[Senate Hearing 109-]
[From the U.S. Government Publishing Office]



 
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED 
              AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2007

                              ----------                              


                          FRIDAY, MAY 19, 2006

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met, at 8:31 a.m., in room SD-192, Dirksen 
Senate Office Building, Hon. Arlen Specter (chairman) 
presiding.
    Present: Senators Specter, Shelby, and Harkin.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                     National Institutes of Health

STATEMENT OF ELIAS A. ZERHOUNI, M.D., DIRECTOR
ACCOMPANIED BY:
        JOHN E. NIEDERHUBER, M.D., ACTING DIRECTOR, NATIONAL CANCER 
            INSTITUTE
        FRANCIS S. COLLINS, M.D., DIRECTOR, NATIONAL HUMAN GENOME 
            RESEARCH INSTITUTE
        ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE OF ALLERGY 
            AND INFECTIOUS DISEASES
        ELIZABETH G. NABEL, M.D., DIRECTOR, NATIONAL HEART, LUNG, AND 
            BLOOD INSTITUTE

               OPENING STATEMENT OF SENATOR ARLEN SPECTER

    Senator Specter. Good morning, ladies and gentlemen. The 
Appropriations Subcommittee on Labor, Health, Human Services, 
Education, and Related Agencies will proceed with this hearing 
on the National Institutes of Health, and the funding for these 
institutes. We have a rather unusual hearing this morning 
because we have asked representatives of groups advocating 
research on the major illnesses--heart, cancer, Alzheimer's, 
Parkinson's--some 20 in total, to underscore the difficulties 
facing medical research in the United States today.
    As it is well known, this subcommittee, Senator Harkin and 
I, have taken the lead on NIH funding, which has grown from $12 
billion to $29 billion over the past 10 years. Now we have seen 
the increases which we had structured by, candidly, robbing 
Peter to pay Paul. We have a very complex budget on this 
subcommittee which has to fund not only health but education, 
labor, worker safety, Head Start, the bulk of the social 
programs.
    Those programs have been cut in the last 2 fiscal years, 
taking into account actual cuts and inflation, cut by some 
$15.7 billion. The NIH, which I frequently say is the crown 
jewel of the Federal Government, if not the only jewel of the 
Federal Government, has been cut 10.4 percent in the last 2 
years. We find that in fiscal year 2006 there was an actual cut 
of almost $66 million.
    The funding for fiscal year 2007 is level by the 
administration. That means with the inflationary increase there 
is a decrease in the actual dollars which are available. That 
is just unacceptable in a country with an $11 trillion gross 
national product and a Federal budget of $2.8 trillion.
    The advances that have been made by medical science are 
really remarkable, but it takes funding to accomplish that. 
Something personal to me is the lack of adequate funding for 
the National Cancer Institute. In 1970 President Nixon declared 
war on cancer and if that war had been pursued with the same 
intensity as our other wars cancer would have been cured long 
ago.
    My chief of staff, Carey Lackman, a beautiful young woman 
of 48, died of cancer, breast cancer, recently. My son's 
partner's wife, a beautiful young woman, died of breast cancer. 
One of my best friends, Judge Edward Becker, one of the most 
distinguished jurists in America, is suffering great anguish 
and great pain as we speak from prostate cancer. I had a bout 
with Hodgkin's last year myself and if you see me dabbing my 
eyes that is one of the remnants of chemotherapy. Had the Nixon 
war on cancer been pursued, I think I would not have gotten 
Hodgkin's and Carey Lackman would not have died, Paula Klein 
would not have died, Ed Becker would not be in the dire straits 
he is today.
    It is just unconscionable that we are not doing more. That 
is tied to stem cell research. Again, Senator Harkin and I have 
taken the lead there with our legislation which would enable, 
authorize, take the bar away from the Federal Government 
supporting embryonic stem cell research. We had a meeting 
yesterday with Senator Frist, the Majority Leader. I believe we 
are going to have a vote very soon on our issue. It is doubtful 
that we have 67 to override a presidential veto and we are 
talking about organizing a march on The Mall. We would like to 
put 1 million people on The Mall in September, enough people on 
The Mall to be heard in the living quarters of the White House 
just a few blocks away, because the estimate of 110 million 
people being affected directly or indirectly by these ailments 
is enough to produce two-thirds to override a presidential veto 
if in fact the President carries out his statement that he will 
veto the bill.
    Well, we have a very long hearing today. We moved the 
hearing from 9:30 to 9:00 and then we moved it from 9:00 to 
8:30 because Senator Harkin has commitments in Iowa. I am a 
little more flexible. I only have to travel to Pennsylvania. 
But we have a hearing this afternoon in Philadelphia on campus 
safety. It is a very, very busy Congress and I think you have 
seen that from the activities on the confirmation of the 
Supreme Court justices and the immigration bill, the Patriot 
Act, and so many other things we are doing.
    But I do not believe there is any subject as important as 
this one. You keep hearing ``nothing more important.'' Well, we 
may be tied for first place. I do not think that it is true 
that there is no subject more important than this one. I do not 
think there is any subject as important as this one. This is 
number one. Without health there is nothing.
    Senator Harkin.

                    STATEMENT OF SENATOR TOM HARKIN

    Senator Harkin. Mr. Chairman, thank you very much for your 
very eloquent opening statement. I would ask that all my 
statement be made a part of the record. I will just comment on 
it here.
    First, let me thank you, Mr. Chairman, for your courageous 
leadership in this area of always fighting for the funding we 
need for NIH. You led the way on building the funding over 
those years. I was happy to backstop you and support you in 
that. It was a very courageous effort that you led on that.
    I thank you also for your courage in speaking out on the 
budget earlier this year and your continuing to speak out 
against the budget as it affects NIH.
    Let me also thank you for your own personal courage in 
battling Hodgkin's lymphoma last year and the example that you 
set in coming to work every day and holding the hearings in the 
Judiciary Committee and the Supreme Court nominees and taking 
it to the floor even while you were undergoing some pretty 
severe chemotherapy. So it was a great example, I think, of 
personal courage and we thank you for that.
    I would just remind everyone of what Senator Hatfield said. 
When Senator Hatfield left the Senate, he gave his final speech 
on the Senate floor. I will never forget. I was over there to 
listen to it. He said at the time, he said: It is not that the 
Russians are coming. He said: It is the viruses are coming, the 
viruses are coming. How prophetic, how prophetic.
    We did not work hard to double the funding of NIH to then 
have it plateau off for another 20 years. The idea was to get 
it back up where it had been in the 70s, where we had some 40-
some percent of our peer reviewed grants approved and funded. 
That had fallen down and now I think it is down to about--I do 
not have it in front of me. I think it is down to about 19 
percent right now, the lowest ever, the lowest ever.
    The problem--not only is it a problem this year in terms of 
the budget--yes, it is 19 percent right now. About one out of 
every five is accepted for funding. I think that is having a 
ripple effect on researchers, it is having an effect on young 
people who are thinking about research as a lifetime avocation.
    But the problem is also looking ahead. As bad as this 
year's budget is, next year's could be worse. According to OMB 
projections, the administration will cut NIH by $800 million in 
2008 and make more cuts in 2009 and fiscal year 2010.
    Something has got to be done about this. Again, Senator 
Specter, you have been tremendously courageous in speaking out 
and trying to get a better deal for us on the budget. But we 
need to hear from you at NIH, but we also need to hear from the 
groups that are coming later, to tell the human side and give 
the human face as to what is happening to so many people in our 
society.

                           PREPARED STATEMENT

    I have a friend of mine who at this very moment is in the 
final stages of ALS disease. It is one of the worst things you 
can imagine. Yet we dither around and we cannot get stem cell 
research going in this country?
    Well, again, Mr. Chairman, thank you. It has been an honor 
to work with you.
    [The statement follows:]

                Prepared Statement of Senator Tom Harkin

    Thank you, Mr. Chairman. You've led the way on NIH funding, and 
it's been a real honor working with you on this issue.
    Good morning, Dr. Zerhouni, and welcome. We're glad to have you 
back with us today.
    We need a strong NIH now more than ever, for so many reasons. 
First, our security as a Nation depends on it. We often think about 
security only in military terms. But in today's world, we need to be 
just as worried about the threats we face from a bioterrorism attack or 
pandemic flu. NIH research is critically important for protecting us in 
both of those areas.
    We also need NIH to help us through our health care crisis. 
Consider just one disease--Alzheimer's. It's been estimated that 
delaying the onset of Alzheimer's by just 5 years could save $50 
billion a year in medical costs. That would go a long way to solving 
our Medicare problems all by itself.
    We need NIH now, because we're on the cusp of so many exciting 
breakthroughs. Researchers are learning how to match drugs to 
individual patients, based on their genetic code. They're learning more 
about stem cell research. They're making discoveries about the 
interplay between our genes and the environment.
    What a shame, then, to get a budget like the one the President has 
sent us.
    His budget would level-fund NIH, one year after the first cut to 
this agency since 1970. Eighteen of the 19 institutes would get less 
funding than they did last year. The number of research project grants 
would drop by about 640. And the success rate for grant applications 
would remain at a record low of just 19 percent.
    We're at a point now where only 1 out of every 5 grant applications 
is accepted for funding. I'm sure there are a lot of young researchers 
out there who are wondering, ``Why bother applying to NIH? Why bother 
going into research at all?''
    Senator Specter and I didn't work so hard to double NIH funding 
just so we could watch the President cut it to the bone from then on 
out. But that seems to be the President's plan. As bad as this year's 
budget is, next year's will probably be even worse. According to OMB 
projections, the Administration will cut NIH by $800 million in fiscal 
year 2008, and make more cuts in fiscal year 2009 and fiscal year 2010.
    We're going to hear firsthand what the President's budget will mean 
for many diseases from our second group of speakers. I want to thank 
the representatives of the 20 advocacy groups that are with us today 
for taking the time to be here.
    Mr. Chairman, I look forward to the testimony.

    Senator Specter. Thank you very much, Senator Harkin. Thank 
you for your leadership on these issues and the partnership 
which I think has been very productive for our country.
    Senator Shelby.

                 STATEMENT OF SENATOR RICHARD C. SHELBY

    Senator Shelby. Thank you, Mr. Chairman. Mr. Chairman, I 
ask that my written statement be made part of the record and I 
will be brief.
    This is a very important hearing and I am here this morning 
to help you. I think the President, George W. Bush, is going to 
have to speak out on this issue, that is properly funding NIH 
medical research. We are falling behind and we cannot, because 
we have led the world. We continue to lead the world, although 
we are struggling as far as finances are concerned.
    Mr. Chairman, you and Senator Harkin, who are the leaders 
of this committee, I can tell you I am going to do everything I 
can. We are challenged in the research everywhere in 
biomedical, but in autoimmune areas there is a lot of hope 
there. I am particularly interested in the lupus area. We are 
challenged there. I am going to do everything I can as a member 
of the Appropriations Committee to help fund, properly fund, 
medical research through NIH. You have made a difference and 
you will make a tremendous difference in the future.

                           PREPARED STATEMENT

    But, as Senators Specter and Harkin both know, it is not 
going to be easy, but we cannot go backward. We cannot cede 
this to anybody else in the world. We are the leaders. We have 
got to stay there.
    Thank you, Mr. Chairman.
    [The statement follows:]

            Prepared Statement of Senator Richard C. Shelby

    Mr. Chairman, thank you for holding this important hearing today. I 
want to thank all of you for taking the time to be here today. It is 
vitally important for me to hear directly from you on what your 
agency's needs are, and the challenges you might face in the coming 
months. We as a Nation are facing a integral moment in funding critical 
research. Finding viable treatments and possible cures for many of our 
common afflictions is our most important goal, but I think early 
detection of disease is fundamentally important to containing costs in 
the long-term.
    As we begin to move forward in the appropriations process it is of 
the utmost importance that we ensure adequate funding for these 
indispensable research institutions. Millions of Americans rely on the 
life saving work they perform and it is imperative that we as 
appropriators fully support them.
    Federal funding for medical research is critical and while we have 
worked diligently to increase funding, more is left to do.
    I am hopeful that this hearing today will provide a forum to 
discuss the issues that must be addressed by researchers.
    Thank you for your time and I look forward to your testimony.

    Senator Specter. Thank you very much, Senator Shelby.
    We now welcome Dr. Elias Zerhouni, the Director of the 
National Institutes of Health. He had an illustrious career 
before coming to be the 15 Director of NIH. He had been 
executive vice dean at Johns Hopkins University School of 
Medicine, chair of the Department of Radiology and Radiological 
Science. He received his medical degree from the University of 
Algiers School of Medicine and completed his residency in 
diagnostic radiology at Johns Hopkins.
    Thank you for your leadership in this very vital area, Dr. 
Zerhouni, and we look forward to your testimony.

               SUMMARY STATEMENT OF DR. ELIAS A. ZERHOUNI

    Dr. Zerhouni. Thank you, Mr. Chairman. Thank you, Senator 
Harkin, Senator Shelby. I submitted a written testimony. What I 
would like to do really is just summarize the salient points of 
the testimony, to allow as much time as possible for questions.
    Senator Specter. Thank you, Dr. Zerhouni.
    Dr. Zerhouni. What I would like to do is really direct your 
attention to the screens.

                  RETURN ON INVESTMENT ON NIH FUNDING

    What I would like to address are the fundamental questions 
that I think all of us would like to have an answer to, to be 
able to set policy for the future. First and foremost, what is 
the return on the American people's investment at the National 
Institutes of Health? Second, what has this NIH budget doubling 
delivered for the American people? Third, what is our future 
strategy? Where is NIH heading? When you talk about medical 
research it is important to understand that it is not a 100-
meter dash, it is a marathon, and we have to sustain the effort 
over time.
    First, let me just remind everyone that biomedical research 
has delivered enormous returns to the American people. I am 
just going to give two examples here. Many more are in the 
testimony. In coronary heart disease, if you look at the 
progress over the past 30 years, there has been a 63 percent 
decrease in mortality. Over a million early deaths are averted 
every year because of the research of the past 30 years. 
Economists tell us that this is worth $2.6 trillion in economic 
return because a cohort of individuals who would have died in 
their 50s now do not and then can produce economic return. We 
have enormously exciting, effective strategies for not only 
curing, but preventing and ultimately eliminating coronary 
heart disease.
    Now, you may ask yourself, what was the investment that the 
American people, that each one of us made to achieve that? 
Well, over the past 30 years each one of us has spent about 
$3.70 per year for medical research related to coronary heart 
disease. If you look at the total cumulative total over 30 
years for heart research, it is $110 per person. I submit to 
you that medical research has delivered, for an investment that 
I think is extremely effective in its return.
    Cancer is another example. If you look at cancer--and you 
mentioned the war on cancer, Senator--for the first time in 
recorded history, this year we have a lower number of deaths 
from cancer in the United States, despite an increasing 
population and an increasing average age of the population. We 
have 10 million survivors. This is due to the advent of early 
screening, early detection, new therapies.
    What has this cost us? $8.60 per person per year over the 
past 30 years. The total investment for each one of us is $260 
over 30 years. I do not think there is an investment that I can 
describe that any agency can be as proud of as the National 
Institutes of Health is of its effectiveness. We have delivered 
not only better cures, but also a healthier life for Americans, 
who live now longer and healthier lives, with a disability rate 
that has dropped by 30 percent over the past 22 years because 
of improvements in bone health, in heart health, and many other 
advances.
    Since 1982 the disability rates have dropped by 30 percent 
and in the past 30 years American life expectancy has increased 
by over 6 years, from a total investment cumulative over 30 
years, of about $1,300 per American.
    This is not just what we have done in the past. We continue 
to deliver. If you look at just the advances of the past year--
I am just going to take a few examples. If you look at the 
impact of the human genome and genomics, we identified over 20 
genes just in the past 12 months that relate to prostate cancer 
and the causes of prostate cancer, in mental health about 
obsessive compulsive disorder, and one of the most exciting 
ones is in vision disease, where we have found genes that may 
explain over 70 percent of cases of what we call age-related 
macular degeneration, the fastest rising cause of blindness in 
American seniors.
    Vaccines: We have the first global candidate vaccine on 
HIV/AIDS, that Dr. Fauci and his team developed. Yesterday the 
FDA approved the first preemptive cancer vaccine against 
cervical cancer. We have expanded the Avian Flu trials. We have 
one vaccine in trial and a second one in development. This 
would not have been possible without the support of Congress 
and your support here on this committee.
    But we realize that biomedical research must continue to 
deliver and we have a challenge in front of us. We all know 
that the rising cost of health care and the burden of disease 
is going to be a challenge for all of us. We see the curve. We 
see that it is not sustainable. Society spends about $7,100 per 
American per year on health care costs. The total NIH spending, 
$95 per American per year, has to do something, must do 
something, to change that picture.
    This is the vision of NIH. Our vision, all of us as 
scientists at NIH, is to use our investment and deliver a 
complete transformation of medicine, because if we keep 
practicing medicine the way we know it today, 25 years from now 
it just will not be sustainable. So discoveries and new ways of 
not only curing disease, but preventing disease, preempting 
disease altogether, is the key.
    We will do this through what we call the four P's of 
medicine. It will be more predictive because of our 
understanding of molecular events. It will be more personalized 
because we know that every one of us reacts differently to 
different diseases. It will have to be increasingly preemptive 
because this is where it is the least costly. But we cannot do 
this without the participation of everyone, and this is why we 
say the fourth P is, in the context of chronic diseases like 
diabetes or obesity, it will require us to include the patients 
as partners in this new medicine.

                          PREPARED STATEMENTS

    So my message is very simple. We have delivered, we 
continue to deliver, and we will deliver, and the return on 
investment is in my view one of the most remarkable returns 
that anyone can describe, and we will continue to do so. I am 
happy to take any questions.
    [The statements follow:]

              Prepared Statement of Dr. Elias A. Zerhouni

    Mr. Chairman and distinguished members of the subcommittee, it is 
an honor and a privilege to appear before you today to present the 
National Institutes of Health (NIH) budget request for fiscal year 2007 
and discuss the priorities of NIH for this year and beyond.

                             BUDGET REQUEST

    The request for NIH is $28.4 billion in fiscal year 2007, the same 
as the fiscal year 2006 level for the Agency. The budget request will 
support the research programs managed by NIH's Institutes and Centers. 
At this budget level, NIH will increase the biodefense research program 
by $110 million for Advanced Development. Support for the Pandemic 
Influenza Preparedness Plan will increase by $17 million. We have also 
chosen to carefully invest in several trans-NIH strategic initiatives. 
The NIH Roadmap, an incubator for new ideas and initiatives that will 
accelerate the pace of discovery, increases by $113 million. We 
allocated $40 million to the Institutes and Centers to launch the 
Genes, Environment and Health Initiative to accelerate discovery of the 
major genetic and environmental factors for diseases that have a 
substantial public health impact. We have also directed $15 million to 
the new ``Pathway to Independence'' program to increase our support of 
new investigators.
    I will focus my testimony on the return of the investment in NIH 
for the American people. In particular, I will discuss how discoveries 
fueled by this investment are transforming the practice of medicine. We 
can now clearly envision an era when the treatment paradigm of medicine 
will increasingly become more predictive, personalized and preemptive. 
We will strike disease before it strikes us with the hope of greatly 
reducing overall costs to society. We expect to move away from the 
costly and predominantly curative model of today, which requires us to 
wait for the disease to occur before intervening. I will share with you 
the strategic vision of NIH and discuss the many management innovations 
we have implemented to ensure optimal stewardship of taxpayers' 
resources.

       SELECTED ACCOMPLISHMENTS OF NIH AND THEIR IMPACT ON HEALTH

    The achievements of NIH and our private sector partners in medical 
research are difficult to overstate. According to the latest report on 
the Nation's health from the Centers for Disease Control and Prevention 
(CDC), life expectancy continues to rise, now at an unprecedented 78 
years for the total U.S. population. Since 1950, the age-adjusted death 
rate for the total population declined by a remarkable 43 percent. Life 
expectancy has increased by one year in every five for the past 30 
years. Americans are not only living longer, they are healthier. For 
instance, the disability rate of American seniors dropped by almost 30 
percent in the past 20 years, owing to a range of scientific advances.
    The following are samples of the many advances driven by the 
investment in NIH.

             ADVANCES IN CARDIOVASCULAR DISEASE AND STROKE

    Thirty years ago, it was common for a man or woman to suddenly die 
of a heart attack or stroke between the ages of 50 and 60. Had this 
trend continued unabated, today more than 1.6 million lives would have 
been lost per year. Fortunately, today the toll is much less. The death 
rates from cardiovascular disease have declined by 63 percent and by 70 
percent for stroke. Were it not for the ground-breaking research on the 
causes and treatment of heart disease, supported in large part by NIH, 
including recent developments such as drug coated stents, safe levels 
of blood pressure and cholesterol lowering therapies, heart attacks 
would still account for 1.2 to 1.3 million deaths per year instead of 
the actual 515,000 deaths experienced today. The estimated total 
cumulative investment in cardiovascular research at the NIH per 
American over the past 30 years, including the doubling period, is 
about $110, or about $4 for each American per year over the entire 
period.

                           ADVANCES IN CANCER

    The mortality rates of cancer, the second leading cause of death in 
the United States, have been falling for several years, and this year, 
for the first time in history, the absolute number of cancer deaths in 
the United States has decreased. More effective therapies have led to 
improved outcomes for more than 10 million American cancer survivors. 
With the increase in budgets between 1999 and 2003, the National Cancer 
Institute has stimulated a paradigm shift in cancer therapy. We are 
seeing the emergence of targeted therapies, with the unprecedented 
ability to use specific molecular targeting to treat tumors with novel 
agents. We can also detect and treat cancer at earlier stages. The 
National Cancer Institute's (NCI) Early Detection Research Network 
(EDRN), launched in 1999, has identified a number of biomarkers that 
allow for the earlier detection of breast, prostate, colon, lung and 
other cancers. This year, NCI, in collaboration with the Human Genome 
Research Institute, has launched a cancer genome pilot project to help 
further our understanding of the basic biology of cancer and identify 
additional treatment targets. The estimated total cumulative investment 
at the NCI per American over the past 30 years, including the doubling 
period, is about $258, or about $9 per American per year over the 
entire period.

                          ADVANCES IN HIV/AIDS

    Without the development and testing of antiretroviral drugs, there 
would be no hope for patients with HIV/AIDS. The development of Highly 
Active Antiretroviral Therapies primarily resulted from the work of a 
large cadre of NIH-supported scientists and their counterparts in the 
pharmaceutical industry. Their discoveries about the cellular 
mechanisms of the disease have transformed AIDS into a manageable 
disease, preventing hundreds of thousands of hospitalizations and early 
deaths. To date, 21 antiretroviral drugs and 4 combination formulations 
have been approved by the FDA. Many more less toxic AIDS drugs are 
currently in development. Today, fewer than 50 HIV-infected babies are 
born each year in the United States, sparing 16,000 to 20,000 children 
from AIDS through the use of antiretroviral drugs to prevent mother-to-
child transmission. Mother-to-child transmission rates in developing 
countries have declined by 40 percent with the use of drug therapy. 
With the introduction of these new drugs, economists estimate the 
aggregate potential value of improved survival has been nearly $400 
billion for those infected through 2000. They estimate the aggregate 
potential value for all past and future cohorts of individuals infected 
with HIV is almost $1.4 trillion.
    With the additional resources provided during the doubling of the 
NIH budget, we launched the Vaccine Production Program (VPP) Laboratory 
to efficiently translate candidate research vaccines, including HIV 
vaccines, into useable products. Since its inception in 2001, this 
program has overseen the manufacture of over 29 bulk pharmaceutical 
compounds formulated into 14 different vaccine products for HIV, as 
well as West Nile, SARS and Ebola Virus, and expanded our network of 
clinical trial sites across the globe. This program is enabling NIH to 
serve the needs of the American people in an age of global risks of 
infectious diseases.

           ADVANCES AGAINST THE THREAT OF PANDEMIC INFLUENZA

    Thanks to fundamental advances in viral genomics and genetic 
engineering, NIH has been able to help in the development of 
countermeasures against both seasonal and pandemic influenza viruses. 
We now have a vaccine against the H5N1 virus and will develop a second 
one in conjunction with CDC. Without such a vaccine, and others under 
development and testing, we would be completely defenseless against the 
potential pandemic that threatens the entire world. We are investing in 
research and development to hasten the production process by converting 
from egg-based to cell culture-based vaccines. We are developing novel 
vaccine approaches using a variety of molecular biological techniques, 
and we launched discovery efforts for new anti-viral compounds against 
pandemic flu. We initiated a project to identify the genomes of 
thousands of human and avian influenza viruses, and, to date, 831 
influenza genome sequences from human isolates have been deposited in 
NIH's GenBank, allowing researchers across the world to better 
understand influenza viruses and develop countermeasures.

                   DEVELOPMENT OF BIODEFENSE RESEARCH

    Since 2001, NIH has directed more than $10 billion toward 
protecting the American public from bioterrorism. The 2001 intentional 
release of anthrax underscored the reality of a bioterrorism threat 
posed by other Category A agents such as smallpox, plague, tularemia, 
hemorrhagic fevers, and botulinum toxin. NIH responded swiftly. 
Promising vaccine candidates for Ebola and smallpox are currently in 
clinical trials. Identification of the three-dimensional structure of 
the anthrax toxin complex is fueling the search for compounds that 
block the toxin's effects, and the discovery of the key mechanism of 
Ebola virus cell entry prompted experiments demonstrating that Ebola 
infection could be blocked in laboratory tests. We continue to build a 
national biodefense research infrastructure that will position the 
Nation to respond even more quickly and precisely to bioterrorism.

               ADVANCES IN DIABETES AND RELATED ILLNESSES

    Nearly 21 million Americans have diabetes, a disease that can cause 
damage to multiple organs and lead to death. Without NIH research, the 
improvements of the past two decades in the therapies for diabetes 
would not have occurred. Through large prospective trials, made 
possible by the doubling of our budget, we have assessed the relative 
value of drug based approaches versus weight loss and physical 
activity, and showed it is possible to reduce the risk of type 2 
diabetes by 58 percent with lifestyle modifications alone.
    Diabetes can also result in vision loss. Four million American 
adults suffer from diabetic retinopathy, the outcome of damage to the 
tiny blood vessels in the light-sensitive retina lining the inside of 
the eye. Nearly a million have the advanced vision-threatening stage of 
the disease. The National Eye Institute completed a series of landmark 
clinical trials to develop novel treatments for diabetic retinopathy. 
Without these new treatments, 450,000 patients who have advanced 
disease today would otherwise likely be blind in 5 years. As a 
consequence, of those currently at risk, only 27,000 would progress to 
legal blindness, and only 9,000 would become blind today. In addition 
to reduced suffering and disability, the economic savings from these 
treatments will reach as much as $1.6 billion per year.
    As another example of payoff from recent NIH research, end-stage 
renal disease (ESRD)--kidney failure requiring dialysis or 
transplantation, a complication of diabetes and high blood pressure--
results in direct federal expenditures of approximately $20 billion per 
year. Through the 1980s and 1990s, the incidence of ESRD nearly doubled 
each decade, but in the last five years overall rates have stabilized--
and even declined in certain population groups. This improvement has 
been driven by monitoring for proteins in urine to prevent kidney 
disease or detect it in its early stages. Compared with earlier 
projections, the savings in federal health care expenditures are 
approximately $1 billion dollars per year.
    Without the investment in medical research, people with diabetes 
would be living shorter, less productive, and less hopeful lives.

                 ADVANCES IN IMAGE-GUIDED MICROSURGERY

    Increases in the NIH budget allowed new investments in the use of 
imaging technologies like CAT scanning, MRI or ultrasonography for the 
development of new microsurgical techniques. These minimally invasive 
therapies are changing the fate of many patients, including patients 
with Parkinson's disease, through deep brain stimulation. These new 
techniques are also promising to revolutionize the treatment of 
epilepsy, a disease that affects over 2.7 million Americans. As we move 
forward with such research, we expect that surgery will become less 
invasive, more precise and less dangerous, with far less operative 
complications.

      ADVANCES IN HEALTH INFORMATION FOR SCIENTISTS AND THE PUBLIC

    The National Library of Medicine of the NIH provides the American 
public with high quality, reliable information. The NIH web sites 
(www.nih.gov) are now recognized by independent organizations as the 
most successful health related web sites, with over 2 million queries 
per day. Millions of patients and their families regularly consult NIH 
web sites for up to date information in English and Spanish, a 
capability made entirely possible by the doubling of the NIH budget. 
The web-based ClinicalTrials.gov represents a landmark effort to 
provide information to patients and physicians across the country on 
NIH-funded clinical trials.
    NIH also leads the research field in developing information 
technology for biomedical research. No biomedical scientist develops a 
project without first consulting the suite of powerful informational 
research tools available through the NIH National Library of Medicine's 
PubMed, a growing digital archive of peer-reviewed research articles 
and scientific databases.

                           NEW RESEARCH TOOLS

    NIH researchers have pioneered powerful new research tools and 
methods such as high throughput DNA sequencing, protein identification 
with mass spectrometry, gene expression arrays, the determination of 
thousands of new protein structures, and imaging technologies which 
were simply unavailable before the doubling of the NIH budget. A great 
illustration of the impact of these advances has been the 
identification of the cause of the SARS virus in less than a month and 
the current tracking of pandemic flu viruses. These tools have greatly 
accelerated the research process itself, spurred progress and spawned 
new discoveries in all areas of biomedical research. Perhaps nowhere 
else have these technological advances in imaging and genotyping 
elicited more excitement than in the field of mental and behavioral 
health, elucidating genes linked to schizophrenia, depression, bipolar 
disorder and anxiety. These discoveries are allowing for the first time 
direct visualization of brain structure and function to study the brain 
circuitry involved in thinking and a range of behaviors.

              NEW DIAGNOSTIC AND THERAPEUTIC TECHNOLOGIES

    Some of NIH's successes can be measured in new medical 
technologies. Advances in research are driving an increase in the 
number of technologies being licensed to companies for 
commercialization. In fiscal year 2004, there were thousands of active 
licenses between federally funded research institutions and companies 
worldwide. Out of these technologies, several thousand companies are 
making many new products that have an immeasurable impact on public 
health. Today, from NIH funded research, more than 300 new drug 
products and vaccines targeting more than 200 diseases--including 
various cancers, Alzheimer's disease, heart disease, diabetes, multiple 
sclerosis, AIDS and arthritis--are in clinical trials. These outcomes 
are accomplished through the on-going network of successful 
collaborations with our colleagues in private industry.

                   THE CHANGING LANDSCAPE OF DISEASE

    Disease and injury are constant threats to humankind and are never 
static. New diseases can emerge at any time, such as HIV/AIDS, SARS, 
Pandemic Flu, obesity or many other conditions. Bioterrorism did not 
figure significantly in the NIH agenda in 2001, but is now a top 
priority of the agency. Twenty years ago the impact of Alzheimer's 
disease was not fully appreciated, nor were its causes known.
    As the result of our success in preventing and treating acute and 
short term conditions such as heart attacks, stroke, cancer and many 
infectious diseases, we are living longer. Our increasingly older 
population faces the new challenge of multiple chronic conditions which 
now consume about 75 percent of healthcare expenditures. This shifting 
burden of health care from acute to chronic diseases is perhaps the 
greatest challenge we face.
    Health care costs in the United States have risen to more than $2 
trillion. The amount spent on health care per person has doubled, from 
$3,461 in 1993 to $7,110 today. The causes of health care inflation are 
varied and complex, requiring different, nation-wide solutions.
    We are in a race against the overwhelming human and economic 
consequences of disease. We can win this race, but only if we use 
research discoveries to transform medicine as we know it. Thanks to 
recent research advances, we can foresee a future of more effective 
medical treatment that might be less expensive than current practices.

       STRATEGIC VISION FOR NIH: FROM CURATIVE TO PREEMPTIVE CARE

    We are in an era of great scientific opportunity. Advances in our 
understanding of basic human biology allowed NIH to sequence the human 
genome by 2003, two years ahead of schedule, and to complete the 
Haplotype Map, showing the variation between individual humans, in 
October 2005, also ahead of plans. One of the greatest scientific 
achievements in history, the genome blueprint, along with work in 
systems biology and proteomics, are driving a revolutionary period in 
the life sciences. We are on the brink of transforming medical 
treatment in the 21st Century. Our hope is to usher in an era where 
medicine will be predictive, personalized and preemptive.
    Toward this goal, NIH is strategically investing in research to 
further our understanding of the fundamental causes of diseases at 
their earliest molecular stages so that we can reliably predict how and 
when a disease will develop and in whom. Because we now know that 
individuals respond differently to environmental changes according to 
their genetic endowment and their own behavioral responses, we can 
envision the ability to precisely target treatment on a personalized 
basis. Ultimately, this individualized approach, completely different 
than how we treat patients today, will allow us to preempt disease 
before it occurs.
    Consider, for instance, how better predictive and personalized 
treatments could improve the safety and effectiveness of drugs. As we 
know, drugs do not fall into the ``one size fits all'' category. The 
same drug can help one patient and harm another. Recent research shows 
that we will be increasingly able to know which patients will benefit 
from treatment and which patients might be harmed. This field of study 
is known as pharmacogenetics. Using the latest genomic data, enabled by 
the doubling of the NIH budget, the NIH established a Pharmacogenetic 
Research Network which is studying the interactions of drugs and 
molecules as well as the biological processes that eliminate compounds 
from the body. In the first five years of this program, the researchers 
in this network made numerous discoveries.
    For example, they learned that 10 percent of the North American 
population exhibits a genetic variation that puts them at high risk for 
life-threatening reactions to irinotecan, a cancer drug. We now know 
that patients with this variation should be given lower than prescribed 
doses of this successful drug, thus potentially saving their lives.
    NIH researchers also discovered variations in a gene involved in 
the body's response to more than half of all medications. Understanding 
these differences could explain critical individual as well as racial 
and ethnic differences in drug responses. Other genetic variations 
discovered by the NIH network will have an impact on asthma treatment, 
the risk of sudden death from irregular heartbeats and the proper use 
of blood thinning medications to avoid deadly bleeding complications.
    In another example of emerging personalized medicine, cancer 
researchers have developed a test that helps determine the risk of 
recurrence for women who were treated for early stage, estrogen-
dependent breast cancer. This information can help a woman and her 
doctor decide whether she should receive chemotherapy in addition to 
standard hormonal therapy. This test has the potential to change 
medical practice by sparing tens of thousands of women each year the 
unnecessary and harmful side effects associated with chemotherapy at 
large potential cost savings.

                   RAPID ADVANCES IN THE GENOMIC ERA

    Because of a hundred fold reduction in the cost of genomic 
technology, we can now study, at affordable costs, the differences 
between patients who have a disease and their normal counterparts. 
Recently, this revolutionary approach led to the discovery of two 
previously unsuspected factors that can identify who is at risk and how 
to protect patients from age-related macular degeneration, an 
increasing cause of blindness in our aging population, with over 7 
million Americans at risk. Last month, a key transcription factor that 
may be responsible for a large percentage of cases of diabetes was 
discovered.
    These breakthroughs form the basis of our budget request for the 
Genes and Environment Initiative, supported by Secretary of Health and 
Human Services Michael Leavitt, because it will give us the 
unprecedented ability to discover, over the next three years, the 
potential causes of the 10 most common diseases afflicting the U.S. 
population. With this funding, if approved, we will also launch a 
technology development effort for enabling scientists to measure many 
types of environmental exposures at the individual level. Taken 
together, these efforts will lead to better understanding of the 
environmental and genetic factors in the development of many diseases.
    Imagine a world where we will be able to tell each patient whether 
they need to take action to preempt altogether the development of 
costly and painful diseases. Imagine telling them that they do not need 
to take expensive medications for life because they are not at risk of 
disease. A more predictive, personalized and preemptive form of 
medicine is no longer just a dream, but a vision to strive for as 
rapidly as we can.

                         MANAGEMENT INNOVATIONS

    NIH has an enormous and growing scope of mission. We conduct or 
support research on over 6,600 diseases and conditions, from the most 
common to the rarest. In 2005, more than 43,000 research grant 
applications went through our rigorous two-tiered review process, with 
about 22 percent of applications ultimately receiving funding.
    More than 80 percent of the NIH budget supports extramural research 
at 3,100 institutions around the world, employing about 200,000 
scientists and other research personnel. Another 10 percent of the 
budget goes into the NIH intramural program, consisting of 
approximately 6,000 scientists, where work is focused on public health 
priorities and cutting edge research. The hub of the intramural 
program, the NIH Clinical Center on the Bethesda campus, is the world's 
largest dedicated clinical research complex.
    NIH is spending $95 per American this year on medical research, and 
we need to make every dollar count. With the growth and increasing 
complexity of the agency, NIH has aggressively moved to transform its 
management strategies and decision-making processes. To streamline, 
harmonize and better coordinate decisions that affect the entire 
agency, in 2003, I established the NIH Steering Committee, composed of 
nine Institute Directors who serve on a rotating basis. Six working 
groups support the Steering Committee. This new governance structure 
has enabled greater coordination and harmonization between the 27 
Institutes and Centers at NIH.
    NIH has addressed the need for more robust means to oversee the 
vast NIH research portfolio, and plan and launch trans-NIH initiatives. 
While the NIH successfully developed important trans-NIH initiatives 
such as the Roadmap for Medical Research, the Strategic Plan for 
Obesity Research, and the Neuroscience Blueprint, the agency is now 
implementing even more rigorous and transparent processes and 
developing cutting-edge tools to analyze, assess and manage the array 
of research it supports. This will provide better information to 
support planning and priority-setting in areas of shared Institute and 
Center interests. To reinforce these accomplishments, NIH is 
establishing a new office within the Office of the Director--the Office 
of Portfolio Analysis and Strategic Initiatives (OPASI).
    Review of our programs by the Office of Management and Budget under 
the congressionally mandated Government Performance and Results Act 
(GPRA) provides evidence that our programs are effective. We have been 
rated in the top 15 percent of federal organizations.
    NIH's effective performance is reflected in recent scores as 
measured by the OMB Program Assessment Rating Tool (PART). In the 
fiscal year 2007 PART, the Buildings and Facilities Program and the 
Intramural Research Program both received the highest possible rating 
of effective, with scores of 96 percent and 90 percent, respectively. 
On the fiscal year 2006 PART, the NIH Extramural Research Program 
achieved a similarly high 89 percent. These high scores demonstrate 
exemplary management and substantial progress toward meeting NIH 
performance measures. To date, approximately 90 percent of NIH's budget 
has been PARTed and rated effective.

         TRANSLATING DISCOVERIES INTO BETTER MEDICAL TREATMENT

    Rapidly translating our discoveries from the bench to the bedside 
is a top priority of the NIH. The opportunities have never been greater 
to use modern research methodologies such as genomics, proteomics, 
metabolomics, high sensitivity biochemical methods and other novel 
strategies to bring new insights to the study of human populations and 
more rapidly achieve the goal of making medicine predictive, 
personalized and preemptive.
    To accelerate progress, NIH recently introduced the institutional 
Clinical and Translational Science Award (CTSA). The CTSA program will 
stimulate institutions across the country in transforming Clinical and 
Translational Science in the U.S.A. to (1) captivate, advance, and 
nurture a cadre of well-trained multi- and inter-disciplinary 
investigators and research teams; (2) create an incubator for 
innovative research tools and information technologies; (3) synergize 
multi- and inter-disciplinary clinical and translational research; and 
(4) accelerate the application of new knowledge and techniques to 
clinical practice at the front lines of patient care.

                TRAINING A NEW GENERATION OF SCIENTISTS

    New visions require new talent. In times of constrained budgets the 
most important action NIH needs to take is to preserve the ability of 
young scientists with fresh ideas to enter the competitive world of NIH 
funding. To that effect, NIH has launched the new ``Pathway to 
Independence'' program which will support, for each of the next five 
years, 150 to 200 recently trained scientists conducting independent, 
innovative research.

                               IN SUMMARY

    Our Nation's investment in biomedical research has dramatically 
improved health outcomes. The return on the investment of the American 
people at NIH is nothing short of spectacular. Thanks to the support of 
Congress, we are able, through our science, to respond in record time 
to emerging threats such as SARS, Pandemic Flu and biodefense needs. We 
have learned how to decrease the incidence of many diseases and other 
disabilities for old and young Americans. The estimated total 
cumulative investment at the NIH per American over the past 30 years 
including the doubling period is about $1,334 or about $44 per American 
per year over the entire period. In return, Americans have gained over 
six years of life expectancy and are aging healthier than ever before.
    The President and Congress have wisely invested in biomedical 
research. We are acutely aware that NIH research is often the only hope 
for millions of people afflicted by disease. In the battle for health, 
NIH also believes that it needs to accelerate the pace of progress, as 
it is only through a fundamental transformation of medicine that 
solutions to the rising burden of healthcare will be found.
    I will be happy to answer any questions you may have.

    
    
    
                                 ______
                                 
             Prepared Statement of Dr. John E. Niederhuber

    Mr. Chairman and Members of the Committee: I am please to present 
the fiscal year 2007 President's budget request for the National Cancer 
Institute (NCI). The fiscal year fiscal year 2007 budget includes 
$4,753,609,000, a decrease of $39,747,000 below the fiscal year 2006 
enacted level of $4,793,356,000 comparable for transfers proposed in 
the President's request.

                       OUR GOAL REMAINS THE SAME

    Four years ago, we put the NCI on a trajectory towards the 
Challenge Goal of eliminating suffering and death due to cancer as 
early as the year 2015. Since that time, we have vigorously and 
aggressively managed NCI's portfolio of investments in cancer research 
across that entire continuum of the process of cancer, whether we've 
been focusing on understanding genetic mutations that were responsible 
for susceptibility to cancer or focusing on issues that have to do with 
survivorship and living with, rather than dying from, cancer.
    NCI has been a major leader in the molecular metamorphosis of 
biomedical medicine that has benefited all fields of medical research. 
Without the Nation's support of NCI's pioneering role in funding 
research--including basic science, clinical trials, and translational 
investigations--into the molecular and genetic processes that underlie 
all disease and the training of new cancer researchers, it is unlikely 
that the advances we are seeing today in many health areas--from AIDS 
to macular degeneration--would have occurred at the pace they have. 
These leadership efforts must be sustained going forward.
    The Nation's past commitment to cancer research has proven its 
worth: mortality rates have declined for all cancers combined while 
incidence rates have stabilized or increased slightly, detection and 
treatments have improved, new therapeutic options offer startling 
promise. Today there are nearly 10 million cancer survivors in the 
United States compared to approximately 3 million cancer survivors in 
1971 when the National Cancer Act was established. Also, in 1971 fewer 
than half of those found to have cancer lived 5 years beyond their 
diagnosis; today the 5 year survival rate is 64 percent for adults and 
79 percent for children aged 14 or younger. The latter figure is truly 
remarkable given how few children survived even a couple of years after 
being diagnosed in the early 1970s. NCI's continued commitment is 
manifested today in far-reaching programs that have advanced our basic 
understanding of the genetic changes responsible for this dreaded 
disease. The Nation's investment and the actions of Congress are 
directly responsible for the development of a nation-wide network of 61 
NCI-designated cancer centers and a highly successful Community 
Clinical Oncology Program (CCOP), founded in 1983. Through the network 
of 64 CCOP grantees, community investigators participate actively in 
NCI-sponsored cancer prevention, control, and treatment clinical 
trials. These programs place cutting-edge research directly in 
communities and put access to cancer clinical trials into the hands of 
local physicians. Because of their participation in NCI trials, 
community clinicians more readily adopt new regimens, ensuring that 
these advances are rapidly made part of the standard of care.
    Recently, NCI's leadership team has initiated a series of site 
visits to innovative community-based cancer centers as potential models 
for a new NCI initiative, the Community Cancer Centers Program (CCCP). 
The CCCP would help foster replication of successful community models 
across the country, set the standards for multi-specialty state-of-the-
art care, provide access to early phase clinical trials, and ultimately 
improve cancer care and outcomes. This program is especially designed 
to bring academic standards of care and clinical trials directly to the 
segments of our population who either through age or resources cannot 
leave their community.

                        A RECORD OF REAL SUCCESS

    The past year in cancer research shows a record of substantial and 
heartening achievement. We are expanding our foundation of knowledge 
and the technical tools with which rapid advances can be made in 
understanding the mechanisms of cancer. We are exponentially increasing 
the opportunities to manage this lethal disease. Building on NCI-funded 
research, large-scale clinical trials in 2005 yielded results that will 
have profound effects in preventing and treating many cancers.
    For example, three different clinical trials showed that adding 
trastuzumab (Herceptin) to standard adjuvant chemotherapy 
significantly reduced the risk of recurrence in women with the early-
stage breast cancer, HER-2/neu positive, which has an over expression 
of protein in the gene. Approximately 50,000 women in the United States 
are diagnosed with HER-2/neu positive breast cancer each year, 
representing about 20 percent of invasive breast cancers.
    Equally stunning results were seen in the trial of a vaccine that 
protects against two strains of human papillomavirus (HPV) that cause 
over 70 percent of cervical cancers, a disease that kills more than 
200,000 women each year, including many in developing countries. Study 
results concluded that women who received the vaccine during a 2-year 
study were protected against precancerous lesions caused by HPV. NCI 
made the initial discoveries linking HPV to cervical cancer, which led 
to creation and testing of HPV vaccines that are based on technology 
also developed at the Institute. It is an outstanding exemplar in this 
era of molecular medicine of how NCI's knowledge about the etiology of 
the disease enabled creation of a vaccine against a specific cancer.
    In January, an NCI-sponsored trial reported that women who received 
chemotherapy directly in their abdomens as part of treatment for 
advanced ovarian cancer lived more than a year longer than women who 
received the same chemotherapy intravenously. The findings confirm and 
expand recent research showing that intraperitoneal (IP) chemotherapy, 
which delivers drugs directly to the abdominal cavity through a 
catheter, can significantly increase survival for some women with the 
disease. As the results were made public, NCI issued a rare clinical 
announcement to raise awareness about IP chemotherapy for ovarian 
cancer among physicians and patients. The NCI announcement--the first 
since 1999--was warranted because IP chemotherapy is widely regarded as 
an old technology and previous trials have generated little interest 
among physicians. Ovarian cancer causes the most deaths of any 
gynecological cancer in the United States and frequently goes 
undetected until tumors spread beyond the ovaries.
    Another notable advance came last September with the announcement 
of results from the NCI-sponsored Digital Mammographic Imaging 
Screening Trial (DMIST). The study found that digital mammography is 
more accurate than film mammography for women with dense breasts, as 
well as for several other groups of women, including women under 50 and 
pre- and perimenopausal women. Overall, DMIST offers a model case study 
of how NCI can be an agent of change, pursuing new approaches to 
research, partnering with the private and public sectors, and fueling 
the development of technologies to achieve an important advance. It is 
particularly noteworthy that NCI and the American College of Radiology 
Imaging Network (ACRIN) secured the involvement in DMIST of four 
companies that developed and manufactured digital mammography machines 
for our use in clinical trials: Fischer Medical, Fuji Medical, General 
Electric Medical Systems, and Hologic.
    Finally, NCI has made strides to address the widespread disparities 
in cancer screening, treatment, and care for disadvantaged, mostly 
minority populations. One approach to closing this access gap is NCI's 
Patient Navigator Research Program, which relies on personal guides to 
shepherd disadvantaged cancer patients into standard care. NCI supports 
a number of Patient Navigator Program pilot projects in minority 
communities and about $24 million in grants will be awarded over the 
next 5 years as part of the program.

               ADVANCED TECHNOLOGIES ACCELERATE PROGRESS

    The technology revolution is speeding up and enabling the discovery 
process. Nanotechnology has emerged as a key strategy for imaging 
molecular features of cancer and will ultimately lead to personalized 
medicine. NCI's investment in nanotechnology is a powerful example of 
leveraging resources from the private sector through our Centers of 
Cancer Nanotechnology Excellence.
    Of equal significance, in December 2005 NCI and the National Human 
Genome Research Institute (NHGRI) launched The Cancer Genome Atlas 
(TCGA) Pilot Project, a comprehensive effort to accelerate 
understanding of the molecular basis of cancer and which evolved from 
the Human Genome Project (HGP). The TCGA Pilot Project will develop and 
test the science and technology needed to systematically identify the 
genetic changes in a small number of cancers.
    Additionally, NCI's cancer Biomedical Informatics Grid 
(caBIGTM) is creating a unifying technology platform or 
``world-wide web'' for cancer research. caBIGTM is well on 
the way to its goal to create a network of interconnected data, 
applications, individuals, and institutions that will redefine how 
cancer research is conducted and care is provided. This initiative has 
also whetted considerable commercial interest.

                       INTERAGENCY COLLABORATIONS

    Addressing the cancer problem requires that NCI work across 
institutional and sector boundaries, share knowledge, and bring 
together the diverse members of the Department of Health and Human 
Services (DHHS) family of agencies, as well as other federal offices, 
that can help develop systems-based solutions to the cancer problem.
    The NCI and FDA Interagency Oncology Task Force (IOTF) continues to 
remove bottlenecks in the process of developing and approving safe, 
more effective cancer interventions. During 2005, IOTF helped foster 
the creation of two important initiatives: the Exploratory 
Investigational New Drug (IND) process to streamline the early clinical 
development of new drugs and biologics; and the NCI Regulatory Affairs 
Liaison position to help NCI-funded researchers navigate through FDA's 
IND application process. Both will help eliminate obstacles to the 
rapid development of promising new anticancer agents.
    DHHS Secretary Mike Leavitt announced last month the Oncology 
Biomarker Qualification Initiative (OBQI)--an unprecedented interagency 
agreement among NCI, FDA, and the Centers for Medicare and Medicaid 
Services (CMS) to collaborate on improving the development of cancer 
therapies and the outcomes for cancer patients through biomarker 
development and evaluation.

                               CONCLUSION

    We must do more to continue the acceleration of discovery, 
development, and delivery of the interventions that will hasten the 
transformation of our traditional view of cancer as a death sentence 
into a disease that we can prevent, eliminate, or control. This will be 
the legacy we leave our children.
    While progress is evident, there is much that remains to be 
accomplished. We are committed to face the challenge of making 
difficult choices between those programs that we will continue to grow 
and nurture and those that have already advanced our knowledge. The 
decisions will be science driven. This is an unprecedented era of 
discovery. The opportunities to apply powerful new technologies to 
advance our knowledge and the opportunities to change the course of 
cancer have never been greater.
                                 ______
                                 
              Prepared Statement of Dr. Francis S. Collins

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2007 President's budget request for the National Human 
Genome Research Institute (NHGRI). The fiscal year 2007 budget includes 
$482,942,000, a decrease of $3,107,000 from the fiscal year 2006 
enacted level of $486,049,000 comparable for transfers proposed in the 
President's request.
    On October 26, 2005, an international consortium of dedicated 
scientists from six countries, led by the NHGRI, published a new map of 
the human genome called ``HapMap'' that may prove even more powerful 
than the human genome sequence because of its medical applications.
    The Human Genome Project (HGP) spelled out the letters of the 99.9 
percent of the DNA code that we all share. The haplotype map, or HapMap 
for short, provides detailed knowledge of the 0.1 percent that 
represents variation in the genome. The HapMap reveals the way in which 
this genetic variation is organized into chromosomal neighborhoods and 
provides a powerful tool to uncover those spelling differences in the 
human instruction book that predispose some people to diabetes, 
Alzheimer's disease, heart disease, or cancer. As with the HGP, all of 
the data has been placed in the public domain.
    Since early deliberations about the HGP 20 years ago, scientists 
and physicians have dreamed of the day when we would be able to apply 
the tools of genomics to the diagnosis, treatment, and prevention of 
those common diseases that fill up our hospitals and clinics, causing 
untold suffering, misery, and premature death. The completion of the 
HapMap brings us a major step closer to the realization of that dream.
    The HapMap project could not have succeeded without the support of 
multiple NIH institutes, the U.S. Congress, and the dedication of more 
than 2,000 scientists across the world who delivered on every promise 
of the project. In fact, in its brief three-year life, this project 
produced a map three times more detailed than originally thought 
possible. The NHGRI and other NIH institutes can now move quickly to 
build on this success to discover the genetic and environmental factors 
that cause disease, and to utilize this information to develop better 
means of individualized prevention and treatment.

                       ONGOING NHGRI INITIATIVES

Use of Comparative Genomics to Understand the Human Genome
    The NHGRI continues to support the sequencing of the genomes of 
non-human species such as the chimpanzee, dog, and mouse because of 
what they tell us about the human genome. The first comprehensive 
comparison of the genetic blueprints of humans and chimpanzees, 
published in Nature to wide acclaim in September 2005, shows our 
closest living non-human relatives share identity with 96 percent of 
the human DNA sequence. The sequence of the dog genome was published in 
December 2005, revealing many interesting details about the remarkable 
diversity of man's best friend, and greatly empowering the ability to 
track down the genes involved in many chronic illnesses (like cancer) 
where dogs are excellent models for human disease.
Sequencing technology advances, on the way to the $1,000 genome
    DNA sequencing enables a detailed description of the order of the 
chemical building blocks, or bases, in a given stretch of DNA, and is a 
powerful engine for biomedical research. Though DNA sequencing costs 
have dropped by three orders of magnitude since the start of the HGP, 
sequencing an individual's complete genome for medical purposes is 
still prohibitively expensive. Two bold new advances in sequencing 
technology recently developed by NHGRI-funded researchers promise to 
greatly reduce this cost. Ultimately, the NHGRI's vision is to cut the 
cost of whole-genome sequencing to $1,000 or less. If achieved, this 
would enable the sequencing of individual genomes as part of routine 
medical care, providing health care professionals with a more accurate 
means to predict disease, personalize treatment, and preempt the 
occurrence of illness.

Knockout Mouse Project
    The technology to ``knockout'' or inactivate genes in mouse 
embryonic stem cells has led to many insights into human biology and 
disease. However, information about knockout mice have only been 
published and made available to the research community for about 10 
percent of the estimated 20,000 mouse genes. Recognizing the wealth of 
information that mouse knockouts can provide, the NHGRI coordinated an 
international meeting in 2003 to discuss the feasibility of a 
comprehensive project. These discussions have now resulted in a trans-
NIH, coordinated, five-year cooperative research plan that will produce 
knockout mice for every mouse gene and make these mice available as a 
community resource.

Chemical Genomics--Roadmap--Molecular Libraries and PubChem
    The NHGRI has taken a lead role in developing a trans-NIH chemical 
genomics initiative. This is part of the NIH Roadmap, and now offers 
public-sector researchers access to high throughput screening of 
libraries of small organic compounds that can be used as chemical 
probes to study the functions of genes, cells, and biochemical 
pathways. This powerful technology provides novel approaches to explore 
the functions of major components of the cells in health and disease. 
All the data generated for this project is stored in the new PubChem 
database at the National Library of Medicine.

Bench-to-Bedside in Intramural Research--The Example of Progeria
    As just one example of the focus of the NHGRI intramural program on 
translational research, rapid advances have recently been achieved in 
the study of progeria, a rare genetic disease of childhood 
characterized by dramatic acceleration of aging. In 2003, NHGRI 
researchers discovered that progeria is caused by a single letter 
misspelling in a gene known as lamin A. The lamin A protein undergoes a 
particular modification known as farnesylation. That same modification 
activates the protein product of the famous ras oncogene; ten years of 
hard work has made available a class of cancer drugs that blocks this 
step. Remarkably, cell culture and mouse model experiments suggest 
these drugs may also have benefits for children with progeria. Serious 
consideration of a clinical trial is now underway, just three years 
after gene discovery.

The Surgeon General's Family History Initiative
    Family medical history is a source of genetic information that can 
help more accurately determine an individual's risk for specific 
diseases. However, to date, this resource has been underutilized in 
health. To address this, Surgeon General Richard Carmona established 
the U.S. Surgeon General's Family History Initiative, a collaborative 
effort between a number of Department of Health and Human Services 
agencies, with leadership from NHGRI. The second annual National Family 
History Day was celebrated on Thanksgiving Day 2005, when a new and 
improved version of the software tool called ``My Family Health 
Portrait'' was released to help individuals compile their own family 
history information. This initiative should have an impact on patient-
healthcare provider interaction, facilitating the development of more 
accurate family history information for patient medical records, and 
leading to more personalized and effective disease prevention and 
treatment strategies.

                         NEW NHGRI INITIATIVES

The Genes and Environment Initiative (GEI) and the Genetic Association 
        Information Network (GAIN).
    Just this February, the Department of Health and Human Services 
announced the creation of two related groundbreaking initiatives in 
which NHGRI will play a leading role, to speed up research on the 
causes of common diseases such as asthma, arthritis, the common 
cancers, diabetes, and Alzheimer's disease.
    The Genes and Environment Initiative (GEI) is a trans-NIH research 
effort to combine comprehensive genetic analysis and environmental 
technology development to understand the causes of common diseases. NIH 
will invest $68 million in GEI in fiscal year 2007. Using the newly 
derived HapMap, GEI will search for the specific DNA variations that 
are associated with an increased risk of common illnesses. For the more 
than a dozen disorders chosen for investigation under GEI, NIH will 
study roughly 1,000 cases and 1,000 controls will be studied. Finding 
the variants that predispose a person to common disease is one of the 
highest priorities of current biomedical research, as this will enable 
developing personalized medicine and identifying new drug targets.
    To ensure that GEI takes advantage of the wide breadth of expertise 
that is available on DNA variations for common disorders, NIH has begun 
partnering under the Genetic Association Information Network with the 
Foundation for the NIH, Pfizer, and Affymetrix to begin research on 
seven diseases during this fiscal year.
    But genes alone do not tell the whole story. Recent increases in 
chronic diseases like diabetes, childhood asthma, obesity or autism 
cannot be due to major shifts in the human gene pool as those changes 
take much more time to occur. They must be due to changes in the 
environment, including diet and physical activity, which may produce 
disease in genetically predisposed persons. Therefore, GEI will also 
invest in innovative new technologies/sensors to measure environmental 
toxins, dietary intake and physical activity, and using new tools of 
genomics, proteomics, and understanding metabolism rates to determine 
an individual's biological response to those influences.

The Cancer Genome Atlas (TCGA)
    In December, the National Cancer Institute (NCI) and the National 
Human Genome Research Institute (NHGRI) jointly launched a very 
important new effort to accelerate our understanding of the molecular 
basis of cancer through the application of genome analysis 
technologies, including large-scale genome sequencing. Thanks to the 
tools and technologies developed by the Human Genome Project and recent 
advances in using genetic information to improve cancer diagnosis and 
treatment, it is now possible to envision a comprehensive effort to map 
the changes in the human genetic blueprint associated with all known 
forms of cancer. The overall effort, called The Cancer Genome Atlas, 
will begin in 2006 with a three year, pilot project totaling $100 
million to determine the feasibility of a full-scale effort to explore 
the universe of genomic changes involved in all types of human cancer. 
This atlas of genomic changes will provide: (1) new insights into the 
biological basis of cancer which in turn will lead to new tests to 
detect cancer in its early, most treatable stages; (2) new ways to 
predict which cancers will respond to which treatments; (3) new 
therapies to target cancer at its most vulnerable points; and (4) 
ultimately, new strategies to prevent cancer altogether.

                        OTHER AREAS OF INTEREST

Education of Health Care Professionals
    To enable the translation of basic genetic discoveries into health 
care practice, the NHGRI has developed numerous educational programs to 
prepare health care professionals for this revolution. Specifically, 
the NHGRI continues to play a lead role in the National Coalition for 
Health Professional Education in Genetics (NCHPEG), which is leading a 
national effort to achieve genetic literacy amongst health 
professionals. NHGRI also worked closely with the American Academy of 
Family Physicians, who featured genomic medicine as their educational 
focus for 2005.

Minority Outreach Activities
    The NHGRI has been at the forefront of ensuring that minority 
scientists and students are equipped to meet the new challenges of 
genome research for the 21st century. The institute has sponsored new 
initiatives to reach out to diverse populations including research, 
education, and outreach collaborations on the role of genetic factors 
in health disparities. In conjunction with the National Council of La 
Raza, NHGRI has developed a community-based model education program for 
provision of genetics information to underserved Latino communities. 
NHGRI is also working with Alaska Native communities and the University 
of Washington to expand community-based education programs in Alaska 
Native communities.

Genetic Nondiscrimination
    The NHGRI remains very concerned about the impact of potential 
genetic discrimination on research and clinical practice. Through many 
surveys and research projects funded by the Ethical, Legal, and Social 
Implication (ELSI) program of the Institute, it is clear many Americans 
remain concerned about the possible misuse of their genetic information 
by insurers or employers. In February 2005, the Senate unanimously 
passed the Genetic Information Nondiscrimination Act of 2005 (S. 306), 
which would address these concerns; the companion bill H.R. 1227 is now 
pending in the House. The Bush Administration has issued a Statement of 
Administrative Policy in support of the legislation. This issue remains 
a high priority for the Institute.
                                 ______
                                 
               Prepared Statement of Dr. Anthony S. Fauci

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Institute of Allergy 
and Infectious Diseases (NIAID) of the National Institutes of Health 
(NIH). The fiscal year 2007 budget of $4,395,496,000 includes an 
increase of $12,195,000 over the fiscal year 2006 appropriated level of 
$4,383,301,000, comparable for transfers proposed in the President's 
request.
    The mission of NIAID is to conduct and support research to 
understand, treat, and prevent infectious and immune-related diseases. 
Infectious diseases include well-known killers such as HIV/AIDS, 
malaria, and tuberculosis; emerging or re-emerging threats such as 
influenza; and ``deliberately emerging'' threats from potential agents 
of bioterrorism. Immune-related disorders include autoimmune diseases 
such as type 1 diabetes and rheumatoid arthritis as well as asthma, 
allergies, and problems associated with transplanted tissues and 
organs.
    NIAID has a two-fold mandate. First, NIAID must plan and execute a 
comprehensive and long-term basic and clinical research program on 
well-recognized endemic infectious and immune-mediated diseases. 
Second, and in this case it is unique among the NIH Institutes, it must 
respond quickly with targeted research to meet new and unexpected 
infectious disease threats as they arise, often in the form of public 
health emergencies. Part of the expansion of the NIAID research 
portfolio in recent years has been driven by unprecedented scientific 
opportunities in the core NIAID scientific disciplines of microbiology 
and immunology. Advances in these key fields have led to a better 
understanding of the human immune system and the mechanisms of 
infectious and immune-mediated diseases. But the scope of NIAID 
programs also has grown because of a growing realization that 
biomedical research is a key component of a successful response to new 
challenges posed by emerging and re-emerging infectious diseases such 
as pandemic influenza and HIV/AIDS, the threat of bioterrorism, and the 
increase in asthma prevalence among children.

