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



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

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

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

                                HEARINGS

                                before a

                          SUBCOMMITTEE OF THE

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                       ONE HUNDRED SIXTH CONGRESS

                             SECOND SESSION

                                   on

                       H.R. 4577 and 5656/S. 2553

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

                               __________

                         Part 1 (Pages 1-572)

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

                               __________

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                      COMMITTEE ON APPROPRIATIONS

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

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

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

                           Professional Staff

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

                         Administrative Support

                             Kevin Johnson
                       Carole Geagley (Minority)


                            C O N T E N T S

                              ----------                              

                       Tuesday, February 29, 2000

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

                        Thursday, March 30, 2000

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

                       NONDEPARTMENTAL WITNESSES

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



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

                              ----------                              


                       TUESDAY, FEBRUARY 29, 2000

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

                          DEPARTMENT OF LABOR

                        Office of the Secretary

STATEMENT OF ALEXIS M. HERMAN, SECRETARY


               OPENING STATEMENT OF SENATOR ARLEN SPECTER


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


                OPENING STATEMENT OF SENATOR TOM HARKIN


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


                           PREPARED STATEMENT


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

                Prepared Statement of Senator Tom Harkin

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

               SUMMARY STATEMENT OF HON. ALEXIS M. HERMAN

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

                           PREPARED STATEMENT

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

                 Prepared Statement of Alexis M. Herman

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

     HELPING WORKING FAMILIES AT A TIME OF UNPRECEDENTED PROSPERITY

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

                         THREE STRATEGIC GOALS

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

                          A PREPARED WORKFORCE

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

Youth opportunity movement

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

Youth opportunity grants

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

Responsible reintegration for young offenders

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

Safe schools/healthy students

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

Job Corps

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

Universal reemployment

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

Fathers work/families win

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

Disability initiatives

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

                       HOMELESS VETERANS PROGRAMS

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

Economic indicators

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

                           A SECURE WORKFORCE

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

                           QUALITY WORKPLACES

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

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

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

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

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

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

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

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

                               CONCLUSION

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

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                        Office of the Secretary

STATEMENT OF HON. DONNA SHALALA, SECRETARY

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

                           PREPARED STATEMENT

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

                Prepared Statement of Hon. Donna Shalala

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

                          A PROUD HISTORY. . .

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

                     EXPANDED HEALTH CARE COVERAGE

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

Expanding coverage under Medicaid and SCHIP

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

Increasing access to health care for uninsured individuals

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

Long-term care

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

Nursing home quality initiative

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

               RENEWED SUPPORT FOR CHILDREN AND FAMILIES

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

                HHS YOUTH VIOLENCE PREVENTION ACTIVITIES

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

Expanding substance abuse activities

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

Improving mental health services

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

Enhancing head start

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

Increasing parental responsibility through child support enforcement

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

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

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

Advancing innovative treatments for asthma

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

                     GREATER SCIENTIFIC ADVANCEMENT

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

Investing in biomedical research

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

Using science to improve quality of care and reduce medical errors

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

Food safety initiative

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

                      CREATING A HEALTHIER AMERICA

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

HIV prevention initiative

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

Ryan White

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

Family planning

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

Preventing emerging infectious diseases

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

Combating bioterrorism

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

Investing in HHS laboratory and health infrastructure

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

               RIGOROUSLY EVALUATING PROGRAM PERFORMANCE

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

                     A ROAD MAP TO A BETTER AMERICA

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

                        FISCAL MANAGEMENT AT CDC

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

                        DEPARTMENT OF EDUCATION

                        Office of the Secretary

STATEMENT OF HON. RICHARD W. RILEY, SECRETARY

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

                      STATE OF AMERICAN EDUCATION

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

                     THE GOOD NEWS ABOUT EDUCATION

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

                 DEPARTMENT OF EDUCATION BUDGET REQUEST

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

                   TEACHER RECRUITMENT AND RETENTION

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

                21ST CENTURY COMMUNITY LEARNING CENTERS

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

                      SCHOOL SAFETY AND DISCIPLINE

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

           SMALL, SAFE AND SUCCESSFUL HIGH SCHOOLS INITIATIVE

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

                SAFE SCHOOLS/HEALTHY STUDENTS INITIATIVE

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

                  CHILDREN'S HEALTH INSURANCE PROGRAM

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

               SAFE AND DRUG-FREE SCHOOLS AND COMMUNITIES

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

                          SCHOOL MODERNIZATION

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

                        PELL GRANT MAXIMUM AWARD

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

                     COLLEGE OPPORTUNITIES TAX CUT

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

                           PREPARED STATEMENT

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

              Prepared Statement of Hon. Richard W. Riley

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

                        INCREASED ACCOUNTABILITY

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

                    IMPROVING LOW-PERFORMING SCHOOLS

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

                        MODERNIZING OUR SCHOOLS

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

                          MASTERING THE BASICS

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

                       IMPROVING TEACHER QUALITY

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

                        NEW PATHWAYS TO COLLEGE

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

                     MAKING COLLEGE MORE AFFORDABLE

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

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

                Opening Statement of Senator Ted Stevens

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

                 Importance of Technology in Education

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

                        Long-distance education

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

                 Balance budget request with resources

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

                           PREPARED STATEMENT

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

               Prepared Statement of Senator Ted Stevens

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

               TRANSPORTATION FUNDING FOR WELFARE WORKERS

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

                              BIOTERRORISM

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

               MEETING DIVERSE NEEDS OF SCHOOL DISTRICTS

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

                      PREVENTION OF UOUTH VIOLENCE

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

              MASS MEDIA ENTERTAINMENT AND YOUTH VIOLENCE

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

                 PENSIONS PAID VIA LUMP SUM VS. ANNUITY

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

                     CDC'S BUILDINGS AND FACILITIES

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

                       CLINICAL TRIALS DATA BASE

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

             Prepared Statement of Senator Dianne Feinstein

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

                               EDUCATION

California's needs

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

Fiscal year 2001 education budget

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

Head Start

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

Impact aid

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

Immigrant education

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

                               CHILD CARE

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

                              HEALTH CARE

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

            NATIONAL INSTITUTES OF HEALTH

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

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

                               HEAD START

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

              COGNITIVE SKILLS AND STANDARDS IN HEAD START

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

                  CUSTOMER SATISFACTION IN HEAD START

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

            SHOULD HEAD START BE TRANSFERRED FROM HHS TO ED?

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

              FOCUS ON COGNITIVE SKILLS IN EARLY CHILDHOOD

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

              HHS AND EDUCATION COORDINATION ON HEAD START

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

                               HEAD START

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

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

                     HEAD START STAFF SALARY LEVELS

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

               OPENING STATEMENT OF SENATOR PATTY MURRAY

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

                      CLASS SIZE REDUCTION FUNDING

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

                   ROLE OF FEDERAL EDUCATION PROGRAMS

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

               CLASS SIZE REDUCTION--USE OF PROGRAM FUNDS

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

                     CLASS SIZE AND SCHOOL VIOLENCE

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

              EDUCATIONAL TRAINING AND WELFARE RECIPIENTS

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

                    DR. WILLIAM BELLINI'S STATEMENT

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

                     QUOTE FROM THE WASHINGTON POST

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

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

                               OIG REPORT

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

                        DELTA REGIONAL AUTHORITY

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

                RURAL HEALTH CENTERS IN THE DELTA REGION

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

            YOUTH SAFETY AND HEALTH QUESTIONS FOR THE RECORD

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

                    STEM CELL RESEARCH AND DIABETES

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

               Prepared Statement of Senator Slade Gorton

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

                     ADDITIONAL COMMITTEE QUESTIONS

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

                          DEPARTMENT OF LABOR

          Question Submitted by Senator Kaye Bailey Hutchison

                          BONUS INCENTIVE ACT

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

                NATIONAL MINE SAFETY AND HEALTH ACADEMY

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

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

                             CONVENTION 176

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

           WORKER ADJUSTMENT AND RETRAINING NOTIFICATION ACT

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

                    WORKFORCE INVESTMENT ACT IMPACT

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

                     TRAVELING SALES CREW INDUSTRY

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

           JOB TRAINING HIGHLIGHTS OF THE 2001 BUDGET REQUEST

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

                               PAY EQUITY

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

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

              Questions Submitted by Senator Arlen Specter

           LOW INCOME HOME ENERGY ASSISTANCE PROGRAM (LIHEAP)

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

                             WORKER HEALTH

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

                  HEALTH CARE ACCESS FOR THE UNINSURED

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

                        FAMILY CAREGIVER PROGRAM

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

                             MEDICAL ERRORS

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

                             YOUTH VIOLENCE

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

          MEDICARE COVERAGE OF INJECTABLE DRUGS AND BIOLOGICS

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

                       LIVER ALLOCATION POLICIES

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

                         HEALTH CENTERS WAIVERS

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

                      BATTERED WOMEN AND CHILDREN

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

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

                               CHILD CARE

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

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

                           STATUS OF REPORTS

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

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

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

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

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

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

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

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

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

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

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

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

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

                INTERNATIONAL CONFERENCE ON RURAL AGING

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

                        OBESITY IN WEST VIRGINIA

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

              MEDICARE REIMBURSEMENT OF AMBULANCE SERVICES

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

                               HEAD START

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

                             IMMUNIZATIONS

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

                                HIV/AIDS

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

                                 BIDIS

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

                             NIH SALARY CAP

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

      STATE CHILDREN'S HEALTH INSURANCE PROGRAM (SCHIP) ENROLLMENT

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

        REPORTS REQUESTED IN LAST YEAR'S APPROPRIATIONS LANGUAGE

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

                     INDIAN HEALTH SERVICE FUNDING

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

                        CLINICAL TRIALS DATABASE

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

                           CANCER REGISTRIES

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

                 CANCER AND ENVIRONMENTAL RISK FACTORS

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

                   HEALTH STATUS OF AMERICAN INDIANS

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

                               HANTAVIRUS

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

                         INDIAN HEALTH RESEARCH

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

                      INDIAN HEALTH SERVICE BUDGET

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

                         INDIAN HEALTH RESEARCH

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

     NATIONAL INSTITUTES OF HEALTH/DEPARTMENT OF ENERGY PARTNERSHIP

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

                                DIABETES

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

                               NIH BUDGET

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

                               NIH BUDGET

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

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

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

                        DEPARTMENT OF EDUCATION

              Questions Submitted by Senator Arlen Specter

                          CLASS SIZE REDUCTION

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

              FLEXIBILITY IN CLASS SIZE REDUCTION PROGRAM

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

                          SCHOOL CONSTRUCTION

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

                FEDERAL SHARE OF SPECIAL EDUCATION COSTS

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

       TEACHER RECRUITMENT AND PROFESSIONAL DEVELOPMENT PROGRAMS

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

 PROFESSIONAL DEVELOPMENT PROGRAMS AND EARLY INTERVENTION ADDRESS THE 
                            ACHIEVEMENT GAP

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

  IMPLEMENTATION OF TEACHER RECRUITMENT AND PROFESSIONAL DEVELOPMENT 
                                PROGRAMS

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

                    EDUCATION FOR INCARCERATED YOUTH

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

                   12-MONTH WORKING YEAR FOR TEACHERS

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

                       YOUTH VIOLENCE PREVENTION

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

           VOLUNTARY SINGLE-SEX SCHOOL AND CLASSROOM PROGRAMS

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

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

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

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

   IMPACT AID FUNDING AND THE ADMINISTRATION'S CONSTRUCTION PROPOSAL

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

           FLEXIBILITY OF BLOCK GRANTS OVER TARGETED PROGRAMS

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

                     TURNING AROUND FAILING SCHOOLS

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

              CLASS SIZE REDUCTION PROGRAM--TEACHERS HIRED

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

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

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

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

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

                       EDUCATIONAL TAX INCENTIVES

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

                        BYRD SCHOLARSHIP PROGRAM

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

DEPARTMENT OF EDUCATION EXPENDITURES FOR NEEDS-BASED STUDENT FINANCIAL 
                               ASSISTANCE

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

Obligations in the SFA Account in Fiscal Year 1999

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

DEPARTMENT OF EDUCATION EXPENDITURES FOR MERIT-BASED STUDENT FINANCIAL 
                               ASSISTANCE

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

          REWARDING EXCELLENCE IN STUDENT FINANCIAL ASSISTANCE

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

                          SCHOOL CONSTRUCTION

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

    TEACHER CERTIFICATION--NATIONAL BOARD FOR PROFESSIONAL TEACHING 
                               STANDARDS

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

               DEPARTMENTAL RESPONSE TO TEACHER SHORTAGES

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

 RECOGNIZING HIGHER EDUCATION INSTITUTIONS WITH EFFECTIVE ALCOHOL AND 
                        DRUG PREVENTION PROGRAMS

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

                         TITLE I HOLD HARMLESS

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

 STRENGTHENING TITLE I ACCOUNTABILITY PROVISIONS TO INCREASE ACADEMIC 
                              ACHIEVEMENT

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

      REAUTHORIZATION PROPOSAL TO INCREASE TITLE I ACCOUNTABILITY

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

                       IMMIGRANT EDUCATION FUNDS

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

              FLEXIBILITY OF CLASS-SIZE REDUCTION PROGRAM

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

                        REDUCTION IN IMPACT AID

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

                PAYMENTS FOR HEAVILY IMPACTED DISTRICTS

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

                           HEAD START PROGRAM

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

                 HHS AND ED COORDINATION ON HEAD START

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

          TEACHING OF COGNITIVE SKILLS IN HEAD START PROGRAMS

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

                   HEAD START PROGRAM STAFF SALARIES

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

                          SUBCOMMITTEE RECESS

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


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

                              ----------                              


                        THURSDAY, MARCH 30, 2000

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

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                     National Institutes of Health

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

               OPENING STATEMENT OF SENATOR ARLEN SPECTER

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

              SUMMARY STATEMENT OF DR. RUTH L. KIRSHSTEIN

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

                          PREPARED STATEMENTS

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

             Prepared Statement of Dr. Ruth L. Kirschstein

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

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

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

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

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

Realizing the Potential of the fiscal year 2001 Budget Request

    Generous increases in the last two budget cycles have allowed the 
NIH to begin many new programs. The funds requested for fiscal year 
2001 will advance these programs and, with sound management, allow us 
to begin new ones. To ensure that NIH can support new initiatives that 
offer the most promise of expanding knowledge and improving health, and 
to ensure our ability to support a healthy number of new and young 
investigators, we will limit growth in commitments and in the size of 
awards to a two percent average increase for new and continuing grant 
awards. In addition to initiatives on mental health, cancer, and 
diabetes, new activities include:
    Clinical Research.--To take full advantage of rapid research 
advances in the last five years, which have provided abundant new 
therapies to study, the NIH will begin a series of programs to expand 
clinical research. Career development programs will continue to improve 
the number and quality of investigators. We will start new pilot and 
early-phase clinical trials thereby speeding the testing of new 
therapies. We will develop new, and expand older, networks for multi-
center studies of pediatric cardiovascular disease, diabetes, digestive 
diseases, and treatment for drug abuse. We will establish new multi-
center clinical trials to evaluate complementary and alternative 
medical practices for insomnia, pain relief, and liver diseases. 
Moreover, the public will have greater access to new information on an 
expanded national clinical trials database (ClinicalTrials.gov) to be 
launched soon . It will carry information on the many clinical trials 
funded by the NIH, by other federal agencies, and by industry.
    Health Disparities.--The NIH has a central role to play in 
eliminating persistent, even increasing, health disparities through 
medical research, research training, and dissemination of 
scientifically sound medical information. In fiscal year 2001, the NIH 
will continue to invest in this area, allocating $20 million to 
establish a new Coordinating Center for Research on Health Disparities 
within the Office of the NIH Director. A new trans-NIH Working Group 
will develop a strategic plan to eliminate or reduce health disparities 
among different segments of the American population. The plan, will 
include goals, timetables, and mechanisms for tracking budgets and 
accomplishments.
    Genetic Medicine.--Last November, the Human Genome project finished 
sequencing one billion of the estimated three billion base pairs of 
human DNA and deposited them in GenBank, NIH's public database, thus 
putting us on schedule to have a working draft of the full human genome 
by this spring. Scientists can use this information to find the genes 
involved, e.g., in heart diseases, cancer, epilepsy, Alzheimer's, and 
psychiatric disorders. Companion activities, like developing genomic 
resources for organisms such as mice, rats, and fruit flies, will help 
speed the arrival of more precise medical interventions. We are rapidly 
moving to a time when diagnosis, treatment and even prevention will 
depend on a precise understanding of the genetic makeup of an 
individual.
    Neurosciences.--This is a particularly exciting time for expansion 
of research in fields of neuroscience, such as neurogenetics and 
imaging. To foster collaboration and sharing of ideas among the many 
Institutes which support intramural research in this area, we are 
requesting funds for construction of a facility for the new National 
Neuroscience Research Center to house outstanding trans-NIH 
neuroscience research programs. A total of $73 million is requested 
over two years, with $47 advance for fiscal year 2002.
    Other Sciences, Including Biomedical Computing.--Many medical 
advances build on the knowledge and technology of other scientific 
disciplines. To exploit our new understanding of biological processes, 
we need new teams of diverse and skilled researchers to overcome 
complex technological and research problems. In fiscal year 2001, NIH 
will establish an Office of Bioengineering and Bioimaging to help the 
Institutes and Centers set priorities in these areas of science and to 
enhance collaboration with other agencies.
    Based on a report by outside experts, NIH has developed the 
Biomedical Information Science and Technology Initiative to work toward 
an intellectual fusion of biomedicine and information technology. In 
fiscal year 2001, the NIH plans to provide the infrastructure to train 
the next generation of interdisciplinary scientists, to develop new 
means for storing, managing, and accessing vast data collections, and 
to enhance basic research in biomedical computing.
    Mr. Chairman, that concludes my opening statement. I will be glad 
to respond to any questions.
                                 ______
                                 
               Prepared Statement of Dr. Yvonne T. Maddox

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

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

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

                    THE OFFICE OF DISEASE PREVENTION

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

         THE OFFICE OF BEHAVIORAL AND SOCIAL SCIENCES RESEARCH

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

                THE OFFICE OF RESEARCH ON WOMEN'S HEALTH

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

                          OTHER OD ACTIVITIES

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

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

                          THE BURDEN OF CANCER

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

                       PROGRESS IN BASIC RESEARCH

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

               NEW APPROACHES TO DETECTION AND DIAGNOSIS

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

                             IMAGING CANCER

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

      MOLECULAR TARGETS--NEW APPROACHES TO PREVENTION & TREATMENT

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

        CLINICAL TRIALS--A CORNERSTONE OF PROGRESS FOR PATIENTS

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

                 QUALITY CANCER CARE--A RESEARCH AGENDA

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

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

                     PROGRAMS FOR GENOMIC ANALYSIS

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

                 PROGRAMS OF EXCELLENCE IN GENE THERAPY

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

                   USING MRI TO DIAGNOSE HEART ATTACK

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

                       CLINICAL RESEARCH NETWORKS

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

                    FOCUS ON THE INDIVIDUAL PATIENT

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

                     ADDRESSING HEALTH DISPARITIES

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

                           NEUROFIBROMATOSIS

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

                          PRESIDENT'S REQUEST

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

                 GOVERNMENT PERFORMANCE AND RESULTS ACT

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

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

               DISCOVERING SOLUTIONS TO COMPLEX PROBLEMS

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

        BURDEN OF DENTAL AND CRANIOFACIAL DISEASES AND DISORDERS

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

              GENE DISCOVERIES: THE RAPID RATE OF PROGRESS

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

               ORAL INFECTION LINKED TO SYSTEMIC DISEASE

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

                  GENES OF INFLAMMATION AND TOOTH LOSS

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

                       GENETICS OF TOOTH AGENESIS

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

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

                        POWERFUL RESEARCH TOOLS

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

           RESEARCH ADVANCES: PKD, HEPATITIS C, AND DIABETES

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

                         FUTURE RESEARCH PLANS

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

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

                   USES OF FISCAL YEAR 2000 INCREASE

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

                        A HEALTHY BRAIN FOR LIFE

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

                HALTING THE PROCESS OF NEURODEGENERATION

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

                  REPAIRING THE INJURED NERVOUS SYSTEM

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

                      REDUCING HEALTH DISPARITIES

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

                WORKING TOGETHER TO FIGHT BRAIN DISEASE

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

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

                             GLOBAL HEALTH

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

           INFECTIOUS DISEASES: CHALLENGES AND OPPORTUNITIES

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

                    THE PROMISE OF PATHOGEN GENOMICS

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

                          VACCINE DEVELOPMENT

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

               ACQUIRED IMMUNE DEFICIENCY SYNDROME (AIDS)

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

                        IMMUNE-MEDIATED DISEASES

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

                     ADDRESSING HEALTH DISPARITIES

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

                               CONCLUSION

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

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

                 SNAPSHOT OF THE CELL'S PROTEIN FACTORY

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

                           MAJOR INITIATIVES

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

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

                           MENTAL RETARDATION

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

                           HEALTH DISPARITIES

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

                              HIV RESEARCH

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

                    PEDIATRIC TRAUMA REHABILITATION

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

                          BEHAVIORAL RESEARCH

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

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

                     THIRTY YEARS OF ACCOMPLISHMENT

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

                               LOW VISION

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

                         TRANSLATIONAL RESEARCH

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

                       VISUAL HEALTH DISPARITIES

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

                  FUTURE DIRECTION OF VISION RESEARCH

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

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

                      HIGH THROUGHPUT TECHNOLOGIES

    In my testimony before this Committee in 1997, I updated you on our 
efforts to develop and validate high throughput technologies for 
carcinogenicity and toxicity testing, including transgenic animal 
models. Today, I am pleased to report that because of our leadership in 
this area of research, transgenic animal models, as a tool to study 
chemical carcinogenesis, is the subject of intense research. In fact, a 
recent paper used one of these models to successfully assess chemical 
carcinogenesis in vascular tissue. The hope is that such animal models 
can be used in a carcinogenicity testing strategy, potentially reducing 
our dependence on the conventional two-year rodent bioassay. The 
transgenic bioassays use fewer animals, cost less, and take less time 
because of their increased sensitivity to carcinogens and low incidence 
of spontaneous tumors. While I am optimistic that transgenic animals 
will be validated for assessment of carcinogenic or toxic potential of 
chemicals, we have already initiated efforts to develop the second 
generation of alternative test systems based on differential gene 
expression. Given that gene expression is continuously modulated by 
environmental cues, exposure to toxic agents can be expected to elicit 
unique patterns of gene expression. Thus, DNA microarray technology, 
which can monitor gene expression, could be a sensitive tool to assess 
toxicity. The assumption is that toxic exposures are likely to evoke 
quantitative and qualitative changes in gene expression. Therefore, 
this technology should allow toxicologists to expose cells or tissues 
to chemicals whose toxicity is unknown and match the results against 
the ``signature,'' or common set of changes in gene expression, 
produced by a known class of toxicants. This would reduce the need for 
lengthy and expensive rodent bioassays (conventional and transgenic) 
and would lend itself to testing at low doses and to automation. Today, 
I want to announce our intent to establish a DNA Microarray Resource 
Center to develop and distribute so-called ``Tox-Chips'' containing 
candidate genes--genes known to be involved in cell growth and 
proliferation and in the biotransformation of environmental carcinogens 
or toxin--derived from human, mouse and other animal sources. This 
approach to developing and applying this new technology to the field of 
toxicology will ensure that all investigators will have access to this 
expensive resource and that the products are the highest quality.
               susceptibility to environmental toxicants
    It is well known that most smokers do not develop lung cancer and 
most women exposed in utero to diethylstilbestrol never develop vaginal 
and cervical cancer. A common question asked of physicians is, ``Why 
me, Doc?'' One answer to this question is that genetically-determined 
differences in susceptibility are at least partly responsible.
    Significant advances in our understanding of human genetics have 
shown that specific genes play key roles in disease susceptibility. For 
example, mutations in BRCA1, P53, XPB, and ATM are predisposing for 
breast cancer, Li-Fraumeni syndrome, xeroderma pigmentosum, and ataxia 
telangiectasia, respectively. Thus, it is reasonable to expect that 
several of the genetic alterations in other genes will also have a 
significant influence on disease susceptibility. With rapid advances in 
cloning and sequencing of the human genome, it is now possible to 
identify the genetic alterations responsible for differences in 
susceptibility. The ``sequence'' of the entire human genome will be 
elucidated within the next 12 months. However, the order of the bases 
in the human genome is not one sequence but rather many variations of a 
common theme. In fact, sequence variation is ubiquitous in human 
populations; what differs is the frequencies of these variations.
    Susceptibility also is influenced by the timing of exposure, the 
gender and behavior of the individual, the nutritional state and 
socioeconomic status. For example, exposure during rapid or critical 
stages of development of the various organ systems such as embryonic 
development, adolescence, puberty and old age, is likely to be an 
important factor in disease development. We currently have little 
information to guide decision-making with respect to these issues since 
most toxicologic assessments have been done in adults, both animals and 
humans, under otherwise optimal conditions.
    To investigate the genetic basis for differences in predisposition 
to disease, NIEHS extended the domain of genomic mapping and sequencing 
to address the challenge of genetic diversity. The Environmental Genome 
Project, initiated two years ago, seeks to identify genetic changes 
that increase risk for disease development, and the results from these 
studies will have profound implications for the practice of medicine 
and environmental health risk assessment. The challenge will be to 
create a repository of all common variants--a diversity map--and 
correlate them with specific environmental exposures and disease 
phenotypes through functional and epidemiologic studies.
    Today, I am announcing our intent to support the development of 
Comparative Mouse Genomics Centers that will make use of all available 
DNA sequence variation data to produce novel transgenic and knockout 
mouse models which will mirror specific variants of human 
environmentally responsive genes found in the general population. The 
Mouse Genomics Centers will bring together a team of investigators to 
develop mouse models of environmentally relevant human diseases, 
provide a comprehensive analysis of their phenotype and genotype, and 
validate them for their use by the research community. The new models 
produced by the Centers will then be used by the scientific community 
to study diseases resulting from specific insults, including exposure 
to environmental agents, viruses, nutritional factors, pharmacological 
drugs, and other physical and chemical stresses.
    It is important to emphasize that susceptibilities modify risk 
rather than cause disease. This ``gene-hunt'' and ``mouse-model'' 
development exercise could have profound implications for risk 
assessment in terms of setting standards for environmental exposures. 
Data on the prevalence of susceptibility genes could take the guesswork 
out of environmental decision-making with respect to susceptible 
populations. These studies challenge a fundamental tenet of toxicology; 
that is, that the dose makes the poison. We now know that it is the 
host, plus the dose and the time of exposure, that makes the poison.
                          exposure assessment
    Exposure monitoring is a ``right-to-know'' issue for citizens who 
are involuntarily exposed to environmental pollutants. However, little 
is known about actual human exposure and body burdens of environmental 
pollutants. This knowledge gap hampers regulatory decision-making and 
introduces uncertainties in setting exposure limits. It also limits our 
capacity to develop effective prevention strategies. Exposure is 
typically estimated using indirect surrogates of environmental quality 
such as toxic release and production inventories and environmental 
monitoring. Individual exposure, though, is highly variable and is a 
function of individual uptake, metabolism, excretion and behavior. So 
the assumption that everyone living in the same geographic area have 
similar exposure is seriously flawed. What we need are direct measures 
of exposure based on tissue analysis or deposition. Simple monitoring 
of levels of chemicals in the environment does not necessarily reflect 
amounts taken up and deposited in tissues.
    Exposure assessment is emerging as a scientific field due to the 
revolutionary advances in genetics, molecular imaging, molecular 
biology, and microenvironmental and personal measurement technology. As 
these technologies become more robust, sensitive and inexpensive, they 
will provide the scientific foundation for the quantitative assessment 
of human health risk. Exposure analysis provides the long-awaited 
connection between toxicology and epidemiology, and will provide the 
basis for hypothesis-driven research and examination of exposure-
disease relationships.
    Several public health areas will benefit from improvements in 
exposure assessment. The absence of adequate exposure data restricts 
our ability to (1) evaluate low-dose effects of exposure to chemicals 
encountered in the home, workplace and general environment, (2) 
identify at-risk populations based on age (e.g., children), genetic 
susceptibility and socioeconomic status, (3) design studies to 
efficiently evaluate exposure/response relationships, (4) make full use 
of the human genome effort for studying gene/environment interactions, 
and (5) to link exposure to human diseases.
    In September 1999, the NIEHS and the American Industrial Health 
Council co-sponsored an interagency workshop on ``The Role of Human 
Exposure Assessment in the Prevention of Human Disease.'' With more 
than 400 participants, the three-day workshop represented experts from 
the various federal agencies, public interest groups, academia, and 
industry. Participants considered the workshop a landmark event in the 
field of exposure assessment in that it provided the vision and 
enthusiasm for moving the field of exposure assessment away from solely 
an applied discipline to one in which hypothesis-driven research can 
effectively connect technological advances to public health problems 
and controversies. Since the workshop, NIEHS has developed a 
collaborative relationship with the National Center for Health 
Statistics and the U.S. Geological Survey to develop a population-based 
geographical information system and disease prevalence maps.
    In conclusion, the power of the science base for environmental 
health decision-making can now be transformed at a pace that could not 
have been foreseen a decade ago by even the most astute visionaries. 
The scientific opportunities presented here develop an entirely new 
framework to understand how environmental exposures affect human 
health.
                                 ______
                                 
               Prepared Statement of Dr. Richard J. Hodes
    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's non-AIDS budget request for the National Institute on 
Aging (NIA) for fiscal year 2001, a sum of $721,651,000, which reflects 
an increase of $37,933,000 over the comparable fiscal year 2000 
appropriation. Including the estimated allocation for AIDS, total 
support requested for the National Institute on Aging is $725,949,000, 
an increase of $38,088,000 over the fiscal year 2000 appropriation. 
Funds for NIA efforts in AIDS research are included within the Office 
of AIDS Research budget request.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
Prominent in the performance data is NIH's first performance report 
which compares our fiscal year 1999 results to the goals in our fiscal 
year 1999 performance plan. As our performance measures mature and 
performance trends emerge, the GPRA data will serve as indicators to 
support the identification of strategies and objectives to continuously 
improve programs across the NIH and the Department.
    Since the NIA's inception in 1974, tremendous strides have been 
made in uncovering the mysteries of the aging process, reducing disease 
and disability, and improving the quality of life for older Americans. 
The pace of scientific discovery has been impressive, and the Institute 
anticipates building upon these advances in the future. I am pleased to 
report the NIA's recent progress, in reducing disability and extending 
healthy active years of life for all Americans.
                      alzheimer's disease research
    Alzheimer's disease (AD), the most common cause of dementia, is the 
result of abnormal changes in the brain that lead to a devastating 
decline in intellectual abilities and changes in behavior and 
personality. Tragically, as many as four million Americans \1\ now 
suffer from Alzheimer's disease--a number that threatens to increase 
dramatically as the population of people most at risk for dementia, 
those aged 85 and older, reaches almost 20 million by the middle of the 
21st century.\2\ NIA, as the lead Federal agency responsible for 
Alzheimer's disease research, recognizes the urgency of this looming 
public health threat and is supporting basic, clinical, and behavioral 
research to improve AD diagnosis, treatment, and patient care, and to 
delay, and eventually prevent, the onset of this devastating disease. 
Advances in our understanding of AD over the last 20 years have been 
substantial, enabling the NIA to launch the Alzheimer's Disease 
Prevention Initiative. In collaboration with other Federal agencies and 
the private sector, the AD Prevention Initiative is invigorating 
discovery of new treatments, risk and preventative factors, methods of 
early detection and diagnosis; and strategies for improving patient 
care and alleviating caregiver burdens. The initiative is also 
accelerating movement of promising new treatments and prevention 
strategies into clinical trials, and is improving understanding of 
normal brain function.
---------------------------------------------------------------------------
    \1\ Small, GW, Rabine, Barry, PV, Barry, PP, et. al. Diagnosis and 
Treatment of Alzheimer's Disease and Related Disorders. JAMA 16: 1363-
1371, 1997.
    \2\ Bureau of the Census, Middle Series Projections, 1996.
---------------------------------------------------------------------------
    In 1999, the NIA launched the first large-scale AD prevention 
clinical trial supported by the NIH, the Memory Impairment Study (MIS), 
being conducted at more than 65 medical research institutions in North 
America. In this trial, vitamin E, and donepezil (Aricept) will be 
evaluated over a three-year period for their effectiveness in slowing 
or stopping the conversion from mild cognitive impairment (MCI), a 
condition characterized by a memory deficit without dementia, to AD. 
Other ongoing or upcoming AD prevention trials will examine the 
effectiveness of ibuprofen (an anti-inflammatory drug) in reducing the 
development of AD; the effect of estrogen replacement therapy in 
preventing AD in women with a family history of the disease; and 
whether treatment with a variety of agents, such as aspirin, vitamin E, 
antioxidants, or combined folate/B6/B12 supplementation can prevent AD. 
The effects of these agents on normal age-related decline will also be 
evaluated. Information about ongoing clinical trials is available to 
the public through the NIA-supported Alzheimer's Disease Education and 
Referral Center web site (www.alzheimers.org) and toll-free number (1-
800-438-4380).
    The ability to assess the effectiveness of early treatments or 
interventions, such as those being tested in the AD Prevention 
Initiative, will be enhanced by our ability to visualize brain function 
using new imaging techniques. In a recent study, investigators used 
magnetic resonance imaging (MRI) to determine volume measurements of 
the hippocampus, the region of the brain responsible for memory 
function, in individuals diagnosed with mild cognitive impairment 
(Chart #1). Based on three years of observations, researchers found 
that in older people with MCI, the smaller the hippocampus at the 
beginning of the study, the greater the risk of developing AD later. 
This imaging study illustrates how abnormal cerebral function or 
anatomy can be detected before clinical diagnosis and how diagnostic 
advances can help ensure the effective application of emerging early 
interventions. Advances in imaging techniques also have important 
diagnostic implications for other neurodegenerative diseases, such as 
Parkinson's disease.
    Developing effective treatments for AD based on advances in basic 
research is a major focus of NIA-supported studies. The ability of 
researchers to conceptualize effective treatments was enhanced by the 
discovery of two enzymes, beta and gamma secretase, that are involved 
in the clipping of a normal cell surface protein to produce the amyloid 
peptide that forms the senile plaques found in the brains of AD 
patients (Chart #2). Identifying and understanding how these two 
enzymes work will accelerate the development of interventions to block 
their action and stop the development of AD plaques. NIA will also 
support research to evaluate the potential of an immunization approach 
recently developed by researchers in the private sector, which, in 
mice, prevented the formation of amyloid plaques associated with AD.
    A transgenic mouse strain that expresses a human tau gene and 
develops AD-like tau tangles has been developed. This model will help 
scientists understand how tau produces AD in the brain, and together 
with other AD models, will move researchers closer to developing 
effective preventive or treatment interventions. In another study, 
researchers demonstrated that shrinkage and dysfunction of certain 
brain cells that occur with age might be reversible. Researchers 
inserted into skin cells a gene that makes human nerve growth factor 
(NGF) and then injected the modified cells into the brains of 
experimental animals. After three months, the older animals injected 
with NGF-expressing cells had brains that resembled those of younger 
animals. Such gene transfer approaches to recovering cellular function 
could eventually have important implications for the treatment of AD 
and other chronic age-related neurodegenerative disorders in humans.
                            biology of aging
    Research on the biology of aging has led to a revolution in 
understanding the cellular and molecular changes that occur with aging 
and the abnormal changes that are risk factors for or accompany age-
related diseases. Further, research is revealing genetic and other 
biologic factors associated with extended longevity in animal models, 
contributing to the development of interventions to reduce or delay 
age-related degenerative processes in humans. Presently, caloric 
restriction is the only intervention known to slow the intrinsic rate 
of aging in mammals. Rodents and other laboratory animals that are 
given a diet that includes necessary nutrients, but 30 to 40 percent 
fewer calories than in usual diets, live far beyond their normal life 
spans and have reduced rates and later onset of diseases. A recent 
study analyzed the gene expression profiles of cells from young and 
from old mice on usual or calorically restricted diets. Of the 6,347 
genes surveyed by new micro-array techniques, fewer than one percent 
displayed a greater than twofold decrease in expression. Thus, the 
aging process may be associated with changes in expression of a limited 
subset of genes, rather than involving widespread changes in most 
genes. It was further observed that caloric restriction completely or 
partially suppressed age-associated alterations in expression of a 
large proportion of genes. This type of molecular assessment of 
mammalian aging will provide new tools to evaluate experimental 
interventions for age-related conditions.
    Over the last ten years, numerous genes have been implicated in 
normal aging processes, in age-related pathologies and diseases, and in 
determination of longevity in several species including humans (Chart 
#3). Understanding the molecular genetics of aging and longevity is a 
rapidly advancing field; recent research advances have greatly expanded 
our knowledge of genes and biological pathways which play significant 
roles in determining longevity and health span. Recent discoveries in 
non-mammalian species including S. cerevisiae (yeast), C. elegans, 
(roundworms), and D. melanogaster, (fruit flies), have identified 
striking effects of mutations, either singly or in specific 
combinations, on lifespan, increasing life spans 2 to 3 times longer 
than those of (wild type) normally aged animals. These findings suggest 
signaling and metabolic pathways that may be critical in determining 
longevity. In addition, cross-species comparisons have identified 
homologous (similar) genes in animals and in humans that have similar 
or related functions. For example, mutations that double the life span 
of C. elegans occur in genes that are homologous to genes associated 
with insulin and glucose (sugar) metabolism in humans, and may 
therefore be relevant to weight control and diabetes.
                    reducing disease and disability
    Studies have shown that disability rates for people age 65 and 
older have been falling at an accelerating pace since 1982 and that the 
benefits of this trend extend to both men and women, and to minority 
groups. Initial field reports from the 1999 wave of the National Long-
Term Care Survey indicate that disability rates have continued to fall. 
These data parallel heartening news from investigators who found that 
many centenarians remain functionally independent for the vast majority 
of their lives. More research is needed to understand the genetic and 
environmental factors responsible for centenarians' prolonged good 
health and extreme longevity. Similarly, more research is necessary to 
understand the causes and economic consequences of the decline in 
disability rates and to further accelerate these improvements.
    Increasingly, researchers are understanding the benefits of 
exercise, especially for older people, as a key to preventing or 
delaying the onset of disease and disability. Specifically, studies 
have revealed that moderate physical activity can: reduce the risk of 
falls; benefit people suffering from a variety of ailments, including 
osteoarthritis and depression; and may enhance learning, memory and the 
generation of brain cells. There is also scientific evidence that 
exercise may be a factor related to increased life expectancy and the 
number of years people live free of disability. In a recent study, it 
was shown that becoming fit, even in later years (as measured by 
performance on an exercise treadmill test), is associated with lower 
mortality rates (Chart #4). The study, which included 9,000 men aged 20 
to 82, compared death rates in physically unfit men who remained unfit 
over five years with physically unfit men who became fit during the 
same period. The study found that unfit men aged 60 and over who became 
fit had death rates 50 percent lower than those who remained unfit. In 
another clinical trial involving chronically ill older adults, aged 70 
and older, researchers reported that one year of increased physical 
activity, combined with chronic-illness self-management resulted in 
fewer reported hospitalizations and total hospital days. These studies 
show that exercise can benefit older people and that it is never too 
late to start. The challenge remains to motivate more people to engage 
in regular physical activity--particularly older women and minorities 
who, according to national surveys, are consistently less active. Last 
year, the National Institute on Aging published a free manual, 
Exercise: A Guide from the National Institute on Aging, the cornerstone 
of the Institute's ongoing campaign to encourage older people to 
exercise. The Guide is based on scientific evidence and is intended to 
help people design their own exercise program. To date, the Institute 
has distributed over 230,000 copies.
                      reducing health disparities
    Health disparities are associated with a broad, complex, and 
interrelated array of factors, including race, ethnicity, gender, 
socioeconomic status, age, education, occupation, and as yet unknown 
lifetime and lifestyle differences. Prevalence rates of specific 
diseases are also associated with race, ethnicity and socioeconomic 
status. One recent multi-ethnic epidemiologic study indicated that 
prevalence rates for Alzheimer's disease may be higher for African-
Americans and Hispanics. In an examination of genetic risk factors for 
AD, although APOE4 is associated with higher risk of AD among 
Caucasians, African Americans and Hispanic elders with the APOE4 allele 
were not at higher risk than those with other APOE alleles. 
Understanding the genetic and environmental risk factors contributing 
to this difference will be crucial to developing effective 
interventions to reducing the disparity.
    NIA has made reducing health disparities a major priority of its 
five-year strategic plan. Last year, with support from the NIH Office 
of Research on Minority Health, the NIA intramural program designed a 
mobile medical research vehicle to extend the opportunity to 
participate in the Baltimore Longitudinal Study of Aging and in other 
clinical research projects to minority and socioeconomically diverse 
subjects. The NIA, working with the National Advisory Council on Aging, 
also undertook a comprehensive review of its minority aging research 
activities and training initiatives. The NIA is developing an 
implementation plan to integrate the resulting recommendations into its 
programs, such as the Resource Centers for Minority Aging Research, 
which provide mentoring and training opportunities to individuals 
interested in studying the health of minority elders, and the 
Alzheimer's Disease Centers satellite clinics, which recruit minorities 
for research protocols conducted by the NIA's 28 AD centers.
    Investigators supported by the NIA continue to report exciting 
scientific advances that may help eliminate health disparities among 
groups of elders. Investigators recently published a study, which 
suggests that there is a difference between African-American and 
Caucasian women in their experience of peri-menopausal symptoms. 
African-American women were significantly more likely than white women 
(58 percent vs. 29 percent) to experience hot flashes, but fewer than 7 
percent had discussed menopausal management with their physicians. 
Given our developing understanding of hormone replacement therapy in 
controlling menopausal symptoms as well as in reducing risk of problems 
in later life, such as osteoporosis, improved, culturally-appropriate 
patient education programs should be encouraged.
    A decade ago, few interventions were available to address the major 
health concerns of older people. Entering the 21st century, the outlook 
has improved considerably. More interventions exist and research into 
treating, as well as preventing, the onset of age-related diseases is 
escalating. With the knowledge this research will derive, aging will be 
a healthier, more vigorous stage of life. I am happy to answer your 
questions.
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               Prepared Statement of Dr. Stephen I. Katz
    Mr. Chairman and Members of the Subcommittee: I am pleased to 
present the President's non-AIDS budget request for the NIAMS for 
fiscal year 2001, a sum of $363,479,000, which reflects an increase of 
$19,021,000 over the comparable fiscal year 2000 appropriation. 
Including the estimated allocation for AIDS, total support requested 
for the NIAMS is $368,712,000, an increase of $19,232,000 over the 
fiscal year 2000 appropriation. Funds for the NIAMS efforts in AIDS are 
included within the Office of AIDS Research budget request.
    I am honored to appear before this Subcommittee. I want to begin by 
providing a context for the research mission of our Institute. As the 
Director of the NIAMS, I am acutely aware that the every day life of 
the American people is enormously improved by the research that our 
Institute supports. Children on the playground, women and ethnic 
minorities who are disproportionately afflicted by the many diseases 
that affect their daily activities, adults in the work place, and 
elderly Americans striving to live independently--all have their lives 
enhanced or compromised by the health and functioning of their bones, 
joints, muscle, and skin. Ensuring improved quality of life and 
increased longevity of life for all Americans is our primary mission.
    I want to express my appreciation for the fiscal year 2000 
appropriation--the second year of an extraordinary budget that enabled 
us to invest in medical research with much more breadth and depth than 
ever before. I will share specific examples of ways in which we 
invested our budget over the last year and some of the research 
directions we are pursuing.
                           clinical research
    The focus of most of my remarks today will be on clinical research. 
While the backbone of medical science has been and will continue to be 
fundamental research on how the body functions, the ultimate goal of 
research supported by the NIH is improving public health. In order to 
achieve this, we must also serve as translators--translating the basic 
research findings from the laboratory to improving patient care at the 
bedside as well as utilizing the information learned at the patient 
bedside to inform more focused and sophisticated basic studies. This 
translation is the cornerstone of the research supported by the NIAMS.
    Highlights of particularly exciting and promising translational 
research on bones, joints, muscles and skin include the findings that 
lower doses of estrogen than we normally prescribe can be effective in 
preventing osteoporosis, that some of the new treatments for rheumatoid 
arthritis can be targeted directly at the disease-causing factors, that 
normal hair growth is controlled by genes that encode for proteins that 
may be excellent targets for new therapies, and that proteins that are 
essential for normal muscle formation can, in mouse models, be produced 
by injecting particular genes into the muscles that contain the 
defective proteins. These examples provide only a broad sample of some 
of the most recent findings from research studies that we have 
supported.
    The reality is that clinical research is vitally important, but is 
also very costly. The significant increase in our appropriation last 
year enabled us to launch a number of clinical initiatives in 
particularly challenging areas of health, including: (1) Pilot studies 
in rheumatic diseases and skin diseases--These studies include expanded 
research on some of the most difficult public health challenges such as 
leg ulcers, rheumatoid arthritis, scleroderma, lupus, spondylitis and 
others where new treatment approaches are needed. (2) Osteoporosis in 
men--A major clinical trial will determine the extent to which the risk 
of fracture in men is related to bone mass and structure, biochemistry, 
lifestyle, tendency to fall, and other factors. The study will also 
seek to determine if bone mass can be correlated with an increased risk 
of prostate cancer. (3) Combination therapies for osteoporosis--It is 
important to determine whether combinations of drugs, often produced by 
different pharmaceutical companies, will be more effective and have 
fewer side effects than any of the drugs used alone for osteoporosis. 
(4) Treatment of back pain--Back pain is very common and has a serious 
impact on people's personal and professional lives, and results in 
significant costs to businesses and the American economy. We have 
launched a major clinical trial studying surgical versus nonsurgical 
treatment of three different back disorders. We anticipate that this 
study will have a significant effect on clinical practice and the cost 
of medical services for people with any of these three back disorders. 
(5) The Spondylitis Consortium--The NIAMS has partnered with the 
American Spondylitis Association in establishing the North American 
Spondylitis Consortium to search for genes that determine 
susceptibility to ankylosing spondylitis, a painful inflammatory 
disease of the spine, also known as arthritis of the spine. and (6) 
Clinical research training and career development--Because we need to 
develop and maintain a pipeline of researchers who are training to 
plan, conduct, analyze, and disseminate the findings of clinical 
research, the NIAMS has enthusiastically embraced and participated in 
the NIH initiatives to develop and maintain careers in clinical 
research.
                              autoimmunity
    The NIAMS supports a broad and diverse portfolio of research on 
autoimmunity, including studies of rheumatoid arthritis, systemic lupus 
erythematosus, Sjogren's syndrome, scleroderma, alopecia areata, and 
many blistering skin diseases--all potentially devastating chronic 
diseases which exact a huge toll in human suffering and economic costs. 
The additional funds provided by Congress for the Autoimmunity 
Initiative last year provided the opportunity for the NIAMS to expand 
its research in the following key areas: (1) pilot trials on innovative 
therapies for rheumatoid arthritis and scleroderma; (2) target organ 
damage in autoimmune diseases, also focusing on scleroderma and 
rheumatoid arthritis; (3) autoimmune rat repository and transgenic 
resource--a national resource and development center for rat models of 
autoimmune disorders; (4) NIAMS patient data registries--in which 
information will be collected on neonatal lupus and on juvenile 
rheumatoid arthritis, with an expansion to include genetic studies; and 
(5) new imaging technologies for autoimmune diseases, through a project 
involving in vivo imaging of tiny blood vessels in animal models of 
rheumatoid arthritis.
                              fibromyalgia
    The NIAMS has a firm commitment to identifying the causes of 
fibromyalgia and improving the daily life of people affected by this 
debilitating disease, and we have a broad portfolio of research in this 
area. Last year the NIAMS as well as the NIDCR, NINDS, and the ORWH 
funded fifteen new clinical and basic research studies on fibromyalgia, 
and we are confident that these new studies will provide much-needed 
information on the causes of fibromyalgia as well as new strategies for 
treatments.
                            muscle diseases
    People affected by muscle diseases face profound changes and 
challenges in their every day lives. We now know that many of these 
diseases are caused by genetic mutations, and we are supporting 
research to further define these mutations and to overcome the current 
barriers to effective gene therapy of muscle diseases. We are 
optimistic that genetic manipulation of skeletal muscle will improve 
therapy for muscle diseases such as Duchenne muscular dystrophy and 
Facioscapulohumeral dystrophy. The Institute, in collaboration with the 
National Institute of Neurological Disorders and Stroke, is sponsoring 
workshops in both of these areas in May 2000 and we are looking forward 
to hearing recommendations from experts in these fields on research 
directions we could pursue in fiscal year 2001.
                             osteoarthritis
    As many Americans are well aware, osteoarthritis is the most common 
disease of joints. The NIAMS continues to support a substantial amount 
of research across the full spectrum of scientific approaches and 
strategies to understand this disease and improve life for affected 
people. In July 1999 we sponsored a major conference on osteoarthritis 
with the participation of leading experts in this field and many 
related fields. We used this opportunity to have a tandem educational 
meeting for patients whose daily lives are affected by osteoarthritis. 
We learned a great deal about the disease from both kinds of experts--
those doing research on osteoarthritis and those living with it. We are 
carefully considering the recommendations made from both sets of 
experts to strengthen our portfolio in osteoarthritis using the fiscal 
year 2001 appropriation, particularly in the area of prevention. The 
NIAMS is also partnering with our colleagues in the National Institute 
on Aging, the Food and Drug Administration, many pharmaceutical 
companies, and several professional and voluntary lay organizations to 
try to create a public-private partnership to identify biomarkers for 
osteoarthritis. Our goal is to support clinical and laboratory 
evaluations of biomarkers and imaging techniques as potential surrogate 
endpoints for clinical trials that would assess the efficacy of 
osteoarthritis disease-modifying interventions.
                              osteoporosis
    We have known for some time that osteoporosis has genetic 
components, but the genes that are actually associated with fractures 
themselves had not previously been identified. Scientists have found 
that older women who have the gene for apolipoprotein E, also known as 
APOE*4, are at increased risk for hip and wrist fractures. We know 
about this gene from other studies of its association with common, 
late-onset forms of Alzheimer's disease and with osteoporosis in 
patients on dialysis. This represents a promising area for further 
study in patients with osteoporosis as well as those with Alzheimer's 
disease, who are known to have a higher risk of hip fracture.
    In March 2000 the NIAMS and other NIH components will hold a 
Consensus Development Conference on osteoporosis to address many key 
questions and to bring a focus to scientific opportunities that could 
be pursued in this major public health problem that compromises daily 
activities for millions of Americans of all ages. The information that 
comes from this Conference will be broadly disseminated to physicians 
and other caregivers, as well as to the public.
                      systemic lupus erythematosus
    In genetic studies of lupus, researchers have found an association 
between the disease and a region on chromosome 1. Fine mapping of this 
region has identified another candidate gene involved in immune 
function. Studies of the genetics of lupus may identify potential 
therapeutic targets and may facilitate the development of markers of 
disease activity. While medical research has certainly made a 
significant difference in the daily lives of people (primarily women) 
with lupus, this remains a major public health problem that compromises 
the quality and longevity of life for many Americans. In addition to 
the many systems of the body that are affected, patients with lupus 
also have a higher risk of neuropsychiatric manifestations and 
accelerated atherosclerosis. In 1999 the NIAMS sponsored workshops in 
both of these areas, and we intend to follow-up on the many excellent 
recommendations from experts who participated in these two meetings.
                             skin diseases
    Gene therapy has potential for treating many skin diseases, 
diseases that significantly compromise daily life for millions of 
Americans both physically and psychologically. In addition, skin can 
also serve as a factory for the production of molecules including 
hormones such as insulin and human growth hormone that are used in the 
treatment of many systemic diseases. Skin provides a number of 
advantages for gene therapy approaches, including the ability to remove 
genetically altered skin by simple excision if problems develop. The 
NIAMS is supporting a scientific conference in March 2000 to increase 
the level of interest in gene therapy using skin and to identify 
scientific opportunities and needs in this area.
                           health disparities
    While we know that disease can strike people at every age, of 
either gender, and in every ethic group, we also know that many 
diseases affect women and members of minority groups 
disproportionately--both in increased numbers and increased severity of 
the diseases. Even if variables such as socioeconomic status, access to 
health care, and insurance coverage are eliminated, the fact remains 
that diseases like lupus, scleroderma, osteoarthritis, and vitiligo all 
account for disparities in the health of women and minorities. We are 
actively seeking to understand the causes of these gender and ethnic 
differences, and we are expanding our commitment to better 
understanding of health disparities. We are also increasing our efforts 
to disseminate health information to minority populations and have 
established a toll-free line in both Spanish and English as well as 
produced a number of our publications in Spanish. Plans are underway 
for a workshop to address promising opportunities for research in this 
area. In addition, members of our Intramural Research Program are 
designing an outreach program targeted toward the minority community. 
While it is still in preliminary stages, it will ultimately include 
both local and national outreach efforts.
                               conclusion
    Bones, joints, muscles, and skin are central components of the 
human body. When the functions of any of these areas are affected, the 
daily lives of people are compromised. We are committed to continuing 
to support basic research as well as the many clinical studies 
underway, including those exploring the roles of genetics, the 
environment, diet, and behavior in disease. I cite our scientific 
achievements with pride, and I pledge to continue my commitment to 
support high quality science that will continue to improve the health 
of the American people.
    The NIH budget request includes the performance information 
required by the Government Performance Results Act (GPRA) of 1993. 
Prominent in the performance data is NIH's first performance report 
which compares our fiscal year 1999 results to the goals in our fiscal 
year 1999 performance plan. As our performance measures mature and 
performance trends emerge, the GPRA data will serve as indicators to 
support the identification of strategies and objectives to continuously 
improve programs across the NIH and the Department.
    I will be happy to answer any questions you may have.
                                 ______
                                 
