 2002 nationwide.\7\
    Without NFJP, who would serve these individuals? The One Stop system?
    The same system that served less than 1 percent of this population in
    PY 2002? The One Stop system does not have language or culturally
    appropriate staff and cannot be expected to develop appropriate
    staffing in a few short months. The One Stop system does not do
    outreach to overcome Farmworkers' barriers to services, such as lack of
    transportation, isolation, and sunrise to sunset workdays. Nor can
    Farmworkers, if they somehow manage to access the One Stop system, be
    expected to use a computerized system for job search assistance and
    labor market information--a system targeting high school graduates, an
    education level far beyond that attained by the average Farmworker.
    ---------------------------------------------------------------------------
        \7\ www.workforceatm.org
    ---------------------------------------------------------------------------
        Throughout our history, Rural Opportunities Inc. has always sought
    to assist Farmworkers in achieving their dreams by placing them in jobs
    of their choosing--within or outside of agriculture. Often Farmworkers
    wish to upgrade skills to stay on the farm and find a full-time job in
    agriculture or an agriculture-related industry. In PY 2002,
    agricultural upgrades accounted for 30 percent of all of the jobs in
    which ROI assisted Farmworkers to find placements. In Pennsylvania, we
    have achieved significant success in the past by working with the
    Mushroom Industry to design and implement job training. In New York, we
    have done the same with the Dairy Industry. ROI continues to experience
    high demand from Farmworkers for training in welding and in obtaining
    Class I Licenses, both of which secure higher paying year-round
    employment on the farms. Ironically, a concern we often hear from those
    in Agriculture and Ag-related Industries is that their interests are
    not met by the primarily urban or village-based One Stop System.
    Although as a case management and individual skills-based effort NFJP
    does not train as many Farmworkers for skilled farm positions as the
    Industry would like, NFJP does address the Industry's needs.
        In his March 2004 presentation to the ROI Board of Directors,
    George Lamont, a New York State Grower and Executive Director of the
    New York State Horticultural Association, presented his hierarchy of
    needs for the Farmworkers he employs: Job Skills Training and English
    as a Second Language were two of the top three.
        The One Stop Delivery System often has recognized how under-
    equipped it is to meet the needs of the Farmworker population and
    supports the continuation of the National Farmworker Jobs Program, as
    evidenced in the following excerpts:
      --Your agency's interaction with migrant and seasonal farmworkers, a
            population that is traditionally underserved by other agencies,
            is integral to their well-being.\8\
    ---------------------------------------------------------------------------
        \8\ Joseph Kuchere, Workforce Investment Board Chair, Niagara
    County Workforce Investment Board, letter of support, 2003.
    ---------------------------------------------------------------------------
      --We realize that without the services provided by the NFJP,
            farmworkers would not have access to training and job placement
            outside of agriculture due to the multi-barriers many of them
            possess. The removal of these barriers requires staff that has
            the skills and cultural sensitivity to assist this special
            population as well as those who can provide services evenings
            and weekends to meet the critical demand of migrant and
            seasonal farmworkers.\9\
    ---------------------------------------------------------------------------
        \9\ Ana Maria Murabito, Council of Industry of Southeast New York,
    letter of support, 2003.
    ---------------------------------------------------------------------------
      --You have provided these services and truly changed the lives of
            hundreds of farmworkers by providing needed tools that lead to
            self-sufficiency for them and their families.\10\
    ---------------------------------------------------------------------------
        \10\ Ibid.
    ---------------------------------------------------------------------------
      --Your agency staff has the needed skills and cultural sensitivity to
            assist this population to overcome barriers pertaining to self-
            sufficiency for themselves and their families.\11\
    ---------------------------------------------------------------------------
        \11\ Glenn L. Decker, Commissioner of Social Services, Ulster
    County, letter of support, 2003.
    ---------------------------------------------------------------------------
        The National Farmworker Jobs Program grantees have developed a
    sophisticated service delivery infrastructure in the past 30+ years,
    capable of meeting farmworkers' needs and generating high levels of
    success. As an NFJP grantee, Rural Opportunities Inc. has built a
    support structure of additional resources that allows us to leverage
    NFJP dollars--for every $1 provided by NFJP, we can bring an additional
    $3 to bear on the host of problems faced by Farmworkers in each state
    we serve. The NFJP is more successful because of this and the
    Farmworker population is far better served. ROI has been recognized for
    the fact that 96 cents of every funding dollar go to client
    services.\12\
    ---------------------------------------------------------------------------
        \12\ Rochester Business Journal, Non-profit Agencies Vary Widely in
    Outlay for Overhead Expenses. January 4, 2002; Volume17; Number 40.
    ---------------------------------------------------------------------------
        In closing, ROI requests that the Subcommittee recommend an
    appropriation of $80,000,000--restoring the NFJP program to full
    funding and recognizing the enormous potential of the NFJP program
    grantees. Though this appropriation will not ensure that every eligible
    Farmworker receives the services needed, it will enable the program to
    hold its ground in providing high quality, culturally appropriate
    services to this population so desperately in need.
                                     ______

        Prepared Statement of the California Workforce Investment Board

        My name is Morgan Clayton, Chairman of the Kern County California
    Workforce Investment Board. I whole-heartedly support the continued
    funding of the National Farmworkers Jobs Program, as authorized in
    section 167 of the Workforce Investment Board (WIA). While our Board
    represents a Grantee for this program, we also serve as the Local Area
    for the WIA formula-funded programs in the California counties of Kern,
    Inyo and Mono. From this unique perspective we have come to appreciate
    the need for the National Farmworker Jobs program and urge its
    continued full funding in fiscal year 2005 and beyond.
        In providing services to both Farmworkers and the general
    population for more than 20 years, it has become clear that the farm
    workers have unique needs in the areas of basic skills, Vocational
    English-as-a-Second Language, job training and access to available
    services. A separate program ensures that these needs continue to be
    addressed. While we continue to enjoy many successes in serving farm
    workers through our network of rural one-stop career centers, those
    one-stops simply could not exist without a serious commitment of
    federal funding to targeted rural workers, especially farm workers.
        On behalf of the Workforce Invest Board of Kern County, I am adding
    our support for the continued, full funding of the National Farmworker
    Jobs Program.
                                     ______

       Prepared Statement of the National Association of State Workforce
                                    Agencies

        Chairman Specter, Senator Harkin, and distinguished Members of the
    Subcommittee. On behalf of the National Association of State Workforce
    Agencies, I thank the Subcommittee for the opportunity to share
    information on the contributions our members provide in strengthening
    our nation's economy by linking workers and jobs. The members of our
    association constitute state leaders of the publicly-funded workforce
    investment system vital to meeting the employment needs of business and
    workers. It is the funding you appropriate that makes much of the
    workforce system services and infrastructure possible.
        Mr. Chairman, the nation's publicly-funded workforce system
    continues to build on the critical link between businesses in need of
    employees and workers in need of employment. The state agencies
    administering job training and employment assistance programs
    throughout our country are cognizant of the need to provide effective
    services. We recognize it is no longer enough to wait for a dislocated
    worker to walk through the door of our one-stop offices, or for the
    phone to ring from a prospective employer in need of skilled workers.
    Instead, the workforce system is transforming its operations to meet
    employer demands for skilled workers in the 21st century.
        One can look at the latest Workforce System Results report
    published by the Employment and Training Administration (ETA) for
    evidence of our workforce system's performance and continued
    improvement. This report shows state workforce programs ``are either
    meeting their Government Performance and Results Act (GPRA) goals, or
    have improved their performance from the previous year.'' These results
    were achieved while our nation's economy continues its recovery with
    sustained high demand on our system. Although the system continues to
    improve, we are concerned the upward trend in performance might level
    off in the near future if it does not obtain sufficient resources to
    meet an ever-growing demand.
        A recent survey of state workforce agency administrators yields a
    consistent concern that the infrastructure needed to maintain services
    business and workers have come to expect is aging and in need of
    repair. We are becoming increasingly aware of limitations to the
    expectation that we can do more with less and the effect of level or
    reduced funding on the quality and quantity of our services. Although
    we strive to continue improving our service levels regardless of our
    annual appropriations, under funding of our programs makes state
    decision-making harder and ultimately can lesson the quality and
    quantity of services we will be able to provide.

               STATE UNEMPLOYMENT INSURANCE ADMINISTRATION GRANTS

        The Social Security Act requires the Secretary of Labor to allocate
    grants to states that are necessary for proper and efficient
    administration of their unemployment insurance programs. However, the
    President's budget has not proposed sufficient amounts and Congress has
    often appropriated less than the President's insufficient request for
    many years. The result is states often receive less than is necessary
    for proper and efficient administration of their unemployment
    compensation programs.
        Insufficient funding has forced many states to delay indefinitely
    technological upgrades. Many states are unable to automate their aging
    benefits and tax systems. The inability to improve infrastructure
    hampers states ability to combat fraud, such as identity theft and
    unemployment tax evasion.
        NASWA's request for state administration of unemployment
    compensation in fiscal year 2005 exceeds the Administration's request
    by $439 million, totaling $3.140 billion. This amount is estimated to
    be necessary for the states to operate their unemployment compensation
    programs properly. We believe this amount is necessary because a new
    budget formulation and allocation system, known as the Resource
    Justification Model (RJM), provides estimates of the amounts states
    need for proper and efficient administration of the UI program.
        NASWA also requests Congress enact an immediate transfer of $9
    billion as a special Reed Act distribution to state trust fund accounts
    to improve trust fund solvency, avoid employer tax hikes, and improve
    UI administration, employment services and unemployment benefits.
    Unemployment trust fund solvency has continued declining during the
    past year. State unemployment trust fund balances fell from $51.57
    billion on September 30, 2001 to $28.13 billion on September 30, 2003.
    Benefits increased from $27.35 billion in fiscal year 2001 to $41.8
    billion in fiscal year 2003. Six months ago, one state borrowed to
    maintain trust fund solvency. Today eight states are borrowing. Many
    other states are planning to borrow or substantially increase state
    unemployment taxes or cut unemployment benefits to maintain trust fund
    solvency.
        If a transfer of $9 billion as a Reed Act distribution does not
    occur in the next five months, many states will be forced to borrow,
    cut benefits, or collect additional revenue through state unemployment
    payroll taxes on employers. Collection of additional employer taxes is
    unnecessary given the $19.9 billion balance credited to the federal
    unemployment trust fund accounts. Using already-paid employer
    unemployment taxes for the UI and ES programs is a far better purpose
    during this period of high unemployment than merely maintaining
    balances in federal trust fund accounts.
        Mr. Chairman, as you know the workforce system received an $8
    billion Reed Act distribution in 2002. Some in Congress and the
    Administration have said states are ``sitting'' on these funds, not
    using them in valuable ways. We can assure you that this is not the
    case. A recent survey of NASWA members found states have used all of
    the 2002 distribution for economic stimulus, improved UI benefits and
    administration and employment services. The $8 billion allowed states
    to cut unemployment payroll taxes for employers by more than $4 billion
    and improve state unemployment trust fund solvency, unemployment
    insurance administration and employment services. A Reed Act
    distribution in 2004 would stimulate further the economy by allowing
    many states to avoid raising employer taxes that will increase the cost
    of hiring new employees and slow the rate of job creation.

             WORKFORCE INVESTMENT ACT & EMPLOYMENT SERVICE PROGRAMS

        ETA Assistant Secretary DeRocco recently said in her testimony
    before this subcommittee, the WIA programs that are delivered by the
    state and local workforce partners continue to meet or substantially
    meet the majority of their established performance targets this past
    year. Some 83 percent of adults and 89 percent of dislocated workers
    were still working in the third quarter following receiving services
    against respective GPRA targets of 80 percent and 88 percent
    respectively. After receiving services, adults increased their annual
    earnings on average by $3,030 and dislocated workers averaged 88
    percent of their pre-dislocation earnings.
        For older youth ages 19 to 21 receiving services by the publicly-
    funded workforce system, 70 percent were employed in the first quarter
    after receiving services. Sixty-three percent of younger youth (ages 14
    to 18) who entered the program without a high school diploma or
    equivalent, attained a diploma or equivalent by the first quarter after
    receiving services.
        In order to meet the needs of both workers and businesses over the
    coming year, NASWA recommends the following funding levels for WIA
    programs for fiscal year 2005: $1.5 billion for dislocated worker state
    allocations; $950 million for adult training; and $1.128 billion for
    youth training activities. These amounts represent the funding levels
    allocated for the system in fiscal year 2002.
        Our members are concerned about the Administration's proposed
    funding cut of $91 million to Employment Service (ES) programs and the
    elimination of the $35 million for Reemployment Services. Funding for
    employment services has not been increased in over 8 years. However,
    most states have supplemented their budget with state or Reed Act
    funds. While NASWA members can support funding for new initiatives
    proposed by the Administration ($250 million for Community Colleges,
    $50 million for piloting Personal Reemployment Accounts, and $35
    million for the Prisoner Reentry Initiative), they are concerned about
    reductions to existing programs.
        NASWA requests $330.5 million more than was requested by the
    Administration for fiscal year 2005 employment service state allotments
    for a total of $991.7 million. In many parts of the country, the one-
    stop career centers are built on the ES program. The Administration,
    state workforce agencies, and local One-Stop centers have accepted a
    new focus on the business customer. The majority of services provided
    to the business community have been provided with ES funds. During the
    period ending December 31, 2003, the ES provided service to 9.2 million
    applicants.

                               TRADE ACT FUNDING

        Each year, many states deal with a shortfall of funding for worker
    training benefits under the Trade Act. States have been forced to
    freeze spending and turn many workers away. Turning workers away has
    become especially prevalent over the past few years as the number of
    trade impacted workers rises. We look forward to working with Congress
    on finding sufficient spending levels for trade programs in fiscal year
    2005.

                            LABOR MARKET INFORMATION

        NASWA supports a return to ETA's earlier investment levels of $150
    million for one-stop/America's Labor Market Information System (ALMIS)
    funding. The importance of adequate funding to state agencies for labor
    market information has intensified as states attempt to work with the
    Administration on its new ``high growth job training initiative.''
    State and local labor market information and high quality employment
    projections are critical to the identification of industry sectors and
    occupations where the employment growth will occur and ensure that
    training dollars are wisely invested.
        NASWA also calls for the Administration's leadership and support
    for funding of the new collaborative effort between the Bureau of Labor
    Statistics and the Bureau of Census to develop a unified wage record
    program. This new effort will afford better measurement of program
    performance and improved understanding of the labor market.

                   VETERANS EMPLOYMENT AND TRAINING PROGRAMS

        Two year's ago, Congress approved the Jobs for Veterans Act, giving
    states greater flexibility to serve their veteran populations. NASWA
    supported many provisions in this legislation, especially those that
    gave states more flexibility in integrating the veterans' employment
    and training programs into the one-stop career center system.
        The Jobs for Veterans Act requires states to submit to the
    Secretary of Labor, ``a plan that describes the manner in which the
    state shall furnish employment, training, and placement services
    required under this chapter for the program year.'' NASWA members
    believe the annual plan required by the Jobs for Veterans Act will be
    greatly improved by moving the funding for these programs from a fiscal
    year to a program year funding cycle. By transitioning funding to a
    program year (July 1 to June 30) and aligning it with most other
    employment and training programs, the plans that state workforce
    agencies submit to the Department will reflect future program year
    services based on established budget outlays. Program year funding
    supports integrating VETS-funded programs into WIA one-stop career
    center systems and planning and performing on the same cycle as other
    one-stop partners. The workforce system looks forward to another year
    of high performance and improvement. NASWA greatly appreciates your
    support. Thank you for considering our request.
                                     ______

         Prepared Statement of the National Youth Employment Coalition

        On behalf of the National Youth Employment Coalition (NYEC) and its
    more than 270 members, I am writing to thank you for being the champion
    for the Department of Labor's Reintegration of Young Offenders program.
    If not for your heroic efforts, this small, yet important program would
    have ceased to exist years ago.
        As you know, the Administration's fiscal year 2005 budget proposes
    to supplant the $49 million Reintegration of Young Offenders program
    with a new $90 million Prisoner Reentry Program. While NYEC applauds
    the Administration for its commitment to helping adult prisoners
    successfully return to society, details are still vague about how or
    whether this new program would involve young offenders. Additional
    resources to help reintegrate adult prisoners to society should not
    come at the expense of existing programs that help reintegrate
    incarcerated youth and prevent other court-involved youth from
    recidivating and being incarcerated.
        According to the Bureau of Justice Statistics, approximately
    120,000 youth under the age of 18 are currently incarcerated in
    juvenile detention centers, state prisons, and local jails. Most will
    be released in the next few years. While youth in general are being
    hard hit by the sluggish economy, court-involved youth face additional
    barriers to employment. There is a growing consensus among youth
    development experts that youth who come under court supervision have
    multiple issues that must be addressed in comprehensive and coordinated
    ways, if they are to attain employment at wages that will sustain a
    constructive life path. DOL's Youth Offenders Demonstration grantees
    provide coordinated services to young offenders, gang-involved youth,
    and at-risk youth to help them find employment, reduce dependency, and
    break the cycle of crime and recidivism. Court-involved youth who are
    at-risk of being incarcerated, and youth already in secure facilities
    receive training and employment opportunities in addition to education;
    substance abuse treatment as needed; mental health services; aftercare;
    housing assistance and family support services; and juvenile justice
    supervision. Several of our members have received competitive grants
    through the Reintegration of Young Offenders program in the past and
    many others plan to apply when the Department of Labor announces that
    funds are available for the fiscal year 2003 grant cycle.
        We must sustain our national investment in services and support for
    court-involved youth to enable these youth to positively contribute to
    their communities. Without resources such as the Responsible
    Reintegration of Young Offenders program, many more will fail to
    successfully transition into productive employment and instead will
    join the more than 2 million people currently incarcerated.
        Again, thank you so much for your long-standing commitment to
    court-involved youth.
                                     ______

         Prepared Statement of the National Youth Employment Coalition

        The National Youth Employment Coalition (NYEC) is a network of over
    270 youth employment, education, and development organizations
    dedicated to promoting policies and initiatives that help young people
    succeed in becoming lifelong learners, productive workers and self-
    sufficient citizens. We urge you to increase federal funding for youth
    employment/development programs under the Workforce Investment Act
    (WIA). In addition, we urge you to restore funding for the
    Reintegration for Young Offenders Program to its fiscal year 2003 level
    of $54 million, and ensure that these funds continue to be targeted at
    helping reintegrate incarcerated young offenders and prevent court-
    involved youth from recidivating or being incarcerated.
        We understand that this year's federal budget is particularly tight
    and we face a historically large deficit. However, our nation is facing
    a silent crisis--hundreds of thousands of youth are not being provided
    the opportunities they need to develop the academic and job skills they
    need to succeed in the 21st century workplace. We continue to hear
    reports that youth are having difficulty finding jobs in this sluggish
    economy because many employers are hiring adults for jobs for which
    they would hire youth in a tighter labor market. These reports are
    confirmed by the Bureau of Labor Statistics' January 2004 data, which
    shows that youth (age 16 to 19) have lost more than one million jobs
    since January 2000; and only 34 percent of youth were employed (part-
    or full-time) in January 2004--marking the lowest youth employment rate
    for the month of January since 1965.
        Despite record levels of youth joblessness, combined federal
    funding for the WIA youth formula and the Youth Opportunity Grant
    Program has been cut by more than 26 percent--from $1.352 billion in
    fiscal year 2002 to $995 million in fiscal year 2004. The
    Administration's fiscal year 2005 budget proposes a slight increase to
    $1.001 billion for the WIA youth formula; however, the House WIA
    reauthorization bill and the President's reauthorization plan propose
    using 25 percent of the formula funds to launch a new National
    Challenge Grant program. While we support new programs that help youth
    prepare for jobs and careers and prevent them from dropping out of
    school, funding for such a new program should not come at the expense
    of current programs that are already stretched to the breaking point.
        We cannot afford to allow our nation's youth development/employment
    system to erode further. Therefore we were very pleased to learn that
    the Senate's fiscal year 2005 budget resolution includes an amendment,
    sponsored by Senators Enzi (R-WY) and Cantwell (D-WA), that would
    increase WIA funding by $250 million in fiscal year 2005. We urge you
    this year to begin increasing funds for the WIA youth formula to
    restore funding to the $1.4 billion level. An additional $250 million
    should be provided in the event that the new National Challenge Grant
    program is authorized as a result of WIA reauthorization.
        The Administration's fiscal year 2005 budget also proposes to
    supplant the $49-million Young Offenders program with a new $90-million
    Prisoner Reentry Program. While NYEC applauds the Administration for
    its commitment to helping prisoners successfully return to society,
    details are still vague about how or whether this new program would
    involve youth. Additional resources to help reintegrate adult prisoners
    to society should not come at the expense of existing programs that
    help reintegrate incarcerated young offenders and prevent court-
    involved youth from recidivating or being incarcerated. At minimum,
    funds currently targeted at court-involved youth under the
    Reintegration for Young Offenders Program should be maintained to
    fiscal year 2003 levels ($54 million) and set aside for young offenders
    within the structure of the new prisoner reentry program.
        According to the Bureau of Justice Statistics, approximately
    120,000 youth under the age of 18 are currently incarcerated in
    juvenile detention centers, state prisons, and local jails. Most will
    be released in the next few years. While youth in general are being
    hard hit by the sluggish economy, court-involved youth face additional
    barriers to employment. There is a growing consensus among youth
    development experts that youth who come under court supervision have
    multiple issues that must be addressed in comprehensive and coordinated
    ways, if they are to attain employment at wages that will sustain a
    constructive life path. DOL's Youth Offenders Demonstration grantees
    provide coordinated services to young offenders, gang-involved youth,
    and at-risk youth to help them find employment, reduce dependency, and
    break the cycle of crime and recidivism. Court-involved youth who are
    at-risk of being incarcerated, and youth already in secure facilities
    receive training and employment opportunities in addition to education;
    substance abuse treatment as needed; mental health services; aftercare;
    housing assistance and family support services; and juvenile justice
    supervision.
        We understand that you face difficult decisions this year as you
    seek to spread limited federal resources for a range of national needs.
    Yet we must sustain our national investment in services and support
    disadvantaged youth to enable these young people to positively
    contribute to their communities. Without resources such as the WIA
    youth formula and the Responsible Reintegration of Young Offenders
    program, many more will fail to successfully transition into productive
    employment.
        We thank the Committee for its attention to these important
    programs for our youth and our emerging workforce.
                                     ______

       Prepared Statement of the National Coalition for Homeless Veterans

                                  INTRODUCTION

        The National Coalition for Homeless Veterans appreciates the
    opportunity to submit recommendations on fiscal year 2005
    appropriations for and program management issues related to the U.S.
    Department of Labor (DOL).
        The National Coalition for Homeless Veterans (NCHV), established in
    1990, is a nonprofit organization with the mission of ending
    homelessness among veterans by shaping public policy, promoting
    collaboration, and building the capacity of service providers. NCHV's
    nearly 250 member organizations in 42 states and the District of
    Columbia provide housing and supportive services to homeless veterans
    and their families, such as street outreach, drop-in centers, emergency
    shelter, transitional housing, permanent housing, recuperative care,
    hospice care, food and clothing, primary health care, addiction and
    mental health services, employment supports, educational assistance,
    legal aid and benefit advocacy.
        The VA estimates that more than 299,000 veterans are homeless on
    any given night; more than 500,000 experience homelessness over the
    course of a year. Conservatively, one of every three homeless adult
    males sleeping in a doorway, alley, box, car, barn or other location
    not fit for human habitation in our urban, suburban, and rural
    communities has served our nation in the Armed Forces. Homeless
    veterans are mostly males (2 percent are females); 54 percent are
    people of color. The vast majority are single, although service
    providers are reporting an increased number of veterans with children
    seeking their assistance; 45 percent have a mental illness; 50 percent
    have an addiction.
        America's homeless veterans have served in World War II, Korea, the
    cold war, Vietnam, Grenada, Panama, Lebanon, anti-drug cultivation
    efforts in South America, Afghanistan, and Iraq. 47 percent of homeless
    veterans served during the Vietnam Era. More than 67 percent served our
    nation for at least 3 years and 33 percent were stationed in a war
    zone.
        Male veterans are twice as likely to become homeless as their non-
    veteran counterparts, and female veterans are about four times as
    likely to become homeless as their non-veteran counterparts. Like their
    non-veteran counterparts, veterans are at high risk of homelessness due
    to extremely low or no income, dismal living conditions in cheap hotels
    or in overcrowded or substandard housing, and lack of access to health
    care. In addition to these shared factors, a large number of at-risk
    veterans live with post traumatic stress disorders and addictions
    acquired during or exacerbated by their military service. In addition,
    their family and social networks are fractured due to lengthy periods
    away from their communities of origin. These problems are directly
    traceable to their experience in military service or to their return to
    civilian society without appropriate transitional supports.
        Contrary to the perceptions that our nation's veterans are well-
    supported, in fact many go without the services they require and are
    eligible to receive. One and a half million veterans have incomes that
    fall below the federal poverty level. Neither the VA, state or county
    departments of veteran affairs, nor community-based and faith-based
    service providers are adequately resourced to respond to these
    veterans' health, housing, and supportive services needs. The VA plays
    only a limited role in providing employment services to veterans,
    administering just one small supported employment program for veterans
    with serious disabilities.
        The U.S. Department of Labor and state and local workforce agencies
    bear primary responsibility for ensuring that veterans are provided
    opportunities to prepare for and obtain productive employment.
    Accordingly, we urge Congress to provide full funding for the programs
    of the Department of Labor Veterans Employment and Training Service
    (VETS) in order to ensure that our nation's workforce services system
    is equipped to fulfill their obligations to our nation's veterans.

        FISCAL YEAR 2005 APPROPRIATION RECOMMENDATION--HOMELESS VETERAN
                             REINTEGRATION PROGRAM

        The Homeless Veterans Reintegration Program (HVRP), within the
    Department of Labor's Veterans Employment and Training Service (VETS),
    provides competitive grants to community-based, faith-based, and public
    organizations to offer outreach, job placement and supportive services
    to homeless veterans. HVRP is the primary employment services program
    accessible by homeless veterans and the only targeted employment
    program for any homeless subpopulation. Homeless veterans have many
    additional barriers to employment than non-homeless veterans due to
    their lack of housing. HVRP grantees remove those barriers through
    specialized supports unavailable through other employment services
    programs. Grantees are able to place HVRP participants into employment
    for $2,100 per placement, a tiny investment for moving a veteran out of
    homelessness, and off of dependency on public programs.
        DOL estimates that 16,800 homeless veterans will be served through
    HVRP at the fiscal year 2004 appropriation level of $19 million. This
    figure represents just 3 percent of the overall homeless veteran
    population, which the Department of Veterans Affairs estimates numbers
    more than 500,000 over the course of a year. An appropriation at the
    authorized level of $50 million would enable HVRP grantees to reach
    approximately 44,000 homeless veterans.
        HVRP grants are funded on a 3-year cycle. DOL representatives have
    indicated that if funding is not increased for the program this year,
    it is unlikely there would be a competition for new start grants in
    fiscal year 2005. Additionally, HVRP is being used as the account to
    fund a joint Department of Labor and Department of Veterans Affairs
    initiative authorized by Congress to assist veterans incarcerated in
    their reentry to the community. This decision essentially adds a new
    purpose to the HVRP program, for which additional funds are needed.
        We urge Congress to appropriate at least $50 million for HVRP in
    fiscal year 2005 Labor-HHS-Education appropriations legislation.

                                                [In millions of dollars]
    ----------------------------------------------------------------------------------------------------------------
                                                                                    Fiscal year
                                                              ------------------------------------------------------
                                                                                              2005
                                                                   2003         2004     administration   2005  NCHV
    ----------------------------------------------------------------------------------------------------------------
    Funding for Homeless Veterans Reintegration Program......         18.2         19.0           19.0          50.0
    ----------------------------------------------------------------------------------------------------------------

       FISCAL YEAR 2005 APPROPRIATION RECOMMENDATION--VETERANS WORKFORCE
                               INVESTMENT PROGRAM

        The Veterans Workforce Investment Program (VWIP), within the
    Department of Labor's Veterans Employment and Training Service (VETS),
    provides grants to states and community-based, faith-based, and local
    public organizations to offer workforce services targeted to veterans
    with service connected disabilities, with active duty experience in a
    war or campaign, recently separated from the service, or facing
    significant barriers to employment (including homelessness). VWIP
    grants last for twelve months and currently have a limit of $255,000.
    The fiscal year 2004 appropriation for VWIP is $7.5 million.
        At least 80 percent of total VWIP funds is distributed via
    competition. State governments have traditionally been the exclusive
    eligible applicant for competitive funds. The states then publish
    requests for proposals, to which local governments, workforce
    investment boards, and community organizations may respond. The states
    monitor the projects and frequently provide matching funds to increase
    opportunities. While matching funds are not required, applicants can
    gain up to ten points on their application if they demonstrate
    effective leveraging. In 2003, VWIP competitive funds were awarded to
    state agencies in AL, CA, HI, IN, ME, MA, PA, TN, and TX.
        VETS may reserve 20 percent of total VWIP funds for discretionary
    grants. VETS uses discretionary funds for studies, demonstration
    projects, and additional funding to supplement competitive grants.
    Discretionary grant applications are accepted directly from local
    governments, workforce investment boards, community-based, and faith-
    based organizations. In 2003, VWIP discretionary funds were awarded to
    organizations in CA, DC, FL, MS, NY, SC, OH, PA, and VA.
        Both those agencies that receive VWIP funds and those hoping to
    apply face the problem of resource scarcity. Due to funding
    limitations, agencies and organizations receive VWIP funds in only 16
    states. The need for the type of targeted assistance that VWIP offers
    is clearly needed in all states. Additionally, caps on the size of
    grant awards make it difficult for existing grantees to recruit and
    retain staff. This limits program effectiveness and the collaborative
    process.
        We urge Congress to appropriate at least $33.5 million for VWIP in
    fiscal year 2005 Labor-HHS-Education appropriations legislation.

                                                [In millions of dollars]
    ----------------------------------------------------------------------------------------------------------------
                                                                                    Fiscal year
                                                              ------------------------------------------------------
                                                                                              2005
                                                                   2003         2004     administration   2005  NCHV
    ----------------------------------------------------------------------------------------------------------------
    Funding for Veterans Workforce Investment Program........          7.5          7.5            7.5          33.5
    ----------------------------------------------------------------------------------------------------------------

    program management recommendation--priority of service for veterans in

                           DOL JOB TRAINING PROGRAMS

        The Jobs for Veterans Act (Public Law 107-288) establishes a
    priority of service for veterans in the receipt of employment,
    training, and placement services provided under qualified job training
    programs of the Department of Labor. We request the Committee's
    assistance in ensuring that qualified job training programs fully
    extend priority of service for veterans as required by this law.
        We recommend that the Committee, through report language, urge the
    Secretary of Labor to ensure that states, localities, and nonprofit
    organizations receiving workforce investment funds from the Department
    of Labor screen all applicants for services for military service status
    and implement the priority for those qualified. Further, we recommend
    that the Committee urge the Secretary of Labor to develop and
    disseminate a guide for veterans in accessing workforce investment
    services.
        In addition, we recommend that the Committee encourage the
    Secretary to develop and disseminate a guide for assisting veterans
    service organizations and homeless veteran service providers in
    accessing workforce investment funds and workforce investment planning
    processes. Also, we recommend that the Committee encourage the
    Secretary to develop and disseminate a technical assistance guide to
    inform state and local workforce systems on the workforce services
    needs of veterans, the current limitations of veteran-specific programs
    in meeting those needs, and the responsibility of mainstream workforce
    systems to prioritize veterans for services and to collaborate with
    homeless veteran service providers and veterans service organizations.
        Finally, we recommend that the Committee urge the Secretary to
    compel state workforce agencies to increase their outstationing of
    disabled veterans outreach program specialists and local veterans
    employment representatives in locations where homeless veterans
    congregate, including grantees under the homeless provider grant and
    per diem program and the homeless veterans reintegration program.

                         TRANSITION ASSISTANCE PROGRAM

        Individuals leaving the military are at high risk of homelessness
    due to a lack of job skills transferable to the civilian sector,
    disrupted or dissolved family and social support networks, and other
    risk factors that preceded their military service. Separating service
    members must be made aware of the factors that contribute to
    homelessness and receive information about sources of preventive
    assistance before they exit the military. The Transition Assistance
    Program (TAP) has been established to ease the transition of separating
    service members to the civilian sector. We are concerned that the TAP
    curriculum, which is developed and administered by the Department of
    Labor, does not currently include a component on homelessness.
        We urge the Committee, through report language, to instruct the
    Secretary of Labor to ensure that a module on homelessness prevention
    be added to the TAP curriculum. The module should include a
    presentation on risk factors for homelessness, a self-assessment of
    risk factors, and contact information for preventative assistance
    associated with homelessness.

                                   CONCLUSION

        The National Coalition for Homeless Veterans appreciates the
    opportunity to submit recommendations to Congress regarding the
    resources and activities of the U.S. Department of Labor. We look
    forward to continuing to work with the Appropriations Committee in
    ensuring that our federal government does everything within its grasp
    to prevent and end homelessness among our nation's veterans. They have
    served our nation well. It is beyond time for us to repay the debt.
                                     ______

        Prepared Statement of the National Association of Home Builders

        On behalf of the over 215,000 members of the National Association
    of Home Builders (NAHB), as well as our workforce development arm, the
    Home Builders Institute (HBI), we thank you for the opportunity to
    submit this statement for the record on the Responsible Reintegration
    of Youth Offenders program, as well as the newly-proposed Prisoner Re-
    entry Initiative.
        NAHB members are involved in home building, remodeling, multifamily
    construction, property management, subcontracting, design, housing
    finance, building product manufacturing and other aspects of
    residential and light commercial construction. Known as ``the voice of
    the housing industry,'' NAHB is affiliated with more than 800 state and
    local home builder associations around the country. NAHB's builder
    members will construct about 80 percent of the more than 1.6 million
    new housing units projected for 2004, making housing one of the largest
    engines of economic growth in the country.
        One of the most pressing problems confronting our industry has been
    a shortage of skilled workers. Record numbers in the construction of
    new homes, retirements and lackluster interest in the construction
    trades by younger generations, compounded by insufficient training
    opportunities for those interested in construction, are among the many
    factors contributing to the shortages. According to the Bureau of Labor
    Statistics, some 240,000 workers are needed each year to meet the
    nation's demand for housing.

                HOME BUILDERS INSTITUTE (HBI) PROGRAM BACKGROUND

        Each year, the Home Builders Institute (HBI) works through various
    programs to train and place several hundred youth in residential
    construction jobs. Through real-life, hands-on training, some of our
    nation's most at-risk youth learn a skill, and a second chance at a
    productive and successful life and career. Since 1994, HBI has focused
    a significant portion of its effort and resources on one particular
    targeted population, adjudicated youth, through its Project CRAFT
    (Community Restitution Apprenticeship-Focused Training) program.
    Project CRAFT is targeted solely to adjudicated youth and was piloted
    in 1994 through a Department of Labor demonstration grant. This program
    has successfully combined employers, the juvenile justice system,
    workforce development and other systems, in one overall approach, and
    has been implemented at 12 sites in nine states (Colorado, Ohio,
    Florida, Maryland, New Jersey, North Dakota, South Carolina, Tennessee,
    and Texas). Funding for HBI's work on this program has come largely
    through funds provided under the Responsible Reintegration of Youth
    Offenders budget line.
        Project CRAFT incorporates the apprenticeship concept of hands-on
    training and academic instruction, utilizing its Pre-Apprenticeship
    Certificate Training (PACT), numeracy, literacy and employability
    skills curricula. Under the supervision of journey-level trade
    instructors, students learn residential construction skills while
    completing community service construction projects. More than 90
    percent of Project CRAFT graduates achieve success through industry
    jobs each year. Since 1994, Project CRAFT has helped more than 2,000
    high-risk youth, and in addition to offering adjudicated youth trade
    skills and job placement, community service projects by students saved
    taxpayers more than $225,000 in labor costs alone in 2002-2003. During
    2002, Project CRAFT graduates were placed in jobs with an average wage
    of $8.29/hour, and performed over 28,000 hours of community service.
    Recidivism rates for Project CRAFT have averaged between 10-15 percent,
    with the Nashville, Tennessee program and Orlando, Florida programs
    experiencing impressive recidivism rates of 9 percent and 6 percent
    respectively. Additionally, students in the program tend to evidence
    one grade level of improvement in math and language skills attributable
    largely to the formal education component that includes contextual
    learning. Math and communication skills are continually reinforced as
    students are challenged to apply these skills to everyday situations in
    the field and in the classroom.
        Project CRAFT efforts were recognized by the Department of Labor
    and the National Youth Employment Coalition when in September 2002, the
    program received a PEPNet (Promising and Effective Practices Network)
    Award. We are also grateful to the Senate Subcommittee on Labor, Health
    and Human Services and Education for its acknowledgement of Project
    CRAFT in fiscal year 2004 Report Language, and its years of dedicated
    support for the Responsible Reintegration of Youth Offenders program.

              RESPONSIBLE REINTEGRATION OF YOUTH OFFENDERS PROGRAM

        NAHB and HBI's encouraging experience with Project CRAFT is an
    example of the enormous success of the Responsible Reintegration of
    Youth Offenders pilot program, and the reason why we very strongly
    support the continuation of funding for a youth-focused program
    targeting adjudicated youth with training that provides this at-risk
    population with important job- and life-skills. The Responsible
    Reintegration of Youth Offenders Program has helped to bring together
    industry and government in a partnership with tangible positive
    outcomes. Since 1994 the program has earned a reputation as a
    worthwhile investment of taxpayer dollars, a significant and important
    resource to the nation's building industry, and a major contributor to
    the future success of hundreds of young people. It is a demonstration
    model that works, and as such deserves to be touted and replicated. We
    hope that its proven success and recognition as a model intervention
    will help enable it to receive continued funding.

                           PRISONER RE-ENTRY PROGRAM

        In its fiscal year 2005 budget proposal, the White House introduced
    a new program called the ``Prisoner Re-entry Initiative,'' with a
    stated focus to ``support activities to help individuals exiting prison
    make a successful transition to community life and long-term
    employment.'' (See fiscal year 2005 Budget Appendix, page 706) This
    program appears to have a focus only on adult offenders, and the budget
    does not clearly state whether youth-focused programs would be eligible
    to participate in the Prisoner Re-entry Program.
        NAHB and HBI support goals of the Prisoner Re-entry program, and
    agree that there is undoubtedly enormous potential for successful
    programming targeting adult offenders. However, we also strongly
    believe that it would be short-sighted policy to exclude adjudicated
    youth from the Department's workforce development efforts, and ill-
    advised to bring its notable successes such as Project CRAFT to an end.
    We believe that any funding targeted to training those who are re-
    entering society must include a component targeted to the youth
    offender population. We believe that the Prisoner Re-entry program, as
    laid out by the Department of Labor, has failed to clarify whether
    youth and youth-focused programs would be eligible for participation in
    the new program.
        As we have stated, the president's newly proposed Prisoner Re-entry
    program has significant potential for helping the adult offender
    community receive important training and job skills. And we believe
    that HBI is well-positioned to participate in an adult-focused program
    through its Project TRADE (Training, Restitution, Apprenticeship,
    Development and Education) program--which is the sister program to the
    youth-focused Project CRAFT. Designed to train and place adult
    offenders in employment in the home building industry, TRADE is
    currently being implemented in Colorado Springs. Project TRADE has
    trained over 500 adult offenders in the residential construction trade
    since 1995 through programs in Maryland, North Carolina, Oregon,
    Pennsylvania, Virginia, Washington, Tennessee and Colorado. We believe
    that Project TRADE's emphasis on adult offenders complements the work
    done by Project CRAFT's emphasis on youth offenders.

                                   CONCLUSION

        NAHB and HBI continue to strongly support the goals of the
    Responsible Reintegration of Youth Offenders program. We also support
    the Department of Labor's interest in targeting a program to adult
    offenders. However, we are concerned that the Department of Labor has
    not clearly laid out which populations would be served by the new
    program. Our own effort to secure from DOL a definitive understanding
    of the eligible populations has resulted in differing opinions and
    further confusion over the program's goals and targets. We believe that
    the Responsible Reintegration of Youth Offenders demonstration program
    has been highly successful, as evidenced by our own success with
    Project CRAFT, and we fervently hope that any proposal supported by
    congressional appropriators will take into account the needs of both
    the youth and adult ex-offender populations, and will clearly lay out
    congressional intent to continue serving the youth ex-offender
    population. We believe it would be an error to overlook the tremendous
    success achieved by the Responsible Reintegration of Youth Offenders
    program, and while we hope that such a move is not the intent of the
    Department of Labor, we urge appropriators to clarify the goals of the
    Prisoner Re-entry program, and to continue supporting those programs
    that target adjudicated youth.
        Again, we thank the subcommittee for this opportunity to share our
    views on the Responsible Reintegration of Youth Offenders program, and
    Prisoner Re-entry Initiative, and look forward to working with you to
    promote training programs that help America's at-risk youth acquire the
    skills they need for successful and productive careers.
                                     ______

        Prepared Statement of the Southern California Elderly Nutrition
                                  Partnership

        Chairman Specter, Ranking Member Harkin, Members of the
    Subcommittee: The Southern California Elderly Nutrition Partnership
    (SOCALENP) is submitting this written testimony in support of a 5
    percent increase in funding for the Older Americans Act Nutrition
    Programs as part of the fiscal year 2005 appropriations bill for the
    Departments of Labor and Health and Human Services.
        SOCALENP is a regional partnership formed by six major providers of
    elderly services in southern California, which serve nearly 2,500,000
    meals annually to 80,000 seniors. We are funded by a grant from the
    Altria Corporation. We came together to strengthen our advocacy voice
    not only on behalf of the seniors we serve in Southern California but
    also for all seniors who benefit from the Older Americans Act nutrition
    programs. It is important to note that these programs are more than a
    meal. They provide an essential link between seniors and their
    communities.
        California has not only the highest population in the nation but
    also the largest number of older citizens of any state. For example,
    California has 10 percent of all persons in the United States over the
    age of 65. California serves the second highest number of both
    congregate and home delivered meals of any state in the nation.
        The President's budget for fiscal year 2005, while providing a $3
    million increase for the nutrition programs, represents only a .2
    percent increase from fiscal year 2004. This means that funding did not
    even come close to keeping up with inflation. In fact, this is a
    chronic problem facing the nutrition programs. Whereas inflation has
    increased by more than 45 percent since 1990, funding for the elderly
    nutrition programs has increased by only 23.8 percent with an
    especially woeful 9 percent increase for the congregate nutrition
    program in that time.
        Furthermore, data for fiscal year 2002 indicates that the programs,
    while serving more seniors, are serving them fewer meals. This defeats
    a primary purpose of the program, which is to be able to provide these
    seniors with one third or more of their RDA's through the program. Data
    provided by AARP indicates that without any adjustment in the
    President's budget just over 5 million congregate and home delivered
    meals nationwide would have to be eliminated in fiscal year 2005. Since
    the underlying Older Americans Act calls for services to be targeted to
    the elderly especially those with the greatest economic need, the loss
    of a meal for this sector of seniors is far more devastating.
        We seek this modest increase primarily to ensure that we and other
    service providers can maintain our commitments to eligible seniors and
    avoid adding to waiting lists either in the congregate or home
    delivered meals program.
        Each member of this Subcommittee knows of Older Americans Act
    nutrition programs operating in their state. They probably have taken
    time to visit one of the sites where meals are served, which we are
    sure left a lasting memory of the need for these services. This program
    has enjoyed tremendous success over more than 30 years. It is a value-
    added proposition providing essential services to seniors and doing so
    in an efficient and localized manner. These highly leveraged federal
    dollars are invested in maintaining the nutritional health and
    independence of our nation's seniors, which helps to reduce
    institutionalization, shorten hospital stays, and allow seniors to
    remain active in their communities.
        We hope you can commit the necessary $30 million to allow this 5
    percent increase to be achieved in fiscal year 2005. We believe our
    request is modest and fiscally responsible when one considers the
    return on these funds both in terms of its preventive value to the
    seniors and the ability of service provider to leverage other support
    for the programs. These programs are truly more than a meal.
                                     ______

     Prepared Statement of the Association for Professionals in Infection
                            Control and Epidemiology

        Thank you for this opportunity to submit testimony on behalf of the
    Association for Professionals in Infection Control and Epidemiology
    (APIC).
        All of us will at some point be admitted to a hospital--or will
    visit our loved ones while they receive care at a health care facility.
    Our hospitals, the very institutions we depend upon to save our lives,
    are fighting for their survival. In recent years, only the highest risk
    patients are admitted--those individuals that require the highest level
    of care. Unfortunately, many facilities are facing severe nursing
    shortages; we have patients waiting for days in Emergency Departments .
    . . not for lack of beds, but for lack of personnel to staff the beds.
        At the very same time, we are being asked to prepare for the
    unthinkable--not just natural disasters but intentional terrorist acts
    against our citizens. As a partner in public health preparedness, we
    are dedicating resources to create the capacity to respond effectively.
    At the very time we are working with our public health partners at the
    local, state and federal levels, we are also being asked--or rather,
    required--to use our extremely limited and precious resources to meet
    unproven, unnecessary regulatory mandates. The most flagrant, and one
    that we thought we had proven had no scientific merit is the recent
    decision by the Administrator of the Occupational Safety and Health
    Administration (OSHA) to enforce the General Industry Respiratory
    Protection Standard (or GIRPS) for potential exposures to patients with
    Mycobacterium tuberculosis (MTB).
        On December 31, 2003, New Years Eve, Assistant Secretary Henshaw
    placed two notices in the Federal Register. The first notice stated
    that due to the fact that TB is at the lowest incidence level in
    recorded history, thanks to CDC guidelines and public health efforts,
    OSHA was withdrawing the proposed rule for preventing occupational
    exposure to tuberculosis. We commended the agency for this decision.
        The second notice stated, however, that OSHA intended to apply the
    General Industry Respiratory Protection Standard to exposure to
    patients with potentially infectious M. tuberculosis.
        OSHA altered its normal course of rulemaking by effecting
    significant regulatory changes without providing any opportunity for
    public review and comment. This decision was not necessary, nor was it
    precipitated by any preexisting requirement. It appears to have been
    done completely at the discretion of the OSHA Administrator.
        It has never been understood or assumed by the health care
    community that the General Industry Respiratory Protection Standard
    would apply to exposure to patients with potentially infectious TB. In
    fact, when the GIRPS was revised in 1998, the language in the standard
    specifically stated that these requirements did not apply to health
    care or to exposure to TB. The health care community therefore relied
    upon the proposed TB rulemaking for public comment regarding
    respiratory protection, instead of commenting on the revision of the
    GIRPS.
        Assistant Secretary Henshaw contends that he cannot reopen a final
    rule for comment, as we are requesting. It is our understanding that
    the OSHA Administrator can, at any time, choose to reopen a rule for
    further consideration, regardless of whether that rule is proposed or
    final. In fact, Secretary Henshaw chose to open the rule on December
    31, 2003, by announcing his decision to include exposure to TB under
    this regulation. It therefore stands to reason that he can open the
    rule again, to allow for public review and comment, as is the normal
    course of action.
        APIC respectfully requests that OSHA delay application and
    enforcement of this standard for occupational exposure to patients with
    potentially infectious TB until at least January 2005, and meanwhile
    pursue avenues to open the rule for public review and comment. It is
    vital that OSHA ensure that its decisions are based on sound scientific
    evidence, and allow for the affected parties to voice their concerns
    about the implications of these actions. We hope the Subcommittee will
    assist us by confronting OSHA on this decision, and require the agency
    to reopen the rule for adequate public consideration and comment.
        We thank you for this opportunity to provide testimony to the
    Subcommittee.
                                     ______

     Prepared Statement of the Mexican-American Opportunity Foundation and
                  the Career Services Center, Kern County, CA

        In Jalisco, Mexico in the year 1976, Roberto and Maria Sanchez had
    a little girl they named Maria. When I was 4 years old my dad brought
    our family of twelve to the USA where they worked as farmworkers to
    support us while my oldest brother took care of us. A year later I
    started kindergarten. I remember my first day. My sister took me to
    school. I grabbed her leg because I didn't want to stay. I attended
    Carl Clemens Elementary School, then Thomas Jefferson Junior High
    School for 3 years. I graduated from there in 1991 and went on to Wasco
    Union High School where I graduated in 1995.
        Three days after I graduated, I married Francisco Yerena. I
    thought, now with my new name, life will be different. In 1999, I gave
    birth to a boy. I named him Francisco. Everything seemed perfect. Being
    a young couple it was hard financially. My husband struggled as a
    seasonal farm worker trying to provide for us. I tried to attend
    Bakersfield College, but due to financial hardship, I had to quit
    school and get a job. I remember when I had my first job at Richland
    pre-school as a substitute teacher's aide and my husband left for
    Mexico to see about his papers. This made it harder for me and my son
    to survive. I knew something had to change.
        I decided to go to the Career Services Center to get a better job.
    I went to my appointment and they gave me a basic skills test. Dinorah
    Castro of Employers' Training Resource called me back about a work
    experience program at the Mexican-American Opportunity Foundation
    training center. I worked there as a receptionist for four months.
    During these four months it was hard on us financially. I traveled
    everyday from Wasco to Bakersfield. At the end of my work day, I picked
    up my son from the babysitter and by the time I got home, it was very
    late. I fixed dinner and spent what time I had with my son. My husband
    finally returned after being gone for eight months and he had to find
    employment which only took him a couple of days.
        I was so happy that the Mexican-American Opportunity Foundation's
    Administrator, Magda Menendez, referred me to the Mexican-American
    Opportunity Foundation pre-school for an interview. It was very
    exciting for me and I was so nervous waiting to hear from them. On
    February 9, 2004, they hired me as a substitute teacher and while I am
    working full time, I also attend Bakersfield College so I can get my
    teaching degree.
                                     ______

                    DEPARTMENT OF HEALTH AND HUMAN SERVICES

        Prepared Statement of the Blue Cross and Blue Shield Association

        The Blue Cross and Blue Shield Association (BCBSA), which
    represents 41 independent, locally operated Blue Cross and Blue Shield
    Plans throughout the nation, is pleased to submit written testimony to
    the subcommittee on fiscal year 2005 funding for Medicare contractors.
        Blue Cross and Blue Shield Plans play a leading role in
    administering the Medicare program. Many Plans contract with the
    federal government to run much of the daily work of paying Medicare
    claims accurately and timely. Blue Cross and Blue Shield Plans serve as
    Part A Fiscal Intermediaries (FIs) and/or Part B carriers and
    collectively process most Medicare claims.
        This testimony focuses on three areas:
        I. Background, including a description of Medicare contractor
    functions;
        II. Current financial challenges facing Medicare contractors; and
        III. BCBSA recommendations for Medicare contractor fiscal year 2005
    funding.

                                 I. BACKGROUND

        Blue Cross and Blue Shield Medicare contractors are proud of their
    role as Medicare administrators. While workloads have soared, operating
    costs--on a unit cost basis--have declined about two-thirds from 1975
    to 2004. In fact, contractors' administrative costs represent less than
    1 percent of total Medicare benefits.
        Medicare contractors have four major areas of responsibility:
        1. Paying Claims.--Medicare contractors process all the bills for
    the traditional Medicare fee-for-service program. In fiscal year 2005,
    it is estimated that contractors will process over 1.1 billion claims,
    nearly 4 million every working day.
        2. Providing Beneficiary and Provider Customer Services.--
    Contractors are the main points of routine contact with Medicare for
    both beneficiaries and providers. Contractors educate beneficiaries and
    providers about Medicare and respond to over 50 million inquiries
    annually.
        3. Handling Hearings and Appeals.--Beneficiaries and providers are
    entitled by law to appeal the initial payment determination made by
    carriers and FIs. These contractors handle nearly 8 million annual
    hearings and appeals.
        4. Special Initiatives to Fight Medicare Fraud, Waste, and Abuse.--
    All contractors have separate fraud and abuse departments dedicated to
    assuring that Medicare payments are made properly. Few government
    expenditures produce the documented, tangible savings of taxpayers'
    dollars generated by Medicare anti-fraud and abuse activities. For
    every $1 spent fighting fraud and abuse, Medicare contractors save the
    government $14.

                        II. CURRENT FINANCIAL CHALLENGES

        Of utmost importance to attaining outstanding performance is an
    adequate budget. Medicare contractors have been underfunded since the
    early 1990's, however, and the largest portion of the contractor
    budget--Medicare operations--faces particularly severe funding
    pressures. Medicare operations activities include claims processing,
    beneficiary and provider education and communications, hearings and
    appeals of claims initially denied, and systems maintenance and
    security.
        The underfunding of CMS and its Medicare contractors has gotten
    even more acute since the passage of the Health Insurance Portability
    and Accountability Act (HIPAA) and other legislation that places new
    responsibilities on contractors, without sufficient resources to
    perform those duties. For example, between 1992 and 2002, Medicare
    benefits outlays increased 97 percent; claims volume increased 50
    percent; yet Medicare operations funding increased a mere 26 percent.
    Contractor staffing only increased by 6 percent during this time even
    though many new responsibilities were added and claims volume continued
    to rise. Clearly funding has not kept pace with additional work. In
    addition, the recently enacted Medicare reform legislation includes
    significant changes that will require additional resources for
    contractors to implement.
        Whenever possible, contractors respond to reduced funding by
    achieving significant efficiencies in claims processing, but it is not
    enough to keep pace with rising Medicare claims volume and diminishing
    funding levels. It should be noted that contractors are already
    extremely efficient. Currently, contractors' administrative costs
    represent less than 1 percent of total Medicare benefits.
        Inadequate budgets for Medicare operations also impact Medicare's
    fight against fraud and abuse. While many think of Medicare operations
    activities as simply paying claims, these activities are Medicare's
    first line of defense against fraud and abuse and are critically linked
    to activities under the separately-funded Medicare Integrity Program
    (MIP). As an example, many of the front-end computer edits (e.g.,
    preventing duplicate payments and detecting inaccurately coded claims
    or claims requiring additional screening) are funded through Medicare
    operations.
        Inadequate funding impacts different functions at different times,
    but always disrupts the integration of all the functional components
    needed to ``get things right the first time.'' It thus results in
    inefficiency and higher costs.

       III. BCBSA FISCAL YEAR 2005 FUNDING RECOMMENDATIONS FOR MEDICARE
                                  CONTRACTORS

        BCBSA is pleased that many Members of this subcommittee recognize
    the need for adequate administrative resources at CMS. We are concerned
    the Administration's fiscal year 2005 budget does not appropriately
    reflect the expected costs to cover Medicare contractor workloads and
    it relies on a proposal for $205 million in new user fees from
    providers. BCBSA urges Congress to take the following steps to allow
    Medicare contractors to meet increased workloads as well as beneficiary
    and provider needs:
    A. Increase Medicare Contractor Operations Funding to $1.81 Billion for
            Fiscal Year 2005
        Medicare contractors continue to face increases in Medicare claims
    volume. Further reductions in administrative costs, as proposed in the
    President's budget, would seriously jeopardize contractors' ability to
    administer Medicare. BCBSA recommends:
                1. Claims processing funding must be maintained
        The President's budget would decrease Part B claims processing
    costs by $0.02 per claim to $0.63 under the assumption that
    standardized electronic transactions under HIPAA will provide savings.
    Part A claims payment remains the same at $0.87. Available contractor
    data through the first quarter of fiscal year 2004 show the HIPAA
    transactions rule has not resulted in lower claims processing costs. In
    fact the average cost for contractors to process a Part B claim is
    $0.73, and over $1 for a Part A claim. Medicare electronic claims
    submission rates were already high prior to HIPAA implementation--98
    percent of Medicare Part A and 84 percent of Medicare Part B. The
    current unit costs for processing Medicare Part B claims must be
    maintained in fiscal year 2005, requiring an additional $15.4 million.
                2. Appeals funding must be enhanced
        The President's budget provides no increase to handle ongoing
    appeals, even though CMS projects the appeals volume will rise in
    fiscal year 2005. Adequate funding is imperative for contractors to
    sufficiently handle the nearly 8 million appeals that providers and
    beneficiaries are expected to submit. BCBSA recommends an additional
    $5.5 million for these important activities.
    B. Increase Medicare Integrity Program (MIP) Funding to $740 Million
        Congress created Medicare Integrity Program (MIP) under HIPAA to
    provide a permanent, stable funding authority for the portion of the
    Medicare contractor budget that is explicitly designated as fraud and
    abuse detection activities. Funding was capped at $720 million for
    fiscal year 2003 and subsequent years, however, despite continuing
    increases in claims volume (15 percent increase in claims is projected
    in fiscal years 2004-2005). This freeze in funding concurrent with
    increases in workload seriously erodes contractors' ability to fight
    fraud and abuse and ensure the accuracy and appropriateness of Medicare
    payments.
        Contractors' enhanced anti-fraud and abuse efforts due to MIP
    funding have contributed to the significant decline in improper claims
    and deficient documentation submitted by providers. In addition, MIP
    saves money. HHS data shows a $14:1 return on the investment.
                1. MIP Funding Should Be Increased
        BCBSA urges Congress to authorize an immediate increase in the MIP
    appropriation to $740 million for fiscal year 2005, with provision for
    automatic increases in future years. Medicare contractors need these
    resources to effectively combat Medicare waste, fraud and abuse and to
    keep pace with rising workloads. MIP contributes to the decline in
    improper claims submissions and it saves Medicare money. HHS data show
    a $14:1 return on the investment.
    C. Reject New User Fees
        BCBSA is very concerned that once again CMS recommends new user
    fees of $205 million from doctors, hospitals and other providers to
    support contractor operations. History has shown user fees to be an
    unpredictable stream of funding. In order for contractors to maintain
    performance, funds must be consistent and reliable.
        Congress has consistently rejected user fees similar to those
    recommended in the President's budget. Congress should reject them
    again and provide $1.81 billion in appropriated funds for Medicare
    contractors and $740 million for MIP.

                                               MEDICARE CONTRACTOR BUDGET
                                                [In millions of dollars]
    ----------------------------------------------------------------------------------------------------------------
                                                                                       Fiscal year
                                                                   -------------------------------------------------
                                                                                           2005
                                                                          2004        administration    2005  BCBSA
                                                                                      recommendation  recommendation
    ----------------------------------------------------------------------------------------------------------------
    Medicare Operations...........................................            1,701            1,704         1,814.7
    Medicare Integrity Program....................................              720              720           740.0
                                                                   -------------------------------------------------
          Total Contractor Budget.................................            2,421            2,514         2,555.0
    ----------------------------------------------------------------------------------------------------------------

                                     ______

            Prepared Statement of the American Diabetes Association

        Thank you for the opportunity to submit testimony on the important
    issue of funding the diabetes program at the Centers for Disease
    Control and Prevention (CDC) and diabetes research at the National
    Institutes of Health (NIH). Our government needs to significantly
    increase diabetes funding at these agencies not only for the 18 million
    Americans who currently have diabetes, but also for the 40 million who
    are at high risk for developing diabetes in the immediate future.
        The Association is aware that the Subcommittee is in a particularly
    difficult economic position this year. For that reason, the Association
    is asking the Subcommittee to adopt one request that is feasible even
    under the proposed budget numbers: the American Diabetes Association
    strongly urges the Subcommittee to add an additional $10 million to the
    budget of the Division of Diabetes Translation at CDC.
        Diabetes is a serious disease, and is a contributing and underlying
    cause of many of the diseases on which the federal government spends
    the most health care dollars. Diabetes is a significant cause of heart
    disease (which costs our nation $183.1 billion each year), a
    significant cause of stroke ($43.3 billion each year), the leading
    cause of kidney disease ($40.3 billion). Diabetes is also the leading
    cause of adult-onset blindness and lower limb amputations.
    Additionally, aside from all of these related conditions, diabetes
    alone costs our nation $132 billion a year.
        Approximately 42,000 people suffering from diabetes live in each
    congressional district. The following illustrates how diabetes affects
    your district in realistic terms:
      --177 of your constituents will develop heart disease this year
            because of diabetes.
      --154 of your constituents will develop end stage renal disease this
            year because of diabetes.
      --129 of your constituents will lose a foot or leg this year because
            of diabetes.
      --55 of your constituents will go blind this year because of
            diabetes.
        Given the systemic damage diabetes imposes throughout the body, it
    is no surprise that the life expectancy of a person with the disease
    averages 10-15 years less than that of the general population.
        Unfortunately, the spread of diabetes will only get worse in the
    coming years unless we see a significantly larger funding commitment by
    the federal government. Indeed, a CDC report issued in January of this
    year finds that the prevalence of diabetes nationwide increased by over
    60 percent between 1990 and 2001. If diabetes keeps increasing at this
    rate, its prevalence will double in just over 15 years.
        The Association hopes that an additional $10 million this year for
    the Division of Diabetes Translation--a request strongly supported by
    the Congressional Diabetes Caucus, comprised of 280 Members of
    Congress--would simply be the first step in a 5-year effort to double
    to budget of the Division. Although the medical research community has
    made tremendous strides in the area of diabetes over the past two
    decades, the benefits of this research have not been fully realized by
    a majority of the Americans affected by this disease. The federal
    government must commit more resources to ensure that important research
    findings are effectively and adequately translated into public health
    interventions. To this end, we believe strongly in the work funded by
    the Division of Diabetes Translation.
        However, the Division's fiscal year 2004 budget of $67 million--and
    the President's $67 million request for fiscal year 2005--represents a
    miniscule commitment to diabetes prevention and control. Indeed, for
    every $1 that diabetes costs this country, the federal government
    currently invests less than $.01 to help Americans prevent and manage
    this deadly disease.
        In 2003 the Division provided support for more than 50 state- and
    territorial-based diabetes control programs to reduce the complications
    associated with diabetes. However, funding constraints required the
    Division to provide severely limited support to 26 states, 8
    territories, and D.C. for capacity-building diabetes programs. Slightly
    more substantive support was provided to the other 24 states for basic
    implementation programs. Although every state and territory has at
    least a capacity-building program, unfortunately these programs do not
    even come close to addressing the needs statewide. Instead, they simply
    serve as a rudimentary framework upon which a more comprehensive
    program can be built.
        CDC also conducts other activities to help people currently living
    with diabetes. For example, CDC works with NIH to jointly sponsor the
    National Diabetes Education Program (NDEP), which seeks to improve the
    treatment and outcomes of people with diabetes, promote early
    detection, and prevent the onset of diabetes. In addition, CDC funds
    work at the National Diabetes Laboratory to support scientific studies
    that will improve the lives of people with diabetes.
        Even while the Division of Diabetes Translation conducts a number
    of activities to help people with diabetes, it suffers a similar
    problem as its NIH counterpart, NIDDK. Compared to other diseases,
    diabetes remains significantly underfunded at CDC. If adequately
    funded, the Division would be able to fund a basic implementation
    program in every state as well as conduct and fund additional projects
    to assist people with diabetes. Without fully-funded diabetes programs
    and projects in all parts of the country, it will be exceedingly
    difficult--if not impossible--to control the escalating costs
    associated with diabetic complications and to stem the epidemic rise in
    diabetes rates.
        The American Diabetes Association supports the President's support
    for the Steps to a Healthier U.S. Initiative, and is encouraged that
    this program focuses--among other things--on obesity and diabetes. We
    strongly believe, though, that funds made available for this new
    Initiative should not take away from funds that would otherwise be made
    available to the Division of Diabetes Translation. State Diabetes
    Prevention and Control Programs--when provided with enough funding--are
    proven commodities that have been extremely successful in helping
    Americans prevent and manage their diabetes. Americans in every state
    should have access to such quality programs.
        Chronic diseases, including diabetes, account for nearly 70 percent
    of all health care costs as well as 70 percent of all deaths annually.
    However, less than $1.25 per person is directed toward public health
    interventions focused on preventing the debilitating effects associated
    with chronic diseases, demonstrating that federal investment in chronic
    disease prevention remains grossly inadequate. We cannot ignore those
    Americans who are currently living with diabetes and other diseases.

                            RECENT FUNDING INCREASES

        The American Diabetes Association appreciates that Congress has
    begun to give greater attention to diabetes research at NIH in recent
    years and that the current Administration has proposed an overall
    increase in the NIH budget. However, during much of the past decade,
    diabetes funding has stagnated even while the burden has grown
    significantly. Indeed, from 1987-2001, appropriated diabetes funding as
    a share of the overall NIH budget has dropped by more than 20 percent
    (from 3.9 percent to 2.9 percent) while the death rate due to diabetes
    has increased by more than 40 percent. Thankfully, the past 4 years
    have brought larger increases in diabetes funding than we had seen over
    the majority of the decade. Only over these years did the growth in
    diabetes research funding finally keep pace with the growth of the
    overall NIH budget. At a time when diabetes is exploding across our
    nation, it remains essential that we increase the research funding
    levels for diabetes.
        Mr. Chairman, we appreciate the increases of the last few years.
    Congress should be proud of the bi-partisan support for the effort to
    double the NIH budget. But this should not equate to an automatic
    institute-by-institute doubling.
        Some institute budgets are larger not only due to scientific
    opportunities, but due to special consideration in years past.
    Unfortunately, across-the-board percentage increases make it difficult,
    if not impossible, to address funding shortfalls for diseases that now
    have promising scientific opportunities. Diseases like diabetes that
    have not received funding commensurate with their national burden, as
    well as with existing scientific opportunities, continue to fall behind
    as a result of this funding strategy.
        Across-the-board increases for all institutes simply do not allow
    the Congress, or the nation, to deal with the serious problem of
    diabetes anytime soon. While on the surface across-the-board increases
    appear equitable to everyone, it actually perpetuates inequity in
    absolute dollar terms. In reality, a 15 percent increase means much
    more for diseases and institutes with large budgets, and far less for
    diseases and institutes with small budgets.
        Continuing with an across-the-board approach for Institute funding
    means that these discrepancies in funding will continue to grow. This
    is not inherently bad so long as the difference accurately reflects the
    scientific opportunities and health impact of disease on the nation.
    But in the case of diabetes at least, it does not.
        The net effect of an across-the-board approach is that past funding
    legacies still affect the funding priorities at NIH to this day. By not
    constantly making an honest assessment of the health challenges faced
    by our nation and by not looking harder at the scientific opportunities
    facing the research community, NIH has perpetuated an inequality in
    funding based on decisions made many years before.

                                   CONCLUSION

        I firmly believe that we could rapidly move toward curing,
    preventing, and managing this disease by increasing funding for
    diabetes programs and research both at CDC and NIH. Your leadership can
    help accomplish this goal.
        The American Diabetes Association strongly urges the committee and
    Congress increase the budget of the Division of Diabetes Translation by
    $10 million in fiscal year 2005 as the first step in a 5-year doubling
    plan. A doubling of the Division's budget would allow the Division to
    finally implement a Basic Implementation Diabetes Prevention and
    Control Program in every state and territory, thus moving the
    government in the direction of truly helping all Americans with
    diabetes. Additionally, we urge the Subcommittee to increase funding at
    NIH for diabetes research as much as possible in these strict economic
    times.
        Speaking on behalf of the 18 million Americans with diabetes--a
    disease that crosses gender, race, ethnicity and political party; a
    disease that is among the most costly, debilitating, deadly and
    prevalent in our nation; and a disease that is exploding throughout our
    nation--I appreciate the opportunity to submit this testimony. The
    American Diabetes Association is prepared to answer any questions you
    might have on these important issues.
                                     ______

          Prepared Statement of the American Society for Microbiology

        The American Society for Microbiology (ASM), the largest single
    life science society with 43,000 members, is pleased to submit
    testimony on the fiscal year 2005 budget for the Centers for Disease
    Control and Prevention (CDC). The CDC is the nation's lead agency for
    protecting the health and safety of the public, both nationally and
    globally. Threats to public health and security have steadily increased
    in number and complexity over time, despite medical successes and
    technical innovation. The work of the CDC is of unprecedented
    importance in safeguarding public health.
        The ASM is concerned that funding for CDC is not keeping pace with
    its growing responsibilities to address new health threats. The $6.9
    billion fiscal year 2005 request for the CDC is a 2.8 percent reduction
    below last year's $7.1 billion. The ASM endorses the CDC Coalition's
    recommendation of $8.1 billion in fiscal year 2005 for CDC, followed by
    annual increases to achieve $15 billion for the agency by fiscal year
    2008. Increased support is crucial to the CDC's primary goals for
    protecting public health: surveillance and response, basic and applied
    research, training and education, and prevention and control.
        The CDC's ability to mobilize rapidly to prevent or contain disease
    is an urgently needed line of defense against the economic and social
    havoc that can result from public health threats. In 2003, the CDC was
    essential in identifying the cause of the Severe Acute Respiratory
    Syndrome (SARS) epidemic in Asia and the first case of human monkeypox
    in the United States. Agency personnel also trained approximately 8,800
    U.S. clinical laboratory staff in terrorism preparedness and response,
    while others investigated numerous outbreaks of infectious and food-
    borne diseases, as well as chronic disease diagnoses among diverse
    populations. Proposed cuts to a number of CDC programs could jeopardize
    the agency's activities to address health threats.
        The ASM is concerned that the proposed fiscal year 2005 budget
    represents no or only slight increases in CDC programs such as emerging
    and re-emerging infectious diseases, antimicrobial resistance and
    domestic HIV/AIDS programs. The ASM also recommends that new
    bioterrorism preparedness initiatives be funded without redirecting
    resources from needed on-going state and local programs, as proposed in
    the fiscal year 2005 budget. By adequately enlarging the CDC
    appropriation, Congress would strengthen significantly our defenses
    against naturally and intentionally caused disease in the United States
    and elsewhere.

                     INFECTIOUS DISEASES AND PUBLIC HEALTH

        The National Center for Infectious Diseases (NCID) supports
    programs to prevent and control endemic, new and reemerging infectious
    diseases in the United States and abroad. The proposed fiscal year 2005
    budget for the CDC includes $400.8 million for infectious diseases, an
    increase of $31.3 million over fiscal year 2004 funding. Most of the
    increase benefits two CDC programs: $27.5 million to expand the CDC's
    Global Disease Detection Initiative to $51 million, and $2 million to
    increase West Nile virus (WNV) research as well as state and local
    health department WNV surveillance and response capabilities. Because
    of increased world trade and travel, nations can no longer ignore any
    type of infectious disease and global strategies have become
    fundamental to CDC's public health activities. The ASM supports the
    budgetary increases proposed for these two programs, but is concerned
    that critical components of the CDC infectious diseases mission also
    need additional resources in the fiscal year 2005 budget.
        In 2003 the Institute of Medicine (IOM) released a strongly worded,
    cautionary report on Microbial Threats to Health. The IOM report points
    out that infectious disease public health needs have been and will
    continue to increase. Between 1973 and 2003, more than three dozen
    newly emerging diseases were identified. Most recently, hantavirus,
    West Nile virus, SARS, bovine spongiform encephalopathy (BSE), and
    monkeypox became known enemies to public health in the United States.
    In the 1990s, the CDC revitalized its infectious disease programs to
    better reflect the emergence of new infectious diseases. By investing
    in partnerships with local and state health departments, academic
    research and teaching institutions, private industries, other federal
    agencies, world health organizations, and health agencies and
    researchers in other nations, the CDC expanded its ability to detect
    and contain infectious disease, as it intensified its own research and
    training programs. The vital need for CDC programs was emphasized
    dramatically last year with the SARS epidemic and hundreds of human WNV
    infections. The need remains as urgent today with concern about BSE and
    avian flu now in the United States.
        Experts predict a major pandemic during this century and the most
    likely source remains influenza. A hallmark of pandemics and many small
    scale emerging infectious diseases is that they are zoonoses. Zoonotic
    diseases, infections which are naturally transmitted between animals
    and man, represent one of the leading causes of illness and death from
    infectious diseases and nearly all emergent episodes of the past 10
    years have involved zoonotic infectious agents. In the United States
    alone, an influenza pandemic could cause an estimated 89,000 to 207,000
    deaths and cost the nation from $71-167 billion in health care costs
    and lost productivity. Additional budgetary resources are needed to
    address issues such as zoonoses and influenza, which were highlighted
    in the IOM report. CDC infectious diseases should be increased by an
    additional $50 million.We recognize that significant investment will be
    required to enhance efforts to address the threat of pandemic influenza
    in order to develop a newer generation influenza vaccine that can be
    quickly produced and deployed, to strengthen the public health
    infrastructure at the state and local levels, and to ensure needed
    vaccines and antiviral medicines are readily available. We recommend
    that the Department of Health and Human Services (DHHS) assess the
    needs for resources to address pandemic flu within the NIH, CDC and FDA
    and coordinate the planning activities.
        The goal of the CDC's new Global Disease Detection Initiative
    within its epidemic services and infectious disease control programs is
    to work faster and better in recognizing and controlling any infectious
    disease threatening public health. The CDC operates in a global arena,
    establishing myriad programs and collaborations beyond the nation's
    borders and sending quick-response assessment teams around the world.
    It recently funded five university schools of public health and three
    non-government organizations to assist malaria-endemic African
    countries, where the disease kills and disables millions. CDC personnel
    provide consistent epidemiological expertise and lab support to nations
    under siege, most recently the Congo (Marburg virus disease), Uganda
    and Gabon (Ebola hemorrhagic fever), Saudi Arabia and Yemen (Rift
    Valley fever), and more. CDC programs will be expanded in five
    countries including Brazil and China and new sites will be created in
    six others, most of them in Africa. The CDC also will continue to be a
    major implementing agency for the U.S. Department of State's Mother to
    Child HIV Prevention Initiative inaugurated last year. The new Global
    Disease Detection initiative includes improvement of the existing
    international surveillance network for influenza, to bolster the early
    warning system for identifying more uncommon viruses.
        The multi-faceted network of disease surveillance in the United
    States expands and changes annually. The CDC last year enhanced its
    surveillance of prion diseases and responded to the first confirmed
    U.S. case of BSE in cattle. Food-borne illness surveillance has grown
    into one of the most extensively used networks: 76 million Americans
    suffer from contaminated foods each year at an estimated cost of over
    $1 billion. The CDC's PulseNet is credited with revolutionizing food-
    borne surveillance in this country and overseas; recently it was
    expanded to incorporate a total of 21 participating countries. In 2003,
    it was critical in identifying U.S. outbreaks of salmonellosis from
    tomatoes and eggs, E. coli O157 infection from beef, and listeriosis
    from raw milk cheese. The CDC coordinates U.S. influenza surveillance
    and recently expanded its sentinel surveillance sites through one of
    many data-collecting networks. The 891 influenza sites will not only
    alert officials to impending flu epidemics, but also to other
    respiratory diseases.
        Effective as surveillance networks are in preventing further spread
    of disease, protecting the public must stress prevention through
    effective education and science-based efforts. For instance, the CDC
    supplies funding to most states to promote appropriate use of
    antibiotics and thus limit the rising medical costs associated with
    antibiotic resistance. The agency has implemented a National Hepatitis
    C Prevention Strategy by establishing coordinators in all 50 state
    health departments. It developed guidelines for the prevention of
    perinatal group B streptococcal disease that have resulted in a 70
    percent reduction since 1993. An initiative begun last year expects to
    increase HIV testing in this country and enhance prevention, in
    recognition that the rate of new infections (about 40,000 each year)
    has remained stable despite education efforts over the past two
    decades. The ``Advancing HIV Prevention'' approach shifts strategies to
    reduce even further the barriers to early HIV diagnosis and quality
    medical care.
        In response to the 2001 Public Health Action Plan to Combat
    Antimicrobial Resistance (AR), the CDC announced a new extramural
    applied research grant program in 2003, to fund research in the areas
    of mechanisms of dissemination of AR genes, resistance in specific
    human pathogens of public health concern and the characterization of
    strains of community-associated methicillin-resistant Staphylococcus
    aureus (MRSA). The goal of the applied research program is to prevent
    and control the emergence and spread of antimicrobial resistance in the
    United States. Approximately $25 million is being requested for
    antimicrobial resistance research, surveillance, prevention and control
    activities. Considering the magnitude of the problem of antimicrobial
    resistance, additional new funding should be provided in the CDC budget
    to address the alarming issue of antimicrobial resistance.
        Each year about 48,000 Americans die from vaccine-preventable
    diseases; worldwide, these diseases cause an estimated 2.4 million
    childhood deaths. The fiscal year 2005 CDC budget request includes $1.9
    billion for a number of significant vaccination programs. Some, like a
    stockpile of all routinely recommended childhood vaccines, already are
    in progress. Others are new, like an inventory of childhood influenza
    vaccine. The immunization budget will continue to provide global
    immunization activities ($151 million), including the goal of global
    polio eradication by 2005.

                        NATIONAL SECURITY AND BIODEFENSE

        Intentional release of biological weapons troubled the CDC well
    before events of 2001, but the enormity of those attacks brought home
    the grave potential of bioterrorism. The attacks also forced the CDC to
    shift much of its mission focus to bioterrorism preparedness, in
    collaborations with other federal, state, and local health
    organizations. The agency quickly formed emergency response teams,
    established extensive state-of-the-art communication systems, and
    concentrated on basic and applied research related to possible
    bioweapons. The fiscal year 2005 request of $1.1 billion would continue
    CDC efforts related to terrorism preparedness and emergency response at
    a funding level identical to that implemented so effectively in fiscal
    year 2004. The ASM recognizes the dire consequences of bioterrorism and
    supports extensive funding of CDC preparedness programs. However, the
    programmatic impact of removing $105 million from state/local programs
    and $25 million from internal CDC activities to subsidize CDC's
    component in a new cross-agency Biosurveillance initiative deserves
    evaluation.
        The new Biosurveillance Initiative was designed by a coalition of
    federal agencies after the Homeland Security Council identified early
    bioattack warning and surveillance as top priority areas in need of
    improvement. The CDC's contribution, funded at $130 million in the
    proposed fiscal year 2005 budget, includes three new program
    activities, the BioSense surveillance system ($100 million), real-time
    laboratory reporting ($20 million), and expanded border health
    inspection and quarantine capability ($10 million). The BioSense
    program represents a new and largely untested generation of infectious
    disease surveillance that does not rely upon mandatory or voluntary
    case reporting from healthcare providers. Instead, sets of anonymous
    health data will be automatically and electronically gathered from pre-
    determined sources like over-the-counter retail sales of home health
    remedies and visits to emergency rooms. This system is intended to
    provide public health officials with ``a near real-time sense'' of the
    community's health status and to reduce the time needed to detect
    threats from days or weeks to hours.
        The ASM strongly supports two programs of the new initiative which
    build on the importance of trained personnel who respond locally but
    work together within the national goal of preventing bioterrorist
    attacks. One program will expand the CDC's existing Laboratory Response
    Network (LRN) by adding animal diagnostics and food safety capabilities
    to public health, clinical, and private commercial laboratories. The
    other program recognizes that every day more than 2 million people
    travel to or through this country by air, sea or land, and that each
    year, more than 350,000 new immigrants arrive. It adds new,
    strategically placed quarantine stations and creates multidisciplinary
    teams able to respond to infectious disease emergencies at U.S.
    seaports, border crossings, and airports.
        By the end of fiscal year 2004, over $3 billion will have been
    allocated by the CDC to upgrade state and local health departments
    since the 2001 terrorist attacks. Supporting this nationwide community
    of anti-terrorism capability extends the CDC's own efforts and provides
    a greater return on funding investments. CDC support also comes from
    the many wide-ranging communication networks used by the CDC to
    disseminate new scientific information, health risk alerts, and
    population- or disease-specific updates. An example is the Epidemic
    Information Exchange, Epi-X, which provides swift exchange of
    information among more than 2,000 key public health officials
    nationwide. The Public Health Information Network sends health alerts
    and advisory messages to one million recipients, including 90 percent
    of all county public health departments. The Laboratory Response
    Network, to be expanded under the new Biosurveillance Initiative,
    already includes 113 members in the United States and elsewhere; an
    increasing number of these labs could confirm the presence of anthrax,
    tularemia, and smallpox, and more than half are qualified to handle
    some of the most dangerous pathogens.
        The complex CDC infrastructure used to prevent bioterrorism also
    incorporates the training of specialized personnel, the stockpiling of
    crucial supplies needed in mass emergencies, and the careful monitoring
    of pathogens and other toxic agents used in research. Management of the
    Strategic National Stockpile has been returned to the HHS from the
    Department of Homeland Security, as a source of smallpox vaccine and
    other medical supplies shippable to any scene of mass trauma in the
    United States. The Epidemic Intelligence Service grew from 148 officers
    in 2001, to 167 in 2003; 49 of these first-line responders are assigned
    to local or state health departments. With the U.S. Department of
    Agriculture, this year the CDC will inspect 300 laboratories using
    potential bioagents in research, through the Select Agent Program that
    controls the possession and transfer of infectious agents. The SAP
    program should have adequate resources.

                            BUILDINGS AND FACILITIES

        A total of $81.5 million is proposed in the fiscal year 2005 budget
    for CDC buildings and facilities. CDC is undertaking and has made
    substantial progress in a 10-year effort to rebuild its physical
    infrastructure and replace and upgrade decrepit out-dated buildings and
    facilities. State of the art, safe and secure laboratories and
    facilities, as well as modern equipment, are essential to an effective
    CDC response to the broad range of public health threats facing the
    country and the world. The ASM recommends that Congress appropriate
    $250 million for CDC's critical infrastructure needs.
                                     ______

            Prepared Statement of the InterTribal Bison Cooperative

                          INTRODUCTION AND BACKGROUND

        My name is Ervin Carlson, a Tribal Council member of the Blackfeet
    Tribe of Montana and President of the InterTribal Bison Cooperative.
    Please accept my sincere appreciation for this opportunity to submit
    testimony to the honorable members of the Appropriations Subcommittee
    on Labor, Health and Human Services and Education. The InterTribal
    Bison Cooperative (ITBC) is a Native American non-profit organization,
    headquartered in Rapid City, South Dakota, comprised of fifty-three
    (53) federally recognized Indian Tribes located within 18 States across
    the United States.
        Buffalo thrived in abundance on the plains of the United States for
    many centuries before they were hunted to near extinction in the 1800s.
    During this period of history, buffalo were critical to survival of the
    American Indian. Buffalo provided food, shelter, clothing and essential
    tools for Indian people and insured continuance of their subsistence
    way of life. Naturally, Indian people developed a strong spiritual and
    cultural respect for buffalo that has not diminished with the passage
    of time.
        Numerous tribes that were committed to preserving the sacred
    relationship between Indian people and buffalo established the ITBC as
    an effort to restore buffalo to Indian lands. ITBC focused upon raising
    buffalo on Indian Reservation lands that did not sustain other economic
    or agricultural projects. Significant portions of Indian Reservations
    consist of poor quality lands for farming or raising livestock.
    However, these wholly unproductive Reservation lands were and still are
    suitable for buffalo. ITBC began actively restoring buffalo to Indian
    lands after receiving funding in 1992 as an initiative of the Bush
    Administration.
        Upon the successful restoration of buffalo to Indian lands,
    opportunities arose for Tribes to utilize buffalo for tribal economic
    development efforts. ITBC is now focused on efforts to assure that
    tribal buffalo projects are economically sustainable. Federal
    appropriations have allowed ITBC to successfully restore buffalo the
    tribal lands, thereby preserving the sacred relationship between Indian
    people and buffalo. The respect that Indian tribes have maintained for
    buffalo has fostered a serious commitment by ITBC member Tribes for
    successful buffalo herd development. The successful promotion of
    buffalo as a healthy food source will allow Tribes to utilize a
    culturally relevant resource as a means to achieve self-sufficiency.

            FUNDING REQUEST FOR PREVENTATIVE HEALTH CARE INITIATIVE

        The InterTribal Bison Cooperative respectfully requests an
    appropriation for fiscal year 2005 in the amount of $3,000,000 in the
    form of an earmark to the Department of Health and Human Service
    Department's budget. ITBC intends to utilize the funds to conduct a
    national demonstration project focused on the delivery of bison meat to
    Native Americans suffering from diet related diseases.
        The Native American population currently suffers from the highest
    rates of Type 2 diabetes. The Indian population further suffers from
    high rates of cardio vascular disease and various other diet related
    diseases. Studies indicate that Type 2 diabetes commonly emerges when a
    population undergoes radical diet changes. Native Americans have been
    forced to abandon traditional diets rich in wild game, buffalo and
    plants and now have diets similar in composition to average American
    diets. More studies are needed on the traditional diets of Native
    Americans versus their modern day diets in relation to diabetes rates.
    However, based upon the current data available, it is safe to assume
    that disease rates of Native Americans are directly impacted by a
    genetic inability to effectively metabolize modern foods. More
    specifically, it is well accepted that the changing diet of Indians is
    a major factor in the diabetes epidemic in Indian Country.
        Approximately 65-70 percent of Indians living on Indian
    Reservations receive foods provided by the USDA Food Distribution
    Program on Indian Reservation (FDPIR) or from the USDA Food Stamp
    Program. The FDPIR food package is composed of approximately 58 percent
    carbohydrates, 14 percent proteins and 28 percent fats. Studies have
    shown that the FDPIR food package has not been compatible with the
    genetic compositions of Native Americans and has been a major factor in
    the high incidence of diet-related disease among Native Americans.
    Indians utilizing Food Stamps generally select a grain based diet and
    poorer quality protein sources such as high fat meats based upon
    economic reasons and the unavailability of higher quality protein food
    sources.
        Buffalo meat is low in fat and cholesterol and is compatible to the
    genetics of Indian people. ITBC intends to develop a health care
    initiative that would educate Indian Reservation families of the
    benefits of incorporating buffalo meat into their diets. In conjunction
    with educating Reservation families on the benefits of buffalo meat,
    ITBC intends to develop methods to make buffalo meat accessible for
    Indian families and to promote incorporation of buffalo into their
    diets. ITBC intends to coordinate with Reservation health care
    providers in nutritional studies of Reservation populations that
    incorporate buffalo meat into diet packages.
        ITBC believes that incorporating buffalo meat will positively
    impact the diets of Indian people living on Reservations. A healthy
    diet for Indian people that results in a lower incidence of diabetes
    and other diet related illnesses will reduce Indian Reservation health
    care costs and result in a savings for taxpayers.

              FUNDING REQUEST FOR ITBC TRAINING AND LABOR PROGRAM

        The InterTribal Bison Cooperative respectfully requests an
    appropriation for fiscal year 2005 in the amount of $500,000. This
    amount is $400,000 above the fiscal year 2004 appropriation for ITBC
    and is critical to maintain last years funding level and to develop
    ITBC's training and labor program.
        In fiscal year 2004, the ITBC and its member Tribes were funded at
    $100,000, a decrease of $200,000 from the previous year. ITBC is now
    requesting $500,000 for fiscal year 2005 for job training as part of
    ITBC's labor initiative. To insure the success of ITBC's buffalo
    restoration efforts to Indian lands, training for the various jobs
    related to the buffalo projects is essential. Most member Tribes of
    ITBC have reservation unemployment rates of 72 percent. Jobs
    opportunities on most Indian Reservations are limited, low-paying, and
    often seasonal and temporary. The jobs created by buffalo restoration
    to Indian lands will positively impact Tribal unemployment rates and
    the overall Reservation poverty levels. Raising buffalo as an economic
    development effort requires skilled labor in permanent employment. ITBC
    has developed a job training program incorporating on-the-job training
    and work experience for youth that specifically addresses the unique
    needs of managing and maintaining buffalo. ITBC's training program
    further focuses on strengthening the economic development opportunities
    of buffalo restoration with training specific to meat processing,
    veterinary science, wildlife and biological services, infrastructure
    development, business and management training, and the overall
    development of a skilled workforce.
        Sufficient funding for job training is critical to the success of
    the buffalo restoration projects. The increase in funding will ensure
    that ITBC can provide job training, job growth training to ITBC member
    tribes. Without funding at the requested level, the buffalo restoration
    projects have less assurance of success.

                           ITBC GOALS AND INITIATIVES

        In addition to developing a preventative health care initiative,
    ITBC intends to continue with buffalo restoration efforts and the
    Tribal buffalo marketing initiative.
        In 1991, seven Indian Tribes had small buffalo herds, with a
    combined total of 1,500 animals. The herds were not utilized for
    economic development but were often maintained as wildlife only. During
    ITBC's relatively short 10-year tenure, it has been highly successful
    at developing existing buffalo herds and restoring buffalo to Indian
    lands that had no buffalo prior to 1991. Today, through the efforts of
    ITBC, over 35 Indian Tribes are engaged in raising over 15,000 buffalo.
    All buffalo operations are owned and managed by Tribes and many
    programs are close to achieving self-sufficiency and profit generation.
    ITBC's technical assistance is critical to ensure that the current
    Tribal buffalo projects gain self-sufficiency and become profit-
    generating. Further, ITBC's assistance is critical to those Tribes
    seeking to start a buffalo restoration effort.
        Through the efforts of ITBC, a new industry has developed on Indian
    reservations utilizing a culturally relevant resource. Hundreds of new
    jobs directly and indirectly revolving around the buffalo industry have
    been created. Tribal economies have benefited from the thousands of
    dollars generated and circulated on Indian Reservations.
        ITBC has also been strategizing to overcome marketing obstacles for
    Tribally raised buffalo. ITBC is presently assisting the Assiniboine
    and Gros Ventre Tribes of the Fort Belknap Reservation, who recently
    purchased an USDA approved meat-processing plant, with a coordination
    scheme to accommodate the processing of range-fed Tribally raised
    buffalo.

                                   CONCLUSION

        ITBC has proven highly successful since its establishment to
    restore buffalo to Indian Reservation lands to revive and protect the
    sacred relationship between buffalo and Indian Tribes. Further, ITBC
    has successfully promoted the utilization of a culturally significant
    resource for viable economic development.
        ITBC has assisted Tribes with the creation of new jobs, on-the-job
    training and job growth in the buffalo industry resulting in the
    generation of new money for tribal economies. ITBC is also actively
    developing strategies for marketing Tribally owned buffalo. Finally,
    and most critically for Tribal populations, ITBC is developing a
    preventive health care initiative to utilize buffalo meat as a healthy
    addition to Tribal family diets to reduce the incidence of diet-related
    illnesses.
        ITBC strongly urges you to support its request for a $3,000,000
    earmark to the Department of Health and Human Service Department's
    budget to develop the critically needed preventative health care
    initiative utilizing Tribally produced buffalo.
                                     ______

         Prepared Statement of the Medicare Payment Advisory Commission

        The Medicare Payment Advisory Commission (MedPAC) was created by
    the Congress to provide it with independent policy advice and technical
    assistance concerning the Medicare program and other aspects of the
    health care system. To carry out its responsibilities MedPAC requests a
    budget appropriation of $9.905 million for fiscal year 2005. This
    request for a $605,000 increase over the Commission's fiscal year 2004
    appropriation reflects the expanded responsibilities assigned to the
    Commission by the Medicare Prescription Drug, Improvement, and
    Modernization Act of 2003 (MMA) (Public Law 108-173), including 16
    additional reports and the requirement to advise the Congress on the
    new prescription drug benefit. The most significant increases in
    MedPAC's fiscal year 2005 budget will fund data analysis and research
    contracts to meet those requirements.

                                   WHO WE ARE

        MedPAC is a federal advisory commission authorized under section
    1805 of the Social Security Act (42 U.S.C. 1395 b-6), as added by
    section 4022 of the Balanced Budget Act of 1997 (BBA) (Public Law 105-
    33). Broadly defined by statute, the Commission's responsibilities are
    to:
      --consider Medicare payment policies for private plans and
            traditional fee-for-service Medicare,
      --determine the effects of Medicare payment policies on the delivery
            of health care services, and
      --analyze the implications for Medicare of changes in the broader
            health care system.
        MedPAC is a small efficient operation. The Commission consists of
    17 Commissioners, appointed by the Comptroller General of the General
    Accounting Office, who possess expertise in biomedical, health
    services, and health economics research and who draw on their
    experiences as consumers, providers, employers, and payers. The
    Commission meets publicly throughout the year as it develops its
    recommendations. An executive director, analytic and administrative
    personnel staff the Commission. Staff are highly trained health policy
    analysts and economists. The Commission has less than 40 staff and
    outsources 40 percent of its budget for tasks such as data analysis,
    programming, printing, editorial work, and selected research projects
    to maintain efficiencies. We have also achieved efficiencies by
    migrating data analysis to personal computers and moving from printed
    to electronic reports.
        The MMA requires that the expertise of the Commission's membership
    be expanded to include pharmaceuticals, and we expect that to occur
    when new commissioners are appointed in 2004. Over the coming fiscal
    year, MedPAC will make a significant investment in resources to be able
    to provide advice on the implementation of the prescription drug
    benefit and other program changes introduced by the MMA. Judging from
    our experience during consideration of the legislation, we also
    anticipate a significant use of resources to respond to Congressional
    inquiries about the new benefit and program changes.

                                   WHAT WE DO

        Each year, our annual appropriations provide the resources
    necessary to complete the Commission's required activities, including:
      --March report to the Congress. Delivered on March 1 of each year,
            this report includes recommendations on the appropriate levels
            of payment for Medicare providers and policies to address the
            distribution of payments within each payment sector.
      --June report to the Congress. Delivered on June 15 of each year,
            these reports have addressed issues such as Medicare in rural
            America, innovations and variations in the Medicare program,
            and a variety of other topics.
      --Reports required by other legislation. The new Medicare legislation
            requires MedPAC to issues 16 reports on a variety of topics--12
            of which are due during fiscal year 2005.
      --Comments on administrative actions. MedPAC is required to comment
            on payment-related reports that the Secretary submits to the
            Congress and other proposed rules issued by the Centers for
            Medicare & Medicaid Services (CMS).
        To support the Congress, MedPAC also anticipates Congressional
    requests for the following projects not specifically mandated by law:
      --Policy briefs on topics of interest, including issues such as a
            primer on prescription drug formularies, descriptive
            information on beneficiaries eligible for both Medicare and
            Medicaid, information about employer-sponsored insurance
            benefits, and other issues that generate interest throughout
            the year.
      --A Medicare data chartbook in June 2004, similar to the one produced
            in 2003 in response to requests by health committee staff.
      --Requests for data and analysis from the health committee staff
            (more than 100 last year).
             medpac reports provide information and recommendations
        MedPAC's fiscal year 2003 reports informed the Congress on wide
    range of Medicare issues. During the past year, the Commission
    completed our annually mandated March and June reports, eight reports
    mandated under the BBRA and BIPA, and other reports and studies as
    requested by the Congress. In addition, six reports were developed for
    MedPAC by external contractors and issued during 2003, and the
    Commission has submitted written comments to the Secretary of the
    Department of Health and Human Services on nine proposed rules.
        In a program that spends $272 billion, MedPAC's payment update
    recommendations have important implications for the beneficiaries, the
    medical delivery system, and the federal budget. The March 2004 report
    focuses on payment policies and presents recommendations to Congress on
    updating payments to hospitals, physicians, and other providers, as
    well as refinements to their payment systems. It also includes
    refinements to the payments for private plans as well as
    recommendations to add quality incentives to the payment systems for
    end-stage renal disease patients and private plan enrollees.
        The June 2004 report will address a range of issues of importance
    to the Congress as it considers both future legislation and CMS
    implementation of the MMA. The report will address a broad range of
    policy issues, including disease management, the dual eligible
    population, information technology, and an overview of issues
    surrounding implementation of the new drug benefit. It will also
    include analyses of long-term care hospitals, innovations in
    purchasing, and hospices.
        We anticipate production and submission of a Medicare data
    chartbook in June 2004, similar to the one produced in 2003 and as
    requested by health committee staff--although publication will depend
    upon our assessment of those resources we must commit to studies
    mandated by the MMA.
        During the rest of fiscal year 2004 and into 2005, MedPAC will also
    be working on the 16 studies mandated by the MMA. These reports cover
    issues such as the effect of new provisions to aid rural hospitals,
    analysis of the volume of physician services, changes in use of Part B
    drugs by oncology patients, and beneficiary cost sharing in plans. In
    addition, the Institute of Medicine is required to consult with the
    Commission on a study about quality incentives in the payment system,
    and GAO and CMS will collaborate with us on an analysis of specialty
    hospitals.
        MedPAC will also comment on CMS administrative actions and review
    new payment systems for providers such as long-term care hospitals and
    inpatient rehabilitation facilities. The MMA assigned the Secretary
    more than 30 reports on which MedPAC will comment. Given the volume of
    rules and reports the Secretary must promulgate in the coming year to
    implement the new drug benefit and other MMA provisions, we anticipate
    that reviewing those actions will require a substantial amount of
    resources.

       MEDPAC PROVIDES TESTIMONY, BRIEFINGS, AND ASSISTANCE TO HILL STAFF

        During calendar year 2003, the Commission testified before three
    Congressional committees. The Commission chair testified before the
    House Ways & Means, Subcommittee on Health, on the Commission's March
    Report to the Congress (March 6, 2003) and on Medicare cost-sharing and
    supplemental insurance (May 1, 2003). The Commission's executive
    director testified before the Senate Special Committee on Aging on
    disease management in traditional Medicare (November 4, 2003). In March
    2004, the Commission chair testified on improving quality through
    Medicare payment policy before the House Ways & Means, Subcommittee on
    Health.
        The Commission has provided additional support to the Congress.
    From February through April 2003, the Commission briefed the Senate
    Committee on Finance on selected payment systems. On separate
    occasions, the executive director also briefed the members of the House
    Energy and Commerce Committee and the House Rural Caucus. In addition,
    the executive director briefed staff of the rural health caucus on
    rural Medicare provider payments.
        MedPAC staff regularly brief the health committee staff on ongoing
    work by the Commission. This includes a series of conference calls and
    face-to-face meetings prior to each public meeting to discuss research,
    gather feedback, and provide information about Commission deliberations
    and upcoming recommendations. Commission staff has also responded, both
    orally and in writing, to numerous requests from Congressional staff on
    a wide variety of topics. Not including minor requests, Commission
    staff has filled over 100 direct requests for information from
    Congressional staff, involving providing data and other substantive
    analyses or explanations. Staff have also had more than 20 meetings
    with or briefings for Congressional staff on related topics.
        We anticipate our level of support to the Congress including
    testimony, briefings, and technical assistance will increase in the
    next year as issues concerning the implementation and implications of
    new provisions in the MMA become more apparent.