              EMERGING AND RE-EMERGING INFECTIOUS DISEASES

    Despite advances in medicine and public health such as antibiotics, 
vaccines, and improved sanitation, the World Health Organization (WHO) 
estimates that infectious diseases still account for approximately 26 
percent of all deaths worldwide, including about two-thirds of all 
deaths among children younger than five years of age. Moreover, the 
pathogens we face are not static, but change dramatically over time as 
new microbes emerge and familiar ones re-emerge with new properties or 
in unusual settings.
    Influenza is perhaps the most pertinent example of a re-emerging 
disease. Influenza viruses continually accumulate small changes such 
that a new vaccine must be made for each influenza season. When a 
totally new influenza virus against which the global population has no 
natural immunity emerges, a worldwide pandemic can result if the new 
viruses are able to transmit efficiently between people. Three such 
pandemics occurred in the 20th century, in 1918, 1957, and 1968. The 
pandemics of 1957 and 1968 were severe infectious disease events that 
killed approximately two million and 700,000 people worldwide, 
respectively. The 1918-1919 pandemic, however, was catastrophic. Public 
health experts estimate that the 1918 pandemic killed more than 500,000 
people in the United States and more than 50 million people worldwide.
    The highly pathogenic H5N1 avian influenza virus currently found in 
domestic and migratory birds in Asia, Africa, the Middle East, and 
Europe is of great concern. Although H5N1 is primarily an animal 
pathogen, it nonetheless has infected more than 170 people; more than 
half of all confirmed H5N1 patients have died. At this time, the virus 
is not able to spread efficiently from animals to humans and is 
extremely inefficient in spreading from person to person, but the 
feared human influenza pandemic could become a reality if the H5N1 
virus mutates further or mixes its genes with human influenza viruses, 
remains highly virulent, and acquires the capability to spread 
efficiently from person to person.
    It is imperative that we prepare for the possibility that a new 
influenza virus will emerge to cause a 1918-like pandemic among human 
beings. It is important to note, however, that our ability to cope with 
a pandemic--with a sufficient supply of effective vaccines and 
antiviral drugs, effective infection control, and clear public 
communication--will to a large extent depend on how well we cope with 
seasonal influenza. It is clear that we have not yet optimized our 
preparedness and responsiveness to this recurring disease, which, 
according to estimates of the Centers for Disease Control and 
Prevention (CDC), kills an average of about 36,000 people in the United 
States each year. The serious vaccine shortage that occurred in the 
2004/05 influenza season underscored the difficulties we face in 
annually renewing the influenza vaccine supply, and highlights the 
pressing need to move toward adoption of newer vaccine manufacturing 
techniques and other strategies that can improve the surge capacity, 
flexibility and speed with which vaccines are made.
    NIAID supports numerous research projects that lay the foundation 
for improved influenza vaccine manufacturing methods, new categories of 
vaccines that work against multiple influenza strains, as well as the 
next generation of anti-influenza drugs. Some of these are basic 
research projects intended to increase our understanding of how animal 
and human influenza viruses replicate, interact with their hosts, 
stimulate immune responses, and evolve into new strains. Other projects 
are more targeted, such as a program to screen compounds for antiviral 
activity against influenza viruses. One particularly important effort 
is to develop a vaccine that raises immunity to parts of the influenza 
virus that do not vary from season to season. Not only would such a 
vaccine provide continued protection over multiple influenza seasons, 
it might also offer considerable protection against a newly-emerged 
pandemic influenza virus and thereby substantially improve our 
preparedness for pandemic threats.
    The Department of Health and Human Services (DHHS) Pandemic 
Influenza Response and Preparedness Plan designates NIAID as the lead 
agency for research and development efforts related to pandemic 
influenza. In this capacity, NIAID has developed and is clinically 
evaluating several candidate H5N1 vaccines, including inactivated and 
live-attenuated vaccines, as well as other strategies such as 
recombinant subunit and DNA vaccines. The potential benefits of NIAID 
research to the American public have been clear and immediate. The pre-
pandemic H5N1 vaccine that is currently being stockpiled by DHHS was 
shown in clinical trials by NIAID to be safe and capable of inducing an 
immune response that would be predictive of being protective against 
the H5N1 virus. The dose of vaccine required for this protection, 
however, is high; and current NIAID studies are aimed at enhancing the 
response to lower doses of the H5N1 vaccine, particularly with the use 
of adjuvants, which are compounds that have been shown to enhance the 
immune response to vaccines. NIAID also conducts surveillance for the 
molecular evolution of influenza viruses among animals and humans in 
Asia and elsewhere, and tracks changes in the virus that might allow it 
to be transmitted more easily among people. The Institute also is 
evaluating new antiviral drugs against H5N1 influenza as well as 
combinations and varied doses of existing drugs. In addition, NIAID is 
working to establish a clinical trials network in Southeast Asia to 
conduct research on emerging infectious diseases, with an initial 
emphasis on influenza.
    Influenza is by no means the only emerging and re-emerging 
infectious disease threat that the world faces. For example, malaria is 
a substantial and growing problem compounded by the emergence of drug-
resistant malaria parasites and insecticide-resistant mosquito vectors. 
NIAID supports a large malaria research portfolio; one recent study 
identified a specific parasite gene that is essential for full 
maturation of the parasites in mice. Disrupting this gene not only 
prevented the onset of disease in mice, but injection of the modified 
parasites stimulated an immune response that protected them from 
subsequent infection with unmodified, fully-virulent malaria parasites. 
This indicated that genetically attenuated parasites might be useful as 
a malaria vaccine in the future.
    Tuberculosis (TB) is an example of a microbial disease that has 
reemerged in recent years. Infection with Mycobacterium tuberculosis is 
estimated to be prevalent in one-third of the world's population and is 
especially common among persons infected with HIV. NIAID supports a 
large portfolio of research to develop new drugs, vaccines, and 
diagnostics for TB and to evaluate improved treatment and preventive 
regimens. Recently, two novel, engineered TB vaccines developed with 
NIAID support entered Phase I clinical trials in the United States. 
These promising candidates are the first new TB vaccines to be tested 
in people in more than 60 years. In addition, the Global Alliance for 
TB Drug Development and NIAID have collaborated to develop a promising 
new TB drug candidate, which is now being tested in clinical trials. 
NIAID also has made substantial research progress on West Nile Virus, 
multi-drug resistant tuberculosis (MDR-TB), SARS, and other new or re-
emerging infections.

                           HIV/AIDS RESEARCH

    HIV/AIDS was first recognized as an emerging disease only 25 years 
ago. Today it is a global catastrophe. According to the Joint United 
Nations Program on HIV/AIDS (UNAIDS), approximately 40 million people 
worldwide are living with HIV/AIDS, and their number is increasing by 
more than 5 million people every year--about 14,000 each day. In the 
United States, more than one million people are living with HIV/AIDS, 
and approximately 40,000 new infections occur annually. Worldwide, more 
than 25 million people with HIV have died since the pandemic began, 
including more than 520,000 in the United States. In 2004, there were 3 
million deaths worldwide due to HIV/AIDS. These statistics are grim 
reminders of the physical and emotional devastation to individuals, 
families, and communities coping with HIV/AIDS, and of the terrible 
impact of HIV/AIDS on regional and global security and the global 
economy.
    Development of a vaccine that protects against HIV/AIDS is one of 
the highest priorities of the NIAID. The scientific challenges that 
must be overcome, however, are extraordinary. Because the immune 
system, with rare exceptions, has not been shown to contain HIV on its 
own, an HIV vaccine will have to elicit an even stronger immune 
response than elicited by natural HIV infection if it is to prevent 
infection. To help meet these challenges, NIAID established the Center 
for HIV/AIDS Vaccine Immunology (CHAVI) in June 2005. CHAVI's mission 
is to tackle the fundamental immunological obstacles in HIV vaccine 
research and to design, develop, and test novel HIV vaccine candidates. 
The establishment of CHAVI complements NIAID's continued support of 
other innovative research projects conducted through a highly 
cooperative and collaborative global research and development program.
    Among many HIV vaccine research efforts, NIAID scientists have 
developed a two-part vaccination strategy, consisting of an initial 
(prime) vaccination followed by a later (boost) vaccination. The 
priming dose is a ``naked'' DNA vaccine, and the boost is a recombinant 
adenovirus vaccine, which is based on a highly attenuated version of a 
common cold virus. Both components contain genes from three different 
subtypes of HIV that together cause about 85 percent of all HIV 
infections around the world. An initial Phase I clinical trial showed 
that the pair of vaccines was well-tolerated and induced substantial 
immune responses. Building on these promising findings, NIAID recently 
launched a second phase of testing of this ``prime-boost'' strategy. 
This project is a collaboration between three international clinical 
trial networks--NIAID's HIV Vaccine Trials Network, the non-profit 
International AIDS Vaccine Initiative, and the U.S. Military HIV 
Research Program--and expands the safety and immunogenicity testing of 
the prime-boost strategy in the Americas, South Africa, and Eastern 
Africa. Also underway and slated to complete enrollment this year is 
the evaluation of a candidate adenoviral vaccine administered without a 
DNA vaccine to determine whether it may be useful alone in preventing 
HIV infection or disease.
    The use of potent combinations of anti-HIV drugs, many of which 
were developed with NIAID support, has dramatically reduced the numbers 
of AIDS deaths in industrialized countries. Most recently these drugs 
have had a major impact on several developing countries in sub-Saharan 
Africa, the Caribbean, South America and Asia, as drugs have become 
available to them. Indeed, these drug regimens have transformed the 
complexion of HIV/AIDS throughout the world, saving the lives of 
millions of people. These results are some of the most cogent examples 
of the practical benefits of NIH-supported research. But we cannot be 
complacent in our success. Anti-HIV drug regimens often cause serious 
side effects and frequently lose their effectiveness due to the 
emergence of resistant forms of HIV within a patient. Clinical research 
is moving new classes of AIDS drugs closer to market and defining how 
to optimally use currently licensed medications. Basic HIV research 
continues to uncover additional viral and cellular targets for therapy. 
For example, several potential drug targets have been identified by 
determining the mechanisms that HIV uses to gain entry into host cells. 
These include fusion inhibitors, the first of which was recently 
approved by the Food and Drug Administration (FDA). In addition, 
several inhibitors of the HIV enzyme that allows the virus to enter and 
integrate into an infected cell's genes have shown great promise in 
clinical trials.

                          BIODEFENSE RESEARCH

    The potential use of biological agents in a terrorist attack is a 
serious threat to the citizens of our nation and the world. Research to 
mitigate this threat is a key focus of NIAID. The NIAID Strategic Plan 
for Biodefense Research, developed shortly after the terrorist attacks 
of 2001, outlines three essential pillars of the NIAID biodefense 
research program: infrastructure needed to safely conduct research on 
dangerous pathogens; basic research on microbes and host immune 
defenses that serves as the foundation for applied research; and 
targeted, milestone-driven development of medical countermeasures to 
create the vaccines, therapeutics and diagnostics that we would need in 
the event of a bioterror attack. Implementation of this plan enhances 
not only our preparedness for bioterrorism, but also for naturally 
occurring endemic and emerging infectious diseases. In addition, NIAID 
was recently given the role of coordinating and facilitating NIH 
research into countermeasures to mitigate harm to civilians from 
chemical and radiological/nuclear weapons. Other NIH Institutes and 
Centers will also contribute substantially to these efforts. The NIH 
Strategic Plan and Research Agenda for Medical Countermeasures against 
Radiological and Nuclear Threats was released in June 2005, and the NIH 
Strategic Plan and Research Agenda for Medical Countermeasures against 
Chemical Threats is scheduled to be released in mid-2006.
    Perhaps the most tangible signs of NIAID's biodefense research 
progress are the biocontainment research facilities now under 
construction, which will be capable of safely containing dangerous 
pathogens, enabling scientists to study such agents. For example, 
through its extramural program, NIAID is supporting the construction of 
two National Biocontainment Laboratories--capable of safely containing 
the most deadly pathogens--as well as thirteen Regional Biocontainment 
Laboratories nationwide. In addition, three intramural biocontainment 
labs--on the NIH campus, on the National Interagency Biodefense Campus 
at Fort Detrick in Fredrick, MD, and at the NIAID Rocky Mountain 
Laboratories in Hamilton, MT--are either complete or under 
construction. NIAID also has established a nationwide network of 
Regional Centers of Excellence (RCEs) for Biodefense and Emerging 
Infectious Diseases Research; two new RCE awards were announced on June 
1, 2005, bringing the total number of RCEs nationwide to ten.
    The investment in biodefense research has already yielded 
substantial dividends, some of which are of immediate benefit while 
others provide considerable promise for the future. Our basic research 
and clinical trials have already greatly increased our ability to 
respond to the threats of smallpox, anthrax, and Ebola with new and 
improved vaccines. For example, in November 2004, DHHS awarded a 
contract for the acquisition of 75 million doses of a new anthrax 
vaccine to be held in the Strategic National Stockpile. NIAID's support 
of the development of this vaccine was instrumental in making this 
initiative possible. In addition, NIAID-supported scientists recently 
discovered that a poxvirus infection may be halted by a cancer drug 
aimed not at the virus, but at the host cellular machinery that the 
virus needs to spread from cell to cell. Although much work remains, 
this research provides a lead to not only a new therapeutic approach to 
poxviruses such as smallpox, but also a means of circumventing 
antiviral drug resistance for other viruses. In another example of 
critical new discoveries, NIAID-supported scientists demonstrated that 
host cell proteins called cathepsins play an essential role in the 
Ebola virus' ability to enter and infect cells, and that inhibitors of 
cathepsin activity block viral entry and reduce the production of 
infectious Ebola viruses. This suggests that drugs that inhibit the 
activity of cathepsins might be useful as anti-Ebola therapies.
    NIAID's implementation of its Strategic Plan for Biodefense 
Research has been aided by the enactment of the Project BioShield Act 
of 2004. Project BioShield provides NIH additional flexibility in 
awarding contracts, cooperative agreements, and grants for research and 
development of critical medical countermeasures. The BioShield Act also 
provides NIH with streamlined personnel authority, which has allowed 
NIAID to hire highly-qualified individuals to fill key positions 
related to product development. Lastly, Project BioShield provides 
NIAID with additional authority for the construction of research 
facilities, which NIAID used to award grants in fiscal year 2005 for 
the construction of four Regional Biocontainment Laboratories.

                  RESEARCH ON IMMUNE-MEDIATED DISEASES

    Autoimmune diseases, allergic diseases, asthma and other 
immunologic diseases are significant causes of chronic disease and 
disability in the United States and throughout the world. Autoimmune 
diseases affect 5 to 8 percent of the U.S. population; asthma and 
allergic diseases together are the sixth leading cause of chronic 
disease and disability in this country; and asthma is the leading cause 
of hospitalizations and school absences among children. A promising 
strategy to treat and prevent immune-mediated diseases is known as 
immune tolerance. Immune tolerance therapies are designed to preprogram 
immune cells in a highly specific fashion to eliminate injurious immune 
responses, such as those seen in autoimmune diseases, while preserving 
protective responses needed to fight infection. The NIAID has 
established a comprehensive program in immune tolerance research, 
including basic research, preclinical testing of promising strategies 
in nonhuman primates, and clinical evaluation through the Immune 
Tolerance Network (ITN), a consortium of more than 80 investigators in 
the United States, Canada, Western Europe, and Australia. Currently, 
NIAID is supporting more than 40 clinical trials of immune tolerance 
strategies to treat autoimmune diseases, allergic diseases, and 
transplant rejection.
    NIAID-supported research in immune-mediated diseases has led to 
significant advances in our understanding of how to manage these 
diseases. For example, NIAID-supported scientists recently identified 
novel ways to non-invasively assess the risk of kidney graft rejection 
by using immunologic and genetic biomarkers present in urine. If 
validated in larger studies, these biomarkers would allow physicians a 
non-invasive way to monitor transplant recipients for organ rejection, 
and intervene before organ injury, a significant advance in the 
clinical management of transplant patients.
    NIAID also remains committed to improving the health of children 
with asthma, particularly those who live in our Nation's inner cities. 
For example, NIAID-supported researchers recently published the results 
of a study on the effect of home-based interventions that reduce 
exposure to common allergens such as cockroaches, house dust mites, and 
tobacco smoke. The study found that the interventions resulted in 20 
percent fewer days with asthma symptoms and 14 percent fewer 
unscheduled clinic visits through the intervention year. We anticipate 
that our extensive research portfolio will continue to illuminate the 
causes of asthma and other immune-mediated conditions, and lead to new 
interventions to reduce the burden of these serious diseases.

                               CONCLUSION

    The research conducted at NIAID and at NIAID-sponsored laboratories 
encompasses a broad array of basic, applied and clinical studies. This 
research has resulted in tangible benefits to the American public and 
to individuals throughout the world. By supporting talented researchers 
and emphasizing a balance of basic studies and targeted research, we 
hope to continue to develop innovative technologies and treatments to 
combat a wide range of important diseases that afflict humanity.
                                 ______
                                 
              Prepared Statement of Dr. Elizabeth G. Nabel

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2007 President's Budget request for the National Heart, 
Lung, and Blood Institute (NHLBI). The fiscal year 2007 budget includes 
$2,901,012,000, a decrease of $20,745,000 over the fiscal year 2006 
enacted level of $2,921,757,000.
    The NHLBI was established as the National Heart Institute in 1948 
with a mandate ``to improve the health of the people of the United 
States'' through research on diseases of the heart and circulation. And 
that is exactly what we have done. I believe it is no exaggeration to 
claim that, over the past decades, biomedical research has made more 
progress in cardiovascular disease than in any other major chronic 
health problem. The impact on death rates alone constitutes a 
monumental validation of this country's public investment in the NIH 
and the NHLBI.
    The United States experienced an epidemic of coronary heart disease 
(CHD) during the twentieth century and, had the trend continued 
unabated, more than 1.6 million lives would be lost to CHD this year. 
In actuality, the toll will be less than 500,000 deaths, reflecting a 
63 percent decline in age-adjusted mortality since 1950.\1\  Mortality 
from stroke, the third most common cause of death in the United States, 
declined 70 percent over that time. The effect on longevity has been 
remarkable--looking just at recent data, we can see that between 1970 
and 2000 the life expectancy of the average American increased by 6 
years, and nearly 4 years of that gain was due to reductions in deaths 
from cardiovascular disease.
---------------------------------------------------------------------------
    \1\ Data in this statement regarding mortality and life expectancy 
are from U.S. Vital Statistics.
---------------------------------------------------------------------------
    Much of the reduction in death rates has come from improved 
treatments for CHD. Not so long ago, atherosclerosis followed an 
inexorable course and, once an artery became occluded, blood flow could 
not be restored. Increasingly sophisticated technological developments 
in revascularization--coronary artery bypass surgery (1968), balloon 
angioplasty (1977), stents (1994), and now ``drug-eluting'' stents--
coupled with vastly improved diagnostic procedures and new medications, 
have literally given many patients a new lease on life. NHLBI-supported 
basic and applied research studies, as well as carefully designed 
clinical trials, have enabled scientists to develop these 
interventions, to assess their utility and safety, and to determine the 
characteristics of patients most likely to benefit from them. Millions 
of Americans suffer from cardiovascular disease, and this research has 
contributed enormously to our ability to help them live longer and 
healthier lives.
    We are equally pleased to reflect on improvements that have 
occurred in our ability to treat acute heart attacks. In past 
generations, doctors could only stand by while a heart attack ran its 
course and they had little to offer the patient but bed rest and a 
prognosis of rapid death or severely restricted life as a ``cardiac 
cripple.'' All that changed in the 1980s when scientists determined 
that most heart attacks occur because of a blood clot in an artery that 
feeds the heart. The development of thrombolytic--``clot-busting''--
therapy followed. NHLBI-sponsored clinical trials of thrombolysis 
demonstrated that the procedure could limit the area of damaged heart 
muscle and decrease mortality. This was revolutionary, and it rapidly 
influenced how heart attack is treated.
    The greatest benefit of thrombolysis, however, accrues in the 
initial minutes and hours after onset of the attack and, unfortunately, 
many patients do not reach the emergency room in time. In the 1990s the 
NHLBI initiated a successful trial of community-based interventions to 
reduce delays in seeking and receiving treatment for heart attack 
symptoms. The knowledge gained was used to develop Act in Time to Heart 
Attack Signs, a far-reaching public education campaign launched by the 
NHLBI during the NIH budget doubling. Also during the doubling, the 
Institute began a pilot program at Suburban Hospital to test a new 
approach to diagnosing heart attack patients who may be candidates for 
thrombolytic therapy. For many patients arriving at the emergency room 
with chest pain, diagnosis 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 is having 
great success in using MRI (magnetic resonance imaging) technology to 
provide a diagnosis in about 35 minutes, and we believe it may form the 
basis for a better approach to delivering prompt therapy to patients 
who are likely to benefit from it. In light of recent evidence that 
thrombolytic therapy may benefit patients who experience a clot-based 
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.
    Let me mention some special efforts to improve treatment of 
coronary heart disease in a highly vulnerable population--patients with 
obesity and type II diabetes. Although there is near-universal optimism 
that a cure for diabetes will ultimately be found, in the meantime the 
majority of patients are suffering and dying from cardiovascular 
disease. We are working to identify approaches to prevent and treat 
these complications, and I am happy to note that the budget doubling 
enabled us to move forward with full funding of two major new clinical 
trials in this area. The ACCORD trial is testing the extent to which 
control of blood pressure, cholesterol, and glucose levels to 
thresholds beyond those that are currently recommended will reduce the 
occurrence of cardiovascular problems. The BARI-2D trial, focused on 
diabetic patients who already have coronary heart disease, is weighing 
the merits of revascularization versus medical treatment and, in 
addition, studying two different approaches to controlling blood sugar. 
These trials are effortful and expensive because they involve multiple 
complex issues in diabetes management. However, they address a critical 
public health need, given the escalating prevalence of obesity and 
diabetes in the United States, and many among us are likely to benefit 
from their findings.
    Much as we celebrate these advances in treatment, let me assure you 
that we have never lost sight of our ultimate objective--prevention. 
Indeed, we have had considerable success in identifying risk factors 
such as high blood pressure and cholesterol, developing and evaluating 
methods to control them, and translating the research findings into 
messages for health-care professionals, patients, and the general 
public. During the budget doubling, we launched The Heart Truth, an 
education campaign to raise awareness that heart disease is the leading 
cause of death in American women and call women to take action to 
reduce their risk of developing heart disease. Already we have evidence 
that the campaign's message, ``Heart disease doesn't care what you 
wear--it's the #1 killer of women,'' has raised awareness throughout 
the nation. Last June we launched We Can! (Ways to Enhance Children's 
Activity and Nutrition), a national education program to help children 
8-13 years of age stay at a healthy weight. We Can! offers parents and 
families tips and activities to encourage healthy eating, increase 
physical activity, and reduce sedentary or screen time. It also 
provides resources to help community groups and health professionals 
work toward these goals.
    Much of what we know about factors that put people at risk of 
developing cardiovascular diseases has come from the multigenerational 
Framingham Heart Study, begun in 1948. I am delighted to announce that 
the NHLBI, in conjunction with Boston University, recently unveiled a 
plan to take this study to the next level. Our new Framingham Genetic 
Research Study will entail up to 500,000 analyses of the DNA of 9,000 
study participants. By identifying genetic variations that relate 
strongly to participant characteristics (e.g., blood pressure and 
cholesterol levels, overweight and obesity) and to outcomes (e.g., 
stroke, congestive heart failure, diabetes), we hope to refine our 
understanding of individual risk and identify carefully focused new 
strategies for treatment and prevention. We at the NHLBI share Dr. 
Zerhouni's vision of an approach to medical care that is predictive, 
personalized, and preemptive and we believe this new endeavor 
constitutes a major step toward realizing that goal.

                   PEDIATRIC HEART AND LUNG DISORDERS

    Tremendous progress has been made in treating congenital 
cardiovascular malformations, the most common type of birth defect in 
the United States. Many of us remember when these conditions 
constituted a death sentence, but today we have an array of surgical 
and medical treatments, as well as reliable and effective methods for 
providing monitoring and support. As a result, more than 90 percent of 
these babies live to celebrate a first birthday. Indeed, the prognosis 
has improved so much that there are now more adults than children 
living with congenital heart defects, according to data from the Adult 
Congenital Heart Association. Nonetheless, congenital heart disease is 
still a major contributor to infant mortality and many challenges 
remain. Thanks to the budget doubling, we have been able to expand 
significantly our efforts in this area by funding two additional 
Specialized Centers of Research in Pediatric Cardiovascular Disease, 
establishing a clinical research network to enable rapid evaluation of 
new treatment approaches, and soliciting research proposals to develop 
devices for infants and children who experience cardiopulmonary failure 
and circulatory collapse.
    As recently as 35 years ago, many premature infants died within 
hours of birth from neonatal respiratory distress syndrome (RDS), a 
condition caused by lack of a substance called surfactant that keeps 
the lung's air sacs open for breathing. The NHLBI's long-term 
investment in basic, applied, and clinical research has nearly 
relegated neonatal RDS to history. With development of special 
ventilation techniques to sustain babies until their lungs matured, 
introduction of a prenatal test for lung maturity, and demonstration 
that antenatal corticosteroid treatment could accelerate lung 
maturation, U.S. deaths from this disorder fell 60 percent between 1970 
and 1984--from 10,000 to 4,000 per year. Then, in the 1980s, NHLBI-
supported studies of surfactant structure, function, and regulation and 
efforts to identify the genes for surfactant proteins culminated in 
development of surfactant replacement products for testing in clinical 
trials. Since 1990, when two surfactant treatments were approved for 
widespread clinical use, neonatal RDS mortality has fallen more than 75 
percent, to about 1,000 deaths per year.

                                 ASTHMA

    For centuries, asthma was viewed a bronchial spasm problem and 
treated--with limited success--as such. Our intensive research effort 
in recent years led to the realization that asthma is a manifestation 
of chronic inflammation and immune dysfunction. This insight 
revolutionized treatment, the mainstay of which now is anti-
inflammatory medications to treat the underlying disease, with 
bronchodilators used chiefly for quick relief of symptoms. The NHLBI 
has also been a pioneer in development of self-management strategies 
and their application, especially for inner-city minority children; 
evidence indicates favorable effects on emergency room visits and 
school absences in this vulnerable population. Results of all these 
efforts are rapidly incorporated into national guidelines that set the 
standard for modern asthma management. Clinical research networks have 
proven invaluable for rapidly assessing new treatment strategies, and 
during the budget doubling we were able to renew our highly productive 
adult Asthma Clinical Research Network and initiate the Childhood 
Asthma Research and Education Network, which addresses pediatric 
asthma. We also began a program focused on severe asthma. These efforts 
are enabling us to make good on our promise to patients, ``Your asthma 
can be controlled--expect nothing less.'' And we are now talking with 
increasing confidence about curing asthma, going beyond the initial 
promise of asthma control.

                          SICKLE CELL DISEASE

    As recently as 1970, the average patient with sickle cell disease 
died in childhood. Today, life expectancy is about 45 years. NHLBI 
research has led to a standard of care that begins with screening of 
newborns, provides prophylaxis for potentially lethal childhood 
infections, and offers transfusion therapy to prevent stroke in high-
risk children. A clinical trial demonstrated the value of the drug 
hydroxyurea in preventing painful crises, acute chest syndrome (a life-
threatening respiratory complication), and need for transfusions in 
adult patients. With the budget doubling, we have been able to 
undertake a hydroxyurea trial in children, and also to assess the value 
of stem cell transplantation as a possible cure. Our hope and 
expectation is that further gains in longevity and quality of life will 
be achieved.
    I would be pleased to respond to any questions that the Committee 
may have.
                                 ______
                                 
Prepared Statement of Dr. Duane Alexander, Director, National Institute 
                 of Child Health and Human Development

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2007 President's budget request for the National 
Institute of Child Health and Human Development (NICHD). The fiscal 
year 2007 budget includes $1,257,418,000, a decrease of $7,351,000 over 
the fiscal year 2006 enacted level of $1,264,769,000 comparable for 
transfers proposed in the President's request.
    The mission of the NICHD is vital to the NIH goal of ensuring the 
overall health and well-being of the American people. Our research 
focuses on both child health and human development. Increasingly, 
researchers are confirming that lifelong health and well-being are 
strongly influenced by events occurring early in life.
    Understanding human development evolves from understanding normal 
growth and change processes before birth through adulthood. It begins 
at the most basic molecular and cellular levels and encompasses 
cognitive, behavioral, physical and social development. By 
understanding what goes ``right,'' NICHD research provides clues as to 
what may go ``wrong,'' laying the critical scientific foundation not 
only for understanding many disease processes, but also for preventing 
them altogether.

                 FETAL DEVELOPMENT: JUMP START ON LIFE

    We now know that both undernourished and obese mothers have 
children with increased risk of chronic disease later in life. This is 
a problem world wide and it is an increasing problem in the United 
States.
    To understand and reverse the epidemic of type 2 diabetes among 
young people, we need to look beyond their diet. The health and 
nutrition of the mother during fetal development influences not only 
how children function but also the later development of diabetes, high 
blood pressure, heart disease and other conditions. To better 
understand fetal origins of adult disease, researchers recently 
discovered links between birth weight and stress hormone (cortisol) 
levels in boys and girls who were small at birth, but healthy term 
babies. Cortisol helps to regulate blood pressure, energy production, 
and response to stress. The researchers found that the lower birth 
weight boys had higher levels of cortisol under stressful conditions 
compared to the higher birth weight boys. They found that the lower 
birth weight girls had higher cortisol levels at the beginning of the 
day. This discovery demonstrates how low birth weight can have lasting, 
yet different, effects on stress hormone levels in girls and boys. 
These alterations in cortisol may predispose children to obesity, 
hypertension, and glucose intolerance later in life.

                        PREDICTING PREECLAMPSIA

    Preeclampsia is a sudden, dangerously high increase in high blood 
pressure that threatens the health of a pregnant woman and her fetus. 
Preeclampsia strikes without warning and can result in maternal 
seizures and even death. The researchers studying this condition found 
that women who, in mid-pregnancy, have a lower level of a substance 
known as placental growth factor were more likely to develop 
preeclampsia. This advance may lead to a screening test for 
preeclampsia and a treatment to help women avoid the condition.

          OBSTETRIC PHARMACOLOGY--TREATMENT FOR PREGNANT WOMEN

    Most drugs used to treat pregnant women are prescribed without full 
knowledge about safety and efficacy. In many cases, no data exists to 
predict how the drug's dynamics may interfere with a woman's pregnancy. 
To fill this knowledge gap, the NICHD has established the Obstetric-
Fetal Pharmacology Research Units (OFPRU) Network to develop improved 
safety and efficacy drug information for pregnant women. One drug 
currently being studied is used to control gestational diabetes. 
Gestational diabetes affects up to 15 percent of all pregnancies 
according to the March of Dimes. The condition results from a sudden 
inability of the body to remove sugar from the blood. Untreated, 
gestational diabetes results in large, stocky babies who may cease 
breathing unexpectedly, have difficulty feeding, and must eat 
frequently to avoid seizures. Children of mothers with gestational 
diabetes are also likely to become obese during childhood and 
adulthood.
    For many years, physicians treated gestational diabetes with 
injections of insulin. Recently, however, physicians began treating 
pregnant women with glyburide, which stimulates the pancreas to 
gradually release small quantities of insulin. Many patients preferred 
the convenience of taking a pill to giving themselves an injection. 
Although many pregnant women have taken glyburide, no studies have ever 
tested the drug's effectiveness in treating gestational diabetes. A new 
study is examining the use of glyburide in pregnancy, to determine if 
the current dosing schedule is the most effective means to treat the 
disorder.

                        PREMATURE BIRTH RESEARCH

    Reducing preterm birth (PTB) is a major public health priority and 
a major research priority for this Institute. One out of eight infants 
in the United States is born preterm. This amounts to about 476,000 
infants a year. The March of Dimes estimates that babies born too soon 
or too small cost the U.S. health system $18.1 billion a year. Preterm 
infants face a number of serious health problems and life-threatening 
conditions. PTB accounts for nearly half of the neurological problems 
among newborns who are at risk of having learning disabilities and 
mental retardation. When preterm infants reach adulthood, they also 
face much higher risks of cardiovascular disease and diabetes.
    The NIH investment in preterm birth research is paying dividends. 
For the first time, we now have a method to reduce the risk of PTB for 
some women. One of our studies found that weekly injections of a 
synthetic form of progesterone reduces the chances of preterm delivery 
in women who had already given birth prematurely. For the first time, 
this research gives doctors an intervention that has been shown to be 
both safe and effective in reducing the risks of preterm birth. This 
discovery also illustrates how quickly research can be turned into 
practice. Shortly after this research was published, The American 
College of Obstetricians and Gynecologists recommended that all of 
their members use progesterone to prevent PTB for women with previous 
PTB. Another study found that pregnant women who have a condition known 
as bacterial vaginosis have a greater likelihood of delivering 
prematurely. For many years, these women have been treated with 
antibiotics. Contrary to existing clinical thinking, treating the 
infection with an antibiotic during pregnancy did not reduce the 
incidence of preterm birth. Still another NICHD study found that women 
with a condition known as trichomoniasis are also at increased risk for 
preterm delivery. The study found that giving antibiotics does not 
reduce the risk of preterm birth associated with infection; moreover, 
this treatment actually increased the preterm birth rate.
    The new knowledge gained from each of these three studies was 
created by one of the multidisciplinary clinical research networks 
supported by the NICHD. With these networks in place, NICHD scientists 
working with researchers around the country can answer important 
scientific questions quickly, and work through professional 
organizations to help clinicians translate the new knowledge into 
practice.
    The NICHD recently established the Genomics and Proteomics Network 
for Premature Birth Research. This new network will focus on the 
hereditary information in DNA and the structure and function of 
proteins to understand the underlying processes that lead to preterm 
birth.

          GENES MAY HOLD THE KEY TO TREATING UTERINE FIBROIDS

    Each year, more than 200,000 women in the United States undergo a 
hysterectomy to treat the chronic pain and abnormal bleeding caused by 
fibroids. Scientists are exploring alternative ways to treat fibroids 
without surgery. Previously, these researchers identified a molecule 
called transforming growth factor beta (TGF-b) that helps to regulate 
several processes including the growth of uterine fibroids. Using a 
powerful new technology, the researchers identified the different genes 
influenced by the growth factor in both normal and fibroid cells. The 
researchers then tested a gene therapy that appeared to block 
production and action of TGF-b. This insight may lead to novel, non-
surgical therapeutic approaches, not only to prevent uterine fibroid 
growth, but also to treat other reproductive conditions.

                BUFFERGEL SHOWN TO BE SAFE CONTRACEPTIVE

    Researchers have made a major step forward in developing 
contraceptives that protect women against HIV. One product, BufferGel, 
can be used with a diaphragm, much like a conventional spermicide. The 
results of a recent study demonstrate that BufferGel is as effective at 
preventing pregnancy as is currently available spermicides. A study is 
now in progress to determine if BufferGel can reduce transmission of 
the AIDS virus.

          GENE PROGRAMS EARLY DEVELOPMENT AND NEURAL MIGRATION

    NICHD researchers made a significant advance in understanding 
dyslexia. In an article that Science Magazine called one of the 10 
major breakthroughs in 2005, the researchers linked the developmental 
gene DCDC2 to dyslexia. This gene functions to control nerve cell 
migration in early brain development. This work suggests that genetic 
miscues alter brain biology in the womb in a way that predisposes 
people to problems later in life.

                   FUTURE RESEARCH: NEWBORN SCREENING

    The NICHD Newborn Screening Initiative is moving forward in its 
effort to develop and employ the latest technology for improving the 
availability, accessibility, and quality of genetic and other 
diagnostic laboratory testing for rare diseases and conditions 
affecting newborns. Ultimately, this research could help identify at-
risk infants as early as possible and provide the data needed to 
develop therapies for many of these conditions. As a cornerstone 
activity, the NICHD funded a major grant for developing and refining a 
newborn screening test for spinal muscular atrophy (SMA), a common 
fatal neuromuscular disease in children. The NICHD will soon be funding 
additional grants to increase understanding of conditions such as SMA 
or other genetic conditions.

             MATHEMATICS AND SCIENCE COGNITION AND LEARNING

    The NICHD is enhancing its program to better understand the 
underlying developmental processes that allow children to learn math 
and science. One goal is to help researchers understand the 
developmental and cognitive processes needed to help children 
transition successfully from arithmetic to algebraic reasoning, a 
fundamental skill needed to allow children to advance their 
understanding of mathematical concepts. In turn, mastering math-related 
concepts such as recognizing patterns, representing relationships, and 
making generalizations is key to learning and understanding science. 
These critical program activities fill a major research need to clarify 
the cognitive factors needed for scientific thinking and learning.

              COMMUNITY-BASED REHABILITATION INTERVENTION

    The aging of the baby-boom generation and expected pressures on the 
U.S. health care system make research into effective therapies in 
community settings a high priority. Clinical trials of rehabilitation 
therapies have demonstrated the efficacy of novel interventions in 
preventing or significantly lessening disabling conditions associated 
with stroke, traumatic brain injury, and other disorders and 
conditions. Little is known, however, about whether and how well such 
therapies will work in less-controlled community practice settings. 
Scientists do not know whether--or how--efficacious rehabilitative 
therapies and even clinical trial design may need to be modified for 
community settings. To address these critical questions, the NICHD will 
solicit applications for clinical trials by scientists partnering with 
persons with disabilities, practitioners, and others in the community.
    Mr. Chairman and members of the Committee, the support you have 
shown for medical research has allowed scientists in research centers 
around the country to make discoveries that advance the health of 
women, children and families. I will be pleased to answer any 
questions.
                                 ______
                                 
Prepared Statement of Dr. Barbara M. Alving, Acting Director, National 
                     Center for Research Resources

    Mr. Chairman and Members of the Committee: It is a privilege to 
present to you, for the first time, as the Acting Director of the 
National Center for Research Resources (NCRR), the President's budget 
request for NCRR for fiscal year 2007, a sum of $1,098,242,000, 
including support for AIDS research, which reflects a net decrease of 
$859,000 over the comparable fiscal year 2006 appropriation.
    By developing and funding essential research resources, NCRR 
connects scientists with one another, as well as with patients and 
communities across the nation. These connections bring together 
innovative research teams and the power of shared resources, 
multiplying the opportunities to improve human health.
    These connections can be seen in the new institutional Clinical and 
Translational Science Awards program, launched in fiscal year 2006, 
which enables researchers to train and collaborate in new ways to move 
findings in the laboratory more quickly to patients. NCRR also is 
bringing patients, advocacy groups, and researchers together to fight 
rare diseases--a unique opportunity to combine patient information and 
support with research knowledge. Other programs are helping 
investigators to create technologies that will make research 
information more accessible and precise through various software tools 
and Internet connections.
    In addition, NCRR-supported technologies help researchers--located 
in isolated regions--share information that benefits underserved 
populations across the country. And at NCRR-supported primate research 
centers, investigators come together to study AIDS vaccines, 
Parkinson's, Alzheimer's, and many other diseases. Perhaps our most 
wide-ranging connections are made through science education--programs 
that reach young and old--on a diverse range of health-related issues.
    These are just a few of the programs that comprise NCRR's 
portfolio, but they illustrate how we are investing research dollars in 
order to bring the power of shared resources to communities and 
researchers across the nation and ultimately improve the health of 
Americans. I would now like to provide you with additional details 
about each of these exciting programs.

             INTEGRATING CLINICAL AND TRANSLATIONAL SCIENCE

    Recognizing that a well-integrated collaborative effort is needed 
to transform basic discoveries into improved medical care, NCRR has 
launched an important new initiative--the Clinical and Translational 
Science Awards (CTSAs)--on behalf of the NIH Roadmap for Medical 
Research. The CTSA Program was initiated to break existing barriers 
between basic and clinical sciences and, above all, to get people to 
work together to speed the delivery of improved health care to the 
public. Developed with extensive input from the scientific community, 
the CTSAs will help research institutions nationwide create an academic 
home for clinical and translational research, essentially generating 
what NIH Director Dr. Elias Zerhouni calls the ``glue'' that fills the 
gaps among scientists in multiple disciplines and thus forms a bridge 
between basic and clinical research.
    In ongoing dialogues with the scientific community, researchers 
also have told us that the CTSA initiative will allow them to 
strengthen the career development pipeline for clinical and 
translational researchers. At the same time, it will build partnerships 
with communities that will ensure that diverse populations, and 
clinical practitioners serving those populations, play an integral part 
in addressing the unique health challenges that they face. With the 
community's participation, the CTSAs will help to deliver improved 
medical care that meets the needs of these diverse patients and their 
communities.

              CREATING PARTNERSHIPS: RARE DISEASES NETWORK

    Another NCRR initiative--the Rare Diseases Clinical Research 
Network--illustrates the importance of bringing patients and 
researchers together. Headed by NCRR in partnership with the NIH Office 
of Rare Diseases, the network is truly a trans-NIH activity, with 
funding coming from five additional NIH institutes. The need for such a 
network is best appreciated when one considers the emotional toll a 
family faces when they find out that their child has a rare disease and 
the desperation they face when they search for medical resources. For 
example, Trish Hertzog, a mother from Philadelphia who agreed that we 
could tell her story to help others, can vividly recall the day her son 
Mathew was born more than a decade ago. Unbeknownst to anyone, 
including his doctors, this seemingly healthy newborn lacked a critical 
gene that helps to remove toxic substances from the body. Within two 
days of his birth, Mathew fell into a coma, as lethal levels of ammonia 
built up in his brain, and died within hours.
    Mathew Hertzog had inherited a rare condition known as a urea cycle 
disorder, which affects only about 1 in 30,000 children. Collectively, 
rare diseases affect about 25 million Americans, according to the 
National Organization for Rare Diseases. Research on rare diseases is 
especially challenging since few patients with the same condition can 
be recruited from any one clinical site.
    To improve outcomes and outreach, the Rare Diseases Clinical 
Research Network unites the efforts of researchers from multiple 
institutions and their patients nationwide. The Network's web site has 
become a source of information for the public, physicians, patients, 
and investigators about rare diseases. The site also contains a unique 
web-based contact registry for patients who wish to learn about 
clinical studies. With this Network now available, parents like Trish 
can obtain information about rare diseases and learn about 
participating in one of the initial clinical trials.

       WIDENING THE NET: UNDER-REPRESENTED POPULATIONS AND AREAS

    NCRR is using the latest advances in technology to promote greater 
inclusion of under-represented minority and rural populations in 
research by boosting capacity in institutions and regions of the 
country that lack high-capacity, broad-bandwidth Internet connections. 
Some states--including Montana, Wyoming, Alaska, Idaho, Nevada, and 
Hawaii--lack access to advanced Internet applications, such as virtual 
laboratories, digital libraries, distance education, as well as 
advanced networking capabilities. This lack of resources hinders the 
ability of the institutions in these states to conduct collaborative, 
data-intensive biomedical studies. In the first phase of a national 
effort called IDeANet, NCRR is enhancing high-speed network 
connectivity in these five rural Western states and Hawaii, which will 
bring these areas on par with connectivity in the other parts of the 
country.
    This effort is part of the Institutional Development Award (IDeA) 
Program, which broadens the geographical distribution of NIH funding 
for biomedical research. Ultimately, IDeANet will expand to include 
NCRR's Research Centers in Minority Institutions Program, which 
enhances the research capacity and infrastructure at minority colleges 
and universities that offer doctorates in health sciences.

                 SPURRING ADVANCES THROUGH DATA SHARING

    Through the Biomedical Informatics Research Network (BIRN), NCRR 
supports the integration of data, expertise, and unique technologies to 
spur scientific advances that would be difficult or impossible in the 
context of individual laboratories. To illustrate this point, five 
volunteer research participants traveled across the country to nine 
different sites to have their brains imaged via magnetic resonance 
imaging (MRI). The data that was collected contributed to a first-of-
its-kind neuroimaging dataset that will enhance large-scale, multisite 
imaging studies for years to come. Scientists found that brain images 
from a single individual appeared surprisingly different when collected 
at different MRI centers--such variance would greatly hamper multi-site 
imaging studies. Through BIRN, scientists have recently developed 
software tools to standardize data and reduce this type of inter-site 
variability in brain scans. This collaboration is just one example of 
how BIRN contributes to solving complex health-related problems. While 
initial efforts are focusing on neuroimaging data, the tools and 
technologies developed by BIRN ultimately may be applied to other 
disciplines.

          PROVIDING CRITICAL LINKS: NONHUMAN PRIMATE RESEARCH

    Studies of nonhuman primates are indispensable to translational 
research, providing a critical link between small laboratory animals 
and human subjects. Many of today's life-saving interventions--
including polio vaccines, AIDS-fighting drugs, and heart surgery 
techniques--depended on preliminary evaluation in nonhuman primates 
like the rhesus macaque. To support such studies, NCRR funds eight 
highly specialized research facilities known as the National Primate 
Research Centers, which bring together researchers with a variety of 
expertise, thereby contributing to studies of major human health 
issues, including cancer and neurodegenerative disorders.
    Because the nation currently lacks a sufficient number of 
clinically trained primate veterinarians, NCRR plans to support an 
initiative to attract and train graduate-level veterinarians in the 
procedures for conducting primate research. A well-trained veterinary 
research corps will enhance the country's capacity to respond to the 
emergence and spread of potentially deadly human diseases, such as 
severe acute respiratory syndrome (SARS), influenza, and hepatitis.

                 PROMOTING SCIENCE AND HEALTH LITERACY

    By supporting collaborations among educators, researchers, 
community groups, museums, and other organizations, NCRR's Science 
Education Partnership Award program increases the public's 
understanding of medical research and delivers information about 
healthy living and career opportunities in science to children and the 
general public. For instance, a novel project at the University of 
Maryland is infusing physical education classes in grades 3-5 with 
science-enriched curriculum to enhance children's knowledge of the 
heart and other muscles and the importance of physical fitness. Another 
project, a partnership involving the University of Hawaii and 
culturally diverse local communities, is designed to enhance biomedical 
education and mentoring for children and their teachers on isolated 
Hawaiian islands. By providing students with opportunities to 
participate in hands-on, inquiry-based research projects, NCRR hopes to 
demystify science and make it more accessible to individuals throughout 
the nation.

                               CONCLUSION

    The future of medical care will depend on our commitment to bring 
together scientists with diverse expertise and to support research 
institutions with varying strengths and research capacities. At the 
same time, we must ensure the participation of researchers and patients 
who are from ethnically and geographically diverse communities and 
share the importance of medical research with educators and students. 
Our goal in the coming year is to enhance these collaborations, 
partnerships, and networks in order to bring the power of shared 
resources to researchers across the nation and maximize our research 
investments.
                                 ______
                                 
Prepared Statement of Dr. Jeremy Berg, Director, National Institute of 
                        General Medical Sciences

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2007 President's budget request for the National 
Institute of General Medical Sciences (NIGMS). The fiscal year 2007 
budget includes $1,923,481,000, a decrease of $12,137,000 from the 
fiscal year 2006 enacted level of $1,935,618,000 comparable for 
transfers proposed in the President's request.
    NIGMS supports a broad spectrum of research central to the National 
Institutes of Health's mission of improving the nation's health. Over 
the years, this foundational work has led to important breakthroughs 
and treatments. Biophysical studies sparked the development of life-
saving drugs for AIDS. Inventive burn and trauma research yielded the 
first artificial skin to treat severely burned patients. Most recently, 
research in pharmacogenetics led the Food and Drug Administration (FDA) 
to change the label of irinotecan, a drug approved in 1996 for 
colorectal, lung, and other cancers. The label now indicates that 
people with a certain genetic variation are at a greater risk for life-
threatening reactions to the drug and encourages doctors to use a lower 
starting dose for those patients.
    In other areas, such as chemistry, groundbreaking basic research 
helped support drug development by the pharmaceutical industry. NIGMS' 
investment in this area was recognized with the 2005 Nobel Prize in 
chemistry, bringing the number of laureates whose research we have 
funded to 57. Long-time grantees Robert H. Grubbs, Ph.D., of the 
California Institute of Technology and Richard R. Schrock, Ph.D., of 
the Massachusetts Institute of Technology were honored for developing a 
revolutionary way of synthesizing new molecules. Their discoveries 
transformed a seemingly esoteric process into a practical tool that is 
now routinely used in the pharmaceutical industry and in other areas of 
the economy, including the plastics industry.

                       STRENGTHENING THE PIPELINE

    In addition to providing stable research support to these chemists, 
NIGMS provided funds to support their transition from trainees to 
independent researchers. The Institute has a number of structured 
programs that offer thousands of trainees access to state-of-the-art 
resources, rigorous curricula, and high-quality ethics training. Each 
year, many scientists receiving NIGMS support launch independent 
careers and join the ranks of top-notch researchers in a wide range of 
scientific disciplines.
    Many creative contributions like the few I have highlighted above 
are the work of individual bright minds. However, as biomedical 
research converges and scientific fields meld together in new ways, 
researchers working in different areas need to combine their talent and 
expertise. Recognizing the dual need for teamwork and individual 
intellectual contribution, NIGMS has invested its resources wisely. In 
addition to funding a substantial number of individual investigators, 
we have broadened our investment by funding large, multidisciplinary 
scientific teams. These programs have served a truly catalytic role in 
tackling issues of great importance to public health, and I would like 
to describe some of their recent advances.

                   THE DAWN OF PERSONALIZED MEDICINE

    The NIGMS-led Pharmacogenetics Research Network (PGRN), a trans-NIH 
project consisting of 12 scientific teams, has just completed its first 
5 years of work with an impressive track record. For example, the 
treatment of childhood leukemia is improving due to the discovery that 
variations in two genes can predict which patients with the most common 
form of the disease have a higher risk of relapse. On the horizon is 
safer dosing of the widely used blood-thinning medicine Coumadin (also 
known as warfarin) due to the discovery that normal variation in two 
genes can put some patients at risk for excessive bleeding or for heart 
attacks and strokes. PGRN researchers have also made important strides 
in unraveling disparities in response to treatments for asthma, a 
disease that affects roughly 20 million Americans, according to the 
American Lung Association. Recent findings show that variation in just 
a few genes affects responses to two mainstay asthma therapies, inhaled 
steroids and beta-agonists. Genetic tests to detect these variations 
may be available within a year.
    Other payoffs from NIGMS investments in pharmacogenetics extend 
beyond implications for individual drug dosing. PGRN research has 
unexpectedly uncovered knowledge that can predict disease risk in 
subsets of patients, including those taking tamoxifen for breast cancer 
and beta-blockers for heart disease. Finally, NIGMS-sponsored research 
in pharmacogenetics is having an impact on policy. PGRN studies have 
played a role in the FDA's recent decision to develop new guidelines 
for personalized medicines. For example, an FDA program that allows 
manufacturers to submit pharmacogenetic data for review has seen a jump 
from six submissions to 25 in the space of 1 year.

                TEAMING SCIENCE FOR PUBLIC HEALTH GAINS

    NIGMS' innovative ``glue grant'' program is a novel approach that 
brings together scientists from different disciplines to attack 
problems beyond the scope of an individual investigator but crucial to 
the future of the public health enterprise. One example of a recent 
glue grant advance is the discovery that genes can help explain why 
patients can have dramatically different reactions to traumatic injury. 
The NIGMS-funded Inflammation and the Host Response to Injury research 
group, which performed this study, will also release this year a set of 
standard operating procedures for the care of critically injured 
patients. This work, while still in the early stages, is moving ahead 
rapidly and will likely improve standards for treatment across the 
nation as well as facilitate the conduct of high-quality research in 
this important field.
    Many areas of basic biomedical research require an incubation 
period before results emerge and new knowledge is translated into the 
clinic. Both pharmacogenetics and much of the complex biology being 
investigated with glue grants are good examples, and the recent 
achievements I've described offer evidence that the wait has been worth 
it. However, in other circumstances NIGMS has invested basic research 
expertise in areas quite ripe for practical development. A case in 
point is the Models of Infectious Disease Agent Study (MIDAS), not yet 
2 years old, which has already made an important mark on the public 
health policy landscape. Several key papers have emerged from this 
highly interdisciplinary effort, and the program continues to be fluid, 
evolving to match public health needs. The MIDAS network is focusing on 
modeling the spread of influenza, and its models are providing key 
inputs to policy makers and health officials engaged in preparing for 
possible influenza pandemics.

                      VALUE OF A SYSTEMS APPROACH

    The ready application of MIDAS research to current flu preparedness 
efforts is apparent, but I'd like to point out that this research is a 
shining example of what may seem a more esoteric concept: systems 
biology. In fact, systems biology is a powerful and promising approach 
for investigating how to control the progression of diseases worldwide.
    Systems biology addresses how the parts of a complex network work 
together to produce the behavior of the overall system. The threads of 
systems biology are apparent in pharmacogenetics, which goes beyond the 
consideration of a drug and its target to examine other molecules that 
affect drug action and determine how apparently subtle variations in 
these molecules can affect drug efficacy and safety. In infectious 
disease modeling, the properties of an infectious agent are 
superimposed on the structure of society, from transportation networks 
to human behavior. Systems biological approaches require 
interdisciplinary teams of scientists working together toward a common 
goal that is often closer to practical applications than are the 
powerful, ``one component at a time'' approaches that have driven 
biomedical research so successfully over the past decades.

                           POWER OF THE MIND

    Let me finish by returning to the contributions of individual 
minds. I'll highlight two relatively young scientists who have been 
recognized by the NIH Director's Pioneer Award program for their 
exceptional potential to make major breakthroughs.
    The first is Sunney Xie, Ph.D., of Harvard University. He is a 
pioneer in the development of methods that can see single biological 
molecules in action. Most biomedical experiments examine millions or 
more molecules, revealing the average behavior of all of them. While 
this information can be highly useful, many details are lost. Dr. Xie's 
methods, developed through an inspired application of techniques from 
physics and chemistry, look at the behavior of one molecule at a time. 
This is like being able to hear one conversation clearly rather than 
hearing the din of a room full of people all talking at once. As these 
methods mature, they have the potential to transform our understanding 
of how gene expression is controlled in normal and diseased cells.
    The second NIH Director's Pioneer Award winner I will mention is 
neurobiologist Erich Jarvis, Ph.D., of Duke University. Dr. Jarvis, an 
African American who grew up amid poverty, drugs, and violence in 
Harlem, seeks to unravel the mysteries of vocal learning. He is 
investigating this question using songbirds as a model system, and he 
has already made important strides in unlocking some of the complexity 
of one of biology's unexplored frontiers: the brain. Although his 
research falls outside the realm of the NIGMS mission and Dr. Jarvis is 
not currently an Institute grantee, I tell you his story for a 
different, very important reason. He is a terrific example of what we 
stand to lose if we do not continue to invest in the creative 
individual sparks of young scientists in our diverse society. At least 
part of Dr. Jarvis's rise to success can be attributed to chances he 
got in school. He participated in the NIGMS Minority Biomedical 
Research Support and Minority Access to Research Careers programs as an 
undergraduate at the City University of New York, Hunter College, where 
he received a bachelor's degree in biology and mathematics. He later 
earned a Ph.D. in molecular neurobiology and animal behavior from the 
Rockefeller University and today works at the forefront of an exciting 
discipline at the intersection of biomedical and behavioral research.
    The creative energies of potential biomedical researchers--not just 
those in fields traditionally related to biomedicine but also those in 
associated fields in the physical, mathematical, behavioral, and social 
sciences--will drive advances leading to improvements in human health 
for many years to come. Nurturing a diverse scientific workforce will 
enhance the vitality of our nation and improve the health of our 
children and their children.
    Thank you, Mr. Chairman. I would be pleased to answer any questions 
that the Committee may have.
                                 ______
                                 
    Prepared Statement of Dr. Patricia A. Grady, Director, National 
                     Institute of Nursing Research

    Mr. Chairman and Members of the Committee: I appreciate the 
opportunity to present the fiscal year 2007 President's budget request 
for the National Institute of Nursing Research (NINR). The fiscal year 
2007 budget includes $136,550,000, a decrease of $792,000 over the 
fiscal year 2006 enacted level of $137,342,000 comparable for transfers 
proposed in the President's request.
    I am pleased to describe some of the exciting research of the 
National Institute of Nursing Research (NINR). NINR is charged with 
supporting research that establishes the scientific basis of quality 
patient care regardless of disease or health status. We fund research 
that affects individuals across the lifespan and all health care 
settings, especially the underserved.
    NINR is currently celebrating the 20th anniversary of its 
establishment at NIH. We have used this occasion not only to take stock 
of our accomplishments, but more importantly, to look toward the future 
role of NINR's research in today's increasingly complex health care 
environment. We are faced with an aging population at a time when our 
Nation is experiencing a shortage of nurses. We are also in an era of 
new technologies, which demands that nurses be technologically-savvy 
and able to adapt these new methods to a variety of patient populations 
and settings. This dynamic health care environment provides many 
opportunities for nursing research to address a variety of challenges 
and improve health care for all patients.
    Let me give you a few examples of how our research has improved 
lives and the promise it holds for the future.

                  HEALTHY MOTHERS AND HEALTHY CHILDREN

    Sleep and Healthy Pregnancies.--Women often complain of fatigue and 
difficulty sleeping during pregnancy, especially as they approach 
delivery. Researchers studied women who slept less than 6 hours per 
night or who experienced frequent sleep disturbances during their 
pregnancy. These women had significantly longer labors and were 3-4 
times more likely to have a cesarean delivery than women who slept 7-8 
hours a night with fewer disruptions. These results highlight the 
importance of adequate sleep during pregnancy, and suggest a need for 
care providers to stress better sleeping habits to their pregnant 
patients.
    Children and Health Disparities.--In fiscal year 2007, NINR will 
solicit new intervention research proposals aimed at reducing health 
disparities among children. NINR is committed to reducing disparities 
in health care, but current research in this area often targets adults. 
Children who live in poverty have little access to health care, and 
these children are disproportionately from minority populations. NINR's 
effort to reduce disparities in child health will target such areas as: 
developing culturally-sensitive interventions to promote physical 
activity and healthy diets in children, reducing health risk factors in 
children that lead to poor health outcomes, and studying how gender and 
immigrant status affect child health and access to health care.

                  STAYING HEALTHY THROUGHOUT ADULTHOOD

    Culturally-sensitive Diet Intervention.--Diabetes is prevalent 
among rural African-Americans, and compliance with dietary self-
management guidelines is often poor. In one study, NINR researchers 
tested a dietary intervention for diabetic African-Americans living in 
rural South Carolina. Through culturally-tailored classes that taught 
healthy food choices and low-fat cooking techniques, participants 
successfully lowered their body weight and fat intake. Other community-
based interventions that include culturally-relevant components show 
similar successes. These types of programs may be important tools in 
promoting health and reducing health disparities.
    Heart Disease in Women.--Heart disease, the number one cause of 
death in the United States, is sometimes more difficult to diagnose in 
women than in men, because women can exhibit different symptoms of 
heart disease than men. Better ways of detecting heart disease are 
therefore needed. NINR investigators are currently developing and 
testing a new screening tool that could predict whether or not certain 
women are at risk for serious heart disease. The test takes into 
account the different symptoms that women with heart disease 
experience, and it factors in the diverse symptoms experienced by women 
of different races.

             UNDERSTANDING AGING AND CARING FOR THE ELDERLY

    Improving Self-management for the Elderly.--The aging American 
population has tremendous implications for our health care system. 
Better tools are needed to prevent and treat the health problems 
experienced by the elderly in a cost-effective manner. Improving self-
management strategies is one way to decrease hospital and long-term 
care costs. Health professionals have developed telehealth programs 
that allow elderly patients to monitor and manage their symptoms at 
home by communicating with their providers over the phone or the 
internet. However, the effectiveness of telehealth interventions has 
not been well-studied. NINR investigators are currently testing a self-
management telehealth intervention for patients with heart failure. The 
investigators will study questions such as: Is the intervention more 
effective than traditional methods of treatment? Are elderly patients 
willing to use the new technology? Do these techniques save money? 
Findings from these studies may help providers better use technology in 
self-management. This could ultimately lead to a higher quality of life 
for patients, and lower health care costs for consumers.
    Caregivers and Depression.--An aging population also means that an 
increasing number of spouses and children will be caring for their 
infirm partners or parents. In addition to significant economic and 
societal costs,\1\ caregiving may also have serious negative health 
impacts. Caregiving can often be a stressful and time-consuming 
experience for those who take on the responsibility. NINR has funded a 
wide range of studies to analyze the burdens experienced by caregivers 
and develop methods to alleviate these burdens. One group of NINR 
researchers surveyed over 2,000 female caregivers of elderly veterans 
with dementia and found that over one-third of the caregivers exhibited 
symptoms of depression. However, less than one in five of those with 
depression were using antidepressants; Caucasians were twice as likely 
as African-Americans to be taking such medications. These results 
suggest that caregivers should be routinely screened for depression and 
that better efforts may be needed to educate informal caregivers about 
the potential benefits of antidepressant therapy.
---------------------------------------------------------------------------
    \1\ Langa KM, Chernew ME, Kabeto MU, Herzon AR, Ofstedal MB, Willis 
RJ, Wallace RB, Mucha LM, Straus WL, Fendrick AM, National Estimates of 
the Quantity and Cost of Informal Caregiving for the Elderly with 
Dementia. J Gen Intern Med 16: 770-778, 2001.
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                PATIENTS AND FAMILIES AT THE END OF LIFE

    The final stage of life is a challenging time for everyone 
involved, from the patient, to attending physicians and nurses, and to 
bereaved family and friends. NINR is the lead NIH institute for end-of-
life research. We are charged with finding ways to improve end-of-life 
care for all involved and ensure that patients experience death with as 
much dignity and comfort as possible. We fund research on such topics 
as: better management of symptoms prior to death; improving 
communication between doctors, patients, and family members; and 
examining factors that influence end-of-life decision-making. NINR 
researchers continue to make important findings in these areas.
    Communicating with Families at the End of Life.--One study found 
that physicians in intensive care units often fail in communicating 
with family members when discussing the withholding or withdrawal of 
care from a dying patient. Problems included failures to listen to the 
concerns or address the emotions of the family members. Physicians also 
failed to properly explain the uses and purpose of palliative care or 
the ethical basis for deciding to remove life-prolonging therapies. A 
better awareness of these gaps can help physicians and nurses improve 
their communication skills for talking to families in difficult times.

            NURSING SHORTAGES AND TRAINING NURSE RESEARCHERS

    The current aging of our population comes at a time when the supply 
of nurses in the United States cannot meet the demand. In addition, new 
advances in medical technology require a more technologically-savvy 
nursing workforce. There was a shortage of approximately 168,000 
registered nurses in the United States in 2003, and this shortage is 
expected to top 1 million by 2020. The field of nursing research is 
experiencing the effects of this shortage. Fewer nurses mean fewer 
nurse researchers, and that means fewer nursing faculty.
    NINR continues to fund innovative initiatives to train new nurse 
researchers. Our Nursing Partnership Centers to Reduce Health 
Disparities partner research-intensive universities with minority-
serving institutions to increase the number of researchers from 
underserved populations. We also continue to collaborate with 
universities on training students in fast-track baccalaureate-to-
doctoral programs to speed the process of developing new nurse 
scientists and faculty.