             Prepared Statement of Dr. James F. Battey, Jr.
    Mr. Chairman and Members of the Committee, I am pleased to present 
the President's non-AIDS budget for the National Institute on Deafness 
and Other Communication Disorders (NIDCD) for fiscal year 2001, a sum 
of $276.4 million, which reflects an increase of $14.3 million over the 
comparable fiscal year 2000 appropriation. Including the estimated 
allocation for AIDS, total support requested for NIDCD is $278 million, 
an increase of $14.3 million over the fiscal year 2000 appropriation. 
Funds for the NIDCD efforts in AIDS research are included within the 
Office of AIDS Research budget request. Within the last year, we have 
witnessed outstanding research progress in human communication and 
communication disorders by NIDCD-supported scientists and clinicians, 
progress further accelerated by the efforts of other NIH institutes.
                              development
    How Inner Ear Hair Cells Grow.--In humans, auditory sensory cells 
(hair cells) and other internal parts of the ears develop within the 
third month of development. These fragile, highly specialized cells, 
which are essential for the hearing process, are often damaged or lost 
as a consequence of noise, genetic mutation, drugs or other 
environmental insults. The resulting hearing impairment is permanent, 
since these cells do not regenerate in humans. NIDCD-supported 
scientists are examining the cellular and molecular processes that 
direct progenitor cells to differentiate into hair cells, leading to 
new approaches to stimulate hair cell regeneration after damage. These 
investigators have shown that in the mouse, the Math1 gene is essential 
for regulating the development of hair cells and progenitor cells. 
These findings provide novel insight into the molecular mechanisms 
regulating hair cell differentiation and specification.
                         infancy and childhood
    Better Procedures to Screen Infants for Hearing Impairment.--The 
American Speech-Language-Hearing Association estimates that as many as 
12,000 infants each year in the U.S. are born with significant hearing 
loss, making it a common congenital disorder. Research supported by 
NIDCD has shown that detection of hearing impairment and intervention 
within the first six months after birth is very important for 
optimizing language development in young children. In a five-year, 
multi-center study, NIDCD-supported scientists determined the optimal 
test procedures for neonatal hearing screening. This study was the 
first controlled comparison of normal hearing and hearing-impaired 
infants evaluating physiological responses to sound. The development of 
precise and timely diagnostic screening techniques for hearing 
impairment is the first step in providing early intervention strategies 
that will optimize the development of either spoken or signed language 
skills. The NIDCD is supporting research to develop and validate 
intervention strategies that are tailored to the individual with 
hearing impairment.
    Hereditary Hearing Impairment--Gene Discovery and Implications.--
Not only is hearing screening becoming available to all newborns, 
breakthroughs in medical genetics will enable scientists to identify 
the precise genetic change leading to hereditary hearing impairment. 
NIDCD-supported scientists have learned that about one-third of all 
recessive hereditary hearing impairment within the U.S. is caused by 
mutations in the GJB2 gene. But further studies have shown that there 
is significant variation in the degree and time-of-onset of hearing 
impairment among individuals with exactly the same mutation in both 
GJB2 genes. Given this variation, it would be difficult to predict 
onset and degree of impairment in these infants using only data from a 
GJB2 genetic test. The NIDCD is interested in pursuing areas of 
research to develop and validate diagnostic genetic tests, to assess 
the potential impact of genetic testing and the utilization of genetic 
information on attitudes and behaviors of various cultural groups and 
individuals.
    Otitis Media--Vaccine Development and Genetic Susceptibility.--In 
an NIDCD-supported study, scientists have discovered that there is a 
strong heritable component to prolonged time with and recurrent 
episodes of otitis media (middle ear infection) in children. The 
results of this study may have future implications for primary care 
physicians to identify children and siblings at high risk for otitis 
media for careful monitoring and early intervention. In addition, with 
the recent emergence of antibiotic resistant bacterial isolates, it is 
clear that the best long-term strategy for otitis media is prevention. 
NIDCD scientists have developed a detoxified lipooligosaccharide-
protein conjugate to be used as a possible vaccine against nontypable 
Haemophilus influenzae, a leading cause of otitis media in children for 
which there is no vaccine currently available. A Phase I clinical study 
is nearing completion in adult volunteers to evaluate the safety and 
potential efficacy of the investigational vaccine. Preliminary data 
from this study show that the vaccine is able to elicit the production 
of specific antibodies against the bacteria in a number of volunteer 
subjects. The results of this trial suggest that this investigational 
vaccine may be useful for preventing otitis media in children.
    Cochlear Implants May Improve Language Achievement in Children.--
The cochlear implant is an array of electrodes that converts sound into 
electrical impulses that stimulate the acoustic nerve, restoring the 
perception of sound. It is the only neural prosthesis in widespread 
clinical use with over 20,000 recipients, about one-half of whom are 
children. Scientists supported by the NIDCD conducted a study to 
measure language achievement in children with cochlear implants. The 
study, comparing a group of children who had received cochlear implants 
and a second group who were using hearing aids, showed significant 
differences in language achievement levels favoring the children using 
cochlear implants.
    Improved Methods for Diagnosing Early Childhood Stuttering.--
Stuttering is a disorder that typically begins between the ages of 2 
and 5. When it persists, the disorder causes serious impairment in 
verbal communication that is often associated with significant 
difficulties in emotional and social adjustments. NIDCD is supporting a 
large-scale longitudinal investigation of children who stutter to 
examine various aspects of stuttering as it persists or subsides during 
childhood. In addition, the study is identifying risk factors that can 
help differentiate between children who develop persistent stuttering 
and those who tend to recover. The data reveal a strong genetic 
component to stuttering and differences in genetic liability between 
different subsets of children who stutter. Based on these findings, 
NIDCD-supported investigators have initiated a genetic association 
study to map and identify the genes that predispose individuals to 
stutter.
    Defining and Identifying Specific Language Impairment in 
Children.--Specific Language Impairment (SLI) is a language disability 
observed in the absence of any other cognitive disorders, affecting as 
many as 8 percent of all kindergarten-age children. Research to 
understand and treat SLI has been hampered by the lack of uniformity in 
the definitions and measures that are used to identify preschool-aged 
and older children, adolescents or adults with SLI. NIDCD-supported 
researchers have developed definitional guidelines and research 
directions that will lead to enhanced abilities to diagnose and assess 
SLI, determining that a brief non-word repetition task is a powerful 
predictor of SLI. This test differentiates between children who will 
benefit from language intervention and children who will not require 
intervention to achieve normal language skills.
    Eliminating Health Disparities in Hearing and Language Disorders.--
As research moves forward to reduce the burden of disease in America, 
the NIDCD is committed to the idea that all segments of American people 
should benefit from this progress. In comparison to the general U.S. 
population, Native American children have one of the highest rates of 
otitis media. The NIDCD is continuing its support of a study on the 
epidemiology of this disorder and hearing loss among Native American 
infants, from birth to age two, at the White Earth Reservation in 
Minnesota. Recent assessment shows that intervention programs should 
focus on parental smoking as a significant risk factor for otitis media 
in Native American infants. The study also includes the development and 
implementation of prevention strategies to reduce the burden of otitis 
media such as promoting breastfeeding.
    Treatment for Deafness Caused by Neurofibromatosis Type 2.--The 
NIDCD is conducting research on neurofibromatosis type 2 (NF2), a 
genetic disorder that often results in bilateral tumors of the acoustic 
nerves causing deafness in children and adults. Scientists supported by 
the NIDCD have determined that specific mutations in the NF2 gene 
result in different levels of severity of the disease. This finding 
will facilitate early DNA-based diagnoses that will improve disease 
management and increase the preservation of hearing in NF2 patients. 
For many individuals with NF2, surgical intervention required to remove 
tumors also involves resection of both acoustic nerves, so that sound 
perception cannot be restored with cochlear implantation. To help these 
individuals, NIDCD is supporting research to develop a specialized 
auditory prosthesis for NF2 patients. Multiple, ultraminiature 
microelectrodes have been implanted directly into the ventral cochlear 
nucleus of animals, the portion of the central auditory system where 
the acoustic nerve fibers once made connections. These animal studies 
have demonstrated the safety of this technique and deaf NF2 patients 
are now scheduled to be fitted with these devices within the next few 
years with the hope of restoring auditory perception.
                               adulthood
    The Hazards of Noise-Induced Hearing Loss.--When an individual is 
exposed to sounds that are too loud, the hair cells needed to detect 
sound in the inner ear can be damaged, resulting in noise-induced 
hearing loss (NIHL). NIHL is a major health concern, but it is 
preventable. In a public outreach effort, the NIDCD has launched the 
``WISE EARS!'' campaign, where a national coalition of over 60 
government agencies, public organizations, businesses, industries and 
unions is working to inform the public about the risk of NIHL.
    Molecular Mechanisms Governing Our Sense of Taste.--In humans, the 
loss of taste sensation can contribute to the loss of appetite and poor 
nutrition, a particularly common problem for older Americans. In a 
collaborative effort joining molecular biologists supported by the 
National Institute of Dental and Craniofacial Research, NIDCD, and 
investigators at the University of California, San Diego, candidate 
sweet and bitter taste receptors have been cloned and characterized. 
These receptors are selectively expressed in a non-overlapping subset 
of taste receptor cells on the tongue. This research is an important 
step in determining the molecular pathway activated by sweet and bitter 
substances, and will guide future research studies in identifying 
additional molecules in this poorly understood pathway.
    Genetic Association and Age-Related Causes for Hearing Loss.--A 
recent NIDCD-supported study has demonstrated that a genetic component 
exists for age-related hearing loss. It is likely that different 
mutations in the same genes that cause profound hereditary hearing 
impairment in children also cause age-related hearing loss 
(presbycusis), a common problem for older Americans. With the ability 
to predict who is at increased risk, better strategies to minimize or 
delay hearing loss within the aging population can be developed.
    NIDCD/Department of Veterans Affairs Hearing Aid Clinical Trial 
Yields Important Results.--The prevalence for hearing impairment 
significantly increases with age and hearing aids are the most common 
means of assistance for persons with hearing loss. The Department of 
Veterans Affairs and the NIDCD conducted a multi-center trial, which 
included elderly volunteers, to compare the efficacy of three commonly 
used hearing aid circuits. Data from the trial showed that performance 
differences among the three hearing aid circuits were minimal. Of 
greater importance, the trial demonstrated that each circuit improved 
speech recognition with improvement observed under both quiet and noisy 
listening conditions. NIDCD remains committed to support research 
leading to smaller and better hearing aids, capitalizing on 
bioengineering advances in microelectronics.
     The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
Prominent in the performance data is NIH's first performance report 
which compares our fiscal year 1999 results to the goals in our fiscal 
year 1999 performance plan.
    My colleagues and I will be happy to respond to any questions you 
may have.
                                 ______
                                 
               Prepared Statement of Dr. Steven E. Hyman
    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Institute of Mental 
Health (NIMH) for fiscal year 2001, a sum of $896,059,000, an increase 
of $50,083,000 (or 5.9 percent) above the comparable fiscal year 2000 
appropriation. Including the estimated allocation for AIDS, total 
support requested for NIMH is $1,031,353,000, an increase of 
$56,680,000 over the fiscal year 2000 appropriation. Funds for the NIMH 
efforts in AIDS research are included in the Office of AIDS Research 
budget request.
                        areas of new investment
    This has been a remarkable year for the NIMH, both in our 
development of scientific programs and in our ability to contribute to 
public understanding of mental illness. Thanks to a healthy increase in 
our budget, we expanded our new Translational Centers program, which 
aims to bring basic science as rapidly as possible into the clinical 
arena. We built on our investment in studies of genetic risk factors 
for schizophrenia, manic depressive illness, and early onset major 
depression, with particular emphasis on expanding our gene repository 
for research on autism. We initiated two major clinical trials, one on 
best use of new antipsychotic drugs and one on the treatment of 
individuals with depression who do not benefit from standard, initial 
treatments. We reported the findings of a multi-site collaborative 
study on treatment of attention deficit hyperactivity disorder, a 
public health problem of immense concern to parents, teachers, and 
health care providers, and we have initiated epidemiologic studies that 
will enable us to address disparities in mental health treatment 
outcomes with ever greater effectiveness.
             heightened public awareness of mental illness
    Growing recognition that mental illnesses are real diseases of an 
organ, the brain; that they are diagnosable and treatable; that they 
represent an enormous public health burden--for example, depression is 
the leading cause of disability in the United States; and that current 
treatments can have an enormous impact on diminishing that burden 
spurred several important public education efforts in 1999. These 
included the White House Conference on Mental Health and Mental 
Illness, and the Surgeon General's Report on Mental Health, the first-
ever on this topic. Responding to a report from the National Center for 
Health Statistics that 31,000 Americans committed suicide in 1996, more 
than half again the approximately 20,000 U.S. homicides that year, the 
Surgeon General issued a Call to Action to Prevent Suicide, which now 
is the ninth leading cause of death in the U.S. and, as the Centers for 
Disease Control reports, the third-leading cause of death among 15 to 
24 year old Americans. NIMH has been privileged to play a critical role 
in providing scientific data and educational materials for all three of 
these activities.
    We have come far in the science of mental illness and mental 
health, but we still have much to learn. We are thankful that the 
generous support of the American people, through the Congress, has made 
it possible to attack difficult problems at many levels. Perhaps most 
critical to our long-term goals of curing--and ultimately preventing--
serious and disabling diseases like autism, schizophrenia, manic 
depressive illness, depression, anxiety disorders, and eating 
disorders, is our enhanced ability to expand long-term investments 
aimed at understanding the fundamental organization of brain and 
behavior. This is a time of remarkable progress in molecular and 
cellular biology, systems-level neurobiology, and cognitive 
neuroscience, and a time of unparalleled opportunity afforded by 
technologies ranging from gene chips to noninvasive neuroimaging. As 
our basic science matures, we have initiated programs aimed at speeding 
and enhancing the translation of that basic science into clinical 
applications.
                   centers for translational science
    What do I mean by ``translational science?'' Let me describe 
briefly how several projects at one Center link basic and clinical 
research. Collaborating scientists at the University of Pittsburgh and 
Carnegie Mellon University are testing a hypothesis that certain 
abnormalities in thinking (or cognition) that are characteristic of 
schizophrenia reflect an impairment of functions in a particular brain 
region, the dorsal lateral prefrontal cortex. This disorder typically 
strikes in the late teen years or early twenties--just when families 
and, indeed, society are completing their investment in the education 
of a young person. Thus, this project is examining in animal models and 
in clinical research how the brain's circuitry changes over the course 
of development and, particularly during adolescence. Since both genes 
and environment influence brain development, one component of this 
study uses new gene chip technologies to examine how genes influence 
the circuitry of the prefrontal cortex; using the new chip technology, 
the investigator can determine which genes have been active and which 
have been suppressed in the post-mortem brains of patients with 
schizophrenia compared with normal controls; a similar gene analysis is 
being done with adolescent monkeys. Other facets of the project involve 
studies of a neurotransmitter, dopamine, that plays a critical role in 
memory functions served by the prefrontal cortex, and functional brain 
imaging studies of patients with schizophrenia and controls, with the 
aim of determining the extent to which cognitive abnormalities can be 
ascribed to the effects of dopamine on frontal cortex. What's exciting 
is that each of these discrete projects is addressing fundamental 
biological questions, allowing investigators to relate findings 
obtained from basic animal studies to clinical research with an 
unprecedented degree of coordination. Given the awesome complexity of 
the brain, we believe that team efforts like this have the best chance 
of understanding what goes wrong in the brain in schizophrenia.
    In another Translational Center, investigators are exploring the 
relationship between fear and stress in animal models; a key aim is to 
determine whether the effects of stress on fear circuits mimic changes 
that occur in fear-related disorders in humans, such as post-traumatic 
stress disorder, anxiety and panic disorders, and paranoid 
schizophrenia. Investigators at NYU, Columbia University, and 
Rockefeller University, are using an identical behavioral paradigm--
fear conditioning--to examine fear circuits from multiple perspectives, 
in animal and human studies. One effort that will benefit immensely 
from its interaction with other Center studies will follow up on 
findings that acute and chronic stress inhibits neurogenesis--that is, 
the generation of new neurons in the adult brain. This question has 
extraordinary ramifications for understanding mental disorders and 
refining treatments.
          identifying vulnerability genes for mental disorders
    We have greatly augmented our investment in the genetics of 
schizophrenia, manic depressive illness, major depression, autism, and 
other mental disorders. It is now certain that these disorders have a 
genetic component, but solving the genetics and identifying disease 
vulnerability genes is extremely difficult because vulnerability to 
these disorders results from the effects of many genes, each 
contributing relatively small and interactive effects, as opposed to an 
illness, such as Huntington's disease, in which a single gene 
contributes a large effect. However, as we have learned from other 
central nervous system disorders, such as Alzheimer's disease, the 
discovery of vulnerability genes can lead to the identification and 
validation of exciting new targets for development of therapies. During 
the coming year, all of our genetics efforts will be aided by the 
sequencing of the human, mouse, and other animal model genomes and by 
ongoing projects to investigate human genetic diversity, especially as 
it might apply to disease risk.
                      treatment research on autism
    Pending findings from the genetics studies that I mentioned, NIMH 
remains deeply committed to improving treatments currently available 
for autism, a brain disorder that affects between 1 to 2 of every 1,000 
Americans, with often devastating, lifetime effects on thinking, 
feeling, and social functioning--all uniquely human attributes. A 
network of five NIMH-supported psychopharmacology research units are 
evaluating drug treatments for autism, such as risperidone and 
valproate. Among studies of psychosocial treatments in autism, we fund 
two projects evaluating parent training interventions that are tailored 
to the particular characteristics of child and family. Of course, we 
participate in the NIH Autism Coordinating Committee.
                   new clinical effectiveness trials
    During the last fiscal year, NIMH has initiated large-scale 
clinical trials on the best use of new antipsychotic medications and 
the treatment of individuals who failed to respond to initial 
antidepressant treatments. Along with our ongoing trials in adolescent 
depression and in bipolar disorder, which we initiated over the past 
two years, this thrust represents a substantial recommitment to 
clinical treatment studies for people with mental illness. These 
particular studies represent a new frontier in clinical treatment 
research because they will study truly representative samples of 
individuals with mental disorders. That is, eligibility for 
participating in these treatment studies no longer is limited to 
rarified populations within academic health centers, but is open to 
general populations in diverse health care settings. This new approach 
requires NIMH take great care to observe appropriate stewardship of the 
trials while our field develops the infrastructure and expertise to 
conduct such trials. In future years, we hope to expand this program to 
address such issues as depression in young children, and mood disorders 
that co-occur with psychotic disorders. We are also interested in 
cross-NIH collaborations to focus on co-occurring substance use 
problems with mental disorders.
                       research on youth violence
    As recognition grows that violence by young people represents a 
public health problem, we are encouraging a new generation of studies 
that will attend, particularly, to the relationships between mental 
disorders and violence, including suicide. We know that anxiety 
disorders, depression, or suicidal ideation often co-occur with 
behavior problems, and that the combination of depression with conduct 
problems may be a combustible mix. Also, youth with conduct problems 
often exhibit inattention and impulsiveness, often coexisting with 
hyperactivity. We are coordinating our research involving dissemination 
of prevention and early intervention strategies with the Centers for 
Disease Control and other federal agencies, including the departments 
of Education and Justice. Finally, I am pleased to report that NIMH 
will assume a lead role in developing a Surgeon General's report on the 
topic of youth violence. Dr. Satcher and, indeed, all of us have been 
gratified by the overwhelmingly positive response of the American 
public to the Surgeon General's Report on Mental Health, and we believe 
this follow-up report will be an effective and highly credible means of 
educating the public about the interaction of mental disorders and 
youth violence.
                multi-modal treatment assessment of adhd
    In December, NIMH and collaborating investigators reported findings 
from the landmark Multi-Modal Treatment Assessment Study--the MTA 
study--of attention deficit/hyperactivity disorder, a major public 
health problem that affects 3-5 percent of school children. The 
experiences of 600 children enrolled in the study revealed that 
carefully monitored medication management, with monthly followup and 
input from teachers, is more effective than intensive behavioral 
treatment. For measures such as improved academic performance and 
family relations, combining behavioral therapy and medication proved 
effective and satisfying to parents and teachers and permitted somewhat 
lower doses of medication. Among the important insights of the MTA 
study was documentation of the extent of undertreatment or 
inappropriate medication treatment in normal, community-based care.
                     research on health disparities
    A primary goal of NIMH and NIH research is to ensure that advances 
in treatment benefit all Americans, including racial and ethnic 
minorities who experience significant disparities of outcomes with 
respect to many illnesses. Within the past year, NIMH conducted the 
first two of a projected series of State-wide conferences on mental 
health needs and opportunities that permit us to hear, first-hand, 
citizens' perspectives on health disparities. We initiated a large-
scale study of the epidemiology of mental disorders among African 
Americans and plan on parallel studies to understand the epidemiology 
of mental disorder in other minority groups. These studies will 
complement a new, state-of-the-science epidemiologic study of mental 
disorders in the broader population that will be funded under a 5-year, 
$7.3 million dollar grant to investigators at Harvard University who 
will survey a representative sample of 10,000 Americans ages 15 and 
over. For several decades, NIMH has set the standard for modern mental 
health epidemiologic research, and this new study will ensure that we 
have data necessary to allocate resources and design policies in this 
era of massive change in the U.S. health care system.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
Prominent in the performance data is NIH's first performance report, 
which compares our fiscal year 1999 results to the goals in our fiscal 
year 1999 performance plan. As our performance measures mature and 
performance trends emerge, the GPRA data will support the 
identification of strategies and objectives to improve programs across 
the NIH and the Department.
    NIMH is committed to a research portfolio that stretches from 
molecules and genes to brain and behavior to clinical investigation to 
health services research and economics. This research portfolio is 
thriving thanks to the development of new scientific approaches ranging 
from genomics to neuroimaging to new clinical trial designs. In 
parallel, we have been able to renew our Institute structure and also 
the vitality of our Intramural Research Program by a combination of 
rigorous review and recruitment of outstanding scientists. I look 
forward to this new millennium with humility about the scope of the 
problems that we must address but great optimism about the ability of 
our research community to meet the challenge.
    I will be pleased to answer any questions.
                                 ______
                                 
Prepared Statement of Dr. Alan I. Leshner, Director, National Institute 
                             on Drug Abuse
    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's non-AIDS budget request for the National Institute on 
Drug Abuse (NIDA) for fiscal year 2001, a sum of $496.3 million, which 
reflects an increase of $27.1 million over the comparable fiscal year 
2000 appropriation. Including the estimated allocation for AIDS, total 
support requested for NIDA is $725.5, million an increase of $38.1 
million over the fiscal year 2000 appropriation. Funds for the NIDA 
efforts in AIDS research are included within the Office of AIDS 
Research budget request.
                   building on recent accomplishments
    Thanks to the commitment of both the Administration and the 
Congress, including particularly this Committee, NIDA has been able to 
launch some truly significant activities in the past year. Perhaps the 
most noteworthy undertaking has been establishing the foundation for a 
vehicle that will increase dramatically the quality of drug addiction 
treatment throughout this country. Last year, we promised to build a 
National Drug Abuse Treatment Clinical Trials Network (CTN) to test and 
disseminate new science-based addiction treatments in real life 
settings. I am pleased to be able to tell you that we not only have 
established the first five nodes of this Network, but are about to 
begin implementing the first three protocols. Moreover, adding five 
more nodes to this infrastructure this year will take the CTN one step 
closer to becoming the truly national research and research 
dissemination network that we know it can and should be. Under NIDA's 
overall guidance, the CTN will foster partnerships between treatment 
researchers and community-based treatment providers to move well-tested 
science-based addiction treatments into use in diverse patient 
settings.
    We are also building other areas of our research portfolio to 
better inform how this country approaches drug addiction, including 
looking more closely at the role genetic factors may play in 
determining the likelihood someone will become addicted to drugs. In 
the same way we are making great progress in understanding how genetics 
can predispose one to cancer, heart disease, or diabetes, drug abuse 
researchers are making similar advances in the addiction arena as well. 
By better understanding the factors determining an individual's 
vulnerability to addiction, our treatment and prevention success rates 
will dramatically improve.
    The research community is committed to this endeavor. The response 
to NIDA's ``Genetics of Drug Addiction Vulnerability'' Initiative has 
been overwhelming. We were able to fund five new grants last year to 
examine the role of genetics in nicotine, cocaine, and heroin 
addiction, and we hope to support in the coming years some of the other 
outstanding proposals we received in response to this initiative.
          long-term neurobehavioral effects of drugs of abuse
    Advances within NIDA's neuroscience research portfolio also 
continue coming at an accelerated pace. Let me give you one example of 
how far our science has come since last year's appropriations hearing. 
You may recall that I showed you images of how drugs, such as 
methamphetamine and MDMA (Ecstasy), produce long-lasting changes in 
brain function, changes that persist even years after the individuals 
stopped using the drugs. Researchers have now taken those research 
findings one step further and have begun to unravel exactly how these 
brain changes dramatically affect an individual's behavior.
    For example, researchers studying the residual effects of 
methamphetamine in users who were drug free for ten months before this 
study began, found that they had significantly impaired motor and 
memory function. When they were asked to complete a battery of tests 
that examined working memory and reaction times, as well as verbal 
memory skills, these former methamphetamine users did far worse than 
non-drug-using individuals. Importantly, the researchers also found 
that the impaired memory in the former users was clearly associated 
with significant reductions in the functioning of the brain's dopamine 
neurotransmitter systems, in this case the number of dopamine reuptake 
transporters. And the study showed that the greater the degree of 
transporter loss, the greater the memory deficits.
    Researchers at NIDA's intramural program have found similar 
cognitive deficits with chronic cocaine abusers. Thus, these studies 
are clarifying how it is that illicit drugs compromise cognitive and 
behavioral abilities.
    NIDA-supported researchers are not just using new imaging and 
molecular genetic technologies, they are also making significant 
contributions to the field by advancing the technology themselves. This 
is best exemplified by our efforts in the fast paced world of 
nanotechnology. For example, NIDA-supported researchers recently 
developed a biosensor system to analyze what is happening inside a 
single cell. These techniques are allowing us to see how important 
neurotransmitters like dopamine are stored and can move in and out of 
cells. This opens up many new avenues of research; allowing us to see 
with much greater resolution the impact that drugs of abuse have on the 
brain.
           determinants of drug use preferences and patterns
    Understanding why some individuals abuse drugs while others do not 
and why some develop more problematic drug use than others are some of 
the most challenging dilemmas being probed by researchers today. As we 
bring new and improved technologies and new groups of researchers into 
the search for answers to these questions, we are beginning to unveil 
some important and astonishing results. For example, using the advanced 
brain imaging technique of positron emission tomography (PET), 
researchers have found the first clues as to why some individuals are 
prone to use stimulant drugs and why some are not. As an example, as 
shown in POSTER 1, these studies have shown a dramatic association 
between an individual's pre-drug exposure brain dopamine receptor 
levels and how much the individual reports ``liking'' or ``disliking'' 
a psychostimulant. Here you see two individuals with different levels 
of dopamine D2 receptors shown before any drug exposure. (Brighter 
colors represent higher numbers of receptors). The individual whose 
brain is shown on top and who had high levels of D2 receptors reported 
an unpleasant response to the mild stimulant methylphenidate. On the 
other hand, the individual on the bottom, with low D2 receptor levels, 
found the stimulant quite pleasant. This suggests that differences in 
brain chemistry predisposes people to respond in different ways to 
drugs of abuse.
         understanding the transition from drug user to addict
    In past years, we also have shown you data clearly indicating that 
we know quite a bit about both the behavioral and the biological 
differences between addicted and non-addicted individuals. What we do 
not know much about, however, is the literal transition that occurs 
between these states. What is actually happening both behaviorally and 
biologically when one moves from being an occasional to a compulsive, 
addicted drug user? What changes an individual from a voluntary to a 
compulsive drug user? Understanding this transition is central, of 
course, to developing more effective addiction prevention and treatment 
strategies, and its importance has led NIDA to develop a focused 
``Transition to Addiction'' initiative.
    NIDA-supported researchers will approach these issues from many 
disciplinary perspectives. As just one example, they will use new 
molecular biology techniques, such as microarrays, to build on recent 
discoveries from animal studies suggesting that gradual increases in 
the levels of a specific brain protein, delta Fos B, are a critical 
part of this transition process. We know that this protein triggers the 
expression of other genes and the use of this technology will help 
identify which genes are expressed, when, and where in the brain.
          research bringing about shifts in national strategy
    Scientific advances have not only improved our fundamental 
understanding of addiction, but continue to reduce many of the public 
health and safety consequences of this destructive disease as well. 
Nowhere is this better exemplified than in the philosophical shift in 
strategic thinking about drug abuse and its consequences that is 
occurring throughout many levels of society. A case in point is how 
advances in addiction research are leading to a blending of criminal 
justice and health approaches to dealing with drug abuse and 
criminality. NIDA-supported research has demonstrated that treating 
drug users while under criminal justice control dramatically reduces 
recidivism to both later drug use and later criminality by 50 to 70 
percent. This finding is one of the reasons why NIDA and other facets 
of the Department of Health and Human Services have teamed with the 
Justice Department to work toward making drug abuse treatment more 
commonplace in the criminal justice environment.
                     addressing health disparities
    Members of minority populations are disproportionately affected by 
the consequences of drug abuse. Accordingly, NIDA is taking extra 
effort to understand the causes of and contributing factors to these 
inequalities and working to ensure that minority issues are addressed 
and minority populations are adequately represented not only in NIDA's 
comprehensive research portfolio, but in our research communities as 
well. NIDA supports a wide array of programs to recruit minority 
populations into drug addiction research fields. In fact, NIDA has 
increased the number of supported minority researchers by 97 percent in 
the past six years. In the last few years, NIDA has also put together 
three new working groups representing African-American, Asian-Pacific 
Islander, and Hispanic researchers and scholars to help recruit and 
train new minority investigators and improve the quantity and quality 
of minority-related research.
    These working groups are helping NIDA expand opportunities for 
working with scholars who are most knowledgeable about these 
populations. Minority researchers will be particularly helpful as NIDA 
increases its efforts to study the impact and health consequences of 
drug abuse in minority populations. By simultaneously increasing 
research and research training efforts, NIDA expects to make 
significant improvements in racial and ethnic disparities.
         rapid and authoritative research dissemination efforts
    As the world's ability to exchange information expands 
exponentially, NIDA continues to take full advantage of these 
opportunities to disseminate science-based information more effectively 
and rapidly to a wide variety of audiences. For example, when one of 
our early drug warning systems, NIDA's Community Epidemiology Work 
Group, noted increases in the use of ``club drugs'' such as 
methamphetamine and ecstasy among adolescents and young adults, NIDA 
initiated a multi-element research and education campaign to stave off 
further growth of this problem. NIDA will increase funding for relevant 
research by 40 percent. In addition, the Institute has joined with an 
array of partners in the drug abuse professional and constituency 
communities to launch a multi-media education campaign as well. We 
developed and disseminated a community drug alert bulletin that has 
been sent to over 150,000 people, developed a new website 
(www.clubdrugs.org), and teamed with the American Academy of Child and 
Adolescent Psychiatry, the Community Anti-Drug Coalitions of America, 
Join Together, and National Families in Action to hold a national 
meeting to increase awareness and attention to this problem, share 
research findings, and identify research gaps.
    We also have taken an idea from what has become a NIDA bestseller, 
our Prevention booklet, ``Preventing Drug Use Among Children and 
Adolescents: A Research-Based Guide,'' and created a corresponding 
``Principles of Drug Addiction Treatment: A Research-based Guide.'' 
Since the guide debuted in October, more than 100,000 copies have been 
disseminated. This lay language booklet provides health care providers, 
patients, families, and policy makers with the latest science-based 
information on drug treatment. It describes the nature of addiction and 
the addiction treatment enterprise, and then outlines 13 overarching 
principles that characterize effective drug addiction treatment.
    We are also taking full advantage of other dissemination 
opportunities. In fact, we are doing exactly what members of this 
Committee encouraged us to do last year. We are taking state-of-the-art 
brain scans showing the effects of drug abuse and addiction and using 
them as the core of a multi-media public education campaign. What you 
see here is a portion of a story board (POSTER 2) for one of our public 
service announcements emphasizing how drug use can damage your brain in 
important ways. In addition to using powerful images, we are using 
findings from the prevention research arena on what works and what does 
not work to develop persuasive, and scientifically accurate messages. 
We plan to send these messages to television outlets nationwide this 
spring.
                 government performance and results act
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
Prominent in the performance data is NIH's first performance report 
which compares our fiscal year 1999 results to the goals in our fiscal 
year 1999 performance plan. As our performance measures mature and 
performance trends emerge, the GPRA data will serve as indicators to 
support the identification of strategies and objectives to continuously 
improve programs across the NIH and the Department.
                               conclusion
    In conclusion, NIDA is taking advantage of emerging technologies to 
confront the disease of addiction head on. Our comprehensive research 
portfolio, our track record in sharing our research findings, and a 
continued commitment from the Administration and the Congress to 
furthering the science will serve as this Nation' s best defense 
against this devastating public health and safety plague. I will be 
pleased to answer any questions you might have.
                                 ______
                                 
                 Prepared Statement of Dr. Enoch Gordis
    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's non-AIDS budget request for the NIAAA for fiscal year 
2001, a sum of $288,578,000, which reflects an increase of $14,587,000 
over the comparable fiscal year 2000 appropriation. Including the 
estimated allocation for AIDS, total support requested for the NIAAA is 
$308,661,000, an increase of $15,427,000 over the fiscal year 2000 
appropriation. Funds for the NIAAA's efforts in AIDS research are 
included within the Office of AIDS Research budget request.
    Nearly 14 million American adults meet diagnostic criteria for 
alcohol addiction or abuse, and 100,000 Americans die of alcohol-
related causes each year, according to NIAAA epidemiology data. While 
death is the ultimate consequence of alcohol-use disorders, their 
impact on the living, in sheer numbers, is even greater. The NIAAA's 
epidemiology research reveals that 442,000 people occupy hospital beds 
each year as a result of these disorders. The financial burden that 
alcohol misuse imposed on the Nation in 1998 was approximately $185 
billion, in direct and indirect costs, according to the Lewin Group. 
The sequelae of alcohol-use disorders include damage to the liver, 
brain, and other organs; cancer; fetal alcohol syndrome and the 
lifetime disabilities it produces; accidental injury to self and 
others; property damage; crime; broken families; and loss of 
productivity that deprives the Nation of valuable resources.
    Biological, behavioral, and social factors converge to produce 
alcohol-use disorders, making them particularly complex diseases. In 
terms of biology, alcohol is unique among addictive substances, in that 
it targets not just one but many neurotransmitter systems--chemical 
messengers between nerve cells--resulting in unusually pervasive 
effects on the entire nervous system and in unique challenges for 
scientists. Researchers have made striking advances in identifying the 
molecular structures where alcohol binds to these neurotransmitter 
systems and in learning how variations in genes determine alcohol's 
actions on them.
                              neuroscience
    Because alcohol's effects on the nervous system are so pervasive, 
neuroscience is a particularly active field of research at the NIAAA. 
One promising area involves neuropeptide Y (NPY), a substance in the 
brain that increases food consumption and relieves anxiety. Studies are 
underway to determine the role of NPY in controlling alcohol 
consumption. Preliminary studies suggest that NPY may, indeed, play a 
role in propensity for alcohol. Surprisingly, these studies revealed 
that mice in which the NPY gene was inactivated (knocked out) drank 
more alcohol than did their normal siblings and were less sedated by 
alcohol. If NPY is found to play a key role in human alcohol-use 
disorders, NPY and its receptors--its ``docking sites'' on cells--
become potential targets for medications to control alcohol intake.
    Physical problems from long-term alcohol use do not necessarily 
resolve once people stop drinking. Using new MRI techniques, 
researchers have found persistent damage in the cerebellum, the locus 
of gait and balance in the brain, even in long-abstinent alcoholics. 
Previous anatomic measurements of cerebellar damage were difficult, 
because of the cerebellum's convoluted structure, resulting in less 
accurate data. Scientists can use these new imaging techniques to 
clarify the potential for reversing cerebellar damage in recovered 
alcoholics and to explore a new topic: the role of cerebellar damage in 
cognitive impairment.
    These and other findings from the NIAAA's comprehensive 
neuroscience portfolio reflect the ubiquitous nature of alcohol's 
effects on the nervous system. For example, research designed to 
identify the protein structures where alcohol binds to nerve cells may, 
one day, provide groundwork for development of better medications to 
treat alcoholism. In another protein-related finding, NIAAA-supported 
scientists have found that genes in the brains of deceased human 
alcoholics produced less of a crucial nervous-system protein, myelin, 
than did those in nonalcoholics. With this information, scientists can 
better define changes in gene activity that result in damage to 
specific areas of alcoholics' brains. Other investigators are 
identifying alcohol-related neurobiological risks that fluctuate during 
adolescence and that might be related to the higher risk of adult 
alcoholism predicted by earlier onset of drinking in the young.
                                genetics
    That genetics underlies much of the biology of alcohol-use 
disorders is unquestionable. Variations in genes result in variations 
in many components of the nervous system, and, thus, in how people's 
bodies handle alcohol. The way in which people's bodies' handle alcohol 
affects, in turn, their behaviors toward alcohol and risk for 
alcoholism. Evidence suggesting that alcoholism is a polygenetic 
disease--that many genes contribute to it--greatly complicates the 
search for the genes involved.
    The Collaborative Studies on the Genetics of Alcoholism (COGA), a 
major project supported by the NIAAA, has identified several 
chromosomal regions likely to contain genes that influence the risk for 
alcoholism. The NIAAA is pleased to announce that it is making 
available to the general scientific community the substantial data and 
DNA samples generated by COGA. Scientists who take advantage of these 
resources can analyze them further in their own research projects, 
expediting the search for genes that contribute to alcoholism. The data 
also can be used to evaluate new methods of statistically analyzing 
genetic data, not only for alcoholism, but also for other diseases.
    Among the goals of the COGA project is to elucidate the genetics of 
alcoholism in African Americans. While COGA recruits both Caucasian and 
African-American subjects, the latter have not been present in numbers 
large enough to permit a reliable examination of whether the genetic 
basis of alcoholism is different in Black Americans than in White 
Americans. Through a NIAAA grant, Howard University Medical School will 
study this question and contribute its findings to the growing COGA 
database.
    Neuropeptide Y, discussed earlier, is one of more than 20 
substances that NIAAA scientists study as gene knockouts, to determine 
their influence on alcoholism. Some of these substances are found to 
increase alcohol consumption; others are found to reduce it. A recent 
study examined the effects of knocking out, in mice, the gene that 
produces protein kinase C epsilon (PKC ), an enzyme involved in 
intracellular signaling. Absence of PKC resulted in significantly less 
alcohol consumption and abnormally high sensitivity to alcohol's 
sedating properties. Insensitivity to alcohol's sedating effects is 
among the factors that portend alcoholism at some point in life. Since 
much of the mouse genome resembles the human genome, these types of 
findings may lead to clues about human genetic defects related to 
alcoholism.
                               toxicology
    Alcohol is unique among abused drugs in the extent of the organ 
damage it causes. Animal studies by NIAAA intramural researchers have 
demonstrated that chronic alcohol use leads to a decrease in essential 
fatty acids (EFAs), nutrients that play a crucial role in brain health. 
The same investigators recently demonstrated that EFA-deficient rats 
lose nerve cells in an area of the brain involved in memory and 
learning, another common result of chronic alcohol use. The NIAAA 
continues to perform research to evaluate the potential of EFA 
supplementation to reduce organ damage among alcoholics.
    Between 40 percent and 90 percent of U.S. deaths from cirrhosis are 
due to alcohol, according to NIAAA epidemiology data. These statistics 
underscore the importance of understanding the potential for reversing 
this currently irreversible disease. Scientists suspect that an immune-
system protein, tumor necrosis factor (TNF), plays a 
role in alcohol-induced liver damage. NIAAA-funded researchers recently 
found that alcohol-fed mice in which TNF's molecular receptor 
had been genetically knocked out, eliminating TNF's actions, 
suffered liver pathology seven times less severe than that of alcohol-
fed mice with normal TNF levels. This finding strongly 
supports the assertion that TNF is involved in alcohol-induced 
liver damage and is lent even more significance by the recent 
development of pharmaceuticals that inhibit TNF in the 
treatment of inflammatory diseases, such as arthritis.
                  advances in prevention and treatment
    Recent studies illustrate what the NIAAA's prevention research can 
contribute to decisions about alcohol legislation. Many states have 
taken the important step of lowering their legal definition of 
drunkenness from a blood-alcohol concentration (BAC) of 0.10 percent to 
0.08 percent. However, studies of simulated merchant-ship piloting by 
maritime cadets revealed that even half of that concentration, a BAC of 
0.04, resulted in significantly impaired performance. The cadets failed 
to sense their decreased judgment, underscoring the hazards of alcohol 
use in the context of heavy-machinery operation and the workplace. Many 
states still allow people to drive cars with a BAC more than twice that 
of the alcohol-impaired cadets.
    The public also benefits from prevention findings that the NIAAA 
provides to alcohol-treatment practitioners. Thirty percent of 
Americans are subjected to domestic violence at some point in their 
lives, according to studies published in the New England Journal of 
Medicine and funded by the National Institute of Mental Health, the 
Emergency Medical Foundation, and the UCLA Southern California Injury 
Prevention Research Center. NIAAA-funded investigators recently 
concluded, in the Journal of Studies on Alcohol, that a combination of 
behavioral marital therapy and standard treatment for alcoholism 
resulted in a six-fold reduction in domestic violence. Of significance 
here is not only the magnitude of reduction in violence, but also that 
the reduction is sustained, as investigators determined in a 2-year 
follow-up study.
    In the treatment arena, NIAAA-supported studies reveal that the new 
medication nalmefene is at least as successful in preventing relapse 
among recovering alcoholics as is naltrexone, the recently FDA-approved 
drug of choice. Nalmefene may have advantages over naltrexone, 
including less risk of liver toxicity, providing another option for 
recovering alcoholics whose livers have been damaged by alcohol. A 
Finnish company plans to seek FDA approval for this new medication.
                         adolescent alcohol use
    During last year's hearings, the NIAAA reported that initiation of 
drinking earlier rather than later in youth is associated with a 
dramatically higher risk of alcoholism at some point in life. For this 
and many other reasons, the NIAAA continues to make drinking among 
adolescents a research priority. The ``hard-wiring'' of the brain is 
vulnerable to change during adolescence, including change caused by 
toxic substances. Investigators supported by the NIAAA have found that 
adolescent animals are less sensitive than adult animals to the motor-
incapacitating and sedating effects of alcohol. This suggests that 
adolescents have higher drinking capacities, perhaps putting them at 
higher risk for alcohol-related problems. Other researchers have found 
that human youths who engaged in heavy, protracted drinking during 
early and middle adolescence, when compared with nonabusing adolescents 
of similar demographics, score significantly more poorly on 
neuropsychological tests, and that these deficient scores may persist. 
For example, young people who have withdrawn from alcohol recently have 
poor visuospatial functioning, and those who have withdrawn in the past 
show poor retrieval of verbal and nonverbal information.
    The Washington Post and CNN recently reported another NIAAA 
finding: An estimated one in four U.S. children is exposed to 
alcoholism in the family. The stressful and unpredictable environment 
in such families can lead to a variety of problems in these children.
                                outreach
    In addition to conducting research on adolescent alcohol abuse, the 
NIAAA has taken a leadership role in the Surgeon General's campaign to 
prevent alcohol use among youth and engages in numerous outreach 
activities. Recently, the NIAAA issued a pamphlet that educates parents 
about alcohol use among youth, and this pamphlet now is being written 
in Spanish. The NIAAA also is collaborating with the Robert Wood 
Johnson Foundation to recruit governors' spouses in a National 
Leadership Initiative to Keep Children Alcohol-Free. In January, the 
NIAAA and Mothers Against Drunk Driving held two press briefings, one 
for editors of teen magazines and the other for editors of women's 
magazines. The NIAAA and the Substance Abuse and Mental Health Services 
Administration (SAMHSA) are preparing to award a grant for public-
service announcements aimed at preventing underage drinking. In 
addition, prominent scientists and 10 college presidents have formed a 
subcommittee of the NIAAA Advisory Council, to identify ways of 
reducing binge-drinking among college students.
    Other NIAAA outreach activities include Alcohol Screening Day, the 
first of which was held last year. Almost 500 college campuses were 
among the 1,700 sites that participated. Approximately 52,000 people 
attended, and 29,000 of them asked to be screened. This successful 
event will be held again on April 6, 2000.
    To ensure that its research findings reach the people to whom they 
matter most--people who suffer from alcohol disorders--the NIAAA, in 
collaboration with State agencies and SAMHSA, cosponsors a Research-to-
Practice initiative. Senior clinical investigators spend several days 
at alcohol-treatment facilities, giving staff hands-on help in 
incorporating innovations from basic and clinical research into their 
treatment regimens.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
Prominent in the performance data is NIH's first performance report, 
which compares our fiscal year 1999 results to the goals in our fiscal 
year 1999 performance plan. As our performance measures mature and 
performance trends emerge, the GPRA data will serve as indicators to 
support the identification of strategies and objectives to continuously 
improve programs across the NIH and the Department.
    My colleagues and I will be happy to answer any questions you may 
have.
                                 ______
                                 