                                    OUTREACH

        During 2003, as in previous years, MedPAC has exchanged information
    and advice with other government entities involved in crafting and
    assessing Medicare policy. We have met and conferred with staff from
    the General Accounting Office, the Centers for Medicare & Medicaid
    Services, the Congressional Budget Office, the Congressional Research
    Service, the Agency for Healthcare Research and Quality, and the
    Assistant Secretary for Planning and Evaluation. Exchanges with these
    government entities will continue so that we coordinate our work and
    minimize redundancy.
        As in past years, MedPAC has continued to gather input to its
    policy deliberations through meetings with outside groups. Members of
    the Commission and staff will continue to meet with outside interest
    groups in order to gather information for MedPAC's findings and
    recommendations. In addition, in order to increase our understanding of
    the health care market and the impact of Medicare payment policy on
    providers, staff have made site visits to gather information. Such
    efforts will continue this year.
        During 2003, Commission staff extended its public outreach through
    speaking at a number of conferences. Another venue for public outreach
    has been staff publication of original articles based on Commission
    research. Members of the staff will continue to reach out to external
    groups through attendance at and presentations to academic and
    professional conferences, as well as publication of articles based on
    work at the Commission. Such efforts increase staff knowledge of the
    broader Medicare policy context and expand public understanding of the
    work of the Commission.

                    MEDPAC RECOMMENDATIONS HAVE BEEN ADOPTED

        The Congress and CMS have adopted MedPAC's recommendations on a
    range of issues. For example, the MMA reflected several of the
    Commission's recent recommendations on dialysis payments, the update
    for home health services, the home health rural add-on, updates to
    payments for services provided at ambulatory surgical centers,
    increases for physician services, and inpatient hospital payments.

                 OUR APPROPRIATION REQUEST FOR FISCAL YEAR 2005

        For fiscal year 2005, MedPAC requests $9,905,000, which is $605,000
    more than the amount requested for fiscal year 2004. Medicare, a more
    than $270 billion program, represents one of the Congress' highest
    priorities. The requested budget of just over $9.9 million to better
    understand the policy concerns for this vital program is both
    justifiable and reasonable. This amount is necessary not only to
    maintain but to increase the current level of analysis, hold Commission
    meetings, develop data, and meet our mandated responsibilities to the
    Congress.
        Our fiscal year 2005 request is driven by several factors. As
    required by our authorizing legislation, during fiscal year 2005 we
    will submit our March and June reports. In addition, we will complete a
    significant number of new tasks, including:
      --Complete 12 mandated reports included in the MMA. In addition,
            MedPAC is required to consult with the IOM, GAO, and CMS on
            other reports mandated in the legislation.
      --Respond to more than 30 payment-related reports submitted to the
            Congress by the Secretary.
      --Increase the analytic scope of the commission to include
            prescription drugs.
        The majority of the increase in MedPAC's budget is for research
    contracts, computer programming, and commercial contracts to accomplish
    these new tasks. External research contracts enhance our efficiency by
    providing access to areas of expertise and additional work force on an
    as-needed basis. Because of MedPAC's increasing workload, access to
    external research contractors is critical to providing timely advice to
    Congress on key Medicare policy issues.
        The increased funding will also enable us to respond to the growing
    volume of informal Congressional requests for information. In addition,
    it has become increasingly clear that the data available to assess the
    Medicare program is inadequate and that we must strive to expand data
    sources and analysis. Fulfilling Congressional requests and expanding
    data sources requires increased staff time and increased computer costs
    for data analysis.
        While we do have significant increases in the expenses discussed
    above, MedPAC has achieved certain economies. We have significantly
    decreased spending on mainframe computer costs by moving data to
    personal computers. In addition, continued migration away from printed
    to electronic reports and internet-based resources has saved a
    significant amount of money for printing and reproduction. We
    anticipate these expenses will decline even further in fiscal year 2005
    even though we will be delivering 12 additional reports to the Congress
    during the fiscal year.
        More reports, more requests for information, and more timely data
    lead to an increase in our budget request. Small size, efficient
    operations, and increased economies enable us to take on increased
    responsibilities within, what is by any measure, a small budget in
    relation to the increased leverage it gives the Congress on the
    Medicare program.
                                     ______

                  Prepared Statement of Research to Prevention

        Since June 2003, the Centers for Disease Control and Prevention
    (CDC) has undertaken a strategic planning effort to prepare the agency
    to address the health challenges of the 21st century. The Futures
    Initiative has involved gathering information from thousands of
    partners, stakeholders and the public regarding CDC's organization,
    scope and reach. Key findings include a need to strengthen CDC's role
    in health promotion and prevention of disease, disability, and injury.
    To accomplish this, one overarching goal was identified--``All people
    will achieve their optimal lifespan with the best possible quality of
    health in every stage of life.''
        Research to Prevention, a national coalition committed to improving
    the nation's health through prevention, wholeheartedly concurs with
    this goal and urges Congress to provide sufficient resources to permit
    CDC to maximize its chronic disease prevention efforts throughout the
    country. The coalition's members include the nation's premier voluntary
    health organizations and health provider organizations, including: the
    American Association of Diabetes Educators, the American Cancer
    Society, the American Diabetes Association, the American Heart
    Association, the Arthritis Foundation, the Chronic Disease Directors,
    the Epilepsy Foundation, the Lance Armstrong Foundation, Partnership
    for Prevention, Prevent Blindness America and the National Health
    Council.
        Research to Prevention aims to make prevention and control of
    chronic diseases and disability a national policy and funding priority
    by educating policymakers and advocating for vital funding increases
    for comprehensive public health programs that address the nation's
    leading causes of death and disability. Research to Prevention is
    seeking a $340 million increase in funding in fiscal year 2004 for
    State-based chronic disease prevention and control programs at the
    Centers for Disease Control and Prevention (CDC). We also support an
    increase in funding for the Youth Media Campaign, Racial and Ethnic
    Approaches to Community Health (REACH), the Preventive Health and
    Health Services Block Grant, as well as Secretary Thompson's Steps to a
    Healthier U.S. initiative. The attached chart provides detail on the
    specific requested funding levels.
        Chronic diseases are responsible for more than 70 percent of all
    U.S. deaths and more than 75 percent of all health care expenditures in
    the United States. The number of deaths alone, however, fails to convey
    the full picture of the toll of chronic disease. More than 125 million
    Americans live with some form of chronic disease, and millions of new
    cases are diagnosed each year. These serious conditions are often
    treatable but not always curable. Thus, an even greater burden befalls
    Americans from the disability and diminished quality of life resulting
    from chronic disease.
        One-third, or approximately $300 billion, of the nation's health
    care budget is spent on older Americans who often have preventable or
    controllable chronic diseases and conditions. Much of the disability in
    old age can be delayed or prevented altogether, potentially improving
    quality of life and saving the nation billions of dollars in health
    care expenditures and the costs of long-term care.
        Chronic disease is not just an issue among older adults. One-third
    of the years of potential life lost before age 65 is due to chronic
    disease. The obesity epidemic in this country is taking its toll on
    young people. Since 1980, obesity rates have doubled among children and
    tripled among adolescents. Unhealthy diet and physical inactivity play
    an important role in many chronic diseases and conditions. As our lead
    prevention agency, CDC needs additional resources to work with states,
    schools and local communities to implement promising approaches for
    preventing obesity.
        To curb the excessive burden of chronic diseases, both in human and
    economic terms, the nation must ensure that research advances are
    applied, evaluated and implemented at the state and local level with
    comprehensive, sustainable prevention programs. CDC plays an essential
    role in translating and delivering at the community level what is
    learned from research--especially ensuring that those populations
    disproportionately affected by chronic disease and disabilities receive
    the benefits of our nation's investment in medical research. Effective
    interventions need to be developed and implemented to reduce the
    disabling consequences of these diseases, including blindness, kidney
    failure, paralysis, fractures, joint deterioration, and limb loss.
        Research to Prevention stands ready to work with the Members of
    this Subcommittee to help make it possible for every state in the
    nation to develop and deliver health promotion, health education and
    disease prevention programs to address chronic diseases and disability.
    By committing a minimum increase of $340 million in fiscal year 2005
    for state-based chronic disease programs, we can work to make this a
    reality.
        All states need and deserve statewide implementation grants for the
    leading causes of death and disability (heart disease and stroke,
    diabetes, cancer and arthritis) and their risk factors (physical
    activity, nutrition, obesity, and tobacco use). Emerging chronic
    conditions, such as epilepsy and complications associated with chronic
    disease, such as vision loss and oral disease must also be addressed.
    States also need to track progress statewide through disease registries
    and behavioral surveys, including the stroke and cancer registries and
    the Behavioral Risk Factor Surveillance System (BRFSS). The BRFSS
    information is essential for planning, conducting and evaluating public
    health programs at the national, state and local levels. Additionally,
    private organizations rely on the survey data to develop health
    promotion programs to reduce the prevalence of unhealthy behaviors and
    to document their effectiveness.

                              YOUTH MEDIA CAMPAIGN

        Research to Prevention supports a $89 million increase above fiscal
    year 2004 to restores funding to its $125 million level in fiscal year
    2001. This campaign--known as VERB--is designed to give kids a positive
    advertising message about being physically active through paid media,
    partnerships, and community efforts. In February 2004, the CDC released
    the first survey results that indicate physical activity among the
    nation's youth is increasing as a result of the VERB campaign. A 34
    percent increase in weekly free-time physical activity sessions among
    8.6 million children ages 9-10 in the United States. R2P believes that
    VERB should be expanded so that even more children will be exposed to
    healthy messages and increase their chances of becoming more physically
    active.

                                     REACH

        Research to Prevention supports a $12.7 million increase in the
    REACH program for a total of $50 million in fiscal year 2005. Launched
    in 1999, the REACH 2010 is the cornerstone of CDC's efforts to
    eliminate racial and ethnic disparities in health. This project is
    designed to eliminate health disparities in cardiovascular disease,
    immunizations, breast and cervical cancer screening and management,
    diabetes, HIV infections/AIDS, and infant mortality. The racial and
    ethnic groups targeted by REACH 2010 are African Americans, American
    Indians, Alaska Natives, Asian Americans, Hispanic Americans, and
    Pacific Islanders. REACH 2010 is unique because it works across public
    and private sectors to conduct community-based prevention research to
    identify the causes of health disparities. Culturally appropriate,
    community-driven programs are critical for eliminating racial and
    ethnic disparities in health. A $50 million allocation would support
    expansion of community-driven programs and evaluation of successful
    efforts to build capacity; target action; conduct community/systems
    change; eliminate health disparities; and translate and disseminate
    results.

               PREVENTIVE HEALTH AND HEALTH SERVICES BLOCK GRANT

        Research to Prevention supports an increase of $76.7 million to
    additional clinical services, preventive screening, laboratory
    research, outbreak control, workforce training, public education, data
    surveillance, and program evaluation. The funds are used to target the
    265 national health objectives in Healthy People 2010 which address
    cardiovascular disease, cancer, diabetes, emergency medical services,
    injury and violence, infectious disease, environmental health,
    community fluoridation, and sex offenses. Because of the allowed
    flexibility in the use of the funds, states allocate their block grant
    resources to address areas of greatest need and target populations. A
    strong emphasis is placed on programs for adolescents, communities with
    limited health care services, and disadvantaged populations. Since so
    many states lack funding to address many of the chronic diseases,
    states have used much of their block grant money to address the leading
    killers. This program facilitates coordination between states and their
    local governments since approximately 43 percent of PHHS block grant
    funds were distributed by the states to meet county and local public
    health needs.

                 THE ADMINISTRATION'S HEALTHY STEPS INITIATIVE

        Research to Prevention supports the Secretary's goals of reducing
    the burden of chronic diseases and applauds him for his continuing
    commitment to chronic disease prevention. The requested increase of
    $81.3 million to support the Steps to a Healthier U.S. Initiative can
    assist the states, local governments and community organizations to
    increase their efforts to improve health and well being. While the
    states already distribute approximately 75 percent of their CDC
    resources directly to community programs, they still lack the resources
    necessary to reach many of their communities. States are the engine to
    reach those communities and the Secretary's Steps Initiative provides
    the gas for the engine. State-based chronic disease funding and the
    Steps Initiative need to advance together if we are to reduce death and
    disability and enhance quality of life.
        Research to Prevention thanks the Subcommittee for the opportunity
    to submit testimony and stands ready to work with all Members to reduce
    and prevent the economic and social burden of chronic disease on our
    nation.

                         RESEARCH TO PREVENTION MEMBERS

        American Association of Diabetes Educators; American Cancer
    Society; American College of Preventive Medicine; American Dental
    Association; American Diabetes Association; American Heart Association;
    American Public Health Association; American School Health Association;
    Arthritis Foundation; Association of State and Territorial Chronic
    Disease Program Directors; Association of State and Territorial
    Directors of Health Promotion and Public Health Education; Coalition of
    National Health Education Associations; Center for Science in the
    Public Interest; Eli Lilly and Company; Epilepsy Foundation; Lance
    Armstrong Foundation; Missouri Primary Care Association; National
    Health Council; National Kidney Foundation, Inc.; Oncology Nursing
    Society; Partnership for Prevention; Prevent Blindness America; Society
    for Public Health Education; and YMCA of the USA.

         CDC CHRONIC DISEASE PROGRAMS--FISCAL YEAR 2005 RECOMMENDATIONS
                            [In millions of dollars]
    ------------------------------------------------------------------------
                                               Fiscal year          Increase
                                     ------------------------------   over
                                                                     fiscal
                                        2003      2004    2005 R2P    year
                                       enacted   enacted   targets    2004
    ------------------------------------------------------------------------
    NATIONAL CENTER CHRONIC DISEASE      963.1   1,024.4   1,613.5     589.0
     PREVENTION AND HEALTH PROMOTION
    Chronic Disease Line............     790.5     853.8   1,353.5     499.6
    Arthritis.......................      15.6      15.8      25.0       9.2
        Lupus.......................       1.0       1.0  ........  ........
    Cancer Prevention and Control...     287.8     313.6     410.0      96.4
        B&C Mort Prev...............     199.4     209.5     250.0      40.5
        WISEWOMAN...................      14.0      14.0      20.0       6.0
        Comprehensive Cancer........       9.4      11.9      25.0      13.1
        Ovarian.....................       4.4       4.9      10.0       5.1
        Prostate....................      14.0      15.5      20.0       4.5
        Colorectal..................      13.4      14.9      25.0      10.1
        Skin........................       1.6       2.2      10.0       7.8
        Registries..................      45.6      49.7      65.0      15.3
    Community Health Promotion......      22.1      24.0      37.3      13.3
        BRFSS.......................       6.9       8.1      18.0      10.0
    Com Health Promotion............       8.9       8.3       8.3  ........
        Compl/Alt Med...............       1.7       1.8       2.0       0.2
        Glaucoma/Vision Screening...       4.7       5.8       9.0       3.2
    Diabetes........................      63.3      66.9     150.0      83.1
    Epilepsy........................       7.5       8.2      13.2       5.0
    Heart Disease and Stroke........      43.0      45.7      80.0      34.3
        Paul Coverdell Stroke              5.0       5.0       5.0  ........
         Registry...................
    Nutrition/Phys Activity/Obesity.      34.1      44.7      75.0      30.3
        Micronutrients..............       5.0       0.4  ........  ........
        Iron Overload...............       0.4       0.4  ........  ........
    Oral Health.....................      11.7      12.4      20.0       7.6
    Prevention Research Centers.....      26.8      26.7      26.7  ........
    Safe Motherhood /Infant Health..      54.0      53.9      53.9  ........
    School Health...................      57.8      62.4      82.4      20.0
        Coordinated School Health...      10.8      15.7      35.7      20.0
        HIV.........................      47.0      46.7      46.7  ........
    Tobacco.........................      99.9      99.7     130.0      30.3
    ADDITIONAL TARGETS:
        STEPS.......................      15.4      43.7     125.0      81.3
        Youth Media Campaign........      51.0      35.8       5.0      89.2
        PHHS BLOCK GRANT............     135.0     133.3     210.0      76.7
        REACH.......................      37.6      37.3      50.0      12.7
    ------------------------------------------------------------------------

                                     ______

        Prepared Statement of the Association of University Programs in
                         Occupational Health and Safety

        Thank you for the opportunity to present testimony to the
    Subcommittee in support of funding for the National Institute for
    Occupational Safety and Health (NIOSH) and for the NIOSH-funded
    Education and Research Centers (ERCs). My name is Jackie Agnew, and I
    am the Director of the Education and Research Center at Johns Hopkins
    University Bloomberg School of Public Health.
        I am testifying on behalf of the Association of University Programs
    in Occupational Health and Safety (AUPOHS), the organization that
    represents 16 multi-disciplinary, NIOSH-supported, university-based
    Education and Research Centers (ERCs). The ERCs are regional resources
    for all parties involved with occupational health and safety--industry,
    labor, government, academia, and the general public. The ERCs play the
    following roles in helping the nation reduce losses associated with
    work-related illnesses and injuries:
      --Prevention Research.--Developing the basic knowledge and associated
            technologies to prevent work-related illnesses and injuries.
      --Professional Training.--Graduate degree programs in Occupational
            Medicine, Occupational Health Nursing, Safety Engineering, and
            Industrial Hygiene to provide qualified professionals in
            essential disciplines.
      --Research Training.--Preparing doctoral-trained scientists who will
            respond to future research challenges and who will prepare the
            next generation of occupational health and safety
            professionals.
      --Continuing Education.--Short courses designed to enhance
            professional skills and maintain professional certification in
            occupational health and safety disciplines. These courses are
            delivered on-campus at the 16 ERCs as well as through distance
            learning technologies.
      --Regional Outreach.--Responding to specific requests from local
            employers and workers on issues related to occupational health
            and safety.

         THE SCOPE OF THE PROBLEM OF OCCUPATIONAL INJURY AND ILLNESSES

        The many causes of occupational injury and illness represent a
    striking burden on America's health and well-being. Yet, despite
    significant improvements in workplace safety and health over the last
    several decades:
      --There were 5,524 occupational fatalities in 2002, for an average of
            15 workers per day who died from work-related injuries; and
      --More than 4.7 million workers sustained work-related injuries and
            illnesses in the private sector alone in that same year.
      --The economic toll of work-related illness and injury on the
            nation's employers, workers and their families, and society
            overall reached an estimated $45.8 billion in 2001, with $137.4
            to $229 billion more in indirect costs.
        This is an especially tragic situation because most work-related
    fatalities, injuries and illnesses are preventable with effective,
    professionally directed, health and safety programs. Although our
    nation has made tremendous progress in reducing occupational illnesses
    and injuries during the past 30 years, leading to a decline in the rate
    of total recordable cases from 11.0 to 7.1 cases per 100 full-time
    workers between 1973 to 1997, the burden of occupational illnesses and
    injuries remains unacceptably high.
        Furthermore, we do not live in a static environment. The rapidly
    changing workplace continues to present new health risks to American
    workers that need to be addressed through occupational safety and
    health research. For example, by the year 2005, an estimated 33 percent
    of the U.S. workforce will be 45 years or older. Work-injury fatality
    rates begin increasing at age 45, with rates for workers 65 years and
    older nearly three times as high as the average for all workers.
    Despite being the primary federal agency for occupational disease and
    injury prevention in the nation, NIOSH receives only about $1 per
    worker per year for its mission of research, professional education,
    and outreach.

                               HOMELAND SECURITY

        The heightened awareness of terrorist threats, and the increased
    responsibilities of first responders and other homeland security
    professionals, illustrates the need for strengthened workplace health
    and safety in the ongoing war on terror. The NIOSH ERCs play a crucial
    role in preparing Occupational Safety and Health (OSH) professionals to
    identify and ameliorate vulnerabilities to terrorist attacks and other
    workplace hazards and increase readiness to respond to biological,
    chemical, or radiological attacks.
        Thanks to the Subcommittee's support for occupational health and
    safety research, NIOSH developed more effective methods to test for
    anthrax contamination in congressional offices. These procedures were
    quickly adopted by the Coast Guard, the FBI, and government building
    contractors.
        In addition, occupational health and safety professionals have
    worked for several years with emergency response teams to minimize
    losses in the event of a disaster. NIOSH took a lead role in protecting
    the safety of emergency responders in New York City and Virginia, with
    ERC-trained professionals applying their technical expertise to meet
    immediate protective needs and conducting ongoing activities to
    safeguard the health of clean-up workers.
        In the face of the growing concerns surrounding homeland security,
    ERCs have rapidly upgraded research coordination and expanded training
    opportunities, including sponsoring national and regional forums on
    response to bioterrorism and other disasters.

              THE NEED FOR OCCUPATIONAL SAFETY AND HEALTH MANPOWER

        The NIOSH ERCs were reviewed by the DHHS Office of the Inspector
    General in 1995. The resulting report affirmed the efficacy of the ERCs
    in producing graduates who pursue careers in occupational safety and
    health. Since the ERCs are regional, they are ready to respond to
    various trends in industries throughout the country. And because they
    provide training that is multi-disciplinary, ERCs graduate
    professionals who can protect workers in virtually every walk of life.
    Despite the recognized success of the ERCs in training qualified
    occupational health and safety professionals, the country continues to
    have ongoing shortages. The manpower needs are especially acute for
    doctoral-level trained professionals who can conduct research and help
    in implementing the National Occupational Research Agenda.
        In May 2000, the Institute of Medicine issued its final report on
    the education and training needs for occupational safety and health
    (OSH) professionals in the United States. This report concluded that
    ``the continuing burden of largely preventable occupational diseases
    and injuries and the lack of adequate OSH services in most small and
    many larger workplaces indicate a clear need for more OSH professionals
    at all levels.'' Specific needs identified by the IOM report include:
      --An insufficient number of doctoral-level graduates in occupational
            safety, thus limiting the nation's capacity to perform
            essential research and training in traumatic injury prevention.
      --An inability to attract physicians and nurses into formal OSH
            academic training programs, thus limiting the resources needed
            to deliver occupational health services.

              NEW NIOSH INITIATIVE: MOVING RESEARCH INTO PRACTICE

        The health of the U.S. economy depends upon a healthy and
    productive workforce. Through its targeted research and prevention
    programs, as well as its programs of tracking diseases, injuries, and
    hazards; capacity building; and rapid dissemination of useful
    information, NIOSH contributes to the nation's progress in reducing
    workplace injuries and illnesses and enhancing the health and safety of
    U.S. workers.
        In 1996, NIOSH established the National Occupational Research
    Agenda (NORA), a framework to guide and promote occupational safety and
    health research through a consensus-building process with more than 500
    outside organizations and individuals. The NORA process identified the
    top 21 research priorities for occupational safety and health for the
    nation.
        NIOSH has long been committed to translating research results into
    practical recommendations and disseminating them through its
    publications. For example, ``Alerts'' help employers and workers
    identify and respond to work-related health hazards, and ``Workplace
    Solutions'' provide practical advice on hazard control. NIOSH is now
    building even further on these efforts by launching Research to
    Practice, or r2p, a new initiative to transfer research findings,
    technologies, and information into effective prevention practices and
    products and to promote their adoption in workplaces.
        The goal of the NIOSH r2p initiative will be to increase the use in
    the workplace of effective NIOSH and NIOSH-funded research findings.
    NIOSH will achieve this goal by translating its research findings into
    practice as quickly as possible, targeting its dissemination efforts,
    and evaluating and demonstrating the effectiveness of these efforts in
    improving worker health and safety. ERCs will play a prominent role in
    this process.
        In addition, in coordination with the HHS Secretary's Steps to a
    HealthierUS initiative, NIOSH is introducing Steps to a HealthierUS
    Workforce to encourage workplace health programs that effectively
    integrate or coordinate efforts to promote both personal health and
    workplace health. Through NORA, r2p, and Steps to a HealthierUS
    Workforce, NIOSH will continue to work to achieve its goal of
    preventing work-related illnesses and injuries. These efforts will
    continue to be enhanced through partnerships, outreach, and capacity-
    building to enable NIOSH to leverage resources and expertise.

                      RECOMMENDATION FOR FISCAL YEAR 2005

        AUPOHS requests an increase of $5 million for ERCs, and we are
    supporting a $30 million total increase over the $277 million
    appropriated in fiscal year 2004 for NIOSH.--This would provide $307
    million for NIOSH and $24.7 million for ERCs in fiscal year 2005. Given
    that much of NIOSH's extramural research program is carried out by our
    institutions, sustaining the academic infrastructure provided by the
    ERCs is essential to the success of NORA, r2p, and Steps to a
    HealthierUS Workforce. Our recommendation would ensure that our
    nation's universities have the capacity and manpower to implement these
    initiatives and expand training programs to improve the health and
    productivity of American workers.
        Funding for NIOSH and the ERCs would reduce the staggering burden
    of occupational illnesses and injury on the American economy, recently
    estimated at $240 billion. To put this number in perspective, these
    costs dwarf the $33 billion for AIDS and the $67 billion for
    Alzheimer's disease, and they are greater than the $164 billion
    economic cost for all circulatory diseases and the $171 billion cost of
    cancer. Yet federal support for occupational safety and health research
    pales in comparison--for example, cancer research receives 17 times as
    much federal funding.
        Thank you for the opportunity to report the great need for research
    and training in occupational safety and health.

             NIOSH-SUPPORTED EDUCATION AND RESEARCH CENTERS (ERCS)

        Deep South ERC (University of Alabama at Birmingham and Auburn
    University); Harvard University; Johns Hopkins University; New York /
    New Jersey ERC (Mt. Sinai Medical Center and Hunter College); Northern
    California ERC (UC Berkeley, UCSF); Southern California ERC (UCLA and
    UC Irvine); Texas ERC (University of Texas and Texas A&M University);
    University of Cincinnati; University of Illinois at Chicago; University
    of Iowa; University of Michigan; University of Minnesota; University of
    North Carolina at Chapel Hill; University of South Florida; University
    of Utah; and University of Washington.
                                     ______

                   Prepared Statement of Rotary International

        Chairman Specter, Senator Harkin, members of the Subcommittee,
    Rotary International appreciates this opportunity to submit testimony
    in support of the polio eradication activities of the U.S. Centers for
    Disease Control and Prevention (CDC). The effort to eradicate polio has
    been likened to a race--a race to reach the last child. This race
    requires the dedication to make the sacrifices necessary to achieve
    success. Like some great relay team, the major partners in the global
    polio eradication effort have joined with national governments around
    the world in an unprecedented demonstration of commitment to cross the
    finish line of this historic public health goal. We cannot allow the
    great distance we have traveled to diminish our resolve. Though we may
    be weary, our adversary is weakening. The victory over polio is closer
    than ever!

               PROGRESS IN THE GLOBAL PROGRAM TO ERADICATE POLIO

        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 CDC's
    polio eradication activities, the battle against polio would be
    impossible. Thanks to your leadership in appropriating funds, the
    international effort to eradicate polio has made tremendous progress.
      --The number of polio cases has fallen from an estimated 350,000 in
            1988 to less than 800 in 2003--a more than 99 percent decline
            in reported cases (see Exhibit A). More than 200 countries and
            territories are polio-free, including 4 of the 5 most populous
            countries in the world (China, United States, Indonesia, and
            Brazil).
      --Transmission of the poliovirus has never been more geographically
            confined. The Western Hemisphere, the Western Pacific and the
            European regions are certified polio-free. Wild poliovirus
            transmission is confined to a limited number of polio ``hot-
            spots'' within six countries.
      --More than 2 billion children worldwide have been immunized during
            NIDs in the last 5 years, including more than 150 million in a
            single day in India.
      --All polio-endemic countries in the world have conducted NIDs and
            established high quality surveillance of Acute Flaccid
            Paralysis (AFP). The eradication of polio in the Democratic
            Republic of Congo, Sudan, and Somalia shows that polio
            eradication strategies are successful even in countries
            affected by civil unrest.
        From the launch of the global initiative in 1988, to the
    eradication target date of 2005, 5 million people who would otherwise
    have been paralyzed will be walking because they have been immunized
    against polio. Tens of thousands of public health workers have been
    trained to investigate cases of acute flaccid paralysis and manage
    massive immunization programs. Cold chain, transport and communications
    systems for immunization have been strengthened. A network of 147 polio
    laboratories has been established to analyze suspected cases of polio
    and monitor transmission of polio. This network will continue to
    support the surveillance of other diseases long after polio has been
    eradicated.
        Give the tremendous progress that has been made in reducing the
    incidence of polio and diminishing the areas in which the virus
    circulates, the world currently faces an unprecedented opportunity to
    stop the transmission of wild poliovirus. However, significant
    challenges remain as obstacles to the ultimate achievement of our goal
    of a polio-free world. In 2003, Nigeria surpassed India to become the
    country with the highest number of polio cases. The surge in polio
    cases in Nigeria also resulted in importations of cases into several of
    the countries that neighbor Nigeria. The risk of importations into west
    and central African countries, and around the world, is magnified by
    financial constraints that limit the scope of immunization activities.
        Continued political commitment is essential in all polio endemic
    countries, to support the acceleration of eradication activities. The
    ongoing support of donor countries is essential to assure the necessary
    human and financial resources are made available to polio-endemic
    countries. Access to children is needed, particularly in Nigeria, where
    political and financial differences between key states and the federal
    government were unexpectedly given voice in the form of untrue rumors
    about the safety of the oral polio vaccine. As a result, immunization
    activities in the states that need them most were delayed and/or
    suspended during the effort to address local concerns. Polio-free
    countries must maintain high levels of routine polio immunization and
    surveillance. The continued leadership of the United States is critical
    to ensure we meet these challenges.

                        THE ROLE OF ROTARY INTERNATIONAL

        Since 1985, Rotary International, a global association of more than
    30,000 Rotary clubs, with a membership of over 1.2 million business and
    professional leaders in 166 countries, has been committed to battling
    this crippling disease. In the United States today there are nearly
    7,700 Rotary clubs with some 400,000 members. All of our clubs work to
    promote humanitarian service, high ethical standards in all vocations,
    and international understanding. Rotary International stands hand-in-
    hand with the United States Government and governments around the world
    to fight polio through local volunteer support of National Immunization
    Days, raising awareness about polio eradication, and providing
    financial support for the initiative. In 2003, members of Rotary clubs
    around the world announced the results of their second polio
    eradication fundraising campaign. Rotarians far exceeded the U.S. $80
    million goal they had set by raising U.S. $119 million in cash and
    commitments. Rotary firmly believes that the vision of a world without
    polio can be realized and that the time for action is now. By the time
    the world is certified polio-free, Rotary's contribution to the global
    polio eradication effort will exceed U.S. $600 million.
        Rotary International's commitment to the global polio eradication
    represents the largest contribution by an international service
    organization to a public health initiative ever. These funds have been
    allocated for polio vaccine, operational costs, laboratory
    surveillance, cold chain, training and social mobilization in 122
    countries. More importantly, tens of thousands of Rotarians have been
    mobilized to work together with their national ministries of health,
    UNICEF and WHO, and with health providers at the grassroots level in
    thousands of communities.
        In the United States, Rotary has formed and leads the United States
    Coalition for the Eradication of Polio, a group of committed child
    health advocates that includes Rotary, the March of Dimes Birth Defects
    Foundation, the American Academy of Pediatrics, the Task Force for
    Child Survival and Development, the United Nations Foundation, and the
    U.S. Fund for UNICEF. These organizations join us in expressing our
    gratitude to you for your staunch support of the international program
    to eradicate polio. For fiscal year 2004, you appropriated a total of
    $106.4 million for the polio eradication efforts of the CDC. This
    investment has helped to make the United States the leader among donor
    nations in the drive to eradicate this crippling disease.

                        FISCAL YEAR 2005 BUDGET REQUEST

        For fiscal year 2005, we respectfully request that you maintain the
    level of funding that was provided in fiscal year 2004 ($106.4 million)
    for the targeted polio eradication efforts of the Centers for Disease
    Control and Prevention. It is important to meet this level of funding
    due to the increased costs of the accelerated eradication program, and
    to respond to the increase in supplementary immunization activities in
    endemic countries, the need to maintain immunity in polio-free areas
    and maintain certification standard surveillance. This will ensure that
    we protect the substantial investment we have made to protect the
    children of the world from this crippling disease by enabling us to
    conduct the necessary eradication activities to eliminate polio in its
    final strongholds--the Indian sub-continent and sub-Saharan Africa.

     THE ROLE OF THE U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

        Rotary commends CDC for its leadership in the global polio
    eradication effort, and greatly appreciates the Subcommittee's support
    of CDC's polio eradication activities. For fiscal year 2004, the
    Subcommittee appropriated a total of $106.4 million for the CDC's
    global polio eradication activities. Due to Congress' unwavering
    support, in 2004 CDC is able to:
      --Support the international assignment of more than 200 long-term
            epidemiologists, virologists, and technical officers to assist
            the World Health Organization and polio-endemic countries to
            implement polio eradication strategies, and 16 technical staff
            to assist UNICEF and polio-endemic countries. This includes 19
            CDC staff on direct assignment to WHO and UNICEF.
      --Provide $50 million to UNICEF for approximately 540 million doses
            of polio vaccine and $9 million for operational costs for NIDs
            in all polio-endemic countries and other high-risk countries in
            Asia, the Middle East and Africa. Most of these NIDs would not
            take place without the assurance of CDC's support.
      --Provide over $18 million to WHO for surveillance, technical staff
            and NIDs' operational costs, primarily in Africa. As successful
            NIDs take place, surveillance is critical to determine where
            polio cases continue to occur. Effective 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.
      --Train virologists from all over the world in advanced poliovirus
            research and public health laboratory support. CDC's Atlanta
            laboratories serve as a global reference center and training
            facility.
      --Provide the largest volume of both operational (poliovirus
            isolation) and technologically sophisticated (genetic
            sequencing of polio viruses) lab support to the 147
            laboratories of the global polio laboratory network. CDC has
            the leading specialized polio reference lab in the world.
      --Serve as the primary technical support agency to WHO on scientific
            and programmatic research regarding: (1) laboratory containment
            of wild poliovirus stocks following polio eradication, and (2)
            when and how to stop or modify 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 all 47 countries of the Americas are free of indigenous
    measles, due in part to improvements in the public health
    infrastructure implemented during the war on polio. The disease
    surveillance system--the network of laboratories and trained personnel
    established during the Polio Eradication Initiative--is now being used
    to track measles, rubella, yellow fever, meningitis, and other deadly
    infectious diseases. NIDs for polio have been used as an opportunity to
    give children essential vitamin A, which, like polio, is administered
    orally, saving the lives of 1.25 million children since 1998. The
    campaign to eliminate polio from communities has led to an 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. Additionally, the unprecedented
    cooperation between the public and private sectors serves as a model
    for other public health initiatives. Polio eradication is a cost-
    effective public health investment, as its benefits accrue forever.

            RESOURCES NEEDED TO FINISH THE JOB OF POLIO ERADICATION

        The World Health Organization estimates that $765 million is needed
    from donors for the period 2004-2005 to help polio-endemic countries
    complete the polio eradication strategy. In the Americas, some 80
    percent of the cost of polio eradication efforts was 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 ask the
    United States to continue its financial leadership in order to see this
    initiative to its successful conclusion as quickly as possible.
        The United States' commitment to polio eradication has stimulated
    other countries to increase their support. Other countries that have
    followed America's lead and made special grants for the global Polio
    Eradication Initiative include the United Kingdom ($425 million), the
    Netherlands ($112 million), and Canada ($85 million). Japan, which has
    contributed $231 million, recently expanded its support to polio
    eradication efforts in Africa. Even the tiny country of Luxembourg has
    invested in global polio eradication by contributing $4.2 million. In
    both 2002 and 2003 the members of the G8 committed to provide
    sufficient resources to eradicate polio as part of its Africa Action
    Plan. In addition to the ongoing contributions made by historic donors
    such as United States, the United Kingdom, and Canada, new commitments
    of $37 million and $4 million were made by France and Russia in
    response to the G8 pledge.
        Intense political commitment on the part of endemic nations is also
    essential to ensuring polio eradication is achieved. In January 2004,
    health ministers of the six remaining endemic countries (Afghanistan,
    Egypt, India, Niger, Nigeria, and Pakistan) gathered at a meeting
    convened at WHO in Geneva to declare their commitment to supporting
    intensified supplementary immunization activities in the ``Geneva
    Declaration for the Eradication of Poliomyelitis.'' In addition,
    resolutions supporting polio eradication were taken by the African
    Union and the Organization of the Islamic Conference. Each of these
    resolutions encourages member states to place a high priority on
    completing the job of polio eradication.
        Your discipline, commitment and endurance have brought us to the
    brink of victory in the great race against this ancient scourge. Polio
    cripples and kills. It deprives our children of the capacity to run,
    walk and play. Other great health crises loom on the horizon. Your
    continued support for this initiative helps ensure that today's
    children possess the strength and vitality to grow up and fight against
    the health threats of future generations.

                                     ______

            Prepared Statement of the National Council on Folic Acid

        The National Council on Folic Acid (NCFA) is a partnership of over
    80 national organizations and associations, state folic acid councils
    and government agencies whose mission is to improve health by promoting
    the benefits and consumption of folic acid. Our goals are to reduce
    folic acid preventable birth defects by recommending that women of
    childbearing age take 400 micrograms of synthetic folic acid daily,
    from fortified foods and/or supplements, in addition to consuming food
    folate from a varied diet and to communicate and promote emerging and
    new science on folic acid, especially that relate to maternal and child
    health. The undersigned members of NCFA respectfully recommend that at
    least $5 million be appropriated in fiscal year 2005 for the Centers
    for Disease Control and Prevention's Folic Acid Education Campaign.

                          FOLIC ACID AND BIRTH DEFECTS

        Folic acid, a B-vitamin, is critical for proper cell division and
    growth. It is especially important during the early weeks of pregnancy
    when the embryonic neural tube, which later becomes the brain and
    central nervous system, is forming and closing. Defects in closure of
    the neural tube result in the development of a group of birth defects
    commonly referred to as neural tube defects (NTDs). The two most common
    NTDs are spina bifida and anencephaly. Closure of the neural tube
    occurs early in the development, before most women know that they are
    pregnant. The consumption of only 400 micrograms of folic acid daily
    taken prior to conception and early in gestation can prevent as many as
    70 percent of NTDs.
        The birth defects such as anencephaly and spina bifida, have a
    great social and economic impact on our nation. The average total
    lifetime cost to society for each infant born with spina bifida is
    approximately $532 thousand, while estimated annual medical and
    surgical costs for persons living with spina bifida in the United
    States exceed $200 million.\1\ Fortification of the grain supply is a
    significant factor in the 32 percent decline in the rates of spina
    bifida. In order to continue this trend, however, considerable effort
    is still needed to increase the number of reproductive aged women who
    consume 400 micrograms of folic acid each day. But, due to the growing
    popularity of low-carbohydrate diets many women are abandoning bread
    and other grains, thereby reducing their intake of folic acid.
    ---------------------------------------------------------------------------
        \1\ Centers for Disease Control and Prevention, MMWR, 1989.
    ---------------------------------------------------------------------------
                      FOLIC ACID AWARENESS AND COUNSELING

        Only 20 percent of women know that folic acid can prevent birth
    defects.\2\ Consequently, women generally are low consumers of folic
    acid, with only 30 percent of all women consuming a vitamin supplement
    with folic acid every day. Of those who take a daily multi-vitamin, 25
    percent forget to take it every day.
    ---------------------------------------------------------------------------
        \2\ March of Dimes, June 2002.
    ---------------------------------------------------------------------------
        We know that health care providers should screen women of
    childbearing age for folic acid consumption in an effort to promote
    taking a daily multi-vitamin and to prevent neural tube defects. We
    also know that 53 percent of women not taking a daily multi-vitamin
    indicated that they would likely do so if their health provider simply
    encouraged them.\3\
    ---------------------------------------------------------------------------
        \3\ March of Dimes, June 2002.
    ---------------------------------------------------------------------------
        Following that logic, the undersigned NCFA members recommend that
    at least $5 million be appropriated to fund the Centers for Disease
    Control and Prevention's Folic Acid Education Campaign, which is housed
    with the National Center on Birth Defects and Developmental
    Disabilities. This funding is necessary to continue the Center's
    programming devoted on raising folic acid public awareness and training
    of health professionals on how to discuss folic acid consumption with
    their patients.
                                     ______

        Prepared Statement of the American Academy of Family Physicians

        The 93,700-member American Academy of Family Physicians submits
    this statement for the record in support of the Section 747 Primary
    Care Medicine and Dentistry Cluster. The Academy also supports the
    Agency for Healthcare Research and Quality (AHRQ) and rural health
    programs.
        Section 747 is the only national program that funds family
    physician training and includes dollars for general internal medicine/
    general pediatrics; physician assistants and general/pediatric
    dentistry. The fiscal year 2004 spending bill provides only $82 million
    to Section 747, a figure that is $10 million below the fiscal year 2003
    levels. The Congressionally established Advisory Committee on Training
    in Primary Care Medicine and Dentistry (ACTPCMD) recommends $198
    million for Section 747.

            SECTION 747 PRIMARY CARE MEDICINE AND DENTISTRY CLUSTER

    Background
        Section 747 supports family medicine training programs in medical
    school and in residency programs. It is specifically designed to meet
    two goals: increase the number of primary care physicians, and boost
    the number of people who will provide care to the underserved. The
    Institute of Medicine defines primary care physicians as family
    physicians, general internists and general pediatricians.
        Family physicians provide comprehensive, coordinated and continuing
    care to patients of both genders and all ages and ethnicities,
    regardless of medical condition. These residency-trained, primary care
    specialists treat babies with ear infections, adolescents who are
    obese, adults with depression and seniors with multiple, chronic
    illnesses. And because they focus on prevention, primary care, and
    integrating care for patients, they are able to treat illnesses early;
    cost-effectively and when necessary, help patients navigate our complex
    health system and find the right subspecialists.
        Section 747 funding has led thousands of physicians to go into
    primary care and family medicine and serve millions of patients. A
    study by the Robert Graham Center for Policy Studies showed that
    medical schools that received Section 747 family medicine funds
    produced more medical students who:
      --Practiced in family medicine or primary care;
      --Practiced in a rural area; or
      --Practiced in a whole county Primary Care Health Professions
            Shortage Area (HPSAs) (i.e., counties with inadequate numbers
            of family physicians, general pediatricians, general internists
            or obstetrician/gynecologists).
        The study showed that continued funding during the years of medical
    school training had more of a positive impact than intermittent
    funding.
        Another Graham Center report revealed that more Americans depend on
    family physicians than any other medical specialty: without family
    physicians, the majority of U.S. counties would become Primary Care
    Health Professions Shortage Areas. Of the 3,142 counties in the United
    States, 1,184 (38 percent) are full or partial county HPSAs, which
    includes more than 41 million Americans.

    Funding for Programs Historically Under Threat
        However, the health professions programs have been under fire for
    many years, and, as a result, funding has been threatened during
    several fiscal cycles. For example, the Administration's fiscal year
    2005 budget would eliminate funding for Section 747 and cuts funding
    severely for Title VII. Reasons differ for these cutbacks, but center
    mainly around disagreements regarding the long-term role of the federal
    government in training physicians, and uncertainty about program
    outcomes and effectiveness.
        Most recently, the Office of Management and Budget (OMB) attempted
    to express these arguments in the 2003 Program Assessment Rating Tool
    (PART). In that document, OMB criticized all of the Title VII Health
    Professions programs as lacking a focused objective. However, Section
    747, in particular, has a clear purpose and has been successful in
    achieving its goals. The OMB evaluation lumps all of the programs
    together and does not evaluate them individually. By definition, these
    programs will have different goals, different levels of effectiveness
    and different histories, making the PART evaluation unsophisticated, at
    best. Additionally, since the federal government has been struggling
    with a budget shortfall, programs with the slightest amount of negative
    attention have been tempting targets for budget cutbacks.
        Nonetheless, these training programs still enjoy a great deal of
    support from members of the Appropriations Committees in both the
    Senate and House, which the Academy appreciates. And, with the
    exception of the fiscal year 2004 spending bill, Congress has
    consistently restored funding for these programs.
        The Academy strongly believes that the federal government must
    maintain appropriate funding for Section 747 family medicine training
    programs. The rationale for this comes from two sources: the steady
    reliance on family physicians in the current U.S. healthcare system and
    the Academy's new proposal to restructure future Section 747 family
    medicine training programs for the coming healthcare system. In short,
    family physicians are key to a modern healthcare system and more money
    is needed to modernize their training.

    Preserve the U.S. Health Care Safety Net
        The Academy supports the Administration's commitment to funding
    increases to build more Community Health Centers (CHC) and supplement
    the National Health Service Corps (NHSC). However, we believe that
    increasing funding for CHCs and the NHSC is only a partial solution.
    Without support for family physician training, there will be fewer of
    the physicians who work in these centers or practice in underserved
    areas. Thousands of family physicians will be needed if the growth in
    the number of CHCs sites and NHSC staff is to be realized.
        Specifically, nearly half of the physicians who staff the nation's
    Community Health Centers are family physicians. And, since 1971, the
    National Health Service Corps has placed more than 18,000 health care
    providers in underserved areas: almost half of the NHSC doctors were
    family physicians. Finally, according to data from the National
    Association of Community Health Centers, in 2002, the majority of CHC
    employees were primary care physicians who were responsible for almost
    22 million patient visits.

    Invest in Cost-Effective, Quality Care
        Unlike all other developed countries, the United States does not
    have a primary care-based health care system. While other developed
    countries have about equal numbers of primary care doctors and
    subspecialists, less than one-third of the U.S. physician workforce is
    primary care doctors (including family physicians). As a result, about
    two thirds of the U.S. physician workforce is made up of
    subspecialists.
        In addition, compared to those in other developed countries, we
    spend the most per capita on healthcare but have the worst healthcare
    outcomes. More than 20 years of evidence have shown that a primary
    care-based health system produces greater health and economic benefits.
    Boosting support for Section 747, which funds training for family
    physicians and for other primary care disciplines, could allow patients
    in the United States to enjoy those benefits.
        Specifically, research reveals that primary care is effective:
    leading to reduced all-cause mortality and mortality due to
    cardiovascular and pulmonary diseases; less emergency department and
    hospital use; better preventive care; better detection of breast
    cancer, and reduced incidence and mortality due to colon and cervical
    cancer. Studies have also shown proof of efficiency: fewer tests;
    higher patient satisfaction; lower medication use and lower care-
    related costs. Finally, the data indicates that primary care promotes
    equity among different populations: health disparities are reduced,
    particularly for areas with the highest income inequality, resulting in
    improved vision, more complete immunization, better blood pressure
    control, and better oral health. Supporting Section 747 family medicine
    training would produce more family physicians, physicians who are cost-
    effective and provide high quality care.

                  AGENCY FOR HEALTHCARE, RESEARCH AND QUALITY

        The Academy recommends $443 million for the Agency for Healthcare,
    Research and Quality (AHRQ). AHRQ conducts primary care and health
    services research geared to physician practices, health plans and
    policymakers that helps the American population as a whole. In short,
    the agency translates research findings from basic science entities
    like the National Institutes of Health (NIH) into information that
    doctors can use every day in their practices. Another key function of
    the agency is to support research on the conditions that affect most
    Americans.

    AHRQ Translates Research into Everyday Practice
        Congress has provided billions of dollars to the National
    Institutes of Health, which has resulted in important insights in
    preventing and curing major diseases. AHRQ takes this basic science and
    produces information that physicians can use every day in their
    practices. AHRQ also distributes this information throughout the health
    care system. In short, AHRQ is the link between research and the
    patient care that Americans receive.
        For example, research shows that that beta blockers reduce
    mortality. AHRQ supported research to help physicians determine which
    patients with heart attacks would benefit from this medication.
    AHRQ Supports Research on Conditions Affecting Most Americans
        Most typical Americans get their medical care in doctors' offices
    and clinics. However, most medical research comes from the study of
    extremely ill patients in hospitals
        AHRQ studies and supports research on the types of illness that
    trouble most people. In brief, AHRQ looks at the problems that bring
    people to their doctors every day--not the problems that send them to
    the hospital.
        For example, AHRQ supported research that found older
    antidepressant drugs are as effective as new antidepressant medications
    in treating depression, a condition that affects millions of Americans.
    Provisions in the Medicare Modernization Act
        In addition, the new Medicare law also directs the agency to study
    the ``clinical effectiveness and appropriateness of specified health
    services and treatments.'' While the law authorizes $50 million for
    this effort, the Academy supports the $75 million figure that is
    included in the Senate budget resolution.
        Moreover, the law asks the agency to establish a new ``Citizens'
    Health Care Working Group,'' to initiate a nationwide public debate
    about improving the health care system with the goal of providing every
    America high quality and affordable health care coverage. The AAFP also
    supports funding for this new commission.

                             RURAL HEALTH PROGRAMS

        Continued funding for rural programs is vital to provide adequate
    health care services to America's rural citizens. We support the
    Federal Office of Rural Health Policy; Area Health Education Centers;
    the Community and Migrant Health Center Program; and the NHSC. State
    rural health offices, funded through the National Health Services Corps
    budget, help states implement these programs so that rural residents
    benefit as much as urban patients.

                                   CONCLUSION

        The Academy urges Congress to increase funding for Section 747
    family medicine training (the Advisory Committee on Training in Primary
    Care Medicine and Dentistry $198 million for Section 747); $443 million
    for AHRQ and support for rural health programs. Federal support is
    vital to sustain and improve America's health care system.
                                     ______

               Prepared Statement of the Tri-Council for Nursing

        The Tri-Council for Nursing appreciates the opportunity to comment
    on fiscal year 2005 appropriations for nursing programs. The Tri-
    Council for Nursing is an alliance of four national nursing
    organizations--the American Association of Colleges of Nursing (AACN),
    the American Nurses Association (ANA), the American Organization of
    Nurse Executives (AONE), and the National League for Nursing (NLN). The
    Tri-Council is focused on leadership and excellence in nursing.
    Together, we represent the breadth and scope of nursing; including
    practicing nurses, nurse executives, nurse educators, and nurse
    researchers.
        The Tri-Council gratefully acknowledges this Subcommittee's support
    for nursing education and research. We appreciate your continued
    recognition of the important role nurses play in the delivery of health
    care services and the increased need to fund nursing education
    programs, nursing research, and innovative practice models.
    Unfortunately, the nursing shortage continues to worsen, therefore we
    are again urging you to invest in nursing.
        Today, the burgeoning nursing shortage is impacting health care
    delivery throughout the nation. The increasing health care demands of
    the aging U.S. population and changes in the nurse workforce have
    combined to create a shortage unlike any other. A fundamental shift has
    occurred in the registered nurse (RN) workforce over the last two
    decades. As occupational opportunities for young women have expanded,
    and the changing health care environment has increased stresses on
    nursing, the number of young people entering nursing has declined. The
    lack of young people in nursing has resulted in a steady and dramatic
    increase in the average age of the U.S. nurse. Today, the average
    working RN is over 43 years old. The average nurse educator is over 50
    years old.
        This shortage is growing just as the need for nursing services is
    mounting. America's demand for nursing care is expected to balloon over
    the next 20 years as a result of the aging of the population, advances
    in technology, and various economic and policy factors. On February 11,
    2004, the Bureau of Labor Statistics reported that registered nursing
    will have the greatest job growth of all U.S. professions in the time
    period spanning 2002-2012. During this ten-year period, health care
    facilities will need to fill more than 1.1 million RN job openings. The
    Division of Nursing at the Health Resources and Services Administration
    projects that, absent aggressive intervention, the supply of nurses in
    America will fall 29 percent below requirements by the year 2020.
        The nursing shortage is already having a detrimental impact on the
    health care system. Numerous recent studies have shown that nursing
    shortages contribute to medical errors, poor patient outcomes, and
    increased mortality rates. A study published in the May 30, 2002, New
    England Journal of Medicine reported that higher levels of nursing care
    correlate with better patient care. And a Joint Commission on the
    Accreditation of Healthcare Organizations (JCAHO) study published in
    2002 shows that nearly one-quarter of all unanticipated deaths or
    injuries result from nurse shortages. Another study published in the
    October 23, 2002 Journal of the American Medical Association found that
    among the surgical patients studied, there was a pronounced correlation
    between nursing shortages and both patient mortality and failure to
    rescue.
        This growing nursing shortage has effects well beyond domestic
    health care. Nurses are integral in everything from adequate terrorism
    preparedness, to veterans' health delivery, to disaster response. In
    addition, the activation of military reserves is drawing nurses out of
    the domestic labor market. Therefore, this shortage threatens our very
    strength as a nation.

                         NURSING WORKFORCE DEVELOPMENT

        Federal support for Nursing Workforce Development in Title VIII of
    the Public Health Service Act (PHSA) is unduplicated and essential.
    Recognizing the impact of the nursing shortage, the 107th Congress took
    the visionary step of passing the Nurse Reinvestment Act (Public Law
    107-205). This law improved the programs of Title VIII to meet the
    unique characteristics of today's shortage. It contained public service
    announcements, geriatric training grants, and a nurse faculty loan
    repayment program. It also expanded existing programs in Title VIII to
    include a scholarship program, career ladder programs, and retention
    grants for enhancing patient care delivery systems.
        In fiscal year 2004, the hard work of this Subcommittee resulted in
    $142 million in funding for Title VIII programs. We strongly urge you
    to increase funding for Title VIII programs by at least $63 million to
    a total of $205 million in fiscal year 2005. The Tri-Council believes
    that the need for this increase is borne out by the HRSA information
    for 2003 indicating that only 2 percent of the applications for nursing
    scholarships were funded, and a mere 8 percent of the nurse education
    loan repayments were funded.
        The Title VIII authorities are:

    Nurse Education, Practice, and Retention Grants
        This section, formerly known as the Basic Nurse Education and
    Practice, was expanded and reorganized by the Nurse Reinvestment Act.
    Education grant areas were reorganized to include: expanding
    enrollments in baccalaureate nursing programs; developing internship
    and residency programs to enhance mentoring and specialty training; and
    providing new technologies in education including distance learning.
        Practice grant areas include: expanding practice arrangements in
    non-institutional settings to improve primary health care in medically
    underserved communities; providing care for underserved populations
    such as the elderly, HIV/AIDS patients, substance abusers, homeless,
    and domestic abuse victims; providing skills necessary to practice in
    existing and emerging health systems; and developing cultural
    competencies.
        Retention grant areas include career ladders and improved patient
    care delivery systems. The career ladders program supports education
    programs designed to assist individuals in obtaining clinical and
    theoretical education required to enter the profession, and to promote
    career advancement within nursing. In fiscal year 2003, HRSA received
    301 applications for career ladder grants. Unfortunately, funding
    levels allowed HRSA to award a total of 12 grants.
        Enhancing patient care delivery system grants encourage nurses to
    remain in patient care by providing grants to facilities to enhance
    collaboration and communication among nurses and other health care
    professionals, and to promote nurse involvement in the organizational
    and clinical decision-making processes of a health care facility. Best
    practices for these nurse administration programs have been identified
    by the American Nurse Credentialing Center's Magnet Recognition
    Program. These best practices have been shown to double nurse retention
    rates, increase nurse satisfaction, and improve patient care. In fiscal
    year 2003, HRSA received 122 applications for enhanced patient care
    delivery systems; HRSA was able to fund 14.
        Nurse Education, Practice, and Retention Grants received $31.8
    million in fiscal year 2004 appropriations.

    National Nurse Service Corps
        The nurse service corps is comprised of a loan repayment program
    and a scholarship program, the Secretary of HHS has the authority to
    allocate funds between the two areas. The Nurse Education Loan
    Repayment Program (NELRP) repays nursing student loans in return for at
    least 2 years of practice in a facility with a critical nursing
    shortage. For the first 2 years of service, the NELRP will repay 60
    percent of the RN's student loan balance. If the nurse elects to stay
    for another year, an additional 25 percent of the loan will be repaid.
    Within 3 years, a nurse can pay off 85 percent of his/her student
    loans.
        The NELRP has benefited from the support of this Subcommittee, as
    well as the administration. It boasts a proven track record of
    delivering nurses to facilities hardest hit by the nursing shortage.
    HRSA has given NELRP funding preference to skilled nursing facilities,
    disproportionate share hospitals, and departments of public health.
    However, lack of funding has hindered the full implementation of this
    program. In fiscal year 2003, HRSA received more than 8,300
    applications for the NELRP. Due to lack of funding, only 602 loan
    repayments were awarded. Therefore, 92 percent of the nurses willing to
    immediately begin practicing in facilities hardest hit by the shortage
    were turned away from this program.
        The nursing scholarship program offers funds to nursing students
    who, upon graduation, agree to work for at least 2 years in a health
    care facility with a critical shortage of nurses. Preference is given
    to students with the greatest financial need. Like the loan repayment
    program, the nursing scholarship program as been stunted by a lack of
    funding. For fiscal year 2003, HRSA received more than 4,500
    applications for the nursing scholarship. Due to lack of funding, a
    mere 94 scholarships were awarded. Therefore, 98 percent of the nursing
    students willing to work in facilities with a critical shortage of
    nurses were also denied access to the corps.
        The National Nurse Service Corps received $26.7 million in fiscal
    year 2004 appropriations.

    Nurse Faculty Loan Program
        This program establishes a loan repayment fund within schools of
    nursing to increase the number of qualified nurse faculty. Nurses may
    pursue a master's or doctoral degree. They must agree to teach at a
    school of nursing in exchange for cancellation of up to 85 percent of
    their educational loans, plus interest, over a 4-year period. Loans may
    cover the costs of tuition, fees, books, laboratory expenses, and other
    reasonable education expenses.
        This program is critical given the worsening shortage of nursing
    faculty. Last year, schools of nursing were forced to turn away tens of
    thousands of qualified applicants due largely to the lack of faculty.
    In fiscal year 2003, HRSA awarded 55 nurse faculty loan repayments.
        The Nurse Faculty Loan Program received $4.9 million in fiscal year
    2004 appropriations.

    Nursing Workforce Diversity
        This program provides funds to enhance diversity in nursing
    education and practice. It supports projects to increase nursing
    education opportunities for individuals from disadvantaged
    backgrounds--including racial and ethnic minorities, as well as
    individuals who are economically disadvantaged. Racial and ethnic
    minorities currently comprise more than 25 percent of the nation's
    population and will comprise nearly 40 percent by the year 2020. Only
    12 percent of the RNs in the United States come from diverse
    backgrounds. Increasing the number of RNs from diverse races and
    cultures allows them to address the prevention, treatment, and
    rehabilitation needs of an increasingly diverse population. For fiscal
    year 2003, HRSA received 122 submissions for nursing workforce
    diversity grants. HRSA was only able to fund 20.
        Nursing Workforce Diversity received $16.4 million in fiscal year
    2004 appropriations.

    Advanced Nurse Education
        Advanced practice registered nurses (APRNs) are registered nurses
    (RNs) who have attained advanced expertise in the clinical management
    of health conditions. Typically, an APRN holds a master's degree with
    advanced didactic and clinical preparation beyond that of the RN. Most
    have practice experience as RNs prior to entering graduate school.
    Practice areas include, but are not limited to: anesthesiology, family
    medicine, gerontology, pediatrics, mental health, midwifery,
    neonatology, and women's & adult health. Title VIII grants have
    supported the development of virtually all initial state and regional
    outreach models using distance learning methodologies to provide
    advanced study opportunities for nurses in rural and remote areas.
        These grants also provide traineeships for masters and doctoral
    students. Title VIII funds more than 60 percent of U.S. nurse
    practitioner (NP) education programs and assists 83 percent of nurse
    midwifery programs. Over 45 percent of advanced nursing graduates go on
    to practice in medically underserved communities, and in areas with
    large Medicaid populations. Many provide care to minority or
    disadvantaged patients. In fiscal year 2003, HRSA funded 35 advanced
    education nursing grants, 335 advanced education nursing traineeships,
    and 69 nurse anesthetist traineeships.
        Advanced Education Nursing received $58.6 million in fiscal year
    2004 appropriations.

    Comprehensive Geriatric Education Grants
        This authority awards grants to train and educate nurses in
    providing health care to the elderly. Funds are used to train
    individuals who provide direct care for the elderly, to develop and
    disseminate geriatric nursing curriculum, to train faculty members in
    geriatrics, and to provide continuing education to nurses who provide
    geriatric care. The growing number of elderly Americans and the
    impending health care needs of the baby boom generation make this
    program critically important. In fiscal year 2003, HRSA received 92
    applications for the comprehensive geriatric training program, 17
    grants were funded.
        Comprehensive Geriatric Education Grants received $3.5 million in
    fiscal year 2004 appropriations.

                 NATIONAL INSTITUTE OF NURSING RESEARCH (NINR)

        The Tri-Council also urges the Subcommittee to increase funding for
    the NINR, one of the institutes at the National Institutes of Health
    (NIH). Nursing research is an integral part of the effectiveness of
    nursing care. Advances in nursing care arising from nursing and other
    biomedical research improves the quality of patient care and has shown
    excellent progress in reducing health care costs. Research programs
    supported by the NINR address a number of critical public health and
    patient care questions. The research is driven by real and immediate
    problems encountered by patients and families. Study results offer the
    clear prospect of improving health, reducing morbidity and mortality,
    and lowering costs and demand for health care.
        Recent studies have focused on the effects of hospital
    restructuring, such as changes in nurse staffing, on patient care; the
    incidence and risk factors for uterine rupture in pregnancies following
    cesarean section; and the means to help family caregivers provide high-
    quality long, term care for loved ones with chronic health care needs.
    In addition, NINR is leading the NIH research on end-of-life and
    palliative care. The NINR is the second-lowest funded institute at NIH
    and provides vital health care research for the nursing community. The
    Tri-Council recommends increasing funding for the NINR in fiscal year
    2005.

                                   CONCLUSION

        While the Tri-Council is encouraged by a recent resurgence of
    interest in the nursing profession, we are concerned by the fact that
    Title VIII funding levels have not been sufficient to assist qualified
    students enter the nursing profession. The nursing shortage will
    continue to worsen if significant investments are not made in nursing
    workforce development programs. Recent efforts have shown that
    aggressive and innovative recruitment efforts can help avert the
    impending nursing shortage--if they are adequately funded.
        Thirty one years ago, this committee invested $153.6 million in the
    fiscal year 1974 programs of Title VIII. Inflated to today's dollars,
    this long-ago appropriation would equal $574 million (more than four
    times the fiscal year 2004 appropriation). Today's shortage is more
    dire and systemic than that of the 1970's. The Tri-Council asks you to
    meet today's shortage with a relatively modest investment of $205
    million in Title VIII programs. Additionally, an investment in the NINR
    will help assure that these nurses are equipped with the information
    needed to provide the best care possible.
                                     ______

       Prepared Statement of the National Area Health Education Centers
                                  Organization

                  SUMMARY OF FISCAL YEAR 2005 RECOMMENDATIONS

      --Increase funding for the health professions and nursing education
            programs under Title VII and Title VIII of the Public Health
            Service Act to at least $550 million for fiscal year 2005.
      --Restore funding for Area Health Education Centers (AHECs) to fiscal
            year 2003 level of $33.1 million.
      --Restore funding for Health Education Training Centers (HETCs) to
            fiscal year 2003 level of $4.3 million.
        Mr. Chairman, and members of the subcommittee, I am pleased to
    present this testimony on behalf of the National AHEC Organization
    (NAO).
        By way of brief introduction, my name is Linda Kanzleiter. I am an
    Assistant Professor at the Pennsylvania State University College of
    Medicine and the Associate Director for the dual state Pennsylvania-
    Delaware Area Health Education Center Program (PA-DEL AHEC).
        As a member of NAO, the professional organization representing the
    national network of Area Health Education Center Programs (AHECs) and
    Health Education Center Programs (HETCs), I come to you today to
    demonstrate the AHEC/HETC network as a well-established national system
    of community and academic partnerships that increases access to quality
    health care services for our nation, especially the growing number of
    uninsured and underinsured populations by improving the supply and
    distribution of our health professions workforce.
        Three essential strategies were developed: the Neighborhood Health
    Centers, later to be named Community Health Centers (1964); the
    National Health Service Corps (NHSC) established in 1970; and the
    Carnegie Commissions Report establishing the AHEC program (1970) and
    HETC program, established for Border and non-border areas (1989). The
    three programs were created in different acts and at different times,
    but were brought together within the Public Health Service within a 3-
    year period.
        The Community Health Centers are dedicated to providing
    preventative and ambulatory health care to the most uninsured and
    underinsured populations by placing point-of-service facilities in
    these areas; and the NHSC is committed to placing health professionals
    to the areas which have the most difficult time recruiting and
    retaining health professionals. However, it is the AHEC & HETC
    organization that recruits, trains and retains a health professions
    workforce committed to working with the underserved. This goal is
    accomplished through bridging the resources of academia to communities.

                    THE NATIONAL AHEC AND HETC ORGANIZATION

        The effectiveness of the AHEC & HETC organization rests with its
    community and academic leadership, collaborative practices and
    committed partnerships of numerous community-based organizations
    representing 48 AHEC & HETC programs, which direct 180 centers housed
    in 43 states.
        Fundamental to the health care infrastructure of the nation is the
    recruitment and retention of a qualified health professions workforce.
    The strategic functions of the AHEC & HETC programs is to facilitate
    the recruitment and retention of the current and future health care
    professions workforce as a means to increase access to health care
    services, and to provide a vehicle to access community-based and
    academic-based health professionals integral to the promotion,
    development, dissemination and management of public and community
    health issues. Claude Earl Fox, former Administrator of HRSA, said it
    so well: ``AHEC programs are a catalyst in both the communities they
    bridge--spurring the academic enterprise to attend to the needs of the
    underserved people--and sparking the community of people served to
    involve themselves in the training of health professionals. This is a
    necessary first step in addressing the health needs of any community.''
        The strength of the national AHEC & HETC organization is their
    cultural diversity and scope of work. The key functions of the AHEC &
    HETC network rests with access and building capacity, which:
      --Creates community-based education and training networks that are
            developed through linking health professionals and their
            practices in underserved areas with academic centers and
            programs to create clinical training experiences for primary
            care residents, medical students, dental medicine students,
            nurse practitioners, physician assistants, nurses and other
            allied health students.
      --Recruits practitioners from the incumbent health professions
            workforce to medically underserved communities through
            established recruitment programs and special placement
            opportunities. Special re-entry programs offered to retrain
            nurses and other health careers for return to the workforce,
            and job re-training offered to adult learners interested in
            developing a career ladder or career change.
      --Retains practitioners working with disenfranchised populations and
            medically underserved communities through innovative and
            traditional continuing medical education programs, building
            linkages between the community practitioners and academic
            centers, providing telemedicine initiatives and self directed
            educational modules to maintain knowledge and skills of health
            professionals, and fostering telemedicine programs for clinical
            consultation in some areas.
      --Prepares interested primary and secondary students from rural,
            urban and cultural diverse communities for college and/or
            career programs in the health professions through academic
            readiness programs. With a cultural and ethnic diversity
            blending the nation, emphasis is placed on preparing under-
            represented minority students into the health careers through
            science, math, and English preparatory programs.
      --Retains the commitment of high school students, medical students,
            health professions students and residents through the pipeline
            of health professions education and training through selective
            mentoring, shadowing and special interest programs.
      --Builds capacity within the health care community to address
            community and public health issues such as bioterrorism,
            Healthy People 2010 objectives.

                             THE PA-DE AHEC PROGRAM

        The PA-DE AHEC Program is celebrating its 10th Anniversary this
    year. Although Delaware is new to the Commonwealth's and national AHEC
    organization, the leadership of the Delaware region brings an in-depth
    understanding of its state's health professions needs and a commitment
    to the mission of the national organization and Pennsylvania AHEC
    program.
        The PA-DE AHEC Program houses an innovative dual state system that
    integrates and bridges academic centers with communities to strengthen
    and increase access:
      --To health care services, especially in underserved communities,
      --To communities and health care personnel integral to the public
            health infrastructure,
      --To the academic and community-based health professions workforce,
      --To the vital educational resources required to maintain the skills
            and knowledge of those vested with safe-guarding the health of
            Pennsylvania and Delaware,
      --To the primary and secondary educational systems fostering
            interests in health careers, especially for cultural and
            ethically diverse schools students,
      --To the medical, dental and mental health practice communities
            facilitating and responding to community and public concerns.

                          THE PA-DE AHEC ORGANIZATION

        The PA-DE AHEC Program has developed a dual state infrastructure
    that includes: the University of Pittsburgh Schools of Medicine,
    Nursing, Dentistry, Pharmacy and Public Health; the Pennsylvania State
    University College of Medicine, School of Nursing and Agromedicine
    Program; the Philadelphia College of Osteopathic Medicine; Temple
    University Schools of Medicine, Pharmacy, Nursing and Dentistry; Thomas
    Jefferson University, Jefferson Medical College and College of Nursing;
    Drexel University School of Medicine, University of Pennsylvania School
    of Dental Medicine and Midwifery Program, and Delaware University,
    School of Nursing.
        Our medical education and training infrastructure also includes
    over 90 health science institutions, and a community-based teaching
    network of over 1,000 physicians and health professionals representing
    12 medical, oral and public health disciplines, and numerous community
    organizations inclusive of Pennsylvania's 67 counties and Delaware's
    three counties.

    About Pennsylvania and Delaware
        Pennsylvania and Delaware, like the rest of the nation, share the
    problem of mal-distribution of health care providers and limited access
    to essential health care services. Pennsylvania houses a population of
    over 12 million people within a geographic range of 46,000 square
    miles, and supports one of the largest aging populations in the nation.
    Traditional market forces have not been very effective in making health
    care available to rural and inner city residents. It is estimated that
    21 percent or greater have no health care coverage and a significant
    proportion remain underinsured. Primary care access and provider
    shortage in the state have resulted in areas of 55 of 67 counties being
    designated as Health Professional Shortage Areas (HPSA), Medically
    Underserved Areas (MUA) or both. Dental Health Professions Shortage
    Areas and Mental Health Shortage Areas are representative of an
    increased number of counties without oral and mental health services.

    Increasing Access to Health Care
        The PA-DE AHEC has facilitated placement of over 31,000 students,
    representing 78,500 clinical training weeks. These students are
    primarily recruited to train in underserved communities. Working with
    51 community health centers, federally qualified centers, and NHSC
    designated centers, the PA-DE AHEC fosters clinical training
    experiences that teach students the rewards and challenges of working
    with at-risk populations and the special knowledge and skills required
    to provide quality health care in communities with limited resources.

                  HEALTH PROFESSIONS RECRUITMENT AND RETENTION

        Promoting the NHSC and State Loan Repayment and Scholarship
    programs are important first steps to introducing providers to
    Pennsylvania and Delaware. Developing and implementing math, science
    and English programs for students in disadvantaged school districts
    facilitates entrance into the health careers through a Grow Your Own
    approach to the health professions crisis. Special initiatives are also
    promoted in areas of nursing with re-entry programs (refresher courses
    for licensed nurses not practicing for five or more years), retraining
    programs that offer promotional and career advancement, and remedial
    programs that are targeted to the special adult learner seeking
    admission to the health careers. All AHEC regions look to facilitate
    nursing programs focused on recruitment, re-entry, retraining and
    retention initiatives.
        In addition, the PA-DE AHEC Program provides self-directed study
    programs as way for practitioners to access continuing professional
    education programs in respect to the increasing professional and
    practice demands of their office and community. For example the most
    recent program, PA-DE AHEC is offering a self-directed learning program
    on the screening, diagnosing and treatment of endocrine disease,
    psychiatric disorders and co-morbidity. Web-based learning in areas of
    tobacco cessation and tobacco cessation pharmacopeias are also venues
    of self directed programs. In addition, statewide satellite broadcasts
    with capabilities to over 520 down link sites within the system add
    another venue for continuing professional education.

                          PUBLIC HEALTH INFRASTRUCTURE

        Responding to the national, state and local needs of preparedness
    teams and public health workers, the PA-DE AHEC Program is an integral
    partner to the emerging public health infrastructure. The PA-DE AHEC
    provides, through its academic and community partnerships, program
    development as well as critical access to communities, at-risk
    populations and the health professions workforce for emerging public
    health issues, such as bioterrorism preparedness training to health
    professionals, especially to agricultural and migrant communities. In
    addition we work with public health officials in areas of health
    promotion and disease prevention programs, which focus on minority
    health disparities and cultural sensitivity training for safety net
    providers. Many community and public health programs are also delivered
    to respond to the Healthy People 2010 objectives.

                           CRITICAL WORKFORCE ISSUES

        Regardless of the 30 years of well-intended efforts by countless
    health professionals and policy makers, the nation's health care
    ``safety net'' program is not able to meet the growing health care
    needs of the country's uninsured and underinsured populations. Young
    adults no longer see clinical nursing as an acceptable career path, In
    fact, other health professions are at-risk; pharmacy is another
    example. Rural hospitals and health systems are also closing
    frequently; which adds another dimension to limiting access to health
    care services. The impact of hospital and system closures contributes
    to the unemployment rate in local communities and decreases the
    economic base. This fractured health care system looks to address the
    health care needs of an aging nation, which requires much of its health
    professions workforce.
        Pennsylvania and Delaware are faced with similar concerns. Only 13
    percent of Pennsylvania primary care physician workforce practice in
    rural areas. Furthermore, 25 percent of primary care physicians in the
    Commonwealth are 55 or older indicating a large number of potential
    retirees. Equally troublesome is documentation indicating that 20
    percent will leave primary care practice in the state because of lack
    of practice coverage, reimbursement issues, lack of technology in rural
    areas, and professional isolation. Time is of the essence, and the
    important message is that AHEC is the foundation for recruiting,
    retaining and distributing a health professions workforce for the
    nation.
        Mr. Chairman, I respectfully ask the Subcommittee to support our
    recommendation to increase funding for the Health Professions and
    Nursing Education programs under Title VII and Title VIII of the Public
    Health Service Act to a minimum of $550 million for fiscal year 2005.
    Our recommendations are consistent with those of the Health Professions
    and Nursing Coalition.
                                     ______

             Prepared Statement of the National League for Nursing

        The National League for Nursing (NLN)--representing more than 1,300
    schools of nursing, 14,000 faculty and individual members, and 18
    constituent leagues--appreciates the Subcommittee's past support for
    nursing education and your continued recognition of the important role
    nurses play in the delivery of our nation's health care services. NLN
    is concerned, however, that the advancements made by Congress to help
    alleviate the nursing shortage will be lost during the fiscal year 2005
    appropriations process unless additional resources are expended. We
    urge your continued support for Title VIII--Nursing Workforce
    Development Programs by ensuring that these programs are funded at a
    minimum level of $205 million for fiscal year 2005.
        Today's nursing shortage is very real and very different from any
    experienced in the past. The new nursing shortage is evidenced by an
    aging workforce; acute nursing shortages in certain geographic areas;
    and a shortage of nurses and nurse educators adequately prepared to
    meet patient need in a changing health care environment. As a result,
    the supply of appropriately prepared nurses and nursing faculty is
    inadequate to meet the needs of a diverse population. This shortfall
    will grow more serious over the next 5 years.
        Congress did an admirable job of passing the Nurse Reinvestment Act
    in 2002. The new monies used to fund loans and scholarships are
    appreciated. However, it has become abundantly clear that significantly
    more funding is required to meet the existing need. In fiscal year
    2003, for example, only 55 nurse faculty loans were awarded. Yet last
    year, schools of nursing were forced to turn away 29,284 qualified
    nursing students because of a lack of prepared nurse educators to teach
    them. This number is significantly greater than the 18,476 students who
    were turned away in 2002.
        Schools of nursing are suffering from a continuing and growing
    shortage of faculty, which prevents these institutions from admitting
    many qualified students who are applying to their programs. NLN's 2002
    Faculty Survey concludes that not enough qualified nurse educators
    exist to teach the number of nurses needed to ameliorate the nursing
    shortage. According to the Survey, this situation is not expected to
    improve in the near future, since an adequate number of nurse educators
    are currently not in the education pipeline.
        The NLN Survey found three trends impacting the future of nursing
    education over the next decade:
    The aging of the nurse faculty population
        An average of 1.3 full-time faculty members per program left their
    positions in nursing education in 2002. About half the Survey
    respondents had at least one unfilled budgeted full-time faculty
    position and some have as many as 15 such positions.
        Approximately 1,800 full-time faculty members leave their positions
    each year. About 10,000 master's level nurses graduate per year, 15
    percent of whom would have to go into teaching just to maintain the
    status quo. Since this is highly unlikely, the gap between unfilled
    positions and the candidate pool will widen significantly.
    The increasing number of part-time faculty
        The number of part-time faculty has increased since 1996--nearly 17
    percent in baccalaureate programs and 14 percent in associate degree
    programs. Approximately 23 percent of the estimated number of faculty
    FTEs is now provided by part-time faculty.
        Part time employees are often not an integral part of the design,
    implementation, and evaluation of the overall nursing education
    program. Many may hold other positions that often limit their
    availability to students. Further, many part-time faculty have not been
    prepared for the faculty role.
    The large number of nursing faculty who are not prepared at the
            doctoral level
        Approximately half the full-time faculty in baccalaureate and
    higher degree programs holds a doctoral degree. In associate degree
    programs, doctorally-prepared faculty account for only 6.6 percent and
    the number is slightly more than 5 percent in diploma programs. Only
    350 to 400 nursing students receive doctoral degrees each year and the
    pool of doctorally-prepared candidates for full-time nursing
    professorships is very limited.
        Educators without doctoral degrees may lack credibility within a
    university setting and have limited opportunities to assume leadership
    positions. Institutions with low numbers of doctorally-prepared
    educators may be less likely to get funds to support research or
    educational innovations.
        As important as educational incentives for future practicing nurses
    are the scholarships for doctoral students, who will instruct the next
    generation of nurses. Please do not allow us to lose ground in the
    fight against the nursing shortage--fund Title VIII nursing programs at
    a level commensurate with the severity of the health care crisis facing
    the nation today.
        Your support will help ensure that nurses exist in the future who
    are prepared and qualified to take care of you, your family, and all
    those in this country who will need our care. If you have any questions
    about NLN's position or we can be of further assistance to you, please
    feel free to contact Kathleen Ream, NLN Manager of Government Affairs,
    at 703-241-3974.
                                     ______

     Prepared Statement of the National Association of Children's Hospitals

        The National Association of Children's Hospitals (N.A.C.H.) is
    pleased to have the opportunity to submit the following statement for
    the hearing record in support of the Children's Hospitals' Graduate
    Medical Education (CHGME) Payment Program in the Health Resources and
    Services Administration (HRSA).
        On behalf of the nation's 60 independent children's teaching
    hospitals, we thank the Subcommittee for the remarkable achievement
    that Congress made last year in continuing to provide full, equitable
    GME funding for these hospitals, giving them a level of federal support
    for their teaching programs that is comparable to what all other
    teaching hospitals receive through Medicare. We urge the Subcommittee
    to continue to provide equitable funding for Children's Hospitals GME
    in fiscal year 2005 so that these institutions will have the resources
    to train and educate the nation's pediatric workforce.
        N.A.C.H. is a not-for-profit trade association, representing more
    than 120 children's hospitals across the country. Its members include
    independent acute care children's hospitals, acute care children's
    hospitals organized within larger medical centers, and independent
    children's specialty and rehabilitation hospitals.
        N.A.C.H. seeks to serve its member hospitals' ability to fulfill
    their four-fold missions of clinical care, education, research, and
    advocacy devoted to the health and well being of all of the children in
    their communities. Children's hospitals are regional and national
    centers of excellence for children with serious and complex conditions.
    They are centers of biomedical and health services research for
    children, and they serve as the major training centers for future
    pediatric researchers, as well as a significant number of our
    children's doctors. These institutions are major safety net providers,
    serving a disproportionate share of children of low-income families,
    and they are also advocates for the public health of all children.

               BACKGROUND: THE NEED FOR CHILDREN'S HOSPITALS GME

        While they account for less than 1 percent of all hospitals, the
    independent children's hospitals train nearly 30 percent of all
    pediatricians, half of all pediatric specialists, and a majority of
    future pediatric researchers. They also provide required pediatric
    rotations for many other residents. They train about 4,000 residents
    annually, and the need for these programs is even more heightened by
    the growing evidence of shortages of pediatric specialists around the
    country.
        Prior to initial funding of the CHGME program for fiscal year 2000,
    these hospitals were facing enormous challenges to their ability to
    maintain their training programs. The increasingly price competitive
    medical marketplace was resulting in more and more payers not covering
    the costs of care, including the costs associated with teaching.
        The independent children's hospitals were essentially left out of
    what had become the one major source of GME financing for other
    teaching hospitals--Medicare--because they see few if any Medicare
    patients. They received only 1/200th (or less than 0.5 percent) of the
    federal support that all other teaching hospitals received under
    Medicare. This lack of GME financing, combined with the financial
    challenges stemming from their other missions, was threatening their
    teaching programs, as well as other important services.
        In addition to their teaching missions, the independent children's
    hospitals are a significant part of the health care safety net for low-
    income children. On average, they devote nearly half of their patient
    care to children who are assisted by Medicaid or are uninsured. More
    than 40 percent of their care is for children assisted by Medicaid, and
    Medicaid covers only about 84 percent of the cost of that care. Without
    the Medicaid disproportionate share hospital (DSH) payments, Medicaid
    would cover only about 76 percent of children's hospitals' patient care
    costs. Further, these hospitals provide many important services from
    dental care to child abuse programs that are either uncovered or very
    underpaid.
        The independent children's hospitals also are essential to the
    provision of care for seriously and chronically ill children in this
    country. They devote more than 75 percent of their care for children
    with one or more chronic or congenital conditions. They provide more
    than 40 percent to 75 percent of the inpatient care to children with
    many serious illnesses--from children with cancer or cerebral palsy,
    for example, to children needing heart surgery or organ transplants. In
    some regions, they are the only source of pediatric specialty care. The
    severity and complexity of illness and the services and resources that
    these institutions must maintain to assure access to this quality care
    for all children are also often inadequately reimbursed.
        The CHGME program, and its relatively quick progress to full
    funding in fiscal year 2002, came at a critical time. Between 1997 and
    2000, independent children's hospitals on average experienced declining
    operating margins and total margins. By fiscal year 2000 more than a
    quarter of the hospitals were not able to cover their operating costs
    with operating revenues, and nearly 20 percent were not able to cover
    their total costs with total revenues. Thanks to the CHGME program,
    these hospitals have been able to maintain and strengthen their
    training programs.
        Continuing this critical CHGME funding is more important for these
    hospitals than ever in light of state budget shortfalls in many states
    and the resulting pressures for significant reductions in state
    Medicaid programs. Because children's hospitals devote such a
    substantial portion of their care to children of low-income families,
    they are especially affected by cutbacks in state Medicaid programs.
        The pediatric community, including the American Academy of
    Pediatrics, Association of Medical School Pediatric Department Chairs,
    and others, has recognized the critical importance of the GME programs
    of the independent children's teaching hospitals, not only to the
    future of the individual hospitals and their essential services but
    also to the future of the nation's pediatric workforce and the
    provision of children's health care and advancements in pediatric
    medicine overall.
        Lastly, many of the independent children's hospitals are a vital
    part of the emergency and critical care services in their communities
    and regions. They are part of the emergency response system that must
    be in place for bioterrorism other public health emergencies. Expenses
    associated with preparedness will add to their continuing costs in
    meeting children's needs.

                             CONGRESSIONAL RESPONSE

        In the absence of any movement towards broader GME financing
    reform, Congress in 1999 authorized the Children's Hospitals' GME
    discretionary grant program to address the existing inequity in GME
    financing for the independent children's hospitals and ensure that
    these institutions could receive equitable federal support to sustain
    their teaching programs. The legislation was reauthorized in 2000
    through fiscal year 2005 and provided for $285 million through fiscal
    year 2001 and such sums as may be necessary in the years beyond.\1\
    Congress passed both the initial authorization (as part of the
    ``Healthcare Research and Quality Act of 1999'') and the
    reauthorization (as part of the ``Children's Health Act of 2000'').
    ---------------------------------------------------------------------------
        \1\ The Lewin Group, an independent health policy analysis firm
    calculated in 1998 that independent children's teaching hospitals
    should receive approximately $285 million in federal GME support for
    nearly 60 institutions to achieve parity with the financial
    compensation provided through Medicare for GME support to other
    teaching hospitals.
    ---------------------------------------------------------------------------
        With the support of this Subcommittee, Congress appropriated
    initial funding for the program in fiscal year 2000, before the
    enactment of its authorization. Following that enactment, Congress
    moved substantially toward full funding for the program in fiscal year
    2001 and completed that goal, providing $285 million in fiscal year
    2002, $290 million in fiscal year 2003, and $303 million in fiscal year
    2004. This represents an extraordinary achievement for the future of
    children's health care as well as for the nation's independent
    children's teaching hospitals.
        The $285 million appropriated in fiscal year 2002 was distributed
    at the end of the fiscal year through HRSA to 59 children's hospitals
    according to a formula based on the number and type of full-time
    equivalent (FTE) residents trained, in accordance with Medicare rules
    as well as the complexity of care and intensity of teaching the
    hospitals provide. Consistent with the authorizing legislation, HRSA
    allocates the annual appropriation in bi-weekly periodic payments to
    eligible independent children's hospitals.

                            FISCAL YEAR 2005 REQUEST

        N.A.C.H. respectfully requests that the Subcommittee continue
    equitable GME funding for the independent children's hospitals by
    providing $303 million for the program in fiscal year 2005--the level
    of funding requested by President Bush and equal to the fiscal year
    2004 appropriation enacted in January 2004. We are grateful for the
    administration's recognition of the significance of the CHGME program.
        Adequate, equitable funding for CHGME is an ongoing need.
    Children's hospitals continue to train new pediatric residents and
    researchers every year. Children's hospitals have appreciated very much
    the congressional support they have received, including the attainment
    of the program's authorization in fiscal year 2002 and continuation of
    full funding with an inflation adjustment in fiscal year 2003 and
    fiscal year 2004. Now, N.A.C.H. asks Congress to maintain this progress
    by enactment of the President's request.
        Support for a strong investment in GME at independent children's
    teaching hospitals is consistent with the repeated concern the
    Subcommittee has expressed for the health and well being of our
    nation's children--through education, health, and social welfare
    programs. It also is consistent with the Subcommittee's repeated
    emphasis on the importance of enhanced investment in the National
    Institutes of Health (NIH) overall, and in NIH support for pediatric
    research in particular, for which we are very grateful.
        The CHGME funding has been essential to the ability of the
    independent children's hospitals to sustain their GME programs. At the
    same time, it has enabled them to do so without sacrificing support for
    other critically important services that also rely on hospital subsidy,
    such as many specialty and critical care services, child abuse
    prevention and treatment services, poison control centers, services to
    low-income children who have inadequate or no coverage, mental health
    and dental services, and community advocacy, such as immunization and
    motor vehicle safety campaigns.
        In recommending an fiscal year 2005 appropriation of $303 million
    for CHGME, the Bush administration specifically cited the both the
    program's clear purpose and its impact on the financial health of
    children's hospitals.
        In conclusion, the Children's Hospitals GME Payment Program is an
    invaluable investment in children's health. The future of the pediatric
    workforce and children's access to quality pediatric care, including
    specialty and critical care services, could not be assured without it.
    Again, N.A.C.H. thanks this Subcommittee and Congress for your
    continuing leadership and support.
        For further information, please contact Peters D. Willson, vice
    president for public policy, N.A.C.H., at 703/797-6006 or
    pwillson@nachri.org.
                                     ______

        Prepared Statement of the Community Medical Centers, Fresno, CA

        With over 43 million people in the United States lacking health
    insurance, the situation is reaching a crisis. National polls of
    Americans have ranked affordable health care as a leading concern
    behind the economy and jobs, and national security and terrorism. The
    issue is of greater concern for those of us who live in the Central San
    Joaquin Valley in California.
        In the San Joaquin Valley, we face even greater challenges with the
    delivery of health care. While the national average for uninsured
    hovers around 15 percent, the Central San Joaquin Valleys sees a figure
    closer to 20 percent. As the region poises itself to address the
    chronic double-digit unemployment (from 14 percent-17 percent) and an
    equally high rate of poverty (20 percent-30 percent) through aggressive
    economic development and work force training initiatives, we cannot
    ignore the need for accessible health care for the uninsured.
        The health statistics also point to the need to develop a pro-
    active and aggressive approach to the situation. They are:
      --The third highest asthma mortality rate in the nation
      --The highest incidence of diabetes among the Hispanic population
      --The highest rates of teen pregnancy in the state
      --The lowest immunization rates in the nation (62 percent at age 2
            vs. 79 percent nationally)
      --Late or no prenatal care for pregnant women
        Community Medical Centers is a $574 million locally owned, not-for-
    profit health care corporation based in Fresno, California and is
    committed to improving accessibility to health care in the area. As a
    result of a landmark decision by the Fresno County Board of Supervisors
    in 1996, the County of Fresno and Community Medical Centers embarked
    upon a 30-year partnership obligating Community to provide care to the
    uninsured and underinsured residents of Fresno County.
        Community, along with other health care providers such as Sequoia
    Community Health Foundation, a Federally Qualified Health Center, has
    been committed to developing a network of outpatient clinics throughout
    the county with a hub facility to be located on the campus of the
    Regional Medical Center in downtown Fresno. This outpatient clinic is
    to be adjacent to the UCSF Fresno Medical Education and Research
    Center, which is currently under construction, and in-patient hospital
    services as well. It is only by enhancing access to health care through
    multiple primary care sites can we begin to address the many health
    care needs of a burgeoning population, both young and old.
        This Outpatient Care Clinic will serve as a hub to a network of
    clinics throughout the County of Fresno housing primary and specialty
    care including a children's clinic, a women's clinic focusing on
    obstetrical and gynecological needs, asthma treatment and education,
    diabetes treatment and education as well as surgical follow-up.
        We would like to ask for your assistance in securing $1 million in
    funding for the purposes of constructing an outpatient care clinic on
    the campus of the Regional Medical Center in Fresno. We understand that
    this request would require a special earmark under the Health Resources
    Services Administration account in the Labor/Health and Human Services
    appropriations bill. We are also aggressively pursuing funding through
    multiple private foundations to secure the bulk of the funding for this
    $24 million facility. We believe that this facility and a comprehensive
    approach to addressing the need for health care services in our region
    is the best option to improve the quality of life in the Central San
    Joaquin Valley.
                                     ______

          Prepared Statement of the American Museum of Natural History

                  ABOUT THE AMERICAN MUSEUM OF NATURAL HISTORY

        The American Museum of Natural History [AMNH] is one of the
    nation's preeminent institutions for scientific research and public
    education. Since its founding in 1869, the Museum has pursued its
    mission to ``discover, interpret, and disseminate--through scientific
    research and education--knowledge about human cultures, the natural
    world, and the universe.'' It is renowned for its exhibitions and
    collections, and with nearly four million annual visitors--
    approximately half of them children--its audience is one of the
    largest, fastest growing, and most diverse of any museum in the
    country. Museum scientists conduct groundbreaking research in fields
    ranging from all branches of zoology, comparative genomics, and
    informatics to earth, space, and environmental sciences and
    biodiversity conservation.
        Today more than 200 Museum scientists with internationally
    recognized expertise, led by 46 curators, conduct laboratory and
    collections-based research programs as well as fieldwork and training.
    Scientists in five divisions (Anthropology; Earth, Planetary, and Space
    Sciences; Invertebrate Zoology; Paleontology; and Vertebrate Zoology)
    are documenting changes in the environment, making new discoveries in
    the fossil record, and describing human culture in all its variety. In
    the Museum's Institute for Comparative Genomics, established in 2001,
    researchers are mapping the genomes of non-human organisms as well as
    creating new computational tools to retrace the evolutionary tree.
        The Museum is also a distinguished training institution, which
    serves up to 80 undergraduates, doctoral, and postdoctoral trainees
    annually. These training programs support doctoral and postdoctoral
    scientists with highly competitive research fellowships, and offer
    talented undergraduates an opportunity to work with Museum scientists.
    The Museum's doctoral and post-doctoral training program, dating from
    1908, is the oldest and largest of any such program at a scientific
    museum. The Museum currently has collaborative programs with Yale
    University, Columbia University, Cornell University, New York
    University, and CUNY. The training encompasses the entire range of
    science covered in the Museum's mission, which includes astrophysics,
    earth sciences, evolutionary biology, zoology, paleontology,
    comparative genomics, biodiversity sciences, and anthropology.
        The AMNH collections of some 32 million natural specimens and
    cultural artifacts are a major scientific resource, providing the
    foundation for the Museum's interrelated research, education, and
    exhibition missions. 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 biological
    collections are many spectacular individual collections, including the
    world's most comprehensive collections of dinosaurs, fossil mammals,
    North American butterflies, spiders, Australian and Chinese amphibians,
    reptiles, fishes, and one of the world's most important bird
    collections. Collections such as these provide vital data for Museum
    scientists as well as for more than 250 national and international
    visiting scientists each year.
        The Museum interprets the work of its scientists, highlights its
    collections, addresses current scientific and cultural issues, and
    promotes public understanding of science through its renowned permanent
    and temporary exhibits (such as the Genomic Revolution in 2001) as well
    as its comprehensive education programs. These programs attract more
    than 400,000 students and teachers and more than 5,000 educators for
    professional development opportunities. The Museum also takes its
    resources beyond its walls through the National Center for Science
    Literacy, Education, and Technology, launched in 1997 in partnership
    with NASA.

                         COMPARATIVE GENOMICS RESOURCES

        The American Museum shares with DHHS a fundamental commitment to
    improving the nation's health and education and advancing the research,
    training, facilities, and technology that support them. The Museum is
    deeply engaged in the area of comparative genomics; a partnership
    between the Museum and DHHS/HRSA would further mutual goals for
    improving the nation's health and welfare through research and training
    in genomic science.

    Genomic Science and Training Resources
        DHHS leads the nation's health-related research and genome science,
    advanced sequencing technologies, instrumentation, and facilities. The
    American Museum, in turn, is home to a preeminent molecular biology
    research and training program and leads science education and outreach
    efforts. In the era of genomics, museum collections have become
    critical baseline resources for the assessment of genetic diversity of
    natural populations; studying genomic data in a natural history context
    makes it possible to more fully understand the impacts of new
    discoveries in genomics and molecular biology. Genomes of the simplest
    organisms provide a window into the fundamental mechanics of life, and
    understanding their natural capabilities can help solve challenges in
    biodefense, medicine, and health care. In the Museum's molecular
    laboratories, in operation now for 11 years, more than 40 researchers
    in molecular systematics, conservation genetics, and developmental
    biology conduct genetic research on a variety of study organisms. The
    labs also nourish the Museum's distinguished training programs that
    serve up to 80 undergraduates, doctoral, and postdoctoral trainees
    annually.

    Frozen Tissue Collection
        The Museum offers unique resources in support of its molecular
    program. These include an expansion of its collections to include
    biological tissues and isolated DNA preserved in a super-cold storage
    facility. Because this collection preserves genetic material and gene
    products from rare and endangered organisms that may become extinct
    before science fully exploits their potential, it is an invaluable
    resource for research in many fields including genetics, comparative
    genomics, and biodefense. Capable of housing 1 million specimens, it
    will be the largest super-cold tissue collection of its kind. In the
    past 3 years, 22,000 specimens not available at any other institute or
    facility have already been accessioned. At the same time, the Museum is
    pioneering the development of collection and storage protocols for such
    collections. To maximize use and utility of the facility for
    researchers worldwide, the Museum is also developing a sophisticated
    website and online database that includes collection information and
    digitized images.

    Cluster Computing
        The Museum also has exceptional capacity in parallel computing, an
    essential enabling technology for phylogenetic (evolutionary) analysis
    and intensive, efficient sampling of a wide array of study organisms.
    Museum scientists have constructed an in-house 700-processor computing
    cluster--the fastest parallel computing cluster in an evolutionary
    biology laboratory and one of the fastest installed in a non-defense
    environment.
        Museum investigators have taken a leadership role in developing and
    applying new computational approaches to deciphering evolutionary
    relationships through time and across species; their pioneering efforts
    in cluster computing, algorithm development, and evolutionary theory
    have been widely recognized and commended for their broad applicability
    for biology as a whole. The bioinformatics tools Museum scientists are
    creating will not only help to generate evolutionary scenarios, but
    will also inform and make more efficient large genome sequencing
    efforts. Many of the parallel algorithms and implementations
    (especially cluster-based) will be applicable in other informatics
    contexts such as annotation and assembly, breakpoint analysis, and non-
    genomic areas of evolutionary biology as well as in other disciplines.