                        NINR AND THE NIH ROADMAP

    NINR has incorporated two key themes of the NIH Roadmap into its 
research agenda: Interdisciplinary Research Teams of the Future and Re-
engineering the Clinical Research Enterprise. Historically, NINR has 
maintained a focus on interdisciplinary research, but increased 
collaborations made possible by the Roadmap have fully introduced 
nursing science to the rest of the scientific community. They have also 
enabled nurse scientists to expand the breadth of their own work. 
Because of the strongly clinical emphasis of the NINR research 
portfolio, the Roadmap's clinical research initiatives are ideally 
suited to NINR. We will actively pursue Roadmap initiatives that seek 
to develop new technologies to measure patient symptoms and quality of 
life, and others that strive to develop skilled clinical investigators 
with strong multidisciplinary backgrounds.

                               CONCLUSION

    In conclusion, NINR continues to discover effective approaches to 
meeting the challenges of today's dynamic health care environment, 
while looking ahead to meet the health care needs of tomorrow. We will 
strive to improve the quality of care and quality of life for all 
individuals, especially the underserved, regardless of age or disease. 
We will also train the next generation of leaders in nursing research. 
The past twenty years have demonstrated the power of nursing research. 
The future holds endless opportunities.
    Thank you, Mr. Chairman. I will be happy to answer any questions 
that the Committee might have.
                                 ______
                                 
    Prepared Statement of Dr. Richard J. Hodes, Director, National 
                           Institute on Aging

    Mr. Chairman and Members of the Committee: The NIA is requesting an 
fiscal year 2007 budget of $1,039,828,000, a decrease of $6,803,000, or 
.6 percent below the fiscal year 2006 enacted level.
    Thank you for this opportunity to participate in today's hearing. I 
am Dr. Richard Hodes, Director of the National Institute on Aging, and 
I am pleased to be here today to tell you about our progress making and 
communicating scientific discoveries that will improve the health and 
well-being of older Americans.
    There are today approximately 35 million Americans ages 65 and 
over, according to the U.S. Bureau of the Census, and this number is 
expected to rise dramatically in the coming decades as members of the 
Baby Boom generation reach retirement age. These older Americans are 
more likely than at any other time in history to enjoy good health and 
an active lifestyle: Data from the National Long Term Care Survey 
(NLTCS) indicate that the rate of disability among older Americans 
dramatically declined from the 1980s through the mid 1990s, even among 
the ``oldest old,'' people age 85 and older. At the same time, however, 
the downward trend in disability among the elderly may be in danger of 
reversal. Data from the National Health Interview Survey show that, 
over the same period, the disability rate actually rose significantly 
for people ages 18-59, with the growing prevalence of obesity an 
important factor in this trend. Now, in fact, some demographers are 
forecasting a complete leveling-off of the disability decline in the 
coming decade.\1\
---------------------------------------------------------------------------
    \1\ Goldman DP et al. Consequences of Health Trends and Medical 
Innovations for the Future Elderly. Health Affairs online special issue 
``Health and Spending of the Future Elderly.'' R5-R17, 2005.
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    The mission of the National Institute on Aging (NIA) is to improve 
the health and well-being of older Americans through research. In 
support of its mission, the Institute conducts and supports an 
extensive program of research on all aspects of aging, from the basic 
cellular and molecular changes that occur as we age, to the prevention 
and treatment of common age-related conditions, to the behavioral and 
social aspects of growing older, including the demographic and economic 
implications of an aging society. In addition, the NIA is the lead 
Federal agency for research related to the all-important effort to 
prevent and treat Alzheimer's disease (AD). Finally, our education and 
outreach programs provide vital information to older people across the 
Nation on a wide variety of topics, including living with chronic 
conditions, maintaining optimal health, and caregiving.

           ALZHEIMER'S DISEASE AND THE NEUROSCIENCE OF AGING

    Alzheimer's disease is a devastating condition with a profound 
impact on individuals, families, the health care system, and society as 
a whole. Approximately 4.5 million Americans are currently battling AD, 
with annual costs for the disease estimated to exceed $100 billion.\2\ 
Moreover, the rapid aging of the American population threatens to 
increase this burden significantly in the coming decades: By 2050, the 
number of Americans with AD could rise to some 13.2 million, an almost 
three-fold increase.\3\
---------------------------------------------------------------------------
    \2\ Data from the Alzheimer's Association. See also Ernst, RL; Hay, 
JW. ``The U.S. Economic and Social Costs of Alzheimer's Disease 
Revisited.'' American Journal of Public Health 1994; 84(8): 1261--1264. 
This study cites figures based on 1991 data, which were updated in the 
journal's press release to 1994 figures.
    \3\ Hebert, LE et al. ``Alzheimer Disease in the U.S. Population: 
Prevalence Estimates Using the 2000 Census.'' Archives of Neurology 
August 2003; 60 (8): 1119-1122.
---------------------------------------------------------------------------
    Dr. Zerhouni has told this Committee about the NIH's new paradigm 
for biomedical research that is ``predictive, personalized, and 
preemptive.'' This vision greatly informs the NIA's comprehensive 
program of Alzheimer's disease research. NIA-supported investigators 
conduct research on topics across the spectrum of AD-related inquiry, 
from basic brain biology to clinical trials of potential interventions. 
Through these studies, we are uncovering new predictors of individual 
risk for AD, and using this information, along with a greater 
understanding of specific pathways mediating disease processes, we are 
developing new approaches to prevention and treatment.
    Risk Factors and Early Diagnosis.--Population studies suggest that 
conditions affecting the circulatory system may be associated with 
higher risk for dementia, or that the presence of vascular disease may 
influence the progression of AD. One recent report indicated that AD 
dementia may be exacerbated by other cerebrovascular problems such as 
small strokes, while another linked untreated high blood pressure in 
mid-life with increased risk of dementia in later life. The possible 
association of diabetes, insulin resistance, and AD is garnering 
increased attention as well; recent findings from at least four long-
term studies link diabetes with decline in cognitive function. The NIA 
recently funded two clinical trials to examine directly whether 
diabetes-related interventions might be effective in preventing or 
delaying cognitive decline or development of Alzheimer's disease.
    Research suggests that the earliest AD pathology begins to develop 
in the brain long before clinical symptoms yield a diagnosis; the 
ability to make an accurate early diagnosis of AD would be highly 
beneficial. Improvements in brain imaging, coupled with the development 
of more sensitive cognitive tests, are enabling us to diagnose AD in 
the research setting with greater precision than ever before. Imaging 
techniques may become important for a number of other reasons, 
particularly in helping investigators understand events unfolding in 
specific regions of the brain in the very early stages of Alzheimer's 
disease and in assessing the effectiveness of potential therapeutic 
strategies. To speed both the development of imaging techniques and the 
discovery of biological markers to detect Alzheimer's disease, the 
National Institute on Aging and other Federal partners, in conjunction 
with nine pharmaceutical/biotech companies, the Institute for the Study 
of Aging, and the Alzheimer's Association, announced the Alzheimer's 
Disease Neuroimaging Initiative in October 2004. The study will test 
whether serial MRI, PET, or other biological markers can be used in 
conjunction with clinical and neuropsychological assessment to measure 
earlier and with greater sensitivity the development and progression of 
mild cognitive impairment (MCI) and early Alzheimer's disease. This 
major public-private partnership could help researchers and clinicians 
develop new treatments and monitor their effectiveness as well as 
lessen the time and cost of clinical trials. The study, which is taking 
place at approximately 50 sites across the United States and Canada, 
began recruitment in late 2005; approximately 800 people ages 55 to 90 
will participate over the five years of the study.
    Prevention and Treatment.--Results of a growing number of studies 
are suggesting that diet and exercise may have significant benefits on 
not only physical but also cognitive health. For example, in one recent 
study, researchers related fruit and vegetable consumption among 13,388 
older women over a 10-16 year period to subsequent cognitive 
performance and found that women consuming the most green leafy 
vegetables experienced slower decline than women consuming the least 
amount. Long-term epidemiologic studies now also suggest that exercise 
may have a specific influence on aspects of cognitive decline, and 
researchers are hoping that clinical trials will be able to directly 
test the therapeutic value of exercise and diet for improved cognitive 
performance and, eventually, for reduced risk of AD. Small clinical 
trials currently are ongoing to test the effects of exercise on 
cognitive decline, both in older adults with normal cognition and in 
persons with mild cognitive impairment with memory decline; a larger 
trial that would include a cognitive component is in the planning 
stages. In addition, the planned Lifestyle Interventions and 
Independence for Elders (LIFE) study, which has been designed to 
determine whether physical exercise is effective for preventing major 
mobility disability or death, will include a cognitive component. 
Clinical trials are also ongoing to test the effects of a variety of 
dietary supplements, including antioxidants and alpha-lipoic acid, on 
cognition.
    Investigators are also searching for drugs that will be effective 
in stopping the progression of AD or, ultimately, preventing the 
disease altogether. Recently, investigators announced the discovery of 
the first agent shown to delay the clinical diagnosis of Alzheimer's in 
people with amnestic mild cognitive impairment, an MCI subtype strongly 
correlated with the later development of AD. The investigators found 
that individuals who took the drug donepezil (Aricept) were at reduced 
risk of progressing to a diagnosis of Alzheimer's disease during the 
first year of the trial, but by the end of the three-year study there 
was no benefit from the drug. Although donepezil's effects were 
limited, the results are nonetheless encouraging. And although too 
little is known about donepezil's long-term effects to support a 
recommendation for its routine use to forestall the diagnosis of AD in 
people with mild cognitive impairment, these findings do suggest that 
chemoprevention of AD is possible and support our hope that future 
clinical studies will lead to more significant progress.

                      OTHER AGING-RELATED RESEARCH

    Diseases of aging continue to affect many older men and women, 
seriously compromising their quality of life. Diseases and conditions 
currently under study at the NIA include:
    Obesity.--Overweight and obesity are widespread in the United 
States and are associated with an array of health problems, including 
heart disease, stroke, osteoarthritis, adult-onset diabetes, certain 
types of cancer and physical disability. NIH has assigned a high 
priority to research on obesity.
    These activities range from basic research on the genetic and 
biological mechanisms of overweight and obesity to human intervention 
studies. For example, recent studies of C. elegans, tiny worms 
frequently used for genetic studies, are providing important insights 
about fat regulation and storage that may that may be applicable in 
humans. NIA-supported researchers used RNA interference (RNAi), a 
technique in which genes are inactivated one at a time to determine 
their function, to screen the worm's genome and found some 417 genes 
involved with fat regulation and storage. Many of the genes they found 
have human counterparts, a number of which had not been previously 
implicated in the regulation of fat storage. The genes identified in C. 
elegans may ultimately suggest new targets for treating human obesity 
and its associated diseases.
    Research has also shown that many of the disabling conditions 
affecting older people could be diminished through regular exercise and 
that fitness affects mortality risk regardless of an individual's body 
fat. One study, which followed men 30-83 years of age for an average of 
eight years, found that within each category of body fatness, ``fit'' 
men--as measured by exercise testing--were at a lower risk of death. In 
addition, among fit men, obesity was not significantly related to risk 
of death. In another study, low fitness increased mortality risk in men 
approximately fivefold for cardiovascular disease and threefold for 
all-cause mortality. Low fitness was associated with higher mortality 
in all weight groups.
    At a 2004 NIA and Centers for Medicare and Medicaid Services (CMS) 
sponsored workshop, researchers used published findings and trends to 
postulate that if the United States were able to prevent obesity until 
a person reaches 65 years of age by adjusting the body mass index for 
all cohorts entering Medicare, we could realize a significant decline 
in the percent with heart disease and diabetes, a significant increase 
in the percent without disability, and a cost savings to Medicare on 
the order of $10 billion annually over the subsequent 30 years.\4\
---------------------------------------------------------------------------
    \4\ Lakdawalla, DN et al. The Health and Cost Consequences of 
Obesity Among the Future Elderly. Health Affairs on line special issue 
``Health and Spending of the Future Elderly.'' R30-41.
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    Heart disease.--Each year over 1 million Americans undergo 
angioplasty,\5\ Aa procedure in which a long, thin tube attached to a 
tiny balloon is used to access and widen a blood vessel at the site of 
narrowing or blockage. However, a significant number of these 
individuals go on to experience restenosis, or gradual narrowing of the 
artery at the site of the blockage; this condition is aggravated by the 
implanting of stents (tiny metal scaffolds placed inside the artery to 
hold it open). Restenosis usually occurs within six months of 
angioplasty and results from the migration of cells from the middle of 
the arterial wall into the inner layer of the artery, where they 
multiply and block normal blood flow. Recognizing that cell division is 
crucial to the development of restenosis, NIA scientists tested the 
anticancer drug paclitaxel (Taxol), which arrests cell division, as a 
means of preventing the tissue growth that leads to vessel narrowing, 
and found that stents coated with paclitaxel can delay restenosis both 
safely and effectively. The investigators obtained a patent for these 
paclitaxel-coated stents, and a cooperative research and development 
agreement was established with private industry partners to begin 
clinical testing. Today, paclitaxel is one of only two drugs that, when 
applied to stents, have been shown to safely reduce the incidence of 
restenosis in humans. FDA approval of paclitaxel-coated stents was 
granted in March 2004, and currently over 70 percent of the drug-
eluting stents used worldwide are paclitaxel-coated. Approximately 1.8 
million patients worldwide have received paclitaxel-coated stents to 
date.
---------------------------------------------------------------------------
    \5\ Data from the National Heart, Lung, and Blood Institute.
---------------------------------------------------------------------------
    Diabetes.--NIH investigators searching for potential treatments for 
type 2 diabetes conducted a study of the compound exendin-4, an analog 
of a hormone that is naturally released after eating and that can lower 
blood sugar in people with diabetes. The investigators found that 
exendin-4 is safe and effective, and in April 2004, the Food and Drug 
Administration approved exenatide (ByettaTM), a synthetic 
derivation of exendin-4, for the treatment of type 2 diabetes.

                  HEALTH COMMUNICATIONS AND PROMOTION

    The NIHSeniorHealth website continues to be a major initiative that 
enables the growing number of ``wired seniors'' to find credible aging-
related health information in an online format that is compatible with 
their cognitive and visual needs, as evidenced by NIH-supported 
research. Conceived by NIA and jointly developed with the National 
Library of Medicine (NLM), the website now includes 26 health topics 
developed by eleven NIH Institutes. Each month, 52,000 unique visitors 
browse over a half a million pages. NIHSeniorHealth serves as a model 
for web designers seeking to make sites accessible to older adults. To 
increase the number of older adults skilled in searching for health 
information online, NIA has developed and is evaluating a senior-
friendly Internet training curriculum geared around NIHSeniorHealth and 
NLM's MedlinePlus web site for those who train older individuals to use 
computers.
    Changes in public health policy may necessitate the development of 
new communications strategies and techniques targeted at older 
Americans, as was demonstrated with the passage of Medicare Part D, the 
``prescription drug benefit'' for U.S. seniors. NIA-supported 
researchers are currently using established datasets to rapidly collect 
information and analyze patterns of use under Medicare Part D; their 
findings have been communicated to the CMS on an ongoing basis and will 
inform the creation of new strategies for tailored communications that 
will assist older Americans in understanding and maximizing use of this 
important new program.
    Thank you for the opportunity to testify before this Subcommittee. 
I would be happy to answer any questions you may have.
                                 ______
                                 
  Prepared Statement of Dr. Sharon Hrynkow, Acting Director, Fogarty 
                          International Center

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2007 President's Budget for the Fogarty International 
Center (FIC). The fiscal year 2007 budget includes $66,681,000, which 
reflects an increase of $303,000 over the fiscal year 2006 enacted 
level of $66,378,000 comparable for transfers proposed in the 
President's request.
    Forty-seven years ago, Congressman John E. Fogarty noted, ``Time 
and time again, it has been demonstrated that the goal of better health 
has the capacity to demolish geographic and political boundaries and to 
enter the hearts and minds of men, women, and children in the four 
corners of the earth. It is an issue which serves as a forceful 
reminder of the oneness, the essential brotherhood of man.'' 
Congressman Fogarty, the visionary namesake of the National Institutes 
of Health's (NIH's) John E. Fogarty International Center for Advanced 
Study in the Health Sciences (Fogarty), recognized that when it comes 
to disease, we are truly one world. His words and those of his 
Congressional colleagues implored us to work for ``a healthy America, 
in a healthier world.''
    Today, Fogarty works to meet this goal in two ways: by supporting 
the whole of the NIH mission via international partnerships, and 
through the support of global health research and training programs 
aimed at improving the health of citizens in the United States and 
around the globe. As a nation, our interest in global health stems not 
only from humanitarian concerns, but also from an enlightened self-
interest. Such interests involve protecting our nation from imported 
diseases, and political and economic considerations--healthy, stable 
countries make strong allies and trading partners. In addition, through 
partnerships with scientists from around the world, we are able to 
identify new strategies and new understandings of disease processes, 
including HIV/AIDS, tuberculosis, and chronic diseases such as heart 
disease, that affect us all. I welcome this opportunity to relate 
Fogarty's progress over the past year and proposed plans for fiscal 
year 2007. While Fogarty's programs span over 20 topical areas, I will 
focus on three exemplars in this summary.

                      THE BATTLE AGAINST HIV/AIDS

    Fogarty continues to place a high priority on combating HIV/AIDS 
the deadliest pandemic of modern times. According to UNAIDS, an 
estimated 4.9 million people worldwide became newly infected with HIV 
in 2004--the highest number of new cases reported in any single year 
since the beginning of the pandemic. As the United States works to 
combat the spread of AIDS domestically and globally, trained scientists 
in countries hard-hit by AIDS are crucial allies in our fight. In the 
18-year history of Fogarty's flagship AIDS program, the AIDS 
International Research and Training Program (AITRP), Fogarty has helped 
train 2,000 health scientists, including Ph.D. and Masters level 
researchers from developing countries working on AIDS. More than 50,000 
have received short-course training in their home countries through 
this program. These scientists represent a substantial increase in the 
global capacity to fight AIDS and provide a wealth of allies in our 
international struggle.
    Haiti has the largest number of people living with AIDS in the 
Caribbean. For almost two decades, Fogarty has invested in research and 
public health infrastructure to combat the HIV/AIDS crisis there. Haiti 
has now begun to ``turn the corner on AIDS,'' according to Dr. Jean 
Pape, Haiti's leading AIDS researcher and long-standing Fogarty 
collaborator. As a result of Fogarty's work and that of partner 
agencies, HIV seroprevalence at a key sentinel site in Haiti dropped 
from 6.3 percent in 1993 to 2.9 percent in 2003.
    Due to this strong research base, Dr. Pape's institution received a 
grant from the President's Emergency Plan for AIDS Relief (PEPFAR), 
allowing 2,000 patients to receive antiretroviral therapy. An analysis 
of the first 1,000 patients at the one-year follow-up indicates 
outcomes comparable to those achieved in the United States in terms of 
survival; other indicators show reduced amounts of HIV in the blood of 
AIDS patients, as well as increased amounts of cells that are critical 
to staving off the impacts of HIV. None of this would have been 
possible without the vision and foresight of Fogarty, working hand in 
glove with NIH partners, including the National Institute of Allergy 
and Infectious Diseases.
    In fiscal year 2007, Fogarty plans to expand both major AIDS 
programs in its portfolio. The AITRP expansion would involve new U.S. 
universities, including minority institutions, important partners as we 
work to address global health challenges and the range of U.S. 
challenges on AIDS. In addition, Fogarty's new training program in 
clinical, operational and health services research would be expanded to 
build much needed expertise in monitoring and evaluating AIDS programs 
abroad.

ADDRESSING THE THREAT OF EMERGING AND RE-EMERGING INFECTIOUS DISEASES: 
                       PREDICTION AND PREEMPTION

    Little is known about the ecological factors that lead to the 
emergence or re-emergence of infectious diseases, including potentially 
pandemic diseases such as avian flu. We do know that most new diseases 
come from animals, both wild and domesticated. But beyond that we have 
little ability to predict the emergence of new diseases, or how new or 
existing diseases spread among animals, and from animals to humans. To 
better understand the relationships between ecological factors that 
drive emergence and transmission of infectious agents, and to develop 
predictive models that would suggest practical modes to interrupt 
disease spread, Fogarty led the development of a unique interagency 
program on the Ecology of Infectious Diseases (EID). The EID program 
fills a critical gap in our national effort to protect the health of 
the public--both in the United States and globally--against the threat 
of epidemic and emerging infectious diseases. The program links 
microbiologists, veterinarians, physicians, ecologists, geospatial 
scientists, and mathematical modelers together into transdisciplinary 
teams to create new knowledge and new methods to predict and prevent 
the spread of infectious disease. In its first years of operation, the 
EID program has already linked experts from 23 countries and has 
supported publication of over 200 scientific articles on dozens of 
human and wildlife diseases, including schistosomiasis, Hanta virus, 
cholera, and severe acute respiratory syndrome (SARS).
    SARS was first reported in southern China in the winter of 2002-
2003, and within a few months it had spread to over two dozen 
countries. Within a month of its discovery, SARS was recognized as a 
viral respiratory illness caused by a newly identified coronavirus 
(CoV), yet the origin of the virus and how it was initially transmitted 
to humans remained a mystery. Preliminary evidence suggested that the 
palm civet (a raccoon-like mammal common in live animal markets in 
southern China) might have spread the virus to humans. However, the 
occurrence of related viruses in bats led some to think these animals 
may have been involved. A team of Fogarty-funded researchers from the 
United States, China, and Australia collected and analyzed specimens 
from nine species of bats in their native habitats in southern China. 
The team studied the presence of antibodies to the SARS virus and 
performed genome sequencing of viral isolates from positive tissues, 
comparing these genome sequences to that of the SARS virus. Study 
results indicate that bats are the natural reservoir of the SARS virus, 
suggesting that palm civets played an intermediary role in human 
infections. These findings have major implications for development of 
public health strategies to combat the spread of SARS. In fiscal year 
2007, FIC expects to expand the EID program in terms of the number of 
projects supported and their scope, simultaneously increasing the focus 
on supporting translation of research findings and predictions into 
action.
    As we consider the daunting challenge of pandemic avian influenza, 
programs such as the EID can provide a critical component in our 
ability to predict and prevent emergence and transmission of this and 
other disease threats. The United States and its global partners will 
be better poised to make effective interventions to prevent the spread 
of avian flu through understanding of migration patterns of reservoir 
bird species, the interactions between humans, domestic animals and 
birds, and the pathogen dynamics in and among these hosts. We cannot 
predict the spread of this disease, in its current zoonotic form, using 
mathematical or statistical models if we do not support the fieldwork 
necessary to sample wild and domesticated birds (work done by 
ornithologists, veterinarians, and ecologists). The field data are 
useful only for post field analysis if we integrate them into 
predictive models. The interagency EID program is unique in its 
integration of these methods into interdisciplinary teams to understand 
the biology and predict disease emergence and transmission.

                 THE GLOBAL BURDEN OF TRAUMA AND INJURY

    According to the World Health Organization (WHO), the numbers and 
the global burden due to trauma and injury are on the rise: more than 
1.2 million people are killed in traffic accidents annually, and up to 
50 million more are injured or disabled. If current trends continue, 
the number of people killed and injured on the world's roads will rise 
by more than 60 percent between 2000 and 2020. Almost 90 percent of 
deaths due to injuries take place in poorer countries--this is true for 
all forms of such trauma including road accidents, war, homicides, and 
suicides. And, according to the Association for Safe International Road 
Travel, road traffic accidents are the second leading cause of death 
for Americans abroad.
    To address this growing challenge, Fogarty, working closely with 
the Centers for Disease Control and Prevention, WHO, the Pan American 
Health Organization, and eight other NIH institutes, initiated a 
research training program to build the capacity of developing country 
investigators and institutions to conduct human trauma and injury 
research. The International Collaborative Trauma and Injury Research 
Training (ICTIRT) program involves collaborators from United States and 
developing country institutions to train the next generation in basic 
and applied science, the epidemiology of risk factors, acute care and 
survival, rehabilitation, and the long-term mental health consequences 
of trauma and injury, including civil strife. Benefits of this program 
will accrue not only to developing countries but, as low-cost and 
effective strategies are identified, to communities around the world. 
This program was initiated with awards in fiscal year 2005 and fiscal 
year 2006. We anticipate new awards in fiscal year 2006 and fiscal year 
2007.

                               CONCLUSION

    The programs and international initiatives of the Fogarty 
International Center are a living testament to the vision of 
Congressman John E. Fogarty. As we consider the daunting global 
challenges of AIDS, avian influenza and chronic problems, including 
obesity and mental health disorders, we understand the 
interconnectedness of the United States and the global community. These 
challenges require us to move forward with efficiency and diplomacy, 
for the benefit of the American people and the global community.
                                 ______
                                 
Prepared Statement of Dr. Thomas R. Insel, Director, National Institute 
                            of Mental Health

    Mr. Chairman and members of the Committee: I am pleased to present 
the fiscal year 2007 President's budget request for the National 
Institute of Mental Health (NIMH). The fiscal year 2007 budget includes 
$1,394,806,000, which reflects a decrease of $8,709,000 under the 2006 
enacted level of $1,403,515,000 comparable for transfers proposed in 
the President's request. In my statement, I will call to your attention 
our Nation's most prevalent mental and behavioral disorders and include 
a brief review of our research activities and accomplishments.

                 THE BURDEN AND COST OF MENTAL ILLNESS

    Mental disorders are common, chronic, and disabling. They cause 
more disability than any other class of communicable medical illness in 
American adults under age 45, according to the World Health 
Organization's Global Burden of Disease report. The National 
Comorbidity Survey Replication (NCS-R), funded by NIMH and released in 
May 2005, documents the prevalence and severity of specific mental 
disorders in the United States. The study shows that half of all 
lifetime cases of mental illness begin by age 14, making these the 
chronic diseases of the young. About 6 percent of the U.S. population 
is afflicted with a severely disabling mental disorder in a given year. 
Most troubling, this landmark study has demonstrated that despite 
effective treatments, there are long delays--sometimes decades--between 
first onset of symptoms and when people seek and receive treatment.
    The cost in human suffering from these mental diseases is 
compounded further by their economic burden. According to the 
President's New Freedom Commission on Mental Health (2003), individuals 
with serious mental illnesses represent the single largest diagnostic 
group (35 percent) on the Supplemental Security Income (SSI) rolls. 
Medicaid is the largest single payer of mental health services, with 
more than 50 percent of all mental health expenditures paid for by the 
public sector (including Medicaid, Medicare, state and local 
governments.
    The good news is that there now are some extraordinary new tools 
and technologies, such as neuroimaging and genomics, with which to 
address these urgent public health needs. Our major challenge is to 
integrate and translate basic research discoveries and technological 
advances into practical strategies that can help all communities, 
including children, the socioeconomically disadvantaged, and others 
facing barriers to mental health care.

                     ENVISIONING PERSONALIZED CARE

    Research efforts stemming from former President George Bush's 
proclamation of the 1990s as the Decade of the Brain established that 
mental disorders (autism, bipolar, depression, schizophrenia, and 
others) are brain disorders. The current decade is one in which many 
major candidate molecules, cells, and circuits for normal and abnormal 
brain function are being identified for the first time. Through these 
discoveries research will definitively identify the specific brain 
pathways that underlie each of the major mental disorders. By 
identifying the features of the brain that go awry in mental illnesses, 
we will have clear new targets to test how biological, behavioral, and 
environmental factors affect illness and to develop more effective 
interventions with the ultimate vision of delivering personalized care 
through pre-emptive treatments and strategic preventions.
    Currently, there are effective treatments for many mental disorders 
such as depression and anxiety disorders. Studies show that even from a 
business standpoint, treating these disorders is highly cost-effective; 
national business groups are encouraging employers to support such 
treatments in order to reduce healthcare costs while also improving 
productivity and reducing absenteeism.
    Not all treatments work for everyone, however, and clearly there 
remains room for improvement in both diagnosis and treatment. In mental 
disorders, just as in the rest of medicine, diagnosis should rely on 
detection of biomarkers of the specific disease, and treatments should 
be based on medication and/or behavioral interventions targeting 
specific brain regions and processes. For a person with mental illness, 
one can imagine that a future clinician would use a cognitive task 
together with neuroimaging and genetics to diagnose and select a 
specific treatment, just as a contemporary cardiologist uses a stress 
test and echocardiogram to diagnose ischemic heart disease and select 
the proper intervention.
    It is critical to realize that this vision does not mean designing 
exotic technologies for a few privileged patients. The ultimate goal is 
personalized or individualized care for a broad spectrum of people with 
mental disorders. Now, specific treatments for any given patient are 
largely developed through trial and error. As researchers learn more 
about the brain pathophysiology of mental disorders and related 
behavioral and environmental factors, treatments will become more 
specific. Early detection of mental illnesses will require a thorough 
understanding of the range of risks that affect brain processes, which 
in turn is based on a comprehensive understanding of genetics and 
experience.

                       PRACTICAL CLINICAL TRIALS

    As noted above, we have treatments that are helpful for nearly all 
of the mental disorders. But these treatments are not optimal; recovery 
is often slow, incomplete, and compromised by adverse effects. Since we 
do not know who will respond completely and who will develop adverse 
effects, each clinician depends on trial and error with each patient. 
The Institute has developed practical clinical trials in more than 
10,000 patients to help clinicians individualize treatments. Practical 
clinical trials, or ``effectiveness studies,'' are designed to examine 
changes in symptoms and functioning, changes which are vital to 
determining whether a treatment improves quality of life, caregiving 
burden, or health service use. The designs of practical clinical trials 
help increase relevancy to real-world clinical practice to help 
clinicians answer the question: what is the best treatment for my 
patient? Each of the following NIMH-funded practical clinical trials 
provides results from the largest and longest studies of their kind.
    In the Clinical Antipsychotic Trials of Intervention Effectiveness 
(CATIE) Study, 1,432 schizophrenia patients from 56 sites, including 
private practices, community health care centers, and state facilities, 
were randomly assigned to treatment with one of five medications for 18 
months. In the first phase of analysis the study found that newer, 
``atypical'' antipsychotics are not much more effective than older, 
conventional antipsychotics; however all the medications studied have 
unique side effect profiles, some of which include significant weight 
gain and metabolic side effects, thus increasing risk for diseases such 
as diabetes. Later phases of this study will examine crucial issues 
including effects of switching from one treatment to another, use of 
health services, and cost-effectiveness.
    Another example is the Treatment for Adolescents with Depression 
Study (TADS), which compared short- and longer-term effectiveness of 
medication and psychotherapy for depression in 439 adolescents. TADS 
was designed to test best-practice care for depression and was carried 
out by 13 academic and community clinics across the country. 
Researchers found that fluoxetine (a selective serotonin reuptake 
inhibitor) in combination with cognitive behavioral therapy was more 
effective against adolescent depression than either one alone. In 
addition, clinically significant suicidal thinking was greatly reduced 
in all four treatment groups, with those receiving medication combined 
with cognitive therapy showing the greatest reduction. This is an 
especially important finding, considering recent concerns that the use 
of antidepressant medications themselves may induce suicidal behavior 
in youths. This study shows that treatment leads to a significant 
improvement of depression overall. It is vital that all patients being 
treated for depression be closely monitored.
    The Sequenced Treatment Alternatives to Relieve Depression Trial 
(STAR-D) examines 4,041 adults with major depression, particularly 
those who previously showed poor outcomes to treatment, to see if 
switching medications or augmenting the initial drug be more likely to 
achieve a remission. The study, conducted at 41 sites coordinated by 14 
regional centers, will also answer how the side effects of the various 
medications compare and how psychotherapy compares with medication for 
treatment-resistant depression.
    In the Systematic Treatment Enhancement Program for Bipolar 
Disorder (STEP-BD) trial, 4,360 participants with bipolar disorder from 
20 private, state, and community practice sites underwent various 
treatment pathways to find the most effective long-term and acute 
treatments and ways to prevent relapse. In the first phase, slightly 
more than half of the first group of 1,469 participants (58 percent) 
achieved recovery. In addition, almost half of the recovery group had a 
recurrence during the follow-up period, and the majority (70 percent) 
of recurrences was characterized by a return to a depressive state. In 
the following phases of the trial, not yet published, various 
treatments will be tried such as mood-stabilizing medications, 
antidepressants, atypical antipsychotics, and various ``talk'' 
therapies, to see which is best for acute treatment, long-term 
treatment, and prevention of relapse.

                  NIMH INITATIVES FOR FISCAL YEAR 2007

    To further advance the vision of personalized mental health care, 
NIMH will pursue two collaborative initiatives in fiscal year 2007. The 
first is the Autism Phenome Project, in collaboration with the NIH 
Autism Coordinating Committee, the Centers for Disease Control and 
Prevention, and the Department of Energy. Just as the Human Genome 
Project identified the sequence and organization of human DNA, the 
phenome project seeks to identify the various clinical characteristics 
(phenotypes) and subtypes of autism and autism spectrum disorders. 
Identifying specific phenotypic subtypes will aid research on genetic 
and other potential causes and suggest more specific approaches to 
treatment.
    The second collaborative initiative is with the Department of 
Defense (DOD) and the Department of Veterans Affairs (VA) to study the 
mental health needs of active duty, National Guard, and Reserve 
personnel including their transition to VA health services. In 
particular, representative groups of men and women will be studied over 
time to assess post-deployment adjustment difficulties (including post-
traumatic mood and anxiety disorders, and substance use and abuse 
disorders), the development and effectiveness of early detection and 
intervention methods, and the possibility of decreasing the risk of 
developing chronic conditions, disability, and death in those with 
adjustment difficulties.
    These initiatives, in conjunction with the exciting research 
already underway, will enable NIMH to make significant gains in the 
upcoming years. We intend to realize our vision of translating basic 
research and technologies to improved diagnosis, treatment, and 
preventive strategies that will allow development of personalized 
mental health care for the millions of Americans affected by mental 
illnesses.
                                 ______
                                 
Prepared Statement of Dr. Stephen I. Katz, Director, National Institute 
           of Arthritis and Musculoskeletal and Skin Diseases

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2007 President's budget request for the National 
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). 
The fiscal year 2007 budget includes $504,533,000, a decrease of 
$3,399,000 below the fiscal year 2006 enacted level of $507,932,000.
    The NIAMS was created by an Act of Congress nearly 20 years ago, 
and since its inception, the Institute has contributed to significant 
research progress in areas of public health importance across diseases 
that are common, costly, and have a major impact on quality of life, 
disability, and mortality. Research milestones in the history of the 
Institute include the development of life-saving treatments for kidney 
failure in patients with lupus, and ground-breaking work to uncover the 
genetic bases of periodic fever syndromes that affect both children and 
adults, among many others.
    Most recently, investments that NIAMS made as a result of the NIH 
budget doubling are bringing results that will directly benefit 
patients. These include support for large-scale clinical trials in 
areas of high public health impact, such as osteoporosis and back pain; 
efforts in biomarkers research and epidemiology studies for common 
conditions such as osteoarthritis, as well as uncommon, but often 
devastating, disorders such as scleroderma; and new initiatives in 
translational research for diseases such as muscular dystrophy. Looking 
to the future, NIAMS will continue its commitment to fund outstanding 
science across a broad spectrum to enable us to better understand, 
treat, and, ultimately, prevent diseases of the bones, joints, muscles, 
and skin.

                          PREVENTIVE MEDICINE

    The NIAMS has made significant investments in studies to identify 
risk factors and biomarkers of disease, in an effort to facilitate the 
early identification of signs and symptoms, and to develop 
interventions that are more effective. This is particularly important 
from a public health perspective for common conditions such as 
osteoporosis and osteoarthritis that already afflict tens of millions 
of Americans, and will affect even more as the U.S. population ages in 
the coming decades.
    In the area of osteoporosis, the NIAMS, along with the National 
Institute on Aging, has provided steady support for the Study of 
Osteoporotic Fractures (SOF), a multi-site clinical investigation to 
determine the risk factors for osteoporotic fractures in older women. 
Begun in 1986, SOF scientists recruited 9,704 white women aged 65 and 
older from 4 metropolitan areas for this study. In 1997, an additional 
662 African American women who are now seen with the original cohort 
were enrolled. Major contributions from this long-term study include 
the findings that bone mineral density (BMD) of the hip is the best 
predictor of all types of fractures, and that weight loss and parental 
history of hip fractures are among the most important risk factors for 
this condition. SOF investigators have also learned that the 
relationship of BMD and fracture risk is similar in white and African 
American women, but that at every level of BMD, fracture rates are 30 
to 40 percent lower in African American women. These insights are 
providing clinicians with important information about which women are 
at most risk for this debilitating disease, so that prevention 
strategies may be used more effectively. Similar epidemiological 
studies have now been launched to learn about risk factors for 
osteoporosis in men.
    With respect to osteoarthritis, the NIAMS partnered with the 
National Institute on Aging, several other NIH components, and four 
pharmaceutical companies in establishing the Osteoarthritis Initiative, 
a public-private partnership aimed at developing clinical research 
resources that support the discovery and evaluation of biomarkers and 
surrogate endpoints for osteoarthritis clinical trials. For the first 
time, a public-private partnership is bringing together new resources 
and commitments to help find biological markers for the onset and 
progression of osteoarthritis. Recruitment of participants is actively 
underway, and by the end of fiscal year 2005, more than 3,800 
participants have been recruited. One year follow-up measurements have 
been carried out on over 1,000 participants, and will continue for the 
next 4 years. All data and images collected will be available to 
researchers worldwide to help quicken the pace of scientific studies 
and biomarker identification. This consortium serves as a model for 
future endeavors that link the public and private sectors.

                            COMPLEX GENETICS

    The NIAMS is taking full advantage of the explosion of information 
related to genetics, genomics, and proteomics to pursue the causes of 
complex diseases, and how best to treat them. This includes recent work 
which identified a genetic variation that doubles the risk of 
developing rheumatoid arthritis. Scientists have long suspected that 
autoimmune diseases such as rheumatoid arthritis result from a 
combination of genetic and environmental factors. Now, a NIAMS-funded 
research team has identified a specific genetic variation, called a 
single nucleotide polymorphism or SNP, that increases rheumatoid 
arthritis risk twofold. The SNP is located within a gene that codes for 
a particular enzyme that is known to be involved in controlling the 
activation of white blood cells, called T cells, that play an important 
role in the body's immune system. Under normal conditions, the enzyme 
works as a negative regulator: it inactivates a specific signaling 
molecule which, in turn, interrupts the communications and keeps immune 
cells from becoming overactive. However, in cases where the SNP is 
present in one or both copies of a person's genes for this enzyme, the 
team found that the negative regulation by the enzyme appears to be 
inefficient, allowing T cells and other immune cells to respond too 
vigorously, causing increased inflammation and tissue damage. The 
implications of this finding go beyond a better understanding of 
rheumatoid arthritis risk. It may also help explain why different 
autoimmune diseases tend to run in families, since this gene variant is 
also found in diabetes and lupus.
    In other efforts, researchers have recently made breakthroughs in 
understanding the genetics underlying psoriasis, a chronic skin disease 
characterized by scaling and inflammation. This disorder occurs when 
skin cells rapidly pass from their origin below the surface of the skin 
and pile up on the surface before they have a chance to mature. Usually 
this movement (also called turnover) takes about a month, but in 
psoriasis it may occur in only a few days. Recent studies funded by the 
NIAMS are helping scientists and doctors to understand the disease 
process at the molecular level, and what role genes play in 
predisposing people toward psoriasis. In one such project, researchers 
investigated the role of both genes and the environment in psoriasis, 
psoriatic arthritis, and atopic dermatitis, another inflammatory skin 
condition. The researchers found similarities in genetic susceptibility 
for psoriasis and atopic dermatitis. As for psoriatic arthritis--a 
condition in which inflamed joints produce symptoms of arthritis for 
patients who have or will develop psoriasis--they found that the 
presence of modifier genes can indicate which people with psoriasis are 
also at risk for psoriatic arthritis.

                         TRANSLATIONAL RESEARCH

    A key ingredient in research success is translation: work to bring 
insights from the laboratory bench to the patient bedside, and back 
again, with the ultimate goal of improving patient care and public 
health. In this vein, NIAMS has recently launched a new program to 
bring together basic and clinical scientists in a targeted and 
organized way. The Centers of Research Translation (CORT) program 
emphasizes the translation of results from basic to clinical studies, 
as well as translating findings from clinical research to enhance and 
focus the approaches used in basic studies--all with the goal of 
improving public health.
    This commitment to translational research is bringing results in 
many areas, including the field of muscular dystrophy research. NIAMS 
supports two of the six Senator Paul D. Wellstone Muscular Dystrophy 
Cooperative Research Centers: the first, at the University of 
Pittsburgh, focuses on gene and stem cell therapies to treat muscle 
disease; and the second, located at the University of Pennsylvania, is 
examining strategies to inhibit muscle degeneration and promote muscle 
growth. These centers promote side-by-side basic, translational, and 
clinical research; provide resources that can be used by the national 
muscular dystrophy and neuromuscular communities; and provide training 
and advice about muscle diseases for researchers and clinicians.
    The Institute has also launched new initiatives to encourage 
translational research in all forms of muscular dystrophy, and to 
stimulate career development opportunities for muscle disease 
researchers. These efforts are designed to facilitate the development 
of new and more effective treatments for muscular dystrophy, and to 
increase the number and quality of investigators in basic, 
translational, and clinical research focused on this disease.

                         REGENERATIVE MEDICINE

    Regenerative medicine--a multidisciplinary field that involves the 
life, physical, and engineering sciences--is an emerging area of 
research that cuts across several NIAMS programs. For example, 
important advances have been made recently in the development of 
promising new polymers for cartilage repair. Cartilage is a tissue that 
lacks capacity for self-repair. However, multidisciplinary studies by 
biologists, engineers, physicians, and other are providing new 
strategies for treating degenerative cartilage that may result in 
treatments for articular cartilage lesions. Researchers funded by the 
NIAMS have developed a class of injectable materials based on a 
biodegradable polymer, OPF (oligo-polyethylene glycol fumarate), for 
cartilage tissue engineering. Short-term studies in experimental 
animals demonstrated excellent tissue filling and integration resulting 
from implantation of these materials into cartilage defects. The 
polymers were also designed to deliver bioactive molecules (such as 
growth factors) as well as cells (such as chondrocytes or progenitor 
cells) to cartilage lesions to enhance tissue repair. Early results 
show that chondrocytes remain viable, proliferate, and synthesize 
cartilage matrix components in these polymer gels. Taken together, 
these results indicate that OPF gels are promising materials for cell 
delivery in cartilage repair strategies.

                               CONCLUSION

    The scientific advances and innovative initiatives highlighted 
above paint a picture of research progress that has benefited millions 
of American children and adults. In the coming fiscal years, NIAMS will 
focus on strategic collaborations by building partnerships to pursue 
shared goals across public, academic, and private research entities. A 
primary example of such a coordinated effort is the Collaborative 
Initiative on Bone Strength. NIAMS--in conjunction with other NIH 
components, the Food and Drug Administration, and industry partners--is 
exploring a potential public-private collaboration on bone strength. 
The main goals of such an initiative would be to provide data 
supporting the use of new bone strength markers as surrogate endpoints 
for fractures in clinical trials, and to find measurements that predict 
risk of fracture more accurately than does bone density. This would 
facilitate the continued development and approval of new treatment 
alternatives to prevent fractures through the support of clinical 
trials that are smaller, shorter, and less expensive than current 
studies.
    Finally, NIAMS is placing a high priority on strengthening the 
pipeline of well-trained investigators across the Institute's areas of 
research interest. This commitment includes funding for the new NIH 
award program, ``Pathway to Independence,'' to support young 
investigators, as well as an enhanced emphasis on basic, translational, 
and clinical training at the major research centers supported by NIAMS. 
All of these activities are driven by our dedication to fulfill the 
mandate that Congress gave the Institute when it created NIAMS; namely, 
to reduce the burden of illness and to enrich the quality of life for 
all Americans affected by diseases within our mission.
                                 ______
                                 
 Prepared Statement of Raynard Kington, Deputy Director, Office of the 
                                Director

    Mr. Chairman, Members of the Committee: I am pleased to present the 
fiscal year 2007 President's budget request for the Office of the 
Director (OD). The fiscal year 2007 budget includes, $667,825,000, an 
increase of $140,259,000 over the fiscal year 2006 appropriation of 
$527,566,000 comparable for transfers proposed in the President's 
request. The OD provides leadership, coordination, and guidance in the 
formulation of policy and procedures related to biomedical research and 
research training programs. The OD also is responsible for a number of 
special programs and for management of centralized support services to 
the operations of the entire NIH.
    The OD guides and supports research by setting priorities; 
allocating funding among these priorities; developing policies based on 
scientific opportunities and ethical and legal considerations; 
maintaining peer review processes; providing oversight of grant and 
contract award functions and of intramural research; communicating 
health information to the public; facilitating the transfer of 
technology to the private sector; and providing fundamental management 
and administrative services such as budget and financial accounting, 
and personnel, property, and procurement management, administration of 
equal employment practices, and plant management services, including 
the implementation of environmental and public safety regulation. The 
principal OD offices providing these activities include the Office of 
Extramural Research (OER), the Office of Intramural Research (OIR), and 
the Offices of: Science Policy; Communications and Public Liaison; 
Legislative Policy and Analysis; Equal Opportunity; Budget; and 
Management. This request contains funds to support the functions of 
these offices. In addition, the OD also maintains several trans-NIH 
offices and programs to foster and encourage research on specific, 
important health needs. I will now discuss the budget request for the 
OD in greater detail.

                    NIH ROADMAP FOR MEDICAL RESEARCH

    Responding to 21st Century biomedical challenges, the NIH Roadmap 
for Medical Research serves as a test bed for trans-NIH programs 
designed to accelerate the pace and translation of biomedical 
discovery. Derived from stakeholder input, Roadmap initiatives are 
bearing fruit with infrastructure, tools and training programs that 
serve and intersect the needs of NIH research disciplines and missions. 
Several large initiatives follow a ``hub-and-spoke'' model that 
connects projects and research centers to one another and to the 
research community at large. For example, the National Centers of 
Biomedical Computing have created a networking `hub' to cooperatively 
develop a number of computing resources that are being followed quickly 
by investigator-initiated projects (spokes) that will use and assess 
these resources. Recognizing that gaps in scientific knowledge can be 
filled in many types of ways, the Roadmap invests in people with 
innovative, high-risk ideas and in programs and training to foster the 
development of new research teams and disciplines. Re-engineering of 
clinical research is also underway with efforts to harmonize research 
policies, develop tools to examine patient-reported outcomes, integrate 
clinical research networks, and accelerate multidisciplinary and 
translational research training. The NIH Roadmap for Medical Research 
is lowering barriers to biomedical research and harnessing the 
collective knowledge from multiple disciplines to make the next great 
leap forward in biomedical discovery. The fiscal year 2007 budget 
request for NIH Roadmap for Medical Research is $110,700,000, an 
increase of $28,530,000 over the fiscal year 2006 level.

                        OFFICE OF AIDS RESEARCH

    The Office of AIDS Research (OAR) plays a unique role at NIH, 
establishing a roadmap for the AIDS research program. OAR coordinates 
the scientific, budgetary, legislative, and policy elements of the NIH 
AIDS research program. Our response to the AIDS epidemic requires a 
unique and complex multi-institute, multi-disciplinary, global research 
program. Perhaps no other disease so thoroughly transcends every area 
of clinical medicine and basic scientific investigation, crossing the 
boundaries of the NIH Institutes and Centers. This diverse research 
portfolio demands an unprecedented level of scientific coordination and 
management of research funds to identify the highest priority areas of 
scientific opportunity, enhance collaboration, minimize duplication, 
and ensure that precious research dollars are invested effectively and 
efficiently, allowing NIH to pursue a united research front against the 
global AIDS epidemic. OAR oversees the development of the annual 
comprehensive trans-NIH AIDS-related research plan and budget, based on 
scientific consensus about the most compelling scientific priorities 
and opportunities that will lead to better therapies and prevention 
strategies for HIV disease. The Plan serves as the framework for 
developing the annual trans-AIDS research budget; for determining the 
use of AIDS-designated dollars; and for tracking and monitoring those 
expenditures. OAR also identifies and facilitates multi-institute 
participation in priority areas of research and facilitates NIH 
involvement in international AIDS research activities. The fiscal year 
2007 budget request for OAR is $59,290,000, which is a decrease if 
$1,000,000 below the fiscal year 2006 level.

                  OFFICE OF RESEARCH ON WOMEN'S HEALTH

    The Office of Research on Women's Health (ORWH), the focal point 
for women's health research for the Office of the Director, 
strengthens, enhances and supports research related to diseases, 
disorders, and conditions that affect women, and sex/gender studies on 
differences/similarities between men and women; ensures that women are 
appropriately represented in biomedical and biobehavioral research 
studies supported by the NIH to facilitate analyses by sex/gender; and 
develops opportunities for the advancement of women in biomedical 
careers and investigators in women's health research. ORWH is 
developing a novel initiative, entitled Advancing Novel Science in 
Women's Health Research (ANSWHR), with the NIH ICs to support 
innovative research in women's health and sex/gender issues. ORWH will 
continue funding for new or continuing programs through new RFAs for 
its highly successful interdisciplinary programs: Specialized Centers 
on Research (SCORs) Affecting Women's Health and Building 
Interdisciplinary Research Careers in Women's Health (BIRCWH). 
Reissuance of these interdisciplinary programs will insure the 
continuation of advances in sex and gender factors in women's health 
research and the mentored development of junior faculty by bridging 
advanced training with research independence resulting in more clinical 
researchers performing in women's health research. The fiscal year 2007 
budget request is $$40,949,000, which is the same as the fiscal year 
2006 level.

           OFFICE OF BEHAVIORAL AND SOCIAL SCIENCES RESEARCH

    The NIH's long history of funding behavioral and social sciences 
research has contributed significantly to our understanding, treatment, 
and prevention of disease and to the promotion of health and well-
being. To further NIH's ability to capitalize on such opportunities, 
Congress established the Office of Behavioral and Social Sciences 
Research (OBSSR) to provide leadership in developing research programs 
that are likely to improve our understanding of processes underlying 
health and disease and to provide directions for intervention. OBSSR 
works to ensure that behavioral and social sciences research is 
integrated into the greater NIH health research enterprise.
    As Secretary Leavitt's announcement of the Genes, Environment and 
Health Initiative (GEHI) made clear, very little is known about how 
various characteristics of the environment interact with genetics to 
influence susceptibility to illness. The GEI's focus is interactions 
among genetics, environmental toxins and individual behaviors (dietary 
intake and physical activity) that influence the risk of developing a 
number of common diseases. Based on recommendations from an OBSSR-
supported Institute of Medicine study examining the state of the 
science on gene-social environment interactions, OBSSR is collaborating 
with ICs to develop research initiatives at the interface of social and 
genetic factors and health. Moreover, the office is initiating training 
institutes in genetics for behavioral and social scientists to provide 
them with the expertise they need to function in interdisciplinary 
research teams working in this area.
    Another area of trans-NIH emphasis has been effective design, 
communication and implementation of health and clinical information to 
ensure optimal outcomes across groups of diverse stakeholders. OBSSR's 
participation in the ``Dissemination and Implementation Research in 
Health'' program will help identify and overcome many barriers to the 
widespread adoption of evidence-based social and behavioral 
interventions to treat and prevent illness. The promise of these 
efforts lies in their potential to improve treatment and prevention of 
illness, the use of these tools to address disparities in health 
outcomes, and the possibility of demonstrating opportunities for more 
cost-effective health policy and practice.
    To continue such groundbreaking work in the behavioral and social 
sciences, the fiscal year 2007 budget request for OBSSR is $26,121,000, 
the same amount as the fiscal year 2006 level.

                      OFFICE OF DISEASE PREVENTION

    The primary mission of the Office of Disease Prevention (ODP) is to 
stimulate disease prevention research across the NIH and to coordinate 
and collaborate on related activities with other federal agencies as 
well as the private sector. There are several other offices within the 
ODP organizational structure.
    The Office of Medical Applications of Research (OMAR) has as its 
mission to work with NIH Institutes, Centers, and Offices to assess, 
translate and disseminate the results of biomedical research that can 
be used in the delivery of important health interventions to the 
public. The ODP has two additional specific programs/offices that place 
emphasis on particular aspects of the prevention and treatment of 
disease the Office of Dietary Supplements (ODS) and the Office of Rare 
Diseases (ORD).
    In fiscal year 2007, the ODS requests a budget of $26,807,000, the 
same amount as the fiscal year 2006 level. ODS promotes the scientific 
study of the use of dietary supplements by supporting investigator-
initiated research, and stimulating research through the conduct of 
conferences and presentations at national and international meetings. 
Other current ODS efforts include:
  --Sponsorship of systematic reviews on the efficacy and safety of 
        dietary supplements in reducing the risk of chronic diseases 
        such as cancer and heart disease.
  --Collaborations for the development, validation, and dissemination 
        of analytical methods and reference materials for dietary 
        supplements.
  --Support for and development of databases of dietary supplement 
        information including:
    --National Health and Nutrition Examination Survey (NHANES);
    --Collaboration with USDA to develop an analytically-based database 
            of dietary supplement ingredients;
    --Plan to develop a dietary supplement label database;
    --International Bibliographic Information on Dietary Supplements 
            (IBIDS);
    --CARDS, a database of federally funded research on dietary 
            supplements.
  --Collaboration with other federal agencies to develop a coordinated 
        approach to assessment of the health effects of bioactive 
        factors in food and dietary supplements.
  --Publishing Fact Sheets on dietary supplements for consumers.
    Another component of ODP, the ORD, was formally established through 
the Rare Diseases Act of 2002, Public Law 107-280. The budget request 
for fiscal year 2007 for ORD is $15,548,000, the same amount as the 
fiscal year 2006 level. The following are highlights of ORD activities: 
(1) An Extramural Rare Diseases Clinical Research Network that involves 
10 consortia with 70 sites, and 30 patient support organizations for 
almost 50 rare diseases. Twenty-two clinical protocols have been 
approved and another 25 will be developed during 2006. (2) ORD provides 
support for 20 Bench-to-Bedside research projects in the NIH Intramural 
Research Program and supports collaborative research efforts with the 
National Human Genome Research Institute. (3) ORD also co-funds with 
the NIH institutes and centers approximately 80 to 100 scientific 
conferences per year to identify scientific opportunities or stimulate 
research where it is lagging or lacking. (4) To assist the rare 
diseases research community and patients with rare diseases, ORD 
initiated a pilot program to develop genetic tests from gene 
discoveries in the research laboratories to the clinic. (5) ORD is 
developing a Web-based database of rare diseases bio-specimen 
repositories in the United States to facilitate access to human 
biomaterials for research.

                      OFFICE OF SCIENCE EDUCATION

    The Office of Science Education (OSE), within the Office of Science 
Policy, develops science education programs to enhance efforts to 
attract young people to biomedical and behavioral science careers and 
to improve science literacy in both adults and children. The OSE 
creates programs to improve science education in schools (the NIH 
Curriculum Supplement Series); creates programs that stimulate interest 
in health and medical science careers (LifeWorks Web site); creates 
programs to advance public understanding of medical science, research, 
and careers; and advises NIH leadership about science education issues. 
Programs target diverse populations including under-served communities, 
women, and minorities, with a special emphasis on the teachers of 
students from Kindergarten through grade 12. The OSE Web site is a 
central source of information about available education resources and 
programs, http://science.education.nih.gov. The fiscal year 2007 budget 
request for OSE is $3,839,000, the same as the fiscal year 2006 level.

                 LOAN REPAYMENT AND SCHOLARSHIP PROGRAM

    The NIH, through the Office of Loan Repayment and Scholarship 
(OLRS), administers the Loan Repayment and Undergraduate Scholarship 
Programs. The NIH Loan Repayment Programs (LRPs) seek to recruit and 
retain highly qualified physicians, dentists, and other health 
professionals with doctoral-level degrees to biomedical and behavioral 
research careers by countering the growing economic disincentives to 
embark on such careers, using as an incentive the repayment of 
educational loans. There are loan repayment programs designed to 
attract individuals to clinical research, pediatric research, health 
disparities research, and contraception and infertility research, and 
to attract individuals from disadvantaged backgrounds into clinical 
research. The AIDS, intramural Clinical, and General Research Loan 
Repayment Programs are designed to attract investigators and physicians 
to the NIH's intramural research and research training programs. The 
NIH Undergraduate Scholarship Program (UGSP) is a scholarship program 
designed to support and enhance the training of undergraduate students 
from disadvantaged backgrounds in biomedical research careers and 
employment at the NIH. For fiscal year 2006, the UGSP plans to award 
scholarships and provide funding for summer internship service pay-back 
for twenty (20) individuals and provide funding for twenty-one (21) 
individuals performing one-year service payback at a cost of $768,000. 
In fiscal year 2006, the Loan Repayment Program for Research Generally 
(GR-LRP) plans to award contracts to fifty-one (51) individuals 
entering into initial three-years contracts, and forty (40) contracts 
to individuals entering into one-year renewal contracts at a cost of 
$5,286,000. Lastly, the NIH Clinical Research Loan Repayment Program 
for Inidividuals from Disadvantaged Backgrounds (CR-LRP) plans to award 
contracts to two (2) individuals entering into initial two-year 
contracts, and ten (10) contracts to individuals entering into one-year 
renewal contracts at a cost of $483,000 in fiscal year 2006. The fiscal 
year 2007 budget request for OLRS is $7,141,000, the same as the fiscal 
year 2006 level.

         OFFICE OF PORTFOLIO ANALYSIS AND STRATEGIC INITIATIVES

    In fiscal year 2005, the NIH established a new office within the 
Office of the Director, the Office of Portfolio Analysis and Strategic 
Initiatives (OPASI). The OPASI is made up of three divisions, focused 
on (1) resource development and analysis (including the development and 
deployment of knowledge management; (2) strategic coordination; and (3) 
evaluation and systematic assessments. Collectively, these three 
divisions identify and integrate information to support the planning 
and implementation of trans-NIH initiatives that address exceptional 
scientific opportunities and emerging public health needs. More 
specifically, OPASI is facilitating a ``functional integration'' of 
strategic planning and evaluation activities across the agency. The 
fiscal year 2007 budget request for OPASI is $3,000,000, an increase of 
$1,020,000 over the fiscal year 2006 level.
    When fully staffed by fiscal year 2008, OPASI will have 
approximately 72 FTEs. Thirteen existing FTEs transferred to OPASI in 
fiscal year 2006, and approximately 16 FTEs will be recruited during 
fiscal year 2006. The NIH is in the process of recruiting for a 
Director, OPASI and expects to fill this position in 2006. Funding for 
fiscal year 2007 will cover additional recruitments and Office 
operations in an amount consistent with OPASI's structure and 
responsibilities. In addition to salaries to support the FTEs, funding 
will be used to pay for contractual services, supplies, equipment, 
office rent and other services.
    Through these efforts, the NIH Director and the IC Directors will 
have access to more consistent information to improve coordination and 
facilitate collaboration across the agency, and to inform priority 
setting and budget decisions. The governance process for OPASI will 
likely be carried out by a new working group of the NIH Steering 
Committee, as described above. The group will be charged with 
monitoring the overall effectiveness of the office, advising on policy 
and planning issues, and forecasting the need for changes in OPASI's 
activities, among other areas.
    Thank you, Mr. Chairman for giving me the opportunity to present 
this statement; I will be pleased to answer questions that the 
Committee may have.
                                 ______
                                 
Prepared Statement of Dr. Story C. Landis, Director, National Institute 
                  of Neurological Disorders and Stroke

    Mr. Chairman and Members of the Committee, I am Story Landis, 
Director of the National Institute of Neurological Disorders and Stroke 
(NINDS). I am pleased to present the fiscal year 2007 President's 
budget request for NINDS.
    The mission of the NINDS is to reduce the burden of neurological 
disorders by developing ways to prevent or to treat these diseases. 
Epilepsy, autism, cerebral palsy, muscular dystrophy, spinal muscular 
atrophy (SMA), and hundreds of other disorders are first evident in 
infancy or childhood. Multiple sclerosis, spinal cord injury, migraine, 
and traumatic brain injury are among the many nervous system diseases 
that are prevalent in young adults. Stroke, dementias, chronic pain, 
and Parkinson's disease will increase, if unchecked, with the aging of 
our population. The impact of neurological disorders on people, on 
their families, and on our economy is immense.

                           CLINICAL RESEARCH

    The NINDS currently supports more than 1,000 clinical research 
projects, of which more than 125 are clinical trials of interventions 
to prevent or treat disease. Ongoing clinical trials are testing drugs, 
natural biological molecules, surgery, deep brain stimulation, 
hypothermia, radiation, immunotherapy, and behavioral therapies for 
disorders including amyotrophic lateral sclerosis (ALS), brain tumor, 
cerebral palsy, epilepsy, headache, Huntington's disease, multiple 
sclerosis, muscular dystrophy, myasthenia gravis, pain, Parkinson's 
disease, spinal muscular atrophy, stroke, Tourette syndrome, and 
traumatic brain injury.
    Last year an NINDS clinical trial showed that aspirin prevents 
stroke effectively for the many people with partially blocked arteries 
in the brain who have had a previous stroke or TIA (mini stroke). 
Aspirin works as well as warfarin, a drug that requires monthly 
monitoring and carries the risk of major hemorrhage and heart attack. 
This trial is another step in a long march of advances that guide 
physicians in preventing stroke in particular risk groups. The U.S. 
Centers for Disease Control and Prevention estimated that the death 
rate from stroke declined by 18.5 percent for the U.S. population from 
1993 to 2003, and progress is continuing with results like these.
    Each year also brings results from several NINDS preliminary 
clinical trials. Current drugs for Parkinson's disease ultimately fail 
because they do not halt the progressive death of brain cells that 
causes this disease. The Neuroprotection Exploratory Trials in 
Parkinson's Disease (NET-PD) is a network of 50 clinical centers 
throughout the United States that efficiently tests drugs to slow the 
underlying disease. NET-PD has completed phase II trials of four drugs 
that had been rigorously selected for testing from candidates suggested 
by scientists around the world, and just published the results of the 
first two. NET-PD will move quickly to a large, definitive clinical 
trial to test the safety and effectiveness of at least one of these 
drugs in preventing Parkinson's disease.
    In addition to clinical trials, other types of clinical studies 
lead to new treatment or prevention strategies. An epidemiological 
study this year found that men who exercised vigorously as young adults 
had a 50 percent lower risk of developing Parkinson's disease in later 
life than men who had low levels of physical activity. Other studies 
determined how to predict which patients with glioblastoma, a common 
and deadly brain tumor, will respond to a new class of anti-cancer 
drugs, and discovered why infant seizures do not respond to drugs that 
are effective in adults and what other drugs might work better.
    The NINDS Clinical Research Collaboration (CRC), now under 
development, will extend the reach of clinical research into more 
communities across the United States. The CRC engages community 
practice and academic neurologists to speed clinical studies; minimize 
costs; make clinical trials more accessible to diverse participants; 
facilitate trials of rare diseases; and improve transfer of research 
results to clinical practice in the community. Complementing the CRC, 
the NINDS is building a network to develop emergency treatments for 
neurological disorders. Stroke, seizures, traumatic brain and spinal 
cord injury, and other neurological disorders account for perhaps 5 to 
10 percent of all medical emergencies. This program brings together 
specialists in emergency medicine, neurological disease and clinical 
trials.