              Prepared Statement of Dr. Patricia A. Grady
    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's non-AIDS budget request for the National Institute of 
Nursing Research (NINR) for fiscal year 2001, a sum of $84,714,000, 
which reflects an increase of $2,672,000 over the comparable fiscal 
year 2000 appropriation. Including the estimated allocation for AIDS, 
total support requested for NINR is $92,524,000, an increase of 
$2,985,000 over the fiscal year 2000 appropriation. Funds for the NINR 
efforts in AIDS research are included within the Office of AIDS 
Research budget request.
    I would like to thank the Committee for your interest and support 
for NINR and for nursing research. In this period of rapid 
technological and demographic change, it is imperative that nursing 
research grow to help meet present and future needs and expectations of 
our nation's people for improved health care. More people will live 
longer and face chronic illness and disabilities in older age. More 
will be caregivers who will need to know how to live their own lives 
while caring for ill relatives and friends. Many will be minorities at 
risk for experiencing disparities in the incidence, prevalence and 
seriousness of disease and access to care. How people live and how they 
experience illness will be influenced by new technologies in the 
healthcare system. Increasingly, they will demand a role in managing 
their own health. Individuals will appreciate the value of prevention, 
but will still need help in achieving healthier lifestyles. And 
virtually everyone wants to die with dignity and a sense of control. 
Today I will discuss our targets for fiscal year 2001 that relate to 
these concerns.
       chronic disease--a long-range view about long-term illness
    Chronic illness continues to be an important NINR research 
emphasis. We are investigating how to both avoid complications of 
disease and disability and control symptoms such as pain, nausea and 
poor sleep. Other studies will be directed at patients who are 
discharged early from the hospital and still need substantial care at 
home. A special focus will be on family caregivers, who have varying 
expertise and financial and complex care demands for multiple lengthy 
illnesses.
    In addressing early hospital discharge, recent nursing research has 
verified the value of a transitional care model that has been tested in 
several patient populations. The model uses a multidisciplinary team 
and involves comprehensive discharge planning, including determination 
of patient care needs outside the hospital, and follow-up in the home 
by advanced practice nurses specializing in geriatrics. As the chart 
shows, six months following discharge, the intervention group of older 
adults with common medical and surgical problems had 48 percent fewer 
rehospitalizations, 54 percent fewer multiple hospital readmissions, 
and 65 percent fewer days in the hospital at a 48 percent savings to 
the healthcare system when compared to controls. Widespread use of this 
model could save significant healthcare dollars and improve quality of 
care.
    Early hospital discharge has placed a research spotlight on family 
caregivers, who often undertake the responsibility for care of their 
ill relatives. Caregivers of Alzheimer's patients bear special burdens. 
They must cope with the physical downward spiral of illness, and they 
also must deal with the stress of patients' behavioral problems that 
include agitation, depression, and wandering. Nurse researchers have 
developed a successful intervention that offers behavioral management 
skill training to caregivers. Five months after the intervention, 
researchers found that caregiver stress continued to be reduced when 
coping with disruptive behaviors of older adults in their care. The 
study also showed a moderate decrease in caregivers' perceptions of 
their burdens in providing care. Furthermore, those who were initially 
depressed were less depressed. These positive results may be applicable 
to caregivers of patients with other chronic illnesses, such as stroke 
or congestive heart failure.
    A life-long chronic illness that often starts in childhood, Type I 
diabetes, represents 5 to 10 percent of the total number of people with 
diabetes, and can seriously impact physical health and quality of life. 
Our research on adolescents with this condition compared two types of 
recommended intensive therapies--either multiple daily injections of 
insulin--three or more a day--or subcutaneous infusion of insulin 
delivered by insulin pump--a therapy which is currently used by fewer 
than 5 percent of young people. Adjusting to the insulin pump has been 
difficult for young adults, but when they are provided with an 
intervention consisting of instruction and support, the outcomes have 
been positive. Advanced practice nurses visited the adolescents every 
four to six weeks and provided them with diabetes education, 
adjustments in managing their diabetes and clinical assessments, 
including measurements of hypoglycemia and adherence to dietary 
restrictions. Investigators found that compared to teens on multiple 
daily injections of insulin, those who used the insulin pump had fewer 
severe hypoglycemic episodes and were able to maintain their blood 
glucose levels within the proper range. The ``pump'' group scores also 
showed better self esteem, coping skills, and quality of life. This 
finding identifies the education and support that enables adolescents 
to use the newer pump technology effectively.
    NINR is committed to expand chronic illness research in fiscal year 
200l to help patients manage their conditions over time. This involves 
a major investment of resources. We will focus on strategies to be 
applied broadly across chronic illnesses, including prevention of 
disease and its complications, self-monitoring by patients of the 
course of their disease, and promotion of patient success in problem 
solving and in maintaining a healthy lifestyle.
              the end of life--an emerging research focus
    Just as biomedical advances are changing the way we live with 
illness, they are also changing the way we eventually die. The duration 
of both chronic illness and the dying process has been prolonged. In 
fiscal year 2001, we will expand our focus on end of life to better 
understand at what point palliative care becomes the primary goal. We 
also need to know how best to facilitate communication and decision 
making among all involved in the end-of-life period--the patient, 
nurse, physician, family, and friends.
    NINR is pleased that the response to last year's Request for 
Applications for research on end-of-life care resulted in more than 100 
applications--an impressive result for a relatively new area of 
research. Those that were funded will form a basis upon which to build 
an important, growing effort.
                  health disparities--closing the gap
    Another area of importance to nursing research and to the nation is 
reduction of persistent health disparities among certain populations in 
our country. We must provide interventions that are more responsive to 
the needs of our multiethnic and multicultural society. Nursing 
research has long incorporated ethnic and cultural factors in designing 
projects and testing interventions--with the goal of tailoring care to 
the individual patient's needs. Yet more research is needed to identify 
why disparities exist and what to do about them.
    Let me provide an example of nursing research that addresses an 
area of disparity in a growing population. For many years, there were 
few resources available for Hispanics with arthritis to help them 
manage their condition. Limited fluency in English had the effect of 
excluding them from most health research projects. In response to this 
need, nurse researchers developed and tested a successful Spanish 
language arthritis education program. This endeavor was not limited to 
translation from English to Spanish. Cultural differences within Latino 
communities and accurate Spanish language measurement tools were also 
addressed. During the program, patients learned how to exercise, 
communicate with health care professionals, and manage pain, fatigue 
and depression. Throughout a one-year period, patients experienced 
significant improvements in all areas. The components of this course 
have provided a useful model that is being tested for Hispanic 
populations with coronary artery disease, chronic obstructive pulmonary 
disease, and Type II diabetes.
    NINR plans to continue its ongoing programs next year to help 
eradicate healthcare disparities. We will focus specifically on 
diabetes and its gaps in morbidity across ethnic groups. We will 
emphasize strategies for effective self-management of illness, and 
investigate the influence on health of genetics, education, poverty, 
diet, behavior and social support. Another goal is to increase the 
number of well-trained investigators to conduct minority health 
research. To do this, we plan to expand core research centers and 
career development opportunities.
                           clinical research
    Most nursing research studies are clinical in nature, although they 
can also involve basic research. An example of a recent finding 
concerns the use of feeding tubes to provide required nutrition. Every 
year an estimated one million hospital patients or residents of nursing 
homes are fed through use of feeding tubes. Incorrect insertion or 
dislocation of the tube may deliver food to the respiratory system, 
which can be fatal to the patient. Studies have shown that current 
clinical methods that rely on a stethoscope rather than X-rays for tube 
placement are correct only 6 to 34 percent of the time. Nurse 
investigators have discovered that an accurate, less costly alternative 
to both techniques is measuring pH and bilirubin levels in aspirated 
contents from the feeding tube. This method has identified the 
misplacement of tubes in lungs with 100 percent accuracy and is less 
expensive and safer than repeated X-rays.
    Another important innovation for clinical research and practice is 
telehealth--a long distance technology to reach underserved areas, such 
as rural communities. NINR has been active in supporting telehealth 
studies for treatment and monitoring of patients and for providing 
health information. In the next fiscal year, NINR plans to expand 
research to determine the effects of telehealth on various patient 
populations and cost savings associated with telehealth strategies. We 
also plan to target patients most likely to benefit from telehealth 
interventions, identify barriers, and find ways to integrate telehealth 
into other treatment and care regimens.
                   building nursing research capacity
    Next year provides an opportunity to initiate new programs to 
increase the nursing research capacity. In the current fiscal year, we 
are launching the Summer Genetics Institute for extramural researchers. 
This new eight-week training course emphasizes genetics in clinical 
practice, in the research laboratory, and in nursing curricula. Other 
training initiatives include an intramural career transition award that 
combines postdoctoral training with subsequent support for beginning 
research at an extramural institution.
    NINR continues its collaboration with the Office of Research on 
Minority Health in a career development program for minority nurse 
researchers. Studies being carried out by these minority investigators 
include reduction of serious developmental problems of migrant infants, 
suicide prevention in a population of rural Indian youth, and improving 
screening for prostate cancer in African-American men. NINR is also 
collaborating with the National Coalition of Ethnic Nursing 
Associations on a workshop to identify important research questions and 
training needs for minority nurse scientists.
             government performance and results act (gpra)
    Prominent in the GPRA performance data is NIH's first performance 
report which compares our fiscal year 1999 results to the goals in our 
fiscal year 1999 performance plan. As our performance measures mature 
and performance trends emerge, the GPRA data will serve as indicators 
to support the identification of strategies and objectives to 
continuously improve programs across the NIH and the Department.
                               conclusion
    In conclusion, health research, health care, and health choices are 
increasingly interdependent, and nurses and nurse researchers play a 
vital role in all three areas. Continued growth of nursing research is 
critical to meet public demands and urgent national health needs. Our 
contributions to the scientific foundation that nourishes the work of 
healthcare practitioners are already making a difference in health care 
or have significant potential to do so. This base of knowledge merits 
expansion in creative new directions. NINR looks forward to the 
challenge.
    Mr. Chairman, I am pleased to answer any questions the Committee 
may have.
                                 ______
                                 
              Prepared Statement of Dr. Francis S. Collins
    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's non-AIDS budget request for the National Human Genome 
Research Institute (NHGRI) for fiscal year 2001, a sum of $353.4 
million, which reflects an increase of $21.8 million over the 
comparable fiscal year 2000 appropriation. Including the estimated 
allocation for AIDS, total support requested for the NHGRI is $357.7 
million, an increase of $21.9 million over the fiscal year 2000 
appropriation. Funds for the NHGRI efforts in AIDS research are 
included within the Office of AIDS Research budget request. The NIH 
budget request includes the performance information required by the 
Government Performance and Results Act (GPRA) of 1993. Prominent in the 
performance data is NIH's first performance report that compares our 
fiscal year 1999 results to the goals in our fiscal year 1999 
performance plan. As our performance measures mature and performance 
trends emerge, the GPRA data will serve as indicators to support the 
identification of strategies and objectives to continuously improve 
programs across the NIH and the Department.
    This is my seventh appearance before this Subcommittee. I am again 
pleased to report that the Human Genome Project continues to be ahead 
of schedule and under budget. When I appeared before you last February, 
Human Genome Project scientists had just completed sequencing the DNA 
of the worm known as C.elegans; laying out the entire genetic code of 
an animal for the first time. At that time, 405 million base pairs of 
human DNA sequence had been deposited in GenBank by the large scale 
human DNA sequencing pilot projects that were initiated in 1996. These 
projects tested new ways to apply sequencing strategies to the large 
and complex human genome.
                          human dna sequencing
    A lot has happened in a year. Following the success of the pilot 
projects, the NHGRI, the Department of Energy, and our international 
partners (the U.K., France, Germany, Japan, and China) initiated last 
March full-scale production sequencing of the 3 billion bases that 
comprise the human genetic instruction book. The newly tested 
sequencing strategies, coupled with advances in sequencing technology, 
provided the necessary foundation to begin full-scale production.
    Later this year, this international consortium will produce a 
``working draft'' of the human genome sequence, an essential resource 
for the whole research community. The working draft will provide 90 
percent coverage of the human genome with an accuracy of 99.9 percent. 
Then we will move on to complete the final, highly accurate, finished 
human genome sequence in 2003 or sooner, two years ahead of the 
original schedule
    All sequence data produced by the international consortium is 
deposited every 24 hours in GenBank, where it is freely available to 
any researcher with an internet connection, without restrictions on 
use. The rapid public availability of the sequence is invaluable to 
academic scientists studying the molecular basis of human health and 
disease, as well as corporate researchers engaged in drug development. 
By November 17, 1999, the consortium had deposited the sequence of one 
billion bases in the human genome. Today, over half of the sequence, 
approximately 1.7 billion base pairs of non-redundant sequence, resides 
in GenBank. This marks the production of over a billion base pairs of 
human DNA since last year's hearing.
    To reach this milestone, Human Genome Project participants actually 
had to sequence over 12 billion base pairs of human DNA in overlapping 
pieces. As project manager, I know this could not have been done 
without the tireless work of the hundreds of dedicated scientists and 
technicians at the major sequencing centers. The largest five of these 
are referred to as the G-5 (the Whitehead Institute at MIT, the 
Washington University School of Medicine in St. Louis, the Baylor 
College of Medicine in Houston, the DOE's Joint Genome Institute in 
California, and the Sanger Centre in the U.K.) and will do about 85 
percent of the work.
                             chromosome 22
    The Human Genome Project achieved another historic milestone this 
year when an international scientific team announced the unraveling of 
the genetic code of an entire human chromosome for the first time. The 
33.5 million base pairs of Chromosome 22 were published in the December 
2, 1999 issue of the journal Nature. Research now will focus on 
determining what it all means. Sequencing and mapping efforts have 
already revealed that genes on chromosome 22 are implicated in the 
workings of the immune system, congenital heart disease, schizophrenia, 
mental retardation, birth defects, and several cancers including 
leukemia, but many more secrets will be discovered in this decoded 
text. The results of this work give scientists insights into the way 
genes are arranged along the DNA molecule and pave the way for major 
advances in the diagnosis and treatment of disease.
    Until last year, scientists were uncertain about whether an entire 
human chromosome could be sequenced in this manner. For example, they 
did not know whether insurmountable problems would prevent completing 
the assembly of large stretches of contiguous sequence. The work done 
on chromosome 22 not only answered any doubts about the ability to 
sequence a chromosome, it validated the strategy being pursued by the 
publicly supported Human Genome Project in sequencing the entire human 
genome.
                       beyond the human sequence
    While laying out the precise sequence of the 3 billion letters of 
the human genome is an awesome and audacious undertaking, it is but one 
of the many important objectives of the Human Genome Project. The 5-
year research plan published in the October 23, 1998 issue of Science 
outlines seven other ambitious goals critical to the success of the 
Project. One such tool is a catalog of common genetic variants.
                        human genetic variation
    Any two human beings, regardless of ethnic or racial self-identity, 
are 99.9 percent the same at the genetic level. But certain changes in 
the sequence, some as subtle as a single letter change, contribute to 
disease or disease risk. Today, to find the misspelling, or 
misspellings, that contribute to common diseases, such as cancer, 
Parkinson's disease, asthma, depression, or heart disease, researchers 
must study pedigrees and search through large chromosome 
``neighborhoods'' using the genetic map. But having the reference 
sequence, and new technologies for finding those places in the genome 
that vary among us, means that assembling a catalog of common genetic 
variants is now possible, and will greatly speed the process of disease 
gene discovery.
    Most variants will be single letter differences, known as SNPs or 
single nucleotide polymorphisms. Any SNPs found to be associated with a 
disease will provide targets for further study to understand the 
biological processes underlying health and disease and facilitate 
development of diagnostic tests. This understanding will in turn fuel 
development of improved prevention and treatment strategies. Because 
genetic variants can also contribute to individual differences in 
response to drugs, the identification and understanding of these 
variants will allow doctors to choose the most effective drug based on 
a patient's particular genetic makeup.
    In fiscal year 1999, with contributions from 16 NIH institutes, the 
NHGRI began an initiative to discover and catalog common variants in 
human DNA. In the next two years, NIH-supported researchers expect to 
find about 100,000 SNPs. Over the past year, this initiative has been 
complemented by an innovative collaboration in the private sector. Last 
April 15, a collaborative effort of 10 large pharmaceutical companies 
IBM Motorola and the Wellcome Trust, announced the formation of The 
SNPs Consortium (TSC). The Consortium's goal is to identify an 
additional 310,000 SNPs. All SNPs identified by either the NIH or TSC 
are regularly deposited into the publicly available SNP database. This 
collaboration between the public and private sectors has already 
produced and deposited 25,000 SNP's into the public database.
                    sequencing the laboratory mouse
    Last fall, NHGRI began sequencing of the genome of the laboratory 
mouse, one of The most frequently used mammals in biomedical research. 
Ten laboratories, now referred to as the Mouse Genome Sequencing 
Network (MGSN), collectively received funding. All mouse sequence 
produced will fall under the same data release principles adhered to 
for the sequencing of the human genome, i.e., assemblies greater than 
2,000 base pairs will be released to public databases within 24 hours.
    Mouse and humans are approximately 70 percent identical at the 
genetic level. Both genomes contain approximately 3 billion base pairs 
and encode an estimated 100,000 genes. The invaluable contribution of 
mouse models toward a better understanding of human disease has long 
been recognized in biomedical research. For example, mouse models 
provide scientists with unprecedented insights into the molecular basis 
of disease and the response to potential therapeutic agents. Intramural 
scientists at NHGRI are developing and utilizing mouse models to study 
a diverse array of human diseases. These include brain disorders such 
as Huntington's disease, Parkinson's disease, neural crest disorders, 
and blood disorders such as acute myeloid leukemia.
    Sequencing the mouse is a priority for a wide spectrum of 
biomedical scientists. Every institute at NIH, with support of the NIH 
Office of the Director, made a contribution to the first year of 
funding. NHGRI has assumed responsibility for funding the mouse 
sequencing network in the second year and beyond. A significant 
fraction of NHGRI's fiscal year 2000 increase is dedicated to support 
of mouse sequencing.
                        finishing the fly genome
    Looking ahead, achievement of another significant milestone is just 
around the comer. Publication of the complete sequence of the fruit 
fly, Drosophila melanogaster, is expected within a matter of weeks. The 
fruit fly is another useful model organism for studying genetics, with 
a genome of 160 million base pairs of DNA. Providing this research tool 
is important because understanding the role of a gene in the human body 
is often clarified by comparing its DNA code to that of other 
organisms.
    NHGRI supported scientists at the University of California at 
Berkeley and the Baylor College of Medicine carried out the initial 
scaffold sequencing of the fruit fly genome. In 1998, encouraged by 
NHGRI, Celera Genomics began a collaboration with these groups. In 
order to facilitate the work in both sectors, a Memorandum of 
Understanding (MOU) was prepared between the publicly funded scientists 
and Celera Genomics to outline the respective roles of each of the 
partners. The MOU maintained the public sequencing effort's commitment 
to seeing that complete, accurate sequence for this important model 
organism is made freely accessible to all scientists by requiring that 
the annotated sequence be released to GenBank upon publication.
                tools for understanding the human genome
    Once we have the sequence of the human and key model organisms in 
hand, we will need the tools to allow us to explore and understand its 
significance in health and disease. While this exploration will take 
many years, it will be aided by tools now in development by the Human 
Genome Project; tools that enable researchers to study the entire 
genome and all its genes in a single experiment.
    NHGRI has launched a number of initiatives to develop tools to 
understand gene function that will grow in coming years. One such 
initiative is the Mammalian Gene Collection, led jointly by NHGRI and 
NCL This initiative will create a complete collection of cloned and 
sequenced genes for humans and other mammals. In the future, scientists 
will be able to go to the freezer to pull out any gene they want to 
study. In parallel, new technologies such as microarrays are being 
developed, that can measure and compare the extent to which a gene is 
active under various conditions and in various tissues. The NHGRI 
intramural program is one of the world leaders in this technology. Many 
other clever approaches to studying gene function are being explored 
and the field is expanding rapidly.
    Both genomic sequencing and these new functional studies generate 
vast amounts of data that must be organized, stored and analyzed in 
order to allow scientists to pursue new leads in medical research. One 
significant outcome of the Human Genome Project has been the 
transformation of biology into a field that is rich in data, which has 
spawned a new discipline, called computational biology. New tools for 
handling data to make it readily accessible to scientists, as well as 
new approaches for understanding the significance of the data, are 
urgently needed. In view of this need, NHGRI plans to place a major 
emphasis on funding computational genomics studies in the future. In 
fiscal year 2001, NHGRI will launch a new Genome Centers of Excellence 
program to support the development of novel technology and 
computational approaches for studying the function of genomes. in 
addition to funding innovative science, these Centers will also provide 
an environment in which a new generation of genomic scientists can be 
trained. The concept for the centers is similar to that recommended by 
an Advisory Committee to the NIH Director for ``Programs of Excellence 
in Biomedical Computing.'' The NHGRI anticipates that these Genome 
Centers of Excellence will meet many of the objectives outlined in the 
Committee's report, known as the ``BISTI'' (Biomedical Information 
Science and Technology Initiative) report.
            safeguarding the fair use of genetic information
    From the outset of the Human Genome Project, the NHGRI has 
supported research into the ethical, legal, and social implications 
(ELSI) of genomic research and fostered the development of relevant 
policy recommendations. We have a fundamental obligation to assess and 
deal with concerns such as protecting the privacy and fair use of 
genetic information, and the integration of new genetic technologies 
into health care. If we do not and the public is fearful of obtaining 
or disclosing genetic information, or has limited access to genetic 
technologies, the promise of genetic medicine will not be realized and 
we will have achieved little.
    Progress on safeguarding the fair use of genetic information was 
made just in the last few weeks. On February 8, 2000, President Clinton 
signed an Executive Order to protect federal workers from 
discrimination based upon their genetic information. This is built on 
the bedrock principle that an individual's predictive genetic 
information should be used for their benefit and not for harm. A 
variety of important organizations, such as the American Medical 
Association, Hadassah, the Genetic Alliance, the American College of 
Medical Genetics, the Biotechnology Industry Organization (BIO) and the 
National Society of Genetic Counselors, immediately expressed their 
support for the President's action.
    The Executive Order, which built upon the recommendations published 
by the NIH-DOE ELSI Working Group and the National Action Plan on 
Breast Cancer, is an important step toward assuring federal workers 
that their genetic information will be kept private and be used against 
them by their employer. It also provides federal and state legislators 
with a useful template for extending protections to all workers. We 
hope to see this step built upon in 2000 by the passage of effective 
federal legislation barring the discriminatory use of predictive 
genetic information in health insurance and employment.
                               conclusion
    The dramatic progress of the Human Genome Project has exceeded the 
expectations of even the most optimistic just a few years ago. In a 
matter of months, the majority of the fundamental ``Book of Life'', the 
human sequence, will be in hand. Having this virtual guidebook to the 
human genome will permit many exciting opportunities. Combining this 
with the catalog of human variation, and with new tools and 
technologies developed by the Human Genome Project, will lead to 
unlocking the mysteries of diseases, such as diabetes, Parkinson's, 
schizophrenia, and common forms of cancer. That in turn will allow new 
approaches to prevention based on each individual's disease risk 
factors. And we can, a few years hence, predict a host of new gene-
based therapies specifically designed to fit an individual's genetic 
makeup.
    Mr. Chairman, and members of the committee, it has truly been a 
privilege to be a part of this historic effort, known as the Human 
Genome Project. At the beginning of the new millennium, genetics has 
come to encompass nearly every aspect of health research and will 
surely transform how we diagnose and treat disease in the future. It 
will enhance our concepts of shared humanity, regardless of racial or 
ethnic identity.
    My colleagues and I will be happy to respond to any questions you 
may have.
                                 ______
                                 
            Prepared Statement of Dr. Judith L. Vaitukaitis
    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's non-AIDS budget request for the National Center for 
Research Resources (NCRR) for fiscal year 2001, a sum of $602.7 million 
which reflects an increase of $33.6 million over the Fiscal Year 2000 
appropriation. Including the estimated allocation for AIDS, total 
support requested for NCRR is $714.2 million, an increase of $39.1 
million over the fiscal year 2000 appropriation. Funds for the NCRR 
efforts in AIDS research are included within the Office of AIDS 
Research.
    It is a pleasure once again to have the opportunity to present the 
accomplishments of NCRR-supported investigators and future directions 
for NCRR programs. Before the recent turn of the millennium, doomsayers 
predicted the end of the world as we know it, and in some respects they 
were right. Advances in computer technology, bioengineering, imaging 
technologies, neuroscience and genomics will revolutionize biomedical 
research in the 21st century. The NCRR mission is unique among the NIH 
institutes and centers. While the other NIH components focus on 
particular diseases, organ systems, or categories of research, NCRR 
alone has a trans-NIH mandate--to develop and maintain the research 
infrastructure that enables all lines of biomedical inquiry. This 
effort transcends both clinical and basic research. NCRR's nationwide 
networks for basic and clinical research discern the molecular causes 
of disease, develop new preventive strategies, and assess novel 
therapies for diseases that affect majority as well as minority 
populations across this Nation. By providing scientists access to 
advanced technologies and sophisticated research facilities for 
collaborative clinical and basic research, NCRR serves as a 
facilitator--or catalyst--for biomedical discovery.
    One of NCRR's main objectives is to utilize scarce or expensive 
resources to the fullest by sharing them among many investigators. This 
strategy is efficient and cost effective. Each year more than 20,000 
investigators, supported by more than $2.5 billion in competitive grant 
support from the other NIH components, use NCRR-supported research 
resources. To meet the needs of biomedical investigators for access to 
costly technologies, NCRR collaborates with the Department of Energy 
and the National Science Foundation (NSF) to provide access for 
biomedical investigators to high-energy x-rays at the synchrotron 
facilities operated by those two agencies. In addition, NCRR provides 
access to advanced computing for health-related research by partnering 
with the NSF-supported San Diego Supercomputer Center, one of the two 
National Partnerships for Advanced Computational Infrastructure 
currently supported by the NSF.
    NCRR-funded resources have been critical to numerous projects that 
advance biomedical science. Many NCRR-supported discoveries have 
immediate benefits for patients; others help basic research move 
forward toward this ultimate goal. For example, separate groups of 
scientists, using NCRR-supported beamlines for x-ray crystallography, 
have determined the three-dimensional structure of ribosomes--our 
cells' protein factories--in unprecedented detail. These studies may 
expedite discovery of newer, more effective antibiotics. Animal studies 
conducted at an NCRR-supported primate center have shown that it is 
possible, by gene therapy, to reverse the brain cell destruction that 
is characteristic of Alzheimer's disease; and NCRR-supported clinical 
investigators have developed methods to assess changes in particular 
areas of the brain of depressed patients. The identification of these 
specific brain areas is fundamental to designing improved treatments 
for depression. According to the National Institute of Mental Health, 
depression affects more than 19 million American adults and costs 
society more than $30 billion in 1990.
        bioengineering, computers, and advanced instrumentation
    The ongoing technological revolution has made it abundantly clear 
that biomedical science is no longer the sole province of physicians, 
biochemists, and biologists. Engineers, physicists, and computer 
scientists are essential partners for developing and adapting new 
instruments and technologies for health-related research. For example, 
improved imaging systems are needed to investigate the pathophysiology 
of human disease by studying patients as well as small animals and 
nonhuman primates as disease models. To obtain the same resolution as 
in humans, these imaging systems must have sensitivities that are up to 
2,500 fold greater. NCRR proposes to support further technological 
development of high resolution imaging tools that include computed 
tomography, magnetic resonance imaging (MRI), and positron emission 
tomography.
    Functional MRI imaging has provided investigators a powerful 
technology for studies of the human brain and has contributed 
significantly with other complementary technologies to a virtual 
revolution in neuroscience research. To further take advantage of these 
imaging and related technologies, NCRR proposes to support the 
establishment of regional MRI imaging resource centers where experts in 
developing and using functional MRI can work with neuroscientists to 
study brain disorders and also explore novel therapies, including stem 
cell therapy to arrest, reverse, or even cure neurodegenerative 
diseases. NCRR plans to functionally link those NCRR-supported 
Biomedical Technology Research Resource Centers equipped with 
sophisticated imaging capabilities with General Clinical Research 
Centers at the same host institution in order to accommodate patients 
from across this country for studies of neurodegenerative and other 
brain disorders, supported by NIH categoric institutes.
    The use of high-level computers and advanced computer programs are 
essential components of today's biomedical research, but many 
biomedical scientists are not sufficiently familiar with 
bioinformatics, a key enabling technology. To help alleviate this 
urgent need, NCRR proposes to establish bioinformatics centers that 
will advance research in particular areas of biomedical investigation, 
as part of the Biomedical Information Science and Technology Initiative 
(BISTI). Those centers will create homes for interdisciplinary teams 
that will establish nurturing environments for exploration and 
research. Biomedical investigators are generating data in profuse 
quantities. For example, a single biomedical laboratory can produce up 
to 100 terabytes of information a year--about the same as the 
information in one million encyclopedias. In order to be useful, the 
data must be indexed and stored, analyzed and abstracted. To facilitate 
analysis of this data, NCRR proposes to establish another program that 
will foster development of tools to design future studies.
    Synchrotron resources--which produce the high-energy x-rays used 
for determining the 3-D structures of molecules--have an enormous 
impact on structural biology and drug design. The number of NIH users 
at NCRR-supported synchrotron beamlines doubled between 1995 and 1997, 
and requests for access to these facilities are increasing at an 
exponential rate. NCRR proposes to alleviate the projected substantial 
shortfall for access to beamtime by adding more technical staff so that 
technical support is available around the clock. New beamlines at the 
Advanced Photon Source at the Argonne National Laboratory may allow 
investigators to address more advanced structural biology grand 
challenges. In addition, several new beamlines must be built at the 
Advanced Light Source at the Lawrence Berkeley National Laboratory and 
designed for high throughput studies of less complex structures to meet 
the anticipated high volume of need for this approach. This effort will 
combine new developments in beamline design, x-ray detectors, 
cryocrystallography, robotics, and computational software.
                            genetic medicine
    Manifestations of gene action are explored through phenotypic 
assessment of genetically altered animals and biologic characterization 
of macromolecules expressed by both normal and altered genes. NCRR 
proposes to support regionally-linked resource centers for phenotypic 
studies of genetically altered research animal models. These resource 
centers will provide a critical infrastructure for analysis of gene 
function in animal models of human diseases. NCRR must provide those 
regional resources and several other biorepositories for genetically 
altered biologic collections and additional funding for more technical 
staff to help maintain the rapidly expanding biologic collections. 
Additional staffing is also needed to curate and standardize the 
genetic databases for those important research models--including flies, 
fish, and worms. Without continuous updating and editing, databases 
quickly become useless and as a result, unnecessary duplication of 
research results.
                           health disparities
    NCRR proposes to help alleviate health disparities for several 
diseases that disproportionately affect minority populations by 
competitively establishing several Comprehensive Centers on Health 
Disparities (CCHD). Those centers are to be hosted by medical schools 
located at universities that have an NCRR-supported Research Centers in 
Minority Institutions (RCMI) facility for clinical research. The NCRR 
CCHD initiative will focus on diabetes, AIDS, and infant mortality, but 
initially will place increased emphasis on cancer screening and 
management of cardiovascular disease and stroke. This effort will be in 
partnership with appropriate categoric NIH institutes and with nearby 
General Clinical Research Centers.
                           research capacity
    NCRR proposes to continue support for construction or renovation of 
biomedical research facilities to assure that state-of-the-art research 
laboratories are available to conduct the most sophisticated research. 
According to a 1998 National Science Foundation survey, at least 65 
percent of biomedical research laboratories are inadequate to host 
sophisticated research. Grant awards for construction or renovation 
through NCRR's Research Facilities Improvement program are not intended 
to be the major source for institutional funding of research laboratory 
construction or renovation.
    NCRR proposes to expand its Animal Facility Improvement program to 
meet institutions' needs nationally to upgrade animal research 
facilities to perform genetic research with rodents, nonhuman primates 
and other animal models. To assist research-performing Historically 
Black Colleges and Universities and other minority-serving institutions 
in bringing their animal research facilities up to AAALAC standards, 
NCRR proposes a special initiative to address this problem.
                           career development
    Over the past several years, fewer young physicians have pursued 
research careers. To help address that problem, NCRR has initiated 
programs to increase the number of young physicians in the clinical 
research pipeline. NCRR proposes to extend that effort in fiscal year 
2001. That effort includes expanded support for a year-long medical 
student mentored clinical research training program. The intent of this 
program is to serve as a catalyst for young physicians to pursue 
careers in patient-oriented research. The institutional GCRC or the 
RCMI-funded Clinical Research Center will serve as a focal point for 
patient-oriented research, through mentored didactic training and 
``hands-on'' research. This new program will support up to 90 students 
per year. NCRR also proposes to increase the number of Mentored 
Patient-Oriented Research Career Development Awards to physicians and 
dentists at GCRC sites. This very successful program was formerly known 
as the Clinical Associate Physician (CAP) program.
    A serious shortage exists of trained veterinary pathologists to 
meet the collaborative research needs of scientists to assess the 
phenotypic manifestations of genetically altered animal models of human 
disease. To enhance the pipeline, NCRR proposes to initiate a one-year 
program for veterinary students that will provide a mentored biomedical 
research experience at research-intensive institutions. In addition, 
NCRR proposes to increase the number of Special Emphasis Research 
Career Award to train veterinarians in health-related research as 
pathobiologists. The NCRR programs are intended to address the 
inadequate number of research-trained veterinarians who participate in 
biomedical research.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
Prominent in the performance data is NIH's first performance report 
which compares our fiscal year 1999 results to the goals in our fiscal 
year 1999 performance plan. As our performance measures mature and 
performance trends emerge, the GPRA data will serve as indicators to 
support the identification of strategies and objectives to continuously 
improve programs across the NIH and the Department.
    My colleagues and I will be happy to respond to any questions you 
may have.
                                 ______
                                 
              Prepared Statement of Dr. Stephen E. Straus
    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's non-AIDS budget request for the National Center for 
Complementary and Alternative Medicine for fiscal year 2001, a sum of 
$71,362,000, which reflects an increase of $3,381,000 over the 
comparable fiscal year 2000 appropriation. Including the estimated 
allocation for AIDS, total support requested for the National Center 
for Complementary and Alternative Medicine is $72,392,000, an increase 
of $3,381,000 over the fiscal year 2000 appropriation. Funds for the 
National Center for Complementary and Alternative Medicine efforts in 
AIDS research are included within the Office of AIDS Research budget 
request.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
Prominent in the performance data is NIH's first performance report 
that compares our fiscal year 1999 results to the goals in our fiscal 
year 1999 performance plan. As our performance measures mature and 
performance trends emerge, the GPRA data will serve as indicators to 
support the identification of strategies and objectives to continuously 
improve programs across the NIH and the Department.
    At the outset, I should note that NCCAM's work reflects the growing 
public interest in complementary and alternative medicine (CAM) and the 
belief that various CAM therapies may play a role in improved public 
health. Approximately 42 percent of U.S. healthcare consumers spent $27 
billion on CAM therapies in 1997. CAM enjoys particular popularity 
among baby boomers. A number of practices, once considered unorthodox, 
have proven safe and effective and assimilated seamlessly into current 
medical practice. Diet and exercise are today commonly used to prevent 
and control disease. Acupuncture is routinely applied to manage chronic 
pain and nausea associated with chemotherapy. Some of our most 
important drugs--digitalis, vincristine, and taxol--are of botanical 
origin.
    Additional CAM practices have the potential to prevent and treat 
chronic disease, to improve understanding of how healing works and to 
be integrated into the routine practice of medicine. Absent definitive 
evidence of effectiveness, however, alternative practices may impart 
untoward consequences for large numbers of people.
    As the NCCAM's first permanent director, I am excited by the 
challenge afforded me to help provide the American public the guidance 
it deserves. As CAM use by the American people has steadily increased, 
many have asked whether reports of success with these treatments are 
valid. It is critical that untested but widely used CAM treatments be 
rigorously evaluated for safety and efficacy. It is similarly important 
to identify promising new approaches worthy of more intensive study. 
The promising areas for future investments are numerous.
    In order to best seize these opportunities, the NCCAM's strategy 
must differ from that used by other NIH Institutes and Centers. Others' 
projects are usually driven by basic science discoveries. In contrast, 
the NCCAM must focus first on definitive clinical trials of widely 
utilized modalities that, from evidence-based reviews, appear to be the 
most promising. Credible, not anecdotal, data must be provided to the 
public, and we must educate conventional medical practitioners about 
the panoply of effective CAM practices, so they can be integrated into 
patient care. In recognition of these needs, Congress responded in 1998 
by elevating the NIH Office of Alternative Medicine (OAM), expanding 
its mandate, creating the NCCAM, and affording it administrative 
authority to design and manage its own research portfolio. The Congress 
continued to reflect the growing interest in CAM by further increasing 
funding for the Center in fiscal year 2000 to $68.4 million. We are 
indeed appreciative of this support. The Congress vested the NCCAM with 
a broad statutory mandate to conduct and support CAM research, support 
research training, and disseminate information on validated CAM 
therapies. Accordingly, the NCCAM is currently developing a strategic 
plan to ensure that our continued growth, development and research 
directions are consistent with these responsibilities. Five strategic 
areas have been identified as: Investing in research; training CAM 
investigators; expanding outreach; facilitating integration; and 
practicing responsible stewardship.
    In seeking to fulfill its mandate, the NCCAM has undertaken a 
number of initiatives, established critical contacts with CAM 
practitioners, and begun to fashion the scientific underpinning that 
will enable future research discoveries.
    Before describing these activities, I want to share with the 
Subcommittee my vision of where I expect complementary and alternative 
medicine to be in the years to come. As a result of rigorous scientific 
investigation, several therapeutic and preventative modalities 
currently deemed elements of CAM will prove effective. Therefore, in 
future years, these interventions will be integrated into conventional 
medical education and practice, and the term ``complementary and 
alternative medicine'' will be superseded by the concept of 
``integrative medicine.'' The field of integrative medicine will be 
seen as providing novel insights and tools for human health, and not as 
a source of tension that insinuates itself between and among 
practitioners of the healing arts and their patients. Advances in 
neurobiology will reveal more about ancient practices such as 
acupuncture and meditation, as well as the phenomenon of ``the placebo 
effect'' as we tap the healing power of the mind. The medical basis for 
effectiveness of selected herbal and nutritional supplements will be 
clarified, leading to their standardization and routine use. Other 
modalities will be found unsafe or ineffective, and an informed public 
will reject them.
    My vision is an optimistic one. However, I am confident that, as it 
is realized, the NCCAM will have not simply expanded in those ways 
required to meet its research mission. Rather, owing to a tradition of 
superb science and consumer service, the NCCAM will become the leader--
and recognized as such--within a vibrant, and global, CAM research 
community.
    Already, I have begun to recruit key experts to join me in 
developing our programs in intramural research, clinical research, 
international and traditional health studies, and traditional medicine 
and indigenous systems. We will continue to grow our intellectual 
capital and research capacity. Setting these cornerstones in place will 
enable us, together with our partners in CAM research, to provide 
definitive answers regarding CAM treatments.
                        current research studies
    In its first year, NCCAM has developed a diverse research portfolio 
in partnership with the other NIH Institutes and Centers. I am pleased 
to highlight for you our support of some of the largest, and certainly 
the most definitive Phase III clinical trials ever undertaken for a 
range of CAM therapies.
    For centuries, extracts from the leaves of the Ginkgo biloba tree 
have been used as Chinese herbal medicine to treat a variety of medical 
conditions, including age-related decline in memory. A new NCCAM study, 
in collaboration with the National Institute on Aging (NIA), may help 
resolve these questions. This study includes four clinical centers and 
will enroll almost 3,000 participants who will receive either Ginkgo 
biloba or a placebo.
    Arthritis is a major public health problem for older Americans. 
Accordingly, in collaboration with NIAMS, NCCAM has mounted two 
critical clinical trials for the treatment of osteoarthritis. One is 
the first U.S. multi-center study to investigate the dietary 
supplements glucosamine and chondroitin sulfate--two natural 
substances, found in and around joint cartilage. The other study is an 
evaluation of acupuncture for the treatment of pain associated with 
osteoarthritis.
    I am pleased to report that our study of St. John's wort for 
depression is nearing completion. This study, sponsored by the NCCAM, 
NIMH, and the NIH Office of Dietary Supplements (ODS), represents the 
largest and most rigorous assessment of the effectiveness and safety of 
St. John's wort. Investigations of St. John's wort illustrate the 
complex challenges afforded by some CAM modalities. A recent study 
reported in The British Medical Journal showed that St. John's wort is 
more effective than placebo in treatment of depression, and perhaps as 
effective as an older generation anti-depressant drug Imipramine. 
NCCAM's study, which is considerably larger than the European trial, 
compares St. John's wort with placebo and with Zoloft, currently one of 
the most commonly used anti-depressants. However, the therapeutic 
promise of St. John's wort and of botanical products like it, is 
accompanied by risks that the public has largely ignored. An NIH study 
published February 12th in the Lancet found that St. John's wort, when 
taken together with the important HIV protease-inhibiting drug, 
Indinavir, increased the rate at which Indinavir was eliminated from 
the bloodstream, to the extent that blood levels fell below the 
acceptable level for effective AIDS treatment.
    NCCAM continues support for four Specialized Research Centers 
(cardiovascular disease, substance abuse, pediatrics and chiropractic) 
funded originally by the Office of Alternative Medicine. By the end of 
fiscal year 1999, NCCAM made five additional Specialty Research Center 
awards. The nine Center grants total approximately $63 million. Each 
focuses on one of several areas, including pediatrics, addiction, 
cardiovascular disease (CVD), minority aging and CVD, aging, 
neurological disorders, craniofacial health, arthritis, and 
chiropractic medicine. In addition to these nine Centers, NCCAM and ODS 
jointly established two Dietary Supplements Research Centers to advance 
the science of botanicals, including issues of their composition, 
safety, and biological action. Another request for Center grant 
applications focusing on asthma and cancer recently was released for 
fiscal year 2000. This, coupled with our anticipated solicitation of 
one more botanical center in fiscal year 2000, will likely bring our 
total number of NCCAM-supported centers to as many as 15.
    Benign prostatic hyperplasia (BPH), or non-cancerous enlargement of 
the prostate, is the most common benign tumor found in men. Anecdotal 
reports suggested that the botanical product saw palmetto decreases 
prostate swelling. To determine the validity of these observations, 
NCCAM, in collaboration with National Institute on Diabetes and 
Digestive and Kidney Diseases (NIDDK), is supporting the first 
rigorously designed, placebo-controlled study to evaluate the effect of 
saw palmetto extract on symptoms and quality of life in men.
                  future scientific plans and projects
    Because of the dearth of credible scientific evidence on CAM 
practices, there is unprecedented opportunity for determining the 
efficacy and safety of CAM modalities. We have developed the following 
initiatives to address them:
    NCCAM has planned a collaboration on the treatment of liver disease 
with the NIDDK and the National Institute of Allergy and Infectious 
Diseases (NIAID). The project will examine the efficacy of milk thistle 
extract--Silybum marianum--when used to treat Hepatitis C and other 
hepatic diseases.
    NCCAM has already begun a number of activities that will serve to 
facilitate the integration of validated CAM therapies into conventional 
medical practice. The NCCAM plans to make awards to foster 
incorporation of CAM information into the curricula of medical and 
allied health schools and continuing medical education programs. Also, 
the NCCAM must educate eager medical students about CAM so that they 
may knowledgeably guide an avid patient base toward safe and effective 
CAM applications. We must also work to overcome the reluctance of 
conventional physicians to consider validated CAM therapies and to 
assimilate proven ones into their practice. The Center has established 
a Clinical Research Curriculum Award (CRCA) to attract talented 
individuals to CAM research and to provide them with the critical 
skills that are needed.
    A majority of the CAM modalities practiced in this country have 
arisen from the traditional healing practices of other nations. Some of 
the practices have ``evolved'' or been adapted to work within the 
context of our society, and often in parallel with conventional medical 
practices. Moreover, most of these practices are not well documented 
within the context of their native cultures or understood within the 
context of our own. Unraveling these issues will provide some important 
insights into how these CAM modalities are practiced and impact upon 
the health of U.S. minority populations--new immigrants like Hmong 
(from southeast Asia) and established groups like the Navajo. Likewise, 
the development of culturally sensitive studies will enable NCCAM to 
establish methodological feasibility and strengthen the scientific 
rationale for proceeding to full-scale, randomized, clinical trials on 
the application of traditional, indigenous systems. The ability to 
validate some of these therapies will also expand healthcare options 
for those who are primarily consumers of convention medicine. The 
international character of CAM necessitates that the NCCAM develop a 
broad-based international research program that reaches out to CAM 
practitioners across the world. Therefore, in collaboration with 
several other ICs, NCCAM is committed to support locally-based, 
traditional, indigenous research projects in countries where the 
opportunities for promising CAM research are greatest. That process 
will ensue with the forthcoming appointment of a Director for 
International and Traditional Medicine Studies, who will develop a 
long-range plan for the pursuit of studies on a global scale. 
Foreshadowing this appointment, I have already authorized NCCAM 
support, in collaboration with the NICHD, for international studies of 
traditional medical approaches to the health of women and children.
    The NCCAM will establish an Intramural Research Program that will 
develop a critical mass of CAM research to stimulate collaboration in 
the NIH Clinical Center with other Institutes and Centers, our Federal 
research partners, and others. The intramural program will serve as a 
focus for training future CAM researchers. Last month I formed a search 
committee to identify the Director of this program.
                       information dissemination
    Specific statutory authority enables the NCCAM to disseminate 
information regarding the safety and effectiveness of CAM therapies to 
health care providers and the public. A focal point for information 
about NCCAM programs and research findings, the NCCAM Information 
Clearinghouse develops and disseminates fact sheets, information 
packages, and publications to enhance public understanding about CAM 
research supported by the NIH. Its quarterly newsletter, Complementary 
& Alternative Medicine at the NIH is distributed to 6,000 subscribers. 
The NCCAM's award winning World Wide Web site, first established two 
years ago, reflects the NCCAM's growth in size and stature. Averaging 
more than 460,000 hits per month, the site includes links to NCCAM 
program areas, news and events, research grants, funding opportunities, 
and resources. Assembled by NCCAM from the National Library of 
Medicine's (NLM) MEDLINE database, the CAM Citation Index (CCI) affords 
the public access to approximately 175,000 bibliographic citations 
searchable by CAM system, disease, or method. Also, in February 1999, 
NCCAM joined the federally supported Combined Health Information 
Database (CHID), which includes a variety of health information 
materials not available in other government databases, including nearly 
1,000 CAM citations not available elsewhere.
    To facilitate our outreach to the general public, I have initiated 
a series of town meetings; the first will be held on March 15 in 
Boston, in conjunction with the Center for Alternative Medicine and 
Education of Beth Israel Deaconess Medical Center.
    I am now happy to take your questions about these or any other of 
NCCAM's activities and plans.
                                 ______
                                 