             COMPARATIVE GENOMICS RESEARCH AND TRAINING INITIATIVE

        Building on these unique strengths in comparative genomics, and in
    concert with the health, education, and training goals of DHHS, in 2001
    the Museum launched an ambitious initiative--The Institute of
    Comparative Genomics. Equipped with the parallel computing facility,
    molecular labs with DNA sequencers, ultra-cold storage units, vast
    biological collections, and researchers with expertise in the methods
    of comparative biology, as described above, the Institute is positioned
    to be one of the world's premier facilities for mapping the genome
    across a comprehensive spectrum of life forms.
        The Institute is establishing a distinguished research and training
    record. Museum scientists have pioneered theoretical and analytical
    approaches and are leading major new international research projects in
    assembling the ``tree of life.'' They have developed efficient software
    for the interpretation of microarray data, which can be used to support
    more accurate diagnosis of pathogens, and novel methodologies and
    algorithms for analyzing genomic, chromosomal, and other data to
    discern evolutionary relationships among organisms. Current projects
    include sequencing pathogens and, with NIH and DOE support, tracing the
    evolution of pathogenicity and transfer of disease-causing genes over
    time and between species.
        The Museum is also successfully promoting public understanding of
    genomic science. The landmark exhibition, The Genomic Revolution, seen
    by approximately 500,000 visitors in New York and now touring
    nationally, examined the revolution taking place in molecular biology
    and its impact on modern science and technology, natural history,
    biodiversity, and our everyday lives. The Museum has also hosted
    several conferences on important topics related to genomics: Sequencing
    the Human Genome: New Frontiers in Science and Technology, an
    international conference featuring leading scientists and policymakers
    in Fall 2000; Conservation Genetics in the Age of Genomics in Spring
    2001; and New Directions in Cluster Computing in June 2001, which
    explored how parallel computing enables genomic science and other
    fields. In June 2002, the Museum hosted an international conference
    examining current knowledge of life's history, Assembling the Tree of
    Life: Science, Relevance, and Challenges.
        As it moves forward, the Institute, working in cooperation with New
    York's outstanding biomedical research and educational institutions, is
    focusing on molecular and microbial systematics, on constructing large
    genomic databases, and on expanding our understanding of the evolution
    of life on earth and the evolution of critical organismal form and
    function through analysis of the genomes of selected microbes and other
    non-human organisms. Development of Institute activities entails
    expanding expertise in microbial systematics and the molecular
    laboratory program that now trains dozens of graduate students every
    year; utilizing the latest sequencing technologies; employing parallel
    computing applications that allow scientists to solve combinatorially
    complex problems involving large real world datasets; and continuing to
    advance public understanding of genomic science through educational
    materials, scientific conferences, and exhibits.
        So as to contribute its unique capacities to the nation's genomics
    research and training efforts, the Museum seeks to partner with DHHS/
    HRSA in a facilities/instrumentation initiative. We request $1 million
    to equip our National Research and Training Laboratory for Comparative
    and Microbial Genomics, a state-of-the-art molecular laboratory. When
    equipped, the expanded facility will provide up-to-date instrumentation
    for graduate and postdoctoral trainees as well as for senior
    scientists. The Museum will contribute its participatory share to this
    project with funds from nonfederal as well as federal sources.
                                     ______

       Prepared Statement of the American Academy of Physician Assistants

        On behalf of the more than 51,000 clinically practicing physician
    assistants in the United States, the American Academy of Physician
    Assistants (AAPA) is pleased to submit comments on fiscal year 2005
    appropriations for Physician Assistant (PA) education programs that are
    authorized through Title VII of the Public Health Service Act.
        A member of the Health Professions and Nursing Education Coalition
    (HPNEC), the American Academy of Physician Assistants supports the
    HPNEC recommendation to provide at least $550 million to support the
    Titles VII and VIII programs in fiscal year 2005, including $18 million
    to support PA educational programs, as recommended by the Advisory
    Committee on Primary Care Medicine and Dentistry.
        The Academy believes that the recommended 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 with the Administration's proposal to
    eliminate funding for most Title VII programs, including zero funding
    for training in primary care medicine and dentistry. As Members of the
    Subcommittee are aware, these programs are designed to help meet the
    health care delivery needs of the nation's Health Professional Shortage
    Areas (HPSAs). By definition, the nation's more than 3,800 HPSAs
    experience shortages in the primary care workforce that the market
    alone can't address. 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 2005.

                 OVERVIEW OF PHYSICIAN ASSISTANT (PA) EDUCATION

        PA programs provide students with a primary care education that
    prepares them to practice medicine with physician supervision.
    Physician assistant programs are located at schools of medicine or
    health sciences, universities, teaching hospitals, and the Armed
    Services. All PA educational programs are intensive education programs
    that are accredited by the Accreditation Review Commission on Education
    for the Physician Assistant.
        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 2-year cycle
    and reregister every 2 years. Also to maintain certification, PAs must
    take a recertification exam every 6 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, 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. Forty-seven
    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. Nineteen percent of all PAs practice in
    non-metropolitan areas where they may be the only full-time providers
    of care (state laws stipulate the conditions for remote supervision by
    a physician). Approximately 41 percent of PAs work in urban and inner
    city areas. Approximately 44 percent of PAs are in primary care. Nearly
    one-quarter practice in surgical specialties. Roughly 80 percent of PAs
    practice in outpatient settings. In 2003, an estimated 192 million
    patient visits were made to PAs and approximately 236 million
    medications were prescribed or recommended by PAs.

      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 44 million today. Simultaneously, the
    number of medically underserved communities continues to rise, from
    1,949 in 1986 to more than 3,800 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.
        Furthermore, now that there is compelling evidence that race and
    ethnicity correlate with persistent, and often increasing, health
    disparities among U.S. populations, increasing the diversity of health
    care professionals is essential. Title VII programs are unique in that
    they seek to recruit providers from a variety of backgrounds. This is
    particularly important, as studies have found that those from
    disadvantaged regions of the country are 3 to 5 times more likely to
    return to those underserved areas to provide care versus other areas.

                   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.
        Publi 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 1990-2002 reveals
    that students graduating from PA programs supported by Title VII are 84
    percent more likely to be from underrepresented minority backgrounds
    and 32 percent more likely to practice in underserved settings, than
    students graduating from PA programs that were not supported by Title
    VII.
        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 underserved areas, including new sites in border
    communities, and to establish non-clinical rural rotations to help
    students understand the challenges faced by rural communities. One
    Texas program uses Title VII funds for the development of web based and
    distant learning technology and methodologies so students can remain at
    clinical practice sites. A PA program in New York, where over 90
    percent of the students are ethnic minorities, uses Title VII funding
    to focus on primary care training for underserved urban populations by
    linking with community health centers, which expands the pool of
    qualified minority role models that engage in clinical teaching,
    mentoring, and preceptorship for PA students. 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. Currently, 36 percent of PAs met
    their first clinical employer through their clinical rotations.
        Changes in the health care marketplace reflect a growing reliance
    on PAs as part of the health care team. Currently, 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 supply. Additionally, the Bureau of
    Labor Statistics projects that the number of available PA jobs will
    increase 49 percent between 2002 and 2012. Title VII funding has
    provided, and continues to provide, a crucial pipeline of trained PAs
    to underserved areas. One way to assure an adequate supply of physician
    assistants, especially PAs likely to practice in underserved areas, is
    to continue offering financial incentives, such as funding preferences,
    to PA programs that emphasize recruitment and placement of people
    interested in primary health care in medically underserved communities.
        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.
    Nor has the Title VII support for PA education kept pace with increases
    in the cost of educating PAs. A review of PA program budgets from 1984
    through 2002 indicates an average annual increase of 6.5 percent, a
    total increase of 218 percent over the past 18 years; yet, federal
    support has remained relatively static.

                  RECOMMENDATIONS ON FISCAL YEAR 2005 FUNDING

        A recent report by the Advisory Committee on Training in Primary
    Care Medicine and Dentistry quotes a study in the Journal of Rural
    Health: ``In 1997, Title VII funded programs increased the rates of
    graduates entering health profession shortage areas (HPSAs), resulting
    in 1,357 providers . . . Doubling the funding of these programs . . .
    could decrease the time for HPSAs elimination to as little as 6
    years.'' The Advisory Committee concluded that ``. . . Title VII
    remains a modest investment, but, as has been demonstrated, one with
    substantial future payoffs in terms of system quality, access to care,
    and a culturally competent system of care for the entire population.''
        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 2005. 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 or bioterrorist
    attack, 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.
        Furthermore, while the Academy applauds the Administration's
    proposal to strengthen national security by increasing support for
    health emergency preparedness initiatives, it should not do so at the
    expense of Title VII programs. Training is the key to preparedness, and
    Title VII, section 747, is an ideal mechanism for educating primary
    care providers in public health competencies, facilitating population
    based and community-based skills and training, and increasing the
    alliance between public health and primary care providers. This is
    particularly important for our Nation's most disadvantaged and
    underserved populations, because they are the most vulnerable during
    medical emergencies because of a lack of resources and access to care.
        The Academy respectfully requests that the Title VII and VIII
    health professions programs receive $550 million in funding for fiscal
    year 2005, including $18 million to support PA educational programs, as
    recommended by the Advisory Committee on Primary Care Medicine and
    Dentistry.
        Thank you for the opportunity to present the American Academy of
    Physician Assistants' views on fiscal year 2005 appropriations.
                                     ______

        Prepared Statement of the National Alliance for the Mentally Ill

        Chairman Specter, Senator Harkin and members of the Subcommittee, I
    am Margaret Stout of Johnson, Iowa. I current serve as President of the
    National Alliance for the Mentally Ill (NAMI) and Executive Director of
    NAMI's statewide Iowa affiliate. I am pleased to offer NAMI's view on
    the Subcommittee's fiscal year 2005 bill.
        NAMI is the nation's largest grassroots advocacy organization,
    220,000 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.
        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.
        The cost of mental illness to our nation is enormous. President
    Bush's White House Mental Health Commission--which completed its work
    in 2003--found that the direct treatment cost exceeds $71 billion
    annually. This does not include the $79 billion in estimated indirect
    costs of benefits and social services (including 35 percent of SSI
    benefits and 28 percent of SSDI benefits). These direct and indirect
    costs do not measure the substantial and growing burden that is imposed
    on ``default'' systems that are too often responsible for serving
    children and adults with mental illness who lack access to treatment.
    These costs fall most heavily on the criminal justice and corrections
    systems, emergency rooms, schools, families and homeless shelters.
    Moreover, these costs are not only financial, but also human in terms
    of lost productivity, lives lost to suicide and broken families.
    Investment in mental illness research and services are--in NAMI's
    view--the highest priority for our nation and this Subcommittee.

                 FUNDING FOR SERVICES PROGRAMS AT SAMHSA & CMHS

        The Center for Mental Health Services (CMHS)--part of the Substance
    Abuse and Mental Health Services Administration (SAMHSA)--is the
    principal federal agency engaged in support for state and local public
    mental health systems. Through its programs CMHS provides flexible
    funding for the states and conducts service demonstrations to help
    states move toward adoption of evidence-based practices. Funding for
    all SAMHSA and CMHS programs is part of the Fiscal Year 2005 Labor-HHS-
    Education Appropriations bill that Congress will soon consider.

    CMHS Programs and the Crisis Confronting the Public Mental Health
            System
        During the recent economic downturn and resulting crisis the state
    budgets are facing, we are witnessing widening of gaps in the public
    mental illness treatment system in many states. This is resulting in
    unprecedented cuts being enacted by states in both direct spending on
    mental illness treatment and supportive services, and in Medicaid
    funding of such services. Deep cuts to front-line clinics and providers
    in the public mental health system, curbs on access to newer more
    effective medications and closure of acute care beds in the community
    are just a few of the misguided strategies that states are employing to
    close their widening budget gaps. 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: increased risk
    of suicide, the growing number of chronic homeless adults and the
    growing trend of ``criminalization'' of mental illness and the stress
    it is placing on state and local jails and prisons.

    The Need to Focus on Recovery-Oriented Evidence-Based Practices
        As states continue to cut funding for mental illness treatment and
    supportive services, CMHS programs are becoming an increasingly
    important source of funding for the states. First and foremost, states
    should be encouraged to use their CMHS Block Grant funds to prevent
    further cuts in services for children and adults with severe mental
    illnesses. NAMI also supports targeting of CMHS dollars toward
    investment in evidence-based, outreach-oriented service delivery models
    for persons with severe mental illness in the community. The need to
    focus limited resources on evidence-based models (such as Programs of
    Assertive Community Treatment (PACT) and integrated treatment for co-
    occurring disorders) was recommended in 2003 by the President's ``New
    Freedom Initiative'' Mental Health Commission Report. This landmark
    report called for a reform of the public mental health system to
    eliminate system fragmentation and better reflect the priorities of
    recovery and community integration.

    NAMI Supports the Bush Administration's Request for a ``Mental Health
            System Transformation'' Initiative
        The President's fiscal year 2005 budget includes a request for $44
    million at CMHS for a new state incentive grant program for ``Mental
    Health System Transformation.'' This initiative is intended to help
    states follow through on the July 2003 recommendations in the White
    House ``New Freedom Initiative'' Mental Health Commission report. Under
    the proposal, funds would be allocated to states on a competitive basis
    to support the development of comprehensive state mental health plans
    to reduce system fragmentation and increase access to evidence-based
    services that promote recovery from mental illnesses. States would be
    required to use funds to develop plans that cut across multiple systems
    such as housing, criminal justice, child welfare, employment and
    education. In subsequent years, up to 85 percent of funds could be used
    to support community-based programs, with the remaining 15 percent
    available for state planning and coordination. NAMI strongly supports
    this proposal as critical to the effort to reform our nation's
    fragmented and underfunded public mental health system and bridge the
    gap between scientific advances and practice.

    NAMI Supports the ``Samaritan'' and ``ELHSI'' Initiatives to End
            Chronic Homelessness
        The President's fiscal year 2005 budget proposes $70 million to
    continue the ``Samaritan Initiative'' to end chronic homelessness over
    the next decade, with funding spread across SAMHSA, HUD and the VA. In
    addition, the Bush Administration is seeking a $5 million increase for
    the Projects for Assistance in Transition from Homelessness (PATH)
    program--boosting fiscal year 2005 funding to $55 million. PATH is a
    formula grant program to the states that funds outreach and engagement
    services for homeless individuals with severe mental illnesses. CMHS
    estimates that this increase in the PATH program will result in 154,000
    homeless individuals with severe mental illnesses being served by state
    and local PATH grantees. NAMI also urges additional funding in fiscal
    year 2005 for the PATH program to address inequities in the program's
    interstate funding formula that have the allocation for many smaller
    rural states frozen since the mid-1990s.
        NAMI urges full funding of the ``Samaritan Initiative'' in fiscal
    year 2005 and the proposed increase for PATH. Individuals with severe
    mental illnesses and co-occurring substance abuse disorders make up the
    largest share of the more than 150,000 people who experience chronic
    homelessness--those who stay homeless for a year or more. In addition
    to supporting the Administration's Samaritan Initiative and the
    recommended increases for PATH, NAMI also supports funding for the
    Ending Long-Term Homeless Services Initiative (ELHSI) program at SAMHSA
    to assist states and localities in funding services for new permanent
    supportive housing being developed through HUD's McKinney-Vento
    program. Funding at SAMHSA for Samaritan and ELHSI is critical to
    producing and sustaining 150,000 units of permanent supportive housing
    that will all but eliminate chronic homelessness. Ending chronic
    homelessness through permanent supportive housing will pay for itself,
    as communities save hundreds of millions of dollars in that communities
    are relieved of the costs related to keeping people homeless--including
    those associated with shelters, emergency rooms and jails.
    Funding for CMHS Programs in the President's fiscal year 2005 Budget
        In addition to the initiatives noted above, NAMI also supports
    ongoing activities at CMHS:
      --Mental Health Block Grant.--CMHS's largest program, the Mental
            Health Block Grant (state formula grant program), would receive
            a $2 million increase under the President's fiscal year 2005
            budget proposal (boosting funding to $436 million).
      --Children's Mental Health program at CMHS.--The President is
            requesting a $4 million increase for the Children's Mental
            Health program, increasing funding to $106 million.
      --Programs of Regional and National Significance.--CMHS's own
            discretionary budget--known as Programs of Regional and
            National Significance (PRNS)--would increase under the
            President's budget to $271 million. This includes the $44
            million mental health system transformation initiative noted
            above.
      --Co-Occurring Disorders.--The request for fiscal year 2005 for the
            PRNS program includes $15.2 million in ongoing and new funding
            for best practices and targeted capacity expansion grants to
            foster increased access to integrated treatment for individuals
            with co-occurring mental illness and substance abuse disorders.
            SAMHSA has an important leadership role to play on this issue.
            NAMI strongly urges this Subcommittee to support expansion of
            SAMHSA's activities on this critical priority.
      --Jail Diversion.--NAMI is disappointed that the President's budget
            does not request continued funding for the $7 million Jail
            Diversion program at CMHS. NAMI strongly supports the Jail
            Diversion program and urges continuation of funding in fiscal
            year 2005.
      --Suicide Prevention.--NAMI strongly supports continuation and
            expansion of CMHS's best practices grants and contracts to
            support suicide prevention. The President's ``New Freedom
            Initiative'' Mental Health Commission report contains important
            recommendations on making suicide prevention a national
            priority. NAMI supports these recommendations as critical to
            addressing the estimated 30,000 suicides that occur every year
            in our country--90 percent of which involve a victim with a
            mental disorder.
          national institute of mental health (nimh) research funding
        The National Institute of Mental Health (NIMH) is the only federal
    agency with the main objective of funding biomedical research into
    serious mental illnesses. Increased funding and focus is needed to
    achieve the promise of exciting gains in understanding the brain in
    upcoming years.

    NIMH--Smallest Proposed Increase in 8 Years
        For fiscal year 2005, the President is proposing a $1.421 billion
    budget for the NIMH. This is a $39 million increase--2.2 percent--over
    the amount Congress appropriated for NIMH for fiscal year 2004 ($1.39
    billion). While this exceeds the average 0.5 percent increase for all
    domestic discretionary spending, it is below the 2.7 percent increase
    proposed for all of the National Institutes of Health (NIH)--which
    would increase to $28.805 billion under the President's budget. In
    addition, this proposed increase for NIMH for fiscal year 2005 is below
    the 3.6 percent increase that Congress enacted for fiscal year 2004 and
    far below the 8 percent and 9 percent annual increases that were
    achieved between fiscal year 1998 and 2003.
        This minimal budget increase is expected to have a serious impact
    on the ability of NIMH to sustain ongoing multi-year research grants
    that have been initiated over the past 3-4 years and fund new grant
    proposals relevant to serious mental illness. This is especially the
    case if Congress accepts a proposal being floated by NIH to limit
    annual ``cost of doing research'' adjustments to individual grants to 1
    percent per year. NAMI remains very concerned that this coming fall-off
    in budget increases for NIH does not wipe out the new research that has
    been undertaken at NIMH in recent years, and take advantage of the
    significant opportunities to advance treatments and cures for serious
    mental disorders.
        Mr. Chairman, NAMI is deeply grateful for your leadership on this
    Subcommittee in seeking a strong budget for NIH and NIMH. The
    bipartisan commitment to scientific research that you and Senator
    Harkin continue to demonstrate is an example to your colleagues in
    Congress and in the Administration. We commend you for your amendment
    on the Senate floor during debate on the fiscal year 2005 budget
    resolution to increase NIH funding above the President's request. NAMI
    urges you and your colleagues to make every effort to fund in NIMH at
    the ``professional judgment'' recommendation for fiscal year 2005--
    $1.555 billion, or $172.8 million above the fiscal year 2004 level.

    ``Roadmap to Recovery and Cure''--NAMI's Advocacy Goals and Strategies
            on Mental Illness Research
        This month, the NAMI Policy Research Institute is releasing a new
    report, Roadmap to Recovery and Cure, urging significant increases in
    the NIMH budget for basic, clinical and health services research
    focused on serious mental illness. The reality is that dramatic
    improvements in the lives of individuals with mental illness can be
    achieved over the next decade if research is expanded and the treatment
    system reformed and brought into closer alignment with research.
        Among the conclusions in Roadmap to Recovery and Cure are that
    serious mental illness research has been underfunded, compared to other
    chronic, disabling illnesses, and is insufficiently prioritized at
    NIMH. The task force also found that psychiatric research has only
    begun to enter the modern era of biomedical research and requires the
    development of a strong base of basic and interdisciplinary research,
    large, policy-relevant clinical trials and services research directly
    tied to service delivery. It is important to note that all of these are
    integral to the Bush Administration's Roadmap to Medical Research
    initiative that is currently driving research priorities at NIH.
        Among the recommendations in this report are:
      --Significant and accountable increases in NIMH funding of basic,
            clinical and services research focused on serious mental
            illness--$1 billion over 5 years,
      --Increased application of the NIH's Roadmap to Medical Research
            initiative to serious mental illness,
      --Continuation and expansion of clinical trials focused on serious
            mental illness,
      --Coordination of serious mental illness research, dissemination, and
            service system policy efforts by the federal government, and
      --Increased training and support of researchers and mental health
            care providers.

    The Case for Increased Federal Investment in Mental Illness Research
        Further research is imperative if we are to prevent the next
    generation from suffering. Much has to be learned. The causes and
    mechanisms of diseases such as schizophrenia and bipolar disorder are
    mostly unknown. We do not yet have laboratory tests that can diagnose
    these illnesses. There are no side-effect free treatments. And, of
    course, there is no primary preventive measure or cure currently
    available.
        Treatment is imperfect; it does not work well for all individuals
    living with these brain diseases. There are no cures for severe mental
    illnesses, and existing treatments and services shown to be effective
    are all too often not available to the people who need and deserve
    them. While steady research-funding gains have been achieved, NAMI
    believes that severe mental illness research, from the most basic to
    services research, remains underfunded, given the tremendous scientific
    opportunities that exist and the severe burden that these diseases
    present to the public as well as to our families.
        The public health burden associated with severe mental illness is
    enormous, accounting for a large percentage of costs imposed by all
    illnesses in the United States. An independent study by the World Bank
    and World Health Organization (DALY: Disability Adjusted Life Years)
    found that four of the top ten causes of disability worldwide are
    severe mental illnesses: major depression, bipolar disorder,
    schizophrenia, and obsessive-compulsive disorder, accounting for 25
    percent of the total disability resulting from all diseases and
    injuries.

    Where Should Funding at NIMH Be Directed?
        Greater Focus & Accountability on Severe Mental Illness.--NAMI
    believes that more focus is needed at NIMH on severe mental illness
    research. NAMI therefore urges Congress to require NIMH to provide an
    accounting of new and existing research grants broken down by specific
    illnesses.
        Basic Neuroscience.--NIMH needs to continue progress that has been
    made in unraveling the mysteries of molecules, genes, and brain
    interconnections related to higher brain functioning in brain health
    and serious disease.
        Treatment Research.--Currently there is a lack of understanding
    about which treatments work best for which patients, in what
    combination, and with what risks and costs. NIMH has invested in
    significant research to improve this understanding and it should be
    continued and expanded in the current budget. Importantly, new
    treatments must be developed as well.
        Services Implementation.--There are many important, even crucial
    research questions relevant to the treatment system that serves
    individuals with severe mental illnesses--ranging from improving the
    provision of evidence-based care to identifying exactly how much public
    monies are being spent on a treatment system that more often than not
    is failing.
        Consumer and Family Involvement in Research.--All of these efforts
    at NIMH must be done with a greater involvement with and accountability
    to those patients with severe illnesses and their families. Recent
    efforts at NIMH have moved in this direction, but more needs to be done
    to integrate families and patients into annual reporting and strategic
    planning on research investments and accomplishments.

                                   CONCLUSION

        Chairman Specter, Senator Harkin and members of the Subcommittee,
    thank you for the opportunity to offer NAMI's views on your fiscal year
    2005 bill.
                                     ______

      Prepared Statement of the Association of Maternal and Child Health

                                    Programs
        Mr. Chairman and members of the subcommittee, the Association of
    Maternal and Child Health Programs (AMCHP) is pleased to submit
    testimony on the Maternal and Child Health Services Block Grant as you
    consider the fiscal year 2005 funding request for the Department of
    Health and Human Services. AMCHP is a national non-profit organization
    representing the leaders of state public health programs for maternal
    and child health, and children with special health care needs in all 50
    states, the District of Columbia, and eight additional jurisdictions.
    AMCHP appreciates the subcommittee's continued support of the MCHBG,
    the common source of funding for our members.
        I urge you to provide $807 million for the Maternal and Child
    Health Services Block Grant (MCHBG) in fiscal year 2005. This funding
    level is necessary to maintain at least fiscal year 2003 levels of
    service in every state. Additionally, continued funding ($5 million)
    within the Special Projects of Regional and National Significance
    (SPRANS) set-aside for MCH oral health grant activities is critical. As
    I will explain below, these funds are needed to help state MCH programs
    that have been hit hard by state budget cuts, rising demand for
    services, and years of federal flat funding.
        Maternal and child health programs help to increase immunization
    and newborn screening rates, reduce infant mortality, prevent childhood
    accidents and injuries, and reduce adolescent pregnancy. Each year,
    more than 27 million women, infants, children and adolescents,
    including those with special health care needs, are served by MCH Block
    Grant funds. Half of the 4 million women who give birth annually
    receive some prenatal or postnatal services made possible by the MCHBG.
        State maternal and child health programs need strong financial
    support to meet the challenges ahead. Unfortunately, this year 31
    states (Alabama, Arkansas, Colorado, Illinois, Indiana, Iowa, Kansas,
    Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota,
    Mississippi, Missouri, Montana, Nebraska, New Mexico, North Dakota,
    Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee,
    Texas, Utah, Vermont, West Virginia, Wisconsin, Wyoming) receive less
    in MCH block grant funding than in fiscal year 2003. These cuts range
    from a few thousand dollars to over $1.6 million. Please see the chart
    at the end of this testimony.
        The President's fiscal year 2005 budget flat funds the MCH Block
    Grant at $730 million again. The President also proposes to add the
    Universal Newborn Hearing Screening/Trauma Programs to the MCHBG
    without the $13 million that the programs received in fiscal year 2003.
    This would force states to cut other worthy MCH programs in order to
    continue important hearing screening activities or to scale back their
    hearing screening activities. According to a recent report, thanks to
    the HRSA funding, the number of infants screened for hearing loss at
    birth rose almost 20 percent in 2003. Today, 86 percent of infants born
    in hospitals nationwide are screened for hearing loss, up from 25
    percent in 1999.
        The need for increased funding is clear and I urge you to provide
    $807 million for the Maternal and Child Health Services Block Grant in
    fiscal year 2005. This increase assures that every state receive at
    least the amount that they received from the MCH Block Grant in fiscal
    year 2003. Without this funding, states' ability to serve the millions
    of American women, children, and their families who rely on these
    programs (approximately 27 million in 2002) would be jeopardized. In
    every state, Title V is a safety net program for low-income women and
    children, often the payor of last resort for needed medical services
    when other sources of payment (either public or private) are not
    available.
        State programs funded through the MCH Block Grant make a
    difference. Without sufficient funding, over 18 million children will
    be without the vital health care they need, over 2 million pregnant
    women will not receive prenatal and postnatal care and have a healthy
    pregnancy, and almost 1 million children with special health care need
    will have to battle a fragmented health care system on their own to get
    the services they require.
        Below are specific examples of how reductions at the state and
    federal levels have affected state maternal and child health programs.
    Please keep in mind that the actual effect of the cuts will not be
    fully felt until fiscal year 2005. That's why it is important that you
    provide sufficient funding in the fiscal year 2005 for the Maternal and
    Child Health Services Block Grant.

                                      OHIO

        Ohio received one of the steepest cuts in aid, losing $1.5 million
    (or 6 percent) between fiscal year 2003 and fiscal year 2004 in federal
    MCH funding. Combined with a $7.5 million decline in the state funds
    available to support MCH, the ability for the program to maintain
    services to the 266,000 women, infants, and children who received
    services in 2002 has been severely compromised. Ohio's Children with
    Special Health Care Needs (CSHCN) program, because of both state cuts
    and cuts in the Ohio MCH Block Grant, has had to decrease the number of
    diagnoses covered by the CSHCN Treatment Program and to change the
    eligibility rules to reduce the services provided. Three diagnosed
    conditions (Tonsils/adenoids, Serous otitis media, Hernias--except
    diaphragmatic) were eliminated from the list of those eligible to
    receive services, affecting almost 600 children.
        Other changes may reduce, by as much as 25 percent, the 5,000
    children who rely on the program. Co-payments are increased for
    families. Children with special health care needs require more frequent
    office visits. Raising co-payments can significantly impact the
    financial and physical health of these families and their children if
    they are unable to pay them. These families turn to Title V when
    insurance (either private or public) cannot provide the services. The
    Ohio Specialty Field Clinic Program received a 20 percent decrease in
    MCH block grant and other funding support. The Specialty Clinic Program
    provides access to pediatric specialists for children in Ohio. The
    number of clinics will be cut, all in rural Ohio where the greatest
    need for services are. This will affect the access to care for 300
    children in Ohio's rural areas. Cardiac Specialty Clinics will be
    closed as of July 1, 2004. Funding reductions also slow the ability to
    respond to emerging issues, such as an increase in Ohio's infant
    mortality rate.

                                    ALABAMA

        Alabama lost $450,000 in federal funding. Combined with state cuts,
    the MCH program has had to significantly cut back services and staff.
    Funding for the Monsky Developmental Clinic was slashed by 50 percent.
    The Monsky Developmental Clinic provides developmental assessments of
    children with suspected or documented developmental delay (primarily
    for children from low income families). The clinic maintains a highly
    specialized multi-disciplined staff of professionals. Monsky is one of
    two clinics in Alabama that provides this service for children with
    special health care needs and serves the South Alabama region. The MCH
    program is the largest financial supporter of the clinic. MCH also lost
    a public health nurse position that had been working to engage the
    growing Hispanic community. Without funding to fill the position, it
    will be difficult to pro-actively address perinatal issues in the
    growing Hispanic/Latino population in Alabama. There were 2,630 live
    births to Hispanic/Latino Alabama residents in CY 2002: a 14.7 percent
    increase over the number in CY 2001.

                                      IOWA

        Iowa lost approximately $355,000 in fiscal year 2004. These cuts
    forced the Iowa Children with Special Health Care Needs program (Iowa
    Health Specialty Clinics program at the University of Iowa) to cut
    nutrition services to all children with special needs across Iowa,
    close the regional specialty clinic in Waterloo, cut the Dubuque clinic
    by 80 percent, and cut two other clinics by 20 percent. Scores of
    parents, teachers and educators who teach children who receive services
    through these clinics have written letters to the CSHCN program
    protesting the closures and/or reductions at these sites citing the
    devastating effect on those in need of the services.

                                     TEXAS

        Texas received a reduction of $753,000 (3 percent) in federal MCH
    funds. That reduction along with a reduction in state funds for MCH in
    2004-2005 will drastically increase the unmet needs of the MCH
    population in Texas. Currently, the MCH program addresses less than 10
    percent of the MCH population-in-need. For example, Title V MCH fiscal
    year 2004 contracts funding for population-based services (i.e.,
    initiatives directed toward teen pregnancy, childhood obesity,
    immunization, etc) was decreased by 33 percent and by 13 percent for
    direct services (prenatal care, child well-check visits, dental, family
    planning, etc.). In 2001, the Texas Children with Special Health Care
    Needs program instituted a waiting list that has grown to 1,200
    families and is expected to continue to increase.

                                   WISCONSIN

        Wisconsin loses $776,600 (or 6 percent). Options being considered
    to address this shortfall include applying an across-the-board cut to
    local projects as well as at the state and regional offices. A
    reduction to local projects translates to less activities and services
    received by the maternal and child health population. This will
    translate to children and families not receiving necessary services. In
    light of these cuts and the many more that I am unable to include in
    this testimony, I strongly urge you to provide states increased
    resources through the MCH block grant in fiscal year 2005 to protect
    services to low income pregnant women, infants, children with special
    health care needs and their families. $807 million in fiscal year 2005
    does just that.
        Again, thank you for this opportunity to testify.

    ----------------------------------------------------------------------------------------------------------------
                                                                                Fiscal year
                                                                     --------------------------------
                                  State                                                    2004         Difference
                                                                        2003 actual     conference
    ----------------------------------------------------------------------------------------------------------------
    Alabama.........................................................     $12,866,149     $12,415,309       -$450,840
    Alaska..........................................................       1,146,370       1,180,409          34,039
    Arizona.........................................................       7,406,094       7,842,357         436,263
    Arkansas........................................................       7,785,008       7,524,664        -260,344
    California......................................................      44,341,423      48,441,501       4,100,078
    Colorado........................................................       7,794,869       7,603,353        -191,516
    Connecticut.....................................................       4,946,958       4,998,766          51,808
    Delaware........................................................       1,982,247       2,034,791          52,544
    District of Columbia............................................       7,050,811       7,170,736         119,925
    Florida.........................................................      20,017,388      20,994,684         977,296
    Georgia.........................................................      17,316,887      17,348,033          31,146
    Hawaii..........................................................       2,281,433       2,392,416         110,983
    Idaho...........................................................       3,373,874       3,387,761          13,887
    Illinois........................................................      23,969,437      23,027,020        -942,417
    Indiana.........................................................      12,665,552      12,318,758        -346,794
    Iowa............................................................       7,115,676       6,760,133        -355,543
    Kansas..........................................................       5,151,370       4,963,545        -187,825
    Kentucky........................................................      12,553,023      11,948,246        -604,777
    Louisiana.......................................................      15,533,194      14,293,453      -1,239,741
    Maine...........................................................       3,546,787       3,518,418         -28,369
    Maryland........................................................      12,212,800      12,367,885         155,085
    Massachusetts...................................................      12,046,095      11,968,951         -77,144
    Michigan........................................................      21,596,187      19,903,294      -1,692,893
    Minnesota.......................................................       9,845,406       9,427,666        -417,740
    Mississippi.....................................................      11,169,460      10,337,878        -831,582
    Missouri........................................................      13,318,533      13,030,039        -288,494
    Montana.........................................................       2,609,133       2,560,004         -49,129
    Nebraska........................................................       4,270,142       4,183,264         -86,878
    Nevada..........................................................       1,581,541       1,996,035         414,494
    New Hampshire...................................................       2,023,344       2,071,712          48,368
    New Jersey......................................................      12,102,033      12,348,050         246,017
    New Mexico......................................................       4,798,959       4,723,796         -75,163
    New York........................................................      42,726,728      43,708,310         981,582
    North Carolina..................................................      17,183,075      17,522,028         338,953
    North Dakota....................................................       2,007,580       1,882,687        -124,893
    Ohio............................................................      24,889,019      23,310,577      -1,578,442
    Oklahoma........................................................       8,041,242       7,791,761        -249,481
    Oregon..........................................................       6,484,811       6,579,878          95,067
    Pennsylvania....................................................      26,051,877      25,621,198        -430,679
    Rhode Island....................................................       1,768,713       1,890,246         121,533
    South Carolina..................................................      12,151,811      11,952,796        -199,015
    South Dakota....................................................       2,469,092       2,357,003        -112,089
    Tennessee.......................................................      12,693,368      12,419,315        -274,053
    Texas...........................................................      38,661,981      37,908,796        -753,185
    Utah............................................................       6,336,960       6,222,721        -114,239
    Vermont.........................................................       1,746,907       1,742,951           3,956
    Virginia........................................................      12,947,026      13,001,114          54,088
    Washington......................................................       9,364,663       9,613,745         249,082
    West Virginia...................................................       7,058,712       6,712,857        -345,855
    Wisconsin.......................................................      11,916,084      11,261,938        -654,146
    Wyoming.........................................................       1,333,642       1,309,374         -24,268
                                                                     -----------------------------------------------
          Subtotal..................................................     572,251,474     567,892,222      -4,359,252
    ----------------------------------------------------------------------------------------------------------------

                                     ______

          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). NTEU represents more than 150,000 federal
    employees across 29 agencies and departments of the federal government,
    including employees in a number of divisions of the Department of
    Health and Human Services.
        NTEU represents employees in the following divisions of the
    Department of Health and Human Services: the Health Resources and
    Services Administration (HRSA), Substance Abuse and Mental Health
    Services Administration (SAMHSA), Administration for Children and
    Families (ACF), Administration on Aging (AoA), Office of the Secretary
    (OS), Office for Civil Rights (OCR), Program Support Center (PSC) and
    the National Center for Health Statistics (NCHS). NTEU also represents
    employees in the Social Security Administration's Office of Hearings
    and Appeals (OHA).
        As the Chairman knows, for several years now, most federal agencies
    have struggled to accomplish their missions to the best of their
    abilities within tight fiscal constraints. Many federal agencies have
    not had the necessary funds to adequately train their employees, others
    have been forced to downsize to the point where they are not staffed
    appropriately for their missions and still other agencies have not had
    the resources to use the tools at their disposal to attract and retain
    the workforces they know they need for the future. These tools include
    recruitment and retention bonuses as well as the ability to help
    employees with student loan expenses--tools that the private sector
    knows are imperative to attracting and retaining the best employees.
        The federal government faces an unprecedented recruitment and
    retention crisis. In addition to adequately funding agencies to perform
    their missions, NTEU believes that a major step toward making the
    federal government an employer of choice is a commitment by Congress
    and the Administration to establish a fair process for setting federal
    salaries. As you know, Mr. Chairman, for 2 years in a row now, despite
    a bipartisan and bicameral commitment to pay parity between the
    Nation's military and civilian employees, the President has chosen to
    implement a smaller pay raise for civilian employees only to see that
    raise overturned by subsequent Congressional action.
        The message this sends federal employees is that they are not as
    important as their military counterparts, that they are somehow not as
    deserving of a fair pay raise. Here it is March 2004 and the pay raise
    these employees should have received the first pay period in January
    has still not reached their paychecks. While the full 4.1 percent pay
    raise is retroactive to January, agencies are still struggling to
    update their payroll systems and implement the full amount of the pay
    raise. We are told it may be several more months before all federal
    employees receive the full pay raise Congress approved.
        Adequate and stable agency funding coupled with appropriate federal
    pay and benefits are the keys to ensuring that the government is able
    to attract and retain the federal employees it requires. The need for
    the federal government to hire and maintain a highly skilled workforce
    has never been more clear. Federal employees protect our Nation's
    medical supplies, they help secure our borders and they provide
    important services and information to their fellow taxpaying citizens
    every day.
        The Administration's fiscal year 2005 budget request continues to
    hold federal agencies to unrealistic funding levels. We cannot continue
    to ask our agencies to do more while ignoring their requests for
    appropriate funding.
        The Administration's fiscal year 2005 request for program
    management funding at the Health Resources and Services Administration
    (HRSA) is $158 million. Although this figure represents a $3 million
    increase in administrative funds over the fiscal year 2004 funding
    level, it is important to remember that HRSA's 2004 funding level
    represented a reduction of $9 million from the prior year. For an
    agency charged with insuring access to quality health care, especially
    to underserved populations--services that are in desperate need of
    expansion--a considerably larger increase in program management funding
    is called for. HRSA cannot effectively accomplish its mission without
    additional resources.
        The President's budget proposes a substantial increase in funding
    for the National Center for Health Statistics (NCHS) for fiscal year
    2005, a budget increase that is long overdue. As you know, the work
    NCHS undertakes is critical to ensuring that national health care
    initiatives are effective and the agency has been held to unrealistic
    funding levels for too many years now. NTEU hopes the fiscal year 2005
    budget request will be enacted for NCHS.
        The budget request for program management funds in 2005 at the
    Substance Abuse and Mental Health Services Administration (SAMHSA) is
    $92 million, the same as the agency's funding level for fiscal year
    2004. SAMHSA is the federal agency charged with improving the quality
    and availability of treatment and intervention programs for those
    suffering from substance abuse and mental illness. It is discouraging
    to see this important agency held to an unrealistic funding level for
    the coming fiscal year and I am hopeful that program management funding
    for SAMHSA in fiscal year 2005 can be increased.
        The President's budget proposal for fiscal year 2005 for the
    Administration for Children and Families (ACF), represents an increase
    of $12 million for federal administration of the programs ACF oversees.
    Funding restrictions in past years have hampered this agency's ability
    to accomplish its missions and NTEU strongly supports increased funding
    for the federal administration of ACF programs.
        However, at the same time, we must continue to state our strong
    opposition to legislation pending in Congress to reauthorize the Head
    Start Program. As you know, the Head Start Program allows many children
    from low-income families to access a package of educational and social
    services that supplement the student's learning. Under the direction of
    the federal government, the Head Start Program has enhanced the
    opportunities of millions of American children since its inception.
    Legislation that seeks to limit the involvement of the federal
    government with the Head Start Program, such as H.R. 2210, is
    shortsighted and threatens to move the program in the wrong direction.
    Similarly, S. 1940, which encourages contracting out the oversight of
    the Head Start Program to profit-driven firms in the private sector,
    must be reconsidered. I hope that the Committee will carefully review
    the Head Start reauthorization legislation before it is voted on by the
    full House and Senate.
        The President's budget recommends only a slight improvement in
    funding for program administration for the Administration on Aging
    (AoA), holding the agency's program administration funding level to $18
    million for 2005. With our country's rapidly growing older population,
    this is particularly troublesome. The Administration on Aging helps
    older Americans remain independent and productive and offers nutrition,
    caregiver support and preventive health programs. These are precisely
    the type of programs desperately in need of expansion, yet the fiscal
    year 2005 budget proposal, like the 2004 budget before it offers little
    in the way of new funding for these critical areas. The AoA funding
    level, too, requires the careful scrutiny of this Subcommittee.
        The Office of the Secretary (OS) of the Department of Health and
    Human Services is slated to receive increased funding in fiscal year
    2005. Federal employees working in the Office of the Secretary help
    administer all of the programs operated by the Department of Health and
    Human Services. It is critical that this office be effectively funded
    and NTEU is pleased to see a significant funding increase for this
    division. We urge the Committee to approve this request.
        The President's budget recommends a small increase in program
    funding for the Office for Civil Rights (OCR). The recommendation would
    increase this agency's resources from their 2004 funding level of $34
    million to $35 million in 2005. The HHS Office for Civil Rights helps
    to ensure that all individuals have proper access to the services and
    programs the Department offers. Moreover, this agency helps promote the
    privacy of medical information. In past years, OCR has been woefully
    under funded and NTEU urges this body to carefully review their funding
    needs for 2005.
        The Department of Health and Human Services' Program Support Center
    (PSC) offers a range of administrative services both to HHS agencies
    and other federal departments that seek out its services. The
    President's fiscal year 2005 budget, which requests an increase in
    expenses for this key agency over their fiscal year 2004 funding level,
    deserves to be adopted by this body.
        NTEU also represents employees in the Office of Hearing and Appeals
    (OHA) of the Social Security Administration. As the Chairman knows very
    well, OHA's mission is to assist those claimants who have been found
    ineligible for Social Security disability benefits by providing a due
    process hearing on their cases. The continuing backlog of cases before
    OHA prevents a fair and timely hearing for the thousands of individuals
    whose disability cases must be heard there. One of the problems facing
    OHA is that it lacks sufficient decision makers to handle its
    continuing and rapidly growing workload.
        For almost a decade, SSA's disability program has been in crisis.
    In 1995, SSA introduced a program called the Senior Attorney Program
    that was instrumental in reducing the backlog and improving processing
    times. The agency's experienced staff attorneys were given the
    authority to decide and issue fully favorable decisions--without the
    time and expense of a full hearing--in those cases where the evidence
    clearly identified an individual as disabled. In every respect, the
    Senior Attorney Program was a success. Unfortunately, SSA chose to
    terminate this innovative program as it undertook its Hearings Process
    Improvement (HPI) plan, a plan SSA now admits was unsuccessful.
        On a more positive note, current Social Security Commissioner
    Barnhart has undertaken an objective review of the entire disability
    system. Finally, senior SSA officials truly understand the strengths
    and deficiencies of the current system. This insight combined with the
    Commissioner's commitment to create a process which serves the needs of
    the public rather than the dictates of the bureaucracy, have led her to
    propose a plan for implementing fundamental process changes that will
    provide a level of service of which we all can be proud.
        The plan is comprehensive and involves extensive changes such as
    the eventual replacement of paper folders with electronic folders,
    elimination of the Reconsideration Determination, elimination of the
    Appeals Council, a completely revamped quality assurance system, and
    the creation of the Reviewing Official position to provide an
    intermediate step between the State Agency and the ALJ. NTEU is
    convinced that this plan, if implemented, will result in an efficient,
    effective, and most importantly, a fair adjudicatory process.
        In a particularly important initiative proposed by the
    Commissioner, a Reviewing Official, or RO position, will be created.
    This individual will be an attorney and will apply the same
    adjudicatory standards to the disability determination process, as will
    the Administrative Law Judges. Past experience from the Senior Attorney
    Program indicates that the creation of this position in conjunction
    with the other improvements the Commissioner seeks to put in place will
    result in many disabled claimants being awarded benefits in as little
    as 30 days.
        The President has recognized the importance of providing SSA with
    sufficient resources to enable SSA to implement the Commissioner's plan
    to improve the Social Security disability program. NTEU asks that the
    Congress approve the budget requests of the President regarding the
    funding of the Commissioner's Approach to Disability Adjudication.
        However, as good as the Commissioner's plan is, it does not provide
    immediate relief for those currently waiting for a disability decision.
    Unfortunately, it will be October 2005 at the earliest before the
    Commissioner's recommendations can be implemented. In the meantime, the
    backlog will continue to grow.
        Given the present state of resources, the current workload, and the
    direction that the Commissioner's Approach is taking the Agency, the
    Commissioner should immediately reinstate the original Senior Attorney
    Program. In addition to making a positive, immediate, and effective
    impact on the backlog, it would act as a good transition to the
    Reviewing Official. All qualified OHA Attorney Advisors should be
    empowered to issue fully favorable on-the-record decisions. During the
    period from 1995 to 1999 Senior Attorneys issued over 220,000 fully
    favorable on-the-record decisions, and the cases pending at OHA hearing
    offices fell from over 550,000 cases to 311,000 cases. A well designed
    and well managed Senior Attorney program should be able to process at
    least 60,000 fully favorable reversals in a year without reducing the
    number of ALJ decisions or affecting the overall reversal rate at OHA.
        Implementing the original Senior Attorney Program would require
    limited new hiring and the impact on the backlog would be swift and
    striking. I strongly recommend that this Committee both carefully
    review and embrace the Commissioner's new disability plan and also
    encourage SSA to implement the original Senior Attorney Program once
    again without delay.
        Thank you very much for your attention to these issues. I very much
    appreciate the opportunity to share this testimony with you.
                                     ______

               Prepared Statement of the Oncology Nursing Society

        The Oncology Nursing Society (ONS) appreciates the opportunity to
    submit written comments for the record regarding funding for cancer and
    nursing related programs in fiscal year 2005. ONS, the largest
    professional oncology group in the United States composed of more than
    30,000 nurses and other health professionals, exists to promote
    excellence in oncology nursing and the provision of quality care to
    those individuals affected by cancer. As part of its mission, the
    Society honors and maintains nursing's historical and essential
    commitment to advocacy for the public good.
        This year more than 1.3 million Americans will be diagnosed with
    cancer and more than 560,000 will lose their battle with this terrible
    disease. Despite these grim statistics, significant gains in the War
    Against Cancer have been made through our nation's investment in cancer
    research and its application. Research holds the key to improved cancer
    prevention, early detection, diagnosis, and treatment but such
    breakthroughs are meaningless unless we can deliver them to all
    Americans in need. One barrier to ensuring that all people benefit from
    breakthroughs in cancer research is that recent studies have reported
    126,000 registered nurse vacancies in hospitals and 13,900 registered
    nurse vacancies in nursing homes.
        To ensure that all people with cancer have access to the
    comprehensive, quality care they need and deserve, ONS advocates
    ongoing and significant federal funding for cancer research and
    application, as well as programs to help ensure an adequate oncology
    nursing workforce to care for people with cancer. The Society stands
    ready to work with policymakers at the local, state, and federal levels
    to advance policies and programs that will reduce and prevent suffering
    from cancer and sustain and strengthen the nation's nursing workforce.

        SECURING AND MAINTAINING AN ADEQUATE ONCOLOGY NURSING WORKFORCE

        Over the last 10 years, the setting in which treatment for cancer
    is provided has changed dramatically. An estimated 80 percent of all
    Americans receive cancer care in community settings including cancer
    centers, physicians' offices, and hospital outpatient departments.
    Treatment regimens are as complex, if not more so, than regimens given
    in the inpatient setting a few short years ago. Oncology nurses are on
    the front lines in the provision of quality cancer care for individuals
    with cancer--administering chemotherapy, managing patient therapies and
    side-effects, working with insurance companies to ensure that patients
    receive the appropriate treatment, providing counseling to patients and
    family members, and engaging in myriad other activities on behalf of
    people with cancer and their families.
        Overall, age is the number one risk factor for developing cancer.
    Approximately 77 percent of all cancers are diagnosed at age 55 and
    older. Currently, Medicare beneficiaries account for more than 50
    percent of all cancer diagnoses and 64 percent of cancer deaths. Of
    serious concern is that over the next 10 to 15 years the number of
    Medicare beneficiaries with cancer is estimated to double while more
    than 1.1 million registered nurse job openings will need to be filled
    by 2012 to meet growing patient demand and replace retiring nurses.
    With an increasing number of people with cancer needing high quality
    health care coupled with an inadequate nursing workforce, our nation
    could quickly face a cancer care crisis of serious proportion with
    limited access to quality cancer care, particularly in traditionally
    underserved areas. A study in the New England Journal of Medicine found
    that nursing shortages in hospitals are associated with a higher risk
    of complications--such as urinary infections and pneumonia, longer
    hospital stays, and even patient death. Without an adequate supply of
    nurses, there will not be enough qualified oncology nurses to provide
    the quality cancer care to a growing population of people in need and
    patient health and well being could suffer.
        Further, of additional concern is that our nation also will have a
    shortage of nurses available and able to conduct cancer research and
    clinical trials. With a shortage of nurses in cancer research, our war
    against cancer will take longer because of unfulfilled staffing needs
    coupled with the reality that in some practices and cancer centers
    resources could be funneled away from cancer research to pay for the
    hiring and retention of oncology nurses to provide direct patient care.
    Without a sufficient supply of trained, educated, and experienced
    oncology nurses, our nation will falter in its delivery--or
    application--of the benefits from our federal investment in research.
        ONS has joined with others in the nursing community in advocating
    $205 million as the fiscal year 2005 funding level necessary to support
    implementation of the Nurse Reinvestment Act and the range of nursing
    workforce programs housed at the U.S. Health Resources and Services
    Administration (HRSA). Enacted in 2002, the Nurse Reinvestment Act
    included new and expanded initiatives, including loan forgiveness,
    scholarships, career ladder opportunities, and public service
    announcements to advance nursing as a career. Despite the enactment of
    this critical measure, HRSA fails to have the resources necessary to
    meet the current and growing demands for our nation's nursing
    workforce. For example, in fiscal year 2003 HRSA received 8,321
    applications for the Nurse Education Loan Repayment Program but only
    had funding to award 602--a rate of 7.2 percent. Also in fiscal year
    2003, the agency received 4,512 applications for the Nursing
    Scholarship Program but only could fund 94--a rate of 2.1 percent.
    Further exacerbating the current situation is that nursing programs
    turned away more than 11,000 qualified students last fall, in part due
    to a shortage of faculty. If funded sufficiently, the components and
    programs of the Nurse Reinvestment Act would help address the multiple
    factors contributing to the nationwide nursing shortage, including the
    shortage of faculty, decline in nursing student enrollments, and poor
    public perception of nursing as a viable and worthwhile profession.
        ONS strongly urges Congress to provide HRSA with a minimum of $205
    million in fiscal year 2005 to ensure that the agency has the resources
    necessary to fund a higher rate of Nurse Education Loan Repayment and
    Nursing Scholarship applications as well as implement other essential
    endeavors to sustain and boost our nation's nursing workforce. Nurses--
    along with patients, family members, hospitals, and others--have joined
    together in calling upon Congress to provide this essential level of
    funding. One Voice Against Cancer (OVAC)--a collaboration of more than
    50 national nonprofit organizations representing millions of
    Americans--has added a request of $205 million for the Nurse
    Reinvestment Act funding to its fiscal year 2005 appropriations
    advocacy agenda. ONS and its allies have serious concerns that without
    full funding, the ``Nurse Reinvestment Act'' will prove an empty
    promise; the current and expected nursing shortage will worsen and
    people will not be have access to the quality cancer care they need and
    deserve.

     BOOST OUR NATION'S INVESTMENT IN CANCER PREVENTION, EARLY DETECTION,
                                 AND AWARENESS

        Approximately two-thirds of cancer cases are preventable through
    lifestyle and behavioral factors and improved practice of cancer
    screening. Although the potential for reducing the human, economic, and
    social costs of cancer by focusing on prevention and early detection
    efforts remains great, our nation does not invest sufficiently in these
    strategies. While as a nation we spend almost $1 trillion a year on our
    health care system, we only allocate about 1 percent of that amount for
    population-based prevention. By the year 2020, cancer and other chronic
    disease expenditures will reach $1 trillion or 80 percent of health
    care costs. The nation must make significant and unprecedented federal
    investments today to address the burden of cancer and other chronic
    diseases and to reduce the demand on the healthcare system and diminish
    suffering in our nation both for today and tomorrow.
        As the nation's leading prevention agency, the Centers for Disease
    Control and Prevention (CDC) plays an important role in translating and
    delivering at the community level what is learned from research--
    especially ensuring that those populations disproportionately affected
    by cancer receive the benefits of our nation's investment in medical
    research. Therefore, ONS joins with our partners in the cancer
    community--including One Voice Against Cancer--in calling on Congress
    to provide additional resources for physical activity, nutrition, and
    tobacco control programs and other cancer-related screening,
    prevention, and public health education efforts supported through the
    CDC to support and expand much-needed and proven effective cancer
    prevention, early detection, and risk reduction efforts. Specifically,
    ONS advocates:
      --$250 million for the National Breast and Cervical Cancer Early
            Detection Program;
      --$65 million for the National Cancer Registries Program:
      --$25 million for the Colorectal Cancer Prevention and Control
            Initiative;
      --$25 million for the Comprehensive Cancer Control Initiative;
      --$20 million for the Prostate Cancer Control Initiative;
      --$10 million for the National Skin Cancer Prevention Education
            Program;
      --$9 million for the Ovarian Cancer Control Initiative;
      --$5 million for the Geraldine Ferraro Blood Cancer Program;
      --$130 million for the National Tobacco Control Program; and
      --$70 million for the Nutrition, Physical Activity, and Obesity
            Program.

                SUSTAIN AND SEIZE CANCER RESEARCH OPPORTUNITIES

        Our nation has benefited immensely from our past federal investment
    in biomedical research at the National Institutes of Health (NIH). ONS
    has joined with the rest of the cancer community in advocating $30.19
    billion for the NIH in fiscal year 2005. This increase of 8.5 percent
    over fiscal year 2004 funding will allow NIH to sustain and build on
    its research progress resulting from the recent NIH budget doubling
    effort while avoiding the severe disruption to that progress that would
    result from a minimal increase.
        Cancer research is producing extraordinary breakthroughs--leading
    to new therapies that translate into longer survival and improved
    quality of life for cancer patients. We have seen extraordinary
    advances in cancer research resulting from our national investment that
    have produced effective prevention, early detection and treatment
    methods for many cancers. To that end, ONS calls upon Congress to
    allocate $6.2 billion to the National Cancer Institute (NCI) in fiscal
    year 2005 as recommended by the NCI Director in the Bypass Budget
    submitted to Congress annually under the requirements of the National
    Cancer Act of 1971. The NCI Bypass Budget represents the best
    estimation of the scientific community regarding the resources needed
    to continue our battle against cancer.
        The National Institute of Nursing Research (NINR) supports basic
    and clinical research to establish a scientific basis for the care of
    individuals across the life span--from management of patients during
    illness and recovery to the reduction of risks for disease and
    disability and the promotion of healthy lifestyles. These efforts are
    crucial in translating scientific advances into cost-effective health
    care that does not compromise quality of care for patients.
    Additionally, NINR fosters collaborations with many other disciplines
    in areas of mutual interest such as long-term care for older people,
    the special needs of women across the life span, bioethical issues
    associated with genetic testing and counseling, and the impact of
    environmental influences on risk factors for chronic illnesses such as
    cancer. ONS joins with the nursing community in advocating an
    allocation of $160 million for NINR in fiscal year 2005.

                                   CONCLUSION

        ONS stands ready to work with policymakers to advance policies and
    support programs that will reduce and prevent suffering from cancer
    this year and sustain and strengthen our nation's nursing workforce.
    Moreover, ONS maintains a strong commitment to working with Members of
    Congress, other nursing societies, patient organizations, and other
    stakeholders to ensure that the oncology nurses of today continue to
    practice tomorrow and that we recruit and retain new oncology nurses to
    meet the unfortunate growing demand that we will face as the baby boom
    generation ages. We thank you for this opportunity to discuss the
    funding levels necessary to ensure that our nation has a sufficient
    nursing workforce to care for the patients of today and tomorrow and
    that our nation continues to make gains in our fight against cancer.
                                     ______

    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 2005
    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
    admire your consistent support.

                            GROWING NURSING SHORTAGE

        AWHONN supports the advancement of quality care through an adequate
    nurse workforce. Data from the Bureau of Health Professions, Division
    of Nursing's National Sample Survey of Registered Nurses--February
    2002, confirm that of the approximate 2.7 million registered nurses in
    the nation, only about 82 percent of these nurses were working full-
    time or part-time in nursing. The increase in the number of licensed
    RNs that was reported from 1996-2000 was the lowest increase reported
    in previous national surveys. In addition to the shrinking pipeline of
    nurses coming into the program, the dominant factor in this shortage is
    the impending retirement of up to 40 percent of the workforce by 2010
    or soon thereafter. This will occur at the same time that the needs of
    the aging baby boomer population will markedly increase demand for
    health care services and the services of registered nurses.
        This critical demand is reinforced by the fact that in February
    2004, the U.S. Bureau of Labor released statistics detailing how
    registered nurses have the largest projected 10-year job growth in the
    United States. Labor projects a need for 2.9 million nurses in 2012, up
    from 2.3 million actively working nurses that was projected in 2002. As
    a result, it will take long-term planning and innovative initiatives at
    the local, state and federal level to assure an adequate supply of a
    qualified nurse workforce for the nation.

    Nurse Workforce Development Programs
                AWHONN recommends a total of $205 million for fiscal year
                        2005 to fund the Nurse Workforce Development
                        programs in Title VIII
        The Nurse Education Act (Public Health Service Act, Title VIII),
    enacted in 1964, represents the only comprehensive federal legislation
    to provide funds for nursing education. The programs authorized in this
    portion of Public Law 105-392 help 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 2002 Congress enacted the Nurse Reinvestment Act
    which provides funding for new and expanded programs. These programs
    include scholarships, career ladders, internships and residencies,
    retention programs and faculty loans designed to encourage students to
    consider nursing, keep nurses in nursing and ensure that nurse
    educators are plentiful enough to educate future nurses that we
    desperately need. The new programs received an initial appropriation of
    $20 million in fiscal year 2003. This appropriation was in addition to
    $93 million in funding provided for existing Title VIII programming.
    Unfortunately, due to limited funding in the first 2 years of the new
    authorization the loans and scholarships programs have not been
    successful in providing support to students in nursing schools. In the
    first year, only 574 loan repayment contracts were made nationally,
    averaging roughly 11 loan repayment agreements per state and less than
    2 percent of all scholarship applicants were funded.
        The shortage of registered nurses and the effect of the shortage on
    nurse staffing and patient safety demand a significant increase in
    funding for these nurse education programs. Nursing is the largest
    health profession with over 2.7 million nurses, yet only one-tenth of 1
    percent of the federal health funding of the nation is directed to
    nursing education. A significant increase in funding for these programs
    would lay the groundwork to expand the nursing workforce, through
    education, clinical training and retention programs, in order to
    address some of the serious nursing shortage issues. This investment in
    nursing education and retention will ultimately benefit us all through
    improved patient care and health outcomes.
        The nursing shortage is not confined solely to care providers;
    there is also a growing, significant shortage of nurse faculty. The
    American Association of Colleges of Nursing (AACN) reports that the
    average age of nursing professors is 52, and for associate professors
    the average age is 49. The impending retirement of these seasoned
    educators will impact the ability of our schools and universities to
    meet the educational health care needs of the nation. In addition, each
    year nearly 1,800 full-time faculty members leave their positions while
    only 350 to 400 nursing students receive doctoral degrees. According to
    AACN, U.S. nursing schools turned away over 11,000 qualified applicants
    to baccalaureate nursing programs in 2003 due to insufficient faculty,
    clinical sites, classroom space, and budget constraints. While the
    capacity to implement faculty development is currently available
    through Section 811 and Section 831, adequate funding and direction is
    needed to ensure that these programs are fully operational. Options to
    provide support for full-time doctoral study are essential to rapidly
    prepare the nurse educators of the future. AWHONN suggests that a
    portion of the funds be allocated for faculty development and
    mentoring. Further, AWHONN recognizes the importance of appropriate
    investments in advanced practice nursing programs. As in other
    professions the advanced degree has become a necessary achievement for
    career advancement and registered nurses who pursue the MSN degree are
    a part of the cadre of nurses who go on to become faculty. Our nation
    does need more nurses with basic training to enter the field, but
    focusing only on these nurses only addresses half the problem. The
    nursing shortage encompasses nursing faculty--advanced practice nursing
    and basic nursing must both receive additional funding, but not one at
    the expense of the other.

    Maternal and Child Health Bureau
                AWHONN recommends $850 million in funding in fiscal year
                        2005 for the Maternal and Child Health Bureau
        This program provides comprehensive, preventive care for mothers
    and young children, as well as an array of coordinated services for
    children with special needs. In fact, the Maternal Child Health Block
    Grant (MCH) serves over 80 percent of all infants in the United States,
    half of all pregnant women, and 20 percent of all children.
        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, in NINR research, to improve
    the prenatal health-related behavior of women and reduce rates of child
    abuse and neglect as well as maternal welfare dependence.

    Indian Health Service
                AWHONN recommends an fiscal year 2005 appropriation of
                        $5.54 billion for IHS.
        The Indian Health Service (IHS) is the principal Federal health
    care provider and health advocate for Indian people with the goal of
    ``ensur[ing] that comprehensive, culturally acceptable personal and
    public health services are available and accessible to all American
    Indian and Alaska Native people.'' IHS is tasked with an enormous
    responsibility in providing care to over half of the American Indian
    population.
        The American Indian and Alaska Native people have long experienced
    lower health status when compared with other Americans. Lower life
    expectancy and the disproportionate disease burden exist perhaps
    because of inadequate education, disproportionate poverty,
    discrimination in the delivery of health services, and cultural
    differences. These are broad quality of life issues rooted in economic
    adversity and poor social conditions.
        A recent study of federal health care spending per capita found
    that the United States spends $3,803 per year per federal prisoner,
    while spending about half that amount per year, per Native American:
    $1,914. per capita health care spending for the U.S. general population
    is $5,065 per year. A significant increase in funding over fiscal year
    2004 spending levels is necessary for the Federal government to fulfill
    its responsibility to Indian Country and achieve its stated goals.
        While the nursing shortage continues nationwide, IHS has been
    disproportionately impacted by the lack of RNs. IHS nurses are older,
    with an average age of 48 and nearly 80 percent of RNs are over the age
    of 40, and the average vacancy rate for RNs is 14 percent. IHS
    administers three interrelated scholarship programs designed to meet
    the health professional staffing needs of IHS and other health programs
    serving Indian people. These programs are severely under-funded.
    Targeted resources need to be invested in the IHS health professions
    programs in order to recruit and retain registered nurses in Indian
    Country.
        Additionally, Section 112 of the Indian Health Care Improvement
    Act, Public Law 94-437, authorizes grants to public or private schools
    of nursing, tribally-controlled community colleges and tribally-
    controlled post secondary vocational institutions for the purpose of
    recruiting, training and increasing the number of professional nurses
    who deliver health care services to Indian people. On average, Section
    112 programs provide five undergraduate scholarships per year and two
    master's program scholarships. This important program should be
    expanded to provide many more scholarships, both at the undergraduate
    and graduate levels, in an effort to offer meaningful relief to the
    nursing shortage for IHS healthcare providers and the patients they
    serve.

    National Institute of Nursing Research (NINR)
                AWHONN recommends an increase of $25 million over fiscal
                        year 2004 funding levels for the NINR, resulting in
                        an fiscal year 2005 appropriation of $160 million
        NINR engages in significant research affecting areas such as:
    health disparities in ethnic groups, training opportunities for
    management of patient care and recovery, and telehealth interventions
    in rural/underserved populations. These research programs directly help
    patients and families and contribute to decreased medical costs and
    increased quality of patient care. This research allows us to refine
    the practice and provide quality patient care in its current
    challenging environment.
        NINR research improves health outcomes for women. Recent public
    awareness campaigns target differences in the manifestation of
    cardiovascular disease between men and women. The differing symptoms
    are the source of many missed diagnostic opportunities among women
    suffering from the disease, which is the primary killer of American
    women. In a study funded by NINR, researchers were able to
    qualitatively analyze the intensity of pain and limitation of activity
    experienced by women suffering from angina, both of which were found to
    be of greater intensity than that experienced by men. The study
    concluded that the gender variation could significantly impact
    diagnosis and treatment of female patients suffering from related
    cardiovascular problems.
        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 a 10 percent increase in funding for NICHD
                        for fiscal year 2005, bringing the appropriation to
                        $1.315 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.
        Recently NICHD announced the publication of research that led to
    the finding of predictors of preeclampsia, a life-threatening
    complication impacting 5 percent of all pregnancies. Abnormal levels of
    two molecules found in the blood, soluble fms-like tyrosine kinase 1
    (sFlt-1) and placental growth factor (PlGF), seemed to predict the
    development of preeclampsia. This finding has been touted as the most
    promising lead yet discovered in the effort to prevent and cure
    preeclampsia.

    National Institutes of Environmental Health Sciences (NIEHS)
                AWHONN supports an 8 percent increase in funding for NIEHS
                        for fiscal year 2005, bringing the appropriation to
                        $680 million
        Research conducted by the NIEHS plays a critical role in what we
    know about the relationship between our environmental exposures and
    disease onset. Through the research sponsored by this Institute, we
    know that Parkinson's disease, breast cancer, birth defects,
    miscarriage, delayed or diminished cognitive function, infertility,
    asthma and many other diseases and ailments have confirmed
    environmental triggers. Our expanded knowledge, as a result, allows
    both policy makers and the general public to make important decisions
    about how to reduce toxin exposure and reduce the risk of disease and
    other negative health outcomes.
        One impressive collaborative research project spearheaded by the
    NIEHS is the recent development of Breast Cancer and the Environment
    Research Centers. These centers, co-funded by the National Cancer
    Institute, will study the prenatal-to-adult environmental exposures
    that may predispose a woman to breast cancer. Recognizing that one in
    eight women in the United States can expect to have breast cancer in
    her lifetime, and that the causes of most of these cases are not known;
    the centers will enroll different ethnic groups of young girls and
    study their life exposures to a wide variety of environmental,
    nutritional and social factors that impact puberty.

    Centers for Disease Control and Prevention (CDC)
                AWHONN recommends an fiscal year 2005 appropriation of $7.9
                        billion for the CDC
        For nearly 60 years, the Centers for Disease Control and Prevention
    (CDC) has evolved to assume responsibility for programs in infectious
    disease surveillance, control and prevention, injury control, health in
    the workplace, prevention of heart disease, cancer, stroke, obesity and
    other chronic diseases, improvements in nutrition and immunization,
    environmental effects on health, prevention of birth defects,
    laboratory analyses, outbreak investigation and epidemiology training,
    and data collection and analysis on a host of vital statistics and
    other health indicators. Now more than ever, CDC's role in protecting
    the nation's health through prevention has become evident as we address
    issues of terrorism, emergency preparedness and health system capacity
    and infrastructure. Increased funding for CDC is critical.
        For over 30 years, CDC has been deeply involved in the prevention
    of birth defects through programs like the Folic Acid Education
    Campaign and the new National Center on Birth Defects and Developmental
    Disabilities (NCBDDD). The public health impact of birth defects is
    tremendous. Of the 4 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. CDC funds several programs critical
    to reducing the number of children born with birth defects.
    ---------------------------------------------------------------------------
        \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.
    ---------------------------------------------------------------------------
        Heart disease and stroke are the first and third leading causes of
    death in the United States, causing one death every 33 seconds and $298
    billion a year in healthcare costs and lost productivity, according to
    CDC estimates. Women are most commonly misdiagnosed for cardiovascular
    disease and nearly 8 million women are currently living with
    cardiovascular disease. Cardiovascular disease kills nearly half of all
    American women. Additionally, 61 percent of American adults are
    overweight or obese and nearly 14 percent of children and adolescents
    are overweight. Obesity is considered a major public health problem
    because it serves as the gateway disease for many other illnesses
    including but not limited to: depression, type 2 diabetes,
    hypertension, congestive heart failure, stroke, poor female
    reproductive health and pregnancy complications. These are but two
    examples of illnesses with programmatic public health funding through
    CDC. Any cuts to these programs will potentially leave millions of
    Americans without primary prevention programs that ultimately save
    lives and money. We respectfully request that you provide CDC chronic
    disease prevention and health promotion programs with $1.1 billion to
    ensure that these programs have the resources necessary to translate
    preventive health research into practice. This investment will save
    lives and billions in health care costs and productivity.
        Please find below a summary of AWHONN formal funding
    recommendations for these and other federal health programs.

    ----------------------------------------------------------------------------------------------------------------
                                                                                   President's
                       Programmatic area                     Final fiscal year    budget fiscal     AWHONN's request
                                                                    2004            year 2005
    ----------------------------------------------------------------------------------------------------------------
    Nurse Workforce Development Programs...................       $142,763,000       $147,000,000       $205,000,000
    Maternal & Child Health Block Grant....................        730,000,000        730,000,000        850,000,000
    Indian Health Service..................................      3,671,000,000      3,356,000,000      5,540,000,000
    Title X--Family Planning...............................        278,000,000        278,000,000        350,000,000
    Newborn Hearing Screening..............................         13,000,000  .................         13,000,000
    AHRQ...................................................        305,000,000        305,000,000        443,000,000
    NIH....................................................     28,041,000,000     28,805,000,000     31,685,500,000
    NINR...................................................        135,000,000        139,000,000        160,000,000
    NICHD..................................................      1,242,000,000      1,281,000,000      1,315,000,000
    NIEHS..................................................        631,000,000        650,000,000        680,000,000
    CDC....................................................      6,972,000,000      6,859,000,000      7,900,000,000
    ----------------------------------------------------------------------------------------------------------------

        Thank you for the opportunity to submit testimony on these critical
    areas of funding.
        Contact: Lisa M. Greenhill, MPA, Legislative Manager Department of
    Public Affairs Association of Women's Health, Obstetric and Neonatal
    Nurses 2000 L St. NW, Suite 740, Washington, DC 20036 (202) 261-2402
    lisag@awhonn.org
                                     ______

              Prepared Statement of the American Heart Association

        Heart disease, stroke and other cardiovascular diseases kill more
    Americans each year than the next 5 leading causes of death combined,
    putting people of all ages at risk. Cardiovascular diseases remain our
    nation's No. 1 killer and a major cause of disability. We are concerned
    that our government is still not devoting sufficient resources for
    research and prevention to America's No. 1 killer--heart disease--and
    to our country's No. 3 killer--stroke.

                      STILL NO. 1--AN UNHAPPY DISTINCTION

        Cardiovascular diseases represent a continuing crisis of pandemic
    proportions. More than 64 million Americans suffer from these diseases,
    and risk factors are on the rise. While smoking is the top preventable
    cause of death, the obesity epidemic is catching up. Obesity rates are
    rising in adults and in children. Also, an estimated 50 million
    Americans have high blood pressure, 37 million adults have high
    cholesterol, and more than 11 million have diagnosed diabetes. Also,
    cardiovascular diseases cost Americans more than any other disease--an
    estimated $368 billion in medical expenses and lost productivity in
    2004. Heart disease is the major cause of premature, permanent
    disability of American workers, accounting for about 20 percent of
    Social Security disability payments. Stroke is a main cause of
    disability. Heart defects are the most common birth defect and cause
    more infant deaths than any other birth defect.

                          YOU ARE PART OF THE SOLUTION

        Now is the time to capitalize on progress in understanding heart
    disease, stroke and other cardiovascular diseases. Promising, cost-
    effective breakthroughs in treatment and prevention are on the horizon.
    A continued, sustained investment in the NIH and appropriate funding
    for NIH heart disease and stroke will support promising and critically
    needed new initiatives and the translation of that research into useful
    clinical and state programs. For fiscal year 2005, we urge you to:
    Appropriate $30.6 billion for the National Institutes of Health (NIH)--
            to provide a continued, sustained investment in life-saving
            medical research
        NIH research provides new treatment and prevention strategies,
    creates jobs, and maintains America's status as the world leader in the
    biotechnology and pharmaceutical industries.
    Provide $2.5 billion for NIH heart research and $410 million for NIH
            stroke research
        Researchers are on the brink of advances to enhance prevention and
    to provide new treatments so you and your loved ones can be spared the
    pain and suffering of heart disease and stroke.
    Allot $80 million for Heart Disease and Stroke for the CDC to expand,
            intensify and coordinate prevention like expanding the State
            Heart Disease and Stroke Prevention Program and augmenting the
            Paul Coverdell National Acute Stroke Registry
        Science must be translated into state programs that hearten
    Americans to make healthy lifestyle choices to avert and control heart
    disease and stroke and track and improve stroke care delivery.
    Support $45 million to continue to help our communities treat cardiac
            arrest in time to save victims' lives by initiating automated
            external defibrillator (AEDs) programs
        The Rural Access to Emergency Devices Act (part of Public Law 106-
    505) and the Community Access to Emergency Defibrillation Act (part of
    Public Law 107-188) help communities purchase AEDs and train emergency
    and lay responders in their use.

                HEART AND STROKE RESEARCH BENEFITS ALL AMERICANS

        The doubling of the NIH budget has led to new breakthroughs in
    treating heart disease and stroke patients and their risk factors for
    these diseases. Several examples follow.
        High Blood Pressure.--A clinical trial concluded that customary
    diuretic drugs should be the first treatment for lowering blood
    pressure. The diuretic tested as well or better than some newer types
    of drugs in preventing high blood pressure complications, including
    fatal and non-fatal heart attacks, strokes and heart failure. The cost
    implications are significant because diuretics cost a fraction of the
    price of the newer drugs.
        Hormone Replacement Therapy.--Researchers concluded that long-term
    estrogen plus progestin therapy risks outweigh its protective benefits.
    Women study participants taking estrogen plus progestin had increased
    risks of heart attack, stroke, breast cancer and blood clots.
        Heart Attack.--More than 5 million patients with chest pain visit
    emergency departments each year, but only about 40 percent can be
    immediately diagnosed with heart attack using standard diagnostic
    tests. Results from a collaborative study using advanced, non-invasive
    magnetic resonance imaging showed that MRI can detect a heart attack in
    emergency room patients with chest pain more accurately and faster than
    standard diagnostic tests. Since patients can be scanned in under 40
    minutes, MRI technology will save lives and reduce disability among
    survivors by allowing doctors to diagnose heart attacks and start
    treatment faster.
        Recurrent Stroke Prevention.--Results of two clinical trials showed
    that aspirin was just as effective in preventing recurrent strokes as
    expensive drugs. Outcomes of the first trial indicated that aspirin
    appears to be as effective as warfarin in preventing a second stroke,
    when heart conditions such as atrial fibrillation, a common heart
    rhythm and rate problem, are not present. Results from the second study
    showed that aspirin is as effective as ticlopidine, a type of clot
    inhibitor, in preventing a second stroke in African-Americans who have
    twice the risk of suffering or dying from a stroke, compared to whites.
    These results will dramatically change physician care in preventing
    second strokes in the general public and in African-Americans. Given
    the lower cost, ease of administration and reduced side effects,
    compared to warfarin and ticlopidine, aspirin will be a cost-effective
    method in preventing subsequent strokes.
        We join other members of the research community in advocating for
    an fiscal year 2005 appropriation of $30.6 billion for the NIH to
    provide a continued, sustained investment in life-saving medical
    research and support investigation into new therapies. The NIH budget
    for heart disease and stroke remains disproportionately under funded
    compared to the enormous burden of these diseases and the numerous
    promising scientific opportunities that could advance the fight against
    these disorders. Heart disease, stroke and other cardiovascular
    diseases meet the NIH's criteria for priority setting (public health
    needs, scientific quality research, scientific progress potential,
    portfolio diversification and adequate infrastructure support), but the
    NIH still invests only 7 percent of its budget on heart research and a
    mere 1 percent on stroke research. We have a particular interest in
    individual NIH components that relate directly to our mission. Our
    funding recommendations for these Institutes follow.

             HEART RESEARCH CHALLENGES AND OPPORTUNITIES FOR NHLBI

        Advances have been made by more than 50 years of American Heart
    Association-funded research and more than a half-century of investment
    by Congress in the National Heart, Lung, and Blood Institute. While
    more people are surviving heart disease and stroke, they can cause
    permanent disability, requiring costly medical care and loss of
    productivity and quality of life.
        We urge this Committee to appropriate funding for the NHLBI and for
    its heart disease and stroke-related efforts to support and expand
    current activities and to invest in promising and critically needed new
    initiatives to aggressively advance the battle against heart disease
    and stroke. To accomplish this goal, we advocate an appropriation of
    $3.5 billion for the NHLBI, including $2.1 billion for heart disease
    and stroke. This added investment is needed to focus on heart disease
    and stroke challenges and opportunities. Several of these follow.
        Heart Failure Management.--Heart failure is a major cause of
    hospitalization and readmission. Medicare recipients represent about 65
    percent of repeat hospitalizations within 1 year. Yet, perhaps 50
    percent of these hospitalizations are avoidable. Additional funding
    would allow the NHLBI to initiate a planned multi-center, randomized
    trial to evaluate management strategies for heart failure patients in
    terms of their ability to prevent death or hospital readmission. Costs,
    quality of life, physician compliance, and patient adherence to
    prescribed treatment will also be assessed. This clinical trial will
    identify and disseminate useful and effective tools for translation of
    proven therapies for heart failure into patient care.
        Tissue Engineered Blood Vessel Replacement and Repair.--A need
    exists to develop alternatives to natural blood vessels for adults who
    endure heart artery bypass surgery and for children born with complex
    heart defects who need multiple blood vessel grafts. With increased
    funding, this planned initiative will complement exiting tissue
    engineered research programs to stimulate efforts to ``grow'' small-
    diameter, functional blood vessels.
        Cardiovascular Health Study.--Initiated in 1987 to determine risk
    factors for development and progression of cardiovascular diseases in
    nearly 6,000 Americans age 65 and older, the Cardiovascular Health
    Study (CHS) is scheduled to end in 2005. The wide variety and
    complexity of data and samples collected in the CHS represent an unique
    national research resource. With increased funding, this planned
    proposal will stimulate innovative use of CHS data and material,
    provide opportunities for open and efficient use of the information for
    the entire scientific community; and continue follow-up of study
    participants.
        Community-Responsive Interventions to Reduce Cardiovascular Risk in
    American Indians and Alaskan Natives.--American Indian and Alaska
    Native communities bear a disproportionate burden of heart disease,
    stroke and other cardiovascular diseases. But, few preventive
    interventions have been tested. Tribal leaders have urged that research
    in their communities focus on finding solutions for the most serious
    issues these populations face, including cardiovascular diseases. To
    address the concerns of the tribal leaders, with increased funding,
    researchers will evaluate approaches to reducing behavioral
    cardiovascular disease risk factors in American Indian and Alaskan
    Native populations. A central part of this planned initiative will be
    the development of interventions that can be incorporated into
    community patient care programs or delivered through other public
    health avenues in native communities.

             STROKE RESEARCH CHALLENGES AND OPPORTUNITIES FOR NINDS

        Stroke is the No. 3 killer of Americans and a major cause of
    permanent disability. Many of America's 4.8 million stroke survivors
    face debilitating physical and mental impairment, emotional distress
    and huge medical costs. About 1 in 4 stroke survivors is permanently
    disabled. An estimated 700,000 Americans will suffer a stroke this
    year, and nearly 164,000 will die. In addition to the elderly, stroke
    also strikes newborns, children and young adults.
        We urge you to provide sufficient funding for the NINDS to support
    and expand current activities and to invest in promising and critically
    needed new initiatives to aggressively prevent stroke, protect the
    brain during stroke and enhance rehabilitation. To accomplish this
    goal, we advocate for an fiscal year 2005 appropriation of $1.8 billion
    for the NINDS, including $204 million for stroke. Some challenges and
    opportunities follow:
        Strategic Stroke Research Plan.--As a result of congressional
    report language during the fiscal year 2001 appropriations process, the
    NINDS convened a Stroke Progress Review Group. Their report serves as a
    blueprint for a long-range strategic stroke research plan. They
    identified serious gaps in stroke knowledge and outlined 5 research
    priorities and 7 resource priorities that would spur stroke research.
    But, more funding is needed to continue to implement this plan.
        Emerging Stroke Risk Factors.--Although more Americans are
    controlling major stroke risk factors, such as high blood pressure and
    smoking, the number of stroke victims continues to rise. Scientists are
    defining new risk factors, re-examining existing ones and reconsidering
    the long-held belief that no difference exists in risk between young
    and older patients with similar risk factors. Researchers are studying
    heart valve disease, irregular heartbeats, the role of inflammation in
    damaging arteries, and the long-term effects of high blood pressure.
    Increased funding to study these areas may lead to new ways to prevent
    stroke.
        Therapeutic Strategies for Stroke.--Several major clinical trials
    have identified new methods for preventing and treating stroke in high-
    risk populations. But, with the increased number of strokes, and with
    the disparities in stroke treatment, new ways to prevent strokes, to
    raise awareness, and to better treat strokes need to be developed and
    evaluated. Funding for new clinical studies is vital for developing
    cutting-edge stroke treatment and prevention.
        Stroke Education.--Less than 5 percent of patients eligible for
    tPA--the only FDA approved emergency treatment for clot-based stroke--
    receive it. As a member of the Brain Attack Coalition, a group of
    organizations devoted to fighting stroke, we work with the NINDS to
    increase public awareness of stroke symptoms and the need to call 9-1-
    1. Together, we launched a public education campaign, Know Stroke, Know
    the Signs. Act in Time, and we are striving to develop systems to make
    tPA available to appropriate patients. When these measures are
    implemented, stroke treatment will change from supportive care to early
    brain-saving intervention. More funding is needed to educate the public
    and health providers about stroke.

       RESEARCH IN OTHER NIH INSTITUTES BENEFIT HEART DISEASE AND STROKE

        Research seeking to prevent and find better treatments for heart
    disease, stroke and other cardiovascular diseases is supported by other
    NIH entities like the National Institute on Aging, the National
    Institute of Diabetes and Digestive and Kidney Diseases, the National
    Institute of Nursing Research and the National Center for Research
    Resources. It is important to provide sufficient additional resources
    for these entities to continue and expand their critical work.

                   AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

        The AHRQ acts as a ``science partner'' with public and private
    health care sectors in improving health care quality, reducing health
    care costs and broadening access to essential services. They help
    develop evidence-based information needed by consumers, providers,
    health plans and policymakers to improve health care decision making.
    We join with the Friends of AHRQ in advocating for an appropriation of
    $443 million for the AHRQ to advance health care quality, cut medical
    errors and expand the availability of health outcomes information.

                   CENTERS FOR DISEASE CONTROL AND PREVENTION

        Prevention is the best way to protect Americans' health and ease
    the financial burden of disease. Resources must be made available to
    bring research to places where heart disease and stroke strike--our
    towns and neighborhoods. Setting the pace on prevention, the CDC builds
    a bridge between what we learn in the lab and translates findings into
    programs in the communities where we live. We advocate an fiscal year
    2005 appropriation of $8.1 billion for the CDC, with a $340.5 million
    increase for state-based chronic disease prevention and health
    promotion programs.
        Within that figure, we support an appropriation of $80 million for
    the CDC's Heart Disease and Stroke line to better expand, intensify and
    coordinate prevention activities against these diseases such as
    enhancing the State Heart Disease and Stroke Prevention Program, and
    the Paul Coverdell National Acute Stroke Registry. It will also allow
    the CDC to start a heart attack and stroke signs health communications
    campaign, public and health care provider education, and invest in
    standardized methodology on lipid and other measurements. A Heart and
    Stroke Division, with ample resources and capacity, would heighten
    CDC's efforts on these diseases.
        Thanks to this Committee's support since fiscal year 1998, the
    CDC's State Heart Disease and Stroke Prevention Program covers 33
    states. But, only 11 states receive funding to actually implement
    programs to help prevent and control heart disease and stroke. The
    remaining 22 states have completed program planning and are prepared
    and waiting to implement a state-tailored program. This initiative
    allows states to design and/or implement programs to meet state
    specific needs to prevent heart disease, stroke and other
    cardiovascular diseases. Since cardiovascular diseases remain the No. 1
    killer in every state, each state needs funding for basic
    implementation of a State Heart Disease and Stroke Prevention Program.
    With fiscal year 2004 funding, the CDC can only elevate one state from
    planning to program implementation.
        An appropriation of $80 million would allow the CDC to expand the
    number of states participating in this State Heart Disease and Stroke
    Prevention Program by 5 states to conduct a state-tailored heart
    disease and stroke prevention plan, and elevate 10 more states from the
    planning stage to program implementation and support the other
    currently funded states. Also, the CDC would enlarge the Paul Coverdell
    National Acute Stroke Registry. This registry tracks and improves
    delivery of acute stroke care--care that can mean the difference
    between a fairly normal life and long-term disability. The CDC
    developed and conducted registry prototypes from 2001-2003 and will
    begin to fund three state registries in fiscal year 2004.
        We recommend the following fiscal year 2005 funding levels for the
    following CDC programs:
      --$210 million for the Preventive Health and Health Services Block
            Grant;
      --$70 million for the Nutrition, Physical Activity and Obesity
            Program;
      --$125 million for the Youth Media Campaign;
      --$82.4 million for the School Health Education Program; and
      --$130 million for the Office of Smoking and Health.

                  HEALTH RESOURCES AND SERVICES ADMINISTRATION

        About 340,000 Americans die each year from sudden cardiac arrest.
    About 95 percent of the victims die before reaching a hospital. AEDs
    are small, easy-to-use devices that can shock a heart back into normal
    rhythm and restore life. The Rural Access to Emergency Devices Act and
    the Community Access to Emergency Defibrillation Act authorize funds
    for state and local governments to start AED programs. States, cities
    and towns nationwide eagerly await funds from these vital public health
    service grant awards, with available funds far below state requests. An
    appropriation of $45 million is required to support these authorized
    programs.

                            DEPARTMENT OF EDUCATION

        Physical inactivity is a key risk factor for heart disease and
    stroke. Yet, our youth have fewer chances for physical education.
    Congress has been appropriating money for the Carol M. White Physical
    Education for Progress (PEP) Act to provide funding for school-based
    physical education programs, which teach life-long physical activity
    habits and thus prevents diseases, like heart disease and stroke. We
    advocate for an appropriation of $100 million for PEP.

                                 ACTION NEEDED

        Increasing funding for research, prevention and treatment programs
    will allow continued strides in the battle against heart disease,
    stroke and other cardiovascular diseases. Our government's response to
    this challenge will help define the health and well being of Americans
    for decades.
                                     ______

    Prepared Statement of Living Cities: The National Community Development
                                   Initiative

        Thank you, Senator Specter and Subcommittee members, for the
    opportunity to share with you the views of Living Cities: The National
    Community Development Initiative on the administration's fiscal year
    2005 budget request for the Office of Community Services within the
    U.S. Department of Health and Human Services (HHS.)
        Living Cities is a nonprofit consortium of 15 major financial and
    philanthropic organizations working to increase the vitality of cities
    and improve the lives of people in distressed urban neighborhoods.
    These organizations are AXA Community Investment Program, Bank of
    America, the Annie E. Casey Foundation, J.P. Morgan Chase & Company,
    Deutsche Bank, Fannie Mae Foundation, Robert Wood Johnson Foundation,
    W.K. Kellogg Foundation, John S. and James L. Knight Foundation, John
    D. and Catherine T. MacArthur Foundation, the McKnight Foundation,
    Metropolitan Life Insurance Company, Prudential Financial, the
    Rockefeller Foundation, and Surdna Foundation.
        In addition, HHS and the U.S. Department of Housing and Urban
    Development (HUD) are investment partners in Living Cities. HHS and HUD
    representatives attend Living Cities meetings, but are not voting
    members of the organization. Neither HUD nor HHS had any involvement in
    the preparation of this testimony, and the testimony does not represent
    either agency's views in any way. This testimony also does not
    represent the views of individual member organizations in Living
    Cities. This testimony is entirely and exclusively on behalf of Living
    Cities, a stand-alone charitable organization.
        Started as NCDI in 1991, Living Cities has worked with the Local
    Initiatives Support Corporation (LISC) and The Enterprise Foundation to
    make strategic investments in the work of nonprofit community
    development corporations (CDCs) in 23 cities--Atlanta, Baltimore,
    Boston, Chicago, Cleveland, Columbus, Dallas, Denver, Detroit,
    Indianapolis, Kansas City, Los Angeles, Miami, Minneapolis-St. Paul,
    Newark, New York City, Philadelphia, Phoenix, Portland, Oregon, San
    Antonio, San Francisco Bay Area, Seattle, and Washington, D.C.
        The results are tangible. Improvements can be seen in transformed
    neighborhoods--new homes, places of employment, and the visible
    presence of stronger community organizations. The Living Cities
    investment of $254 million has directly supported the creation of
    almost 20,000 affordable housing units and 1.7 million square feet of
    commercial, industrial and community facilities developed by CDCs, and
    has leveraged $2.2 billion, a leverage ratio of nearly 9:1. The federal
    investment in the Living Cities initiative over the first decade was
    $36 million, achieving a leverage ratio of 61:1 for these federal
    dollars.
        Based upon our experience, we find that urban neighborhoods have
    the workers, purchasing power, and physical assets ready to be tapped
    through a combination of public and private investments. That is why
    our collaborative is doubling our commitments in the current decade,
    increasing our investments by an additional half-billion dollars
    between 2001 and 2011.

                          IMPORTANCE OF ACCOUNTABILITY

        We believe that lessons can be drawn from Living Cities' experience
    of investing in distressed urban neighborhoods, useful lessons for
    policy and funding decisions to strengthen distressed communities
    nationwide. Like this Subcommittee, we demand individual accountability
    and results from the entities that receive Living Cities resources.
    Since our inception, we have engaged outside experts to take a hard
    look at what CDCs are achieving. We are glad to share the results of
    these studies with the Subcommittee.
        Beyond our own research, two federal agencies, the General
    Accounting Office and the Office of Management and Budget, this year
    applauded the successful use of federal NCDI/Section 4 funds to
    strengthen CDCs by improving their internal management, increasing
    their capacity, and widening their impact.

              HHS/OCS: A VITAL PARTNER IN COMMUNITY REVITALIZATION

        The history of CDCs is well known. CDCs began forming in the 1960s
    to address the failure of mainstream government and market structures
    to provide decent housing, safe neighborhoods, good jobs, and resident
    participation in planning for their own future. From the outset of the
    CDC movement, communities that were served ranged from a few square
    blocks in a single urban neighborhood to multi-county rural areas.
    Target populations have been equally diverse--including all races and
    ethnic groups, farmers, immigrants, welfare recipients, small business
    owners, juveniles, the homeless. What has been consistent among CDCs is
    that each one has come from and represents a community, and each one
    has harnessed resources from both the public and private sectors of the
    economy.
        Different administrations have lent their support to CDCs over the
    decades. During the 1960s, CDCs were viewed as complementary to
    government. Their role was to encourage neighborhood development,
    promote anti-poverty strategies, and deliver social services--with
    generous federal support provided to fuel them. During the Reagan
    years, CDCs came to be seen by some as alternatives to government. CDCs
    developed stronger alliances with state and local governments and with
    private sector partners. These alliances expanded the impact of CDCs.
    By the 1990s, CDCs were viewed as playing a dual role--as complementary
    to government and as enhancements to markets.
        As you know, the Department of Health and Human Services, Office of
    Community Services, Community Services Block Grant Act Secretary's
    Discretionary Fund for Community Economic Development is a significant
    program of federal assistance to CDCs. This program has been a resource
    that is critical to the success of community development, a resource
    that needs to continue.
        We focus here on the Discretionary Grant Program of the Office of
    Community Services, because this program has stood the test of time and
    has proven to be very successful in using federal dollars to leverage
    private sector investments to create jobs through economic development
    projects sponsored by CDCs. This success is illustrated by the
    following examples of economic development projects selected from some
    of the CDCs and cities in which Living Cities invests.
    Asociacion de Puertorriquenos en Marcha, Inc. in Philadelphia
        Received a $500,000 grant from the Office of Community Services
    that leveraged investment to support $5,100,000 in total development
    costs for the Gateway Plaza in Philadelphia.
        The OCS grant created 125 jobs.
    Abyssinian Development Corporation in New York City
        Received a $500,000 grant from the Office of Community Services
    that leveraged investment to support $16,000,000 in total development
    costs for the Pathmark Supercenter.
        The OCS grant created 275 jobs.
    Northeast Neighborhood Development in Cleveland
        Received a predevelopment grant of $75,000 to perform market and
    business studies on the potential for improving the retail climate of a
    key intersection in its community.
        While the program is still underway, the OCS grant has already
    created 10-15 jobs.
    Vermont Slauson Economic Development Corporation in Los Angeles
        Received a $450,000 grant from the Office of Community Services
    that leveraged investment to support $1,200,000 in total development
    costs for the Ranch Markets project.
        The OCS grant created 70 jobs.
    Bethel New Life in Chicago
        Received a $700,000 grant from the Office of Community Services
    that leveraged investment to support $3,225,000 in total development
    costs for the Material Recovery Facility project.
        The OCS grant created 145 jobs.
    Jane Addams Resource Corporation in Chicago
        Received a $250,000 grant from the Office of Community Services
    that leveraged investment to support $1,100,000 in total development
    costs for the 4422-36 North Ravenswood project and a $300,000 OCS grant
    that leveraged investment to support $1,000,000 in total development
    costs for the 4410 North Ravenswood project.
        These OCS grants together created 55 jobs.
        In order to build on such successful public and private investments
    in distressed urban neighborhoods, Living Cities finds it to be
    critically important to continue investment in job creation for low-
    income people and to continue funding at the highest possible level for
    programs that have a long history of success. As we have committed to
    doubling our investment in the current decade, we urge the Subcommittee
    to support a commensurate increase in funding for the OCS Discretionary
    Grants Program. We also offer to work with the Subcommittee to explore
    ways in which the OCS grants can foster further public/private
    cooperation so as to leverage additional private investment by Living
    Cities.
        The work that has been done over the past decade to strengthen CDCs
    has increased their capacity to participate in the OCS Discretionary
    Grants Program. CDCs are providing the infrastructure to achieve
    economic and social redevelopment of low-income neighborhoods. CDCs
    take the risks as early investors, providing seed money and working
    capital for community development projects that become catalysts for
    further private investment. They encourage the participation of
    residents in the redevelopment of their communities, prepare the
    workforce for employment, develop local businesses and provide capital
    and technical support to other businesses in their target areas. CDCs
    secure funding for these activities from government, financial
    institutions, corporations, foundations and other individual funders
        Living Cities is supporting CDCs in these activities through our
    investments in their work and by supporting research on urban markets,
    including the collection of data on which business and investment
    decisions are based. Based upon our experience, we see that even very
    troubled neighborhoods can revive when community leaders, government,
    and the private sector work together.
        We are optimistic about the future of America's cities, given the
    very real progress we see. In the past decade, the population of the
    nation's largest 50 cities grew by nearly 10 percent. This was
    accompanied by a rise in city incomes that outpaced the national
    average (7 percent versus 4 percent, respectively) and an increase in
    housing units, homeownership and mortgage lending. At the same time, in
    certain urban areas concentrated poverty fell 24 percent in the last
    decade and urban crime decreased. Inner cities have become hubs of
    economic activity, with annual retail spending power of $85 billion or
    the equivalent of 7 percent of U.S. retail spending. Business
    investment has returned to some urban markets, bringing goods, services
    and job opportunities. This progress bodes well for the economic
    strength of cities, their regions, and the nation, economic strength
    that we believe depends upon strong economies in urban neighborhoods.

                            PILOT CITIES INITIATIVE

        Now in the second decade, Living Cities funders have challenged
    themselves to do more. First, we have committed to investing an
    additional $500,000,000 in the current decade. We also are building on
    the successes of the first 10 years by creating a new investment model,
    the Pilot Cities Initiative in Baltimore, Chicago, Miami and the Twin
    Cities of Minneapolis and St. Paul. This initiative is creating new
    ways for Living Cities investment partners and other funders to align
    resources over a sustained period of time in order to have a greater
    positive impact in distressed communities.
        Through this new, more powerful model, funders will engage in
    collaborative efforts to develop healthier neighborhoods by enhancing
    the linkages between inner city neighborhoods and their residents and
    the larger economies of their cities and their regions. This initiative
    also will encourage CDCs to develop new relationships with philanthropy
    and to expand the impact of economic development by working more
    closely with other institutions that are serving the same
    neighborhoods.

                                   CONCLUSION

        Despite the significant gains made in Living Cities communities
    during the first decade and our ambitious plans for the next, we have
    learned that future gains will be severely limited without additional
    federal investment. We respectfully request that the Subcommittee
    consider:
      --Increasing the current funding level for the OCS Discretionary
            Grants Program by an amount that Living Cities will match;
      --Encouraging the use of grants to attract further private investment
            and foster more public/private partnerships; and
      --Allowing funding dollars to be used to collect data that document
            the opportunities in the workforce and the purchasing power of
            lower-income communities, with OCS serving as the lead federal
            agency in gathering and making information accessible to people
            who make business and investment decisions.
        It will take a concentrated national effort, but we are determined
    to see cities across the country reach and sustain healthy status in
    our time, a level that is worthy of the richest society in the history
    of humankind. With the support of private and public resources,
    including the OCS Discretionary Grants Program, CDCs can continue their
    significant work towards the goal of economic well-being, a goal that
    includes job opportunities for low-income people.
        Thank you for this opportunity to present our views regarding this
    important program to the Subcommittee.
                                     ______

      Prepared Statement of the American Public Transportation Association

                                  INTRODUCTION

        Mr. Chairman, thank you for the opportunity to submit a statement
    for the record to the Subcommittee on Labor, Health and Human Services
    and Education regarding the fiscal year 2005 Labor, Health and Human
    Services and Education Appropriations Bill.
        We submit our views to the Subcommittee to make the point that not
    only can public transportation make a critical difference in how people
    get to jobs, health care, training and other social services, but can
    also provide significant cost efficiencies in the process. It is our
    hope to work with committee staff in developing report language to
    highlight this important issue.