                    GENES AND NEUROLOGICAL DISORDERS

    In December, the journal Science chose the discovery of a gene 
defect that can cause Tourette syndrome as one of the 10 most important 
scientific advances of the year. Since the NIH budget doubling began, 
scientists have identified more than 100 genes associated with 
neurological diseases including ALS, ataxias, Batten disease, dyslexia, 
dystonia, epilepsy, muscular dystrophies, Parkinson's disease, 
peripheral nerve diseases, and spinal muscular atrophies.
    Gene discoveries often have a rapid impact on patients and 
families. They yield definitive DNA diagnostic tests that are faster, 
cheaper, and more accurate, and allow genetic counseling and attention 
to special risks of people with particular inherited disorders. For 
example, patients with ataxia used to undergo MRI brain scans, 
withdrawal of spinal fluid for analysis, tests for amino acids and 
organic acids, lipoprotein electrophoresis, urine heavy metal screens, 
thyroid function tests, and sometimes painful nerve or muscle biopsies 
to get a diagnosis, costing thousands of dollars over several months. 
Today, a commercially available DNA test can often give a definitive 
diagnosis of a genetic neurological disorder within a week for a few 
hundred dollars.
    Gene findings also jumpstart therapy development. Over the last 
year, studies of therapies in animal models, another benefit from gene 
discoveries, have shown promise for neurofibromatosis, muscular 
dystrophy, Fragile X syndrome, Huntington's disease, hereditary 
ataxias, and several other disorders. Therapies are already moving from 
animal models into NIH or private sector clinical trials, including 
ceftriaxone for ALS, anti-oxidants for ataxia-telangiectasia, myostain 
inhibitors and gentamicin for muscular dystrophy, and coenzyme Q10 for 
Huntington's disease. The pace is remarkable after decades without 
progress for many of these diseases.
    Knowing where and when genes are active is key to understanding the 
nervous system in health and disease. Most genes are active at some 
time and place in the brain, yet only a small fraction of these have 
been well characterized, so the NINDS initiated the GENSAT (Gene 
Expression Nervous System Atlas) to map gene activity in the brain 
across development. GENSAT also generates valuable research tools 
including strains of mice in which a visible marker is turned on where 
and when the gene of interest is active. Using these mice, scientists 
this year found new insights into Parkinson's disease that could not 
have been revealed without this resource. The studies showed that one 
of two previously undistinguishable types of nerve cells is selectively 
affected in Parkinson's disease, helped explain why brain movement 
control circuits malfunction, revealed the molecular mechanism that 
kills those cells, and identified a potential new target for drugs to 
slow Parkinson's disease.

                         TRANSLATIONAL RESEARCH

    With the budget increases, the NINDS implemented major programs to 
move insights from basic research to practical therapies ready for 
testing in clinical trials, that is, translational research. The 
Cooperative Program for Translational Research supports research teams 
in academia and small companies. These milestone-driven, investigator-
initiated projects are developing drug, stem cell, or gene therapies 
for Batten disease, Parkinson's disease, Huntington's disease, tuberous 
sclerosis, Duchenne muscular dystrophy, traumatic brain injury, and 
stroke, among other disorders.
    In another translational effort, the NINDS developed the SMA 
Project as a model program to expedite therapy development. The 
contract-based project is making encouraging progress towards its 
ambitious goal--having a drug for SMA ready for clinical trials by the 
end of 2007. A steering committee, with drug development expertise from 
industry, the FDA, academia, and the NIH, first developed a detailed 
drug development plan. To carry out the plan, the project then created 
a virtual drug development company with the tools and facilities for 
identifying ``lead compounds,'' chemically modifying leads into 
potentially improved compounds, testing drug candidates in cell and 
animal models, and coordinating the overall drug development scheme. 
More than 300 compounds have been prepared and are in testing. In 2007, 
the NINDS will address a major barrier in the development of drugs for 
other neurological diseases by extending the contract-based medicinal 
chemistry resource from the SMA Project. Medicinal chemists modify 
weakly active compounds so that drug development teams can test the new 
drugs for improved safety and effectiveness.
    NIH basic science stimulates therapy development in the private 
sector, as well as by the NIH. In the past year, private sector 
clinical studies of clotting Factors VII and VIIa have shown promise 
for serious and hard to treat strokes caused by bleeding in the brain. 
NIH research motivated those studies by showing that these strokes are 
followed by continued expansion of blood filled pockets in the brain, 
called hematomas, which contribute profoundly to disability and death. 
Private sector clinical trials in gene and cell therapies for 
Parkinson's disease begun this year also build upon NINDS research.
    Longstanding NINDS targeted therapy development programs also 
catalyze private sector efforts. For three decades, the Anticonvulsant 
Screening Program (ASP) has fostered industry development of drugs for 
epilepsy, including six drugs in widespread use and several more now in 
clinical testing. Drugs that emerged from the ASP testing program are 
also among the most effective treatments for chronic pain. NINDS 
initiatives begun last year and to begin in 2007 focus on animal models 
for testing drugs that block the development of epilepsy, work for 
treatment resistant epilepsy, and meet the special needs of pediatric 
and geriatric populations.

                         COLLABORATIVE RESEARCH

    The NINDS strongly encourages cooperative efforts among scientists 
and physicians from diverse disciplines, and works closely with other 
parts of the NIH, other government agencies, and non-governmental 
organizations, as well as with companies. As may be evident from the 
discussions of the Clinical Research Consortium, NET-PD, GENSAT, the 
Cooperative Program in Translational Research, and the SMA Project, 
most NINDS programs, whether focused on a particular disease or a 
scientific problem, emphasize collaboration. Other examples include 
research centers on muscular dystrophy, Parkinson's, autism, spinal 
cord injury, stroke and heath disparities, and resources including the 
Human Genetics Repository and the Microarray Consortium.
    The NIH Neurosciences Blueprint, begun in 2005, presents a 
framework to enhance cooperation across the NIH institutes that share 
an interest in diseases of the nervous system. Blueprint initiatives 
have focused on neuroscience tools, training in the neurobiology of 
disease for basic scientists, genome analysis, neuroimaging, genetic 
mouse models, core research facilities, and clinical assessment tools. 
In 2007, the Blueprint will focus on neurodegeneration, which 
contributes to many diseases.
    Among government agencies, the NINDS is working closely with the 
U.S. Army Medical Research Institute of Chemical Defense (USAMRICD) 
because many potential chemical terrorist agents affect the nervous 
system. Cooperative projects with the Veterans Administration include a 
major clinical trial of deep brain stimulation for Parkinson's disease. 
The NINDS also meets regularly with the FDA on stem cells and other 
biological therapies and works with the National Science Foundation on 
common interests including computational neuroscience and informatics.
    More than 300 non-governmental organizations (NGOs) focus on 
diseases within the mission of the NINDS. The World Parkinson 
Conference, held for the first time this February, and a major 
conference on epilepsy planned for March 2007 are two of many recent 
examples of cooperative efforts between NGOs and the NINDS. In June 
2005, the Institute brought together 75 representatives of NGOs at the 
NIH for a day of presentations, informal interaction, and group 
discussions. Based on the strong positive feedback from participants, 
the NINDS will hold similar meetings in the future to explore how we 
can work together in the future.
    Thank you, Mr. Chairman. I would be pleased answer questions from 
the Committee.
                                 ______
                                 
Prepared Statement of Dr. Ting-Kai Li, Director, National Institute on 
                      Alcohol Abuse and Alcoholism

    Mr. Chairman and members of the Committee: I am pleased to present 
the fiscal year 2007 President's budget request for the National 
Institute on Alcohol Abuse and Alcoholism (NIAAA). The fiscal year 2007 
budget includes $433,318,000, which reflects a decrease of $2,612,000 
over the fiscal year 2006 enacted level of $435,930,000 comparable for 
transfers proposed in the President's request.
    Alcohol consumption kills or disables thousands of Americans each 
year. The Centers for Disease Control and Prevention (CDC) reported in 
2005 that, in the mid-1990s, alcohol use and abuse were among the top 
ten causes of death and disability in the United States. CDC also 
ranked excessive alcohol consumption as the third leading preventable 
cause of death in 2001. Motor vehicle crashes are among the most 
visible consequences of alcohol use; CDC estimates that in 2003, 40 
percent of traffic deaths were alcohol-related. However, death and 
disability also result from alcohol-related diseases, such as liver 
cirrhosis, heart disease, stroke, dementia, and certain cancers.
    Despite these consequences, the majority of people who drink are 
able to do so without harm to themselves or others. One of the 
fundamental goals of alcohol research is to determine why some 
individuals cannot limit their drinking. Research has shown clearly 
that half of the risk for developing alcohol use disorders is a 
function of genes, while the other half can be traced to factors in the 
environment, such as family, friends, and culture. The measure of risk 
is not an either/or situation; genes and environmental factors interact 
and influence one another, even at the molecular level.
    Investigating the interplay of genes and environment is an 
important focus across the NIH, with implications for many of the most 
widespread, life-threatening, and costly health conditions affecting 
Americans. One of the exciting areas of research I would like to 
describe today has to do with how new tools we are developing to 
investigate this interaction between genes and environment can 
contribute to an understanding of alcohol dependence.
    As a starting point, we have already identified several genes that 
can raise or lower the risk of developing alcohol dependence. Variants 
in two families of genes that are involved directly in alcohol 
metabolism, for example, can lower risk. These genes encode enzymes 
that break down alcohol. Some people inherit enzyme variants that will 
result, if a person drinks, in especially high levels of a toxic 
byproduct of alcohol metabolism. These individuals feel sick when they 
drink; as a result, they are at lower risk of developing alcohol use 
disorders.
    Other genes that play a role in alcoholism risk encode the 
communication circuitry of brain messenger molecules, the receptors of 
neurotransmitters, a number of which have been linked to alcoholism and 
psychiatric disorders that co-occur frequently with alcoholism. 
Research suggests, for example, that genes for neurotransmitters 
involved in depression and anxiety are also, in some groups, related to 
alcoholism risk. Among the neurotransmitter systems for which research 
has reported a relationship between genes and alcoholism risk: GABA, a 
neurotransmitter that slows the pace of brain signaling and is known to 
be involved in the alcohol response; NPY, a brain protein involved in 
stress responses and memory; serotonin, a neurotransmitter involved in 
the regulation of mood; and brain opioids, which play a role in the 
sensation of pleasure.
    Variants in these neurotransmitter genes influence alcoholism risk 
by shaping how the brain responds to alcohol, regulating how pleasant 
the experience is, or how sedating. An important new direction of 
research has to do with investigating how the opposite can occur: 
alcohol can make lasting changes in genes in ways that can have 
profound effects on health.
    Epigenetics refers to heritable and long-term changes in gene 
function that occur without a change in DNA sequence. Such changes 
could be caused, for example, by elements in the environment, such as 
alcohol, changing how genes are translated into proteins, in other 
words, how the genes are expressed. Epigenetics can help us understand 
how alcohol has lasting effects on health.
    One of the ways alcohol and its metabolites can change gene 
expression is by modifying histones--proteins that intertwine with DNA. 
Stable modification of DNA can also occur. Both of these reactions can 
activate or silence the expression of genes. Alcohol through its 
metabolism contributes to or alters the level of at least two specific 
metabolites that are required for these chemical modifications.
    Epigenetic modifications may be transmitted as the cell divides. 
Thus, these modifications may persist throughout the lifespan. 
Epigenetic changes also have the potential to be passed on to the next 
generation, producing abnormalities in offspring. This research, at the 
forefront of progress in genetics and molecular biology, gives us an 
opportunity to understand the complex mechanisms by which an external 
environmental factor like alcohol interacts with biology. It promises 
to help explain why repeated exposure to alcohol can change permanently 
how a person responds thereafter to the substance, setting the stage 
for dependence. It can help explain why drinking during pregnancy can 
cause irreversible damage to the brain of a fetus. And it may help 
explain what underlies alcohol's destructive effects on such organs as 
the liver, pancreas, and brain, as well as its role in cancers 
associated with heavy alcohol exposure.
    Epigenetics research may also provide a means for investigating the 
long-term effects of alcohol consumption on adolescents. Alcohol is the 
drug most commonly used by youth. Adolescents who drink tend to do so 
intensively; according to 2005 data from the Monitoring the Future 
study, 11 percent of 8th graders, 21 percent of 10th graders, and 28 
percent of 12th graders report drinking 5 or more drinks in a row in 
the past two weeks. This ``binge'' drinking is a particularly hazardous 
pattern of drinking at any age. But during adolescence, when the brain 
is still undergoing developmental change, binge drinking may have 
particular dangers.
    Preliminary studies suggest that alcohol has the potential to 
disturb normal brain development in adolescence and young adulthood. 
NIAAA research has established that youth who begin to drink in their 
early teens are at greater risk later of developing alcohol dependence. 
This increased risk can be explained only partly by inherited 
biological risk factors, suggesting that early drinking itself causes 
changes that manifest themselves in future behavior. Data from NIAAA's 
National Epidemiologic Survey on Alcohol and Related Conditions has 
shown that most cases of alcoholism are established by age 25. This 
suggests that alcoholism, rather than being a disease of middle age, is 
a developmental disorder that has its roots in youth.
    An important NIAAA initiative is aimed at investigating the effects 
of alcohol, including epigenetic effects, on developing brain 
structures and systems that regulate behavior. It will address the 
mechanisms that underlie alcohol-related changes during brain 
development, the dosage and drinking patterns that result in changes, 
and the factors that promote or protect against these changes. An 
important aim of this research is to determine whether and how 
alterations in brain function influence lifetime risk for alcohol use 
disorders, particularly in vulnerable individuals.
    Improving our fundamental understanding of how the environment 
interacts with genes has many potential benefits. For example, 
knowledge of the genes that are related to risk for alcohol problems--
and how variants of these genes might be manifest in physical or 
behavioral traits--can be used to assist in the identification of 
individuals at risk or, in other words, predict who is vulnerable. 
Understanding how alcohol interacts with genes will help define how an 
individual makes the transition from casual drinking to dependence; and 
how long term heavy drinking causes disease.
    Our growing body of knowledge about genes and the cellular 
processes they encode is providing targets for medications development. 
Genetics research is helping to show why no one medication will work in 
every person. The ultimate goal will be to personalize treatment--
similar to the approach in diseases like hypertension or depression--by 
choosing from an array of medications the agent that is most effective 
for a given individual.
    Finally, among its most important potential benefits, the 
investigation of genes and environment will give us a clear picture of 
the impact of alcohol on the long-term health and behavior of 
adolescents. Understanding the mechanisms behind these persistent 
effects will make even more compelling the imperative to identify 
effective ways of preventing adolescents from consuming alcohol, not 
only to safeguard their health and well-being in youth, but to preempt 
the development of alcohol use problems in adulthood.
    Thank you Mr. Chairman. I would be pleased to answer any questions 
that the Committee may have.
                                 ______
                                 
  Prepared Statement of Dr. Donald A.B. Lindberg, Director, National 
                          Library of Medicine

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Library of Medicine 
(NLM) for fiscal year 2007, a sum of $313,269,000, which is $1,641,623 
less than the comparable fiscal year 2006 appropriation.
    Only a few years ago we frequently described the role of the 
National Library of Medicine almost entirely in the context of the 
medical literature--NLM collected and organized the books and journals 
that were then used in the process of making new discoveries that would 
be reported in yet more books and journals. That paradigm, although 
accurate as far as it goes, is no longer sufficient to describe the 
Library's role. Today, the NLM is at the hub of an interconnected world 
of an amazing amount of information, ranging from the published 
literature, to molecular sequence and genomic data, to descriptions of 
clinical trials, to still and moving medical images, to maps of 
chemical spills and other information used for emergency preparedness, 
and to authoritative research-based information prepared especially for 
the general public--for patients and their families and caregivers.
    The range of persons and institutions with which the Library 
interacts is staggering. A National Network of Libraries of Medicine, 
with more than five thousand members, extends the reach of NLM's 
services. Many medical organizations, publishers, academic 
institutions, government agencies, and libraries make data available to 
the world through the National Library of Medicine. The NLM, with a 
staff of experienced medical librarians, scientists, and health 
professionals, creates databases and other Web resources to ensure that 
high quality information is available to all, easily and without 
restriction. The bottom line of all this is that the Library operates 
the most-consulted scientific medical Web site in the world: two 
million people come to the Library's Web site--to learn about diseases, 
search the literature, connect with other information providers, and to 
download terabytes of data--every day.
    As a key member of the NIH research team, the Library works closely 
with scientists on the Bethesda campus and around the country. A prime 
example of this is the work of NLM's National Center for Biotechnology 
Information (NCBI) and the panoply of databases with genomic 
information contributed by NIH and NIH-supported scientists. This 
collaboration extends around the world, with partners at institutions 
in other nations contributing sequence and other data to the NCBI's 
databases. Another example of extensive collaboration is that several 
thousand public and private organizations have agreements with NLM to 
use the Visible Human Project datasets of anatomical information to 
create techniques and software used in teaching and research.
    But the Library is also a bricks and mortar facility on the campus 
of the National Institutes of Health. NLM has two reading rooms that 
are open to the public--one that serves the Library's remarkable 
collection of historical materials and a main reading room. An 
exhibition, ``Visible Proofs: Forensic Views of the Body,'' has just 
been opened in the Library's public area and will be visited by many 
thousands, including students from grade school up. Previous 
exhibitions are now touring the country, extending greatly the work of 
our history of medicine curators.
    A basic function of the National Library of Medicine is to serve as 
a ``court of last resort'' for seekers of medical information. With the 
world's largest collection--eight million items--the NLM is relied on 
by institutions and individuals around the globe.

                  INFORMATION SERVICES FOR THE PUBLIC

    The Library's main portal for consumer health information is 
MedlinePlus, available in both English and Spanish. Much of this 
material is based on research done or sponsored by the NIH Institutes. 
MedlinePlus has more than 700 ``health topics,'' containing, for 
example, overview information, pertinent clinical trials, alternative 
medicine, prevention, management, therapies, current research, and the 
latest news from the print media. In addition to the health topics, 
there are medical dictionaries, a medical encyclopedia, directories of 
hospitals and providers, and interactive ``tutorials'' with images and 
sound. The newest addition to MedlinePlus is a series of surgical 
videos that show actual operations of common surgical procedures. 
Another new aspect of MedlinePlus is ``Go Local,'' that is, a service 
to link users from the MedlinePlus health topics to the health and 
social services in their community that are related to that topic.
    There are other popular NLM Web sites for the public. 
ClinicalTrials.gov was created to give everyone easy access to 
information about human research studies. The site contains information 
on more than 25,000 federally and privately supported trials. It 
includes summaries of the purpose of each study, the recruiting status, 
criteria for patient participation, location(s) of the trial and 
specific contact information. NIHSeniorHealth.gov is maintained by the 
Library in collaboration with the National Institute on Aging and other 
NIH Institutes. At present there are 22 topics of interest to seniors, 
including, for example, Alzheimer's Disease, balance problems, macular 
degeneration, shingles, and stroke. NIHSeniorHealth.gov contains 
information in a format that is especially usable by seniors, with, for 
example, large type, and it also has a ``talking'' function that allows 
users to listen as the text is read to them.
    NLM's Genetics Home Reference provides consumer-friendly summaries 
of genetic conditions and related genes and chromosomes. This 
information resource bridges consumer health information and scientific 
bioinformatics data, and it links to many existing resources, both at 
NLM and at other reliable sites. The Household Products Database 
provides easy-to-understand data in consumer-friendly language on the 
potential health effects of more than 2,000 ingredients contained in 
more than 6,000 common household products. The Household Products 
Database has proved to be popular with the media, and there have been a 
number of newspaper and magazine articles about it. Another consumer 
health site is the colorful Tox Town, which looks at an ordinary town 
and points out many harmful substances and environmental hazards that 
might exist there. Users can click on a town location, like a school, 
office, factory, or park and find information about the toxic chemicals 
that may be encountered there. Other versions are available for a big 
city, a farm, and the U.S.-Mexico border area. There is also a new 
special section with information on toxic chemicals and disaster health 
concerns in the wake of Hurricane Katrina and Hurricane Rita.

           INFORMATION SERVICES FOR THE SCIENTIFIC COMMUNITY

    The most frequently consulted online medical resource in the world 
is PubMed/Medline, an easily searchable database of more than 15 
million references and abstracts for medical journal articles from the 
1950s to the present. Usage of PubMed/Medline by the scientific and lay 
communities has grown considerably since it became free on the Web in 
1997, to over two million searches per day. PubMed also links to the 
sites of participating publishers so that users can retrieve full-text 
articles from 5,000 journals. Where links to electronic full text are 
not available, the user may use PubMed to place an online order for an 
article directly from a library in the National Network of Libraries of 
Medicine.
    PubMedCentral (PMC) is a Web-based repository of biomedical journal 
literature providing free and unrestricted access to the full-text of 
articles. This repository is based on a natural integration with the 
existing PubMed/Medline biomedical literature database of references 
and abstracts. Currently, PMC contains nearly 600,000 full-text 
articles. Recent additions have come from newly published material as 
well as from digitizing back issues that previously were only available 
in printed form. NIH's Public Access policy encourages scientists whose 
work is funded by the NIH to submit their manuscripts to PubMed 
Central. NLM's National Center for Biotechnology Information designed 
and implemented the NIH Manuscript Submission system, a quick and easy-
to-use system for scientists to submit their manuscripts. Creating such 
digital archives as PubMedCentral to ensure that the world's biomedical 
literature is properly recorded and available for future generations, 
is an important NLM responsibility.
    Another heavily used scientific resource is a database of all 
publicly available DNA sequences, called GenBank. The NCBI, which 
maintains GenBank, has also created integrated retrieval tools that 
allow seamless searching of the sequence data and provide links to 
related sequences, bibliographic citations, and other resources. Such 
features allow GenBank to serve as a critical research tool in the 
analysis and discovery of gene function as well as discoveries that 
lead to identification and cures for a number of diseases. One recent 
example of the use of NCBI sequence databases was to identify the first 
polio case in the United States since 1999. The state health laboratory 
in Minnesota had isolated an unknown virus from a hospitalized child 
from an Amish community. The laboratory staff went to the Web, searched 
against the 55 million DNA sequences at NCBI, and found a match to the 
polio virus used in the Sabin oral vaccine. ``Bingo,'' said the 
laboratory's director, ``It was a 98 percent match. We knew we had 
nailed it.''
    A critical need in biomedical research, as identified in the NIH 
Roadmap Initiative, is a repository for what are called ``small 
molecules'' that are crucial in drug development. Small molecules are 
responsible for the most basic chemical processes that are essential 
for life and they often play an essential role in the attack of a 
pathogen, or in the cell's response to the attack. The new PubChem 
database, developed by the NCBI, links the small molecules to their 
biological functions and to the macromolecules with which they 
interact. At present, PubChem includes over 7.5 million records for 
small molecules with over 5 million molecular structures. These data 
have been contributed by public, academic, and commercial resources.
    The NCBI is also doing important work on other issues of current 
public concern. One of these is to provide an Influenza Virus Resource 
that links researchers working on vaccines to genomic data about the 
influenza virus. As the data accumulate and the analyses progress, the 
discoveries made will ultimately lead to better prediction of large-
scale outbreaks, more effective vaccine design, and the saving of many 
human lives. Another area of NCBI work of topical interest is their 
development, in the aftermath of 9/11, of sophisticated software called 
OSIRIS. The software is now being tested within five collaborating 
forensic DNA laboratories to assist in the analysis and validation of 
forensic data and help identify victims from the Gulf Coast states in 
the aftermath of Katrina.
    A recently announced series of initiatives by several NIH 
Institutes directed at understanding the genetic factors underlying 
human disease will require the NCBI to play a key role. Several large-
scale, long-term studies, such as the Framingham Heart Study, will be 
adding genetic information from participants to the clinical data 
already collected. NCBI has been selected by the Institutes to build 
the databases that will incorporate the clinical and genetic data, link 
them to the molecular and bibliographic resources at the NCBI and, for 
the first time, make these data available to the scientific and 
clinical research community.
    NLM remains the principal source of support nationally for research 
training in the field of biomedical informatics. This support is 
especially important as rapidly moving technology in health care and 
biomedical research requires investigators who understand biomedicine 
as well as fundamental problems of knowledge representation, decision 
support, and human-computer interface. Five-year institutional training 
grants from NLM support some 300 pre-doctoral, post-doctoral, and 
short-term trainees across the country.

                        OTHER AREAS OF INTEREST

    The Library has an important role in developing standards for 
Electronic Health Records. As part of its Unified Medical Language 
System (UMLS) project, NLM creates vocabulary databases and software 
tools to assist informatics researchers and system developers in 
automated interpretation and integration of medical knowledge and 
health data. Chief among the UMLS resources is the Metathesaurus, which 
links and provides 4.7 million concept names for 1.2 million concepts 
from 114 vocabularies in a single database format. The UMLS serves as a 
common distribution vehicle for standard code sets and vocabularies 
needed for administrative transactions and electronic health records, 
as well as a resource for advanced natural language processing, 
automated indexing, and enhanced information retrieval. Building on its 
two decades of UMLS experience, the Library also serves as an HHS 
coordinating center for standard clinical vocabularies, such as the 
SNOMED CT clinical terminology. The Library works closely with the 
Office of the National Coordinator for Health Information Technology 
and other organizations to align health data standards into an 
effective interlocking set and to promote more rapid adoption of 
standards-based electronic health records to facilitate patient care, 
public health surveillance, and clinical research.
    Twenty years ago the National Library of Medicine published a long 
range plan that has proved to be of enormous benefit to the 
institution. Out of it grew such initiatives as the Visible Human 
Project, the National Center for Biotechnology Information, and the 
recommendation that the Library engage in an outreach campaign to reach 
minority and other underserved health professionals. The Library is now 
engaged in a similar planning exercise for the next decade. Leaders 
from across the spectrum of health and medicine are meeting at the 
Library to consider four major themes relating to resources and 
infrastructure, outreach to the underserved, support for clinical and 
public health systems, and support for genomics. The plan, which will 
be issued by the NLM Board of Regents and published later in 2006, will 
point the Library in the direction in which it can make its maximum 
contribution to society.
                                 ______
                                 
Prepared Statement of Juanita M. Mildenberg, Acting Director, Office of 
             Research Facilities Development and Operations

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the Buildings and Facilities (B&F) 
Program for fiscal year 2007, a sum of $81,081,000.

                      ROLE IN THE RESEARCH MISSION

    State-of-the-art facilities for scientific research and research 
support facilities are a vital part of the research enterprise. The 
National Institutes of Health's (NIH) Buildings and Facilities (B&F) 
program designs, constructs, repairs and improves the agency's 
portfolio of laboratory, clinical, animal, administrative and support 
facilities at its six installations in four states. These facilities 
house researchers from the NIH Institutes' and Centers' (ICs) 
intramural basic, translational, and clinical research programs; 
science administrators who oversee NIH's grants; the NIH leadership, 
and various programs that support agency operations. The fiscal year 
2007 B&F budget request focuses on the need for responsible utilization 
and stewardship of NIH's past and recent investments in the ``bricks 
and mortar'' of the research enterprise. In order to stay abreast of 
the changing needs of the NIH programs, it is imperative that we 
provide reliable, safe and secure research support facilities that are 
appropriately equipped, operated and maintained.
    The B&F budget request is the product of a comprehensive, corporate 
capital facilities planning process. This process begins with extensive 
consultation across the research community and the NIH's professional 
facilities staff. It works through the Facilities Working Group, an 
advisory committee to the NIH Steering Committee, and the HHS Capital 
Investment Review Board. Through this process, the program demand for 
more effective and efficient facilities designed to support current and 
emerging investigative techniques, technologies, and tools is 
integrated with, and balanced against, the need to repair, renovate, 
and improve the existing building stock to keep it in service and to 
optimize its utility.
    The fiscal year 2007 request provides the necessary funding support 
for the ongoing safety, renovation and repair, and related projects 
that are vital to proper stewardship of the entire portfolio.
    The fiscal year 2007 B&F budget request is organized among three 
broad Program Activities: Essential Safety and Regulatory Compliance, 
Repairs and Improvements and Construction. The fiscal year 2007 request 
provides funds for specific projects in each of the program areas. The 
projects and programs enumerated are the end result of the 
aforementioned NIH facilities planning process and are the NIH's 
capital facility priorities for fiscal year 2007.

                    FISCAL YEAR 2007 BUDGET SUMMARY

    The fiscal year 2007 budget request for Buildings and Facilities is 
$81.1 million. The B&F request contains a total of $14.5 million for 
Essential Safety and Regulatory Compliance programs composed of $2 
million for the phased removal of asbestos from NIH buildings; $5 
million for the continuing upgrade of fire and life safety deficiencies 
of NIH buildings; $1.5 million to systematically remove existing 
barriers to persons with disabilities from the interior of NIH 
buildings; $1 million to allow for environmental remediation activities 
at NIH sites; and $5 million for the continued support of the 
rehabilitation of animal research facilities. In addition, the fiscal 
year 2007 request includes $65.9 million in Repairs and Improvements 
for the continuing program of repairs, improvements, and maintenance 
that is the vital means of maintaining the complex research facilities 
infrastructure of the NIH; and $700,000 in Construction for pre-project 
planning including concept development studies and analyses of NIH-wide 
facility projects proposed in the facilities plan.
    My colleagues and I will be happy to respond to any questions you 
may have.
                                 ______
                                 
  Prepared Statement of Dr. Roderic I. Pettigrew, Director, National 
           Institute of Biomedical Imaging and Bioengineering

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2007 President's budget request for the National 
Institute of Biomedical Imaging and Bioengineering (NIBIB). The fiscal 
year 2007 budget includes $294,850,000; a decrease of $1,960,000 over 
the fiscal year 2006 enacted level of $296,810,000 comparable for 
transfers proposed in the President's request.

                BRIDGING THE PHYSICAL AND LIFE SCIENCES

    The mission of the NIBIB is to improve human health by leading the 
development and accelerating the application of biomedical 
technologies. The Institute is committed to integrating the engineering 
and physical sciences with the life sciences to advance basic research 
and medical care. To demonstrate our commitment, the NIBIB gives 
special consideration for funding to research grant applications that 
bridge and integrate the life and physical sciences.

             TRANSLATING TECHNOLOGY INTO CLINICAL PRACTICE

    Ultimately, the NIBIB seeks to translate research findings made in 
the laboratory into solutions that advance human health by reducing 
disease burden and improving quality of life. One highly successful 
example of a research and commercialization effort supported in part by 
the NIBIB is an automated, digital-imaging device called the ``array 
microscope.'' The system utilizes an array of 100 miniaturized 
objectives to produce a single, seamless sweep of a microscope slide of 
a histopathology sample. The result is a microscopic-level resolution, 
multi-colored digitized image of the pathology sample. The most 
immediate impact of this technology is expected to be in medical 
pathology. These ``virtual slides'' can be easily stored in a patient's 
record and can also be viewed over the Internet, providing immediate 
on-line access to expert second opinions.
    The recently released ``Quantum Project'' initiative is another 
example of how the NIBIB strives to support a more integrated and 
focused research agenda using multidisciplinary approaches to develop 
innovative and marketable technologies. The goal of this unique program 
is to make a ``quantum'' advance in healthcare by funding research on a 
specific project or projects that will translate into new technologies 
and modalities for the treatment, prevention and cure of disease or 
resolve a major health care problem within a reasonable time frame. In 
these ``bench to bedside'' partnerships, a team of interdisciplinary 
scientists will conduct collaborative research that will result in a 
prototype product that can be translated into clinical practice.

              TECHNOLOGIES TO IMPROVE HEALTH CARE DELIVERY

    With the advent of miniaturized devices and wireless communication, 
the way in which doctors care for patients has changed dramatically. 
Empowering clinicians to make decisions at the bedside, or the ``point-
of-care,'' has the potential to significantly impact health care 
delivery and help address the challenges of health disparities. The 
success of such a shift relies on the development of portable 
diagnostic and monitoring devices for near-patient testing. The NIBIB 
has contributed to advances in this area by funding the development of 
sensor and microsystem technologies for point-of-care testing. These 
instruments combine multiple analytical functions into self-contained, 
portable devices that can be used by non-specialists to detect and 
diagnose disease, and can enable the selection and monitoring of 
optimal therapies. These advances limit the reliance on submission of 
samples to centralized laboratories and will make results more readily 
available within minutes as opposed to several hours or days, enabling 
clinicians to make decisions regarding treatment when these decisions 
can have the greatest impact. An example under development at the NIBIB 
is a handheld system for the rapid detection and identification of 
bacteria which cause urinary tract infections. The research team 
anticipates this test could become available in the next two to three 
years. To further capitalize on these advances, the NIBIB is planning 
an initiative to support research on critical areas for the development 
of other hand-held, diagnostic devices. These systems could reduce the 
cost of health care, much as integrated electronics have reduced the 
cost of computing, and greatly simplify and improve patient delivery of 
care.

            NEXT GENERATION MINIMALLY-INVASIVE TECHNOLOGIES

    Advances in imaging technologies have spurred new minimally-
invasive procedures to accurately identify the site of disease and 
injury, provide tissue for a definitive diagnosis, administer treatment 
with minimal trauma, and monitor treatment responses. Image-guided 
interventions are not only more efficient in terms of time and cost, 
but their less invasive nature may result in fewer complications and 
less damage to tissue. For example, NIBIB investigators are developing 
new magnetic resonance imaging (MRI) techniques to detect and treat 
organ rejection non-invasively. The current standard for diagnosing and 
staging rejection is the biopsy, which is invasive, painful, and prone 
to sampling errors that can yield false negative results. The 
development of a non-invasive imaging-based method that can replace the 
biopsy is highly desirable.
    Over the next year, the NIBIB intends to expand its image-guided 
interventions program by supporting research on the development of 
technologies that allow the surgeon to visualize the patient 
seamlessly, in three-dimensional preoperative images; track 
intraoperative changes with real-time imaging; and restore a normal 
sense of touch through robotic tools with sensors for touch feedback, 
or haptics. This research may lead to new minimally-invasive surgical 
procedures with fewer complications, shorter hospital stays, and 
reduced costs. To plan for future initiatives in this area, the NIBIB 
recently organized an interagency retreat to identify high priority 
challenges that can serve as short- and long-term goals. Eight Federal 
agencies and nine NIH Institutes and Centers (ICs) participated in this 
retreat.

                            SMEDICAL ROBOTIC

    First generation surgical robots are already being installed in a 
number of operating rooms around the country. Although these robots 
can't perform surgery on their own, they are certainly lending a 
mechanical hand. Robots are being used in medicine because they allow 
for unprecedented control and precision of surgical instruments and 
reduce trauma to the patient, dramatically improving surgical outcomes 
and lowering health care costs. Robots are also being used in 
rehabilitation as they provide considerable opportunities to improve 
the quality of life for physically disabled people. For example, one of 
the most common stroke disabilities is a paralyzed arm. The NIBIB and 
the National Institute of Child Health and Human Development are 
jointly funding the development of two robotic devices that could 
accelerate rehabilitation of patients with paralyzed arms and reduce 
the cost of physical therapy. These devices can also treat people who 
have experienced catastrophic events, such as war injuries resulting in 
limb loss. Testing with stroke patients is expected to begin this year 
using one device.
    Traumatic injury or neurological diseases can also significantly 
alter or impair the lifestyle of an individual. To help patients lead 
more productive lives, NIBIB scientists are developing a non-invasive 
brain-computer interface to provide both communication and control 
functions. By recording brain waves from the scalp and then decoding 
them, this system allows people to move a cursor to spell words, and 
even to control a robotic arm. Initial efforts to test this new 
technology in the field are underway.

         NANOTECHNOLOGY FOR DISEASE DETECTION AND DRUG DELIVERY

    Detection of dormant metastatic tumor cells is a critical but 
elusive goal in cancer treatment. To find these cells, NIBIB 
researchers are developing non-invasive optical imaging techniques that 
are less costly and more accessible than MRI-based techniques and are 
free of the side effects associated with radioactive imaging agents. 
Microscopic or nanoscale ``bubbles,'' called polymerosomes, containing 
embedded fluorescent materials are the key to this new approach. These 
labeled bubbles are injected directly into a tumor and then imaged. 
Also in development are polymersomes that would deliver chemotherapy 
agents directly to a tumor. The surface of the bubble can carry a 
molecule that would bind to tumor cells, and its membrane would also 
hold fluorescent molecules for detection by optical imaging, with the 
chemotherapy ``payload' carried in the interior. One investigator has 
developed a special device which improves drug release by ultrasonic 
fragmentation of the bubble.

                 ENHANCED SUPPORT FOR NEW INVESTIGATORS

    New investigators are the innovators of the future--they bring 
fresh ideas and technologies to existing biomedical research programs, 
and they pioneer new areas of investigation. Entry of new investigators 
into the ranks of independent, NIBIB-funded research is essential to 
the health of the biomedical imaging and bioengineering research 
enterprise. The NIBIB is specifically targeting new investigators for 
special funding consideration. This proved to be quite successful in 
the first year of this policy, and a continuation of this program is 
planned.

                        TRAINING FOR THE FUTURE

    An important goal of the NIBIB is to train a new generation of 
researchers equipped to meet the modern needs of interdisciplinary and 
transdisciplinary research. Researchers trained in biomedical imaging 
and bioengineering must be able to demonstrate technical competency in 
multiple fields as well as the ability to think independently, 
communicate ideas effectively, work in teams, and contribute to a 
strong vision that transcends a narrow discipline. To this end, the 
NIBIB will work with the community to develop new programs that cross-
train research scientists in the biological and quantitative sciences. 
For example, the NIBIB's Research Supplements to Promote Clinical 
Resident Research Experiences program has been very successful. This 
novel training mechanism is designed to serve as a ``first step'' in 
attracting outstanding clinicians into research careers related to the 
mission of the NIBIB by providing a one to two-year research 
opportunity during residency training.
    The NIBIB has also developed several public and private 
collaborations to catalyze research at this interface. For example, the 
NIBIB and the Howard Hughes Medical Institute partnered in a novel 
public-private partnership to stimulate the development of new 
interdisciplinary graduate training programs that integrate the 
physical, quantitative, and engineering sciences with the life 
sciences. This program will train a new generation of researchers, 
equipped to meet the challenges of the 21st Century.

                  NIH ROADMAP FOR BIOMEDICAL RESEARCH

    An overarching goal of the NIH Roadmap is to facilitate the 
development of broad-based innovative, novel and multidisciplinary 
science and technology that has the potential to further advances in 
health care. This goal is well aligned with the NIBIB mission and is 
actively supported on a number of fronts. For example, over the last 
year NIBIB has been the lead Institute in a Roadmap initiative entitled 
``Innovation in Molecular Imaging Probes.'' Molecular imaging 
approaches can be used to study cellular events and biochemical 
abnormalities. The major roadblocks to in vivo clinical applications of 
molecular imaging are the poor sensitivity and potential toxicity of 
the current probes. This initiative supports research programs that 
will circumvent these roadblocks.

                             NIH BLUEPRINT

    The Neuroscience Blueprint is a framework designed to enhance 
cooperative activities among the NIH ICs that support research on the 
nervous system. During the last year, NIBIB contributed to the 
development of a number of initiatives, leading or participating in 
three project teams. These initiatives aim to support research and 
development of imaging technology for high resolution imaging of neural 
activity that is reflected in electrophysiological signals; and to 
develop a framework to address the critical need for neuroimaging data 
and software tools sharing and integration. The NIBIB also participated 
in the development of neuroscience training initiatives.
                                 ______
                                 
Prepared Statement of Dr. Griffin P. Rodgers, Acting Director, National 
        Institute of Diabetes and Digestive and Kidney Diseases

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2007 President's budget request for the National 
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) a sum 
of $1,844,298,000, which includes $150,000,000 for the Special 
Appropriation for Research on Type 1 Diabetes through Sec. 330B of the 
Public Health Service Act. The NIDDK transfers some of these funds to 
other institutes of the NIH and to the Centers for Disease Control and 
Prevention (CDC). Adjusted for mandatory funds, this is an decrease of 
$10,627,000 from the fiscal year 2006 enacted level of $1,854,925,000 
comparable for transfers proposed in the President's request.
    The NIDDK supports research to combat a wide range of chronic 
health problems, including diabetes and other endocrine and metabolic 
diseases; diseases of the digestive system, kidneys, urinary tract; and 
blood; nutritional disorders; and obesity. Through vigorous research, 
initiated both by investigators and by the Institute, the NIDDK will 
continue to elucidate the fundamental biology underlying health and 
disease. We are pursuing new strategies for disease diagnosis, 
treatment, and ultimately, prevention and cure.

          PREEMPTING CHRONIC DISEASES AND THEIR COMPLICATIONS

    Chronic diseases pose some of the greatest health challenges to the 
Nation today. These diseases and their symptoms range in severity, but 
are often debilitating and sometimes fatal. Some impair fundamental 
body processes, such as metabolism, while others target the kidneys, 
liver, and other vital organs and systems. Though their causes and 
ultimate effects on health may differ, chronic diseases share the grim 
features of constant affliction and impaired quality-of-life. The 
burden of chronic diseases within NIDDK's research purview is immense. 
Recent estimates using national health survey data reveal that diabetes 
(type 1 and type 2) affects nearly 21 million Americans.\1\  About 20 
million Americans have chronically impaired kidney function, which 
places them at increased risk for irreversible kidney failure (end 
stage renal disease) and death.\2\  Digestive diseases, such as 
irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), and 
liver and biliary diseases, wreak havoc with people's lives. ``Benign'' 
diseases of the bladder and lower urinary tract, including urinary 
incontinence and prostate diseases, can be devastating. These chronic 
diseases also exact a heavy economic toll. For example, the healthcare 
and indirect costs of diabetes and its complications totaled $132 
billion in 2002.\3\ The painful, debilitating symptoms of IBS and the 
bladder disease interstitial cystitis (IC) result in loss of work and 
increased medical costs. Costs of chronic diseases that strike the 
digestive system, kidneys, and bladder run into the tens of billions of 
dollars.
---------------------------------------------------------------------------
    \1\ National Institute of Diabetes and Digestive and Kidney 
Diseases. National Diabetes Statistics fact sheet: general information 
and national estimates on diabetes in the United States, 2005. 
Bethesda, MD: U.S. Department of Health and Human Services, National 
Institute of Health, 2005
    \2\ The National Kidney Foundation http://www.kidney.org/
kidneyDisease/. Accessed February 14, 2006.
    \3\ Hogan P, et al, Diabetes Care 26:917-932, 2003.
---------------------------------------------------------------------------
    The tremendous human and monetary costs of chronic disease are 
matched only by the extraordinary interventions often needed just to 
preserve life. Organ transplantation and kidney dialysis are but two 
examples. Although these are extreme measures for the sickest patients, 
they represent some of the victories achieved by biomedical research in 
reducing morbidity and mortality from advanced chronic disease. Our 
goal is to improve these treatments, while we simultaneously seek 
prevention strategies. For example, whole liver transplantation from 
deceased donors is a successful treatment for liver failure, but is 
limited by a shortage of donor organs. A new NIDDK clinical network 
(A2ALL) is maximizing this treatment option in adults by assessing the 
safety and outcomes, for both patients and donors, of new procedures 
that use partial liver transplants from living donors--thereby 
increasing the potential donor pool. Similarly, we are addressing the 
diminished quality-of-life and low five-year survival rates under 
current dialysis treatment, which is typically administered three times 
weekly. A new clinical trial will evaluate the effectiveness of daily 
dialysis.

                    IMPORTANCE OF EARLY INTERVENTION

    For persons already suffering from chronic disease, improved 
treatments will have great benefits. However, it is imperative that 
researchers find ways to intervene at the earliest possible stage of a 
disease. The goals for such research are to: (1) identify and use 
biological information, such as ``biomarkers,'' that can predict an 
individual's susceptibility to disease, disease progression, or disease 
complications--thereby enabling more tailored use of interventions; (2) 
find the most effective interventions to preempt the onset or course of 
disease; and (3) ensure that these predictive tools and interventions 
can be precisely targeted for the benefit of patients. New advances in 
science, technology, and public health research are making these goals 
realizable, with the prospect of significant improvements in public 
health. Examples of potential research payoffs include hepatitis C and 
diabetes complications. In the United States, hepatitis C infection 
affects an estimated 4 million people and is the leading cause of both 
liver cancer and liver failure due to end-stage cirrhosis. Patients who 
do not respond to standard medical therapy with interferon and 
ribavirin are at high risk of developing these severe health problems. 
Ideally, physicians should be able to predict likely ``non-responders'' 
to current therapy and those at risk for disease progression, and then 
tailor interventions to them. While this is not yet possible, ongoing 
studies will help to move the field forward, including a major clinical 
trial (HALT-C) aimed at preventing end-stage cirrhosis and lowering 
risk of liver cancer in ``non-responders'' with advanced disease.
    Likewise, physicians would welcome new, precise methods for 
tailoring interventions to individuals with diabetes so as to reduce 
complications in those at greatest risk, while also lessening treatment 
burden. Landmark clinical trials have demonstrated that tight control 
of blood sugar levels in type 1 diabetes patients significantly reduces 
their overall risk of eye, kidney, nerve, and cardiovascular disease. 
Unfortunately, current therapies to achieve tight control also increase 
the risk of potentially life-threatening bouts of low blood sugar. If a 
simple method existed to identify patients who could tolerate 
``looser'' control of blood sugar levels without an increased risk of 
complications, then therapy could be tailored accordingly. Pinpointing 
the underlying causes of diabetes complications will pave the way to 
such targeted interventions.
    Developing a more personalized approach to medical therapy requires 
a robust toolkit forged from research advances. Therefore, the NIDDK is 
continuing with new initiatives to accelerate translation of 
fundamental research into clinically useful applications. For example, 
we want to be able to stop early scarring of the liver and kidney--
known as fibrosis--before it ignites a series of events leading to 
irreversible organ failure. The NIDDK is fostering new, non-invasive 
imaging methods to reveal fibrosis. Such techniques will enable 
physicians to diagnose, monitor and treat liver and kidney disease more 
effectively. For diseases within the NIDDK mission, we are also 
committed to the discovery of biomarkers--factors, such as molecules, 
that can be measured and used to monitor a patient's disease or 
response to therapy. A new translational initiative encourages research 
to develop and validate these biomarkers for clinical use.
    Critically important for predicting and preempting chronic 
diseases--such as polycystic kidney disease (PKD), focal segmental 
glomerulosclerosis (FSGS), kidney stones, IC, IBD, IBS, non-alcoholic 
steatohepatitis (NASH), and hepatitis B and C--is a thorough 
understanding of their natural history. For example, discovery of PKD 
genes has led to insights into the molecular defect underlying most 
cases of this disease. Promising new medical therapies are being 
explored to prevent or reduce cyst formation, and new trials (HALT-PKD) 
will now test approaches for preventing progressive kidney damage. In 
the kidney disease FSGS, we do yet know all the causative factors, but 
a better understanding of FSGS progression has enabled the NIDDK to 
undertake a trial of therapies to prevent or delay kidney failure in 
patients. A new international patient registry should increase our 
understanding of inherited causes of calcium oxalate kidney stones. The 
cause(s) of the bladder disease IC remains unknown, but studies of a 
promising biomarker from urine may lead to improved diagnosis and 
treatment for patients, as well as to new therapeutic options.
    Our efforts in digestive diseases will be guided by a long-range 
strategic research plan to be developed by a new National Commission, 
as well as by a recently completed Liver Disease Action Plan. We are 
already making progress on several fronts. In IBD, studies of a 
recently identified Crohn's disease susceptibility gene are pointing 
the way to new therapeutic options. Researchers are exploring the 
multiple physical and cognitive factors that appear to play a role in 
IBS. A new clinical research network is studying the biological basis 
of progression from a less serious form of non-alcoholic fatty liver 
disease to the fatty liver, liver inflammation and scarring of NASH, 
and will test strategies to prevent disease progression in both adults 
and children. Studies of the hepatitis B virus continue in order to 
optimize treatment options. A new system to replicate (``grow'') 
hepatitis C virus in the laboratory will significantly enhance research 
to test potential therapeutic targets and open the door to vaccine 
development--complementing ongoing trials such as HALT-C.
    Strikingly, research has revealed that obesity, with its 
comorbidities, is at the nexus of many chronic diseases. The high 
prevalence of obesity in the U.S. population, with nearly 31 percent of 
adults affected,\4\ bears directly on the millions affected with 
chronic diseases. Obese individuals are at increased risk of type 2 
diabetes, and obesity is linked to increased risk of NASH, as well as 
of ESRD via type 2 diabetes and high blood pressure. However, not all 
overweight and obese individuals will develop obesity-associated 
diseases. Age, gender, race, ethnicity, socio-economic status, and 
individual genetics are among the many factors that may influence risk. 
Through initiatives developed by the NIH Obesity Task Force and through 
NIDDK-led efforts, we are encouraging research studies to promote 
prevention and to identify which subsets of obese individuals are at 
risk for developing particular comorbidities, and, in turn, to tailor 
interventions accordingly.
---------------------------------------------------------------------------
    \4\ Flegal KM et al, JAMA 2002;288:1723-1727.
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    Recent data offer promise that we may be able to stem the tide of 
obesity-related health problems. For example, analyses by the United 
States Renal Data System (USRDS) indicate that overall incidence rates 
of ESRD have stabilized in the United States, following a 20 year 
period of annual increases. This finding suggests that there has been a 
successful translation into medical practice of research-based 
knowledge important to preventing ESRD--the use of medications (ACE 
inhibitors) and the benefits of controlling blood sugar and blood 
pressure levels. Unfortunately, this positive result has not yet been 
seen across the entire U.S. population, in that ESRD continues to 
affect minority groups disproportionately. The National Kidney Disease 
Education Program (NKDEP) has a major campaign aimed at reducing the 
burden of kidney disease in African Americans, for whom the risk 
factors of high blood pressure, diabetes, and a family history are 
dangerous red flags. Through its working groups, the program is also 
promoting the standardized, routine reporting of serum creatinine--an 
indicator of kidney function. Use of this simple approach can 
facilitate early detection and treatment of impending or active chronic 
kidney disease in patients. Along the same lines, the National Diabetes 
Education Program (NDEP) has translated into a multi-faceted campaign 
for multiple audiences the impressive results of the Diabetes 
Prevention Program (DPP) clinical trial. This trial demonstrated that 
lifestyle changes--relatively moderate weight loss and increased 
physical activity--can reduce the risk of type 2 diabetes by 58 percent 
in persons at risk for the disease.
    Such hopeful results spur our efforts to further reduce the health 
burden of these chronic conditions through interventions to prevent 
obesity as early as possible. Prevention research needs to address the 
alarming rise in rates of pediatric overweight and obesity nationwide 
over the past three decades. A recent study indicates that 
approximately two million American adolescents have a prediabetic 
condition (IFG) strongly linked to obesity and overweight. Children and 
adolescents are being increasingly diagnosed with type 2 diabetes, 
NASH, and other obesity-associated conditions once found mainly in 
adults. To address key points of vulnerability early in life, the NIDDK 
is spearheading several initiatives, such as defining mechanisms by 
which maternal obesity and diabetes during pregnancy affect the future 
risk of obesity and other chronic diseases in offspring. Another 
initiative is focused on finding ways to prevent or manage weight gain 
in children. Moreover, the new ``HEALTHY'' trial will investigate 
whether a concerted, integrated program in middle schools will help 
reduce the prevalence of obesity-related harbingers of type 2 diabetes 
by improving cafeteria lunches, vending machine offerings, and physical 
education and promoting behavioral change. The tremendous success of 
the intensive lifestyle intervention for adults in the Diabetes 
Prevention Program provides hope that the HEALTHY trial may do the same 
for children.
    The Nation's investment in NIH-funded research offers enormous 
benefits, particularly the opportunity to preempt disease and reduce 
its lifelong costs, both human and economic. To this end, the NIDDK is 
harnessing new technologies, maximizing research investments, and 
capitalizing on new opportunities to achieve early, effective 
intervention for the many chronic diseases within its mission. Thank 
you, Mr. Chairman. I would be pleased to answer any questions that the 
Committee may have.
                                 ______
                                 
  Prepared Statement of Dr. John Ruffin, Director, National Center on 
                 Minority Health and Health Disparities

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Center on Minority 
Health and Health Disparities (NCMHD) for fiscal year 2007, a sum of 
$194,299,000, which represents a decrease of $1,106,000 over the 
comparable fiscal year 2006 appropriation.
    The overall health of the general American population has improved; 
yet as a Nation we continue to be challenged by disparities in health 
among racial and ethnic minority and other health disparity 
populations. There continues to be a disproportionate burden of 
illness, disability and premature death resulting from diseases and 
health conditions such as cancer, cardiovascular disease, HIV/AIDS, 
stroke, obesity, mental illness and diabetes, in these communities.
    The cause of health disparities is multi-factorial in nature. The 
complexity of health disparities merits a strategic, innovative, and 
multi-faceted attack. Genes, biology, culture, race environment, 
socioeconomics, and health behaviors all contribute to this complex 
public health crisis. Biomedical research is essential in transforming 
the health of this Nation. In order to have the greatest impact on 
improving the health of America's underserved populations, at NIH, we 
believe a new biomedical research paradigm is needed--one that is 
predictive, personalized and preemptive. We need a well-coordinated, 
interdisciplinary effort involving traditional as well as non-
traditional partners to get to the crux of the health disparities 
crisis.
    The National Center on Minority Health and Health Disparities was 
established in 2000 to lead the Federal effort in health disparities 
research, research capacity building, and outreach. The NCMHD has 
always recognized the significance of partnerships in resolving health 
disparities. Our programs embody a strategy that emphasizes our efforts 
to build a biomedical research enterprise that is diverse, predictive, 
personalized, and preemptive.
    The NCMHD is committed to training a diverse biomedical research 
workforce to examine issues relevant to the disparities in health of 
America's rapidly increasing racial and ethnic minority populations. 
More than 600 promising research scientists across the country have 
received NCMHD loan repayment awards to conduct health disparities 
research and clinical research. Institutional capacity building has 
been an important area of focus. Through our endowments and research 
infrastructure program, we have funded almost 40 academic 
institutions--ore than half being minority-serving institutions. The 
funding is helping to equip the institutions, their faculty and 
students to engage in avant-garde biomedical research and training. 
Another integral element of our strategy is community participation. 
Our aim is to empower the community to address its own health problems. 
Our communities should include individuals other than patients, who 
must be actively engaged in research intervention and ultimately the 
translation and dissemination of research results into practical 
community tools.
    Advancements in science and technology offer hope for the future. 
The NCMHD has supplied more than 100 individuals, institutions, and 
small businesses with resources to conduct research to help answer some 
of the perplexing issues in health disparities. NCMHD is one of the few 
NIH Institutes or Centers (IC) that focuses on populations and not 
specific diseases or health conditions. Consequently, we have had the 
unique opportunity of partnering with all of the ICs over the past five 
years in our quest to eliminate health disparities. Our partnerships 
and our programs have allowed us to support research into many of the 
diseases and health conditions affecting racial/ethnic minority and 
other health disparity populations. It is through these programs and 
partnerships, that the NCMHD has been able to have far reaching effect 
in improving the health of the Nation's health disparity populations. 
We have made progress, but there is much more to be achieved.

                   HEALTH DISPARITIES RESEARCH AGENDA

    A national health disparities research agenda is fundamental in 
eliminating health disparities. Healthy People 2010, the prevention 
strategy for the Nation, identified a number of health objectives to be 
achieved over a 10-year period. The elimination of health disparities 
among different segments of the population in the United States is one 
of the goals. We have five years left as a Nation to demonstrate how 
far we have come in attaining that goal. The NIH through the leadership 
of the NCMHD has been a principal player in advancing the goals of 
Healthy People 2010. The NCMHD coordinates the development of the 
evolving NIH health disparities research agenda--the NIH Health 
Disparities Strategic Plan. The Plan represents the trans-NIH health 
disparities vision and strategy. Through the Strategic Plan, the NIH 
can aggressively address health disparities by fostering pioneering 
partnerships and initiatives. The NCMHD, through the Institute of 
Medicine (IOM), initiated the five-year evaluation of the NIH Health 
Disparities Strategic Plan. The NCMHD, in collaboration with NIH 
leadership and the Secretary of Health and Human Services will address 
the recommendations of the IOM report in implementing and reshaping the 
NIH health disparities research agenda.

                    NCMHD HEALTH DISPARITIES EFFORTS

    At the NCMHD, we are working to build an inclusive, collaborative, 
and adaptive biomedical and behavioral research enterprise to identify 
innovative diagnostics, treatments, and preventive strategies that will 
eliminate health disparities. NMCHD activities have been numerous and 
far-reaching. The newest NCMHD initiative is the Community-Based 
Participatory Research (CBPR) Program, which supports 25 institutions 
nationwide. The CBPR exemplifies a predictive, personalized and 
preemptive approach to eliminating health disparities. It is a three-
part program that engages the community in all phases of the research 
process and is directed to a specific disease/health condition in a 
particular minority population. It starts with a three-year planning 
grant, followed by a five-year grant to conduct intervention research, 
and concludes with a three-year grant to disseminate the research 
information. The CBPR is a novel approach for the biomedical research 
enterprise, and we anticipate its potential in addressing health 
disparities through projects such as: Project GRACE: A Participatory 
Approach to Address Health Disparities in HIV/AIDS among African 
American Population; Partnership to Overcome Obesity in Hawaii; Project 
AsPIRE (Asian American Partnership in Research); The Healing of the 
Canoe (is aimed at planning, implementing and evaluating a community-
based and culturally competent intervention to reduce health 
disparities and promote health in the Suquamish Tribe reservation 
community); and Partnership for a Hispanic Diabetes Prevention Program 
in Washington.
    The Centers of Excellence Program, ``Project EXPORT'' has been key 
in leading our effort in supporting the advancement of medical research 
and the transformation of the health care system. The program is 
creating new partnerships to enable institutions at all levels of 
capability to maximize their health disparities research, research 
training and community outreach efforts. The 73 Project EXPORT grantees 
have had a tremendous influence on creating more than 100 unique 
partnerships focused on health disparities. We have created an array of 
partnerships with entities such as hospitals; tribal groups; health 
plans; health centers; community and faith-based organizations; civic 
and non-profit health organizations; and local, city, and state 
governments. Biomedical research is important in understanding the 
underlying causes of health disparities, and how to prevent, diagnose 
and treat disease and disability. The research conducted by our Centers 
of Excellence will help to increase that understanding through projects 
such as: Perceived Discrimination in Healthcare among American Indian/
Alaska Natives; Religious Outlook on Organ and Tissue Sharing; 
Inflammation and Asthma; Impact of Coronary Heart Disease Risk 
Perception on Health Behaviors and Physical Activity Assessment in 
Multi-Ethnic Women.
    The NCMHD Loan Repayment Programs support the goals of the new NIH 
Pathway to Independence Program by increasing the number of qualified 
health care professionals who conduct health disparities and clinical 
research. The programs promote a diverse and strong scientific 
workforce. Since its establishment, the Loan Repayment Program has made 
more than 600 new awards to researchers in research disciplines such as 
epidemiology, pharmacology, linguistics, etiology, health policy, and 
behavioral science. The program is fulfilling its Congressional intent 
with the majority of award recipients being from a health disparity 
population. The NCMHD is training research scientists and health 
professionals not only to deal with health disparities on the domestic 
level, but also globally. Through the Minority Health and Health 
Disparities International Research Training Program (MHIRT), 24 
academic institutions have developed international training 
opportunities in health disparities research for faculty and students. 
MHIRT participants will be exposed to research areas including cancer 
epidemiology, reproductive biology, parasitology, and ethnopharmacology 
in countries such as Ethiopia, Ghana, Jamaica, Dominican Republic, 
Australia, and Spain.
    The NCMHD commitment to enhancing research capacity at academic 
institutions is best demonstrated through its Research Endowment 
Program and its Research Infrastructure in Minority Institutions (RIMI) 
Program. The RIMI program is building research capacity in 21 
predominantly minority-serving academic institutions. The NCMHD 
provides endowment grants to eligible institutions to build minority 
health and other health disparities research and training capacity. The 
Endowment program has funded 16 institutions to strengthen teaching 
programs in the biomedical and behavioral sciences; establish endowed 
chairs and programs; obtain state-of-the-art equipment for instruction 
and research; and enhance the recruitment and retention of student and 
faculty from health disparity populations.

                        RESEARCH COLLABORATIONS

    The health disparities phenomenon is almost incomprehensible until 
it is humanized. Hurricane Katrina demonstrated the underlying national 
health crisis that continues to plague America's racial and ethnic 
minority and low-socio economic communities. In some cases, evacuees 
received medical treatment for the first time for chronic and life-
threatening diseases, such as hypertension, cardiovascular diseases, 
diabetes, and mental health disorders.
    Community involvement and partnerships are critical to redress the 
devastation experienced by individuals caught in the path of Hurricane 
Katrina. The NCMHD is collaborating with the HHS Office of Minority 
Health on a HHS $12 million initiative to bring desperately needed 
health care services, information, and hope to racial and ethnic 
minority populations in the Gulf Coast region. The NCMHD provided $5.2 
million in funding to support that initiative. Our Centers of 
Excellence have also been mobilized to participate in the initiative to 
create a Regional Coordinating Center to build a research 
infrastructure for on-going efforts to eliminate health disparities in 
the hurricane-ravaged communities. Such an infrastructure would 
integrate research-based academic facilities, public health, primary 
care, and specialty care officials to engage in innovative approaches 
to relief activities, including developing and testing culturally 
relevant telemedicine response to mental health needs, and other acute 
and chronic diseases; instituting electronic health records for 
individuals in the region through partnerships with academic experts in 
practice-based research; and establishing effective community-based 
screening and surveillance systems to monitor health needs of 
individuals evacuated from hurricane-ravaged communities, as well as 
those returning to communities as they are re-built, with a special 
focus on exacerbations of existing health disparities.
    The NCMHD Visiting Faculty Program is a new program that is 
assisting researchers displaced by the hurricane. The program will help 
to bring displaced scientists who were employed at institutions in the 
Gulf Coast states to the NIH, so that they can continue their research 
efforts.