     Prepared Statement of Dr. Gerald T. Keusch, Director, Fogarty 
                          International Center
    Mr. Chairman and Members of the Committee, I am pleased to present 
the President's non-AIDS budget request for the Fogarty International 
Center (FIC) for fiscal year 2001, a sum of $32,532,000, which reflects 
an increase of $3,620,000 over the comparable fiscal year 2000 
appropriation. Including the estimated allocation for AIDS, the total 
support requested for the FIC is $48,011,000, which is an increase of 
$4,683,000 over the fiscal year 2000 appropriation. Funds for the FIC 
efforts in AIDS research are included within the Office of AIDS 
Research budget allowance.
    I am delighted to relate our progress over the past year and our 
proposed plans for fiscal year 2001. The FIC has taken a lead role in 
formulating and implementing biomedical research and policy. The 
programs of the FIC, developed in close consultation with this 
Committee, reflect our Nation's enduring commitment to global health 
equity. But disparities in health still exist. While one-fifth of the 
world's population enjoys an average life expectancy approaching 80 and 
a life comparatively free of disability, two-thirds of the world's 
population, living in the least well-off countries of Africa, Asia, and 
Latin America, suffer overwhelmingly from the world's burden of illness 
and premature death. According to statistics compiled by the World 
Health Organization (WHO), each year in the developing world 15 million 
children die from infection and malnutrition--40,000 children per day--
and the toll in sickness and life-long disability has even greater 
social, economic, and political consequences. Arguably, reversing this 
deepening disparity is a public health urgency in the new decade that 
demands increasingly creative actions from the scientific community.
    Disparities in health are not limited by national boundaries. 
Research on conditions related to poverty in resource-poor nations have 
universal applications. Most recently, this has been demonstrated by 
the development of short-course treatment regimens for tuberculosis, 
field tested initially in Tanzania and now applied by public health 
authorities throughout the United States. Adapting research advances in 
biomedicine to populations at home and abroad requires a continuing 
commitment to basic science as well as rigorous clinical and applied 
studies. Our mandate at FIC is to serve as NIH's international catalyst 
by enabling U.S. institutions to extend the geographic scope of 
research and training. FIC supports over one hundred U.S. institutions 
that collaborate with more than ninety nations. These efforts are 
multidisciplinary, embracing clinical, epidemiological, basic 
biomedical and behavioral research. They are multisectoral, coordinated 
with our sister institutes at NIH and with international organizations 
with health and development mandates, including the World Health 
Organization and World Bank.
    One principal strategy of the FIC is to create the human capital 
and institutional capabilities in developing nations necessary for a 
productive research enterprise. FIC places priority in four foundation 
disciplines: First, information science and technology, as both an 
analytical tool and a means to create global laboratories without 
walls; second, epidemiological and clinical methodologies necessary to 
characterize disease burdens and devise and evaluate therapeutic or 
preventive interventions; third, human genetics and genomics, so that 
developing nations may contribute to and benefit from international 
efforts to apply genetic discoveries to clinical practice and 
therapeutics; and fourth, ethical principles and practice in patient-
oriented research, with the intent of ensuring the depth and 
transparency of the process of ethical review and the involvement of 
co-investigators and study volunteers as equals in accordance with 
international guidelines as well as local norms.
    The selected examples that follow characterize several of our 
leading priorities in global health research and training.
          developing cost-effective methods of preventing hiv
    Over ninety percent of the world's estimated 33 million persons 
infected with HIV live in developing countries (UNAIDS). Within the 
next five years, 61 of every 1,000 children born in southern Africa 
will not reach their first birthday due to AIDS and increasing 
longevity gains will be reversed. Progress in preventing future 
infections is dependent on rigorous scientific links with developing 
nations. This is the objective of FIC's AIDS International Training and 
Research Program, the most extensive HIV research and training network 
among U.S. schools of medicine and public health and counterparts in 
developing nations. In partnership with the National Institute of 
Allergy and Infectious Diseases, FIC provided training and 
infrastructural support for Ugandan-based trials to prevent perinatal 
HIV transmission through regimens of the anti-retroviral drug 
nevirapine. A single oral dose given to an HIV-infected women in labor 
and another given to her infant within three days of birth reduced the 
transmission rate by half at a cost of $4.00 per mother-infant pair. If 
implemented widely in developing nations, this intervention could 
prevent some 400,000 newborns per year from beginning life infected 
with HIV.
   novel approaches to treatment and control of emerging infectious 
                                diseases
    Coupled with the AIDS crisis, parasitic and other infections 
continue to compound the burdens of mortality and chronic illness as 
well as impede economic growth in affected regions. According to WHO, 
malaria kills close to 2 million people each year, most are children 
under the age of five, and an estimated \1/2\ to 1 billion cases of 
malaria occur, and this is closely associated with poor economic 
performance in the affected countries. Progress will require a new 
public health paradigm: An integrated approach to prevention and 
control, incorporating improvements in case management, rational drug 
use to limit the spread of resistance, monitoring and evaluation of 
control measures, and development of new diagnostic tools, drugs and 
vaccines. Moreover, the spread of HIV is hastened through the use of 
unscreened blood to treat the life-threatening anemia that often 
develops in malaria-infected individuals. This reinforces the need for 
operational strategies to ensure the safety of the blood supply and 
transfusion practices for the anemia of malaria, a major complication 
of the infection. The Multilateral Initiative on Malaria (MIM), an 
alliance of scientific and development agencies and African partners, 
was launched with major support from FIC and NIAID to address these 
critical needs. FIC now serves as the worldwide focal point for the 
MIM. To promote the agenda to reduce the burden of malaria, FIC has 
initiated a new research and training program to link U.S. and, in 
particularly, African institutions. The MIM constitutes a maturing 
model--a paradigm of cross-sectoral cooperation that FIC hopes to adapt 
to other global health urgencies.
    The field of malaria and other tropical infections has reached a 
watershed, demonstrating the potential for application of tools of 
molecular and cell biology to render formerly intractable problems 
approachable. For example, dengue fever and its most severe form, 
dengue hemorrhagic fever/dengue shock syndrome, are considered among 
the most important and widespread reemerging infectious diseases in the 
developing world, including the Caribbean. Global warming impacts on 
mosquito vectors that makes this a threat to the U.S. mainland as well. 
To date, existing methods to diagnose and characterize dengue viruses 
have been costly and complicated to perform, particularly in developing 
countries with limited capabilities and resources. Under FIC support, 
the University of California at Berkeley and the Ministry of Health in 
Nicaragua have developed a new technique to rapidly, accurately, and 
inexpensively define the virus responsible for dengue in Central 
America. This method is known as restriction site-specific PCR 
(polymerase chain reaction). Using this new information, local health 
authorities now are able to track the movement of the dengue virus from 
Asia and Africa to the Americas, which is the start of control efforts.
    Dengue is among more than thirty-five infectious diseases that have 
emerged or reemerged around the world in the past twenty-five years. 
Most recently, the outbreak of encephalitis in the New York region was 
attributed to the West Nile Virus, its first known introduction into 
the Western hemisphere. Although it is not clear how the virus migrated 
to the United States, this outbreak is representative of the continual 
challenge that newly emerging microbes present for U.S. citizens. 
Emerging infectious diseases are infections that are new in the 
population, rapidly increasing in incidence or expanding in geographic 
range. Most are caused by ``microbial traffic''--that is, the 
introduction and dissemination of existing agents into human 
populations either from other species or from smaller populations, 
often precipitated by rapid ecological and environmental change. To 
better comprehend the consequences of changes in terrestrial and marine 
ecosystems on human health, the FIC, in partnership with several NIH 
Institutes, the National Science Foundation, and other U.S. agencies, 
initiated an interdisciplinary research program to elucidate the 
underlying biology of habitat and biodiversity changes that may lead to 
increased disease prevalence in humans and, thus, fill an important gap 
in our understanding of these interrelated dynamics. With this 
information, we will be able to develop data and predictive models to 
anticipate future outbreaks and devise corrective actions before the 
disease strikes.
taking steps to address emerging epidemics of noncommunicable disease: 
                      fiscal year 2001 initiatives
    The classic burdens of infectious diseases in developing nations 
are now joined by a new class of epidemics. According to the Global 
Burden of Disease Study commissioned by the World Bank, over the next 
twenty-five years as populations age and risk exposures shift, non-
communicable diseases will become the leading source of disability and 
premature death in developing nations. Both the pace of these changes 
and the sheer numbers affected will exceed the Western experience. By 
working in partnership with scientists in low- and middle-income 
nations, risk factors may be evaluated and interventions developed that 
will be of benefit to both industrialized and developing nations. The 
emerging epidemics of chronic disease in developing nations constitute 
FIC's major programmatic thrust for fiscal year 2001.
    In cooperation with the WHO Tobacco Free Initiative and multiple 
NIH partners, FIC will establish a research and training program to 
improve international efforts to control the tobacco epidemic. Among 
other objectives, the program will address large gaps in our knowledge 
relating to the burden of death and disability associated with tobacco 
use in developing nations, such as behavioral determinants of smoking 
uptake in youth. The Center also will launch a similar effort directed 
at prevention and management of mental health disorders--an unseen 
epidemic in most developing countries. At any give time, an estimated 
10 percent of the population in developing nations suffers from severe 
anxiety, depressive disorders and other psychosocial problems (World 
Mental Health: Problems and Priorities in Low-Income Nations, Oxford 
University press, 1995). Through international partnerships, we hope to 
begin to rectify the shortfall of well-trained clinical investigators 
and epidemiologists in mental health fields in developing nations. 
Moreover, we will begin to generate epidemiological data on the 
incidence of mental health disorders and risk factors, including 
sociocultural determinants of mental health in societies undergoing 
transition to industrialized economies.
    In fiscal year 2001, the FIC also proposes to create new linkages 
with developing nations in the field of molecular medicine, emphasizing 
research and training related to the complex interplay between genes 
and the environment. The genetic maps, physical maps and technologies 
that have emerged from the human genome sequencing effort have enabled 
the research community to accelerate dramatically the discovery of 
genes underlying disease or risk factors for disease. We are now 
positioned to advance understanding of population genetics and dynamics 
for chronic conditions that affect industrial and developing nations 
alike, such as hypertension, type 2 diabetes, asthma, and breast 
cancer. FIC's long-range goals are to define some of the genes involved 
in multigenic disorders of global priority and then test the predictive 
strength of these particular polymorphisms in prospective, community-
based studies. Ultimately, diagnostic, therapeutic, and prevention 
strategies will evolve.
    Our current efforts in this field already have yielded promising 
leads. Scientists at the University of Washington have teamed with 
scientists from Tel Aviv University in Israel and Bethlehem University 
in the Palestinian Authority to map and clone the genes responsible for 
different types of inherited deafness--both progressive and early-
onset. The incidence of preverbal deafness is an estimated five to ten 
percent in this region, among the highest in the world. Loss of hearing 
may be due to environmental factors or to genetic mutations in any one 
of a large number of genes. These genes encode proteins crucial for the 
proper development, structure and function of the inner ear. There may 
be more than 100 such genes, however only a fraction have been 
identified. Identifying these genes and defining the mutations that 
cause deafness through these novel studies will lead to a better 
understanding of the biology of hearing.
                               conclusion
    These programs and initiatives are representative of a broad 
spectrum of international research and training efforts supported by 
FIC. The programs of FIC recognize a deeper philosophic purpose and 
vision. Advances in biology over the past decades have demonstrated 
social and global interdependence. This is a condition of health for 
the biosphere as much as it is an imperative of societal well-being. 
There is a deepening consensus that individuals and nations share an 
inherited and acquired sense of social altruism--an understanding of 
common fate and a shared set of social obligations. The pursuit of 
health through international scientific cooperation is an inherently 
global enterprise and one that ultimately improves the public health of 
this Nation as well.
    The NIH budget request includes performance information required by 
the Government Performance and Results Act (GPRA) of 1993. Prominent in 
the performance data is NIH's first performance report, which compares 
our fiscal year 1999 results to the goals in our fiscal year 1999 
performance plan. As our performance measures mature and performance 
trends emerge, the GPRA data will serve as indicators to support the 
identification of strategies and objectives to continuously improve 
programs across the NIH and the Department.
    Thank you, Mr. Chairman. I will be pleased to answer any questions.
                                 ______
                                 
             Prepared Statement of Dr. Donald A.B. Lindberg
    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's non-AIDS budget for the National Library of Medicine 
for fiscal year 2001, a sum of $224,942,000, which reflects an increase 
of $14,806,000 over the comparable fiscal year 2000 appropriation. 
Including the estimated allocation for AIDS, total support requested 
for NLM is $230,135,000, an increase of $16,067,000 over the 
appropriation for fiscal year 2000. Funds for the NLM's efforts in AIDS 
research are included within the Office of AIDS Research budget 
request.
                   health information for the public
    In the best tradition of American enterprise, NLM has within a few 
short years re-engineered its information services to benefit directly 
both health professionals and the public. The public has always been 
the ultimate beneficiary of NLM's services. But today's consumer now 
has the same access as doctors and scientists to the Library's immense 
databanks. NLM has also created new services aimed directly at the 
general public that are proving popular with Web users. These changes, 
encouraged by this Committee and supported by Congress, have been 
endorsed by NLM's Board of Regents.
    The NLM has a two-step strategy to maximize the utility of its 
services. The first is to respond to the needs of the Web-using public. 
It is estimated that 40 to 50 percent of Americans are connected to the 
Internet, and health information is a popular topic for searching. In 
three years the Library has seen the number of searches on its MEDLINE 
database rise from 7 million searches a year to 250 million. The 
Library estimates that 30 percent are done by the members of the public 
for themselves and their families. That a database of 10 million 
references and abstracts to medical journal articles would prove to be 
so popular is remarkable and demonstrates an eagerness for 
authoritative health information by the public.
    The Library has created for consumers a new service, MEDLINEplus, 
to complement its databases of scientific literature. MEDLINEplus has 
grown rapidly in little more than a year, and provides links to 
information on 350 diseases and medical conditions. This information, 
reviewed and selected by highly trained medical librarians, originates 
from such trusted sources as the Institutes of NIH and professional 
societies. NLM constantly scans these and other organizations for up-
to-date information and the links are checked daily. MEDLINEplus 
contains a feature unique in the world of Web-based information for the 
public: carefully pre-formulated searches of the MEDLINE database that 
will return references and abstracts deemed especially useful for the 
average consumer.
    A new service, ClinicalTrials.gov, was introduced by NLM on behalf 
of NIH in February 2000. This database, accessible through MEDLINEplus, 
contains vital information about thousands of clinical trials sponsored 
by the NIH and other Federal agencies. Now patients, families, and 
members of the public can find out about cutting-edge research being 
conducted around the U.S. and whether they are eligible to join a 
study. ClinicalTrials.gov contains a statement of purpose for each 
clinical research study, together with the recruiting status, the 
criteria for patient participation in the trial, the location of the 
trial, and specific contact information. The database will be expanded 
to include clinical trials sponsored by private industry and in other 
countries.
    Not all Americans, however, can search the Internet. Thus, NLM's 
second strategy is to improve access for this group by encouraging 
medical libraries to work with local public libraries and other 
community organizations. In 1999 NLM completed a pilot project with 
public libraries in nine states and the District of Columbia. The 
purpose was to evaluate whether these libraries, using the Internet, 
could help meet the needs of the public for good health information. 
The project revealed that MEDLINEplus is an excellent place for 
consumers to begin their search and that public librarians need 
training in answering health reference questions and in finding and 
evaluating health information on the Web. Building on what we learned 
in this project, the NLM made awards in February 2000 to fund 49 
electronic health information projects in 34 states that will increase 
Internet access in many settings, from middle schools serving low 
income and educationally underserved students to shopping malls and 
senior centers. These imaginative and well-targeted projects will 
stimulate medical libraries, local public libraries, and other 
organizations to work together to provide electronic health information 
services for all citizens in a community. Crucial in this effort is the 
Regional Medical Libraries and members of the National Network of 
Libraries of Medicine.
                           health disparities
    The NLM has in place a number of programs that in recent years have 
been directed toward remedying the disparity in health opportunities 
experienced by segments of the American population. One of these 
programs deals with toxic waste sites and other environmental and 
occupational hazards that are much more likely to occur near homes in 
poor neighborhoods than where affluent Americans live. The Library has 
a program to train health professionals, community leaders, and others 
in minority neighborhoods to use the NLM's databases of information 
about hazardous waste information. The Library provides minority 
schools with state-of-the-art equipment, software, and free access to 
computerized information sources, including NLM's own toxicology and 
environmental health information databases. Other Federal agencies have 
joined with NLM and the project has grown from 9 participating minority 
institutions to more than 60.
    Similar to the program for toxicology and environmental health, the 
Library has been working with institutions that serve minority 
populations to encourage the use of NLM information services relating 
to HIV/AIDS. These include the databases AIDSLINE (references and 
abstracts), AIDSTRIALS (clinical trials), AIDSDRUGS (drugs being 
tested), and DIRLINE (organizations that provide health information to 
the public). The NLM has in place a program to train health 
professionals, community organizers, information professionals, and 
patient advocates in the use of these resources. Requests for this 
training have been strong and sustained, and NLM has responded to the 
extent its resources permit. In addition to the programs mentioned 
above, NLM grants and contracts have been targeted to support health 
information programs for African Americans, Latinos, and Native 
American populations in the south; rural hospitals in the Midwest; 
Native Americans in Alaska and the Pacific Northwest; African American 
and Latino populations in the Pacific Southwest; and Puerto Rico. To 
illustrate, telemedicine in rural Alaska is being tested as a strategy 
for controlling costs and for raising the quality of health care for a 
minority population that is scattered across a vast area.
    The NLM is a key participant in the Multilateral Initiative on 
Malaria Research effort in Sub-Saharan Africa. Scientists in many 
developing countries are unable to communicate easily with other 
scientists, search biomedical databases, or collaborate with colleagues 
in industrialized countries. This results in poor coordination and 
monitoring of research, redundancy of effort, and a growing disparity 
in research productivity. The Library is supporting the implementation 
of high end communications hardware and software in remote malaria 
research sites in Mali, Kenya, Cameroon, Ghana, and Tanzania. Since 
Internet connections can effectively carry voice, data, and video image 
transmissions, the Library is helping to bring them to scientists in 
those countries. The Ghana sites, for example, are engaged in malaria 
vaccine development and testing readiness.
                          medical informatics
    A recently released report recommends that the NIH invest heavily 
in computer and information technology so as to be able to manage data 
and model biological processes. It also observes that there is an acute 
need for training specialists competent in computational biology. This 
recommendation falls within the scope of the NLM's medical informatics 
training program under which the Library supports 12 programs at U.S. 
universities to train experts to carry out research in general 
informatics and in the genome-related specialty of bioinformatics. NLM 
plans to augment some of these training programs with additional 
resources so that they can make use of the advantages they already 
enjoy: experienced faculty, curricula, sanctioned university status, 
and ready access to potential candidates. NLM envisions expanding the 
program beyond 12 centers with the addition of training awards to new 
institutions.
    To ensure that the Internet will continue to support the health 
sciences, the NLM is a strong supporter of the Next Generation Internet 
(NGI), a partnership of industry, academia, and government agencies 
that seeks to provide affordable, secure information delivery at rates 
thousands of times faster than today. Advanced medical imaging, for 
example, requires more bandwidth than is currently available. Other 
applications require a guaranteed level of service (for example no data 
loss, or assured privacy protection) that today's Internet cannot 
provide. To help the health sciences prepare to use the capabilities 
the next few years will bring, the Library is supporting the 
development of innovative medical test-bed projects that demonstrate 
the application and use of the capabilities of the Next Generation 
Internet. Spread out over three phases, the support includes a variety 
of telemedicine-related projects, advanced medical imaging, and 
patient-controlled personal medical records systems. In the last phase 
there will be a scale-up of especially promising projects to regional 
or national level.
    The Visible Human Project is an example of a program that requires 
both advanced computing techniques and the capability of the Next 
Generation Internet. The two very large datasets of anatomical data 
represented by the Visible Human Male and Female are being used 
(without charge) by 1,240 licensees in 41 countries, and at four mirror 
sites in Asia and Europe. In addition to the varied uses to which these 
licensees are applying the data (for example, recyclable cadavers, 
virtual colonoscopies, and brain surgery rehearsal), the Library is 
seeking to create a public software ``toolkit'' that will allow anyone 
to use the data to ``create'' any anatomical object. A collaborative 
project of the NLM, in partnership with several NIH Institutes and the 
National Science Foundation, is extending the Visible Human Project by 
developing an extremely detailed atlas of the head and neck.
                          genetics of medicine
    As a result of the accelerating pace of research, the GenBank 
database of DNA sequence information maintained by NLM's National 
Center for Biotechnology Information is growing to gargantuan sizes. It 
now contains some 5 million sequences with a total of nearly 5 billion 
base pairs, and the NCBI Web site, where GenBank is made freely 
available, receives some 800,000 queries per day from 120,000 
scientists and others around the world. In addition to academic 
institutions, major biotechnology and pharmaceutical firms are among 
the heaviest users of the NCBI Web site. They not only search GenBank, 
but use NCBI-created computational tools such as that which allows 
researchers to use the growing body of known 3-dimensional structures 
to infer approximate 3D sequence structure from similarity 
relationships. NCBI scientists have also collaborated with 64 
colleagues from government, university, and commercial laboratories 
around the world to produce a new ``gene map'' that pinpoints the 
chromosomal locations of almost half of all human genes. This milestone 
in the Human Genome Project, available on the Internet, will expedite 
the discovery of human disease genes and by extension, contribute to 
advances in detection and treatment of illnesses.
                             basic services
    Despite the NLM's extensive involvement with computer and 
communications technology, the staff is ever mindful of its 
responsibility to maintain the integrity of the world's largest 
collection of medical books and journals. Increasingly, this 
information is in digital form, and the NLM, as a national library 
responsible for preserving the scholarly record of biomedicine, is 
developing a strategy for selecting, organizing, and ensuring permanent 
access to digital information. Regardless of the format in which the 
materials are received, ensuring their availability for future 
generations remains the Library's highest priority. The expanding NLM 
collection and research and development programs continue to put 
pressure on current NLM storage capacity. The issue of NLM space needs 
will be considered as NIH revises its Master Plan. In the meantime, NIH 
has assigned NLM space in the Natcher Building, located adjacent to the 
NLM Building to address the immediate needs as longer term options are 
developed and evaluated.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
As our performance measures mature and performance trends emerge, the 
GPRA data will serve as indicators to support the identification 
strategies and objectives to continuously improve programs across the 
NIH and the Department.
    My colleagues and I will be happy to respond to any questions you 
may have.
                                 ______
                                 
                Prepared Statement of Dr. Neal Nathanson
    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the AIDS research programs of the 
National Institutes of Health for fiscal year 2001, a sum of 
$2,111,224,000, an increase of $105,041,000 above the comparable fiscal 
year 2000 appropriation. NIH budget request includes the performance 
information required by the Government Performance and Results Act 
(GPRA) of 1993. Prominent in the performance data is NIH's first 
performance report which compares our fiscal year 1999 results to the 
goals in our fiscal year 1999 performance plan. As our performance 
measures mature and performance trends emerge, the GPRA data will serve 
as indicators to support the identification of strategies and 
objectives to continuously improve programs across the NIH and the 
Department.
    The Office of AIDS Research (OAR) is responsible for setting the 
scientific agenda for the large and diverse NIH AIDS research program. 
To this end, we develop the annual AIDS research plan and budget, based 
on the most compelling scientific priorities that will lead to better 
therapies and prevention for HIV infection and AIDS. Those priorities 
are established through a collaborative process involving the NIH 
institutes and non-government experts from academia and industry as 
well as the full participation of the AIDS-affected community.
    Mr. Chairman, at our hearings here last year initiated 
unprecedented attention on the international dimension of the AIDS 
epidemic. Your support and attention to critical global needs at those 
hearings were a catalyst for efforts that have increased throughout the 
year. In January, the United Nations Security Council declared that 
AIDS is now a national security issue, representing a new kind of 
threat to political stability. AIDS in Africa is killing ten times as 
many people as war, sabotaging economic development, leading to massive 
social breakdown, and creating a generation of orphans. Ambassador 
Richard Holbrooke called AIDS ``a direct, cancerous growth on the 
political, social, and economic security of Africa.''
                        the unrelenting pandemic
    By every definition, AIDS is the great plague of the 20th century--
an epidemic of biblical proportions. (Chart 1) AIDS already has killed 
more than 16 million people, surpassing tuberculosis and malaria as the 
leading infectious cause of death worldwide, according to recent data 
from the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the 
World Health Organization (WHO). In 1999, a record 2.6 million people 
died from AIDS--more than in any prior year. UNAIDS estimates that in 
India between 3 and 5 million people are infected, with new infections 
doubling every 14 months. New epidemics are rapidly increasing in 
Russia, Eastern Europe, and in China. AIDS remains a serious threat in 
Latin America and the Caribbean. Africa (Chart 2) remains the epicenter 
of the pandemic, bearing the largest disease burden, with 70 percent of 
people living with AIDS worldwide, 83 percent of global AIDS deaths, 
and 95 percent of the world's AIDS orphans. HIV-infected women aged 15 
to 49 outnumber infected men. In Harare, the capital of Zimbabwe, 40 
percent of adults are HIV-infected. The impact of AIDS on developing 
nations and many former communist countries is staggering, with even 
greater potential disaster to come. AIDS is reversing decades of 
progress from important public health efforts, lowering life 
expectancy, and significantly affecting international businesses. Lost 
productivity and profitability, the cost of sickness and death 
benefits, and the decline in a skilled workforce in the developing 
world will have economic effects worldwide. AIDS is affecting the 
military capabilities of some countries as well as the international 
peacekeeping forces.
               the evolving epidemic in the united states
    In the U.S., the incidence of new AIDS cases has declined, thanks 
largely to expanded use of new antiretroviral therapies that prevent 
progression of HIV infection to AIDS. The previous decline in death 
rates has now leveled off. The state of Illinois just announced a 24 
percent increase in AIDS cases in 1999. Most significantly, the annual 
incidence of new HIV infections has not declined since 1990 (Chart 3). 
This means that although therapeutic interventions are delaying death, 
at least for a time, we have not slowed the epidemic. Chart 4 shows 
that HIV infection rates are continuing to climb in two major groups--
women and minorities. Rates are also increasing in young homosexual men 
and people over 50 years of age. AIDS affects the disenfranchised in 
our society--the poor, the homeless, and those with addictive or mental 
disorders. Further, drug resistant strains of HIV present a serious 
public health concern.
    These data forebode an epidemic of even greater magnitude ahead, 
and shape our most urgent research priorities. These priorities (Chart 
5) address two critical populations--those living in developing 
countries, and the minority populations of the U.S.--with a two-pronged 
agenda: therapeutic research to treat those who are already infected; 
and prevention research to reduce HIV transmission. Our prevention 
agenda includes both vaccine and non-vaccine strategies, such as 
behavioral research, development of topical microbicides, and 
prevention of perinatal transmission.
                    priority: international research
    We are increasing our international AIDS research porfolio. As more 
than 90 percent of new infections occur in developing countries, where 
therapeutic interventions are unaffordable and undeliverable, NIH is 
pursuing interventions that can be implemented in these resource--and 
infrastructure-deprived nations. I will cite just a few examples. A 
recent NIAID-sponsored clinical trial in Uganda demonstrated that 
nevirapine, an antiretroviral drug costing less than $4, given once to 
the mother and once to the baby at birth, could reduce mother-to-child 
transmission by 50 percent. The NIH vaccine research effort underscores 
the crucial role of NIH in addressing prevention needs worldwide. 
Clinical trials within both the new NIAID Vaccine Trials Network and 
Prevention Trials Network are expected to involve international sites. 
The OAR is supporting the first international conference on 
microbicides to stimulate new research initiatives in this critical 
area. To further our efforts and enhance international collaboration, 
the Fogary International Center is expanding its research and training 
programs in many developing nations. The OAR fiscal year 2002 annual 
plan, which we are now developing, includes a special section for 
international research, and we have established an International AIDS 
Research Collaborating Committee to bring together all of the 
Departments of the U.S. government conducting AIDS research, along with 
international partners such as the UNAIDS and the World Bank.
           priority: health disparities in the united states
    The disproportionate impact of the HIV/AIDS epidemic on U.S. 
communities of color is demonstrated graphically on Chart 6. AIDS 
remains the number one cause of death among young African American men. 
OAR established a new group, the Ad Hoc Working Group on Minority 
Research, to advise us on the scientific priorities in this critical 
research area, and we added a new section to our plan on research 
targeting minorities. We are directing increased resources toward new 
interventions that will have the greatest impact on these groups, 
including those that address co-occurrence of other STDs, hepatitis, 
drug abuse, and mental illness, and interventions that consider the 
role of culture, family, and other social factors in the transmission 
and prevention of these disorders in minority communities. NIH is 
making significant investments to improve research infrastructure and 
training opportunities for minorities, and we will continue to assure 
the participation of minority subjects in AIDS clinical trials as well 
as natural history, epidemiologic, and prevention studies. In 
accordance with the Congressional Black Caucus initiative, the OAR has 
provided additional funds to projects aimed at: increasing the number 
of minority investigators conducting behavioral and clinical research; 
targeting the links between substance abuse, sexual behaviors and HIV 
infection; increasing outreach education programs targeting minority 
physicians and at-risk populations; and expanding our portfolio of 
population-based research. We estimate that with this budget request, 
NIH will devote approximately $427 million to research targeting AIDS 
in minority community communities.
                       priority: better therapies
    The development of protease inhibitors has had a significant impact 
on the length and quality of life for many HIV-infected people in the 
U.S. But the news in this area is not good. At the recent scientific 
meeting on retroviruses, the overriding theme was the long and serious 
list of problems for patients receiving these HIV therapies, including: 
(1) failure to obtain a satisfactory reduction in viral load even for 
patients who comply with treatment regimens; (2) expensive and 
complicated regimens that make compliance difficult; (3) drug 
toxicities; (4) metabolic and cardiac complications, including 
diabetes; and 5) drug resistance. We must develop and test new, 
simpler, less toxic, and cheaper anti-HIV drugs. Chart 7 summarizes our 
key priorities to accomplish that goal: (1) develop new targets for the 
design of new antiviral drugs; (2) conduct clinical trials to answer 
key questions such as: At what point in the disease process should 
therapy be initiated and which combination of drugs should be used? At 
what point should the drugs be switched and to which drugs? How can 
toxicities and drug resistance be prevented? How can regimens be 
simplified and compliance improved? and (3) translate research results 
into clinical practice information that is useful to caregivers and 
their patients, particularly in minority communities.
                        priority: hiv prevention
    NIH supports a comprehensive approach to HIV prevention research 
that includes contributions from the biomedical, behavioral, and social 
sciences. The OAR prevention science research agenda (Chart 8) targets 
interventions to both infected and uninfected at risk individuals to 
reduce HIV transmission. In addition, different strategies must be 
applied to each subepidemic in the US and around the world. Our 
biomedical prevention research priorities include areas such as the 
development of topical microbicides for women; perinatal prevention 
strategies, including understanding of breast-feeding risk; and 
management of sexually transmitted diseases that enhance risk of HIV 
transmission. NIH also supports behavioral research strategies, 
including prevention interventions related to drug and alcohol use. We 
are focusing efforts on infected individuals who may not know they are 
infected, but in addition, data suggest that some HIV-infected 
individuals successfully responding to therapy believe that they are 
less infectious and that they cannot be reinfected. As a result, they 
may re-engage in risky behaviors. Thus NIH is supporting research to 
develop HIV prevention interventions targeted to HIV-infected 
individuals.
                           priority: vaccines
    A safe and effective vaccine is the critical missing element in our 
armamentarium. In 1997, the President challenged the nation to develop 
an AIDS vaccine. Consistent with this challenge, NIH has moved forward 
aggressively to build a comprehensive vaccine research enterprise. 
Funds in this request represent more than a 100 percent increase in NIH 
vaccine research since fiscal year 1997. These funds will provide new 
grants to foster innovative HIV vaccine research and allow the 
invigoration and reorganization of the NIH vaccine clinical trials 
effort. The new Dale and Betty Bumpers Vaccine Research Center will be 
occupied this summer. Dr. David Baltimore continues to chair the AIDS 
Vaccine Research Committee which advises the NIH on the overall vaccine 
program. In February 1999, NIH-supported investigators initiated the 
first AIDS vaccine trial in Africa. In collaboration with industry 
partners, NIH has now tested 28 different HIV vaccine candidates, 
individually or in combinations, in over 3000 uninfected volunteers. 
Several new vaccines, including vaccines designed to induce mucosal 
immunity, novel DNA vaccines, and more complex vaccines presenting 
several viral proteins, have entered phase I trials. In addition, 
recent studies of ``therapeutic vaccines'' that do not prevent 
infection, but can prevent or delay disease progression in animal 
models has offered opportunities for additional vaccine strategies.
    There have been significant incremental advances in the development 
of an AIDS vaccine. A number of candidate vaccines have been formulated 
for use in rhesus monkeys where they can be tested for their ability to 
protect against a ``challenge'' with a simian immunodeficiency virus 
that has been shown to produce AIDS in these animals. This permits the 
rapid testing of the potential protective efficacy of vaccine concepts. 
The left part of Chart 9 shows the blood levels of two groups of 
monkeys, one vaccinated and one given a placebo control. The vaccinated 
monkeys had a much reduced infection, with a much better survival than 
the control group. Protection of this magnitude has been seen with 
several candidate vaccines. The right part of the chart shows one of 
the most recent vaccines that has been tested in humans for its ability 
to produce immune responses. Both versions of the vaccine induced the 
production of antibodies and cellular immune responses (CTLs), but only 
in a proportion of immunized subjects. Although this was not a trial of 
effectiveness, the subjects were followed for HIV infections. There 
appeared to be about half as many infections in the immunized subjects, 
although the numbers were too small to be statistically significant. 
Results of this kind are encouraging and lead us to hope that full 
scale trials of vaccine effectiveness may begin in humans in the next 
few years.
                   benefits to other disease research
    AIDS research is unraveling the mysteries surrounding many other 
infectious, malignant, neurologic, autoimmune and metabolic diseases. 
AIDS research has provided an entirely new paradigm for drug design and 
development to treat viral infections. One example this year was the 
development of the new flu drug, Relenza, which directly benefited from 
AIDS research. The drug known as 3TC, developed to treat AIDS, is now 
the most effective therapy for chronic hepatitis B infection. Drugs 
developed to prevent and treat AIDS-associated opportunistic infections 
also provide benefit to patients undergoing cancer chemotherapy or 
receiving anti-transplant rejection therapy. AIDS is also providing new 
understanding of the relationship between viruses and cancer.
                                summary
    The transmissible nature of HIV--between individuals and across 
borders and populations--makes it radically different from non-
transmissible diseases such as heart disease and cancer. There is the 
potential for unlimited spread, and also the possibility for a dramatic 
reduction in new infections--and thus ultimate control of the 
pandemic--in a way that can never be possible for noninfectious 
diseases. The impact of an intervention that reduces the probability of 
transmission, breaking the link in the epidemic chain, extends far 
beyond the treated or protected individual.
    We have made enormous strides in our fight against this horrible 
disease, but these were only small skirmishes in a major global war. As 
this Committee clearly recognizes, our progress will be meaningless 
unless we can make the benefits of our research findings available to 
populations desperately in need both here in our own country and around 
the world. The worldwide human and economic toll of this insidious 
disease is profound, and we will never solve the problem of AIDS for 
our own citizens without controlling the epidemic in the rest of the 
global village. We cannot afford to leave anyone behind.
    We are deeply grateful to the Committee for your steadfast support. 
I would be pleased to respond to any questions you may have.

                           President's budget

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

                            Research Grants

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

                OPENING STATEMENT OF SENATOR TOM HARKIN

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

                           prepared statement

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

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

                           Stem Cell Research

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

                    Stem Cell Research and Diabetes

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

               OPENING STATEMENT OF SENATOR THAD COCHRAN

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

                           prepared statement

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

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

                      Bench to Bedside Application

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

                          state of Cancer Care

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

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

                             youth violence

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

    Senator Specter. Senator Harkin.

                    treatment for Juvenile Diabetes

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

                          Human Genome Project

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

                        AIDS Vaccine Development

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

                           Epilepsy research

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

                          Alzheimer's research

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

                           Juvenile Diabetes

    Senator Kohl. Thank you. Last summer, 9-year-old Lenisha 
Patterson of Germantown, WI, testified before this subcommittee 
on what it is like to live with juvenile diabetes.
    I also have a short statement, which I would submit for the 
record and a statement from 14-year-old, Rachel Malz of 
Wisconsin, describing how diabetes has affected every day of 
her life. Both of these children have asked the subcommittee to 
promise to remember them and all the children who live with 
juvenile diabetes. I am one of 55 Senators who are trying to do 
just that.
    [The statements follow:]
                Prepared Statement of Senator Herb Kohl
    Thank you, Mr. Chairman. And I'd like to welcome you, Dr. 
Kirschstein, and all of your colleagues who have agreed to appear 
before the Subcommittee today.
    As we all know, over the past several years, Congress has provided 
unprecendented funding increases for the NIH. I commend Chairman 
Specter and Senator Harkin for their leadership in ensuring that NIH 
has the resources it needs to achieve one of our nation's most 
important goals: curing disease and alleviating human suffering.
    It is both our hope and also our expectation, that this strong 
investment will result in new treatments and cures for diseases. Not 
only will this improve the quality of life of all Americans, it will 
reduce the need for expensive treatments in the future by keeping our 
nation's health care costs down.
    I strongly support biomedical research and agree that Congress 
should continue to provide the funds necessary to make this a reality. 
However, in addition to providing the dollars, Congress also has the 
responsibility to ensure that these funds are spent wisely. We have 
provided these increases as part of a balanced budget--but we must not 
forget that we have accomplished this by making some tough choices 
between other health and education programs. It is critical that these 
trade-offs can be justified by ensuring that research targets our 
nation's most pressing health needs.
    Again, I thank you, Mr. Chairman, for your support of NIH. I look 
forward to the question period, when we will have a chance to explore 
these priorities and results in more detail.
                                 ______
                                 
             Prepared Statement of Rachel Malz, Madison, WI
    Good morning. My name is Rachel Malz and I am from Madison, WI. I 
am fourteen years old and I was diagnosed with Juvenile Diabetes when I 
was only 21 months old. I do not remember even one day when diabetes 
was not a part of my life. My diabetes has been very difficult to 
control. I was placed on an insulin pump when I was ten to help control 
all the ups and downs. However, at the age of twelve, my kidney tests 
showed some problems, so my doctor started me on an Ace--Inhibitor 
medication. Studies have shown these drugs may help keep my kidneys 
working. As you can see, I am doing all I can to stay as healthy as 
possible until a cure is found. I need all of you in that room today to 
do your part and work together so it will happen soon. Thanks to you 
and to Senator Kohl for the opportunity to share my story.

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

                              NCI'S Budget

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

                             NHLBI's Budget

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

                             NIDCR'S Budget

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

                             NIND'S Budget

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

                        possible Accomplishments

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

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

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

                OPENING STATEMENT OF SENATOR TED STEVENS

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

                            Gene Sequencing

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

                            Methamphetamine

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

                 Complementary and Alternative Medicine

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

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

                    Past and Future Accomplishments

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

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

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

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

                            Budget Increases

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

                          Cancer Group Letters

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

                 Letter From Marin Breast Cancer Watch

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

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

                   Letter From The Breast Caner Fund

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

Senator Dianne Feinstein,
Washington, DC.

Attn: Glenda Booth

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

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

                      (By the Breast Cancer Fund)

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

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

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

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

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

                    Letter From Breast Cancer Action

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

Hon. Dianne Feinstein,
U.S. Senate,
Washington, DC.
    Dear Senator Feinstein: We write on behalf of the undersigned 
organizations and the thousands of people we represent to urge you to 
consider changing the language of the bill to re-authorize the breast 
cancer stamp.
    While we think this is a creative and important program, we 
strongly believe that the funds generated need to be spent in a way 
that might make a significant difference in the breast cancer epidemic. 
That will not happen if the current structure of the stamp program is 
maintained. The 70 percent of stamp proceeds that are allocated to the 
National Institutes of Health (NIH) should be directed by law to the 
National Institute of Environmental Health Sciences (NIEHS). Leaving 
the allocation of funds to the discretion of the NIH means more of the 
same kind of research that has done little to uncover the causes of 
breast cancer.
    We know that you share our concern about how the portion of the 
stamp funds that are directed to the National Institutes of Health are 
spent. Your office has shared with us the letter dated February 14 in 
which Secretary Shalala responds to your questions regarding 
expenditure of the funds. That letter reveals precisely why it is 
important to change the structure of the stamp program. Secretary 
Shalala states that the stamp funds have been allocated by the NIH to 
the National Cancer Institute (NCI), which, in turn, has created a new 
awards program for the funds. The letter states that, of the 400 grant 
applications received, twenty percent relate to environmental causes of 
breast cancer. Notably, the letter does not indicate how many of those 
grants the NCI expects to fund. And, based on the NCI report, 
``Charting the Course: Priorities for Breast Cancer Research,'' which 
is the impetus for the grant program, it is unlikely that many of those 
applications will be funded.
    However, an even greater problem is the definition of 
``environmental factors.'' When advocates use this phrase. they mean 
chemicals and radiation, while the NIH and NCI mean diet, exercise, 
alcohol use, hormones, as well as chemicals and radiation. By using 
this expanded definition, the NCI always appears to be doing more than 
it actually does with regard to research on ``the environment'' and 
cancer.
    As even a brief review of the ``Charting the Course'' report 
reveals, the NCI continues to focus its attention primarily on the 
molecular biology of breast cancer and on so-called ``chemoprevention'' 
strategies. The work being done to identify what in the environment 
might be causing the increased incidence of breast and other cancers is 
not being done at the NCI. If that work is being done at NIH, it is 
being done at the NIEHS.
    As you know, the funds generated by the stamp are small in the 
scheme of what is directed toward and needed to solve the breast cancer 
problem. In light of that, it is all the more important to make sure 
that the funds are spent in a way that at least has a chance of 
addressing some aspect of true prevention. If we are ever to truly 
solve the problem of breast cancer by preventing the disease, we will 
need to discover and eradicate the causes of the disease.
    We look forward to working with you to make the breast cancer stamp 
program as effective as it can possibly be, and we believe that this 
will occur by making the NIEHS the designated recipient of the stamp 
funds allocated to the NIH. We also believe that the stamp will gain 
even more popular support when the public is made aware that the funds 
will be directed into research on possible preventable causes of the 
disease.
    Thank you for attention to these concerns, and for all you do to 
address the concerns of the growing population of people touched by 
breast cancer.
            Sincerely,
                    Barbara A. Brenner, Executive Director, Breast 
                            Cancer Action, and on behalf of Francine 
                            Levien, Executive Director, Marin Breast 
                            Cancer Watch; Catherine Porter, Esq., Legal 
                            Services and Public Policy Coordinator, 
                            Women's Cancer Resource Center; Andrea R. 
                            Martin, Founder and Executive Director, The 
                            Breast Cancer Fund; Sharon Batt, Breast 
                            Cancer Action Montreal; Nora Cody, DES 
                            Action; Judy Norsigian, Boston Women's 
                            Health Book Collective.
                                 ______
                                 
                          cancer group letter
    The importance of lifestyle and other environmental exposures as 
contributing factors of cancer is unquestionable. The pivotal role of 
the environment is reflected in the substantial variation in cancer 
incidence around the world. Furthermore, epidemiologic research has 
succeeded in identifying a wide range of cancer-causing exposures, 
including tobacco use, dietary components, sunlight, ionizing 
radiation, environmental chemicals, infectious agents, obesity, 
exercise, hormones, and reproductive factors. Indeed, the largest 
source of variability in cancer risk is due to behavior. Nevertheless, 
the causes of many cancers remain elusive. While better approaches to 
measuring exposures will provide new insights, it is clear that the 
environment represents only part of the equation in determining who 
will get cancer.
    NCI, as the Nation's leading institute in supporting and conducting 
cancer research, has placed a special focus on breast cancer research. 
NCI has a portfolio of over 1400 individual NCI-funded projects having 
relevance to breast cancer. In fiscal year 1999, NCI expended over $387 
million in research related to breast cancer, and for fiscal years 2000 
and 2001, this figure is expected to be about $425 million and $450 
million respectively.
    To support the full range of research activities necessary to 
conquer cancer, including breast cancer, NCI uses a complex and dynamic 
process to set our scientific and funding priorities. This process is 
driven by several principles:
  --Strive for a balanced portfolio of research in behavior, 
        epidemiology, control, etiology, prevention, detection, 
        diagnosis, treatment, survivorship, rehabilitation, and end of 
        life issues;
  --Link all pieces of the cancer research enterprise through 
        translational research;
  --Rely on our diverse constituencies--including scientific, medical, 
        advocacy and other public communities--to help us identify new 
        opportunities, gaps, and barriers to progress, create new 
        programs, and improve existing ones.
    From a strategic level, we integrate priority setting into all of 
our strategic planning activities. For breast cancer research planning, 
NCI established a Progress Review Group (PRG) in 1997 to assess the 
status of breast cancer research and to provide recommendations on 
direction and priority to speed the progress. The Breast Cancer PRG was 
composed of prominent members of the scientific, medical and advocacy 
communities and their report, published in August 1998 and entitled, 
``Charting the Course: Priorities for Breast Cancer Research,'' is the 
framework NCI uses to support a balanced portfolio of breast cancer 
research (http://wwwosp.nci.nih.gov/planning/prg/
bprgtableofcontents.htm).
    From the research application level, we integrate priority setting 
into the funding of individual research applications based on 
scientific merit. NCI, like the rest of NIH, uses scientific peer 
review panels to competitively determine the technical validity, 
soundness and ranking of the individual grant applications. However, 
NCI has increasingly used lay reviewers/consumer advocates in our 
scientific review panels to provide a consumer perspective. These 
consumer advocates actively participate in discussions, present the 
patient perspective, and vote on the applications. During the last 18 
months, consumers have participated in almost 60 reviews, including the 
panel currently reviewing the applications for the program announcement 
``Insight Awards To Stamp Out Breast Cancer,'' the program that will 
use the funds contributed by consumers in support of the 1997 Stamp Out 
Breast Cancer Act.
    The Insight Awards are a new initiative designed to support 
innovative pilot studies that are likely to generate new understanding 
about breast cancer and to advance underdeveloped areas of research as 
identified by the Breast Cancer PRG's 1998 report. The focus of this 
initiative is to support innovative high risk/high payoff research that 
would not be funded under normal circumstances. Over 400 applications 
have been received and are being competitively reviewed by a peer 
review panel for the available funds. The role of the peer review 
process is to judge the likelihood that the proposed research will have 
a substantial impact on the pursuit of the initiative's goals. The 
applications are being judged solely on the basis of scientific merit, 
with attention given to a balanced research portfolio as articulated in 
the Breast Cancer PRG's report. To preserve the integrity of the peer 
review process, names of individuals participating on review panels 
must remain confidential until the selection of awardees is made.
    Finally, in regard to the question on the status of the breast 
cancer research funds provided by the 1997 Emergency Supplemental 
Appropriations Act (Public Law 105-18), I am submitting a letter sent 
to The Honorable Nancy Pelosi, dated 15 March 2000, along with the 
enclosures that describe the disposition of the funds and the vital 
research it is supporting.
                                 ______
                                 

                  Letter From Dr. Richard D. Klausner

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

Enclosures.

                           Public Law 105-18

                               CHAPTER 6

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                        Office of the Secretary

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

                       Conference Report 105-119

    LABOR, HEALTH AND HUMAN SERVICES, EDUCATION AND RELATED AGENCIES

                        Office of the Secretary

            public health and social services emergency fund
    The conference agreement modifies language proposed by the Senate 
which would have appropriated $15,000,000 to the Public Health and 
Social Services Emergency Fund within the Office of the Secretary for 
competitively awarded research on the environmental links to breast 
cancer. The Senate language designated the funding as an emergency 
appropriation. The House bill had no similar provision.
    The conferees agree that $15,000,000 is appropriated to support 
high priority biomedical research. These funds will be made available 
on a competitive basis and through mechanisms to be determined by the 
Secretary, in consultation with the Directors of the National 
Institutes of Health and the Centers for Disease Control and 
Prevention, and the Deputy Assistant Secretary for Women's Health. The 
conferees request that the Secretary provide a report to both 
Committees on the research plan and allocation methodology accompanying 
these additional funds by July 1, 1997. Among the priorities the 
conferees encourage the Secretary to consider is cancer research, 
especially research investigating the environmental factors that may be 
associated with breast cancer in communities with high incidence of the 
disease. The conferees have removed the emergency designation for these 
funds, offsetting the cost elsewhere within the bill.
                                 ______
                                 
             Department of Health & Human Services,
      Public Health Service, National Institutes of Health,
                                   Bethesda, MD, February 23, 1998.
Hon. John Edward Porter,
Chairman, Subcommittee on Labor, Health and Human Services, Education, 
        and Related Agencies, Committee on Appropriations, House of 
        Representatives, Washington, DC.
    Dear Mr. Porter: On December 19, 1997, in response to the 
Conference Report accompanying the Fiscal Year 1997 Emergency 
Supplemental Appropriations Act (Public Law 105-18), the Secretary of 
Health and Human Services submitted to you our research plan for using 
the $15 million appropriated in the Act for high-priority health 
research. However, after further internal discussion, we have notified 
the Secretary and are now notifying you that we believe we can improve 
upon our original project design for the $12 million we intend to use 
to study gene-environment interactions in the cause of breast cancer in 
high-risk areas of the United States. Our updated research plan is 
enclosed. Please note that this revision still conforms with the 
legislative requirement that all of these funds be awarded on a 
competitive basis.
    Instead of a single, multi-year, multi-center, case-control study 
as originally envisioned, we have determined it would be more 
appropriate to break out the funds into four types of projects, with 
most of these funds awarded in fiscal year 1998. The first project 
would be a contract for a Geographic Information System for the Long 
Island Breast Cancer Study to identify potential environmental risk 
factors for breast cancer. The National Cancer Institute (NCI) plans to 
issue a Request for Proposals for this contract in late winter or early 
spring of 1998 for award in fiscal year 1998. The second and third 
projects would include research grants in the specific areas of 
``Addressing Environmental Factors and Breast Cancer in High-Risk 
Areas'' and ``Interdisciplinary Collaborative Studies of Gene-Gene and 
Gene-Environment Interactions in Breast and Other Cancers.'' Requests 
for Applications (RFAs) for grants in these two areas are expected to 
be issued in the spring of 1998 and awarded in fiscal year 1998. A 
third RFA for research grants on developing and testing accurate 
exposure assessments for breast cancer epidemiology is still being 
developed and will be advertised and awarded in fiscal year 1999. We 
expect to find many different research grants with a multiplicity of 
study designs through each of these RFAs. Both NCI and the National 
Institute of Environmental Health Sciences will contribute the 
expertise of their staffs to these projects, with NCI to have the lead 
responsibility for oversight of the project.
    The portion of the original research plan related to spending $3 
million for research on the adverse health effects of exposure to air 
pollutants, such as ground level ozone and particulate matter, has not 
been revised in this update. Specific announcements regarding the award 
of funds for this project are still under development.
    Thank you for your continuing strong support for medical research.
            Sincerely,
                                       Harold Varmus, M.D.,
                                                          Director.