                                   ABOUT APTA

        The American Public Transportation Association (APTA) is a
    nonprofit international association of over 1,500 public and private
    member organizations including transit systems and commuter rail
    operators; planning, design construction and finance firms; product and
    service providers; academic institutions; transit associations and
    state departments of transportation. APTA members serve the public
    interest by providing safe, efficient and economical transit services
    and products. Over 90 percent of persons using public transportation in
    the United States and Canada are served by APTA members.

      THE EFFICIENCIES OF TRANSPORTATION COORDINATION ARE RECEIVING GREAT
                 ATTENTION FROM CONGRESS AND THE ADMINISTRATION

        Mr. Chairman, the current budgetary climate and the emphasis it has
    brought on doing more with limited resources provides a fitting context
    for our focus on of transportation coordination. We believe that
    relatively minor legislative changes based on simplicity and common
    sense can provide for necessary consistencies across programs to make
    transportation coordination work.
        Recognizing the efficiencies and additional riders and resources
    that are possible through improved coordination, APTA has long believed
    in the potential of greater coordination between human service
    providers and transportation providers. We have long seen the potential
    for coordinated transportation to lower the costs of services to
    taxpayers, enhance the scope and quality of service to customers, and
    to avoid the duplicate purchase and use of equipment.
        In May 2003, the House Committee on Transportation and
    Infrastructure and the House Committee on Education and the Workforce
    held a joint hearing to examine both the potential of and the obstacles
    to coordination. One Member at that hearing noted that enhancing the
    coordination of human services and transportation had been a topic of
    interest to Congress since the 1970s. But, when all was said and done,
    much more was said than done.
        The joint House hearing heard from the General Accounting Office
    (GAO) that there are some 62 federal programs that spend money on
    transportation. The GAO also found that leadership on coordination was
    lacking in that coordination seemed to be on everyone's list of things
    to do but nowhere near the top of anyone's list. There was a Federal
    Coordinating Council but it rarely met. The situation at the federal
    level was replicated at the state level. Where states had leadership on
    coordination through coordinating councils often created by the
    governors, coordination was often impressive. Where that was not the
    case, coordination was simply not happening. Like the tango, it takes
    more than one state or federal agency to coordinate. Those who took
    coordination seriously often found they were ``playing catch with
    themselves.''
        In our observation, Congress and the Administration are now taking
    coordination seriously. Department of Transportation Secretary Norman
    Mineta and Federal Transit Administrator Jennifer Dorn are reaching out
    with some success to get more federal agencies on the dance floor. With
    the launching of the Department of Transportation's ``United We Ride''
    initiative, the Department of Health and Human Services, the Department
    of Labor, the Department of Education, and other federal agencies are
    beginning to recognize best practices at the state level and make
    resources available to enhance state performance. President Bush, to
    his great credit, has issued an Executive Order calling on federal
    agencies to assess their roles in coordination and report back to the
    White House in 1 year on progress they are making to enhance the
    coordination of transportation programs.

      CONGRESS IS ADDRESSING TRANSPORTATION COORDINATION ON SEVERAL FRONTS

        Several pending bills contain language that would bolster the
    coordination of federal transportation programs. APTA is supportive of
    these efforts.
        Pending bills to reauthorize the Federal Transportation Equity Act
    for the 21st Century (TEA 21) contain numerous provisions that will
    enhance transportation coordination, including allowing funding from
    human service programs to be used as a match for FTA programs so long
    as programs are coordinated, broadening the eligibility guidelines for
    Job Access and Reverse Commute (JARC) funding, recognizing Mobility
    Management as an eligible program expense, and requiring local
    certification plans for the New Freedom, JARC, and Elderly and Disabled
    programs.
        As part of the pending welfare reform legislation, the Senate
    Finance Committee has approved an amendment supported by APTA calling
    upon states that use Temporary Assistance for Needy Families (TANF)
    funds for transportation purposes to certify that they have consulted
    with transportation agencies in the provision of such services. It
    seems to be a simple common sense matter, but it often doesn't happen.
    Such certification will make a requirement of what is now often an
    afterthought. The House-passed welfare reform bill (H.R. 4) contains an
    important provision in its TANF program that would treat transportation
    subsidies as ``nonassistance'' for purposes of the Act and therefore
    need not be discontinued when a person exhausts their eligibility for
    public assistance. Like childcare support, transportation aid is
    essential to those who not only want to get a job, but also those
    striving to retain their job.
        Similarly, there are provisions in the Senate's version of the
    Workforce Investment Act that call on state and local workforce
    planners to account for how people are to get to training and available
    jobs. It makes as much sense to coordinate training with available
    transportation as it does to link training to available employment.
    Along with childcare, the ability to get to a job efficiently is often
    the factor that determines whether a person can get and retain
    employment.
        It is APTA's hope that significant progress can be made in the next
    year as both Congress and the Executive Branch focus attention on
    replacing old habits with new habits.

       PUBLIC TRANSPORTATION PROVIDES AFFORDABLE AND EFFICIENT ACCESS TO
                                  HEALTH CARE

        Following the old adage, ``follow the money,'' we note that the GAO
    identified a major source of transportation spending in the Medicaid
    program. Close to $1 billion is spent on transportation to assist
    Medicaid clients. APTA members in Connecticut and Florida have had some
    success offering mainline transit service to those for whom it is
    appropriate through a Medicaid Pass Program. Medicaid clients see their
    transportation options enhanced at the same time the Medicaid program
    sees its costs lowered. Transit operators experience an increase in
    ridership while being reimbursed by the Medicaid program. Such programs
    can be a win/win/win situation for those who need services, those who
    pay for them, and those who provide the service.
        Public transportation has already demonstrated its ability to
    effectively provide non-emergency transportation to health care
    services when given a chance. In 1997, the Healthcare Financing
    Administration estimated it was losing $1.2 billion annually in non-
    emergency medical transportation subsequently states began to
    coordinate services with local transit systems and by 2000 20 percent
    of the nation's Medicaid rides were on public transit.
        While lack of coordination between providers of transportation
    assistance programs for the elderly and disabled and public
    transportation systems is not a new problem, the need for these
    services will continue to grow. According to a recent FTA study, 32
    million senior citizens rely on transit as their driving ability
    decreases; 27 million Americans with disabilities depend on transit to
    maintain their independence; and 37 million people who live below the
    poverty line and cannot afford to drive rely on transit to get to work.
    The population of elderly transit users is expected to rise, growing
    nearly four times faster than the general population between 2010 and
    2030; yet according to the AARP, more elderly people now live in
    suburban settings that lack transit options than ever before.
        Public transportation has worked hard to improve its service.
    Between 1990 and 1999, the percentage of wheelchair accessible buses
    has increased dramatically. Systems continue to update their vehicles,
    including trains and buses, to ensure that individuals with
    disabilities can use their service. With access available to
    populations served by HHS and other social programs across the country,
    public transportation is clearly in a position to help these people and
    save taxpayer dollars right now.

           PUBLIC TRANSPORTATION DELIVERS PEOPLE FROM WELFARE TO WORK

        Similar to its success in helping the elderly and disabled, public
    transportation is already at work helping the population of low-income
    workers and job seekers such as TANF clients by providing low-cost,
    efficient transportation services.
        Many welfare recipients do not own cars and must rely on public
    transportation to get to work. And while most welfare recipients live
    in central cities, most newly created jobs are in the suburbs. Public
    transportation has been successful in many cases in providing
    transportation options to these job seekers, especially under the JARC
    program, but barriers remain. For instance, Fort Worth's transportation
    authority, The T, has noted that it has difficulty coordinating various
    sources of funding to provide transportation service that gets workers
    from the central city to the suburbs because local service providers
    are required to track separate data from both the Department of Labor
    and the Department of Housing and Urban Development.

                                   CONCLUSION

        Mr. Chairman, the public transportation community stands ready to
    provide a cost efficient, easy-to-use and effective solution to the
    increased demand for transportation options for communities served by
    federal programs such as TANF. The U.S. Department of Transportation is
    already required to coordinate with HHS, but it needs to improve
    coordination with HHS as well as with other agencies at all levels of
    government. Many states and local governments are excelling at this
    process. Millions of additional federal dollars could be saved by
    requiring all states to follow their lead.
        Enabling effective coordination between all federal agencies and
    the DOT requires statutory changes to provide the Coordinating Council
    with authority to require recipients of federal funds at all levels to
    work together. Taking advantage of the TEA 21 and TANF reauthorizations
    to require state and local governments that receive TANF and JARC funds
    to coordinate their services would be an excellent first step. This
    will put the experience and resources of transit to use to effectively
    serve our disadvantaged populations.
        Mr. Chairman and Members of the Committees, we urge you to take
    public transportation service and the cost efficiencies it provides
    into consideration as you mark up your fiscal year 2005 appropriations
    bill. We would be pleased to work with your staff in developing report
    language in that regard.
        In closing, APTA would like to urge this Subcommittee to remain
    vigilant as you monitor the progress of executive agencies and the
    Coordinating Council in the next year. Progress is being made but there
    is much more to do.
        Thank you.
                                     ______

         Prepared Statement of the Coalition of Northeastern Governors

        The Coalition of Northeastern Governors (CONEG) is pleased to
    provide this testimony for the record to the Senate Subcommittee on
    Labor, Health and Human Services, and Education regarding fiscal year
    2005 appropriations for the Low Income Home Energy Assistance Program
    (LIHEAP). The Governors appreciate the Subcommittee's consistent
    support for the LIHEAP program, and we recognize the difficult
    decisions facing the Subcommittee in this time of severe fiscal
    constraints. However, in light of sharply higher home energy prices, we
    request the Subcommittee to provide $3 billion for LIHEAP in regular
    fiscal year 2005 funding and $3 billion in advance appropriations for
    fiscal year 2006.
        LIHEAP is a vital tool in making home energy more affordable for
    almost 5 million of the nation's very low-income households--the
    elderly and disabled on fixed incomes and families with young children.
    Recent survey data compiled by the National Energy Assistance
    Directors' Association (NEADA) provide a glimpse of the difficult
    choices made by low-income households and the strong, ongoing need for
    LIHEAP assistance. The percentage of income spent on total home energy
    by these low-income households can be four times higher than average
    households. For many of these households, annual income is simply not
    sufficient to pay high winter heating bills, even in periods of
    economic growth. Even after taking constructive actions to reduce their
    home energy use, too many low-income residents are forced to make
    dangerous choices between heating their homes, paying the full rent or
    mortgage, seeking medical attention, or purchasing food or vital
    medications. The NEADA survey found that an estimated 38 percent of
    LIHEAP recipients went without medical or dental care; approximately 28
    percent did not make a rent or mortgage obligation; 30 percent did not
    fill a prescription or take the full dosage; and 21 percent became sick
    because the home was too cold.
        The rise in winter heating fuel prices hits these vulnerable
    citizens especially hard. The Northeast is heavily dependent on
    deliverable home heating fuels such as home heating oil, kerosene, and
    propane. Price volatility in these fuels adversely affects the low-
    income households who, without the disposable income to purchase fuels
    off-season, typically enter the market when both the demand for and
    price of fuels are high.
        Rapidly rising energy prices, the very cold winter conditions in
    many parts of the country, and the continued high unemployment among
    low-wage workers continue to put heightened demand on the states'
    already stretched LIHEAP programs. In fiscal year 2004, states expect
    to serve an estimated 4.8 million low-income households with LIHEAP
    assistance, an increase of 6 percent over the 2002-2003 period.
    However, the number of low-income households eligible for LIHEAP
    assistance increased by a similar 6 percent--to approximately 34.6
    million households. In short, in spite of the welcomed increase in
    LIHEAP funding, only a fraction--approximately 15 percent of eligible
    households--continue to be served at current LIHEAP funding.
        An increase in the regular LIHEAP appropriation to $3 billion for
    fiscal years 2005 and 2006 will enable states across the nation to
    reach more of those vulnerable citizens in need of assistance and more
    fully implement cost-effective measures to meet their continuing energy
    needs. Today, most winter heating programs have exhausted their program
    resources at the end of the heating season, leaving little or no
    resources for cooling programs this summer; or they have limited
    ability to assist families who, in arrears on heating bills, face the
    prospect of having their home heating source cut off. In addition,
    without funds to carryforward to the new heating season, state LIHEAP
    programs lack the capability to undertake the ``pre-buy'' programs that
    help stabilize heating fuel prices for low-income households and expand
    the reach of limited program funds. An increased federal appropriation,
    and advance funding, would allow states to manage the program resources
    in a manner to better take advantage of market opportunities.
        Enactment of advance funding is vital to the states' program
    planning activities for the coming heating season. In the Northeast,
    where the heating season begins in early October, states generally
    spend up to 70 percent of the LIHEAP funds during the first two
    quarters of the fiscal year. Therefore, states must begin to plan and
    do program outreach in the spring and summer if they are to begin their
    LIHEAP program as soon as the new fiscal year starts. Advance funding
    helps ensure that states have the necessary funds to open their
    programs and provide timely assistance to low-income families who lack
    the financial resources to bear the initial costs of deliverable home
    heating fuels.
        The current uncertainty of world energy markets underscores the
    importance of states being able to prepare for the potential of
    volatile energy prices. These preparedness activities, while critical,
    cannot fully shield our lowest-income citizens from the impacts of
    higher heating fuel prices. Your support for fiscal year 2005 LIHEAP
    appropriations at the $3 billion level and the enactment of advance
    fiscal year 2006 appropriations is urgently needed to enable our states
    to help mitigate the potential life-threatening emergencies and
    economic hardship that confront the region's most vulnerable citizens.
        We thank the Subcommittee for this opportunity to share the views
    of the Coalition of Northeastern Governors, and we stand ready to
    provide you with any additional information on the importance of the
    Low Income Home Energy Assistance Program to the Northeast.
                                     ______

          Prepared Statement of the American Public Power Association

        The American Public Power Association (APPA) is the national
    service organization representing the interests of over 2,000 municipal
    and other state and locally owned utilities in 49 of the 50 states (all
    but Hawaii). Collectively, public power utilities deliver electricity
    to one of every seven electric consumers (approximately 40 million
    people), serving some of the nation's largest cities. However, the vast
    majority of APPA's members serve communities with populations of 10,000
    people or less.
        We appreciate the opportunity to submit this statement supporting
    funding for the Low-Income Home Energy Production Assistance Program
    (LIHEAP).
        APPA has consistently supported an increase in the authorization
    level for LIHEAP to $3.4 billion annually--an increase that was
    embodied in the stalled Energy Policy Act and has also been advanced
    more recently in the Senate's version of the Poverty Prevention and
    Reduction Act, a bill that has not yet been considered in the House. In
    the absence of final action on an increased authorization level for the
    program, the Administration's request of $2 billion for fiscal year
    2005 ($1.8 billion in state block grant funding and $200 million in
    emergency funding) is a good start. However, APPA believes that the
    Subcommittee should consider appropriating the $3.4 billion necessary
    in fiscal year 2005 to more fully meet the energy needs of low-income
    households.
        APPA is proud of the commitment that its members have made to their
    low-income customers. Many public power systems have low-income energy
    assistance programs based on community resources and needs. Our members
    realize the importance of having in place a well-designed low-income
    customer assistance program combined with energy efficiency and
    weatherization programs in order to help consumers minimize their
    energy bills and lower their requirements for assistance. While highly
    successful, these local initiatives must be coupled with a strong
    LIHEAP program to meet the growing needs of low-income customers. In
    the last several years, volatile home-heating oil and natural gas
    prices, severe winters, high utility bills as a result of the western
    electricity crisis, and the effects of the economic downturn have all
    contributed to an increased reliance on LIHEAP funds.
        Also when considering LIHEAP appropriations this year, we encourage
    the Subcommittee to provide advanced funding for the program so that
    shortfalls do not occur in the winter months during the transition from
    one fiscal year to another. LIHEAP is one of the outstanding examples
    of a state-operated program with minimal requirements imposed by the
    federal government. Advanced funding for LIHEAP is critical to enabling
    states to optimally administer the program.
        Thank you again for this opportunity to relay our support for
    increased LIHEAP funding for fiscal year 2005. We look forward to a
    favorable outcome.
                                     ______

        Prepared Statement of the Meals On Wheels Association of America

        Mr. Chairman and Members of the Subcommittee, we are Enid A. Borden
    and Margaret B. Ingraham, Chief Executive Officer and Director of
    Policy and Legislation, respectively, of The Meals On Wheels
    Association of America (MOWAA). The Association represents local
    community-based meal programs from every state that provide congregate
    and home-delivered meals and other nutrition services to older persons
    in need. It is on behalf of MOWAA, its member programs, and the
    literally hundreds of thousands of frail, elderly and at-risk
    individuals that they serve that we present this testimony.
        As part of the appropriations process in which this subcommittee
    engages every year, you doubtless hear from hundreds, probably
    thousands of individuals and organizations representing programs funded
    through the enormous bill under your purview. Each comes to advocate
    for a specific project or program and to make the case as to why that
    program merits a particular level of federal financial support in the
    next fiscal year. In that regard, MOWAA is no different from the others
    from whom you have heard. But in other ways--significant ones that we
    will enumerate briefly--MOWAA, or rather the senior meal programs that
    are our members--are significantly different.
        Please allow us the opportunity to put our request in an historical
    and human perspective. In 1972 when it reauthorized the Older Americans
    Act, Congress included senior nutrition programs among the services
    funded under the Act. Today, ``Meals On Wheels,'' as those programs
    have come to be popularly called, are perhaps the most widely
    recognized and universally lauded of Older Americans Act programs. It
    should come as no surprise to you that we also believe they are the
    most important. Why? The answer is simple. Because food is fundamental
    to life and health and psychological and emotional well-being. There is
    no arguing that fact. All of us eat regularly, generally 21 meals per
    week and we even may sneak a snack here or there when we get hungry.
    But many of America's most vulnerable citizens, the frail and at-risk
    elderly, have no ability to shop for or to prepare meals for
    themselves. For them, home-delivered meal programs are a virtual
    lifeline. In some cases, they are the only source of nutritious food
    that a senior has; and even then, most programs have the resources to
    provide only five meals each week.
        Last year, according to the Administration on Aging over 253
    million meals were served with Older Americans Act funds. That is
    impressive indeed. But the sad reality on the underside of that success
    is that hundreds of thousands of equally needy seniors were not served.
    A conservative estimate is that 4 out of every 10 home-delivered meal
    programs have waiting lists. And currently, the old-old age group
    (defined as 85 and older) is the fastest growing cohort in the U.S.
    population. So, simply stated, if appropriations levels are not
    increased, and increased substantially, the unspeakable will occur.
    That is, even larger numbers or frailer individuals will be going
    hungry. Mr. Chairman and members of the subcommittee, we believe that
    is unacceptable in this the wealthiest nation on the planet.
        Earlier we mentioned historical context. Let me return to that. In
    fiscal year 1992, 20 years after the establishment of OAA nutrition
    programs, the federal financial commitment was just over $607 million.
    (That figure represents the sum of Title III C-1, III C-2 and NSIP
    (then called USDA/NPE)). For fiscal year 2004, the President has
    requested $719 million. Yes, that is an increase; but it is a grossly
    inadequate one. For during the intervening years since 1992, other
    important factors have changed. First, there is inflation. Then there
    is the population shift, which has dramatically increased the number of
    individuals needing assistance with nutrition services. In 1992 there
    were 42.7 million individuals age 60 and older in the United States,
    and approximately 3.3 million of those were 85+. In this year (2004)
    the number of those 85+ is over 4.7 million. That, by any standard, is
    astounding growth. And it is growth that has gone largely
    uncompensated. Here is what we mean by that.
        We asked one of this country's most distinguished actuaries to look
    at these numbers, to look at population growth and inflation (by
    applying the annual CPI-U) and then to produce an ``equivalent''
    appropriation level. That is, we asked him to calculate what the
    federal commitment to each elder was in fiscal year 1992 and then to
    determine what funding levels these senior meal programs should have
    received in fiscal year 2004 to ensure parity with 1992. Why parity?
    Because we know that you agree that today's elders are just as
    important a part of our society today as they were 12 years ago.
    Today's elders--your parents and grandparents and perhaps even siblings
    and neighbors, certainly your constituents--are as deserving as those
    who came before them of receiving senior nutrition program services
    when they can no longer provide meals for themselves. Had you provided
    parity in 2004 with 1992, based on the changes in the CPI-U and the 85+
    population alone, the funding level would have been approximately
    $1.158 billion, an almost 61 percent increase over the $719 million
    being requested by the Administration for the next fiscal year. This
    year's request, in fact, is less than the 1992 enacted level for
    Nutrition Services Incentive Program (NSIP, formerly USDA); it is less
    than the 2002 enacted level for Title III C-1; and it is the same level
    as the fiscal year 2003 enacted level for Title III C-2. In other
    words, overall the request is much less than adequate for us to keep
    faith with the older population that depends on local community-based
    meal programs in every State in this great country. We are not so
    unrealistic as to believe that we can achieve parity in 1 year,
    although we do believe our case has merit. Mr. Chairman and members of
    the subcommittee, the Meals On Wheels Association of America does
    urgently and sincerely request that you increase funding for senior
    meal programs by no less than 10 percent for each line item over last
    year's levels, to approximately $786 million combined.
        The year 2005 will mark the 40th Anniversary of the Older Americans
    Act, and we can think of no more fitting way to recognize the
    invaluable contribution that OAA programs have made in the lives of
    older Americans and to demonstrate Congress' continued commitment to
    elders than by adopting funding levels that will help local programs
    serve those in need.
        Before we close we do want to make one more point, that is often
    overlooked when it comes to senior nutrition programs. These senior
    meal programs that receive funding through the Older Americans Act
    exemplify how effectively public-private partnerships can serve
    citizens in need. For that is what these programs are: public-private
    partnerships that reflect the unique needs and characteristics of the
    communities in which they operate and that rely on a number of funding
    sources. Federal dollars are only a portion of the funds on which these
    programs rely in order to operate. But they are a critical part, for
    they enable programs to leverage money from a variety of other sources,
    such as States and local governments, foundations, corporations and
    individuals. In the home-delivered program, for example, each $1 in
    federal funds leverages $3.35 from other sources. So even a modest
    increase in funding of 10 percent could assist in a major way in
    meeting unmet need.
        As you consider our request, you may want to keep in mind in whose
    behalf MOWAA is making it. Each and every one of these ``frail,
    homebound individuals'' is unique, just as you and I, so it is
    impossible to give you a description that covers them all. But here is
    a simple profile: the average Meals On Wheels recipient is an elderly
    woman in her very late seventies or eighties; she is more than twice as
    likely as her contemporaries to live alone, apart from family and
    friends. She is likely to be functionally impaired (have trouble
    walking, for example) and have three or more diagnosed chronic health
    conditions. In addition, she probably has an income below 200 percent
    of poverty. Whatever the reason, she cannot shop, cook, or prepare
    meals for herself. In other words, she relies on Meals On Wheels
    programs to ensure she gets proper nutrition. And without that, she
    would probably be at risk of being forced to move out of her home
    prematurely into an institutional care facility. These folks reside in
    cities and suburbs and rural communities across America.
        Thank you for the opportunity to bring these issues to your
    attention. Again, on behalf of MOWAA, local meal programs across
    America, and, most important, the at-risk and frail seniors that turn
    to them for meals and other nutrition services, we ask that you give
    serious consideration to renewing the commitment of your colleagues in
    previous Congresses and to increasing funding to a level that moves
    resolutely toward a level that is commensurate with that of a decade
    ago. A 10 percent increase for fiscal year 2005 is a good first step.
                                     ______

     Prepared Statement of the National Association of Nutrition and Aging
                               Services Programs

        Chairman Specter and Ranking Member Harkin: The National
    Association of Nutrition and Aging Services Programs (NANASP), a
    professional membership organization representing the interests of
    members at all levels of the aging network dedicated to providing
    quality nutrition and other direct services for older Americans,
    recommends an increase of 10 percent for the three Older Americans Act
    (OAA) nutrition programs as part of the fiscal year 2005 appropriations
    bill for the Department of Health and Human Services under your
    jurisdiction.
        This position is taken in concert with the position of the 50-
    member Leadership Council of Aging Organizations (LCAO) of which NANASP
    is a member. LCAO supports a 10 percent across the board increase for
    all Older Americans Act programs.
        NANASP's focus is the congregate and home delivered meals programs
    and the Nutrition Services Incentive Program, since our more than 800
    members nationally work on the front lines every day providing seniors
    with nutrition and related services.
        The President's budget called for a slight increase in funding of
    $4.35 million for the three OAA nutrition programs. However, the amount
    of the increase is only 0.6 percent of the total funding and does not
    even come close to inflation, estimated at 3 percent over the past
    fiscal year. In fact, the nutrition programs are entering a second
    decade of a funding deficit which is eroding the effectiveness of the
    programs for those being served. Whereas inflation has increased by
    44.45 percent since 1990, funding for the OAA has only increased by
    24.4 percent. Also since 1990, funding has only increased 9.8 percent
    for the congregate nutrition program.
        Administration data for fiscal year 2002 indicates that while the
    OAA nutrition programs are serving more individuals, they are serving
    fewer meals to these individuals. This defeats a main benefit of the
    program which is to provide eligible seniors with a minimum of one-
    third of their required daily dietary allowance. The reduction in meals
    can present genuine hardships to the seniors who are served, especially
    those in the greatest economic need who are to be targeted for service
    under the Older Americans Act.
        Furthermore, data provided by AARP forecasts that nearly 5 million
    meals will be cut from both the congregate and home delivered meals
    programs if no adjustments are made to the President's fiscal year 2005
    budget. The question to ask is how do these meals get replaced?
        A modest 10 percent increase in the nutrition programs constitutes
    about $71 million. This will help these programs to maintain services
    to their existing seniors thus avoiding the need for new or expanded
    waiting lists. Older adults waiting for basic services often wind up on
    nursing homes and are at risk for losing their homes and independence.
        The Older Americans Act nutrition programs are a proven success
    story with more than 30 years of serving seniors in your state and
    throughout the country. Funds provided for these programs are
    investments in promoting and maintaining the independence of seniors.
    The Older Americans Act nutrition programs are more than just a meal.
    These are preventive programs: they help avert malnutrition and control
    chronic conditions such as diabetes, and through socialization and
    other individual contact help keep seniors from becoming isolated.
        Programs with the longevity and proven track record of the elderly
    nutrition programs need to be supported with adequate, but fiscally
    reasonable funding levels. That is what we advocate today.
        NANASP encourages you and all members of the Subcommittee to visit
    an elderly nutrition program in your state either during the upcoming
    spring recess or during May, which is Older Americans Month. NANASP is
    happy to provide you with the names and addresses of programs from your
    state. See firsthand how these programs are great value propositions.
    They provide value through their services to seniors and they provide
    value to the taxpayer dollar by delivering a core service and more in
    an efficient and localized manner in a home or community setting where
    older adults want to stay.
                                     ______

                         NATIONAL INSTITUTES OF HEALTH

          Prepared Statement of the American Institute for Stuttering

        Mr. Chairman and members of the Subcommittee, I am Catherine S.
    Montgomery, Executive Director of the American Institute for Stuttering
    (AIS). AIS was founded in 1997 in response to the need for a
    comprehensive treatment and training facility for stuttering in the
    United States. It is the only nonprofit facility in this country that
    offers both intensive and non-intensive treatment options for people of
    all ages while also providing clinical training to both new and
    established speech-language pathologists.
        Stuttering is one of the few disorders that people still laugh at.
    The disorder wreaks havoc in one's life that few understand, and much
    of it is silent suffering, below the surface. Healthy intelligent
    children who stutter are placed in ``special classes'' and labeled
    eccentric, mentally ill and emotionally disturbed. In all honesty, many
    of these children have IQs 10 to 14 points higher than the general
    population. Public education is needed to rectify a long history of
    neglect and misunderstanding.
        Developmental stuttering typically begins between the ages of 3 and
    8 years of age. Some of the most important work now being done in
    stuttering is in early intervention treatment. It is very cost
    effective, yet many do not receive treatment due to a lack of
    clinicians trained specifically in speech-language pathology. There is
    also a dire lack of public awareness about the necessity for earlier
    diagnosis and treatment possibilities.
        Despite the fact that stuttering affects approximately 3 million
    people in the United States, it remains almost imperceptible as a
    public health issue. It should be noted that suicide among teenagers
    who stutter is 3 to 4 times higher than the general population. AIS is
    launching ``Let's Talk,'' a national public education and fundraising
    campaign to create a major cultural shift in public attitudes about
    stuttering.
        ``Let's Talk'' targets six program objectives to better serve the
    stuttering community:
        1. Public Education
        2. Research
        3. Clinical Treatment
        4. Treatment Scholarships
        5. Clinical Training
        6. Advocacy
        The American Institute for Stuttering has embarked upon a new
    professional relationship with New York Medical College and Ben Watson,
    Ph.D. Dr. Watson is among the few preeminent researchers in the United
    States whose focus is on learning more about the neurological roots of
    stuttering. He is now conducting two new exciting studies that will
    help move us along in our search for the cause of stuttering.
        We know a great deal about the speech and language abilities and
    brain function of adults who stutter and we are learning a great deal
    about the speech and language abilities of young children at the onset
    of stuttering. Some people who stutter as children do not stutter as
    adults. The reason for that is not known but Dr. Watson is exploring
    this question through investigation of speech, language and brain
    function in young children who do and who do not stutter.
        Previous studies show that brain activity in some people who
    stutter differs from that seen in nonstutterers. We now need to find
    out if, and how these differences in brain activity are related to
    stuttering. To answer these questions, scientists from New York Medical
    College and the Harlem Hospital Center are studying brain activity in
    persons who stutter during the production of both stuttered and fluent
    speech. This study may clarify the relationship between changes in
    brain activity and fluency breakdown.
        The disorder of stuttering has been one of the most seriously
    misunderstood of human handicapping conditions. Approximately 1 percent
    of the population of the United States, some 3 million Americans,
    suffer this inability to speak freely and try to cope with the daily
    agonizing struggle and ridicule that accompanies it. The American
    Institute for Stuttering is dedicated to filling the serious void in
    the availability of quality treatment and training.
        The American Institute for Stuttering asks that you support a 10
    percent increase in the budget of the National Institutes of Health in
    order to maintain the momentum that has been built up over the past
    half-decade. Further, we would ask that additional funds be made
    available for the National Institute of Deafness and Other
    Communications Disorders (NIDCD) to support stuttering research. There
    is currently about $3 million of federal funding dedicated to
    stuttering research. This works out to about $1 per person afflicted
    with this disorder. Moreover, Mr. Chairman, we respectfully request
    that the committee provide NIDCD with resources to support a consensus
    conference on stuttering. Such a conference will bring together the
    leading scientists in the field to assess the current state of the
    science and will hopefully identify future research opportunities.
        Thank you for this occasion to present this testimony.
                                     ______

          Prepared Statement of the National Primate Research Centers

        The Directors of the National Primate Research Centers (NPRCs)
    respectfully submit this written testimony for the record of the U.S.
    Senate Appropriations Subcommittee on Labor, Health and Human Services,
    and Education. The NPRCs appreciate the commitment that the members of
    this Subcommittee have made to biomedical research through strong
    support for the National Institutes of Health (NIH). Given your
    leadership on this issue, the NPRCs urge Congress to direct resources
    to vital biomedical research infrastructure in order to ensure that the
    success of the federal investment in NIH will not be compromised as a
    result of deficient research resources.
        The NPRCs are a national network of eight primate research centers
    supported by the NIH National Center for Research Resources (NCRR). The
    centers comprise the National Primate Research Program (NPRP), which
    was developed in 1960 in response to recommendations provided to
    Congress by the National Heart Institute Advisory Council. This program
    seeks to address human health problems through scientific research
    using the animal models that most closely resemble humans in their
    genetics, physiology, and disease processes--primates. The NPRCs were
    developed specifically as resources to advance primate research by
    providing specialized research facilities and technologies as well as
    unique living environments for primates. NPRCs support research that is
    sponsored by nearly every institute of NIH. For example, NPRCs conduct
    research to help understand and treat diseases such as heart disease,
    cancer, diabetes, Alzheimer's, Parkinson's, and AIDS. They also conduct
    research on emerging infectious disease and on many aspects of
    biodefense. Each NPRC makes its facilities available to investigators
    from around the country. In fact, the NPRCs support more than 1,500 NIH
    funded investigators each year. This collaborative research environment
    allows scientists to combine their individual expertises beyond the
    scope of established disciplinary research projects.
        Research involving animals is a vital element in achieving this
    goal of continued medical progress for human health. The specific
    availability of information in the primate genome, which is quite
    similar to the human genome, makes primates essential in studies that
    require an integrated understanding of a whole biological system.
    Primate studies allow scientists to answer fundamental questions
    regarding both specific diseases and normal physiological processes
    that cannot be addressed directly in humans or effectively in more
    evolutionarily distant species such as rodents. Recent reports suggest
    that extensive analysis of genome structure and function in nonhuman
    primates could make immediate and significant contributions to the
    overall mission of NIH by accelerating progress in understanding many
    human diseases.
        In the 1950's, primate research produced the first vaccine for one
    of the world's worst childhood killers, the Polio virus, reducing the
    number of cases in the United States from 58,000 to one or two per
    year. Primates have also served as the best model for various types of
    HIV research, and their availability for use has resulted in at least
    14 licensed anti-viral drugs for treatment of HIV infection. Primate
    models will continue to be necessary to defend the world against future
    and assuredly occurring scourges of which we have already had hints,
    like SARS and West Nile Virus. In addition to these deadly viral
    epidemics, primate research has enabled the discovery of better
    treatments and therapies for diseases such as diabetes, heart disease,
    high blood pressure, kidney disease, depression, and other psychiatric
    illnesses. Treatments for stroke and cataracts, and the advancement of
    prenatal and postnatal care have also resulted from primate research.
    Furthermore, in addition to the potential to provide answers for long-
    standing research questions, primate research provides an unparalleled
    opportunity to address more recently defined research priorities such
    as those relating to the threat of bioterrorism.
        Mr. Chairman, as you and your Subcommittee work to define your
    priorities for the year and set goals for the future, NPRCs ask that
    you continue the commitment of support for NIH and its mission by
    providing the highest funding level possible in the NIH appropriations
    bill. An increase would enable researchers to continue vital merit
    based studies on devastating diseases and disabilities, as well as
    address new and emerging national health priorities. The NPRCs believe
    this increase is justified by both the health needs and research
    capabilities of the nation. The President's budget asks for a 2.6
    percent NIH increase; however, NPRCs, the Ad Hoc Group for Medical
    Research Funding, and other leaders of the research community hope for
    more. Funding for NIH has helped to expand our nation's capabilities in
    biomedical research, and develop new treatments and cures for many
    diseases, but many unsolved human health mysteries still remain.
    Medical research is a long-term process and in order to continue to
    meet the evolving challenges of improving human health we must not let
    our commitment wane. It is therefore essential to sustain the momentum
    of NIH-funded research so that it continues to meet the goal of
    improving the health of all Americans.
        NIH relies on the NPRCs to provide centralized, professional care,
    management, and research conducted with primates. Consequently, the
    NPRCs, which are funded by annual NIH P51 base grants, have become an
    indispensable national scientific resource. Increased base grant funds
    from NIH/NCRR to meet the current and projected NPRC operational and
    modernization costs are critical to the success of NPRCs and their
    programs. NPRCs directors ask that you direct NIH to adopt and fund the
    NPRP Five Year Federal Advancement Initiative, developed by the NPRCs
    directors, for the NPRP, which addresses necessary upgrades and program
    capacity expansions. The total anticipated cost of the NPRP Federal
    Advancement Initiative would be $100 million over the current funding
    level for the NPRP P51 base grant during the 5 year period of fiscal
    years 2005-2009. Over 5 years, the NPRP Federal Advancement Initiative
    aims to increase the following by 20 percent : (1) the nationwide
    availability of primates; (2) the quality and capacity of primate
    housing and breeding facilities, as well as the availability of related
    state-of-the-art diagnostic and clinical support equipment at NPRCs;
    and (3) the number of personnel trained in primate care and management
    at the NPRCs. The NPRCs urge Congress to direct NIH to adopt and fund
    the Federal Advancement Initiative, beginning with a $36 million
    increase in funding for the P51 base grant in fiscal year 2005. The
    NPRCs also ask that Congress directs NIH to engage in a meaningful
    planning process to invest in the long-term needs of the NPRCs.
        For 2 consecutive years, language strongly in support of NPRCs has
    appeared in the report accompanying the Labor/HHS/Education
    Appropriations bills. The reports recognize the importance of the NPRCs
    as well as centers' demanding resource requirements. The fiscal year
    2004 House report directs NCRR to periodically assess NPRCs needs, and
    to increase the P51 base grant funds for the centers. The report also
    directs NCRR to submit the first of the periodic assessments along with
    the fiscal year 2005 budget request. As you know, the Senate issued
    report language stating that NCRR is expected to fully commit to the
    Five Year Federal Advancement Initiative. Thus far, while NPRCs have
    seen modest increases in base grant funds, the initiative has yet to be
    applied and funded by NCRR.
        Biomedical researchers across the nation are experiencing shortages
    in the availability of primates for essential research. NPRCs, the
    federally funded primate resource, have found it increasingly difficult
    to provide sufficient numbers of primates for ambitious and high
    priority federal research projects on cancer, AIDS, and biodefense. In
    many cases, NIH funded scientists must wait a year or more to begin
    their research due to the limited availability of primates and/or
    space. These critical shortages can only be addressed by expanding
    existing breeding colonies and developing bridging programs to
    effectively use under-utilized species of primates in research.
    Ultimately, this would reduce the wait period for the use of primates,
    expediting the start of critical research projects. Presently, the
    budget of each NPRC falls below the amount required to maintain crucial
    services at existing levels. By adopting and funding the Federal
    Advancement Initiative, not only will the centers be able to sustain
    existing programs, but they will have the ability to build much needed
    programs that will better serve the nation's federally funded primate
    researchers.
        Accommodating and properly caring for increasing numbers of
    primates also requires additional funding to modernize and expand
    primate housing and research facilities. As primate populations grow
    and primate resources increase, proper infrastructure will be necessary
    to house and care for these additional animals. Under the Federal
    Advancement Initiative, additional P51 base grant funds will also be
    invested in repairs, renovation, and construction of research
    facilities, as well as the purchase of modern laboratory equipment.
    These are essential upgrades needed to ensure that the federally funded
    research community can translate new discoveries into treatments and
    cures. Increased funding under the P51 will give the NPRCs the ability
    to develop the state-of-the-art capabilities and facilities necessary
    to keep pace with the expanded NIH research agenda.
        Since nonhuman primates represent the most sophisticated and
    relevant animal models for many areas of biomedical research, there is
    a heightened need to use primate models prior to human clinical trials,
    as well as a heightened responsibility to properly care for and manage
    these animals. Thus, the Federal Advancement Initiative proposes to use
    increased P51 base grant funding to ensure that adequate numbers of
    experts are trained in laboratory animal medicine and research. Each
    NPRC requires a highly trained and experienced primate management team
    comprised of behavioral specialists, veterinarians, and primate
    research experts. As the number of primates at the NPRCs grows,
    proportional expansion of the primate management teams is essential to
    maintain primate health and research success.
        The NPRCs provide scientists across the nation with unmatched
    access to these crucial research models in the process of making
    significant medical discoveries and translating these discoveries into
    effective therapies and treatments. This is an essential and valuable
    centralized service for researchers who cannot afford to use and
    maintain scarce and expensive primates solely for individual research
    projects. For every dollar provided to the NPRCs, more than $10 in NIH
    research is leveraged, which is equivalent to approximately $600
    million in NIH research that could not otherwise be carried out.
        With this in mind, the NPRCs express their sincere hope that the
    nation will continue to sustain the healthy development of its
    biomedical research program and that this Subcommittee will continue
    its support and leadership on behalf of NIH and its research partners
    across the nation.
        Mr. Chairman, as you and your Subcommittee work to define your
    priorities for the year and set goals for the future, the NPRCs
    directors ask that you direct NIH to adopt and fund the NPRP Five Year
    Federal Advancement Initiative. Investing in and enriching the NPRCs
    will help to expand our nation's capabilities in biomedical research,
    and enable the development of new treatments and cures for many
    diseases. NIH adoption of the NPRP Federal Advancement Initiative will
    allow NPRCs, as well as NIH, to continue to meet and advance the goal
    of improving the health of all Americans.
        Thank you for the opportunity to submit this written testimony and
    for your attention to the recommendations of the NPRCs concerning
    funding for NIH in fiscal year 2005 and implementation of the NPRCs
    Five Year Federal Advancement Initiative.
                                     ______

       Prepared Statement of the FacioScapuloHumeral Muscular Dystrophy
                                    Society

        Mr. Chairman, it is a great pleasure to submit this testimony to
    you today.
        My name is Carol Anne Perez, of Lexington, Massachusetts, and I am
    testifying as Executive Director of the FacioScapuloHumeral Muscular
    Dystrophy Society (FSH Society, Inc.) and as an individual who has
    lived with the devastating facioscapulohumeral muscular dystrophy
    (FSHD) disorder for nearly 70 years.
        Facioscapulohumeral muscular dystrophy (FSHD) is the third most
    prevalent form of muscle disease. FSHD is a neuromuscular disorder that
    is transmitted genetically to 120,000 people. Conservatively, it
    affects 14,000 persons in the United States. For men, women, and
    children the major consequence of inheriting FSHD is progressive and
    severe loss of all skeletal muscles gradually bringing weakness and
    reduced mobility. The usual pattern is of initial noticeable weakness
    of facial, scapular and upper arm muscles and subsequent weaknesses of
    other skeletal muscles. Retinal and cochlear disease, as well as mental
    retardation, can be associated with FSHD. 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 are 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 and their children and grandchildren as
    well. As a human services professional, wife, mother, and grandmother I
    am now in wheelchair due to the effects of FSHD.
        In accordance with its primary purpose of serving the FSHD
    community, both in the United States and abroad, the FSH Society,
    through outreach at home and international networking, has brought
    together more than 3,000 FSHD-affected families committed to working
    cooperatively. From the moment of their introduction into the FSH
    Society, these families, and, in many instances, their friends are
    bonded with their fellow members both by their common knowledge of what
    it is to live with FSHD and by the ardent desire they all feel to be
    part of a concerted effort to discover how to treat the disease and,
    ultimately, to cure it.
        People who have FSHD must cope with continuing, unrelenting,
    unpredictable and never-ending losses. The most unlucky, those who are
    affected from birth, are deprived of virtually all the ordinary joys
    and pleasures of childhood and adolescence. But no matter at which
    stage of life the disease makes itself known, there is never after that
    any reprieve from continuing loss of physical ability, or ever for a
    moment relief from the physical and emotional pain that FSHD brings in
    its train. Every morning, FSHD sufferers wake up to face the reality
    that neither a cause for their disease nor any treatment for it has yet
    been found.
        Insidiously and systematically, FSHD denies a person the full range
    of choices in life. FSHD affects the way you walk, the way you dress,
    the way you work, the way you wash, the way you sleep, the way you
    relate, the way you parent, the way you love, the way and where you
    live, and the way people perceive and treat you. You cannot smile, hold
    a baby in your arms, close your eyes to sleep, run, walk on the beach,
    or climb stairs. Each new day brings renewed awareness of the things
    you may not be able to do the next day. This is what life is for tens
    of thousands of people affected by FSHD worldwide.
        Through the FSH Society, FSHD patients have found ways to be useful
    to medical and clinical researchers working on their disease. The FSH
    Society acts as a clearinghouse for information on the FSHD disorder
    and on potential drugs and devices designed to alleviate its effects.
    It fosters communication among FSHD patients, their families and
    caregivers, charitable organizations, government agencies, industry,
    scientific researchers, and academic institutions. It solicits grants
    and contributions from members of the FSH Society, and from
    foundations, the pharmaceutical industry, and others to support
    scientific research and development. It makes grants and awards to
    qualified research applicants. In less than 5 years, the FSH Society
    has raised more than $1 million for research and has invested it in two
    dozen innovative research programs internationally. One of the FSH
    Society's key assets, its Scientific Advisory Board, is composed of
    international experts whose awareness of current FSHD research ensures
    both that new research is not duplicative but complementary and that it
    will fill gaps in existing knowledge. The FSH Society's work in
    education, advocacy, and training has led to increased funding in the
    United States and abroad. It was a key participant in drafting the
    Muscular Dystrophy Community Assistance Research and Education Act of
    2001 (MD CARE Act) which in the United States mandates research and
    investigation into all forms of Muscular Dystrophy.
        The Appropriations Committees in both the U.S. House and the U.S.
    Senate have repeatedly instructed the National Institutes of Health
    (NIH) to enhance and broaden the portfolio in FSHD and muscular
    dystrophy in general. The NIH accounting for the total overall NIH and
    the subset of muscular dystrophy appropriations in millions of dollars
    for the past 5 years follows:

    NATIONAL INSTITUTES OF HEALTH (NIH) APPROPRIATIONS HISTORY SOURCE: NIH/OD BUDGET OFFICE & NIH CRISP DATABASE ON-
                                                          LINE
                                                  [Dollars in millions]
    ----------------------------------------------------------------------------------------------------------------
                                                          NIH        MD         MD        FSH      FSHD       FSHD
                       Fiscal year                      overall   research   percent   research   percent   percent
                                                        dollars    dollars    of NIH    dollars    of MD    of  NIH
    ----------------------------------------------------------------------------------------------------------------
    2000.............................................    $17,821     $12.6      0.071      $0.4      3.18     0.0022
    2001.............................................     20,458      21.0      0.103       0.5      2.38     0.0024
    2002.............................................     23,296      27.6      0.118       1.3      4.71     0.0056
    2003.............................................     27,067      39.1      0.144       1.5      3.83     0.0055
    2004E............................................     27,887      40.2      0.144       2.7      6.71     0.0097
    ----------------------------------------------------------------------------------------------------------------

        Due to major initiatives from the volunteer health agencies and the
    extramural community of researchers, FSHD research at the NIH and
    funding through the NIH is moving ahead at a steady pace though
    seemingly incredibly slow for those of us suffering from FSHD.
    Notwithstanding these positive changes at the NIH as well as major
    cooperative initiatives from the volunteer health agencies and the
    extramural community of researchers, we realize that major changes are
    slow but we are hopeful that this year the NIH will initiate new and
    increased funding for FSHD.
        Funding increases for FSHD as related to the entire muscular
    dystrophy portfolio are not keeping pace with all muscular dystrophy.
    FSHD is the third most prevalent form of muscle disease and a common
    muscular dystrophy. Yet, in 2003 it received only 3.83 percent of the
    total NIH wide muscular dystrophy portfolio and that number has
    improved slightly to an estimated 6.71 percent for fiscal year 2004.
        Mr. Chairman, as you know, the National Institute of Child Health
    and Human Development (NICHD), the National Institute of Arthritis and
    Musculoskeletal Disorders (NIAMS), and, the National Institute of
    Neurological Disorders and Stroke (NINDS) are three of the National
    Institutes of Health (NIH) institutes called upon by the Muscular
    Dystrophy Community Assistance Research and Education Act of 2001 (MD
    CARE Act) to develop a research plan for muscular dystrophy (MD)
    research and education conducted through the National Institutes of
    Health. Certainly, other NIH institutes will be called into action
    where appropriate such as NHLBI, NEI, NIA, NIMH, NHGRI, NCRR, FIC, and
    OD.

      NATIONAL INSTITUTES OF HEALTH (NIH) MUSCULAR DYSTROPHY AND FSHD APPROPRIATIONS HISTORY SOURCE: NIH/OD BUDGET
                                           OFFICE & NIH CRISP DATABASE ON-LINE
                                                [In millions of dollars]
    ----------------------------------------------------------------------------------------------------------------
                                                               Total NIH    NIAMS      NINDS      NICHD     NIH wide
                           Fiscal year                           dollars   dollars    dollars    dollars    dollars
                                                                 on MD      on MD      on MD      on MD     on FSHD
    ----------------------------------------------------------------------------------------------------------------
    2000.....................................................       12.6        4.8        4.9        1.2        0.4
    2001.....................................................       21.0        9.2        8.2        0.5        0.5
    2002.....................................................       27.6       11.1        9.8        0.6        1.3
    2003.....................................................       39.1       15.5       13.2        4.5        1.5
    2004E....................................................       40.2       15.9       13.5        4.7        2.7
    2005E....................................................       41.0       16.3       13.7        4.8        2.8
    ----------------------------------------------------------------------------------------------------------------

        In fiscal year 2004 year-to-date, the National Institute of Child
    Health and Human Development (NICHD) does not have a single research
    grant or project directly focused or covering FSHD. NICHD is spending
    $0 out of an estimated $4.7M on directly titled FSHD projects. NICHD is
    spending 0 percent of its muscular dystrophy budget on FSHD.
        In fiscal year 2004 year-to-date, the National Institute of
    Arthritis and Musculoskeletal Disorders (NIAMS) is funding two directly
    titled projects on FSHD and the NIH FSHD Research Patient Registry. The
    directly titled grants and contracts are 5-R21-AR-48318-03 at $198,000,
    5-R21-AR-48327-03 at $125,000, and, 3-N01-AR-02250-004 $175,754.
    Directly focused and titled research grants on FSHD actually decreased
    in fiscal year 2004 due to the expiration of a third R21 and no new
    directly titled and relevant projects being funded. No new projects
    directly titled and focused on FSHD have been initiated in the past 3
    years. Not a single one. The total direct expenditure from the lead
    institute on FSHD muscular dystrophy, the NIAMS, was $498,754. The
    NIAMS is spending 3.1 percent of its total muscular dystrophy budget on
    FSHD. Something is definitely and clearly wrong with this picture.
        In fiscal year 2004 year-to-date, the National Institute of
    Neurological Disorders and Stroke (NINDS) is funding seven directly
    titled projects on FSHD and the NIH U54 Cooperative Research Center at
    the University of Rochester. The NINDS is currently funding four R21
    style grants, two R01 style grants, the U54 MD CRC, and the NIH FSHD
    Research Patient Registry. NINDS has increased its portfolio by one R21
    grant, two R01 grants and one U54 Cooperative Research Center in the
    last year. The NINDS is spending 16.3 percent of its total muscular
    dystrophy budget on FSHD. The NINDS has shown an uncanny ability to
    move the field of FSHD research ahead with many excellent research
    projects as well as sponsoring the unprecedented NIH Cooperative
    Research Center. The second request for applications for the next round
    of Wellstone Muscular Dystrophy Centers has just been announced. The
    late Senator Wellstone would have been proud of the achievements made
    to date in the area of muscular dystrophy and it is very befitting and
    appropriate that the muscular dystrophy research centers create a
    living memory for his substantial efforts.
        While it is recognized that research grants, grant applications and
    interest of the researchers may ebb and flow, we are seriously
    concerned and perplexed with the total lack of presence by the NICHD in
    FSHD and weak showing of FSHD grants and the dip in direct FSHD support
    by the NIAMS, ostensibly the lead institute at the NIH, on muscular
    dystrophy. FSHD is the third most prevalent form of muscular dystrophy
    and the NIAMS has 3.1 percent of its dystrophy portfolio allocated to
    this disease. In the case made that the NIH is not receiving enough
    grants applications for FSHD, it can be said that the volunteer health
    agencies and extramural community of researchers have done everything
    in our power to grow the area of research and to promote new
    researchers and research projects. The NIH needs to recognize that
    there is a systemic problem as relates to FSHD and that the extramural
    research community needs to know that there are specific grant
    mechanisms and announcements with money associated.
        The NINDS, NIAMS, NICHD and relevant NIH institutes understand that
    FSHD is a unique disease and that there are exciting breakthroughs
    around understanding the molecular basis of FSHD. Elucidation of the
    molecular pathogenic pathways of the FSHD disease is instrumental to
    improved patient diagnosis, counseling, management and treatment. It is
    now generally accepted that FSHD is caused by a deletion (contraction)
    of D4Z4 repeats on the chromosome 4q. New mutations are frequently
    encountered and approximately half of cases seem to be due to somatic
    rearrangements. An interesting gender difference in disease expression
    in mosaic patients--males are more susceptible to disease--suggest a
    hormonal modulation of the phenotype. FSHD is associated with a genomic
    rearrangement and it is unlikely that the D4Z4 deletion structurally
    compromises a putative FSHD gene. Evidence strongly supports a model in
    which the D4Z4 contraction induces a change in the chromosomal
    environment, more specifically the chromatin structure, which in its
    turn modulates the gene expression of gene(s) in cis or in trans. This
    may occur by a spreading or looping mechanism, or more speculatively,
    by a mechanism similar to transvection as chromosome ends of 4q and 10q
    seem to exhibit a higher pairing frequency and other forms of cross
    talk. However, identification of the exact molecular mechanism and the
    crucial target gene(s) has still to be done. There is increasing
    evidence for FSHD-specific changes in the chromatin structure and the
    histone code. Most arguments suggest a unique (novel) pathogenic
    mechanism behind FSHD. Elucidation of this intricate molecular network
    is instrumental to the development of evidence-based treatment (and
    preventive) strategies.
        The following is a non-exhaustive list of top priority research
    targets and areas for investigation that has been given by FSHD
    research experts to the NIH for consideration as the NIH research plan
    is developed. The order is not intended to indicate priority rating.
    (1.) Detailed characterization of individual candidate genes on
    chromosome 4q; (2.) Identification of the difference between 4qA and
    4qB; only short 4qA is causing FSHD; (3.) The molecular causes and
    consequences of the exchange between 4q and 10q; (4.) Chromatin
    structure and nuclear organization--histone code; methylation,
    acetylation etc.; (5.) Establishment of the gene expression modulation
    on chromosome 4q and genome-wide; (6.) Development of functional models
    in vitro (cellular) and in vivo (transgenic); (7.) Implementation of
    systems biology (integrated -omics and bioinformatics) to reveal
    molecular and metabolic pathways involved; (8.) Harmonize and
    standardize molecular diagnostic procedures; (9.) Systematic
    ascertainment and characterization of (homogenous) patient populations
    for clinical trials; (10.) Generation of tools and reagents to monitor
    (pharmacological, training, or gene therapy) interventions; (11.)
    Identification of additional FSHD loci and genes.
        Congress has been very generous with the NIH. Congress has
    repeatedly mandated more effort in muscular dystrophy research in
    general and FSHD research in particular. But this is not happening. We
    ask Congress to continue its support for the overall budget increases
    for the NIH as this will alleviate the serious budget constraints faced
    by this most remarkable federal agency. We also ask that Congress
    request an explanation from the program staff and Directors of the NIH
    NIAMS and NICHD for the inability to do better in the area of FSHD
    despite repeated Congressional requests. We implore Congress to request
    the NIH to specifically build the research portfolio on FSHD through
    all available means, including re-issuing specific calls for research
    on FSHD at an accelerated rate, to make up for historical and present
    neglect.
        Mr. Chairman, we trust your judgment on the matter before us. We
    believe the Committee should explore why muscular dystrophy in general
    and FSHD in particular has been left behind in the great rise in
    research support at the NIH. Frankly, we are extremely frustrated that
    amid a huge increase in funding and strong unambiguous expressions of
    Congressional support, the NIH commitment in facioscapulohumeral
    muscular dystrophy (FSHD) is so feeble. Mr. Chairman thanks to your
    extraordinary efforts, consideration and work in this area I have hope
    that we will find solutions and that hope keeps me going.
        Mr. Chairman, again, thank you for providing this opportunity to
    testify before your Subcommittee.
                                     ______

            Prepared Statement of the American Psychological Society

                           SUMMARY OF RECOMMENDATIONS

      --As a member of the Ad Hoc Group for Medical Research Funding, APS
            recommends $30.78 billion for NIH in fiscal year 2005.
      --APS requests Committee support for increased behavioral and social
            science research and training at NIH in order to: better meet
            the Nation's health needs, many of which are behavioral in
            nature; realize the exciting scientific opportunities in
            behavioral and social science research, and; accommodate the
            changing nature of science, in which new fields and new
            frontiers of inquiry are rapidly emerging.
      --Committee support is requested for specific behavioral science
            activities at a number of individual institutes. This testimony
            provides examples to illustrate the exciting and important
            behavioral and social science work being supported at NIH.
        Mr. Chairman, Members of the Committee: On behalf of our members, I
    want to thank the Committee for your leadership in the bipartisan
    effort to double NIH budget. As a member of the Ad Hoc Group for
    Medical Research Funding, the American Psychological Society recommends
    $30.78 billion for NIH in fiscal year 2005.
        While the process of doubling the budget of NIH was completed on
    schedule, by no means is our work finished. We must think of that
    process not as a culmination, but as the beginning of something
    miraculous in the world of science and discovery. Within NIH budget, my
    testimony focuses on the behavioral and social science research
    activities of NIH.

      OVERVIEW--BASIC AND APPLIED PSYCHOLOGICAL RESEARCH RELATED TO HEALTH

        The effects of behavior on health are indisputable. Many serious
    health conditions--heart disease, lung disease, diabetes,
    schizophrenia, AIDS, and so many more--are behavioral in origin.
    Consider, for example, the devastating health consequences of smoking,
    drinking, taking drugs, engaging in risky sexual behaviors. None of
    these conditions can be fully understood without an awareness of the
    behavioral and psychological factors involved in causing, treating and
    preventing them.
        APS members include thousands of scientists who, with NIH support,
    conduct basic, applied, and clinical research related to physical and
    mental health at our Nation's leading universities and colleges.
    Virtually every institute at NIH supports some amount of psychological
    science. 24 of the 27 institutes at NIH fund behavioral science
    research, and seven institutes commit over $100 million to this
    enterprise. Six institutes commit over 20 percent of their resources to
    behavioral science research. That places these pursuits squarely at the
    forefront of the most pressing health issues facing this nation. We ask
    that you continue to help make behavioral research more of a priority
    at NIH, both by providing maximum funding for those institutes where
    behavioral science is a core activity, and by encouraging NIH to
    advance a model of health that includes behavior in deciding its
    scientific priorities.

         BEHAVIORAL SCIENCE RESEARCH TRAINING--A GUARANTEED INVESTMENT

        The National Academy of Sciences is currently conducting its
    congressionally authorized study of research personnel needs with
    regard to the National Research Service Awards. In recent years, NIH
    has chosen to only implement the recommendations of NAS selectively, if
    at all. NAS produces unbiased, highly analytical reports, and they
    should receive more attention from all of the NIH institutes. This is a
    serious issue in behavioral science at NIH, where the demand for
    behavioral science investigators at NCI, NIMH, and other institutes
    outpaces the current supply of behavioral science researchers. In order
    to meet the future needs of research in health and behavior, NIH must
    have a comprehensive training strategy in place today, one that focuses
    on training young investigators in the core disciplines of behavioral
    and social science research as well as in multidisciplinary
    perspectives.
        This Committee has expressed interest in this study in the past.
    Your colleagues in the House stated in their fiscal year 2004
    appropriations report, ``The Committee recognizes the continuing need
    for young investigators and clinical scientists, and encourages NIH to
    increase its support for research training and loan repayment programs.
    The Committee is aware that the National Academy of Sciences is
    currently conducting its congressionally authorized study of research
    personnel needs with regard to the National Research Training Awards.
    This Committee has expressed interest in this study in the past, and is
    looking forward to receiving NAS's recommendations with regard to
    health research training priorities.''----(H. Rpt. 108-188 p. 97)
        I would now like to turn my attention to the behavioral science
    research that is taking place at the individual institutes.

                   NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH)

        Strengthening Clinical Science and Evidence Based Treatment.--In
    January, the National Institute of Mental Health hosted a conference in
    cooperation with the Academy of Psychological Clinical Sciences. Its
    goal was to begin a dialogue on the growing gap between psychological
    clinical science training and clinical treatment. Building a solid
    footing for the training and development of future clinical researchers
    was the broad aim of the gathering. The meeting between the Academy and
    NIMH brought leaders of the two groups together to outline the
    challenges to clinical science training and develop a strategy for
    strengthening that training. Also discussed was the need to encourage
    more students to pursue research careers, and support the use of
    evidence-based treatments by practitioners. We believe this is the
    perfect illustration of what Congress had in mind when it chose to
    double the NIH budget; applying advances in science and research to the
    treatment of those in need, and watching the two fields progress as one
    to the benefit of all. We ask the Committee to support the efforts of
    NIMH as the institutes takes this very complex first step in the on-
    going fight against mental illness.
        Basic Behavioral Research at NIMH.--The behavioral science research
    branch at NIMH plays a pivotal role at the institute, funding research
    in cognitive science, personality and social cognition, and
    biobehavioral regulation. Knowledge derived from the investigation of
    basic behavioral processes is critical to the specification of
    behavioral abnormalities in mental disorders, as well as to the
    identification of risk and protective factors and the development of
    effective interventions. NIMH is to be commended for promoting the
    transfer of knowledge into application. At the same time, basic
    behavioral research at NIMH must continue to receive the same strong
    support it traditionally receives there. This is crucial, as NIMH is a
    de facto source of basic behavioral knowledge that is tapped by many
    other institutes. Until other institutes begin to support larger
    amounts of basic behavioral science research connected to their
    respective missions, it is essential that NIMH's programs of research
    into behavioral phenomena such as cognition, emotion, psychopathology,
    perception, development, and others continues to flourish. The National
    Mental Health Advisory Council has formed a task force that is
    currently examining the basic science portfolio of NIMH, including
    basic behavioral science. Their charge is to recommend the best course
    of research for the future, based on past successes and the current
    direction that research is headed in. Basic behavioral research is
    critical not only to the mission of NIMH, but also to the health of the
    nation. We ask the Committee to encourage NIMH's continued efforts to
    strengthen the ties between basic and clinical behavioral research, and
    to monitor NIMH's basic behavioral science portfolio in order to ensure
    continued progress in our understanding of the causes, treatment, and
    prevention of mental illness and the promotion of mental health.

             NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES (NIGMS)

        NIGMS is the only National Institute specifically mandated to
    support research not targeted to specific diseases or disorders. That
    legislative mandate also extends to behavioral science research. The
    research mission of NIGMS encompasses ``general or basic medical
    sciences and related natural or behavioral sciences [emphasis added]
    which have significance for two or more other national research
    institutes.''----(TITLE 42, CHAPTER 6A, SUBCHAPTER III, Part C, subpart
    11, Sec. 285k) Unfortunately, NIGMS does not now support behavioral
    science research or training. This is an enormous oversight, given the
    wide range of fundamental behavioral topics with relevance to a variety
    of diseases and health conditions. Congress addressed this issue for
    the past 5 years in the reports on the fiscal year 2000, fiscal year
    2001, fiscal year 2002, fiscal year 2003, and fiscal year 2004
    appropriations for NIH. Specifically, you said: ``The Committee
    believes that NIGMS has a scientific mandate to support basic
    behavioral research because of the clear relevance of fundamental
    behavioral factors to a variety of diseases and health conditions. The
    Committee encourages the NIGMS to incorporate basic behavioral research
    as part of its portfolio, especially in the areas of cognition,
    behavioral neuroscience, behavioral genetics, psychophysiology,
    methodology and evaluation, and experimental psychology.''
        Last September, Senators Specter, Harkin, and Inouye engaged in a
    colloquy on this subject, which appeared in the Congressional Record.
    All three of these Senators agreed on the important role that basic
    behavioral science plays in our national research agenda. Pressing
    national health issues such as post-traumatic stress disorder,
    unintentional injuries, and tobacco, alcohol and drug addiction can all
    benefit from basic behavioral research. We ask the committee to please
    continue its efforts to have NIGMS include basic behavioral research
    and research training in its portfolio.
        In response to these repeated requests from Congress, a working
    group has been established with the charge of examining the basic
    behavioral science research portfolio for the whole of NIH. Consisting
    of experts in basic behavioral sciences from both inside and outside
    NIH, this group was established to offer recommendations on the future
    of this research, in terms of both what should be studied and at which
    institutes. It will report its findings to the NIH Director's Advisory
    Council. In their fiscal year 2005 Congressional Justification
    document, NIGMS cited this working group and committed to working with
    it. We ask that the committee monitor the progress of this working
    group and carefully evaluate its findings.
        Basic behavioral research in addiction (significance for NIDA,
    NIAAA, NCI and NHLBI), obesity (significance for NIDDK, NHLBI, and
    NICHD), behavioral genetics (significance for NIDA, NIAAA, NINDS, and
    NHGRI) and neuroscience (significance for NIMH, NINDS, and NHGRI) just
    to name a few, are all within the NIGMS mission. We ask the Committee
    to direct NIGMS to develop a plan for establishing a basic behavioral
    science research program at NIGMS.

                    NATIONAL INSTITUTE ON DRUG ABUSE (NIDA)

        NIDA is committed to bringing the Nation the best possible
    prevention and treatment interventions for drug abuse and addiction by
    harnessing the power of science. They accomplish this mission through a
    wide variety of research centers and projects, all of which are on the
    cutting edge of today's science and research methods.
        National Drug Abuse Treatment Clinical Trials Network (CTN).--
    NIDA's National Drug Abuse Treatment Clinical Trials Network (CTN) is
    helping bring new medications and behavioral treatments for addiction
    to communities. Since its establishment in 1999, the CTN has expanded
    from 5 to 17 sites across the country. The mission of the CTN is to
    conduct studies of behavioral, pharmacological, and integrated
    behavioral and pharmacological treatment interventions of therapeutic
    effect in rigorous, multi-site clinical trials to determine
    effectiveness across a broad range of community-based treatment
    settings and diversified patient populations; and then transfer the
    research results to physicians, providers, and their patients to
    improve the quality of drug abuse treatment throughout the country
    using science as the vehicle.
        Brain, Behavior, and Health: An Integrative Approach.--Scientific
    understanding has reached a stage where all the elements of the human
    brain can be mapped out. NIDA will take a leadership role in working
    with other NIH Institutes and Centers and with external groups, to
    better understand the interactions among brain, behavior, and health.
    Understanding these connections will help us NIDA in the development of
    new prevention strategies. Science will find ways to make us better
    able to modify behavior in ways that encourage people to take advantage
    of existing preventive strategies. All the research initiatives being
    put forward by NIDA for fiscal year 2005 will be undertaken within this
    integrated approach to brain, behavior, and health.
        Comorbidity.--The mentally ill are at very high risk for substance
    abuse and addiction. Comorbidity between drug abuse and mental illness
    needs to be addressed in order to provide treatments and services that
    are truly effective. NIDA would like to expand research to better
    understand the comorbid nature of these disorders and to translate this
    knowledge into improved prevention and treatment strategies. We ask
    this Committee to increase NIDA's budget in proportion to the overall
    increase at NIH in order to reduce the health, social and economic
    burden resulting from drug abuse and addiction in this Nation.

           NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA)

        NIAAA has broadened its behavioral science portfolio in order to
    understand the underlying psychological and cognitive processes that
    lead people to drink, and the impact of chronic alcohol abuse on those
    processes.
        Advancing Behavioral Therapies for Alcoholism.--Behavioral, non-
    pharmacological therapies currently are the most widely used method of
    treating alcohol dependence and alcohol abuse. To advance the
    effectiveness of behavioral therapies, NIAAA is examining approaches to
    improving clinicians' abilities to engage and retain adults and
    adolescents in treatment. NIAAA plans to expand research on the
    mechanisms of action of successful behavioral therapies, behavioral
    therapies for alcohol-abusing patients who have psychiatric disorders,
    which significantly complicates therapeutic interventions, and
    combinations of new medications with behavioral therapies to sustain
    recovery.
        Underage Drinking.--After the successful launch of NIAAA's
    initiative to reduce college drinking through education and
    intervention (the web site has received over 12 million hits in just
    under 2 years), the attention of the institute has gone one step
    further and is now more committed than ever to the eradication of
    underage drinking. Risk factors for alcoholism manifest largely in
    adolescence, and possibly in childhood. Underage drinking leads to
    problems for young people that will have long term effects on their
    lives. This is a public health risk that requires the best research,
    including behavioral and psychological science research that Congress
    can support. The development of better prevention strategies and
    learning more about the mind/body interaction, as well as environmental
    influences, are some of the steps that NIAAA has taken in this fight
    against a formidable and destructive opponent. We ask this Committee to
    increase NIAAA's budget in proportion to the overall increase at NIH in
    order to reduce the health, social and economic burden resulting from
    alcohol abuse and addiction.

                        NATIONAL CANCER INSTITUTE (NCI)

        Having already established itself as a leader among NIH Institutes
    in many fields of research, NCI has made enormous advances in the
    behavioral sciences.
        NCI's Behavioral Research Program.--Scientists estimate that as
    many as 50 percent to 75 percent of cancer deaths in the United States
    are caused by human behaviors such as smoking, physical inactivity, and
    poor dietary choices. NCI's comprehensive behavioral science research
    program ranges from basic behavioral science to research on the
    development, testing and dissemination of disease prevention and health
    promotion interventions in areas such as tobacco use, diet, and even
    sun protection. Focusing on transdisciplinary and collaborative
    research, NCI's Behavioral Program has expanded to five branches,
    including a basic biobehavioral research branch, a health communication
    and informatics research branch, and the tobacco control research
    branch.
        Health Communications.--Recognizing the central role of effective
    communication in addressing issues of health and behavior, NCI has also
    undertaken a major effort to develop science-based communications
    strategies for disseminating information and persuasive messages about
    cancer prevention and treatment to the public. Researchers are
    exploring innovative strategies for communicating cancer information to
    diverse populations, looking at various communication approaches such
    as message tailoring and framing with application in multiple
    communication channels. These messages draw from a foundation of basic
    behavioral and social science research into such issues as how people
    learn and remember health information, how they perceive health risks,
    and how they are persuaded to adopt healthy behaviors.
        We ask Congress to support NCI's behavioral science research and
    training initiatives and to encourage other institutes to use these
    programs as models.
        I would now like to turn to some crosscutting initiatives in which
    behavioral research plays a critical role.
        NIH Roadmap.--There has been much attention paid in recent months
    to the cross NIH initiative known as the ``Roadmap.'' This project will
    take NIH into the 21st century by revolutionizing the way the
    institutes think about research and its application into and impact on
    health services. Transdisciplinary teams of researchers, including
    behavioral scientists, will conduct high risk/high reward research that
    will put us on a path towards a healthier population. An excellent
    example of this transdisciplinary research and the importance of
    behavioral science is an RFA for health research training issued under
    the Roadmap program entitled: INTERDISCIPLINARY HEALTH RESEARCH
    TRAINING: BEHAVIOR, ENVIRONMENT AND BIOLOGY. Among the goals of the RFA
    is the study of mental disorders by approaches that integrate
    neuroscience, genetics, behavioral science, computational science/
    modeling, and clinical sciences, in an attempt to understand the
    confluence of genetic, biological, behavioral and environmental factors
    involved in the etiology, treatment and prevention of these disorders.
        Obesity.--Obesity is a health problem all too often overlooked;
    yet, recently it has begun to receive the attention it is warranted. It
    is no longer a condition that can be overlooked, as it is the leading
    cause of health problems in America, even more so than smoking.
    Motivation, counseling, marketing and communication are all important
    tools if we are to create a healthier nation led by healthier children.
    If we are to see results, the message that we communicate must be
    rooted in science and research. Evidence based research, translated
    into practice, will ensure safe and effective messages. The use of
    science in promoting behavioral changes should not and cannot be
    ignored. It has shown us that obesity leads to increased risk of
    diabetes, heart disease, and even cancer. The behavioral and
    physiological changes that occur during high-risk periods for weight
    gain must be clarified. This information can then be used to design
    individualized interventions, in order to prevent future weight gains
    and obesity. Research in this field benefits several institutes, such
    as NHLBI, NICHD, NIDDK, NIA, and NCI.
        Sexual Behavior Research and Peer Review.--Recently, much publicity
    has been given to research conducted at NIH that involves human
    sexuality and sexually transmitted disease. This research is critical
    to the health of all Americans, and must continue unimpeded. Recent
    attacks on NIH for supporting research in health and behavior are
    motivated by objections to particular behaviors or to the populations
    being studied. These attacks are intended to stop funding of research
    relating to such things as reproductive functioning, sexually
    transmitted diseases, substance abuse, and other public health
    problems. This research has enormous implications for understanding and
    preventing a range of health problems, including HIV and AIDS; problems
    of physical, mental and social development in children; violence;
    addiction; teen pregnancy; and numerous other conditions that stem from
    behavioral threats to health. These problems are not limited to
    particular segments of our society; the health and economic
    consequences of these behaviors affect individuals, families and
    communities of all ethnic backgrounds, professions, and income levels.
    Our best and only hope for combating these issues is a robust health
    research agenda based on scientific priorities and methods. The
    American Psychological Society strongly supports the scientific peer
    review system of the National Institutes of Health and we encourage
    Congress and the public to reject efforts to undermine that system by
    attacking selected grants. NIH's system for evaluating research
    proposals ensures that the best science is brought to bear on our
    nation's most pressing public health problems. On this subject, NIH
    director Zerhouni wrote to Congress: ``I fully support NIH's continued
    investment in research on human sexuality, and I believe that the peer
    review process has worked properly and provided a level of valuable and
    independent view in this important area of research.'' In the interest
    of public health, our Nation's leaders must take whatever steps are
    necessary to protect the scientific peer review system from the
    chilling effects of ideological influences.
        It is not possible to highlight all of the worthy behavioral
    science research programs at NIH. In addition to those I've discussed
    here, many other institutes play a key role in NIH behavioral science
    research enterprise. These include the National Institute on Aging, the
    National Heart Lung and Blood Institute, the National Institute of
    Child Health and Human Development, the National Institute of
    Neurological Disorders and Stroke, and within NIH Director's office,
    the Office of Behavioral and Social Sciences Research. Behavioral
    science is a central part of the mission of each of these, and each
    deserves the Committee's support.
        This concludes my testimony. Again, thank you for the opportunity
    to discuss NIH appropriations for fiscal year 2004 and specifically,
    the importance of behavioral science research in addressing the
    Nation's public health concerns. I would be pleased to answer any
    questions or provide additional information.
                                     ______

              Prepared Statement of the American Thoracic Society

                        SUMMARY--FUNDING RECOMMENDATIONS
                            [In millions of dollars]
    ------------------------------------------------------------------------
                               Agency                               Amount
    ------------------------------------------------------------------------
    National Institutes of Health..............................     30,000.0
        National Heart, Lung and Blood Institute...............      3,165.8
        National Institute of Allergy and Infectious Disease...      4,733.3
        National Institute of Environmental Health Sciences....        694.1
        Fogarty International Center...........................         71.5
        National Institute of Nursing Research.................        148.5
    Centers for Disease Control and Prevention.................      7,500.0
        National Institute for Occupational Safety and Health..        306.9
        Office on Smoking and Health...........................        130.0
        Environmental Health: Asthma Activities................         70.0
        Tuberculosis Control Programs..........................        528.0
    ------------------------------------------------------------------------

        The American Thoracic Society (ATS) is are pleased to submit our
    recommendations for programs in the Labor Health and Human Services and
    Education Appropriations Subcommittee purview.
        The American Thoracic Society, founded in 1905, is an independently
    incorporated, international education and scientific society that
    focuses on respiratory and critical care medicine. The Society's
    members help prevent and fight respiratory disease around the globe
    through research, education, patient care and advocacy. The Society's
    long-range goal is to decrease morbidity and mortality from disorders
    and life-threatening acute illnesses.

                           MAGNITUDE OF LUNG DISEASE

        Lung disease in America is a serious problem. Each year, an
    estimated 342,000 Americans die of lung disease. Lung disease is
    responsible for 1 in every 7 deaths, making it America's number three
    cause of death. More than 35 million Americans suffer from a chronic
    lung disease. In 2002, lung diseases cost the U.S. economy an estimated
    $141.8 billion in direct and indirect costs.
        Lung diseases represent a spectrum of chronic and acute conditions
    that interfere with the lung's ability to extract oxygen from the
    atmosphere, protect against environmental or biological challenges and
    regulate a number of metabolic processes. Lung diseases include chronic
    obstructive pulmonary diseases, lung cancer, tuberculosis, pneumonia,
    influenza, sleep disordered breathing, pediatric lung disorders,
    occupational lung disease, sarcoidosis, asthma and severe acute
    respiratory syndrome (SARS).
        The ATS is pleased that the Subcommittee provided increases in the
    National Institutes of Health (NIH) and the Centers for Disease Control
    and Prevention (CDC) budget last fiscal year. The ATS is pleased that
    the Administration and Congress modestly increased the National
    Institute of Health (NIH) budget in fiscal year 2004. However, we are
    extremely concerned with the President's fiscal year 2005 budget that
    proposes a mere 2 percent increase for NIH and signficiant cuts for
    CDC. We ask that this Subcommittee recommend a 10 percent increase for
    NIH. In order to stem the devastating effects of lung disease, research
    funding must continue to grow to sustain the medical breakthroughs made
    in recent years. While our statement will focus on selected parts of
    the Public Health Service, we are firmly committed to appropriate
    funding for all sectors of our nation's public health infrastructure.

                                      COPD

        Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading
    cause of death in the United States and the third leading cause of
    death worldwide. Yet, COPD remains relatively unknown to most
    Americans. COPD is the term used to describe the airflow obstruction
    associated mainly with emphysema and chronic bronchitis and is a
    growing health problem.
        While the exact prevalence of COPD is not well defined, it affects
    tens of millions of Americans and can be an extremely debilitating
    condition. It has been estimated that 13.3 million patients have been
    diagnosed with some form of COPD and as many as 24 million more are
    undiagnosed.
        In 2001, 13.3 million adults, aged 18 and older in the United
    States were estimated to have COPD. In addition, according to the new
    government data based on a 2001 prevalence survey, 3 million Americans
    have been diagnosed with emphysema and 11.2 million are diagnosed with
    chronic bronchitis. In 2001, 118,000 people in the United States died
    of COPD, with the death rate for women with COPD surpassing the death
    rate of men with COPD. COPD costs the U.S. economy an estimated $32.1
    billion a year.
        Medical treatments exist to address symptom relief and slow the
    progression of the disease. Today, COPD is treatable but not curable.
    Fortunately, promising research is on the horizon for COPD patients.
    Research in the genetic susceptibility underlying COPD is making
    progress. Also, there are promising research leads on medications to
    repair damage to lung tissue caused by COPD. Additional research is
    needed to pursue these leads.
        Despite these promising leads, the ATS feels that research
    resources committed to COPD are not commensurate with the impact COPD
    has on the United States and the world. Clearly more needs to be done
    to make Americans aware of COPD, its causes and symptoms. We understand
    that the National Heart Lung and Blood Institute (NHLBI) is developing
    a public education program on COPD. The ATS supports this effort and
    encourages the NHLBI to partner with the patient and physician
    community in developing the COPD public education campaign.
    Additionally, we recommend the Subcommittee encourage NHLBI to devote
    additional resources to finding improved treatments and a cure for
    COPD. It affects tens of millions of Americans and can be an extremely
    debilitating condition. It has been estimated that 13.3 million
    patients have been diagnosed with some form of COPD and as many as 24
    million more are undiagnosed.
        The ATS is pleased to announce the formation of a new congressional
    caucus that will focus on COPD. On March 30, 2004, the Congressional
    COPD Caucus officially began its work and the ATS encourages members of
    this Subcommittee to join.

                                     ASTHMA

        Asthma is a chronic lung disease in which the bronchial tubes of
    the lungs become swollen and narrowed, preventing air from getting into
    or out of the lung. A broad range of environmental triggers that vary
    from one asthma-sufferer to another causes these obstructive spasms of
    the bronchi.
        Last month, the CDC issued a new report indicating that asthma
    rates have risen for the past 10 years. It is estimated that close to
    20.3 million people suffer from asthma, including an estimated 6.3
    million children. While some children appear to out grow their asthma
    when they reach adulthood, 75 percent will require life-long treatment
    and monitoring of their condition.
        Asthma is expensive. The growth in the prevalence of asthma will
    have a significant impact on our nation's health expenditures,
    especially Medicaid. The direct medical costs and indirect costs for
    asthma are estimated to exceed $14 billion annually. Asthma also
    represents the most common cause of school absenteeism due to chronic
    disease. In 2001, there were 2 million emergency room visits due to
    asthma.
        Asthma also kills. In 2001, 4,200 people in the United States died
    as a result of an asthma attack. Approximately 65 percent of these
    deaths occurred in women. A disproportionate share of these deaths
    occurred in African American families.
        As the prevalence of asthma has grown, so has asthma research.
    Researchers are developing better ways to treat and manage chronic
    asthma. Research supported by the National Heart, Lung and Blood
    Institute (NHLBI) has discovered genetic components as well as how
    infectious disease contributes to asthma. NHLBI researchers have also
    developed better animal models to allow expression of selected
    asthmatic genetic traits. This will allow researchers to develop a
    greater understanding of how genes and environmental triggers influence
    asthma's onset, severity and long-term consequences.
        Progress is being made to fight the growing asthma epidemic. We are
    pleased to report that the fourth American Lung Association Asthma
    Clinical Research Centers (ACRC) Network study began in September 2003.
    That study hopes to determine if patient education and the ways of
    presenting asthma drugs can improve treatment. The first ACRC study
    concluded that a considerable reduction in the number of
    hospitalizations, resulting in lower health care costs, could be
    achieved if all people with asthma were vaccinated for influenza. The
    19 ACRC centers around the United States evaluate treatment, education
    and other intervention strategies for asthma in adults and children.
    This network is one of the largest clinical research networks in the
    United States and will continue to develop innovations that will
    directly benefit patients.
        The ATS also feels that the Centers for Disease Control and
    Prevention (CDC) must play a leadership role in the ways to assist
    those with asthma. National statistical estimates show that asthma is a
    growing problem in the United States. However, we do not have accurate
    data that provide regional and local information on the prevalence of
    asthma. To develop a targeted public health strategy to respond
    intelligently to asthma, we need locality-specific data. CDC should
    take the lead in collecting and analyzing this data.
        Last year, Congress provided approximately $37 million for the CDC
    to conduct asthma programs. CDC will use these funds to conduct asthma
    outreach, education and tracking activities. We recommend that CDC be
    provided $70 million in fiscal year 2005 to expand programs and
    establish grants to community organizations for screening, treatment,
    education and prevention of childhood asthma.
        In the past, Congress enacted legislation that directs the National
    Asthma Education and Prevention Program at NHBLI to develop a plan for
    the federal government to respond to the growing asthma epidemic in the
    United States. This plan should bring together key public and private
    organizations to develop a national asthma plan to coordinate the many
    elements of an effective public health response to asthma. Components
    of a national plan should include research, surveillance, patient and
    provider education, community awareness, indoor and outdoor air
    quality, and access to health care providers and medication.

                                  TUBERCULOSIS

        The first lung disease research began with the treatment of those
    who had tuberculosis (TB) (TB) or ``consumption'', as it was called at
    the turn of the 20th century. Tuberculosis is an airborne infection
    caused by a bacterium, Mycobacterium tuberculosis. Tuberculosis
    primarily affects the lungs but can also affect other parts of the
    body, such as the brain, kidneys or spine.
        Tuberculosis is spread through coughs, sneezes and close proximity
    to someone with active tuberculosis. People with active tuberculosis
    are most likely to spread the disease to others they spend a lot of
    time with, such as family members or coworkers. It cannot be spread by
    touch or sharing utensils used by an infected person.
        Tuberculosis takes a toll on the U.S. economy, with total direct
    and indirect costs of $1.1 billion. There are an estimated 10 million
    to 15 million Americans who carry latent tuberculosis infection. Each
    has the potential to develop active tuberculosis in the future. About
    10 percent of these individuals will develop active disease at some
    point in their lives. In 2003, there were 14,871 cases of active
    tuberculosis reported in the United States. This is only a 1.4 percent
    decline in the number of cases reported in 2002 and is the smallest
    annual decrease reported since 1992, the year the incidence of
    tuberculosis peaked during a period of resurgence from 1985-1992.
        Upon review of this information, many have concluded that a cycle
    of neglect has begun, reminiscent of the previous resurgence. The ATS,
    in collaboration with the National Coalition for Elimination of
    Tuberculosis, recommends an increase of $105 million for TB control in
    fiscal year 2005 to allow the CDC undertake an unprecedented
    initiative, Intensified Support and Activities to Accelerate Control
    (ISAAC) to enhance, maximize and target resources to sustain the
    momentum of the past decade and accelerate the control and elimination
    of tuberculosis. ISAAC targets tuberculosis in African Americans,
    tuberculosis along the United States-Mexico border, allows for
    universal genotyping of all culture positive TB cases and expands
    clinical trials for new tools for the diagnosis and treatment of
    tuberculosis.
        In the summer of 2000, the Institutes of Medicine (IOM) published a
    report, entitled: Ending Neglect: The Elimination of Tuberculosis in
    the United States. The report documents the cycles of attention and
    progress toward TB elimination, the periods of insufficient funding and
    the re-emergence of tuberculosis. The IOM report provides the United
    States with a road map of recommendations on how to eliminate
    tuberculosis in the United States. The IOM report identifies needed
    detection, treatment, prevention and research activities. The report
    concludes that with proper funding, organization of prevention and
    control activities and research for development of new tools,
    tuberculosis can be eliminated as a public health problem in the United
    States. We have endorsed the IOM report and its recommendations. The
    components of ISAAC begin to fully implement the recommendations of the
    IOM.
        While declining overall TBB rates is good news, the slowing of the
    decline in rates and the emergence and spread of multi-drug resistant
    TtuberculosisB poses a significant threat to the public health of our
    nation. Increased support is needed if the United States is going to
    continue progress toward the elimination of tuberculosis.
        The NIH also has a prominent role to play in the elimination of
    tuberculosis. Currently there is no highly effective vaccine to prevent
    TB transmission. However, the recent sequencing of the TB genome and
    other research advances has put the goal of an effective TB vaccine
    within reach. The National Institute of Allergy and Infectious Disease
    has developed a Blueprint for Tuberculosis Vaccine Development. We
    encourage the subcommittee to fully fund the TB vaccine blueprint.
    Fogarty International Center TB Training Programs
        The Fogarty International Center (FIC) at NIH provides training
    grants to U.S. universities to teach AIDS treatment and research
    techniques to international physicians and researchers. The goal is to
    develop a cadre of health professionals in the developing world who can
    begin controlling the global AIDS epidemic.
        Because of the link between AIDS and TB infection, the FIC has
    created supplemental TB training grants for these institutions to train
    international health care professionals in the area of TB treatment and
    research. This supplemental program has been highly successful in
    beginning to create the human infrastructure to treat the nearly 2
    billion people who have tuberculosis worldwide.
        However, we believe TB training grants should not be offered
    exclusively to institutions that have received AIDS training grants.
    The TB grants program should be expanded and open to competition from
    all institutions. The ATS recommends that Congress provide an
    additional $3 million for the FIC to expand the TB training grant
    program from a supplemental grant to an open competition grant.

          NIOSH--RESEARCHING AND PREVENTING OCCUPATIONAL LUNG DISEASE

        The ATS is extremely concerned that the president's budget proposes
    to cut the National Institute of Occupational Safety and Health (NIOSH)
    extramural research program. We strongly encourage this subcommittee to
    reject the Administration's proposed cut to the NIOSH research program.
    Occupational safety and health research are valuable and deserve
    additional funding.
        Protecting the health of our nation's workforce will require
    research, training, tracking and new technologies. We recommend that
    the Subcommittee provide a $30 million increase for the NIOSH budget.
    The $30 million increase will be used for the NIOSH Emergency
    Preparedness agenda, including activities at the National Personal
    Protective Technology Laboratory, improve workers' safety, and invest
    in protective technology that will help our nation respond to the
    growing threat of bioterrorism. In addition, increased NIOSH funding is
    needed for NIOSH-sponsored prevention, intervention and information
    programs. These programs respond to existing workplace health programs,
    conduct prevention education programs, and work with labor and industry
    groups to lower the risk of workplace injury and illness.
        Finally, the overall funding increase for NIOSH will increase
    training of occupational health professionals in the United States. A
    recent IOM Report, Safe Work in the 21st Century: Education and
    Training Needs for the Next Decades Occupational Safety and Health
    Personnel, identified a growing shortage of trained occupational health
    professionals in the United States. Unlike the majority of medical
    subspecialties, occupational health professionals do not receive
    Medicare training support. One such program is the Capacity Building
    for Worker safety and health that includes training opportunities for
    occupational health professionals at NIOSH--sponsored Centers of
    Excellence. We believe more funds are needed in order to track the
    incidence of serious work-related illnesses and injury.

                           PHYSICIAN WORKFORCE SUPPLY

        As the number of people diagnosed with lung diseases rises, we need
    to ask, who will be treating lung disease patients in the future? The
    ATS is also concerned about the supply of physicians in the United
    States. The ATS is concerned about the supply of physicians in the
    United States. A recent study published in the Journal of the American
    Medical Association predicts that there will be an acute shortage of
    physicians trained to treat patients with critical care illness and
    lung disease starting in 2007.\1\ While the study focuses on supply of
    pulmonary/critical care physicians, what is driving the shortage is the
    predicated increase in demand for physician services caused by the
    aging of the U.S. population.
    ---------------------------------------------------------------------------
        \1\ D. Angus, et al. Current and Project Workforce Requirements for
    Care of the Critically Ill and Patients with Pulmonary Disease: Can We
    Meet the Requirements of an Aging Population? JAMA 2000; 284:2762-2770.
    ---------------------------------------------------------------------------
        Policy makers have given much thought and attention to how the
    aging population will affect Social Security and other programs for the
    elderly. Significant attention has been given to the acute shortage of
    nurses. However, such forward thinking does not seem to be applied to
    our physician workforce.
        We are pleased that Bureau of Workforce Analysis at the Health
    Resources and Services Administration (HRSA) will be conducting a study
    on physician workforce supply in the United States. We are hopeful that
    the HRSA study will confirm the looming shortage of physicians in the
    United States and make policy recommendations on how best to add
    physicians to the workforce before it becomes a serious crisis.

                    LUNG-DISEASE OPPORTUNITIES AND ADVANCES

        Pulmonary researchers have made significant advances in lung
    disease research. NHBLI has identified areas of lung disease research
    that it will be exploring in the next year. One area of focus will be
    acute lung injury (ALI) and acute respiratory distress syndrome (ARDS).
    NHLBI created Specialized Centers of Clinically Oriented Research
    (SCCOR) in translational research in acute lung injury. Patients
    experiencing ALI and ARDS suddenly develop severe lung inflammation
    that results in hypoxemia, loss of lung compliance and possibly multi-
    organ system failure. The SCCOR program will foster multi-disciplinary
    basic and clinical research related to ALI and ARDS, which will
    eventually have a positive impact on their prevention, diagnosis and
    treatment.
        Another area of focus is COPD and lung cancer research. Nearly a
    quarter of a million Americans die each year of either COPD or lung
    cancer. NHLBI hopes to address the gap in knowledge that a common
    pathogenetic mechanism may be involved as a risk factor for COPD and
    lung cancer. The research will focus on a search for the similarities
    of the cellular and molecular mechanisms that lead to COPD and lung
    cancer. This new research could have important implications for the
    prevention and management of both diseases.
        One area of new and emerging research conducted by the NHBLI deals
    with Sleep-disordered breathing (SDB). SDB is a medical condition
    associated with upper airway obstruction and cessation of breathing
    that leads to repeated episodes of asphyxia during the night. SDB is
    very prevalent in the U.S. population with conservative estimates set
    at 2 percent to 3 percent of all children, 5 percent of middle age
    adults, and in excess of 15 percent of the aged population. The major
    health-related implications and morbid consequences of SDB include the
    neurocognitive and cardiovascular morbidities, depression,
    hypertension, increased frequency of myocardial infarction and stroke,
    and increased frequency of motor vehicle accidents due to the increased
    sleepiness induced by the disruption of sleep in SDB patients. Both the
    frequency of SDB and its consequences are anticipated to increase in
    the next decades due to the aging of the overall U.S. population and
    the ongoing epidemic of obesity that afflicts our country. The ATS
    supports the need for more research into the causes, diagnosis and
    treatment of SDB.
        In conclusion, lung disease is a growing problem in the United
    States. It is this country's third leading cause of death, responsible
    for 1 in 7 deaths. The lung disease death rate continues to climb.
    Overall, lung disease and breathing problems constitute the number one
    killer of babies under the age of 1 year. Worldwide, tuberculosis kills
    3 million people each year, more people than any other single
    infectious agent. The level of support this Subcommittee approves for
    lung disease programs should reflect the urgency illustrated by these
    numbers.
                                     ______

        Prepared Statement of the American Society of Clinical Oncology

        The American Society of Clinical Oncology (ASCO) is the world's
    leading professional society representing more than 20,000 physicians
    and health care providers engaged in cancer treatment and research.
    ASCO appreciates the opportunity to submit a statement for the
    Subcommittee record. This is a time when cancer clinical researchers
    faces tremendous challenges and also significant opportunities, and we
    recommend several actions that will ensure the efficient translation of
    basic research findings into new treatments.
        ASCO members owe a tremendous debt to this Subcommittee and the
    Congress for your leadership over the past decade in boosting the
    funding for the National Institutes of Health (NIH). The doubling of
    the NIH budget between fiscal year 1999 and fiscal year 2003 is a
    particularly impressive accomplishment, but Congress acted as a
    steadfast friend to research for many years before the period by
    guaranteeing that NIH had the resources it needed to support basic,
    translational, and clinical research.
        With the resources that have been provided to NIH and to biomedical
    researchers across the country, our knowledge of the genetic,
    molecular, and cellular basis of many diseases has increased
    dramatically. There has been a revolution in our understanding of
    cancer, and the traditional approach to cancer, which was based on the
    site of the cancer, is changing. Instead of seeking to develop
    treatments based on the location of the cancer, we are instead looking
    for treatments that correct the underlying genetic or molecular defect
    that causes the disease. The promise of cancer research has never been
    greater, although realizing that promise will be difficult and will
    require significant resources.
        ASCO and others in the research community are aware of the current
    budget situation and the effect it will likely have on NIH
    appropriations. Nevertheless, we strongly urge that Congress make every
    effort to boost NIH funding, as continued funding increases will ensure
    that the basic research progress made in recent years will continue and
    that those basic research findings will be translated to new
    treatments. We endorse the recommendation of the Federation of American
    Societies for Experimental Biology and others in the research community
    that NIH funding be increased by 10 percent in fiscal year 2005, to a
    total of $30.6 billion.

                                THE NIH ROADMAP

        The leaders of NIH have given serious consideration to reforms that
    will equip NIH to remain the world's leading biomedical research
    institute in the 21st century. ASCO believes that the three main areas
    of focus of the Roadmap--establishing new pathways to discovery,
    developing research teams of the future, and re-engineering the
    clinical research enterprise--are appropriate, and achieving these
    goals of the Roadmap would equip researchers for developing new
    treatments.
        We are gratified that the NIH Roadmap emphasizes the need to re-
    engineer the clinical research enterprise. Although the cancer clinical
    trials system at the National Cancer Institute (NCI) is strong and has
    been a major factor in advances in cancer care, we welcome the NIH
    Roadmap's critical look at clinical trials systems as a means of
    improving those systems. Clinical researchers must be provided the
    tools, including informatics and tissue or specimen repositories, to
    conduct their work efficiently, and the Roadmap acknowledges the need
    for those investments.
        In addition, the drafters of the NIH Roadmap properly identify a
    crisis in clinical research training and suggest steps to enhance
    training. ASCO has initiated programs to improve the training of cancer
    clinical researchers, and we welcome the special attention that NIH is
    directing to this issue.
        Implementation of the NIH Roadmap initiatives cannot be
    accomplished at the expense of successful core programs at NCI and
    other institutes, but Congress should foster the important reforms
    outlined in the Roadmap.

                       THE CANCER CLINICAL TRIALS SYSTEM

        NCI has supported the development of a sophisticated system for
    conducting clinical trials that depends heavily on the participation of
    community oncologists, along with oncologists at cancer centers around
    the nation. Patients who are treated in the community have the option
    of enrolling in clinical trials, as their oncologists are almost
    certainly part of the nation's clinical trials system. This system of
    treatment, where the majority of cancer patients receive their care in
    the community and have access to the full range of treatment options,
    including clinical trial enrollment, has evolved over the last 30
    years.
        The Medicare Modernization Act of 2003 (MMA) changes dramatically
    the method by which cancer chemotherapy services provided by
    oncologists in their offices are reimbursed by Medicare. The current
    system of payment for cancer chemotherapy drugs will be shifted from an
    average wholesale price methodology to an average sales price
    methodology, and accompanying reductions will be made in reimbursement
    for the services required to administer chemotherapy in the physician's
    office. The estimates are that, in the aggregate, reimbursement for
    cancer chemotherapy services will not decline from 2003 to 2004.
    However, ASCO's preliminary predictions suggest a dramatic reduction in
    payment for cancer care beginning in January 2005. One of the tasks
    facing ASCO is to monitor this situation carefully and report to
    Congress the effects of reimbursement changes.
        We realize that this Subcommittee does not have jurisdiction over
    Medicare. We are raising this issue with the Subcommittee, however,
    because the potential effects of Medicare reimbursement changes include
    a serious threat to the clinical research enterprise. In surveys that
    ASCO has conducted among its members who are engaged in office-based
    practice, a significant number of those surveyed indicate that, in
    light of the potential Medicare reimbursement changes in 2005, they
    will be less inclined to participate in clinical research. Some members
    have already reported that they have stopped participating in clinical
    trials. ASCO members have for years reported that the per person
    payment they receive for NCI-funded clinical trials is inadequate to
    pay the costs associated with enrolling a patient on trial and
    collecting and reporting data from the trial. These physicians have
    subsidized NIH-funded trials with payments from industry-sponsored
    trials and from clinical income. According to reports from the field,
    oncologists will not be able to continue this cross-subsidization,
    because the funds simply will not be available to support this
    longstanding ad hoc practice.
        The task ahead of us now is translating the significant advances in
    our fundamental knowledge of cancer into new treatments. In no area of
    research are the opportunities greater than in cancer, and those
    opportunities will be realized by the rapid completion of clinical
    trials testing new therapies. If the community physicians who enroll
    the majority of patients in clinical trials are no longer actively
    participating in clinical research, the clinical research enterprise
    will be slowed.
        At the same time that ASCO monitors the effects of MMA cancer
    reimbursement changes and develops appropriate reform proposals,
    Congress should encourage NCI to undertake a review of the current
    system of paying for clinical trials. An immediate action that NCI can
    take is improving the payments to physicians for enrolling cancer
    patients in trials. Modest increases in payments have been approved by
    NCI in recent years, but they are inadequate. In addition, ASCO
    believes that more substantial changes--beyond a boost in the per-
    patient rate of payment--may be necessary to ensure that oncologists at
    cancer centers and in the community continue to participate in clinical
    research and that all other players in clinical research, including NCI
    and industry, remain committed to participation in cancer clinical
    research. This is an urgent matter, and we recommend action by NCI to
    address it.