                               CONCLUSION

    During its initial five years the NCMHD has strived to be 
inclusive, creative, and adaptable to changing circumstances. The 
programs highlighted are but some examples of what is being done to 
eliminate health disparities. We need to build on these successes and 
further our activities. Toward this end, the NCMHD will sustain and 
expand its primary strategies. Research capacity building will continue 
to extend beyond academia to involve community and faith-based 
organizations, individuals, and businesses at the local and grassroots 
level. Training and the diversification of the health, scientific, and 
technological workforce will remain key areas of focus in developing 
innovative projects. Prevention, treatment, cultural competency, and 
healthcare delivery for urban and rural communities will continue to be 
approached aggressively.
    Through our vision of the future embodied in the NIH Health 
Disparities Strategic Plan, the NCMHD renews its commitment to build a 
solid and diverse national biomedical research enterprise of 
individuals and institutions dedicated to eliminating health 
disparities. With our NIH Institute and Center collaborations and our 
partnerships with scientific institutions and community-based 
organizations across the Nation, the NCMHD will advance scientific 
discovery to ensure the health of all Americans. All citizens should 
have an equal opportunity to live long, healthy and productive lives.
                                 ______
                                 
    Prepared Statement of Dr. David A. Schwartz, Director, National 
               Institute of Environmental Health Sciences

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget for the National Institute of Environmental 
Health Sciences (NIEHS) for fiscal year 2007, a sum of $637,323,000 
which reflects a decrease of $3,809,000 from the fiscal year 2006 
appropriation.

                              INTRODUCTION

    As the Director of NIEHS, I am grateful for this opportunity to 
present our vision for the Institute and environmental health sciences. 
Our vision at NIEHS is to prevent disease and improve human health by 
using environmental sciences to understand human biology and human 
disease. Environmental agents contribute to many conditions of public 
importance, including cancer, neurodevelopmental disorders, autoimmune 
diseases, and chronic lung disease. While many of our investigators are 
focused on understanding the causes of disease, we are also involved in 
studies of susceptibility, basic mechanisms of disease, and identifying 
novel approaches to intervention and disease prevention.
    Recent NIEHS-supported research illustrates the range of our 
Institute's science. In studying asthma, NIEHS scientists examined the 
mechanisms controlling the body's own system for achieving balance 
between airway constriction and airway relaxation. They discovered a 
natural bronchodilator, deficient in asthmatics, that relaxes the 
airway; absence of this enzyme in mice increases the development of 
allergen-induced asthma. In other work, investigators studied the role 
of supplements in preventing birth defects. While folate has been shown 
to prevent spina bifida, a defect in the spinal column, epidemiologists 
have now discovered that women who take folate supplements during 
pregnancy are at reduced risk of giving birth to a child with cleft lip 
and palate birth defects. Finally, NIEHS-supported studies have shown 
that short-term exposure to ozone can increase mortality rates. These 
studies demonstrated that a 10-part per billion (ppb) increase in the 
previous week's ozone was associated with a significant increase in 
cardiovascular and respiratory mortality.

                           CURRENT CHALLENGES

    Today, we find ourselves at a critical junction where new tools and 
opportunities for substantial scientific achievement intersect with our 
growing understanding of cellular and molecular mechanisms by which 
environmental exposures exert their effects. Our challenge is to take 
advantage of these advances and to forge new frontiers to improve our 
nation's health. To help ensure that the best opportunities are 
identified and funded, we have made several programmatic and scientific 
changes at the Institute since last April. Importantly, these changes 
are consistent with our strategic plan that we initiated ten months ago 
and have involved the efforts of many talented individuals across the 
country. Concurrently, we are engaged in developing critical 
partnerships to address areas of public health concern that involve the 
missions of multiple organizations.

                 INTEGRATIVE RESEARCH ON HUMAN DISEASE

    Environmental health science is not limited to an organ system, 
disease or population, but spans the full spectrum of human health and 
disease. The interdisciplinary nature of our work requires the right 
mix of specialists. As NIEHS increases its focus on common human 
diseases, interdisciplinary teams of scientists will be needed to 
integrate clinical, epidemiological, and toxicological research with 
basic mechanistic studies. To optimize the creation of these 
interdisciplinary research teams, I have begun a number of programmatic 
changes. I have created an Office of Translational Biomedicine that 
will re-focus the NIEHS intramural and extramural programs so that our 
basic research discoveries can be rapidly applied to improvements in 
human health. In our division of extramural research, I have initiated 
a new program, DISCOVER (Disease Investigation for Specialized 
Clinically Oriented Ventures in Environmental Research), that brings 
together extramural scientists with expertise in basic, clinical, and 
population-based research to focus on a disease related to 
environmental exposures. Among intramural investigators, I have 
developed a new program, the Director's Challenge, that also supports 
multidisciplinary research teams to attack basic problems, like 
inflammation and oxidative stress, that can be induced by environmental 
exposures and can influence the development of many different diseases. 
I am re-engineering our Environmental Health Science Research Centers 
so that they include a clinical component in their research, thus 
enhancing the disease focus and relevance of these centers. I have also 
directed funds to build a new clinical research unit on campus so that 
our intramural research program can be integrated into human biology 
and human disease.

                 RECRUIT AND TRAIN THE NEXT GENERATION

    A more integrative approach to understanding complex human diseases 
will require innovative scientists with the type of training that can 
take advantage of new technologies and research opportunities. NIEHS 
has initiated a number of changes that address our future workforce 
needs. We have re-engineered our existing training programs so that we 
can better identify and encourage promising students at all levels to 
pursue careers in environmental health research. The existing T32 
training grants program will be broadened to include other training 
opportunities in interdisciplinary research and genetics and genomics. 
We will also train physician-scientists by expanding our MD, PhD 
training program and by supporting young investigators in their 
transition to early faculty positions (developed a K12 training 
program. We have also instituted the Outstanding New Environmental 
Scientist, or ONES, award to help young, talented investigators make 
the transition from mentored to independent research. These grants will 
assist young scientists in launching innovative research programs 
focusing on problems of environmental exposures and human biology, 
human pathophysiology, and human disease by providing support for both 
the research and the start-up costs that are needed to establish a 
laboratory.

                    EXPAND COMMUNITY-LINKED RESEARCH

    The likelihood of exposure to environmental agents increases in 
economically disadvantaged communities and is associated with an excess 
disease burden in these communities. The NIEHS traditionally supports 
research relevant to understanding those health disparities and 
community concerns. We will continue to support research, both 
domestically and globally, that can offer insights into how to reduce 
exposures and disease in these settings. We will also be involved in 
developing quick responses to emerging environmental health issues, 
such as arose in the aftermath of Hurricane Katrina, when NIEHS 
launched a website that used a Global Information System to assess 
environmental hazards caused by the storm, as well as coordinated a 
local team of physicians and support staff to deliver medical care. 
Beginning in fiscal year 2006, NIEHS is planning to support a research 
program to investigate the health consequences of Hurricane Katrina. 
This project will examine the role of genes, the environment, and gene-
environment interaction in the exacerbation of airway disease from 
exposure to mold and microbial toxins in New Orleans following 
Hurricane Katrina.

                  RE-EVALUATE PROGRAMMATIC INVESTMENTS

    We have decided that investigator-initiated research needs to be 
prioritized at NIEHS and are rigorously re-evaluating other existing 
programs and approaches to determine if we need to re-conceptualize or 
eliminate some of these efforts. We have developed two new programs 
aimed at using environmental agents to understand basic mechanisms in 
human biology. One is the Epigenetics Initiative which explores 
intrauterine environmental and nutritional factors that can alter gene 
expression and generate developmental abnormalities or functional 
changes. The other is the Comparative Biology of Environmental Disease 
which uses novel ``-omics'' technologies and comparative biology 
approaches to study environmentally-relevant disease pathways. These 
studies will help us understand why people exposed to the same 
environmental stressors respond differently. Finally, we have 
reorganized the National Center for Toxicogenomics to insure a more 
timely and relevant product. In order to achieve these new programs and 
priorities, I have decided that the Comparative Mouse Genomics Centers 
Consortium has fulfilled its mission of infrastructure development and 
will not be re-competed.

      GENE, ENVIRONMENT AND HEALTH INITIATIVE--A NOVEL PARTNERSHIP

    Currently, we have inadequate techniques to precisely measure 
environmental exposures. This situation is in marked contrast to the 
robust tools that have been recently developed for the fields of 
genetics and genomics. To be able to assess the role that environmental 
exposures and genetic variation play in the risk of developing disease, 
we simply need more robust tools to measure the environmental exposures 
and the biological responses to these agents. While these tools are 
absolutely vital in moving the field of environmental health sciences 
forward, these tools will be invaluable to investigators in all areas 
of biomedical research. To further this goal, the NIH, with the support 
of the Secretary, has developed the Gene, Environment and Health 
Initiative. Our goal in this initiative is to develop tools to 
precisely measure individual biological responses to changes in our 
environment, diet, and activity level so that we can understand the 
relationship between various environmental exposures and human health 
and disease.

                  NIEHS STRATEGIC PLAN--A NEW OUTLOOK

    The NIEHS recently embarked on a strategic planning exercise, the 
final version of which can be viewed on our website and will soon be 
distributed in hardcopy. This document represents the efforts of many 
scientists and advocacy groups. I have been gratified by the intense 
interest and involvement from citizens and scientists throughout the 
country. This document is truly a national plan that represents our 
collective wisdom of where environmental health sciences needs to go in 
order to reap full benefit of our investments and opportunities. Many 
of the suggestions have already been incorporated into our new programs 
and we will continue to design programs that are responsive to this 
plan.

                                SUMMARY

    The opportunities within environmental health sciences are greater 
than they have ever been. With our recent nationally supported 
strategic plan and the exciting partnerships that we are developing, it 
is my belief that environmental health sciences will continue to 
strengthen. With an improved relevance to major public health concerns, 
better technology for teasing out important environmental contributors 
to disease, an integrated approach to research, and a re-energized 
workforce, I expect the NIEHS to provide many of the important 
scientific advances of the future. Ultimately, this knowledge will be 
used to reduce the burden of many important diseases both in this 
country and abroad. I would be happy to answer any questions you might 
have.
                                 ______
                                 
   Prepared Statement of Dr. Paul A. Sieving, Director, National Eye 
                               Institute

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2007 President's budget request for the National Eye 
Institute (NEI). The fiscal year 2007 budget includes $661,358,000, 
which reflects a decrease of $5,398,000 under the fiscal year 2006 
enacted level of $666,756,000 comparable for transfers proposed in the 
President's request.
    As the Director of the NEI it is my privilege to report on the 
progress laboratory and clinical scientists are making in combating 
blindness and visual impairment and about the unique opportunities that 
exist in the field of vision research.

                            RETINAL DISEASES

    Retinal diseases are a diverse set of sight-threatening conditions 
that include age-related macular degeneration (AMD), diabetic 
retinopathy, retinopathy of prematurity, retinitis pigmentosa, Usher's 
syndrome, ocular albinism, retinal detachment, uveitis (inflammation) 
and cancer (choroidal melanoma and retinoblastoma).
    Of these diseases, AMD is the most frequent cause of vision loss 
and legal blindness in older-age Americans, making it a research 
priority for the NEI. AMD causes degeneration of the macula, the 
central part of the retina that gives us fine, sharp visual detail. AMD 
is thought to result from the confluence of genetic predisposition and 
chronic exposure to environmental risk factors.
    On the genetic side of the equation, identifying subtle alterations 
in a gene or genes in AMD and other late onset diseases has been 
complicated by the fact that traditional genetic research strategies 
and tools are either inadequate or too cumbersome in their application. 
The development of more sophisticated genetic tools has enabled 
scientists to scan the entire human genome more quickly and 
efficiently. Using data from the Human Genome Project and the 
International HapMap Project, four different NEI supported laboratories 
identified a common variation in a gene called complement factor H 
(CFH) that accounts for an estimated 50 percent of the risk of 
developing AMD.
    The CFH protein regulates an inflammatory response that is 
typically triggered by infectious microbes. Alterations in the CFH gene 
are postulated to poorly regulate this response, leading to chronic, 
localized inflammation and ensuing damage to cells in the center of the 
retina, the macula, and its neighboring tissues. Inflammation is 
thought to play a role in many other common diseases such as 
Alzheimer's disease, Parkinson's disease, multiple sclerosis, kidney 
disease, stroke, and atherosclerosis. Although the cells, tissues, and 
molecular events in these diseases are diverse, they may share some 
common disease mechanisms that present an opportunity to cross 
pollinate findings from diverse research areas.
    The discovery of the CFH gene will allow researchers to create 
animal models and evaluate therapies that control chronic inflammation. 
The CFH gene also illustrates the potential of a new paradigm for 
medicine in the 21st century. This new paradigm holds that the practice 
of medicine should be preemptive, personal and predictive. The CFH gene 
presents the possibility to one day identify at-risk patients and 
intervene well before pathology is clinically detectable.

              STRABISMUS, AMBLYOPIA AND VISUAL PROCESSING

    Developmental disorders such as strabismus (misalignment of the 
eyes) and amblyopia (commonly known as ``lazy eye'') are among the most 
common eye conditions that affect the vision of children. It is 
estimated that 20 percent of preschool children ages 3-4 have these and 
other treatable eye conditions.\1\
---------------------------------------------------------------------------
    \1\ Comparison of preschool vision screening tests as administered 
by licensed eye are professionals in the Vision in Preschoolers Study. 
Ophthalmology 111(4):637-50, 2004.
---------------------------------------------------------------------------
    In an effort to identify children with treatable eye conditions, 
many states are developing guidelines for preschool screening programs. 
However, none of the commonly used vision tests have been evaluated in 
a research-based environment to establish their effectiveness. To 
address this issue, the NEI supported a large, multi-center study 
called the Vision in Preschoolers (VIP) Study to determine which tests 
and test conditions can effectively identify preschoolers in need of a 
comprehensive eye exam. Previously VIP Study researchers found that in 
the hands of licensed eye care professionals, the best performing tests 
were able to detect 90 percent of children with the most severe visual 
impairments. This year, VIP Study investigators found that specially 
trained nurses and lay people can achieve results that are comparable 
to screenings performed by licensed eye care professionals. Given that 
most eye screening programs rely on lay people and nurses, this finding 
validates the effectiveness of this approach.

                    GLAUCOMA AND OPTIC NEUROPATHIES

    Glaucoma is a group of eye disorders that causes optic nerve damage 
that can lead to severe visual impairment or blindness. Elevated 
intraocular pressure (IOP) is frequently, but not always, associated 
with glaucoma. Glaucoma is a major public health problem and published 
studies find that the disease is three times higher in African 
Americans than in non-Hispanic whites.\2\
---------------------------------------------------------------------------
    \2\ The Eye Diseases Prevalence Research Group: Prevalence of open-
angle glaucoma among adults in the United States. Arch Ophthalmol 
122:532-538, 2004.
---------------------------------------------------------------------------
    The defining event that leads to vision loss in all forms of 
glaucoma is the degeneration of retinal ganglion cells (RGC) in the 
back of the eye. These cells relay visual information to the brain 
through the optic nerve and their loss effectively severs the neural 
network that allows us to process visual information. However, little 
is known about the molecular events that result in RGC degeneration. 
Using high dose radiation and bone marrow rescue to explore 
inflammatory responses in an animal model of glaucoma, researchers 
unexpectedly discovered that this procedure prevents the loss of RGCs. 
The neuroprotection offered by this procedure was complete, highly 
reproducible, and lasting. Normally, by 12-14 months, these glaucoma 
susceptible mice have complete RGC loss. At 14 months, treated mice had 
no detectable signs of disease. Although the mechanism that offers 
neuroprotection is not yet known, researchers speculate that it is due 
to radiation, because the transferred bone marrow was genetically 
identical to the original bone marrow the mice were born with. This 
highly novel treatment protocol offers a tool to understand 
neurodegeneration and, with refinement, could have important 
implications for the treatment and prevention of neurodegenerative 
diseases.

                            CORNEAL DISEASES

    The cornea is the transparent tissue at the front of the eye. 
Corneal disease and injuries are the leading cause of visits to eye 
care professionals, and are some of the most painful ocular disorders. 
In addition, approximately 25 percent of Americans have a refractive 
error known as myopia or nearsightedness that requires correction to 
achieve sharp vision; many others are far-sighted or have 
astigmatism.\3\
---------------------------------------------------------------------------
    \3\ The Eye Diseases Prevalence Research Group: The prevalence of 
refractive errors among adults in the United States, Western Europe, 
and Australia. Arch Ophthalmol. 122:495-505, 2004.
---------------------------------------------------------------------------
    Inflammation is a common immune response to injury and infection in 
the body. In the cornea, however, inflammation can cause extreme 
discomfort and result in vision loss. Nonetheless, the cornea retains a 
remarkable capacity for wound repair while actively suppressing an 
inflammatory response. Scientists have recently discovered that two 
lipids, lipoxin A4 (LXA4) and docosahexaenoic 
acid-derived neuroprotectin D1 (NPD1), are formed in the cornea and act 
as anti-inflammatory agents during corneal infection and wound healing. 
Topical treatment with LXA4 and NPD1 in mice with corneal 
injuries increased the rate of tissue repair and inhibited inflammation 
without impairing the recruitment of key immune leukocytes, which are 
normally associated with inflammation, into the wounded tissue. 
Moreover, a transgenic mouse that lacks these lipids exhibited delayed 
wound healing and attenuated leukocyte recruitment. The identification 
of these anti-inflammatory lipids in the cornea and their enhancement 
of wound healing by topical application suggest their use as 
therapeutic agents to overcome aberrant and damaging inflammatory 
responses in the eye.

                                CATARACT

    Cataract, an opacity of the lens of the eye, interferes with vision 
and is the leading cause of blindness in developing countries. In the 
United States, cataract is also a major public health problem. The 
enormous economic burden of cataract will worsen significantly in 
coming decades as the American population ages.
    The lens is a dense, compact structure containing two cell types: 
metabolically active epithelial cells and quiescent fiber cells. 
Throughout the life-time of an individual, the lens carries out a 
process of continued growth with epithelial cells dividing and 
differentiating into fiber cells. During this process, the emerging 
fiber cells become denuded of organelles such as the nucleus and 
mitochondria. This process in part helps the lens achieve the high 
transparency needed for clear vision. Scientists have previously found 
that the lens uses proteins involved in a biological process called 
programmed cell death or apoptosis to rid lens fiber cells of their 
organelles. This past year, vision researchers have discovered the 
biologic process that regulates apoptosis such that it allows for the 
elimination of organelles without resulting in cell death.
    The process is termed Apoptosis-related Bcl-2 and Caspase-dependent 
(ABC) differentiation. In this process, a number of proteins that 
normally lead to cell death such as caspases--proteins that break-down 
internal cellular structures--are expressed to denude organelles. The 
caspase proteins are balanced by the simultaneous induction of pro-
survival molecules such as bcl-2, a protein that binds to cell death 
proteins and inhibits further damage or death to fiber cells. The 
discovery of ABC differentiation in the lens will allow researchers to 
better understand lens cell renewal and determine whether faulty 
mechanisms in this process might lead to cataract formation.

                              NIH ROADMAP

    A goal of the NIH Roadmap Nanomedicine Initiative is to 
characterize quantitatively the molecular scale components or 
nanomachinery of cells and to precisely control and manipulate these 
molecules and supramolecular assemblies in living cells to improve 
human health. The NEI has a leadership role in implementing the NIH 
Roadmap Nanomedicine Initiative. Under this initiative, a Request for 
Applications (RFA) was prepared to award Nanomedicine Center Concept 
Development Awards. These concept development awards were created to 
allow applicants time and resources to develop the concept for a 
Nanomedicine Center that would address various issues in nanomedicine 
including, biomolecular dynamics, intracellular transport, and protein-
protein interactions. Understanding these fundamental biologic 
processes at the nanoscale level will allow scientists to engineer 
molecular structures, assemblies, and organelles for treating diseased 
or damaged cells and tissues. Of the applications, four Nanomedicine 
Centers were awarded in fiscal year 2005. The Centers will be dedicated 
to understanding the nanobiology that underlies protein folding 
machinery; ion channels and ion transport proteins; synthetic signaling 
and motility systems; and mechanical biology. The NIH expects to fund 
additional Nanomedicine Centers in fiscal year 2006. The Nanomedicine 
Initiative will also benefit eye research in a more direct way. Current 
NEI grantees are exploring the use of nanotechnology to assist in 
corneal wound healing and drug delivery to the retina. Increased 
support of nanomedicine through the NIH Roadmap will undoubtedly speed 
progress in these areas.

                       NIH NEUROSCIENCE BLUEPRINT

    The NIH Neuroscience Blueprint is a collaborative effort among 15 
NIH institutes and centers to accelerate the pace of discovery and 
understanding in neurosciences research. In an effort to better 
understand all elements of the nervous system, the Blueprint will focus 
on the development of tools and resources that will facilitate research 
on the processes of development, neurodegeneration, and plasticity that 
underlie the health and disorders of the nervous system. One of the 
approaches to develop these tools and resources is a cellular level 
approach to discovering the key molecules involved in nervous system 
function. There is still a need to identify the location, the 
developmental timing, and the cellular function of most of the genes 
and proteins expressed in the brain. Mapping of the neurogenome is 
being conducted by creating and analyzing transgenic mice to map gene 
expression and activity to different cell types and regions of the 
mouse central nervous system. The NEI component of this effort will be 
to ensure that the genes involved in neurons of the complete visual 
system are included in the neurogenome map.
    Mr. Chairman, this concludes my prepared statement. I would be 
pleased to respond to any questions you or other members of the 
committee may have.
                                 ______
                                 
Prepared Statement of Dr. Stephen E. Straus, Director, National Center 
               For Complementary And Alternative Medicine

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's fiscal year 2007 budget request for the National Center 
For Complementary And Alternative Medicine (NCCAM). The fiscal year 
2007 budget includes $120,554,000, a decrease of $911,000 over the 
comparable fiscal year 2006 appropriation of $121,465,000.
    NCCAM has made significant progress in discovering the potential of 
complementary and alternative medicine (CAM) to prevent and treat 
disease. During NCCAM's first 7 years, the Center has formed a research 
enterprise that addresses the challenges of conducting CAM research as 
well as training investigators, conducting outreach, and facilitating 
the integration of proven CAM therapies into the health care that 
Americans receive.

                           SETTING THE COURSE

    Through national surveys, we know that two-thirds of Americans are 
using some form of CAM each year. We are gaining understanding of which 
Americans use the various CAM modalities and for which health purposes. 
These patterns of CAM use will inform NCCAM's research priority setting 
in fiscal year 2007, along with guidance from two key documents:
  --The NCCAM Strategic Plan for 2005-2009 (developed with input from 
        the public and scientific and medical communities nationwide); 
        and
  --The Institute of Medicine's 2005 report, ``Complementary and 
        Alternative Medicine in the United States.''
    In fiscal year 2007, NCCAM will again collaborate with the Centers 
for Disease Control and Prevention to support the National Health 
Interview Survey to capture changes in trends of the American public's 
use of CAM.

                    FURTHERING THE RESEARCH MISSION

    Seven years of NCCAM investments in CAM research translate to the 
support of more than 1,200 projects (in research, training, and career 
development) at over 260 U.S. institutions. There has been a 20-fold 
increase in the number of CAM papers published in leading scientific 
journals by NCCAM grantees. In fiscal year 2007, building upon this 
strong foundation, NCCAM plans to further enhance CAM research in the 
following areas.

A Flourishing Centers Program
    NCCAM has expanded and refined its approach to research centers. As 
a result, the Center now has a diverse cadre of multidisciplinary 
research centers at conventional and CAM institutions nationwide.
  --Centers of Excellence for Research on CAM.--Six centers with 
        outstanding research records direct teams of CAM and 
        conventional investigators to explore, using cutting-edge 
        technologies, how CAM therapies may work.
  --Developmental Centers for Research on CAM.--Scientists and 
        practitioners at 18 CAM and conventional institutions have 
        forged research partnerships. In fiscal year 2007 there will be 
        new Phase I developmental centers for CAM institutions just 
        launching programs of research, and Phase II developmental 
        centers for CAM institutions prepared to undertake more 
        sophisticated research studies.
  --International Centers for Research on CAM.--Two centers support 
        U.S. investigators who collaborate with experts in the 
        traditional medical systems of their own countries, building 
        research expertise and capacity abroad and providing foreign 
        researchers with valuable experience in navigating the NIH 
        grants system.
  --Botanical Research Centers.--Seven dietary supplement research 
        centers focusing on studies of botanical products are funded by 
        NCCAM and the NIH Office of Dietary Supplements. Research 
        conducted by these centers will advance the scientific base of 
        knowledge about the safety, effectiveness, and mechanisms of 
        action of botanicals.

Studies of Herbals and Other Dietary Supplements
    Herbals and other dietary supplements are widely used by the 
American public and they are a research priority for NCCAM. Studying 
botanicals, however, has presented special research challenges related 
to product characterization, standardization, and dosage. With the 
advice of experts in herbal medicine and leaders of the dietary 
supplement industry, NCCAM is improving product consistency for 
research studies and thus increasing the probability that the studies 
NCCAM funds will yield accurate findings.
    In this regard, the Center has developed research-quality cranberry 
products to use in studies of urinary tract infections and standardized 
an extract of milk thistle (silymarin), for study in patients with 
chronic viral hepatitis and non-alcohol-related steatohepatitis, a 
collaborative project with the National Institute of Diabetes and 
Digestive and Kidney Diseases.
    NCCAM has worked with several NIH partners to design, conduct, and 
fund large clinical trials of dietary supplements. The largest of these 
was reported in February 2006 in the New England Journal of Medicine: a 
4-year study (co-funded by the National Institute of Arthritis and 
Musculoskeletal and Skin Diseases) of glucosamine and chondroitin 
sulfate, two dietary supplements widely used by people with knee 
osteoarthritis. In this study, the two supplements combined did not 
provide statistically significant pain relief for all the participants, 
compared to placebo. However, a small subset of participants with 
moderate-to-severe pain had significant pain relief. An ancillary study 
is continuing to determine whether the combination of these supplements 
can prevent or delay further joint deterioration, a common long-term 
outcome for people with osteoarthritis.

A Broad Research Portfolio
    There are hundreds of different practices, products, and approaches 
that comprise CAM. Thus, the research that NCCAM funds is wide-ranging. 
Areas that NCCAM will emphasize further in fiscal year 2007 include:
  --Manual therapies.--The mechanisms of action underlying the effects 
        of manipulative and body-based therapies such as chiropractic 
        and massage are little understood. Therefore, NCCAM is 
        launching an initiative in fiscal year 2007 on the biology of 
        manual therapies to better understand the effects of these 
        techniques on the body.
  --Mind-body medicine.--One recent NCCAM-funded study found that tai 
        chi combined with standard medical care benefits patients with 
        chronic heart failure. Studies of meditation and mindfulness-
        based stress reduction in various health conditions are under 
        way. NCCAM is also redirecting the focus of its intramural 
        research program to emphasize studies of mind-body medicine.
  --Echinacea.--Research on echinacea is being done both because of the 
        public health burden of the common cold and the public's 
        widespread use of this natural product. A study of a single 
        dosage of Echinacea purpurea to treat viral colds in healthy 
        children was recently completed by an NCCAM grantee. A larger 
        study is being undertaken in which a range of doses of this 
        popular herb will be assessed for its ability to prevent colds 
        in children.
  --Immune responses.--Many CAM interventions are believed to affect 
        the immune system, either by enhancing its ability to thwart 
        infection or by suppressing an overactive response, as occurs 
        in autoimmune diseases. NCCAM is exploring the immune effects 
        and basic mechanisms of action of various CAM modalities such 
        as traditional Chinese herbal mixtures, ginseng, green tea, and 
        Ginkgo biloba.

               EXPANDING TRAINING AND CAREER DEVELOPMENT

    There can be no significant CAM research progress without a 
sufficient cadre of investigators who are both skilled in rigorous 
research and knowledgeable about CAM practices. NCCAM has increased the 
number, quality, and diversity of the CAM research community using a 
variety of approaches and grant mechanisms. In fiscal year 2007, NCCAM 
will offer three new training opportunities: supplements to existing 
research grants, in order to attract more CAM practitioners into 
research endeavors; the CAM Practitioner Research Career Development 
Award, for CAM practitioners interested in research; and the NCCAM 
Career Transition Award, to help outstanding postdoctoral research 
fellows in their transition to an independent career in CAM research.

                       DISSEMINATING INFORMATION

    From the outset, NCCAM has made it a priority to help 
practitioners, patients, and the public make informed decisions about 
CAM. The Center conducts outreach to public and professional audiences 
through a variety of channels: information clearinghouse, website, 
quarterly newsletter, conferences, Distinguished Lecture Series, and 
online continuing education. With the National Library of Medicine, the 
Center publishes CAM on PubMed, an online database of more than 400,000 
research papers on CAM.

                        FACILITATING INTEGRATION

    NCCAM is committed to facilitating the integration of safe and 
effective CAM therapies into conventional medicine. One example of this 
effort is within the NIH itself. The Center is establishing a new 
Integrative Medicine Consult Service at the NIH Clinical Center, to 
provide integrative medical consultations and enrich patient care. In 
addition, NCCAM continues to provide CAM curriculum development grants 
to conventional medical, dental, and nursing schools.

                        COLLABORATING ACROSS NIH

    NCCAM continues its collaborations with other NIH Institutes and 
Centers, as a contributing member of the biomedical research community. 
For example, NCCAM is a partner in several of the NIH Roadmap for 
Medical Research initiatives, including the Exploratory Centers for 
Interdisciplinary Research. Also, by participating in efforts like the 
NIH Neuroscience Blueprint, the NIH Pain Consortium, and the Trans-NIH 
Obesity Initiative, NCCAM can accelerate efforts to unlock the 
potential of CAM therapies through these multidisciplinary research 
initiatives.

                       LOOKING TOWARD THE FUTURE

    Mindful of the lessons learned in our first 7 years as an NIH 
Center, and with growing understanding of the scientific opportunities 
and public health priorities to be addressed with CAM approaches, NCCAM 
will continue to explore options to sustain and improve the health and 
well-being of the American people.
    Thank you, Mr. Chairman. I would be pleased to answer any questions 
that the Committee may have.
                                 ______
                                 
    Prepared Statement of Dr. Lawrence A. Tabak, Director, National 
             Institute of Dental and Craniofacial Research

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Institute of Dental and 
Craniofacial Research (NIDCR) for fiscal year 2007. The fiscal year 
2007 budget includes $386,095,000, a decrease of $3,241,000 from the 
fiscal year 2006 level of $389,336,000, comparable for transfers 
proposed in the President's Request.

             STRENGTHENING THE EVIDENCE BASE IN DENTAL CARE

    Health care decisions should be guided by the preponderance of 
clinical research data, or evidence, whenever possible. This approach 
is known as ``evidence-based medicine'', a concept that has evolved 
into a driving force in healthcare.
    Recognizing the concept's value, dentistry also has embraced an 
evidence-based approach. Yet, having sufficient clinical data from 
which to build that base can be challenging. For some oral health 
problems, evidence-based approaches are possible; for many others, 
knowledge gaps must be filled before an evidence-based approach can 
take root. As the nation's leading supporter of oral, dental, and 
craniofacial research, the NIDCR is uniquely positioned to fill those 
gaps while continuing its efforts in the laboratory to develop new and 
even more effective ways to prevent, diagnose, and treat dental 
diseases. I would like to highlight over the next few minutes how the 
NIDCR is sowing the clinical seeds of progress to advance evidence-
based dentistry in America and, above all, improve the nation's oral 
health.

                    PRACTICE-BASED RESEARCH NETWORKS

    Healthcare providers sometimes comment that too often they are not 
included as participants in research, noting that their clinical 
experience and insight are significant assets to understand and address 
patients' most pressing health concerns. I believe that there is much 
to be gained from engaging clinical practitioners in research. That is 
why the NIDCR recently established three regional practice-based 
research networks (PBRNs) to investigate everyday issues in oral 
healthcare.
    Each PBRN involves 100 or more oral health practitioners who will 
propose and conduct studies of common dental procedures across a range 
of patient and clinical conditions. For example, some of the early 
investigations will gather data on methods dentists use to restore 
teeth with deep decay, and to assess caries risk. Each network will 
conduct 15 to 20 clinical studies over the next seven years. The PBRNs 
also will collect information to generate data on disease, treatment 
trends, and the prevalence of less common oral conditions.
    While the PBRNs aim high, their success will be rooted in their 
focus on real-world clinical issues and their ability to generate 
information that will be of immediate value to practitioners and 
patients alike. The studies will involve topics and procedures that 
clinicians themselves identify as relevant and in need of systematic 
research to help guide clinical decisions. I believe the PBRNs have the 
potential to generate a body of high quality clinical research data in 
a relatively short period of time. Most importantly, their research 
will substantially enhance the base of evidence clinicians can use to 
inform treatment decisions, translate newer information into daily 
practice, and directly affect and improve routine dental care.

               GREATER EMPHASIS ON LARGE CLINICAL STUDIES

    The nation's progress against heart disease, cancer, and infectious 
diseases has been accelerated by large clinical studies yielding 
results that can be generalized and can clarify the interplay of many 
variables. In dentistry, clinical research traditionally has involved 
smaller studies with fewer participants. The NIDCR is changing this 
trend by supporting larger clinical studies whose outcomes have the 
potential to fundamentally change dental practice and improve public 
health. I would like to tell you about some examples.

                 PERIODONTAL DISEASE AND PRETERM BIRTH

    In the United States, about one in eight babies is born 
prematurely.\1\ Preterm babies can be so small and underdeveloped that 
they must remain hospitalized for months and, if they survive, spend 
years battling chronic health problems. This heartbreaking situation 
has spurred scientists to identify risk factors associated with 
premature births. Risk factors such as smoking, hypertension, and 
diabetes allow doctors to identify women who are more likely to deliver 
prematurely and to tailor their prenatal care. However, identification 
of risk factors is a work in progress. One in four of preterm births 
(more than 125,000 per year) occurs without any known explanation.\2\ 
Scientists have assembled an intriguing body of preliminary evidence to 
suggest that women who have severe gum, or periodontal, disease during 
pregnancy are at increased risk of preterm delivery. This raises the 
question: Does treatment for periodontal disease during pregnancy help 
women reach full term and give birth to healthy babies?
---------------------------------------------------------------------------
    \1\ Martin JA, Hamilton BE, et al. Births: Final data for 2003. 
National vital statistics reports; vol. 54 no 2. Hyattsville, MD: 
National Center for Health Statistics. 2005.
    \2\ Offenbacher S, Katz V, et al. Periodontal infection as a 
possible risk factor for preterm low birth weight. J Periodontol, vol. 
67(10) p. 1103-13.
---------------------------------------------------------------------------
    The NIDCR is supporting the first large, controlled Phase III 
clinical trials to answer this important public health question. Two 
studies involve over 2,600 women of various racial, ethnic, and 
economic backgrounds. The first, called the Obstetrics and Periodontal 
Therapy (OPT) trial, will soon report its findings, providing for the 
first time the clinical data needed to offer sound scientific advice on 
this issue. The results of the second study, called the Maternal Oral 
Therapy to Reduce Obstetric Risk (MOTOR) trial, should be forthcoming 
next year.

                BETTER PAIN TREATMENTS FOR JAW CONDITION

    Temporomandibular joint and muscle disorder (TMJMD) is an umbrella 
term for conditions affecting the area in and around the 
temporomandibular joint, or TMJ. The TMJs connect the jaw to the skull. 
Common symptoms of TMJMD include persistent pain in the jaw muscles, 
restricted jaw movement, and jaw locking.
    Although TMJ disorders vary in their duration and severity, for 
some people the pain becomes severe and permanent. NIDCR recently 
launched a large, seven-year clinical study to accelerate research on 
better pain-control treatments for TMJMDs. The study, called Orofacial 
Pain: Prospective Evaluation and Risk Assessment (OPPERA) will collect 
data on 3,200 healthy volunteers for three to five years to see how 
many develop TMJMD, opening a largely unexplored window from which to 
observe the early stages of the disorder. With this unique vantage 
point, they can gather data on key genetic, physiologic, and 
psychological variables involved in TMJMD pain, ultimately weaving the 
information into more effective treatments.
    Only a decade ago, a large study tracking the development of TMJMD 
over time would have been scientifically problematic, because little 
was known about the basic mechanisms of human pain. However, because 
progress in the basic sciences has fed the knowledge pipeline, pain 
researchers have now better defined the molecular circuitry involved in 
pain transmission, thereby providing the conceptual framework for this 
important clinical study.

                   MOLECULAR MEDICINE AND ORAL CANCER

    In the fight against cancer, future weapons of choice likely will 
fall within the therapeutic category of molecular medicine. The concept 
builds on world-wide efforts to design cancer treatments targeting the 
precise molecules that drive the tumor process, leaving normal cells 
unscathed. As envisioned, molecular medicine will increase the benefits 
of treatment and limit greatly the unwanted side effects that now 
afflict cancer patients. For the vision to become reality, scientists 
first must learn to correctly identify distinctive features of the 
genetic and/or protein profiles of developing tumors. Much progress has 
been made in the laboratory, but the promise of molecular diagnostics 
remains largely unready for translation to patient care.
    An NIDCR-supported project that has successfully taken that 
critical step is a partnership between scientists, dental educators, 
and a community clinic in British Columbia. The partners have 
integrated molecular techniques with existing screening tools by 
combining certain molecular discoveries with clinical use of toluidine 
blue, a chemical dye used to determine whether or not to biopsy an 
abnormal growth. The technique hinges on laboratory work that showed an 
association in early oral lesions between toluidine blue retention and 
the presence of cells with distinct, cancer-predisposing chromosomal 
abnormalities. The program already has identified several people 
requiring treatment for oral cancer and pre-cancerous lesions.

                    DRY MOUTH AND RADIATION THERAPY

    Persistent dry mouth often occurs in head and neck cancer patients 
because radiation from the therapy damages the salivary glands. This 
irreversible, chronic dryness makes normal chewing and swallowing 
difficult, and leads to a range of painful oral diseases. Recently, 
NIDCR scientists teamed with researchers at the National Cancer 
Institute to develop an important new lead in protecting the salivary 
glands during radiation therapy to the head and neck. Their work 
involves a synthetic chemical called Tempol, which possesses a unique 
ability to protect cells against radiation. In mice, administration of 
Tempol 10 minutes prior to radiation therapy to the head and neck 
provided significant protection to the salivary glands. Critically, 
Tempol did not protect tumors from radiation, and thus did not diminish 
the beneficial effects of the radiation therapy. Future clinical trials 
in people are likely.

            REDUCING DISPARITIES IN THE NATION'S ORAL HEALTH

    Although the Nation's oral health has improved greatly over the 
past several decades, this progress has not been equally shared by 
millions of low income and underserved Americans. To help reverse this 
trend, the NIDCR supports five Centers for Research to Reduce Oral 
Health Disparities. The centers are designed to explore, understand, 
and improve the oral health of those who reside in underserved 
communities. The researchers seek creative but practical approaches 
that are inexpensive, can be easily applied, and are exportable to 
other underserved communities.
    This year, the Disparities Centers reported several noteworthy 
findings. For example, after a two-year clinical study, San Francisco 
researchers found that infants and small children who receive at least 
one fluoride varnish treatment per year can cut their dental caries 
rate in half. Fluoride varnish is a concentrated fluoride in a resin or 
synthetic base that is applied directly onto the teeth. The treatment 
is inexpensive and is more easily used with very small children than 
other preventive measures, such as dental sealants and mouth rinses.
    Meanwhile, the Disparities Center at the University of Washington 
is evaluating the oral health benefits of gum and candy sweetened with 
xylitol rather than caries-promoting sugars. Xylitol, a natural 
substance found in certain fruits, has been shown to fight tooth decay. 
The team is refining the optimal dose to satisfy taste and fight decay. 
Xylitol use exemplifies an easily adopted, self-administered, 
scientifically validated approach that may be useful in underserved 
populations.

                   IMPROVING THE NATION'S ORAL HEALTH

    As these highlights demonstrate, the NIDCR has made a strong 
commitment to expand clinical research and to build the evidence base 
that will inform better clinical practice. At the same time, progress 
in basic science continues to provide new and exciting leads that can 
translate into large clinical trials, yielding results with the 
potential to transform dentistry and public health. Above all, the 
NIDCR seeks to find practical solutions to intractable problems and, in 
so doing, improve the Nation's oral health.
                                 ______
                                 
Prepared Statement of Dr. Nora Volkow, Director, National Institute on 
                               Drug Abuse

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2007 President's budget request for the National 
Institute on Drug Abuse (NIDA). The fiscal year 2007 budget estimate is 
$994,829,000, a decrease of $5,200,000 from the fiscal year 2006 
enacted level of $1,000,029,000, comparable for transfers proposed in 
the President's request.

                              INTRODUCTION

    The National Institute on Drug Abuse, within the National 
Institutes of Health (NIH), is once again pleased to report continuing 
declines in overall drug use among our Nation's youth. NIDA has focused 
much of its research on the vulnerable adolescent period of 
development, since this is when drug abuse typically takes hold and can 
bend a young life toward long-term drug abuse problems or addiction. 
Research findings elucidating the mechanisms of action and destructive 
consequences of drugs of abuse on the brain and body appear to be 
getting through to this population. For example, the 2005 Monitoring 
the Future (MTF) Survey of 8th, 10th, and 12th graders shows a dramatic 
19 percent reduction in use since 2001. However, areas of significant 
concern remain, including the alarmingly high rates of non-medical use 
of painkillers among 12th graders, the high rates of stimulant abuse 
among 12th graders, and the spread of methamphetamine abuse to new 
geographic areas of the country.
    Therefore, while we can acknowledge and appreciate the positive 
effects of evidence-based prevention and treatment efforts, we also 
recognize the need to keep pace with emergent problems. To this end, 
ongoing support of leading edge research by NIDA scientists continues 
to enhance innovative prevention and treatment interventions, while 
collaborations with other Institutes and public and private partners 
make optimal use of our research infrastructure.

         PRESCRIPTION DRUG ABUSE--THE PROBLEM WITH PAINKILLERS

    According to the 2004 National Survey on Drug Use and Health, 
nearly three-fourths of the estimated 6 million people aged 12 and 
older who reported non-medical use of prescription psychoactive drugs 
said they abuse pain relievers in particular, with young adults (18-25) 
showing the greatest increases in lifetime use from 2002-2004. Even 
younger populations are involved, revealed by findings from NIDA's 2005 
MTF Survey.
    NIDA is tackling this growing problem from multiple angles, seeking 
to understand the factors that have brought us to this point so that we 
may reverse negative trends and stop new ones from emerging. Underlying 
factors include the fact that opioids are now among the most commonly 
prescribed medications, that society is more accepting of using 
medications to treat all kinds of health problems, and that the 
Internet provides greater access to prescription drugs.
    In response to these concerns, NIDA's new initiative on 
prescription opioids and treatment of pain is soliciting a broad range 
of preclinical and clinical studies from across the sciences. We will 
examine the basic mechanisms involved in pain and how their interaction 
with prescription painkillers influences addiction potential--for 
example, whether opiates are equally addictive to an individual in pain 
versus one who is not in pain. Research on the basic interactions 
between pain and opioid systems is needed to inform physicians about 
associated abuse risks and to guide their prescribing practices.
    Other strategies for reducing prescription painkiller abuse include 
developing alternative pain medications and promoting better delivery 
systems for painkillers to minimize abuse potential. Recent studies 
have identified a subset of cannabinoid receptors (i.e., CB2 receptors) 
as promising new targets for treating chronic pain from nervous system 
injury. In addition, because of their lack of activity in brain reward 
centers and diminished abuse liability, novel CB2-based medications 
present an attractive alternative for treating chronic pain. 
Buprenorphine/naloxone, a recently approved medication for the 
treatment of opioid addiction, represents another approach. Acting on 
the same brain receptors as drugs like heroin and morphine, 
buprenorphine does not produce the same high, physical dependence, 
harsh withdrawal symptoms, or dangerous side effects. Further, its 
unique formulation with naloxone, an opioid antagonist, produces severe 
withdrawal symptoms in addicts who inject it to get high, thereby 
lessening the likelihood of diversion while maintaining desired 
therapeutic properties. NIDA is planning a multiple trial study to 
evaluate the effectiveness of buprenorphine in the treatment of the 
pain patient who is addicted to his/her pain medication and to help 
develop guidelines on how to treat these types of patients.

                    GENES, ENVIRONMENT, AND BEHAVIOR

    A person's individual genome, or genetic makeup, plays an important 
role in determining his or her vulnerability to or protection against 
addiction. Studies of heredity have shown that about 40-60 percent of 
predisposition to substance abuse can be attributed to genetics, with 
environment impacting how those genes function or are expressed. 
Addiction is a quintessential gene-x-environment interaction disease: 
that is, a person must be exposed to drugs (environment) to become 
addicted, yet exposure alone is not determinative--genes interact with 
this environment to create a vulnerability to addiction. Growing 
knowledge about the dynamic interactions of genes with the environment 
confirm addiction as a complex and chronic disease of the brain with 
many contributors to its expression in individuals.
    NIDA is studying these interactions to see what they reveal about 
vulnerability to addiction and to other adverse effects of abused 
drugs. For example, one recent study found that carriers of a common 
variant of the COMT gene were more likely to exhibit psychotic symptoms 
and to develop schizophreniform disorder if they used marijuana.
    Thus, people with particular genes may suffer more harmful effects 
from drugs of abuse.
    To expedite the translation of findings that could help identify 
the location of genes that confer vulnerability or protection, NIDA is 
supporting innovative research to help design, develop, and market 
technology to conduct rapid behavioral throughput screens for 
identifying genetic vulnerability using animal models of drug abuse and 
addiction. This information could then become part of a database of 
candidate genes for drug abuse, for eventual mapping and for targeted 
therapeutic application. Advances in genetics research in addiction are 
already suggesting ways to tailor our interventions to have the 
greatest impact. For example, a recent study showed that distinct 
alleles of the dopamine receptor gene led to different outcomes 
according to the type of smoking cessation therapy used--bupropion or 
nicotine replacement therapy. Such findings provide a glimpse of a 
future in which a patient's genetic background will be a major factor 
in selecting the most appropriate therapeutic course of action.
    Other NIDA studies are also helping to unravel the ways in which 
environmental factors, such as stress, induce brain changes that 
interact with drugs of abuse and alter behavior. It is well known that 
stress is a major cause of relapse to drug abuse in recovering addicts 
and can prompt the release of a neurochemical, corticotrophin releasing 
factor (CRF). Recent research showed that in cocaine-exposed animals, 
stress-induced CRF triggered drug-seeking behavior, even as long as 3 
weeks after exposure. This research highlights the concept of 
persistent brain changes leaving individuals vulnerable to certain 
relapse triggers like stress. Moreover, stress may be common to a 
variety of conditions, including depression, anxiety, and some forms of 
overeating and obesity. By revealing the precise brain mechanisms 
involved in stress, our research can lead to treatments that for these 
conditions.
    We are also learning how environmental factors not only alter the 
expression but the structure of genes involved in brain function, which 
then influences an individual's behavior. Known as ``epigenetics,'' 
this field gives researchers an opportunity to investigate gene-
environment interactions, including the deleterious changes to brain 
circuits resulting from drug abuse. Understanding how drugs of abuse 
effect epigenetic changes may help in developing interventions to 
counter or prevent such changes. A recent study of demonstrated that 
cocaine caused significant structural changes to the DNA in regions 
containing genes implicated in shaping the brain's response to drugs of 
abuse; furthermore, in animals genetically engineered to minimize those 
changes, the rewarding effects of cocaine were dramatically reduced. 
These results show how gene-environment interactions can change the 
brain and drive behaviors associated with drug addiction. NIDA is 
supporting innovative research to help design, develop, and market 
technology to conduct rapid behavioral throughput screens for 
identifying gene/environment interactions.

                          SOCIAL NEUROSCIENCE

    NIDA is targeting the influence of social factors both in 
individual and group decision-making. This focus is critical not just 
to understanding drugs of abuse but other health behaviors as well. For 
instance, a social neurobiological perspective is being applied in NIDA 
studies investigating the mechanisms underlying adolescents' increased 
sensitivity to social influences (i.e., peers) and decreased 
sensitivity to negative consequences of their behavior that together 
make them particularly vulnerable to drug abuse.
    A recent NIDA request for research in the emerging field of social 
neuroscience is soliciting studies from basic to clinical science as we 
work to examine how neurobiology and the social environment interact in 
abuse and addiction processes (e.g., initiation, maintenance, relapse, 
and treatment). We now have the tools to see how genetics, epigenetics, 
and brain chemistry can change social behavior and how the social 
interactions of an individual can change his or her brain. For example, 
studies of early maternal behavior in animals demonstrated that 
offspring receiving low levels of care during their first week of life 
developed an over-responsive stress system that lasted a lifetime. In 
this case, genes responsible for regulating stress responses were 
``silenced'' by environmental manipulation. Some of these changes can 
be reversed in adulthood by targeted intervention, making this research 
area ripe for developing approaches to counteract the effects of 
adverse environmental impacts, which in the case of stress are known to 
increase the risks for substance abuse.
    We are also committed to efforts to better characterize 
``phenotypes'' of social environments and to understand their 
interaction with other vulnerabilities, such as genetics. One approach 
could include strategies such as mapping community risk factors for 
drug use (e.g., parental practices, family structure, school systems, 
socio-economic status, neighborhood characteristics, and drug 
availability) and to use that knowledge to inform us about mediators of 
the social stressors that elevate risk for drug abuse. A better 
understanding of this relationship is relevant both for the treatment 
of drug addiction and for psychotherapeutic interventions for mental 
illnesses, which also involve social aspects of human behavior.

                     DRUG ADDICTION TREATMENT WORKS

    NIDA's research findings have demonstrated that drug addiction 
treatment works. Moreover, comprehensive treatments (i.e., those that 
include a combination of available medications, behavioral treatments, 
and job training and referral services) tailored to the needs of the 
individual patient have the highest success rates. We continue to work 
with the private sector to develop medications to use with behavioral 
therapies to treat drug addiction, and are pursuing collaborations with 
pharmaceutical companies to move novel and promising compounds forward 
to clinical evaluation. In addition, NIDA's initiative focusing on 
pilot clinical trials of new addiction medications will invigorate the 
field by helping investigators generate sufficient safety and efficacy 
data to support full-scale clinical trials and expedite the possible 
progression of novel medications to real-world use.
    Over the past year, we have made great progress in identifying 
potential medications for treating drug addiction, including addiction 
to stimulants such as cocaine and methamphetamine. Several promising 
compounds have been identified in animal studies, and initial clinical 
efficacy for drug abuse has been demonstrated for medications marketed 
for other uses: disulfiram, prescribed for alcoholism; modafinil, for 
treatment of narcolepsy; and gamma-vinyl GABA (not marketed in the 
United States) and topiramate, both used to treat seizure disorders. 
Progress is also being made in the area of vaccine development for 
cocaine and nicotine addiction, and Rimonabant, a cannabinoid receptor 
blocker is a promising candidate for treating marijuana addiction. 
Close to being approved for marketing by the pharmaceutical industry as 
a weight loss aid, Rimonabant may also have the potential to prevent 
relapse to cocaine, heroin, and methamphetamine abuse, and nicotine 
addiction. Marinol, another cannabinoid receptor agonist, may also show 
promise as a treatment for marijuana withdrawal symptoms.
    Interventions are also needed to treat comorbid mental disorders 
and addiction. For example, given that an estimated 15-30 percent of 
patients with substance abuse problems also suffer from comorbid ADHD, 
as found in research studies, NIDA has launched a large clinical study 
in our Clinical Trials Network (CTN) to test whether treatment of ADHD 
with methylphenidate, in parallel with treatment for substance abuse, 
will improve outcomes in those who suffer from both conditions.
    We are also developing drug abuse treatments for use in the 
criminal justice system. Our research findings show that drug treatment 
works even for people who enter it under legal mandate, with outcomes 
as favorable as for those who enter treatment voluntarily. To 
illustrate, in a Delaware Work Release study sponsored by NIDA, those 
who participated in prison-based treatment followed by aftercare were 
seven times more likely to be free of drugs after 3 years than those 
who received no treatment. Moreover, nearly 70 percent of those in the 
comprehensive drug treatment group remained arrest-free after 3 years--
compared to only 30 percent in the no-treatment group. We are helping 
to integrate drug treatment into the criminal justice system and 
improve outcomes for offenders through our comprehensive Criminal 
Justice Drug Abuse Treatment Studies (CJ-DATS) initiative, undertaken 
in collaboration with Federal, state, and local criminal justice 
partners.
    NIDA research has demonstrated the value of drug addiction 
treatment programs in helping patients recover from the complex disease 
of addiction. Faith-based and community-centered programs are often 
part of long-term recovery, yet their effectiveness and role in 
delivering treatment needs to be studied more extensively. NIDA is 
conducting research to examine this role.

                   HIV/AIDS AND MINORITY DISPARITIES

    The latest data from the Centers for Disease Control and Prevention 
(CDC) suggest that the HIV/AIDS epidemic is evolving, with drug abuse 
still a major vector in its spread. Progress in treating injection drug 
abuse has helped to decrease HIV transmission among this highly 
vulnerable population, influenced by a multi-pronged approach including 
community-based outreach to reduce risky behaviors and development of 
medications such as methadone and buprenorphine to treat injecting drug 
users. But while this approach has helped reduce U.S. cases from this 
route of transmission, other countries, such as Russia and Southeast 
Asia, continue to report that injection drug abuse accounts for a large 
proportion of their HIV/AIDS cases. Thus NIDA is supporting 
international studies to promote HIV prevention practices and use of 
medications to treat drug addiction. Depot-Naltrexone is one such 
possibility, since it is a long-acting opioid antagonist medication 
expected to soon receive approval for treatment of alcohol addiction. 
Because efforts to decrease drug abuse also modify the behaviors that 
can lead to HIV transmission, we believe strongly that drug abuse 
treatment is HIV prevention.
    Early detection of HIV helps prevent HIV transmission and increase 
health and longevity. NIDA-supported research indicates that routine 
HIV screening, even among populations with prevalence rates as low as 1 
percent, is as cost effective as screening for other conditions such as 
breast cancer and high blood pressure. These findings have important 
public health implications, but require efforts to increase HIV 
screening acceptability (similar to mammography) in order to be 
effective.
    We are also deeply concerned about the disproportionate impact of 
HIV/AIDS on African Americans. For while they represent just 13 percent 
of the U.S. population, African Americans account for 42 percent of 
AIDS cases diagnosed since the start of the epidemic, according to CDC. 
In fact, data from the CDC's National Vital Statistics Report published 
in 2003 show that HIV/AIDS is the leading cause of death among all 
African Americans 25-44 years old, ahead of heart disease, accidents, 
cancer, and homicide.
    To address these disparities, NIDA is encouraging research on the 
nexus of drug abuse and HIV/AIDS among African Americans to understand 
the risk factors and the pathways between them and to develop 
culturally sensitive prevention and treatment programs for drug abuse 
and HIV/AIDS. We are committed to making sure this research is 
translated in a meaningful way.

                   FROM BENCH TO BEDSIDE TO COMMUNITY

    NIDA is proud of our myriad efforts to translate the results of our 
basic and clinical research on the brain and body effects, getting new 
treatments into the hands of providers who will use them, disseminating 
prevention messages to people who will hear them, and raising the 
awareness of people who can help change the course of drug abuse 
treatment in this country. Our audiences are many and include 
physicians, teens, teachers, judges, parents, and others.
    Through our physician outreach initiative, we are funding efforts 
to develop strategies for primary care physicians to better identify 
and serve drug abusing patients through use of science-based screening 
and brief interventions. We are also supporting development of a pilot 
judicial training curriculum in Cook County, Illinois, to help criminal 
court judges understand the neurobiology of addiction and the 
effectiveness of treatment. The goal of this program is to better 
inform judicial decision-making with regard to substance-abusing 
offenders. These efforts will be applied to the Federal court system as 
well. We also support grants to evaluate results from drug courts to 
achieve optimal dissemination and improve outcomes, and we will soon 
publish a book of treatment principles for application with individuals 
involved in the criminal justice system.
    Our education portfolio continues to grow and includes a wealth of 
materials, such as our NIDA Goes Back to School Initiative, a science 
education campaign to provide middle school students with information 
about how drugs work in the brain. An interactive website complements 
this effort, allowing students and teachers to easily obtain additional 
information about drugs of abuse. To help young people understand the 
risks of drug abuse leading to HIV infection, NIDA and our partnering 
organizations--including the American Academy of Child and Adolescent 
Psychiatry, the AIDS Alliance for Children, Youth, and Families, and 
the United Negro College Fund Special Programs Corporation--recently 
launched a multimedia educational campaign, including a public service 
announcement and website, to help young people ``learn the link'' 
between drug abuse and HIV infection. We are translating these 
materials into Spanish and making them culturally relevant for 
different populations.
    We are also collaborating with our sister agency, the Substance 
Abuse and Mental Health Services Administration (SAMHSA) and with the 
National Institute of Mental Health on a new initiative to enhance the 
capacity of community-based providers of drug abuse treatment services. 
We continue to work with SAMHSA, supporting the development and 
dissemination of research-based products through their Addiction 
Technology Transfer Centers across the country, applying findings from 
our Clinical Trials Network and other research. And because addictive, 
psychiatric, and neurological disorders emerge from common neural 
substrates, a tremendous amount of inter-Institute collaboration has 
taken place--an approach we will continue to emphasize, given its 
ability to produce sharable findings and cost efficiencies.

                               CONCLUSION

    Our investment in basic and clinical research has changed the way 
people view drug abuse and addiction in this country. We now know how 
drugs work in the brain, their health consequences, how to treat people 
already addicted, and what constitutes effective prevention strategies. 
As science advances, NIDA's comprehensive research portfolio is 
strategically positioned to capitalize on new opportunities. We 
continue to make great strides in translating and disseminating the 
products of our research, so they can be used in real communities by 
people who need them, providing front-line clinicians around the 
country with the tools needed to reduce drug abuse and addiction in our 
Nation. To make the most of scarce resources, we depend on a rigorous 
planning and priority-setting process that not only supports our strong 
commitment to reducing drug abuse and HIV transmission in this country, 
but extends to other health fields represented by NIH. Sustaining the 
momentum of our efforts will lead to even more discoveries that will 
improve the health and safety of all Americans.
    Thank you, Mr. Chairman. I will be pleased to answer any questions 
the Committee may have.

                         IMPACT OF BUDGET CUTS

    Senator Specter. We will now proceed with questioning by 
the Senators, 5 minutes each.
    Dr. Zerhouni, you say you will continue to deliver. How is 
that possible when you have had more than a 10 percent 
decrease, considering inflation, which amounts to about $3 
billion? The comments that I hear relate to there being a 
panic, panic among the applicants for NIH research. How can you 
continue to deliver with that kind of a budget?
    Dr. Zerhouni. It is very important to realize that medical 
research cannot be funded through ups and down. We have to 
sustain the investment over time, and it is clear that medical 
research requires support for scientists. What is happening 
right now is that through the doubling we have generated a new 
generation of scientists. We have over a 50 percent increase in 
the number of scientists.
    Senator Specter. What is the consequence of the cut?
    Dr. Zerhouni. The consequence of the cut is very simple. If 
you keep investing below and lose purchasing power, the most 
important impact on research is loss of scientists. This is 
what we have seen in the past and this is what may happen again 
if we do not sustain our investment in medical research.

                  PREPAREDNESS FOR PANDEMIC INFLUENZA

    Senator Specter. Dr. Fauci, there is a great concern, as we 
all know, about pandemic influenza. This subcommittee has held 
a series of hearings on the subject. How are we doing? What are 
the prospects for being prepared if that wave should strike us 
in the United States?
    Dr. Fauci. From the standpoint of the scientific 
preparation for developing vaccines and drugs, from the last 
time I testified before you, Mr. Chairman, which was just a 
couple of months ago, we have made even more progress. We have, 
as you know, as Dr. Zerhouni alluded to, we have a vaccine that 
is currently in clinical trial in different age groups and 
demographic groups. We have tested it and published the results 
in healthy young adults. We have tested it in the elderly and 
in children. As I mentioned to you at the last hearing, the 
vaccine appears to be very well tolerated and induces an immune 
response that would be predictive of being protective.
    There is a big problem with it, though. The problem relates 
to the fact that the dose that is required to induce the level 
of immunity that you would predict would be protective is 
prohibitively high, which is leading us to the studies that are 
ongoing now, namely the use of what we call adjuvants, or 
compounds which expand the capability of the immune system to 
respond. Those studies are ongoing right now.

                     FUNDING FOR PANDEMIC INFLUENZA

    Senator Specter. Is the funding adequate?
    Dr. Fauci. We could do more with more funding, there is no 
doubt about that. I would be----
    Senator Specter. How much do you need?
    Dr. Fauci. It is difficult to put a number on it, except to 
say that----
    Senator Specter. Well, if you cannot put a number on it, we 
cannot.
    Dr. Fauci. Well, we need--for example, if I could bring one 
component up that I think would be of interest to this 
committee, is that we are currently pursuing rather 
aggressively the concept of what we call a universal influenza 
vaccine, namely a vaccine that cross-reacts from season to 
season and would also be protective against the pandemic flu.
    Senator Specter. Dr. Fauci, I am reluctant to cut off a 
witness with your distinctive record. Give us in writing what 
funding you need.
    Dr. Fauci. Okay, I could do that for you.
    [The information follows:]

                     Funding for Pandemic Influenza

    The National Institute of Allergy and Infectious Diseases (NIAID) 
supports a robust and diverse portfolio of research on influenza, 
including pandemic influenza. Many opportunities to accelerate the 
research and development of medical countermeasures against influenza 
as well as to advance our understanding of influenza viruses could be 
pursued in fiscal year 2007 and fiscal year 2008 should additional 
funds become available. In its professional judgment that is outside 
the context of other competing priorities, NIAID estimates that it 
could obligate an additional $212 million in influenza research in 
fiscal year 2007 above the budget request and an additional $458 
million in fiscal year 2008.
    NIAID could use such funds to accelerate research and development 
of antiviral drugs, vaccines, adjuvants, and diagnostics for influenza. 
For example, NIAID could accelerate the development and clinical 
testing of promising universal vaccine candidates, which could offer 
protection against multiple influenza virus strains, and the 
development of new and improved vaccine strategies for influenza such 
as recombinant subunit vaccines and gene-based vaccines that may allow 
for more rapid production of a vaccine against a pandemic strain of 
influenza, should one emerge. These additional funds also could 
facilitate the expansion of critical research resources, such as animal 
models and clinical trials infrastructure that are essential for the 
development of medical countermeasures against influenza.
    Underpinning efforts to develop medical interventions against 
pandemic influenza is research into the basic biology and disease-
causing mechanisms of influenza viruses. With additional funding, NIAID 
could expand basic research in the areas of influenza virology, 
pathogenesis, epidemiology, immunology, genomics, proteomics, and 
systems biology as well as to expand international animal surveillance 
activities. This research is crucial to the development of antiviral 
drugs, vaccines, and diagnostics for influenza.