Enclosure.

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

                          [February 23, 1998]

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

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

                          [February 23, 1998]

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

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

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

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

                     Additional committee questions

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

                     clinton/blair joint statement
    Question. What was the significance of the joint statement issued 
by the President and Prime Minister Tony Blair? Was this statement 
intended to undermine research efforts in the private sector?
    Answer. The President and Prime Minister Tony Blair agreed that it 
was important to take notice, at the the highest levels of their 
governments, of the progress the two countries have made in human 
genomics and of the era of new opportunities unfolding before us. For 
that reason, they issued a joint statement of position to help ensure 
that human genomic discoveries are used as effectively as possible for 
the advancement of human health throughout the world. The statement 
consisted of two equally important, complementary principles, designed 
to maximize scientific opportunities to understand the human genome, as 
well as medical and economic opportunities for the development of 
health care products.
  --First, the statement reiterated the principle that raw fundamental 
        sequence data from the human genome--the ordering of the A's, 
        T's, C's, and G's that make up DNA--should be distributed as 
        broadly as possible, in an unencumbered manner, for use by 
        scientists around the world. This principle has been a 
        condition of funding by the Human Genome Project, which makes 
        genomic sequence data freely available over the Internet in a 
        public database called GenBank. New sequence data are deposited 
        daily by Human Genome Project participants.
  --Second, the statement makes clear that intellectual property 
        protection for gene-based inventions will play an important 
        role in stimulating the development of health care products, 
        which will in turn allow the public to realize the full medical 
        benefits of the fundamental scientific discoveries. As a new 
        generation of medical discoveries begins to rely on gene-based 
        technologies, it is essential that we afford these technologies 
        the kind of intellectual property protection that has enabled 
        the development of every other wave of medical innovations.
    No. The complementary principles described in the statement are 
beneficial to both the private sector and the public. They reinforce 
the public-private partnership that has fueled the genomics and 
biotechnology enterprises, by enabling fundamental biological 
discoveries as well as the entrepreneurship that can capitalize on 
those discoveries and bring innovations to market. Key companies 
involved in genomics were quick to issue statements endorsing the joint 
statement.
                          human genome project
    Question. Why did talks breakdown between the public Human Genome 
Project negotiators and Celera Genomics? Do you see any way the public 
Human Genome Project can maximize research dollars through 
collaborating with private sector companies?
    Answer. Representatives of The Human Genome Project, Doctors Martin 
Bobrow, Francis Collins, Harold Varmus and Robert Waterston, met with 
representatives of Celera Genomics Corporation on December 29, 1999, to 
discuss a possible collaboration to sequence the human genome. At that 
meeting Celera and Human Genome Project (HGP) representatives presented 
quite divergent terms for such a collaboration. In a February 28, 2000, 
letter to Celera, HGP representatives summarized the December 29, 1999 
discussion and described how specific terms for collaboration presented 
by Celera would conflict with the underlying principles of the Human 
Genome Project to make sequence data rapidly and freely available to 
all. On March 7, 2000 Celera Genomics President, J. Craig Venter 
responded that Celera Genomics continues to be interested in pursuing 
good faith discussions toward collaboration. On March 9, Dr. Collins 
sent a letter to Celera indicating that he had received its letter and 
would discuss possible next steps with the other HGP representatives.
                              human genome
    Question. What are the likely developments in medicine over the 
next 10 years that will result from unraveling the human genome?
    Answer. The Human Genome Project will reveal all the human genes 
and many of the variations in DNA that make individuals unique and 
affect our susceptibility to disease. Scientists will understand the 
genetic factors that influence the development of complex diseases--
like heart disease, diabetes, Alzheimer's disease, and cancer--that are 
caused by several genes in interaction with each other and 
environmental influences. Detailed understanding of the molecular 
causes of disease will suggest new treatments.
    In the next decade, predictive genetic tests will become available 
for a few dozen complex diseases. If you find you are at high risk for 
various ailments you will be able to adopt strategies (like changes in 
diet, lifestyle, medical surveillance, and treatment with drug therapy) 
to reduce your risk of becoming ill.
    If you fall through that preventive medicine safety net and get 
sick anyway, new treatments will begin to be available. Some likely 
will be gene therapies. Others will be drug therapies designed on the 
basis of an understanding of gene function. These therapies will be 
more precisely tuned for the problem that you have and, because of 
early diagnosis, will be available at an earlier stage in the disease 
process. This new generation of preventive and therapeutic 
interventions based upon your genetic information, which likely will 
come along first for cancer, will revolutionize medicine and improve 
our ability to prevent, diagnose, and treat the diseases that afflict 
us and our families.
    While both parties are open to continued discussions about the 
terms of a possible collaboration, it remains unclear whether the 
specific terms that meet the distinct goals of each of the two sectors 
are possible.
    Several productive public-private collaborations have marked the 
Human Genome Project during its short history. For example, several 
years ago, Merck & Company, Inc. decided to fund the generation of a 
public collection of human EST (Expressed Sequence Tag or gene snippet) 
sequences. More recently, on January 19, 1999 a memorandum of 
understanding (MOU) was signed between Celera Genomics and the Berkeley 
Drosophila Genome Project Group, a consortium of research groups 
working at the University of California at Berkeley, Lawrence Berkeley 
National Laboratory, Baylor College of Medicine and Carnegie 
Institution of Washington. The group is funded by the NIH, the 
Department of Energy and the Howard Hughes Medical Institute. The MOU's 
stated purpose was to produce a complete, annotated, and publicly 
accessible sequence of the Drosophila genome at a reduced cost and an 
accelerated pace. The DNA sequence of the fruitfly, Drosophila 
melanogaster was published in Science on March 24, 2000.
    Presently, the National Human Genome Research Institute (NHGRI) is 
working with a consortium of groups to develop a plan to identify an 
estimated 700,000 single nucleotide polymorphisms (SNPs) (common areas 
in the human genome where the sequence varies by a single letter) over 
the next two years. The SNP Consortium (TSC) is a unique group of 10 
pharmaceutical companies, IBM, Motorola and the Wellcome Trust of the 
United Kingdom, in partnership with leading HGP academic centers. 
Variant SNPs, that are identified, will be placed in the public domain 
for all to use. Many of the variants will be responsible for traits 
that distinguish one person from another. Others will be found to 
contribute to an individual's risk of developing complex diseases such 
as cancer, heart disease, and diabetes. The NIH and TSC have been 
coordinating efforts since TSC's inception. For example, efforts by 
both the NIH and TSC to discover SNPs are using DNA samples from the 
NIH SNPs resource so that data from the two efforts will be comparable. 
In addition, the SNP data generated from both projects are deposited in 
the public database, dbSNP. Finally, NIH and TSC investigators 
participate in joint scientific and technical meetings to share 
information and coordinate strategies.
    Each of these collaborations combine public and private resources 
to generate genomic information that is freely accessible, without 
restriction, to both public and private sector scientists. As a result, 
more information has been available to the scientific community more 
rapidly than expected. The NIH welcomes these opportunities by which 
workable models for collaboration between the public and private 
sectors can be achieved.
                              mouse genome
    Question. Why is it important to sequence the mouse genome if you 
already have the human genome?
    Answer. The human genome is a very complex structure that will take 
decades or even centuries to understand fully. One of the best tools 
for understanding it is to compare it with other genomes. For example, 
if a certain region in the mouse genome is almost identical to the same 
region in the human genome, this is a clue that the region codes for an 
important function. If the function of such a region of the mouse 
genome is known, it can be deduced that the function of the human 
region is the same or is similar. Because we have been studying on mice 
for many years, we know a great deal about the biology of mice and 
mouse genes, an area that is difficult to study in humans. As a result, 
the ability to compare mouse and human sequence is expected to provide 
a tremendous boost for understanding human genetics. For this reason, 
having the sequence of the mouse is critically important.
                     sequencing of the human genome
    Question. A working draft is useful, but what are your plans for 
finishing the sequence of the human genome to high accuracy?
    Answer. The Human Genome Project is committed to finishing the 
human sequence to a level of high accuracy. This has been the goal from 
the beginning of the project and it has not changed. The current plan 
is for each group to finish those sections that it has sequenced to the 
working draft status. An international working group has been 
discussing the details of strategy for finishing the sequence over the 
last few months and has come up with a plan that all have endorsed. The 
goal is to complete this by 2003, but it may well be possible to finish 
earlier.
                              human genome
    Question. What plans does your institute have to encourage research 
on understanding the genome, once the sequence is in hand? What role 
will computers play in this next phase?
    Answer. NHGRI has been supporting technology development for 
research on functional genomics for some time. Recently we have 
intensified our efforts by supporting two new initiatives. The first is 
the Mammalian Gene Collection in collaboration with the NCI. This 
project will assemble a catalogue of cloned and sequenced human genes 
and make them available to researchers. This collection will be a 
critical tool for understanding the human genome. In addition, NHGRI 
will shortly issue a request for applications for Centers of Excellence 
in Genomic Science. These centers will focus on novel approaches to 
studying genomic questions. We expect that they will become centers for 
technology development and computational biology, whereby new 
methodologies are created that assist scientists in understanding the 
human genome sequence and how it functions.
    Databases, using computers, will store the information on DNA 
sequence, DNA variants, and a large amount of information on gene 
structure and function. Researchers will be able to access this 
information from their lab computers. Using computers, they will be 
able to analyze the data to discover more about how genes work, for 
example, by comparing human with mouse sequence to find genome regions 
important for gene regulation. They will also be able to use computers 
to make discoveries by combining the genomic information with their own 
research results, such as mapping genes for diseases.
                        children and depression
    Question. Children and depression--Dr. Hyman, you have often said 
that a depressed child is at quite a disadvantage in terms of ability 
to learn, form relationships, and develop overall in a healthy way. It 
is critical that each child in distress have the best possible chance 
of being noticed and evaluated in a thorough, competent way. What 
effect might failure to do this have on the apparently increasing 
incidence of violence among children and adolescents?
    Answer. We can only speculate on this, as studies which would 
unravel the effects of untreated depression in children, for ethical 
reasons, have not been undertaken. We agree that children who are 
depressed can be identified, that valid assessment approaches are 
available, and that some treatments and preventive strategies, 
including school-based programs specifically for these children, have 
been rigorously tested. A major problem is that too often these 
treatments and preventive approaches are not available to children who 
need them. Instead unevaluated programs are offered under the guise of 
providing a ``service.''
    There have been several longitudinal studies of children with 
different patterns of risk, and these studies indicate that there is a 
cumulative and negative effect to ignoring such risks. Children with 
certain patterns of risks may go on to exhibit serious behavior 
problems in adolescence. Many of these behavior problems can be avoided 
by early detection, careful assessment, and implementation of well-
established intervention programs.
    Question. Suicide--To what do you attribute rising suicide rates 
among young people? What can we do about this?
    Answer. In addition to a possible increase in the likelihood of 
reporting youth suicides, the rising youth suicide rates have been 
linked to increased substance use among the nation's youth. For 
example, an association between lower state drinking age and higher 
youth suicide rates has been shown.
    So far there are no proven prevention efforts shown to reduce youth 
suicide rates, and some school-based awareness programs have actually 
caused distress in vulnerable youth. NIMH and NIDA just released a 
program announcement encouraging researchers to submit applications 
that test various approaches to preventing youth suicidal behavior.
    Question. Dr. Hyman, can you tell us what you are doing to address 
the legal and ethical issues that may interfere with the need to do 
critical research on depression and suicide? Should people who are (or 
who may be) suicidal be allowed to participate?
    Answer. NIMH staff, and experts in (1) clinical research with 
suicidal patients, (2) bioethics, and (3) legal issues pertaining to 
liability risks with suicidal patients have developed a draft document, 
Safety and Ethical Issues to Consider for Persons at High Risk for 
Suicidal Behavior in Intervention Trials. Its purpose is to propose 
ways to minimize risk and consider the ethical issues unique to 
conducting research on suicidal behavior, in order to promote more 
research on effective interventions to reduce suicidal behaviors. 
Currently, the draft is being circulated to OPRR staff, representatives 
from the National Advisory Mental Health Council, professional and lay 
advocacy communities, Institutional Review Boards (IRB) and Data Safety 
Monitoring Boards (DSMB) members, and former research participants, for 
comment.
    As the draft was being developed, the audience in mind included 
researchers conducting clinical trials designed to reduce the rate of 
suicidal behaviors, and the IRBs and DSMBs that must review and monitor 
them. However, the document is also intended to be useful for 
researchers conducting any type of treatment trials aimed at reducing 
symptomatology in disorders known to carry a high risk for suicidal 
behavior. The adequate incorporation of plans to increase safety, 
minimize risk, and consider the ethical issues pertaining to 
individuals who may become suicidal in treatment trials, could allow 
more individuals who are at risk for becoming suicidal to participate 
in a greater number of treatment trials.
        national institute of neurological disorders and stroke
    Question. Dr. Fischbach, your Institute recently undertook a major 
effort to produce a five-year research plan for Parkinson's disease 
research. How can this kind of initiative advance the research into 
Parkinson's disease and should this kind of process be duplicated for 
other disease research areas?
    Answer. The Parkinson's disease research agenda proposes a 
comprehensive approach--understanding the disease, developing 
treatments, creating research capabilities, and enhancing the research 
process. We are optimistic that such an approach will result in 
significant progress against Parkinson's and other neurodegenerative 
disorders. It may prove to be a good model for many diseases. We were 
particularly pleased by the enthusiastic participation of leaders from 
the Parkinson's research community, from other fields that can 
contribute to the effort, and from the patient advocacy groups.
    NINDS embarked on a strategic planning process last year, and we 
continue to refine it in terms of next steps and procedures for 
implementation. The strategic plan is based on broad, cross-cutting 
themes (such as neurodegeneration), each one of which touches on many 
disorders. The plan has already produced many initiatives that address 
both basic neuroscience and specific disease problems. We plan to 
complement this approach with additional plans focused on specific 
disorders, and began with Parkinson's disease. Using a slightly 
different approach, we are collaborating with the National Cancer 
Institute to develop a plan for brain tumor research. We plan to 
proceed with other disease-specific plans at the rate of two or three 
per year.
    Our view is that there are several useful models that can be 
employed (including the more traditional but highly effective approach 
of sponsoring workshops), depending on specific disease issues and the 
state of the science. In general, however, we do not favor the 
inclusion of funding proposals in long-range plans. We are concerned 
that a proliferation of such budget-oriented plans would decrease our 
ability to take advantage of new, unexpected opportunities, both in 
terms of the specific disease being reviewed and more broadly in other 
disease areas of interest.
                  consensus conference on osteoporosis
    Question. Dr. Katz, I understand that a Consensus Development 
Conference on Osteoporosis will be held at the NIH. What are the 
specific issues that this conference will examine?
    Answer. NIH held a Consensus Development Conference on Osteoporosis 
Prevention, Diagnosis, and Therapy on March 27-29, 2000. The NIAMS was 
the primary organizer of this conference. Fellow sponsors included the 
NIH Office of Medical Applications of Research, nine other NIH 
Institutes and Offices, and the Agency for Healthcare Research and 
Quality. Well over 1,000 people attended presentations during the 3-day 
conference.
    Osteoporosis occurs in all populations and at all ages. About 10 
million people in the United States have osteoporosis, and an 
additional 18 million individuals are at increased risk for the 
disorder.
    The consensus panel was charged with addressing the following five 
questions: (1) What is osteoporosis and what are its consequences? (2) 
How do risks vary among different segments of the population? (3) What 
factors are involved in building and maintaining skeletal health 
throughout life? (4) What is the optimal evaluation and treatment of 
osteoporosis and fractures? (5) What are the directions for future 
research?
    In general, the panel found that nutrition, exercise, and medicines 
can play important roles in the prevention and treatment of 
osteoporosis. The panel noted that maintaining optimal bone health is a 
lifelong process that should begin in childhood. Bone mass attained 
during childhood is perhaps the most important determinant of life-long 
skeletal health. At all ages, physical activity and good nutrition, 
particularly adequate calcium and vitamin intakes, aid in developing 
and maintaining strong bones. Exercise can also reduce the risk of 
falls, a major cause of fractures in people with osteoporosis.
    While hormone replacement therapy remains a common treatment and 
prevention option; the panel suggested that more information is needed 
as to how estrogen reduces the incidence of fractures. There are new 
medicines for preventing and treating osteoporosis, such as 
bisphosphonates and selective estrogen receptor modulators. New 
technologies have improved the detection of loss of bone mineral, a key 
predictor of osteoporotic fracture, although the panel recognized that 
no standard exists for comparing different screening devices.
    The panel's recommendations for future research included 
identifying and intervening in disorders that can impede the 
achievement of peak bone mass in children of ethnic diversity; 
improving diagnosis and treatment of secondary causes of osteoporosis, 
such as that resulting from the use of glucocorticoids (for example, 
prednisone); collecting data necessary to establish testing guidelines 
for osteoporosis; developing quality-of-life measurement tools that 
incorporate gender, age, and race/ethnicity; conducting randomized 
clinical trials of combination therapies to prevent or treat 
osteoporosis; and developing a paradigm for the management of 
fractures.
                  screening and treating osteoporosis
    Question. Do we have good screening mechanisms for osteoporosis? 
And once we diagnose an individual with osteoporosis are there adequate 
treatment protocols?
    Answer. Fortunately, research over the last decade has led to some 
very reliable methods for assessing bone mass/bone mineral density. 
Dual energy x-ray absorptiometry (DXA) has been developed and used in 
some large studies that confirm the association of low bone mineral 
density with high fracture risk. This technology can assess the bone 
mineral density of two important sites of fracture in the body--the hip 
and the spine. The results of this test can be used to identify 
individuals at high risk of fracture who may profit from interventions 
designed to slow bone loss.
    There are several medications available to treat osteoporosis. 
Estrogen has the longest history in the prevention/treatment of 
osteoporosis. Two newer medications called bisphosphonates are approved 
by the FDA for osteoporosis--alendronate and risedronate. These 
medications are bone-specific and have been shown to reduce fractures 
in clinical trials. Another approach to osteoporosis has been the 
development of Selective Estrogen Receptor Modulators (SERMs). These 
drugs mimic the positive effects of estrogen in the bone but have been 
modified to diminish some of the deleterious effects of estrogen on the 
breast and the uterus. Currently, there is one SERM that has been 
approved by the FDA for osteoporosis--raloxifene. However, this is an 
active area of research. NIH is sponsoring a workshop on Selective 
Estrogen Receptor Modulators April 26-28, 2000, to develop a research 
agenda in this important area.
                        osteogenesis imperfecta
    Question. I understand that in 1999 you supported a workshop on the 
development of new strategies for Osteogenesis Imperfecta, also known 
as brittle bone diseases. Can you summarize the outcome of that 
workshop? And please tell us how your 2001 budget reflects these 
recommendations?
    Answer. In September of 1999 the NIAMS partnered with the 
Osteogenesis Imperfecta Foundation, the Children's Brittle Bone 
Foundation, and the NIH Office of Rare Diseases to sponsor a meeting on 
Osteogenesis Imperfecta (OI). The goal was to stimulate new clinical 
approaches to OI by calling attention to recent findings in several 
areas of basic biology and model systems. These areas include stem cell 
manipulation and gene therapy strategies, cell-matrix interactions, and 
the role of growth factors and cytokines in bone turnover. The workshop 
also assessed recent advances toward the ultimate goal of developing 
techniques for correcting the underlying genetic defects in OI. In 
addition, recent observations suggest that the metabolic consequences 
of collagen defects, such as effects on the activities of osteoblasts 
and osteoclasts, play an important role in the pathogenesis of OI. 
Exploring these new findings could lead to therapeutic approaches, such 
as pharmacological interventions, that could have an significant impact 
on the clinical management of OI. A number of research recommendations 
resulted from the workshop, and the NIAMS is currently assessing future 
research directions.
    The opportunities for basic research advances to move the field 
forward seem to be particularly promising. NIAMS is planning an 
initiative in fiscal year 2001 to capitalize on the opportunity to 
better understand how the bone cells in patients with osteogenesis 
imperfecta are programmed and can be re-programmed by therapeutic 
intervention.
                              osteoporosis
    Question. With the aging of the population is osteoporosis becoming 
a problem for men, as well as women? And if so, do you recommend that 
men over 65 take advantage of bone density screening?
    Answer. Although American women are four times as likely to develop 
osteoporosis as men, an estimated one-third of hip fractures worldwide 
occur in men. Studies have shown that men tend to develop osteoporosis 
about 10 years later in life than women. This difference has been 
attributed to a higher peak bone mass in men at maturity and to a more 
gradual reduction in sex steroid influence in aging men. The lifetime 
risk of older men for fractures of the hip, spine, or wrist is 
considerable, and the Institute is committed to providing a particular 
focus on osteoporosis in men, in addition to its extensive portfolio of 
research on osteoporosis in women. In fiscal year 1999, the NIAMS 
launched a major study of osteoporosis in men. This is a 7-year study 
that will enroll and then follow 5,700 men 65 years and older for an 
average of 4 to 5 years, and will determine the extent to which the 
risk of fracture in men is related to bone mass and structure, 
biochemistry, lifestyle, tendency to fall, and other factors. The 
study, which is supported in part by the National Institute on Aging 
and the National Cancer Institute, will also try to determine if bone 
mass is associated with an increased risk of prostate cancer.
    As mentioned above, men tend to develop osteoporosis somewhat later 
than women. It is not clear that it would be advantageous to screen all 
men over 65. Rather physicians should be aware of some of the factors 
that place men at high risk of an osteoporotic fracture such as 
previous low impact fractures, especially spine fractures that may be 
manifest by a loss of height, the use of certain drugs like prednisone, 
and the diagnosis of primary hyperthyroidism. In addition, low body 
weight and diseases that lead to malabsorption of food, or a family 
history of low impact fractures, may raise suspicion of low bone mass.
                       medicare and osteoporosis
    Question. Given the aging of our population, do you see the 
problems of treating bone diseases, which is paid for by the Medicare 
program, as one that will consume a large portion of the Medicare money 
in the next 20 years?
    Answer. The aging of the American population will certainly add to 
the number of individuals at risk of fractures. It is estimated that 
one out of two women will develop an osteoporotic fracture in her 
lifetime. Men have a lower risk but are increasingly living to an age 
when their fracture risk is also high. Serious efforts at the 
prevention of bone loss need to be directed to reducing the number of 
individuals affected. Efforts directed at the young can be particularly 
important as the development of an adequate bone mass at maturity is 
important protection against fractures later in life. These efforts 
need to be focused on increasing physical activity, maintaining a 
healthy body weight and adequate calcium intake. The recent Consensus 
Development Conference on Osteoporosis estimated that only about 25 
percent of boys and 10 percent of girls ages 9 to 17 meet the calcium 
intake recommendations of the Institute of Medicine.
    However, the seniors of the next few decades are already adults and 
there is a great deal that can be done to prevent bone loss in adults. 
In fact, some of the same preventive measures that are effective in 
building bone mass in adolescence are effective in maintaining bone 
mass later in life. Low physical activity in older populations is a 
significant factor in bone loss but also affects the balance and 
coordination that protect against falls. Active seniors have fewer 
falls and less serious ones. Calcium and vitamin D can also prevent 
bone loss, and their intake in senior adults are seriously below the 
recommended levels. In some individuals at high risk of fracture, 
medications directed to slowing bone loss can be a cost-effective 
strategy.
                              osteoporosis
    Question. If the treatment of bone diseases is going to be a major 
expense to the Medicare program, do you think you and your fellow 
institute directors are investing enough money in bone research in 
order to improve the quality of life for our seniors and to reduce the 
cost to Medicare?
    Answer. I am pleased to tell you that bone research is indeed a 
major priority for the NIH. A number of NIH components plus 
representatives from other agencies participate in the Federal Working 
Group on Bone Diseases--a collaboration that helps to coordinate 
research activities across the Federal government and provide 
recommendations for future research efforts. NIAMS supports bone 
research across the full spectrum from basic studies on how bone is 
normally built up and how bone breaks down in disease to clinical 
studies to improve our diagnostic and therapeutic abilities; and to 
prevention studies, especially those that target young people in their 
prime years for building strong bones. We also support major clinical 
trials that are looking at the value of combining some of the available 
drugs for treating osteoporosis, to determine the enhanced value that 
combinations of drugs may have against osteoporosis. In addition, we 
have recently supported a Consensus Development Conference at the NIH 
on osteoporosis, and experts identified a number of promising avenues 
for the NIH to consider and pursue. Finally, in the area of information 
dissemination, the NIAMS and other ICs fund the NIH Osteoporosis and 
Related Bone Diseases National Resource Center that provides 
comprehensive and timely information to patients, their families, and 
their health care providers. While there are always opportunities for 
funding additional research, I believe that the NIH research efforts in 
bone--those already underway as well as those planned for the future--
reflect the major priority we give to this area of research.
                           muscular dystrophy
    Question. Why has NIAMS been unable to provide as many muscular 
dystrophy related single investigator grants as other institutes?
    Answer. The NIAMS, together with the National Institute of 
Neurological Disorders and Stroke (NINDS), considers research on the 
muscular dystrophies to be a priority area. We will continue to work 
with the extramural muscular dystrophy research community, as well as 
interested patient organizations, to stimulate and support promising 
studies in this area. In fiscal year 1999, the NIAMS invested nearly 
$5.4 million in muscular dystrophy projects, an increase of over 40 
percent from the previous fiscal year.
    A number of exciting studies with implications for our 
understanding of the muscular dystrophies have been supported by the 
NIAMS in recent years. One such investigation used gene therapy to 
restore muscle function in a hamster model of limb-girdle muscular 
dystrophy (LGMD). In another NIAMS-funded study, researchers 
successfully used the common antibiotic gentamicin to restore the 
function of the gene that encodes for the protein dystrophin in mouse 
models of Duchenne muscular dystrophy (DMD). In a third project, NIAMS-
supported researchers used gene therapy in mice to give the body a 
boost in fighting the effects of aging on muscle, and to help repair 
the damage caused by injury and muscle-wasting disorders such as 
muscular dystrophy. These projects underscore the potential of treating 
human forms of LGMD, DMD and other muscular dystrophies with gene 
therapy approaches.
    Another area of excitement relates to a new protocol developed with 
support from the NIAMS that makes it possible to obtain an almost 
unlimited number of a special class of adult stem cells from a small 
sample of bone marrow. These adult stem cells have the ability to 
develop into cells of muscle, nerve, bone, cartilage and fat. Because 
of their vast potential for differentiation, they may be excellent 
therapy vectors for a number of skeletal diseases, including muscular 
dystrophy.
    Next month, the NIAMS--in partnership with the NINDS and the NIH 
Office of Rare Diseases--will support two research meetings on muscular 
dystrophy. The first is an international scientific conference centered 
on clinical and molecular studies of facioscapulohumeral dystrophy 
(FSHD). The meeting will bring together researchers who are already 
involved in FSHD projects, as well as scientists who are working in 
related fields and may be able to contribute to progress on FSHD. The 
second meeting will focus on therapeutic approaches for DMD. This 
workshop is aimed at addressing key questions in improving treatments 
for DMD, identifying areas of needed scientific knowledge, and the 
critical next steps to promote effective therapy. The NIH expects to 
build on the insights from these two meetings to develop new program 
initiatives related to the muscular dystrophies. Such initiatives would 
complement on-going efforts to stimulate research in this area, 
including the currently active program announcement on the pathogenesis 
and therapies of the muscular dystrophies.
    Question. Why is there no separate study section for muscle 
biology? Would a separate study section enhance research and integrate 
efforts?
    Answer. The NIH Center for Scientific Review (CSR), which conducts 
the peer review process, is currently involved in a comprehensive 
assessment of its study section structure, led by Dr. Bruce Alberts, 
the President of the National Academy of Sciences. The purpose of this 
assessment is to ensure that CSR provides a rigorous, unbiased review 
system that facilitates the advance of all areas of biomedical 
research, including muscle biology. Indeed, muscle disease review 
issues are being considered as part of the assessment. CSR will also be 
meeting with scientists at the Duchenne muscular dystrophy workshop in 
May to discuss this and other review concerns. The outcome of these 
discussions will help guide future decisions about the review of 
muscle-related research grant applications.
    There is no simple answer to the question of whether a dedicated 
study section would enhance the success of muscular dystrophy research 
applications or otherwise improve coordination of muscle-related 
research. It is important to consider that the NIH receives a broad 
range of research applications on muscle functioning and disease, and 
diverse areas of scientific expertise are required to review those 
applications. Whether it is desirable--or, indeed, even feasible--to 
cluster all muscle research proposals into a single study section is 
one of the questions being explored by the CSR assessment described 
above.
                            magnetic therapy
    Question. Has the use of magnets been proven scientifically?
    Answer. Todate, there have been only a few, rigorous, double-
blinded, randomized trials investigating the efficacy of magnet therapy 
(e.g. Vallbona et al., 1997, Weintraub, 1998; Taylor et al, In press). 
Although the results of these trials suggest that magnet therapy is 
more effective than placebo for pain management, a definitive statement 
on magnet therapy's efficacy awaits completion of a large, multi-site 
randomized controlled trial. The research portfolio of the National 
Center for Complementary and Alternative Medicine (NCCAM) includes 
rigorous studies of magnet therapy.
    Question. Are there any dangers in using magnets like sleeping on a 
magnetic pad or magnets in your shoes? I heard somewhere that they are 
not recommended for people with heart problems--they cause problems 
with electrical currents.
    Answer. Static magnetic fields appear to be safe. In 1987, the 
World Health Organization reported that ``the available evidence 
indicates the absence of any adverse effects on human health due to 
exposure to static magnetic fields up to two Tesla.'' Given that the 
typical static magnet used to treat disease produces a magnetic field 
of only a few thousands of a Tesla in strength, there is little 
intrinsic danger to using magnet therapy. Supporting this contention, 
the few well-designed clinical trials investigating static magnets have 
not reported any severe adverse events associated wit the intervention 
(e.g. Vallbona et al., 1997, Weintraub, 1998; Taylor et al, In press). 
Although no cause and effect was established, there has been one case 
report of a person who developed a myeloma after sleeping on a magnetic 
mattress for five years (Burns 1994). Concerning the use of static 
magnets by individuals with heart disease, there is conflict evidence 
whether low level electromagnetic fields produce changes in heart rate 
(Cook et al., 1994; Korpinen and Partanen, 1994) and blood pressure 
(Korpinen and Partanen, 1996). Until these issues are addressed for 
static magnetic fields, caution might be suggested for individuals 
suffering from severe hypertension. Caution may also be advised for 
individuals with cardiac pacemakers or wearing cardiac infusion pumps.
                                 ______
                                 
              Questions Submitted by Senator Thad Cochran
                           infectious disease
    Question. The NIH has invested heavily in infectious disease 
research. We have done a good job of developing vaccines to combat many 
infectious diseases, including HIV. However, one area that is of 
concern to me is that of drug resistance in infectious diseases. We now 
have bacteria that are becoming resistant to our last lines of 
antibiotic treatment.
    What is the NIH doing to insure appropriate use of antibiotics? 
What is the NIH doing to stimulate the development of new antibiotics 
to combat drug resistant bacteria?
    Answer. The NIH co-chairs with the Food and Drug Administration 
(FDA) and the Centers for Disease Control and Prevention (CDC) an 
Interagency Task Force on Antimicrobial Resistance. The initial public 
activities of this Task Force were announced in the Federal Register, 
Vol. 64, No. 123, Monday, June 28, 1999. This was in conjunction with a 
July 1999 public meeting organized by ten Federal agencies (the CDC, 
the FDA, the NIH, the Health Care Financing Administration, the Health 
Resources and Services Administration, the Agency for Health Care 
Research and Quality, the Environmental Protection Agency, the 
Department of Defense, the U.S. Department of Agriculture, and the 
Department of Veterans' Affairs) to coordinate Federal programs 
relating to antimicrobial resistance. The purpose stated in the 
preceding notice was ``To solicit input from invited consultants 
regarding items to be included in a Public Health Action Plan that, 
when published, will serve as a blueprint for activities of Federal 
agencies to combat antimicrobial resistance. The Plan is being 
developed by a Task Force composed of Federal personnel from several 
Federal agencies and departments, co-chaired by the CDC, the FDA, and 
the NIH.'' It should also be noted that the fiscal year 2000 
appropriations report language for CDC mentions this existing Task 
Force and the recommendation that a report be done within a year of 
enactment of the legislation--the above mentioned Public Health Action 
Plan is in response to this report language. Accordingly, four focus 
areas were selected for grouping the discussions and outcome: 
Surveillance, Prevention and Control, Research, and Product 
Development. The issue of appropriate use of antimicrobials, including 
antibiotics, is within the purview of Prevention and Control, and is 
addressed in the connotation of ``judicious use.'' The NIH is 
collaborating in the overall development of the Action Plan in the role 
of Co-Chair, and also plans to collaborate with the appropriate 
agencies coordinating any resulting actions relating to judicious use 
of antimicrobials, principally the CDC and the FDA, for any action 
items that fall within the scope of the NIH mission.
    The NIH funds a diverse portfolio of grants and contracts to study 
antimicrobial resistance in major viral, bacterial, fungal, and 
parasitic pathogens. The National Institute of Allergy and Infectious 
Disease (NIAID) has a lead role in many of these activities, but 
numerous other Institutes and Centers at the NIH also support and 
participate in research related to antibiotic resistance.
    The NIH-funded projects include basic research on the disease-
causing mechanisms of pathogens, host-pathogen interactions, and the 
molecular mechanisms responsible for drug resistance, as well as 
applied research to develop and evaluate new or improved products for 
disease diagnosis, intervention, and prevention. Numerous genome 
projects seek to identify new gene targets for the development of drugs 
and vaccines. Other NIH-sponsored activities with relevance to 
antimicrobial resistance include physician and researcher training and 
education. In addition, the NIAID supports a number of clinical trials 
networks with the capacity to assess new antimicrobials and vaccines 
with relevance to drug-resistant infections. Among these are the AIDS 
Clinical Trials Groups, the Mycoses Study Group, the Collaborative 
Antiviral Study Group, the Vaccine and Treatment Evaluation Units, and 
the Tuberculosis Research Unit. The NIAID supports contracts that 
screen for novel anti-tuberculosis drugs by testing in vitro and in 
animal models. The candidate drugs are selected for screening from 
submissions by academic and private sector researchers worldwide and 
from the National Cancer Institute's (NCI) chemical repository.
    With regard to other NIAID-specific projects, the Institute funds a 
diverse portfolio of grants examining antimicrobial resistance among 
the major nosocomial bacterial pathogens, for example, multi-drug 
resistant Staphylococcus aureus, enterococci, and Escherishia coli. 
Current research support is aimed at:
  --Identifying new diagnostic techniques, novel therapeutics, and 
        preventive measures to minimize infection with resistant 
        pathogens, prevent the acquisition of resistance traits, and 
        control the spread of resistance factors and resistant 
        pathogens in hospital settings;
  --Understanding the molecular biology and genetics of resistance gene 
        acquisition, maintenance, and transmission;
  --Exploring novel approaches to combat resistance through passive or 
        active immunization;
  --Identifying natural antimicrobial peptides that may prove useful as 
        new classes of antibiotic-like drugs; and
  --Through the use of molecular characterization, continuing efforts 
        to determine the degree of spread of multi-resistant 
        international clones of Streptococcus pneumoniae in the United 
        States and the rest of the world.
    The NIAID is also creating a Bacteriology and Mycology Study Group 
to design and conduct multi-center clinical studies of interventions 
for serious fungal and healthcare-associated resistant bacterial 
infections. Key aspects of the effort will be to: formulate and 
implement a scientific research agenda; establish a multi-center 
clinical studies group; establish a clinical studies coordinating unit; 
provide leadership and organization of the study group; and conduct, 
complete, and report the results of the clinical studies. This project 
will be funded in the spring of 2001.
    Finally, the NIAID recently released a Request for Applications 
(RFA), ``Challenge Grants: Joint Ventures in Biomedicine and 
Biotechnology.'' The purpose of this initiative is to support research 
and development efforts whose outcomes could significantly reduce the 
impact of infectious diseases nationally and worldwide. The RFA was 
issued in response to the fiscal year 2000 Public Health and Social 
Services Emergency Fund appropriation of $20,000,000 designated for 
``NIH Challenge Grants and Partnerships.'' This new initiative is 
intended ``to promote joint ventures between the National Institutes of 
Health and the biotechnology, pharmaceutical, and medical device 
industries'' and involves a ``one-on-one matching of federal dollars by 
qualified organizations that are conducting R&D activities in 
biomedical research or biotechnology with commercializable potential or 
conducting research in promising therapies.''
    The NIAID has identified areas of high importance where it believes 
successful product research and development combined with existing 
infrastructures and federal challenge grant funding could significantly 
impact a major health or medical problem. Bacterial drug resistance is 
an evident area of focus in this solicitation in two specific areas: 
tuberculosis (TB), and emerging and resistant infections, including 
drug resistant staphylococci and enterococci.
    It is the intention of these challenge grants to encourage the 
private sector to develop new TB drugs, including: identification of 
potential new drug targets and novel classes of drugs (making use, 
where appropriate, of the Mycobacterium tuberculosis genome sequence 
and high throughput approaches); preclinical development of novel 
classes of drugs and optimization of lead compounds; and clinical 
testing of potential new therapies. The NIAID also seeks to encourage 
the private sector to increase its commitment to TB vaccine development 
through these challenge grants. In particular, it encourages the use of 
whole genome approaches for the identification of promising protective 
antigens, and the development of both pre-exposure and post-infection 
candidate vaccines from pre-clinical through clinical testing.
    Similarly, through the challenge grants mechanism, the NIAID seeks 
to interest the private sector in pursuing preclinical and clinical 
studies of passive or active immunization candidates to protect against 
resistant staphylococcal infection, first in the most vulnerable 
populations such as severely-ill hospitalized patients and patients 
facing major surgery and at risk for infection, and then also for 
potentially broader application to community situations. Novel 
therapies, such as bacteriophage therapy, will be considered as 
candidates for study for enterococci.
                          parkinson's disease
    Question. The committee just received the Parkinson's Disease 
Research Agenda from your office.
    Do you agree with the report that a cure for Parkinson's is now a 
comprehensive goal if a comprehensive approach is pursued?
    Answer. A cure for Parkinson's is a realistic goal, given what is 
known about the disease and the research tools now available to us. The 
research agenda proposes a comprehensive approach--understanding the 
disease, developing treatments, creating research capabilities, and 
enhancing the research process. We are optimistic that such an approach 
will result in significant progress against Parkinson's and other 
neurodegenerative disorders.
    Question. Is the NINDS sufficiently staffed to implement such a 
plan?
    Answer. The plan reflects our best professional judgment as to what 
could be accomplished if funding were available to implement all 
aspects of the research agenda, but without taking into account fiscal 
constraints or other competing priorities of NIH and the rest of the 
Federal government. In order to do this, more staff would be required 
to develop the necessary initiatives and work collaboratively with the 
research and patient communities.
                                diabetes
    Question. One of NIH's initiatives for 2001 deals with genetics 
research and exploiting genomic discoveries. One area where genetics 
research could be essential is in the area of diabetes, especially 
juvenile diabetes.
    Do genomic discoveries show promise in the area of juvenile 
diabetes and is funding sufficient to do this?
    Answer. Type 1 diabetes has a strong genetic determinant, in which 
more than one gene is believed to play a role. These genes make some 
individuals more susceptible to developing diabetes than others. In 
addition, genetic factors may cause some individuals with diabetes to 
be more prone to developing the serious and life-threatening 
complications associated with type 1 diabetes. Knowledge of the genetic 
defects underlying diabetes will be critical not only for identifying 
individuals at risk for diabetes and its complications, but also for 
identifying targets for effective treatment and prevention.
    The NIDDK is attempting to provide cutting-edge genetics and 
genomics resources to our investigators. We have already begun to move 
in this direction, with a biotechnology initiative on microarray 
technology that will be useful to diabetes researchers and other NIDDK 
investigators, and with a major effort planned for a Diabetes Genome 
Anatomy Project (DGAP) to locate and analyze the function of genes in 
all the various types of tissue relevant to diabetes. Start up of the 
DGAP initiative is currently slated for fiscal year 2001.
    The NIDDK envisions DGAP as a trans-NIH effort involving several 
Institutes with a research interest in diabetes and its complications. 
This project would collect genomic information on the spectrum of genes 
expressed in all tissues relevant to diabetes and its complications. It 
would build upon an ongoing NIDDK initiative on the functional genomics 
of the developing pancreas. While our ongoing effort supports the 
production and sequencing of complementary DNA libraries based on 
multiple stages of pancreatic development, the DGAP would be much 
broader. Objectives would be to obtain full length cDNAs from tissues 
relevant to diabetes; to discover novel genes in tissues affected by 
diabetes; to conduct expression profiling to determine patterns of gene 
expression in disease; and to perform functional phenotyping of 
expressed products in tissues affected by diabetes. More importantly, 
this initiative--if undertaken at a full-scale level--would allow for 
the cataloging of all information obtained in a diabetes relational 
database with automated data mining and query support. This database 
would be developed and offered as a resource for all diabetes 
investigators and could be used in the development of new assays, 
identification of potential therapeutic agents, and points of departure 
for new studies into diabetes and its complications. Information 
obtained through an initiative such as this has the potential to 
further our understanding of the causes and mechanisms of diabetes, to 
identify targets for effective treatment and prevention, and to serve 
as a springboard for the development of future investigator-initiated, 
hypothesis-driven research. The degree to which we can undertake all 
components of this initiative and the timeline for implementation will 
be dependent on resource availability.
                                 ______
                                 