                     MINORITY ENROLLMENT IN CLINICAL TRIALS

        It is estimated that fewer than 5 percent of adults with cancer
    enroll in clinical trials. The rate of participation is even lower
    among minorities. ASCO commends NCI for its efforts to boost
    involvement of African American, Hispanic, Asian American, and American
    Indian patients in clinical trials, in part through the Minority-Based
    Community Clinical Oncology Program. This program includes 11 minority-
    based CCOPs and involves more than 40 hospitals and 100 minority
    investigators. We also support the Special Population Networks, which
    involve research institutions and community providers in investigations
    of the causes of cancer disparities. This knowledge is vital to our
    efforts to erase cancer disparities, and NCI is properly investing
    resources in this research initiative.

          RESEARCH TO COMBAT BIOTERRORISM AND ENSURE HOMELAND SECURITY

        ASCO is pleased that the biodefense request for fiscal year 2005
    includes $47 million for the Public Health and Social Services
    Emergency Fund, which will support targeted research to develop medical
    countermeasures to treat nuclear or radiological injuries. Cancer
    researchers have expertise that will be critical to this effort, which
    includes: (1) developing drugs to prevent injury from radiological
    exposure; (2) improving methods for measuring radiological exposure,
    and (3) developing methods or drugs to restore injured tissues and
    eliminate materials from contaminated tissue. Cancer researchers are
    actively engaged in research to understand the late and long-term
    effects of cancer treatment, including chemotherapy and radiation
    therapy, and their expertise in these research areas equips them to be
    engaged in the targeted research that will likely be funded by the
    Public Health and Social Services Emergency Fund.
        ASCO appreciates the opportunity to submit this statement.
    Congress, through its strong support of NIH, has facilitated an
    explosion of knowledge about cancer and other serious and life-
    threatening illnesses. Although we are poised to translate those basic
    research findings into new treatments, the clinical trials system for
    testing treatments is fragile. ASCO urges Congress to protect the
    clinical trials system, so that we can capitalize on the tremendous
    investment in basic research during the past decade.
                                     ______

         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 was founded in 1946.
    Since its inception, the Society's highest priority has been to support
    research aimed at finding the cause of MS, better treatments, and a
    cure. In 2004, the National MS Society will spend over $31 million on
    MS research supporting over 300 MS investigations. By the end of 2004,
    the Society cumulatively will have expended some $420 million since
    awarding its first three grants in 1947. This represents the largest
    privately funded program of basic, clinical, and applied research and
    training related to MS in the world.
        Multiple sclerosis is a chronic, unpredictable and often disabling
    disease of the central nervous system. Symptoms range from numbness in
    the limbs, to loss of vision, and in some instances partial or total
    paralysis. The progress, severity and specific symptoms of MS in any
    one person can vary and cannot yet be predicted, but advances in
    research and treatment are giving hope to those affected by the
    disease.
        The federal investment in the National Institutes of Health (NIH)
    plays a major role in MS research. There are two institutes that
    conduct or fund the majority of MS research: the National Institute of
    Neurological Disorders and Stroke (NINDS) which funds 75 percent, and
    the National Institute of Allergy and Infectious Diseases (NIAID) which
    funds about 20 percent.
        For fiscal year 2004 and fiscal year 2005, it is estimated that NIH
    expenditures on MS research will be $101.3 million and $102.8 million,
    respectively. While this demonstrates a good NIH investment in MS, the
    amount seems low considering that the annual direct and indirect
    disease cost is approximately $20 billion for all people with MS in the
    United States.\1\
    ---------------------------------------------------------------------------
        \1\ Based on a 1994 Duke University study, indexed for 2002 by the
    National MS Society, the average annual cost of MS is estimated at
    $50,000 per person due to lost wages, increased medical care and other
    expenses. Nationwide, there are an estimated 400,000 people with MS.
    ---------------------------------------------------------------------------
        To ensure an adequate federal investment in MS research, the
    Society has a three-pronged strategy: (1) request funding for specific
    research priorities relevant to MS; (2) encourage collaboration across
    NIH institutes and between NIH and outside organizations; and (3)
    advocate for a 10 percent funding increase for NIH overall in fiscal
    year 2005. The National MS Society has had a long and productive
    relationship with NIH, particularly with NINDS. Our founder Sylvia
    Lawry helped spearhead the legislation that established NINDS in 1950.
    Intramural scientists from NINDS serve on our scientific advisory
    committees and help the Society make research project decisions. These
    outstanding scientists/physicians volunteer their time to ensure that
    the research supported by the Society and NIH are in concert, and not
    in opposition.

                   FUNDING RESEARCH PRIORITIES RELEVANT TO MS

        The National MS Society will continue to pursue research
    opportunities with NIH in priority areas that are key to furthering the
    understanding of MS. We also will closely monitor NIH's progress in
    expanding its commitment to MS research as suggested by Congress.
        Last year, as part of our NIH advocacy efforts, the Society had the
    following congressional ``report language'' added by the House and
    Senate Appropriations Conference Committee as an instruction to NIH in
    the fiscal year 2004 omnibus appropriations package:

        ``The conferees urge NINDS to increase its overall investment in
    multiple sclerosis (MS) research. Special emphasis on imaging,
    biological markers and clinical trials for new therapeutics should be
    areas of high priority. The conferees are pleased to note the
    development of a joint symposium on MS genetics sponsored by NINDS and
    the National MS Society, and encourage the Institute to take a more
    active role at the NIH in furthering MS genetics research by developing
    collaborative strategies with the National Human Genome Research
    Institute and other relevant NIH institutes. The conferees request that
    NIH report back to Congress no later than September 30, 2004 with
    progress in its efforts to expand its commitment to multiple sclerosis.
    The conferees also are pleased to note a major success in past years in
    the creation of a joint collaborative research program in `gender and
    immunity' between the National Institute on Allergy and Infectious
    Diseases (NIAID) and a major voluntary association for the disease, in
    which NINDS participates. The conferees encourage NINDS to seek similar
    collaborative activities related to MS.''

        The Society was pleased that late in 2003 NINDS funded a 5-year $30
    million clinical trial that will test the effects of combining two of
    the MS injected therapies against the use of a single therapy. As part
    of this clinical trial, NINDS is including an additional $3-4 million
    to study the correlation between the clinical course of MS and data
    from biological markers (magnetic resonance imaging). The Society also
    was pleased that in 2003 NINDS and NMSS co-sponsored a scientific
    workshop on the role of genetics in MS. As an outcome of this workshop,
    the Society is looking to work closely with NINDS on genetics projects,
    such as the development of a collaborative and international MS
    genetics network. Such a network would facilitate the execution of
    small and large-scale studies utilizing both the latest technology to
    find genes that may confer susceptibility to MS.
        We look forward to the year-end report from NINDS on its commitment
    to MS research.
        In 2004, we will look to NINDS to establish a Working Group on MS
    (as has been done for Parkinson's Disease) to initiate planning to
    ensure that MS research is adequately supported throughout NIH and to
    collect information on research obstacles.

                        THE IMPORTANCE OF COLLABORATION

        We cannot overemphasize the importance of collaboration. The
    National MS Society encourages NIH to increase collaboration across
    institutes and to pursue collaborative opportunities with other
    organizations.
      --Collaboration fosters an interdisciplinary approach to the
            investigation of complex biomedical problems.
      --Jointly funded research projects significantly leverage limited
            resources and advance the research agendas of all involved
            parties.
        We are pleased to see that NIH Director Zerhouni made collaboration
    (both intramural and extramural) one of the pillars of his Roadmap
    Initiative--a 3-year plan addressing key research issues throughout
    NIH. As we see it, there is no other choice.
        To date, the Society has been successful with NIH on jointly
    funding a major initiative on gender and immune function. In 2001, the
    Society entered into a $20 million collaborative project with NIAID and
    other NIH institutes to investigate gender effects on the immune
    function, including autoimmunity. This is important because most
    autoimmune diseases (including MS) are far more prevalent in women than
    men. The Society is co-funding six projects and will contribute up to
    $4 million to this project. We would like to engage in other
    collaborative projects, especially with NINDS.
        The Society asks Congress to urge NIH to increase inter-institute
    collaboration as well as collaboration with external public, non-
    profit, educational and private sector organizations. Possible areas
    for collaborative research could include:
      --Neurological repair.--How to effect recovery of tissue (and
            function) lost due to neurodegenerative diseases, including MS.
      --Neurological degeneration.--Using MS as a model to study
            neurological degeneration in diseases such as Alzheimer's
            Disease, Parkinson's Disease and MS.
      --Genetics.--The role of genetics in susceptibility to, and disease
            course of neurological and immunological disorders, including
            MS.
      --Imaging.--Creation of Magnetic Resonance Imaging (MRI) centers to
            study repair, neuroprotection and other clinical issues that
            cut across a number of neurological disorders such as stroke,
            Alzheimer's Disease, Parkinson's Disease and MS. One possible
            eligibility requirement for these centers could be that a
            facility have expertise in at least two diseases.
      --Pediatric research into diseases that rarely, but sometimes affect
            children.
        We believe the NIH Director should establish inter-institute,
    cross-disease working groups in the above areas to examine and
    recommend worthy research topics that will set the stage for future
    collaborative projects.
        Increased internal and external collaboration, which we hope will
    occur at NIH, points to the need for improved research tracking. The
    Society also asks that Congress recommend a standard project coding
    mechanism across all NIH institutes, so that the true research
    investment in various diseases is accurately represented to the public.

               OVERALL NIH FUNDING INCREASE FOR FISCAL YEAR 2005

        The Society is concerned that NIH may face a second year of overall
    low funding increases. Furthermore, in fiscal year 2003 and fiscal year
    2004, only bioterrorism research received a healthy increase, with much
    smaller increases allocated for disease research. We fear the same may
    occur in fiscal year 2005. This is particularly disappointing after the
    fiscal years 1999-2003 funding campaign that doubled the NIH budget in
    the 5 year period.
      --We urge Congress to appropriate a 10 percent fiscal year 2005
            funding increase for NIH.
      --While there is a need to increase our country's investment in
            bioterrorism research, we ask Congress to balance the fiscal
            year 2005 NIH appropriation to allow growth across all NIH
            institutes and all areas of disease research.
        We thank the Subcommittee for this opportunity to comment and
    applaud your commitment to advancing the health and well-being of all
    Americans through investment in biomedical research.
                                     ______

         Prepared Statement of the Association of American Universities

        Mr. Chairman and members of the subcommittee: The Association of
    American Universities, representing 60 prominent research universities
    in the United States, appreciates this opportunity to submit testimony
    in support of the National Institutes of Health (NIH). Some 85 percent
    of the NIH budget is spent on research grants and contracts at higher
    education institutions across the United States. NIH research grants
    support nearly 40,000 graduate students and post-docs in universities
    and help develop a robust and diverse base of scientific talent
    critical to the future success of the nation's medical research
    efforts. AAU and its member research universities are very aware of the
    current restraints on domestic discretionary spending due to proposed
    funding increases for defense and homeland security programs, but have
    concerns about the long-term vitality of the biomedical research
    enterprise if the committee does not recognize that our nation's
    investment in NIH is also a top priority. AAU strongly urges the
    committee to provide a 10 percent increase in the fiscal year 2005 NIH
    budget because today's medical science translates into accelerated
    cures for tomorrow.
        Past investment in NIH and our national biomedical research
    enterprise--the medical science performed by more than 217,000
    scientists at more than 2,800 institutions around the country--has led
    to an exponential increase in the complexity of medical questions that
    can be asked and answered. NIH Director Elias Zerhouni has testified
    eloquently before your subcommittee about the health care revolution of
    a generation ago: medical research has transformed formerly lethal
    diseases into manageable afflictions and has given patients and their
    families more years of life. In the past 20 years, some of mankind's
    gravest scourges, such as childhood cancers, have been tamed. Deaths
    from heart attack and stroke have been cut by hundreds of thousands per
    year. HIV/AIDS, which was a death sentence 10 years ago, has become an
    onerous but survivable burden for those fortunate enough to live in the
    United States and receive triple-drug therapies. Today's biomedical
    research enterprise offers the hope of cures that add not just years to
    life, but quality of life to those years. AAU endorses the NIH
    ``Roadmap for Research'' developed by Dr. Zerhouni and his colleagues
    as an important framework for making the strategic investments that
    will fully capitalize on recent breakthroughs in genomics,
    bioinformatics, and molecular medicine. Cures--not just therapies--for
    juvenile diabetes, heart disease, osteoporosis, stroke and multiple
    cancers are within our grasp, if we can accelerate promising new
    research.
        NIH-supported scientists have transformed the health and quality of
    life of all Americans. To take just one example, more than half of all
    cancers treated today will be cured. U.S. medical science is the envy
    of the world and the hope of mankind because science--not politics or
    ideology--has determined what research is supported. Recent investments
    in NIH funded research have:
      --Yielded 100 new cancer drugs that are now in clinical trials. NIH-
            supported university research, for example, has produced
            therapies that target prostate cancer cells and the blood
            supply of other solid tumors, leaving healthy tissues
            untouched.
      --Facilitated clinical trials to further develop at least 11 vaccines
            to address the HIV subtypes that together cause most of the HIV
            infections around the world. Since 1987, NIH's National
            Institute for Allergy and Infectious Diseases (NIAID) has
            enrolled more than 3,357 volunteers in 53 Phase I & Phase II
            preventive HIV vaccine trials of 28 candidate vaccines.
      --Enabled scientists to identify the first drug to have an effect on
            both insulin production and insulin action as a potential
            therapeutic agent for type 2 diabetes. This example of an NIH
            investment in basic research could help the 17 million
            Americans who suffer from this disease.
      --Revolutionized biomedical science through the sequencing of the
            human genome. Researchers now are able to locate, identify, and
            describe the function of many human genes. This new knowledge
            will lead to genetic tests to diagnose diseases and the
            development of drug therapies that are tailored to individual
            patients.
        AAU urges the committee to provide appropriate funding for NIH or
    many promising opportunities will not be funded. If NIH receives
    inadequate funding in fiscal year 2005, we will lose significant
    opportunities to cure disease and comfort the afflicted. A 10 percent
    increase for NIH will:
      --Enable faster and cheaper genomic sequencing. Currently it costs
            $2-3 billion to sequence an entire genome. An investment of $50
            million today will enable the development of new technologies
            that will cut the cost of sequencing to $100,000 for a complex
            mammal within 5 years and drive the cost of an entire genome to
            $1,000 within 10 years.
      --Support the new science of proteomics that has enabled physicians
            to distinguish among different types of ovarian or breast
            cancer tumors and reveal patterns that may have important
            clinical implications. Because of previous investments, doctors
            can now tailor therapies such as chemotherapy and radiation to
            patients based upon their tumor types, dramatically increasing
            cure rates and reducing the suffering of women who don't have
            to undergo painful therapies needlessly. Today's investment
            will drive the cost of diagnosis down to pennies per patient
            and further individualize cancer therapies.
      --Fund the National Cancer Clinical Trial Database that allows
            patients to access information about NCI funded research by
            disease type; enables scientists to use recent technological
            innovations to produce vast amounts of information about the
            genes and proteins active within cancer cells; and allows
            cancer funding agencies to coordinate research efforts across
            agencies.
      --Further reduce the time it takes to develop a vaccine, which has
            plummeted from 15 years to fewer than four. For example, two
            vaccine candidates for West Nile virus were in clinical trials
            within 3 years of West Nile's arrival in the continental United
            States. And biomedical researchers were able to take the
            knowledge and tools made possible by the NIH doubling to
            identify and sequence the SARS virus in a matter of weeks. As
            the nation braces for newly emerging infectious diseases such
            as bird flu or a bioterror attack, we must continue to develop
            new or improved vaccines.

                                   CONCLUSION

        As a nation, we enjoy the benefits of a system that recruits
    talented individuals and encourages them to compete for research
    funding. These individuals undergo a lengthy, rigorous and highly
    selective apprenticeship before they apply for their own research
    funds. The competition for research support is fierce, and at best only
    about 30 percent of the applicants for NIH funds are successful. When
    the success rate falls substantially below this level, important
    projects are disrupted and promising young people are dissuaded from
    research careers. Thus, in order to sustain the high quality of the
    biomedical research system, we must continue to provide resources to
    encourage the research of our nation's best scientists.
        It is imperative that this committee continue its legacy of bi-
    partisan support for NIH--the future health of the nation depends of
    it. In a year when defense and homeland security are top priorities,
    the committee must not allow investments for NIH to erode. The
    scientific community is tirelessly working to translate research into
    tangible benefits for all Americans. The health and quality of millions
    of lives depends on strong support from this committee for the fiscal
    year 2005 NIH budget.
        Thank you for this opportunity to submit testimony and please let
    me know if you have questions.
                                     ______

       Prepared Statement of the March of Dimes Birth Defects Foundation

        The 3 million volunteers and 1,400 staff members of the March of
    Dimes appreciate the opportunity to submit the Foundation's federal
    funding recommendations for fiscal year 2005. The March of Dimes is a
    national voluntary health agency founded in 1938 by President Franklin
    D. Roosevelt to prevent polio. Today, the Foundation works to improve
    the health of mothers, infants and children by preventing birth defects
    and infant mortality through research, community services, education,
    and advocacy. The March of Dimes is a unique partnership of scientists,
    clinicians, parents, members of the business community, and other
    volunteers affiliated with 54 chapters in every state, the District of
    Columbia and Puerto Rico.
        The volunteers and staff of the March of Dimes are deeply concerned
    that for the first time since 1958, the infant mortality rate increased
    in 2002. Increases in deaths due to premature birth, birth defects, and
    maternal complications during pregnancy are the top reasons for this
    increase. In our judgment, the modest funding increases recommended
    below would have an immediate and positive impact on this disturbing
    trend.

                         NATIONAL INSTITUTES OF HEALTH

        The March of Dimes joins the larger research community in
    recommending a 10 percent increase in funding for the National
    Institutes of Health (NIH), bringing total federal support to just over
    $30 billion. A sustained investment in medical research is vital to
    discovering the interventions needed to prevent and treat diseases and
    conditions. Because of the profound impact on women and children of the
    work supported by the National Institute of Child Health and Human
    Development, funding for this Institute is of particular interest to
    the March of Dimes.

    National Institute for Child Health and Human Development
        The mission of the National Institute for Child Health and Human
    Development (NICHD) is closely aligned with that of the March of Dimes.
    The Foundation recommends an overall increase in funding of 10 percent
    for NICHD. With this increase in resources, NICHD could expand research
    in several areas that are crucial to improving the health of women and
    children. Additional funds would permit expansion of research into
    preterm labor and delivery and into the causes of birth defects, and
    would enable NICHD to begin implementing the National Children's Study
    of environmental and genetic influences on child health and
    development.
        According to the National Center for Health Statistics, in 2002,
    more than 480,000 babies were born prematurely in the United States--1
    in 8 births. Since 1981, the preterm birth rate has increased nearly 29
    percent. Premature birth accounts for 23 percent of deaths in the first
    month of life. Those babies that survive are more likely than full-term
    infants to face serious multiple health problems including cerebral
    palsy, mental retardation, chronic lung disease, and vision and hearing
    loss. Preterm labor can happen to any pregnant woman and the causes of
    nearly half of all preterm births are unknown. An analysis of Agency
    for Healthcare Research and Quality data conducted by the March of
    Dimes Perinatal Data Center estimated that the total national hospital
    bill for premature babies was $13.6 billion in 2001. With overall
    hospital charges increasing rapidly--13 percent in 2001--the financial
    burden of prematurity is expected to worsen until we know how to
    prevent preterm births.
        The March of Dimes recommends a 10 percent increase for NICHD in
    fiscal year 2005 and an increase of at least $50 million over the next
    5 years to boost prematurity-related research. This increase should be
    devoted to a comprehensive biomedical research program to study preterm
    delivery etiology, prevention and treatment regimens.

                CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

    Division of Reproductive Health
        The National Center for Chronic Disease Prevention and Health
    Promotion, Division of Reproductive Health works to promote optimal
    reproductive and infant health, but does not have the resources it
    requires to study the growing problem of preterm birth. Therefore, the
    March of Dimes recommends a $20 million increase in fiscal year 2005 to
    expand research related to preterm birth. The growing problem of
    preterm birth requires an expanded, comprehensive prevention research
    agenda to identify the causes, risk factors and ways to prevent preterm
    birth. In particular, two specific programs should receive additional
    funding: (1) the Pregnancy Risk Assessment Monitoring System and (2)
    epidemiological research.
        The Pregnancy Risk Assessment Monitoring System (PRAMS) is a state-
    specific, population based surveillance system designed to identify and
    monitor maternal behaviors and experiences before, during, and after
    pregnancy. Currently, CDC supports cooperative agreements with 31
    states that allow PRAMS to cover about 60 percent of all U.S. births.
    Data collected through PRAMS is used by researchers and policy makers
    to increase understanding of adverse pregnancy outcomes, to develop and
    modify maternal and child health programs, and to incorporate the most
    up to date research findings into standards of practice. The March of
    Dimes recommends an increase of $5 million to expand PRAMS so that CDC
    can develop national estimates on behavioral as well as demographic
    risk factors for preterm birth.
        Epidemiological research conducted at CDC is vital to reducing the
    incidence of preterm labor and delivery. The March of Dimes recommends
    an increase of $15 million to expand research on the prevention of
    preterm delivery for women at risk, focusing especially on factors
    contributing to higher rates of preterm delivery in African-American
    women. Increasing CDC's activities related to preterm birth will
    improve early detection of women at risk for preterm labor and lead to
    new interventions for those at greatest risk.

    National Center on Birth Defects and Developmental Disabilities
        According to CDC, birth defects are the leading cause of infant
    mortality accounting for more than 20 percent of all infant deaths and
    are responsible for about 30 percent of all pediatric hospital
    admissions. Of the 4 million babies born each year in the United
    States, approximately 150,000 are born with one or more serious birth
    defects. In addition, birth defects are the fifth-leading cause of
    years of potential life lost and contribute substantially to childhood
    morbidity and long-term disability. The causes of about 70 percent of
    all birth defects are still unknown.
        The National Center on Birth Defects and Developmental Disabilities
    (NCBDDD) works to prevent birth defects for which causes have already
    been identified and conducts research on those defects for which causes
    have not yet been found. The March of Dimes urges members of the
    Subcommittee to increase funding for the Center to $160 million in
    fiscal year 2005 (includes the transfer of Hereditary Blood Disorders
    Division). This modest increase will provide the resources necessary to
    expand prevention activities where causes are known, and to accelerate
    the pace of research where causes have not as yet been identified. An
    increase of $15.9 million in funding for prevention, surveillance, and
    research activities is vital to making progress in the fight against
    birth defects.

                Prevention: Folic Acid Education Campaign

        The NCBDDD is conducting a national public and health professions
    education campaign designed to increase the number of women taking
    folic acid daily. According to CDC, each year, an estimated 2,500
    babies are born with neural tube defects (NTDs), birth defects of the
    brain and spinal cord, including anencephaly and spina bifida. CDC
    estimates that up to 70 percent of NTDs could be prevented if all women
    of childbearing age consume 400 micrograms of folic acid daily,
    beginning before pregnancy. Fortification of the grain supply together
    with health provider and consumer education has resulted in a 32
    percent decline in the rates of spina bifida. However, the growing
    popularity of low-carbohydrate diets has caused an increasing number of
    women to reduce or eliminate their daily intake of bread and other
    grains. A 2003 Gallup Organization survey conducted for the March of
    Dimes found that only 32 percent of women in the United States between
    the ages of 18 and 45 take a multivitamin containing folic acid on a
    daily basis, up only 4 percent since 1995. When asked what would make
    them more likely to take a multivitamin containing folic acid on a
    daily basis, 33 percent of women said they would be more likely to do
    so on the advice of their doctor or health care provider. Therefore, it
    is critical that CDC step up its campaign to educate every woman of
    childbearing age about the importance of taking a daily multivitamin
    containing folic acid.
        To enable CDC to educate more women of child bearing age and their
    health providers about the importance of folic acid, the March of Dimes
    recommends an appropriation of at least $5 million in fiscal year 2005
    for the Folic Acid Education Campaign.

                Surveillance: State Cooperative Agreements to Improve Birth
                        Defects Tracking

        NCBDDD funds state initiatives to develop, implement, and/or expand
    community-based birth defects tracking systems, programs to prevent
    birth defects, and activities to improve access to health services for
    infants and children with birth defects. Surveillance forms the
    backbone of a vital public health network. CDC is currently supporting
    cooperative agreements with 28 states, each funded at an annual level
    of between $100,000 and $200,000 for each of 3 years. The March of
    Dimes encourages Subcommittee Members to add $3.4 million (a total of
    $7.5 million) to state-based birth defects surveillance activities. As
    you may know, resources have not been adequate to fund all states
    seeking assistance. Additional funding is needed to support creation of
    programs where none exist and improvement of programs already receiving
    support.

                Research: Regional Centers for Birth Defects Research and
                        Prevention
        NCBDDD currently funds 10 regional Centers for Birth Defects
    Research and Prevention (each Center receives approximately $900,000
    per year) to conduct epidemiological research on birth defects. The
    centers are located in Arkansas, California, Georgia, Iowa,
    Massachusetts, New Jersey, New York, North Carolina, Texas, and Utah.
    These centers obtain data and identify cases for inclusion in the
    National Birth Defects Prevention Study, the largest case-control study
    of birth defects ever conducted. The centers study the effectiveness of
    primary prevention of birth defects, the teratogenicity of various
    drugs, the environmental causes of birth defects and the genetic
    factors pertaining to susceptibility to environmental causes of birth
    defects. For example in response to a scientific study showing a
    possible association between the drug loratadine, also sold under the
    brand name Claritin, and the occurrence of the birth defect
    hypospadias the National Birth Defects Prevention Study conducted a
    study that showed no association. This information will be useful to
    any woman who takes loratadine and becomes pregnant. The March of Dimes
    encourages the Subcommittee to add $10 million (for a total of $17.3
    million in funding) to support the important and promising work of the
    regional centers.

                            ADDITIONAL CDC PROGRAMS

    National Immunization Program
        Immunizations are critical to the health and well-being of
    children. CDC's National Immunization Program provides grants to 64
    state, local, and territorial public health agencies to reduce the
    incidence of disability and death resulting from vaccine preventable
    diseases. The March of Dimes urges the Subcommitttee to continue its
    longstanding policy of ensuring that federal vaccine programs are
    adequately funded to move the nation closer to the goal of vaccinating
    at least 90 percent of children and adults. To account for vaccine
    price increases, introduction of new vaccines, and to facilitate
    implementation of recent Institute of Medicine recommendations, the
    March of Dimes recommends an overall increase of $180 million in fiscal
    year 2005 for the National Immunization Program.

    Polio Eradication
        The March of Dimes was founded to find ways of preventing
    poliomyelitis. Although success in developing the Salk and Sabin
    vaccines enabled the Foundation to shift its focus to a new set of
    challenges, we continue to support completing the task of polio
    eradication worldwide. Global polio eradication will save lives and
    reduce unnecessary health-related costs. The March of Dimes supports a
    funding level of $106.4 million for CDC's fiscal year 2005 global polio
    eradication activities. With polio epidemics now confined to only 6
    countries (Nigeria, India, Pakistan, Niger, Egypt and Afghanistan), it
    is important that the U.S. government maintain its commitment to
    completion of the worldwide eradication initiative.

    National Center for Health Statistics
        The Foundation also supports the vital work of the National Center
    for Health Statistics (NCHS) which provides information essential for
    research and programmatic initiatives. NCHS' surveys to assess the
    health status of American's care are critical to many programs and
    initiatives. For example, the National Vital Statistics System is a
    major source of information on utilization of health services, preterm
    births, low birthweight as well as outcomes including birth defects and
    infant mortality. Increased funding would allow CDC to modernize this
    system using web-based technology that would facilitate rapid
    compilation of data and improvement in the accuracy and completeness of
    information obtained from health professionals and facilities. This
    information is needed to track trends in birth outcomes and to support
    birth defects registries. Additional resources would also enable CDC to
    continue the National Survey of Family Growth which provides essential
    information on factors affecting birth outcomes.

              HEALTH RESOURCES AND SERVICES ADMINISTRATION (HRSA)

    Newborn Screening
        Newborn screening is a public health activity used to identify
    genetic, metabolic, hormonal and/or functional conditions in newborns.
    Many such disorders, if left untreated, can cause disability, mental
    retardation, and even death. Although nearly all babies born in the
    United States undergo newborn screening tests for some genetic birth
    defects, the number and quality of these tests varies from state to
    state. The March of Dimes recommends that every baby born in the United
    States receive, at a minimum, screening for a core set of nine
    metabolic disorders as well as hearing deficiencies.
        In fiscal year 2004, the Congress provided first-time funding for
    implementation of Title XXVI of the Children's Health Act of 2000. This
    program is designed to strengthen state newborn screening programs; to
    improve states' ability to develop, evaluate, and acquire innovative
    testing technologies; and to establish and improve programs to provide
    screening, counseling, testing and special services for newborns and
    children at risk for heritable disorders. The March of Dimes proposes
    an appropriation of $25 million to support HRSA's work with states to
    expand the heritable disorders (newborn screening) program authorized
    through Title XXVI.

    Maternal and Child Health Block Grant
        Title V of the Social Security Act, the Maternal and Child Health
    (MCH) block grant, funds community-based services such as home visiting
    and respite care for children with special health care needs. MCH
    complements Medicaid and the State Children's Health Insurance Program
    by providing ``wrap-around'' services and other needed health services.
    The March of Dimes recommends fully funding the block grant at the
    authorized level of $850 million and notes that in order to hold states
    harmless an appropriation of $807 million is required. Additional
    funding would enable states to expand critical services such as
    prenatal and infancy home visitation programs, strategy that helps
    improve birth outcomes. According to the Maternal and Child Health
    Bureau, 900,000 children with special health care needs use MCH
    services. These children would also benefit as increased resources
    would enable states to raise spending limits for home visits respite
    care, physical and occupational therapy, durable medical equipment, and
    other support services.

    Consolidated Health Centers
        Consolidated (Community) Health Centers are an important source of
    obstetric and pediatric care for more than 13 million individuals, 40
    percent of whom are uninsured. The Foundation recommends new funding
    sufficient to increase the number of centers and to improve the scope
    of perinatal services provided. Adding funds to this program would be
    consistent with the President's 5-year plan to create and expand health
    center sites in 1,200 communities and to increase the number of
    patients served annually to more than 16 million.
        Thank you for the opportunity to testify on the federally supported
    programs of highest priority to the March of Dimes. The Foundation's
    staff and volunteers look forward to working with Members of the
    Subcommittee to improve the health of mothers, infants and children.

           MARCH OF DIMES FISCAL YEAR 2005 FEDERAL FUNDING PRIORITIES
                            [In millions of dollars]
    ------------------------------------------------------------------------
                                                         Fiscal year
                                                ----------------------------
                      Program                                 2005 March  of
                                                     2004          Dimes
                                                   funding    recommendation
    ------------------------------------------------------------------------
    National Institutes of Health (Total)......     27,878.0       30,666.0
        National Institute of Child Health &         1,242.0        1,366.0
         Human Development.....................
        National Human Genome Research                 479.0          527.0
         Institute.............................
        National Center on Minority Health and         192.0          211.0
         Disparities...........................
    Centers for Disease Control and Prevention       6,972.0        8,100.0
     (Total)...................................
        Center on Birth Defects and                    113.0      \1\ 160.0
         Developmental Disabilities............
            Regional Centers for Birth Defects           7.3           17.3
             Research & Prevention.............
            State Cooperative Agreements to              4.1            7.5
             Improve Birth Defects Tracking....
            Folic Acid Education Campaign......          2.5            5.0
        Immunization...........................        644.0          824.0
            Polio Eradication..................        106.4          106.4
        Safe Motherhood/Infant Health (NCCDPHP)         54.0           74.0
            Pregnancy Risk Assessment                    7.1           12.0
             Monitoring System.................
            Prevention Research (Preterm Birth)          1.3           16.3
        National Center for Health Statistics..        128.0          181.0
    Health Resources and Services                    6,600.0        8,000.0
     Administration (Total)....................
        Maternal and Child Health Block Grant..        730.0          850.0
            Newborn Screening..................          2.0           25.0
        Newborn Hearing Screening..............         10.0           10.0
        Consolidated (Community) Health Centers      1,617.0        1,867.0
        Healthy Start..........................         98.0           98.0
    Agency for Healthcare Research and Quality.        304.0          390.0
    ------------------------------------------------------------------------
    \1\ Fiscal year 2005 funding recommendation includes $22 million
      transfer of the Hereditary Blood Disorders Division and $25 million in
      new funding.

                                     ______

                 Prepared Statement of the NephCure Foundation

                SUMMARY OF RECOMMENDATIONS FOR FISCAL YEAR 2005

      --A 10 percent increase for the National Institutes of Health and the
            National Institute of Diabetes and Digestive and Kidney
            Diseases (NIDDK).
      --Continue to expand the NIDDK Nephrotic Syndrome (NS)/Focal
            Segmental Glomerulosclerosis (FSGS) research portfolio by
            aggressively supporting grant proposals in this area and
            encouraging the National Center for Minority Health and Health
            Disparities (NCMHD) to initiate studies into the incidence/
            cause of NS/FSGS in the African-American population.
      --The NephCure Foundation enthusiastically supports the Scientific
            Conference/Workshop being sponsored by the National Institute
            of Diabetes & Digestive & Kidney Diseases (NIDDK). The workshop
            will take place early in 2005 and will examine areas of promise
            surrounding glomerular disease and will develop a future agenda
            for Focal Segmental Glomerulosclerosis (FSGS) research.
      --The NephCure Foundation encourages follow up to the 2005 scientific
            workshop in hopes that it will initiate grant proposals focused
            on achieving the goals and opportunities developed by the
            workshop.
        Mr. Chairman, and members of the subcommittee, I am pleased to
    present testimony on behalf of the NephCure Foundation (NCF), a non-
    profit organization driven by a blue-ribbon panel of respected medical
    experts and a dedicated band of patients and families working for a
    common goal--to save kidneys and lives.
        I am Ed Hearn, former Major League Baseball Player for the Kansas
    City Royals. My career as a professional athlete came to an abrupt end
    in 1988, when I was diagnosed with Focal Segmental Glomerulosclerosis
    (FSGS), a debilitating and degenerative kidney disease. Today, after
    two life-changing kidney transplants, a successful bout against cancer,
    the aid of a breathing machine each night, a $3,000 IV once a month,
    and $40,000 of medication per year, I live to tell my story and to
    speak for those suffering from FSGS. My hope is that we can find the
    means to prevent this life-threatening disease from affecting our youth
    and from jeopardizing the normalcy of their lives as it has mine and
    many others. I remain hopeful that a cure for FSGS will be discovered,
    but until then, we must focus on prevention.

                TREATMENT TRIALS BEGINNING, BUT NO CURE IN SIGHT

        Mr. Chairman, FSGS is one of a cluster of glomerular diseases that
    attack the one million tiny filtering units contained in each human
    kidney. These filters are called nephrons and the diseases attack the
    portion of the nephron called the glomerulus, scarring and often
    destroying the irreplaceable filters. Scientists do not know why
    glomerular injury occurs and they are not sure how to stop its
    inevitable destruction of the kidney.
        When I was a teenager, doctors found protein in my urine and told
    me that some day I might have kidney trouble. I thought ``Fine, maybe
    I'll have to deal with that when I'm an old man down the road.'' Some
    day happened much sooner than anyone expected. I believe that because I
    was a highly-conditioned athlete--and catchers are more conditioned
    than most--my body initially masked the symptoms of FSGS.
        My first kidney transplant lasted more than 7 years until the FSGS
    returned. I received a second kidney from my aunt in 2000, but my body
    rejected it almost immediately, and I received a third transplant in
    May 2002. My story is not unique; there are thousands of other people
    in this country who have had their lives disrupted due to the sudden
    onset of FSGS.
        We are extremely thankful that an NIDDK-funded clinical trial began
    this year to study the efficacy of the current treatments for FSGS, and
    that ancillary studies are underway to examine tissue samples of
    injured glomerulus. However, these clinical trials hold no particular
    hope for patients who suffer from FSGS.
        As children are most often affected by this disease, there are
    thousands of young people who are in a race against time, hoping for a
    treatment that will save their lives. The NephCure Foundation today
    raises its voice to speak for them all, asking you to take specific
    actions that will aid our quest to find the cause and the cure of NS/
    FSGS.
        First and foremost, we support a 10 percent increase for the
    National Institutes of Health and the National Institute of Diabetes
    and Digestive and Kidney Diseases (NIDDK).

                    TOO LITTLE DATA ABOUT A GROWING PROBLEM

        When glomerular disease strikes, the resulting Nephrotic Syndrome
    causes loss of protein in the urine and symptoms such as edema, a
    swelling that often appears first in the face. For example, many
    physicians mistake children's puffy eyelids as an allergy symptom.
    Stories of similar misdiagnoses are common at our Foundation. With
    experts projecting a substantial increase in Nephrotic Syndrome in the
    coming years, there is a clear need to educate pediatricians and family
    physicians about glomerular disease and its symptoms.
        The NephCure Foundation has numerous education programs underway,
    including patient education seminars; the most recent of which took
    place in May 2003. News of our most recent activities can be found on
    our web site at www.nephcure.org. However, our efforts alone are not
    enough.
        NIDDK launched a major federal outreach program early in 2002--the
    National Kidney Disease Education Program--we seek your support in
    urging NIDDK to assure that glomerular disease receives high visibility
    in this important program.

                GLOMERULAR DISEASE STRIKES MINORITY POPULATIONS

        Nephrologists tell us that glomerular diseases such as FSGS affect
    a disproportionate number of African-Americans and, according to NIDDK,
    ``the worst prognosis is observed in African-American children.''
    NephCure officials have described this situation in a meeting with Dr.
    John Ruffin, director of the National Center for Minority Health and
    Health Disparities (NCMHD).
        As the NCMHD becomes fully operational and plans programs, our
    Foundation will continue to work with the Center to encourage the
    creation of programs to study the high incidence of glomerular disease
    within the African-American population.
        We ask the Committee to join with us in expanding the NS/FSGS
    research portfolio by requesting that the National Center for Minority
    Health and Health Disparities seize the opportunity to establish
    research into the phenomenon of glomerular disease within the African
    American community.

                          MORE BASIC SCIENCE IS NEEDED

        The current FSGS clinical trials which follow an estimated 400
    patients over a 3-year period, are limited, according to the RFA, to
    examining the ``impact of immunomodulatory therapy on proteinuria.''
    While the trials may lead to safer or more efficient care for children
    with FSGS, no one is suggesting that they will bring us closer to
    finding the cause and cure. Science has yet to prove that FSGS is an
    immune-mediated disease.
        Scientists tell us that much more needs to be done in the area of
    basic science, beginning with collection of tissue and fluid samples
    from a large number of patients on which years of important scientific
    research can be founded. NephCure is collaborating with the NIH in a
    major way to work for such progress.
        The National Institute of Diabetes and Digestive and Kidney
    Diseases (NIDDK) has agreed to match, dollar-for-dollar, funds raised
    by NephCure that will allow researchers to obtain DNA samples from
    hundreds of FSGS patients in upcoming clinical trials. The NIDDK will
    match up to $300,000 raised by NephCure for a combined total of
    $600,000. These trials are an ancillary study in conjunction with the
    first-ever national medication trials of FSGS treatment that may
    possibly lead to better understanding of the more common Nephrotic
    Syndrome, which can be a precursor to FSGS.
        We enthusiastically support NIDDK in sponsoring a scientific
    workshop/conference to take place early in 2005, with the intent to
    review the most promising existing science in glomerular disease, and
    focus on methods of translating this scientific information into
    improved patient care. This goal is consistent with the NIH Roadmap to
    Research initiative developed by NIH Director, Dr. Elias Zerhouni.
        We sincerely believe that the workshop will expose opportunities
    and challenges in glomerular disease research, and evaluate the
    resources needed to carry out these opportunities and challenges. The
    workshop/conference will lend hope to the thousands of young people
    whose kidneys and lives are threatened by this terrible disease, and
    give meaning and honor to their heroic stories.
        The NephCure Foundation encourages follow up to the scientific
    workshop/conference in hopes that it will generate grant proposals
    focused on achieving the research goals and opportunities developed by
    the workshop.
        We anticipate the potential for a Program Announcement and the
    potential for a Special Emphasis Program Announcement resulting from
    the conference or some other traditional mechanism to generate grant
    proposals. These mechanisms to encourage investigator initiated grant
    proposals should help to continue to expand the NS/FSGS portfolio at
    NIH.
        Mr. Chairman, as you know, patient support and advocacy groups such
    as the NephCure Foundation work closely with medical research
    organizations. They share a mutual understanding that unless major
    research efforts are undertaken, advances and improvements in the
    health of patients will not occur. Every year, the NephCure Foundation
    participates in advocating increased funding for the NIH and NIDDK. We
    want to reiterate how deeply grateful we are for your leadership and
    that of the subcommittee on medical research matters, which means so
    much for the health of the people in our nation.
        I will be pleased to answer any questions you may have.
                                     ______

         Prepared Statement of the Digestive Disease National Coalition

                  SUMMARY OF FISCAL YEAR 2005 RECOMMENDATIONS

      --Provide increased funding for the National Institutes of Health
            (NIH) at 10 percent for fiscal year 2005. Increase funding for
            the National Cancer Institute (NCI), the National Institute of
            Diabetes and Digestive and Kidney Diseases (NIDDK) and the
            National Institute of Allergy and Infectious Diseases by 10
            percent for fiscal year 2005.
      --Continue focus on digestive disease research and education at NIH,
            including the areas of Inflammatory Bowel Disease (IBD),
            Hepatitis and other liver diseases, Irritable Bowel Syndrome
            (IBS), Colorectal Cancer, Endoscopic Research, Pancreatic
            Cancer, Celiac Disease, and Hemochromatosis.
      --$25 million for the Centers for Disease Control and Prevention's
            (CDC) Hepatitis Prevention and Control activities.
      --$30 million for the Centers for Disease Control and Prevention's
            (CDC) National Viral Hepatitis Roundtable Program
        Chairman Specter, thank you for the opportunity to again submit
    testimony to the Subcommittee. Founded in 1978, the Digestive Disease
    National Coalition (DDNC) is a voluntary health organization comprised
    of 25 professional societies and patient organizations concerned with
    the many diseases of the digestive tract. The Coalition has as its goal
    a desire to improve the health and the quality of life of the millions
    of Americans suffering from both acute and chronic digestive diseases.
        The DDNC promotes a strong federal investment in digestive disease
    research, patient care, disease prevention, and public awareness. The
    DDNC is a broad coalition of groups representing disorders such as
    Inflammatory Bowel Disease (IBD), Hepatitis and other liver diseases,
    Irritable Bowel Syndrome (IBS), Pancreatic Cancer, Ulcers, Pediatric
    and Adult Gastroesophageal Reflux Disease, Colorectal Cancer, Celiac
    Disease, and Hemochromatosis.
        Mr. Chairman, the social and economic impact of digestive disease
    is enormous and difficult to grasp. Digestive disorders afflict
    approximately 65 million Americans. This results in 50 million visits
    to physicians, over 10 million hospitalizations, collectively 230
    million days of restricted activity. The total cost associated with
    digestive diseases has been conservatively estimated at $60 billion a
    year.
        The DDNC would like to thank the subcommittee for its past support
    of digestive disease research and prevention programs at the National
    Institutes of Health (NIH) and the Centers for Disease Control and
    Prevention (CDC). With respect to the coming fiscal year the DDNC is
    recommending an increase of 10 percent to $30 billion for the National
    Institutes of Health (NIH) and all of its Institutes. Specifically the
    DDNC recommends that the National Cancer Institute (NCI), the National
    Institute of Diabetes and Digestive and Kidney Disease (NIDDK), and the
    National Institute of Allergy and Infectious Diseases (NIAID be given
    $5.25 billion, $2.01 billion, and $4.77 billion respectively. We at the
    DDNC respectfully request that any increase for NIH does not come at
    the expense of other Public Health Service agencies.
        With the historic doubling of the budget for NIH completed and the
    challenging budgetary constraints the Subcommittee currently operates
    under, the DDNC would like to highlight the research being accomplished
    by NIDDK which warrants the increase for NIH.

                           INFLAMMATORY BOWEL DISEASE

        In the United States today about 1 million people suffer from
    Crohn's disease and ulcerative colitis, collectively known as
    Inflammatory Bowel Disease (IBD). These are serious diseases that
    affect the gastrointestinal tract causing bleeding, diarrhea, abdominal
    pain, and fever. Complications arising from IBD can include anemia,
    ulcers of the skin, eye disease, colon cancer, liver disease,
    arthritis, and osteoporosis. Crohn's disease and ulcerative colitis are
    not usually fatal but can be devastating. The cause of IBD is still
    unknown, but research has led to great breakthroughs in therapy.
        In recent years researchers have made significant progress in the
    fight against IBD. In 1998, the FDA approved the first drug ever
    specifically to fight Crohn's disease, a remarkable milestone. The DDNC
    encourages the subcommittee to continue its support of IBD research at
    NIDDK and NIAID at a level commensurate with the overall increase for
    each institute. The DDNC would like to applaud the NIDDK for its strong
    commitment to IBD research through the Inflammatory Bowel Disease
    Genetics Research Consortium. The DDNC urges the Consortium will
    continue its work in IBD research. The DDNC would also commend NIDDK
    for organizing and hosting the upcoming meeting entitled: ``Research on
    Inflammatory Bowel Disease'', later this month.
        Given the recent advancements in treatment for these diseases and
    the increased risk that IBD patients have for developing colorectal
    cancer, the DDNC strongly believes that generating improved
    epidemiological information on the IBD population is essential if we
    are to provide patients with the best possible care. Therefore the DDNC
    and its member organization the Crohn's and Colitis Foundation of
    America encourage the CDC to initiate a nationwide IBD surveillance and
    epidemiological program in fiscal year 2005.

                    HEPATITIS C: A LOOMING THREAT TO HEALTH

        It is estimated that there are over 4 million Americans who have
    been infected with Hepatitis C of which over 2.7 million remain
    chronically infected. About 10,000 die each year and the Centers for
    Disease Control and Prevention (CDC) estimates that the death rate will
    more than triple by 2010 unless there is additional research,
    education, and more effective treatments and public health
    interventions. Hepatitis C infection is the largest single cause for
    liver transplantation and one of the principal causes of liver cancer
    and cirrhosis. There is currently no vaccine for hepatitis C, and
    treatment has limited success, making the infection among the most
    costly diseases in terms of health care costs, lost wages, and reduced
    productivity. Patients who are older at the time of infection, those
    who continually ingest alcohol, and those co-infected with HIV
    demonstrate accelerated progression to more advanced liver disease.
        The DDNC applauds all the work NIH and CDC have accomplished over
    the past year in the areas of hepatitis and liver disease. An example
    of this commitment has been the convening of the second National
    Institutes of Health Management of Hepatitis C Consensus Development
    Conference, which occurred in June 2002. The Conference made 17
    specific and high priority research recommendations that need to be
    pursued to develop better treatments and a cure for hepatitis. The DDNC
    urges that these recommendations be funded in fiscal year 2005. The
    DDNC also commends NIDDK for the establishment of the Biliary Atresia
    Research Consortium and the Adult-to-Adult Living Donor Liver
    Transplant Cohort Study. The convening of conferences on Hepatitis C
    and Renal Disease and Hepatitis C in Prisons, plus the New Direction
    for Therapy of Primary Biliary Cirrhosis are just some more positive
    examples of the work NIDDK has undertaken to combat hepatitis and liver
    disease. The DDNC urges NIDDK to continue support research in this
    area.
        The DDNC supports $30 million for the CDC's Hepatitis Prevention
    and Control activities. The hepatitis division at CDC supports the
    hepatitis C prevention strategy and other cooperative nationwide
    activities aimed at prevention and awareness of hepatitis A, B, and C.
    The DDNC also urges the CDC's leadership and support for the National
    Viral Hepatitis Roundtable to establish a comprehensive approach among
    all stakeholders for viral hepatitis prevention, education, strategic
    coordination, and advocacy.

                          COLORECTAL CANCER PREVENTION

        Colorectal cancer is the third most commonly diagnosed cancer for
    both men and woman in the United States and the second leading cause of
    cancer-related deaths. Colorectal cancer affects men and women equally.
    Although colorectal cancer is preventable and curable when polyps are
    detected early, a General Accounting Office report issued in March 2000
    documented that less than 10 percent of Medicare beneficiaries have
    been screened for colorectal cancer. This report revealed a tremendous
    need to inform the public about the availability of screening and
    educate health care providers about colorectal cancer screening
    guidelines. In 2003, the New York City Department of Health has
    recommended colonoscopy for everyone over age 50 to prevent colorectal
    cancer.
        The DDNC recommends a funding level of $25 million for the CDC's
    Colorectal Cancer Screening and Prevention Program. This important
    program supports enhanced colorectal screening and public awareness
    activities throughout the United States. The DDNC also supports the
    continued development of the CDC-supported National Colorectal Cancer
    Roundtable, which provides a forum among organizations concerned with
    colorectal cancer to develop and implement consistent prevention,
    screening, and awareness strategies.

                               PANCREATIC CANCER

        In 2002, an estimated 28,300 people in the United States were found
    to have pancreatic cancer and approximately 28,200 died from the
    disease. Pancreatic cancer is the fifth leading cause of cancer death
    in men and women. Only 2 out of 10 patients will live 1 year after the
    cancer is found and only a very few will survive after 5 years.
    Although we do not know exactly what causes pancreatic cancer, several
    risk factors linked to the disease have been identified:
        (1) Age.--Most people are over 60 years old when the cancer is
    found;
        (2) Sex.--Men have pancreatic cancer more often than women;
        (3) Race.--African Americans are more likely to develop pancreatic
    cancer than are white or Asian Americans;
        (4) Smoking
        (5) Diet.--Increased red meats and fats; and
        (6) Diabetes
        The National Cancer Institute (NCI) has established a Pancreatic
    Cancer Progress Review Group charged with developing a detailed
    research agenda for the disease. The DDNC commends NIDDK for the
    establishment in 2002 on an initiative entitled: Liver, Pancreas, and
    Gastrointestinal Cell Genome Anatomy Project. The DDNC hopes this new
    initiative will call more attention and greater resources to the
    diseases of the Pancreas. The DDNC encourages the Subcommittee to
    provide an increase for pancreatic cancer research at a level
    commensurate with the overall percentage increase for NCI and NIDDK.

                         IRRITABLE BOWEL SYNDROME (IBS)

        IBS is a disorder that affects an estimated 35 million Americans.
    The medical community has been slow in recognizing IBS as a legitimate
    disease and the burden of illness associated with it. Patients often
    see several doctors before they are given an accurate diagnosis. Once a
    diagnosis of IBS is made, medical treatment is limited because the
    medical community still does not understand the pathophysiology of the
    underlying conditions.
        Living with IBS is a challenge, patients face a life of learning to
    manage a chronic illness that is accompanied by pain and unrelenting
    gastrointestinal symptoms. Trying to learn how to manage the symptoms
    is not easy. There is a loss of spontaneity when symptoms may intrude
    at any time. IBS is an unpredictable and fickle disease. A patient can
    wake up in the morning feeling fine and within a short time encounter
    abdominal cramping to the point of being doubled over in pain and
    unable to function.
        The unpredictable bowel symptoms may make it next to impossible to
    leave your home. It is difficult to ease the pain than may repeatedly
    occur periodically throughout the day. A patient can become reluctant
    to eat for fear that just eating a meal will trigger symptoms all over
    again. IBS has a broad and significant impact on a person's quality of
    life. It strikes individuals from all walks of life and results in a
    significant toll of human suffering and disability.
        While there is much we don't understand about the causes and
    treatment of IBS, we do know that IBS is a chronic complex of systems
    affecting as many as one in five adults. In addition:
      --It is reported more by women than men;
      --It is the most common gastrointestinal diagnosis among
            gastroenterology practices in the United States;
      --It is a leading cause of worker absenteeism in the United States;
            and
      --It costs the U.S. Health Care System an estimated $8 billion
            annually.
        Mr. Chairman, much more can still be done to address the needs of
    the nearly 35 million Americans suffering from irritable bowel syndrome
    and other functional gastrointestinal disorders.

                                 CELIAC DISEASE

        Celiac Disease is a life-long condition in which the body develops
    an allergy to gluten, a protein found in wheat, barley, and rye, which
    can result in damage to the small intestine. Celiac disease affects as
    many as 2 million Americans. Onset of the disease can occur at any age.
    The common symptoms of Celiac Disease include fatigue, anemia, chronic
    diarrhea or constipation, weight loss, and bone pain. The only
    treatment for celiac disease is strict adherence to a gluten-free diet.
    Undiagnosed and untreated celiac disease can lead to other disorders
    such as osteoporosis, infertility, neurological conditions, and in rare
    cases cancer. Persons with Celiac Disease often have other associated
    autoimmune disorders as well.
        The DDNC along with our Celiac Disease applauds the NIDDK for
    organizing and hosting the upcoming meeting entitled ``Consensus
    Development Conference on Celiac Disease.'' The DDNC urges the
    Subcommittee to recommend more research, medical education, and public
    awareness around Celiac Disease.
        The DDNC understand the challenging budgetary constraints and times
    we live in that is subcommittee is operating under, yet we hope you
    will carefully consider the tremendous benefits to be gained by
    supporting a strong research and education program at NIH and CDC.
    Millions of Americans are pinning their hopes for a better life, or
    even life itself, on digestive disease research conducted through the
    National Institutes of Health.
        Mr. Chairman, on behalf of the millions of digestive disease
    sufferers, we appreciate your consideration of the views of the
    Digestive Disease National Coalition. We look forward to working with
    you and your staff.
    Digestive Disease National Coalition
        The Digestive Disease National Coalition was founded 25 years ago.
    Since its inception, the goals of the coalition have remained the same:
    to work cooperatively to improve access to and the quality of digestive
    disease health care in order to promote the best possible medical
    outcome and quality of life for current and future patients with
    digestive diseases.
                                     ______

      Prepared Statement of the First Candle/Sudden Infant Death Syndrome
                                    Alliance

                  SUMMARY OF FISCAL YEAR 2005 RECOMMENDATIONS

      --Provide a 10 percent increase for fiscal year 2005 to the National
            Institutes of Health (NIH) and a proportional increase of 10
            percent to the individual institutes and centers, specifically,
            the National Institute of Child Health and Human Development
            (NICHD).
        --Transition from NICHD's successful SIDS 5-year research plan to a
                more comprehensive plan focusing on SIDS, stillbirth, and
                miscarriage.
      --Continue to fund the SIDS and Other Infant Death Program Support
            Center at the Maternal and Child Health Bureau, within the
            Health Resources and Services Administration (HRSA).
      --Fund 3 SIDS death scene protocol demonstration projects through the
            Centers for Disease Control and Prevention (CDC) in rural,
            urban, and suburban settings to provide a nation-wide protocol
            for dealing with SIDS death scenes.
        Mr. Chairman and members of the Subcommittee, thank you for again
    allowing First Candle/SIDS Alliance the opportunity to submit testimony
    to this Subcommittee. First Candle is a national voluntary health
    organization uniting parents, caregivers, and researchers nationwide
    with government, business, and community service groups. Our mission is
    to promote infant health and survival during the prenatal period
    through 2 years of age through advocacy, education, and research, while
    at the same time providing compassionate grief support to those
    affected by an infant death.
        Mr. Chairman, we still need your help, commitment, and support to
    help solve the mysteries of Sudden Infant Death Syndrome (SIDS) and
    stillbirth and ensure healthy pregnancies for all women.
        Despite the fact that SIDS cases have been documented for years,
    organized scientific research into SIDS only began in the mid 1970's.
    In the three decades since, scientists are now beginning to make
    significant progress in unraveling this enigma of SIDS, which robs
    families of their infant children. As an example of this progress, we
    now know that in many SIDS related deaths there is an abnormality or
    under-development in a region of the infant's brain, which is thought
    to control the heart and lung functions. In these cases, the
    irregularity may hamper normal respiratory activity. While this may not
    be the sole cause of SIDS, it could contribute to a larger respiratory
    problem leading to death when combined with other circumstances.
        As a direct result of SIDS research and the ``Back to Sleep''
    educational and awareness campaign on infant sleep positioning, SIDS
    deaths have been reduced by 50 percent since 1992, leading to the
    greatest decline in infant mortality rates in over 20 years.
        Despite this exceptional news, our research and educational
    campaign is far from finished. There are still more than 2,500 SIDS
    deaths in the United States each year and SIDS continues to be the
    number one cause of death for children between 1 month and 1 year of
    age. SIDS is a major component of the United States infant mortality
    rate. In spite of these facts, we still do not yet understand the
    causes of SIDS nor do we possess any guaranteed method for its
    prevention.
        Stillbirth is the death of an infant in-utero past 20 completed
    gestational weeks. The majority of these deaths occur at or near full-
    term; therefore, otherwise healthy babies die shortly before or during
    birth. There are more than 26,000 parents in the United States alone
    that experience a stillbirth annually, and it is estimated that nearly
    two-thirds of all stillbirth deaths remain unexplained. This translates
    to more than 70 stillborn babies delivered in the United States each
    day. More than half of these deaths are at 28 weeks or more gestation,
    and one in five full term babies are stillborn.
        In spite of these statistics and the impact stillbirth has on
    families, little attention has been paid to the problem. There is a
    dire need for increased public awareness and federal funding to support
    stillbirth research and education programs. In 2003, NICHD committed $3
    million to conduct five projects, which focus on central data
    collection and research protocols for stillbirth deaths. First Candle
    urges the Subcommittee to support continued funding for stillbirth
    research at NICHD.
        First Candle is grateful for the Subcommittee's past support of
    SIDS activities, especially the support of NICHD. We urge you to again
    provide the additional funding necessary for the third Five-Year SIDS
    Research Plan to ensure that NICHD can continue to address critical
    SIDS research initiatives and expand on their recent funding for
    stillbirth research. Specifically, First Candle is supporting a funding
    increase of 10 percent for NIH overall, and a 10 percent increase for
    NICHD. We respectfully ask that the increases for NIH do not come at
    the expense of other Public Health Service agencies. Further research
    is essential to find the reasons for and means of preventing the
    tragedies of SIDS and stillbirth.
        First Candle urges the Subcommittee to support infant death
    educational, awareness, and counseling activities that take place at
    the MCHB, and the death scene investigation protocol demonstration
    projects at the CDC. These programs are a vital companion to the
    research conducted at NICHD. Without prevention, awareness, counseling,
    and standardized investigation procedures, competent scientific
    research does not translate into meaningful advances for parents and
    families.

                   HIGHLIGHTS OF FEDERALLY FUNDED ACTIVITIES

    National Institute of Child Health and Human Development (NICHD)
        The mechanism of SIDS is still unknown; there are no clinical or
    biologic tests to identify a newborn at high risk of succumbing to
    SIDS; and more work is needed to increase the implementation of ``Back
    to Sleep'' among all caregivers and in communities with high rates of
    infant death. To address and focus its efforts on these challenges,
    NICHD has developed and implemented three SIDS Five-Year Research
    Plans. Now that NICHD is focusing more globally on infant health, First
    Candle is encouraging the institute to transition from their successful
    SIDS 5-year research plan to a more comprehensive plan focusing on
    SIDS, stillbirth, and miscarriage.

    Maternal and Child Health Bureau (MCHB)
        First Candle has entered into a collaborative effort with MCHB to
    kickoff the ``Healthy Child Care America Back to Sleep Campaign''. This
    initiative builds on the success of the ``Healthy Child Care America''
    and ``Back to Sleep'' campaigns to unite child care, health, and SIDS
    prevention partners across the country to reduce the number of SIDS-
    related deaths in child care settings.
        The MCHB continues to support a number of SIDS and Other Infant
    Death related services and programs, including the following
    activities:
      --National SIDS Resource Center, a major source of current
            information about SIDS.
      --Maternal and Child Health Service Block Grant (MCH), which grants
            funds to states providing a range of services to SIDS families.
            Block grant funds support activities like: contact families
            immediately after death, discussion of autopsy results with the
            family, and support and counseling through the first year of
            bereavement. Unfortunately, in many jurisdictions across the
            country, funds for these services have been decreased or
            eliminated due to budgetary difficulties.
      --Field training and curriculum to health care providers for case
            management of families who have experienced an infant death,
            and the development of model programs, particularly for the
            underserved and minorities. Demonstration grants have been
            established and are continuing in four states to target
            services for specific populations: California, Massachusetts,
            Missouri, and New York.
      --National SIDS & Infant Death Program Support Center to address SIDS
            service issues at the federal level on an ongoing basis. First
            Candle runs this center, which opened in 1999, and has
            experienced notable success. The support center is working to
            expand bereavement services to family members of those who
            experience stillbirth and miscarriage.

    Centers for Disease Control and Prevention (CDC)
        To develop a better statistical figure on SIDS cases, Congress
    recommended in 1993 the establishment of a standard death scene
    protocol to offset discrepancies on unexplained infant deaths between
    states. It was hoped that this protocol would be adopted by states not
    only for statistical measure, but to help avoid what can become awkward
    and emotionally charged misunderstandings at the death scene. In 1996,
    CDC published the protocol, and since that time several states have
    adopted the standard. It is First Candle's long term goal to ensure
    that all states fully adopt and implement the protocol. To help realize
    this goal, First Candle would like Congress to appropriate funds for
    CDC to heed Congress' recommendations for the past several years and
    implement the demonstration projects that follow these guidelines in
    several community settings nationwide. We recommend a demonstration
    project in each of the following, a rural community setting, an urban
    community setting, and a suburban community setting. We would also
    encourage CDC to implement a nationwide survey to measure how many
    locales have already implemented the protocol independently and to
    analyze the results thus far.
        In conclusion, we are all too painfully aware that SIDS has
    historically been a mystery, leaving in its wake devastated families
    and bewildered physicians. Not only have there been no answers on the
    cause of SIDS, but there have been no answers on how to effectively
    prevent its occurrence. Today we are beginning to find some of the
    answers on cause and prevention, and therefore reduce the risk of SIDS.
    Because of the ``unknown'', however, babies are still vulnerable even
    when parents and caregivers take the cautionary steps to prevent SIDS
    deaths. This tragedy will continue if research efforts are stalled or
    halted, especially when we are at the point where so much progress has
    been made. Now is the time for a re-energized effort against this
    tragic syndrome. Staggering statistics and the critical need for public
    awareness and research into the scope and causes of stillbirth has led
    to the joining together of parents and professionals to formally
    advocate for research into the causes and prevention of pre-term infant
    death. Now is the time for research into the horrible tragedy of
    stillbirth that too frequently becomes the outcome of a seemingly
    normal pregnancy.
        On behalf of the thousands of families who have been devastated by
    the loss of a baby to SIDS, stillbirth, or miscarriage and the millions
    of concerned and frightened parents, I ask for your support, and thank
    you again for allowing First Candle to submit this testimony.
    First Candle/Sudden Infant Death Syndrome Alliance
        First Candle/SIDS Alliance is an organization of parents and
    friends of SIDS, Stillbirth and Other Infant Death victims along with
    medical, business, and civic groups who are concerned about the health
    our nation's children. The Alliance is engaged in ongoing efforts to
    expand its scientific program, strengthen services for families, and
    provide public education and advocacy opportunities. An important goal
    is to improve community understanding and elevate SIDS, Stillbirth and
    Other Infant Death to the level of societal concern appropriate to one
    of our nation's major causes of infant mortality.
                                     ______

              Prepared Statement of the National Sleep Foundation

                  SUMMARY OF FISCAL YEAR 2005 RECOMMENDATIONS

      --Provide a 10 percent increase for fiscal year 2005 to the National
            Institutes of Health (NIH) and a proportional increase of 10
            percent to the individual institutes and centers, specifically,
            the National Heart, Lung, and Blood Institute (NHLBI).
      --Urge the National Center on Sleep Disorders Research (NCSDR) to
            partner with other federal agencies, such as the Centers for
            Disease Control and Prevention (CDC), and voluntary health
            organizations, such as the National Sleep Foundation (NSF), to
            develop a collaborative sleep education and public awareness
            initiative.
        Mr. Chairman and members of the Subcommittee, thank you for
    allowing me present testimony today on behalf of the National Sleep
    Foundation or NSF. I am Dr. James Walsh, Chairman of the Board of
    Directors of the National Sleep Foundation, Executive Director of the
    Sleep Medicine and Research Center affiliated with St. John's Mercy and
    St. Luke's Hospitals, and Clinical Professor of Psychiatry at St. Louis
    University. The National Sleep Foundation is an independent, non-profit
    organization whose mission is to enhance public awareness about the
    need for sufficient restorative sleep, to increase the detection and
    treatment of sleep disorders, to foster sleep-related programs and
    policy for the betterment of public health, and to promote sleep
    research. We work with thousands of sleep medicine and other health
    care professionals, researchers, patients, drowsy driving victims
    throughout the country, and collaborate with many government and
    private organizations with the goal of preventing health and safety
    problems related to sleep deprivation and untreated sleep disorders.
        Sleep problems, whether in the form of medical disorders, or
    related to work schedules and a 24/7 lifestyle, are ubiquitous in our
    society. At least 40 million Americans suffer from sleep disorders; yet
    more than 60 percent of adults have never been asked about the quality
    of their sleep by a physician, and fewer than 20 percent have ever
    initiated such a discussion. Millions of individuals struggle to stay
    alert at school, on the job, and on the road. The latest estimates from
    the National Highway Transportation Safety Administration and the
    Federal Motor Carriers Safety Administration implicate fatigue and
    sleepiness in 1.1 million crashes annually. A recent study in Sweden
    showed that sleep disturbances are the second greatest risk factor for
    fatal accidents at work. Sleep apnea, a sleep-related breathing
    disorder which affects at least 5 percent of adult Americans, is
    closely related to some of America's most pressing health problems,
    such as obesity, hypertension, heart failure, and diabetes. Chronic
    insomnia, experienced by 10 percent of our population is a strong risk
    factor for depression and other widespread mental health conditions.
    Sleep disorders, sleep deprivation, and excessive daytime sleepiness
    add approximately $15 billion to our national health care bill each
    year. The National Center on Sleep Disorders Research estimates that by
    the year 2050, sleep problems will affect as many as 100 million
    Americans.
        Sleep science has clearly demonstrated the importance of sleep to
    health and well being, yet research studies continue to show that
    millions of Americans are at risk for the serious health, safety
    consequences of sleep disorders and inadequate sleep. Moreover their
    quality of life suffers and the personal and national economic impact
    is staggering. NSF believes that every American needs to understand
    that good health includes healthy sleep, just as it includes regular
    exercise and balanced nutrition. We must elevate sleep to the top of
    the national health agenda. We need your help to make this happen.
        Our biggest challenge is bridging the gap between the outstanding
    scientific advances we have seen in recent years and the level of
    knowledge about sleep held by health care practitioners, educators,
    employers, and the general public. This gap in knowledge is being
    discussed as I present this testimony today, by hundreds of concerned
    professionals. Yesterday and today, the National Center on Sleep
    Disorders Research, the National Heart, Lung, and Blood Institute, and
    the Trans-NIH Sleep Research Coordinating Committee are sponsoring a
    translational conference entitled ``Frontiers of Knowledge in Sleep and
    Sleep Disorders: Opportunities for Improving Health and Quality of
    Life.'' This two-day program has assembled health care providers,
    public health and education experts, policy makers, patient advocacy
    organizations, sleep medicine specialists, and other stakeholders. It
    is intended to address how information about sleep and sleep disorders
    can translate into improvements in public health and safety using cost-
    effective, comprehensive, and broadly-applied strategies for education,
    societal change, and improved sleep-related health care.
        This conference is an important step in translating research into
    practice and into a broad-based public health message. The development
    of a sleep education and public awareness initiative would serve as a
    key legacy for the sleep translational conference and provide a forum
    for dissemination of the outcomes of the sleep translational
    conference. The National Sleep Foundation has been leading the way on
    public education regarding sleep and sleep disorders since it was
    founded in 1990. NSF and others have done a lot, but so much more needs
    to be done in order to educate the public and actually change behavior.
    Because resources are limited and the challenges great, we think
    creative and new partnerships need to be created to address the issues
    that are before us.
        Therefore, we recommend that The National Center on Sleep Disorders
    Research be encouraged to partner with other federal agencies, such as
    the Centers for Disease Control and Prevention, and voluntary health
    organizations, such as NSF, to develop an ongoing, inclusive mechanism
    for public and professional awareness on sleep, sleep disorders, and
    the consequences of fatigue. Such a collaboration between federal
    agencies and voluntary health organizations would create an opportunity
    for dramatically improving public health and safety as well as the
    quality of life for millions, if not all, Americans.
        Thank you again for the opportunity to present testimony before you
    today. I would be pleased to address any comments or questions.
                                     ______

       Prepared Statement of the International Foundation for Functional
                           Gastrointestinal Disorders

                  SUMMARY OF FISCAL YEAR 2005 RECOMMENDATIONS

      --Provide a 10 percent increase, to $30.8 billion, for fiscal year
            2005 to the National Institutes of Health (NIH) budget. Within
            NIH, provide proportional increases of 10 percent to the
            various institutes and centers, specifically, the National
            Institute of Diabetes and Digestive and Kidney Diseases
            (NIDDK). We request NIDDK's budget to be increased by 10
            percent to $1.85 billion.
      --Continue to accelerate funding for extramural clinical and basic
            functional gastrointestinal research at NIDDK.
      --Continue to urge NIDDK to develop a strategic plan setting research
            goals on IBS and functional bowel diseases and disorders.
      --Urge NIDDK to develop a standardization of scales to measure
            incontinence severity and quality of life and to develop
            strategies for primary prevention of fecal incontinence
            associated with childbirth.
      --Provide funding to NIDDK and the National Cancer Institute (NCI)
            for more research on the causes of esophageal cancer.
        Chairman Specter and members of the Subcommittee, thank you for the
    opportunity to present this written statement regarding the importance
    of functional gastrointestinal and motility research at the National
    Institutes of Health.
        IFFGD, the International Foundation for Functional Gastrointestinal
    Disorders, has been serving the digestive disease community for 13
    years. We work to broaden the understanding about functional
    gastrointestinal and motility disorders in adults and children.
        Through publications, professional symposia, and other means IFFGD
    addresses issues and raises awareness about disorders and diseases that
    many people are uncomfortable and embarrassed to talk about. Bowel
    conditions are often hidden in our society. Not only are they
    misunderstood, but the burden of illness and human toll has not been
    fully recognized.
        The majority of the diseases and disorders we address have no cure.
    We have yet to completely understand the pathophysiology of the
    underlying conditions. Many patients face a life of learning to manage
    chronic illnesses that are often accompanied by pain and a variety of
    gastrointestinal symptoms. The costs associated with these diseases are
    great; conservative estimates range between $25-$30 billion annually.
    The human toll is not only on the individual but also on the family.
    Economic costs spill over into the workplace and every aspect of daily
    life. In essence these diseases reflect lost potential for the
    individual and society.

                               FECAL INCONTINENCE

        At least 6.5 million Americans suffer from fecal incontinence.
    Incontinence is neither part of the aging process nor is it something
    that affects only the elderly. Incontinence crosses all age groups from
    children to older adults, but is more common among women and in the
    elderly of both sexes. Often it is a symptom associated with various
    neurological diseases and cancer treatments. Yet, as a society, we
    rarely hear or talk about the bowel disorders associated with multiple
    sclerosis, diabetes, colon cancer, uterine cancer, and a host of other
    diseases.
        Causes of fecal incontinence are many and may include damage to the
    anal sphincter muscles, nerve damage, loss of storage capacity in the
    rectum, chronic diarrhea, or pelvic floor dysfunction. People who have
    fecal incontinence may feel ashamed, embarrassed, or humiliated.
    Society is not tolerant of loss of bowel control. Some individuals with
    incontinence don't want to leave the house out of fear they might have
    an episode of incontinence in public. Most try to hide the problem as
    long as possible and may not reveal it to their own doctor unless
    asked. Isolation adds to the burden of illness as these individuals
    withdraw from friends and family, and social support.
        In November 2002, IFFGD sponsored, with NIH support, a
    multidisciplinary consensus conference--``Advancing the Treatment of
    Fecal and Urinary Incontinence Through Research: Trial Design, Outcome
    Measures, and Research Priorities.'' The proceedings were disseminated
    in the January 2004 Supplement of Gastroenterology, the journal of the
    American Gastroenterological Association. Among other outcomes, the
    conference resulted in six key research recommendations to address
    currently unmet needs:
        1. More comprehensive identification of quality of life issues
    associated with fecal incontinence and improved assessment and
    communication of treatment outcomes related to quality of life.
        2. Standardization of scales to measure incontinence severity and
    quality of life.
        3. Assessment of the utility of diagnostic tests for affecting
    management strategies and treatment outcomes.
        4. Development of new drug compounds offering new treatment
    approaches to fecal incontinence.
        5. Development and testing of strategies for primary prevention of
    fecal incontinence associated with childbirth.
        6. Further understanding of the process of stigmatization as it
    applies to the experience of individuals with fecal incontinence.

                         IRRITABLE BOWEL SYNDROME (IBS)

        IBS affects between 25 and 45 million people of all ages in the
    United States (an estimated 10 to 15 percent of the population). The
    disorder affects people of all ages, even children. Approximately 60 to
    65 percent of IBS sufferers in the United States are reportedly female
    and 35 to 40 percent are male. This chronic disease is characterized by
    a group of symptoms, which can include abdominal pain or discomfort
    associated with a change in bowel pattern, such as loose or frequent
    bowel movements, and/or hard or infrequent bowel movements. Although
    the cause of IBS is not understood, it is becoming clear that this
    disease needs a multidisciplinary approach in research.
        Similar to other chronic illnesses and depending on severity, IBS
    can be emotionally and physically debilitating. Because of persistent,
    unpredictable, and often painful bowel symptoms, maintaining work or
    academic schedules becomes challenging. Individuals who suffer from
    this disorder may distance themselves from social activities and even
    may fear leaving their home.
        In the House and Senate Fiscal Year 2004 Labor, Health and Human
    Services, and Education Appropriations bills, Congress recommended that
    the National Institute of Diabetes and Digestive and Kidney Diseases
    (NIDDK) develop an IBS strategic plan. The development of a strategic
    plan on IBS would greatly increase the institute's progress toward the
    needed research on this functional gastrointestinal disorder.

                     GASTROESOPHAGEAL REFLUX DISEASE (GERD)

        Gastroesophageal reflux disease, or GERD, is a very common disorder
    affecting both adults and children, which results from the back-flow of
    acidic stomach contents into the esophagus. GERD is often accompanied
    by persistent symptoms, such as chronic heartburn and regurgitation of
    acid. But sometimes there are no apparent symptoms, and the presence of
    GERD is revealed when complications become evident. Symptoms of GERD
    vary from person to person. The majority of people with GERD have mild
    symptoms, with no visible evidence of tissue damage and little risk of
    developing complications. However, periodic heartburn is a symptom so
    common that many people overlook its potential to cause tissue damage
    and disease. This is unfortunate because, through awareness and a
    diagnosis, individuals can receive one of several treatment options
    available for GERD. Untreated, GERD may lead to severe complications
    such as inflammation, stricture, or Barrett's esophagus, a potentially
    pre-cancerous condition.
        Gastroesophageal reflux, involving regurgitation of gastric
    contents into the esophagus, affects as many as one-third or more of
    all full term infants born in America each year, but generally resolves
    by 6 to 12 months of age. Gastroesophageal reflux disease (GERD)
    results when symptoms persist or tissue damage occurs. Medical therapy
    may then be required in order to control the disease, which in infants
    commonly manifests as symptoms such as regurgitation with poor weight
    gain, esophagitis, respiratory symptoms, or irritability. In children
    and adolescents, the natural history of GERD is similar to that of
    adult patients, in whom GERD tends to be persistent and may require
    long-term treatment.

                               ESOPHAGEAL CANCER

       Approximately 13,000 new cases of esophageal cancer are diagnosed
    every year in this country. Although the causes of this cancer are
    unknown, it is thought that it may be more prevalent in individuals who
    develop Barrett's esophagus. Diagnosis usually occurs when the disease
    is in an advanced stage; early effective screening tools are needed.

                      GASTROINTESTINAL MOTILITY DISORDERS

        Gastrointestinal motility disorders can affect any part or parts of
    the gastrointestinal tract. Gastroparesis, chronic intestinal pseudo-
    obstruction (CIP), and Hirschsprung's disease, are just a few examples
    of gastrointestinal motility disorders.
        Gastroparesis is a painful disorder where the nerves to the stomach
    are damaged or stop working, which leads to the stomach taking too long
    to empty its contents. Symptoms of gastroparesis can include: nausea,
    vomiting, early satiety or an early feeling of fullness when eating,
    weight loss, abdominal bloating, and abdominal discomfort. This
    disorder is often a complication of diabetes. An estimated 20 percent
    of people with type 1 diabetes develop gastroparesis. Individuals with
    type 2 diabetes can also develop gastroparesis.
        Approximately, 200 new cases of Chronic Intestinal Pseudo-
    Obstruction or CIP are diagnosed in American children each year. This
    rare and serious disorder occurs when coordinated contractions, or
    peristalsis, in the intestinal tract become altered and inefficient.
    When this happens, nutritional requirements cannot be adequately met.
    CIP is often life threatening and treatment challenging. Continued
    clinical and basic research is needed before the disease is fully
    understood, and improved treatment or ultimately a cure found.
        Hirschsprung's disease (HD) is a serious and sometimes life-
    threatening congenital disorder that is caused by absence of nerve
    cells in the rectum and/or colon, which can cause obstruction,
    inflammation, and severe constipation. It occurs in about one out of
    every 5,000 American children born each year. The treatment is
    primarily surgical to remove the abnormal bowel. Approximately 10-20
    percent of children with HD will continue to have complications
    following surgery. These complications include infection, fecal
    incontinence, and persistent constipation.

      FUNCTIONAL GASTROINTESTINAL AND MOTILITY DISORDERS AND THE NATIONAL
                              INSTITUTES OF HEALTH

        The International Foundation for Functional Gastrointestinal
    Disorders recommends an increase to $30.8 billion or 10 percent for NIH
    overall, and a 10 percent increase for NIDDK, or $1.85 billion.
    However, we request that this increase for NIH does not come at the
    expense of other Public Health Service agencies.
        We urge the subcommittee to provide the necessary funding for the
    expansion of the NIDDK's research program on functional
    gastrointestinal (GI) and motility disorders, this increased funding
    will allow for the growth of new research, a prevalence study and a
    strategic plan on IBS, and increased public and professional awareness
    of functional GI and motility disorders.
        A primary goal of IFFGD's mission is to ensure that advancements
    concerning GI disorders result in improvements in care and the quality
    of life of those affected. As we all work together, it is hoped this
    goal will be realized and the suffering and pain millions of people
    face daily will end.
        Mr. Chairman, on behalf of millions of patients and the families of
    those with functional GI or motility disorders thank you for your
    consideration.
    The International Foundation for Functional Gastrointestinal Disorders
        The International Foundation for Functional Gastrointestinal
    Disorders is a nonprofit education and research organization founded in
    1991. IFFGD addresses the issues surrounding life with gastrointestinal
    (GI) functional and motility disorders and increases the awareness
    about these disorders among the general public, researchers, and the
    clinical care community.
                                     ______

          Prepared Statement of the Hepatitis Foundation International

                  SUMMARY OF FISCAL YEAR 2005 RECOMMENDATIONS

      --Continue the great strides in research and prevention at the
            National Institutes of Health (NIH) by providing a 10 percent
            budget increase for fiscal year 2005. Increase funding for the
            National Institute for Allergy and Infectious Diseases (NIAID)
            and the National Institute of Diabetes and Digestive and Kidney
            Diseases (NIDDK) by 10 percent.
      --$41 million in fiscal year 2005 for a hepatitis B vaccination
            program for high risk adults at CDC as recommended by the
            National Hepatitis C Prevention Strategy.
      --$40 million in fiscal year 2005 for CDC's Prevention Research
            Centers.
      --Continued support of the National Viral Hepatitis Roundtable.
        Mr. Chairman and members of the subcommittee thank you for your
    continued leadership in promoting better research, prevention, and
    control of diseases affecting the health of our nation. I am Thelma
    King Thiel, Chairman and Chief Executive Officer of the Hepatitis
    Foundation International (HFI), representing members of 425 patient
    support groups across the nation, the majority of whom suffer from
    chronic viral hepatitis.
        Currently, five types of viral hepatitis have been identified,
    ranging from type A to type E. All of these viruses cause acute, or
    short-term, viral hepatitis. Hepatitis B, C, and D viruses can also
    cause chronic hepatitis, in which the infection is prolonged, sometimes
    lifelong. While treatment options are available for all types of
    hepatitis, individuals with chronic viral hepatitis (types B, C, and D)
    represent the majority of liver failure and transplant patients.
    Treatment options and immunizations are available for most types of
    hepatitis (see below). However, all types of viral hepatitis are
    preventable.

                                  HEPATITIS A

        The hepatitis A virus (HAV) is contracted through fecal/oral
    contact (i.e. fecal contamination of food, or diaper changing tables if
    not cleaned properly), and sexual contact. In addition, eating raw or
    partially cooked shellfish contaminated with HAV can spread the virus.
    Children with HAV usually have no symptoms; however, adults may become
    quite ill suddenly experiencing jaundice, fatigue, nausea, vomiting,
    abdominal pain, dark urine/light stool, and fever. There is no
    treatment for HAV; however, recovery occurs over a 3 to 6 month period.
    About 1 in 1,000 with HAV suffer from a sudden and severe infection
    that may require a liver transplant. Luckily, a highly effective
    vaccine can prevent HAV. This vaccination is recommended for
    individuals who have chronic liver disease (i.e. HCV or HBV) or
    clotting factor disorders, in addition to those who travel or work in
    developing countries.

                                  HEPATITIS B

        Hepatitis B (HBV) claims an estimated 5,000 lives every year in the
    United States, even though we have therapies to both prevent and treat
    this disease. This disease is spread through contact with the blood and
    body fluids of an infected individual. Unfortunately, due to both a
    lack in funding to vaccinate adults at high risk of being infected and
    the absence of an integrated preventive education strategy,
    transmission of hepatitis B continues to be problematic. Additionally,
    there are significant disparities in the occurrence of chronic HBV-
    infections. Asian Americans represent four percent of the population;
    however, they account for over half of the 1.3 million chronic
    hepatitis B cases in the United States. Current treatments have limited
    success in treating the chronically infected and there is no treatment
    available for those who are considered ``HBV carriers.'' Preventive
    education and vaccination are the best defense against hepatitis B.

                                  HEPATITIS C

        Infection rates for hepatitis C (HCV) are at epidemic proportions.
    Unfortunately, as many are not aware of their infection until several
    years after infection, we are dealing with an ``epidemic of
    discovery.'' This creates a vicious cycle, as individuals who are
    infected continue to spread the disease, unknowingly. Hepatitis C is
    also spread through contact with an infected individual's blood. The
    CDC estimates that there are over 4 million Americans who have been
    infected with hepatitis C, of which over 2.7 million remain chronically
    infected, with 8,000-10,000 deaths each year. Additionally, the death
    rate is expected to triple by 2010 unless additional steps are taken to
    improve outreach and education on the prevention of hepatitis C, new
    research is undertaken, and case-finding is enhanced and more effective
    treatments are developed. As there is no vaccine for HCV, prevention
    education and treatment of those who are infected serve as the most
    effective approach in halting the spread of this disease.

                             PREVENTION IS THE KEY

        Only a major investment in immunization and preventive education
    will bring these diseases under control. All newborns, young children,
    young adults, and especially those who participate in high-risk
    behaviors must be a priority for immunization, outreach initiatives and
    preventive education. We recommend that the following activities be
    undertaken to prevent the further spread of all types of hepatitis:
      --Provide effective preventive education in our elementary and
            secondary schools helping children avoid the ravages of health
            problems resulting from viral hepatitis infection.
      --Training educators, health care professionals, and substance abuse
            counselors in effective communication and counseling
            techniques.
      --Public awareness campaigns to alert individuals to assess their own
            risk behaviors, motivate them to seek medical advice, encourage
            immunization against hepatitis A and B, and to stop the
            consumption of any alcohol if they have participated in risky
            behaviors that may have exposed them to hepatitis C.
      --Expansion of screening, referral services, medical management,
            counseling, and prevention education for individuals who have
            HIV/AIDS, many of whom may be co-infected with hepatitis.
        HFI recommends an increase of $41 million in fiscal year 2005 for
    further implementation of CDC's Hepatitis C Prevention Strategy. This
    increase will support and expand the development of state-based
    prevention programs by increasing the number of state health
    departments with CDC funded hepatitis coordinators. The Strategy will
    use the most cost-effective way to implement demonstration projects
    evaluating how to integrate hepatitis C and hepatitis B prevention
    efforts into existing public health programs. Additionally, HFI
    recommends that $10 million be used to train and maintain hepatitis
    coordinators in every state.
        CDC's Prevention Research Centers, an extramural research program,
    plays a critical role in reducing the human and economic costs of
    disease. Currently, CDC funds 26 prevention research centers at schools
    of public health and schools of medicine across the country. HFI
    encourages the Subcommittee to increase core funding for these
    prevention centers, as it has been decreasing since this program was
    first funded in 1986. We recommend the Subcommittee provide $40 million
    for the Prevention Research Centers program in fiscal year 2005.

                            INVESTMENTS IN RESEARCH

        Investment in the National Institutes of Health (NIH) has led to an
    explosion of knowledge that has advanced understanding of the
    biological basis of disease and development of strategies for disease
    prevention, diagnosis, treatment, and cures. Countless medical advances
    have directly benefited the lives of all Americans. NIH-supported
    scientists remain our best hope for sustaining momentum in pursuit of
    scientific opportunities and new health challenges. For example,
    research into why some HCV infected individuals resolve their infection
    spontaneously may prove to be life saving information for others
    currently infected. Other areas that need to be addressed are:
      --Reasons why African Americans do not respond to antiviral agents in
            the treatment of chronic hepatitis C.
      --Pediatric liver diseases, including viral hepatitis.
      --The outcomes and treatment of renal dialysis patients who are
            infected with HCV.
      --Co-infections of HIV/HCV and HIV/HBV positive patients.
      --Hemophilia patients who are co-infected with HIV/HCV and HIV/HBV.
      --The development of effective treatment programs to prevent
            recurrence of HCV infection following liver transplantation.
      --The development of effective vaccines to prevent HCV infection.
        The Hepatitis Foundation International supports a 10 percent
    increase for NIH in fiscal year 2005. HFI also recommends a comparable
    increase of 10 percent in hepatitis research funding at the National
    Institute of Diabetes and Digestive and Kidney Diseases and the
    National Institute of Allergy and Infectious Diseases.

                      NATIONAL VIRAL HEPATITIS ROUNDTABLE

        Victims of hepatitis suffer emotionally as well as physically. They
    experience discrimination in employment, strained personal
    relationships and severe depression when treatments fail to control
    their illness as well as during their treatment. Traditionally,
    however, there has not been an organized effort to periodically convene
    all stakeholder organizations that play a role in hepatitis prevention,
    education, treatment and patient advocacy. Successfully addressing
    viral hepatitis will require a comprehensive and strategic approach
    developed by all key stakeholders.
        In order to fill this void, HFI and CDC co-founded the ``National
    Viral Hepatitis Roundtable.'' HFI believes that a National Viral
    Hepatitis Roundtable will enhance and assist CDC's viral hepatitis
    mission for the prevention, control, and elimination of hepatitis virus
    infections in the United States, as well as the international public
    health community. It will provide an infrastructure for the sharing of
    information and education of all stakeholders.
        The ``National Viral Hepatitis Roundtable'' is a coalition of
    public, private, and voluntary organizations dedicated to reducing the
    incidence of infection, morbidity, and mortality from viral hepatitis
    in the United States through research, strategic planning,
    coordination, advocacy, and leadership.
        HFI is dedicated to the eradication of viral hepatitis, which
    affects over 500 million people around the world. We seek to raise
    awareness of this enormous worldwide problem and to motivate people to
    support this important--and winnable--battle. Thank you for providing
    this opportunity to present our testimony.
    The Hepatitis Foundation International
        The Hepatitis Foundation International (HFI) is dedicated to the
    eradication of viral hepatitis, a disease affecting over 500 million
    people around the world. We seek to raise awareness of this enormous
    worldwide problem and to motivate people to support this important--and
    winnable--battle.
        Our mission has four distinct parts:
      --Teach the public and hepatitis patients how to prevent, diagnose,
            and treat viral hepatitis.
      --Prevent viral hepatitis by promoting liver wellness and healthful
            lifestyles.
      --Serve as advocates for hepatitis patients and the related medical
            community worldwide.
      --Support research into prevention, treatment, and cures for viral
            hepatitis.
                                     ______

     Prepared Statement of the Charles R. Drew University of Medicine and
                                    Science

                SUMMARY OF RECOMMENDATIONS FOR FISCAL YEAR 2005

      --A 10 percent increase for all institutes and centers at the
            National Institutes of Health (NIH), specifically the National
            Center for Research Resources (NCRR), the National Center for
            Minority Health and Health Disparities (NCMHD), and the
            National Cancer Institute (NCI).
      --Urge NCI to continue to support the establishment of collaborative
            minority health comprehensive cancer centers at historically
            minority institutions in collaboration with existing NCI cancer
            centers. Continue to urge NCRR and NCMHD to collaborate on the
            establishment of a cancer center at a historically minority
            institution.
      --Urge the Department of Health and Human Services, particularly the
            Office of Minority Health (OMH), to develop a focused effort on
            faculty support to address the residency training programs at
            minority medical institutions.
        Mr. Chairman and members of the subcommittee, thank you for the
    opportunity to present you with testimony. Charles R. Drew University
    is one of four predominantly minority medical schools in the country,
    and the only one located west of the Mississippi River.
        Charles R. Drew University of Medicine and Science is located in
    the Watts-section of South Central Los Angeles, and has a mission of
    rendering quality medical education to underrepresented minority
    students, and, through its affiliation with the University of
    California Los Angeles (UCLA) at the co-located King-Drew Medical
    Center, Drew provides valuable health care services to the medically
    underserved community. Through innovative basic science, clinical, and
    health services research programs, Drew University works to address the
    health and social issues that strike hardest and deepest among inner
    city and minority populations.
        The population of this medically underserved community is
    predominately African American and Hispanic. Many of these people would
    be without health care if not for the services provided by the King-
    Drew Medical Center and Charles R. Drew University of Medicine and
    Science. This record of service has led Charles R. Drew University (in
    partnership with UCLA School of Medicine) to be designated as a Health
    Resources and Services Administration Minority Center of Excellence.

                        A RESPONSE TO HEALTH DISPARITIES

        Racial and ethnic disparities in health outcomes for a multitude of
    major diseases in minority and underserved communities continue to
    plague this nation that was built on a premise of equality. As
    articulated in the Institute of Medicine report entitled ``Unequal
    Treatment: Confronting Racial and Ethnic Disparities in Health Care'',
    this problem is not getting better on its own. For example, African
    American males develop cancer 15 percent more frequently than white
    males. Similarly, African American women are not as likely as white
    women to develop breast cancer, but are much more likely to die from
    the disease once it is detected. In fact, according to the American
    Cancer Society, those who are poor, lack health insurance, or otherwise
    have inadequate access to high-quality cancer care, typically
    experience high cancer incidence and mortality rates. Despite these
    devastating statistics, we are still not doing enough to try to combat
    cancer in our communities.
        In response to these findings and the high cancer rate in our own
    community, Charles R. Drew University of Medicine and Science proposes
    that a Minority Health Comprehensive Cancer Center be built on its
    campus.
        The Center would specialize in providing not only medical treatment
    services for the community, but would also serve as a research
    facility, focusing on prevention and the development of new strategies
    in the fight against cancer.
        Mr. Chairman, the support that this subcommittee has given to the
    National Institutes of Health (NIH) and its various institutes and
    centers has and continues to be invaluable to our University and our
    community. The dream of a state of the art facility to aid in the fight
    against cancer in our underserved community would be impossible without
    the resources of NIH.
        To help facilitate the establishment of a Minority Health
    Comprehensive Cancer Center at Charles R. Drew University of Medicine
    and Science, the University is seeking support from the National
    Institutes of Health's National Center for Research Resources (NCRR),
    the National Center for Minority Health and Health Disparities (NCMHD),
    and the National Cancer Institute (NCI).

               ACADEMIC RENEWAL AND CLINICAL FACULTY RECRUITMENT

        Some of the major challenges faced in sustaining high quality
    graduate medical education programs in ``safety-net'' medical centers
    with missions focused on the medically underserved, are directly
    related to the lack of sufficient numbers of clinical faculty highly
    trained in academic medicine. To address these challenges, a plan for
    academic enrichment is proposed.
        The plan is a strategic initiative to position Charles R. Drew
    University in the first decade of the 21st Century, as a leader in
    Urban Academic Health Sciences with an emphasis on training physicians
    and other health professionals to meet the needs of the medically
    underserved. The Plan for Academic Enrichment is an opportunity to
    enhance the impact of Charles R. Drew University as a national center
    of excellence in meeting the national, state, and local challenge of
    preparing a diverse complement of excellent physicians and other health
    professionals to close the health disparity gap by affording culturally
    sensitive quality care to the medically underserved and economically
    disadvantaged. A central component of the plan is the enrichment of
    academic excellence through the recruitment of new, highly qualified
    clinical teaching faculty, with solid research skills, to be members of
    the Charles R. Drew College of Medicine faculty to strengthen both the
    graduate and undergraduate medical education programs.

                                   CONCLUSION

        Despite our knowledge about racial/ethnic, socio-cultural and
    gender-based disparities in health outcomes, the ``gap'' continues to
    widen in most instances. Not only are minority and underserved
    communities burdened by higher disease rates, they are less likely to
    have access to quality care upon diagnosis. As you are aware, in many
    minority and underserved communities preventive care and/or research is
    completely inaccessible either due to distance or lack of facilities
    and expertise. This is a critical loss of untapped potential in both
    physical and intellectual contributions to the entire society.
        Even though institutions like Drew are ideally situated (by
    location, population, and institutional commitment) for the study of
    conditions in which health disparities have been well documented,
    research is limited by the paucity of appropriate research facilities.
    With your help, this cancer center will facilitate translation of
    insights gained through research into greater understanding of
    disparities in cancer incidence, morbidity and mortality and ultimately
    to improved outcomes.
        We look forward to working with you to lessen the burden of cancer
    for all Americans through greater understanding of cancer, its causes,
    and its cures. We also look forward to working with the Department of
    Health and Human Services to address the residency training program
    issues at Charles R. Drew University.
        Mr. Chairman, thank you for the opportunity to present on behalf of
    Charles R. Drew University of Medicine and Science.
                                     ______

                   Prepared Statement of Mended Hearts, Inc.