                          CANCER GENOME ATLAS

    Senator Specter. Let me turn now to Dr. Niederhuber with 
respect to the cancer-genomics initiative. Can that be 
implemented with the current funding? What do we need to 
successfully prosecute the war against cancer?
    Dr. Niederhuber. Well, Senator Specter, thank you. We are 
very committed, the National Cancer Institute, with our 
partner, the National Human Genome Research Institute, to 
initiate a pilot project on the Cancer Genome Atlas. Each 
Institute has committed $50 million from our existing resources 
to do that. This will be a pilot project which is helping us 
understand the technology needs, the technology advancements, 
and our ability to do this project.
    Senator Specter. Dr. Niederhuber, would you supplement your 
testimony today with a memorandum as to what you need as to 
that program and as to the war on cancer overall?
    Dr. Niederhuber. Absolutely, sir.
    Senator Specter. Give us a winning strategy for that war?
    Dr. Niederhuber. Absolutely.
    [The information follows:]

                          Cancer Genome Atlas

    The Cancer Genome Atlas program is the product of several years of 
investment by the NCI in the Cancer Genome Anatomy Project (C-GAP) and 
other large scale genomics programs, some of which were performed in 
collaboration with the NHGRI. These efforts culminated in 2003 with a 
report from the NCI's National Cancer Advisory Board (NCAB) which 
recommended that the two Institutes undertake a pilot program to 
determine the feasibility of systematically developing an ``atlas'' of 
all genetic alterations involved in cancer.
    Active planning for The Cancer Genome Atlas, or TCGA, began in the 
latter half of 2002 as a consequence of progress and convergence of 
science and advanced technologies in three distinct areas. First, the 
completion of the sequencing of the human genome provided for the first 
time in history a benchmark to begin to understand the effect of 
genetic changes on the etiology and progression of diseases such as 
cancer. Second, our years of investment in understanding cancer at the 
molecular level resulted in the discovery of some very important 
genetic changes in cancer cells that led to the development of targeted 
drugs such as Gleevec and Herceptin. Based on an understanding of the 
specific genetic alterations driving specific tumors, these targeted 
drugs allowed oncologists for the first time to target specific genetic 
alterations in patients with chronic myelogenous leukemia (CML) and 
breast cancer, respectively. Finally, the pace of technology 
development in analyzing all aspects of genes and their products is 
accelerating--setting the stage for large scale interrogation of the 
genome to understand the role of genetic mutation in diseases such as 
cancer. Interestingly, one of the major requirements for this project 
is the development of an unprecedented data management system and 
ultimately an accompanying database; NCI's investment in the Cancer 
Bioinformatics Grid (caBIG) over the past several years provides the 
advanced technology platform needed to meet this need.
    Cancer is a disease of changes in genes that occur over an 
individual's lifetime. Three kinds of genetic alterations contribute to 
cancer--those that occur in the DNA of egg or sperm and are passed from 
a parent to offspring (germline mutations), those that occur as a 
result of exposure to the environment (somatic mutations) and changes 
in DNA that lead to changes in genes that control proteins involved in 
transcription and translation. Additionally, changes in gene function 
can occur without a change in the sequence of DNA (epigenetic changes). 
TCGA will finally facilitate an in-depth understanding of how these 
types of genetic changes differ in terms of their role in an 
individual's inherited risk vs. those changes that arise from 
environmental exposure. It is the latter category of mutations that 
will allow scientists to obtain a clear picture of the impact of these 
somatic mutations on the major pathways that appear to drive many of 
the major hallmarks of cancer cells. Overall, the TCGA pilot project, 
much like the Human Genome Project, has the potential to create an 
unparalleled knowledge base, drive a new era of discovery by scientists 
from all fields of biomedical research and ultimately provide a new 
paradigm for the prevention, detection and treatment of chronic 
diseases such a cancer.
    The NCI and NHGRI believe strongly that TCGA is one of the most 
important projects undertaken in medicine to date. It leverages all 
that has gone before and for the first time will allow scientists to 
apply our understanding of the human genome sequence to cancer--a 
disease that will strike over 1.4 million Americans this year and kill 
over 560,000 at a cost of well over $190 billion. We are committed to 
getting this project underway within current budget constraints. The 
NCI has identified funds for redeployment from other projects, and the 
NHGRI will dedicate a large portion of its sequencing capacity to 
performing this first-ever large scale effort in medical sequencing.
    The information generated by the TCGA pilot project will provide 
the necessary scientific data by which the Institutes and the 
scientific community can evaluate the preliminary outcomes of the 
research.
    The convergence of our understanding of cancer at the molecular 
level, advanced genome analysis technologies, especially 
bioinformatics, and experience gained in the Human Genome Project, 
allow us to now undertake TCGA, a project that promises to contribute 
significantly to the development of 21st century medicine. Both the NCI 
and the NHGRI are committed to leveraging these strengths to ensure 
that we move forward toward our goal of personalized medicine for 
cancer and all diseases.

                   A WINNING STRATEGY AGAINST CANCER

    NCI has developed a Strategic Plan to reduce and eliminate the 
suffering and death due to cancer with the help of the scientific 
community. The Plan sets forth a framework within which NCI can use its 
funding, infrastructure, tools, and intellectual resources to lead and 
work with others. We set forth eight strategic objectives in the Plan 
and these will be instrumental in guiding our operational level plans 
and serve as an organizer for measuring and reporting progress. A 
complete description of the Strategic Plan can be found on NCI's web 
site at http://www.cancer.gov/aboutnci/2015.
    There are two basic tactics--preempting cancer and ensuring the 
best outcomes for all--embodied in the Plan's objectives.
    To preempt cancer at every opportunity, there are four strategic 
objectives:
  --Understand the causes and mechanisms of cancer;
  --Accelerate progress in cancer prevention;
  --Improve early detection and diagnosis; and
  --Develop effective and efficient treatments.
    To ensure the best outcomes for all, there are four strategic 
objectives:
  --Understand the factors that influence cancer outcomes;
  --Improve the quality of cancer care;
  --Improve the quality of life for cancer patients, survivors, and 
        their families; and
  --Overcome cancer health disparities.
    To achieve these objectives requires numerous funding vehicles and 
support mechanisms throughout the cancer research community. The steps 
we could take in order to accelerate progress to eliminate the 
suffering and death due to cancer include:
  --Rapid development of an integrated technology initiative;
  --Deployment of a modern integrated clinical trials infrastructure;
  --Expansion and integration of the Cancer Centers program; and
  --Mechanisms and Flexibilities--streamlined procurement and review 
        processes to acquire materials and services and coordination of 
        licensing and patenting activities.
    An integrated advanced technology initiative for cancer could 
provide a linkage between the National Cancer Program and R&D 
initiatives being developed in selected national laboratories and 
advanced technology facilities located in more than 40 states and 
regions. Connected in real-time through a common bioinformatics grid, 
forming a ``network of networks'' of science, technology, and 
treatment, such an initiative could serve to accelerate the emerging 
discipline of molecular oncology. This would create a pipeline of new 
personalized cancer diagnostics and therapeutics from bench concept to 
bedside and community delivery. In the next few years, such an 
initiative could:
  --Accelerate the implementation of a nationwide high-end information 
        technology grid for bioinformatics that could be uniquely 
        adapted for real-time data sharing. NCI's pilot version, called 
        caBIG, is slated for full-scale implementation this year and, 
        during the pilot phase, was implemented among 50 Cancer 
        Centers, FDA, and other organizations.
  --Develop a comprehensive biomarker discovery and validation program.
  --Foster the application of emerging technologies, such as 
        nanotechnology, and integrate molecular agents with advanced 
        imaging devices.
  --Accelerate a nationwide real-time medical information electronic 
        system for research and medical data sharing using technologies 
        and devices currently employed by the banking industry and 
        large-scale commercial enterprises.
  --Enhance the discovery and validation of new targets of genes and 
        proteins critical to cancer development.
    NCI could deploy a more modern and integrated infrastructure for 
cancer clinical trials. This clinical research infrastructure could:
  --Strengthen collaborations with industry, FDA, Centers for Medicare 
        and Medicaid Services, and other public, private, academic, and 
        patient advocacy organizations to oversee the conduct of cancer 
        clinical trials.
  --Develop new infrastructure and procedures to standardize, 
        coordinate, and track clinical trials development and accrual 
        across all NCI-supported clinical trials.
  --Increase utilization of imaging tools in screening and therapy 
        trials, evaluate new imaging probes and methodologies, enable 
        access to the imaging data from trials in an electronic format, 
        and facilitate evaluation of image-guided interventions.
  --Expand access and improve the timeliness for completion of the 
        highest priority clinical studies.
  --Foster the development of a cadre of established clinical 
        investigators who could work between bench and bedside.
  --Pilot new approaches and develop prototypes for clinical trials 
        networks that could improve the efficiency, coordination, and 
        integration of our national efforts.
  --Develop a common clinical trials informatics platform that could be 
        made available to the full range of investigators working 
        within the cancer clinical trials system.
    NCI plans to accelerate the expansion and integration of the NCI-
designated Cancer Centers program, including the addition of 14 new 
Cancer Centers, increasing the number of centers to 75. The Cancer 
Centers program could:
  --Implement progressive bioinformatics and communication systems to 
        achieve horizontal integration.
  --Fund additive programs in collaborative, multidisciplinary 
        research, and require integration and sharing of results.
  --Broaden the geographic impact of the centers, networks, and 
        consortia and vertically integrate them with community and 
        regional health care delivery systems.
  --Improve the access of minority and underserved populations to 
        state-of-the-art research and resources.
  --Create and strengthen partnerships with government agencies and 
        community organizations.
  --Broadly provide expertise and other resources to caregivers, 
        patients and families, and appropriate health agencies.
    In addition to appropriations, flexible legislative authorities 
related to exemptions from specific parts of current procurement, grant 
review and processing, and licensing and patenting rules could also 
help accelerate progress. A streamlined procurement process could 
facilitate the acquisition of materials and services to support the R&D 
activities. Technology development could also be enhanced by sufficient 
flexibility and integration to enable interactions among a wide array 
of laboratories and other entities. Expedited review procedures and 
workflow processing could help to award funds in sequence as needed. 
Coordination of the licensing and patenting activities among grantees, 
contractors, and the intramural program could also be useful for many 
of the multicomponent technology platforms that could be created 
through an advanced technology effort.

                         WOMEN'S HEART DISEASE

    Senator Specter. Let me turn now to Dr. Nabel. What have 
the results been with the Women's Health Study? With respect to 
heart disease, we know that women are affected differently. I 
want the record to note that my question ends with no red 
light, but you can proceed.
    Dr. Nabel. Thank you, Mr. Chairman.
    The women's health initiative was an important study 
conducted over 15 years with 161,000 women in this country ages 
50 to 79 participating. We gathered important information about 
heart disease, the number one killer of women in this country.
    From other studies, we realize that heart disease often 
manifests itself in women differently than men. We have come to 
recognize what those symptoms are. We have come to recognize 
that some of the diagnostic tests have to be different and we 
have come to recognize that some of the treatments have to be 
specifically focused towards women.
    These studies have given us a tremendous amount of 
information. We now have engaged in a very large public 
awareness education campaign and we are in the midst of helping 
women to understand what their risks are for heart disease and 
how to seek help when they need it.
    Senator Specter. Thank you.
    Senator Harkin.

                       NATIONAL CHILDREN'S STUDY

    Senator Harkin. Thank you, Mr. Chairman.
    Dr. Zerhouni, of all the proposed cuts in the budget there 
is one that I think may be discouraging than all the rest, and 
that is the planned elimination of the National Children's 
Study. We passed this legislation back in 2000. It was going to 
be the largest long-term study of children's health ever 
conducted in the United States. It was going to involve 100,000 
children from before birth to adulthood. The idea was to better 
understand the link between the environments where the children 
are raised and their physical and emotional health and 
development.
    We have already spent about $50 million planning the study, 
4 to 5 years of planning on it. Now I understand that the study 
is going to stop. Why is that?
    Dr. Zerhouni. Well, the study has had a pilot phase to 
evaluate feasibility. The issue really is, you are talking 
about a very long study with a large budgetary impact, and at 
the end it was just a matter of budgetary priorities which led 
to the decision of not completing the pilots at this time, but 
to look at other times when the budgets will be easier.
    Senator Harkin. I understand that the budgetary impact was 
$70 million. Is that correct or not?
    Dr. Zerhouni. If you look at--the $70 million is not just a 
1-year expenditure. In fact, you have to continue that 
expenditure. If you committed to that expenditure, Senator, 
then you have committed to the $3.2 billion or thereabouts 
total over the total study. Why? Because once you launch the 
study you have to continue recruitment of the 100,000 children, 
the parents, and so on.
    So if you look on the screen that tries to describe the 
evolution, it is $69 million in 2007, $111 million in 2008, 
$192 million, $194 million, and so on. So this is what led to 
the budgetary conclusion for these tight fiscal times. 
Committing to 2007 meant not just 2007, but a whole series of 
budgetary commitments, and in the context of projections it was 
very hard to see how it would fit in.

                       WOMEN'S HEALTH INITIATIVE

    Senator Harkin. Well, as you know, it was supposed to start 
by the end of this fiscal year.
    Dr. Nabel, how long was the women's health initiative 
study?
    Dr. Nabel. 15 years, Mr. Senator.
    Senator Harkin. 15 years.
    Dr. Nabel. Yes.
    Senator Harkin. Obviously, we got a lot of good information 
out of it.
    Dr. Nabel. We sure did.
    Senator Harkin. What did that cost, do you know?
    Dr. Nabel. In total, about $710 million.
    Senator Harkin. For the 15 years. How many women did it 
cover?
    Dr. Nabel. 161,000 women.
    Senator Harkin. This is 100,000 children and it was 
supposed to be how many years study? About 20----
    Dr. Zerhouni. 21 plus 4, so about 25 years, and about $3.2 
billion is the number I remember, but upwards of that.
    Senator Harkin. Well, it seems to me from the women's 
health initiative we learned the benefits of long-term studies, 
long-term longitudinal studies. It seems to me with everything 
that is impacting on obesity, to diabetes to mental health, 
kids and how they grow up, there is just a lot of things that 
need to be taken into account. If you do these studies, then 
you would be able to factor some of these things in after a 
longer period of time.
    I just find this very disturbing that we are cutting this 
program. I am hopeful that we can put this back in the budget. 
Maybe this is another result of the President's budget. I do 
not know. Is that what it is? I am just asking it rhetorically. 
I do not expect an answer, but I am just asking this 
rhetorically. If that is what it is, then we have got to find 
the money to put back in there.
    This did not just come up. This is something that we had 
talked about for a long time with your predecessor and others, 
about getting this very long-term study done. We just assumed, 
at least I did anyway, that it was on track and that we were 
going to do it, and all of a sudden this year it pops up and it 
is going to be eliminated. EPA was coming in on the study, I 
think, also CDC was also going to partner in the study, if I am 
not mistaken.
    Dr. Zerhouni. No, you are not mistaken, Senator. It was a 
trans-governmental study. It was not just an NIH study. It 
really involved 14 different departments. Environmental health 
was important, genetic health was important. Education was 
involved as well. So 14 Federal agencies were involved.
    Senator Harkin. Well, I am just wondering what kind of a 
priority would this be in the scheme of things. Is this just 
something that we can just drop out the bottom, or is this 
really an important study to be done? Is it important or not?
    Dr. Zerhouni. So the issue is really an issue of 
prioritization, and you have a pilot phase study so we can 
evaluate whether or not to go forward. But you mentioned 
yourself the critical factor of sustaining success rates, and 
so in the context of those decisions you can see where, in a 
constant sum budget, studies like this will have a large impact 
on success rates across the board. Therefore, when you look at 
the investments that medical schools and others have made over 
the doubling period, what we are seeing is a large increase in 
demand for grants at the time when the supply for grants is 
sort of flattening.
    So the real tension right now is, how do you sustain a 
vibrant research enterprise across the board and at the same 
time look at issues like this one, which is a very valid issue 
to look at? That is what the tension is and that is where the 
budgetary decisions came up.
    Senator Harkin. Thank you, Dr. Zerhouni.
    Thank you, Mr. Chairman.
    Senator Specter. Thank you very much, Senator Harkin.
    Senator Shelby.

                          AUTOIMMUNE DISEASES

    Senator Shelby. Thank you, Mr. Chairman.
    I want to, doctor, focus on the area of autoimmune, 
specifically lupus. It is estimated that 1.5 million Americans 
suffer from lupus. Ninety percent of those being diagnosed are 
women. This is a terribly painful disease, as you well know. It 
has been about 40 years, it is my understanding, since a new 
drug has been developed and approved for treatment of lupus. Is 
there any hope in sight for new treatment, because this is in 
the area, as I understand it, of autoimmune, in which you do a 
lot of research?
    So how do we--first, what do you see down the road there?
    Dr. Zerhouni. This is an excellent, excellent question, in 
a field of research, autoimmune disease, that affects 5 to 8 
percent of Americans. It is not just lupus, Senator.
    Senator Shelby. It is all autoimmune, is it not?
    Dr. Zerhouni. Right, it is all autoimmune. It is a whole 
category of diseases that we are now beginning to understand. 
Breakthroughs over the past year indicate that we may have 
actually developed technologies where we could develop--we 
could detect years before the disease really starts the markers 
of the disease and maybe intervene earlier.
    What I would like to do is ask my colleague Dr. Fauci, who 
is the Director of the National Institute of Allergy and 
Infectious Diseases, who has a lot of knowledge in autoimmune 
diseases, to perhaps address some of that.
    Senator Shelby. That would be good. Thank you, doctor.
    Dr. Fauci. Thank you, Dr. Zerhouni.
    Senator Shelby, there are some very promising areas in the 
whole arena of autoimmune diseases. There is still a long way 
to go, but, very briefly, as Dr. Zerhouni mentioned in his 
opening statement, it falls within that area of predictive and 
ultimately preemptive and preventive, in the sense that we now 
are developing rapidly, not only with lupus, much more 
sensitive diagnostic tests that can give you a feel for the 
ultimate evolution of an autoimmune disease.
    One among many therapeutic modalities that I would just 
submit for your consideration that we are very excited about is 
the whole area of what is called immune tolerance. Immune 
tolerance means that you manipulate the immune system to get it 
to not respond to a particular antigen. In other words, you 
tolerize it to it.
    This has been something that has been very exciting in 
animal studies. Now, with a network involving multiple 
institutes within the NIH, the immune tolerance network, we 
have been able to tolerize the body against rejecting 
transplanted organs. We found very rapidly that that can be 
applied to diseases of autoimmunity.

                               PREDNISONE

    Senator Shelby. Is that what Prednisone does?
    Dr. Fauci. Well, Prednisone is a drug that dampens globally 
the immune system. But we are talking about when we talk about 
tolerance, specifically training the body either not to reject 
an organ that is transplanted or not to respond to tissues that 
are self tissues. Patients should not respond to self antigens, 
but for reasons that relate to genetic, environmental, and 
other factors, they inappropriately react against their own 
tissues.
    So now we try to tolerize them and dampen the immune 
response only specifically for the particular tissue that they 
are attacking, not general immunosuppression, because one of 
the real problems with treating any autoimmune disease, if you 
induce a global immunosuppression you have a lot of 
complications that relate to immunosuppressive therapy, much 
the way cancer patients have complications related to 
chemotherapy.

                                 LUPUS

    Senator Shelby. What could you say to the 1.5 million or 
more lupus sufferers out there right now in the pipeline?
    Dr. Zerhouni. Well, if I may, Dr. Fauci, I would like to 
show you the evolution of our investments in lupus research.
    What I want to tell you is that there is really hope 
because, one, we have made advances in genomics that allow us 
to now identify some genetic factors in patients with lupus. 
Two, we really understand the immune response very specifically 
and we believe that the T-cells that respond in lupus may be a 
target for treatments. We also have research that suggests that 
perhaps a viral connection exists as well.
    So over the past 2 years, 3 years, there has been a 
multiplication of new ideas thanks to the doubling and many 
people looking at it. What we intend to do is sustain it. We 
have ideas of how to in fact focus on autoimmune diseases 
across NIH and do the basic research across all institutes that 
will serve every one of these diseases.
    So, Senator, it is a difficult disease. It is not an easy 
disease. If you have known anyone with lupus----
    Senator Shelby. My wife.
    Dr. Zerhouni. I am sorry, Senator. I did not know about 
that. It is something that we really care about.
    Senator Shelby. Thank you very much.
    Mr. Chairman, thank you.

                            PROGRAM FUNDING

    Senator Specter. Thank you, Senator Shelby.
    Obviously, we would like to have a lot more time to go into 
greater detail on many subjects. But what we would appreciate 
your doing is giving us a supplemental memorandum as to what 
the cuts will mean for your ongoing programs. I would like to 
share that with all of our colleagues in the House. Second, 
what it would take to adequately fund the issues you are 
working on and what you could accomplish with the figure you 
put on as being adequate.
    Dr. Zerhouni, your statistics are very impressive and the 
showing of a trillion dollars in savings compared to a modest 
investment, that is the kind of things Congress needs to hear. 
That is the kind of things which impresses the Congress.
    [The information follows:]

                            Program Funding

    Within the context of a deficit-reduction budget, the President's 
Budget request had to weigh many competing priorities, and still 
proposed to hold spending for NIH at a straightlined level for fiscal 
year 2007. In fiscal year 2006, NIH reduced all noncompeting Research 
Project Grant (RPG) awards by -2.35 percent, and the average cost of 
competing RPGs was held at the fiscal year 2005 level. The fiscal year 
2007 President's Budget Request provides no inflationary increases for 
noncompeting continuation awards and holds the average cost of 
competing RPGs to the fiscal year 2006 level, which could lead to an 
erosion of the research buying power of NIH research projects. Within 
its available funds, however, NIH is supporting the highest priority 
research activities, including making strategic investments in 
biodefense, the NIH Roadmap, a new program for new investigators, and 
the Clinical and Translational Sciences Award program.
    If additional funds were available above these priorities, such as 
an increase for fiscal year 2007 above the Biomedical Research and 
Development Price Index inflator of 3.8 percent, NIH would be able 
restore the buying power of its research program, and fund additional 
projects, from basic, translational, and clinical research to 
therapeutic development and advanced technologies. All of these 
activities could serve to advance our understanding of the mechanisms 
underlying human health and disease and contribute to improving human 
health. Examples of projects that were not funded in the President's 
Budget Request, but could be undertaken are as follows:
    Large-scale Genome Study for Serious Mental Disorders.--This study 
could speed development of new effective treatments for the 13 million 
Americans suffering from seriously debilitating mental disorders that 
prevent people from participating in daily life at home, work, or 
social settings for over 80 days per year and results in early death or 
suicide for 30,000 individuals each year.
    Schizophrenia Treatment Research.--This proposed study could build 
on recent advances in schizophrenia treatment to determine whether an 
early intervention of aggressive pharmacotherapy, combined with focused 
rehabilitative efforts, can prevent long-term disability and suffering 
of schizophrenia, devastating mental illness affecting 2.4 million 
adult Americans.
    Protocols for Treating Autism Spectrum Disorders Early.--These 
studies could bolster efforts to determine the most effective treatment 
regimens to improve outcomes for children and families struggling with 
the life-long disability and pain of autism spectrum disorders.
    The Atherosclerosis Prevention Trial.--Although drugs to lower low-
density lipoprotein (LDL) cholesterol levels are known to reduce the 
risk of major adverse cardiovascular events, it is not yet known 
whether additional benefits can be realized by lowering LDL cholesterol 
beyond current treatment guidelines. A multi-center, randomized 
clinical trial could determine whether aggressive lowering of low-
density lipoprotein cholesterol beyond current treatment guidelines 
further reduces major adverse cardiovascular events.
    Program to Reduce Cardiovascular Disease Risk in Young Adults by 
Preventing Weight Gain.--Studies could develop and evaluate promising 
intervention approaches for preventing weight gain in young adults, 
which is a major risk factor for cardiovascular disease (CVD) and 
associated CVD risk factors including elevated cholesterol, high blood 
pressure, and diabetes.
    Systolic Blood Pressure Intervention Trial.--Although drug 
treatment to lower blood pressure, both systolic and diastolic, is 
known to reduce CVD mortality, it is not yet known whether additional 
benefits can be realized by lowering systolic pressures beyond current 
treatment guidelines. A multi-center trial could determine whether 
treating systolic blood pressure to a lower goal than currently 
recommended further reduces cardiovascular disease mortality and 
morbidity, particularly for those aged 50 years and older in whom 
systolic blood pressure is more strongly associated with CVD risk than 
diastolic blood pressure.

                  PREPAREDNESS FOR PANDEMIC INFLUENZA

    Senator Specter. Dr. Fauci, if you would supplement what 
you have testified to on pandemic flu. There is enormous 
concern in this country today and we would like to know to what 
extent are we prepared. Being prepared is a tough subject to 
answer, but to what extent are we prepared. When you say that 
more funding would be of material assistance, I think there is 
something that we are prepared to fund.
    Senator Harkin took the lead and put a figure of $7 
billion. We came close to $6 billion, and contracts have been 
let for five big companies for a billion dollars. It is scary. 
It could be devastating. So let us know, and this subcommittee 
is prepared to take the lead again.
    [The information follows:]

                  Preparedness for Pandemic Influenza

    The Department has made great strides to improve the Nation's 
preparedness for a pandemic influenza outbreak. For example, HHS has 
stockpiled roughly 8 million doses of vaccine against one H5N1 virus 
strain. Given, a two-dose vaccination schedule, this would allow 
vaccination of 4 million people. The Department also recently invested 
more than $1 billion in the development of cell-based vaccine 
technology; shifting from the current egg-based technology is critical 
to quickly producing vast quantities of vaccine should a pandemic 
develop. Our goal is to build the capacity to vaccinate all 300 million 
Americans within 6 months of a pandemic outbreak. The Strategic 
National Stockpile now contains sufficient antivirals to treat nearly 7 
million people, and with another 19 million courses on order, it should 
contain 26 million courses by the end of 2006. HHS is also enabling 
States and other entities to purchase up to 31 million antiviral 
treatment courses off of the Federal contract. Our goal is to have 
enough antivirals on hand for 25 percent of the population, or 
approximately 75 million individuals. In addition, we have purchased 
150 million N95 respirators, surgical masks and other personal 
protective equipment. Planning summits have been held in all but two 
States, and almost every State has either a draft or final pandemic flu 
plan in place. As Secretary Leavitt has stated, ``Preparation is a 
continuum. Every day we prepare brings us closer to being ready. We are 
better prepared than we were yesterday. And we must be better prepared 
tomorrow than we are today.''
    The National Institute of Allergy and Infectious Diseases (NIAID) 
is a major component of these preparation efforts. For example, NIAID 
has made progress in the development of an H5N1 influenza vaccine. 
NIAID-supported researchers at St. Jude Children's Research Hospital 
obtained a clinical isolate of a highly virulent H5N1 influenza virus 
in Vietnam in early 2004, and used a technique called reverse genetics 
to create a non-virulent vaccine reference strain from this isolate. 
NIAID then contracted with sanofi pasteur and Chiron Corporation (now 
Novartis) to manufacture pilot lots of the inactivated virus vaccine 
for use in clinical trials. The sanofi pasteur vaccine has been tested 
in healthy adults and is currently in clinical testing in healthy 
elderly people and children. The Chiron vaccine is currently in 
clinical testing in healthy adults.
    Results from the trial of the sanofi pasteur vaccine in healthy 
adults provide both good and sobering news. The good news is that the 
vaccine is well-tolerated, and induces an immune response that augurs 
well for protecting people against the H5N1 virus. The sobering news is 
that larger doses of the H5N1 vaccine than typically used for yearly 
influenza vaccine are needed to elicit immune responses in the majority 
of people that would be predictive of protection. However, preliminary 
results from a Phase I clinical trial of an H9N2 influenza vaccine 
candidate made by Chiron suggest that addition of an adjuvant--a 
vaccine component that increases the immune response--may help to 
reduce the required dose. Clinical trials of H5N1 candidates using 
adjuvants and other strategies to improve immune responses at lower 
doses of vaccine are ongoing or imminent.
    In addition, NIAID intramural researchers are working with 
colleagues from MedImmune, Inc. under a Cooperative Research and 
Development Agreement (CRADA) to produce and test multiple vaccine 
candidates for potential pandemic influenza strains, including H5N1 
strains. The researchers have developed three live-attenuated H5N1 
vaccine candidates, designed for nasal spray delivery, that have been 
shown to be protective in mice. The CRADA capitalizes on the long 
history of NIAID research and development of respiratory virus 
vaccines, including fundamental research that was key to the 
development of FluMist, the licensed nasal spray influenza vaccine 
manufactured by MedImmune. The researchers have produced a clinical lot 
of a candidate H5N1 vaccine based on a strain isolated in Vietnam in 
2004, and clinical trial of this vaccine is expected to begin later 
this year.
    NIAID also supports a number of basic and applied research projects 
that could lead to significant advances in the development and 
production of vaccines against potential pandemic strains of avian 
influenza. This includes investigation of cell culture-based vaccine 
production as an alternative to chicken egg-based vaccine production--
as noted above, an endeavor to which the Department of Health and Human 
Services recently committed $1 billion that was awarded to several 
pharmaceutical companies. In addition, NIAID conducts and supports 
research into new vaccine platforms, including recombinant subunit 
vaccines, in which cultured cells are induced to make various influenza 
virus proteins that are then purified and used in a vaccine; gene-based 
vaccines, in which influenza genetic sequences are injected directly 
into a person to stimulate an immune response; and vector approaches 
that insert the genes of influenza virus into another non-virulent 
virus (the vector) and inject the vector vaccine as a carrier to 
present the influenza proteins to the vaccine recipient. For example, a 
gene-based influenza vaccine developed by researchers at the NIAID 
Vaccine Research Center is expected to enter Phase I clinical trials 
later in 2006.
    In addition to efforts to develop vaccines against potential 
pandemic influenza strains, NIAID is supporting basic and applied 
research to develop improved antiviral drugs against influenza. These 
efforts include a screening program for new drugs, as well as targeted 
drug development and clinical trials. NIAID-supported researchers are 
conducting studies of varying doses and combinations of existing 
antiviral medications, developing and testing long-acting next-
generation antivirals, and evaluating novel drug targets for potential 
prevention and treatment of influenza using in vitro and animal models.
    Because a pandemic influenza virus could emerge anywhere in the 
world, NIAID helps to conduct global surveillance and molecular 
analysis of circulating influenza viruses. For example, NIAID funds a 
long-standing program to detect the emergence of influenza viruses with 
pandemic potential, in which researchers in Hong Kong and at St. Jude 
Children's Research Hospital collect and analyze influenza viruses from 
wild birds and other animals in Asia and North America and generate 
candidate vaccines against them.
    NIAID is also supporting a collaborative effort to release full 
genomic sequence information for several thousand influenza viruses to 
the public domain. More than 1,000 influenza viruses have been 
sequenced. Readily available sequence data will allow researchers to 
further study how influenza viruses evolve, spread, and cause disease, 
which may ultimately lead to improved methods of treatment and 
prevention; identify specific characteristics of previous pandemic 
strains, which may help focus preparedness efforts; and identify genes 
that are highly conserved among various strains, and therefore act as 
possible targets for broadly protective therapeutics or vaccines.
    Lastly, NIAID is collaborating with Oxford University, the Wellcome 
Trust and the World Health Organization to establish a small network of 
clinical sites in Southeast Asia to conduct clinical research on avian 
influenza and other emerging infectious diseases. A key purpose of the 
effort is to build an independent clinical research capacity in these 
countries. Five sites in Vietnam, four sites in Thailand and two in 
Jakarta will be established.

    Senator Specter. I had thought it would be helpful if you 
stayed to hear the other testimony, but now that we have given 
you this homework your time is too valuable. So we will stay 
and forge on alone.
    Thank you very much for coming in. Thank you for what you 
are doing for America and the world.
    Senator Shelby. Mr. Chairman, can I just take 1 second?
    Senator Specter. Certainly.
    Senator Shelby. I just want to commend you for bringing all 
these people together. This is a blue ribbon panel if I have 
ever seen one and I have seen a lot of panels in the Congress, 
as you have. We appreciate what NIH has done and we will be 
ashamed of ourselves if we do not properly fund you for the 
benefit of the American people.
    Senator Specter. That is high praise coming from Senator 
Shelby because he usually deals with bankers.
    Senator Specter. Senator Harkin.

                     MULTI-BUG APPROACH ON VACCINES

    Senator Harkin. Mr. Chairman, I want to thank the panel and 
all the people from NIH for coming down here today.
    Dr. Fauci, in your supplement that the chairman spoke to 
you about, I wanted to delve a little bit into the multi-bug 
approach on vaccines that I understand you are working on, 
rather than just the one bug, one vaccine approach. So I would 
like to know a little bit more about that and where that 
stands.
    Dr. Collins, in regards to--there is some interesting work 
going on in terms of the relating of genes and environment. I 
know you are doing some stuff on that and I would also like to 
be kind of brought up to speed on that, too, if you could 
submit that.
    Thank you.
    [The information follows:]

                     Multi-Bug Approach on Vaccines

    The National Institute of Allergy and Infectious Diseases (NIAID) 
is supporting research and development of alternate approaches to 
dealing with the threat of emerging and re-emerging infectious diseases 
such as influenza.
    For example, NIAID is pursuing the development of a ``universal 
vaccine'' that protects against multiple virus strains such as those 
resulting from antigenic drift associated with seasonal influenza and 
antigenic shift associated with pandemic influenza. As influenza 
viruses circulate, the genes that determine the structure of their 
surface proteins undergo small changes. Sometimes the change in the 
genes results in a slight change in the antigenic properties of the 
protein, a process commonly referred to as ``antigenic drift''. 
Antigenic drift is the basis for the changes in seasonal influenza 
observed during most years, and is the reason that we must update 
influenza vaccines annually. Influenza viruses also can change more 
dramatically. For example, viruses sometimes emerge that can jump 
species from natural reservoirs, such as wild ducks, to infect domestic 
poultry, farm animals, or humans. When an influenza virus jumps species 
from an animal, such as a chicken, to infect a human, the result is 
usually a ``dead-end'' infection that cannot readily spread further in 
the human population. However, mutations in the virus could develop 
that allow human-to-human transmission. Furthermore, if an avian 
influenza virus and another human influenza virus were to 
simultaneously co-infect a person or animal, the two viruses might swap 
genes, possibly resulting in a virus that is readily transmissible 
between humans, and against which the population would have no natural 
immunity. These types of significant changes in influenza viruses are 
referred to as ``antigenic shift.'' When an ``antigenic shift'' occurs, 
a global influenza pandemic can result. Historically, pandemic 
influenza is a proven threat. In the 20th century, influenza pandemics 
occurred in 1918, 1957, and 1968.
    The NIAID is supporting a number of research projects to develop a 
vaccine that induces a potent immune response to the common elements of 
the influenza virus that undergo very few changes from season to season 
and from strain to strain. Although this is a difficult task, such a 
``universal'' influenza vaccine would not only provide continued 
protection over multiple seasons, it might also offer protection 
against a newly emerged pandemic influenza virus and thus substantially 
reduce the susceptibility of the population to infection by any 
influenza virus--making the country far less vulnerable to influenza 
viruses emerging from avian and other animal sources.
    One relatively stable element of the influenza virus is a protein 
called M2. The external portion of the M2 protein is very similar in 
influenza viruses from year to year and from strain to strain. A 
``universal'' influenza vaccine targeting the M2 protein, or other 
conserved elements, could be protective against a range of influenza 
strains. NIAID-supported researchers have demonstrated that vaccines 
made with bioengineered versions of M2 can protect mice from lethal 
influenza virus. The scientists now are testing cross-reactivity 
between different species and strains of influenza, examining how long 
the immunity provided by these vaccines lasts, and evaluating whether 
the influenza viruses can evade these vaccines by developing mutations 
in their M2 proteins.
    In addition, researchers at the NIAID Vaccine Research Center (VRC) 
are developing and testing gene-based influenza vaccines that will 
protect against multiple strains of influenza. As a first step, initial 
candidate vaccines, each containing the gene encoding the hemagglutinin 
(H) surface protein of an influenza virus isolated from a recent human 
outbreak of influenza (H1N1, H3N2 or H5N1), have already shown promise 
in animal studies. VRC researchers plan to develop additional gene-
based vaccines for all common variants of hemagglutinin, as well as 
other influenza viral proteins, such as nucleoprotein and the M2 
protein. In future, the VRC will incorporate both conserved and 
variable genes from multiple influenza strains into DNA and adenovirus 
vectors that can readily be produced by existing manufacturing 
processes.
    A second approach, while not technically a vaccine, is an immune 
enhancer which specifically targets a component of the immune system 
and enhances one's ability to respond to a broad range of microbial 
threats. Studies of the human innate immune system, which is comprised 
of ``first responder'' cells and other defenses that provide a first 
line of defense against a wide variety of pathogens, have been moving 
forward rapidly. These advances suggest it may be possible to develop a 
relatively small set of fast-acting, broad-spectrum countermeasures 
that can boost innate immune responses to many pathogens or toxins, 
including influenza. The capability to boost the innate immune system 
also could lead to the development of more powerful vaccine additives, 
called adjuvants, that can increase vaccine potency. The concept of 
immune enhancers has been demonstrated in early stage clinical studies, 
but requires further research and development to be applied to pandemic 
influenza vaccination.

               Genes, Environment, and Health Initiative

    On February 8, 2006, HHS Secretary Leavitt announced that the 
President's budget proposal for fiscal year 2007 included $68 million 
for the Genes, Environment and Health Initiative (GEI), a research 
effort by the National Institutes of Health (NIH) to combine a type of 
genetic analysis and environmental technology development to understand 
the causes of common diseases such as asthma, arthritis, many types of 
cancer, diabetes, and Alzheimer's disease. This represents a $40 
million increase above the $28 million already planned for such efforts 
by the NIH for fiscal year 2007.
    If approved by Congress, $26 million of the requested $40 million 
increase in funding would go to genetic analysis and $14 million to the 
development of new tools to measure environmental exposures that affect 
health. The discoveries made through these efforts can potentially lead 
to profound advances in disease prevention and treatment. By seizing 
the historic opportunity provided by the Human Genome Project and the 
International HapMap Project, this initiative would speed the discovery 
of genetic risk factors for common diseases. But, as it has been said, 
genetics loads the gun; environment pulls the trigger. GEI will also 
provide markedly improved ways to measure and analyze the environmental 
contribution to disease, so that we can understand the complex 
interplay among genes and environment that is responsible for all human 
health and disease.
    The NIH has recently formed a Coordinating Committee of 
representatives from 13 Institutes and Centers that would develop the 
content, priorities, and implementation of the initiative, should it be 
approved by the Congress. Similar to the management of NIH Roadmap 
initiatives, specific functions of the Coordinating Committee include: 
(a) identification of research priorities and opportunities relevant to 
the program, (b) guidance and support of the development and 
implementation of specific research initiatives related to the program, 
(c) evaluation of proposals for specific activities to be conducted 
under the auspices of the program, and (d) facilitation of appropriate 
NIH-wide communication of program goals, initiatives, and findings. Two 
subcommittees have been formed, one to focus on the genetics component 
of GEI and the other to focus on its environmental component. These 
subcommittees will do the necessary planning for the proposed program 
during the current year and will be prepared to help administer the 
initiative, provided fiscal year 2007 funds are made available. 
Attached is a breakdown of the proposed budget for the initiative. 
Since the initiative is so early in its planning stages, the number of 
grants that would be awarded eventually is not known at this time.
    Through initiatives such as GEI, we stand on the threshold of 
creating a future that would revolutionize the practice of medicine by 
allowing us to predict disease, identify environmental triggers, 
develop more precise therapies and, ultimately, prevent the development 
of disease in the first place.

    Senator Specter. Thank you all very much.
    We turn now to our next panel: Dr. Knapp, Dr. Auerbach, Dr. 
Chao, Dr. Comstock, Dr. Emerson, Ms. Eng, and Dr. Fox.
    We have taken the unusual step of inviting 20 witnesses to 
this hearing to give us a bird's eye view or a thumbnail 
sketch, to mix metaphors, as to what is happening in specific 
lines of medical research. We have allocated as much time as we 
can, consistent with the schedule. It is not enough.
    Dr. Knapp represents the entire group on medical research 
and there has been an allocation of 3 minutes for him and an 
allocation for every other witness, regrettably, of only a 
minute and a half. But that is the best we can do, and you have 
submitted written statements, all of which will be made a part 
of the record, and that will give us an opportunity to have 
some insights on your views and what is happening in your 
specific fields.
    We are going to just indicate the group you are associated 
with, as opposed to going over your curriculum vitae's, which 
are all very, very impressive. Dr. Knapp, we start with you, 
representing the Ad Hoc Group for Medical Research.

STATEMENT OF RICHARD M. KNAPP, M.D., CHAIR, AD HOC 
            GROUP FOR MEDICAL RESEARCH
    Dr. Knapp. Good morning. My name is Dick Knapp and I chair 
the Ad Hoc Group for Medical Research.
    Mr. Chairman, all Americans owe you and Senator Harkin an 
enormous debt of gratitude for your unwavering commitment to 
medical research and your continued leadership in the support 
of the NIH, and we applaud your efforts to add funds to the 
2007 budget to permit a $2 billion increase in NIH funding.
    The President's budget claims to freeze NIH at the 2006 
level, but for almost all NIH institutes and centers this 
budget represents a cut, not a freeze. This budget proposal 
represents the fourth consecutive year that NIH funding has 
failed to keep pace with inflation. In inflation-adjusted 
dollars, as you pointed out, Mr. Chairman, this budget 
represents a loss of almost 11 percent of purchasing power 
since 2003.
    Mr. Chairman, we are well on our way to undoubling the NIH 
budget that you and your colleagues fought so hard to achieve. 
As you heard from Dr. Zerhouni, NIH-funded research is driving 
the transformation of the practice of medicine. At a time of 
unparalleled scientific opportunities and unprecedented health 
challenges, NIH should be positioned to support more research, 
not less. Yet, under this President's budget NIH would fund 10 
percent fewer competing research project grants in 2007 than 4 
years ago.
    Because new investigators are essential to NIH's future, as 
Dr. Zerhouni pointed out, NIH-sponsored training should be 
supported as a top priority. However, due to fiscal 
constraints, the NIH has been unable to meet the stipend 
recommendations it made in 2001, and the President's budget 
proposes no stipend increases in 2007.
    The flattening of the NIH budget also undermines the 
Nation's biomedical research infrastructure. Mr. Chairman, and 
you Senator Harkin have emphasized the need for increased 
support for the renovation and construction of extramural 
research facilities and the acquisition of state of the art 
laboratory instrumentation. Yet this budget again fails to 
request funds for the NIH extramural facilities program and the 
budget proposes to cut funding for shared instrumentation 
grants by nearly 8 percent below the level of 2005.
    This morning's witnesses will describe how NIH research has 
safeguarded and improved the lives of all Americans while at 
the same time serving as a catalyst for new products and 
technologies, creating skilled jobs and contributing to the 
Nation's economic growth.

                           PREPARED STATEMENT

    We share your concern that the continued flattening of the 
NIH budget threatens further progress in all of these areas. 
Thank you for the chance to be here.
    [The statement follows:]

                 Prepared Statement of Richard M. Knapp

    Mr. Chairman and members of the subcommittee, my name is Dick 
Knapp, and I chair the Ad Hoc Group for Medical Research Funding, a 
coalition of more than 300 patient and voluntary health groups, medical 
and scientific societies, academic and research organizations, and 
industry. The Ad Hoc Group is pleased to have the opportunity to 
provide an overview of the President's fiscal year 2007 budget for the 
National Institutes of Health (NIH).
    Mr. Chairman, the members of the Ad Hoc Group, and indeed, all 
Americans, owe you and Senator Harkin an enormous debt of gratitude for 
your unwavering commitment to medical research and your continued 
leadership in support for the NIH. We share your belief that much of 
what has been accomplished in the past half century to help save lives 
and improve the health of all Americans can be attributed, directly or 
indirectly, to the NIH. And we applaud your efforts to add funds to the 
fiscal year 2007 budget resolution to permit a $2 billion increase in 
the NIH budget. In January, the Ad Hoc Group joined four other major 
medical research advocacy groups in calling for the NIH budget to be 
increased by a minimum of $1.4 billion (5 percent) in fiscal year 2007.
    The President's budget for fiscal year 2007 proposes $28.35 billion 
in budget authority through this subcommittee for the NIH, which is an 
increase of less than $1 million over the current year's level. Much 
has been made of this proposal for flat funding. But for most areas of 
research, this budget represents a cut, not a freeze. Under the 
President's proposal, the fiscal year 2007 budgets for almost all NIH 
institutes and centers would be reduced below the fiscal year 2006 
levels.
    In addition, it is important to recognize that this year's budget 
is not a one-year aberration. The President's overall request is $64.5 
million less than what NIH received in fiscal year 2005, and the 
proposed budgets for most institutes and centers are between 1 and 1.5 
percent lower than two years ago. If adopted, the President's budget 
would represent the fourth consecutive year that NIH funding has failed 
to keep pace with inflation as measured by the Biomedical Research and 
Development Price Index. In fact, in terms of inflation-adjusted 
dollars, the President's budget represents a loss of 11 percent of 
purchasing power since 2003, as shown in the attached graph. Mr. 
Chairman, we are well on our way to ``undoubling'' the NIH budget that 
you and your colleagues fought so hard to achieve.
    It is the cumulative effect of this multi-year ``flattening'' of 
the NIH budget that is cause for concern. The flattening has had and 
would continue to have a severe impact across the pillars of NIH: basic 
research, translational and clinical research, research training, and 
the research infrastructure.
    NIH-funded researchers have blazed new trails for medical research. 
Basic research forms the knowledge foundation needed to achieve 
continued scientific advancement. And as you have heard from Dr. 
Zerhouni, the discoveries resulting from the investment in NIH-funded 
research are driving the transformation of the practice of medicine 
through the development of novel and personalized therapies, cures, and 
prevention strategies.
    According to the Congressional Justification accompanying the 
President's budget, in fiscal year 2007 NIH will be able to support 
37,671 total research project grants (RPGs). This is 1,570 fewer RPGs 
than NIH funded in fiscal year 2004. What is more critical is the 
reduction in the number of new and competing RPGs. Under the 
President's budget, NIH will be able to award 9,337 competing RPGs in 
fiscal year 2007, a decrease of 1,074 compared to fiscal year 2003. 
This is 10 percent reduction in just four years. At a time of 
unparalleled scientific opportunities and unprecedented health 
challenges, NIH should be positioned to support more research, not 
less.
    In addition, a key function of NIH is to support training awards to 
encourage new investigators into basic and clinical medical research 
careers. Because an influx of new investigators is essential to NIH's 
future, NIH-sponsored training opportunities should be supported as a 
top priority, with realistic funding levels for stipends, tuition, and 
benefits. Under the President's budget, the NIH will be able to support 
17,499 full-time training positions (FTTPs) in the Ruth L. Kirschstein 
National Research Service Award (NRSA) program. This is a reduction of 
139 since fiscal year 2005. Furthermore, in 2001 the NIH recommended 
increased stipend support for NRSA recipients; however, the agency has 
been unable to meet these objectives due to fiscal constraints. For 
example, stipends for pre-doctoral students and post-doctoral fellows 
have fallen significantly short of NIH's targets, and the President's 
budget provides no increases for stipends above the fiscal year 2006 
levels. How are we to continue to attract the best and brightest 
students with stipends that are unduly low in view of the high level of 
education and professional skills involved in biomedical research?
    The flattening of the NIH budget also undermines the nation's 
biomedical research infrastructure. NIH extramural research 
infrastructure grants are essential if research institutions are to 
update or replace aging research laboratories. Senator Harkin 
recognized the critical importance of the research infrastructure to 
the continued leadership of the United States in medical research when 
he championed the Twenty-First Century Research Laboratories Act, which 
was enacted in 2000. This legislation emphasized the need for increased 
support for the renovation and construction of extramural research 
facilities and the acquisition of state-of-the-art laboratory 
instrumentation. Yet once again, the President's budget fails to 
request funds for the peer-reviewed, competitively awarded, extramural 
research facilities grant program administered through NIH's National 
Center for Research Resources.
    Federal funding also is critical to equip core facilities at 
biomedical research institutions with state-of-the-art technologies. 
NIH administers two competitive grant programs that award funds to 
institutions to purchase present and emerging technologies: the Shared 
Instrumentation Grant Program for groups of NIH-supported investigators 
to obtain commercially-available equipment that costs more than 
$100,000; and the High-End Instrumentation Grant Program to acquire 
more expensive equipment, such as structural and functional imaging 
systems, electron microscopes, and supercomputers. These grants 
maximize the utility of federal research funds by allowing a number of 
scientists with similar instrumentation needs to share such equipment, 
and promote interactions among scientists, frequently across scientific 
disciplines, thereby catalyzing mutually rewarding new research 
collaborations. Yet, the President's budget proposes to reduce funding 
for these programs to $64.4 million, which is 7.7 percent below the 
fiscal year 2005 level.
    This morning's witnesses will give specific examples of how the 
research supported and conducted by NIH has had a profound and far-
reaching impact on society in many important ways, serving as a 
catalyst for new products and technologies, creating skilled jobs, 
contributing to the nation's economic growth, and most importantly, 
safeguarding and improving the lives of all our citizens. Mr. Chairman, 
we share you concern that the continued flattening of the NIH budget as 
proposed by the President threatens further progress in all of these 
areas. 




    Senator Specter. Thank you, Dr. Knapp.
    Dr. Judith Auerbach, representing the Foundation for AIDS 
Research.

STATEMENT OF JUDITH AUERBACH, Ph.D., VICE PRESIDENT, 
            PUBLIC POLICY AND PROGRAM DEVELOPMENT, 
            AMFAR, THE FOUNDATION FOR AIDS RESEARCH
    Dr. Auerbach. Good morning, Mr. Chairman, and thank you 
very much. I am Judy Auerbach from amFAR and I will speak very 
quickly since we have only 90 seconds.
    There are now more than 1 million HIV-infected people in 
the United States and the rates of HIV infection have risen 
dramatically among vulnerable populations, including racial and 
ethnic minority women and men. To make headway in the fight 
against AIDS, we need a strong Federal commitment to research 
leading to more effective treatment and prevention methods.
    During the doubling of NIH's budget, the Agency was able to 
expand the knowledge base in basic research focusing on human 
immunology, macromolecular biology, structural biology, and 
behavioral research. This led to a dramatic increase in the 
number of vaccine and therapeutic candidates in the pipeline 
and to the implementation of crucial HIV prevention trials in 
populations most at risk of infection.
    But much of this progress is in jeopardy with current and 
proposed cuts. Factoring in the recent recalculation, AIDS 
research at NIH was cut by about 2.4 percent between 2005 and 
2006 and will be cut another 6 percent under the President's 
2007 request. This has grave consequences for grants overall, 
for expanded trials of promising prevention technologies and 
therap eutics, and for new and seasoned investigators.
    The number of R01's in AIDS research decreased by 5 percent 
in both numbers and dollars from 2005 to 2006 and would 
decrease even further in 2007. Under current budget 
constraints, it is anticipated that the AIDS clinical trials 
networks will be allocated only about 54 percent of what it is 
estimated they will need over the next 7 years. This means 
important effectiveness trials of new prevention technologies 
and new therapeutics will not be launched. Research institutes 
are losing potential new investigators and more experienced 
ones are demoralized, knowing that the majority of submissions 
are triaged and unscored and that funding is not likely until 
resubmission, even if then.
    So altogether this means that important AIDS research will 
not be undertaken and people at risk for or living with HIV and 
AIDS will not have access to lifesaving interventions.
    My time is over, so I will stop there. Thank you.
    Senator Specter. Thank you, Dr. Auerbach.
    Dr. Moses Chao, Christopher Reeve Foundation.
STATEMENT OF MOSES CHAO, M.D., CHRISTOPHER REEVE 
            FOUNDATION
    Dr. Chao. Thank you, Mr. Chairman.
    In the past 10 years we have witnessed a remarkable 
turnaround in neuroscience research. It used to be dogma that 
the adult spinal cord could not regenerate or recover from 
serious injury. But now through basic research we know of 
specific genes, proteins, and cells that can stimulate the 
repair of the spinal cord, and we are now ready to convert 
these findings into new therapies.
    But the United States is falling behind because of the 
decrease in NIH funding. The decrease has affected many 
scientists, including my own lab, because the level of funding 
has actually dropped to 10 percent. What that means is 1 out of 
10 grants is being funded and that has produced some drastic 
consequences, because many innovative applications and 
promising experiments are not supported or carried out.
    More distressingly, there is a huge negative impact on the 
recruitment of our next generation of young scientists because 
of this discouraging situation. So we believe that this is the 
time to invest in basic research to advance the progress that 
we have made in this area. Christopher Reeve often argued that 
what we learn about spinal cord regeneration has direct 
implications to many diseases, including glaucoma, Alzheimer's 
disease, and Parkinson's disease. Therefore, to put the brakes 
on funding basic research will interfere with new scientific 
discoveries that will be aimed at improving the health of all 
Americans.
    Thank you.
    Senator Specter. Thank you, Dr. Chao.
    Ms. Amy Comstock, Parkinson's Action Network.

STATEMENT OF AMY L. COMSTOCK, CHIEF EXECUTIVE OFFICER, 
            PARKINSON'S ACTION NETWORK
    Ms. Comstock. Good morning. Thank you, Chairman Specter and 
Senators Harkin and Shelby. I am Amy Comstock, the Chief 
Executive Officer of the Parkinson's Action Network, and I am 
here on behalf of Parkinson's patients, their families, and all 
of the national Parkinson's organizations.
    Parkinson's disease is now listed among the 15 leading 
causes of death in this country. Yet there is still no cure and 
no known treatments that even slow the progression of the 
disease. In fact, since the introduction of dopaminergic 
treatments nearly 50 years ago, our community is still 
struggling with mere variations of that treatment for this 
progressive disease.
    Even with the introduction of deep brain stimulation for 
Parkinson's disease, we are still only responding to the 
symptoms of the disease and not doing that very well sometimes, 
and certainly not for a long duration.
    So I am here this morning, quite frankly, to use the word 
that we are terrified of flat funding at NIH. Not only will 
flat funding eat into all forms of research currently under way 
at NIH, but we are particularly fearful that it will have a 
disproportionate impact on clinical and translational research, 
which is exactly the kind of research that we need the most.
    Clinical research is very expensive to conduct, but it is 
what we have to have in order for treatments to make it through 
the drug development pipeline and become available to patients. 
For example, there is a handful of drugs slated for clinical 
trials right now at NIH that in fact may be what we need so 
badly. They may be compounds that can slow the progression of 
the disease.

                           PREPARED STATEMENT

    We have to have these trials, but we cannot have them 
without funding. With flat funding, even if those trials are 
conducted--we have to do the math--other research would be cut 
at NIH. Therefore, we strongly support a minimum of 5 percent 
increase for NIH.
    Thank you.
    [The statement follows:]

                 Prepared Statement of Amy L. Comstock

    Thank you Chairman Specter, Ranking Member Harkin, and 
distinguished members of the Subcommittee for convening this hearing on 
NIH appropriations. I am the Chief Executive Officer of the Parkinson's 
Action Network (PAN). PAN represents the Parkinson's community, 
including the more than one million Americans currently fighting 
Parkinson's disease (PD), and their families, and the national 
Parkinson's organizations, such as The Michael J. Fox Foundation for 
Parkinson's Research, Parkinson's Disease Foundation, National 
Parkinson Foundation, Parkinson Alliance, and American Parkinson 
Disease Association.
    As I am sure you all you know, PAN was instrumental in helping 
garner Congressional support for this Subcommittee's doubling of the 
NIH budget over five years during the late 1990's and early in this 
decade. We continue to work in conjunction with so many to prevent the 
proposed freeze in funding for NIH. Flat-funding would, in effect, 
constitute a significant cut, as the Biomedical Research and 
Development Price Index (BRDPI) is estimated to have increased by 5.5 
percent for fiscal year 2005, and will likely increase by 4.1 percent 
for fiscal year 2006, and 3.8 percent in fiscal year 2007. Accordingly, 
in order to not lose ground in ongoing research, we support the medical 
research advocacy community's recommendation for a 5 percent increase 
above the fiscal year 2006 funding level for the National Institutes of 
Health.
    We cannot turn our backs on our most promising research, which may 
happen if this funding is not provided. The Parkinson's community is 
particularly concerned with several clinical trials that may be 
eliminated without sufficient funding and direction.
    These clinical trials are a part of a study going on at NIH right 
now that embody the kind of translational research most promising to 
the Parkinson's community and is desperately needed. NET-PD 
(Neuroprotection Exploratory Trials in Parkinson's Disease) is a trial 
to study compounds that may slow the progression of Parkinson's 
disease. Research into treatments that might slow progression is 
particularly important as current treatments for PD alleviate some 
symptoms but do not slow progression of the disease. Despite the 
potential value, this program may be halted or cut back if NIH does not 
receive adequate funding. Yet, NET-PD is exactly the kind of 
translational research that we strongly support NIH aggressively 
pursuing.
    We believe that there is hope for today's Parkinson's disease 
patients and their families. There are emerging therapies that should 
be pursued--even therapies that could potentially reverse the 
progression of the disease. These are the neuro-restorative therapies, 
such as neural growth factors, gene therapies, and tissue transplants 
including stem cells, which ultimately may restore function in patients 
suffering from Parkinson's disease as well as other neurodegenerative 
disorders. However, if this important research is not aggressively 
pursued it may take many more years than necessary to determine if this 
hopeful research may become much-needed therapies for today and 
tomorrow's Parkinson's patients.
    On behalf of the Parkinson's community, I thank you for your 
continued interest in Parkinson's disease issues and your support for 
better treatments and a cure for Parkinson's. I would be happy to 
answer any questions you may have.

    Senator Specter. Thank you, Ms. Comstock.
    We turn now to Dr. Steven Emerson on the cancer issue. Give 
my regards and thanks to Dr. John Glick, my oncologist.

STATEMENT OF STEPHEN EMERSON, M.D., ASSOCIATE DIRECTOR 
            FOR CLINICAL RESEARCH, ABRAMSON CANCER 
            CENTER, UNIVERSITY OF PENNSYLVANIA HOSPITAL
    Dr. Emerson. Good morning, Chairman Specter, Senators 
Harkin and Shelby. My name is Steve Emerson. I am the associate 
director for clinical research at the Abramson Cancer Center at 
Penn. Our outgoing director, Dr. Glick, sends his regards. He 
is no stranger to this committee.
    First off, I want to thank you all for your continued 
support for the health and welfare of this country by means of 
health care research over the past several years. Without your 
support, we could not have done what we have done. In the area 
of cancer where I work, I have seen in the 25 years I have been 
working a change where 25 years ago a cancer diagnosis was 
uniformly and relatively quickly fatal, to now where over half 
the patients who walk in my office know that they will live at 
least 5 years, if not be cured of their cancer.
    But still we are only partway there and at this point 
cancer is still the largest cause of death in all Americans 
under the age of 85. It is still a huge killer. We have a long 
way to go.
    Now, you have heard a lot about the issues with the 
doubling of the budget and yet where we are with the flat 
budgets going forward. I want to concentrate on just one part 
of that. One of my roles at Penn is head of training and the 
mentoring of the next generation of investigators. What you see 
with the budget being flat is actually a reduction in all new 
R01's being funded to this year the eleventh percentile, next 
year much lower. This is one-third the level of funding in 
terms of numbers of grants and chances of getting funded that 
it was even 3 years ago, and that is going to get worse next 
year.
    Worse than that, the money per grant is being cut 30 
percent off even the best grants. So the funds going in for new 
research have plummeted. That is the source of the panic you 
are talking about. So for new investigators that we have all 
invested in, the outlook for them for careers, for taking care 
of all of us and for finding new cures, it is hard to convince 
them what the future is. If we do not correct this, all of the 
goodwill and investment we have made in the infrastructure with 
the road map, all the collaborative work, all the genomics and 
cancer that we have put this investment into will go to waste 
because we will not have a next generation of scientists to 
take advantage of it.