               Questions Submitted by Senator Tom Harkin
                         mental health research
    Question. In several recent Mental Health Advisory Council reports 
you have recommended improving the relevance of prevention research 
into early interventions, clinical research to actual practice, and of 
behavioral research to serious mental illnesses. Could you please 
discuss some of the difficulties you've encountered in your efforts to 
change the institute's course toward the greatest public health needs? 
Where does NIMH stand relative to other NIH institutes on the rate of 
grants submitted and funded? Is the relative quality of the science in 
the grant submissions and proposals received NIMH rising or declining?
    Answer. Mental disorders and suicide together account for over 15 
percent of the burden of disease in established market economies such 
as the United States. The mission of the National Institute of Mental 
Health is to reduce the burden of mental disorders. NIMH also takes the 
lead in understanding the impact of behavior on HIV transmission and 
pathogenesis, and in developing effective behavior preventive 
interventions in areas such as violence. These collectively constitute 
an enormous area of responsibility. Over the past several years, NIMH 
has systematically examined its overall research portfolio and 
conducted even more in-depth reviews of selected programs, areas of 
science, and disorders, all with the objective of refocusing programs 
to bring the best science to bear on areas of greatest disease burden: 
depression; schizophrenia, bipolar disorder, obsessive compulsive 
disorder, and childhood autism, to name a few. In particular we have 
tried to ensure that knowledge gained is relevant to the full range of 
patients: from children to the aged; both sexes; all genders, races, 
ethnic groups; and to individuals with co-occurring conditions. This 
refocusing process has encountered significant challenges. One has been 
the need for extensive reorganization of programs within the 
Institute's intramural and extramural research programs. On the 
intramural side, certain laboratories and clinical units have been 
phased down or terminated in order to permit new growth and 
initiatives. Extramural staff and program realignments have been even 
more extensive and, often, difficult. It also has been quite 
challenging to shift the direction of the larger extramural community--
for example, to motivate basic behavioral researchers to examine and 
revise many time-tested research paradigms in order to make research 
more relevant to clinical questions, or to encourage investigators to 
take a potentially risky step outside a given area of expertise into 
uncharted areas such as translational research. Although we have 
encountered some resistance and doubts about the need for change, these 
efforts are paying off.
    Since we rejoined the NIH in 1993, the ratio between competing 
research project grant applications submitted and awards funded, or 
success rates, has been consistently lower by 3-5 percent from the 
aggregated average for all NIH Institutes and Centers. The functional 
consequence of this differential for scientists is that an application 
for funding to the NIMH had a 16 percent lower chance of success than 
for NIH in the aggregate. This was also true for the most recent 1999 
fiscal year when the success rate for NIMH was 27 percent in comparison 
to the aggregate NIH success rate of 32 percent. Most NIMH applications 
are reviewed in committees with applications from several different NIH 
Institutes, and NIMH applications have been consistently judged 
somewhat better than average by those committees.
    Although precise data is not available, it is my opinion that since 
joining NIH, NIMH science is stronger than it has ever been. The 
science has been kept sharp by strong competition within NIH review 
committees and the new seriousness of scientific review within the 
intramural research program. As indicated in the paragraph above, NIMH 
scientists have performed well in review comparisons with scientists of 
other institutes.
             research on children's mental health disorders
    Question. As I understand it, research on children's mental 
disorders at NIMH still lags behind so much other research, with few 
treatments available that work for obsessive-compulsive disorder (which 
often begins in childhood) and bipolar disorder (which increasingly is 
seen as beginning in childhood and adolescence). What is NIMH's plan 
for strengthening this research and assuring the development of more 
effective treatments for children?
    Answer. NIMH is actively planning a series of projects. A new 
program announcement is being crafted that will focus specifically on 
children with serious mental illnesses, including obsessive-compulsive 
disorders, bipolar disorders, eating disorders, schizophrenia, among 
others. The object of the announcement is to encourage a broad range of 
studies on the onset, course, risk processes, and treatments for 
serious mental illnesses in children and associated disabling 
impairments. In addition, next week NIMH is hosting a meeting to 
identify key research gaps in identification and treatments for 
children with bipolar illnesses, with the aim to further advance 
studies in these areas. Also, NIMH is currently supporting seven 
Research Units of Pediatric Psychopharmacology, several of which focus 
on bipolar illnesses in children.
                   research on minority mental health
    Question. The landmark 1998 Schizophrenia PORT study, found that 
the gap between science and accessible treatment has never been wider. 
Moreover, this lack of ``translation'' was at its worst in the African 
American community, leading to significant health disparities. African 
Americans with schizophrenia were more likely to experience 
overmedication with anti-psychotic medications, increased side-effects, 
and under-treatment of depression to a higher degree than other racial/
ethnic groups. What is NIMH doing to improve the translation of 
scientific advances into real world treatment, in general, and 
especially in the African American community?
    Answer. Since the completion of the Schizophrenia PORT study, NIMH 
has funded additional studies to look, in depth, into reasons for the 
disparities in treatment. One study is designed to determine if 
adherence to treatment recommendations will lead to improved outcomes 
and whether minority status has an impact on what treatments are 
provided. In addition, the NIMH has issued a report, Bridging Science 
and Service, that calls for more research on improving the delivery of 
treatments in community populations, especially those who are 
traditionally underserved. NIMH also recently launched four new major 
clinical treatment studies that will provide data on how to treat some 
of the most severe mental illnesses in real-world settings. These 
studies are required to include minority populations so the results 
will be relevant to them.
    Currently, the NIMH Committee on Health Disparities is drafting a 
document delineating the specific research priorities for the next 5 
years. The report will focus on what the state of disparities is; why 
they exist and approaches to remedy the situation. In addition, the 
National Advisory Mental Health Council just issued a new report, 
Translating Behavioral Science into Action, which calls for research 
that takes into account the importance of individual, sociocultural, 
and organizational factors on the differences in help seeking, 
treatment, and outcomes from treatment.
    In the past, studies of treatment in schizophrenia tended to be 
small scale, industry sponsored, and focused on safety and short term 
efficacy. The data gathered were useful in obtaining regulatory (FDA) 
approval, but provided little guidance for practitioners on how best to 
treat patients in the community. Moreover, for a number of reasons, 
African Americans tended to be underrepresented in these treatment 
trials. The net result was that clinicians had to base many treatment 
decisions, particularly in minority patients, on prior experience, 
opinion, and their own experiences, rather than objective data. To 
remedy this situation, NIMH recently initiated a multie-year, multi-
site, multi-million dollar project to study new antipsychotic drugs in 
people with schizophrenia (Clinical Antipsychotic Trials of 
Intervention Effectiveness, CATIE). One of the project's highest 
priorities is to include a representative sampling of patients with 
adequate representation of minorities and not be limited to middle 
class or upper class patients. There will be considerable outreach 
efforts to African Americans with schizophrenia, including recruitment 
of study sites in African American communities. Important 
characteristics of the trial are that all subjects participating in the 
trial will receive state-of-the-art care, and clinicians involved in 
the trial will be guided on best clinical practice and will have world-
class experts available for consultation. While the number of patients 
treated in this trial will represent an insignificant fraction of the 
totality of people with schizophrenia, NIMH anticipates that the 
experience with patients and clinicians in African American communities 
gained through CATIE will greatly facilitate subsequent translation of 
CATIE's findings into that community as well as aid in dissemination of 
optimal clinical practices to mental health professionals providing 
care to African American people with schizophrenia.
                          nimh research agenda
    Question. A recent National Advisory Mental Health Council report 
notes that the behavioral science portfolio at NIMH has not been well-
focussed on the areas of greatest public health need and makes a number 
of recommendations to improve the relevance of this portfolio. Could 
you discuss some of the factors which contributed to this lack of 
attention to many of our serious mental illnesses, what you think 
behavioral research can contribute, and how you can redirect existing 
research resources to develop more relevant behavioral research?
    Answer. Until recently, NIMH has focused relatively little 
organized effort to bridge basic behavioral science and severe mental 
illness. In part this has reflected the Institute's encouragement of 
investigator-initiated research, which, in turn, reflects academic 
traditions within psychiatry and psychology that often place a higher 
value on basic research than on clinically oriented (or applied) 
research. In addition, clinical and basic behavioral scientists have 
traditionally operated in separate academic departments unfamiliar with 
the language, concepts and problems of each other's disciplines. 
Because clinical populations have not been accessible to basic 
researchers, they have often focused on normal or less ill populations. 
Academic incentive systems and the segmentation of funding and outlets 
for publication have not promoted cross-disciplinary studies. Training 
programs in basic behavioral science often discourage exposure to 
clinical problems and clinical settings so that behavioral scientists 
may be unaware of basic research issues and opportunities posed by 
research on mental illness.
    Finally, when NIMH has attempted to encourage targeted research 
that can bridge between basic behavioral research and severe mental 
illness, relatively few researchers have responded. This lack of 
interest in certain types of behaviorally oriented translational 
research indicates the necessity for more specific targeted efforts to 
stimulate interest in these areas.
    Basic behavioral science will contribute to understanding and 
solving otherwise intractable public health problems related to serious 
mental illness in a number of areas:
Understanding Symptoms of Illness
    The symptoms of serious mental illness involve attention, abstract 
thinking, social interaction, motivation, and emotion. Behavioral 
science should offer new ways of assessing these behavioral processes 
that will: (1) help link them to underlying neurobiologic processes; 
(2) allow their evaluation as indicators of risk prior to the 
development of full-blown illness; and (3) facilitate the objective 
assessment of response to targeted treatment interventions.
Encouraging Behavior Change
    Theory-driven behavior-change interventions are highly successful 
in HIV/AIDS, yet remarkably, behavioral theory has rarely focused on 
health behaviors related to serious mental illness. More than half of 
all schizophrenia relapses can be attributed to lack of adherence with 
treatment recommendations. The application of theory-based behavior-
change principles to the problem of adherence should result in 
effective approaches to substantially reduce morbidity in schizophrenia 
and other serious mental illness.
Improving Treatments
    Learning theory should guide new treatment development for mental 
illness as well as treatment dissemination. Despite advances in 
psychopharmacology, patients with serious mental illness must learn 
ways of adapting to deficits and disabilities; learning theory should 
inform the development of new cognitive-behavioral interventions for 
skills training and illness self-management. At the same time, because 
research advances are very slow to influence everyday care, we need a 
better understanding of physician and provider behavior as related to 
the diffusion of innovations.
Encouraging Help-Seeking
    Evidence indicates that delay in seeking treatment contributes to 
morbidity at the onset of serious mental illnesses including major 
depression, bipolar disorder and schizophrenia. Behavioral science 
should contribute to our understanding of the psychological and social 
processes, including the influence of social norms and stigma, that 
impede timely symptom recognition and help-seeking for serious mental 
illness.
Helping Families Cope with Mental Illness
    Mental illness in a child or spouse can have a profound effect on 
family relationships, which in turn influence both the ill individual 
and other family members. Relationship research should explicate the 
adaptive responses of families that influence treatment outcome for the 
ill family member, including adherence to treatment recommendations. At 
the same time, better ways of characterizing and alleviating the family 
burden created by serious mental illness must be developed. The 
presence and severity of symptoms alone cannot account for the 
disabilities associated with mental illnesses. Behavioral science 
should contribute to a better understanding of the multidimensional 
nature of social, vocational and instrumental functioning to refine the 
choice of rehabilitation interventions. It should also aid in 
identifying the different treatment needs of individuals who are 
grouped within a single diagnostic category.
Understanding the Inheritance of Mental Disorders
    Evidence indicates that defining mental disorders in terms of 
behavioral dimensions rather than specific diagnoses may more closely 
approximate inherited phenotypes. Behavioral science may aid in finer 
characterization and measurement of these behavioral phenotypes to 
facilitate the linkage of behavioral diseases to specific sets of risk 
genes.
    ``Translating Behavioral Science into Action,'' the report of the 
National Advisory Mental Health Council's Behavioral Science Workgroup, 
provides a wealth of specific recommendations for redirecting existing 
research resources. Measures commenced or soon to begin include:
  --A Request for Applications (RFA) with set-aside funds that focuses 
        on basic behavioral processes in mental illness is under 
        development to jump start cross-disciplinary collaborations 
        between basic behavioral researchers and clinical 
        investigators.
  --Simultaneously, a new Program Announcement (PA) will outline a 
        trajectory of research support to include both developing and 
        mature translational research centers to provide an 
        infrastructure for new research, speed the translation of 
        findings, and encourage interaction across basic, clinical and 
        services research. These efforts will signal a serious and 
        ongoing commitment on the part of NIMH to apply behavioral 
        science methods to the problems of mental illness.
  --An ancillary study PA encourages behavioral scientists to access 
        the patient populations and infrastructure developed as part of 
        the NIMH clinical trial initiatives.
  --Workshops bringing together behavioral and clinical scientists have 
        been initiated in the areas of (1) adherence in serious mental 
        illness; (2) informed consent and clinical research; (3) 
        research ethics; and (4) integrating behavioral science with 
        public health.
  --Staff have worked with current behavioral scientist grantees to 
        encourage redirection into areas more closely dealing with 
        mental disorders.
  --Training activities are being examined to identify ways to overcome 
        barriers to cross-disciplinary training experiences that are 
        required to facilitate translational research.
                             schizophrenia
    Question. Given the many changes underway at NIMH in terms of the 
funding of clinical research and the clinical research centers, how are 
you moving to assure that the research base studying schizophrenia is 
strengthened and expanded?
    Answer. NIMH is strengthening and expanding its research base with 
regard to schizophrenia in the following ways: (1) initiating a large, 
sustained effort in the area of clinical trials of typical and atypical 
antipsychotics for treatment of schizophrenia, and supporting Centers 
and other grants addressing a large number of schizophrenia treatment 
issues; (2) bolstering our program for the Silvio O. Conte Centers for 
the Neuroscience of Mental Disorders in the area of schizophrenia (2 
Centers to date); (3) undertaking major, innovative new efforts to 
investigate genetic contributions to schizophrenia; these efforts 
include a centralized, international respository for genetic samples 
and for services to genetics investigators; (4) funding a large number 
of R01-type grants focused on the neurobiology of schizophrenia, using 
methods such as brain imaging, electrophysiology, 
electromagnetoencephalography, etc.; (5) funding an extensive portfolio 
of basic neuroscience research relevant to schizophrenia and other 
mental disorders, (6) initiating new epidemiological and other efforts 
to understand non-genetic risk factors for schizophrenia and to 
characterize, in more insightful ways, the very early stages of the 
disorder; (7) continuing to support a large intramural research program 
targeting a number of aspects of schizophrenia.
                         advocates on comittees
    Question. NIMH was a leader in asking members of the general 
public--often consumers with severe mental illnesses or their family 
members--to serve on scientific peer review committees looking at 
treatment research. As you know, there was a good deal of skepticism 
about the wisdom of including non-scientists on the committees. Could 
you provide us with your assessment of how that innovative project has 
turned out?
    Answer. Public participant reviewers have successfully served for a 
year on the NIMH's service and interventions review committees. Public 
reviewers included individuals who have suffered from mental disorders, 
family members of those suffering from mental disorders, mental health 
care policymakers, and mental health care providers. All committee 
members were asked for their assessment of how well the process worked. 
The most common feedback was that the inclusion of public reviewers was 
useful and that the public reviewers had done an excellent job. The 
public reviewers, many of whom experienced the committee process for 
the first time, were impressed with the efforts of the committee 
members and the serious and objective nature of the deliberations. NIMH 
will continue to request feedback from all reviewers to help inform and 
improve the process of public participation in its review meetings. 
Future plans are to help public reviewers focus on the review issues 
about which they can best contribute such as determining public health 
importance and human protection issues, and to continue adding and 
training new public reviewers to ensure a broad diversity of opinions 
and experiences.
                        human subject protection
    Question. NIMH has been dealing with ethical issues in research on 
mental illnesses for a number of years and has instituted a new Mental 
Health Advisory Council review process to examine human subjects 
protections before grant approval. Has this new review process been 
useful? Is it helpful to have non-scientists on the review panel?
    Answer. The NIMH Human Subject Research Council Workgroup has been 
in existence for a year and will meet next on May 3, 2000. It has 
helped assure that applications considered for funding meet the highest 
scientific and ethical standards, and that proper protections for human 
research volunteers are in place. Having bioethicists and consumers on 
this group has been particularly useful in considering research risks, 
benefits, alternatives, and informed consent issues.
                         co-occurring disorders
    Question. NIAAA's strategic plan hardly mentions the problem of co-
occurring disorders. What plans does NIAAA have to address co-occurring 
disorders--and in particular, is the institute sponsoring any research 
to help establish the most effective treatment approaches when 
alcoholism and a mental disorder occur together?
    Answer. The strategic plan of the National Institute on Alcohol 
Abuse and Alcoholism (NIAAA) is a blueprint of the Institute's major 
goals and objectives and the strategies for achieving them. Many 
elements of this plan were developed with input from the National 
Advisory Council, with significant input from scientists in alcohol-
related areas as well as other research areas. The plan also reflects 
advice from a broad spectrum of sources--researchers, health care 
providers, over 250 liaison organizations, policymakers, people 
recovering from alcoholism and their families, and others. It is a 
``live'' document that the Institute will be updating periodically. 
While researchers interested in the causes of disease will differ on 
whether studying the patient with co-occurring disease is a promising 
research strategy, the NIAAA is addressing the issue of co-occurring 
disorders throughout the strategic plan and the research portfolio.
    Alcohol's effects on the human body are ubiquitous,both physically 
and psychologically. For example, chronic alcohol use is associated 
with a range of diseases, from liver damage to depression. In terms of 
psychological comorbidity, the challenge for alcohol investigators is 
to determine whether specific diseases occur regardless of alcoholism, 
are the result of alcoholism, or contribute to the development of 
alcoholism. Numerous studies in this regard are underway. For example, 
topics of studies on depression range from delivery of services for 
depressed substance abusers to observing the outcome of treating 
depressed alcoholics for depression alone, alcoholism alone, or both 
conditions. The Institute's research on co-occurring psychiatric 
disorders also includes studies of alcoholics with post-traumatic 
stress syndrome and bipolar disorder and clinical trials of alcoholics 
with social phobia and depression. Neuroscience contributes vital 
information to studies of treatment for alcoholism and co-occurring 
disorders, since they identify the biological mechanisms that underlie 
these conditions. The NIAAA conducts numerous neuroscience studies on 
mental health, from research on alcoholism and schizophrenia to 
research on development of alcohol use and abuse in adolescents with 
attention-deficit hyperactivity disorder.
           treatment options for dually diagnosed individuals
    Question. Drug abuse and psychiatric disorders frequently occur 
together and these ``dually-diagnosed'' individuals pose special 
treatment problems. I understand that NIDA's ambitious Clinical Trials 
Network will address this issue. Could you please review for us what 
the existing research says about the most effective treatment 
approaches for these dually-diagnosed individuals and discuss why these 
approaches have generally not been adopted by the drug abuse and mental 
health treatment communities?
    Answer. Data from the Epidemiological Catchment Area Study showed 
that 53 percent of individuals with substance use disorders met 
criteria for one or more mental disorder, and that about one-third of 
individuals who have a mental disorder also experience alcohol and 
other drug abuse disorders in their life. In the National Comorbidity 
Study, 47 percent of individuals with a past year substance use 
disorder diagnosis had a comorbid mental disorder. Affective, anxiety, 
personality and psychotic disorders were most commonly comorbid with 
substance abuse or addiction disorders.
    Among treatment-seeking substance abusers and addicts, psychiatric 
comorbidity has been found to be commonplace. In a recent study in 
Baltimore, psychiatric comorbidity was detected in 47 percent of heroin 
addicts one month after stabilization on methadone. Antisocial 
personality disorder (25 percent) and major depression (16 percent) 
were the most common diagnoses. Psychiatric comorbidity was associated 
with increased severity of drug use and severity of associated social 
problems. In other studies increased psychiatric symptoms have been 
associated with increased HIV risk behaviors.
    Clinical studies have shown that people who have comorbid mental 
and addictive disorders tend to have poorer treatment outcomes, to 
relapse more frequently, and are less responsive to psychiatric 
medications during continued use. Furthermore, studies have 
demonstrated that treatment of a comorbid mental disorder with 
appropriate psychiatric and drug addiction medications and 
psychotherapy and drug addiction counseling is important to the 
effective treatment of the addictive disorder and results in better 
outcomes and reduced relapse rates.
    Several studies have now shown that integrated treatment programs, 
which combine mental health and substance abuse interventions, offer 
much greater promise than the totally separate programmatic approaches 
found in many communities. In addition to a comprehensive integration 
of services, successful programs include assessment, assertive case 
management, motivational interventions for patients who do not 
recognize the need for substance abuse treatment, behavioral 
interventions for those who are trying to attain or maintain 
abstinence, family interventions, housing, rehabilitation, and 
pharmacotherapy.
    Since the late 1980's new models of treatment for the dually 
diagnosed--with a primary aim of integrating services----have been 
evolving. This integration is accomplished through the use of 
multidisciplinary teams that include both mental health and substance 
abuse professionals who are cross-trained. However, despite the 
encouraging research findings regarding the effectiveness of integrated 
treatment for this population, implementation continues to be slow 
because of problems related to the organization and financing of 
programs. Organizational guidelines have been developed for dual 
diagnosis programs, but few large systems have successfully integrated 
services.
    It appears that more research needs to be done on the organization 
and financing of integrated treatment programs (health services 
research). In addition, many of the basic components of integrated 
treatment (family psychoeducation; motivational interventions; 
behavioral treatments for substance abuse; integrating 
pharmacotherapies, etc.) are still being developed and refined. 
Research is needed to address the effectiveness of the appropriate 
combination of these components.
    Of course, another major barrier to successful implementation of 
this integrated approach is the lack of cross-training for health 
substance abuse and mental health professionals.
    In summary, research has informed us that it is important to 
diagnose both substance abuse and mental disorders when they are 
comorbid and provide fully effective treatments for both disorders. 
Several studies have demonstrated the significant benefits of 
integrated substance abuse and psychiatric services in the same 
treatment setting rather than separate and parallel treatment. Benefits 
included increased engagement and retention in treatment, decreased 
addiction severity and decreased psychiatric symptomatology. For the 
most psychiatrically severe patients, these integrated interventions 
must include Assertive Community Outreach, which fosters continuous 
engagement and re-engagement in treatment, provides crisis intervention 
and other community-based services, and supports medication compliance 
and attendance at both psychiatric and drug treatment services. 
Research is continuing on the refinement of the components of treatment 
services and their effectiveness in combination therapy.
    NIDA's National Drug Abuse Treatment Clinical Trials Network (CTN) 
will also serve as a potential vehicle for treating dually diagnosed 
patients. Since the CTN will be testing efficacious therapies in real 
life settings with diverse patient populations, dually-diagnosed 
patients will be included in some treatment protocols with appropriate 
analyses of these patients conducted to improve the treatment strategy 
even more. Additionally, the CTN will develop protocols to test 
therapies specifically targeted to co-morbid patients. For example, 
this may include using antidepressants as an adjunct to behavior 
therapies for depressed drug addicts.
                           autoimmune disease
    Question. What is the status of the NIH's report on autoimmune 
disease research? What is the timing on submission of that report?
    Answer. The Report of the NIH Autoimmune Diseases Coordinating 
Committee summarizes recent basic and clinical research programs 
supported by NIH and non-Federal organizations, highlighting 
coordination and collaborative activities in ten thematic areas; recent 
and ongoing activities of the NIH Autoimmune Diseases Coordinating 
Committee; and emerging opportunities to improve treatment and develop 
preventive approaches for autoimmune diseases. Twenty-two NIH 
Institutes, Centers, and Offices; the U.S. Food and Drug 
Administration; the Centers for Disease Control and Prevention; the 
Veterans' Administration; and ten private organizations with an 
interest in autoimmune diseases are represented on the Committee. The 
research programs supported by these groups comprise a broad range of 
basic, pre-clinical, and clinical endeavors addressing many different 
diseases, organ systems, and aspects of autoimmune disease.
    The Committee will submit the report to the Office of the Director, 
NIH, for clearance and hopes to release the report in the very near 
future.
    Question. What is the total amount that NIH is spending for 
research on all autoimmune diseases?
    Answer. The NIH spent $393.2 million on autoimmune disease research 
in fiscal year 1999, and expects to spend $434.6 million in fiscal year 
2000, and $456.9 million in fiscal year 2001.
    Question. What are some research initiatives NIH is funding to 
develop better treatments for these diseases?
    Answer. Autoimmune diseases are immune-mediated disorders in which 
the immune system attacks the body's own tissues. Treatment of these 
diseases depends largely on immunosuppressive agents that have many 
side effects, for example, steroids and cytotoxic therapies. However, 
more specific and less toxic immune therapies have shown efficacy in 
animal studies. As highlighted below, the NIAID, in collaboration with 
many other federal and private organizations, has developed new 
programs to assist in moving these promising therapies to clinical 
practice.
    Immune Tolerance.--The induction of immune tolerance is a major 
therapeutic goal for the treatment of many immune-mediated diseases, as 
it will eliminate or reduce the life-long dependence of many patients 
on costly and toxic immunosuppressive drugs. Tolerance induction 
strategies seek to modify or block deleterious immune responses, such 
as those responses that cause the body to attack its own organs and 
tissues in autoimmune disorders, or the immune responses that result in 
the rejection of transplanted organs, tissues, and cells. A number of 
promising reagents for the induction of immune tolerance are being 
developed and can now be tested in clinical trials.
    In September 1998, the NIAID published a long-term plan, now 
available on the web (http://www.niaid.nih.gov/publications/immune/
bookcover.htm) to accelerate research on immune tolerance, particularly 
in the clinical setting. In September 1999, the NIAID, with co-
sponsorship of the National Institute of Diabetes and Digestive and 
Kidney Diseases (NIDDK) and the Juvenile Diabetes Foundation 
International (JDFI), established one of the major research programs 
emanating from this plan, the Immune Tolerance Network (http://
paramount.bsd.uchicago.edu/frameset.html). Leading investigators from 
more than 40 institutions in the U.S., Canada, Western Europe, and 
Australia are participating in the design and evaluation of clinical 
trials of tolerance induction therapies for autoimmune diseases, asthma 
and allergic diseases, kidney transplantation, and islet 
transplantation for type 1 diabetes. In the six months since the 
inception of this major clinical research program, the Network has 
initiated the development of clinical trials for a variety of immune-
mediated disorders, including islet transplantation for systemic lupus 
erythematosus, and multiple sclerosis. The Network is also implementing 
a study to assess the immune status of kidney transplant recipients who 
have voluntarily discontinued immunosuppressive therapy yet maintained 
a functioning transplant over long periods of time. Network-supported 
scientists are also designing studies of several approaches to measure 
the induction, maintenance, and loss of tolerance in humans in 
conjunction with these clinical trials. Examples include the use of new 
biotechnologies, such as the complementary ``gene chip'' microarray 
technology, which will profile changes in gene expression associated 
with tolerance induction therapies, and the ELISPOTR assay that will 
enable scientists to analyze the expression of immunomodulatory 
proteins during treatment with tolerogenic therapies. In order to 
stimulate new insights that will lead to wider application of 
tolerogenic approaches, all Network-supported clinical trials will 
include studies of the underlying mechanisms of immune regulation as an 
integral part of the protocols.
    The NIDDK, with the NIAID and the National Institute of Child 
Health and Human Development (NICHD), is cosponsoring a clinical trial 
to test the ability of subcutaneous or oral insulin by inducing immune 
tolerance to prevent or delay the development of type 1 diabetes in 
relatives of patients with the disease who are at risk for development 
of the disease in the next five years. The JDFI and the American 
Diabetes Association are also sponsoring this multi-center, nationwide 
trial.
    The program, Human Islet Transplantation into Humans, will support 
clinical studies using new methods to induce immune tolerance, to 
prevent reoccurrence of the autoimmune destruction of beta cells in the 
islet, and to prevent transplant rejection. The NIDDK, the NIAID, and 
the JDFI support this program.
    Immune Modulation.--Traditional immunosuppressive and cytotoxic 
therapies used to treat autoimmune diseases have many serious side 
effects, including a decreased ability to fight infection, tissue and 
bone fragility, and malignancy. In contrast, immunomodulatory 
approaches seek to modify immune injurious responses without the need 
for global immunosuppression. Examples include recently approved drugs 
that target the tumor necrosis factor, an important mediator of 
inflammation in rheumatoid arthritis and inflammatory bowel disease. 
This targeted approach appears to be more potent and less toxic than 
the use of cytotoxic agents or cortocosteroids in treating these 
disorders.
    In fiscal year 1999, the NIAID, with co-sponsorship of the NIDDK, 
the National Institute of Arthritis and Musculoskeletal and Skin 
Diseases (NIAMS), and the Office of Research on Women's Health (ORWH) 
of the National Institutes of Health, established the Autoimmunity 
Centers of Excellence to design and conduct pilot clinical trials of 
the safety and potential efficacy of new strategies for immune 
modulation in multiple autoimmune diseases. Three clinical trials of 
promising approaches are under development: prevention of kidney damage 
in systemic lupus erythematosus through interruption of a specific 
immune pathway, the complement pathway; induction of remissions in 
systemic lupus erythematosus through removal of a specific immune cell, 
the B cell; and prevention of the development of autoantibodies in 
children at risk for type 1 diabetes through the use of insulin. These 
Centers will also conduct pilot clinical trials of tolerance induction 
strategies and provide important safety and efficacy data for further 
evaluation by the Immune Tolerance Network.
    Another new research program will focus, in part, on the 
development of novel treatments for the many rare immune-mediated 
diseases, some of which affect less than 200,000 people. NIH support in 
this area is particularly important due to limited industrial interest 
in diseases with a small market potential. A fiscal year 2000 NIAID 
research initiative, Clinical Trials and Clinical Markers of Immune 
System Diseases, will support the testing of new therapeutic approaches 
for certain rare immune-mediated disorders, including primary 
immunodeficiency diseases and autoimmune diseases. Under this 
initiative, the development of new biological markers and surrogate 
endpoints to measure disease risk, activity, stage, and therapeutic 
response will be encouraged. The availability of specific and easily 
measured biological markers will facilitate the design and evaluation 
of new therapeutic strategies.
    In fiscal year 1998, the NIAID initiated a program called the 
Hyperaccelerated Award/Mechanisms in Immunomodulation Trials to support 
investigator-initiated research applications for mechanistic studies to 
be conducted in conjunction with clinical trials for immune-mediated 
diseases. The applications focus on utilization of patient samples to 
define: mechanisms of disease pathogenesis; immunological mechanisms 
underlying the clinical intervention; and surrogate/biomarkers markers 
of disease activity and therapeutic effect. The ``parent'' or ``core'' 
clinical trial must have independent financial support, either from 
industry, private foundations, or a federal agency. This program, 
cosponsored by the National Institute on Aging (NIA), NIAMS, NIDDK, the 
National Heart, Lung and Blood Institute (NHLBI), the National 
Institute of Neurological Disorders and Stroke (NINDS), and the ORWH, 
has been highly successful. In the 18 months since its inception, the 
NIH has received 29 applications and funded eight projects in 
autoimmune diseases, allergy and asthma, and transplantation in 
collaboration with six industry partners. Through a number of steps to 
expedite peer review and award, applications are accepted monthly and 
awards are made within 13 weeks of receipt.
    In fiscal year 2000, the NIDDK, the NIAID, and the NICHD will begin 
a new program, New Strategies for the Treatment of Type 1 Diabetes, 
supporting clinical studies to test new approaches to treat type 1 
diabetes, including studies of immunomodulation.
    Other Therapeutic Approaches--Another approach to the treatment of 
immune-mediated diseases involves ``replacing'' the immune system 
through transplantation of hematopoietic stem cells. In many cases, the 
patient's own stem cells are used to ensure that the transplanted cells 
do not react against the body's own tissues. Stem cell transplantation 
is currently being used for the treatment of several autoimmune 
diseases, and anecdotal reports suggest that this approach holds 
promise for inducing remission or decreasing disease severity. However, 
well-controlled clinical trials of efficacy have not yet been 
conducted. Therefore, in fiscal year 1999, the NIAID implemented a 
research initiative, Stem Cell Transplantation for Autoimmune Diseases, 
to design and conduct rigorous clinical trials of the safety and 
efficacy of this new therapeutic strategy.
    In fiscal year 1999, the research initiative, Pilot Clinical Trials 
on Innovative Therapies for Rheumatic and Skin Diseases, was 
implemented under the leadership of the NIAMS to develop innovative 
therapies for the treatment of rheumatic and skin diseases. Awards were 
made for research on Wegener's granulomatosis, rheumatoid arthritis, 
scleroderma, systemic lupus erythematosus, and ankylosing spondylitis.
    In fiscal year 1999, the NHLBI began an investigator-initiated 
clinical trial of Cyclophosphamide in the treatment of the pulmonary 
fibrosis associated with systemic sclerosis. In systemic sclerosis, 
interstitial pulmonary fibrosis is frequent (80 percent) and is now the 
leading cause of death. The mortality rate of patients with impaired 
pulmonary function is 40-45 percent within 10 years of onset. 
Uncontrolled studies suggest that cyclophosphamide may stabilize or 
improve lung function in systemic sclerosis patients. The study is a 
five-year, 13-center, parallel-group, double-blind, randomized, 
controlled, phase III clinical trial of oral cyclophosphamide versus 
placebo to assess the efficacy of cyclophosphamide in stabilizing or 
improving the course of pulmonary disease in scleroderma. NIAMS also 
contributes to the support of this study.
    In fiscal year 2000, the NIDDK with the NIAID and the JDFI will 
sponsor new Diabetes Centers of Excellence to support basic research 
into the pathogenesis of type 1 diabetes and to develop new therapeutic 
approaches to this autoimmune disease.
    Question. How does NIH intend to increase coordination of research 
on the family of autoimmune diseases?
    Answer. In fiscal year 1998, both the Senate and the House 
Appropriations Committee Reports addressed the importance of 
coordination of NIH-supported research activities relating to 
autoimmune diseases. The NIH recognized the need for coordination and 
collaboration in this area and in fiscal year 1998 established the 
Autoimmune Diseases Coordinating Committee under the direction of the 
NIAID. Twenty-two NIH Institutes, Centers, and Offices, the U.S. Food 
and Drug Administration, the Veterans Administration, the Centers for 
Disease Control and Prevention, and private organizations that sponsor 
research in this area are represented on the Committee. Some of the 
private organizations include the Juvenile Diabetes Foundation 
International, the Arthritis Foundation, the National Multiple 
Sclerosis Society, the Systemic Lupus Erythematosus Foundation, the 
Sjogren's Foundation, and the American Autoimmune Related Diseases 
Association.
    Since its initial meeting in June 1998, the Committee has collected 
and analyzed information on current research activities and funding 
levels and established multi-Institute collaborative working groups in 
areas of common interest and relevance to multiple autoimmune diseases. 
In addition, the Committee's efforts have facilitated a variety of 
other activities to further enhance coordination of research and 
increase partnerships between public and private organizations. 
Examples include:
  --Extensive collaboration among many NIH Institutes, Centers, and 
        Offices in planning and cosponsoring several new research 
        initiatives in fiscal year 1999;
  --Establishment of public-private research partnerships between the 
        NIH and the Juvenile Diabetes Foundation International, the 
        Arthritis Foundation, and the Crohn's and Colitis Foundation of 
        America;
  --Cosponsorship of workshops and scientific symposia by the NIH, the 
        Juvenile Diabetes Foundation International, the Arthritis 
        Foundation, and the Crohn's and Colitis Foundation of America;
  --Participation of NIH staff in scientific planning activities of 
        non-Federal organizations, such as the National Multiple 
        Sclerosis Society, the Alliance for Lupus Research, and the 
        Juvenile Diabetes Foundation International.
    The Autoimmune Diseases Coordinating Committee was instrumental in 
the development, coordination, and implementation of several new 
initiatives in fiscal year 1999. The guiding principles of this 
planning process included an emphasis on: cross-disciplinary research 
addressing multiple autoimmune diseases; support for a mechanism-based 
approach, encompassing fundamental investigations of disease 
pathogenesis and clinical trials involving new diagnostic and 
therapeutic approaches; and selected research programs focusing on 
specific diseases, new technologies, and/or extraordinary scientific 
opportunities.
    Several new trans-NIH initiatives emerged from this process, and 
nine previously planned activities in later stages of development 
received increased support. Support was provided for the following 
initiatives, the majority of which involved joint sponsorship by 
multiple NIH components:
  --New Imaging Technologies in Autoimmune Diseases
  --Environment/Infection/Gene Interaction in Autoimmune Diseases
  --Autoimmunity Centers of Excellence
  --Multiple Autoimmune Disease Genetics Consortium
  --Target Organ Damage in Autoimmune Disease
  --Stem Cell Transplantation for Treatment of Autoimmune Diseases
  --Immune Tolerance Network
  --Non-human Primate Transplantation Tolerance Cooperative Study Group
  --Human Immunology Centers of Excellence
  --Clinical Trials and Clinical Markers for Immunologic Diseases
  --Rat Autoimmune Disease Genetic Resource
  --Rat Autoimmune Model Repository
  --Pilot Trials on Innovative Therapies for Rheumatic and Skin 
        Diseases
  --Immunological Phenotyping of Mouse Mutants
  --Human Rheumatic Diseases Registries
  --Hyperaccelerated Award/Mechanisms in Immune Disease Trials
  --Rheumatic Diseases Registries
    In November 1999, the Autoimmune Diseases Coordinating Committee 
established Collaborative Working Groups to encourage NIH, other 
federal agencies, and private organizations to prospectively develop 
jointly sponsored initiatives in areas of overlapping interest. Several 
initiatives are likely to be published in the coming year from this 
collaborative process.
    The major challenges facing autoimmune diseases research today are 
the: development of a mechanism-based, conceptual understanding of 
autoimmune disease; translation of this knowledge into new, broadly 
applicable strategies for treatment and prevention of multiple 
diseases; and development of sensitive tools for early and definitive 
diagnosis, disease staging, and identification of at-risk individuals. 
Through the collaborative programs outlined above, NIH-supported 
scientists are vigorously pursuing these goals.
                                 ______
                                 
                Questions Submitted by Senator Herb Kohl
                                epilepsy
    Question. Dr. Fischbach, I am very pleased that today NINDS is 
sponsoring a conference on curing epilepsy. I am hopeful that the 
discussions at the conference will lead to a clearer strategy for 
research into this debilitating disease. With that goal in mind, I have 
several questions:
  --Report language last year discussed curing epilepsy, not just 
        finding new treatments for it. What is NINDS doing differently 
        to change its focus from finding new treatments to finding a 
        cure to stop epilepsy dead in its tracks?
  --What is NINDS's strategy for focusing on the population with 
        intractable epilepsy?
    Answer. Our approach to curing epilepsy is reflected in the title 
of a major, White House-initiated conference we sponsored last month--
``Curing Epilepsy: Focus on the Future.'' In light of recent science 
advances, and with the enthusiastic support of the research and patient 
communities, we are defining ``cure'' as the prevention of epilepsy 
before it occurs in people at risk, and the total elimination of 
seizures without treatment side effects in those who develop the 
disease. Our approach is threefold. We want to pursue innovative 
approaches to medical treatment, including the identification of new 
targets for drugs and new methods such as high throughput screening to 
identify useful medicines. We want to improve existing surgical 
treatments and develop new ones aimed at modifying the circuitry of the 
brain and take advantage of new methods such as various types of 
stimulation to prevent or interrupt the destructive cascade of seizure 
activity. And we want to harness the power of genomic information to 
understand how the mutant genes responsible for many forms of epilepsy 
lead to disease so that we can identify ways to prevent or reverse that 
process.
    ``Intractable epilepsy'' is a term that we hope will become 
obsolete as our research strategies bear additional fruit. The approach 
I have just outlined for epilepsy in general is really the same we hope 
to apply to those for whom existing treatments have failed--better 
drugs, more effective surgery, and application of what we already know 
and expect to learn about the role of genes in epilepsy.
                          alzheimer's disease
    Question. It is my understanding that some research has shown that 
Alzheimer's Disease begins to destroy the brain cells of its victims 10 
to 20 years before outward symptoms appear. Do we currently have the 
tools to diagnose Alzheimer's Disease in its earliest stages and, if 
not, what research is being done to develop that capability?
    Answer. Alzheimer's disease (AD) is a degenerative disorder of the 
central nervous system where neuropathological changes may begin 
several decades before the disease is recognized clinically. Therefore, 
the most cost-effective therapies will prevent the onset of AD before 
it ever manifests itself clinically. These preventative therapies can 
only be developed if we can understand and predict the initial stages 
and events in the brain that lead to the development of AD.
    Targeting early pathological processes necessitates development of 
biochemical, neuropsychological, neuroimaging and genetic markers that 
are sufficiently sensitive and accurate to identify at-risk individuals 
along the spectrum from normal aging through mild cognitive impairment 
(MCI) (a condition characterized by memory deficit without dementia) to 
AD. Most recently, diagnostic research has focused on people with MCI. 
These people are at increased risk of developing AD since 15-20 percent 
annually convert to AD versus 1-2 percent in the general population 
over the age of 65. A number of ongoing imaging studies are evaluating 
persons who exhibit early pre-clinical or clinical signs of AD and 
comparing their neuroimaging and biochemical measures to those of older 
individuals who are not cognitively impaired in an attempt to identify 
the earliest biochemical and imaging markers that distinguish AD from 
normal age-related changes.
    Current neuroimaging studies are assessing whether it is possible 
to measure aspects of brain function and/or structure to identify 
individuals who are at-risk for AD before they develop the symptoms of 
the disease. Structural and functional imaging have been shown to be 
useful in identifying diagnostic markers of AD; however, in the past, 
most imaging studies have been cross-sectional and designed to 
demonstrate differences between older controls and patients who were 
already demented. Recently published research has conducted magnetic 
resonance imaging (MRI) studies in longitudinally followed individuals 
diagnosed with MCI who were at increased risk of AD. The studies 
measured two areas of the temporal lobe of the brain, the hippocampus 
and the entorhinal cortex, because these brain structures play a 
central role in memory function and are the sites of the earliest 
pathology in AD. The studies found that in older individuals with MCI, 
hippocampal and entorhinal cortex atrophy were predictive of an 
increased risk of subsequent conversion to AD; that is, the smaller the 
brain volumes, the greater the risk. The implication of these studies 
is that it may be possible to identify people who are beginning to 
develop the brain structural changes associated with the disease prior 
to the clinical diagnosis of AD.
    Recognition and characterization of brain changes prior to the 
clinical symptoms or diagnosis of AD has important implications for 
improving the timing and effectiveness of interventions. If diagnostic 
procedures can be developed to detect early changes in the brain, it 
may be possible to develop treatments that will stop the 
neuropathological and biochemical lesions of AD before clinical 
deterioration begins.
    Improved diagnosis of AD could also improve the design of drug 
trials. Focusing drug trials on persons at highest risk for disease is 
more efficient and less costly, and, among highest risk persons with 
minimal or no clinical symptoms, has the added benefit of testing the 
effectiveness of preventing progression of symptoms to a clinical 
diagnosis of AD. Finally, earlier and more accurate diagnosis provides 
patients and families important information allowing them to better 
plan for future care needs and management of their personal affairs.
                      duchenne muscular dystrophy
    Question. As you know, 1 in 3,500 boys worldwide will be stricken 
with Duchenne Muscular Dystrophy, the most common fatal childhood 
genetic disease. There is no treatment. Each day, two boys in the 
United States die from this disease. After hearing the stories of these 
boys, I am very concerned about the lack of research being done at NIH 
on Duchenne and Becker Muscular Dystrophy--as well as on neuromuscular 
disorders generally. The dystrophin gene was discovered through NINDS-
sponsored research in 1987; yet no new treatments have emerged. In 
1999, less than 1 percent of NIH funds were spent on over 40 different 
forms of neuromuscular disorders.
    It is my understanding that there are currently only 17 active 
research grants for muscular dystrophy research. Do you believe that is 
sufficient? What is NIAMS doing to encourage and fund more research 
grants in this area?
    Answer. The NIAMS, together with the National Institute of 
Neurological Disorders and Stroke (NINDS), considers research on the 
muscular dystrophies to be a priority area. We will continue to work 
with the extramural muscular dystrophy research community, as well as 
interested patient organizations, to stimulate and support promising 
studies in this area. In fiscal year 1999, the NIAMS invested nearly 
$5.4 million in muscular dystrophy projects, an increase of over 40 
percent from the previous fiscal year.
    A number of exciting studies with implications for our 
understanding of the muscular dystrophies have been supported by the 
NIAMS in recent years. One such investigation used gene therapy to 
restore muscle function in a hamster model of limb-girdle muscular 
dystrophy (LGMD). In another NIAMS-funded study, researchers 
successfully used the common antibiotic gentamicin to restore the 
function of the gene that encodes for the protein dystrophin in mouse 
models of Duchenne muscular dystrophy (DMD). In a third project, NIAMS-
supported researchers used gene therapy in mice to give the body a 
boost in fighting the effects of aging on muscle, and to help repair 
the damage caused by injury and muscle-wasting disorders such as 
muscular dystrophy. These projects underscore the potential of treating 
human forms of LGMD, DMD and other muscular dystrophies with gene 
therapy approaches.
    Another area of excitement relates to a new protocol developed with 
support from the NIAMS that makes it possible to obtain an almost 
unlimited number of a special class of adult stem cells from a small 
sample of bone marrow. These adult stem cells have the ability to 
develop into cells of muscle, nerve, bone, cartilage and fat. Because 
of their vast potential for differentiation, they may be excellent 
therapy vectors for a number of skeletal diseases, including muscular 
dystrophy.
    Next month, the NIAMS--in partnership with the NINDS and the NIH 
Office of Rare Diseases--will support two research meetings on muscular 
dystrophy. The first is an international scientific conference centered 
on clinical and molecular studies of facioscapulohumeral dystrophy 
(FSHD). The meeting will bring together researchers who are already 
involved in FSHD projects, as well as scientists who are working in 
related fields and may be able to contribute to progress on FSHD. The 
second meeting will focus on therapeutic approaches for DMD. This 
workshop is aimed at addressing key questions in improving treatments 
for DMD, identifying areas of needed scientific knowledge, and critical 
next steps to promote effective therapy. The NIH expects to build on 
the insights from these two meetings to develop new program initiatives 
related to the muscular dystrophies. Such initiatives would complement 
on-going efforts to stimulate research in this area, including the 
currently active program announcement on the pathogenesis and therapies 
of the muscular dystrophies.
    Question. What, if any, coordinated strategy exists between NIAMS 
and NINDS to focus research on Duchenne and integrate scientific 
discoveries from related research? Would a consensus conference on 
Duchenne/Becker Dystrophies be beneficial in creating that focus?
    Answer. NIAMS and NINDS share the lead for Duchenne/Becker muscular 
dystrophy research. NIAMS brings to this role a perspective as the lead 
institute for basic studies of muscle biology and most muscle diseases. 
NINDS leads in the study of the many neurological disorders that affect 
neuromuscular control. Since the discovery of the muscular dystrophies, 
neurologists have played a major role in diagnosis and care of children 
and in research on these disorders. Interactions among medical 
professionals from several disciplines are increasingly important in 
studying and treating the muscular dystrophies, and the involvement of 
several components of NIH in muscular dystrophy research reflects this.
    Some have expressed concern that no single component of NIH is 
responsible for all muscular dystrophy research. The division of 
responsibilities for muscular dystrophy research among components of 
NIH reflects the biological complexities of the disease, and there are 
substantial benefits from bringing a coordinated approach from multiple 
perspectives focused on muscular dystrophy. This issue in general is an 
important one for NIH. Biology does not abide by administrative 
divisions. Most disorders, including the muscular dystrophies, affect 
many aspects of physiology, benefit from a wide range of fundamental 
biological research, and require that we explore diverse strategies for 
treatment. It is therefore essential to bring to bear expertise and 
resources from all parts of NIH, as appropriate. The need for 
coordination is very real, and we must be vigilant. For muscular 
dystrophy, NIAMS and NINDS together take the lead and have initiated 
joint solicitations, scientific workshops and other activities, 
involving other components of NIH.
    As noted earlier, the NIAMS and NINDS are presently partnering with 
the NIH Office of Rare Diseases to sponsor a workshop on therapeutic 
approaches for DMD. A number of scientific questions will be explored 
at this meeting with the goal of moving currently studied therapies 
toward human trials. Institute staff have worked closely with the DMD 
research community, as well as patient advocates, to develop the agenda 
for this workshop. At present, an NIH consensus conference on DMD may 
be premature--as the primary goal of such conferences is to develop a 
report evaluating state-of-the-art scientific information on a given 
biomedical technology with the purpose of resolving a particular 
controversial issue in clinical practice. However, it is our 
expectation that the meeting we are sponsoring this spring on DMD will 
provide an important focus for new approaches to this disorder, and 
will serve as the basis for future programmatic efforts.
    Question. Concerns have been raised that there is no separate study 
section for muscle biology within any of the institutes of NIH. Why is 
this the case? Do you believe the NIH is properly organized to evaluate 
and coordinate muscle biology-related research--specifically related to 
Duchenne/Becker Muscular Dystrophy?
    Answer. The NIH Center for Scientific Review (CSR), which conducts 
the peer review process, is currently involved in a comprehensive 
assessment of its study section structure, led by Dr. Bruce Alberts, 
the President of the National Academy of Sciences. The purpose of this 
assessment is to ensure that CSR provides a rigorous, unbiased review 
system that facilitates the advance of all areas of biomedical 
research, including muscle biology. Indeed, muscle disease review 
issues are being considered as part of the assessment. CSR will also be 
meeting with scientists at the Duchenne muscular dystrophy workshop in 
May to discuss this and other review concerns. The outcome of these 
discussions will help guide future decisions about the review of 
muscle-related research grant applications.
    There is no simple answer to the question of whether a dedicated 
study section would enhance the success of muscular dystrophy research 
applications or otherwise improve coordination of muscle-related 
research. It is important to consider that the NIH receives a broad 
range of research applications on muscle functioning and disease, and 
diverse areas of scientific expertise are required to review those 
applications. Whether it is desirable--or, indeed, even feasible--to 
cluster all muscle research proposals into a single study section is 
one of the questions being explored by the CSR assessment described 
above.
                           diabetes research
    Question. Over 175,000 adults in Wisconsin were diagnosed with 
diabetes in 1996. In addition to the physical and life-threatening 
complications diabetes sufferers face, the costs of diabetes in 
Wisconsin total nearly $2.3 billion annually.
    I realize that funds for trans-NIH diabetes research are estimated 
to increase by 15.7 percent in fiscal year 2000, with a 14.7 percent 
increase for NIH overall. In recent years, NIH has recommended to 
Congress allocations among institutes that generally spread the funding 
increase evenly among Institutes.
    Do you think that across-the-board allocations adequately fund all 
new scientific opportunities equally? How does this across-the-board 
approach square with the assertion by NIH that allocations should be 
made on the basis of scientific opportunity, the greatest need, and the 
greatest potential for breakthroughs?
    Answer. NIH recommendations to Congress regarding allocations to 
the Institutes and Centers (ICs) vary each year to reflect many factors 
and consultations. The NIH solicits advice from a large number of 
individuals and groups, including the members of the scientific 
community, patient advocacy groups, Congress, the Administration, and 
NIH staff. Each IC convenes meetings of its national advisory council 
or board to review a broad range of policies and sponsors many 
workshops and conferences to gather opinions on specific areas of 
science. The efforts of the ICs to seek external advice are further 
augmented by those of the NIH Director through meetings of the Advisory 
Committee to the Director and the Council of Public Representatives.
    Also, last year, for the first time, the NIH held a Budget Retreat 
to develop its research priorities and to establish areas of research 
emphasis in preparation of the President's 2001 budget. Retreat 
participants included ten external advisors in addition to the NIH and 
IC leadership. As reflected in the fiscal year 2001 budget request, 
proposed increases by IC range from 10.8 percent for the Fogarty 
International Center to 3.3 percent for the National Institute on 
Nursing Research.
    The final fiscal year 2000 appropriation, incorporating NIH 
recommendations, also provided a range of funding levels across the 
NIH. Increases ranged from 36.6 percent for the newly-established 
National Center for Alternative Medicine, to 14.4 percent for the 
National Institute of Diabetes and Digestive and Kidney Diseases, with 
other ICs receiving an increase in the range of 12-13 percent. By any 
measure, the amount the NIDDK received in fiscal year 2000 was 
substantial and unprecedented and will allow a major commitment of 
resources to new diabetes initiatives. We will increase our diabetes 
research efforts by over 17 percent--more than two percentage points 
over the fiscal year 2000 increase provided to the NIDDK as a whole. 
This increase will permit new and significantly expanded research on 
type 1 and type 2 diabetes and diabetes complications. Some examples 
include: expanded support for studies of islet transplantation in 
humans, including support of six new research projects and the 
establishment of an islet transplant registry; increased support of the 
type 2 diabetes genetic linkage consortium; identifying and 
characterizing the genes involved in pancreatic endocrine development 
and function; funding of two new Diabetes Endocrinology Research 
Centers; novel approaches to imaging functional islet beta cells; 
understanding and combating the increase of type 2 diabetes in 
children, especially from minority groups; approaches to diabetic foot 
complications--a major cause of amputations particularly affecting 
minority populations; studies of the cause and treatment of diabetic 
neurologic complications; and, together with the NHLBI, support of two 
major clinical trials relating to cardiovascular complications of 
diabetes.
    Question. Can you tell us how you plan to allocate the increases 
you have been receiving as a result of Congress' commitment to doubling 
NIH spending overall? For example, what will be the breakdown of 
expenditures applied to existing programs and research projects, 
compared to money provided to exciting new research initiatives 
identified by the Diabetes Research Working Group (DRWG)?
    Answer. Over 70 percent of our approximate $150 million increase 
over fiscal year 1999 will be used to meet commitments for non-
competing continuations in fiscal year 2000. Much of the remaining 
fiscal year 2000 increase will be directed toward congressional 
emphases in diabetes and prostate disease. We are making a major 
commitment of resources to new diabetes initiatives, by increasing our 
diabetes research efforts by over 17 percent--more than two percentage 
points over the 15 percent increase provided to the NIDDK as a whole.
    The increase provided to NIDDK in fiscal year 2000 will permit new 
and significantly expanded research on type 1 and type 2 diabetes and 
on diabetes complications. Some examples include: expanded support for 
studies of islet transplantation in humans, including support of six 
new research projects and the establishment of an islet transplant 
registry; increased support of the type 2 diabetes genetic linkage 
consortium; identifying and characterizing the genes involved in 
pancreatic endocrine development and function; funding of two new 
Diabetes Endocrinology Research Centers; novel approaches to imaging 
functional islet beta cells; understanding and combating the increase 
of type 2 diabetes in children, especially from minority groups; 
approaches to diabetic foot complications--a major cause of amputations 
particularly affecting minority populations; studies of the cause and 
treatment of diabetic neurologic complications; and, together with the 
NHLBI, support of two major clinical trials relating to cardiovascular 
complications of diabetes.
    Question. What amount of funds would it take for the NIDDK to fully 
implement its share of the recommendations of the DRWG? Can you find 
the money to meet the DRWG recommendations in the context of a doubling 
of the overall NIH budget if NIDDK is generally increased by the same 
percent as the overall NIH increase each year, give or take a percent?
    Answer. The DRWG Strategic Plan made both scientific and funding 
recommendations for fiscal year 2000 through fiscal year 2004 for each 
Institute and Center of the NIH, as well as for the NIH as a whole. For 
the NIDDK specifically, the DRWG recommended that diabetes research 
funding reach $501.1 million in fiscal year 2000; $654.8 million in 
fiscal year 2001; and continue to rise to $989.7 million in fiscal year 
2004. For the entire NIH, the DRWG recommended that diabetes research 
funding reach $827 million in fiscal year 2000; $1.074 billion in 
fiscal year 2001; and continue to rise to $1.6 billion by fiscal year 
2004.
    Diabetes research is receiving significant funding increases across 
the NIH--rising from a funding level of $457.6 million in fiscal year 
1999, to an estimated $525.1 million in fiscal year 2000 and an 
estimated $561 million for fiscal year 2001. However, the NIDDK cannot 
fully implement all of the recommendations of the DRWG, even in the 
context of a doubling of the NIH budget, assuming that its percentage 
funding increase generally matches the overall percentage increase for 
the NIH proper. In fiscal year 2000, for example, even if the NIDDK had 
been able to apply the entirety of its funding increase of $150 million 
to diabetes research, it would still have fallen substantially short of 
the target funding level of $501.1 million set for it by the DRWG.
    The five-year funding trajectory recommended by the DRWG for NIDDK 
and NIH diabetes research, respectively, would represent an increase in 
excess of 3.5 times fiscal year 1999 funding levels. Thus, even if its 
budget doubled in five years, it would not be possible for the NIDDK to 
implement all of the DRWG recommendations in the time frame specified 
without seriously harming research programs on other diseases of 
national concern that are within the NIDDK's research 
responsibilities--and the DRWG itself recommended against the diversion 
of funds from other programs.
    Question. Can you give us your opinion of the DRWG report? To what 
extent do you agree that it provides a serious outline for the 
direction in which our diabetes research portfolio ought to go?
    Answer. The Diabetes Research Working Group (DRWG) Strategic Plan 
serves as an important guidepost which the NIH is using to help frame 
its diabetes research agenda. The Strategic Plan represents a year-long 
deliberative planning process conducted by twelve eminent scientific 
leaders in diabetes research and four lay representatives, including 
representatives from both the Juvenile Diabetes Foundation 
International and the American Diabetes Association. The DRWG also 
solicited advice from many ad hoc scientific experts and public 
commentary. The Working Group evaluated all aspects of diabetes health 
issues, as well as the state-of-the-science, in an effort to develop a 
comprehensive plan. Thus, the recommendations of the DRWG Strategic 
Plan reflect the consensus of many talented scientists and concerned 
patients about the most promising avenues we can pursue to achieve 
greater understanding and more effective treatments for diabetes and to 
realize means to prevent and cure both forms of the disease and its 
complications. The NIH has already undertaken many new initiatives 
related to the extraordinary opportunities and special needs identified 
by the DRWG and will continue to use the DRWG Strategic Plan as a 
scientific framework for additional new initiatives in the years ahead, 
along with advice from our National Advisory Council and emerging 
scientific leads from conferences, workshops and other sources of 
external advice.
                            multiple myeloma
    Question. As you well know, this committee and our colleagues in 
the House both addressed research for multiple myeloma in our 
respective reports last year. I especially want to thank the chairman 
of this committee, Senator Specter for his leadership on this issue.
    It is my understanding that you decided to include multiple myeloma 
in next month's scheduled Progress Review Group (PRG) for leukemia and 
lymphoma. Will this, in your opinion, fulfill the intent of the report 
language requesting a consensus conference or scientific workshop on 
multiple myeloma? Do you think the PRG will fundamentally change the 
NCI's multiple myeloma research program?
    Answer. The Leukemia, Lymphoma and Myeloma (LLM) PRG will be an 
excellent way to address the report language requesting a consensus 
conference/scientific workshop on multiple myeloma. It will undoubtedly 
have an impact on the direction of NCI's myeloma research program. 
There are nevertheless some issues that need explanation:
    The PRG process may be a more useful approach for scientific 
planning than either a consensus conference or a scientific workshop. 
Like a consensus conference, a PRG identifies a set of recommendations 
upon which all group members agree. However, a PRG goes well beyond a 
consensus conference by identifying research needs and opportunities 
that experts in the field agree are the most important. PRG 
participants do this by reviewing many research needs and opportunities 
and then prioritizing them. Consequently, a PRG also goes well beyond a 
scientific workshop, which also can involve a large number of 
participants but rarely results in a list of research priorities and 
recommendations.
    In order that each of the three cancers receives sufficient 
attention during the PRG process, NCI has named three co-chairs, one 
for each cancer type. This arrangement will provide leadership for each 
cancer being reviewed by the PRG. In addition, NCI is committed to 
sufficient advocate participation throughout the PRG process. Clinical 
and scientific experts, however, will often have interests in more than 
one of these diseases, and therefore it makes sense to combine these 
cancers within one PRG .NCI is confidant that a combined PRG will have 
a great impact on the direction of the Institute's myeloma research 
program, since prior PRGs have resulted in substantial adjustments to 
the Institute's breast cancer and prostate cancer programs. It is 
likely that there will be some recommendations/actions that serve all 
three groups of cancers as well as some recommendations/actions that 
serve the unique needs of each disease and community.
    The Leukemia, Lymphoma, Myeloma PRG is already well underway. The 
PRG leadership team will meet in June 2000 to select the PRG membership 
and to begin planning the PRG's agenda.
    Question. Although multiple myeloma is a hematological cancer--
according to NCI SEER data, it is the second fastest growing 
hematologic cancer in the United States--it's most obvious effects are 
in the bone destruction caused by the plasma tumors. Are there any 
plans to increase collaboration between NCI and NIAMS on the issue of 
bone disease and multiple myeloma?
    Answer. NCI is currently collaborating with NIAMS in a multi-center 
epidemiologic study, entitled ``Osteoporotic Fractures in Men 
(MR.OS).'' A major goal of this study is to assess the relationships 
among risk factors of osteoporotic fractures and prostate cancer in 
older men (>65 years old). A total of 5,700 men will be recruited in 
six diverse geographical areas and will be followed for seven years. 
MR. OS will provide a unique perspective on prostate cancer occurrence 
influenced by the skeletal, hormonal, and lifestyle determinants 
associated with osteoporosis. Findings could provide avenues for 
additional research leading to preventive strategies for prostate 
cancer.
    Another NCI-NIAMS collaboration involving studies of bone disease 
is the long-term support of the ``Rochester Epidemiology Project'' at 
the Mayo Foundation. Data have been collected during the past 34 years 
on the population of Rochester and Olmsted Counties, Minnesota, and 
several studies within the Project have published results on bone 
fractures associated with chronic disease and osteoporosis in the 
elderly. Investigators have also reported the incidence and trends in 
rates of multiple myeloma in Olmsted County during 1978 through 1990.
    As scientific advances and new technologies increase research 
capabilities to explore associations between bone disease and multiple 
myeloma, the NCI and NIAMS look forward to collaborating in this 
endeavor.
    Question. Does the NCI have any plans, or would it consider, 
establishing a working relationship with the CDC to develop more 
comprehensive epidemiological and occupational health statistics to 
support myeloma research activities?
    Answer. NCI investigators currently collaborate with several 
investigators at the CDC on epidemiologic and surveillance studies of 
multiple myeloma and other hematopoietic malignancies. One study with 
CDC's National Center for Environmental Health, includes multiple 
myeloma and collects biological specimens needed to analyze 
occupational and environmental exposures in the general population. In 
another study, NCI investigators found a relationship between risk of 
multiple myeloma and exposure to solvents among workers at a U.S. Air 
Force base. NCI supports the continuation and expansion of 
collaborative activities with the CDC to explore and develop new 
methods and approaches to better understand the origins of multiple 
myeloma and the reasons for the unusually high rates in certain 
populations such as African-Americans.
    NCI and the CDC have recently established a Memorandum of 
Understanding (MOU) for implementing an enhanced and more coordinated 
national cancer surveillance effort. NCI and CDC share a vision for a 
federally integrated comprehensive national cancer surveillance system. 
This system will build upon and strengthen the existing infrastructure, 
improve the availability of high quality data used to measure the 
nation's cancer burden, and advance the capacity for surveillance 
research. The scope of this coordinated cancer surveillance system 
includes coverage of the entire U.S. population using high quality data 
to measure cancer risk and health behaviors, incidence, treatment, 
morbidity, mortality, and other outcomes. As leaders and catalysts in 
federal cancer control activities, NCI and CDC enter into this 
agreement to enhance cancer surveillance at national, state and 
regional levels. This includes developing ways of looking at each 
cancer site nationally. Geographic Information Systems (GIS) 
methodologies will enable researchers to link environmental exposures 
with unusually high occurrences of cancer on a geographic basis. The 
SEER registry and the CDC Cancer Surveillance System, especially 
working in collaboration, can help identify new hypotheses for causal 
studies in multiple myeloma.
    In addition, the NCI coordinates and supports many epidemiological 
studies conducted intramurally and extramurally, on multiple myeloma 
and other lymphoproliferative diseases. Intramural investigators are 
collaborating with investigators participating in the SEER program in a 
large case-control study of non-Hodgkin's lymphoma to which a multiple 
myeloma component has recently been added. Under analysis is a multi-
centered case-control study of multiple myeloma in blacks and whites in 
the United States. It is designed to identify the risk factors for this 
tumor. A new study linking total population registries, cancer 
registries, and hospitalizations for auto-immune diseases is in the 
planning phase in an effort to clarify the risk of familial occurrences 
of multiple myeloma and other hematopoietic malignancies. Also, 
analyses of existing case-control data are being conducted as novel 
occupational, geographic, and environmental hypotheses arise.
                                 ______
                                 
