[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: 
[email protected]
                                 ______
                                 
             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 
[email protected].
                                 ______
                                 
    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 
[email protected]
                                 ______
                                 
          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

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