        I am Robert H. Gelenter, the legal representative for the Mended
    Hearts, Inc, a national heart disease patient support group of more
    than 289 chapters across the country and in Canada. We visit patients
    in about 460 hospitals throughout the United States. I have been
    appointed by the group to assist in this lobbying effort--a volunteer
    position.
        More than 28 years ago, I was diagnosed with a rare heart disease.
    After having severe chest pains and trouble breathing for more than 2
    years, I was diagnosed with hypertrophic cardiomyopathy, a disease in
    which the heart enlarges. The heart muscle eventually thickens so much
    that it can't pump blood effectively and does not grow in the normal
    parallel patterns. An estimated 36 percent of young athletes who die
    suddenly die from this disease. But, it affects men and women of all
    ages. It is sudden and one of the things known about this disease is
    sudden cardiac death. There is no cure for this disease. Medication may
    work and there is surgery that may or may not alleviate the pain. If
    that doesn't work a patient may need a heart transplant, yet spare
    organs are scarce. The doctor who made my diagnosis was trained at the
    National Heart, Lung, and Blood Institute of the National Institutes of
    Health.
        Initially, I received several medications which allowed me to
    engage in most activities. But, some activities, such as walking up
    hills, gave me problems like shortness of breath and severe chest
    pains. But, generally I could function normally. However, after about
    11 years, the discomfort was increasing, and it became apparent that I
    was in serious trouble. I could not walk 60 feet without having to stop
    to catch my breath. Sometimes the pain was so great that I would almost
    double over in the middle of the street. My wife told me that my face
    would become gray. The perspiration would pour off by body. If I was
    lucky I could find a chair to sit on. The quality of my life had
    deteriorated so drastically that I knew I needed some treatment.
        Finally in 1988, I went to Georgetown University Medical Center for
    an angiogram--the gold standard for diagnosing heart problems. The
    cardiologist who performed the angiogram told me that he had bad news
    and worse news. The bad news was that I had a 95 percent blockage in my
    left anterior descending heart artery--the so-called ``widow makers
    spot.'' The worse news was that I had a major chance of having a major
    heart attack with a less than a 5 percent chance of surviving that
    heart attack because of the hypertrophic cardiomyopathy. At this point,
    my wife was quietly crying and I was perspiring profusely. Since
    Georgetown University Medical Center did not have the expertise to
    operate on me, they called the NIH to see if they would accept me as a
    patient. I was sent home pending notice from the NIH.
        My parents begged me to go to New York or San Francisco for second
    opinions. But, I knew that I had run out of alternatives. No matter
    what the result, I needed treatment and I needed it immediately.
        I was accepted by the NIH. After entering the National Heart, Lung,
    and Blood Institute on February 6, I was operated on February 11, 1988.
    No matter how trite the expression--that was the first day of the rest
    of my life. The surgery, considered drastic and rare, is still
    considered the gold standard throughout the world for the treatment of
    hypertrophic cardiomyopathy. The Murrow Procedure, in honor of the
    creator, was developed and improved at the NIH.
        Although this surgery is no longer performed at the National Heart,
    Lung, and Blood Institute, there is another experimental ongoing
    protocol in which the same effect is being attempted by using alcohol
    to deaden the excessive heart tissue.
        Now, I am on medication for the rest of my life. My condition is
    progressive. Eight years ago, I was fitted with a pacemaker to insure
    that my heart beats at the correct rate. I am 100 percent dependent on
    this pacemaker. Without the pacemaker, there are times when my normal
    heart beat is so slow that I would die.
        I am eternally grateful to the physicians funded by the National
    Heart, Lung, and Blood Institute, particularly to Dr. MacIntosh and his
    staff, for the gift of life. Because of this marvelous research
    supported by the NHLBI, I have lived 15 years pain free. I have seen
    two children graduate from college and three grandchildren born, I have
    shared these years with a wonderful wife. I have been able to work at
    my profession--an attorney at law.
        I have had the gift of life restored to me. So to express my
    gratitude for that gift, I visit patients recovering from heart
    episodes at two hospitals, Washington Hospital Center and Washington
    Adventist Hospital.
        I ask for an fiscal year 2005 appropriation of $3.5 billion for the
    NHLBI, including $2.1 billion for its heart disease and stroke-related
    budget.
        My experience is the proof that the research supported by the
    National Heart, Lung, and Blood Institute benefits not just the
    patients at the NIH Clinical Center, but throughout the United States.
    The benefits go worldwide as well.
        Heart attack, stroke and other cardiovascular diseases remain the
    No. 1 killer and major cause of disability of men and women in the
    United States. Nearly 40 percent of people who die in the United States
    die from cardiovascular diseases. This year, more than 930,000
    Americans will die from cardiovascular diseases, including almost
    150,000 under the age of 65.
        Thank you for your support of National Heart, Lung, and Blood
    Institute's heart research.
                                     ______

            Prepared Statement of the American College of Cardiology

                                  INTRODUCTION

        The American College of Cardiology (ACC) is a 30,890 member non-
    profit professional medical society and teaching institution whose
    mission is to advocate for quality cardiovascular care--through
    education, research promotion, development and application of standards
    and guidelines--and to influence health care policy. The College
    represents more than 90 percent of the cardiovascular specialists
    practicing in the United States. The ACC submits for the record this
    statement of support for increased funding for heart-related research
    through the National Heart, Lung, and Blood Institute (NHLBI) in fiscal
    year 2005, as well as support for increased funding for the Agency for
    Health Care Research and Quality (AHRQ), education and awareness
    programs through the Centers for Disease Control and Prevention (CDC)
    State Heart Disease and Stroke Prevention Program, and state and local
    programs designed to increase public access to automated external
    defibrillators (AEDs).
        The ACC expresses its appreciation to Congress for successfully
    completing the doubling of the NIH budget by fiscal year 2003. Although
    the increase in funding has greatly benefited cardiovascular-related
    research, the National Institutes of Health (NIH) still invests only 8
    percent of its budget on heart research and a mere 1 percent on stroke
    research--a funding level that fails to reflect that 40 percent of all
    deaths in this country are attributable to cardiovascular disease. The
    ACC appreciates current budget constraints, but hopes this subcommittee
    will continue its commitment toward medical research funding and the
    improvement of public health in the fiscal year 2005 budget. According
    to a recent study conducted by MEDTAP International and co-sponsored by
    the ACC, national health advancements since 1980 are due primarily to
    investments in health care, and for each additional dollar spent in the
    United States for health care services $2.40 to $3.00 in tangible gains
    have been made.
        The ACC, however, is concerned that President Bush's proposed
    fiscal year 2005 budget calls for only a 2.6 percent increase above
    fiscal year 2004 levels for the NIH and only a 0.3 percent increase for
    the CDC's Heart Disease and Stroke Prevention Program. Low-level
    funding increases for NIH, in addition to inadequate funding levels
    proposed in the President's budget for enhanced public access to AEDs,
    and the flat-funding proposed for the AHRQ, is of great concern to the
    ACC and its members.
        Cardiovascular disease continues to claim more lives each year than
    the next seven leading causes of death combined. Recent data shows that
    in 2001 more than 64 million Americans were shown to have suffered from
    at least one form of cardiovascular disease, of which nearly 1 million
    died as a direct result. The overall (indirect and direct) cost of
    cardiovascular disease for 2004 is estimated to be at least $368.4
    billion. Heart disease is not only tragically rampant in the United
    States, but it is also financially burdensome. The ACC believes that
    further investment in life-saving research, as well as in education and
    awareness programs, is essential to combat the leading cause of death
    of men and women in this country.
        The ACC Supports the Following fiscal year 2005 Appropriations
    Funding Levels:
      --NIH (overall funding)--$30.6 billion
      --NHLBI--$3.5 billion (includes $2.1 billion for heart- and stroke-
            related activities)
      --AHRQ--$443 million
      --CDC State Heart Disease and Stroke Prevention Program--$80 million
      --Community and Rural AED Access--$45 million

                                MEDICAL RESEARCH

        The ACC believes that the federal government must expand its
    financial commitment to medical research, most specifically at the
    NHLBI, through support for the NIH and its new ``NIH Roadmap''
    initiative which was initiated at NIH to help identify major
    opportunities and gaps in biomedical research and allow for greater
    collaboration between all NIH institutes. Increased NHLBI funding over
    the years has allowed investigators to develop better diagnostic tools
    and surgical techniques, as well as study new methods of treatment for
    cardiac patients. We must aim for better patient prevention, early
    cardiovascular disease diagnoses, and improved treatment of our
    patients. As such, the ACC is particularly supportive of initiatives
    related to clinical cardiology and issues of clinical relevance to the
    practice of cardiology. The ACC also firmly believes in the value of
    promoting clinical investigative careers and of large-scale clinical
    trials which aid the discovery and application of therapeutic and/or
    medical treatments to cardiovascular disease. In addition, the ACC
    would like to stress the importance of funding the AHRQ at a level that
    allows for their continued application of research to cardiovascular
    care. AHRQ activities play a large role in ensuring that our members
    can provide patients with the most up-to-date and effective treatments
    available.

    Research Success Due to Past Legislative Investment in NHLBI
        Another major advancement during the NIH doubling was with the
    implementation of a major clinical trial testing approaches to lowering
    the risk of cardiovascular disease in adults with Type 2 diabetes.
    Seventy percent of Americans diagnosed with Type 2 diabetes ultimately
    die of cardiovascular disease. The ACC is quite concerned about the
    cardiovascular health impact of diabetes and obesity in Americans,
    particularly in children. This trial, referred to as Action to Control
    Cardiovascular Risk in Diabetes (ACCORD) evaluates the effects of
    intense blood sugar control along with very aggressive control of blood
    pressure and lipids. The overall goal of ACCORD is to discover a better
    treatment for those suffering from Type 2 diabetes than is presently
    available. The ACC is pleased to see research attention being paid to
    the correlation of diabetes and metabolic syndromes with cardiovascular
    disease, because this devotion of resources helps to gain a better
    understanding of and treatment methods for these debilitating diseases.
    Research Success Due to Investments in Women and Heart Disease
        This year, more women than men will die from cardiovascular
    disease, making the inclusion of women in more heart-related research
    studies absolutely integral. Since 1984, men have experienced a decline
    in deaths due to cardiovascular disease, yet despite a growing number
    of female-specific research initiatives, women have not yet experienced
    this decline.
        To this end, the ACC is proud to be participating in several
    national campaigns this year that help raise awareness about the
    incidence and morbidity of heart disease and stroke in women, including
    the NHLBI's The Heart Truth, and the American Heart Association's ``Go
    Red for Women.'' In addition, on February 20, 2004, the ACC teamed with
    the Sister to Sister Foundation for its National Woman's Heart Day to
    help provide free screenings, educational seminars, cardiovascular
    health information, and fitness and cooking demonstrations to women
    around the country. The ACC is pleased that new clinical studies are
    underway at NIH that will hopefully help clarify the gender differences
    that directly affect diagnosis and treatment of women with heart
    disease.
                Women's Health Initiative
        Thanks to Congress' financial commitment during the doubling of the
    NIH budget, the NHLBI was able to proceed with the Women's Health
    Initiative (WHI) which yielded the first conclusive evidence of risks
    associated with long-term estrogen plus progestin hormone replacement
    therapy (HRT). This groundbreaking discovery changed the delivery of
    care for millions of American women and raised the public's awareness
    regarding heightened risks for heart attack, stroke and/or blood clots
    during long-term HRT use. The ACC was pleased by the findings yielded
    through the WHI and would like to see continued research focused on the
    unique causes and outcomes of heart disease in women. The ACC also
    believes that only through randomized clinical trials can we fully
    understand how medicines and devices affect human health.
                Women's Ischemia Syndrome Evaluation
        The Women's Ischemia Syndrome Evaluation (WISE) Study is a four-
    center, NHLBI study evaluating approximately 1,000 women referred for
    elective diagnostic coronary angiography because of suspected ischemia,
    a shortage of oxygen and blood to the heart muscle. It is the largest
    NIH-funded study dedicated solely to women, with the goal of examining
    the nature and scope of gender differences in both chronic and acute
    cardiac ischemia.
        Prior reports suggested that, compared with men, clinical
    manifestations of ischemic heart disease in women appear approximately
    10 or more years later. Women demonstrate more symptoms suggesting
    ischemic heart disease, yet the symptoms in women, such as chest
    discomfort and dyspnea, are more difficult to interpret.
        There is now a better snapshot of the extent of cardiovascular
    disease in women, thanks to WISE Study findings revealed at the ACC
    Annual Scientific Session in March 2004 (ACC 2004) by Barry L. Sharaf,
    M.D., F.A.C.C. Based on the 4-year, risk-adjusted outcomes by extent of
    coronary disease, there was a 9.4 percent death or myocardial
    infarction (MI) rate (or about 2.7 percent annually) in women with
    minimal or no symptoms of disease detected by angiography. This is an
    unacceptable event rate. In another presentation by Leslee J. Shaw,
    Ph.D., at ACC 2004 regarding the WISE Study, the estimated lifetime
    cost of care for cardiovascular disease detected by angiography was
    detailed. Dr. Shaw found that women with no disease detectable by
    angiography have in excess of three-quarters of a million dollars
    lifetime costs for care. In an era of shrinking health care resources,
    such a high cost is unsustainable. This high rate of death or
    myocardial infarction, combined with escalating health care costs,
    clearly demonstrates the need for improved detection of cardiovascular
    disease in women.
        The ACC believes it is imperative to increase awareness among women
    about their risk of heart disease. Thanks to findings yielded from the
    WISE Study, cardiovascular specialists are gaining a better
    understanding that there is a ``female-pattern'' of ischemia-related
    symptoms that is distinct from that seen in men. Cardiologists have
    also come to understand that a ``clean'' angiogram in symptomatic women
    does not mean a benign outcome. The ACC believes that the WISE Study
    discoveries are a good start in unraveling the mystery of women and
    heart disease, but more research looking at issues like concealed
    plaque and inflammation in the vessel wall, the prognostic ability of
    blood markers, and the role of the microvasculature, needs to be
    conducted.

    NHLBI Research Opportunities Threatened by President's Fiscal Year 2005
            2.5 Percent Funding Increase
        Much progress has been made in cardiovascular research and clinical
    trials to this date, but the ACC believes that if the numbers proposed
    in the President's fiscal year 2005 budget are instituted new and
    exciting opportunities could be postponed if not cancelled, and the
    continuation and/or expansion of current NHLBI cardiovascular research
    programs could also be threatened. The ACC encourages Congress to take
    necessary steps to avoid such a predicament through funding the NHLBI
    at $3.5 billion in fiscal year 2005, so that the following
    fundamentally important programs among others have a chance of
    development.
                Enhancing the Use of Longitudinal Data on Cardiovascular
                        Disease and its Risk Factors in Older Adults: The
                        Cardiovascular Health Study (CHS)
        This initiative would allow for continued utilization of the data
    and specimens collected during the CHS study which began in 1987 and is
    set to terminate in 2005. Specifically, the initiative would ensure
    access to CHS data and specimens to the entire scientific community and
    allow for continued follow-up of study participants. Investigators are
    particularly interested in the research and treatment of cardiovascular
    disease in elderly patients (age 75 and older), a focus area which
    could be enhanced through the use of longitudinal data obtained by the
    CHS.
                Randomized Trial of Heart Failure (HF) Management
        ACC believes that the incorporation of clinical practice methods
    and provider education into NHLBI trials benefits not only
    cardiovascular patients but also the cardiologists who translate new
    therapies into regular cardiovascular care techniques. This trial is a
    perfect example of a mutually beneficial initiative. The multi-center/
    randomized trial would assess costs, quality of life, physician
    compliance, and patient adherence to prescribed treatments in order to
    identify and disseminate clinically useful and effective tools for
    translation of proven therapies for HF into clinical practice.
                Community-Responsive Interventions to Reduce Cardiovascular
                        Risk in American Indians and Alaska Natives
        Despite the fact that American Indians and Alaska Natives are
    disproportionately affected by cardiovascular diseases, the President's
    2.5 percent budget increase for NHLBI in fiscal year 2005 is inadequate
    for fostering the development of preventative intervention into
    community health care systems or through other health care means within
    American Indian and Alaska Native communities. If instituted within the
    fiscal year 2005 budget cycle, this NHLBI program would work to find
    solutions to obesity, diabetes, and cardiovascular diseases within
    these minority communities.

    Priority Research Programs at NHLBI for Fiscal Year 2005
        The NHLBI finds new and innovative methods for yielding research
    and clinical trial results year after year. These results, when
    translated into practice, ensure that cardiovascular specialists and
    other health care providers are able to provide patients with the
    highest quality care possible. Due largely to the medical research and
    education programs supported by the NHLBI, many Americans who suffer
    from or are at risk for cardiovascular disease now have access to a
    greater variety of diagnostic tests, medical treatments, and
    information about prevention. The research priorities set forth by the
    NHLBI are a direct result of input from health care community,
    including that of ACC members. The ACC believes it is imperative to
    appropriately fund the NHBLI in fiscal year 2005 so that the NHLBI can
    continue to create and implement ground-breaking cardiovascular
    research.
        Last year, the ACC recommended the implementation of an NHLBI
    program titled ``Overweight and Obesity Prevention and Control at the
    Worksite,'' which would support the design and testing of innovative
    worksite intervention to prevent and control overweight and obesity in
    adults. Almost two-thirds (61 percent) of American adults are
    overweight or obese, and each year an estimated 300,000 American adults
    die of causes related to obesity. The ACC is pleased that this program
    has officially gained NHLBI recognition and is being considered for
    implementation in fiscal year 2005. Some of the strategies within the
    program include implementing environmental and policy changes to
    increase employees' physical activity, offering healthful food choices
    in cafeterias and vending machines, and enhancing social support from
    fellow workers to encourage improved diet and physical activity. The
    ACC encourages Congress to concur with this NHLBI-recommended program
    and allow for full funding of the ``Overweight and Obesity Prevention
    and Control at the Worksite'' in fiscal year 2005.
        Currently there is a growing need to address cardiovascular
    infections caused by the bacterium Staphylococcus aureus, commonly
    referred to as Staph infections, following cardiac surgery. The ACC
    believes that there is great value in fully funding the NHLBI-proposed
    ``Clinical Trials for the Prevention and Treatment of Infections after
    Cardiac Surgery'' parallel randomized clinical trials. These trials
    would provide conclusive evidence of the need for improved control of
    Staph infections by assessing the costs and benefits of new
    antibacterial strategies. Due to the serious risk of infection
    following cardiac surgery, the ACC hopes that increased funding for the
    NHLBI will allow these important trials to be conducted.
        Collaboration among federal agencies has proven an effective and
    efficient means for enhancing research, facilitating appropriate
    regulation, and providing accurate clinical outcomes data. An
    ``Interagency Registry of Mechanical Circulatory Support for Heart
    Failure'' would create a registry of mechanical circulatory support for
    heart failure, as well as an associated tissue repository for shared
    use by all related federal agencies. Such a registry would help
    standardize reporting of patient characteristics, indications,
    implantation procedures, and adverse events. With increased funding for
    NHLBI in fiscal year 2005, such collaboration will be possible.

    AHRQ--Moving Research into Practice
        The research and education developments that the federal government
    has facilitated are remarkable and promising. However, the best
    research is of no value if it never reaches the patient. The AHRQ is
    charged with ensuring that advances in medicine become the baseline for
    medical care. By fulfilling the mission of placing today's
    breakthroughs in the hands of physicians tomorrow, AHRQ injects up-to-
    the-minute research into day-to-day medical decisions and treatments.
    The research facilitated by the AHRQ provides reliable information on
    health care outcomes, quality, cost, use, medical errors, and access,
    enabling the public to make better-informed decisions about health
    care. The ACC regularly works with AHRQ to create and disseminate
    cardiovascular clinical practice guidelines. Having the AHRQ address
    some of the evidence to practice issues remains a critical step in
    evaluating the utility of practice guidelines.
        For example, in fiscal year 2000, AHRQ released the ``Translating
    Research into Practice II (TRIP II)'' request for applications (RFA).
    The response to this RFA was overwhelming, so much so that currently 13
    studies are underway due to this initiative. TRIP II specifically
    focuses on increasing the frequency of partnerships between researchers
    and health care systems and organizations to heighten the effect of
    practice-based, patient outcome research in applied settings.
        Although the AHRQ remains a vital partner to both the clinical
    research community and other private sector organizations, it has not
    received a funding increase in the past two budget cycles. This
    continuous flat-funding does not allow the AHRQ to adjust to annual
    inflationary costs, nor does it provide the opportunity for new
    development or growth. The ACC is extremely concerned by this funding
    plateau particularly because of the AHRQ's central role in reviewing
    current scientific evidence and providing practical clinical
    information to the public, such as its recent work on blood pressure
    monitoring. The ACC urges Congress to support increased funding of the
    AHRQ at $443 million in fiscal year 2005.

                 CARDIOVASCULAR DISEASE AWARENESS AND EDUCATION

    CDC State Heart Disease and Stroke Prevention Program
        Education and awareness campaigns that focus on for heart disease
    and stroke prevention are in underway at the CDC's State Heart Disease
    and Stroke Prevention Program, but progress has been stalled due to
    insufficient funding. Only 11 of the 33 designated CDC State Heart
    Disease and Stroke Prevention Programs are funded adequately enough to
    progress from the planning stage to the implementation stage. This
    program's inventive heart disease and stroke reduction/control
    programs, particularly among underprivileged Americans, would help to
    reduce the incidence and impact of cardiovascular disease as well as to
    raise awareness of secondary preventative measures.
        The State Heart Disease and Stroke Prevention Program aims to
    prevent and control heart disease and stroke risk factors including
    high cholesterol and blood pressure. Yet, the program can not reach its
    full potential for saving lives and reducing the costs associated with
    the disease unless it becomes a fully functioning national program. The
    ACC encourages Congress to approve an fiscal year 2005 funding level of
    $80 million for the Heart Disease and Stroke Prevention Program at the
    CDC. Approving this funding level would guarantee elevation of
    additional states from the planning to the implementation stage of
    their prevention programs, to continue comprehensively fund those 11
    states whose programs are underway in the ``implementation stage,'' and
    to supply the states that have yet to begin the planning stage with the
    financial means for implementation and establishment of their own State
    Heart Disease and Stroke Prevention Programs.

    Public Access to AEDs
        Since its formal introduction in 1960, cardiopulmonary
    resuscitation (CPR) has been the mainstay in close-chest resuscitation
    of unresponsive cardiac attack victims. While this method is still an
    effective and recommended treatment for helping oxygenated blood reach
    the brain and organs, defibrillation through proper use of an AED is
    the only sure way to restore the heart's normal rhythm. For people
    experiencing sudden cardiac arrest, every minute counts. Unfortunately,
    for every minute that passes without defibrillation, a victim's chance
    of survival decreases by 7-10 percent. In only 8 or 10 minutes, death
    is nearly certain. The price of an AED varies by make and model, but
    typically costs around $3,000--a small price when compared with
    needless loss of life.
        AEDs accurately analyze cardiac rhythms and, if appropriate,
    deliver an electric lifesaving countershock. AEDs are widely used by
    trained emergency personnel and first responders such as firefighters
    and police personnel. Thanks to the growing body of evidence that
    ``public access defibrillation,'' or PAD, can decrease the amount of
    time between cardiac arrest and defibrillation, there has been a
    concerted effort to expand public access to AEDs and to improve
    training and education on these lifesaving devices. AEDs can now be
    found in most high-traffic public areas including schools, shopping
    malls, airports and convention centers.
        The ACC appreciates Congress' continued attention to the importance
    of public access to AEDs with the passage of several legislative
    initiatives over the past few years including the ``Automatic
    Defibrillation in Adam's Memory Act'' (Public Law 108-41), the ``Rural
    AED Act,'' the ``Cardiac Arrest Survival Act,'' and the ``Community
    Access to Emergency Defibrillation Act.'' While the ACC appreciates the
    Congress' commitment to this important issue, the financial commitment
    to Community and Rural AED programs dwindled in the fiscal year 2004
    budget despite the urging of the ACC and the AHA. Community and rural
    AED programs were grouped together and funded at less than $12 million,
    collectively in fiscal year 2004. The ACC is quite concerned that the
    benefits brought to communities around the country through increased
    access to AEDs could go unrealized if AED programs are not funded at a
    higher level in the fiscal year 2005 budget. The ACC, therefore, urges
    Congress to fund community and rural AED public access programs at $45
    million in fiscal year 2005.

                                   CONCLUSION

        The ACC is optimistic about what the future holds for the treatment
    and prevention of cardiovascular disease. The potential for work
    completed through the NHLBI, the CDC State Heart Disease and Stroke
    Prevention Programs, and the AHRQ, is enormous with a strong financial
    commitment from this subcommittee. The ACC encourages the subcommittee
    to continue its investment in cardiovascular research and educational
    programs within the fiscal year 2005 budget and appreciates the
    opportunity to share its views on this important topic.
                                     ______

       Prepared Statement of the National Coalition for Heart and Stroke
                                    Research

        My name is Jack Owen Wood. I solicit your support for more
    aggressive federal funding for research into prevention and treatment
    of the sister diseases, stroke and heart disease. Strokes and heart
    attacks are occurring at an alarming rate.
        I am representing the National Coalition for Heart and Stroke
    Research. The coalition consists of 18 national organizations
    representing more than 5 million volunteers and members united in
    support for increased funding for heart and stroke research. Members of
    the Coalition include: American Academy of Neurology; American Academy
    of Physical Medicine and Rehabilitation; American Association for
    Vascular Surgery; American Association of Neurological Surgeons;
    American College of Cardiology; American College of Chest Physicians;
    American Heart Association; American Neurological Association; American
    Stroke Association; Association of Black Cardiologists; Citizens for
    Public Action on Blood Pressure and Cholesterol, Inc.; Compliment;
    Congress of Neurological Surgeons; Mended Hearts, Inc.; National Stroke
    Association NASPE/Heart Rhythm Society; Society of Interventional
    Radiology; Society for Vascular Surgery; amd WomenHeart: the National
    Coalition for Women with Heart Disease.
        I will deal primarily with one man's personal experience with
    stroke and its functional and financial costs--my own. I have only the
    use of my right arm.
        I was born in 1937, raised in Vicksburg, Mississippi, earned an
    engineering degree at Mississippi State University and currently reside
    in Port Orchard, Washington.
        I worked for the Boeing Company in Seattle, am a former Director of
    the Washington State Energy Office, served as Director of Cost and
    Revenue Analysis and as the Forcasting Manager for a major Northwest
    Area Natural Gas Utility until May 1, 1995.
        On May 1, 1995, at the age of 57, I was stricken and severely
    disabled by my stroke. Two years later I experienced a triple bypass
    heart operation. You might say I've ``been there and done that'' for
    both major cardiovascular diseases. So you see, I am an expert.
        Several years ago I was offered an exciting and rewarding volunteer
    opportunity. I was asked to lead the ``JACK WOOD STROKE VICTOR TOUR''
    for the American Heart Association.
        The JACK WOOD STROKE VICTOR TOUR was a 5-state lobbying tour.
    Through it I tried to meet personally with every Northwest
    Congressional representative on his or her home turf (in Alaska, Idaho,
    Montana, Oregon and Washington). In each meeting I was joined by local
    people, stroke survivors and their families and medical professionals.
    I told my story and asked them to join the Congressional Heart and
    Stroke Coalition and to support increased federal funding for heart and
    stroke research.
        I am proud to say I traveled to 18 communities and met personally
    with 28 members of our delegation or their staff. Nearly half of our
    congressional delegation is now members of the Congressional Heart and
    Stroke Coalition.
        One of the most powerful memories for me was the frequency in which
    Members of Congress or staff members related their personal experience
    with stroke. One member I spoke to lost both parents to stroke. I
    suspect many of you have stories too.
        I realize your interest is greater than the physical impact of my
    stroke. Your concern must include the financial impact, not only to me,
    but also on our country from increased health care costs and lost
    productivity and its many implications.
        I have confronted the difficult and painful task of calculating
    that cost to me. Besides being a man whose stroke took his ability to
    pick up and play with his grandchildren and his livelihood, I remain a
    statistician at heart. I couldn't resist calculating and telling that
    part of my story. But please remember my story is not dissimilar to
    that of many of the 4.8 million stroke survivors in the United States.
    Many of whom were stricken in their prime earning years. Who in a
    matter of moments, seemingly without warning, are transformed from a
    contributor and provider to a receiver and patient.
        Allow me to highlight three figures that I feel sum up my data and
    should be important to you. I estimate that my stroke at age 57:
      --Reduced my earnings before retirement age 65 by over $600,000.
      --Subsequently, the cost to the federal government in lost income and
            other taxes, early Medicare payments and Social Security
            disability payments is over $320,000.
      --My HMO spent approximately $150,000 to respond to and treat my
            stroke.
      --One man, over $1 million.
        About 700,000 Americans will suffer a stroke this year costing this
    nation an estimated $54 billion in medical expenses and lost
    productivity.
        Earlier I described a stroke as occurring seemingly without
    warning. All too often as in my case, people either don't know or
    ignore the signs of a stroke, even one in progress. When my stroke hit
    I denied it. It took me two days after my stroke to acknowledge it and
    seek help. Because of research into new treatments, we now have tPA, a
    clot-busting drug, which if administered within 3 hours of the onset of
    stroke symptoms, can dramatically reduce the damage of clot-based
    strokes. Had I recognized and acknowledged my stroke, gone to a
    hospital with a neurologist on staff and had there been tPA, the impact
    of my stroke most certainly would have been lessened.
        What is even more painful to me is that my impending stroke could
    have been detected. Unfortunately, we need to create easier and less
    expensive diagnostic techniques so that effective diagnostics can be
    given routinely as part of regular health exams. And they must be
    covered through insurance.
        I am not asking for your sympathy. Instead, please think of me as
    two of the ghosts in the famous Dickens' story. Please don't
    misunderstand, I'm not casting you as Scrooge. See me as both the
    ghosts of things past and things yet to be. I too am here to tell you,
    the future, which I represent, needs not be. It is largely up to you.
        I hope my story and estimate of the cost of my stroke convinces you
    that taking on stroke and heart disease through increased research,
    leading to better prevention, diagnosis and treatment is fiscally
    responsible. The human and financial costs are astronomical.
        Thank you for your past support of research.
                                     ______

              Prepared Statement of the Cooley's Anemia Foundation

                                    SUBJECT

        Both Alicia and Michael are Cooley's anemia patients. In their
    testimony, they will point to the research successes and the need to
    continue the focus on the most scientifically opportune fields of
    research. Alicia will describe the tragic impact of the inability of
    some patients to comply with the excruciating treatment regimen for the
    disease and Michael will request the subcommittee's help in supporting
    blood safety surveillance through the CDC and other important research
    at the NIH.

                                  ALICIA SOMMA

        Good morning, Mr. Chairman. My name is Alicia Somma. Michael
    Giammalvo and I both have Cooley's anemia, a fatal genetic blood
    disease for which there is currently no cure. Michael is going to
    describe to the subcommittee what treatment for Cooley's anemia, or
    thalassemia (which is the medical name) is like, and I am going to tell
    you the story of my friend Nick who simply could not stand to undergo
    the treatment.

                               MICHAEL GIAMMALVO

        Good morning, Mr. Chairman. My name is Michael Giammalvo and I am
    13 years old. I was born with Cooley's anemia, which is a fatal genetic
    blood disease. Because my body cannot produce red blood cells like most
    other people's do, I have to receive a blood transfusion every two
    weeks. Getting a blood transfusion that frequently is not fun, but I
    have to do it to stay alive.
        The problem with this treatment is that it creates a very bad side
    effect. When people receive blood transfusions as much as Alicia and I
    do, the iron that is in the transfused blood goes into our bodies. The
    body does not know how to get rid of it, so it builds up in the heart
    and the liver.
        To get rid of the iron, patients have to infuse a drug called
    Desferal. It is in a pump that we wear. The drug is pumped through a
    needle that we have to insert under our skin. Most Cooley's anemia
    patients have to infuse Desferal five days a week for 8-12 hours at a
    time. The needle hurts. I sometimes can't go to my friends' houses for
    sleepovers or do other things that other kids do.
        There are times when I really don't want to take the Desferal and I
    make it hard on my parents. And, some patients, especially ones who are
    a little older than me--teenagers--just stop taking it. Alicia will
    tell you about somebody who did that.

                                     ALICIA

        Mr. Chairman, this is the first time I have spoken in public about
    what happened to my friend Nick Alessi--so please bear with me if this
    is a little hard for me.
        As a child growing up with this fatal illness, it's difficult not
    to feel different. Being the only kid in your class making regular
    week-long trips to the hospital, you can't help but feel alone. Nick
    made that feeling go away for me. Going to get treated and seeing him
    there showed me that I wasn't the only person with Cooley's anemia.
    Sitting in that infusion room, he and I became friends, and he made my
    life normal.
        Constantly updated on each other's health, when I heard Nick hadn't
    been compliant with our nightly treatment, I was crushed, almost as if
    it had happened to me. Over time, he grew very ill, the overloaded iron
    began attacking his heart, and we all knew he was in danger. I spoke
    with his father often, giving him advice on how to deal with this
    enormous obstacle.
        We decided that I should talk to Nick myself, regardless of the
    awkwardness I'd feel, because his condition was getting worse everyday.
    We arranged to have dinner together and discuss his problems, but
    unfortunately, I never got that chance to have that dinner and I never
    got the chance to save my childhood friend. We had all tried our
    hardest to save Nicholas Alessi, and we all failed. It's just hard to
    convince someone that you have to do something so barbaric to yourself
    to save your own life. Dealing with this has been immensely difficult,
    knowing that it could all be prevented. As I said, Nick was my friend
    and now he is gone.
        Mr. Chairman, NIH does research on using non-invasive methods of
    measuring iron in our livers and hearts and on addressing other related
    issues like osteoporosis (which I have even though I am only 18 years
    old), hepatitis C (which more than one third of our patients have), and
    more. CDC spends $2.2 million to monitor the safety of the blood we
    transfuse into our bodies. The FDA is currently reviewing a drug that
    might be taken orally to remove iron, rather than the long, painful
    infusion but it is still months or years away from being available to
    all patients.
        Addressing these issues are all things that only the government can
    do. And, we would not ask this of our government if it were not so
    important. I know that you have a lot of people asking you for a lot of
    things today and that you can't do everything. But, Michael and I are
    here today to speak on behalf of Nick Alessi--because he can't be here
    to speak for himself. Thank you for all you have done and for all you
    will do in the future.
        We would be pleased to answer any questions.
                                     ______

               Prepared Statement of the Doris Day Animal League

        Chairman Specter, Ranking Member Harkin and Members of the
    Subcommittee: The Doris Day Animal League represents 350,000 members
    and supporters nationwide who support a strong commitment by the
    federal government to research, development, standardization,
    validation and acceptance of non-animal and other alternative test
    methods. We are submitting our testimony on behalf of the Society for
    Animal Protective Legislation, too. Thank you for the opportunity to
    present testimony relevant to the fiscal year 2005 budget request for
    the National Institute of Environmental Health Sciences for the Center
    for the Evaluation of Alternative Toxicological Test Methods (NICEATM)
    for the Interagency Coordinating Committee for the Validation of
    Alternative Test Methods (ICCVAM) activities for fiscal year 2005.
        In 2000, the passage of the ICCVAM Authorization Act into Public
    Law 106-545, created a new paradigm for the field of toxicology. It
    requires federal regulatory agencies to ensure that new and revised
    animal and alternative test methods be scientifically validated prior
    to recommending or requiring use by industry. An internationally agreed
    upon definition of validation is supported by the 15 federal regulatory
    and research agencies that compose the Interagency Coordinating
    Committee for the Validation of Alternative Methods (ICCVAM), including
    the EPA. The definition is: ``the process by which the reliability and
    relevance of a procedure are established for a specific use.''

                             FUNCTION OF THE ICCVAM

        The ICCVAM performs an invaluable function for regulatory agencies,
    industry, public health and animal protection organizations by
    assessing the validation of new, revised and alternative toxicological
    test methods that have interagency application. After appropriate
    independent peer review of the test method, the ICCVAM recommends the
    test to the federal regulatory agencies that regulated the particular
    endpoint the test measures. In turn, the federal agencies maintain
    their authority to incorporate the validated test methods as
    appropriate for the agencies' regulatory mandates. This streamlined
    approach to assessment of validation of new, revised and alternative
    test methods has reduced the regulator burden of individual agencies,
    provided a ``one-stop shop'' for industry, animal protection, public
    health and environmental advocates for consideration of methods and set
    uniform criteria for what constitutes a validated test methods. In
    addition, from the perspective of animal protection advocates, ICCVAM
    can served to appropriately assess test methods that can refine, reduce
    and replace the use of animals in toxicological testing. This function
    will provide credibility to the argument that scientifically validated
    alternative test methods, which refine, reduce of replace animals,
    should be expeditiously integrated into federal toxicological
    regulations, requirements and recommendations.

                               HISTORY OF ICCVAM

        The ICCVAM is currently composed of representatives from the
    relevant federal regulatory and research agencies. It was created from
    an initial mandate in the NIH Revitalization Act of 1993 for NIEHS to
    ``(a) establish criteria for the validation and regulatory acceptance
    of alternative testing methods, and (b) recommend a process through
    which scientifically validated alternative methods can be accepted for
    regulatory use.'' In 1994, NIEHS established the ad hoc ICCVAM to write
    a report that would recommend criteria and processes for validation and
    regulatory acceptance of toxicological testing methods that would be
    useful to federal agencies and the scientific community. Through a
    series of public meetings, interested stakeholders and agency
    representatives from all 14 regulatory and research agencies, developed
    the NIH Publication No. 97-3981, ``Validation and Regulatory Acceptance
    of Toxicological Test Methods.'' This report, and subsequent revisions,
    has become the sound science guide for consideration of new, revised
    and alternative test methods by the federal agencies and interested
    stakeholders.
        After publication of the report, the ad hoc ICCVAM moved to
    standing status under the NIEHS' NICEATM. Representatives from federal
    regulatory and research agencies and their programs have continued to
    meet, with advice from the NICEATM's Advisory Committee and independent
    peer review committees, to assess the validation of new, revised and
    alternative toxicological methods. Since then, several methods have
    undergone rigorous assessment and are deemed scientifically valid and
    acceptable. In addition, the ICCVAM is working to streamline assessment
    of methods from the European Union (EU) that have already been
    validated for use within the EU. The open public comment process, input
    by interested stakeholders and the continued commitment by the federal
    agencies has led to ICCVAM's success. It has resulted in a more
    coordinated review process for rigorous scientific assessment of the
    validation of new, revised and alternative test methods.

                           REQUEST FOR APPROPRIATIONS

        On December 19, 2000, the ``ICCVAM Authorization Act'' which makes
    the entity a permanent standing committee, was signed into Public Law
    No. 106-545. For several years, the NIEHS has provided between $1 and
    $2.6 million per fiscal year to the NICEATM for ICCVAM's activities. In
    order to ensure that federal regulatory agencies and their stakeholders
    benefit from the work of the ICCVAM, it is important to fund it at an
    appropriate level. I respectfully urge the Subcommittee to support and
    appropriation for the NIEHS' NICEATM for ICCVAM's activities at $3.5
    million for fiscal year 2005. This appropriation request includes all
    FTEs, funding for independent peer review assessment of test methods
    and meetings of the ICCVAM and other activities as deemed appropriate
    by the Director of the NIEHS.

                     REQUEST FOR COMMITTEE REPORT LANGUAGE

        I also respectfully request the Subcommittee consider the following
    report language for the Senate Labor, Health and Human Services,
    Education and Related Agencies Appropriations bill:

        ``The Committee supports the assessment of scientific validation of
    new, revised and alternative toxicological test methods by the ICCVAM.
    The Committee urges the fifteen regulatory and research agencies
    composing the ICCVAM to use the expertise and credibility of the ICCVAM
    for assessments to obviate their individual consideration of new,
    revised and alternative test methods. The Committee also urges the
    regulatory and research agencies to incorporate scientifically
    validated new, revised and alternative test methods into their
    regulations, requirements and recommendations in an expeditious
    manner.''

        Thank you for the opportunity to submit this request on behalf of
    the Doris Day Animal League and the Society for Animal Protective
    Legislation.
                                     ______

              Prepared Statement of the Jeffrey Modell Foundation

                                    SUBJECT

        Mrs. Modell will, first and foremost, thank the committee and its
    members for its past assistance and support. She will also testify in
    favor of increases in funding for the National Institutes of Health
    (NIH) and the Centers for Disease Control and Prevention (CDC).
    Concerning CDC, she will request an increase in the current program
    that provides funding for a national education and awareness program
    related to primary immunodeficiency diseases to allow the Foundation to
    expand the program to reach underserved African-American and Hispanic
    communities. Within NIH, her testimony will focus specifically on
    NICHD, NIAID and NHLBI.
        Mr. Chairman and Members of the Subcommittee: Thank you for the
    opportunity to testify before you today. I am Vicki Modell and, along
    with my husband Fred, we created the Jeffrey Modell Foundation in 1987
    in memory of our son, who died at the age of 15 as a result of a life
    long battle against one of the 100-plus primary immunodeficiency
    diseases.
        First and foremost, Mr. Chairman, I am here today to thank you and
    all the members of this committee on both a personal and a professional
    level. Personal because whenever Fred and I come to Washington, whether
    it is to testify here before the committee or to meet with the members
    of the subcommittee individually in their offices, every Member of
    Congress and every member of your staffs are unfailingly polite,
    courteous, interested and caring.
        And, professional because over the last seven years that we have
    been coming to Washington, we have been given the opportunity to build
    a partnership with the Congress, the Centers for Disease Control and
    Prevention, the National Institutes of Health, as well as with our own
    supporters in the private sector, including industry and other
    concerned donors.
        We believe that we have maximized the benefits for patients from
    the support that this subcommittee has afforded us. We are going to
    tell you a remarkable story of success, of hope, and of future
    challenges this morning.
        This subcommittee is currently funding CDC with $2.2 million for
    physician education and public awareness of immune deficiencies. The
    Jeffrey Modell Foundation operates the program under a contract with
    CDC. Although we only receive about $1.8 million of the money (CDC
    keeps the rest for its ``administrative expenses''), we have leveraged
    that money into a $15 million national campaign.
        The Foundation has raised more than $1.0 million, largely from our
    supporters in the pharmaceutical and blood-related industries. Working
    with the Ad Council and a major New York City ad firm, we put together
    a media campaign alerting families to the possibility that repetitive
    infections may indicate a deeper, underlying problem and explaining to
    parents how to get their children tested. That campaign has generated
    more than $12 million in donated media time on television and radio, as
    well as magazine ad space.
        But, the campaign has been even more than the advertising.
      --We have conducted physician symposia for CME credit all over the
            country.
      --Working with NIH, we have produced educational materials for
            doctors and families. We have mailed 38,000 posters--one to
            every school nurse in the United States.
      --NICHD has mailed information to every member of the American
            Academy of Pediatrics and the American Academy of Family
            Practice.
      --We have developed and improved a terrific website.
        All of these steps would not be possible without the support of
    this subcommittee, but there is so much more that we can do.
        We fully recognize what a difficult appropriations year this is
    going to be. We know that, like every year, the demands on the
    subcommittee far exceed the allocation that you will likely have
    available. We also understand that our needs are small in the bigger
    picture of funding multi-billion programs like Pell Grants or the No
    Child Left Behind program. Yet, we have taken a small amount of money--
    for which we are eternally grateful--and generated $7 of private money
    for every $1 of government money.
        Mr. Chairman, one of the great unmet needs in our education and
    awareness program is underserved African American and Hispanic
    populations. Any such program concerning an undiagnosed disease needs
    to make special provisions for reaching these groups. You need to seek
    time on different radio stations, different television networks, and
    space in different magazines.
        Yet we know that this must be done. If you visit the Emergency Room
    at our home hospital in New York--Mount Sinai--then you visit the
    infusion room operated by the Department of Immunology, you see two
    very different populations. Yet the research tells us that there is not
    an ethnic component to this disease. That means that the visible
    differences relate to our medical system, not the incidence of disease.
        We are prepared to take on this challenge, much as this Congress
    has been willing to address the problems of health disparities through
    the NIH and elsewhere. We believe that we can begin to make a dent in
    the problem by increasing the funding available for this program to
    $2.7 million from $2.2 million.
        Mr. Chairman, as you know, we have other interests within the
    purview of this committee, as well. We have along history of
    collaboration with NICHD, which has been our strongest supporter under
    the able leadership of Dr. Duane Alexander. We have helped to fund
    research at NIAID. We have funded post-doctoral fellows at NHGRI. We
    are now jointly funding a conference with NHLBI.
        Our interactions with these many NIH institutes has convinced us
    that further increases in their budget--to whatever level fits within
    your allocation--will be put to good use and will benefit chronically
    ill people like our patients.
        Mr. Chairman, as I said in the beginning of my remarks, Fred and I
    are very grateful. We cannot begin to thank you and the subcommittee
    enough for all of the support and encouragement that we have received
    from you whenever we come to Washington. While we may never be able to
    repay all your kindnesses, you should know that the work that you do
    enables the work that we do. And, every young person who is diagnosed--
    early and properly--and then receives treatment is a young person who
    life is better for what you have done.
        Thank you again. I would be pleased to answer any questions.
                                     ______

       Prepared Statement of the American Association for Dental Research

                                    SUMMARY

        Dental research is concerned with the prevention, causes,
    diagnosis, and treatment of diseases and disorders that affect the
    teeth, mouth, jaws, and related systemic diseases. Dental health is an
    important, vital part of health throughout life.

                                  INTRODUCTION

        I am Dr. Michael Alfano, Dean of the New York University School of
    Dentistry. This testimony I am presenting is on behalf of the American
    Association of Dental Research (AADR). The AADR is a non-profit
    organization with over 5,000 individual members and 100 institutional
    members within the United States. AADR's mission is to enhance the
    quality and scope of oral health, advance research and increase
    knowledge for the improvement of oral health, and increase
    opportunities for scientific changes.
        Mr. Chairman and members of the Committee, we want to thank you for
    this opportunity to testify about the exciting advances in oral health
    sciences. I would like to discuss our fiscal year 2005 budget
    recommendations for the National Institute of Dental and Craniofacial
    Research (NIDCR).

                                    OVERVIEW

        Oral health is an important component of health. Good teeth and
    healthy gums for chewing and appearance, as well as taste buds and
    saliva to enjoy food and facilitate speech, all make major
    contributions to quality of life. Over the years, discoveries stemming
    from dental research have reduced the burden of oral disease for many
    Americans--although much remains to be done to reduce further the
    prevalence of oral diseases and their impact on overall health and
    well-being, as identified in Surgeon General (SG) David Satcher's
    Report of 2002: Oral Health in America and reinforced by current SG
    Richard Carmona in his 2003 National Call to Action to Promote Oral
    Health.
        Of even broader interest, however, the oral cavity also offers
    intriguing potential as a diagnostic window to the rest of the body--
    potential being pursued by the National Institute of Dental &
    Craniofacial Research (NIDCR). In fact, the Director of the National
    Institutes of Health, Dr. Elias Zerhouni, believed the potential for
    salivary diagnostics was so promising that he allocated some of his
    discretionary funds toward this research. Dr. Zerhouni has also
    complimented the NIDCR for its salivary research as exemplifying the
    type of interdisciplinary research that will be necessary to improve
    overall health outcomes for patients.

                   SALIVA AS A DIAGNOSTIC AND MONITORING TOOL

        Saliva is the protective fluid of the oral cavity. With its vast
    supply of microbe killers, saliva combats invading pathogens such as
    HIV and a host of bacteria associated with oral and systemic diseases.
    Antibodies directed against pathogens, such as polio and cold viruses,
    are found in saliva. Large salivary glycoproteins, called mucins,
    appear to have antiviral properties as well.
        Oral fluid is also a mirror of the body, containing many compounds
    indicating a person's health and disease status and, like blood and
    urine, its composition may be altered in the presence of disease.
    Saliva, however, may be collected in a much less invasive fashion than
    either blood or urine.
        Technologies are being developed at the NIDCR and by
    multidisciplinary teams in universities supported by grants from the
    NIDCR. These technologies offer huge clinical and commercial
    opportunity and may one day catalyze a shift in our current health
    system of disease detection to real-time health surveillance. For
    example:
      --Studies have uncovered in saliva the presence of a cancer-related
            protein whose concentration increases in the presence of breast
            cancer--a potential diagnostic marker for the early detection
            of breast cancer in women.
      --Saliva is gaining value as a diagnostic aid and potential monitor
            of disease progression in systemic disorders, including
            Alzheimer's disease, Sjoren's syndrome (an important autoimmune
            disease), cystic fibrosis, and diabetes.
      --Saliva is also proving to be an effective tool to monitor levels of
            hormones and therapeutic medications.
      --Research opportunities abound to develop more sensitive and
            specific assays to measure and understand changes in saliva
            beyond oral and systemic diseases in areas such as genetic
            defects, nutritional status, and age-specific changes.

                       GENE THERAPY USING SALIVARY GLANDS

        Gene therapy, substituting effective genes for those that are
    missing or nonfunctional and not producing needed proteins, offers hope
    for many patients, especially those who have conditions caused by a
    deficiency in a single protein, such as Type I diabetes, growth hormone
    deficiency, and hypoparathyroidism. Many of the difficulties involved
    in the delivery of such genes to internal organs can be avoided by
    incorporating functioning genes into salivary glands, which can in turn
    make the deficient protein and provide therapeutic benefit. If
    resources become available, the NIDCR is proposing an evaluation of
    gene transfer techniques in three clinical trials, involving patients
    with:
      --adult growth hormone deficiency,
      --chronic renal failure, and
      --Sjoren's syndrome and salivary gland damage.

                         BIOMIMETICS/TISSUE ENGINEERING

        Advances in the design of materials and an increasing understanding
    of mechanisms by which tissues of the craniofacial complex develop have
    positioned scientists to replace tissues lost as a result of
    developmental defects, pathology, or trauma. Interdisciplinary teams of
    scientists supported by the NIDCR:
      --continued to improve dental restorative and implant materials;
      --identified mechanisms to address osteoporosis and other conditions
            by making one cell type become another, e.g., inducing more
            bone marrow cells to become bone cells rather than fat cells;
      --discovered that the ``baby teeth,'' which children begin to lose
            normally around age six, contain a rich supply of stem cells
            that may have more potential for differentiation into other
            cell types than do adult stem cells, and are identifying these
            other cell types as funding permits; and
      --created a distinct portion of the lower jaw from rat adult stem
            cells that is the precise three-dimensional shape of the human
            mandibular joint.
        Researchers have long dreamed of engineering new teeth, knees,
    hips, and other body parts from a person's own tissues. Research to
    date has provided a solid base for making this dream a reality. Noting
    the ease of access to the oral cavity, Dr. Bruce Baum, a scientist at
    the NIDCR, has noted that ``the mouth is one of the best laboratories'
    in the body to study issues in human biology that go beyond dental
    research.''

                       RESEARCH IN PATIENT CARE SETTINGS

        In November 2003, the NIDCR announced support for Dental Practice-
    Based Research Networks (PBRNs) to provide an infrastructure for
    answering important clinical questions routinely faced by dental
    practitioners (http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-05-
    006.html). Indeed, the 2002 American Dental Association Future of
    Dentistry report specifically recommends that national clinical
    research networks be established that link treatment approaches and
    outcomes in private practice settings.
        By connecting community-based dental providers with experienced
    clinical investigators, PBRNs will enhance clinical research supported
    by the NIDCR and produce findings that are immediately relevant to
    practitioners and their patients. Because research is conducted in the
    real-world environment of dental practice, results may be more readily
    accepted by practitioners and rapidly integrated into dental practice.
    Importantly, PBRNs also provide a very cost-efficient mechanism for
    conducting clinical studies, because they use existing personnel and
    the infrastructure of established dental practices.

                                 RECOMMENDATION

        The National Institute of Dental and Craniofacial Research (NIDCR)
    is the leading agency supporting research in the oral and craniofacial
    area. NIDCR has already begun investing in all of the above areas, but
    the Institute needs additional funding if these initiatives are to
    become a reality. It is requested that an appropriation of $420,000,000
    be provided for NIDCR in fiscal year 2005 to launch a major initiative
    to complete the development of the technology for using saliva as a
    low-cost, non-invasive, diagnostic instrument; to pursue gene therapy
    using the salivary glands; to accelerate efforts in biomaterials and
    tissue engineering (regeneration of teeth and other body parts); and to
    develop fully the recently announced Dental Practice-based Research
    Networks initiative.
        In fiscal year 2005, the AADR also supports an appropriation of
    $30.6 billion for the NIH overall, $20,000,000 for CDC's Division of
    Oral Heath, $182,000,000 for the CDC's National Center for Health
    Statistics, and $443,000,000 for the Agency for Healthcare Research &
    Quality.
                                     ______

         Prepared Statement of the Society for Maternal-Fetal Medicine

        Mr. Chairman and Members of the Committee, I am James Ferguson,
    M.D., President of the Society for Maternal-Fetal Medicine. We
    appreciate the opportunity to testify before this Committee and are
    most appreciative of the support you have provided over the years to
    the National Institutes of Health, in particular the National Institute
    of Child Health and Human Development.
        The Society for Maternal-Fetal Medicine (SMFM), established in
    1977, is a subspecialty organization, which was formed to promote
    research and education on issues that may confront a high-risk pregnant
    mother or unborn fetus. The SMFM has a very strong interest in
    improving pregnancy outcome through basic, translational and clinical
    research. Only through research can complications involving the mother
    or unborn fetus be understood, treated, prevented, and eventually
    solved.
        Maternal-Fetal Medicine is a subspecialty within Obstetrics and
    Gynecology. Maternal-Fetal Medicine subspecialists pursue an additional
    2 to 3 years of fellowship training following completion of their 4
    year residency program in Obstetrics and Gynecology. Maternal-Fetal
    Medicine subspecialists provide consultative services to obstetricians,
    while in other cases they actually assume direct care responsibility
    for the special problems that high-risk mothers or high- risk fetuses
    face. The special problems faced by these mothers may lead to death,
    short-term or in some cases life-long problems for their babies. For
    example:
      --Preeclampsia.--Preeclampsia is a dangerous condition characterized
            by high blood pressure and the presence of protein in the
            urine. It complicates 3 to 4 percent of pregnancies, strikes
            without warning and is a leading cause of maternal and fetal
            death. In some cases, the condition may progress to eclampsia,
            a series of potentially fatal seizures. Although the high blood
            pressure and seizures can be treated, the only cure for
            preeclampsia is delivery of the baby. Surviving infants are at
            increased risk for preterm birth, may be undergrown or have
            serious disorders requiring neonatal intensive care.
      --Preterm Birth.--Preterm birth (Premature delivery) complicates
            approximately 10 percent of births and is a direct contributor
            to over 75 percent of the infant deaths and substantial newborn
            mortality and morbidity. Despite decades of committed research,
            the physiologic mechanisms underlying the onset of the process
            of giving birth, either preterm or term, have yet to be clearly
            identified.
      --Stillbirth.--When fetal death occurs after 20 weeks or more
            gestation, it is referred to as stillbirth. For many parents
            who hear the heartbreaking news that their baby has died in the
            womb, the loss is completely unexpected. Half of all
            stillbirths occur in pregnancies that appear to be problem-
            free. While 14 percent of fetal deaths occur during labor and
            delivery, 86 percent of fetal deaths occur before labor begins.
            The only warning the pregnant woman may have that there is a
            problem is that the baby suddenly is no longer moving or
            kicking. The most common known causes of stillbirth include:
            placental problems, birth defects, growth restriction and
            infections. But for at least half of all stillbirths, the cause
            remains undetermined. Despite the significant and persistent
            burden of stillbirth, the phenomenon has remained largely
            unstudied.
      --Abnormal fetal growth.--Abnormalities in the regulation of fetal
            growth may result in newborns that are significantly overgrown
            or undergrown and suffer complications related to the abnormal
            growth pattern. Inadequate fetal growth may occur in the
            absence of recognized causes e.g., maternal hypertension,
            smoking, or inadequate nutrition, and may be associated with
            intrauterine fetal demise or immediate neonatal and long-term
            consequences for the infant. Excess fetal growth may occur in
            pregnancies complicated by maternal obesity or diabetes,
            despite appropriate nutritional counseling and insulin therapy.
            Currently the management of under-and overgrown fetuses is
            empirical, aimed primarily at selection of safest time for
            delivery. There are no effective treatments to prevent or
            reverse either intrauterine growth restriction or fetal
            macrosomia.
      --Neonatal brain injury.--The precise cause of the majority of cases
            of neonatal brain injury is unknown. In the past, much emphasis
            was placed on hypoxia and ``asphyxia'' as a cause. Recent
            studies suggest that maternal infection and subsequent fetal
            infection may play a major role in the causation of newborn
            brain abnormalities such as periventricular leukomalacia and
            white matter damage.
        The National Institute of Child Health and Human Development
    (NIHCD) has been a leader in the field of maternal-fetal medicine
    research. Its commitment to basic, clinical and translational research
    has lead to new ways to treat and improve the health of pregnant women
    and infants. In the 1960's the birth weight at which infants had a 50-
    percent change for survival was approximately three (3) pounds; today
    it is 1\1/2\ pounds. Research conducted and supported by the NICHD, has
    given preterm infants and their families hope for the future.

                             RECENT ACCOMPLISHMENTS

        NICHD supported research in maternal-fetal medicine has been
    dramatic. Great strides are being made in our understanding of
    pregnancy and its complications. Recent researching findings revealed
    that:
      --abnormal levels of two molecules found in the blood appear to
            predict the development of preeclampsia. This observation is
            the most promising lead yet in the pursuit of this life-
            threatening disorder. If the development of preeclampsia can be
            reliably predicted, treatment strategies may be developed
            before more serious problems arise.
      --women with heightened resistance to the hormone ``insulin'' in the
            early months of pregnancy are at risk to develop preeclampsia.
            This finding suggests that physicians may be able to initiate
            preventive measures early in a pregnancy for women with insulin
            resistance. The research also implicates insulin resistance as
            a causative factor in preeclampsia; thus, it may ultimately be
            possible to prevent preeclampsia by improving insulin
            sensitivity in at-risk women early in a pregnancy or even
            before conception.
      --an anti-diabetes drug, metformin, lowered the risk of a miscarriage
            in the first trimester of pregnancy for women with polycystic
            ovary syndrome (PCOS). The investigators had already
            demonstrated that the drug increases blood flow in the uterus
            and brings about changes in the uterine lining.

                     MATERNAL FETAL MEDICINE UNITS NETWORK

        The National Institute of Child Health and Human Development
    created the Maternal Fetal Medicine Units Network (MFMU) in 1986 to
    address major clinical questions in maternal fetal medicine and
    obstetrics, particularly with respect to the continuing problem of
    preterm birth. The Network supports 14 clinical academic institutions
    and one data center. Typically, the network has four to six studies
    and/or trials ongoing at any given time. This approach provides optimal
    efficiency and cost-effective research. Over the last year, two trials
    studying progesterone for the prevention of preterm birth in high-risk
    women and Factor V Leiden mutations have been completed. This research
    will benefit countless women at risk of preterm birth.Over the last
    year, a trial on the identification of a therapy, progesterone, that
    prevents recurrent preterm birth in high-risk women has been completed.
    This is one of the first advances in this area, despite extensive
    efforts over decades.
    Areas of Need
        NICHD is at the forefront of several novel and important research
    areas, but there are still many areas that we are not close to
    understanding about maternal health, pregnancy, fetal well-being, labor
    and delivery and the developing child.
      --The next major advance in elucidating the etiology of preterm
            delivery involves understanding the mechanism through the
            evaluation of protein and gene expression. These techniques are
            widely used in other medical fields, and it is imperative that
            they are used to understand prematurity. Through these new
            technologies, wide scale, high output genomic and proteomic
            strategies should be used to identify mechanisms underlying
            premature birth.
      --New tools are needed to assess fetal growth; and non-invasive
            methods to assess changes in the uterine cervix and muscle
            (myometrium), and placental changes over time.
      --Research should focus on the pre-pregnancy and early pregnancy
            periods; the role of the cervix; the role of the placenta,
            including functional mechanisms related to pregnancy outcomes
            and fetal well-being, such as fetal growth and preterm
            delivery.
      --Strategies for predicting preterm birth should include multivariate
            analysis, such as that used in neural network analysis, and
            should focus on identifying the potentially reversible changes
            that take place prior to and during the early phase of
            pregnancy.
      --Research should focus on the cases with highest mortality and
            morbidity and should not be diluted by inclusion of less
            relevant cases of preterm birth that are close to term.
      --Research is needed to:
        --develop clinical methods to identify pregnancies where delaying
                delivery is futile or in some cases detrimental.
        --determine the effects of intervention on outcome.
        --identify the risk factors for adverse outcomes arising as result
                of pre-eclampsia, (abruption, preterm birth) in
                hypertensive women.
        --Understand the pathophysiologic abnormalities that lead to
                adverse pregnancy outcome in hypertensive women.
      --Research is needed to explain the exact mechanism of how infections
            lead to brain injury at various stages of pregnancy and brain
            development. In addition, delineation of the biochemical
            pathyway leading to injury may allow for interventions before
            irreversible injury occurs.

                                RECOMMENDATIONS

        Without a sustained and continued investment in the areas of need,
    the health of pregnant women and their babies will continue to be at
    risk. The SMFM therefore recommends:
      --An increase of 10 percent in fiscal year 2005 for the National
            Institutes of Health, bringing its total budget to $30.6
            billion, as supported by the Ad Hoc Group for Medical Research
            Funding.
      --An increase of 10 percent or $1.366 billion in fiscal year 2005 for
            the National Institute of Child Health and Human Development.
      --NICHD fully support the MFMU Network so that it can continue to
            address important research questions, with an emphasis on
            issues pertaining to preterm births and low birth weight
            deliveries.
      --That the NICHD have a major initiative to focus on genomics and
            proteomics to hasten a better understanding behind the
            pathophysiology of premature birth, discover novel diagnostic
            biomarkers, and ultimately aid in formulating more effective
            interventional strategies to prevent premature birth.
      --That the NICHD fully fund the cooperative network of clinical
            centers and data center to study stillbirth.
        Thank you Mr. Chairman and Members of the Committee for the
    opportunity to express our concerns and recommendations before this
    Committee.
                                     ______

       Prepared Statement of the National Coalition for Osteoporosis and
                             Related Bone Diseases

        Mr. Chairman and Members of the Committee: I am Joan Goldberg,
    Executive Director of the American Society for Bone and Mineral
    Research. I am here today on behalf of the National Coalition for
    Osteoporosis and Related Bone Diseases (the Coalition). We want to
    thank you for your continued support of the National Institutes of
    Health. Without your support the scientific achievements that have
    translated into direct benefits for millions of Americans afflicted
    with bone diseases such as Osteoporosis, Osteogenesis Imperfecta and
    Paget's disease of bone could not have been possible.
        The participants of the Coalition are the National Osteoporosis
    Foundation, the American Society for Bone and Mineral Research, the
    Paget Foundation for Paget's Disease of Bone and Related Disorders and
    the Osteogenesis Imperfecta Foundation. The Coalition is committed to
    reducing the impact of bone diseases through expanded basic, clinical,
    epidemiological, and behavioral research and through education leading
    to improvements in patient care.
        What do we know about bone? One misconception is that bone is a
    static tissue. Bone is a living tissue that makes up the body's
    skeleton. It is a truly remarkable structural material, which makes it
    ideal for its function of structural support. Bone provides mobility,
    protection of vital organs, and housing of the bone marrow. It is also
    a reservoir for calcium. This dynamic and highly tuned organ
    simultaneously balances growth to achieve strength and resilience, and
    repair without overgrowth. This balance is achieved by bone remodeling.
    An imbalance in remodeling, however, leads to the debilitating bone
    diseases such as osteoporosis, paget's disease of bone and osteogenesis
    imperfecta. These diseases are responsible for a large portion of
    healthcare expenditures in the United States. For example:
      --OSTEOPOROSIS, or porous bone, is a disease characterized by low
            bone mass and structural deterioration of bone tissue, leading
            to bone fragility and an increased susceptibility to fractures
            of the hip, spine, and wrist. It is a major public health
            threat for 44 million Americans. Of the 10 million who have
            osteoporosis, 80 percent are women. Today, 2 million men have
            osteoporosis and almost 12 million more are at risk for the
            disease. Men with low levels of testosterone are especially at
            risk. This includes men being treated with certain medications
            for prostate cancer. Osteoporosis is responsible for more than
            1.5 million fractures annually, including over 300,000 hip
            fractures; 700,000 vertebral fractures; 250,000 wrist
            fractures; and 300,000 fractures at other sites. The estimated
            national direct expenditures (hospital and nursing homes) for
            osteoporotic and associated fractures were $17 billion in 2001
            ($47 million each day) and the cost is rising.
      --PAGET'S DISEASE OF BONE, the second most prevalent bone disease
            after osteoporosis, is a chronic skeletal disorder that may
            result in enlarged or deformed bones in one or more regions of
            the skeleton. Excessive bone breakdown and formation can result
            in bone that is dense, but fragile. Complications may include
            arthritis, fractures, bowing of limbs, and hearing loss if the
            disease affects the skull. Prevalence in the population ranges
            from 1.5 percent to 8 percent depending on the person's age and
            geographical location. Paget's disease primarily affects people
            over 50.
      --OSTEOGENESIS IMPERFECTA (OI) causes brittle bones that break easily
            due to a problem with collagen production. For example, a cough
            or sneeze can break a rib, rolling over can break a leg. There
            are four recognized types of OI, representing extreme
            variations in severity and affecting 20,000 to 50,000 people in
            the United States. In severe cases fractures occur before and
            during birth. Undiagnosed OI may result in accusations of child
            abuse. Besides fragile bones, people with OI may have hearing
            loss, brittle teeth, short stature, skeletal deformities, and
            respiratory difficulties.
      --FIBROUS DYSPLASIA is a chronic disorder of the skeleton, which
            causes expansion of one or more bones due to abnormal
            development of fibrous tissue within the bone. Any bone can be
            affected, and involvement can be in one or several bones.
            Though many bones can be affected at once, fibrous dysplasia
            does not spread from one bone to another. At present there are
            no approved medical therapies. Surgery is sometimes recommended
            for severe complications.
        Another bone-related complication of bone that must be called to
    your attention is bone metastasis (cancer spreading to bone). Bone
    metastasis is a frequent complication of cancer and occurs in up to 70
    percent of patients with breast cancer and prostate cancer, and in
    approximately 15 to 30 percent of patients with lung, colon, stomach,
    bladder, uterine, rectal, and renal cancer. Bone metastases cause
    severe pain and fracture and once tumors spread to bone, they are
    incurable.
        Federal funding appropriated by the Congress has allowed the
    National Institutes of Health to conduct and support research that has
    reduced the adverse impact of bone disease on quality of life. Research
    has--
      --taught us how many Americans have low bone mass and therefore are
            at risk for osteoporosis. These individuals can now address
            their risk with exercise, diet, other behavioral and lifestyle
            changes, and medication, as appropriate.
      --demonstrated that a variety of drugs currently available can reduce
            bone loss and fractures, and even build bone.
      --led to a better understanding of calcium metabolism and, as a
            result, manufacturers of a variety of food products have
            fortified their products with this vital nutrient.
      --identified the necessity of vitamin D, protein, iron, etc., in
            addition to calcium in building and maintaining strong bones,
            while also spotlighting the major public health problem of
            vitamin D deficiency.
      --helped us to understand the need for weight-bearing exercise to
            build and maintain bone density and strength training to
            increase balance and flexibility to reduce falls.
      --identified a genetic component in many bone diseases, paving the
            way for the development of genetic approaches to diagnosis and
            treatment.
      --decreased fracture risk and extended the lifespan for children with
            OI.
        It is apparent that the quality of life related to bone disease is
    improving for many Americans, but much still remains to be achieved in
    areas such as:

                              DIAGNOSTICS/IMAGING

      --DXA is an imaging test that measures bone mineral density (BMD). It
            is the gold standard for predicting fracture risk, yet it may
            both under-diagnose and over-diagnose patients at risk.
            Moreover, DXA uses databases that are largely based on BMD
            scores of white women. Relating BMD scores to fracture risk for
            women of other racial groups and ethnicities--and doing the
            same for men--is even more imprecise.
      --New diagnostic measures are required to predict fragility and
            fracture risk better through assessing skeletal strength three
            dimensionally, focusing on internal bone micro-architecture or
            structure.

                           TREATMENT/PHARMACOTHERAPY

      --Much attention has been focused on the Women's Health Initiative
            study results and the risks involved in estrogen treatment.
            However, more information is needed about low-dose estrogen and
            its bone-protective benefits and risks.
      --Most current drug treatments for osteoporosis work by slowing down
            the natural process of bone breakdown. PTH, a hormone, actually
            builds bone. However, we need more studies to learn how best to
            use the drugs currently available, for what populations, with
            or after what drug regimens, for how long, and how best to
            assess response and interaction with exercise and diet.
      --The discovery of new molecules with unexpected roles in modulating
            bone mass points the way to development of other new therapies.
            One example is leptin, a molecule made by fat cells.
      --A 5-year observational study suggested that regular intravenous
            doses of pamidronate (a bisphosphonate) helped increase bone
            mineral density, reduce fractures, increase mobility, and
            decrease bone pain in children with osteogenesis imperfecta.
            Controlled clinical drug therapy trials will enable assessment
            of the potential use of bisphosphonate drugs to improve quality
            of life for children and adults.
      --The discovery that tumor cells increase the number of natural-
            occuring cells that destroy bone has improved treatment and
            quality of life for patients with bone metastases through the
            use of drugs called bisphosphonates. However, further research
            is needed to study the path of bone disease in breast cancer,
            prostate cancer, multiple myeloma, and other cancers that
            spread to bone.
      --Research is needed to improve survival and quality of life and to
            prevent metastatic osteosarcoma for the approximately 600
            children and teenagers in the United States who develop this
            cancer. Specifically, research is needed to:
        --Identify new intervention targets for therapy;
        --Develop better predictors of response to osteosarcoma treatment;
        --Develop in vivo and in vitro preclinical assays to improve
                treatment;
        --Study metastatic osteosarcoma biology compared to biology of
                normal bone cells and that of other cancer cells.

                                NOVEL APPROACHES

      --Investigations into genetic approaches for bone disease are
            critical and stem from recent findings that bone doesn't form
            when one protein--Cbfa-1--is missing. Understanding how this
            protein is activated or turned on may lead to new therapies for
            bone disease.
      --The identification and study of families with very high bone mass
            who never fracture have led to the discovery of the involvement
            of the ``wnt pathway'' in regulating bone mass. This pathway
            has not only become a potential therapeutic target for
            controlling skeletal mass, but has recently been implicated in
            the bone loss experienced in multiple myeloma (a bone- and
            blood-related cancer).
      --Understanding the role of genes and the underlying abnormal
            functioning of cells involved in bone breakdown in patients
            with Paget's disease is critical to developing new treatments.
            We need additional investigation to understand the role the
            bone microenvironment plays in the development of Paget's
            disease and to identify the molecular processes involved.
      --Bone marrow transplantation is being tested in the laboratory for
            the treatment of osteogenesis imperfecta. One technique
            requiring further development focuses on genetically
            engineering bone precursor cells, which reside in the bone
            marrow, so that the faulty osteogenesis imperfecta gene which
            causes frequent fractures would be blocked or turned off. Then
            these engineered cells could be transplanted back into the bone
            marrow to form healthy bone.
      --The use of specific exercise regimes--such as jumping--in the
            growing child, and of vibrating devices, for adults, represent
            exciting avenues for continued exploration into low-cost
            approaches to strengthen bone.
      --The potential for genetic therapy to cure osteogenesis imperfecta
            has been demonstrated in the test tube. Suppressing the gene
            that causes the mutant collagen must now be demonstrated in
            animal models.
        Bone research must be considered a trans-NIH issue given that bone
    diseases can lead to or be linked to other diseases such as cancer.
    Studies are currently being supported and conducted by the National
    Institute of Arthritis and Musculoskeletal and Skin Diseases (the lead
    institute for bone research), the National Institute on Aging, the
    National Institute of Diabetes and Digestive and Kidney Diseases, the
    National Institute of Child Health and Human Development, the National
    Institute of Dental and Craniofacial Research and the National Cancer
    Institute.
        Mr. Chairman and members of the committee we are most appreciative
    of your past support for the programs of the National Institutes of
    Health. The momentum in research cannot stop. The American people are
    expecting and holding fast to the hope that one day cures will be found
    for the debilitating diseases of bone.

                                RECOMMENDATIONS

        The National Coalition for Osteoporosis and Related Bone Diseases
    believe that improved treatments and a cures are in sight, but greater
    federal funding will be necessary if these advances are to be achieved.
    The Coalition, therefore:
      --Joins the Ad Hoc Group for Medical Research Funding in urging the
            Committee to provide an appropriation of $30.6 billion in
            fiscal year 2005 for the National Institutes of Health--an
            increase of 10 percent.
      --Supports the NIAMS Coalition recommendation of a 10 percent
            increase for the National Institute of Arthritis and
            Musculoskeletal and Skin Diseases, the lead bone research
            institute.
      --Supports increased funding for NIA, NIDCR, NIDDK, NCI, and NICHD,
            other Institutes that also fund bone-related research, as well
            as seeks additional support for bone programs at NIBIB and
            NCAM.
      --Requests more funding for training, transitional grants and debt
            repayment programs for young investigators and clinical
            scientists.
        Mr. Chairman, thank you for the opportunity to testify before this
    Committee.
                                     ______

       Prepared Statement of the American Association for Cancer Research

        The American Association for Cancer Research (AACR) is the world's
    oldest, largest, and most prestigious professional society of cancer
    scientists and clinicians. The AACR embraces the mission of our 22,000
    members to advance the prevention, detection, control and cures of
    cancer through research, education, and communication.
        The AACR is the authoritative voice for those who constitute a
    continuum of cancer research. It is the work of those within this
    continuum that contributed to reduced death rates and stabilized
    incidence in lung, breast, prostate and colorectal cancers during the
    last decade. The effort to contain cancer is achievable, and the
    progress we have made is encouraging for the future.
        Research by members of the AACR will lead to new ways of
    preventing, controlling and curing cancers in people of all ages.
    Scientists are mining information from the Human Genome Project to
    discover how cells use genetic information to become cancers.
    Researchers are identifying the genes that cause cancer and are
    designing targeted drugs that help regulate those genes. Other
    molecules target the proteins that are encoded by the cancer causing
    genes. Early detection technologies that use novel imaging methods to
    find the cancer causing genes and proteins in tumors are enabling
    clinicians to devise tailored treatment strategies with better odds of
    helping patients and with fewer side effects.
        Discoveries within laboratories will aid in preventing, detecting,
    and controlling the disease of cancer, empowering cancer patients with
    a better quality lifestyle and a more productive, longer life. Some
    will be cured. Others, through novel means of early detection or
    powerful new therapeutics, will circumvent the arduous plight of
    cancer.
        Opportunities in cancer research have never been so abundant. New
    challenges await us. Those challenges stem in part from the changing
    demographics within the United States and across the world. We are an
    aging population in the United States. As we age, our risk of cancer
    increases. Only 2.2 people in every 100,000 Americans under the age of
    65 develop cancer. Once past that landmark age, 10 times that number of
    people develop cancer.
        In the next 15 years, one-fifth of the American people will become
    65 years or older. Already, 12 percent of the American population is 66
    years or older. The risk of getting cancer is compounded by the large
    number of people entering this higher risk category. The number of
    people who develop cancer is expected to grow exponentially. As a
    society, we have the opportunity to avert this pending crisis.
        Two recent actions have started us in the right direction to avoid
    a cancer crisis of epidemic proportions. The first was the recent
    completion of the 5-year doubling of the NIH budget. The second was the
    bold Challenge Goal pronounced in 2001 by the Director of the National
    Cancer Institute: To eliminate the suffering and death from cancer by
    2015. The American Association for Cancer Research supports the
    Director's challenge goal and stands ready to assist and contribute in
    any way possible to meet this challenge.
        The state of scientific knowledge and technology has never been
    greater. Continued strong investment now will allow us to accelerate
    the pace of discovery and optimize the use of existing and new
    knowledge for the development and delivery of effective new cancer
    treatments.
        Many of these opportunities are cogently set forth in A Plan and
    Budget Proposal for Fiscal Year 2005 prepared by the Director of the
    National Cancer Institute. Informally referred to as the ``Bypass
    Budget,'' this document is mandated by Congress as part of the National
    Cancer Act of 1971. Its purpose is to set forth the National Cancer
    Institute's forward-looking strategic plan to build on its research
    successes, support the cancer research workforce with the technologies
    and resources it needs, and ensure that research discoveries are
    applied to improve human health. The Bypass Budget is provided directly
    to the President for formulating the budget request to Congress. It is
    developed in close consultation with all sectors of the cancer
    community, including scientists and cancer survivors, and represents
    the NCI Director's best professional judgment on the opportunities
    available and the resources needed to optimize progress in the fight
    against cancer in that fiscal year.
        The American Association for Cancer Research strongly supports the
    concept of the Bypass Budget. It is a vital tool to generate further
    research advances. AACR has identified a series of priority areas for
    investment--within the scope of the National Cancer Institute's action
    plan--that will significantly contribute to the achievement of the
    Director's Challenge Goal.
        In core scientific areas, AACR has identified the following
    priorities:
      --Enhancing Investigator-initiated Research.--Individual
            investigators in their laboratories and clinics are the
            foundation stone for innovations and advances in biomedical
            science. Their discoveries lead to better science and its
            productive application to patient care. Yet fewer than one-
            quarter of peer reviewed and approved research grant requests
            from these scientists are funded by the NCI. Increased funding
            for competing research grants and resources for investigator-
            initiated research are vital to the success of the cancer
            research enterprise.
      --Molecular Targets of Prevention, Diagnosis, and Treatment.--Some of
            the most promising recent advances in cancer research have come
            from our increased understanding of the molecular causes of
            cancer. Intensified research will increase the number of
            effective cancer interventions directed at validated targets.
      --Development of Cancer Imaging and Molecular Sensing Technologies.--
            Imaging advances are increasingly important in cancer treatment
            and care to non-invasively assess cancer progression.
        In the area of public health, AACR includes the following among its
    priorities:
      --Research on Tobacco and Tobacco-related Cancers.--Tobacco use is
            the leading preventable cause of death in the United States and
            is linked to nearly one-third of all deaths from cancer.
            Significant research investments are essential to accelerate
            research to understand, prevent, and treat tobacco use and
            addiction and to develop effective public health strategies to
            combat it.
      --Research on Obesity, Physical Activity, Diet, and Nutrition.--
            Obesity may soon exceed tobacco as the primary cause of cancer.
            Extensive further research is critical to develop effective
            preventive strategies and interventions to protect the majority
            of our population that is at risk.
      --Reducing Cancer-related Health Disparities.--The burden of cancer
            falls unequally on our society, with the low-income, medically
            underserved, elderly, and minority populations affected
            disproportionately by the disease. Further research is urgently
            needed to discover the causes for these disparities and to
            develop and deliver effective interventions to eliminate them.
        In addition to the recommendations above, AACR has identified five
    other priority areas that are of key importance to accelerating
    progress against cancer:
      --Cancer Prevention.--Cancer prevention and behavioral modification
            must be fundamental components of any realistic attempt to meet
            the Director's 2015 Challenge Goal. Concentrated and
            accelerated research is essential to generate new knowledge and
            advances in this largely uncharted territory.
      --Aging and Cancer.--Close to 60 percent of all new cancers are in
            persons older than 65. Further research is urgently needed to
            adequately prepare for the impact of our aging population on
            our nation's healthcare system.
      --Training Translational Researchers.--The number of physician-
            scientists who take findings from the laboratory through the
            preclinical, clinical, and regulatory processes to the
            patient's bedside are dwindling. This kind of translational
            cancer research demands a high level of research skill. Managed
            care allows very little time for physicians to engage in such
            research, and there is minimal funding and no defined career
            path for translational and clinical cancer researchers.
            Increased federal funding for training is crucial to attract,
            educate, train, and retain these clinical personnel if we are
            to have the skilled workforce needed to defeat cancer in the
            near future.
      --Expanding Our National Clinical Trials Program.--Patients in
            clinical trials receive the most advanced treatment and
            prevention approaches for their particular cancers. These
            trials are highly cost effective; however, fewer than 5 percent
            of adult cancer patients participate in clinical trials, as
            compared to nearly 80 percent of children with cancer.
            Augmented funding for the national clinical trials program is
            necessary so that adult participation, especially by minority
            and underserved patients, is doubled to at least 10 percent.
      --Extending the Bioinformatics Infrastructure.--The value of the vast
            expansion of biomedical knowledge generated by today's
            researchers will match its potential value and usefulness only
            when it is collected, organized, integrated, stored, and made
            readily and universally accessible to the entire research
            community. Funding is needed to develop the state-of-the-art
            bioinformatics infrastructure for data mining and integration
            that is vital to accelerate research progress.
        To maintain this nation's leadership in advanced biomedical
    research, and to take advantage of the abundant opportunities for
    research progress, we ask that you provide the National Institutes of
    Health with a sufficient level of funding to sustain the research
    momentum generated by the completion of the 5-year doubling of the
    budget. NIH officials and outside experts have testified that annual
    increases of at least 10 percent are required to preserve the research
    energy that has been unleashed by the doubling.
        The cancer community is grateful for the 3.1 percent increase in
    the budget that the NIH received in 2004, but is deeply concerned about
    its impact on future progress. This is particularly troubling in light
    of the President's fiscal year 2005 Budget Request that only seeks a
    2.6 percent increase for the NIH for next year. AACR shares this
    concern and urges the Committee to move boldly to furnish the funding
    levels necessary to undertake promising new research initiatives and to
    extend ongoing cutting-edge research through 2005 and beyond.
        Specifically we urge your support to increase the budget of the
    National Institutes of Health to at least $30.61 billion in 2005. This
    10 percent increase will allow the NIH to sustain and build upon its
    research progress while avoiding the severe disruption caused by cuts
    or nearly flat funding that is less than the rate of inflation.
        We also ask that you fully fund the fiscal year 2005 Bypass Budget
    of the National Cancer Institute. At that level of funding, the NCI
    will be able to realize many of the vitally important research priority
    areas identified above and make the boldest strides possible against
    this disease. Thus, the AACR requests that the Committee fund the
    fiscal year 2005 NCI Bypass Budget request of the Director in the
    amount of $6.2 billion.
        We have made remarkable progress in cancer research since the
    passage of the National Cancer Act in 1971. Your unflagging support for
    biomedical research for more than three decades has saved millions of
    lives and nurtured the productive research careers of thousands of our
    brightest and most dedicated scientists. More than 9.6 million cancer
    survivors alive today attest to the successful achievement of many of
    the goals of the National Cancer Act. With your continued positive
    support and leadership, the cancer community will be able to capitalize
    on the research momentum to convert our discoveries and new knowledge
    into the strategies and therapies that will make the Director's 2015
    Challenge Goal a reality for all Americans.
                                     ______

             Prepared Statement of the Lymphoma Research Foundation

        I am Melanie Smith, Director of Public Policy and Advocacy for the
    Lymphoma Research Foundation (LRF). I would like to express our
    appreciation for the opportunity to submit this statement to the record
    of the Labor, Health and Human Services and Education Appropriations
    Subcommittee. The LRF is the nation's largest lymphoma voluntary health
    organization, devoted to funding lymphoma research and providing
    information about the diseases to individuals diagnosed with lymphoma
    and their families and friends.
        Our ultimate goal is to find a cure for all forms of lymphoma. To
    that end, we fund some of the world's leading lymphoma researchers at
    outstanding academic institutions. These researchers are engaged in
    research aimed at understanding the basic mechanisms of lymphoma and
    improving the current treatments for the disease. LRF also aims to
    equip those who are diagnosed with lymphoma with up-to-date information
    about treatment options. The organization sponsors educational
    conferences at which the leaders in lymphoma research and treatment
    address patients and families regarding cutting-edge research and the
    most recent developments in therapies.

                             BACKGROUND ON LYMPHOMA

        Lymphoma is a major health problem. This year, approximately 54,400
    cases of non-Hodgkin's lymphoma (NHL) will be diagnosed in this
    country, and more than 19,400 Americans will die from NHL. Also this
    year, 7,880 cases of Hodgkin's lymphoma will be diagnosed, and more
    than 1,320 Americans will die from the disease. Lymphoma is the most
    common form of blood cancer and the third most common form of childhood
    cancer. Nearly 500,000 Americans are living with lymphoma.
        In recent years, there have been exciting reports regarding the
    improvements in treatments for a number of forms of cancer, as well as
    reports that the incidence of cancer overall is declining. Regrettably,
    NHL stands in contrast to the general trends in cancer incidence, and
    the treatment options for NHL remain inadequate. Since the early 1970s,
    incidence rates for NHL have nearly doubled, although incidence rates
    have stabilized the last few years. And the 5-year survival rate for
    NHL stands at 57 percent. These are not satisfactory numbers, and they
    serve as measures of the work we still have to do.

                              RESEARCH ON LYMPHOMA

        In recent years, we have learned a great deal about the genetic,
    molecular, and cellular basis of cancer. We do not know the cause of
    most lymphomas, but there is increasing information to suggest a link
    between environmental factors and infections and the development of
    many lymphomas. The environmental factors include chemicals, toxins,
    and ultraviolet light, and the infectious agents include simian virus-
    40, hepatitis C, and Epstein Barr virus. There is also evidence that in
    some individuals, immune dysfunction is a critical factor in the
    development of lymphoma.
        Our knowledge of cancer has improved significantly in the last
    decade, in large part due to the strong commitment of Congress to the
    National Institutes of Health (NIH) and its willingness to boost NIH
    funding, year after year. These funds have supported strong basic and
    clinical researchers who are focused on unlocking the secrets to
    cancer. There is a need to sustain that commitment to NIH, in order to
    equip scientists engaged in basic research and facilitate the
    translation of basic research findings into new treatments. This is
    certainly true in the case of lymphoma. There is a need to clarify the
    interactions among the environmental, viral, and immunogenetic factors
    that contribute to development of lymphoma and to ensure the
    development of new treatments based on our enhanced understanding of
    lymphoma.
        Over the last decade, several new lymphoma treatments have been
    developed, expanding the options for those who are diagnosed with the
    disease. Lymphoma patients and researchers have clearly benefited from
    the nation's significant investment in research, and Congress deserves
    the appreciation of the community of lymphoma patients and researchers.
    Among the lymphoma treatments approved in the last decade are a
    monoclonal antibody and two different radioimmunotherapies. While we
    applaud the new treatments of the last decade, they are not a magic
    bullet; for many, lymphoma continues to be a fatal disease.
        New therapies that capitalize on different research approaches are
    currently under investigation. These include therapeutic vaccines,
    immunotherapies, and proteasome inhibitors. Other work is focused on
    refining the chemotherapy regimens and developing treatment regimens
    with lower toxicities. All of this work deserves the support of private
    and public research funders.

                        ROLE OF NIH IN LYMPHOMA RESEARCH

        Although LRF plays a critical and creative role in funding lymphoma
    research, NIH is, and will remain, the key player in this field. NIH is
    the pivotal player not only because of the magnitude of its financial
    commitment to lymphoma research, but also because of the role it can
    play in bringing together all of the partners in the research
    community--NIH intramural researchers, academic researchers, private
    foundations, industry, and the Food and Drug Administration (FDA).
        NIH is also in the best position to encourage, facilitate, and fund
    the translation of basic research findings into new treatments. It is
    absolutely critical that we not lose the research momentum that has
    been the result in significant part of the doubling of the NIH budget
    between 1999 and 2003. This will require much more attention to
    translational and clinical research.
        LRF recommends that NIH strengthen its lymphoma research program by
    several actions:
      --The National Cancer Institute (NCI) should boost its support for
            translational and clinical lymphoma research. NCI should
            evaluate its current investment in clinical research and expand
            or initiate programs to strengthen the clinical research
            effort.
      --NCI should also enhance its support for correlative studies of
            tumor biology and treatment response, as well as its investment
            in research on the late and long-term effects of current
            lymphoma treatments.
      --The rate of payment for enrolling patients in NCI-sponsored
            clinical trials must be increased, as the current rate is
            inadequate to meet the costs associated with enrolling a
            patient in a clinical trial and collecting and analyzing the
            data associated with trial participation.
      --NCI should enhance its research effort focused on understanding the
            complex interaction among environmental, viral and
            immunogenetic factors that are involved in the initiation and
            promotion of lymphoma.
      --Although NCI has historically been the lead institute in funding
            lymphoma research, other institutes--the National Heart, Lung
            and Blood Institute (NHLBI), the National Institute on Aging
            (NIA), and the National Institute of Environmental Health
            Sciences (NIEHS)--should also evaluate and improve their
            lymphoma research programs. NIEHS has recently launched a
            targeted program to investigate the environmental links to
            breast cancer, and a lymphoma-focused program would be a
            logical outgrowth of the breast cancer program.
        A strong partnership among voluntary health agencies like LRF,
    academic researchers, industry, NIH, and FDA will be optimal for
    advancing lymphoma research and improving the outlook for those who are
    diagnosed with the disease. New strategies are necessary for the rapid
    translation of basic research findings into new treatments. These
    strategies may include systems for funding collaborative research
    projects that engage researchers in multiple institutions and multiple
    disciplines, including academic researchers and industry. Private
    foundations are looking at creative means to ensure that their research
    dollars are optimized, and we encourage NIH to employ the same creative
    and flexible approaches.

    ROLE OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION IN BLOOD CANCER
                                   EDUCATION

        LRF is actively engaged in providing patients and their families
    and caregivers complete and up-to-date information about lymphoma,
    lymphoma research, and lymphoma treatment options. Because of our
    strong history in this area, we were gratified when Congress authorized
    and funded a program at the Centers for Disease Control and Prevention
    (CDC) for public and patient education on blood cancers. According to
    the authorizing statute and appropriations report language, the
    appropriated funds are intended to support private sector organizations
    that are engaged in blood cancer education. We believe these funds can
    be used effectively by organizations that have extensive experience in
    these educational efforts, and we encourage Congress to fund the
    program in fiscal year 2005, for a second year, to ensure that there is
    no sudden discontinuation of a worthy educational initiative.
        LRF believes that strong partnerships will be a key feature of
    efforts to improve lymphoma treatments and provide lymphoma patients
    current information about their disease and treatment options. We
    encourage NCI to fund collaborative research ventures, and we urge CDC
    to support those private organizations that have years of experience in
    patient education. Those who receive a diagnosis of lymphoma face
    difficult choices, and we must work together to improve their options.
                                     ______

    Prepared Statement of WomenHeart, the National Coalition for Women With
                                 Heart Disease

        Heart disease is the leading cause of death for American women,
    killing nearly 500,000 each year. Yet, according to a recent American
    Heart Association poll, less than half (46 percent) of women know this
    basic fact and, even more troubling, only 13 percent think that heart
    disease is their own most important health risk.
        Ignorance often has fatal consequence. Women are not educated about
    their risk factors for heart disease so often do not take the necessary
    steps, such as cholesterol and blood pressure checks, to prevent or
    intervene in the earliest stages of the disease. They also are unaware
    of the signs and symptoms of heart attacks in women, which may differ
    than those in men. As a result, they do not get to the emergency room
    quickly enough to receive life-saving treatment. Many often die at
    home.
        We ask the Subcommittee to increase funding for public education
    programs to increase women's knowledge of their heart disease risks and
    symptoms. Specifically, we urge a $10 million appropriation for NIH's
    National Heart, Lung and Blood Institute's existing ``Heart Truth''
    campaign, which has been only modestly funded to-date. Through its
    adoption of the Red Dress as the national symbol for women and heart
    disease awareness, and the First Lady's participation in its public
    event, the campaign has put this long-ignored crucial women's health
    issue on the national agenda and is reaching thousands of women through
    its media relations and community outreach initiatives. However, a more
    significant campaign is needed to reach the millions of American women
    who are at-risk for or undiagnosed with heart disease.
        Thank you for your consideration.
        The National Coalition for Women with Heart Disease is the nation's
    only patient advocacy organization representing the 8,000,000 that aims
    to increase their quality of life and quality of healthcare through
    support, information and advocacy. It is a non-profit public charity
    headquartered in Washington, DC.
                                     ______

       Prepared Statement of the Upper County Branch, Montgomery County,
                              Maryland Stroke Club

                      A STROKE SURVIVOR: A PERSONAL STORY

        Hello. My name is Susan Emery. I am the presiding officer of the
    Upper County Branch of the Montgomery County Stroke Club and I'm a
    stroke survivor.
        Our club conducts education and support activities for stroke
    survivors, their family members, and caregivers. We serve people in the
    Maryland suburbs of Washington, D.C., and are fortunate to be in the
    same county as the National Institutes of Health. We have benefited on
    many occasions by the participation of NIH staff members in our
    membership meetings. They have been generous in sharing information
    about their research into stroke prevention and treatment with us.
        On December 26, 1965 at the age of 9, I was playing a new game with
    my brother and a few friends at the kitchen table. That's the last
    thing that I remember. I was unconscious for the next 2 days. My mother
    first learned, incorrectly, that I had spinal meningitis. I was
    transferred to another hospital where my mother was told that I had
    little chance of survival. Yet I'm here, more than 37 years later, and
    I've survived a stroke.
        People seldom associate strokes with children. These strokes are
    rare, but they do happen. There are about three cases of stroke per
    year in every 100,000 children under age 14. One of the difficulties in
    dealing with strokes in children is getting the right diagnosis
    quickly. There are often delays in diagnosis of childhood stroke.
        I spent 2 weeks in the hospital and the following 4 months in
    intensive physical therapy. My tenth birthday was spent in the
    hospital, and I have a picture in my photo album of myself with my
    mother and a new friend. My right eye is turned down, my mouth is
    turned down, but I'm still smiling. During the 4 months in therapy at
    Holy Cross in Detroit, I learned the basics: how to walk, how to talk,
    and how to move the fingers on my right hand. My mother followed the
    doctor's instructions and sent me back to school very quickly, where
    classmates helped me button and unbutton my coat and carry my books,
    and teachers taped papers to the desk so I could learn to write again.
    I survived that 4 months, and would never wish to repeat it.
        I've been in therapy six times in my life. I need to tell you about
    the one time that was the most important to my family. I was 26 years
    old and had just had my first child. I kept her safe, for I knew my
    limitations. I always used my left hand to support her. But when she
    was 6 months old, she got to be a little heavy, and twice, as I was
    putting her on the floor to change her diaper, my right hand slipped
    from under her buttocks. She fell only inches in both cases and didn't
    even notice. But I noticed. I went in for 2 or 3 months of therapy
    close to Denver, Colorado, where I was living at the time. Here for the
    first time, they helped my right hand and arm dexterity through
    occupational therapy. I also learned that I had aphasia--the inability
    to speak, write or understand spoken or written language because of
    brain injury--because I called things like cornucopias, unicorns
    instead of fruit baskets. Instead of the word being the same, I picked
    a word that sounded the same. These therapists in Colorado worked with
    my mind and my body and I will forever be in their debt.
        Close to 15 years ago, I made a new life for myself in Maryland.
    Here, I've been an outpatient at the National Rehabilitation Hospital
    three times: once for my right foot, once for my Achilles tendon and
    once for my right knee. I've seen numerous physiatrists, all of whom
    are excellent in their field. I've also seen my fair share of
    therapists. Since I've had therapy off and on for most of my life, I
    can honestly say that the first few times you go in to see a therapist,
    you'll come out hurting more than when you went in. But in the long
    run, they help tremendously.
        On a work related note, I received a Bachelor of Science in 1978
    from Michigan State University in Computer Science and worked for 12
    years in the field. I started working in the telecommunications
    industry in 1990, and got a Master of Science from the University of
    Maryland, University College in Telecommunications Management. I now
    work for ITT Industries as a senior engineer on a contract supporting
    the Federal Aviation Administration's leased telecommunications
    activities, and have worked there for more than 6 years. I've done more
    than survive. I've become a productive member of society.
        Stroke research has changed my life. Without the research carried
    out 40 to 50 years ago, I would not have benefited from electric shock
    therapy that made me understand the muscles that moved my fingers.
    Without research done 30 years ago, I may not have been able to
    understand how to exercise my hand for dexterity. Without research
    performed 10 years ago, the people around me would not understand that
    they need to get me to the hospital quickly if ever I have another
    stroke. Without current support, researchers may never understand how
    to stop strokes before they happen or how to make current stroke
    survivors live healthier lives.
        Stroke remains America's No. 3 killer and a major cause of
    permanent disability. An estimated 4.8 million Americans live with the
    consequences of stroke and about 1 in 4 is permanently disabled. Yet,
    stroke research receives a mere 1 percent of the National Institutes of
    Health budget. I strongly urge you to significantly increase funding
    for the National Institutes of Health-supported stroke research,
    particularly for National Institute of Neurological Disorders and
    Stroke-supported stroke research. NIH stroke research is essential to
    prevent strokes from happening to children and adults in the first
    place, and to advance recovery and rehabilitation of those who survive
    this potentially devastating illness.
                                     ______

           Prepared Statement of the Illinois Neurofibromatosis, Inc.

        Thank you for the opportunity to present testimony to the
    Subcommittee on the importance of continued funding for
    Neurofibromatosis (NF), a terrible genetic disorder closely linked to
    cancer, learning disabilities, heart disease, brain tumors, and other
    disorders affecting up to 150 million Americans in this generation
    alone. Thanks in large measure to this Subcommittee's support;
    scientists have made enormous progress since the discovery of the NF1
    gene in 1990. Major advances in just the past year have ushered in an
    exciting era of clinical and translational research in NF with broad
    implications for the general population.
        I am David Evans, representing Illinois Neurofibromatosis, Inc.,
    which is a participant in a national coalition of NF advocacy groups. I
    have lived with NF my entire life. Although I have not suffered any of
    NF's severe symptoms; I have experienced the social problems caused by
    being afflicted with NF. I have endured rude comments and harassment my
    entire life. On July 4, 1996 I was threatened with arrest if I would
    not leave a water park in Crestwood, Illinois. After other patrons
    complained to the owner, he informed me that I looked ``terrible'' and
    should wear a shirt or leave. I explained NF to him and assumed the
    matter was settled. Later however, he brought in the police and I was
    forced to leave. As a result of this experience I became active in
    Illinois NF, Inc. and have been on the board of directors since 1997.

                                  WHAT IS NF?

        NF is a genetic disorder involving the uncontrolled growth of
    tumors along the nervous system which can result in terrible
    disfigurement, deformity, deafness, blindness, brain tumors, cancer,
    and/or death. NF can also cause other abnormalities such as unsightly
    benign tumors across the entire body and bone deformities. In addition,
    approximately one-half of children with NF suffer from learning
    disabilities. It is the most common neurological disorder caused by a
    single gene. While not all NF patients suffer from the most severe
    symptoms, all NF patients and their families live their lives with the
    uncertainty of not knowing whether they will be seriously affected one
    day because NF is a highly variable and progressive disease.
        Approximately 100,000 Americans have NF, and it appears in
    approximately 1 in every 3,500 births. It strikes worldwide, without
    regard to gender, race or ethnicity. Approximately 50 percent of new NF
    cases result from a spontaneous mutation in an individual's genes, and
    50 percent are inherited. There are two types of NF: NF1, which is more
    common, and NF2, which primarily involves acoustic neuromas and other
    tumors, causing deafness and balance problems. Advances in NF research
    will benefit over 150 million Americans in this generation alone
    because NF is directly linked to many of the most common diseases
    affecting the general population.