           Questions Submitted by Senator Barbara A. Mikulski
                   workplace environment of nih's oeo
    Question. What is Acting NIH Director Dr. Ruth Kirschstein 
personally doing to address concerns about the workplace environment of 
the NIH Office of Equal Opportunity (OEO) and the OEO Director's 
treatment of OEO employees?
    Answer. Dr. Kirschstein has been deeply concerned and personally 
involved in the issues related to the workplace environment of the NIH 
Office of Equal Opportunity (OEO). She has discussed these issues with 
all the persons involved and after such discussions did not appear to 
improve matters, she assigned the NIH Ombudsman the task of resolving 
the issue. The Ombudsman with the services of a mediator, experienced 
in this area, developed a process of a series of meetings, some 
separately with individual or groups of employees, at which they have 
had the opportunity to raise specific concerns privately and some 
separately with the Director, OEO. In addition, the two mediators have 
held joint meetings between the employees and the Director, OEO, at 
which views were exchanged. It has become clear that the issues of 
which you are aware, raised by some OEO employees do not represent 
those of all OEO employees. Nevertheless, it is clear that the issues 
are real and must be and are being settled.
    A good deal of progress has been made. The Director, OEO has been 
responsive to the concerns raised by the employees, and has undertaken 
certain necessary steps to address the most pressing matters. In 
addition, the NIH has resolved the specific concerns of two OEO 
employees, and has entered into agreements with them that fully satisfy 
their concerns. Other actions are in progress and we are optimistic 
that a satisfactory outcome will result.
                        minority representation
    Question. Please specify what specific steps NIH is taking to 
address the following items, providing specific timetables for actions 
that NIH will take to:
  --ensure that NIH has sufficient representation at all levels of 
        African Americans, Native Americans, Latinos/Hispanics, Asian 
        Pacific Americans and how NIH Institute and Center Directors 
        will be held accountable for meeting established goals (OEO)
  --retain African Americans at NIH (OEO)
  --improve the tenure rate of African American scientists at NIH (OIR)
    Answer. While no Federal agency can legally assure that its actions 
will result in complete representation of all minority groups based on 
their availability in the work force, including persons with 
disabilities, many proactive steps are underway by the NIH to achieve a 
diverse organization. Under the auspices of the NIH Affirmative Action 
Planning Program (AAP), each Institute and Center (IC) has the 
flexibility to set annual hiring goals. Based on an annual analysis of 
underrepresentation that is conducted of the various occupational 
series, goals are then established, based upon projections of 
anticipated hiring need. Individually tailored recruitment strategies, 
necessary to address the specific underrepresented EEO groups within 
its organization, are targeted for each vacancy. At the end of each 
fiscal year, the ICs report their accomplishments.
    IC recruitment strategies vary, according to the targeted audience 
and the vacancies under consideration. They may include the use of: 
Career Opportunity Training Agreements, the Student Temporary 
Employment Program, advertising of vacancies on the Internet, exhibits 
at conferences such as those of the Association of American Indian 
Physicians (AAIP), the American Council on Education, the American 
Indian Science and Engineering Society (AISES), the National Hispanic 
Medical Association, the Student National Medical Association, the 
Hispanic Association of Colleges and Universities (HACU), and the 
Society for the Advancement of Chicanos and Native Americans (SACNAS). 
Additional recruitment activities are held at other professional 
meetings as well, including those of the Mexican-American Engineers and 
Scientists (MAES), the Association of Minority Health Professions 
Symposium (AMHPS) on Careers in Biomedical Professions, the League of 
United Latin American Citizens, the National Council of LaRaza, and the 
National Black Nurses Association. Additionally, EEO Officers attend 
local career fairs at George Washington University, Morgan State 
University, University of Maryland-Baltimore Campus, and Bowie State 
University.
    Responsibilities for Equal Employment Opportunity Programs are 
included as an integral part of managerial performance elements to 
establish accountability. The OEO guidance to IC Directors on specific 
areas for inclusion in their annual accomplishment reports, as required 
for SES managers, serves to maintain consistency across IC lines. All 
SES managers have a separate element which is reviewed by their 
respective IC Director. All IC Directors' annual accomplishments and 
accompanying proposed ratings are reviewed by a subgroup of the NIH 
Performance Review Board. The Director, OEO, is a voting member of that 
group. Additionally, the NIH requires a performance appraisal covering 
EEO Program accomplishments for supervisors and managers through the 
use of either the stand alone critical EEO performance element or an 
overall supervisory or management element that incorporates EEO 
responsibilities. An EEO Program element is also part of the annual 
Commissioned Corps performance review mechanism and is one of 18 
critical elements that comprise an officer's annual rating.
    In June 1999, the NIH established a Corporate Recruitment Task 
Force designed to develop global trans-NIH recruitment strategies 
including those needed to address barriers to minority representation 
in the NIH work force. Its members include IC EEO and Personnel 
Officers as well as Office of Equal Opportunity(OEO) staff members. 
Common goals include the development of a unified corporate approach to 
recruitment and related issues such as relocation matters, recruitment 
techniques, and targeted occupations common to all or most ICs. 
Implementation of the Task Force's objectives is scheduled to begin in 
fiscal year 2001.
    The recruitment of minority and women scientists is extremely 
competitive both within the Federal government and private enterprise. 
NIH continues to use the pay flexibility provisions of Title 42 and 
Title 38 to attract candidates to the NIH campus. Additionally, the NIH 
AIDS Research, Clinical Research, and General Research Loan Repayment 
Programs are used as recruitment incentives for minority and women 
scientists. The NIH Undergraduate Scholarship Program offers 
competitive scholarships to students from disadvantaged backgrounds who 
are committed to careers in biomedical research. In 1999, 10 
scholarships were awarded to African American (1), non-minority (4), 
Asian/Pacific Islander (1), and Hispanic (4) students.
    To foster an environment that attracts and retains minority 
employees, the OEO sponsors Workforce Diversity Initiative (WDI) 
activities. These activities promote equal opportunity goals, engender 
respect for the similarities and differences that employees bring to 
the workplace and assist managers and supervisors in learning how to 
capitalize on those similarities and differences while promoting 
quality, fairness and efficiency. For example, the OEO sponsored an 
educational project entitled the ``NIH Diversity Book Bridge Project.'' 
This project took a fresh approach of using literature as a tool to 
discuss diversity issues. Guidance is regularly provided to the IC 
Diversity Catalysts to supplement the Catalysts Implementation Manual 
which was designed to identify specific duties for the newly appointed 
Catalysts in the ICs. The OEO staff provided a second document, 
``Guidelines for OEO Diversity Program Managers'' (DPMs), for the OEO 
staff in their role as consultants to the ICs in the implementation of 
the WDI. Sharing the guidelines on DPM roles with the ICs was meant to 
reinforce the value of developing long term strategies and processes to 
promote the WDI throughout the NIH. In November of 1999, Vice President 
Gore's Special Diversity Task Force recognized the NIH diversity 
process as a best practice, referencing in particular, the unique 
appointing of Diversity Catalysts in each of the ICs. Some of the ICs 
have incorporated the Quality of Work Life Plans into their diversity 
initiatives as a method of creating a healthy work environment for 
employees.
    The NIH is also deeply involved in several ongoing Departmental 
Minority Initiatives. For example, the employment aspects of the 
Departmental Hispanic Agenda for Action and other minority initiatives 
related to annual recruitment activities are addressed. During fiscal 
year 1999, there was a significant increase in the number of HACU 
interns as compared to the participation rate of 10 during the previous 
fiscal year. Total participation during fiscal year 1999 numbered 21: 7 
during the Spring Semester and 14 during the Summer. There were 7 
students enrolled in the Washington Internship for Native American 
Students (WINS) Program, and 10 African American interns from the 
National Association for Equal Opportunity in Higher Education (NAFEO) 
Program.
    Data shows that NIH needs to continue its efforts to address the 
retention of African Americans, particularly African American males in 
the scientific occupations. Several years ago, an exit interview 
program was established and a questionnaire was administered to all 
employees leaving the Agency. Based on the low response rate to the 
questionnaire, however, the program was discontinued. Lacking the 
ability to clearly identify a pattern of the reasons employees left the 
NIH, other actions have been taken to try to improve the NIH work 
climate as much as possible. For example, the Center for Cooperative 
Resolution has been shown as an effective alternative to the 
traditional methods of conflict management. Headed by an Ombudsman, the 
Center regularly evaluates new approaches to conflict resolution and 
encourages employees to develop new and more effective ways to deal 
with issues they face in the workplace. The Center has addressed more 
than 400 cases with a resolution rate of better than 80 percent. The 
Center offers a variety of alternative dispute resolution processes, 
including facilitation, mediation, shuttle diplomacy, and systems 
change. Within the past year, the Center has begun other initiatives 
such as the implementation of a seminar series on conflict for 
executives, utilization of Peer Panels, as well as preparation of 
preliminary plans for partnering agreements for scientific 
collaborations. More and more employees are becoming informed of the 
availability of the Center from briefings, publicity, and its 
reputation for efficiency, confidentiality, and neutrality. At the same 
time, the Federal discrimination complaint processing mechanism is 
communicated to all employees who may wish to utilize its provisions in 
seeking redress of employment related concerns.
    As reflected above, the objectives of the NIH AAP have served to 
identify and recruit minority members, women, and persons with 
disabilities into the work force. Once recruited, additional 
initiatives mentioned above, such as the WDI, have been taken to create 
and maintain a healthy work environment for employees.
    Tenure at the NIH is granted to outstanding scientists who have 
made major contributions to biomedical research and includes both 
salary support and commitment of research resources subject to rigorous 
review every fouryears. Tenure differs from permanent appointment in a 
civil service position since it includes research support as well as 
salary. Tenure policy and procedures at NIH were completely revamped in 
1993 with additional modifications made in 1996. A major intent of the 
new tenure policy was to provide equality of access and opportunity for 
all individuals qualified for tenure-track positions. Tenure-track 
positions are the principal point of entry for investigators to achieve 
tenure at the NIH. The specifics of the policy and procedures may be 
viewed at the following websites:
    The Tenure-Track Program at http://www1.od.nih.gov/oir/sourcebook/
irp-policy/tenure-track.htm
    Tenure in the NIH Intramural Research Program--Modifications to 
Policy at http://www1.od.nih.gov/oir/sourcebook/irp-policy/tenure.htm
    Search Process for Tenure and Tenure-Track Investigators at http://
www1.od.nih.gov/oir/sourcebook/irp-policy/search.htm
    All tenure-track positions are advertised nationally using an 
advertisement that must be approved by the Deputy Director for 
Intramural Research (DDIR). A Search Committee must be established for 
every tenure-track position that becomes available. The composition of 
the Search Committee must also be approved by the DDIR and each 
committee must have as voting members a scientist who is an under-
represented minority, a woman scientist and a scientist selected by the 
DDIR to serve as his representative.
    Despite these efforts to attract and recruit to NIH under-
represented minority scientists, from January 1999 through March 2000, 
NIH hired a total of 34 tenure-track investigators, of whom 1 (2.9 
percent) is African American. From January 1999 through March 2000, 34 
total investigators successfully achieved tenure, of whom 2 (5.9 
percent) are African Americans. This number represents 100 percent of 
African American candidates considered for tenure.
    To increase the pool of qualified candidates for tenure-track and 
tenured positions at the NIH, the NIH intramural program continues to 
increase efforts to attract under-represented minorities into research 
training programs early in their biomedical research careers, to 
provide training in biomedical research and to acquaint trainees with 
the career opportunities available at NIH. It is expected that research 
training opportunities such as the Summer Internship Program for high 
school, college and graduate students (http://www.training.nih.gov/
student/internship/internship.asp), the Undergraduate Scholarship 
Program (UGSP) for undergraduate students from a disadvantaged 
background (http://ugsp.info.nih.gov/), the Postbaccalaureate 
Intramural Research Training Award for students that have obtained 
their Bachelor's degree and fully intend to pursue doctoral degrees in 
the biomedical sciences (http://www.training.nih.gov/student/Pre-IRTA/
previewpostbac.asp), and the newly created NIH Academy for 
postbaccalaureates interested in domestic health disparities (http://
www.training.nih.gov/student/Pre-IRTA/irtamanualpostbacAcademy.asp) 
will help increase the pipeline of under-represented minorities who can 
successfully compete for tenure-track and tenure positions at the NIH.

                         CONCLUSION OF HEARINGS

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


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

                              ----------                              

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

                       NONDEPARTMENTAL WITNESSES

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

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                           General Healthcare

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

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

         Prepared Statement of the American Medical Association

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

           Prepared Statement of Santa Rosa Memorial Hospital

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

            Prepared Statement of the Condell Medical Center

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

      Prepared Statement of the National Treasury Employees Union

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

          Prepared Statement of the Montefiore Medical Center

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

       Prepared Statement of St. Joseph's Hospital Health Center

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

      Prepared Statement of the American Public Power Association

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

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

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

         Prepared Statement of the National Consumer Law Center

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

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

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

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

    Prepared Statement of the National Alliance for the Mentally Ill

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

  Prepared Statement of the American Public Transportation Association

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

    Prepared Statement of the National Council on Independent Living

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

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

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

              Prepared Statement of the City of Newark, NJ

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

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

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

               Prepared Statement of New York University

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

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

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

  Prepared Statement of the National Association for State Community 
                           Services Programs

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

   Prepared Statement of the American Academy of Physician Assistants

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

 Prepared Statement of the National Jewish Medical and Research Center

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

              Prepared Statement of Idaho State University

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

          Prepared Statement of Babyland Family Services, Inc.

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

    Prepared Statement of the International Brain Injury Association

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

             Prepared Statement of the Epilepsy Foundation

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

               Prepared Statement of Rotary International

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

      Prepared Statement of the American Society for Microbiology

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

          Prepared Statement of The American Heart Association

    Chances are heart attack or stroke will be the death or disabler of 
you or a loved one. Heart attack, stroke and other cardiovascular 
diseases remain America's leading cause of death and a main cause of 
disability. Cardiovascular diseases account for nearly 1 of every 2 
deaths in the U.S.
    The American Heart Association is dedicated to reducing death and 
disability from heart attack, stroke and other cardiovascular diseases. 
We commend this Committee for making fiscal year 2000 funding for the 
National Institutes of Health and the Centers for Disease Control and 
Prevention a top priority. But, we are concerned that our government is 
still not devoting sufficient resources for research and prevention of 
America's No. 1 killer--heart disease--and to our country's No. 3 
killer and a leading disabler--stroke.
    Heart attack, stroke and other cardiovascular diseases have been 
America's No. 1 killer since 1919. Nearly 60 million Americans--1 in 
5--of all ages suffer from one or more of these diseases. Hundreds of 
millions of Americans have major risk factors for these diseases--about 
50 million have high blood pressure, 40 million have elevated blood 
cholesterol (240 mg/dL), 49 million smoke, 106 million adults are obese 
or overweight and 10 million have physician-diagnosed diabetes. As the 
baby boomers age, the number of Americans afflicted by these often 
disabling diseases will increase substantially. Cardiovascular diseases 
cost Americans more than any other disease. Americans will pay an 
estimated $327 billion for cardiovascular-related medical costs and 
lost productivity in 2000. These diseases constitute 4 of the top 5 
hospital costs for all payers, excluding childbirth and its 
complications, and 4 of the top 5 Medicare hospital costs. Heart 
disease is also the leading cause of premature, permanent disability of 
American workers, accounting for nearly 20 percent of Social Security 
disability payments.
                     how you can make a difference
    Now is the time to capitalize on a century of progress in 
understanding heart attack, stroke and other cardiovascular diseases. 
Promising, cost effective breakthroughs in treatment and prevention are 
on the horizon. We challenge our government to stay the course to 
double funding by year 2003 for NIH, for heart and stroke research and 
to translate research into effective clinical and community 
initiatives. This will cut health care costs and improve quality of 
life. For fiscal year 2001 we urge you to do the following.
  --Appropriate a 15 percent increase over fiscal year 2000 funding for 
        the overall NIH--the third step toward the goal of doubling the 
        budget by year 2003. This goal is echoed by groups such as 
        Research!America and the Ad Hoc Group for Medical Research 
        Funding.
    NIH research provides cutting-edge treatment and prevention 
strategies, cuts health care costs, creates jobs and maintains 
America's status as the world leader in biotechnology and 
pharmaceuticals industries.
  --Provide a 15 percent increase over fiscal year 2000 funding for NIH 
        heart research and stroke research.
    Researchers are on the brink of advances that could pave the way to 
prevention and even a cure so you or a loved one will be spared pain 
and suffering from heart disease and stroke.
  --Allot a $25.2 million increase over fiscal year 2000 funding to 
        expand CDC's Cardiovascular Health Program to 11 more states 
        for a total of 29 states.
    We must make our science real and applicable through community 
interventions that encourage Americans to make healthful lifestyle 
choices to prevent heart disease and stroke.
            heart and stroke research benefits all americans
    Thanks to advances in addressing risk factors and in treating 
cardiovascular diseases, more Americans are surviving heart attack and 
stroke. Heart and stroke research and prevention breakthroughs are 
saving and improving lives. Several cutting-edge examples follow.
  --Emergency Cardiac Care.--Daily more than 700 Americans suffer 
        sudden cardiac arrest--the unexpected, abrupt loss of heart 
        function. A particular sequence of actions known as the ``chain 
        of survival'' offers hope. Early use of both breathing and 
        chest compression techniques of cardiopulmonary resuscitation 
        and delivery of a powerful electrical shock to re-start the 
        heart are critical to restore life. Each minute of delay in 
        returning the heart to its normal rhythm decreases chance of 
        survival by 10 percent. Our Operation Heartbeat Program, alone, 
        estimates that 100,000 lives could be saved if automatic 
        external defibrillators were more widely available.
  --Advanced Imaging Technology.--Research has revolutionized imaging 
        technology to diagnose heart disease. You probably know someone 
        who has had an angiogram. In this procedure, a catheter is 
        inserted in an artery and navigated up to the heart. Then a dye 
        is injected so x-rays can show artery narrowing that can 
        trigger a heart attack or a stroke. About 1.2 million patients 
        in 1997 were hospitalized for this procedure which causes 
        discomfort and risk of infection and bleeding, and in rare 
        cases, heart attack or stroke. Now angiograms are being 
        replaced by two new imaging procedures that are easier, safer 
        and cheaper. The high speed CT scan takes fast pictures, 
        producing a measure of blockages in arteries to the heart, and 
        help doctors better tailor treatments. Three-dimensional 
        coronary magnetic resonance angiography (MRA), uses strong 
        magnets to provide detailed images of the arteries to the 
        heart. Taking less than an hour, MRA evaluates heart anatomy 
        and other heart functions, providing a comprehensive, 
        noninvasive, heart examination.
  --Surgery to Reduce Risk for Stroke.--In many cases surgeons can 
        prevent stroke by removing the buildup of plaque from the main 
        artery to the brain that is severely narrowed. Also, it helps 
        stroke survivors reduce their risk of another stroke. About 
        140,000 procedures are performed each year.
  --State-of-the-Art Life-extending drugs.--Research has produced new 
        drugs to help prevent and treat heart attack and stroke. 
        Cutting-edge drugs to control blood pressure and cholesterol 
        are more effective than ever in saving lives and enhancing 
        quality of life. When prevention fails, revolutionary 
        ``clotbuster'' drugs can reduce disability from heart attack 
        and stroke by dissolving blood clots causing the attack. Use of 
        t-PA, within 3 hours of the onset of symptoms, can restore 
        blood flow through the clot-obstructed artery and reduce 
        chances of permanent disability by 33 percent, saving health 
        care costs. T-PA offers hope for the estimated 1.1 million 
        Americans who will suffer a heart attack and 450,000 at risk of 
        a clot-caused stroke this year.
    So Americans can continue to benefit from these types of 
breakthroughs, we support a doubling of the overall NIH budget by year 
2003. We recommend an fiscal year 2001 appropriation of $20.5 billion 
for the NIH, the third step toward that goal. We have a special 
interest in individual NIH entities that relate directly to our 
mission. Our funding recommendations for these institutes and programs 
follow.
         heart research challenges and opportunities for nhlbi
    The above and other advances have been made possible by more than 
50 years of American Heart Association-sponsored research and more than 
a half-century of investment by Congress in the National Heart, Lung, 
and Blood Institute. Thanks to research, no longer does a heart attack 
or stroke necessarily mean immediate death. Now that more Americans are 
surviving, heart attack and stroke can mean permanent disability, 
requiring costly medical care and loss of productivity and quality of 
life.
    We urge this Committee to double the NHLBI budget, including heart 
research, by year 2003. As the next step toward reaching this goal, we 
advocate an fiscal year 2001 appropriation of $2.330 billion for the 
NHLBI, with $1.355 billion for heart and stroke-related research. A 
funding level of this amount will allow NHLBI to expand existing 
programs and invest in promising new initiatives. Several challenges 
and opportunities to advance the battle against heart disease are 
highlighted below.
  --Promoting Adherence to Medical and Behavioral Therapies.--Failure 
        to follow medical recommendations causes tens of thousands of 
        deaths a year, increased hospitalizations and delayed recovery, 
        costing Americans $100 billion annually. An estimated 50 
        percent of patients do not comply with prescribed treatments. 
        Many life-extending drugs for heart attack survivors and heart 
        failure patients are underused. Medical advances are 
        continually improving chances of survival for Americans who 
        suffer from or are at high risk of heart attack, stroke and 
        other cardiovascular diseases. Not all patients or doctors take 
        advantage of information we now know will reduce or treat 
        Americans at risk of heart disease or stroke. Innovative 
        theories about behavioral, cultural, social, psychological, and 
        environmental methods to increase adherence to lifestyle and 
        medical regimens must be tested. Research is needed on 
        effective indicators to measure standard of delivery of care of 
        health systems and to change physician behavior and practices. 
        Increased funding in this area will lead to development of 
        better methods for getting patients and healthcare providers to 
        adhere to cost-effective, lifesaving therapies.
  --Immune System Research Programs for Heart Disease.--Basic knowledge 
        about the body's disease fighting system is increasing rapidly, 
        particularly in its involvement in the causes and development 
        of heart disease and stroke. Innovative approaches are needed 
        to use this knowledge to accelerate progress from basic 
        knowledge to clinical applications. Promising areas that merit 
        further research include, inflammatory response to blood vessel 
        injury that occurs in atherosclerosis (the cause of most heart 
        attacks and strokes); healing of damaged heart tissues after a 
        heart attack; and chronic rejection following heart 
        transplantation. Increased funding in this area would better 
        identify those at risk and may lead to revolutionary treatments 
        to prevent heart disease and stroke.
  --Maintaining Weight Loss.--An estimated 106 million Americans age 20 
        and older are overweight or obese, a condition that increases 
        risk of diseases such as heart attack, stroke, high blood 
        pressure and diabetes. Clinical Guidelines on the 
        Identification, Evaluation, and Treatment of Overweight and 
        Obesity in Adults, supported by NHLBI and National Institute of 
        Diabetes and Digestive and Kidney Diseases, reviews evidence 
        that it is possible for overweight and obese Americans to lose 
        a large amount of weight over six months, but only a few 
        maintain it. Increased funding is needed to start studies to 
        improve understanding of weight loss maintenance. Researchers 
        must examine behaviors that influence obesity, weight loss and 
        weight loss maintenance.
  --Heart attack, stroke and other cardiovascular diseases in women.--
        Cardiovascular diseases remain a main cause of disability and 
        the No. 1 killer of American females, killing more than 500,000 
        a year. Cardiovascular diseases kill more females than the next 
        14 causes of death combined. They kill more females than males. 
        About 1 in 5 females live with consequences of cardiovascular 
        diseases. The clinical course of cardiovascular disease is 
        different in women than in men and current diagnostic 
        capabilities are less accurate in women than in men. Once a 
        woman develops a cardiovascular disease, she is more likely 
        than a man to have continuing health problems and is more 
        likely to die from it. Despite the seriousness of these 
        diseases, they are largely unrecognized by both women and their 
        doctors. Additional funding is needed to allow NHLBI to expand 
        research on cardiovascular diseases in women and to create more 
        informational and educational programs for female patients and 
        health care providers on cardiovascular diseases risk factors 
        as authorized under Public Law 105-340, the Women's Health 
        Research and Prevention Amendments of 1998.
         stroke research challenges and opportunities for ninds
    Stroke is a major cause of disability and America's No. 3 killer. 
America's 4.4 million stroke survivors often face debilitating physical 
and mental impairment, emotional distress and overwhelming medical 
costs. An estimated 600,000 Americans will suffer a stroke this year. 
Considered a disease that strikes our grandparents, stroke also 
afflicts newborns, children and young adults. More Americans are dying 
from stroke than ever before.
    We urge a doubling of the stroke research budget through the NINDS 
by year 2003. An fiscal year 2001 appropriation of $1.184 billion for 
NINDS, with $125 million for stroke research, the next step toward the 
goal, will allow the NINDS to expand studies and start new research to 
prevent stroke, protect the brain during stroke and enhance 
rehabilitation. Some challenges and opportunities follow.
  --Emerging Stroke Risk Factors.--Many Americans are controlling major 
        stroke risk factors, such as high blood pressure and smoking, 
        yet the number of people falling victim to stroke continues to 
        rise. With the growing number of strokes, scientists are 
        defining new stroke risk factors, re-examining existing ones 
        and reconsidering a long-held belief that no difference exists 
        in risk between young and older patients with similar risk 
        factors. Researchers are studying heart valve disease coupled 
        with an irregular heartbeat; elevated white blood cell count 
        that signals an infection leading to inflammation and clogging 
        of arteries; long-term effects of previous high blood pressure; 
        and high levels of C-reactive protein in blood that signals 
        inflammation of blood vessels. Increased funding to study these 
        areas may lead to new ways to prevent stroke.
  --Therapeutic Strategies for Stroke.--Several major clinical trials 
        investigating drugs and techniques have identified progressive 
        methods for preventing and treating stroke in high risk 
        populations. But, more drugs and procedures to prevent strokes 
        need to be developed and evaluated. Funding for new clinical 
        studies are crucial for advancing additional cutting-edge 
        stroke treatment and prevention.
  --Public and Professional Education for Stroke.--T-PA is the first 
        effective FDA-approved emergency treatment for clot-caused 
        stroke. Yet, only 5 percent of those eligible for t-PA receive 
        it. As a member of the Brain Attack Coalition, a group of 
        national organizations committed to fighting stroke, we are 
        working with NINDS to increase public awareness of stroke 
        symptoms and appropriate emergency action. Together, we are 
        sponsoring and distributing a televised PSA on this issue and 
        striving to develop systems to make t-PA readily available to 
        appropriate patients. When these systems are fully implemented, 
        stroke treatment will change from supportive care to early 
        brain-saving intervention. More funding is needed to educate 
        the public about stroke symptoms and the need for prompt 
        treatment and to assure appropriate community response systems 
        are in place. More health professionals must be educated about 
        t-PA and the need for rapid response.
  --Acute Stroke Treatment Centers.--Rapid, early treatment must be 
        available to stroke victims who arrive in the emergency 
        department within the three-hour window of opportunity for t-
        PA. Funding to develop acute stroke treatment centers is key to 
        rapid early treatment. These centers would provide 24-hour 
        emergency transportation, emergency department physician and 
        nurse, a neurologist or stroke specialist, access to a 
        diagnostic neuroradiologist or stroke professional with 
        experiencing in reading and interpreting brain images and a 
        neurosurgeron for treatment of bleeding stroke and serious 
        complications. The centers would provide an opportunity for new 
        stroke treatments to be evaluated early when they could have 
        the most beneficial effect.
        research in other nih institutes benefit heart & stroke
    National Institute on Aging defines how the aging process 
contributes to cardiovascular diseases, a main disabler and No. 1 
killer of older Americans. An fiscal year 2001 appropriation of $62 
million for cardiovascular research will allow continuation of studies 
and expansion into promising areas.
    National Institute of Diabetes and Digestive and Kidney Diseases 
studies help in reducing cardiovascular disease death and disability. 
We advocate an fiscal year 2001 appropriation of $1.313 billion for the 
NIDDK to advance research to help diabetics, 2/3 of whom die from heart 
disease or stroke.
    National Institute of Nursing Research studies play a key role in 
promoting self-care and patient education. NINR research is critical to 
primary and secondary prevention of heart attack, stroke and other 
cardiovascular diseases. We advocate an fiscal year 2001 appropriation 
of $103 million for the NINR.
    Animal research is critical for heart and stroke research. We 
support an fiscal year 2001 appropriation of $776.3 million for the 
National Center for Research Resources to help institutions and 
researchers get animals and provide humane care. Increased resources 
will fortify animal research, help correct deficiencies in research 
animal resources and strengthen Clinical Research Area Centers and 
Biomedical Technology and Infrastructure Areas.
               agency for healthcare research and quality
    AHRQ, the lead health care quality agency, acts as a ``science 
partner'' with public and private health care sectors in improving 
health care quality, reducing its costs and broadening access to 
essential services. AHRQ is an active participant in developing 
evidence-based information needed by consumers, providers, health plans 
and policymakers to improve health care decision making. We concur with 
the Friends of AHRQ's recommendation of an appropriation of $300 
million for the AHRQ to improve health care quality, reduce medical 
errors and expand availability of health outcomes information.
               centers for disease control and prevention
    The best way to protect the health of Americans and lessen the 
enormous financial burden of disease is through prevention. Your 
commitment cannot stop at the laboratory door. You must fund the work 
that brings research into the places where heart disease and stroke 
live--the towns and neighborhoods that populate America.
    The CDC builds the bridge between what we learn in the lab and how 
we live in communities. CDC sets the pace on prevention. We recommend 
an fiscal year 2001 appropriation of $4.1 billion for CDC, with a 
doubling of the chronic disease prevention line for at total of $570 
million.
    As a result of the efforts of this Committee, since fiscal year 
1998, CDC's Cardiovascular Health Program will cover 18 states. This 
initiative allows states to design/and or implement programs to meet 
local needs to prevent and control heart attack, stroke and other 
cardiovascular diseases. In 1997, CDC released a report outlining what 
the nation's priorities should be in chronic disease prevention. The 
report, Unrealized Prevention Opportunities: Reducing the Health and 
Economic Burden of Chronic Disease, said ``strong chronic disease 
prevention programs should be in place in every state to target the 
leading causes of death and disability in our society --and their 
principal risk factors.'' Until the Appropriations Committee started a 
comprehensive Cardiovascular Health Program in fiscal year 1998, the 
CDC-administered Preventive Health and Health Services Block Grant was 
the only source of federal funding to states for targeting 
cardiovascular diseases, the No. 1 killer in every state.
    We laud this Committee's creation and expansion of a state-based 
cardiovascular health program that will be in 18 states in fiscal year 
2000. An fiscal year 2001 appropriation of $50 million for the 
Cardiovascular Health Program will allow CDC to expand it to 11 more 
states for a total of 29 states.
    The WISEWOMAN Program uses CDC's National Breast and Cervical 
Cancer Early Detection Program to also screen uninsured and low-income 
women age 50 and older for heart disease and stroke risk factors. We 
commend this Committee for providing funding to expand the program to 
seven states. An appropriation of $20 million will allow CDC to support 
20 states in WISEWOMAN.
    The Preventive Health and Health Services Block Grant is a vital 
resource for states in addressing heart disease and stroke. It is 
critical in helping states with their role in preventing chronic 
diseases. We recommend an fiscal year 2001 appropriation of $210 
million for the PHHSBG. We urge the Committee to address, as the 
Unrealized Prevention Opportunities document points out, the need to 
target risk factors. We support CDC's efforts to build:
  --a comprehensive nutrition and physical activity program with an 
        appropriation of $30 million;
  --a national program to prevent tobacco use, including a public 
        education campaign to reduce youth access to tobacco, through 
        CDC's Office of Smoking and Health with an appropriation of 
        $130 million; and
  --a comprehensive school health education program with an 
        appropriation of $25 million.
    Coupled with a nationwide Cardiovascular Health Program, these 
initiatives will advance the fight against heart disease and stroke. We 
urge you to make cardiovascular health a national priority.
                             action needed
    Significantly increasing resources for research and community 
intervention programs will allow this nation to continue making strides 
in the battle against heart attack, stroke and other cardiovascular 
diseases.
                                 ______
                                 
                     National Institutes of Health
                            Medical Research
Prepared Statement of the Association of Women's Health, Obstetric and 
                            Neonatal Nurses
    The Association of Women's Health, Obstetric and Neonatal Nurses 
(AWHONN) appreciates the opportunity to comment on the fiscal year 2001 
appropriations for nursing education, research, and workforce programs, 
as well as programs designed to improve maternal and child health. 
AWHONN is a membership organization of 22,000 nurses whose mission is 
to promote the health of women and newborns. AWHONN members are 
registered nurses, nurse practitioners, certified nurse midwives, and 
clinical nurse specialists who work in hospitals, physicians' offices, 
universities and community clinics across North America as well as in 
the Armed Forces around the world.
    AWHONN appreciates the support that this Subcommittee has provided 
for nursing education, research and workforce programs, as well as 
maternal and child health programs in the past. We realize that there 
are many competing priorities for the Subcommittee members, and we 
appreciate your consistent support.
                  national institutes of health (nih)
    AWHONN joins many others in supporting a 15 percent increase for 
the National Institutes of Health in fiscal year 2001. With the 
leadership provided by this Subcommittee, Congress is well on its way 
to doubling NIH funding by 2003. In addition to the overall support, 
there are two specific funding recommendations that AWHONN recommends 
within NIH.
National Institute of Nursing Research
    AWHONN encourages this Subcommittee to support the professional 
judgement budget request of $110 million for the National Institute of 
Nursing Research (NINR).
    One of AWHONN's top priorities is a $20 million dollar increase in 
funding for the National Institute of Nursing Research (NINR). NINR 
engages in significant research affecting areas such as: research on 
health disparities in ethnic groups, training opportunities in genetic 
research and in health disparities, and studying telehealth 
interventions in rural/underserved populations. These research programs 
directly affect patients and families and contribute to decreased 
medical costs and increased quality of patient care.
    In addition, NINR research improves outcomes for women and 
children. A report by the U.S. Agency for Health Care states that the 
most common reason for hospital admission in the United States is 
childbirth. This accounts for 3.8 million annual hospital admissions. 
This is a joyous event in most women's lives, but complications of 
pregnancy such as pre-term birth and low birthweight infants are some 
of the more expensive reasons for hospitalization. Nurse research has 
helped redesign care delivery models that optimize pregnancy outcomes 
and shorten hospital stays for vulnerable low birthweight babies.
    For example, NINR-funded projects have contributed to breakthroughs 
in nursing that have improved infant health after hospital discharge 
for at-risk mothers and babies. One model utilized home follow-up 
assessment and care by an advanced practice nurse and showed decreased 
health system costs by shortening the length of stay of the infant and 
avoiding subsequent re-hospitalization.
    Because of the emphasis on biomedical research in this country, 
there are few sources of funds for high-quality behavioral research for 
nursing other than NINR. It is critical that we increase funding in 
this area in an effort to improve the consumer's experience with the 
health care system, optimize patient outcomes and decrease the need for 
extended hospitalization.
National Institute of Child and Human Development (NICHD)
    AWHONN supports the professional judgment budget, which includes an 
increase of $294 million, bringing the appropriation for NICHD to just 
over $1 billion.
    NICHD seeks to ensure that every baby is born healthy, that women 
suffer no adverse consequences from pregnancy, and that all children 
have the opportunity to fulfill their potential for a healthy and 
productive life unhampered by disease or disability. With increased 
funding NICHD could expand its use of the NICHD Maternal-Fetal Medicine 
Network to study ways to reduce the incidence of low birth weight. 
Prematurity/low birthweight is the second leading cause of infant 
mortality in the United States and the leading cause of death among 
African American infants. AWHONN, like many organizations directly 
involved in initiates to improve the health of women and newborns, 
looks to NICHD to provide national initiatives, such as the Maternal-
Fetal Medicine Network to assist with the care of pregnant women and 
babies.
    On specific example of the important research that evolves from 
NICHD is research that led to the remarkable reduction in the rate of 
HIV transmission from mother to infant during pregnancy and birth. In 
fact, this past year, grantees focused on treatment that reduces the 
viral load during pregnancy finding that the risk of HIV transmission 
from mother to infant can be further reduced. Additionally, NICHD, in 
collaboration with NIAID, is now conducting studies to evaluate whether 
nevirapine, administered during the time a mother is breastfeeding can 
reduce the rate of HIV transmission through breast milk. The results of 
these studies and many others will lead to significant advances in 
ensuring that babies are born healthy, while decreasing maternal 
morbidity.
                department of health and human services
Nurse Education Act (NEA)
    AWHONN is requesting an increase of 15 percent over fiscal year 
2000 to fund the NEA at approximately $78 million. Fiscal year 2000 
funding for the NEA was $67.8 million.
    The Nurse Education Act (Public Health Service Act Title VIII) 
helps schools of nursing and nursing students prepare to meet patient 
needs in a changing health care delivery system, favoring programs in 
institutions that train nurses for practice in medically underserved 
communities and Health Professional Shortage Areas. Reauthorized as the 
Nursing Workforce Development section in 1998, the new NEA gives the 
Department of Health and Human Services more discretion over the focus 
of federal spending, while keeping with previous goals. In addition, 
funds from the Nurse Education Act support projects that would increase 
educational opportunities for minority nurses who would then be able to 
provide culturally competent, linguistically appropriate health care 
services to underserved communities.
    AWHONN supports the continued designation of funds for education 
and training of critically needed primary care providers--advanced 
practice nurses. These nurses--clinical nurse specialists, nurse 
practitioners and certified nurse-midwives--have historically provided 
a pool of qualified providers for underserved communities. Advanced 
practice nurses are providing services in communities where physician 
services are sometimes not even available. Due to the current demand 
for these services, and expected increases in demand, it is critical 
that the Division of Nursing, through the Health Resources Services 
Administration, is provided the funding to address the education and 
training needs of this essential pool of providers.
    While many advance practice nurses are providing greatly needed 
services in critical areas, the nursing community is facing shortages 
in nurses with the competence, skills and experience to meet the 
demands for complex patient care. With greater frequency we are 
receiving calls from our members reporting gaps in staffing resulting 
from fewer and fewer available professional registered nurses. We 
understand that at this time the nursing shortage is regional in 
nature, but the entire nursing community is anticipating a significant 
professional nurse shortage to peak around 2010. With the increasing 
technical complexity of the health care system, it is critical that a 
pool of highly skilled and experienced professional nurses be available 
to safeguard the health of our nation. We anticipate that the aging 
baby boomer generation will require more health care resources in 2010 
at the time when there will be a historic low in nurse supply. While we 
wait for the results of the most recent nurse sample survey to confirm 
these concerns, AWHONN believes it is critical that Congress act to 
ensure the continued supply of professional nurses in our nation.
Maternal and Child Health Block Grant
    Because of the increasing demands for the services provided through 
this block grant, AWHONN recommends a substantial increase for the 
Maternal Child Health Block Grant to $800 million for fiscal year 2001.
    This program provides comprehensive, preventive care for mothers 
and young children, as well as an array of coordinated services for 
children with special needs. MCH programs are facing increased demands 
for services due to continued growth in the Children's Health Insurance 
Program, which in turn identifies more children who are eligible for 
other MCH Services. Title V complements Medicaid and the State 
Children's Health Insurance Program by providing ``wrap-around'' 
services and enhanced access to care in underserved areas.
    Additional funding would give states the resources they need to 
expand prenatal and infancy home visitation programs, an approach that 
has been shown to improve the prenatal health-related behavior of women 
and reduce rates of child abuse and neglect as well as maternal welfare 
dependence. Postpartum home visits can also increase the percentage of 
mothers who choose to breastfeed. Many new mothers can get frustrated 
and stop breastfeeding in the first few days; a visit from a qualified 
health care provider can greatly encourage women to continue 
breastfeeding. This can also positively impact the goals of the Healthy 
People 2010 initiative to raise the rate of initiation of breastfeeding 
to 75 percent and the six-month rate of breastfeeding to 50 percent.
    centers for disease control and prevention--folic acid awareness
    AWHONN recommends an increase to $20 million in the fiscal year 
2001 appropriation to enable CDC to effectively promote folic acid 
awareness.
    For over 30 years, the Centers for Disease Control and Prevention 
(CDC) has been deeply involved in the prevention of birth defects. The 
public health impact of birth defects is tremendous. Of the four 
million babies born each year in the United States, approximately 
150,000 are born with a serious birth defect. According to CDC, the 
lifetime costs of caring for infants born in 1992, with at least one 
birth defect \1\ or cerebral palsy was about $8 billion. The emotional 
and financial burden for the families with affected children is 
devastating.
---------------------------------------------------------------------------
    \1\ These birth defects include: Spina bifida, truncus arteriosus, 
single ventricle, transposition/double outlet right ventricle, 
Tetralogy of Fallot, tracheo-esophageal fistula, colorectal atresia, 
cleft lip or palate, atresia/stenosis of small intestine, renal 
agenesis, urinary obstruction, lower-limb reduction, upper-limb 
reduction, omphalocele, gastroschisis, Down syndrome, and diaphragmatic 
hernia.
---------------------------------------------------------------------------
    The first steps in preventing birth defects includes surveillance, 
to find out what types of birth defects are occurring, how often and 
where, and research into the causes of birth defects. The ultimate goal 
of surveillance and research is to develop and implement strategies to 
prevent birth defects. An example of such a prevention activity is the 
current folic acid education campaign to prevent neural tube defects 
(NTDs). Each year in the United States, an estimated 2,500 babies are 
born with NTDs, birth defects of the brain and spinal cord, such as 
anencephaly and spina bifida. These NTDs are among the most serious, 
costly and preventable birth defects. The lifetime cost of each case of 
spina bifida in 1992 was estimated to be nearly $300,000. Yet, up to 70 
percent of NTDs can be prevented if all women of childbearing age 
consume 400 micrograms of folic acid daily, beginning before pregnancy.
    In an effort to spread this information, AWHONN is working closely 
with the CDC, March of Dimes, and more than 40 public and private 
organizations, to coordinate a national educational campaign through 
the National Council on Folic Acid. Last year Congress increased 
funding for CDC's efforts in support of the folic acid campaign from 
$1.5 to $2 million. However, current funding is woefully inadequate. We 
respectfully request that you provide the CDC $20 million in funding to 
prevent these serious birth defects.
    Thank you for the opportunity to submit testimony on these critical 
areas of funding.
                                 ______
                                 