                           PREPARED STATEMENT

    So thank you all again in the past and in the future for 
your efforts on preserving the NIH budget and its mission. 
Thanks again.
    [The statement follows:]

               Prepared Statement of Dr. Stephen Emerson

    Good Morning, Chairman Specter, Senator Harkin, and Members of the 
Subcommittee. I am Stephen Emerson, Associate Director for Clinical 
Research at the University of Pennsylvania's Abramson Cancer Center, 
one of NIH's original comprehensive cancer centers funded by the 
National Cancer Institute three decades ago. Our outgoing Director, Dr. 
John Glick, no stranger to this Subcommittee, extends his regards and 
regrets his schedule did not permit him to appear this morning.
    Thank you for the opportunity to speak with you today about efforts 
by scientists and clinicians in the ongoing fight against cancer, a 
disease that is the leading cause of death for Americans 85 years of 
age and younger. In the United States last year, 1 of every 4 deaths 
was from cancer. This illness claimed the lives of about 563,700 
Americans, with approximately 1.4 million new cancer cases diagnosed.
    These staggering figures should not, however, diminish the hope 
that exists for all those who fall victim to this disease from the 
dramatic progress we have made in this fight. When the Abramson Center 
opened its doors three decades ago, a cancer diagnosis was a near 
certain, imminent death sentence. But through the efforts of millions 
of people, and as a direct result of the steadfast support of this 
Subcommittee in robust funding for cancer research over the years, 
today about 60 percent of cancer patients can expect to live more than 
five years after diagnosis. Working with our colleagues in partnership 
with organizations like the American Cancer Society and the Friends of 
Cancer Research, there is an aggressive, day-to-day battle to reverse 
the devastating effect that cancer has on the lives of so many 
individuals and families--through research, prevention efforts and 
treatment.
    That effort, however, is under assault, and at great risk, if the 
President's fiscal year 2007 budget for the National Institutes of 
Health, and its proposed allocation for the National Cancer Institute, 
is not reversed. In the Bush 2007 budget proposal, the NCI is slated to 
receive $4.75 billion--a cut of nearly $40 million, or almost 1 
percent, below NCI's fiscal year 2006 level. That is a reduction of $70 
million cut from the fiscal year 2005 level and approximately $186 
million less than what the Congressional Budget Office estimates is 
necessary to maintain current projects, infrastructure and spending 
adjusted for inflation and other factors.
    Within the proposed levels for the NCI, virtually every major 
activity, other than activities for the NIH Roadmap initiative, would 
be reduced. Cancer research activities would be cut $50 million below 
the 2006 level, which itself was slightly reduced from the level 
allocated for 2005. Cancer biology research would be cut nearly $41 
million and research into the causes of cancer would be reduced more 
than $6 million. Overall support for the cancer centers would be 
reduced by more than $2 million, capping a two-year period of real 
decline in the NIH investment for its cancer centers. Even cancer 
control and prevention, one of the single most important areas in our 
efforts to combat this disease, is scheduled to be hit with a nearly 
$2.5 million reduction, reductions that amount to a cumulative decline 
of nearly $17 million over two years.
    These proposed reductions, which I know you oppose Mr. Chairman, 
completely contradict the Administration's stated goal of ending 
suffering and death from cancer by 2015. They fly in the face of the 
spiraling cost of cancer treatment, pegged at more than $72 billion 
annually in the United States, nearly five percent of all health care 
expenditures. And they send the wrong message to the nation at a time 
when the economic burden, excluding the costs for treatment, from 
cancer morbidity and premature mortality is a staggering $120 billion 
annually.
    For the community of scientists and clinicians who have dedicated 
their lives to the prevention, diagnosis and treatment of cancer, and 
who are the members of the team working in every state in our nation to 
meet that 2015 goal, these proposed cuts are both alarming and highly 
discouraging. If enacted, these funding levels would drop success rates 
for scientists proposing research project grants to the NCI to just 16 
percent--that is a 1 in 6 chance of obtaining funding. Such a level 
would mean a drop in the NCI grant success rate of more than 50 percent 
since 1998, and a drop of 43 percent since 2002. For NCI's R01 grants, 
the bread and butter mechanism for most NIH funded scientists, the 
payline for last year is even worse--just 11 percent. Reductions in 
2007 would only erode that level further.
    While older, more established research scientists will likely find 
a way to hold on to most of their core funds, the effect on young 
investigators--the seed corn of our future in this battle--is nothing 
short of devastating. The NIH New Investigators Committee presented 
data last December that showed the average age of a typical new NIH R01 
awardee with an M.D. degree had reached 44. At the same time, the 
percentage of new investigators in competing R01 Awards across NIH 
continues to decline to just 20 percent. For the NCI, the first-time 
investigator success rate for all grant mechanism is worse--just 11 
percent. For R01's, the success rate is again just 17 percent. The 
message these proposed cuts send is that for promising young biomedical 
professionals, a career focused on tackling cancer--whether in the 
fundamental study of genomics, proteomics, and biomarkers, or the more 
applied disciplines directed at generating new diagnostic or treatment 
regimes and devices--is not worth pursuing. The President's budget runs 
the risk of beginning the effective elimination of a whole generation 
of cancer scientists--at the very time when we are turning the corner 
on the fight against this disease.
    Those of us who have spent our lives focused on ending the scourge 
of this disease know that this Subcommittee--more so than any other in 
the U.S. Congress--led the fight for funds to double the NIH budget. 
And there has been tremendous progress against cancer as the number of 
people who died from cancer between 2002 and 2003 decreased for the 
first time, the year corresponding to the last of the large NIH budget 
increases. The Director of the NCI, in his testimony to this Committee 
last month, outlined a number of significant scientific breakthroughs 
in the treatment and diagnosis of breast, ovarian and cervical cancers 
in just the last year. These continue the remarkable success we have 
had in fighting the number two cause of death in the United States.
    The proposed 2007 budget cuts would help to unravel the progress 
this Subcommittee fought so hard to achieve in the doubling of NIH from 
1998-2003. We urge you to redouble your efforts to stop them, and 
provide a modest increase--perhaps an additional $300 million for the 
NCI in the coming year--to help offset declines enacted in 2006 and 
provide for most increases to sustain the pool of young scientists 
whose careers will hopefully be marked by the end of cancer as a 
scourge on so much of our nation and our world.
    Thank you for the chance to present my views to the Subcommittee. 
We would be happy to prepare responses to any questions you might have 
for the record.

    Senator Specter. Thank you, Dr. Emerson.
    Ms. Lauren A. Eng, Spinal Muscular Atrophy Foundation.

STATEMENT OF LAUREN A. ENG, PRESIDENT, SPINAL MUSCULAR 
            ATROPHY FOUNDATION
    Ms. Eng. My daughter is one of the 33,000 American children 
suffering from spinal muscular atrophy, the most common genetic 
killer of young children. One missing gene causes nerves and 
muscles to wither away and most children die by the age of 2. 
But there are many terrible diseases. What makes SMA remarkable 
is the imminence of treatment. SMA represents both the problem 
and the opportunity of drug development for orphan diseases. 
Half of Americans with illness suffer from rare diseases and 
for the vast majority of rare diseases, especially pediatric 
ones, money and scientific advances are wasted because 
discoveries do not move from the bench to the bedside.
    Because of scientific breakthroughs, NINDS chose SMA from 
its 600 diseases for a groundbreaking drug discovery program. 
The SMA project is a shining example that NIH can develop 
treatments and invest in further and basic science that is ripe 
and pays off. With less than $5 million a year, a group of 
potential drugs have already been identified. NIH has been a 
catalyst of advancing research and drug companies are 
interested. It achieved in 3 years what might have otherwise 
taken 10.

                           PREPARED STATEMENT

    But running an astonishing race is useless if you stop 
short of the finish line. Under the proposed budget, 
continuation of the program is at risk. There is funding to 
pursue one drug, but scientists believe at least three should 
be advanced, each costing $15 million to bring to trials. If 
NIH cannot fund this next step, it will have catastrophic 
effect. Academic and industry research will stop. We will have 
wasted the enormous investments and progress made in biomedical 
research, and for my child all of this is the difference 
between life and death.
    [The statement follows:]

                   Prepared Statement of Loren A. Eng

    I am Loren Eng, president of the Spinal Muscular Atrophy (SMA) 
Foundation and am here on behalf of the SMA Coalition. Most 
importantly, I am the mother of Arya Singh, who is one of the 30,000 
children in America dying from Spinal Muscular Atrophy.
    As you may know, SMA is a terrible disease. It is the most common 
genetic killer of babies and young children in America, and it is 
untreatable and fatal. It is often described as a genetic version of 
polio, or the children's equivalent of ALS. In children with SMA, one 
missing gene, and one missing protein causes motor neurons to die. 
Muscles weaken and wither away, leaving the bright minds of its young 
victims trapped by their failing bodies. Most children with SMA die 
within the first few years of life. Some are ``lucky'' and live longer, 
but face extreme disability and suffering.
    But there are many terrible diseases. What makes SMA remarkable is 
the ability to truly make a difference with a modest amount of money 
and smart strategy.
    SMA is a poster child for both the problem and the opportunity of 
drug development for rare pediatric diseases.
    For large diseases, the historical focus on basic science works 
well--large drug companies take that basic science and translate it 
into treatments that save lives.
    However, half of Americans with illness have smaller diseases, and 
for them the system has not worked. Breakthroughs are often achieved in 
basic science, but there are no large drug companies waiting to turn 
those breakthroughs into treatments. For a handful of smaller diseases, 
drug companies will only get involved at later stages where perceived 
risk is lower. But for most small diseases, the basic science is wasted 
because of the challenges of advances research from the bench to the 
bedside. This is especially true for rare pediatric diseases. Money is 
spent, but children still die.
    In the past decade, scientists studying SMA have achieved 
incredible breakthroughs, creating a unique opportunity to develop 
treatments. To its credit, NINDS has recognized the opportunity and 
taken steps to advance basic science with a revolutionary translational 
research effort.
    Just three years ago, the NINDS designated SMA, from among 600 
diseases, as the best candidate for a model new program to translate 
basic science into actual drugs and treatments. The SMA Project 
combined academic and industry expertise, and was a focused and 
strategic effort to translate remarkable science into real solutions.
    In just three years, and for less than $5 million per year, the SMA 
Project has brought us within reach of an effective treatment. 
Investigators have identified a group of potential drugs that may slow 
the progression of the disease. Despite a miniscule budget for the 
project, NINDS has made incredible strides in harnessing the 
community's efforts toward a near term treatment.
    Unfortunately, running a brilliant race is useless if you stop 
before the finish line, and that is what we fear is at risk of 
happening.
    I am not an expert in the federal budget but I do know that:
  --this model SMA program would never have been initiated under this 
        budget,
  --the existing funding of just $5 million a year is at risk, and
  --the very success of the program is at risk.
    The next phase of the project is pre-IND studies but there is only 
enough funding to study JUST one compound. Project scientists say we 
need at least two to three, and each costs $2 million. For clinical 
trials we will need $10 to $15 million each.
    The leadership of the NIH has been a catalyst of incredible 
progress--it expects to advance research to a point when they can be 
``handed off'' to drug companies to fully develop. For a fraction of 
the vast amounts spent on caring for SMA victims, we could develop 
treatments that would save them. With a modest amount of money and 
continued focus, we can save lives, and money.
    If NIH can not provide for these critical next steps, it will have 
a domino effect elsewhere:
  --Young investigators will not focus on SMA,
  --Existing non-government research will stall,
  --Industry will surely not engage, and
  --Other diseases like ALS and DMD will not reap the benefits of SMA 
        research.
    The SMA Project has been a revolutionary effort and a shining 
example of how NIH cannot only fund basic research but actually DEVELOP 
TREATMENTS for deadly diseases.
    Through a solution driven approach, the NIH has achieved in 3 years 
what might have taken a decade. ``Smart investment'' could pay off in 
treatments that save lives. This is an incredible example of finding 
solutions, not just spending money. Of course, in this case, a 
``solution'' means treatment that could save the lives and reduce the 
suffering of 30,000 children.
    We urge you not to stop short now when we are so close. Reducing 
funding for NIH, and for projects like the SMA Project will have 
devastating consequences--we will waste the enormous amounts of money 
that have been spent and progress that has been made. For our daughter, 
it could mean the difference between life and death.

    Senator Specter. Thank you, Ms. Eng.
    We turn now to Dr. Philip Fox, American Association for 
Dental Research.

STATEMENT OF DR. PHILIP C. FOX, DIRECTOR OF CLINICAL 
            RESEARCH, DEPARTMENT OF ORAL MEDICINE, 
            CAROLINAS MEDICAL CENTER ON BEHALF OF THE 
            AMERICAN ASSOCIATION FOR DENTAL RESEARCH
    Dr. Fox. Thank you, Mr. Chairman. I am Dr. Phil Fox and I 
am really representing the dental research community.
    I would like to highlight this morning some advances in 
salivary diagnostics, an area you have not heard much about. 
Diagnosis of most health conditions requires a blood or a urine 
sample and that may be invasive or painful to obtain. But now, 
after many years of research, saliva is poised to be used as a 
noninvasive diagnostic fluid for a number of oral and systemic 
conditions.
    Dental researchers have been able to amplify molecular 
signals that are present in saliva, heralding the advent of new 
tests that allow for earlier diagnosis than is currently 
possible. Saliva is already being used routinely for rapid 
noninvasive HIV diagnosis and saliva-based tests will soon be 
available to detect oral cancer. Further, saliva has the 
potential to detect exposure to chemical and biological weapons 
and is being looked at in autoimmune diseases as well.
    Now, most of this research is funded by the National 
Institute of Dental and Craniofacial Research, the NIDCR. 
However, as you have heard, the investment that is made in the 
NIH doubling is now at risk. I think that we have the research 
equivalent now of being all dressed up and nowhere to go.
    As a result of your past investment, there are many 
unprecedented opportunities in dental research. But the austere 
budget of the last 4 years has resulted in a steady decrease in 
new research grants and many young investigators who are 
leaving the field.
    Imagine a future in which a saliva sample is used for 
quick, painless and less expensive diagnostic tests and to 
monitor many systemic health conditions and exposure to 
chemical and biological weapons. Early diagnosis could save 
thousands of lives. We need you to sustain your commitment to 
NIH and to dental research in order to realize these 
unprecedented scientific opportunities.
    Thank you for your interest and support.
    Senator Specter. Thank you very much, Dr. Fox.
    Unless there is some question from the panel, we will turn 
now to our next group of experts.
    Thank you all very, very much.
    Dr. Knapp. Thank you.
    Dr. Emerson. Thank you.
    Senator Specter. We now call on Ms. Patricia Furlong, Dr. 
Sam Gandy, Ms. Ann Gibbons, Dr. Robert Goldstein, Dr. Lawrence 
Holzman, and Dr. Steven Houser.
    Thank you all very much for joining us. As is the situation 
with all of the witnesses, your full statements will be made a 
part of the record. We turn first to Ms. Patricia Furlong, who 
represents the Project on Muscular Dystrophy. Ms. Furlong.

STATEMENT OF PATRICIA FURLONG, CO-FOUNDER AND CHIEF 
            EXECUTIVE OFFICER, PARENT PROJECT MUSCULAR 
            DYSTROPHY
    Ms. Furlong. Thank you very much, Senator Specter, Senator 
Harkin, and Senator Shelby. I so appreciate this opportunity to 
talk about NIH funding.
    I thought I would start by giving you three examples. In 
1999 a scientist from the University of Pennsylvania with NIH 
support looked at aminoglycosides to suppress premature stop 
codons. Premature stop codons in a genetic sentence could be 
interpreted as a period in the middle of a genetic sentence, 
creating the loss of a significant protein. These 
aminoglycosides are found to suppress a premature stop.
    This particular scientist went to industry and, again with 
his own NIH support, began high throughput screens. Today we 
have a drug in trial called PTC-124. This drug has implications 
for all genetic diseases in terms of a subset of the population 
with premature stops. It is currently in trial and 
demonstrating pharmacological activity in cystic fibrosis and 
in Duchenne muscular dystrophy we do not have the data. But 
this drug has sweeping potential results across the rare 
genetic disease community.
    In 2000 a scientist from Johns Hopkins University looked at 
muscle regulators and found that inhibiting myostatin would 
improve the bulk of the muscle and potentially the strength. 
This drug is currently in trial in muscular dystrophies FSH, 
Becker, and myotonic.
    In the year 2001, the Bowman-Burke inhibitor compound was 
looked at. It is a protease inhibitor that can slow or halt 
muscle degeneration in muscular dystrophy. It had been in trial 
in the National Cancer Institute and was halted, not because of 
any risk to the patient, but primarily due to lack of material. 
This drug is now going into trial through NIH funding in 
muscular dystrophy in January.

                           PREPARED STATEMENT

    It is these cures, potential treatments for all of us, that 
make such a difference in our lives. We ask you to commit to 
NIH funding to supply that NIH, that research enterprise, with 
the funding it needs to help all of us, to give us time with 
the people we love, and to help not only the American people 
but people across the world.
    Thank you.
    [The statement follows:]

                   Prepared Statement of Pat Furlong

    Good morning/afternoon Mr. Chairman and Members of the Committee, 
and thank you for this opportunity to testify on the NIH budget.
    My name is Pat Furlong, Co-Founder and CEO of Parent Project 
Muscular Dystrophy and the mother of two sons who battled Duchenne 
Muscular Dystrophy.
    Thanks to the significant amount of basic research funded by NIH in 
recent years, we are making encouraging progress in our quest to 
develop effective treatments for this always-fatal disease. Right now, 
we are in a Phase II clinical trial on a promising drug for a subset of 
patients with Duchenne muscular dystrophy, and potentially a subset of 
patients with many other genetic conditions.
    It's basic NIH-funded research that served as a foundation and 
provided the spark for this drug, and many other promising therapies 
that are in the works. Without adequate NIH funding to support basic 
research, the medical research tower will rise much lower before 
eventually buckling due to the tremendous strain placed on too few 
resources.
    We are particularly concerned about the negative impact the budget 
crunch will have on young investigators seeking to enter the field of 
Duchenne MD research. The budget limitations we have seen over the past 
few years have made it tremendously more difficult for young, first-
time investigators with meritorious submissions to secure an R01 grant.
    I urge your panel and the entire Senate to continue to lead the way 
in restoring critically needed dollars to support basic NIH research.

    Senator Specter. Thank you very much, Ms. Furlong.
    We now turn to Dr. Sam Gandy, representing the Alzheimer's 
Association.

STATEMENT OF SAM GANDY, M.D., Ph.D., CHAIR, MEDICAL AND 
            SCIENTIFIC ADVISORY COUNCIL, ALZHEIMER'S 
            ASSOCIATION
    Dr. Gandy. Mr. Chairman, members of the subcommittee: As a 
direct result of this subcommittee's leadership and foresight, 
scientists supported by the NIH have made enormous strides 
towards understanding Alzheimer's, a disease that affects 4.5 
million Americans today and will affect as many as 16 million 
in a few decades.
    For the first time in the history of medicine, we have 
Alzheimer's genes in hand and we can now contemplate rational 
therapy for Alzheimer's. With adequate resources, scientists 
will be able to develop medications that modify Alzheimer's 
pathology in as few as 3 years. Achieving that goal will 
relieve a major bottleneck and attract every major 
pharmaceutical company to begin bringing new drugs into human 
clinical trials.
    The current trajectory of NIH cuts threatens to arrest 
progress and devastate the upcoming generation of scientists. 
Current grants are now routinely cut by 18 percent. In my 
institution this is already causing layoffs and I see my 
students turning away from research careers. Budget cuts also 
mean that some of the most promising drug targets will go 
unstudied. An important new molecule was discovered just last 
month. Where will we find the resources to study its potential 
therapeutic value?

                           PREPARED STATEMENT

    The inescapable conclusion is that Federal budget cuts are 
killing more than programs. These cuts are killing the minds of 
millions of Americans. The threat of Alzheimer's is staggering 
in its scope. I urge you and your colleagues to act now to 
reverse the disastrous path upon which we find ourselves.
    Thank you very much for providing me with this opportunity 
to testify.
    [The statement follows:]

                    Prepared Statement of Sam Gandy

    Mr. Chairman and members of the Subcommittee, I appreciate the 
opportunity to be here to discuss Alzheimer's disease, a disease that, 
as we speak today, is robbing 4.5 million Americans of their abilities 
to form memories and thoughts. The disease will ultimately take the 
life of every one of these 4.5 million. Within a few decades, as many 
as 16 million Americans will have Alzheimer's, all of whom will 
eventually succumb to the disease, unless we all, together, take up the 
fight toward a cure or means of prevention.
    As a direct result of the leadership and foresight of this 
Subcommittee, the National Institutes of Health have played essential 
roles in developing and maintaining a cadre of American scientists such 
as myself who have made enormous strides toward understanding 
Alzheimer's and, for the first time in the history of medicine, 
contemplating rational interventions aimed at the underlying disease 
process We now know that Alzheimer's is a disease and not an inevitable 
consequence of aging. We have identified several key genetic mistakes 
that are so malignant that one single mistake in the DNA is sufficient 
to cause the complete picture of Alzheimer's. These DNA mistakes have 
been both necessary and sufficient to supply us with essential 
information that has eluded scientists for the century since Alois 
Alzheimer presented his landmark paper in Munich in 1906. For the first 
time in the history of medicine, we are now able mimic the earliest 
steps in the disease using chemicals, cells, or, most valuably, the 
lowly laboratory mouse. Human Alzheimer genes have enabled us not only 
to create in the laboratory a living brain with Alzheimer's, but, 
astoundingly, we are also now able to cure experimental Alzheimer's in 
the laboratory. These experimental therapies are now entering human 
trials so that we might translate these experimental cures into 
practical medicines for humans.
    To date, four drugs have been approved for treating the symptoms of 
Alzheimer's, but these drugs only help a few patients, and even then, 
only modestly and temporarily. Current Alzheimer drugs leave the basic 
underlying disease untouched and the natural progression from amnesia 
to death proceeds along the standard, predictable, inevitable, and 
cruel path that we know all too well. Yet, from the laboratory, for the 
first time, scientists and physicians see genuine, tangible, 
quantifiable hope. Most experts agree that with adequate resources, 
scientists will be able to develop medications that will modify 
Alzheimer's pathology within the next three years. If the prevailing 
wisdom about the root cause of the disease is validated, a major 
bottleneck will be relieved, and every major pharmaceutical company 
will begin bringing new drugs into human clinical trials.
    But that can only happen if you and your colleagues sustain the 
Alzheimer research enterprise. Alzheimer's drug development will 
certainly be stymied if Congress adopts the President's proposal, where 
for the fourth consecutive year the NIH budget fails to even keep pace 
with inflation.
    The NIH doubling process is directly responsible for the progress 
of Alzheimer's research as a field of study: the field has moved from a 
backwater of obscurity into perhaps the single most visible, most 
competitive, and most exciting research field in experimental 
neurology. Within three years after this Subcommittee first 
appropriated funds for Alzheimer's, the number of scientists drawn into 
this field of study increased three-fold. But because of budget cuts 
over the past three years we are already seeing talented scientists 
turning to other fields.
    The current trajectory of cuts threatens to devastate the upcoming 
generation of scientists. NIH funding of the scientists who populate 
the faculties of our universities is not simply used to buy test tubes 
and chemicals: those funds directly pay the salaries of scientists on 
these faculties. Draconian cuts will render these scientists and 
professors unemployable. And with the loss of this talent, we are 
postponing the day that we can eradicate this deadly disease.
    But perhaps most importantly, persistent budget cuts are shutting 
out opportunities to find ways to cure or prevent Alzheimer's disease. 
In 1998, NIH was funding 30 percent of top-rated grant applications. 
Today, the percentage of Alzheimer projects that actually receive 
funding is down to 18 percent. Some institutes are struggling to 
maintain 10 percent funding. This means that most scientific 
opportunities are being left on the table. It also means that some of 
the most promising clinical trials--the tools we need to translate 
basic research findings into effective clinical treatments--will be 
delayed or scrapped altogether. The inescapable conclusion, for me, at 
least, is that federal budget cuts are killing more than programs; they 
are killing the minds of millions of Americans.
    Mr. Chairman and Senator Harkin, I am certain that you both realize 
that we cannot be a strong nation unless we are a healthy nation. In 
fiscal year 2007, spending on all Medicare beneficiaries benefits will 
total $449.2 billion. Unless we find a way to prevent or cure 
Alzheimer's disease, in less than 25 years, the care of Medicare 
beneficiaries that is attributed to Alzheimer's alone will cost over 
$400 billion, roughly equivalent to today's entire Medicare budget. The 
threat is so enormous that the temptation is to just give in to 
nihilism and cynicism. I urge you and your colleagues to join us in 
resisting this temptation and act now to reverse the disastrous path 
upon which we find ourselves.
    Thank you for the opportunity to testify.

    Senator Specter. Thank you. Thank you, Dr. Gandy.
    Our next witness is Ms. Ann Gibbons, representing Autism 
Speaks.

STATEMENT OF ANN GIBBONS, MEMBER, BOARD OF DIRECTORS, 
            AUTISM SPEAKS
    Ms. Gibbons. I am the mother of a 17-year-old boy with 
autism and I am a member of the board of directors of Autism 
Speaks, and I am here to speak for those who cannot.
    Autism is our Nation's fastest growing developmental 
disorder, affecting 1 in 166 children, up more than tenfold 
from a decade ago and costing our Nation approximately $35 
billion annually. Autism has no known cause, no known cure, and 
few effective treatments. The incidence of autism has increased 
at epidemic proportions, but NIH funding for autism research 
has been frozen over the past 2 years and will remain so in the 
President's 2007 budget.
    Specifically, the first lost opportunity is developing new 
treatment standards for autism. This would support research on 
new or existing early interventions to establish common methods 
of verifiably effective treatment. Early intervention provides 
children with the best possible opportunity to develop in the 
most normal way possible, but not with the President's budget, 
where this critical research will not be funded.
    Another lost opportunity is defining the core features of 
autism, when it begins, its long-term course, and subtypes of 
the disorder that may exist on the autism spectrum. 
Understanding the common features of autism will lead to 
identification of its causes, both genetic and environmental, 
and identify better treatments or even prevention of the 
disease. The President's proposed budget will not fund this 
research.

                           PREPARED STATEMENT

    The incidence of autism will continue to grow, but funding 
for autism research will not. With the President's budget, 
opportunities will be lost, but the pain and suffering of 
autistic children and their families will continue to grow, as 
will the cost to society.
    I just want to thank you all for what you are doing for 
biomedical research.
    [The statement follows:]

                   Prepared Statement of Ann Gibbons

    Mr. Chairman, I am Ann Gibbons, a resident of Bethesda, Maryland, a 
member of the Board of Autism Speaks, and the mother of a 17-year-old 
son with autism.
    Autism Speaks was launched to help find a cure for autism by 
raising the funds to facilitate and quicken the pace of research, to 
raise public awareness of autism, and to give hope to all those who 
suffer from this disorder. Autism Speaks' goal is to give a voice to an 
entire community, to every family dealing with the hardships of autism. 
With its mergers with the National Alliance for Autism Research and the 
Autism Coalition for Research and Education, Autism Speaks now 
represents our nation's largest autism advocacy organization.
    In both of my roles, in my public capacity as an Autism Speaks 
board member and in my private role as a mother of an autistic child, I 
commend you, Mr. Chairman, for your leadership in promoting funding for 
biomedical research and support you in your efforts to secure increased 
funding for the National Institutes of Health this year.
    Funding for understanding the causes of and finding treatments for 
autism is sorely needed. Autism is our nation's fastest-growing 
developmental disorder, now affecting 1 in 166 children in the United 
States, up more than tenfold from just a decade ago. A Harvard School 
of Public Health professor, in a recent book, estimates that it can 
cost $3.2 million to care for an autistic person over the course of his 
or her lifetime, and by conservative estimates autism costs our society 
$35 billion annually in direct and indirect costs.
    Autism has no known cause, no known cure, and few effective 
treatments. And while NIH funding for autism may have tripled in the 
past decade to $100 million, that amount pales in comparison to the 
money spent for research on other diseases and disorders that affect 
fewer individuals.
    Autism research is poised at a turning point. While diagnoses are 
skyrocketing at epidemic rates, many areas of autism research stand on 
the verge of important findings. If adequately funded, this research 
could yield real progress on the diagnosis, treatment and cure for this 
disorder. The President's proposed freeze on NIH funding falls short on 
all counts, and would seriously impede the progress and promise of 
autism research.
    One turning point is the development of new treatment standards for 
autism spectrum disorder. This program would support research on new or 
existing interventions with the goals of establishing common methods of 
treatment and measurements of treatment efficacy. This study could 
hasten the ability to use existing treatments early to improve outcomes 
for children and families struggling with the disability of autism 
spectrum disorders. When autistic children do receive evidence-based 
early intervention service between ages 3 and 5, from 20 to 50 percent 
of them are able to go onto mainstream kindergarten. Early intervention 
is critical in order to provide children with autism the optimum 
opportunity to develop in the most normal way possible.
    Unfortunately, Mr. Chairman, the President's proposed budget for 
fiscal year 2007 will freeze funding for autism, and research leading 
to advances in autism intervention will not be possible.
    Another turning point is the need to define core features of 
autism, including when it begins, its long-term course, and subtypes of 
the disorder that may exist on what is known as the autism spectrum.
    Defining the features of autism could lead toward the long-term 
goal of finding genetic and non-genetic causes of autism and offering 
the possibility of providing better treatments or even prevention of 
the disease. It's also urgent that we better understand the genetic 
associations with autism so that research into the interaction of genes 
with the environment can be understood.
    With the budget proposed by President, this research will not be 
funded, and these advances cannot be made.
    With the President's budget, progress in understanding brain 
development and autism, one of the most devastating disorders affecting 
hundreds of thousands of children, will be slowed or halted. Scientists 
will be unable to realize the full potential of the latest scientific 
techniques, in neuroimaging and genetics technology.
    Mr. Chairman, autism, which the Centers for Disease Control and 
Prevention estimates now affects 300,000 American children between ages 
4 and 17, will continue to grow, with 3 children now being diagnosed 
ever hour. The pain and suffering of autistic children and their 
families will continue, as will the costs to society. But research on 
this devastating disorder will be stymied, progress on potential 
treatments and cures will be stymied as a result of the President 
proposed freeze on spending for biomedical research and on research on 
autism.
    Moreover, we will lose the opportunity to save an entire generation 
of children from this devastating disorder, which can lock people in 
their own worlds, unable to communicate with, and sometimes unable to 
experience the affection of those who love them.
    Mr. Chairman, thank you for giving me the opportunity to speak for 
those with autism and their families.

    Senator Specter. Thank you. Thank you very much, Ms. 
Gibbons.
    Our next witness is Dr. Robert Goldstein, representing the 
Juvenile Diabetes Research Foundation.

STATEMENT OF ROBERT GOLDSTEIN, M.D., Ph.D., CHIEF 
            SCIENTIFIC OFFICER, JUVENILE DIABETES 
            RESEARCH FOUNDATION
    Dr. Goldstein. Thank you, Senators Specter, Harkin, and 
Shelby for this opportunity to testify. I am Robert Goldstein, 
the chief scientific officer for the Juvenile Diabetes Research 
Foundation.
    Without an increase in Federal funding for diabetes 
research, there will be a disproportionate impact on clinical 
translation research. Islet cell transplantation, a procedure 
that has been successfully done experimentally in nearly 600 
diabetes patients, will delay the--the NIH-sponsored clinical 
trials to expand this proven treatment out into the community 
will be seriously delayed.
    In the area of hypoglycemia, dangerously low blood sugar 
can lead to convulsions, coma, or even death. The Diabetes 
Research and Children's Network's efforts to assess new glucose 
monitoring technology will impact on the management of type 1 
diabetes in children.
    Diabetic retinopathy. Anti-angiogenesis drugs that can 
reverse diabetic retinopathy have been discovered, but clinical 
trials to extend and expand these findings to test new classes 
of drugs would be delayed or halted.
    Treatment of new onset of type 1 diabetes. Clinical trials 
using monoclonal antibodies have shown that insulin-secreting 
cells can be protected for up to 2 years. Support studies to 
determine how to prolong this effect, whether treatment prior 
to the onset can prevent diabetes, and whether these therapies 
can be given years after onset would be delayed or curtailed. 
Since type 1 diabetes is an autoimmune disease, this will 
impact understanding of other autoimmune diseases.

                           PREPARED STATEMENT

    Causes of type 1 diabetes. NIH-supported efforts to 
identify the genes responsible for susceptibility will be 
curtailed and delay our ability to effectively prevent disease 
in at-risk populations.
    Thank you for the opportunity to testify.
    [The statement follows:]

                 Prepared Statement of Robert Goldstein

    Chairman Specter, Ranking Member Harkin and Members of the 
Subcommittee, thank you for the opportunity to testify before you today 
regarding the many opportunities that will be lost without an increase 
in federal funding for diabetes research at the National Institutes of 
Health. I am Robert Goldstein, the Chief Scientific Officer for the 
Juvenile Diabetes Research Foundation International.
    In the past 25 years, the number of people with diabetes has more 
than doubled, so that today approximately 20.8 million Americans have 
diabetes. Evidence suggests that 1 in 3 Americans born in 2000 will 
develop diabetes during his or her lifetime. Diabetes is the 6th 
leading cause of death in the United States. The disease cost this 
country $132 billion in 2002, which is almost 5 times NIH's annual 
budget. Only research to better prevent, treat and cure diabetes will 
significantly impact these numbers.
    The Diabetes Research Working Group recommended $1.6 billion in 
fiscal year 2004--the last year of their study--to take advantage of 
the many diabetes research opportunities. We have used appropriations 
to build critical momentum for accelerating the delivery of therapies 
to people with diabetes. There have been major advances (see attached) 
and more importantly programs have been put in place that will insure 
continued advances. Yet funding today is $600 million short of this 
recommendation. Absent an increase in federal funding, this momentum 
will be lost and progress and solutions will be delayed. Specifically, 
the following areas of diabetes research will be seriously impacted:
    Islet Cell Transplantation.--Nearly 600 diabetes patients worldwide 
have now received islet transplants, and enough patients have been 
transplanted that long-term benefits can be documented. Islet cell 
transplants have resulted in significant benefits to people with very 
complicated forms of type 1 diabetes: for instance, at least half of 
the transplant recipients exhibit stabilization or reversal of their 
diabetic eye and nerve diseases. Overall, islet transplant patients 
report a significant improvement in their quality of life. However, 
challenges remain, and we need additional funding for NIH programs and 
NIH/CMS sponsored clinical trials to test new protocols and fully 
understand how to maximize this proven treatment so it is an 
appropriate therapy for all who suffer from type 1 diabetes.
    Hypoglycemia.--Hypoglycemia--episodes of dangerously low blood 
sugar--is the most feared acute complication of diabetes and can lead 
to shaking, convulsions, coma, or even death in extreme cases. Young 
diabetic children who may not be able to recognize or communicate the 
signs of impending hypoglycemia are especially vulnerable. Technologies 
coming onto the market in the near term have the ability to warn 
patients of hypoglycemia, and it is critical that the technology is 
suitable for use in children. The NIH has established the Diabetes 
Research in Children Network (DirecNet) to provide independent 
assessments of glucose monitoring technology and its impact on the 
management of type 1 diabetes in children, and this important work 
would be delayed without additional funds.
    Diabetic Retinopathy.--Diabetes is the leading cause of new 
blindness in working age adults; more than 8.5 million people in the 
United States have diabetic retinopathy or eye disease. Significant 
progress being made on the causes and pathogenesis of diabetic 
retinopathy is generating renewed hope for the prevention or reversal 
of eye disease. For the very first time anti-angiogenesis drugs that 
can actually reverse diabetic retinopathy, as opposed to simply halting 
further progression by means of laser treatment, have been discovered. 
The NIH-supported Diabetes Retinopathy Clinical Research Network 
(DRCR.Net) includes more than 150 collaborating physicians across the 
United States, and provides an organized platform for rapidly 
translating new therapeutic ideas from the research community into 
clinical testing in human patients. Clinical trials to test the 
pipeline of potential new drugs would be delayed, curtailed or halted 
without continued funding.
    Treatment of New Onset Type 1 diabetes.--By the time type 1 
diabetes is diagnosed, patients have already suffered a devastating 
autoimmune attack that has destroyed most of the insulin-producing beta 
cells of the pancreas. Research has shown that a patient's level of 
residual beta cell activity correlates with the ability to more easily 
maintain glucose levels close to normal and reduces the amount of 
insulin that must be injected. A prime research goal is to develop new 
therapies that will help newly diagnosed type 1 diabetes patients 
preserve remaining beta cells and possibly even dampen the immune 
system enough to allow the pancreas to regenerate new beta cells. 
Researchers have identified a drug that can effectively alter the 
clinical course of the disease. A short 1-2 week course of treatment 
with an antibody--named anti-CD3--helps patients maintain or increase 
their ability to produce insulin naturally for up to 18 months after 
diagnosis compared to a placebo. This treatment demonstrates the proof 
of principle that the clinical source of an established autoimmune 
disease can be significantly altered. This work could not have been 
done without the major advances in clinical trial platforms from 
several NIH sponsored programs, including:
  --Immune Tolerance Network, whose goals are to develop new therapies 
        to treat/prevent autoimmune disease and to prevent or treat 
        graft rejection in transplantation by inducing immune 
        tolerance. Among the diseases under investigation by this 
        collaborative effort include type 1 diabetes and islet 
        transplantation; and
  --TRIAL NET which also supports studies aimed at both preventing 
        further destruction of insulin secreting cells in new onset 
        type 1 diabetes, as well as developing the means to prevent 
        disease.
    More extensive studies to determine how long this effect can be 
maintained, and whether the addition of specific antigen therapy or 
other drugs can prolong this effect, will not occur without continued 
support. Similarly, large studies to determine whether early treatment 
prior to disease onset can prevent diabetes or whether these therapies 
can be given years after disease should be supported.
    Genetics and Environmental Causes of Type 1 Diabetes.--The best way 
to attack type 1 diabetes is to stop it before it ever starts, but this 
requires sophisticated knowledge of the underlying causes of disease. 
Ground breaking NIH efforts (T1DGC, TEDDY, TRIGR) to identify the genes 
responsible for susceptibility to type 1 diabetes coupled with the 
identification of environmental triggers (viruses, toxins, dietary 
factors) will be curtailed or abandoned without continued funding, and 
delay our ability to effectively prevent disease in at-risk 
populations.
    Diabetes research has demonstrated a strong return on the federal 
investment. Continued strong federal commitment is needed.
    Thank you again for the opportunity to appear before you today. I 
am happy to answer any questions you may have.
  The NIH and Diabetes Research--A Strong Return on Federal Investment
    Diabetes affects more than 20 million adults and children in the 
United States, up to 7 percent of the population. In 2001, 
approximately $3.8 billion was spent on inpatient care for diabetes; 
two-thirds of those costs could have been saved with appropriate 
primary care for complications. A 2002 study estimated that diabetes--
both type 1 and type 2--caused the U.S. economy $132 billion in direct 
medical costs and indirect costs such as disability, work loss, and 
premature mortality. The disease accounts for more than 30 percent of 
Medicare expenditures. Total diabetes costs are predicted to climb to 
as much as $192 billion per year by 2020.
    Beyond the economic impact is the personal toll that diabetes 
exacts. Individuals with diabetes have twice the prevalence of 
disability as persons without diabetes. In 2002, more than 176,000 
cases of permanent disability were attributed to diabetes at an 
estimated cost of $7.5 billion. That same year diabetes accounted for 
88 million disability days. Persons with diabetes are at greater risk 
for stroke, heart attack, blindness, kidney failure, limb amputation, 
nerve damage, severe dental disease, and complications of pregnancy. 
Type 1 diabetes can reduce a person's expected lifespan by as much as 
15 years.
    The Diabetes Control and Complications Trial (DCCT), a clinical 
trial of 1,441 people with type 1 diabetes, demonstrated that tight 
control of blood glucose through intensive insulin therapy could 
significantly reduce or delay many diabetic complications. This 
landmark finding spurred a shift in the daily management of type 1 
diabetes and energized research in the field. In 1996, at the 
conclusion of the DCCT, it was estimated that implementation of 
intensive insulin management in the entire U.S. diabetic population 
would save 920,000 years of sight, 691,000 years free from end stage 
kidney disease, 678,000 years free from amputation, and 611,000 years 
of life.
    Since the discovery of insulin more than 80 years ago, biomedical 
research has continued to improve the health and lives of diabetes 
patients. The research listed below demonstrates that the field of 
juvenile diabetes research is making advances worthy of a continued 
strong federal investment.
  --Advances in Islet Cell Transplantation.--Since 1999, almost 600 
        diabetes patients worldwide have received islet transplants, 
        and enough patients have been transplanted that long-term 
        benefits are beginning to emerge. This procedure involves 
        isolating the insulin-producing cells, called islet cells, from 
        a donor pancreas, and injecting them into an adult who has 
        juvenile diabetes. Islet cell transplants have resulted in 
        significant benefits to people with very complicated forms of 
        type 1 diabetes: for example, at least half of patients exhibit 
        stabilization or reversal of their diabetic eye and nerve 
        diseases. Overall, islet transplant patients report a 
        significant improvement in their quality of life. Unfortunately 
        this procedure cannot be used in children because the 
        medications that need to be taken to prevent the body from 
        rejecting these donated cells can have many side effects. 
        Researchers are working to improve this procedure and to 
        develop new techniques so that one day the procedure can be 
        suitable for children with juvenile diabetes.
  --Treatment in new Onset Type 1 Diabetes.--Researchers have 
        identified a drug, a monoclonal antibody, that can effectively 
        alter the clinical course of type 1 diabetes: a short 1-2 week 
        course of treatment with the antibody--named anti-CD3--helps 
        patients maintain or increase their ability to produce insulin 
        naturally for up to 18 months after diagnosis compared to a 
        placebo. Treated patients required reduced insulin dosage, and 
        better hemoglobin A1c levels. A larger phase II trial of this 
        procedure is underway. These findings are significant because 
        residual beta cell activity correlates with the ability to more 
        easily maintain glucose levels close to normal, and to prevent 
        the development of the devastating complications of diabetes. 
        Anti-CD3 is at the leading edge of a robust pipeline of 
        potential therapies for reversing new onset type 1 diabetes. 
        The Type 1 Diabetes TrialNet was established in 2001 to ``fast 
        track'' potential diabetes therapies into clinical trials.
  --Advances in Preventing Hypoglycemia.--Significant advances in 
        glucose monitoring technology help patients to determine 
        whether their blood sugars are falling (signaling the need to 
        eat to avoid hypoglycemia) or rising (indicating the need for 
        an insulin dose). Researchers have evidence that patients who 
        use continuous glucose monitoring systems spend more time in 
        the normal glucose range; a critical finding because short term 
        variability in glucose levels may be as important as overall, 
        long-term glucose control in predicting the risk of 
        complications. In 2005, an NIH-funded study validated that 
        newer-generation home blood glucose meters demonstrated a high 
        degree of accuracy over a broad range of glucose concentrations 
        in children with type 1 diabetes. The study was conducted by 
        Diabetes Research in Children Network (DirecNet), a network of 
        clinical centers that provides an independent assessment of 
        glucose monitoring technology and its impact on the management 
        of type 1 diabetes in children. DirecNet is now testing the new 
        continuous glucose monitors, which will be the next wave in 
        diabetes care and represent an essential step toward an 
        artificial pancreas.
  --Reversing of Diabetic Retinopathy.--Diabetes is the leading cause 
        of new blindness in working age adults. Laser treatment can 
        reduce the risk of severe vision loss by 20 to 50 percent and 
        saves up to $1.6 billion per year by preventing or treating 
        diabetic eye disease. New research has discovered anti-
        angiogenesis drugs that can actually reverse diabetic 
        retinopathy, as opposed to simply halting further progression 
        by means of laser treatment. These and other new classes of 
        drugs make up a pipeline that must be tested in clinical 
        trials.
  --Preventing Cardiovascular Disease.--Adults with diabetes are two to 
        four times more likely to have a stroke or to die from heart 
        disease than adults without diabetes. Indeed, heart disease or 
        stroke is the leading cause of death among patients with 
        diabetes, accounting for 65 percent of deaths in this 
        population. Blood pressure control reduces the risk of heart 
        attack and stroke by 33 to 50 percent and the risk of other 
        complications by as much as 33 percent. Nevertheless, 
        additional research is necessary to understand the factors that 
        contribute to increased cardiovascular risk. New findings to 
        design new diagnostic tools that predict or detect the early 
        onset of cardiovascular disease, develop new drugs or devices 
        to reverse cardiovascular damage due to diabetes, and 
        clinically test new therapies in large, randomized trials.
  --Slowing Onset and Progression of Kidney Disease.--Diabetes is the 
        leading cause of kidney failure in the United States, 
        accounting for 44 percent of new cases in 2002. Based on NIH-
        funded research, scientists have made great progress in 
        developing methods that slow the onset and progression of 
        kidney disease in people with diabetes. Drugs used to lower 
        blood pressure (antihypertensive drugs) can slow the 
        progression of kidney disease significantly. Two types of 
        drugs, angiotensin-converting enzyme (ACE) inhibitors and 
        angiotensin receptor blockers (ARBs), have proven effective in 
        slowing the progression of kidney disease. Drugs that lower 
        blood pressure, including ACE inhibitors or angiotensin 
        receptor blockers (ARBs), decrease the onset of kidney disease 
        by 30 to 70 percent.
  --Gaining an Understanding of Kidney Disease Susceptibility.--Some 
        diabetic patients seem to be particularly susceptible to 
        developing diabetic nephropathy, while others show no signs of 
        kidney damage even after many years of living with diabetes. 
        Researchers are actively investigating the genetic factors that 
        influence an individual's susceptibility or resistance to 
        diabetic nephropathy. The Genetics of Kidneys in Diabetes 
        (GoKinD) Study has gathered more than 2,600 participants for 
        the study of the genetic risk factors for type 1 diabetes and 
        diabetic kidney disease. This sample and data collection will 
        provide a resource to facilitate investigator-driven research 
        into the genetic basis of diabetic kidney disease. Furthermore, 
        GoKinD participants form the core of a population registry that 
        could be recruited for future clinical trials.
  --Reducing Incidence of Diabetic Neuropathy.--Two-thirds of all 
        diabetes patients suffer from some degree of nerve damage 
        affecting organs throughout the body. This condition--known as 
        diabetic neuropathy--results in loss of sensation, weakness, or 
        pain in hands or feet, carpal tunnel syndrome, pain in the eyes 
        or face, pain in the chest or abdomen, profuse sweating, loss 
        of balance or coordination, slowed digestion of food or related 
        gastrointestinal problems, urinary incontinence, erectile 
        dysfunction, and a variety of other nerve problems. The 
        inability to feel pain coupled with impaired wound healing 
        often leads to non-healing foot ulcers and, ultimately, 
        amputation of some part of the foot or leg. For this reason, 
        diabetic neuropathy is the most common cause of non-traumatic 
        lower limb amputation. Comprehensive foot care programs to 
        detect and treat skin ulcers before they progress can reduce 
        the rate of amputation by 45 to 85 percent.
  --Understanding Susceptibility to Disease.--The Type 1 Diabetes 
        Genetics Consortium (T1DGC) will identify the genes responsible 
        for susceptibility to type 1 diabetes, leading to a better 
        understanding of pathways to disease. Researchers recently 
        confirmed the discovery of a new gene that contributes to 
        susceptibility to disease. The pathway controlled by this gene 
        implicates it in other autoimmune diseases, not just type 1 
        diabetes, underlining that common pathways may be involved in 
        the development of autoimmunity. This understanding may lead to 
        better diagnosis and new therapies to stop diabetes before it 
        ever starts.
  --Identifying Environmental Causes of Type 1.--The Triggers and 
        Environmental Determinants of Diabetes in Youth (TEDDY) study 
        has screened more than 6,000 newborns to identify the 
        environmental causes of type 1 diabetes in genetically 
        susceptible individuals. Once completed, the TEDDY study will 
        have amassed the largest data set and samples on newborns at 
        risk autoimmunity and type 1 diabetes anywhere in the world.
  --Investigating Vaccine to Prevent Type 1.--Recent studies in animal 
        models have raised the possibility that a ``vaccine'' may be 
        able to prevent type 1 diabetes.
  --Monitoring Progression of Type 1 Onset.--Researchers have developed 
        a means to non-invasively monitor the start and progression of 
        insulitis, the inflammation of insulin producing cells, in 
        mice, which may allow researchers to prediction whether and 
        when individual people will develop type 1 diabetes in the 
        future.
  --Regenerating of Insulin Producing Cells.--Replacement of the lost 
        beta cells through either transplantation of islets from an 
        external source or regeneration of islets within a patient's 
        own pancreas is required to restore physiological control of 
        glucose and cure type 1 diabetes. Development of regenerative 
        treatments to restore beta cells without transplantation will 
        require researchers to understand how beta cells are normally 
        formed in the adult pancreas, and then use that information to 
        identify molecular targets for drugs that can induce that 
        process in diabetic patients. Researchers supported by the NIH 
        Beta Cell Biology Consortium are now uncovering multiple 
        pathways by which new beta cells are formed in the body. The 
        work should help clarify how pancreatic beta cells develop, and 
        it could potentially lead to successful treatments for both 
        type 1 and type 2 diabetes.
  --Identifying Animal Models for Complication Studies.--The Animal 
        Models of Diabetic Complications Consortium (AMDCC) has 
        identified more than 70 animal models for the study of diabetic 
        complications, including a number of promising models for type 
        1 diabetic cardiomyopathy, nephropathy and neuropathy.

    Senator Specter. Thank you, Dr. Goldstein.
    We now turn to Dr. Lawrence Holzman, representing the 
NephCure Foundation.

STATEMENT OF LAWRENCE B. HOLZMAN, M.D., CHAIRMAN, 
            SCIENTIFIC ADVISORY BOARD, NEPHCURE 
            FOUNDATION
    Dr. Holzman. Mr. Chairman and members of the subcommittee: 
Despite advances in dialysis and kidney transplantation, kidney 
failure remains a devastating diagnosis, carrying a survival 
prognosis similar to patients diagnosed with cancer and 
assuring a lifetime of severe medical complications.
    NIH-sponsored investigators have been really remarkably 
successful in advancing our understanding of kidney disease, 
with the goal of preserving and preventing kidney functional 
loss. For example, a recent revolution in our knowledge of the 
biology of the kidney filter has allowed the identification of 
several inherited diseases and promises to provide tools that 
will better allow us to diagnose and treat kidney failure in 
general.
    However, cutting the NIH budget for kidney disease research 
or even failing to keep up with inflationary costs threatens 
present research momentum. As an investigator and as a member 
of an NIH peer review committee that evaluates scientific 
proposals, I can assure you that the effects of a restricted 
NIH budget are already being felt. Threatened by a pay line at 
which only 12 percent of grant applications are funded, 
investigators are reluctant to take risks necessary to 
dramatically advance the field. Delays in funding outstanding 
proposals retard progress and result in loss of uniquely 
trained research personnel.

                           PREPARED STATEMENT

    Finally, despite NIH set-asides designed to protect junior 
investigators, our next generation of talented young people 
observe the anxiety created by funding uncertainty, make 
rational economic decisions, and turn away from a career in 
biomedical science.
    Therefore, we ask you to provide an increase of 5 percent 
in fiscal year 2007 to the NIDDK and to the NIH budget overall.
    Thank you for your attention.
    [The statement follows:]

                 Prepared Statement of Lawrence Holzman

    Mr. Chairman, and members of the Subcommittee, thank you for giving 
me this opportunity to come before you today. I am Dr. Lawrence 
Holzman, Associate Professor of Internal Medicine and Director of the 
NIH-sponsored Nephrology Training Program at the University of Michigan 
Medical School. I also serve as Chairman of the Scientific Advisory 
Board of the NephCure Foundation (NCF), a non-profit organization 
dedicated to fighting idiopathic nephrotic syndrome and focal segmental 
glomerulosclerosis (FSGS).
    Fifteen million Americans have significantly impaired kidney 
function and are at risk of loosing their kidney function entirely. 
Another 400,000 have already lost their kidney function. Despite NIH-
sponsored advances in dialysis and kidney transplantation, kidney 
failure--due to common diseases such as diabetic kidney disease or 
hypertension, or due to relatively rare diseases such as focal 
segmental glomerulosclerosis--remains a devastating diagnosis. Kidney 
failure carries a shortened survival similar to that of many cancers 
and assures a lifetime of severe medical complications. The American 
people spend nearly $20 billion per year to provide medical care for 
these individuals alone. Undeniably, there remains a critical need to 
prevent patients from losing kidney function.
    Recognizing this need, NIH-sponsored investigators have made great 
strides in the basic science and clinical science of kidney disease, 
progress that has begun to slow the incidence of kidney failure. For 
example, during the past decade, a revolution in our understanding of 
the biology of the kidney filter sparked by initial successes in 
molecular genetics has allowed the identification of several inherited 
diseases of the kidney filter and promises to provide tools that will 
much better guide diagnosis and treatment of the patients who are 
likely to lose their kidneys. Dramatic advances in our understanding of 
the biology of cystic diseases of the kidney such as polycystic kidney 
disease has led to promising clinical trials of medications that might 
slow or prevent these diseases. For those patients that have already 
lost their native kidneys to disease, NIH-sponsored research has 
improved our understanding of the immune system, providing hope for 
kidney transplant patients who suffer the dangerous side effects of 
present day anti-rejection medications and who suffer from the 
knowledge that the average kidney transplant lasts only 11 years. 
Moreover, dialysis patients have improved quality of life because NIH 
sponsored clinical research has taught nephrologists how to better care 
for their patients.
    Cutting the NIH-budget for kidney disease research, or even failing 
to keep up with the inflation in costs for doing this research, 
immediately threatens the research momentum that was attained by 
doubling the NIH budget. As an independent investigator, and as member 
of an NIH peer review committee that evaluates independent-investigator 
initiated scientific proposals, I can assure you that the affects of a 
restricted NIH budget are already being felt in a real but difficult to 
quantify fashion. Threatened by a ``pay line'' at which only 12-14 
percent of grant applications are funded (rather than 24 percent just 
three years ago), investigators have become reluctant to take risks 
that must be taken in their research that would dramatically advance a 
field. Delays in funding outstanding proposals (because they must be 
recycled through the application process several times before they are 
funded) retard progress and result in the loss of talented and uniquely 
trained research personnel that cannot be readily replaced. Finally, 
despite NIH set asides designed to protect junior investigators, our 
next generation of talented young people observe the anxiety created by 
funding uncertainty, make rationale economic decisions, and turn away 
from a career in biomedical science, leaving the future of this science 
in jeopardy.
    NIH sponsored biomedical research is an American treasure that 
reaps multifold benefits; it is a treasure that must be nurtured and 
protected. Therefore, we ask you to provide an increase of 5 percent in 
fiscal year 2007 for the National Institute of Diabetes, Digestive, and 
Kidney Diseases (NIDDK), and the NIH overall.
    Thank you.

    Senator Specter. Thank you, Dr. Holzman.
    Our final witness on the panel is Dr. Steven Houser, 
representing the American Heart Association.

STATEMENT OF STEVEN R. HOUSER, Ph.D., DIRECTOR, 
            CARDIOVASCULAR RESEARCH CENTER, TEMPLE 
            UNIVERSITY SCHOOL OF MEDICINE ON BEHALF OF 
            THE AMERICAN HEART ASSOCIATION
    Dr. Houser. Thank you, Senator Specter and Senators Harkin 
and Shelby. I am an American Heart Association volunteer for 
the last 30 years. My day job is at a cardiovascular research 
group at Temple University School of Medicine in North 
Philadelphia. My NIH-funded research focuses on how we can fix 
broken hearts so that people can live healthier, happier lives.
    Thanks to your investments, I believe we are on the 
threshold of making wonderful discoveries that can be 
translated into novel therapies. My lab group works on a very 
simple concept. We have found that in every one of your hearts 
there are stem cells that are making new myocites and blood 
vessels all the time. I believe that we have the opportunity to 
figure out ways to take these cells from each of your hearts, 
expand them, prime them to repair your heart, and save them in 
case you ever need them if your heart becomes damaged.

                           PREPARED STATEMENT

    Unfortunately, the NIH cuts are limiting my ability and the 
ability of my collaborators in Pennsylvania, Iowa, which I just 
visited last week, and Alabama, where I will visit in about a 
month, to pursue these ideas. It is forcing me to cut my staff, 
train fewer people, lay off local workers. I think this has 
impact not just on science and medicine, but on the economies 
of the communities and the States that we are charged to serve.
    So thank you so much for all your hard work with respect to 
these issues, and I would be happy to answer any questions.
    [The statement follows:]

                 Prepared Statement of Steven R. Houser

                       SUMMARY OF RECOMMENDATIONS
------------------------------------------------------------------------
                        Agency                               Amount
------------------------------------------------------------------------
National Institutes of Health........................    $29,800,000,000
    National Institutes of Health Heart Research.....      2,200,000,000
    National Institutes of Health Stroke Research....        357,000,000
        National Heart, Lung, and Blood Institute....      3,100,000,000
        National Institute of Neurological Disorders       1,600,000,000
         and Stroke..................................
Agency for Healthcare Research and Quality...........        440,000,000
Centers for Disease Control and Prevention (plus           8,500,000,000
 funding for pandemic influenza preparedness)........
    Heart Disease and Stroke Prevention Program......         55,000,000
Health Resources and Services Administration: Rural            8,900,000
 and Community Access to Emergency Devices Program...
Department of Education: Carol M. White Physical             100,000,000
 Education Program...................................
------------------------------------------------------------------------

    An estimated 71 million American adults suffer from heart disease, 
stroke, and other forms of cardiovascular disease. Nearly 2,500 
Americans die of cardiovascular disease each day--an average of one 
death every 35 seconds. Heart disease and stroke remain the first and 
third leading causes of death, respectively, for both men and women in 
the United States today and more than half of men and nearly 40 percent 
of women will develop cardiovascular disease during their lifetime. As 
the baby boom generation ages, the prevalence of cardiovascular disease 
will increase dramatically, because although this disease can strike at 
any stage of life--the likelihood increases with age. Deaths from heart 
disease alone are projected to increase by about 130 percent between 
2000 and 2050, according to one report.
    Cardiovascular disease also costs Americans an estimated $403 
billion in medical expenses and lost productivity in 2006--more than 
any other disease and more than the projected budget deficit for that 
year. As the population ages, the combination of demographics and high 
costs will result in a cardiovascular disease crisis with staggering 
implications for health care costs and quality of care.
    Although progress has been made in the treatment of cardiovascular 
disease, there is no cure. In fact, studies suggest that increased 
rates of diabetes, obesity and other risk factors may reverse four 
decades of declining mortality. The most prudent way to address this 
looming crisis is to simultaneously invest in prevention and in the 
development of more cost-effective treatments. Regretfully, the funding 
levels proposed by the President undermine efforts in both of these 
areas.
    When adjusted for biomedical research inflation, the proposed NIH 
budget for cardiovascular disease research is estimated to be 15 
percent lower in 2007 than in fiscal year 2003. Funding levels proposed 
in the budget for the CDC's Heart Disease and Stroke Prevention Program 
remain flat at a time when only 14 states receive the resources 
necessary to implement prevention programs and strategies. In addition, 
the Rural and Community Access to Emergency Devices Program, 
administered by the Health Resources and Services Administration, is 
terminated in the President's budget. This program provides grants to 
rural areas and communities to purchase and place AEDs in schools, 
churches, fire stations, and other locations to save the lives of 
cardiac arrest victims.
    Now is the wrong time to reduce our nation's investment in programs 
that prevent and treat America's leading and most costly cause of 
death. Solving a problem of this magnitude will require a significant 
public investment in these fiscally challenging times, but if we fail 
to take aggressive and deliberate action now--we will pay a terrible 
cost later--both in terms of health care expenditures and human lives. 
The following recommendations from the American Heart Association 
address this problem in a comprehensive but fiscally responsible 
manner.

      INCREASE FUNDING FOR THE NATIONAL INSTITUTES OF HEALTH (NIH)

    NIH-sponsored research has revolutionized patient care and holds 
the key to an eventual cure for all forms of cardiovascular disease. 
Research funded by the NIH also fuels innovation that generates 
economic growth and preserves our nation's role as a world leader in 
the biomedical and biotechnology industries. For fiscal year 2006, NIH 
funding was cut below the previous year's level for the first time in 
35 years. The President preserved this cut in his fiscal year 2007 
budget and reduced NIH further over the next five years by nearly 20 
percent. This five year cut reduces NIH resources in inflation adjusted 
terms by more than one-third from its peak in fiscal year 2003--the end 
of the historical five-year doubling of the NIH budget.
    Recommendation.--The AHA joins the research and patient advocacy 
community in recommending an fiscal year 2007 appropriation of $29.8 
billion for the NIH. This level, which represents a 5 percent increase 
over 2006, covers the increased costs of biomedical research inflation 
and provides additional resources to investigate emerging research 
opportunities.

           INCREASE FUNDING FOR NIH HEART AND STROKE RESEARCH

    From 1993-2003, death rates from cardiovascular diseases have 
fallen by 22 percent, death rates from coronary heart disease have 
declined by 30 percent, and death rates from stroke have fallen by 19 
percent. NIH sponsored heart and stroke research has improved health 
outcomes and in some cases, lowered health care costs. Examples of 
recent NIH-supported research follow.
    Aspirin Prevents Another Type of Stroke.--Aspirin is as effective 
as, and safer than, the blood thinning drug warfarin in preventing 
intracranial arterial stenosis--which accounts for roughly 10 percent 
of all strokes. Aspirin is a low cost therapy that does not require the 
intricate and costly monitoring like the drug warfarin. Researchers 
estimate that use of aspirin rather than warfarin could cut health care 
costs by $20 million each year.
    Blood Test to Screen for Stroke Wins FDA Approval.--A blood test to 
screen for heart disease gained approval to predict stroke risk. The 
test scans the blood for levels of the enzyme lipoprotein-associated 
phospholipase A2, which are higher in potential stroke victims.
    Diuretics Again Initial Therapy for High Blood Pressure.--
Continuing analyses of the Antihypertensive and Lipid-Lowering 
Treatment to Prevent Heart Attack Trial (ALLHAT) for diabetics, blacks 
and non-blacks with high blood pressure confirms, the initial 
conclusion that diuretics should be the initial high blood pressure 
treatment instead of newer, more costly drugs.
    Antibiotics do not Prevent Second Cardiovascular Events.--Results 
of clinical trials have shown that antibiotics are ineffective in 
preventing second events like heart attack, unstable chest pain and 
stroke in patients with existing heart disease. This finding was 
unanticipated.
    Slightly Elevated Blood Pressure Triples Heart Attack Risk.--
Examining data from the Framingham Heart Study, researchers found that 
the 59 million Americans with prehypertension, blood pressures ranging 
from 120-139 over 80-89 mm Hg, are three times more likely to suffer a 
heart attack and nearly twice as likely to experience heart disease 
than those with normal blood pressure. Scientists estimate that 
aggressive treatment would prevent 47 percent of heart attacks.
    Although cardiovascular disease is the leading cause of death in 
the United States, the NIH heart and stroke research budget remains 
disproportionately under-funded compared to the burden of these 
diseases on society. Cardiovascular disease meets NIH's priority 
setting criteria (public health needs, scientific quality of research, 
scientific progress potential, portfolio diversification and adequate 
infrastructure support), yet only 7 percent of the NIH budget is 
invested in heart research and a mere 1 percent is dedicated to stroke. 
Adjusted for medical research inflation, resources for cardiovascular 
research will decline 15 percent since fiscal year 2003 if the 
President's budget is enacted. These declining resources are 
insufficient to support and expand current activities and to invest in 
promising initiatives to aggressively advance the battle against heart 
disease and stroke. Additional funds would be used in the following 
areas:
    Atherosclerosis Prevention Trial Network.--Atherosclerosis is a 
major risk factor for heart disease and stroke. With increased funding, 
the National Heart, Lung, and Blood Institute (NHLBI) could initiate a 
clinical trial to determine whether reducing low-density lipoprotein 
cholesterol, so-called ``bad'' cholesterol, to a level lower than 
currently recommended, reduces major cardiovascular disease events in 
healthy patients at high risk of heart disease and or stroke.
    Systolic Blood Pressure Intervention Trial.--High blood pressure is 
a major risk factor for heart disease, heart failure and stroke. More 
funding would allow the NHLBI to conduct a multicenter clinical trial 
to determine whether reducing systolic blood pressure to a lower level 
than currently recommended could prevent heart attacks and strokes.
    Preventing Weight Gain in Young Adults.--Young adults are at a high 
risk for weight gain. With more resources, NHLBI could develop and test 
innovative practical, cost-effective ways to prevent weight gain in 
young adults to prevent cardiovascular disease.
    Stroke is the No. 3 killer of Americans and a major cause of 
permanent disability. In addition to the elderly, stroke also strikes 
newborns, children and young adults. An estimated 700,000 Americans 
will suffer a stroke this year, and nearly 158,000 will die. Many of 
America's 5.5 million stroke survivors face debilitating physical and 
mental impairment, emotional distress and huge medical costs; about 1 
in 4 survivors are permanently disabled.
    As a result of fiscal year 2001 Congressional report language, the 
National Institute of Neurological Disorders and Stroke (NINDS) 
convened a Stroke Progress Review Group. A report from this group 
provides a long-range stroke strategic plan for stroke research that 
includes 5 research priorities and 7 resource priorities. Multiple 
scientific programs initiated since the report have made impressive 
progress; however, additional funding is needed to implement the plan. 
The fiscal year 2007 estimate for NINDS stroke research falls 50 
percent short of the target for implementation of that year of the 
plan. Additional funds would be used to conduct stroke research in the 
following areas:
    Stroke Translational Research.--Translational studies are vital to 
providing cutting-edge stroke treatment and prevention. Due to budget 
shortfalls, the NINDS has been forced to compress its Specialized 
Programs of Translational Research in Acute Stroke (SPOTRIAS) from the 
planned 10 extramural centers to the five currently funded. SPOTRIAS 
researchers facilitate translation of basic research into patient care 
and evaluate and treat victims rapidly after the onset of stroke 
symptoms.
    Neurological Emergencies Treatment Trials Network.--Limited 
resources will also force the NINDS to scale back its Neurological 
Emergencies Treatment Trials Network. This initiative is designed to 
develop a clinical research network of emergency medicine physicians, 
neurologists and neurosurgeons to develop more and improved treatments 
for acute neurological emergencies, such as stroke, through clinical 
trials.
    Stroke Education.--As a member of the Brain Attack Coalition--a 
group of organizations devoted to fighting stroke--the AHA works with 
the NINDS to increase public awareness of stroke symptoms and the need 
to call 9-1-1. Together, we initiated a public education campaign, Know 
Stroke: Know the Signs, Act in Time, and we are striving to develop 
systems to make tPA available to appropriate patients. In partnership 
with the CDC, the NINDS extended this campaign to launch a grassroots 
program called Know Stroke in the Community to enlist the aid of 
``Stroke Champions'' who educate communities about stroke signs and 
symptoms. When these measures are implemented, stroke treatment will 
shift from supportive care to early brain-saving intervention. 
Additional funds are needed to educate the public and health providers 
about stroke.
    Recommendation.--The AHA recommends an fiscal year 2007 
appropriation of $2.2 billion for NIH heart research. We advocate for 
an appropriation of $3.068 billion for the NHLBI. And, we recommend 
$357 million for NIH stroke research. We advocate for an appropriation 
of $1.612 billion for the NINDS. These appropriations represent a 5 
percent increase over fiscal year 2006--commensurate with the 
Association's overall recommended funding increase for the NIH.