                            LINK TO OTHER ILLNESSES

        Researchers have determined that NF is closely linked to cancer,
    heart disease, learning disabilities, memory loss, brain tumors, and
    other disorders including deafness, blindness and orthopedic disorders.
    Research on NF therefore stands to benefit millions of Americans:
        Cancer.--Research has demonstrated that NF's tumor suppressor
    protein, neurofibromin, inhibits RAS, one of the major malignancy
    causing growth proteins involved in 30 percent of all cancer.
    Accordingly, advances in NF research may well lead to treatments and
    cures not only for NF patients but for all those who suffer from cancer
    and tumor-related disorders. Similar studies have also linked epidermal
    growth factor receptor (EGF-R) to malignant peripheral nerve sheath
    tumors (MPNSTs), a form of cancer which disproportionately strikes NF
    patients.
        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 involved in cancer also causes heart valves to
    close. Neurofibromin, the protein produced by a normal NF1 gene,
    suppresses ras, thus opening up the heart valve. Promising new research
    has also connected NF1 to cells lining the blood vessels of the heart,
    with implications for other vascular disorders including hypertension,
    which affects 45 million Americans. 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.
        Learning disabilities.--Learning disabilities are the most common
    neurological complication in children with NF1. Research aimed at
    rescuing learning deficits in children with NF could open the door to
    treatments affecting 35 million Americans and 5 percent of the world's
    population. Indeed, leading researchers have already rescued learning
    deficits in both mice and fruit flies with NF1, which will benefit all
    people with learning disabilities, not just those with NF as well as
    save federal, state and local governments and school districts billions
    of dollars in special education costs.
        Deafness.--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.

                              SCIENTIFIC ADVANCES

        The progress that has been made in NF research has been nothing
    short of phenomenal. In just over a dozen years since the discovery of
    the NF1 gene, researchers are now on the threshold of developing a
    treatment and cure for this terrible disease. Scientists who previously
    had been pessimistic are now genuinely excited about engaging in
    therapeutic experimentation and the phase II clinical trials already
    being conducted by NIH. Because of NF's implication with so many other
    diseases, many NF researchers believe that NF should serve as a model
    to study all diseases. Indeed, one leading researcher has stated that
    more is known about NF genetically than any other disease.
        In just the past few years, scientists have made major
    breakthroughs bringing NF fully into the translational era, with
    treatments close at hand. These recent advances have included:
      --Phase II clinical trials on two drug therapies;
      --Developing advanced mouse models showing human symptoms;
      --Rescuing learning deficits in mice;
      --Linking NF to hypertension, which affects 45 million Americans, as
            well as congenital heart disease; and
      --Launching natural history studies to analyze the progression of the
            disease.
        Other advances since 1990 include:
      --The discovery of the NF1 and NF2 genes and gene products.--The NF1
            gene was discovered in 1990 and the NF2 gene was discovered in
            1993.
      --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. Most
            strikingly, researchers have discovered that NF regulates both
            the c-AMP pathway affecting learning and memory as well as the
            ras pathway affecting cancer. This discovery, which brought
            together cancer and neurology through NF's controlling both of
            these related pathways, holds monumental implications for
            finding the treatments and cures for many diseases which affect
            a vast segment of the population.
      --Development of advanced animal models.--Researchers have developed
            advanced mouse models which exhibit human symptoms, such as
            malignant tumors, leukemia, and learning disabilities. Such
            animal models provide a unique method for addressing the
            fundamental aspects of disease development and for testing
            therapeutic strategies. NF researchers have also developed the
            fruit fly as a model animal organism to study not only NF but
            many other diseases.
      --Commencement of clinical trials at NCI.--As a result of the
            enormous progress made in NF research, NCI has already
            commenced two clinical trials with pediatric NF1 patients,
            including phase II trials using of farnesyl transferase
            inhibitors and phase I trials using pirfenidone, and is
            developing a third clinical trial.
      --Development of drug and gene therapies.--Leading NF researchers
            have been actively engaged in developing both drug and gene
            therapeutic experimentation in mice and fruit flies. In the
            case of NF1, these experiments have been directly related to
            tumor suppression and learning deficits. Researchers also
            believe that a gene therapy for NF2 can be developed; unlike
            other genetic forms of deafness, in which a 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.
      --Rescuing learning deficits in animal models.--A paper published in
            the January 30, 2002 edition of Nature demonstrated how
            researchers were able to rescue learning deficits in mice with
            the same mutation that causes NF1 in humans--disabilities once
            thought to be irreversible. This discovery has enormous
            implications for the 35 million Americans suffering from
            learning disabilities. Studies on fruit flies have also
            demonstrated that the neurofibromin protein regulates the c-AMP
            pathway which is known to control learning and memory.
      --Development of Infrastructure.--Researchers, with the help of the
            government, have been building expanded national and
            international NF centers, consortia, and other infrastructure
            for clinical and translational research and treatment.

                               FUTURE DIRECTIONS

        NF research has now advanced to the translational and clinical
    stages which hold incredible promise for NF patients, as well as for
    patients who suffer from many of the diseases linked to NF. This
    research is costly and will require an increased commitment on the
    federal level. Specifically, future investment in the following areas
    would continue to advance research on NF:
      --Clinical trials;
      --Development of a clinical trials network to connect patients with
            experimental therapies;
      --Development of new drug and genetic therapies;
      --Further development of advanced animal models;
      --Expansion of biochemical research on the functions of the NF gene
            and discovery of new targets for drug therapy;
      --Natural history studies and identification of modifier genes--
            studies are already underway to provide a baseline for testing
            potential therapies and differentiate among different
            phenotypes of NF; and
      --Development of NF Centers, tissue banks, and patient registries.

                     CONGRESSIONAL SUPPORT FOR NF RESEARCH

        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 seven Institutes at NIH are currently supporting NF
    research (NINDS, NCI, NICHD, NCRR, NEI, NIDCD, and NHLBI), and NIH's
    total research portfolio has increased from $3 million in 1990 to over
    $20 million in fiscal year 2004.
        The enormous advances in NF research would not have been possible
    without Congress's continued support of the NIH, and I would like to
    personally thank the members of this Subcommittee for their leadership
    in doubling the budget of the NIH over 5 years.
        At the same time, we are concerned that the NF research portfolio
    at both the National Cancer Institute and the National Institute of
    Neurological Disorders and Strokes has declined by several million
    dollars in recent years, despite appropriations report language
    recommending a greater investment. Given the potential offered by NF
    research for progress against a range of diseases, and the completion
    of the 5-year doubling of the NIH budget, we are hopeful that NCI and
    NINDS will substantially increase NF research funding. We appreciate
    the Subcommittee's strong support for NF research dating back to 1990,
    and will continue to work with you to ensure that opportunities for
    major advances in NF research are aggressively pursued.
        This Subcommittee has long recognized that our goal should be to
    translate the promise of scientific discovery into an improved quality
    of life for all Americans. The example of the progress realized in NF
    research demonstrates the success of this vision and commitment.
        Thank you again for the opportunity to tell you of the progress and
    potential of NF research.
                                     ______

    Prepared Statement of the American Association for Geriatric Psychiatry

        The American Association for Geriatric Psychiatry (AAGP)
    appreciates this opportunity to present its recommendations on issues
    related to fiscal year 2005 appropriations for mental health research
    and services. AAGP is a professional membership organization dedicated
    to promoting the mental health and well being of older Americans and
    improving the care of those with late-life mental disorders. AAGP's
    membership consists of approximately 2,000 geriatric psychiatrists as
    well as other health professionals who focus on the mental health
    problems faced by senior citizens.
        AAGP would like to thank the Subcommittee for its continued strong
    support for increased funding for the National Institutes of Health
    (NIH) over the last several years, particularly the additional funding
    you have provided for the National Institute of Mental Health (NIMH),
    the National Institute on Aging (NIA), the National Institute on
    Alcohol Abuse and Alcoholism (NIAAA), and the Center for Mental Health
    Services (CMHS) within the Substance Abuse and Mental Health Services
    Administration (SAMHSA). Although we generally agree with others in the
    mental health community about the importance of sustained and adequate
    Federal funding for mental health research and treatment, AAGP brings a
    unique perspective to these issues because of the elderly patient
    population served by our members.
        There are serious concerns, shared by AAGP and researchers,
    clinicians, and consumers that there exists a critical disparity
    between appropriations for research, training, and health services and
    the projected mental health needs of older Americans. This disparity is
    evident in the convergence of several key factors:
      --demographic projections inform us that, with the aging of the U.S.
            population, there will be an unprecedented increase in the
            burden of mental illness among aging persons, especially among
            the baby boom generation;
      --this growth in the proportion of older adults and the prevalence of
            mental illness is expected to have a major direct and indirect
            impact on general health service use and costs;
      --despite the fact that effective treatment exists, the current
            mental health needs of many older adults remain unmet;
      --the number of physicians being trained in geriatric mental health
            research and clinical care is insufficient to meet current
            needs, and this workforce shortfall is projected to become a
            crisis as the U.S. population ages over the next decade;
      --a major gap exists between research, mental health care policy, and
            service delivery; and
      --despite recent significant increases in appropriations for support
            of research in mental health, the allocation of NIMH and CMHS
            funds for research that focuses specifically on aging and
            mental health is disproportionately low, and woefully
            inadequate to deal with the impending crisis of mental health
            in older Americans.

           DEMOGRAPHIC PROJECTIONS AND THE MENTAL DISORDERS OF AGING

        With the baby boom generation nearing retirement, the number of
    older Americans with mental disorders is certain to increase in the
    future. By the year 2010, there will be approximately 40 million people
    in the United States over the age of 65. Over 20 percent of those
    people will experience mental health problems. A national crisis in
    geriatric mental health care is emerging and has received recent
    attention in the medical literature. Action must be taken now to avert
    serious problems in the near future. While many different types of
    mental and behavioral disorders can occur late in life, they are not an
    inevitable part of the aging process, and continued research holds the
    promise of improving the mental health and quality of life for older
    Americans.
        The current number of health care practitioners, including
    physicians, who have training in geriatrics is inadequate. As the
    population ages, the number of older Americans experiencing mental
    problems will almost certainly increase. Since geriatric specialists
    are already in short supply, these demographic trends portend an
    intensifying shortage in the future. There must be a substantial public
    and private sector investment in geriatric education and training, with
    attention given to the importance of geriatric mental health needs. We
    will never have, nor will we need, a geriatric specialist for every
    older adult. However, without mainstreaming geriatrics into every
    aspect of medical school education and residency training, broad-based
    competence in geriatrics will never be achieved. There must be adequate
    funding to provide incentives to increase the number of academic
    geriatricians to train health professionals from a variety of
    disciplines, including geriatric medicine and geriatric psychiatry.
        Current and projected economic costs of mental disorders alone are
    staggering. The direct medical expense to care for a patient with
    Alzheimer's disease ranges from $18,000 to $36,000 a year per patient,
    depending on the severity of the disease. In addition, there are
    substantial indirect costs associated with caring for an Alzheimer's
    disease patient including social support, care giving, and often
    nursing home care. It is estimated that total costs associated with the
    care of patients with Alzheimer's disease is over $100 billion per year
    in the United States. Psychiatric symptoms (including depression,
    agitation, and psychotic symptoms) affect 30 to 40 percent of people
    with Alzheimer's and are associated with increased hospitalization,
    nursing home placement, and family burden. These psychiatric symptoms,
    associated with Alzheimer's disease, can increase the cost of treating
    these patients by more than 20 percent. Although NIA has supported
    extensive research on the cause and treatment of Alzheimer's, treatment
    of these behavioral and psychiatric symptoms has been neglected and
    should be supported through NIMH.
        Depression is another example of a common problem among older
    persons. Approximately 30 percent of older persons in primary care
    settings have significant symptoms of depression; and depression is
    associated with greater health care costs, poorer health outcomes, and
    increased mortality. Of the approximately 32 million Americans who have
    attained age 65, about 5 million suffer from depression, resulting in
    increased disability, general health care utilization, and increased
    risk of suicide. Older adults have the highest rate of suicide rate
    compared to any other age group. Comprising only 13 percent of the U.S.
    population, individuals age 65 and older account for 19 percent of all
    suicides. The suicide rate for those 85 and older is twice the national
    average. More than half of older persons who commit suicide visited
    their primary care physician in the prior month--a truly stunning
    statistic.
        The enormous and widely underestimated costs of late-life mental
    disorders justify major new investments. The personal and societal
    costs of mental illness and addictive disorders are high, but advances
    in research and treatment will help save lives, strengthen families,
    and save taxpayer dollars.

                   THE BENEFITS OF RESEARCH ON PUBLIC HEALTH

        The U.S. Surgeon General's Report on Mental Health (1999) and the
    Administration on Aging Report on Older Adults and Mental Health (2001)
    underscore the prevalence of mental disorders in older persons and
    provide evidence that research has lead to the development of effective
    treatments. These reports summarize research findings showing that
    treatments are effective in relieving symptoms, improving functioning,
    and enhancing quality of life. Preliminary findings suggest that these
    interventions reduce the need for expensive and intensive acute and
    long-term services. However, it is also well demonstrated that there is
    a pronounced gap between research findings on the most effective
    treatment interventions and implementation by health care providers.
    This gap can be as long as 15 to 20 years. These reports stress the
    need for translational and health services research focused on
    identifying the most cost-effective interventions, as well as creating
    effective methods for improving the quality of health care practice in
    usual care settings. A major priority (neglected to date) is the
    development of a health services research agenda that examines the
    effectiveness and costs of proven models of mental health service
    delivery for older persons.
        Special attention also needs to be paid to inadequately or poorly
    studied, serious late-life mental disorders. Illnesses such as
    schizophrenia, anxiety disorders, alcohol dependence and personality
    disorders have been largely ignored by both the research community and
    the funding agencies, despite the fact that these conditions take a
    major toll on patients, their care givers, and society at large. Many
    of AAGP's members are at the forefront of groundbreaking research on
    Alzheimer's disease, depression, and psychosis among the elderly, and
    we strongly believe that more research funds must be focused in these
    areas. Improving the treatment of late-life mental health problems will
    benefit not only the elderly, but also their children, whose lives are
    often profoundly affected by their parents' illness.
        While the funding increases supported by this Subcommittee in
    recent years have been essential first steps to a better future, a
    committed and sustained investment in research is necessary to allow
    continuous progress on the many research advances made to date.

                      NATIONAL INSTITUTE OF MENTAL HEALTH

        In his fiscal year 2005 budget, the President proposed an increase
    of $729 million for the National Institutes of Health (NIH), which
    would bring the entire NIH budget to a level of $28.8 billion. However,
    this 2.6 percent increase over the fiscal year 2004 funding level pales
    in comparison with recent annual double-digit increases. A decline in
    adequate funding increases could have a devastating impact on the
    ability of NIH to sustain the ongoing, multi-year research grants that
    have been initiated in recent years.
        For NIMH, the President is proposing $1.421 billion for scientific
    and clinical research, a 2.8 percent increase over the agency's fiscal
    year 2004 appropriation of $1.382 billion. It is important to note that
    from fiscal year 1999 through fiscal year 2004, NIMH received increases
    that lagged behind the increases received by many of the other NIH
    institutes. Furthermore, the increase proposed by the Administration
    for NIMH for fiscal year 2005 is lower than that proposed for most of
    the other institutes at NIH. As Congress moves forward with
    deliberations on the fiscal year 2005 budget, AAGP believes that NIMH
    should receive a percentage increase that, at the very minimum, is
    equal to the average percentage increase for the other NIH institutes.
        Commendable as recent funding increases for NIH and NIMH have been,
    AAGP would like to call the Subcommittee's attention to the fact that
    these increases have not always translated into comparable increases in
    funding that specifically address problems of older adults. Data
    supplied to AAGP by NIMH indicates that while extramural research
    grants by NIMH increased 59 percent during the 5-year period from
    fiscal year 1995 through fiscal year 2000 (from $485,140,000 in fiscal
    year 1995 to $771,765,000 in fiscal year 2000), NIMH grants for aging
    research increased at less than half that rate: only 27.2 percent
    during the same period (from $46,989,000 to $59,771,000).
        AAGP is pleased that NIMH has recently renewed its emphasis on
    mental disorders among the elderly, and commends the recent creation of
    a new Aging Treatment and Prevention Intervention Research Branch at
    NIMH as well as the establishment of an intra-NIMH consortium of
    scientists concerned with mental disorders in the aging population.
    However, funding for aging mental health research is still not keeping
    pace with that of other adult mental health research, and is actually
    decreasing proportionally when considered in the context of anticipated
    projections in growth of mental disorders in older persons. For
    example, the proportion of total NIMH newly funded extramural research
    grant funding devoted to aging research declined from an average of 8
    percent from fiscal years 1995 to 1999 to a low of 6 percent in fiscal
    year 2000. To reverse this trend, it will also be important to
    constitute grant review committees with specialized expertise in
    geriatrics to ensure a fair review of research proposals. Review
    committees must take into account knowledge of the unique biological
    factors associated with the aging brain, the high prevalence of co-
    occurring medical illnesses, and the specific systems for financing and
    health services delivery for older Americans. In addition, AAGP would
    like the scope of this branch increased into a comprehensive aging
    branch that is responsible for all facets of clinical research,
    including translational, interventions, and disease-based
    psychopathology. Further, the branch should be given adequate resources
    to fulfill its primary mission within NIMH.
        In addition to supporting research activities at NIMH, AAGP
    supports increased funding for research related to geriatric mental
    health at the other institutes of NIH that address issues relevant to
    mental health and aging, including the National Institute of Aging
    (NIA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA),
    the National Institute on Drug Abuse (NIDA), and the National Institute
    of Neurological Disorders and Stroke.

                       CENTER FOR MENTAL HEALTH SERVICES

        It is also critical that there be adequate funding increases for
    the mental health initiatives under the jurisdiction of the Center for
    Mental Health Services (CMHS) within the Substance Abuse and Mental
    Health Services Administration (SAMHSA). While research is of critical
    importance to a better future, the patients of today must also receive
    appropriate treatment for their mental health problems. SAMHSA provides
    funding to State and local mental health departments, which in turn
    provide community-based mental health services to Americans of all
    ages, without regard to the ability to pay. AAGP was pleased that the
    final budgets for fiscal years 2002, 2003 and 2004 included $5 million
    for evidence-based mental health outreach and treatment to the elderly.
    However, AAGP is extremely alarmed to see that this program was
    eliminated in President Bush's fiscal year 2005 budget proposal.
    Restoring and increasing this mental health outreach and treatment
    program must be a top priority, as it is the only Federally funded
    services program dedicated specifically to the mental health care of
    older adults.
        Originally funded in the Fiscal Year 2002 Labor-HHS-Education
    Appropriations (Public Law 107-116), AAGP worked with members of this
    Subcommittee and its House counterpart on this initiative, which was
    intended as a first step in the effort to curb the projected growth of
    older adults in America suffering from mental disorders. The House
    Appropriations Committee Report on Fiscal Year 2002 Labor-HHS-Education
    Appropriations states that $5 million should be appropriated for a
    senior mental health outreach and treatment program within CMHS and
    that the funds are ``intended to begin to address'' the predicted
    increase of older adults suffering from mental illness. Regarding the
    same program, the Senate Appropriations Committee Report states, ``The
    Committee strongly encourages CMHS to devote additional resources in
    fiscal year 2002 and subsequent fiscal years to this issue.''
    Unfortunately, this initiative has not seen the subsequent increases
    its creators intended when Congress created this program.
        Funding for the dissemination and implementation of evidence-based
    practices in ``real world'' care settings must be a top priority for
    Congress. Despite significant advances in research on the causes and
    treatment of mental disorders in older persons, there is a major gap
    between these research advances and clinical practice in usual care
    settings. The greatest challenge for the future of mental health care
    for older Americans is to bridge this gap between scientific knowledge
    and clinical practice in the community, and to translate research into
    patient care. Adequate funding for this geriatric mental health
    services initiative is essential to disseminate and implement evidence-
    based practices in routine clinical settings across the states.
    Consequently, we would urge that the $5 million for mental health
    outreach and treatment for the elderly included in the CMHS budget for
    fiscal year 2004 not only be restored, but also be increased to $20
    million for fiscal year 2005.
        Of that $20 million appropriation, AAGP believes that $10 million
    should be allocated to a National Evidence-Based Practices Program,
    which will disseminate and implement evidence-based mental health
    practices for older persons in usual care settings in the community.
    This program will be a collaborative effort, actively involving family
    members, consumers, mental health practitioners, experts, professional
    organizations, academics, and mental health administrators. With $10
    million dedicated to a program to disseminate and implement evidence-
    based practice in geriatric mental health, there will be an assured
    focus on facilitating accurate, broad-based sustainable implementation
    of proven effective treatments, with an emphasis on practice change and
    consumer outcomes. Such a program should include several development
    phases including identification of a core set of evidence-based
    practices, development of evidence-based implementation, and practice
    improvement toolkits and field-testing of evidence-based
    implementation. This program will provide the foundation for a longer-
    term national effort that will have a direct effect on the well-being
    and mental health of older Americans.

                   AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

        One of the most valuable resources in our efforts to improve access
    to and the quality of geriatric mental health services is the Agency
    for Healthcare Research and Quality (AHRQ). In recent years the Agency
    has supported important research on mental health topics including
    studies on children's mental health issues, the impact of mental health
    parity on consumers' share of mental health costs, improving care for
    depression in primary care, and cultural issues in the treatment of
    mental illness in minority populations. This work has led to important
    contributions to the mental health literature, and the advancement of
    effective diagnosis and treatment of mental illness. We applaud these
    efforts and urge the Committee to increase support for the critical
    work of this Agency.
        However, we are concerned that the research agenda of the Agency
    has not given more attention to geriatric mental health issues. The
    prevalence of undiagnosed and untreated mental illness among the
    elderly is alarming. Conditions such as depression, anxiety, dementia,
    and substance abuse in older adults are often misdiagnosed or not
    recognized at all by primary and specialty care physicians. There is
    accumulating evidence that depression can exacerbate the effects of
    cardiac disease, cancer, strokes, and diabetes. Research has also shown
    that treatment of mental illness can improve health outcomes for those
    with chronic diseases. Effective treatments for mental illnesses in the
    elderly are available, but without access to physicians and other
    health professionals with the training to identify and treat these
    conditions, far too many seniors fail to receive needed care.
        AAGP believes there is an urgent need to translate findings from
    aging-related biomedical and behavioral research into geriatric mental
    health care. By utilizing the resources of the evidence-based practice
    centers under contract to AHRQ, results from geriatric mental health
    research can be evaluated and translated into findings that will
    improve access, foster appropriate practices, and reduce unnecessary
    and wasteful health care expenditures. We urge the Committee to direct
    AHRQ to support additional research projects focused on the diagnosis
    and treatment of mental illnesses in the geriatric population. We also
    believe a high priority should be given to the dissemination of
    scientific findings about what works best, to encourage physicians and
    other health professionals to adopt ``best practices'' in geriatric
    mental health care.

                                   CONCLUSION

        Based on AAGP's assessment of the current need and future
    challenges of late life mental disorders, we submit the following
    fiscal year 2005 funding recommendations:
        1. The current rate of funding for aging grants at NIMH and CMHS is
    inadequate. Funding for NIMH and CMHS aging-related health services
    grants should be increased to be commensurate with current need--at
    least three times their current funding levels. In addition, the
    substantial projected increase in mental disorders in our aging
    population should be reflected in the budget process in terms of dollar
    amount of grants and absolute number of new grants;
        2. Previous years' funding of $5 million for evidence-based mental
    health outreach and treatment for the elderly within CMHS was
    eliminated in President Bush's fiscal year 2005 budget proposal. To
    help the country's elderly access necessary mental health care, this
    funding must be restored and increased to $20 million;
        3. A fair grant review process will be enhanced by committees with
    specific expertise and dedication to mental health and aging;
        4. Adequate infrastructure and funding within both NIMH and CMHS to
    support the development of initiatives in aging research, to monitor
    the number and quality of applicants for aging research grants, to
    promote funding of meritorious projects, and to manage those grant
    portfolios;
        5. The scope of the recently formed Aging Treatment and Prevention
    Intervention Research Branch at NIMH should be increased to include all
    relevant clinical research, including translational, interventions, and
    disease-based psychopathology, and must receive NIMH's full support so
    it may fulfill its primary mission;
        6. AHRQ should undertake additional research projects focused on
    the diagnosis and treatment of mental illnesses in the geriatric
    population, and dissemination of information on best practices; and
        7. Funding for NIAAA must be increased by at least 20 percent to
    enable it to undertake more research and collect more data focused on
    issues such as the link between alcohol use and late-life suicide and
    the impact of alcohol use across the lifespan.
        AAGP strongly believes that the present research infrastructure,
    professional workforce with appropriate geriatric training, health care
    financing mechanisms, and mental health delivery systems are grossly
    inadequate to meet the challenges posed by the expected increase in the
    number of older Americans with mental disorders. Congress must support
    funding for research that addresses the diagnosis and treatment of
    mental illnesses, as well as programs for delivery of geriatric mental
    health services that increase the quality of life for those with late-
    life mental illness.
        AAGP looks forward to working with the members of this Subcommittee
    and others in Congress to establish geriatric mental health research
    and services as a priority at NIMH, CMHS, AHRQ and NIAAA.
                                     ______

          Prepared Statement of the American Society for Microbiology

        The American Society for Microbiology (ASM), the largest single
    life science society with 43,000 members, is pleased to provide
    testimony in support of the nation's investment in the extraordinary
    work of the National Institutes of Health (NIH). Advances in NIH
    research have markedly intensified over the past 5 years during which
    the NIH budget has grown thanks to the foresight of Congress and the
    Administration. Robust funding increases have resulted in rapid strides
    in cutting edge research and new research tools to facilitate the
    development of vaccines, therapies and interventions that save and
    improve the lives of millions of people.
        To ensure that progress is sustained, the ASM recommends that
    Congress make research and public health a high national priority and
    provide an increase of 10 percent for the NIH for fiscal year 2005.
    Continued strong funding increases will enable NIH to accelerate and
    expand promising basic and clinical research that will lead to new
    preventions and treatments for tragic and costly illnesses and
    disabilities that continue to afflict and claim the lives of many
    people. The ASM encourages Congress to provide higher funding levels
    for research and public health that will address the alarming burden of
    disease in the United States and abroad and help prepare the nation for
    novel health threats and the next disease emergency that will
    inevitably occur in the future.
        The public health and security of the nation depend on the
    continuation of strong investments in research and public health. The
    severe acute respiratory syndrome (SARS) epidemic of 2003 highlights
    the continuing need for investment in a strong biomedical and public
    health system that is prepared to respond to emerging diseases, whether
    naturally occurring or intentionally introduced. Previous NIH
    investment in emerging diseases research has allowed expeditious
    studies of SARS to identify targets for antiviral drugs, diagnostics
    and vaccines. Not only are people at risk for chronic diseases such as
    cancer, heart disease, stroke, diabetes and Alzheimer's disease, but
    also from new and emerging infectious diseases, such as the HIV
    pandemic, highly virulent influenza viruses, West Nile Virus, hepatitis
    A and C, and the possibility of the deliberate release of disease by
    bioterrorists, which still remains a threat.
        The accomplishments and investment in biodefense research,
    facilities and resources should also facilitate defenses against
    naturally occurring infectious diseases that pose a real and present
    danger to global public health. Infectious diseases account for 26
    percent of total global mortality and are the third leading cause of
    death in the United States. Despite impressive advances in
    microbiology, old diseases remain entrenched and new ones can appear
    suddenly and spread quickly. Sufficient and sustained federal funding
    for research helps protect against these enemies to public health.

                        INVESTIGATOR INITIATED RESEARCH

        Most of the budget appropriated to the NIH each year flows outside
    the agency to an estimated 212,000 research personnel affiliated with
    approximately 28,000 organizations across the United States and
    elsewhere. This extramural research community competes for NIH grants
    through a merit based peer-review process; of the growing number of
    applications each year, estimated to exceed 35,000, less than one-third
    are projected to receive NIH funding. The proposed fiscal year 2005
    budget supports an increase in the number of new and competing grants
    from 10,135 to 10,393, an additional 258 grants. Investigator initiated
    research is the primary tool by which biomedical research is funded and
    conducted and requires increased funding to take advantage of
    scientific opportunities that lead to new knowledge and its
    applications to health care.

                        NIH ROADMAP FOR MEDICAL RESEARCH

        Within the proposed fiscal year 2005 budget, the NIH Roadmap for
    Medical Research plan would receive $237 million, an increase of $109
    million over fiscal year 2004. Announced in September 2003, this set of
    27 initiatives actuates an agency wide commitment to maximize research
    investment through intensive, multi-disciplinary projects with high
    potential to solve serious health problems. The Roadmap realizes three
    21st-century visions of a vigorous research enterprise: building new
    pathways to discovery through new technologies, databases, and other
    resources; creating multidisciplinary research teams better prepared to
    tackle the complexities of modern research; and re-engineering clinical
    research structures to expedite the rapid translation of discoveries
    from the lab to the clinic. This trans-NIH effort is an approach that
    promises to stimulate research advances and interventions for public
    benefit.

                              BIODEFENSE RESEARCH

        After the anthrax mail attacks of 2001, biodefense research has
    emerged as a major feature of the NIAID's mission to understand the
    pathogenesis of disease-causing microorganisms and host responses to
    them. NIAID scientists now are pursuing numerous countermeasures as
    therapeutics, diagnostics, and vaccines. The agency mobilizes research
    capabilities and extramural partnerships to prepare against
    ``deliberately emerging disease'' outbreaks. The NIH and particularly
    the NIAID have become significant partners in the broad-based, multi-
    faceted U.S. homeland security program. The fiscal year 2005 budget
    highlights the significance of NIAID biodefense efforts, with nearly
    $1.7 billion for research and infrastructure, 4.5 percent above fiscal
    year 2004's $1.6 billion.
        The biodefense agenda at the NIAID reflects a new focus on science
    based security. Basic research forms the backbone of the NIAID
    counterterrorism efforts and includes microbial physiology and ecology,
    genomics, studies of pathogenesis and host defenses, and development of
    animal disease models. Strong funding appropriations by Congress and
    the Administration over the past 2 years have made possible significant
    progress, evidenced by the more than 50 major NIAID biodefense
    initiatives now in place. Most of these initiatives are new, with
    intramural, academic, and industrial partners investigating all aspects
    of bioagents and emerging diseases. Components include expansion of the
    nation's biodefense laboratory infrastructure, enhanced communication
    and data-collecting networks, interdisciplinary studies on potential
    bioweapons, and investigations into basic mechanisms of disease and
    disease pathogens.
        In 2003 NIAID and its collaborators achieved significant successes
    in both basic and applied areas related to biodefense. A candidate
    vaccine against the Ebola virus was found to protect lab monkeys
    against the deadly disease. Other researchers discovered that the
    anthrax bacterium toxin affects host cells in a previously unknown
    manner, which will redirect some aspects of anthrax therapeutics.
    Genome sequencing projects are on going for at least one strain of
    every bacterium, virus or protozoan considered a of priority pathogen.
    This vast genomics effort includes mapping of agents for such diseases
    as anthrax, brucellosis, Q fever, plague, smallpox, and tuberculosis.
    Researchers recently developed a rapid test for measuring antibodies to
    vaccinia that is 5 to 10 times more sensitive than standard detection
    techniques. NIAID has screened more than 800 compounds for antiviral
    activity against poxviruses and two clinical trials of a new smallpox
    vaccine have been completed. The search continues for vaccines against
    a long list of pathogenic bacteria and viruses, including next
    generation vaccines against smallpox and new vaccines for plague,
    tularemia, and other viral hemorrhagic fevers.
        Current NIAID biodefense programs build upon the NIH tradition of
    creating networks of institutions and scientists best qualified to
    solve complex problems. Last year the NIAID funded 8 of the 10 planned
    Regional Centers for Excellence for Biodefense and Emerging Infectious
    Diseases Research (RCEs), at a cost of about $350 million to be
    expended over 5 years. The RCEs will be responsible for a broad range
    of basic and applied research on disease biology, vaccines, and
    antibiotics, as well as development of novel computational and genomic
    approaches. As regional centers of excellence, they also will train new
    generations of science professionals in biodefense research, provide
    facilities for area researchers, and supply facilities and support to
    first-line responders in the event of a biodefense emergency. The NIH
    also is adding new biodefense-research facilities at its own Bethesda
    campus and at other NIH locations. Last fall, NIAID construction grants
    were awarded to leading universities for nine high-level biosafety
    laboratories. These state-of-the-art labs will contain special
    engineering and design features to prevent release into the environment
    of the most deadly microorganisms. The facilities also will be
    available to assist national, state and local public health officials
    when needed. Similar cooperative programs were established by the NIAID
    to encourage biodefense research within the pharmaceutical industry,
    human immunology research institutes, and computational science
    centers. The proposed fiscal year 2005 budget includes continued
    support of these efforts, as well as funding for the final two Centers
    for Excellence and $150 million for an additional 20 high-level
    biosafety laboratories.

                 INFECTIOUS DISEASE RESEARCH AND PUBLIC HEALTH

        Centuries of triumph and defeat mark the human struggle against
    infectious disease. Many infectious diseases persist and continue to
    plague us. Each year populations are beset by one or more previously
    unknown diseases or pathogens. The World Health Organization estimates
    that more than 1,600 die each hour from an infectious disease, half
    under 5 years of age. Others suffer with debilitating infections. For
    instance, an estimated 40 million people worldwide are living with HIV/
    AIDS. Tuberculosis, malaria, and other familiar intractable diseases
    kill or sicken millions annually. New outbreaks surprise and alarm
    nations. Being prepared to detect, treat, and prevent any infectious
    disease is the central, science based mission of the NIAID, with well-
    funded medical research.
        Newly emerging and re-emerging or resurging infectious diseases
    constantly change the landscape of microbiological research, creating
    moving targets for medical intervention and prevention. West Nile
    virus, monkeypox, dengue, multi-drug resistant tuberculosis and malaria
    are current examples of what faces NIAID-supported investigators. Last
    year's SARS outbreak illustrates the breadth and depth of NIAID
    research and response capabilities. It is a cautionary tale of how a
    previously unknown disease can quickly become a global news story of
    significant economic and public health importance. Within months the
    new respiratory illness had caused more than 8,000 cases and nearly 900
    deaths in 30 countries, severely disrupting international trade and
    travel--and yet it became a triumph for science and public health
    efforts, in large part due to effective, well-funded NIAID research.
    NIAID-supported scientists in Hong Kong were the first to show that
    SARS was caused by a virus; within days, they and CDC investigators
    identified the virus as a previously unknown type of coronavirus. An
    ongoing NIAID-funded program of influenza surveillance then found
    animal carriers of the virus in food markets in China. Related NIAID-
    supported work quickly followed, including several genetic analyses of
    the virus underway, an NIAID-developed mouse model of SARS, screening
    of up to 100,000 antiviral compounds for anti-SARS activity, several
    parallel approaches to vaccine development, as well as joint projects
    with private industry, researchers abroad, and China's Center for
    Disease Control. NIAID funding led to quick development of a rapid
    diagnostic test now being improved, and NIAID provides researchers with
    free SARS ``gene chips'' embedded with a reference strain of the virus
    for genetic screening of isolates. NIAID's extensive and multi-layered
    quick response to SARS was possible largely because of previous
    investments in virus and respiratory disease research.
        Each year NIAID responsibilities for novel diseases grow greater,
    not less. Today a new threat of global potential, the so-called bird
    flu or H5N1 influenza, is emerging to join diseases like West Nile
    virus infection and bovine spongiform encephalopathy (BSE) as targets
    of NIAID initiatives. NIH supported laboratories are world leaders in
    research on transmissible spongiform encephalopathies that include BSE,
    Creutzfeldt-Jakob disease in humans, and chronic wasting disease in
    deer and elk. Last year there were more than 9,000 human cases of
    mosquito-borne West Nile virus infection in the United States. Since
    first detected in 1999, WNV has spread throughout North America and
    beyond. NIAID-supported scientists have developed an immunoassay to
    identify WNV and a new treatment already in early clinical trials.
        A myriad of infectious diseases continue to take a toll on people
    worldwide. Infections of the respiratory tract continue to be the
    leading cause of acute illness worldwide. In the United States,
    diarrhea is the second most common infectious illness and diarrheal
    diseases account for 15 to 34 percent of deaths in some countries.
    NIAID funding supports a broad variety of basic and applied research to
    better understand food- and waterborne-illnesses. Sexually transmitted
    infections (STIs) affect over 15 million people in the United States
    each year. NIAID-supported researchers recently discovered an unusual
    bacterium that may be the cause of many reproductive tract infections
    in women. More than 25 STIs have now been identified, and NIAID is
    supporting multiple projects aimed at preventing and treating STIs.
    Currently a new vaccine for genital herpes is in advanced clinical
    trials.
        Together, HIV/AIDS, malaria and tuberculosis account for more than
    5 million deaths each year. One of the principal goals of 21st-century
    medical science is the development of safe and effective vaccines
    against these three global killers. In the United States, more than
    500,000 have died from AIDS-related illness; the CDC estimates that
    850,000 to 950,000 Americans are living with HIV infection. HIV/AIDS
    research continues to be a significant component of NIH research: The
    Administration's fiscal year 2005 budget requests $2.9 billion for HIV/
    AIDS research at NIH, a 2.8 percent increase over fiscal year 2004.
    NIAID investigators continue to develop new treatments, and the number
    of AIDS vaccines in development and testing increases steadily.
        Malaria threatens more than one-third of the world's population and
    kills more than 1 million each year. Although United States cases of
    malaria are unusual, the NIAID has become a leader in the accelerated
    development of malaria vaccines. The agency has initiated its first
    trial of a candidate malaria vaccine in Africa. One-third of the
    world's population also fights tuberculosis, another major global focus
    of the NIAID. A new recombinant vaccine made with several proteins from
    the bacterium that cause TB will soon enter human trials. Scientists
    recently discovered genetic mutations in the tuberculosis bacterium
    that contribute to worrisome antibiotic resistance.
        The increasing use of antimicrobials in humans, animals and
    agriculture has contributed to pathogen resistance to antibiotics and
    some diseases are becoming more difficult to treat because of the
    emergence of drug resistance. NIAID supports antimicrobial research and
    the goals of the Interagency Task Force for Antimicrobial Resistance.
        In recognition of impressive NIAID contributions to public health
    and homeland security, the ASM emphasizes that only sustained financial
    investment will guarantee continued success against today's infectious
    diseases, tomorrow's unpredictable pathogens, and the growing threat of
    antimicrobial resistance.
                                     ______

         Prepared Statement of The Humane Society of the United States

        On behalf of The Humane Society of the United States (HSUS) and our
    more than 8 million supporters nationwide, we appreciate the
    opportunity to provide testimony on our top funding priority for the
    Labor, Health and Human Services, and Education Subcommittee in fiscal
    year 2005.

                           PAIN AND DISTRESS RESEARCH

        An estimated 40 percent of the National Institutes of Health (NIH)
    budget--or currently more than $11 billion--is devoted to some aspect
    of animal research. At this time, no funding is set aside specifically
    for research into alternatives that replace or reduce the use of
    vertebrate animals in research or that reduce the amount of pain and
    distress to which research animals are subjected. NIH may receive $28.8
    billion in fiscal year 2005 if Congress fulfills the President's budget
    request. Out of this funding, we seek $2.5 million (0.009 percent) for
    research and development focused on identifying and alleviating animal
    pain and distress. We recommend that this R&D be conducted under the
    National Center for Research Resources (NCRR, responsible for NIH
    extramural funding). We also urge the Committee to specify in report
    language that NCRR should conduct this research in conjunction with, or
    ``piggy-backed'' onto, ongoing research that already causes pain and
    distress. No pain and distress should be inflicted solely for the
    purpose of this research, given the volume of existing research (we
    estimate a minimum of 20-25 percent of all animal research) that is
    believed to involve moderate to significant pain and/or distress.
        In 1987, NIH announced a program to award grants for ``research
    into methods of research that do not use vertebrate animals, use fewer
    vertebrate animals, or produce less pain and distress in vertebrate
    animals used in research.'' Many of the 17 program awards made from
    1987 to 1989, totaling approximately $2.4 million, involved research on
    non-mammalian models, including projects on frogs, mollusks, and
    insects. Other awards included mathematical modeling and computer
    studies. This program, which was managed out of the Division for
    Research Resources (the precursor to NCRR), no longer exists at NIH,
    and it has not been replaced by any similar program.
        A 2001 survey conducted by an independent polling firm indicates
    that concern about animal pain and distress strongly influences public
    opinion about animal research in general. Public support for animal
    research declines dramatically when pain and distress are involved: 62
    percent support animal research when pain and distress are minimal,
    only 34 percent when moderate, and an even smaller 21 percent when
    animal suffering is severe. Despite this public concern, NIH has not
    continued to sponsor R&D exploring how to minimize animal suffering and
    distress in the laboratory.
        During the past several years, our organization has been reviewing
    institutional policies and practices with respect to pain and distress
    in animal research. We have found that research institutions have
    inconsistent policies due to the lack of information on this subject,
    and that standards vary greatly from one institution to another.
    Painful techniques, such as the use of carbon dioxide to euthanize rats
    and mice, are widely practiced and approved even though studies
    indicate that carbon dioxide exposure for only a few seconds causes
    acute distress to humans. The federal standard for determining
    laboratory animal pain specifies that, if a procedure causes pain or
    distress to humans, it should be assumed to cause pain and distress to
    animals. Furthermore, while human experience can and should provide a
    useful guide in some cases, there are others in which humans are never
    subjected to the conditions facing laboratory animals. Information on
    pain and distress that animals themselves actually experience is
    important. For many accepted laboratory practices there is no
    scientific data regarding the painful or distressing effects on either
    people or animals.
        A lack of data on the recognition, assessment, alleviation, and
    prevention of pain and distress in laboratory animals is commonly cited
    by scientists as a rationale for either not reporting pain and distress
    or not acting to mitigate it. This lack of data is obviously
    detrimental to the welfare of animals used in research, but it is also
    detrimental to the quality of science produced. Uncontrolled,
    undetected, and unalleviated pain, physical distress, or psychological
    distress result in alterations in physiologic and behavioral states,
    and confound the outcome of scientific research. Ultimately, the lack
    of information on pain and distress leads to misinterpretation of
    research results that could result in harmful effects in human beings
    when pre-clinical animal research results are applied to humans in
    clinical trials. It is worth noting that researchers themselves often
    comment publicly at scientific meetings about the urgent need for
    funding in order to properly understand and mitigate pain and distress
    in research animals.
        Our nation takes pride in leading the world in biomedical research,
    yet we lag behind many other countries in our efforts to minimize pain
    and distress in animal subjects. For example, the United Kingdom,
    Sweden, Switzerland, Germany, the Netherlands and the European Union
    all have committed funds specifically for the ``three R's'' (replacing
    the use of animals, reducing their use, and refining research
    techniques to minimize animal suffering).
        We urge the Committee to make this small investment of $2.5 million
    to promote animal welfare and enhance the integrity of scientific
    research. We also respectfully request this accompanying committee
    report language:

        ``The Committee provides $2.5 million for the National Center for
    Research Resources to support research and development focused on
    improving methods for recognizing, assessing, and alleviating pain and
    distress in research animals. No pain and distress should be inflicted
    solely for the purpose of this initiative, since the investigations can
    and should be conducted in conjunction with ongoing research that is
    believed to involve pain and distress under Government Principle IV of
    Public Health Service Policy, which assumes that procedures that cause
    pain and distress in humans may cause pain and distress in animals.''

        Again, we appreciate the opportunity to share our views and top
    priority for the Labor, Health and Human Services, and Education
    Appropriation Act of fiscal year 2005. We hope the Committee will be
    able to accommodate this modest request that will benefit animals in
    research and the quality of the research. Thank you for your
    consideration.
                                     ______

             Prepared Statement of the Society of Nuclear Medicine

        The Society of Nuclear Medicine (SNM) appreciates the opportunity
    to submit written comments for the record regarding funding for
    workforce education and training and biomedical research related
    programs in fiscal year 2005. SNM is an international scientific and
    professional organization founded in 1954 to promote the science,
    technology and practical application of nuclear medicine. Its 14,000+
    members are physicians, technologists and scientists specializing in
    the research and practice of nuclear medicine.
        To that end, SNM advocates ongoing and significant federal funding
    for programs to help ensure an adequate nuclear medicine workforce to
    care for the nation's citizens as well as increasing the our investment
    in biomedical research. The Society stands ready to work with
    policymakers at the local, state, and federal levels to advance
    policies and programs that will reduce and prevent suffering from
    disease.

                           WHAT IS NUCLEAR MEDICINE?

        Nuclear medicine is a medical specialty that involves the use of
    small amounts of radioactive pharmaceuticals, called ``Radiotracers''
    or ``Tracers,'' to help diagnose and treat a variety of diseases. These
    tracers are detected by special types of cameras that work with
    computers to provide nuclear medicine physicians and the patient's
    doctor precise pictures of the area of the body being imaged. It is a
    way to gather medical information that may otherwise be unavailable,
    require exploratory surgery, or necessitate more expensive diagnostic
    tests.
        Nuclear medicine procedures, such as PET (positron emission
    tomography) and SPECT (single-photon emission tomography), often
    identify abnormalities very early in the progression of a disease--long
    before some medical problems are apparent with other diagnostic tests.
    This early detection allows a disease to be treated early in its course
    when there may be a more successful prognosis.
        An estimated 16 million nuclear medicine imaging and therapeutic
    procedures are performed each year in the United States. Nuclear
    medicine procedures are among the safest diagnostic imaging tests
    available. The amount of radiation from a nuclear medicine procedure is
    comparable to that received during a diagnostic x-ray.
        Some of the more frequently performed nuclear medicine procedures
    include:
      --Bone scans to examine orthopedic injuries, fractures, tumors or
            unexplained bone pain.
      --Cardiac scans to identify normal or abnormal blood flow to the
            heart muscle, measure heart function or determine the existence
            or extent of damage to the heart muscle after a heart attack.
      --Breast scans which are used in conjunction with mammograms to more
            accurately detect and locate cancerous tissue in the breasts.
      --Liver and gallbladder scans to evaluate liver and gallbladder
            function.
      --Cancer imaging to detect tumors and determine the severity
            (staging) of various types of cancer.
      --Treatment of thyroid diseases and certain types of cancer.
      --Brain imaging to investigate problems within the brain itself or in
            blood circulation to the brain.
      --Renal imaging in children to examine kidney function.
        securing and maintaining an adequate nuclear medicine workforce
        The field of nuclear medicine is not attracting enough incoming
    students to fill the current demand for nuclear medicine technologists
    (NMTs). Currently, there is approximately an 18 percent vacancy of NMTs
    as determined by the American Hospital Association (AHA). By 2010, the
    Bureau of Labor Statistics (BLS) projects that the United States will
    need an additional 8,000 NMTs to fill the projected demand created by
    the aging workforce and expanding senior population. Over the next 20
    years, the BLS expects that there will be a 140 percent increase in the
    demand for imaging services. The use of diagnostic imaging services has
    been increasing by approximately 4 percent a year, even as the number
    of certified NMTs and registered radiologic technologists has remained
    stable. As a result, imaging technologists often work longer shifts and
    patients can face weeks of delay for routine exams.
        A similar situation to the shortage of NMTs is developing for
    nuclear medicine physicians. According to the American Board of Medical
    Specialties (ABMS), there currently are 4,087 certified nuclear
    medicine physicians in the United States. At the same time, the number
    of physician training programs is also declining, exacerbating the
    future shortage.
        Over the next 20 years, the number of people over the age of 65
    with cancer is expected to double at the exact same time the nation
    will face shortages of medical personnel--including NMTs, physicians,
    nurses, laboratory personnel, and other specialists. New technology and
    an aging population have increased demand for NMTs, but personnel
    capacity is not keeping pace with the need. With an increasing number
    of people needing specialized care--such as nuclear medicine--coupled
    with an inadequate workforce, our nation faces a health care crisis of
    serious proportion with limited access to quality health care,
    particularly in traditionally underserved areas.
        The workforce education and training programs at the Health
    Resources and Services Administration (HRSA) have created a network of
    initiatives across the country that supports the training of many
    disciplines of health providers. These are the only federal programs
    designed to create infrastructures at schools and in communities that
    facilitate customized training designed to bring the latest emerging
    national priorities to the populations at large and meet the health
    care needs of special, underserved populations.
        These important workforce education and training programs are
    designed to increase access to health care in underserved areas by
    improving the quality, geographic distribution, and diversity of the
    health care workforce. To that end, SNM recommends funding of at least
    $550 million to fulfill this mission in the fiscal year 2005.
        Additionally, the number of residency slots for training physicians
    in nuclear medicine is declining. The Society urges Congress to
    establish a nuclear medicine residency-training fund of $2 million per
    year for 5 years. This fund would provide 50 residency training
    positions each year to be used for an additional year of nuclear
    medicine training of radiology residents and additional 2-year nuclear
    medicine residencies. This addition of trained physicians will help
    ease the work force shortage and add to the number of available
    radiation protection experts in the event of a dirty bomb or other
    radiation incident.

                    SUSTAIN AND SEIZE RESEARCH OPPORTUNITIES

        Our nation has profited immensely from our past federal investment
    in biomedical research at the National Institutes of Health (NIH). SNM
    is proud to join with the rest of the public health community in
    advocating $30.19 billion for the NIH in fiscal year 2005. This
    increase of 8.5 percent over fiscal year 2004 funding will allow NIH to
    sustain and build on its research progress resulting from the recent
    NIH budget doubling effort while avoiding the severe disruption to that
    progress that would result from a minimal increase.
        The first successful nuclear magnetic resonance (NMR) experiments
    were performed in 1946 leading to the first nuclear magnetic resonance
    imaging (MRI) exam was performed on a human being in 1977. Critical
    advances in technology development now allow physicians to image in
    seconds what used to take hours. Research in biomedical imaging and
    bioengineering is progressing rapidly and recent technological advances
    have revolutionized the diagnosis and treatment of disease. Therefore,
    SNM requests $325 million for the National Institute of Biomedical
    Imaging and Bioengineering (NIBIB) to further the Institute's research
    in the development and application of emerging and breakthrough
    biomedical technologies that will facilitate improved disease
    detection, management, and prevention.
        Cancer research is producing extraordinary breakthroughs--leading
    to new therapies that translate into longer survival and improved
    quality of life for cancer patients. We have seen extraordinary
    advances in cancer research resulting from our national investment that
    have produced effective prevention, early detection and treatment
    methods for many cancers. To that end, SNM asks the Committee to
    allocate $6.2 billion for the National Cancer Institute (NCI) in fiscal
    year 2005 as recommended by the NCI Director in the Bypass Budget
    submitted to Congress annually under the requirements of the National
    Cancer Act of 1971. The Bypass Budget represents the best estimation of
    the scientific community regarding the resources needed to continue our
    battle against cancer.

                                   CONCLUSION

        The Society of Nuclear Medicine once again stands ready to work
    with policymakers to advance policies that will reduce and prevent
    suffering from disease for all Americans, while ensuring an adequate
    nuclear medicine workforce. Again, we thank you for the opportunity to
    present our views on funding for nuclear medicine workforce and
    research related programs and stand ready to answer any questions you
    may have.
                                     ______

          Prepared Statement of the National Prostate Cancer Coalition

        Mr. Chairman and members of the Committee, thank you for the
    opportunity to share my remarks. The National Prostate Cancer Coalition
    (NPCC) was founded in 1996 to combat a long overlooked killer of men. I
    came to NPCC in 2001, having just recently been impacted by the disease
    myself. In 2000, my grandfather was diagnosed with prostate cancer.
    Having served his country so valiantly in World War II, he was now
    facing a new battle. Luckily, because of early detection through the
    prostate specific antigen (PSA) test and the digital rectal exam (DRE),
    the disease was caught early and, following a radical prostatectomy, he
    is now cancer free. But there are many men who are not so lucky. That's
    why you must adequately fund prostate cancer research for veterans like
    my grandfather, families like mine, and men all over America.
        Under the leadership of this committee we have seen prostate cancer
    research funding increase by nearly $300 million since in the last 6
    years. While we have come a long way, there is still much work to be
    done. For the first year since the founding of NPCC, prostate cancer
    deaths will increase in 2004. Nearly 30,000 lives will be lost to the
    disease. Occurrences of prostate cancer are increasing as well, to over
    230,000 men this year. While cases continue to grow, more men are
    catching the disease in its early stages, when the disease is most
    treatable, by early detection through screening.
        NPCC would like to offer its gratitude on behalf of the 2 million
    American men with prostate cancer for the support this committee has
    offered in the past. The recent doubling of the National Institutes of
    Health's (NIH) budget has helped prostate cancer research funding to
    expand to record levels, but we must ensure this funding is used
    appropriately. To that end, your committee was instrumental in
    requiring NIH and the National Cancer Institute (NCI) to submit a
    professional judgment budget for fiscal year 2003-fiscal year 2008 to
    outline the agencies' plans for prostate cancer research. You have also
    been influential in requesting a fiscal budget for that document, which
    is expected to be submitted to the Committee by April 2004 (Senate Rpt.
    108-081). While no one disputes the historic importance of doubling, we
    ask you to use your oversight capacity to ensure this funding is
    producing results for prostate cancer. Huge sums of taxpayers' money
    have been allocated to NIH over the years and it is now time to examine
    what this windfall has produced. Therefore, we request that you ask NIH
    to submit a yearly update on its prostate cancer research portfolio
    that reflects its progress according to the fiscal year 2003-fiscal
    year 2008 professional judgment budget.
        We are entering an exciting time in biomedical research. The recent
    Food and Drug Administration's approval of Avastin has opened a new
    door for cancer research. Avastin targets cancerous cells by blocking
    their blood supply, an idea that had been previously dismissed by the
    medical community as ``absurd.'' The drug not only signals a turning
    point in changing cancer into a manageable, chronic disease but also
    demonstrates the value of seeking out novel and innovative research. We
    must encourage this kind of research at NIH, including assessing the
    value of stem cell research which has shown promise in research for
    neurological diseases, diabetes, and cancer.
        Developing a new approach to research is a priority for NPCC. The
    Prostate Cancer Research Funders Conference, first convened in 2001 and
    then revitalized last fall, seeks to formulate a collaborative, public-
    private approach to seek out new ways of attacking the problem of
    prostate cancer. Originally co-convened by NPCC and NCI, participants
    now also include the Department of Defense, the Veterans Health
    Administration, the Centers for Disease Control and Prevention, the
    Food and Drug Administration, Canadian and British government agencies,
    private foundations/organizations and representatives from industry.
    Members of the Conference have come together to form a partnership that
    allows them to focus on key objectives and to address commonly
    recognized barriers in research. This could propel research forward
    significantly. As the Conference continues, we ask that the Committee
    make its functionality part of its oversight commitments to prostate
    cancer research. Currently, federal agencies participate voluntarily,
    but they can opt in or out based on the tenure of executive leadership
    and its time-limited decisions. For the conference to be successful
    federal agencies engaged in the prostate cancer research should, in our
    opinion, be required to participate, and we ask for your leadership to
    make that happen.
        Recognizing the importance of cutting edge research initiatives and
    collaborative research efforts, NIH director Elias Zerhouni, M.D.
    recently unveiled the NIH Roadmap. The Roadmap's strategy mirrors that
    of the Funders Conference, specifically by seeking out new approaches
    and ideas and stimulating cross-institutional and cross-center research
    for all NIH driven biomedical research. Believing, we think correctly,
    that the synergies in the Roadmap can achieve outcomes that are greater
    than those any one Institute or Center can achieve, we support its
    efforts to advance key biomedical research initiatives at an
    exponential rate. NPCC applauds the Roadmap and pledges its support to
    take biomedical research in new directions.
        As NIH and NCI look to redefine and increase the efficiencies of
    their research programs, Congress must equip them with the resources
    they need to implement new initiatives. Unprecedented increases in NIH
    and NCI's funding over the last 6 years have created opportunities
    never before available. We must take advantage of these achievements,
    to not do so will not only harm cancer patients everywhere but is,
    quite simply, poor business sense.
        In his fiscal year 2005 budget, President Bush has requested a 2.6
    percent increase ($28.8 billion) in NIH funding over the fiscal year
    2004 level. Over the past 30 years, the agency has averaged an annual
    growth rate of 8 percent. Leading biomedical research groups like the
    Federation of American Societies for Experimental Biology (FASEB) have
    stated if increases are held to 2 percent-3 percent the grant funding
    rate at NIH will drop below 30 percent and approximately 500 fewer
    grants would be funded. To allow NIH and NCI to adequately continue to
    fund promising grants and research first realized during the budget
    doubling, Congress must appropriate at least an 8.5 percent increase
    ($30.25 billion) in funding for these agencies in fiscal year 2005.
    That may seem like a large number, but in reality, it is only a small
    fraction of the estimated $189 billion that cancer alone costs this
    nation yearly.
        Increasing NIH's budget by 8.5 percent would also allow NCI to
    dedicate more than $400 million to prostate cancer research in fiscal
    year 2005. Last year, NCI received only a 3.3 percent increase in
    funding over the previous year's level. Yet, with previously committed
    grant awards and outlays to the NIH Roadmap, NCI is ``effectively
    operating with a budget that is $2.7 million less than last year's
    operating budget (NCI Cancer Bulletin 2/3/04).'' The President's fiscal
    year 2005 budget allocates $4.87 billion to NCI, slightly less than the
    fiscal year 2004 increase. This level will mean even tougher choices in
    awarding grants at NCI. We believe that Congress should fully fund the
    NCI Director's Bypass Budget at $6.2 billion, which would rapidly
    accelerate the nations' fight against all cancers.
        As you know, education and early detection through screening are
    the catalyst to beating prostate cancer. Right now, the PSA blood test
    and DRE physical exam are the best measures for detecting prostate
    cancer early. We ask the Committee to allocate at least $20 million to
    the Center for Disease Control and Prevention's (CDC) prostate cancer
    awareness program. We also encourage the Committee to work with CDC to
    address our concern that the agency places insufficient value on these
    screening tools.
        Thank you again for the leadership you have shown in advancing
    biomedical and, more specifically, prostate cancer research. Under your
    leadership, the nation's war on cancer has reached heights never before
    realized. We look forward to continuing to work with you and the
    members of the Committee until a cure is found.
                                     ______

                            DEPARTMENT OF EDUCATION

       Prepared Statement of the Southern Methodist University School of
                                  Engineering

        Mr. Chairman and Members of the Subcommittee, I am very grateful to
    be able to offer testimony on the importance of maintaining our global
    economic leadership position through a wise and sustained investment in
    engineering education. And, I want to share with you the early success
    of a program called the Texas Engineering and Technical Consortium that
    has emerged as a national model for increasing the technical
    capabilities of our workforce.
        As you know, engineering and technology is an important engine of
    our national economy. The innovations created by our working engineers
    have fueled the information revolution, increased our national
    security, brought more efficient health care, and created a larger food
    supply to the world.
        Our remarkable engineering successes have been the product of our
    talented and highly skilled technical workforce. Unfortunately, recent
    national trends don't bode well for increasing the number of homegrown
    high-tech workers. A 2003 national survey \1\ showed that the level of
    interest in engineering majors by college bound high school seniors has
    declined by 37 percent over the last 12 years. Sadly, this is a
    uniquely American phenomenon; much of the rest of world understands how
    important an engineering and technical workforce will be to their long-
    term economic health. Within the decade, some predict that India and
    China together could graduate nearly 1 million engineers per year, a
    number 20 times greater than the production of engineers here in the
    United States.
    ---------------------------------------------------------------------------
        \1\ ``Maintaining a Strong Engineering Workforce,'' ACT Policy
    Report, authors R. Noeth, T. Cruce, and M. Harmston, 2003.
    ---------------------------------------------------------------------------
        The recently released Hart-Rudman report for the U.S. Commission on
    the National Security/21st Century says:

        ``The harsh fact is that the United States need for the highest
    quality human capital in science, mathematics, and engineering is not
    being met.'' \2\
    ---------------------------------------------------------------------------
        \2\ Road Map for National Security: Imperative for Change, The
    Phase III Report of the U.S. Commission on the National Security/21st
    Century, pp. 30, February 15, 2001.
    ---------------------------------------------------------------------------
    Why is This Important to Both Texas and the Nation?
        Engineering and technology have been drivers of the Texas and
    national economy for nearly 100 years. With the discovery of oil at
    Spindletop by Austrian born engineer Francis Lucas to the kick-start of
    the high tech industry by Jack Kilby's invention of the integrated
    circuit in Dallas, Texas engineers have had a profound and historic
    impact for both our state's and nation's economy. And today, Texas is a
    major hub for engineering innovation--employing nearly half a million
    high tech and engineering workers, with annual wages of $36 billion,
    while exporting $29 billion in goods and services.
        Yet today, this important and large industry is being replenished
    by only 4,500 new college graduates in engineering and computer
    scientists each year. This reality will impact all of us. For example,
    over the next decade, the Joint Strike Fighter program based at
    Lockheed Martin in Ft. Worth, expects to hire twice as many engineers
    each year than the entire state produces. This workforce imbalance is
    bad for Texas and bad for our nation. Our only hope for maintaining
    global leadership in engineering innovation is to invest today in the
    education of the best, most diverse, population of engineers in the
    world.

     A CALL TO ACTION: CONTINUE INVESTING IN SUCCESSFUL PROGRAMS LIKE THE
                   TEXAS ENGINEERING AND TECHNICAL CONSORTIUM

        Fortunately, I am happy to report that the Texas Engineering and
    Technical Consortium, which you supported in last year's budget at $3
    million, is beginning to pay real dividends. Texas Senators Kay Bailey
    Hutchison and John Cornyn led the way in supporting our request for
    federal resources to match state and corporate contributions.
        This innovative effort, aimed at doubling the number of engineers
    and computer scientists graduating from our universities, is already
    having a significant impact. In fact, The Infinity Project, one program
    funded by TETC that I direct, is having a profound effect on national
    engineering education at the high school level--a key barrier to
    college success. This award winning engineering curricula has increased
    high school students' interest in engineering by 40-fold in schools
    that offer the program. And there are other great examples as well.
        The wise investments of the state and federal government, along
    with high-technology companies of Advanced Micro Devices (AMD), Applied
    Materials, Hewlett-Packard, Intel, International SEMATECH, Lockheed
    Martin, Motorola, National Instruments, National Semiconductor, Sabre,
    and Texas Instruments is changing how Texas universities identify,
    recruit, educate, and mentor tomorrow's engineers. Through these
    efforts, TETC is establishing a national model for other states to
    follow as they address their own workforce needs.
        But I am here to tell you that our work has really just begun. As a
    nation, we have struggled for decades to attract a diverse set of well-
    prepared students to the exciting world of engineering, math, and
    science. Permanent solutions to this problem have been elusive--and
    further still, programs that have shown promise often don't get the
    sustained funding necessary to have a real impact.
        Therefore, on behalf of the 34 Texas universities and industry
    leaders participating in TETC, I ask that you continue investing in the
    Texas Engineering and Technical Consortium.
        The program is sound and successful. I ask you to help make our
    progress sustainable.

                                   CONCLUSION

        I want to thank Chairman Arlen Specter, Ranking Member Tom Harkin,
    Members of the Subcommittee and, of course, Senators Hutchison and
    Cornyn once again for supporting TETC. On behalf of all of us across
    this nation who care deeply about the economic health of our country, I
    appreciate your interest in improving the quantity, quality, and
    diversity of America's technical workforce.
                                     ______

       Prepared Statement of the K-12 Science, Technology, Engineering &
                        Mathematics Education Coalition

        We encourage you to continue the federal commitment to math and
    science education by maintaining the peer-reviewed Math and Science
    Partnerships (MSPs) at the National Science Foundation (NSF) and
    supporting robust funding for both the U.S. Department of Education
    (ED) and the NSF Math and Science Partnership programs.
        We urge you to oppose the Administration's budget proposal that
    would phase-out the NSF MSP program and establish a new federal grant
    administered by the Secretary of Education that would, in effect, limit
    individual states' discretion to target much-needed funds for local
    science and mathematics education reforms.
        We believe that the MSPs at both the Department of Education and at
    NSF are necessary and complementary. Without one, the other is
    significantly weakened.
        The competitive, peer-reviewed, NSF MSPs seek to develop
    scientifically sound, model, reform initiatives that will improve
    teacher quality, develop challenging curricula, and increase student
    achievement in mathematics and science. The funds appropriated under
    NCLB for the ED MSPs go directly to the states as formula grants,
    providing funds to all states to replicate and implement these
    initiatives throughout the country.
        While we support the Administration's proposal to increase funding
    for the ED MSPs, we oppose the creation of a new $120 million ED grant
    program that runs counter to congressional intent by focusing only on
    math and reducing state flexibility to target funds to areas of
    greatest need. We encourage you to oppose new restrictions on the
    additional funding slotted for the state-based ED MSPs.
        In summary, we strongly urge Congress to:
      --reject the Administration's proposed phase-out of the NSF MSP
            program;
      --oppose additional restrictions to the ED MSP program; and,
      --provide robust funding for both MSP programs.
        If you have any questions, please contact Patti Curtis at 202-785-
    7385.
                                     ______

                  Prepared Statement of Americans for the Arts

                                    REQUEST

        Americans for the Arts is pleased to submit testimony supporting
    fiscal year 2005 appropriations of $53 million for the Arts in
    Education program of the U.S. Department of Education (USDE).
        Americans for the Arts is one of the leading national nonprofit
    organizations for advancing the arts and arts education in America.
    With a 40-plus year record of objective arts industry research, we are
    dedicated to representing and serving local communities and creating
    opportunities for every American to participate in and appreciate all
    forms of the arts. Our belief in the importance of practical research
    causes us to take special pleasure in supporting USDE's Arts in
    Education program, which is generating impressive evidence on the best
    ways to improve overall academic achievement by integrating the arts
    into the school curriculum. The evidence of improved academic
    achievement is itself impressive. For example:
      --Mississippi's Whole School Initiative found that schools with a
            high degree of implementation far surpassed other schools in
            their ability to meet No Child Left Behind (NCLB) reading
            targets.
      --In Houston, analysis showed that students in participating
            elementary schools out-performed their demographic peers on the
            Iowa Test of Basic Skills, and that the benefits lasted beyond
            graduation and on into middle school.
        We have provided more detailed information on the Mississippi
    example below.
        As members of the Subcommittee know, the Elementary and Secondary
    Education Act provides that funding up to $15 million be directed to
    the John F. Kennedy Center for the Performing Arts and VSA arts. Prior
    to fiscal year 2001, funding never exceeded that level. Since fiscal
    year 2001, however, Congress has appropriated funding sufficient to
    support a broader array of arts education programs. For fiscal year
    2004, Congress appropriated $35.1 million. In addition to the Kennedy
    Center and VSA arts, USDE now supports grants competitions to:
      --further develop established arts education models;
      --support professional development for arts educators in four arts
            disciplines; and
      --establish partnerships between schools and community cultural
            organizations to serve at-risk children and youth.
        We ask the Subcommittee to appropriate $53 million for fiscal year
    2005, with the bulk of the increase to be allocated to the Arts in
    Education Model Development and Dissemination Program, Professional
    Development training in music, theater, dance and the visual arts, as
    well as Cultural Partnerships for At-risk Children and Youth.

                FOUR REASONS TO INCREASE ARTS EDUCATION FUNDING

        The most important reason to support arts education is simply
    stated: arts education works for children. Research increasingly
    confirms its beneficial effects in several areas, including but not
    limited to academic achievement. We refer the Subcommittee to a
    research compendium Critical Links: Learning in the Arts and Student
    Academic and Social Development,\1\ released by the Arts Education
    Partnership in 2002, which includes 62 separate studies pointing to
    ``critical links'' between arts education and reading, writing,
    mathematics, cognitive skills, motivation, social behavior, and the
    school environment. The studies suggest that arts education may be
    especially useful for students who are economically disadvantaged and/
    or in need of remedial instruction.
    ---------------------------------------------------------------------------
        \1\ http://www.aep-arts.org/CLTemphome.html
    ---------------------------------------------------------------------------
        The second reason to increase funding is that schools desperately
    want it. Even now, when the accountability and testing regimens of NCLB
    have focused schools' attention on what some call ``the basics,'' many
    schools understand that the arts are a core academic subject, as NCLB
    indeed stipulates, that they are essential, and that they work. The
    Department of Education's first model grant competition generated a
    flood of applications despite the tiny number of awards. A larger
    amount of funding, coupled with a smaller grant size, will at least
    begin to address the demand. Unfortunately, without an increase in
    funding, USDE will be unable to hold a new grant competition for 2
    years.
        The third reason is that while there is tremendous interest in arts
    education, substantial improvements need to be made to delivery
    systems. USDE's model grants program aims to further develop
    established programs that improve arts education, to evaluate these
    programs, and to disseminate the results. Thus, it is in accord with a
    central principle of the federal role in education: to find out what
    works and to disseminate this information to states and local school
    districts so that they may select and tailor programs to fit their own
    needs and circumstances. This is the reason that we urge the
    Subcommittee to recommend that funding include at least $1 million for
    evaluation and dissemination. We note that each of the projects funded
    under this program include a substantial research component. It is
    particularly important to add this modest amount of funding because the
    USDE's existing and planned research efforts, including the What Works
    Clearinghouse, do not include substantial work on arts education.
        Finally, despite increases in overall federal spending for K-12
    education, and despite the substantial flexibility given to states,
    evidence is beginning to accumulate that schools are neglecting those
    areas of the curriculum that are not subject to the mandatory testing
    requirements of NCLB. The National Association of State Boards of
    Education (NASBE) identified the threat in its 2003 report The Lost
    Curriculum; \2\ in response, NASBE's current quarterly policy journal,
    the State Education Standard,\3\ is devoted entirely to ``ensuring a
    place for the arts in America's schools.'' Earlier this month, the
    Council for Basic Education released a survey \4\ of school principals
    in four states: fully one quarter of them report that they have
    decreased instructional time in the arts. Unfortunately--and perhaps
    even tragically--the shift away from the arts appears most concentrated
    in elementary schools and schools with large minority populations. We
    have supported NCLB, especially its inclusion of the arts as a core
    academic subject, and we believe that the problems facing arts
    education are a consequence that is very much unintended. Nevertheless,
    the problems are real and must be addressed. USDE's model development
    program--if there is sufficient funding for national dissemination--
    provides principals with desperately needed information on how to
    integrate the arts into the curriculum in a way that improves academic
    achievement.
    ---------------------------------------------------------------------------
        \2\ http://www.nasbe.org/Research_Projects/Lost_Curriculum.html
        \3\ http://www.nasbe.org/Standard/index.html
        \4\ http://www.c-b-e.org/PDF/cbe_principal_Report.pdf
    ---------------------------------------------------------------------------
              CASE EXAMPLE: MISSISSIPPI'S WHOLE SCHOOLS INITIATIVE

        In our testimony for fiscal year 2004 funding, we provided
    extensive information on structure and philosophy of the Whole School
    Initiative in Mississippi. This year, we can provide a preliminary
    analysis for the project's final evaluation report, which is due in
    June.

    Recap of the Whole Schools Initiative
        In 2001, the Whole Schools Initiative was 1 of 11 successful
    applicants for a grant from USDE's Arts in Education Model Development
    and Dissemination Program. The program's roots go back to 1991, when as
    a response to ``back to basics'' school reform and the lack of arts
    instruction in Mississippi, the Mississippi Arts Commission (MAC)
    commissioned a study of the Mississippi environment, appropriate
    national arts education models and relevant research. A pilot program
    began in 1992.
        The Whole Schools Initiative was launched in 1998 with a core
    belief that art is essential to every child's education. It is the
    first comprehensive statewide arts education program in Mississippi.
    Its goals are to improve student academic achievement by infusing arts
    into the basic curriculum, to assist the professional and personal
    growth of teachers and administrators through arts experiences, to use
    the arts to increase parental and community involvement in schools and
    to assist schools in building a sustainable system for supporting arts
    infusion. Partnerships include local arts councils, Institutions of
    Higher Learning, the Mississippi Alliance for Arts Education,
    professional artists, local school districts and art museums.
        Not only does the program improve the quality of arts education
    being offered in participating schools, it is often the only chance
    that Mississippi children, in poorly funded schools and from families
    living below the poverty level, will ever have to receive any
    formalized arts instruction. Nineteen of the initiative's 26 schools
    serve student populations where 35 percent or more of the students
    qualify to receive free/reduced lunches, fourteen schools have at least
    70 percent and seven have at least 90 percent. Eleven schools involved
    in the initiative are located in rural communities and others serve
    them. Six of these schools have the lowest per pupil expenditure in the
    state.
        This $1 million grant has allowed MAC to expand its role with
    universities, encouraging the development of pre-service courses that
    to strengthen arts infused instruction and aid arts majors in becoming
    effective instructional leaders. The grant has also enabled MAC to
    expand and refine its evaluation model. A final component of the USDE
    funding is allowing MAC to develop training materials and procedures
    that can be used to replicate the program in other settings. At the end
    of the 3-year grant period, the project will ``blueprint'' a model
    built on a research base, field-tested in a diverse set of schools,
    evaluated internally and externally, and which has already produced
    substantive results.
        This funding has made possible extensive professional development
    opportunities for teachers and administrators. More than 15,000
    students and 800 educators benefit annually from activities at a
    weeklong summer institute, two retreats, and field advisor visits.
    Other ways in which it is strengthening the program include a course
    for education majors that is being developed at the Delta State
    University, a ``teacher friendly'' and ``teacher useful'' interactive
    web site, and the designation of model schools in the north, central,
    and southern regions of Mississippi where the initiative's work may be
    observed.
        Other states will benefit from the documentation and dissemination
    of the initiative. Many states have a strong interest in implementing
    this model but lack the resources, knowledge, and experience to do so.
    States that have approached MAC and participated in the institute
    include New Mexico, Illinois, Kentucky, Florida, and Louisiana.
    Preliminary Results of the Whole Schools Initiative
        The preliminary analysis looks closely at WSI participating
    schools' NCLB performance in literacy, which was reported for the first
    time in the fall of 2003. Literacy was chosen as the analytic focus
    because most of the examined schools were elementary school buildings
    and learning to read was the foremost concern at that level. The first
    part of the analysis examines the performance of the 25 participating
    schools in the spring of 2003 and compares their results to the state
    average and to a matched set of comparison schools. The second examines
    a subset of 18 sites that: (1) completed a teacher survey concerning
    the implementation and impact of the initiative and (2) had grade
    levels that were included in the reporting requirements of NCLB.
        The analysis suggests that two conclusions are warranted. First,
    schools attempting to create an arts-rich environment for their
    students performed as well as--if not slightly better than--both the
    state average for all Mississippi schools and a comparison group of
    schools demographically and geographically similar to themselves.
    Second, schools whose teachers reported higher implementation of WSI
    objectives far surpassed lower implementation schools in enabling their
    students to meet the all-important growth targets of NCLB. The
    implication of the analysis is that rather than stripping the
    curriculum of all but basic direct instruction in literacy and math
    under the spotlight of making adequate yearly progress, schools might
    consider enriching the learning environment with multiple opportunities
    to learn in the arts.

                                   CONCLUSION

        As the example of the Whole Schools Initiative demonstrates,
    federal funds boost the quality and quantity of support for arts
    education as well as the knowledge that can be gained and disseminated
    across the education establishment. Increased funding means more help
    for state departments of education, educators in schools, and local
    education agencies and cultural organizations. Most important, it means
    a better education for our children. We urge the Senate Subcommittee on
    Labor, Health and Human Services, and Education to recommend $53
    million in funding for the USDE's Arts in Education programs in order
    to allow more programs like Mississippi's Whole Schools Initiative to
    flourish.
                                     ______

                 Prepared Statement of the Close Up Foundation

        Mr. Chairman and distinguished members of the Subcommittee, my name
    is Stephen A. Janger, and I am president and founder of the Close Up
    Foundation. I am grateful for the opportunity to submit testimony in
    support of the Close Up Fellowships, previously known as the Allen J.
    Ellender Fellowships, which help low-income students and their
    participating teachers take part in our Close Up Washington civic
    education programs. On behalf of my colleagues at the Foundation and
    hundreds of thousands of young people and educators who have
    participated in Close Up through the years from school systems across
    the country, I want to express my appreciation for this Subcommittee's
    longstanding encouragement and support.
        As you may recall, in my testimony last year, I described the
    impact of world events on Close Up's work--specifically, September 11
    and the more recent hostilities in Iraq. We saw a decline in our
    program enrollments because of fear of travel to Washington, D.C., and
    subsequent travel bans. I am pleased to let you know that program
    enrollments appear to be improving and we are seeing a modest increase
    in participation over last year. I want to let you know also that we
    are doing all we can to broaden efforts to encourage participation in
    our civic education programs, knowing that our mission is more
    important and vital than it has been since our inception in 1971. We
    have reason to believe, based on our conversations with teachers and
    school districts, that next year will see an even more significant
    enrollment expansion because of the continued easing of travel
    anxieties and the relaxation of school travel bans.
        The heart of our mission is the conduct of Close Up's weeklong
    program in Washington, D.C. During this program, students receive 12 to
    14 hours of civic instruction and educational activities each day. Led
    by our trained Program Instructors, young people learn in a ``living
    classroom'' environment through study visits to Capitol Hill,
    embassies, and many of the country's most historic and symbolic sites.
    Policy specialists, journalists, lobbyists, and other insiders help
    show students how government works. Close Up's instructors add to these
    seminars by teaching the basics of government and citizenship through
    highly engaging role-playing, workshops, discussion groups, and
    simulations.
        The centerpiece of the program is typically a face-to-face meeting
    with Members of Congress or your staffs. They are able to engage in a
    dialogue with an elected official or staff member ``close up.'' In
    addition, students often see floor debates and committee hearings. They
    come to understand the process of government, may feel a bit less
    intimidated about how it works, and can begin to see that they have a
    role in the future of our democracy.
        The difficult reality is that it has become more expensive to make
    this unique opportunity available for students from every background
    because the costs from even the most competitive vendors continue to
    increase. To pay for these experiences, our young participants, who
    come from very varied backgrounds and represent a wide range of
    academic performance, often start fundraising during their freshman and
    sophomore years to attend the program in their senior year. They
    generate funds from community contributions, fundraising activities,
    and old fashioned work to support the costs of travel and program
    tuition.
        Not every Close Up participant is fortunate to come from an
    affluent background. Our work with Native Americans, Alaska Natives,
    Hispanics, African Americans, migrant students, the physically
    challenged, and students who are long-term cancer survivors takes us
    each year into populations with need for special help to make possible
    their participation. During my 34 years at Close Up, I have seen tens
    of thousands of these student-participants who have been able to
    participate in our Close Up Washington program only because of the
    Close Up Fellowships. The support of this Subcommittee not only covers
    up to half of a needy student's program, it serves as a meaningful
    ``jump start'' for the student who seeks additional support from local
    businesses, parents, schools and community organizations. In this way,
    the Fellowships have a significant multiplier effect at the community
    level.
        The Carnegie Foundation published last year a highly collaborative
    report called ``The Civic Mission of Schools.'' It may be the most
    significant statement in the civic education field in the last decade.
    It makes a strong case for making civic education much more of a
    priority in our elementary and secondary system of education. It also
    singles out practices, such as the experiential methodology of Close
    Up, as having the most effect. It also suggests that schools themselves
    cannot do it all by themselves. Partnerships, collaborations, use of
    external resources all can help schools better achieve their civic
    mission.
        Beyond the funding support we work to generate each year from the
    corporate and philanthropic sectors, we could not be more proud of the
    partnerships we have been able to forge with states, districts, and
    individual schools. These partnerships not only provide a number of
    individual students and teachers with the opportunity to take part in
    Close Up's Washington program, but also to use this experience as a
    means of strengthening the entire curriculum and extracurricular
    activities as well in the area of civic education. This is another
    strong example of the multiplier effect.
        I believe strongly that schools are still the best tool for
    instilling civic virtue and that community service, service learning,
    and participation in the development of public policy are essential
    training tools for good citizenship. With that in mind, I want to take
    this opportunity to briefly describe one of our programs that holds
    tremendous potential for growth.
        Several years ago, we decided that our work with inner city schools
    needed greater focus and intensity. To that end we developed strong
    working relationships and raised significant extra financial support to
    dramatically increase the amount of fellowship resources for the major
    urban public school districts in Washington, D.C., Houston, and Tulsa.
    Within this current year, we have added Atlanta and Miami to this new
    series of program activities we call the Great American Cities Program.
        Students receive a great deal of financial assistance from
    community support, and much is expected of them both before and after
    their Washington program experience. Students develop and implement
    community projects that contain in some form a public policy dimension.
    Teachers receive in-service training, led by our own staff and other
    experts, on how to foster and develop these programs. This is another
    example of the multiplier effect where Close Up Fellowships have
    provided through the years a partnership with school districts that
    enabled the launch of an innovative and effective program.
        As you will read in a few testimonials following this statement--
    selected from the thousands we receive each year--Close Up's work with
    young people and educators provides inspiration, reduces cynicism and
    enhances understanding about the democratic process. Students see
    firsthand how individuals make a difference and that they themselves
    can leave things a little better than they found them.
        Close Up was started more than three decades ago in another era of
    conflict to help address the disillusionment expressed by many young
    Americans during the Vietnam War. Our work has remained both relevant
    and effective, and is needed now more than ever. America today is faced
    with many policy choices, both international and domestic, that
    threaten to divide us. A greater dialogue among a thoughtful and
    patriotic citizenry is needed to help pull our country together. This
    has been our goal since our inception: to create a public of engaged,
    informed, and responsible citizens that Jefferson believed was the most
    important outcome of our nation's schools.
        In closing, Mr. Chairman, I want to thank this Subcommittee for its
    strong support through the years. The nation's civic education efforts
    cannot afford to take a back seat to other curricula objectives. These
    efforts should underlie our important focus on literacy and science
    testing. It should be second nature to our young people that the
    blessings of this great country, and the responsibilities to sustain
    those blessings through active involvement in the democratic process,
    are the bedrock values and principles from which the liberties of
    personal and academic freedom are derived. These values and these
    principles are what set us apart as a nation.
        The Close Up Foundation takes great pride in its national
    leadership in these values and principles from which we have never
    deviated since we began in 1971. The vital funding that we have
    received from this Subcommittee through the years, combined with our
    own efforts in the private sector to multiply that funding, has made it
    possible for hundreds of thousands of young people and their teachers
    representing every kind of background to understand and appreciate
    these core values and principles. Your continued support at an
    increased level for the Close Up Fellowships will help us do more--
    where it is most needed.
        We respectfully request that this Subcommittee increase the Close
    Up Fellowships to a level of $4 million. This will enable us to
    multiply our efforts even further, so that those who are most often
    neglected or turned away from the civic involvement mainstream are
    brought into the democratic process. This is fundamental to our
    mission.
        Thank you, Mr. Chairman, for your consideration of this request.

                     TESTIMONIALS OF CLOSE UP PARTICIPANTS

        ``I truly believe that your program is the most educational
    governmental program available to students in the United States. With
    the additions of teacher fellowships as well as student fellowships we
    are able to encourage and in fact provide for opportunities to all our
    students regardless of economic status or academic levels.''----Todd
    Lee, Teacher, 2004 Tioga High School, Tioga, North Dakota.

        ``Many members of my staff have had an opportunity to met with a
    number of these students and their participating teachers directly. The
    feedback has been overwhelmingly positive. We are all pleased with the
    excitement for learning expressed about the program. We have also met
    regular with the leaders of the Close Up Foundation and their gifted
    young educators who are charged with conducting the program. To a
    person we are impressed by the integrity, commitment, and the passion
    they bring to their work.''----Dr. David E. Sawyer, Superintendent,
    2003 Tulsa Public Schools, Tulsa, Oklahoma.

        ``Close Up gave me the insider's view of Washington and our
    government. I now have a greater understanding of the political
    process. I learned that I can make a difference, and I now have a
    greater desire to participate in the political system. . . . Close Up
    gave me a passion and interest in the United States government.''----
    Katherine McDermott, Student, 2004 Doniphan-Trumbull High School,
    Doniphan, Nebraska.

        ``Close Up is a huge part of my life. I met amazing people from all
    over the country and each one of those people helped me to fully
    establish and solidify my political views. Because of my involvement in
    Close Up I have been able to help educate my peers about how our
    government works as well as work for educating people about voting.''--
    --Andrea Nowak, Student 2004 Bishop Foley High School, Madison Heights,
    Michigan.

        ``I always had strong political views, but being surrounded by kids
    who `didn't care' about current events, I never had to prove my ideas
    to anyone. Going on Close Up, I realized that not everyone shared my
    views, in fact, some even said I was wrong! . . . While I didn't back
    down, I at least began to understand the other side's argument,
    something I would never have been able to do before. . . . Close Up
    opened me up to a whole new world of ideas, thought, and way of life.
    And while I may not agree, at least I can agree to disagree.''----Emily
    Wolfe, Student, 2004 Newton South High School, Newton Centre,
    Massachusetts.

        ``The Close Up Program, in particular our time on Capital Hill,
    affords students the opportunity to experience democracy in a hands-on
    fashion, thus making it real to them. In addition, it validates the
    necessity of their role in a democratic society.''----Lori Merkel,
    Teacher, 2003 East Valley High School, Spokane, Washington.

        ``This organization provides a unique experience for both students
    and teachers. I am a history teacher at Senn High School in Chicago.
    Like many Chicago Public Schools, we battle the effects of poverty
    every day in our classrooms. The opportunity the Close Up Foundation
    gives to these students is tremendous. This may be the only time in the
    lives of my students where they will have this type of access to
    Washington, DC and the officials who make decisions affecting their
    lives.''----Johanna Klinsky, Teacher, 2004 Nicholas Senn High School,
    Chicago, Illinois.

        ``. . . You . . . may not hear about the lives that are changed
    through your work each day, but please know that your support and
    leadership make dreams come true for students and create life-changing
    experiences. It may sound cliche, but it is so very true: Only in
    America can children who are born in the most humble of circumstances
    have real opportunities to make all of their dreams come true. Truly,
    the broad scope of American education positively impacts every student
    and extends to each student a special invitation to excellence.''----
    Dr. Beverly Boone, Principal, 2003 The Anchor School, Biscoe, North
    Carolina.
                                     ______

                      Prepared Statement of Zero to Three

        Chairman and Members of the Subcommittee: I am pleased to submit
    the following testimony on the Labor/Health and Human Services/
    Education and Related Agencies fiscal year 2005 Appropriations on
    behalf of ZERO TO THREE. My name is Matthew Melmed. For the last 9
    years I have been the Executive Director of ZERO TO THREE. ZERO TO
    THREE is a national non-profit organization that has worked to advance
    the healthy development of America's babies and toddlers for over 25
    years. I would like to start by thanking the Subcommittee for all of
    their work to ensure that our nation's at-risk infants and toddlers
    have access to early intervention and positive early learning
    experiences.
        We know from the science of early childhood development that
    infancy and toddlerhood are times of intense intellectual
    engagement.\1\ During this time--a remarkable 36 months--the brain
    undergoes its most dramatic development, and children acquire the
    ability to think, speak, learn, and reason. All babies and toddlers
    need positive early learning experiences to foster their intellectual,
    social, and emotional development and to lay the foundation for later
    school success. Babies and toddlers living in high-risk environments
    need additional supports to promote their healthy growth and
    development. Disparities in children's cognitive and social abilities
    become evident well before they enter Head Start or Pre-Kindergarten
    programs at age 4. I am here to talk to you today about why it is
    important to increase funding for three programs focused on the unique
    needs of low-income infants and toddlers--Early Head Start, the Child
    Care and Development Fund (CCDF) and Part C of the Individuals with
    Disabilities Education Act (IDEA).
    ---------------------------------------------------------------------------
        \1\ Shonkoff J., and Phillips, D. (Eds.) (2000). National Research
    Council and Institute of Medicine. From Neurons to Neighborhoods: The
    Science of Early Childhood Development. Washington, DC: National
    Academy Press.
    ---------------------------------------------------------------------------
                                EARLY HEAD START

    What is Early Head Start?
        Congress created Early Head Start in 1995 with strong bipartisan
    support. It is the only federal program specifically designed to
    improve the early education experiences of low-income babies and
    toddlers. The mission of Early Head Start is clear: to support healthy
    prenatal outcomes and enhance intellectual, social and emotional
    development of infants and toddlers to promote later success in school
    and life. Research demonstrates that Early Head Start is effective. The
    Congressionally mandated National Evaluation of Early Head Start--a
    rigorous, large-scale, random-assignment evaluation--concluded that
    Early Head Start is making a positive difference in areas associated
    with children's success in school, family self-sufficiency, and
    parental support of child development. Early Head Start serves over
    63,000 low-income families with infants and toddlers through 708
    community-based programs.\2\ Unfortunately, only 3 percent of all
    eligible children and families are served.\3\
    ---------------------------------------------------------------------------
        \2\ U.S. Department of Health and Human Services, Administration
    for Children and Families (2002). Early Head Start Information Folder,
    www.headstartinfo.org/infocenter/ehs_tkit3.htm. 2002 EHS Fact Sheet
    www.acf.hhs.gov/programs/hsb/research/factsheets/02/hsfs.htm.
        \3\ 2002 EHS Fact Sheet www.acf.hhs.gov/programs/hsb/research/
    factsheets/02/hsfs.htm. CPS Annual Demographic Survey, March Supplement
    2001 Table 23 ``Single Years of Age--Poverty Status of People in 2001''
    http://ferret.bls.census.gov/macro/032002/pov/new23_004.html.
    ---------------------------------------------------------------------------
    Is Early Head Start Effective?
        Key to Early Head Start's success is its emphasis on the
    implementation of the Head Start Program Performance Standards, which
    ensure the highest quality care for babies and families and its
    comprehensive approach to serving children and families. What is most
    compelling about the Early Head Start data is that they reflect a broad
    set of indicators, all of which show positive impact--patterns of
    impacts varied in meaningful ways for different subgroups of families.
    For example, the National Evaluation found that Early Head Start
    produced statistically significant, positive impacts on standardized
    measures of children's cognitive and language development; \4\ The
    Evaluation also found that Early Head Start parents were more involved
    and provided more support for learning; and that the program helped
    parents move toward self-sufficiency.
    ---------------------------------------------------------------------------
        \4\ U.S. Department of Health and Human Services, Administration
    for Children and Families (2002). Making a Difference in the Lives of
    Infants and Toddlers and Their Families: The Impacts of Early Head
    Start. Washington, DC.
    ---------------------------------------------------------------------------
    Funding
        Currently, 10 percent of the overall Head Start budget is used to
    serve 63,000 low-income families with infants and toddlers through
    Early Head Start--only 3 percent of all eligible children. An increase
    in the overall Head Start appropriation is needed and will enable more
    eligible infants and toddlers to be served through the 10 percent Early
    Head Start set-aside. Congressional authorizers are currently
    considering an increase in the Early Head Start funding allocation--
    potentially doubling the allocation of funds for infants and toddlers
    enrolled in the program. Given the uncertainty of action on that
    legislation, we encourage the Subcommittee to increase the Early Head
    Start portion of the program to 12 percent of the total appropriation
    for Head Start in fiscal year 2005. Additional funds will enable us to
    protect and continue to build on the firm foundation that currently
    exists and to ensure that more eligible babies and families are able to
    benefit from the services of Early Head Start.

                   THE CHILD CARE AND DEVELOPMENT FUND (CCDF)

    What is CCDF?
        The Personal Responsibility and Work Opportunity Reconciliation Act
    of 1996 revamped the structure of federal funding for child care and
    created the Child Care and Development Fund (CCDF). This streamlined
    block grant attempts to maximize states' flexibility in administering
    child care programs and establishes a single set of rules and
    regulations that apply to all components of the fund. CCDF funding is
    divided into three streams of federal funds: federal mandatory funds
    that do not require a state match; federal mandatory funds that do
    require a state match; and federal discretionary funds that do not
    require a state match. States are required to spend a minimum of 4
    percent of CCDF funds on activities designed to improve the quality of
    child care. Today Congress earmarks $100 million of the CCDF funds for
    strategies to increase the supply and improve the quality of child care
    for infants and toddlers.

    Is CCDF Effective?
        CCDF provides funds to help improve the quality and supply of child
    care for low-income children and families. For example, the infant-
    toddler set-aside of CCDF, currently earmarked through the
    appropriations process, has helped states focus on the unique needs of
    infants and toddlers by investing in specialized infant-toddler
    provider training, providing technical assistance to programs and
    practitioners, and linking compensation with training and demonstrated
    competence. Another example is the quality set-aside of CCDF. The
    quality set-aside, currently 4 percent, provides funds to states in
    order to support and develop innovative strategies for improving the
    quality of child care. Strategies may include: training grants and
    loans to providers; improved monitoring; resource and referral
    counseling for parents to find child care; and other services related
    to improving the quality of child care.

    Funding
        Despite modest increases in federal child care funding, CCDF funds
    are insufficient to serve all eligible children. In fact, the Center
    for Law and Social Policy (CLASP) estimates that states served only
    about 14 percent of federally-eligible children (approximately 1 out of
    7) in fiscal year 2000. Connecticut has an estimated 17,000 children on
    its waiting list for child care assistance and has not served any new
    low-income working families not receiving welfare since August 2002. A
    substantial increase is needed to ensure that all states are able to
    serve more eligible children and families. Although states have made
    great progress in improving the quality of child care for low-income
    children, additional resources are necessary to ensure that more low-
    income children have access to quality child care. We must
    significantly increase the percentage of the quality set-aside (from 4
    to 10 percent) to improve the quality of child care. Finally, because
    the infant-toddler set-aside is earmarked through the appropriations
    process, we must ensure that the set-aside continues to grow as the
    overall funding for CCDF continues to grow.

                                 PART C OF IDEA

    What is Part C of IDEA?
        Part C of the Individuals with Disabilities Education Act (IDEA)
    authorizes the federal support for early intervention programs for
    babies and toddlers with disabilities, and provides federal assistance
    for states to maintain and implement statewide systems of services for
    eligible children, age birth through 2 years, and their families. Under
    Part C, all participating states and jurisdictions must provide early
    intervention services to any child below age 3 who is experiencing
    developmental delays or has a diagnosed physical or mental condition
    that has a high probability of resulting in a developmental delay. In
    addition, states may choose to provide services for babies and toddlers
    who are ``at-risk'' for serious developmental problems, defined as
    circumstances (including biological or environmental conditions or
    both) that will seriously affect the child's development unless
    interventions are provided. The Part C system offers the opportunity to
    maximize the impact of Part B dollars (which provides for the education
    of children with disabilities ages 3-21). Early intervention services
    under Part C may prevent or minimize the need for more costly services
    under Part B later in a child's life. Research shows that intervention
    is more effective if begun before age 3.