      Prepared Statement of the American Society for Microbiology

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

   Prepared Statement of Texas Tech University Health Sciences Center

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

               Prepared Statement of Santa Marta Hospital

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

            Prepared Statement of the University of Michigan

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

        Prepared Statement of the American Physiological Society

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

          Prepared Statement of the American Chemical Society

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

     Prepared Statement of the National Multiple Sclerosis Society

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

          Prepared Statement of New York-Presbyterian Hospital

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

   Prepared Statement of the American Society of Mechanical Engineers

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

    Prepared Statement of the National Coalition for Cancer Research

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

         Prepared Statement of the Children's Heart Foundation

    Mr. Chairman and Distinguished Subcommittee Members: On behalf of 
The Children's Heart Foundation and all who are suffering from 
congenital heart defects we enter this testimony for consideration at 
the fiscal year 2001 budget hearings.
    According to the NIH Guide (Gene Nutrient Interactions in the 
pathogeneses of congenital heart defects), September 1994, 42 percent 
of all birth defects are caused by congenital heart defects. Eight 
percent of all deaths during the first year of life are caused by this 
condition, and of the 30,000 babies born each year with this anomaly, 
2,900 of them will die before their first birthday. Thirty six hundred 
children under the age of fifteen die annually from congenital 
cardiovascular malformations (CCVM) or congenital heart defects.
    In addition to the incredible impact on families, the social costs 
are great as well. Many children who survive infancy are forced into a 
life of dependency on medications, medical procedures, and repeated 
open-heart surgeries. In 1992 nearly $500 million was spent to pay for 
44,000 hospitalized children who were under fifteen years old.
    Because so few of these children live long enough to have children 
of their own, it has been difficult to carry out genetic studies of 
CCVM. However researchers have now come to the conclusion that most 
CCVM occurrences are caused by genetic defects. According to 
information provided by the NHL&BI, the direct cause for at least eight 
different structural heart defects may be genetic.
    While we at The Children's Heart Foundation appreciate the genetic 
studies that have been ongoing at the NIH, we also realize that 
clinical studies on procedures and methods of treatment are vital to 
the future of patients suffering with congenital heart defects. We wish 
to encourage the committee to support more clinical projects in 
congenital heart research. It is our understanding that at present the 
budget for congenital heart research at the NHL&BI is fifty million 
dollars.
    We ask that the members of this committee grant fifty million 
additional dollars to the NHL&BI with directives to increase clinical 
and molecular research concerning congenital heart defects. The 
increase will bring the budget to 100 million dollars, but in a budget 
of, what we understand to be 15 billion dollars this is a small 
increase to support research in America's number one birth defect.
    In the next few pages we will present the stories of some of the 
families who have lived with these life-threatening conditions. One of 
these families has lost the battle while others still live with the 
daily difficulties that accompany their illness. Please accept these 
testimonies and the requests to testify before this committee under the 
auspices of The Children's Heart Foundation.
    Individuals and grassroots efforts can only do so much. Congress 
must take on this effort and increase appropriations. So again, we 
implore this committee to grant an increase of fifty million dollars to 
the fiscal year 2001 budget earmarked to the NHL&BI for congenital 
heart defects research. We thank you for your attention to our 
requests.
                                 ______
                                 
                  prepared statement of jessica cowin
    Mr. Chairman, members of the committee and all who hear this 
testimony. My name is Jessica Cowin and I am 16 years old. I am 
requesting to be slotted to testify before the appropriations 
subcommittee.
    I have had five heart surgeries since I was 4 days old because I 
was born with a hypo plastic left heart. A hypo plastic left heart is a 
heart that has no left side, in other words I had no pump. At 4 days 
and 18 months the doctors performed closed heart surgeries on me. At 5 
years and 13 years, I had open-heart surgeries. All of these surgeries 
worked, for a while, but my heart began to fail in the last two years. 
The doctors and my parents agreed that I needed a heart transplant. It 
was very scary to think that the doctors were going to put someone 
else's heart inside of me, but if I wanted to live longer that's what I 
had to do.
    On September 25, 1999, my mother got a phone call from the 
Children's Memorial Hospital in Chicago (where I have had all of my 
surgeries), saying that they had a heart for me. It has been two months 
since my transplant and even though I am on a lot of medication I 
already feel better. Before the transplant I had no energy and got sick 
more often than other children. It also took me longer to get better. I 
have also missed a lot of school in the past three years and I missed 
my friends, too.
    This has been very stressful for my family because everyone worries 
a lot about me. I still have to go to a lot of doctors, physical 
therapy, counseling and cardiac rehabilitation. I know my mom worries a 
lot about the medical bills even though she tries not to show it.
    Without the research for congenital heart defects, I would not be 
here today. I was born in 1983 at Children's Memorial Hospital. At that 
time they were not even doing heart transplants there. They started 
doing transplants in 1988, when I was 5 years old. I have personally 
benefited from the research of all of my five surgeries.
    My mom tells me that there are still babies born with heart 
problems that do not live and that I am really lucky that I have such 
good doctors and that they knew what to do for me. I agree with her. 
Please provide more federal funding for congenital heart research to 
the National Institute of Health.
                                 ______
                                 
                  prepared statement of andrea piwowar
    My name is Andrea Piwowar. Twenty-three years ago, I was born with 
several congenital heart defects. I was diagnosed with tricuspid 
atresia with transposition of the great arteries and a large 
ventricular septal defect associated with pulmonary hypertension and an 
absent pulmonary valve.
    When I was three months old, I had a banding of the pulmonary 
artery. In January of 1982, I had a modified Fontan, a surgical 
procedure which makes it possible for blood to enter the lungs without 
being pumped in by the right ventricle. This is achieved by connecting 
the pulmonary artery directly to the right atrium. In my situation, 
since I had transposition of the great arteries and a ventricular 
septal defect along with tricuspid atresia, the underlying need for the 
Fontan procedure, the surgeon corrected the transposition and closed 
the hole between the two atria.
    Seven months following the modified Fontan, I had a stroke. In 
December of the same year, I had yet another stroke. It is my 
understanding that it was thought that clots were forming in the 
pulmonary stump; therefore, after the second stroke, I was operated on 
again and the pulmonary stump was removed. The doctors could not find 
where the clots came from. Even to this day, there is no explanation of 
the strokes. After that operation, I was put on Coumadin and Lanoxin.
    As a result of the strokes, which occurred after my corrective 
heart operations, I have both orthopedic and speech impairments and 
require the use of an electric wheelchair for mobility purposes. 
Throughout my childhood, my parents fought for the appropriate 
accommodations to be made in the school systems and for my right to be 
in classes with able-bodied children. I felt like it was necessary for 
me to work harder on class assignments just so I could keep up with the 
class. I also felt that I had to prove myself to my teachers.
    I am now an Indiana University graduate and am currently looking 
for a job. I have had a couple of interviews and have spoken with 
employers and recruiters over the telephone. At times, I feel as if my 
impairments make it difficult for me to make a good first impression 
with potential employers. I have been hung up on while speaking with 
recruiters and employers have postponed and cancelled interviews with 
me.
    Like other patients who have had the Fontan operation, I am 
beginning to see some of its side effects. Within two years, I have had 
atrial fibrillation three times, each time requiring a cardio version 
to get back into normal rhythm. I also have an enlarged atrium which is 
causing my blood return to become sluggish.
    My first bout with atrial fibrillation occurred during the week of 
college midterms. I thought it might have been something that I had 
brought on myself, because I had been working on several projects at 
one time and staying up late to study, but I hadn't done anything 
differently than I did during the previous semester. It wasn't until I 
was in the hospital that I found out that atrial fibrillation was a 
side effect from the Fontan procedure.
    No one had informed me of any possible side effects of the Fontan. 
Only by speaking with my cardiologist and reading personal experiences 
of other Fontan patients I am beginning to understand more about the 
side effects; however, I have yet to understand why some people with 
congenital heart defects have strokes while others do not. As I 
mentioned earlier, no one can explain why I had two strokes after the 
Modified Fontan operation.
    Several years ago, I wrote a letter to Dr. Thilenius, the 
cardiologist who saw me before and after the modified Fontan procedure 
was performed, inquiring about Hypo plastic Left Heart Syndrome. I 
received a response that explained what Hypo plastic Left Heart 
Syndrome was and the surgical procedures that could be performed, 
depending on the severity of this disease. I was also given an 
explanation of my congenital heart defects and the surgical procedure 
that were performed to correct them. I was informed that strokes rarely 
occur after a Fontan procedure, so rarely in fact, that it is not even 
mentioned as a complication, but yet they still occur and no one seems 
to know why.
    So, I ask you, the distinguished members of the subcommittee, to 
increase appropriations to the National Heart Lung and Blood Institute 
to support clinical studies in the area of congenital heart research. 
As more congenital heart research is performed, researchers may 
discover why some people with congenital heart disease are more prone 
to having a stroke than others and find a way to prevent them from 
occurring.
    I would like to submit my request to be given the opportunity to 
testify before you, the distinguished members of the subcommittee, on 
the issue of allocating increased funds to the National Institute of 
Health for congenital heart research.
    Thank you for your time.
                                 ______
                                 
                  prepared statement of megan van pelt
    My name is Megan Van Pelt and I am the mother of a child born with 
a congenital heart defect. Congenital heart defects have been a part of 
my life since I was a child. My Cousin was born with a very severe 
congenital heart defect and underwent many open-heart surgeries. Being 
a child I could have never understood the magnitude or impact on the 
family during this time. Doctors told my aunt that he would not live 
past the age of nine. By the grace of god and congenital heart research 
twenty-nine years later my cousin is still alive and functioning as a 
normal healthy adult. Who could know that twenty-seven years later, I 
myself would deal with the issue of congenital heart defects. In the 
summer of 1997 my husband and I were anxiously awaiting the arrival of 
our first child. During my routine twenty-four week check up I was 
excited to finally see our baby in an ultrasound. As the ultrasound 
progressed the technician informed me that she needed to get the 
obstetrician to come in and look at the baby's heart. After the doctor 
reviewed the tape, he informed me that our unborn child had a complex 
congenital heart defect. For my husband and me the next three months 
were a blur of cardiology visits and Internet research. On October 10, 
1997 my amazing son, John ``Jack'' Ryan Van Pelt, came into our lives, 
changing us forever. Nothing could have prepared me for the next four 
months. Jack was born a navy blue color which according to the doctors 
was normal because of the lack of oxygen his body was getting. Jack 
weighed 4.5 pounds at birth. He was immediately transported to 
Children's Hospital in Chicago. I have never felt so helpless.
    A heart catheterization which was done shortly after Jack arrived 
at Children's Hospital, confirmed the initial diagnosis of 
transposition of the great vessels as well as three holes in his heart. 
This meant that Jack's heart had developed backwards and all his blood 
was flowing in the wrong direction. Because of Jack's size the Cardio-
Thorasic team did not feel that he was strong enough or big enough to 
survive the complicated surgery that he needed. We spent the next two 
months in the Neonatal Intensive Care unit, waiting. Because of his 
heart Jack experienced liver and kidney failure. Everyday was a hurdle 
for Jack and many days were touch and go. I thanked God for everyday I 
had with him.
    Finally on December 4th the surgeons felt Jack's condition was 
deteriorating and the surgery could no longer wait. The surgeons 
explained at length the surgery that Jack would undergo. The procedure 
was relatively new and if successful Jack would not need to undergo 
future surgeries. I will never be able to verbalize how it felt to sign 
my son's life over to this team of doctors. The actual surgery took ten 
hours. When Jack came out of surgery everyone warned us he would look 
horrible, I am happy to say, they were all wrong. My husband and I 
could not believe how pink he now looked. His body was finally 
receiving oxygen. The doctors warned us that the next 48 hours would be 
the most critical. Jack came through with flying colors. He had fought 
for his life and won. My son was a survivor.
    Through those three months I could not believe the amount of people 
I became close to who had children surviving with congenital hearts 
defects and dying from congenital heart defects. This is the number one 
birth defect that children are born with, why don't most parents know 
this? Why isn't there better education? But most importantly why isn't 
there more research? There are children that I met who will undergo 
open-heart surgery every three years as their hearts grow. 
Unfortunately the funding for projects is not there to help researchers 
find ways to fix defects the first time so it will be the only time 
these children are forced to undergo additional lifesaving procedures.
    I am happy to say that Jack is doing very well at the age of two. 
We visit the cardiologist once a year. With every visit I hold my 
breath afraid that he will need another surgery. Should that day come 
we will take it in stride. The most terrifying part of having one child 
with a congenital heart defect becomes the fact that every child you 
have following has an even higher chance of being born with a 
congenital heart defect. One out of every 115 babies is born with a 
congenital heart defect in the U.S. each year. There are many worthy 
causes and issues today, but there needs to be a greater awareness of 
this, our number one birth defect. Because of our experience it has 
been extremely important to my husband and I to give back. We have 
become involved with the Children's Heart Foundation, which raises 
money for research in congenital heart defects. Many of our recipients 
have gone on to receive funding from the NIH for pediatric congenital 
heart research. When it comes right down to it, the funding that is 
needed isn't there. The American Heart Association gives less than 1 
percent of their funding to research of congenital heart defects.
    I ask you to take the time to visit a cardiac wing in a pediatric 
hospital. There is a great chance that your family, friends, or 
associates have been or will be affected by a congenital heart defect. 
My family is reminded of it daily my cousin whom I spoke of earlier and 
his wife are seven months pregnant. Sadly they have just found out 
through ultrasound that their child will need to have open-heart 
surgery. I ask you to sincerely consider dedicating more money for the 
research of pediatric congenital heart research. Help us to educate the 
public and find the answers to the number one birth defect. Thank you 
for your time and consideration. We have an opportunity as the leading 
healthcare nation in the world to find cures and new surgical 
procedures to help these brave young fighters and I encourage you to 
support us in the fight.
    Thank you for your attention.
                                 ______
                                 
                  prepared statement of teresa taylor
    Mr. Chairman; and Members of the Committee. I am requesting to be 
slotted to testify before the appropriation sub-committee and I am 
honored to give my personal testimony.
    My name is Teresa Taylor from Skokie, Illinois in the county of 
Cook, the 21st Congressional District of Illinois in the United States 
of America. I would like to address this committee on behalf of all the 
children born with congenital heart disease, those surviving, and in 
honor of those that have lost their lives including my son, Sam. It is 
with a personal story and a family history that I testify.
    I want to go down on record that my son Sam and countless others 
that have died prematurely not forgotten but remembered. And to be a 
constant reminder for the need for additional federal funding for 
research on congenital heart defects.
    My son Sam, was born in Chicago, Illinois April 1993. He was born 
with hypo plastic left heart syndrome. In other words, his left side of 
his heart was underdeveloped. The left side of the heart is the main 
pumping chamber of the heart and pumps blood to the rest of the body.
    The devastation over our son's condition has caused us great sorrow 
and pain. We knew very little in 1993 of his disease. There was little 
that we could do except listen to the Doctors' prognosis and go along 
with the treatment they suggested. In 1993, the options for Sam were 
immediate open-heart surgery, or wait for a heart transplant. We opted 
to place Sam on a heart transplant list originally called the UNOS 
(united network of organ sharing). We were told that Sam would probably 
get a heart within the next 6-9 weeks. We did not receive a heart when 
we had thought. The heart for Sam came when he was 5 months old. He 
lived in the hospital his whole life on a ventilator. I would not call 
this life support but assistance so that his heart and lungs would not 
flood up with blood while he waited for a heart. Sam died 2 weeks after 
transplantation. He died due to lung and hospital related infections. 
Because Sam waited only two days short of the longest wait for an 
infant heart doctors did not know what to expect of his out come. Today 
doctors know that an infant and most likely any patient waiting for a 
heart transplant cannot survive as long as Sam did on a ventilator. 
Because of Sam, doctors know that it is critical to find better ways to 
manage a patient waiting for a heart transplant and open-heart surgery. 
Today at Children's Memorial Hospital in Chicago, doctors have 
perfected open-heart surgery that would have been used on Sam instead 
of transplantation (the procedure is called Norwood). Research helped 
in this matter and patients like Sam helped them in their research. Sam 
and other children paid with their lives to help doctors understand 
congenital heart defects and find ways to better manage and treat their 
condition.
    I make a plea to this committee, let this show that research is 
direly needed to prevent cases where the doctors only learned after the 
child's death of appropriate treatment for a child with a congenital 
heart defect.
    My story does not end here. I had a brother who died from a 
congenital heart defect called tetralogy of Fallot. Today, many are 
living many more years thanks to research. These dedicated Doctors to 
find ways to manage and treat children with congenital heart defect 
such as tetralogy of Fallot. My family history of congenital heart 
defects goes back at least three generations. All of those in my family 
who died were boys. I would like my daughters to one day have children 
of their own. I would hope that they will feel safe that if they have a 
boy and he is born with congenital heart disease that they will not 
have to grieve for the loss of their son but embrace his survival. It 
is my personal dream to see my son in the face of my daughter's 
children, happy and healthy.
    I want this story to someday have a happy ending to parents across 
the country because federal dollars were spent in providing research in 
this area, we need as parents to take a stand and ask questions. Why 
did this happen to my child, is there research being done in this area, 
what is the treatment for these children, what is their long term 
prognosis, will we learn something from this and can our children have 
the future that they deserve so much?
    I have heard countless stories subsequent to our son Sam's death. 
Stories of survivors with the same condition Sam was born with. These 
children are living today because of research in congenital heart 
defects. I only wish today that my son had this chance for a life. I 
can only wish to carry on a legacy in his name, to help other children 
have a chance to live and enjoy life like other children. The more 
money that can be generated toward research, the more children in the 
future will live with a heart defect not die of it. I plead to this 
committee to pleases allocate more federal dollars to the to the Heart, 
Lung and Blood Institute, and to direct research funds on congenital 
heart disease.
    Thank you for your attention in this matter.
                                 ______
                                 

           Prepared Statement of the Doris Day Animal League

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

    Prepared Statement of the Federation of American Societies for 
                          Experimental Biology

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

     Prepared Statement of the American College of Chest Physicians

    I am Susan Pingleton, M.D., FCCP, President of the American College 
of Chest Physicians, Professor of Medicine at the University of Kansas 
Medical Center, Director of the Pulmonary and Critical Care Division at 
the University of Kansas Medical Center, Medical Director of the 
Medical ICU, Chair of the ICU Committee, and a member of the KU 
Internal Medicine Foundation Board Trustees and the Graduate Medical 
Education Committee.
    Thank you for affording me the opportunity to submit this testimony 
for the record on behalf of the American College of Chest Physicians 
(``ACCP''). The ACCP is a professional medical specialty society of 
more than 14,500 physicians, scientists, allied health professionals 
and educators who specialize in diseases of the heart, lungs, and 
circulatory system. Since it was established in 1935, the College has 
been a leader in cardiopulmonary medicine. Its members are specialists 
in pulmonology, cardiology, cardiovascular and cardiothoracic surgery 
and critical care medicine. The College provides a unique opportunity 
for these specialists to further their professional education and to 
combine expertise from several disciplines in the study of heart and 
lung disease.
    The ACCP appreciates the opportunity to offer its views to this 
important Committee on fiscal year 2001 appropriations for the National 
Institutes of Health (``NIH'') and the Centers for Disease Control and 
Prevention (``CDC''). The ACCP is proud of its historic role in working 
with and supporting various institutes at NIH who in turn support and 
encourage biomedical research of great importance to our patients and 
the entire country.
    The President's budget request for NIH of approximately $18.8 
billion, while laudable, does not go far enough to prevent and combat 
all of the health problems over which the NIH has responsibility. We 
applaud this Committee's efforts to make fiscal year 2000 funding for 
the National Institutes of Health a top priority, but we still need to 
commit substantial resources to research and prevention of pulmonary 
and cardiovascular disease. Therefore, the College urges you to 
appropriate a 15 percent increase over fiscal year 2000 funding for the 
overall NIH. We agree with such groups as the Ad Hoc Group for Medical 
Research Funding and the American Heart Association that an increase of 
this level is necessary to sustain the high standard of scientific 
achievement embodied by the institutes. Thus, we recommend a fiscal 
year 2001 appropriation of $20.6 billion for the NIH. We also support a 
15 percent increase over fiscal year 2000 funding for NIH heart and 
lung research specifically.
    The College supports significant increases to the budgets of the 
National Heart, Lung and Blood Institute (``NHLBI'') and the National 
Institute of Allergy and Infectious Disease (``NIAID'') to levels that 
will enable these fine institutes to continue their wide spectrum of 
research, both basic and applied, for the prevention and treatment of 
cardiovascular and lung disease. With respect to the NHLBI, the ACCP 
recommends a fiscal year 2001 appropriation of $2.330 billion. This 
level of funding will allow the NHLBI to expand many of its existing 
programs and fund exciting new initiatives. The NHLBI is committed to 
maximizing the use of new technologies that are quickly becoming 
available and ensuring that standard health practices throughout the 
country reflect a thorough utilization of the knowledge that 
researchers and health professionals have acquired. This increase in 
funding will allow the NHLBI to expand its programs for genomic 
analysis in cardiovascular, lung, and blood diseases, in an effort to 
more precisely identify the causes and appropriate treatments of 
disease. NHLBI will be able to continue and advance a pilot program 
that is testing new uses of MRI technology to diagnose heart attack 
patients who may be candidates for thrombolytic therapy, a clot-
dissolving treatment that may be able to significantly limit damage 
from heart attacks. This increase in funding will also enable NHLBI to 
establish innovative new clinical research networks, and study the 
underlying reasons for health disparities among various segments of the 
population in order to reduce these disparities.
    Combating asthma is a high priority for the College. We know it is 
a priority for both the NHLBI and NIAID. The ACCP supports a fiscal 
year 2001 appropriation of $935 million for NIAID, not including the 
estimated allocation for AIDS. More than 50 million Americans suffer 
from allergies and/or asthma, and these diseases are major causes of 
illness and disability. The economic costs associated with asthma are 
enormous. Asthma costs the U.S. about $7.5 billion annually. Between 
the years 1980 and 1994, the prevalence of asthma in the U.S. rose 75 
percent. The prevalence of pediatric asthma rose 160 percent during 
these years. In addition, asthma morbidity and mortality rates have 
been increasing in the United States over the last decade, with over 
5,500 people dying in 1996 as a result of an asthma attack. These 
increases have been concentrated disproportionately in children and 
minorities. These increases are alarming to the ACCP. We therefore 
strongly support the efforts of the NHLBI and NIAID in working to 
establish control over this disease.
    The need for continued funding of tuberculosis (``TB'') prevention 
and treatment is painfully clear. TB is the eighth leading cause of 
death worldwide. Two million people will die from TB this year. One out 
of every three people in the world has latent TB, thus creating a huge 
potential for transmission of the disease and development of active TB. 
Multi-drug resistant TB, which is caused by incorrect or incomplete 
treatment, is an increasing problem in this country and throughout the 
world, with as many as 50 million individuals infected. Multi-drug 
resistant TB kills more than half of those infected in the United 
States and is usually fatal in the developing world. These statistics 
underscore the necessity of continued funding for TB prevention and 
treatment activities.
    Given the ease with which TB is transmitted, however, the 
statistics of reported cases do not reveal the whole story. Consider 
these statistics: an infected person with a normal immune system has 
approximately a 10 percent lifetime risk of developing active TB. If a 
person is HIV co-infected, he or she has an 8 percent annual risk of 
developing active TB. Therefore, if a person is infected with HIV and 
TB, and lives five years from the time of the TB infection, there is a 
40 percent chance that person will develop active TB with the risk it 
will be spread to others. If that same person lives 12 years, it is a 
virtual certainty that he or she will develop active TB. With the lives 
of our children at stake, our Nation's future, now is not the time to 
reduce funding for TB. A decrease in federal funding is likely to lead 
to a surge in active TB cases, including deadly multi-drug resistant TB 
cases. Tuberculosis is an immense economic drain on families and on 
nations and is a significant cause of poverty. The ACCP, therefore, 
urges this Committee to increase funding for TB prevention and 
treatment activities. Through its federally-funded research, NIAID has 
already determined the complete genomic sequence of two strains of the 
TB bacterium. These exciting breakthroughs are crucial to NIAID's plans 
to develop a TB vaccine, but these efforts cannot advance without 
Congress's substantial financial support.
    We urge the Congress to support basic and applied research to the 
fullest capabilities. Without it, many of the crucial health benefits 
produced by the NIH would not be possible. With respect to the NHLBI, 
we continue to be impressed with the quality of leadership of its 
Director, Dr. Claude Lenfant. Research sponsored by the NHLBI has led 
to tremendous strides in combating cardiovascular and pulmonary 
diseases as well as hematological disorders. We recognize the strains 
that have been placed upon the federal budget in recent years. 
Nonetheless, diseases of the heart and lungs continue to pose the most 
serious threat to our Nation's health. The desirability of exercising 
fiscal austerity should not cause us to lose sight of the significant 
health and financial benefits of funding medical research. The recent 
scientific achievements of the NIH, and in particular NHLBI, have 
created promising opportunities for understanding disease and improving 
medical care. In order to benefit from these efforts and create new 
opportunities for advancement, Congress must increase its funding of 
both existing and proposed research projects.
    These scientific achievements hold a personal interest for me. I 
was born with a serious heart defect that had to be corrected through 
primitive cardiac surgery when I was a child. I had to be packed in ice 
to slow down my heart rate. Today, bypass machines do this work, 
leaving surgeons to concentrate on the heart itself. My heart stopped 
during the operation, and the resulting nerve and muscle damage to my 
legs required me to learn how to walk again. I was given a low 
probability of surviving past my teenage years, yet here I am today, 
partially due to scientific achievements.
    These experiences led me to enter into the medical profession. They 
also lead me now to support substantially increased funding for 
clinical research. Indeed, we believe that NIH in general and NHLBI in 
particular ought to devote greater resources to clinical research, the 
primary focus of many of our members.
    I am compelled to share with the Committee some very telling NIH 
statistics about the prevalence of heart and lung disease. 
Cardiovascular diseases afflict more than 60 million people. 
Cardiovascular diseases account for nearly 1 out of every 2 deaths in 
the U.S., and lung disease accounts for 1 out of every 7 deaths in the 
U.S. In addition to the untold costs of human suffering, the economic 
costs associated with diseases of the heart, blood vessels, lungs and 
blood represent 25 percent of the total economic costs due to illness, 
injury, and death in 1999. More than 30 million Americans suffer from a 
chronic lung disease. Lung diseases alone cost the U.S. economy an 
estimated $85 billion annually in direct medical expenditures. The most 
telling statistic, however, is that heart disease continues to be the 
number one cause of death in this country. Cerebrovascular disease 
ranks third, and chronic obstructive pulmonary disease (COPD), 
including asthma, ranks fourth. Thus, three of the top four leading 
causes of death are diseases that NHLBI is charged with combating.
    These numbers point to NIH's need for continued federal support for 
its vital programs. The ACCP continues to do its part to support 
research. Through our CHEST Foundation, many ACCP members voluntarily 
donate their own funds every year to support young investigators. This 
year, the CHEST Foundation will award more than 20 clinical research 
grants to young investigators. We believe this is unique compared to 
other medical societies. We are committed to improving the quality of 
the lives of the most important people we represent--our patients. But 
we cannot do it alone. NIH appropriation levels must be increased to 
ensure that our progress toward that goal is not thwarted. The Federal 
Government must not waiver in its strong commitment to biomedical 
advances of the future that would yield tens of billions of dollars in 
health care savings. Therefore, funding levels consistent with the 
important goals and essential mandate of NIH must be achieved.
    As first hand observers of hundreds of thousands of deaths each 
year caused by tobacco usage, the members of the ACCP urge this 
Committee to fully fund the tobacco control efforts of the NIH and 
Centers for Disease Control and Prevention (``CDC''). Smoking is the 
primary cause of preventable death and disability in America, causing 
more than 400,000 deaths, and costing approximately $89 billion 
annually in medical expenses alone. An estimated 48 million Americans 
smoke cigarettes, and over time, about half will suffer death or 
disability as a result of their addiction. Smoking diseases, such as 
lung cancer, emphysema, and coronary artery disease, and other 
cardiopulmonary diseases have become a major socioeconomic problem of 
transcending importance. Treatment of these diseases will continue to 
drain over $800 billion from the Medicare Trust Fund. There are over 40 
diseases/conditions that are caused by or aggravated by the use of 
tobacco. Lung cancer is the leading cause of cancer-related death in 
our population. Yet, the numbers of cancer diagnoses could be 
drastically reduced if we could make serious inroads by curtailing the 
use of tobacco--the number one cause of lung cancer. The NHLBI has made 
important strides in identifying the deleterious health effects of 
smoking, especially with respect to women. The ACCP, which has its own 
Task Force on Women, Smoking, and Lung Cancer, supports the Institute's 
continued efforts in this important area.
    Increasing social, political, and legal pressure nationwide against 
smoking has, overall, made a modest dent in reducing the prevalence in 
smoking. As physicians, we confront on a daily basis debilitating 
disease and death that result from inhalation of tobacco smoke. While 
the ACCP has been active for more than 30 years in educating the public 
about the harms of smoking, even our best efforts cannot match the 
power of Congress to direct funds to combat lung cancer and other 
deadly diseases that result from tobacco use.
    As part of our commitment to improving the health of our patients, 
the ACCP supports the work of the CDC in reducing death and chronic 
morbidity caused by tobacco use. Adequate funding of the tobacco-
related research and state initiatives of the CDC are critical. We urge 
Congress to increase funding for this tobacco prevention work at the 
CDC to $130 million. CDC plays a leadership role in implementing and 
coordinating state-based efforts and is focused on preventing 
initiation among youth and promoting cessation. States that are 
planning to commit tobacco settlement funds to tobacco prevention have 
requested considerable technical assistance from CDC as they seek to 
develop comprehensive and effective state programs. States such as 
Florida, Massachusetts and Mississippi that already have comprehensive 
programs in place relied considerably on CDC's expertise. Funds for 
tobacco prevention at CDC are also used to maintain a comprehensive 
database of smoking and health information and conduct laboratory work 
regarding the dangers of nicotine and other toxic compounds in tobacco. 
An appropriation of $130 million will significantly expand the capacity 
of health and education departments to build and evaluate comprehensive 
tobacco control programs, develop and promote health communication 
campaigns for target audiences, and expand school health programs that 
equip young people with the skills and knowledge to avoid tobacco 
addiction.
    Medical science has made giant strides in eliminating some diseases 
that have afflicted populations in the United States and throughout the 
world. The ACCP continues to seek new and improved treatments and 
procedures to ameliorate the effects of diseases resulting from the 
direct and indirect inhalation of tobacco smoke. We urge this Committee 
to take action to curtail the national epidemic of tobacco-related 
death and disease and to protect our Nation's children from tobacco 
addiction and disease.
    On behalf of the American College of Chest Physicians and our 
millions of patients, I would like to thank you for affording us this 
opportunity to submit our views for your consideration. The ACCP would 
be happy to answer any questions you may have in the future.
                                 ______
                                 
   Prepared Statement of the American Gastroenterological Association
                       summary of recommendations
    The American Gastroenterological Association (``AGA'') urges 
Congress to increase funding for medical research on digestive diseases 
and disorders over fiscal year 2000 by 15 percent for the National 
Institutes of Health (``NIH''), by 41 percent for the Centers for 
Disease Control and Prevention (``CDC''), and by 47 percent for the 
Agency for Healthcare Research and Quality (``AHRQ''). Within NIH, AGA 
recommends at least a 15 percent increase for the National Institute of 
Diabetes and Digestive and Kidney Diseases (``NIDDK''), the National 
Cancer Institute (``NCI''), and the National Institute of Allergy and 
Infectious Diseases (``NIAID'').
                    medical research recommendations
    AGA appreciates the opportunity to present its views regarding 
fiscal year 2001 appropriations for NIH, CDC, and AHRQ. AGA is the 
nation's oldest, not-for-profit specialty medical society, consisting 
of over 10,000 gastroenterologic physicians and scientists who are 
involved in research, clinical practice, and education on disorders of 
the digestive system. As the nation's largest and leading voice of the 
gastrointestinal research community, AGA is uniquely qualified to 
advise Congress on the current status of federally-supported digestive 
disease research programs and the areas in need of further research.
    Each year more than 62 million Americans are diagnosed with 
digestive disorders.--Among the more common gastrointestinal disorders 
are inflammatory bowel disease, irritable bowel disorders, 
gastrointestinal cancers, and foodborne illness. In some of these 
areas, medical research has brought us close to developing lifesaving 
treatments and cures. Yet, in others, we still lack even a basic 
understanding of the cause and transmission of the disease. This 
testimony focuses on these serious health problems and makes 
recommendations on how Congress should allocate this country's precious 
medical research dollars. Specifically, AGA recommends that Congress 
urge NIH to issue research grants in the following areas:
  --Intestinal diseases caused by combinations of luminal (including 
        nutritional and bacterial), environmental, and genetic factors 
        with an emphasis on inflammatory bowel diseases and GI cancers;
  --Modulation and understanding of epithelial injury and repair to 
        include: understanding of epithelial cell cycle regulation in 
        the GI tract; the effect of aging; and studies of epithelial 
        stem cells and their use for developing new approaches to 
        organogenesis;
  --Cellular and molecular regulation of intestinal nutrient and 
        electrolyte transporters--to include effects of nutritional 
        factors, genetic abnormalities, aging, and disruption of 
        transport function to understand physiology and pathobiology; 
        and
  --Development of physiologic tests to characterize the phenotypic 
        subgroups of functional gastrointestinal disorders, including 
        non-ulcer (functional) dyspepsia, functional constipation and 
        irritable bowel syndrome (motility).
    The following discussion supports the need for research in the 
aforementioned areas.
Inflammatory Bowel Disease (Ulcerative Colitis and Crohn's Disease)
    It is estimated that one million Americans have inflammatory bowel 
disease (``IBD'').--The two forms of IBD are Crohn's Disease and 
Ulcerative Colitis. Crohn's Disease usually causes intermittent 
inflammation deep within the intestinal wall of the small intestine 
whereas Ulcerative Colitis causes continuous inflammation and sores in 
the top layers of the lining of the large intestine. Although older and 
younger people may also develop this disease, IBD usually begins 
between the ages of 15 and 40 and persists throughout life with 
remissions. IBD affects people in the prime and most productive years 
of their lives and results in substantial morbidity and economic loss 
to them and society. It is especially brutal in children who may suffer 
developmental delays or stunted growth. People with IBD experience 
abdominal pain, fever, bowel sores, intestinal bleeding, anorexia, 
weight loss, fullness, diarrhea, constipation, and vomiting. In severe 
cases, IBD can cause death. In addition to potentially disabling 
gastrointestinal problems, people with this disease may also suffer 
from arthritis, skin problems, inflammation of the eyes or mouth, 
kidney stones, gallstones, or other diseases of the liver and biliary 
system. Further, approximately five percent of people with ulcerative 
colitis will develop colon cancer with the risk increasing based on the 
duration and extent of involvement of the colon.
    Studies on the cause of IBD are desperately needed in order to have 
a better understanding of the disease and work towards more effective 
management and treatment. Specifically, AGA recommends that NIDDK 
support genomic research aimed at identifying abnormal genes in persons 
with IBD and finding the causes of IBD.
Motility Disorders
    It is estimated that up to thirty percent of all Americans may be 
affected at some time during their lives by motility disorders.--
Irritable bowel syndrome (``IBS''), the most common motility disorder, 
is especially troubling because a patient does not present with any 
pathognomonic symptoms or laboratory findings of the disease, making 
diagnosis and treatment extremely difficult. Instead, patients present 
with abdominal pain, bloating, gas, diarrhea, and constipation. It is 
believed to be caused by overly sensitive intestines that have muscle 
spasms.
    Further research is needed in this area due to the high prevalence 
and the lack of a basic understanding of IBS, a factor which has made 
drug manufacturers reluctant to fund research. If more federally funded 
research was focused on IBS, it would stimulate more private-public 
partnerships, and lead to advances in medical knowledge. As such, AGA 
urges Congress to direct the NIDDK to focus additional resources on IBS 
and to encourage the Office of Research on Women's Health to devote 
more of its attention to these areas of research in light of the high 
incidence of IBS among women. Specifically, AGA recommends that NIDDK 
support research into the development of physiologic tests to 
characterize the phenotypic subgroups of functional gastrointestinal 
disorders, including non-ulcer (functional) dyspepsia, functional 
constipation, and irritable bowel syndrome (motility).
Gastrointestinal Cancers
    Approximately 226,600 new cases of gastrointestinal cancers will be 
diagnosed this year.--Sadly, 129,800 Americans will die from these 
cancers. The most common cancers involve the colon/rectum, stomach/
esophagus, and pancreas.
  --Colorectal cancer is the second leading cause of cancer-related 
        deaths in the United States and ranks fourth as the most common 
        cancer.--Although risk factors, such as race (increased 
        prevalence and mortality for African Americans), influence the 
        development of this cancer, 70 percent to 80 percent of 
        colorectal cancer cases involve average-risk individuals. If 
        diagnosed early, this cancer is highly curable. However, many 
        people with colorectal cancer are asymptomatic until the later 
        stages of the disease and wait to seek professional advise 
        until this time. As such, research and early detection through 
        screening remains the key to preventing, treating, and curing 
        this disease. We applaud Congress for its major step forward in 
        preventing and curing this disease by providing Medicare 
        coverage for screening and declaring March ``National 
        Colorectal Cancer Awareness Month''. We encourage Congress to 
        continue this work and require coverage for screening for all 
        Americans. Further, we urge Congress to support additional 
        research on colorectal cancer. Finally, we commend NCI for its 
        work on the Progress Review Group (``PRG'') for colorectal 
        cancer.
  --Pancreatic cancer will be diagnosed in 28,300 Americans in 2000 
        with 28,200 people projected to die from this disease.--It is a 
        highly lethal form of cancer with the lowest survival rate 
        among all major malignancies. Like other digestive cancers, 
        this cancer is frequently asymptomatic. African Americans have 
        a 50 percent higher incidence and mortality rate than 
        Caucasians. Further, age may increase the risk for this disease 
        because the average age at diagnosis is 70 and it rarely occurs 
        before 40. Diabetes mellitus has also been linked to the 
        development of this cancer. We appreciate NCI's recognition of 
        this growing problem and the need for research in this area 
        through its establishment of pancreatic cancer PRG.
  --Of increased concern to AGA are esophageal and stomach cancers. 
        Lower esophageal and upper stomach cancers are the second most 
        common gastrointestinal cancers.--It is projected that 33,800 
        Americans will be diagnosed and 25,100 will die in 2000 from 
        these cancers. These cancers also often remain undetected 
        because they are asymptomatic or present with vague symptoms. 
        In fact, only 10 percent to 20 percent of patients with stomach 
        cancer are diagnosed at an early stage. Both are more common in 
        African Americans with stomach cancer also occurring more 
        frequently in Hispanics and Asian Americans. Of heightened 
        concern to AGA is Barrett's esophagus, a precursor to 
        esophageal cancer, and the relationship between Barrett's and 
        chronic gastroesophageal reflux disease (``GERD''). Five to ten 
        percent of people with Barrett's esophagus develop cancer of 
        the esophagus. We urge Congress to direct the NCI to fund a 
        Progress Review Group (``PRG'') on esophageal and stomach 
        cancers to further study these deadly diseases. AGA encourages 
        the NIDDK to support research into the modulation and 
        understanding of epithelial injury and repair to include the 
        understanding of epithelial cell cycle regulation in the 
        gastrointestinal tract and studies of epithelial stem cells and 
        their use for developing new approaches to organogenesis and 
        transplantation.
Foodborne Illness
    Foodborne illness is estimated to cost annually $5 to $6 billion 
dollars in direct medical costs and productivity losses.--Most 
foodborne illnesses attack the gut causing gastrointestinal problems 
which may lead to dehydration and shock, and if not treated, death from 
vascular collapse and renal failure. Those populations at-risk for 
severe repercussions from foodborne illness include those with 
decreased immune systems, pregnant women and fetuses, young children, 
elderly, and those with inadequate access to health care. We appreciate 
NIDDK's efforts to further our understanding of this illness through 
its RFA on foodborne illness research which was co-sponsored by AGA 
through the American Digestive Health Foundation (``ADHF'') and the 
National Cattlemen's Beef Association. AGA recommends that Congress 
encourage the NIH, including NIDDK and NIAID, and others conducting 
foodborne illness research like the United States Department of 
Agriculture and the CDC to concentrate more intensively on research 
into treatments for foodborne illness. AGA urges NIDDK and NIAID to 
support research on (1) intestinal diseases caused by combination of 
luminal (including bacterial), environmental, and genetic factors with 
an emphasis on inflammatory bowel diseases, and (2) the reaction of the 
gut to foodborne pathogens, including research on the pathogenesis of 
the disease, the reasons for antibiotic resistance, the reaction of the 
gut to infections, the development of animal models to test therapies, 
and the invention of vaccines or substances that bind with the toxins 
to prevent the illness.
Training of Physician-Scientists
    While research has expanded our medical knowledge and enabled 
providers to better prevent diseases, diagnose disorders, and treat 
people, there is growing concern that the number of physician-
scientists (e.g., investigators who have medical degrees) is declining 
and that this decline will negatively impact many key future research 
endeavors. A recent study documenting this decline points to the 
tremendous debt incurred by medical school graduates who have more 
lucrative options outside of research as a primary cause. See Tamara R. 
Zemlo et al., The Physician-Scientist: Career Issues and Challenges at 
the Year 2000, 14 The FASEB Journal 221-230 (2000). Also influencing 
this trend is a decline in mentorship due to a decrease in the number 
of physician-scientist faculty in basic science departments and the 
increased clinical responsibility currently assumed by such faculty 
members. AGA views this problem as an immediate and serious threat to 
the future of biomedical research generally, and gastrointestinal 
research in particular. As such, AGA urges Congress to take the 
following steps:
  --Increase pre- and post-doctoral research training stipends;
  --Raise the salary cap for individual grant recipients to the maximum 
        amount allowable under the Senior Biomedical Research Service; 
        and
  --Enact the ``Clinical Research Enhancement Act of 1999'' (H.R. 1798, 
        S. 1813).
                                 ______
                                 

  Prepared Statement of the National Depressive and Manic-Depressive 
                              Association

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

 Prepared Statement of the American Association of Colleges of Nursing

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

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

                                 ______
                                 

                Prepared Statement of The Humane Society

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

          Prepared Statement of the National Sleep Foundation

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

  Prepared Statement of the National Center for Learning Disabilities

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

        Prepared Statement of the Council for Chemical Research

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

            Prepared Statement of the Joslin Diabetes Center

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

   Prepared Statement of the Lovelace Respiratory Research Institute

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

    Prepared Statement of the American Society of Clinical Oncology

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

      Prepared Statement of the National Prostate Cancer Coalition

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

          Prepared Statement of the Cancer Leadership Council

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

         Prepared Statement of the Lymphoma Research Foundation

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

    Prepared Statement of the National Nutritional Foods Association

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

            Prepared Statement of the NYU School of Medicine

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

      Prepared Statement of the Texas Neurofibromatosis Foundation

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

Prepared Statement of the Wake Forest University Baptist Medical Center

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

               Prepared Statement of the FDA-NIH Council

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

Prepared Statement of the National Alliance for Eye and Vision Research

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

  Prepared Statement of the American Society of Tropical Medicine and 
                                Hygiene

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

            Prepared Statement of the Society of Toxicology

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

         Prepared Statement of Former Congressman Louis Stokes

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

          Prepared Statement of the Kennedy Krieger Institute

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

  Prepared Statement of the Society for Animal Protective Legislation

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

      Prepared Statement of the Facioscapulohumeral Society, Inc.

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

       Prepared Statement of the Scleroderma Research Foundation

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

     Prepared Statement of the Association of American Universities

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

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

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

          Prepared Statement of the Parkinson's Action Network

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

         Prepared Statement of the Cure For Lymphoma Foundation

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

               Prepared Statement of Mended Hearts, Inc.

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

                    Prepared Statement of Erin Bosch

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

                        DEPARTMENT OF EDUCATION

               Prepared Statement of the CORE Foundation

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

      Prepared Statement of the Pinon Community School Board, Inc.

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

            Prepared Statement of Elmira College, Elmira, NY

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

  Prepared Statement of the Northwest Regional Educational Laboratory

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

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

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

          Prepared Statement of the United Negro College Fund

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

             Prepared Statement of Florida State University

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

             Prepared Statement of the University of Tulsa

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

           Prepared Statement of Fight Crime: Invest in Kids

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

     Prepared Statement of the National Military Family Association

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

 Prepared Statement of the National Indian Impacted Schools Association

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

       Prepared Statement of the United Stribes Technical College

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

                   RELATED AGENCIES/GENERAL TESTIMONY

Prepared Statement of the National Federation of Community Broadcasters

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

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

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

 Prepared Statement of the National Association of Foster Grandparent 
                                Program

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

                        [In millions of dollars]

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

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


      Prepared Statement of the American Museum of Natural History

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

       Prepared Statement of the Colonial Williamsburg Foundation

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

    Prepared Statement of the National Minority Public Broadcasting 
                               Consortia

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

    Prepared Statement of the National Congress of American Indians

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

    Prepared Statement of the National Alliance to End Homelessness

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


       LIST OF WITNESSES, COMMUNICATIONS, AND PREPARED STATEMENTS

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


                             SUBJECT INDEX

                              ----------                              

                        DEPARTMENT OF EDUCATION

                        Office of the Secretary

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

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                     National Institutes of Health

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

                          DEPARTMENT OF LABOR

                        Office of the Secretary

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

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