    Is Part C Effective?
        The Office of Special Education Programs (OSEP) has commissioned
    the National Early Intervention Longitudinal Study (NEILS) to examine
    what happens to infants and toddlers with special needs and their
    families during and after Part C early intervention. NEILS is following
    a nationally representative sample of 3,338 infants and toddlers who
    received early intervention services. The sample consists of children
    from four age groups--the oldest children in the study exited early
    intervention in 1998, the youngest children in the study exited early
    intervention in 2001. For all age groups, the children were found to be
    advancing developmentally and showing greater mastery of milestones
    than they had when they entered early intervention.\5\ For the children
    who entered early intervention between 6 and 12 months and between 12
    and 18 months of age, a significant percentage had mastered many of the
    motor and self-help milestones by 1 year.\6\ Children in these two age
    groups also showed progress with communication and cognition
    milestones.\7\
    ---------------------------------------------------------------------------
        \5\ U.S. Department of Education. (2002). Twenty-Fourth Annual
    Report to Congress on the Implementation of the Individuals with
    Disabilities Education Act, Washington, DC: U.S. Department of
    Education.
        \6\ Ibid.
        \7\ Ibid.
    ---------------------------------------------------------------------------
    Funding
        In spite of reports from states that referrals to Part C continue
    to increase, Part C has received only very small increases over the
    past few years. The fiscal year 2003 Part C appropriation was
    $434,159,000 while the current fiscal year 2004 appropriation for Part
    C is $444,363,000.\8\ Although estimates of children with disabilities
    under age 3 range from 3 percent to 5.2 percent,\9\ as of December 1,
    2002, only 2.24 percent of all infants and toddlers (267,923) were
    served under Part C. Because the federal government is not paying its
    fair share to support the provisions of IDEA, the burden is placed on
    states and on families. And there is wide variation in the percentage
    of infants and toddlers enrolled in Part C across states. For example,
    Massachusetts serves 5.8 percent of infants and toddlers while Nevada
    serves less than 1 percent.\10\ Substantial increases in the Part C
    appropriation are needed to ensure that all eligible infants and
    toddlers are served without having the burden placed on states and
    families.
    ---------------------------------------------------------------------------
        \8\ Council for Exceptional Children, ``Full Funding for IDEA: It's
    a Guarantee, Not Just a Promise.'' February, 2004. Arlington, VA:
    Council for Exceptional Children.
        \9\ Oser, C., & Cohen, J. (2003). America's babies: The ZERO TO
    THREE Policy Center data book. Washington, DC. ZERO TO THREE Press.
        \10\ IDEAdata.com (2004). ``Number and Percentage (Based on 2002
    population estimates) of Infants and Toddlers Receiving Early
    Intervention Services.'' Retrieved April 22, 2004, from
    www.IDEAdata.org
    ---------------------------------------------------------------------------
                                   CONCLUSION

        During the first 3 years of life, children rapidly develop
    foundational capabilities--cognitive, social and emotional--on which
    subsequent development builds. These years are even more important for
    at-risk infants and toddlers. Early Head Start, the Child Care and
    Development Fund, and Part C of IDEA can serve as protective buffers
    against the multiple adverse influences that may hinder their
    development in all domains.
        With the Subcommittee's help, we have made some gains over the past
    few years in increasing funding for early intervention and positive
    early learning experiences for at-risk infants and toddlers. The fact
    remains, however, that our overall policy and funding emphasis is still
    to wait until children are already behind developmentally before
    significant investments are made to address their needs. I urge the
    Subcommittee to change this pattern and invest in infants and toddlers
    early on, when that investment can have the biggest payoff--preventing
    problems or delays that become more costly to address as the children
    grow older. We do not need to accept that vulnerable children will
    inevitably have already fallen behind at age four and then provide
    special education and intensive prekindergarten services to help them
    play catch up. We know how to provide early intervention and positive
    early learning experiences to infants and toddlers that works. I hope
    the Subcommittee will make that initial investment to prevent very
    young children from falling behind.
        Thank you for your time and for your commitment to our nation's
    infants, toddlers and families.
                                     ______

           Prepared Statement of the United Tribes Technical College

                               SUMMARY OF REQUEST

        For 35 years United Tribes Technical College (UTTC) has been
    providing postsecondary vocational education, job training and family
    services to Indian students from throughout the nation. Our request for
    fiscal year 2005 funding for tribally controlled postsecondary
    vocational institutions as authorized under Section 117 of the Carl
    Perkins Vocational and Applied Technology Act is:
      --$8 million under Section 117 of the Perkins Act, which is $800,000
            over the fiscal year 2004 enacted level. This funding is
            essential to our survival, as we receive no state-appropriated
            vocational education monies.
      --Ensure that the provision that has been included since fiscal year
            2002 in the Labor-HHS Education Appropriations Acts that waived
            the regulatory requirement that we utilize a restricted
            indirect cost rate is continued.
      --Funding for renovation of our facilities, many of which are
            original to the Fort Abraham Lincoln army installation. A
            recent study commissioned by the Department of Education shows
            a facility need for UTTC of $49 million.
        Restricted Indirect Cost Issue.--Beginning in fiscal year 2002 the
    Labor-HHS-Education Appropriations Act provided that notwithstanding
    any law or regulation, that Section 117 Perkins grantees are not
    required to utilize a restricted indirect cost rate. We thank you for
    taking this action, and ask that it be continued in the fiscal year
    2005 Act.
        In 2001, the Department of Education, for the first time, directed
    Indian grantees (both Section 116 and 117 grantees) to apply a
    ``restricted indirect cost rate'' to their grants. This means each
    tribal grantee must obtain another indirect cost rate--exclusively for
    its Perkins Act grant--from its cognizant federal agency (which in most
    cases is the Inspector General for the Department of the Interior.)
        The Department gave two reasons for applying a restricted rate to
    these Perkins Act Indian programs: (1) The 1998 Amendments to the
    Perkins Act (Sec. 311(a)) prohibits the use of Perkins Act grant funds
    to supplant non-federal funds expended for vocational/technical
    programs. This ``supplement, not supplant'' limitation previously
    applied to State grants, only; and (2) A long-standing Department of
    Education regulation (promulgated years before the 1998 Perkins
    Amendments) automatically applies the restricted indirect cost rate
    requirement to any Department of Education grant program with a
    ``supplement, not supplant'' provision.
        UTTC has no quarrel with the bases and objectives of the
    ``supplement, not supplant'' rule and seeks no change to this statutory
    provision. The primary targets of this rule are States and possibly
    local government entities that run vocational education programs with
    State or local funds.
        By contrast, however, UTTC has little or no ability to violate this
    rule, as we have no source of non-federal funds to operate vocational
    education programs. Unlike States, we have no tax base and no source of
    non-federal funds to maintain a vocational education program. We depend
    on federal funding for our vocational/technical education program
    operations. Despite our inability to violate the supplanting
    prohibition, we are, nonetheless, being disadvantaged by a Department
    of Education regulation intended to enforce the prohibition against
    States who do have the ability to supplant.
      --Impact of new requirement on grantees.--Under DoEd regulations, a
            ``restricted indirect cost rate'' makes unallowable certain
            indirect costs that are considered allowable by other federal
            programs. Primarily, these are costs that DoEd believes the
            grantee would otherwise incur if it did not receive a Perkins
            grant, such as the cost of the grantee's chief officer and
            heads of departments who report to the CEO, as well as the
            costs of maintaining offices for these personnel.
        Prohibiting the Perkins grant from contributing its appropriate
    share to the grantee's indirect cost pool will most likely mean that
    other federal programs operated by the grantee would be expected to
    pick up a great share of the indirect cost pool. This outcome may well
    result in objections from the other program agencies that do not want
    to bear costs properly attributable to the Perkins grant.
        We are caught between conflicting federal agency requirements and
    will find ourselves unable to recover the necessary share of indirect
    costs attributable to each of the federal programs we operate.
        UTTC Excels.--We bring to your attention the following facts about
    UTTC, an institution with:
      --An 89 percent retention rate
      --A placement rate of 90 percent (job placement and going on to 4-
            year intuitions)
      --A projected return on federal investment of 11 to 1 (2003 study
            comparing the projected earnings generated over a 29-year
            period of UTTC Associate of Applied Science graduates with the
            cost of educating them.)
      --The highest level of accreditation. The North Central Association
            of Colleges and Schools has accredited UTTC again in 2001 for
            the longest period of time allowable--10 years or until 2011--
            and with no stipulations. We are also the only tribal college
            accredited to offer on-line associate degrees.
        The demand for our services is growing and we are serving more
    students.--For the Spring Semester 2004, we enrolled 661 students from
    more than 45 tribes and 17 states. The majority of our students are
    from the Great Plains states, an area that, according to the 2001 BIA
    Labor Force Report, has an Indian reservation jobless rate of 75
    percent. UTTC is proud that we have an annual placement rate of 90
    percent. We hope to enroll 2000 adult students by 2008.
        In addition, as of the Spring Semester 2004, we serve 185 children
    in our Theodore Jamerson Elementary school, and 133 children in our
    infant-toddler and pre-school programs, bringing the population for
    whom we provide direct services to 979.
        UTTC course offerings and partnerships with other educational
    institutions.--UTTC offers 14 vocational/technical programs and awards
    a total of 24 2-year degree and 1-year certificates. We are accredited
    by the North Central Association of Colleges and Schools.
        We are very excited about the recent additions to our course
    offerings, and the particular relevance they hold for Indian
    communities. These programs are: (1) Injury Prevention, (2) On-Line
    Education, (3) Nutrition and Food Services, (4) Tribal Government
    Management, and (5) Tourism.
      --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 We received assistance
            through Indian Health Service to establish the only degree
            granting Injury Prevention program in the nation. Injuries are
            the number one cause of mortality among Native people for ages
            1-44 and the third for overall death rates. IHS spends more
            than $150 million annually for the treatment of non-fatal
            injuries, and treatment of injuries is the largest expenditure
            of IHS contract health funds. (IHS fiscal year 2004 Budget
            Book).
      --On-Line Education.--We are working to bridge the ``digital divide''
            by providing web-based education and Interactive Video Network
            courses from our North Dakota campus to American Indians
            residing at other remote sites and as well as to students on
            our campus. We currently have 47 students (15.5 FTE) taking on-
            line courses. We are accredited by the North Central
            Association of Colleges and Schools to provide on-line
            associate degrees. We were invited by North Central to share
            our experiences in gaining on-line accreditation at their
            March, 2004 meeting in Chicago and did make that presentation.
            We have also been invited by New Mexico State University to do
            the same.
        At this point, nearly half of the students taking on-line courses
    are campus-based students. On-line courses provide the scheduling
    flexibility students need, especially those students with young
    children. Our on-line education is currently provided in the areas of
    Early Childhood Education and Injury Prevention We will be asking
    approval this year from the North Central Association to offer full
    degree on-line programs in the following areas: Health Information
    Technology, Nutrition and Food Science, Elementary Education, and also
    possibly Criminal Justice. This approval is required in order for us to
    offer federal financial aid to the students enrolled in these on-line
    courses.
      --High Demand exists for computer technicians.--In the first year of
            implementation, the Computer Support Technician program is at
            maximum student capacity. In order to keep up with student
            demand, we will need more classrooms, equipment and
            instructors. Our program includes all of the Microsoft Systems
            certifications that translate into higher income earning
            potential for graduates.
      --Nutrition and Food Services.--UTTC will meet the challenge of
            fighting diabetes in Indian Country through education. As this
            Subcommittee knows, the rate of diabetes is very high in Indian
            Country, with some tribal areas experiencing the highest
            incidence of diabetes in the world. About half of Indian adults
            have diabetes (Diabetes in American Indians and Alaska Natives,
            NIH Publication 99-4567, October 1999)
        We offer a Nutrition and Food Services Associate of Applied Science
    degree in an effort to increase the number of Indians with expertise in
    nutrition and dietetics. Currently, there are only a handful of Indian
    professionals in the country with training in these areas. Future
    improvement plans include offering a Nutrition and Food Services degree
    with a strong emphasis on diabetes education and traditional food
    preparation.
        We also established the United Tribes Diabetes Education Center to
    assist local tribal communities and our students and staff in
    decreasing the prevalence of diabetes by providing diabetes educational
    programs, materials and training. We published and made available
    tribal food guides to our on-campus community and to tribes.
      --Tribal Government Management/Tourism.--Another of our new programs
            is tribal government management designed to help tribal leaders
            be more effective administrators. We continue to refine our
            curricula for this program.
        A newly established education program is tribal tourism management.
    UTTC has researched and developed core curricula for the tourism
    program and are partnering with three other tribal colleges (Sitting
    Bull, Fort Berthold, and Turtle Mountain) in this offering. The
    development of the tribal tourism program was well timed to coincide
    with the planned activities of the national Lewis and Clark
    Bicentennial last year. As you may know, Lewis and Clark and their
    party spent one quarter of their journey in North Dakota. UTTC art
    students were commissioned by the Thomas Jefferson Foundation to create
    historically accurate reproductions of Lewis and Clark-era Indian
    objects using traditional methods and natural materials. Our students
    had partners in this project including the National Park Services and
    the Peabody Museum at Harvard University. The objects made by our
    students are now part of a major exhibition in the Great Hall at
    Monticello about the Lewis and Clark expedition.
      --Job Training and Economic Development.--UTTC is a designated
            Minority Business Center serving Montana, South Dakota and
            North Dakota. We also administer a Workforce Investment Act
            program and an internship program with private employers.
        Economic Development Administration funding was made available to
    open a ``University Center.'' The Center is used to help create
    economic development opportunities in tribal communities. While most
    states have such centers, this center is the first-ever tribal center.
        Department of Education Study Documents our Facility/Housing
    Needs.--The 1998 Vocational Education and Applied Technology Act
    required the Department of Education to study the facilities, housing
    and training needs of our institution. That report was published in
    November 2000 (``Assessment of Training and Housing Needs within
    Tribally Controlled Postsecondary Vocational Institutions, November
    2000, American Institute of Research''). The report identified the need
    for $17 million for the renovation of existing housing and
    instructional buildings and $30 million for the construction of housing
    and instructional facilities.
        We continue to identify housing as our greatest need. We have a
    waiting list of students some who wait from 1 to 3 years for
    admittance. For the first time in its history, in the 2002-2003 year,
    we were forced to find housing off campus for our students. Enrollment
    for the 2002-2003 year increased by 31 percent; and in 2003-2004 our
    enrollment increased another 20 percent. In order to accommodate the
    enrollment increase, UTTC partnered with local renters and the Burleigh
    County Housing Authority. Approximately 40 students and their
    dependents were housed off campus. The demand for additional housing
    also presents challenges for transportation, cafeteria, maintenance,
    and other services.
        UTTC has now completed a new 86-bed single-student dormitory on
    campus. This dormitory is already completely full as are all of our
    other dormitories and student housing. To build the dormitory, we
    formed an alliance with the U.S. Department of Education, the U.S.
    Department of Agriculture, the American Indian College Fund, the
    Shakopee-Mdewakanton Sioux Tribe and other sources for funding. Our new
    dormitory has at the same time created new challenges such as shortages
    in classroom, office and other support facility space. However, more
    housing must be built to accommodate those on the waiting list and to
    meet expected increased enrollment.
        Some of our housing must be renovated to meet local, state, and
    federal safety codes. In addition some homes may be condemned which
    will mean lower enrollments and fewer opportunities for those seeking a
    quality education.
        Thank you for your consideration of our request. We cannot survive
    without the basic vocational education funds that come through the
    Department of Education's Perkins funds. They are essential to the
    operation of our campus and essential to the welfare of Indian people
    throughout the Great Plains region and beyond.
                                     ______

     Prepared Statement of the American Indian Higher Education Consortium

        Mr. Chairman and Members of the Subcommittee, on behalf of this
    nation's 34 Tribal Colleges and Universities (TCUs), which compose the
    American Indian Higher Education Consortium (AIHEC), thank you for the
    opportunity to share our fiscal year 2005 funding requests for programs
    within the U.S. Department of Education, and the U.S. Department of
    Health and Human Services--Head Start program.
        This statement will cover two areas: (a) background on the tribal
    colleges, and (b) justifications for our funding requests.

                         BACKGROUND ON TRIBAL COLLEGES

        The Tribal College Movement began in 1968 with the establishment of
    Navajo Community College, now Dine College, in Tsaile, Arizona. Rapid
    growth of tribal colleges soon followed, primarily in the Northern
    Plains region. In 1972, the first six tribally controlled colleges
    established AIHEC to provide a support network for member institutions.
    Today, AIHEC represents 34 Tribal Colleges and Universities located in
    12 states, which were begun specifically to serve the higher education
    needs of American Indian. Annually, these institutions serve
    approximately 30,000 full-and part-time students from over 250
    federally recognized tribes.
        The vast majority of TCUs is accredited by independent, regional
    accreditation agencies and like all institutions of higher education,
    must undergo stringent performance reviews on a periodic basis to
    retain their accreditation status. In addition to college level
    programming, TCUs provide much needed high school completion (GED),
    basic remediation, job training, college preparatory courses, and adult
    education. Tribal colleges fulfill additional roles within their
    respective reservation communities functioning as community centers,
    libraries, tribal archives, career and business centers, economic
    development centers, public-meeting places, and child care centers.
    Each TCU is committed to improving the lives of its students through
    higher education and to moving American Indians toward self-
    sufficiency.
        Tribal colleges provide access to higher education for American
    Indians and others living in some of this nation's most rural and
    economically depressed areas. These institutions, chartered by their
    respective tribal governments, were established in response to the
    recognition by tribal leaders that local, culturally based institutions
    are best suited to help American Indians succeed in higher education.
    TCUs combine traditional teachings with conventional postsecondary
    courses and curricula. They have developed innovative means to address
    the needs of tribal populations and are successful in overcoming
    longstanding barriers to higher education for American Indians. Since
    the first tribal college was established on the Navajo reservation,
    these vital institutions have come to represent the most significant
    development in the history of American Indian higher education,
    providing access to and promoting achievement among students who may
    otherwise never have known postsecondary education success.
        Despite their remarkable accomplishments, tribal colleges remain
    the most poorly funded institutions of higher education in the country.
    Persistently inadequate funding remains the most significant barrier to
    their success. Funding for basic institutional operations of 26
    reservation based colleges is provided through Title I of the Tribally
    Controlled College or University Assistance Act (Public Law 95-471).
    Funding under the Act was first appropriated in 1981. Over 20 years
    later, the funding level has reached just 70 percent of the authorized
    level of $6,000 per full-time Indian student. In fiscal year 2004,
    these colleges are receiving $4,230 per full-time equivalent Indian
    student toward their institutions operating budgets. While mainstream
    institutions have had a foundation of stable state tax-based support,
    TCUs must rely on year-to-year federal appropriations for their basic
    institutional operating funds. Because TCUs are located on Federal
    trust territories, states have no obligation to fund them even for the
    non-Indian state-resident students who account for approximately 20
    percent of TCU enrollments. Yet, if these same students attended any
    other public institution in the state, the state would provide basic
    operating funds to the institution.
        Inadequate funding has left many of our colleges with no choice but
    to operate under severely distressed conditions. Although facilities
    initiatives of the last few years have resulted in widespread
    construction at TCUs, many colleges began in surplus trailers; cast-off
    buildings; and facilities with crumbling foundations, faulty wiring,
    and leaking roofs and have a long way to go. Sustaining quality
    academic programs is a challenge without a reliable source of
    facilities maintenance and construction funding.
        As a result of more than 200 years of Federal Indian policy--
    including policies of termination, assimilation and relocation--many
    reservation residents live in abject poverty comparable to that found
    in Third World nations. Through the efforts of tribal colleges,
    American Indian communities receive services they need to reestablish
    themselves as responsible, productive, and self reliant.

                                 JUSTIFICATIONS

    Higher Education Act
        The Higher Education Act Amendments of 1998 created a separate
    section within Title III, Part A, specifically for the nation's Tribal
    Colleges and Universities (Section 316). Titles III and V programs
    support institutions that enroll large proportions of financially
    disadvantaged students and have low per-student expenditures. TCUs
    clearly fit this definition as they are among the most poorly funded
    institutions in America, yet they serve some of the most impoverished
    areas of the country. TCUs are victims of their own success. This year
    two new tribal colleges are eligible to compete for funding under Title
    III. Despite the increase in the size of the pool of eligible
    institutions, the President's fiscal year 2005 Budget recommends an
    increase of $500,000 to this vital program. We urge the Subcommittee
    fund section 316 at $26 million, an increase of $2.7 million over
    fiscal year 2004 and $2.2 over the President's request, and we ask that
    report language included in since fiscal year 2003 be restated
    clarifying that funds not needed to support continuation grants or new
    planning or implementation grants be available for facilities
    renovation and construction grants.
        The importance of Pell grants to our students cannot be overstated.
    Department of Education figures show that at the majority of all tribal
    college students receive Pell grants, primarily because student income
    levels are so low and our students have far less access to other
    sources of aid than students at mainstream institutions. Within the
    Tribal College system, Pell grants are doing exactly what they were
    intended to do--they are serving the needs of the lowest income
    students by helping people gain access to higher education and become
    active, productive members of the workforce. We urge Congress to fund
    this critical program at the highest possible level.
    Carl D. Perkins Vocational & Applied Technology Education Act
        Tribally-Controlled Postsecondary Vocational Institutions.--Section
    117 of the Perkins Act provides basic operating funds for two of our
    member institutions: United Tribes Technical College in Bismarck, North
    Dakota, and Crownpoint Institute of Technology in Crownpoint, New
    Mexico. We urge Congress fund this program at $8 million and reiterate
    language included since fiscal year 2002 stating that Section 117
    Perkins grantees need not utilize restricted indirect cost rate.
        The President's fiscal year 2005 budget proposes the elimination of
    the Native American Program Section 116, which reserves 1.25 percent of
    appropriated funding to support Indian vocational programs. We strongly
    urge Congress to continue this program, which is vital to the survival
    of vocational education programs being offered at TCUs.
    Greater Support of Indian Education Programs Under ESEA
        American Indian Adult and Basic Education.--This section supports
    adult education programs for American Indians offered by TCUs, state
    and local education agencies, Indian tribes, institutions, and
    agencies. Despite a lack of funding, TCUs must find a way to continue
    to provide basic adult education classes for those Indians that the
    present K-12 Indian education system has failed. Before many
    individuals can even begin the course work needed to learn a productive
    skill, they first must earn a GED or, in some cases, learn to read.
    According to a 1995 survey conducted by the Carnegie Foundation for the
    Advancement of Teaching, 20 percent of the participating students had
    completed a tribal college GED program before beginning higher
    education classes at the tribal college. At some schools, the
    percentage is even higher. Clearly, the need for basic educational
    programs is tremendous, and TCUs need funding to support these crucial
    activities. Tribal colleges respectfully request that Congress
    appropriate $5 million to meet the ever-increasing demand for basic
    adult education services.
        American Indian Teacher Corps.--American Indians are severely
    under-represented in the teaching and school administrator ranks
    nationally. These competitive programs, aimed at producing new American
    Indian teachers and school administrators for schools serving American
    Indian students, support the recruitment, training, and in-service
    professional development programs for Indians to become effective
    teachers and school administrators, and in doing so excellent role
    models for Indian children. We believe that the TCUs are the ideal
    catalysts for these initiatives because of our current work in this
    area and the existing articulation agreements TCUs hold with 4-year
    degree awarding institutions. We request Congress support these
    programs at $10 million and $5 million, respectively, to increase the
    number of qualified American Indian teachers and school administrators
    in Indian Country.

    Department of Health and Human Services/Administration for Child, Youth
            and Families/Head Start
        Tribal Colleges and Universities (TCU) Head Start Partnership
    Program.--The TCU/Head Start partnership has made a lasting investment
    in our Indian communities by creating and enhancing associate degree
    programs in Early Childhood Development and related fields. New
    graduates of these programs can help meet the mandate that 50 percent
    of all program teachers earn an associate degree in Early Childhood
    Development or a related discipline by 2003. One clear impediment to
    the ongoing success of this partnership program is the erratic
    availability of discretionary funding made available for the TCU/Head
    Start partnership. In fiscal year 1999, the first year of the program,
    six TCUs received 3-year awards; in fiscal year 2000, seven additional
    colleges received 3-year grant awards; in fiscal year 2001, duration of
    grants was extended from 3-years to 5-years but only three additional
    TCUs received grants; in fiscal year 2002 no new grants were awarded;
    and in fiscal year 2003, eight new grants were awarded. The President's
    fiscal year 2005 budget includes a request of $6.9 billion for Head
    Start Programs. We request Congress direct the Head Start Bureau to
    designate a minimum of $5 million for the TCU/Head Start Partnership
    program, to allow current grantees ensure that this critical program
    can be continued and be expanded so that all TCUs might participate in
    the TCU/Head Start Partnership program.

                                   CONCLUSION

        Tribal colleges are bringing education to thousands of American
    Indians. The modest Federal investment in the tribal colleges has paid
    great dividends in terms of employment, education, and economic
    development, and continuation of this investment makes sound moral and
    fiscal sense. We very much need help to sustain and grow our programs
    and achieve our missions.
        Thank you again for this opportunity to present our funding
    requests. We respectfully ask the Members of this Subcommittee for
    their continued support of TCUs and full consideration of our fiscal
    year 2005 appropriations request.
                                     ______

                 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.
        Located in Tallahassee, Florida's capitol, FSU is a comprehensive
    Research I university with a rapidly growing research base. The
    University serves as a center for advanced graduate and professional
    studies, exemplary research, and top quality undergraduate programs.
    Faculty members at FSU maintain a strong commitment to quality in
    teaching, to performance of research and creative activities and have a
    strong commitment to public service. Among the current or former
    faculty are numerous recipients of national and international honors
    including Nobel laureates, Pulitzer Prize winners, and several members
    of the National Academy of Sciences. Our scientists and engineers do
    excellent research, have strong interdisciplinary interests, and often
    work closely with industrial partners in the commercialization of the
    results of their research. Florida State University had over $162
    million this past year in research awards.
        FSU recently initiated a new medical school, the first in the
    United States in over two decades. Our emphasis is on training students
    to become primary care physicians, with a particular focus on geriatric
    medicine--consistent with the demographics of our state.
        Florida State University 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 345
    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 to
    our campus.
        At Florida State University, we are very proud of our successes as
    well as our emerging reputation as one of the nation's top public
    research universities.
        Mr. Chairman, let me tell you about a project we are pursuing this
    year through the U.S. Department of Education.
        Florida State University (FSU), with support from the State of
    Florida and Governor Jeb Bush, initiated a state-wide partnership among
    the state's universities, local schools, teachers, principals, and
    other educational leaders to address the highest priority issues in K-
    12 education. The partnership, entitled the Multi-University Reading,
    Mathematics and Science Initiative (MURMSI), is designed to measurably
    improve teaching and learning in Reading, Mathematics and Science in
    Florida's K-20 schools with a special emphasis on students considered
    ``at risk'' due to economic or other conditions. It seeks to develop a
    deeper understanding of ways to improve Reading, Mathematics, and
    Science education through a strategically planned research agenda and
    action plans for change.
        Randomized experiments that are highly valued in other fields, such
    as health, medicine, economics, psychology, political science--and more
    recently Pre-K education--are rare in K-12 education. As a result,
    existing research provides little knowledge about the cause and the
    effect of interventions and programs. The Education Sciences Reform Act
    of 2002 (H.R. 3801) passed by Congress includes language aimed to
    strengthen research design and methodology in education, including use
    of random assignment, when feasible, particularly in cases where
    researchers expect to make claims about causal relationships.
        The connection between research and practice is also a weak link in
    K-12 education. A number of recent publications have substantiated a
    lack of connection between the results of systematic study and
    application in the field. Given the current budget outlook for Florida
    and the nation as a whole, it is critical that the dollars spent on
    education produce improved learning outcomes for students.
        Well-designed research and development on priority educational
    issues can produce measurable gains in student performance. Critical
    knowledge related to improved learning must be produced and, in turn,
    applied throughout the state. To be effective, these R&D efforts must
    directly connect research, teacher preparation, professional
    development, practice and evaluation. To avoid duplication of effort,
    they must also be carefully coordinated across various stakeholder
    groups, including other universities, policy makers, K-12 leaders and
    teachers. By coordinating priorities, each entity can focus on its
    areas of expertise to accomplish the research, development, evaluation
    and dissemination functions essential to support Florida's K-20 system.
        The work of this R&D collaboration--over a period of 5 years--
    involves the following:
      --Assist Florida leaders and decision makers in developing a
            strategically planned research agenda targeting high priority
            statewide problems in K-20 Reading, Mathematics and Science
            education.
      --Initiate, conduct and complete priority research projects (within
            each university) clearly responsive to critical statewide and
            national education needs using a data based, systems oriented
            model.
      --Provide decision-makers timely technical advisories and summaries
            of findings on issues related to education policy and practice.
      --Evaluate the impact of state K-20 initiatives designed to improve
            K-12 student performance in Reading, Mathematics and Science
            and disseminate the results.
      --Design and recommend specific applications of the research findings
            and support implementation programs in school districts.
      --Provide teacher professional development, especially in Reading,
            Mathematics and Science content areas, as teachers need to
            broaden and deepen their knowledge in response to changing
            educational and/or technological needs.
        The first year of this initiative (fiscal year 2003) has been
    funded through a $1.5 million grant awarded to the FSU Learning Systems
    Institute by the U.S. Department of Education. Those resources were
    used to develop the research agenda described above and to initiate
    pilot research projects at universities across the state. During 2004,
    those pilot projects will continue and others will be added. In 2005,
    MURMSI will focus primarily on full implementation of the high priority
    research agenda in K-12 Reading, Mathematics and Science education. All
    aspects of this work will be done through the collaborative partnership
    and consensus-building process with other universities and
    stakeholders. Results of the research projects will be systematically
    shared with policy makers and educators throughout the state.
        We are seeking $3 million in fiscal year 2005 to continue the work
    on this important state-wide project.
        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 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 NCB Development Corporation

        On behalf of NCB Development Corporation, I am pleased to once
    again submit written testimony to the U.S. Senate's Committee on
    Appropriations Subcommittee on Labor, Health and Human Services, and
    Education on the subject of charter school facility finance. I am Terry
    D. Simonette, president and chief executive officer of NCB Development
    Corporation located in the District of Columbia and I would like to
    thank Chairman Specter and Ranking Member Harkin for the opportunity to
    submit this written testimony today on fiscal year 2005 funding for
    charter school facility finance which addresses the needs of the
    underserved and displaced communities under the jurisdiction of the
    Subcommittee. At the outset, let me share with you some background
    information on the NCB Development Corporation and our approach to
    address the charter school facility finance problem. Then I would like
    to share our thoughts on why charter schools should be looked at in a
    community development strategy.
        NCB Development Corporation (NCBDC), an affiliate of National
    Cooperative Bank pursuant to the National Consumer Cooperative Bank Act
    (Public Law 95-351) is a national nonprofit organization that for 25
    years has provided innovative financial and development services to
    improve the lives of low-income individuals, families, and communities.
    By creatively investing in our neighborhoods, advocating elected
    officials around public policy, and collaborating with other national
    and local community-based organizations, NCBDC helps charter schools
    finance and develop facilities; creates a policy environment that
    supports strong, self-sustaining communities; enables community health
    centers to expand to serve more patients; preserves and creates
    affordable housing; and helps socially responsible businesses thrive.
        As you may already know, according to the Center for Education
    Reform, there are currently nearly 3,000 charter schools in 42 states
    and the District of Columbia giving nearly 750,000 students an
    opportunity to receive a quality education. Unlike traditional public
    schools, charter schools are not given a public building in which to
    operate. Instead, it is up to the charter school to find and fund an
    appropriate location. Operators, who are often concerned parents,
    teachers, or nonprofit organizations, typically have little experience
    with planning, zoning, and building code regulations, let alone finding
    affordable space and adequate financing. And very few financing
    organizations are willing to lend to charter schools.
        Since the mid-1990's, NCBDC has been considered an expert in the
    small community of organizations in the forefront of designing and
    implementing innovative financing strategies to meet a charter school's
    demand for capital. To date, between our lending and technical
    assistance programs, NCBDC has assisted 210 charter schools in 19
    states obtain the facilities they require to accomplish their missions
    impacting 38,106 students, provided more than $66 million in facilities
    financing sustaining no monetary defaults and 0 percent loss rates on
    charter school lending, and helped leverage more than $100 million in
    additional funds. Major partners in these initiatives have included the
    U.S. Department of Education, Charter Friends National Network, the
    Florida Consortium of Charter Schools and the Midwest Charter
    Facilities Coalition.
        As a 2001 recipient of a U.S. Department of Education National
    Activities Grant in and in partnership with the Charter Friends
    National Network established the Technical Assistance Project for
    Charter School Facilities to help charter schools develop and finance
    suitable buildings by providing on-the-ground technical assistance and
    workshops in facility development and financing. In the initial round
    of the highly competitive U.S. Department of Education's Charter School
    Facilities Financing Demonstration Grant Program, NCBDC partnered with
    The Reinvestment Fund, a leading community development financial
    institution based in Philadelphia, and Foundations, Inc., a leading
    technical assistance provider. In 2002, we were successful in receiving
    a $6.4 million grant to create the Charter School Capital Access
    Program (CCAP). CCAP successfully met the goal of raising $45 million
    from investors including PNC Bank of Pennsylvania to create a capital
    pool to help charter schools in the Mid-Atlantic States of New York,
    New Jersey, Pennsylvania, Delaware, and Virginia, and in the District
    of Columbia acquire, renovate, or construct facilities. This is a
    leverage ratio of nearly seven private dollars for every one public
    dollar.
        In 2003, the U.S. Department of Education again recognized NCBDC's
    innovative work in charter school facility finance and awarded NCBDC a
    $6 million grant under the Credit Enhancement Program for Charter
    School Facilities, which is a valuable tool for motivating the private
    sector to get involved in charter school capital development. This
    grant will enable NCBDC to enhance facilities loans and educational
    opportunities for children in Florida, Georgia, Minnesota, and
    Wisconsin. NCBDC was one of four and the only repeat grantee having
    been awarded $6.4 million through the Department's initial Charter
    Schools Facilities Financing Demonstration Program as previously
    referenced.
        Because we have seen firsthand the dire need for charter school
    facility finance, NCBDC supports the continuation and expansion of the
    Credit Enhancement for Charter School Facilities Program by increasing
    appropriations levels as authorized by the United States Congress in No
    Child Left Behind (NCLB or Public Law 107-110) signed into law on
    January 8, 2002.
        According to a U.S. General Accounting Office (GAO) report
    commissioned by Congressional Requesters (GAO-03-899, September 2003)
    states: ``The three greatest challenges facing new charter schools were
    securing a facility, obtaining start-up funding and acquiring the
    expertise necessary to run a charter school.'' The 2000 National Study
    of Charter Schools funded by the Office of Educational Research and
    Improvement within the U.S. Department of Education identified two of
    the same obstacles as lack of management expertise and inadequate
    facilities financing, which pose a formidable obstacle for the vast
    majority of start-up and established charter schools. Each of the three
    major financing approaches--municipal bonds, per pupil allocations, and
    conventional financing--offer only limited opportunities for charter
    schools that seek funds to lease, acquire, construct, or renovate a
    facility. There is a no more serious challenge facing charter schools
    nationally than obtaining upfront and ongoing financing for facilities.
    Despite the difficulty in securing credit, charter schools are
    remarkably resourceful in addressing their facilities needs, yet are
    generally unable to take advantage of the financing that is available
    to school districts and typically pay for facilities out of their
    regular operating funds. As a result, finding and funding a building
    impacts limited operating funds which in turn impacts teachers,
    administrative personnel and the purchase of everyday supplies.
        Not finding a suitable home has delayed school openings, and forced
    schools to scale back their programs or shut down altogether, due to
    the inability to find adequate facilities. Charter schools are usually
    distinguished by their relatively small size; perceived instability of
    revenue streams, short operating track records, and political
    uncertainty. These characteristics pose formidable obstacles for the
    private sector, which has a low-risk tolerance and is often reluctant
    to lend in an ``emerging'' market. Consequently, charter schools also
    require new, creative financial models to address their growing demand
    for capital.
        NCBDC applauds the President and the United States Congress in
    their commitment to charter school facility finance including the more
    than $37 million proved in the omnibus appropriations bill signed into
    law on January 23, 2004 (Public Law 108-199) for the continuation of
    the Credit Enhancement for Charter School Facilities Program and the
    President's $100 million request in his fiscal year 2005 budget
    released in February 2004. The Program will continue to assist charter
    schools in acquiring, leasing, and renovating school facilities. This
    is done through a competitive grant process to public and non-profit
    entities for loan guarantees, debt insurance, and other activities that
    facilitate private lending. While the demand for charter school
    facility finance is estimated nationally at more than $2 billion, $37
    million falls far short of the $200 million in grants authorized yearly
    until 2007 in the NCLB, as outlined in the bipartisan Carper-Gregg
    Amendment in the act.
        With our long history of a strong commitment to community
    development, particularly as it relates to underserved urban
    populations, NCBDC believes that strong schools are a cornerstone of
    any thriving community. Good schools keep families involved in
    neighborhoods, and this involvement is essential to community
    revitalization. Public charter schools encourage stability by offering
    parents a tuition-free choice outside the traditional public school;
    charter schools can keep families in communities with under-performing
    public schools. In addition, NCBDC has found that in the process of
    developing a facility, charter schools can be an effective tool for
    urban renewal and neighborhood revitalization. Finally, NCBDC believes
    that strong school-community partnerships, which are encouraged by
    charter schools, help build neighborhoods.
        During this time of rising budget deficits and the rise in the cost
    of the war on terrorism, fiscal constraints make efforts to fulfill
    Congress' commitment to education, especially charter school facility
    finance, far more difficult then it has been in years past. Charter
    advocates, including NCBDC, have long been supportive of the efforts by
    the Administration and Congress to provide adequate appropriations for
    the charter school facilities initiatives set forth in the landmark
    bipartisan NCLB. We are hopeful that this Subcommittee, and ultimately
    this Congress, will provide appropriate charter school funding at the
    authorized levels, as charter schools are continuously faced with the
    lack of funding or expertise to purchase, build, or renovate a building
    and other physical plant requirements.
        NCBDC appreciates this opportunity to reinforce the critical need
    served by supporting expanded funding for charter school facility
    finance. With your assistance, the charter school community can
    continue to make a difference in the lives of this nation's most
    vulnerable children, families, and communities. In summary, NCBDC
    requests a NCLB authorized fiscal year 2005 appropriation level of $200
    million to help charters leverage private financing for facilities and
    start-up costs--an increase of $100 million over the President's fiscal
    year 2005 budget request and $163 million over the fiscal year 2004
    appropriated level. In addition, NCBDC supports the continued expansion
    of the Public Charter Schools Program by supporting the President's
    fiscal year 2005 request of $219 million to provide grants to states to
    support 1,200 new and existing charter schools including $19 million
    for the new Charter Schools Per-Pupil Facilities Aid program.
        Thank you again for allowing NCBDC to present its concerns
    regarding fiscal year 2005 appropriations provision of charter school
    facilities financing in written testimony before the Subcommittee.
                                     ______

                                RELATED AGENCIES

    Prepared Statement of the National Federation of Community Broadcasters

        Thank you for 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 nearly 250 community
    radio stations and related organizations across the country. Nearly
    half our members are rural stations and half are minority controlled
    stations. In addition, our members include many of the new Low Power FM
    stations that are putting new local voice on the airwaves. 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.
        In summary, the points we wish to make to this Subcommittee are
    that NFCB:
      --Requests $410 million CPB for fiscal year 2007, a $10 million
            increase over the fiscal year 2006 advance appropriation;
      --Requests $60 million in fiscal year 2005 for conversion of public
            radio and television to digital broadcasting. Also supports
            funding for the Public TV interconnection system;
      --Requests that advance funding for CPB is maintained to preserve
            journalistic integrity and facilitate planning and local fund
            raising by public broadcasters;
      --Requests report language 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 $410 million for the Corporation for
    Public Broadcasting in fiscal year 2007.--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 community is unable to financially support the
    station 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.
        For the past 28 years, CPB appropriations have been enacted 2 years
    in advance. This insulation has allowed pubic broadcasting to grow into
    a respected, independent, national resource that leverages its federal
    support with significant local funds. Knowing what funding will be
    available in advance has allowed local stations to plan for programming
    and community service and to explore additional non-governmental
    support to augment the federal funds. Most importantly, the insulation
    that forward-funding provides ``go[es] a long way toward eliminating
    both the risk of and the appearance of undue interference with and
    control of public broadcasting.''----House Report 94-245.
        For the last few years, CPB has increased support to rural stations
    and committed resources to help public radio take advantage of new
    technologies such as the Internet, satellite radio and digital
    broadcasting. We commend these activities which we feel provide better
    service to the American people, 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 commends 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
    Spanish. At the same time, American Indian Radio on Satellite (AIROS)
    is distributing programming for the Native American stations, arguably
    the fastest growing group of stations. There are now over 30 stations
    controlled by and serving Native Americans, primarily on Indian
    reservations.
        This last year CPB undertook a comprehensive assessment of the
    Native American Radio system. It recognized the importance of these
    stations in serving local isolated communities (all but one are on
    Indian Reservations) and in preserving cultures that are in danger of
    being lost. The report recognized that ``. . . very difficult
    environments.'' CPB funding is critical to these rural, minority
    stations. CPB's funding of the Intertribal Native Radio Summit in 2001
    helped to pull these isolated stations together into a system of
    stations that can support each other. The report goes on to say
    ``Nevertheless, the Native Radio system is relatively new, fragile and
    still needs help building its capacity at this time in its
    development.''
        CPB also funded a Summit for Latino Public Radio which took place
    this in September 2002 in Rohnert Park, California, home of the first
    Latino Public Radio station. These Summits have expanded the circle of
    support for Native and Latino Public Radio and identified projects that
    will improve efficiency among the stations through collaborations, and
    explore new ways of reaching the target audiences.
        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. An example of this support is the grant that NFCB
    received to update and publish our Public Radio Legal Handbook online.
    This provides easy to read information to stations about complying with
    governmental regulations so that stations can function legally and use
    their precious resources for programming instead of legal fees.
        Finally, community radio supports $50 million in fiscal year 2005
    for conversion to digital broadcasting by public radio and
    television.--It is critical that this digital funding be in addition to
    the on-going operational support that CPB provides. The
    Administration's proposal that digital money should be taken from the
    fiscal year 2005 CPB appropriation would effectively cut stations'
    grants by more than 25 percent. This would have a devastating impact
    during these hard economic times when stations are facing major cuts
    from state and institutional funds. And it would come at a time when
    the local voices of community and public radio are especially important
    to notify and support people during emergency situations and to help
    communities deal with the loss of loved ones--things that commercial
    radio is no longer able to do because of media consolidation.
        While public television's digital conversion needs are mandated by
    the FCC, public radio is converting to digital to provide more public
    service and to keep up with what commercial radio is doing. The Federal
    Communications Commission has approved a standard for digital radio
    transmission. The initial conversion of radio stations is being
    concentrated in 13 seed markets. CPB has provided funding for 42
    stations in these markets to convert to digital, is supporting
    additional research on AM radio conversion, and is working with radio
    transmitter and receiver manufacturers to build in the capacity to
    provide a second channel of programming. Most exciting to public radio
    is the encouraging results of tests that National Public Radio has
    conducted that indicate that stations can broadcast two high quality
    signals, even while they continue to provide the analog signal. The
    development of 2nd audio channels will potentially double the public
    service that public radio can provide, particularly in service to
    unserved and underserved communities. This initial funding will only
    help a small number of the stations that will ultimately need to
    convert to digital or be left behind.
        Community Radio also supports funding for the public television
    interconnection system.
        Federal funds distributed by the CPB should be available to all
    public radio stations eligible for Federal equipment support through
    the Public Telecommunications Facilities Program (PTFP) of the National
    Telecommunications and Information Agency of the Department of
    Commerce. In previous years, Federal support for public radio has been
    distributed through the PTFP grant program. The PTFP criteria for
    funding are exacting, but allow for wider participation among public
    stations. Stations eligible for PTFP funding and not for CPB funding
    include small-budget, rural and minority controlled stations and the
    new Low Power FM service.
        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 2000 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 in general and community radio in particular, more
    important as a local voice than we have ever been. New Low Power FM
    stations are providing new local voices in their communities. Community
    radio is providing essential local emergency information, programming
    about the local impact of the major global events taking place,
    culturally appropriate information and entertainment in the language of
    the native culture, as well as helping to preserve cultures that are
    dying out.
        During this time, the role of CPB as a convener of the system
    becomes even more important. The funding that it provides will allow
    the smaller stations to participate along with the larger stations
    which have more resources, as we move into a new era of communications.
        Thank you for your consideration of our testimony.
                                     ______

           Prepared Statement of the American Association of Museums

        Chairman Specter, Senator Harkin and distinguished members of the
    Subcommittee, the American Association of Museums (AAM) appreciates the
    opportunity to testify on the fiscal year 2005 budget for the museum
    program at the Institute of Museum and Library Services (IMLS). The
    museum program at IMLS is the primary federal entity devoted to
    assisting museums in fulfilling their role as centers for lifelong
    learning for all Americans. We respectfully request your approval of
    the Administration's budget request of $41.4 million for the Office of
    Museum Services, which reflects a strong endorsement of the vital
    public service role museums play in their communities.
        The American Association of Museums, headquartered in Washington
    D.C., is the national service organization that represents and
    addresses the needs of museums and to enhance their ability to serve
    the public. AAM disseminates information on current standards and best
    practices and provides professional development for museum
    professionals to ensure that museums have the capacity to contribute to
    life-long education in its broadest sense and to protect and preserve
    our shared cultural heritage. Since its founding in 1906, AAM has grown
    to more than 16,000 members across the United States--nearly 10,500
    individual museum professionals and volunteers, more than 3,000
    museums, and 2,500 corporate members.
        In its reauthorization of IMLS last year, Congress reaffirmed its
    commitment to the public to ensure that museums will continue to be
    centers of lifelong learning and to protect and preserve our nation's
    heritage. By appropriating federal dollars for these purposes, you
    ensure that society will have museums that are relevant, inspiring and
    accessible.
        Through its grant awards, IMLS has supported museums that are
    responding to the needs of their communities. We are especially excited
    about the new Museums for America program, which provides a critical
    source of funding that supports museums and their roles in public
    service, education and stewardship. With a focus on strategic planning
    and institutional mission, it addresses the specific needs of the
    museum and its community while helping accomplish IMLS's broader
    national goal of creating and sustaining a nation of learners.
        We have already seen the results of IMLS investments in our field.
    Through the 2003 Learning Opportunities Grants, more than $15 million
    was awarded to 169 museums. This included a grant to the State Museum
    of Pennsylvania to create a distance learning program that provides
    professional development to science teachers in Central Pennsylvania.
    As school districts meet the challenges put forward in the No Child
    Left Behind Act, museums are stepping forward with their vast
    collections, research, and staff expertise to strengthen teachers'
    current knowledge and classroom instruction in the method of scientific
    inquiry as well as the other disciplines of arts and humanities.
        A project in Iowa is another example of museum-school
    collaborations. With support from IMLS, the Grout Museum District
    provided a weeklong Museum School to 1,000 third grade students from
    the Waterloo and Cedar Falls public schools district. Children, their
    families and teachers experienced local history. Students applied their
    lessons in math, science, and language to real-world situations while
    gaining a greater understanding and appreciation for how their
    community fits into the larger world.
        With grants from IMLS, these museums developed programs that
    addressed the specific needs of their communities. These examples,
    however, also represent a much larger commitment museums are making to
    public education. A recent IMLS survey also shows that museum
    expenditures in support of K-12 education now exceed $1 billion
    annually. In fact, the percentage of museums' median annual operating
    budgets spent on educational programming has increased four-fold just
    since 1996. With more than 18 million instructional hours in 2000-01,
    museums are offering a broad range of services to schools. They are key
    partners in developing curriculum, providing professional development
    for teachers, and offering direct services to students through visits
    to museums, classroom visits by museum educators, and Web based
    educational materials and programs. In some communities, students
    attend schools that are actually housed in museums and run by museum
    staff.
        The commitment of museums to education does not end with their ties
    to formal education. Museums are also places of lifelong learning. They
    provide an environment rich with opportunity for intergenerational
    learning and sharing where children, their parents, and their
    grandparents can work together to connect ideas and experiences in
    direct, vivid and meaningful ways. Museum visitors can come to know the
    struggles and accomplishments of different cultures and unfamiliar
    people and achieve a deeper understanding of their own families,
    neighborhoods, the country in which they live, and the world.
        Museums do not undertake this educational responsibility without an
    equal commitment to the care, protection and preservation of our
    nation's heritage found in their collections. There are more than 750
    million objects and living specimens being held in the public trust by
    American museums. This number grows as museums continue to acquire the
    material patrimony of our civilization to assure that they remain
    publicly available for generations to come. A rough estimate places the
    annual expenditure for the care of those public collections at $1.1
    billion. The need for conservation is ongoing and these costs will
    continue to grow with time as collections expand and age.
        IMLS makes significant investments in both direct support for
    conservation and assistance to museums with identifying and
    prioritizing their conservation needs. In 2003, Conservation Support
    grants were awarded to 86 institutions. This program requires a 1:1
    match and allows institutions such as the Wentworth-Coolidge Mansion in
    Portsmouth, New Hampshire to make much needed repairs to its gutters,
    improve drainage on the site, and make other improvements that will
    prevent further moisture damage to this national historic landmark and
    its unique contents.
        Through the Conservation Assessment Program, Idaho's Twin Falls
    County Historical Museum, Texas' Sam Houston Memorial Museum, and
    Alabama's Magnolia Grove-Hobson Memorial Shrine were able to have a
    general conservation survey of their collections, environmental
    conditions and sites. Conservation priorities are identified by
    professional conservators who spend 2 days on-site and provide a
    written report to help museums develop strategies for improved
    collections care. Many institutions use the report for long-term
    planning and for attracting financial support to meet the conservation
    needs identified in the report.
        America's museums, by their missions and tax exempt status, exist
    for the benefit of the public. The museums in your states and across
    the country are responsible for preserving the past, defining the
    present and educating for our future. The leadership and support of the
    federal government is critical to each of our nation's museums. The
    United States has a strong tradition of financial support for the
    public service mission of museums through public-private partnerships.
    Museums have three major income sources--private charity and foundation
    grants, earned and investment income, and government funding. Private
    charity represents 36 percent of museums' budgets, earned and
    investment income represents 33 percent and 11 percent respectively,
    and government funding--local, state, and federal--is 25 percent of
    museums' budgets. The largest portion of government funding is from the
    local and state level, with only 2.5 percent coming from the federal
    government. But it is a critical 2.5 percent.
        This diversity of funding sources for museums is critical to their
    long term financial stability, but the recent economic uncertainty has
    strained all sources of funding for museums. The good news is that
    museums are remarkably resilient institutions and are determined to
    continue with their full array of public programs. This commitment is
    due in part to IMLS awards made through the Museum Assessment Program.
        More commonly known as MAP, participating museums can select from a
    menu of four assessments and receive a professional review of their
    operations in that area. Following the review, museums are given
    recommendations and technical assistance which help them identify how
    they measure up to best practices in the field and where they might
    need improvement. This independent report informs an institution as it
    sets priorities and plans to become a better museum. In 2003, 170
    grants were awarded to institutions in 42 states, including the East
    Ely Railroad Depot Museum in Nevada, Kent Plantation House in
    Alexandria, LA, and the Fort Worth Botanic Garden in Texas.
        Museums must remain responsive to the needs of their communities.
    The public is concerned about education and our economy. Our
    institutions are seeking additional new ways to collaborate with the
    schools and teachers to instill in every child a passion for learning.
    We are working with local officials to make our communities vibrant and
    attractive to businesses and tourists. Our nation's museum directors
    and staff are deeply committed to their work and to serving the public.
    Every day in our nation's museums, thousands of museum educators greet
    school buses of children, historians and scientists research our past,
    and registrars catalog and track millions of objects. And museum
    directors across the country are always seeking the resources to
    sustain their institutions so they can fulfill their educational and
    stewardship responsibilities.
        I particularly applaud IMLS and the Administration for recognizing
    that the needs of our museums are not just for the collections or the
    public programs, but also for the ongoing professional development of
    the leaders and staff within our museums--directors, curators,
    registrars, educators, conservators, and many others. In the fiscal
    year 2005 budget, the Administration has requested $1 million for the
    professional development of museum personnel. We will need to invest
    more, but I believe this to be a good start.
        A commitment from the federal government is needed to help museums
    and their staff fulfill their public obligations. In partnership with
    IMLS we believe we can do just that, and I stress the word partnership.
    We fully support the strong U.S. tradition of public-private
    partnerships supporting museums' public service mission. We believe
    that IMLS is in a unique position with its expertise and flexibility to
    help us address these current challenges and to help our museums plan
    for the future. What the agency lacks is the financial resources.
        IMLS needs sufficient funding to help our museums ensure that
    current and future generations have the fullest access to, and
    understanding of, our national heritage through the highest quality
    exhibitions, education programs and digitized materials for the Web.
    Innovation in museums allows them to better serve the public. As I
    noted before, we believe the administration's fiscal year 2005 request
    for the museum programs at IMLS is an important step towards further
    realizing the potential of museum education and community involvement.
        We recognize, Mr. Chairman, that you and your colleagues are under
    intense pressure to balance the funding needs of the many worthy
    programs under your jurisdiction. As you consider that balance, I am
    sure you will recall that last fall you and your colleagues strongly
    endorsed the mission of IMLS by reauthorizing the agency for another 5
    years. That is why we believe $41.4 million for fiscal year 2005 is a
    reasonable and fiscally responsible budget that will serve the public's
    demand for museums that are relevant, inspiring and accessible.
        We appreciate the opportunity to testify before the committee today
    and thank you all for your support of our nation's museums and the
    museum program at IMLS.
                                     ______

              Prepared Statement of the Railroad Retirement Board

        Mr. Chairman and Members of the Committee: We are pleased to
    present the following information to support the Railroad Retirement
    Board's (RRB) fiscal year 2005 budget request.
        The RRB administers comprehensive retirement/survivor and
    unemployment/sickness insurance benefit programs for railroad workers
    and their families under the Railroad Retirement and Railroad
    Unemployment Insurance Acts. The RRB also has administrative
    responsibilities under the Social Security Act for certain benefit
    payments and Medicare coverage for railroad workers. During fiscal year
    2003, the RRB paid $8.9 billion in retirement/survivor benefits to
    about 666,000 beneficiaries, and $94.1 million in unemployment/sickness
    insurance benefits to about 37,000 claimants.
        As we explain in greater detail below, the RRB's budget request for
    fiscal year 2005 is comprised of two parts, $110.66 million for day-to-
    day administrative expenses, plus $4,947,800 for information technology
    infrastructure improvements. This request is intended to meet immediate
    and significant needs of the agency in two principal areas: (1)
    additional staffing, not only to manage current workloads, but even
    more importantly, to begin the process of recruiting and training to
    meet the RRB's staffing needs going forward; and, (2) modernization and
    improvement of our information technology infrastructure to ensure that
    the RRB's automated systems will continue to function effectively and
    efficiently in the future. These are pressing needs that must be
    addressed. However, at the President's proposed budget level of $102.6
    million, not only would these critical, longer-term needs not be
    funded, but the RRB's ability to continue to deliver quality and timely
    service in the short term would also be severely jeopardized.

             REQUEST FOR ADMINISTRATIVE FUNDING IN FISCAL YEAR 2005

        The RRB has demonstrated fiscal responsibility over the years by
    requesting only what was needed to administer the programs under the
    Railroad Retirement and Railroad Unemployment Insurance Acts for which
    we are responsible. Even though our request is $13 million over the
    President's proposed budget, it represents our considered opinion which
    will enable us to continue our successful stewardship of the
    entitlement programs for our constituents. In considering this
    additional funding, we believe it is appropriate to look at the
    financial position of the benefit programs we administer in their
    entirety. Specifically, we would like to point to the successful
    implementation of the Railroad Retirement and Survivors' Improvement
    Act of 2001. Under that Act, we transferred a net $20.39 billion to the
    National Railroad Retirement Investment Trust (NRRIT) from its
    inception in February 2002 through September 30, 2003. The funds held
    by the NRRIT grew to $23 billion during that period, reflecting a 19.9
    percent return on investments in fiscal year 2003, a market value gain
    of $2.7 billion. By comparison, our requested increase in
    administrative funding represents less than one-half of 1 percent of
    that increase.
        A funding level of $110.66 million for ongoing operations would
    allow the RRB to maintain our current high levels of timeliness and
    accuracy in claims processing operations and to provide the quality
    service our customers expect. Our requested appropriation would provide
    sufficient funding for 1,046 FTE's--the same number we plan to use in
    fiscal year 2004. The additional funding would prevent a costly and
    disruptive reduction-in-force and allow us to hire some new employees
    for essential positions.
        The efficient and timely administration of our Acts requires well-
    trained and experienced staff. Although the RRB has already suffered
    significant workforce reductions over the last few years, we have been
    able to maintain and even improve customer service. This has been
    accomplished using a core of experienced staff and productivity gains
    through technology. Our immediate concern today is the aging of our
    workforce. The bulk of the additional funding in fiscal year 2005, is
    to mitigate the expected loss of experienced staff by hiring and
    training new employees and to increase available resources for advances
    in information technology.
        This funding level would also allow us to provide resources for
    important administrative needs, including travel, training and overtime
    to support our service to the public. We would also be able to
    reinstate employee benefit programs, including transit benefit
    subsidies, which have been suspended due to insufficient funding. At
    our request level, an additional $300,000 would also be available for
    information technology. We would use this money to replace aging
    desktop computing equipment and software.

                   ENTERPRISE ARCHITECTURE CAPITAL ASSET PLAN

        Our budget request includes funding the first year of our
    Enterprise Architecture Capital Asset Plan for fiscal years 2005-2007,
    which addresses the major initiatives needed to implement our target
    enterprise architecture. This request is highlighted separately because
    of its significance to the long-term continued viability of agency
    programs, and the realization that movement toward the desired target
    architecture will be a multi-year effort. We are requesting an
    additional $4,947,800 to begin these initiatives in fiscal year 2005.
        Gartner Consulting has recommended that we investigate alternatives
    for our Computer Associates' Integrated Database Management System
    (IDMS) and be prepared to actively retire the platform beyond 2006. The
    Enterprise Architecture Capital Asset Plan includes funding for
    contractual assistance, tools and training to begin this transition as
    well as related initiatives. Funding has been requested in four key
    areas:
      --Infrastructure modernization initiative ($1,445,000).--A variety of
            improvements to the agency's infrastructure are required to
            support our target enterprise architecture. This initiative
            provides agency-wide support at the desktop, systems and
            network levels. Components include improvements to our data
            center infrastructure, client/server software and information
            security.
      --Modernization blueprint initiative ($1,992,800).--The primary
            feature of this initiative is the conversion of the RRB's
            database from IDMS to a relational database management system.
            The agency's day-to-day operations are heavily dependent on
            application systems that are based on IDMS technology. Delaying
            this transition in fiscal year 2005 would create a high risk
            that the loss of these systems could compromise the RRB's
            ability to pay benefits and fulfill its mission in the future.
      --Metadata repository initiative ($555,000).--This project funds the
            development of a preliminary metadata repository, which is a
            critical success factor for implementation of inter-
            governmental and internal data sharing services. The metadata
            repository will enable us to integrate data from various
            sources and mediums, including railroad employers and
            employees, annuitants and beneficiaries, State agencies, and
            other Federal government agencies.
      --E-Government service delivery initiative ($955,000).--This project
            funds our initiative to expand electronic services to the
            public via the RRB Internet website. In addition, this
            initiative funds the continued expansion of a system being
            developed to meet the requirements of the Government Paperwork
            Elimination Act, which will permit private employers to store
            and file electronically, with executive agencies, forms
            containing information pertaining to employees. We will expand
            services to railroad employers by providing for on-line
            completion or transmission of all employer paper forms.

                  PRESIDENT'S PROPOSED FISCAL YEAR 2005 BUDGET

        The President's proposed budget includes $102.6 million for RRB
    administrative expenses in fiscal year 2005. This total includes $100.5
    million for the ongoing costs of current agency operations. In
    addition, the President's proposed budget includes $2.1 million to
    contract with a non-governmental disbursement agent for payment of
    railroad retirement and survivor benefits in accordance with provisions
    of the Railroad Retirement and Survivors' Improvement Act of 2001
    (Public Law 107-90).
        We believe that an appropriation at this level would seriously
    undermine the quality and timeliness of services to our customers in
    fiscal year 2005. The negative impact would also carry forward to
    subsequent years due to staff reductions, administrative cutbacks, and
    further postponement of important automation initiatives.
        The reductions at the President's proposed level of funding for
    fiscal year 2005, would undermine the RRB's ability to process claims
    in a timely manner, including those for retirement, survivor and
    disability annuities. Delays would also occur in processing subsequent
    annuity adjustments, requests for reconsideration and employer reports.
    Customer outreach services would be reduced, creating delays in
    responding to inquiries and taking applications for benefits.
        Customer service would also be affected if we are required to
    contract for the use of a non-governmental disbursement agent in fiscal
    year 2005. Not only would this action increase the RRB's operating
    costs, but our Inspector General and others have questioned whether
    certain services provided by the Department of the Treasury, such as
    reclamations, would be provided as effectively by a non-governmental
    disbursement agent. On March 20, 2003, we submitted a legislative
    proposal to permit the Department of the Treasury to continue to make
    payments of railroad retirement benefits.
        We would need to make extremely deep cuts in funding for
    administrative needs throughout the RRB to operate at the President's
    proposed level in fiscal year 2005. Because 80 percent of our budget is
    used for employees' salaries and benefits, a major staff reduction
    would be unavoidable. We estimate that the President's proposed funding
    would support only 969 full-time equivalent staff years (FTE's), which
    is 77 FTE's less than we now plan to use in fiscal year 2004. To reduce
    agency staffing, we would need to impose a year-long hiring freeze,
    leaving positions unfilled as vacancies occur through attrition. We
    would also need to conduct a reduction-in-force of 39 employees at the
    beginning of fiscal year 2005. The RIF would cost an estimated
    $473,000.
        Information technology (IT) funding would also be severely limited.
    At the President's proposed level of funding, the RRB would have only
    $1,325,000 for investments under our ongoing IT Capital Plan. Although
    e-Government initiatives are essential to maintaining a high level of
    public service and improving productivity in coming years, we would
    need to severely curtail purchases of desktop computing equipment and
    software needed by the agency's staff. In addition, we would have no
    funding available for the major projects in our Enterprise Architecture
    Capital Asset Plan. This plan includes funding to begin migration of
    agency systems from the Integrated Database Management System, which is
    nearing obsolescence. Not funding this initiative creates a high risk
    that the loss of these systems could compromise the RRB's ability to
    pay claims and fulfill our mission in the future.
        The proposed budget would also provide insufficient funding for
    other administrative needs, many of which have been sharply reduced in
    recent years. We have already suspended several of our employee benefit
    programs, including transit benefit subsidies and certain award
    programs, which had contributed considerably to employee morale in the
    past. These programs would continue to be suspended in fiscal year
    2005. We would also continue to severely limit funds allocated for
    variable expenses, such as overtime, travel, training, supplies and
    equipment.
        In addition to the requests for administrative expenses, the
    Administration's budget includes $108 million to fund the continuing
    phase-out of vested dual benefits, and $150,000 for interest related to
    uncashed railroad retirement checks.

                      FINANCIAL STATUS OF THE TRUST FUNDS

        Railroad Retirement Accounts.--As a result of $18.9 billion in net
    transfers to the National Railroad Retirement Investment Trust, the net
    position of the railroad retirement accounts decreased by $18.1 billion
    in fiscal year 2003, to $551.1 million.
        In June 2003, we released the 22nd Actuarial Valuation, including
    the annual report on the railroad retirement system required by Section
    22 of the Railroad Retirement Act of 1974, and Section 502 of the
    Railroad Retirement Solvency Act of 1983. The actuarial valuation
    contains generally favorable information concerning railroad retirement
    financing. However, the long-term stability of the system, under its
    current financing structure, is still dependent on future employment
    levels and investment returns. The valuation included projections of
    the status of the retirement trust funds under three employment
    assumptions. These indicated cash flow problems only under a
    pessimistic employment assumption, and then not until calendar year
    2022.
        Railroad Unemployment Insurance Accounts.--The equity balance of
    the railroad unemployment insurance accounts at the end of fiscal year
    2003 was $51.5 million, an increase of $35.8 million from the previous
    year. The RRB's latest annual report on the financial status of the
    railroad unemployment insurance system, issued in June 2003, was
    generally favorable. The report indicated that even as maximum daily
    benefit rates rise 44 percent (from $52 to $75) from 2002 to 2013,
    experience-based contribution rates are expected to keep the
    unemployment insurance system solvent. The small loan made in fiscal
    year 2002 was repaid in May 2003, and no new loans are anticipated even
    under our most pessimistic assumption. The average employer
    contribution rate remains well below the maximum throughout the
    projection period, but a 1.5 percent surcharge is now in effect and is
    expected for calendar year 2005 and probably 2006. We did not recommend
    any financing changes based on this report.
        In conclusion, we want to stress the RRB's continuing commitment to
    improving our operations and providing quality service to our
    beneficiaries. Thank you for your consideration of our administrative
    budget request. We will be happy to provide further information in
    response to any questions you may have.

           LIST OF WITNESSES, COMMUNICATIONS, AND PREPARED STATEMENTS

                                  ----------
                                                                       Page

    Alexander, Duane, M.D., Director, National Institute of Child
      Health and Human Development, National Institutes of Health,
      Department of Health and Human Services........................   107
        Prepared statement...........................................   127
    Alving, Barbara, M.D., Acting Director, National Heart, Lung, and
      Blood Institute, National Institutes of Health, Department of
      Health and Human Services......................................   107
        Prepared statement...........................................   188
    American:
        Academy of:
            Family Physicians, prepared statement....................   295
            Physician Assistants, prepared statement.................   311
        Association for:
            Cancer Research, prepared statement......................   407
            Dental Research, prepared statement......................   399
            Geriatric Psychiatry, prepared statement.................   416
            Museums, prepared statement..............................   451
        College of Cardiology, prepared statement....................   389
        Diabetes Association, prepared statement.....................   274
        For the Arts, prepared statement.............................   430
        Heart Association, prepared statement........................   331
        Indian Higher Education Consortium, prepared statement.......   442
        Institute for Stuttering, prepared statement.................   345
        Museum of Natural History, prepared statement................   308
        Psychological Society, prepared statement....................   352
        Public:
            Power Association, prepared statement....................   342
            Transportation Association, prepared statement...........   338
        Society:
            For Microbiology, prepared statements..................276, 420
            Of Clinical Oncology, prepared statement.................   362
        Thoracic Society, prepared statement.........................   357
    Association for Professionals in Infection Control and
      Epidemiology, prepared statement...............................   270
    Association of:
        American Universities, prepared statement....................   366
        Farmworker of the Opportunity Programs, prepared statement...   255
        Maternal and Child Health Programs, prepared statement.......   318
        University Programs in Occupational Health and Safety,
          prepared statement.........................................   288
        Women's Health, Obstetric and Neonatal Nurses, prepared
          statement..................................................   327

    Battey, James F., Jr., M.D., Ph.D., National Institute on
      Deafness and Other Communication Disorders, National Institutes
      of Health, Department of Health and Human Services.............   107
        Prepared statement...........................................   191
    Beldon, William R., Deputy Assistant Secretary for Budget,
      National Institutes of Health, Department of Health and Human
      Services.......................................................   107
    Berg, Jeremy M., Director, National Institute of General Medical
      Sciences, National Institutes of Health, Department of Health
      and Human Services.............................................   107
        Prepared statement...........................................   165
    Blue Cross and Blue Shield Association, prepared statement.......   271

    California Workforce Investment Board, prepared statement........   260
    Charles R. Drew University of Medicine and Science, prepared
      statement......................................................   386
    Close Up Foundation, prepared statement..........................   433
    Coalition of Northeastern Governors, prepared statement..........   341
    Cochran, Senator Thad, U.S. Senator from Mississippi:
        Questions submitted by.......................................    70
        Opening statements......................................58, 78, 203
        Prepared statements.........................................58, 204
    Collins, Francis S., M.D., Ph.D., Director, National Human Genome
      Research Institute, National Institutes of Health, Department
      of Health and Human Services...................................   107
        Prepared statement...........................................   143
    Community Medical Centers, Fresno, CA, prepared statement........   308
    Cooley's Anemia Foundation, prepared statement...................   395

    Digestive Disease National Coalition, prepared statement.........   374
    Doris Day Animal League, prepared statement......................   397

    Evans, Samuel London, founder, American Foundation for Negro
      Affairs........................................................    41
        Prepared statement...........................................    42

    FacioScapuloHumeral Muscular Dystrophy Society, prepared
      statement......................................................   349
    Fauci, Anthony S., M.D., Director, National Institute of Allergy
      and Infectious Diseases, National Institutes of Health,
      Department of Health and Human Services........................   107
        Prepared statement...........................................   154
    First Candle/Sudden Infant Death Syndrome Alliance, prepared
      statement......................................................   377
    Florida State University, prepared statement.....................   445

    Grady, Patricia A., Ph.D., Director, National Institute of
      Nursing Research, National Institutes of Health, Department of
      Health and Human Services......................................   107
        Prepared statement...........................................   185

    Harkin, Senator Tom, U.S. Senator from Iowa, opening stateme20, 76, 218
    Hepatitis Foundation International, prepared statement...........   384
    Hodes, Richard J., M.D., National Institute of Aging, National
      Institutes of Health, Department of Health and Human Services..   107
        Prepared statement...........................................   147
    Hrynkow, Sharon H., Acting Director, Fogarty International
      Center, National Institutes of Health, Department of Health and
      Human Services.................................................   107
        Prepared statement...........................................   133
    Hutchison, Senator Kay Bailey, U.S. Senator from Texas, opening
      state-
      ment...........................................................    16

    Illinois Neurofibromatosis, Inc., prepared statement.............   413
    Insel, Thomas R., M.D., Director, National Institute of Mental
      Health, National Institutes of Health, Department of Health and
      Human Services.................................................   107
        Prepared statement...........................................   177
    International Foundation for Functional Gastrointestinal
      Disorders, prepared statement..................................   381
    InterTribal Bison Cooperative, prepared statement................   279

    Jamula, Dr. Melissa, superintendent, Reading School District.....    30
        Prepared statement...........................................    32
    Jeffrey Modell Foundation, prepared statement....................   398
    Jones, C. Todd, Associate Deputy Secretary for Budget and
      Strategic Accountability, Department of Education..............     1

    K-12 Science, Technology, Engineering & Mathematics Education
      Coalition, prepared statement..................................   430
    Katz, Stephen I., M.D., Ph.D., Director, National Institute of
      Arthritis and Musculoskeletal and Skin Diseases, National
      Institutes of Health, Department of Health and Human Services..   107
    Kington, Raynard, M.D., Ph.D., Deputy Director, Office of the
      Director, National Institutes of Health, Department of Health
      and Human Services.............................................   107
        Prepared statement...........................................   180
    Kohl, Senator Herb, U.S. Senator from Wisconsin:
        Opening statement............................................    18
        Questions submitted by.......................................   244
    Landis, Story C., Ph.D., Director, National Institute of
      Neurological Disorders and Stroke, National Institutes of
      Health, Department of Health and Human Services................   107
        Prepared statement...........................................   168
    Landrieu, Senator Mary L., U.S. Senator from Louisiana:
        Opening statement............................................     9
        Prepared statements....................................10, 104, 243
    Li, Ting-Kai, M.D., Director, National Institute of Alcohol Abuse
      and Alcoholism, National Institutes of Health, Department of
      Health and Human Services......................................   108
        Prepared statement...........................................   197
    Lindberg, Donald A.B., M.D., Director, National Library of
      Medicine, National Institutes of Health, Department of Health
      and Human Services.............................................   108
        Prepared statement...........................................   193
    Living Cities: The National Community Development Initiative,
      prepared statement.............................................   335
    Lymphoma Research Foundation, prepared statement.................   409

    March of Dimes Birth Defects Foundation, prepared statement......   368
    Meals On Wheels Association of America, prepared statement.......   343
    Medicare Payment Advisory Commission, prepared statement.........   281
    Mended Hearts, Inc., prepared statement..........................   388
    Mexican-American Opportunity Foundation and the Career Services
      Center, Kern County, CA, prepared statement....................   271
    Murray, Senator Patty, U.S. Senator from Washington:
        Opening statement............................................    11
        Prepared statement...........................................    15
        Questions submitted by.......................................    71
    National:
        Alliance for the Mentally Ill, prepared statement............   314
        Area Health Education Centers Organization, prepared
          statement..................................................   301
        Association of:
            Children's Hospitals, prepared statement.................   305
            Home Builders, prepared statement........................   267
            Nutrition and Aging Services Programs, prepared statement   344
            State Workforce Agencies, prepared statement.............   260
        Coalition for:
            Heart and Stroke Research, prepared statement............   394
            Homeless Veterans, prepared statement....................   264
            Osteoporosis and Related Bone Diseases, prepared
              statement..............................................   404
        Council on Folic Acid, prepared statement....................   294
        Federation of Community Broadcasters, prepared statement.....   448
        League for Nursing, prepared statement.......................   304
        Multiple Sclerosis Society, prepared statement...............   364
        Primate Research Centers, prepared statement.................   346
        Prostate Cancer Coalition, prepared statement................   427
        Sleep Foundation, prepared statement.........................   380
        Treasury Employees Union, prepared statement.................   321
        Youth Employment Coalition, prepared statement...............   263
    NCB Development Corporation, prepared statement..................   446
    NephCure Foundation, prepared statement..........................   372

    Olden, Kenneth, Ph.D., S.C.D., L.H.D., Director, National
      Institute of Environmental Health Sciences, National Institutes
      of Health, Department of Health and Human Services.............   108
        Prepared statement...........................................   174
    Oncology Nursing Society, prepared statement.....................   324

    Paige, Hon. Roderick, Secretary, Office of the Secretary,
      Department of Education........................................     1
        Prepared statement...........................................     4
        Summary statement............................................     2
    Pettigrew, Roderic I., Ph.D., M.D., Director, National Institute
      of Biomedical Imaging and Bioengineering, National Institutes
      of Health, Department of Health and Human Services.............   108
        Prepared statement...........................................   137

    Railroad Retirement Board, prepared statement....................   453
    Research to Prevention, prepared statement.......................   285
    Rotary International, prepared statement.........................   290
    Ruffin, John, Ph.D., Director, National Center on Minority Health
      and Health Disparities, National Institutes of Health,
      Department of Health and Human Services........................   108
        Prepared statement...........................................   120
    Rural Opportunities Inc., prepared statement.....................   257

    Scanlon, Dr. James, superintendent of schools, Quakertown
      Community School District......................................    34
        Prepared statement...........................................    36
    Sieving, Paul A., M.D., Ph.D., Director, National Eye Institute,
      National Institutes of Health, Department of Health and Human
      Services.......................................................   108
        Prepared statement...........................................   117
    Skelly, Thomas, Director, Budget Services, Department of
      Education......................................................     1
    Slobojan, Dr. Marie, director of instruction, Tredyffrin/Easttown
      School District................................................    37
        Prepared statement...........................................    39
    Society:
        For Maternal-Fetal Medicine, prepared statement..............   401
        Of Nuclear Medicine, prepared statement......................   425
    Southern:
        California Elderly Nutrition Partnership, prepared statement.   269
        Methodist University School of Engineering, prepared
          statement..................................................   429
    Specter, Senator Arlen, U.S. Senator from Pennsylvania:
        Opening statements.......................................1, 75, 108
        Questions submitted by......................................59, 101
    Spiegel, Allen M., M.D., Director, National Institute of Diabetes
      and Digestive and Kidney Diseases, National Institutes of
      Health, Department of Health and Human Services................   108
        Prepared statement...........................................   131
    Stevens, Senator Ted, U.S. Senator from Alaska:
        Opening statement............................................    23
        Prepared statements.........................................96, 203
    Straus, Stephen E., M.D., National Center for Complementary and
      Alternative Medicine, National Institutes of Health, Department
      of Health and Human Services...................................   108
        Prepared statement...........................................   171

    Tabak, Lawrence A., D.D.S., Ph.D., National Institute of Dental
      and Craniofacial Diseases, National Institutes of Health,
      Department of Health and Human Services........................   108
        Prepared statement...........................................   200
    The Humane Society of the United States, prepared statement......   424
    Thompson, Hon. Tommy G., Secretary, Office of the Secretary,
      Department of Health and Human Services........................    75
        Prepared statement...........................................    81
        Summary statement............................................    79
    Tri-Council for Nursing, prepared statement......................   297
    Tucker, C. Delores, founder, Philadelphia Martin Luther King, Jr.
      Association for Non-Violent Change.............................    44
        Prepared statement...........................................    47

    United Tribes Technical College, prepared statement..............   439
    Upper County Branch, Montgomery County, Maryland Stroke Club,
      prepared statement.............................................   412

    Vaitukaitis, Judith L., M.D., Director, National Center for
      Research Resources, National Institutes of Health, Department
      of Health and Human Services...................................   108
        Prepared statement...........................................   124
    Vallas, Paul G., chief executive officer, School District of
      Philadelphia...................................................    50
        Prepared statement...........................................    52
    Volkow, Nora D., M.D., Director, National Institute on Drug
      Abuse, National Institutes of Health, Department of Health and
      Human Services.................................................   108
        Prepared statement...........................................   158
    von Eschenbach, Andrew C., M.D., Director, National Cancer
      Institute, National Institutes of Health, Department of Health
      and Human Services.............................................   108
        Prepared statement...........................................   151
    Weaver, James, president, Pennsylvania State Education
      Association....................................................    28
        Prepared statement...........................................    29
    Whitescarver, Jack, Ph.D., Director, Office of AIDS Research,
      National Institutes of Health, Department of Health and Human
      Services.......................................................   108
        Prepared statement...........................................   140
    WomenHeart, the National Coalition for Women With Heart Disease,
      prepared statement.............................................   411

    Zerhouni, Elias A., M.D., Director, National Institutes of
      Health, Department of Health and Human Services................   107
        Prepared statement...........................................   112
        Summary statement............................................   110
    Zero to Three, prepared statement................................   436

                                 SUBJECT INDEX

                                  ----------

                            DEPARTMENT OF EDUCATION

                            Office of the Secretary

                                                                       Page

    Accuracy of Department's Pell Grant Cost Model...................    66
    After School and Saturday Programs...............................    46
    Aggressive Recruitment of Highly Qualified Teachers..............    56
    Alaska Native Education Equity Act...............................    24
    Alaska's Education Challenges....................................    23
    American Foundation for Negro Affairs............................    48
        National Education and Research Fund.........................    49
    Arts in Education................................................69, 71
    Authorization vs. Appropriation Levels for NCLB..................    19
    Barriers to School Choice........................................    60
    Budget Request and Highly Qualified Teachers.....................    59
    Carol M. White Physical Education Program........................    24
    Center for Civic Education's We the People Programs..............    68
    Children Without Homes...........................................    46
    Choice and Supplemental Services.................................    61
    College:
        Enrollment Gap...............................................    65
        For Teens Program............................................    45
    Costs of:
        No Child Left Behing Act.....................................    35
        School Improvement and Choice Requirements...................    60
    Education Program Funds That can be Used for Statewide
      Longitudinal Student Data Systems..............................    64
    Educational Voucher Programs.....................................    14
    Effectiveness of Assessments Being Developed.....................    64
    Enhancement of Assessment Projects Focus on Students With
      Disabilities and Students With Limited English Proficiency.....    62
    Epidemic of Obesity..............................................    24
    Evaluation.......................................................    43
        Of AFNA......................................................    50
    Excerpts of the Evaluation (MGL) Process.........................    43
    Expanding Comprehensive School Choice Options....................    54
    Federal Support for Foreign Language Instruction.................    71
    Fiscal Year 2005 Education Budget Request........................     3
    Flexibility for IDEA and LEP Students............................    35
    Funding for NCLB Programs........................................    73
    Funds for:
        Assessments Required by the NCLB Act.........................    62
        School Improvement...........................................    60
    Grants for Enhanced Assessments..................................    62
    Highlighting Screening Programs in Grant Application Packages....    27
    Historic Levels of Resources and Flexibility.....................     4
    Identifying Districts for Screening Programs.....................    27
    Implementing a Rigorous Corrective Action Plan for Schools Not
      Making Adequate Yearly Progress................................    55
    Increase for Research, Development, and Dissemination............    68
    Increased NCLB Flexibility for Rural and Small Schools...........    24
    Increases in the Fiscal Year 2005 Education Budget...............    25
    Intensive Supplementary Education Services in Low Performing
      Schools........................................................    55
    Internal Revenue Service Data Matching...........................    67
    Jobs for the 21st Century........................................     5
    Key Year for No Child Left Behind................................  3, 4
    Leveraging Educational Assistance Partnerships...................    66
    Limited English Speaking Students................................    35
    Major Program Increases..........................................     5
    Management Improvements..........................................     6
    Mathematics and Science Partnerships.............................    61
    Mid-Session Review Reestimates of Pell Grant Program Costs.......    66
    NCLB Act and:
        Children With Disabilities...................................39, 52
        Limited English Proficient Students..........................    39
        Transferability Provisions...................................    69
    New:
        Flexibility Under NCLB Requirements..........................     7
        Programs Versus Program Eliminations.........................    67
    No Child Left Behind Act..................................2, 28, 34, 51
        And IDEA.....................................................    35
        And Single Sex Education.....................................    13
        Funding Levels...............................................    18
    Pell Grant:
        Cost Estimates...............................................    66
        Maximum......................................................    65
    Pennsylvania Title I Funding.....................................    59
    Physical Education and Obesity...................................    24
    Public School Choice Funding.....................................    15
    Raising Awareness of Existing Programs...........................    26
    Rate of State Spending...........................................    21
    Reading School District..........................................    31
    Regional Educational Laboratories Program........................    68
    Regulatory Flexibility for Special Education and LEP Assessments.     7
    Relationship Between Funding and Achievement.....................    20
    Report on:
        NCLB Implementation..........................................    60
        Writing by the National Commission on Writing................    70
    School:
        Choice and Pell Grants.......................................    72
        District of Philadelphia Programming to Implement No Child
          Left Behind Legislation....................................    54
    Screening Programs for Teenagers.................................    26
    SES Providers....................................................    57
    Single Sex Education..........................................8, 16, 71
        And Title IX.................................................    12
    Spending Rate by States of Federal Education Funds...............    22
    Standards, Curriculum, and Testing...............................    51
    Statewide Longitudinal Data Systems..............................    64
        Not Required by NCLB.........................................    64
    Steps Taken to Reduce Erroneous Federal Student Aid Education
      Payments.......................................................    67
    Striving Readers Initiative......................................    72
    Student Participant of College for Teens Program.................    45
    Students:
        Transferring to Schools not Identified for Improvement Under
          No Child Left Behind Act...................................    59
        Science Achievement..........................................    62
    ``Substantially Equal'' Clause...................................    13
    Supplemental Service Providers...................................    61
    Teacher Certification............................................    16
    Teen Suicide.....................................................    25
    Title I:
        Grants to Local Educational Agencies.........................     4
        School Choice................................................    59
    Tredyffrin/Easttown School District..............................    38
    21st Century Community Learning Centers..........................    69
    Unspent:
        Federal Education Funds......................................    21
        Funds........................................................    23
    Washington Post Op-Ed by Secretary Paige.........................    20

                    DEPARTMENT OF HEALTH AND HUMAN SERVICES

                         National Institutes of Health

    A Strategic Approach to Eliminate Health Disparities.............   120
    Accelerating Research Discoveries Bench to Bedside: Bedside to
      Community NIH Roadmap and Other Initiatives....................   160
    Access to Additional Lines.......................................   224
    Actions Underway.................................................   199
    Addiction and Obesity: Common Neurobiological Mechanisms.........   158
    Additional:
        Committee Questions..........................................   244
        Studies on Innovative Therapies for Rheumatic and Skin
          Diseases (NIAMS)...........................................   212
    Address the Shortage of Advanced Instrumentation Needed to Pursue
      Cutting-Edge Biomedical Research (NCRR)........................   215
    Addressing the Obesity Epidemic..................................   172
    Adolescence, the Developing Brain, and Prevention................   159
    Advancing:
        The NIH Roadmap: Global Positioning..........................   136
        Tomorrow's Technologies Today................................   138
    Age-related Macular Degeneration (AMD)...........................   239
    Alcohol use by Youth.............................................   198
    Animal Drug Compounding..........................................   253
    Anorexia and Bulimia (NIMH)......................................   213
    Autism...........................................................   179
        Research.....................................................   240
    Balancing Large- and Small-Scale Science.........................   167
    Basic and Clinical Research Approaches...........................   188
    Biodefense Agents................................................   228
    Bioinformatics and Computer Networks.............................   126
    Blazing a Trail for the NIH Roadmap..............................   165
    Brain Disorders in the Developing World: Research Across the
      Lifespan
      (FIC)..........................................................   216
    Brain-Communication Interface (NIBIB)............................   215
    Breakthroughs and Advances.....................................110, 112
    Budget...........................................................   115
        Statement..................................................151, 191
    Buildings and Facilities Program.................................   116
    Burden of Mental Illness.........................................   177
    Cancer Biomedical Informatics Grid (ca BIG)....................152, 206
    Cataract.........................................................   118
    Changing Microbial Threats.......................................   135
    Chemistry of Imaging Agents and Molecular Probes (NIBIB).........   215
    Cholera Reduced by Low Tech Water Filtration.....................   186
    Clinical
        Research:
            Resources................................................   125
            Training (NIDCR).........................................   207
        Trial for the Treatment of Inflammatory Eye Disease (NEI)....   211
        Trials.......................................................   170
            In Organ Transplantation (NIAID).........................   209
            Network for the Treatment of Age Related Macular
              Degeneration (AMD) (NEI)...............................   211
            Of HIV/AIDS Vaccine Candidates (NIAID)...................   209
            Of Topical Microbicides (NIAID)..........................   209
    Closing the Health Disparity Gap.................................   121
    Collaborations of Established Clinical Trials Network (CTN) with
      Other Established Networks at NIH (NIDA).......................   213
    Combating the Obesity Epidemic...................................   190
    Communication Disorders (NIDCD)..................................   213
    Comprehensive AIDS Research Plan and Budget......................   141
    Computer-Based Solutions to Biomedical Challenges................   166
    Conduct a Phase III Clinical Trial of Cephalosporin for the
      Treatment of ALS (Lou Gehrig's Disease) (NINDS)................   208
    Connection to Obesity............................................   199
    Control of High Blood Pressure in Young Inner-City African-
      American Men...................................................   185
    Corneal Diseases.................................................   118
    Could:
        Accelerate Progress Toward Development and Implementation of
          Clinical Vocabulary Standards that are Critical to Re-
          engineering the Clinical Research Enterprise (NLM).........   216
        Significantly Expand Capability to Analyze, Annotate, and
          Classify Massive Amounts of Raw Sequence and Protein Data
          to Make It Readily Usable by Researchers (NLM).............   216
        Work with Others to Develop Common Software Platforms for
          Advanced Clinical and Educational Applications of the
          Visible Human and Other Image Data Sets (NLM)..............   216
    Counterfeit Drugs................................................   253
    Cross-Cutting and Cutting-Edge Research..........................   165
    Current Grade Rates..............................................   248
    Cutting Obesity Through Research and Programs....................   128
    Delivering on the Promise of Basic Research......................   200
    Determine Three-Dimensional Structures of Proteins (NIGMS).......   210
    Develop and Support:
        A Clinical Trial to Test a Promising Innovative Technique
          that could Reduce the Size of Uterine Fibroids (OD--Office
          of Research on Women's Health).............................   217
        Women's Health Interdisciplinary Research Centers Especially
          in the Areas of: (OD--Office of Research on Women's Health)   217
    Develop the Next Generation of International Reseachers (FIC)....   216
    Development of:
        A Clinical Trials Consortium (NIA)...........................   212
        Tools for Investigating Model Organisms (NIGMS)..............   210
    Drug Development for Neurological Disorders......................   169
    Emerging Epidemics of Chronic Disease............................   135
    Encouraging Healthy Birth Outcomes...............................   127
    Enhance:
        Capacity for Disaster/Terrorism Mental Health Research (NIMH)   213
        Our Understanding of the Genetic or Heritable Risk Factors
          Associated with Drug Abuse Using the CTN as a Valuable
          Resource (NIDA)............................................   213
        Opportunities for Women in Science...........................   136
    Examining the Safety and Effectiveness of Botanical Products.....   172
    Excellent News: Drug use Declines................................   159
    Expand:
        Feasibility Trial of Daily Dialysis to Determine Effects of
          New, More Intensive Dialysis Modalities on Mortality and
          Cardiovascular Disease (NIDDK).............................   208
        Research:
            Aimed at Developing Medications for Alcoholism (NIAAA)...   214
            On Alcohol Metabolism (NIAAA)............................   214
            On Preventing Drinking by Youth in Rural/Small Urban
              Areas (NIAAA)..........................................   214
        The Specialized Programs of Translational Research in Acute
          Stroke (SPOTRIAS) (NINDS)..................................   209
    FDA FOIA Policies................................................   247
    Fiscal Year 2005 Budget:
        Request....................................................112, 204
        Summary......................................................   117
    Five-Year Randomized Clinical Trial of Chronic Oxygen Use in
      Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
      Patients (NHLBI)...............................................   207
    Full-scale Clinical Trial of Primary Interventions to Prevent or
      Delay Type 2 Diabetes in Children and Adolescents (NIDDK)......   208
    Funding of Research Grants.......................................   232
    Future Cooperative Efforts.......................................   171
    Gene:
        And:
            Environment..............................................   174
            The Nervous System.......................................   168
        Replacement Therapy can Generate New Hair Cells..............   192
        Transfer and the Salivary Glands.............................   200
    Genomic and Proteomic Resources for Premature Birth (NICHD)......   210
    Getting the Medical Community More Involved in Screening and
      Addressing HIV/AIDS and Other Drug Abuse Consequences..........   161
    Glaucoma and Optic Neuropathies..................................   118
    Hair Cell Degeneration and Regeneration in the Inner Ear (NIDCD).   213
    Health:
        Disparities..................................................   126
        Of Minority, Inner City Newborns Improved by Nurse Home
          Visits.....................................................   186
    Helping Young Children Prepare for School........................   129
    Highlights of Program Enhancements...............................   131
    HIV/AIDS:
        Emergency....................................................   134
        Research.....................................................   155
    Hydroxyurea Therapy for Sickle Cell Disease......................   190
    Identify and Test Approaches to Reducing Cardiovascular Disease
      that are Specific to American Indian and Alaska Native
      Populations (NHLBI)............................................   207
    Identifying Genes Important for the Sense of Taste...............   192
    Implications.....................................................   200
    Implicit Preemption..............................................   248
    Import Inspections...............................................   246
    Improve Clinical Trials for Treatment of Inflammatory Bowel
      Disease (IBD) (NIDDK)..........................................   208
    Improving:
        Survival for Victims of Cardiac Arrest.......................   190
        Treatment for Critically Ill Children........................   128
    Increase Support for Translational Research--Maximizing the
      Results of Basic Research to Improve Public Health (NIAMS).....   212
    Increasing the Number of Nurse Investigators.....................   187
    Information Services for the Public..............................   195
    Initiate:
        A Definitive Epidemiological Study (NIDCD)...................   213
        The Very Large Phase III Clinical Trials for Parkinson's
          Disease (NINDS)............................................   208
    Initiative for Pandemic Influenza (NIAID)........................   209
    Initiatives......................................................   187
    Innovative:
        Efforts to Combat Health Disparities.........................   120
        Methods of Newborn Screening (NICHD).........................   210
    Integrate Technology Developed through the Biomedical Informatics
      Research Network (BIRN) into Clinical Research and Other New
      Domains Outside of Neuroscience (NCRR).........................   215
    International Research...........................................   143
    Intramural Programs..............................................   170
    Introduction of New Institute Directors..........................   110
    Investigating Brain-Body Interactions............................   173
    Launch:
        A Trans-NIH Initiative to Learn Whether eHealth Technologies
          are Effective in Enhancing Health Behavior Change and
          Chronic Disease Management (OD--Office of Behavioral and
          Social Sciences Research)..................................   217
        Chemical Counterterrorism Research to Combat Nerve Agents
          (NINDS)....................................................   208
    Loan Repayment and Scholarship Program...........................   185
    Looking Forward..................................................   174
    Lung-Volume-Reduction Surgery (LVRS).............................   189
    Medication to Lower Plasma Lipoprotein (a) [Lp(a)]...............   236
    Microbicides that can Prevent Sexually Transmitted Infections....   130
    Minimally-Invasive, Image-Guided Surgery (NIBIB).................   214
    More Research Using Brain Imaging Techniques (NIDA)..............   213
    Mothers Leaving Welfare had no Effect on Preschoolers............   130
    Mouse Feeder Cell Lines..........................................   224
    Multi-Center Clinical Trial to Evaluate New Treatment Approaches
      for Sarcoidosis (NHLBI)........................................   207
    Multidisciplinary:
        Imaging Research Partnerships for Addressing Important
          Biological or Medical Research Problems of Skeletal Muscle
          and Associated Soft Tissue (NIAMS).........................   212
        Research Teams...............................................   140
    Muscular Dystrophy and Centers Programs..........................   170
    NARMS............................................................   252
    National:
        Advanced Biomedical Technology Initiative....................   153
        Children's Study.............................................   130
    NCMHD Could:
        Fully Launch its Community-Based Research Program (NCMHD)....   215
        Strengthen and Expand its Programs (NCMHD)...................   215
    New:
        Biomaterials for Tissue Engineering..........................   139
        Challenges in Therapeutics Research..........................   142
        Fragile X Centers to Develop Treatment Options...............   128
        Initiatives..................................................   145
        Interventions:
            For Prevention and Control of Heart Failure in Persons
              Aged 65 and Older (NIA)................................   212
            To Improve Pregnancy Outcomes (NICHD)....................   211
        Short Electrode Will Allow Greater Benefit From Cochlear
          Implants...................................................   192
        Way to Identify Usher Syndrome in Children...................   191
    News for Concern: Prescription Drug Abuse Continues..............   159
    NIBIB's Progress.................................................   222
    NIDA: 30 Years of Discovery......................................   158
    NIH Roadmap................................113, 120, 139, 181, 193, 202
        And Clinical Research........................................   131
        For Medical Research.........................................   111
    Obesity..........................................................   244
        And Environment..............................................   176
        Research...................................................221, 235
    Ongoing NHGRI Initiatives........................................   144
    Other:
        Areas of Interest for NHGRI..................................   146
        International Stem Cell Efforts..............................   228
    Otitis Media (NIDCD).............................................   213
    Pain Research....................................................   202
    Patient Navigation Research Program: Eliminating Barriers to
      Timely Delivery of Cancer Diagnosis and Treatment Services
      (NCI)..........................................................   206
    Periodontal Disease and Preterm Birth............................   201
    Postmenopausal Hormone Therapy...................................   189
    Practical Clinical Trials........................................   179
    Practice Based Research Networks of Dental Specialists (NIDCR)...   207
    Preparing the Next Generation of U.S. Global Health Leadership...   136
    Prevention Trials to Assess the Potential Ability of Non-
      steroidal Anti-inflammatory Drugs and a Combination of Anti-
      oxidant Vitamins (NIA).........................................   212
    Priority-Setting.................................................   180
    Program Initiatives..............................................   119
    Program to Accelerate Therapeutic Development for SMA............   170
    Progress:
        In Genetics..................................................   178
        Towards Success..............................................   137
    Projecting Out-Year Budgets......................................   234
    Prospective Studies on Craniofacial Pain & Dysfunction (NIDCR)...   207
    Prostate Cancer..................................................   219
    Proteomics.......................................................   127
    Pursue the Research Needs and Opportunities Identified at the
      Recent NIH Consensus Development Conference on Total Knee
      Replacement (NIAMS)............................................   212
    Putting Research Into Practice...................................   202
    Refocusing the Research..........................................   198
    Regenerative Dental Medicine (NIDCR).............................   207
    Research:
        Activities on Lp(a)..........................................   236
        Base to Assess Early Childhood Learning and School Readiness
          (NICHD)....................................................   210
        In Medical Countermeasures Against Category A Biological
          Agents.....................................................   229
        Initiative on Pediatric Brain-Behavior Development Vital to
          Diagnosing and Treating Child Mental Disorders (NIMH)......   213
        On:
            Immune-Mediated Diseases.................................   157
            Other Emerging and Emerging Infectious Diseases..........   156
            The Consequences of Marijuana, and the Development of new
              Medications............................................   160
        Related to Determining Why Different Individuals Respond
          Differently Upon Treatment with the Same Drugs (NIGMS).....   210
        That NIH Could Fund With an Additional $1.3 Billion..........   205
    Restore the Extramural Research Facilities Improvement Program
      (RFIP) Funds (NCRR)............................................   215
    Retinal Diseases.................................................   117
    Roadmap..........................................................   179
    Robust Program to Evaluate the Toxicology of Nanoscale Materials
      (NIEHS)........................................................   211
    Role:
        In the Research Mission......................................   116
        Of the National Center for Complementary and Alternative
          Medicine...................................................   221
    Rural Health.....................................................   124
    Safer Drugs for use With Children................................   130
    Schizophrenia Treatment Initiative...............................   178
    Science:
        Advances.....................................................   196
        To Service...................................................   178
    Sensors for Medicine.............................................   139
    Serving Special Communities......................................   196
    SIDS Research Supports Program Outreach..........................   129
    Spinal Muscular Atrophy...................................237, 238, 240
    Stem Cells                                                          168
        Lines........................................................   223
        Policy.......................................................   225
        Research...................................................217, 226
    Stewardship....................................................112, 115
    Strabismus, Amblyopia and Visual Processing......................   119
    Strategic Partnerships...........................................   154
    Study:
        The Role of the Intrauterine and Postnatal Environments in
          the Development of Obesity (NIDDK).........................   208
        To Identify Risk Factors for Coronary Heart Disease (CHD) in
          Hispanic Populations (NHLBI)...............................   206
    Success Rates....................................................   233
    Support Planning Grants to Develop and Optimize Models for
      Departments of Clinical Research within Schools of Medicine
      (NCRR).........................................................   215
    Team Science and Interdisciplinary Training......................   167
    Technological Innovations........................................   119
    Technology and Instrumentation...................................   125
    The:
        Future.......................................................   197
        Integration of Brain, Behavior and Health....................   159
        Larger Picture...............................................   199
        NIAID Research Response to the Threat of Bioterrorism........   154
        NIH Roadmap--Clinical Research...............................   189
        NINR Role in the NIH Roadmap.................................   186
        National:
            Children's Study (NICHD).................................   210
            Institute for Biomedical Imaging and Bioengineering......   222
        Office of:
            AIDS Research............................................   181
            Behavioral and Social Sciences Research..................   182
            Disease Prevention.......................................   183
            Research on Women's Health...............................   181
            Science Education........................................   184
        U.S. Epidemic................................................   141
    Tissue Engineered Human Model Systems (NIBIB)....................   214
    Tools for Scientists and Health Professionals....................   194
    Toxicological Evaluation of Nanoscale Materials..................   176
    Trans-NIH Obesity Task Force.....................................   240
    Transdisciplinary Research on Energetics And Cancer (TREC) (NCI).   205
    Translation Research and Roadmap Efforts.........................   133
    Translational Research...........................................   169
    Trauma and Injury (FIC)..........................................   215
    Trials of Hypertension Control and Prevention....................   189
    2015 Challenge Goal..............................................   151
    2 Percent Decrease in Fiscal Year 2006...........................   235
    Understudied Cancers of High Lethality (NCI).....................   206
    Use:
        NIMH Clinical Trial Networks to Launch Trials on Simultaneous
          Use of Multiple Psychiatric Medications for the Severely
          Mentally Ill (NIMH)........................................   213
        Of Metabolomics Technologies for Predicting Toxicological
          Responses (NIEHS)..........................................   211
    Vaccines and Prevention Research.................................   142
    Vocal Fold Paralysis.............................................   193
    Women and Minorities.............................................   143
    Women's Early Warning Signs of Heart Attack......................   186
    Worldwide Pandemic...............................................   140

                            Office of the Secretary

    Abstinence.......................................................   101
        Education....................................................   100
    Access to Recovery...............................................    82
    Additional Committee Questions...................................   100
    Alaska Dental Association........................................    95
    CDC and NIH Budgets..............................................    93
    Childhood Vaccines...............................................    84
    Community and Faith-Based Initiatives............................    84
    Completion of the Doubling of NIH................................    84
    Disease Detection and Bioterrorism Preparedness..................    83
    Drug Reimportation...............................................    91
    Expanding Access to Health Care for Americans....................    82
    Fighting HIV/AIDS................................................    86
    Food Labeling....................................................    97
    Global Funds for AIDS, Malaria, and Tuberculosis.................    93
    Head Start Program...............................................    85
    Health:
        Care Information Technology..................................    86
        Professions................................................100, 101
    Healthcare Delivery..............................................    94
    Improving the Health, Safety, and Well-Being of Our Nation.......    87
    Management Improvements..........................................    87
    Marriage and Healthy Family Development..........................    86
    Mental Health Treatment..........................................    86
    Modernization and Reform Initiatives.............................    87
    Money Follows the Person Initiative..............................    97
    Obesity..........................................................    95
    Orasure..........................................................92, 93
    Positron Emission Tomography.....................................    95
    Prescription Drug Benefit Estimates..............................    87
    Prevention Initiatives...........................................    85
    Stem Cell Research..............................................100 102
    Vaccines.........................................................    91

                                       -