       INCREASE FUNDING AT THE CENTERS FOR DISEASE CONTROL (CDC)

    Basic research must be translated into easy-to-understand guidance 
so that people can apply it to their daily lives. Prevention is the 
best way to protect Americans' health and ease the financial burden of 
disease. Although the clinical literature indicates that increased and 
improved cardiovascular disease interventions can be highly successful, 
investigators have concluded that well-established strategies for 
combating cardiovascular disease are often not being implemented. 
Recent studies suggest that not smoking, maintaining a healthy weight, 
and avoiding diabetes, high blood pressure and high cholesterol, may 
add 10 years to life.
    The AHA commends Congress for supporting CDC's new Division for 
Heart Disease and Stroke Prevention, which provides funding to 33 
states to create programs to educate and prevent first and second 
instances of heart disease and stroke. These state-tailored programs 
facilitate collaboration among public and private sector partners to 
help individuals control high blood pressure, lower elevated 
cholesterol, learn heart disease and stroke signs and symptoms, call 9-
1-1, improve emergency response and quality of care, and eliminate 
treatment disparities. Many of these programs have been successful in 
reducing risk factors--like high blood pressure.
    In fiscal year 2006, only 14 states received funding to implement 
these prevention programs. The remaining 19 states received funds for 
planning; which is now largely complete. Because cardiovascular disease 
remains the No. 1 killer in every state, each state needs basic 
implementation money for this program. However, current funding levels 
will not allow for the expansion of this program.
    Recommendation.--For fiscal year 2007, the AHA recommends an 
appropriation of $8.5 billion plus funding for pandemic influenza 
preparedness for the CDC, including a 10 percent increase over current 
funding to return chronic disease prevention to the same level as 
fiscal year 2002. Within that total, we recommend $55 million to expand 
the Heart Disease and Stroke Prevention Program. This funding level 
would allow the CDC to add up to 4 states to the program, allowing them 
to conduct a state-tailored plan, and elevate 4 more states from 
planning to program implementation, maintain the Paul Coverdell 
National Acute Stroke Registry, and start the development of a state-
based cardiac arrest registry.

RESTORE FUNDING FOR THE RURAL AND COMMUNITY ACCESS TO EMERGENCY DEVICES 
                                PROGRAM

    The Rural and Community Access to Emergency Devices Program 
provides grants to states to train lay rescuers and first responders to 
use AEDs and buy and place them where cardiac arrests are likely to 
occur. During the first year of the program, 6,400 AEDs were purchased 
and 38,800 individuals were trained. AEDs have been placed in schools, 
faith-based and recreation facilities, nursing homes, and other 
locations in communities across our nation.
    About 94 percent of cardiac arrest victims die outside of a 
hospital. Immediate CPR and early defibrillation using an automated 
external defibrillator (AED) can more than double a victim's chance of 
survival. Small, easy-to-use AEDs can shock the heart back into normal 
rhythm. Placing AEDs in more public settings could save thousands of 
lives each year. Communities with comprehensive AED programs that 
include training of anticipated rescuers have achieved survival rates 
of 40 percent or higher.
    The Rural and Community Access to Emergency Devices Program is 
terminated in the President's fiscal year 2007 budget. The budget 
justification asserts that much of the demand for AEDs has been met, 
although between fiscal year 2002 and fiscal year 2004 less than half 
of the grant dollars requested by states for this lifesaving program 
were actually awarded.
    Recommendation.--For fiscal year 2007, the AHA recommends that the 
Subcommittee allocate $8.927 million for HRSA's Rural and Community 
Access to Emergency Devices Program to restore funding to its fiscal 
year 2005 level.

  INCREASE FUNDING FOR THE AGENCY FOR HEALTHCARE RESEARCH AND QUALITY 
                                 (AHRQ)

    The AHRQ is a critical partner with the public and private health 
care sectors. This agency helps develop evidence-based information 
needed by consumers, providers, health plans and policymakers to 
improve health care decision making. Through its Effective Health Care 
Program, AHRQ supports research focusing on outcomes, comparative 
clinical effectiveness, and appropriateness of pharmaceuticals, devices 
and healthcare services for a number of conditions, including ischemic 
heart disease, stroke, and high blood pressure. The new research and 
comparative effectiveness reviews conducted and funded under this 
program will help address issues raised in the Institute of Medicine's 
(IOM) report: Crossing the Quality Chasm.
    The AHRQ's initiative on health information technology (HIT) is a 
key element to the nation's strategy to bring health care into the 21st 
century. This initiative includes more than $166 million in grants, and 
through these and other projects, AHRQ and its partners will help to 
identify challenges to HIT adoption and use, solutions and best 
practices, and tools that will help hospitals and clinicians 
successfully incorporate new HIT. To facilitate this effort, the AHRQ's 
National Resource Center for HIT provides the health care community 
with technical assistance and consulting services to HIT projects, and 
particularly focus on addressing challenges to HIT implementation in 
rural and small community settings.
    Recommendation.--The AHA joins with the Friends of AHRQ in 
advocating for an appropriation of $440 million for the AHRQ to advance 
health care quality, cut medical errors and expand the availability of 
health outcomes information.

  INCREASE FUNDING FOR THE CAROL M. WHITE PHYSICAL EDUCATION PROGRAM 
                                 (PEP)

    Physical inactivity is a key risk factor for heart disease and 
stroke, but Youth Risk Behavior Surveillance data indicates that almost 
half of 12-21 year olds do not participate in any vigorous physical 
activity on a regular basis. Despite recent studies by Action for 
Healthy Kids and the Robert Wood Johnson Foundation showing that almost 
80 percent of parents support daily physical education (PE) in schools 
to help combat physical inactivity and teach life long skills, only 6-8 
percent of schools nationally offer daily PE. One of the primary 
barriers to providing PE is adequate financial resources for equipment, 
program development, and staff training. The Carol M. White Physical 
Education Program helps schools overcome this barrier by providing 
money for school-based physical education activities that teach life-
long physical activity habits. PEP is the only federal program that 
directly supports PE in schools.
    Recommendation.--For fiscal year 2007, the AHA recommends an 
appropriation of $100 million for the Carol M. White Physical Education 
Program. This level of funding will allow the Department of Education 
to expand the program to more districts while maintaining funding for 
the duration of previously awarded grants.
    Although heart disease, stroke, and other cardiovascular disease 
are largely preventable, these diseases continue to exact a deadly toll 
on our nation. As baby boomers age, our nation faces an expanding 
cardiovascular disease crisis unless significant steps are taken. We 
urge the subcommittee to consider these recommendations for the fiscal 
year 2007 budget. Adequate funding of research, treatment and 
prevention programs will save lives and reduce rising health care 
costs.

    Senator Specter. Thank you very much, Dr. Houser.
    Senator Harkin, do you have any comment or question?
    Senator Harkin. Just one. I have a lot of questions for the 
panel, but just one that I just want to ask Dr. Goldstein. Give 
us just a few seconds on your view on the potential of stem 
cell, embryonic stem cell research to benefit juvenile 
diabetes, type 1 diabetes?
    Dr. Goldstein. We are extremely bullish, Senator Harkin, on 
the potential to create insulin-secreting cells that are fully 
functional and respond to glucose. Work has already carried the 
human embryonic stem cell work to the point of producing 
endoderm, which is the tissue that then can create the 
pancreas. Investigators in animal studies can instruct endoderm 
to make pancreas. If we can make pancreas, that will give us 
the precursor cells for beta cells and insulin-secreting cells.
    So we are extremely, extremely optimistic and wish the work 
could go forward with full speed.
    Senator Harkin. Thank you.
    Senator Specter. Senator Shelby, any comment or question?
    Senator Shelby. Yes.
    Is anyone on the panel dealing in the autoimmune area, 
especially dealing with lupus or lupus-related? Dr. Holzman, do 
you want to comment on where we are going? You heard the first 
panel earlier.
    Dr. Holzman. Actually, in this regard I am more the 
clinician dealing with patients on the front lines.
    Senator Shelby. That is very important, the clinical work.
    Dr. Holzman. I am a nephrologist, a person who deals with 
kidney disease, and see many of the most complicated patients 
with lupus and kidney disease. I can tell you first that these 
are patients who suffer dramatically, that their lives are 
spent worrying about not only dealing with the current flare, 
the current problem, but the probability that the disease will 
recur.
    I should say that, thanks to big investments by the NIH in 
clinical trials, there actually have been some new drugs, drugs 
that have actually been around for a while but now are proven 
safer and actually as effective as earlier, more dangerous 
drugs, such as cyclophosphamide. We are now using 
microphenalate moftil as a first-line drug for kidney lupus and 
with I think fairly good success.
    Senator Shelby. So you see a lot of hope there?
    Dr. Holzman. I see a lot of hope there. I think that we 
need to further invest using the latest technology and 
translational studies in this area.
    Senator Shelby. Thank you.
    Thank you, Mr. Chairman.
    Senator Specter. Thank you, Senator Shelby.
    Thank you very much, ladies and gentlemen.
    Senator Shelby. I think Dr. Goldstein was going to say 
something.
    Dr. Goldstein. Real quickly, Senator Shelby. I would just 
like to repeat something that Dr. Fauci said: the support of 
the Immune Tolerance Network, which is a clinical trial 
translation platform for autoimmune diseases, including lupus, 
type 1 diabetes, and others. We learn from each other, from the 
science. Choking that funding off is going to eliminate the 
possibility to do those cutting edge clinical trials.
    Senator Shelby. Thank you.
    Thank you.
    Senator Specter. Thank you very much, ladies and gentlemen. 
We very much appreciate your coming in.
    We now turn to panel three: Dr. Daniel Koo, Dr. Phil 
Landrigan, Mr. Emeran Mayer, Dr. Peter McDonnell, Ms. Sandra 
Raymond, Mr. Herman Taylor, Ms. Suzanne Vogel-Scibilia.
    Our first witness is Dr. Daniel Koo, represent the Deaf and 
Hard of Hearing Alliance, and Dr. Koo is accompanied by an 
interpreter. Dr. Koo, we begin with you.

STATEMENT OF DANIEL KOO, M.D., ON BEHALF OF THE DEAF 
            AND HARD OF HEARING ALLIANCE
    Dr. Koo [speaks through a sign language interpreter]. Mr. 
Chairman, members of the Subcommittee of Senate Appropriations: 
On behalf of the member organizations of the Deaf and Hard of 
Hearing Alliance----
    Senator Harkin. Excuse me. Could you speak into that just a 
little bit louder. I am having a hard time.
    Senator Specter. Senator Thurmond always would say: Bring 
the machine a little closer.
    Dr. Koo. Mr. Chairman and members of the Senate 
Appropriations Subcommittee: On behalf of the member 
organizations of the Deaf and Hard of Hearing Alliance, a 
coalition of professional and consumer organizations serving 
and representing people who are deaf and hard of hearing, it is 
my pleasure to be here with you this morning to discuss the 
President's budget request for NIH's National Institute on 
Deafness and Other Communication Disorders.
    My name is Dr. Koo. I am a postdoctoral fellow at 
Georgetown University conducting neuroimaging studies on 
language and literacy, supported by NIDCD.
    Fiscal year 2007's budget request for NIDCD is $1.9 million 
less compared to the fiscal year 2006 appropriation. The DHHA 
strongly urges Congress not to impose further cuts in NIH or 
NIDCD research funding and that Congress and the administration 
work together to ensure appropriate funding that does not 
compromise current and future research efforts. The DHHA 
applauds current research being conducted related to people who 
are deaf and hard of hearing, specifically the strategies to 
protect hearing, diagnose and prevent hearing loss, and explore 
genetic modifiers.
    However, we urge the NIDCD to continue to pursue and 
support studies that delve into the acquisition and learning of 
oral and-or visual languages, the various communication modes 
and educational settings.
    Cutting the funding most assuredly will prevent the 
expansion of research in this critical area of need. Funding 
support for NIDCD to date has allowed many scientists, like 
myself, to make significant advances in hearing research as 
well as related sensory and cognitive areas. With congressional 
support, the NIDCD can continue its important research that 
aids in preventing hearing loss as well as assisting those who 
are deaf or hard of hearing.

                           PREPARED STATEMENT

    With hearing loss expected to reach 40 million Americans 
within the next generation, scientific work taking place at NIH 
and NIDCD is too critical to the human condition to take a step 
backward at this time.
    Thank you.
    [The statement follows:]

                    Prepared Statement of Daniel Koo

    On behalf of the member organizations of the Deaf and Hard of 
Hearing Alliance, a coalition of professional and consumer 
organizations serving and representing people who are deaf or hard of 
hearing, it is my pleasure to be here with you this morning to discuss 
the President's budget request for the National Institutes of Health, 
specifically the National Institute on Deafness and Other Communication 
Disorders (NIDCD).
    My name is Daniel Koo. I am a post-doctoral fellow at Georgetown 
University conducting neuron-imaging studies on language and literacy 
supported by NIDCD.
    The fiscal year 2007 budget request for NIDCD is $391,556,000, a 
decrease of $1,902,000 compared to the fiscal year 2006 Appropriation. 
The DHHA strongly urges Congress not to impose further cuts in NIH or 
NIDCD research funding, and we ask that Congress and the Administration 
work together to ensure appropriate funding to ensure that current and 
future research efforts are not compromised. With hearing loss expected 
to affect 40 million within one generation, there has never been a time 
when research has been needed so much.
    The DHHA applauds the current research being conducted related to 
people who are deaf or hard of hearing, specifically the strategies to 
protect hearing, diagnose and prevent hearing loss, and explore genetic 
modifiers. However, we urge NIDCD to continue to pursue and support 
studies that delve into the acquisition and learning of oral and/or 
visual languages the necessary precursor to a variety of communication 
modes and settings. Cutting the funding will most assuredly prevent the 
expansion of research in this critical area of need.
    Funding support for NIDCD to date has allowed many scientists like 
myself to make significant advances in hearing research, as well as 
related sensory and cognitive areas that impact the human condition. 
With Congressional support the NIDCD can continue its important 
research that aids in preventing hearing loss as well as assisting 
those who are deaf or hard of hearing. The work taking place at NIH and 
NIDCD is too critical to the human condition to take a step backward at 
this time.
    Members of the Deaf and Hard of Hearing Alliance include: Alexander 
Graham Bell, Association for the Deaf & Hard of Hearing, American 
Academy of Audiology, American Academy of Otolaryngology-Head and Neck 
Surgery, American Speech-Language-Hearing Association, Conference of 
Educational Administrators of Schools & Programs for the Deaf, Council 
of American Instructors of the Deaf, Cued Language Network of America, 
Deafness Research Foundation, Hearing Loss Association of America, 
Media Access Group at WGBH, National Association of the Deaf, National 
Cued Speech Association, Registry of Interpreters for the Deaf, 
Testing, Evaluation, and Certification Unit, and Telecommunications for 
the Deaf, Inc.

    Senator Specter. Thank you very much, Dr. Koo.
    We now turn to Dr. Philip Landrigan, representing the 
Campaign for American Children's Health. Dr. Landrigan.

STATEMENT OF PHILIP J. LANDRIGAN, M.D., MSc, FAAP, 
            PRESIDENT, CAMPAIGN FOR AMERICAN CHILDREN'S 
            HEALTH
    Dr. Landrigan. Good morning, Senator Specter, Senator 
Harkin, Senator Shelby. I'm Philip Landrigan, pediatrician at 
Mount Sinai Medical School in New York City, and I thank you 
for inviting me here this morning to come to speak in support 
of the National Children's Study.
    I'd like first of all to thank all of you for the great 
support that you've given the National Children's Study over 
the past 6 years since its inception in 2000, and thanks most 
particularly for the discussion that you had in support of the 
study just a few minutes ago this morning.
    The reason that this Nation needs the National Children's 
Study is that the children's study will give us information on 
the preventable environmental causes of the major diseases that 
afflict American children today--asthma, which has more than 
doubled; childhood brain cancer has gone up 40 percent; autism, 
you heard a few minutes ago has gone up remarkably; other 
learning disabilities.
    It's been said that the study is expensive and it is. But 
the diseases, the chronic diseases that the study will address, 
cost this Nation more than $600 billion a year. The very same 
logic that Dr. Zerhouni invoked this morning when he spoke of 
the great declines that have been achieved in heart disease 
because of the Framingham study, the women's health initiative, 
that same logic applies to the National Children's Study, and 
it's ironic that I chose to include the same image in my 
testimony as he used in his screen presentation this morning.

                           PREPARED STATEMENT

    If we fail to fund the National Children's Study it will be 
a major opportunity lost. The National Children's Study is our 
generation's best hope, indeed probably our only hope, to get 
on top of the chronic diseases in America's children.
    I thank you.
    [The statement follows:]

               Prepared Statement of Philip J. Landrigan

    Good morning, Mr. Chairman and Members of the Subcommittee. I am 
Dr. Philip J. Landrigan. I am a pediatrician, Professor and Chairman of 
Community & Preventive Medicine, and Professor of Pediatrics at the 
Mount Sinai School of Medicine. I am Principal Investigator for the 
Queens, New York Vanguard Center of the National Children's Study. I am 
also President of the Campaign for American Children's Health, a not-
for-profit organization committed to preserving the health of America's 
children by sustaining the National Children's Study.
    Why Do We Need the National Children's Study? The United States 
needs the National Children's Study because we desperately need the 
information the Study will provide on preventable causes of the major 
diseases that confront America's children today. Information from the 
National Children's Study will provide a blueprint for prevention. The 
diseases of greatest current concern in American children are:
  --Asthma, which has more than doubled in frequency since 1980 and 
        become theleading cause of pediatric hospitalization and school 
        absenteeism;
  --Birth defects, which are now the leading cause of infant death. 
        Certain birthdefects, such as hypospadias, have doubled in 
        frequency;
  --Neurodevelopmental disorders--autism, dyslexia, mental retardation, 
        and attention deficit/hyperactivity disorder (ADHD). These 
        conditions affect 5-10 percent of the 4 million babies born 
        each year in the United States. Reported rates ofautism are 
        increasing especially sharply--more than 20 percent per year;
  --Leukemia and brain cancer in children and testicular cancer in 
        adolescents. Incidence rates of these malignancies have 
        increased since the 1970s, despite declining rates of 
        mortality. Testicular cancer has risen by 55 percent, and 
        primarybrain cancer by 40 percent. Cancer is now the second 
        leading cause of death in American children, surpassed only by 
        traumatic injuries;
  --Preterm birth, which has increased in incidence by 27 percent since 
        1981;
  --Obesity and its consequence, type 2 diabetes. Obesity has trebled 
        in prevalencein the United States. Obesity has become common in 
        even the youngest of our children, and for example, 41 percent 
        of 5-year-olds entering kindergarten in the five boroughs of 
        New York City in 2005 were overweight or frankly obese. The 
        future toll of disease and premature death in these 
        youngsters--from diabetes, heart disease, stroke and probably 
        cancer--will be fearsome.
    We have a responsibility to safeguard our children. They are the 
most vulnerable among us, our most precious resource, and the hope for 
our future. But these rapidly rising rates of chronic disease threaten 
the health of our children and the future security of our nation.
    Indeed, concern is strong among the pediatric community that these 
rapidly rising rates of disease may create a situation unprecedented in 
the 200 years of our nation's history, in which our current generation 
of children may be the first American children ever not to enjoy a 
longer life span than the generation before them. In other words, if we 
do not support the necessary research--especially the National 
Children's Study--and if we fail to take needed preventive action, we 
are actually at risk of losing hard-won ground in children's health.
    What is the National Children's Study?--The National Children's 
Study is a prospective multi-year epidemiological study that will 
follow 100,000 American children, a nationally representative sample of 
all children born in the United States, from conception to age 21. The 
study will assess and evaluate the environmental exposures these 
children experience in the womb, in their homes, in their schools and 
in their communities. It will seek associations between environmental 
exposures and disease in children. The diseases of interest include all 
those listed above. The principal goal of the Study is to identify the 
preventable environmental causes of pediatric disease and to translate 
those findings into preventive action and improved health care.
    The National Children's Study was mandated by Congress through the 
Children's Health Act of 2000. The lead federal agency principally 
responsible for the Study is the National Institute of Child Health and 
Human Development. Other participating agencies include the National 
Institute of Environmental Health Sciences, the Environmental 
Protection Agency, and the Centers for Disease Control and Prevention.
    By working with pregnant women and couples, the Study will gather 
an unprecedented volume of high-quality data on how environmental 
factors acting either alone, or in combination with genetic factors, 
affect the health of infants and children. Examining a wide range of 
environmental factors--from air, water, and dust to what children eat 
and how often they see a doctor--the Study will help develop prevention 
strategies and cures for a wide range of childhood diseases. By 
collecting data nationwide the study can test theories and generate 
hypotheses that will inform biomedical research and he care of young 
patients for years to come. Simply put, this seminal effort will 
provide the foundation for children's healthcare in the 21st Century.
    The Unique Strengths of the National Children's Study.--Six aspects 
of the architecture of the National Children's Study make it a uniquely 
powerful tool for protecting the health of America's children:
    1. The National Children's Study is prospective in its Design.--The 
great strength of the prospective study design is that it permits 
unbiased assessment of children's exposures in real time as they 
actually occur, months or years before the onset of disease or 
dysfunction. Most previous studies have been forced to rely on 
inherently inaccurate retrospective reconstructions of past exposures 
in children who were already affected with disease. The prospective 
design obviates the need for recall. It is especially crucial for 
studies that require assessments of fetal and infant exposures, because 
these early exposures are typically very transitory and will be missed 
unless they are captured as they occur.
    2. The National Children's Study Will Employ the Very Latest Tools 
of Molecular Epidemiology.--Molecular epidemiology is a cutting-edge 
approach to population studies that incorporates highly specific 
biological markers of exposure, of individual susceptibility and of the 
precursor states of disease. Especially when it is embedded in a 
prospective study, molecular epidemiology is an extremely powerful 
instrument for assessing interactions between exposures and disease at 
the level of the individual child.
    3. The National Children's Study Will Incorporate State-of-the-Art 
Analyses of Gene-Environment Interactions.--Recognition is now 
widespread that gene-environment interactions are powerful determinants 
of disease in children. These interactions between the human genome and 
the environment start early in life, affect the health of our children, 
and set the stage for adult disorders. The heroic work of decoding the 
human genome has shown that only about 10-20 percent of disease in 
children is purely the result of genetic inheritance. The rest is the 
consequence of interplay between environmental exposures and 
genetically determined variations in individual susceptibility. 
Moreover, genetic inheritance by itself cannot account for the sharp 
recent increases that we have seen in incidence of pediatric disease.
    4. The National Children's Study Will Examine a Nationally 
Representative Sample of American Children.--Because the 100,000 
children to be enrolled in the Study will be statistically 
representative of all babies born in the United States during the five 
years of recruitment, findings from the Study can be directly 
extrapolated to the entire American population. We will not need to 
contend with enrollment that is skewed by geography, by socioeconomic 
status, by the occurrence of disease or by other factors that could 
blunt our ability to assess the links between environment and disease.
    5. Environmental Analyses in the National Children's Study will be 
conducted at the Centers for Disease Control and Prevention.--The CDC 
laboratories in Atlanta are the premier laboratories in this nation and 
the world for environmental analysis. Because the testing will be done 
at CDC it will be the best available, and the results will be 
unimpeachable.
    6. Samples Collected in the National Children's Study Will be 
Stored Securely and Will be Available for Analysis in the Future.--New 
tests and new hypotheses will undoubtedly arise in the years ahead. 
Previously unsuspected connections will be discovered between the 
environment, the human genome and disease in children. The stored 
specimens so painstakingly collected in the National Children's Study 
will be available for these future analyses.
    The Current State of the National Children's Study.--Congress has 
already laid a firm foundation for the National Children's Study. 
Between 2000 and 2005, the Congress invested more than $55 million to 
design the study and begin building the nationwide network necessary 
for its implementation.
    Seven Vanguard Centers and a Coordinating Center were designated in 
2005 at sites across the nation--in Pennsylvania, New York, North 
Carolina, Wisconsin, Minnesota, South Dakota, Utah and California--to 
test the necessary research guidelines--with plans to expand the 
program to 38 states and 105 communities nationwide.
    The tough job of designing and organizing is nearly complete. 
Funding for the Study this year will permit researchers to begin 
achieving the results that will make fundamental improvements in the 
health of America's children.
    To abandon the Study at this point would mean forgoing all of that 
dedication, all of that incredible effort, and all of the logistical 
preparation.
    The Study Will More Than Pay for Itself.--The National Children's 
Study will yield benefits that far outweigh its cost. It will be an 
extraordinarily worthwhile investment for our nation, and it can be 
justified even in a time of fiscal stress such as we face today.
    Six of the diseases that are the focus of the Study (obesity, 
injury, asthma, diabetes, autism and schizophrenia) cost America $642 
billion each year. If the Study were to produce even a 1 percent 
reduction in the cost of these diseases, it would save $6.4 billion 
annually, 50 times the average yearly costs of the Study itself.
    But in actuality, the benefits of the National Children's study 
will likely be far greater than a mere 1 percent reduction in the 
incidence of disease in children. The Framingham Heart Study, upon 
which the National Children's Study is modeled, is the prototype for 
longitudinal medical studies and the benefits that it has yielded have 
been enormous.
    The Framingham Study was launched in 1948, at a time when rates of 
heart disease and stroke in American men were skyrocketing, and the 
causes of those increases were poorly understood. The Framingham Study 
used path-breaking methods to identify risk factors for heart disease. 
It identified cigarette smoking, hypertension, diabetes, elevated 
cholesterol and elevated triglyceride levels as powerful risk factors 
for cardiovascular disease. These findings contributed powerfully to 
the 42 percent reduction in mortality rates from cardiovascular disease 
that we have achieved in this country over the past 5 decades (see 
Figure, next page).
    The data from Framingham have saved millions of lives--and billions 
of dollars in health care costs. The National Children's Study, which 
will focus on multiple childhood disorders, could be even more 
valuable. 




    The National Children's Study will Yield Benefits in the Near-Term 
Future.--We do not need to wait 21 years for benefits to materialize 
from the National Children's Study. Valuable information will become 
available in a few years' time, as soon as the first babies in the 
Study are born.
    Consider, for example, data on premature births. The rate of U.S. 
premature births in 2003 was 12.3 percent, far higher than the 7 
percent rate in most western European countries. Hospital costs 
associated with a premature birth average $79,000, over 50 times more 
than the average $1,500 cost for a term birth. Just a 5 percent 
reduction in rates of prematurity would cut hospital costs by $1.6 
billion annually. Within just two years, that savings would match the 
full cost of the Study.
    The Study Enjoys Broad Support.--The Study enjoys a broad group of 
supporters, including The American Academy of Pediatrics; Easter Seals; 
the March of Dimes; the National Hispanic Medical Association; the 
National Association of County and City Health Officials; the National 
Rural Health Association; the Association of Women's Health, Obstetric 
and Neonatal Nurses; United Cerebral Palsy; the Spina Bifida 
Association of America; and the United States Conference of Catholic 
Bishops, just to name a few. This broad and diverse group recognizes 
the overwhelming benefits this Study will produce for America's 
children.
    Congress Should Fully Fund the National Children's Study.--Congress 
first authorized the National Children's Study in 2000, and has 
appropriated $55 million since then to design the Study, complete 
preparatory research, and designate the seven Vanguard sites that will 
conduct preliminary testing.
    This has been a wise investment that should not be abandoned just 
as the Study is about to bear fruit. Unfortunately, the Administration 
has not provided continued funding in the fiscal year 2007 budget, a 
decision which threatens to squander the investment already made and to 
throw away the multi-generational benefits the Study will yield.
    Funding for the Study this year requires a commitment of $69 
million. These funds will be used to begin enrolling children in the 
study. They will enable the NIH to continue establishing the 105 study 
sites around the country. We urge Congress to fully fund the National 
Children's Study. It is an investment in our children--and in America's 
future.
    The National Children's Study will give our nation the ability to 
understand the causes of chronic disease that cause so much suffering 
and death in our children. It will give us the information that we need 
on the environmental risk factors and the gene-environment interactions 
that are responsible for rising rates of morbidity and mortality. It 
will provide a blueprint for the prevention of disease and for the 
enhancement of the health in America's children today and in the 
future. It will be our legacy to the generations yet unborn.
    Thank you. I shall be pleased to answer your questions.

    Senator Specter. Thank you very much, Dr. Landrigan.
    We now turn to Dr. Emeran Mayer, representing the Digestive 
Disease National Coalition. Dr. Mayer.

STATEMENT OF EMERAN A. MAYER, M.D., ON BEHALF OF THE 
            DIGESTIVE DISEASE NATIONAL COALITION
    Dr. Mayer. Thank you, Senators Specter, Harkin, and Shelby, 
for this opportunity. I'm here on behalf of the Digestive 
Disease National Coalition, representing the International 
Foundation for Functional Gastrointestinal Disorders. I'm a 
gastroenterologist and director of an NIH-funded research 
center at UCLA dedicated to the study of functional 
gastrointestinal disorders.
    These disorders, specifically irritable bowel syndrome, or 
IBS, are the most common GI disorders in society. They're 
characterized by chronic abdominal pain and discomfort and 
affect women disproportionally. IBS's health care costs are $2 
billion annually and exceed $20 billion when indirect costs are 
included. Yet the cause of this disorder remains incompletely 
understood.
    During the past 10 years, NIDDK has helped advance 
biomedical research in the field, bringing us within reach for 
the first time of several IBS treatments with great potential. 
The NIDDK is embarking on a strategic planning process for 
digestive diseases in which IBS will be a critical component. 
This is essential to advance our understanding, improve 
treatments, and recruit new investigators for the disease.
    The President's proposed cuts to NIH will have a 
detrimental impact on research advancements in digestive 
diseases and specifically in IBS. Such cuts would slow our 
understanding of pathophysiological mechanisms and effective 
treatments, slow or eliminate pivotal clinical trials, and 
prevent the pharmaceutical industry to develop new treatments, 
and most importantly reduce the number of established 
investigators and send a shock wave to young investigators 
considering entering into this field.

                           PREPARED STATEMENT

    It is therefore essential to continue our investment into 
these programs that hold such promise at this point. I urge you 
therefore to prevent the proposed NIH budget cuts and to 
prevent the likely unraveling of all the progress that has been 
made during the past decade.
    Thank you for the opportunity to testify.
    [The statement follows:]

                 Prepared Statement of Emeran A. Mayer

    Chairman Specter and members of the Subcommittee, thank you for the 
opportunity to present testimony before you today on the effect that 
the President's fiscal year 2007 budget for the National Institutes of 
Health (NIH) will have on functional gastrointestinal and motility 
disorders research. My name is Dr. Emeran A. Mayer and I am here today 
representing the International Foundation for Functional 
Gastrointestinal Disorders' (IFFGD) Board of Directors and the IFFGD 
Advisory Board on behalf of the Digestive Disease National Coalition 
(DDNC). I am the Director of the UCLA Center for Neurovisceral Sciences 
& Women's Health (CNS), a translational research program recently 
funded by the NIH that is currently viewed as the leading integrated 
research program in the world in the area of functional digestive 
disorders.
    Functional gastrointestinal disorders, specifically irritable bowel 
syndrome or IBS, and motility disorders are the most common 
gastrointestinal disorders experienced in society and are present in 
about 25 percent of the U.S. population. The impact on the healthcare 
system and society in general is substantial. These disorders comprise 
about 40 percent of gastrointestinal problems for which patients seek 
health care and the frequency of work absenteeism as a result of these 
disorders is second only to the common cold. IBS health care costs to 
society are $2 billion annually and exceed $19 billion when indirect 
factors such as loss of work and productivity are considered. Although 
the cause of IBS is incompletely understood, we do know that this 
disorder needs a multidisciplinary approach in research and often 
treatment, in order to help the millions of patients suffering across 
the country.
    New knowledge on the mechanisms of these disorders, in particular 
in terms of dysregulation of the elaborate interactions between the 
nervous system and the digestive system, has resulted in 
neurophysiological and neuropharmacological investigations which have 
the potential to produce new pharmaceutical agents as well as disease 
management programs for treatment of these disorders.
    The National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK) has been supporting research into the basic and 
translational mechanisms of functional GI disorders including IBS, in 
terms of individual research grants (R-01), career development grants 
to young investigators (K awards), and major support of two research 
centers, including our own at UCLA. These efforts during the past 10 
years have been essential in advancing biomedical research in the field 
and, for the first time, bringing us within reach of several novel 
pharmacological treatments with great potential for IBS. The NIDDK is 
in the process of embarking on a strategic planning process for 
digestive diseases, and IBS will be a critical component of this plan. 
Strategic planning is essential to advancing our understanding of this 
disease, determining improved treatment options for IBS sufferers, and 
assisting in the recruitment of new investigators to conduct IBS 
research.
    Cutting the budget for the NIH, as is proposed in the President's 
fiscal year 2007 budget, will have a detrimental impact on the research 
advancements in this important disease area that have been accomplished 
during the past several years. Specifically, such cuts would have an 
immediate impact in the following areas:
  --It will slow the elucidation of pathophysiological mechanisms and 
        identification of novel targets, which will have a ripple 
        effect on drug development by the pharmaceutical industry. 
        There will be no new drug development without NIH funded basic 
        and translational research.
  --It will slow or eliminate the execution of pivotal clinical trials 
        of novel treatments for IBS.
  --Most importantly, it will slow strategic planning and reduce the 
        number of young investigators dedicated to the field by 
        starting an exodus of such individuals into jobs in the 
        pharmaceutical industry and private practice. Such a reduction 
        in the research base will take years to undo.
    Biomedical research, sponsored by the NIH, has advanced our 
understanding of countless diseases and disorders. It is important to 
continue our investment in these vital programs that hold such promise 
for our nation's future. Therefore, we ask you to provide an increase 
of 5 percent in fiscal year 2007 for the National Institute of Diabetes 
and Digestive and Kidney Diseases and for the NIH overall.

    Senator Specter. Thank you, Dr. Mayer.
    Our next witness is Dr. Peter McDonnell, representing the 
National Alliance for Eye and Vision Research. Dr. McDonnell.

STATEMENT OF PETER McDONNELL, M.D., ON BEHALF OF THE 
            NATIONAL ALLIANCE FOR EYE AND VISION 
            RESEARCH
    Dr. McDonnell. Thank you, Chairman Specter, Senator Harkin, 
Senator Shelby.
    The President's proposed fiscal year 2007 budget would cut 
National Eye Institute funding by 0.8 percent, or $5.3 million. 
This will have a significant detrimental impact on the entire 
NEI research portfolio, especially research programs into age-
related macular degeneration, AMD. As Dr. Zerhouni mentioned 
this morning, this is the leading cause of blindness now in the 
United States. It robs our seniors of their independence.
    I offer three examples. The NEI has identified variants of 
a gene associated with the body's inflammatory response 
responsible for 50 percent of the risk of developing AMD. 
Without adequate funding, NEI will not be able to develop 
diagnostics for early detection of at-risk individuals and 
conduct clinical studies with promising therapies, as well as 
study the impact of the inflammatory response and other 
degenerative eye diseases.
    The NEI has demonstrated that dietary zinc and anti-oxidant 
vitamins actually reduce vision loss in individuals at risk of 
developing AMD. Without adequate funding, NEI will not be able 
to proceed with follow-up clinical studies to identify 
additional dietary supplements used singly or in combination to 
demonstrate even greater protective effects against progression 
to advanced disease.
    NEI's research has resulted in the first generation of FDA-
approved drugs to treat abnormal blood vessel growth in the wet 
form of AMD, halting further vision loss. NEI's ability to 
conduct clinical studies of these therapies in patients with 
macular edema associated with diabetes and diabetic retinopathy 
would also be jeopardized.
    Thank you, Mr. Chairman, and we appreciate the 
subcommittee's efforts to increase NIH and NEI funding in the 
fiscal year 2007 budget.
    Senator Specter. Thank you very much, Dr. McDonnell.
    We now turn to Ms. Sandra Raymond, representing the Lupus 
Foundation of America.

STATEMENT OF SANDRA RAYMOND, ON BEHALF OF THE LUPUS 
            FOUNDATION OF AMERICA
    Ms. Raymond. Good morning, Mr. Chairman, Senator Harkin, 
Senator Shelby.
    Lupus is the prototypical autoimmune disease, so an 
investment in lupus research may in fact produce answers to 
many other autoimmune diseases affecting more than 23 million 
Americans. In recent years, NIH has had funded studies that 
give us great hope that we are on the brink of major 
breakthroughs in lupus research.
    For example, one study, an adult stem cell transplantation 
study, is carried out on only the most severely ill of lupus 
patients, for whom all other treatments have failed. Fifty 
percent of these patients having the procedure had disease-free 
survival for 5 years.
    In another NIH-funded study, researchers identified a gene 
that plays a role in one of the immune system pathways meant to 
fight infection. In people with lupus, this pathway turns on, 
but never turns off.
    Mr. Chairman, should NIH appropriations be curtailed there 
may not be a future generation of scientists to do lupus 
research. Already the hint that funding may be reduced has 
caused leaders in our field to consider better funded areas. 
Cuts in NIH funding could bring to a standstill support of 
clinical trials and large observational studies in lupus and 
could limit research on those at highest risk for lupus, women 
of color.

                           PREPARED STATEMENT

    NIH-funded research currently in progress will lead to new 
and improved treatments for lupus. There has not been a new 
FDA-approved drug for lupus in almost 40 years and the drugs 
that our patients are currently taking are very harsh 
chemotherapies, chemotherapies in lupus as well as in cancer.
    Thank you.
    [The statement follows:]

      Prepared Statement of the Lupus Foundation of America, Inc.

    I am Dr. Michael Madaio, Chief of Nephrology, Professor of 
Medicine, Temple University School of Medicine and a lupus researcher. 
The Lupus Foundation of America, Inc. (LFA) appreciates the opportunity 
to submit written comments for the record regarding funding for lupus 
related programs for fiscal year 2007. The LFA is the nation's leading 
non-profit voluntary health organization dedicated to improving the 
diagnosis and treatment of lupus, supporting individuals and families 
affected by the disease, increasing awareness of lupus among health 
professionals and the public, and finding the causes and cure. As you 
may know, lupus is a debilitating, chronic autoimmune disease that 
causes inflammation and tissue damage to virtually any organ system; it 
can cause significant disability or even death. Lupus is the 
prototypical autoimmune disease; therefore, finding answers to 
questions about lupus may also provide understanding about other 
autoimmune diseases that affect 22 million Americans. The leaders and 
members of the LFA and the 1.5 to 2 million people suffering from lupus 
respectfully request for fiscal year 2007 $29.7 billion for the 
National Institutes of Health (NIH) to support lupus research. 
Specifically, we urge Congress to direct NIH to support and bolster 
lupus research across all relevant institutes, centers, and offices.
    I have been funded for lupus research for over 20 years. I am proud 
to be affiliated with the Lupus Foundation of America as a member of 
the Medical Scientific Advisory Board and Chairman of the Medical 
Advisory Board for the Southeastern Pennsylvania Chapter of the LFA. 
While I am a nephrologist, since my research and clinical practice is 
focused on lupus, I really work day-to-day within the realms of 
nephrology and rheumatology as well as other medical specialties and 
subspecialty areas. I understand the importance of biomedical research 
funding and the impact that federal research funding has had, does 
have, and can have on the lives of the 1.5 million people living with 
lupus and the 22 million Americans with other autoimmune diseases.
    After a tragic 40 year dearth of new treatments to manage this 
often debilitating and devastating disease, the good news is that we 
finally are on the brink of major breakthroughs, thanks to research 
sponsored by the National Institutes of Health. Exciting research and 
strides in treatments for people with lupus are on the horizon and a 
sustained investment now in lupus research will speed the day to better 
treatments and a cure. One exciting study, adult stem cell 
transplantation, was carried out on only the most severely ill of lupus 
patients for whom all other treatments have failed. Fifty percent of 
the patients having the procedure had disease free survival at 5 years. 
In another NIH funded study researchers identified a gene that plays a 
role in one of the immune system pathways meant to fight infection. In 
people with lupus this pathway turns on and never turns off. These 
findings and others will lead to effective ways of treating lupus and 
other autoimmune diseases affecting 23 million Americans.
    Specifically, I am conducting extensive research on lupus 
nephritis, which is kidney involvement in lupus disease. My field is 
advancing rapidly, due in large part to factors directly dependent on 
NIH funding:
  --the burgeoning growth in the number of new animal models, including 
        a wealth of informative transgenic and gene-targeted mutants;
  --increased access to improved powerful technologies such as gene and 
        protein arrays, now available at many institutions and to many 
        investigators through NIH core facilities;
  --new technologies that permit successful query of the very small 
        amounts of human tissue typically available from patients and, 
        collaboration across disciplines and across institutions to 
        bring crucial expertise together;
  --new insights into underlying biology and pathophysiology in 
        immunity and lupus are constantly emerging;
  --technologies to identify biomarkers are improved and accessible; 
        and
  --new approaches to therapy are being explored.
    These endeavors are bearing fruit but they are highly dependent on 
NIH funding.
    If funding for the NIH is cut or level funded, it could cripple or 
paralyze current lupus research efforts.
    As lupus is a systemic disease that can affect any organ or tissue 
elucidating pathogenesis (or cause) and treatments of lupus will have 
direct impact on many other autoimmune diseases (e.g. results and 
treatments translating to other diseases). Providing adequate resources 
to support lupus research will help the nation turn the corner on 
finding better treatments or a cure for lupus while also supporting 
breakthroughs and progress for other disease states. It is important to 
note that the corollary is true: cuts in lupus research funding also 
will have an adverse effect on progress for lupus and for progress in 
related diseases. Cuts in NIH funding could bring to a standstill 
support of clinical trials and large observational studies, and could 
curtail research on those at highest risk for lupus, women of color; it 
also could negatively impact pediatric research at a time when 
researchers have just begun to undertake studies in important new 
areas. Furthermore, insufficient federal funding also could slow much-
needed genetic research when we are just discovering the critical 
components that may contribute to lupus and its effects. Therefore, it 
is critical that biomedical researchers be provided the necessary 
resources to continue seeking answers to the questions that will lead 
to better lupus treatments. Increased research funding will help 
deliver much-needed breakthroughs from the laboratory to patients in 
need.
    The National Institute of Arthritis and Musculoskeletal and Skin 
Diseases (NIAMS), the institute most involved in lupus research, is one 
of the smallest institutes at NIH. In the past 2 years there has been a 
decrease in research funding for NIAMS overall, with a 10 percent 
decrease in new research grants. Currently, only 12-15 percent of the 
grant applications submitted to NIAMS receives funding. Further cuts 
will cause this rate to drop precipitously to below 10 percent next 
year. Just 2 or 3 years ago, funding levels were at 25-30 percent. Cuts 
in research funding, coupled with the rate of biomedical research 
inflation (3-4 percent per year), further erode NIAMS' ability to fund 
lupus research grant applications at the rate necessary to begin making 
real progress. As such, an increase above the rate of biomedical 
research inflation is necessary to allow NIH to sustain and build on 
its research progress resulting from the recent budget doubling while 
avoiding the severe disruption to that progress that would result from 
a lesser increase or cut.
    Furthermore, in the proposed budget for NIAMS for 2007 there will 
be a loss of 10 training grants; each grant funds training for four 
physicians, mostly rheumatologists. Young and senior investigators 
alike are moving into other fields because of the lost of funding. 
Exacerbating the situation, medical schools are struggling financially 
due to public funding cuts thus eliminating any safety net for 
researchers that may have previously existed. As a result, young 
investigators are not attracted to lupus research which means there 
will be not be a future generation of lupus scientists and clinicians 
to do research. Moreover, after having attracted scientists to 
translational immunology in the last 5 to 10 years, when funding was 
increasing, there is now a possibility we could lose both the current 
and next generation of young investigators. Increased funding is 
necessary to support an adequate number of training grants. Without 
research and training funds lupus researchers might be forced to become 
private practice physicians instead, leading to an imbalance in the 
health care system: sufficient numbers of physicians to treat lupus 
patients, but no new treatments with which to care for them, and no 
researchers to develop the cures of tomorrow.
    We recognize and appreciate that Congress and the nation face 
unprecedented fiscal challenges; however, we cannot afford to lose 
ground in biomedical research at such a promising time. The LFA looks 
forward to working with the subcommittee and others in Congress to 
reduce and prevent the suffering caused by lupus. We stand ready to 
serve as a resource for any information you may need in this regard and 
thank you for this opportunity to submit written testimony for the 
record concerning fiscal year 2007 lupus related funding.

    Senator Specter. Thank you very much, Ms. Raymond.
    Our next witness is Dr. Herman Taylor, representing the 
Jackson Heart Study. Dr. Taylor.

STATEMENT OF HERMAN A. TAYLOR, JR., M.D., ON BEHALF OF 
            THE JACKSON HEART STUDY
    Dr. Taylor. Thank you, Mr. Chairman, and good morning, 
Senator Harkin, Senator Shelby. I am Herman Taylor, professor 
and cardiologist at the University of Mississippi Medical 
Center and also with appointments at Jackson State and Talugu 
College.
    I am proud this morning to come to you on behalf of the 
largest study of cardiovascular disease ever undertaken in the 
African American population. It is called the Jackson Heart 
Study. The NHLBI and the National Center for Minority Health 
and Health Disparities are the NIH entities that fund this 
groundbreaking work. We are not only doing research, but we are 
actively involved in training young people to be scientific 
leaders for tomorrow.
    We are accomplishing much, but our challenges are huge. A 
well documented and widening gap has opened up between blacks 
and other citizens of this country with respect to 
cardiovascular health. While most Americans have enjoyed a 40-
year decline in death rates from cardiovascular disease, there 
has been virtually no change in the death rate from 
cardiovascular disease for African Americans in the State of 
Mississippi and certain other urban areas in other parts of the 
country share these equally dismal statistics.
    So while the Jackson Heart Study is a very heartening and 
wonderful undertaking, if the intent is to approach these 
disparities what we have done thus far can be compared to 
throwing a 10-foot rope to a man at the bottom of a 40-foot 
well. It is a great idea, it is a good intention, but it comes 
up short.

                           PREPARED STATEMENT

    If we consider the question of health disparities an 
important national priority, you have to ask yourself what if 
we were equal. Dr. David Satcher asked that question in a 
recent publication and he concluded, looking at CDC statistics, 
that last year 80,000 African Americans died unnecessary deaths 
compared to their white counterparts. In our State 1,200, our 
small southern State, 1,200 African Americans died 
unnecessarily.
    To reverse this trend, we must support research and extend 
the work of the Jackson Heart Study. Thank you.
    [The statement follows:]

              Prepared Statement of Herman A. Taylor, Jr.

    I am proud to come to you today on behalf of the largest and most 
comprehensive study of CVD in the African American community ever 
conducted--the JHS. Through the generous support of 2 NIH components--
NHLBI and the NCMHD--this ambitious and multifaceted project is 
emerging as a leading study on CV disease among African Americans. 
Besides its establishing a growing database of detailed health 
information and test results ranging from advanced images of the heart 
to genetics to measures of stress and psychological parameters, the JHS 
is also an incubator for the scientific leaders of tomorrow through our 
education and training programs that involve minority students in 
didactic classroom sessions and practical research experiences. And 
while we search for answers and train future leaders, we also are 
taking action NOW--to serve the community with important health 
information from our study as well as others.
    We are relatively new, born during the period of NIH budget 
doubling, and already we have accomplished much within the Jackson 
community and beyond. However, despite the promise of the JHS and our 
optimism over its impact, I come to you with a deep concern, summarized 
in the arresting quotes below.

    ``It has been discovered that the health of [blacks] in [parts of] 
Mississippi is deteriorating while the health standards for the nation 
are improving . . . .''--The Wall Street Journal

    ``Cardiovascular deaths in MS seem to be rising while they have 
fallen for the past 30 years for the rest of the country.''--
Circulation (the official organ of the American Heart Association)

    These 2 quotes are distressing, whether you are African American or 
not, whether you are Mississippian or not. However, the magnitude of 
the problem they summarize becomes clearer when you consider that the 
two statements were made 32 years--a full generation--apart. The notion 
that in the richest country in the history of man, one location or 
group within its borders can be so singularly and peculiarly burdened 
from a largely preventable disease is barely credible. But it is true, 
and it has the status quo for around forty years.
    So while the JHS represents an inspired, timely effort of the NHLBI 
and the NCMHD, to freeze research efforts at the current levels of 
funding would be like throwing a 10 foot rope to a man at the bottom of 
a 40 foot hole. We come up short, and despite the right idea and a 
noble attempt, the problem of disparate CV health remains unsolved. To 
extend the reach of the JHS to its full potential, our Study and other 
complementary studies--and the investigators driving them--must thrive, 
and have support for their approaches and new ideas.
    The JHS contributes to extending the research lifeline in several 
important ways. First there is the core JHS Study itself. Classically 
designed in the pattern of the world famous Framingham Study, it offers 
a chance to Study a wide list of possible causes for poorer 
cardiovascular health among African Americans, to inform precise 
interventions that will reduce disparities. Funded through 2013 by 
NHLBI and NCMHD, it is a landmark undertaking. The JHS also is 
innovative in its list of partnering institutions. Besides the guidance 
and support of the NHLBI and the NCMHD, 3 local Jackson Institutions of 
higher learning take active part in making the JHS work--Jackson State 
University, University of Mississippi Medical Center, and Tougaloo 
College all have unique and vital roles in the Study. Comprising a team 
of 2 Historically Black institutions and a third predominantly 
minority-serving institution, this combination has been ground-braking 
and synergistic in the service of this population-based study of an 
African American population. Training of promising young talent from 
the affected population and participation of HBCU's in epidemiological 
research at the highest level is bearing fruit for the Nation in terms 
of a rising cadre of leaders in the relevant fields.
    However, the potential impact of the JHS is bigger than even this 
important core Study will provide. This is because not only is the JHS 
a Study in its own right, it is a platform for critical spin-off 
studies. These ``Ancillary Studies'' require secondary funding that is 
NOT a part of the JHS contract funding. A flat or declining NIH budget 
threatens these important studies, where much of the truly innovative 
work on health disparities could occur. For instance, nearly all of the 
genetics studies of heart disease in the JHS require this ancillary 
funding. The genetics of CVD may be the key in the lock of our 
understanding of much of the current epidemic. Implications of these 
studies may be huge for not only African Americans, but all people 
threatened by the nation's number one killer. Flat budget lines 
severely limit the opportunities for such important studies. This is 
especially devastating to new investigators, those who apply for the 
career development (K) awards that NHLBI has been so committed to 
funding. These young people are the cadre of scientists in whom we are 
investing our future hopes of American world leadership in health 
research, and the ultimate resolution of health disparities.
    The future of innovative science from the JHS is therefore tied in 
important ways to Ancillary studies (R01's) and career development (K) 
awards for new investigators. Holding the line on the NIH budget is to 
worsen a palpable threat scientists now feel--that of being squeezed 
out of a zero-sum game where more and more scientists are fighting each 
other and the rising cost of research in order to launch and sustain 
promising careers. This is especially devastating to new investigators, 
in whom we are investing our future hopes of American world leadership 
in health research.
    Therefore, the JHS at this point in its evolution can be thought of 
as a major platform for scientific discovery--an incredible growing 
database that is a national resource. If the growing brain trust of 
scientists--in Jackson as well as Boston, Bethesda, Minneapolis, 
Baltimore, New York, Chicago and elsewhere--who are showing active 
interest, receive funding for meritorious ideas, the JHS stands to 
produce important breakthroughs in our understanding of the CVD 
patterns seen in AA and others. However, if flat pay lines prevent the 
funding of new ideas for using this unparalleled resource, the 
trajectory of discovery will be blunted, the pace of advance slowed, 
and important scientific opportunity, squandered. And the wisdom shown 
by NCMHD and NHLBI in building this platform for discovery will be in 
many ways betrayed.
    We cannot afford to squander any opportunities to improve health 
overall and eliminate health disparities. I witness the impact of 
failed promises everyday. Among my patients, I see the end result of 
our incomplete understanding of heart disease: in young mothers whose 
hearts fail after childbirth for no good reason--though we have a name 
for it--peripartum cardiomyopathy--we don't understand it, and we don't 
understand why it afflicts Blacks more than other Americans. I see it 
in fathers with no known risk factors, but develop coronary disease 
anyway. I see it in people suffering from morbid obesity who not only 
are at increased risk for disease, but because of their size, 
therapeutic and diagnostic interventions themselves are technically 
much more difficult. Standard operations are often riskier, and 
sometimes impossible to perform. With 1,200 unnecessary deaths from CVD 
among AA in our small Southern state alone, deferring the dream of 
health equality only adds to our regional tragedy of health 
disparities. With 80,000 unnecessary deaths nationally among African 
Americans in 2004 (most from CVD) research retrenchment in the form of 
flat lining or cutting the research budget only defers finding answers 
that were needed yesterday for our Nation's health. An act of national 
compassion and strong resolve is necessary. I pray that this Congress 
and President will engage this great threat to the dream of a healthy, 
vigorous nation. It is in our compelling national interest to do so.
    Thank you, Mr. Chairman. I would be pleased to answer any questions 
that the Committee may have.

    Senator Specter. Thank you very much, Dr. Taylor.
    Our final witness is Dr. Suzanne Vogel-Scibilia, 
representing the National Alliance for Mental Illness.

STATEMENT OF SUZANNE VOGEL-SCIBILIA, M.D., PRESIDENT, 
            NATIONAL ALLIANCE ON MENTAL ILLNESS
    Dr. Vogel-Scibilia. Greetings from Beaver County, 
Pennsylvania, Senator Specter.
    I'm a volunteer with----
    Senator Specter. Whereabouts? Where?
    Dr. Vogel-Scibilia. Beaver.
    Senator Specter. Thank you.
    Dr. Vogel-Scibilia. I'm a volunteer at NAMI and the 
president of the National Alliance on Mental Illness, and I 
have been a practicing psychiatrist and a family member of 
persons with mental illness as well as a consumer with bipolar 
disorder myself. I have had periods of severe illness, but I 
have had a good recovery.
    Unfortunately, though, many people in our country have not 
yet achieved recovery. If Congress cuts funding at the NIMH as 
the President has suggested, we will have to continue to have 
millions of people in this country with chronic disability and 
a $40 billion loss in economic productivity each year alone for 
schizophrenia, not to mention other illnesses.
    Because of the past doubling of the research budget, NIMH 
has brought forth vitally important real world trials to impact 
the treatment of all persons with schizophrenia, bipolar 
disorder, and depression. Unfortunately, though, the future 
gains in medication and treatment options for this vital 
research will not be realized unless further medical support is 
given to these important studies. We will be unable to fund the 
United States whole genome studies for serious mental illness, 
which could transform the understanding of causes and risk 
factors for these devastating illnesses and open up new avenues 
of effective treatment.
    Last, we will be unable to advance schizophrenia and 
bipolar research progress. One example is in the understanding 
if early intervention and medication therapy and rehabilitation 
will prevent disability and morbidity for persons with new 
onset schizophrenia. We will also be unable to address and 
prevent the epidemic of suicide in this country, including a 
substantial number of our young people who die or are disabled 
before their life has truly started, and the elderly who are 
cheated from their retirement years.
    For myself, my children, and the people who belong to over 
1,100 affiliates of NAMI in the United States of America, we 
humbly thank you for all your reform to express our concerns 
and hope that research dollars will be provided to help those 
of us who suffer.
    Thank you very much.
    Senator Specter. Thank you very much, Dr. Vogel-Scibilia.
    One question, Dr. Taylor. When you say ``unnecessary 
deaths,'' how would you define that?
    Dr. Taylor. Yes. The term, sir, refers to deaths that you 
would not expect, given statistical projections, given the 
current level of care and our understanding of risk factors for 
cardiovascular disease. So these are people who--a certain 
number of people are expected to die, of course, from certain 
diseases, like heart disease, every year. Well, these are 
people who you would not expect to have died. Dr. Satcher and 
others have termed these ``unnecessary deaths.''
    Senator Specter. You are saying in effect that that is 
higher for blacks, African Americans, than others?
    Dr. Taylor. Senator, it is substantially higher. Again, the 
national prediction is that 80,000 of these deaths occur from a 
variety of causes and the lion's share of those deaths are due 
to cardiovascular causes.
    Senator Specter. What is the reason for the higher 
incidence of deaths among blacks?
    Dr. Taylor. Well, this is the principal focus of the 
Jackson Heart Study and studies like it, to figure that out. 
Clearly there are higher levels of risk factors, such as 
obesity, hypertension, diabetes. But one must ask the question, 
why are those risk factors higher? We cannot simply say, well, 
there is more hypertension, therefore we expect more deaths. 
The question is why is there more hypertension and related 
problems?
    Also, access to care clearly is a major part of this. But 
historically, African Americans as a group have been 
understudied with regards to what are the true determinants of 
poor health. Studies like the Jackson Heart Study and studies 
related to it I think will help unravel these questions and 
give us detail that we might not even suspect at this point. 
The Jackson Heart Study, for instance, includes studies into 
genetic underpinnings of various illnesses. But on the opposite 
end perhaps of the spectrum, we look very carefully at 
psychological determinants of ill health, at social and 
behavioral parameters that may also impact how well people do 
in terms of their overall health.
    Senator Specter. Senator Shelby.
    Senator Shelby. Thank you, Mr. Chairman.
    Ms. Raymond, what funding do we really need to sustain 
research into lupus at NIH in your judgment?
    Ms. Raymond. Well, presently the amount of funding now 
allocated is around $66 million. In order to really sustain and 
break through, I think we need $200 million.
    Senator Shelby. That is a lot of money.
    Ms. Raymond. A lot of money.
    Senator Shelby. But a lot of promise, too.
    Ms. Raymond. I think so. We have many deaths due to lupus.
    Senator Shelby. Absolutely.
    Ms. Raymond. It is a fatal disease. It is prototypical 
because it affects any organ system, any tissue system in the 
body.
    Senator Shelby. 90 percent of them are women, are they not?
    Ms. Raymond. 90 percent are women and a majority are women 
of color, African American, Hispanic, Asian, and Native 
Americans.
    Senator Shelby. Dr. McDonnell, macular degeneration. What 
is the real promise once you are diagnosed in that area?
    Dr. McDonnell. Well, Senator, this is now with the tidal 
wave of aging Americans, this has taken over from diabetes as 
the major cause of Americans to go blind. It is a progressive 
disease involving--it is almost our Alzheimer's or 
Parkinson's--a neuro- degenerative condition of the cells of 
the retina, of the back of the eye. The eye is part of the 
brain, and this progression occurs.
    Now we believe we have some dietary supplements that may 
slow the progression.
    Senator Shelby. What are these?
    Dr. McDonnell. Anti-oxidant vitamins and zinc have been 
shown, thanks to an NEI-funded study, to delay the progression 
to severe forms of the macular degeneration. Now, we have some 
treatments that can treat severe forms with blood vessels that 
are causing leakage and bleeding and scarring in the back of 
the retina. We also hope to be able to begin and expand upon 
studies of regenerative medicine using stem cells, such as 
would be done in other fields, to restore the cells that are 
lost or damaged from this disease.
    Senator Shelby. So there is great promise everywhere in 
biomedical research. It has just got to be properly funded. Is 
that the bottom line?
    Dr. McDonnell. I agree with that. As you heard, lupus also 
damages the eye. The eye is part of the brain. Fortunately, not 
all patients are afflicted in the eye, but we have patients go 
blind and we need the same treatments that would improve the 
kidney damage and brain damage of lupus also for our eye 
patients.
    Senator Shelby. Thank you.
    Mr. Chairman, thank you.
    Senator Specter. Thank you, Senator Shelby.
    Senator Harkin.
    Senator Harkin. Thank you, Mr. Chairman.
    Dr. Landrigan, thank you for bringing up the children's 
study. That is why I brought it up earlier. You talked about 
the benefits to children, but would it not also benefit adults 
also? I mean, obviously obese children have later complications 
as they grow older. Many of the things that happen to you in 
childhood you carry with you, especially mental health. If you 
have mental health problems early in life and they are not 
attended to, it can manifest itself later on.
    So I just wanted to draw you out a little bit on that in 
terms of the benefits of the children's study, not just to 
kids, but I think across the spectrum.
    Dr. Landrigan. Yes, Mr. Harkin, that is absolutely true. 
There is an expanding body of research, called the early 
origins of adult disease hypothesis. For example, slow fetal 
growth of the baby still in the mother's womb is associated in 
young adult life with an increased risk of diabetes, 
hypertension, and heart disease. There are some intriguing 
clues, more from animal studies than human at the moment, that 
early exposures to toxic chemicals may cause brain damage that 
does not become manifest in childhood, but shows up four, five, 
six decades later in the form of dementia or Parkinson's 
disease.
    So I think it is both to protect America's kids as well as 
future generations of adults that we are seeking the full 
funding for the study to be restored in fiscal year 2007, which 
would be $69 million, and also assurances that the study will 
continue to be funded in the years ahead. It will not succeed 
unless the funding for it is sustained.
    Senator Harkin. Thank you very much.
    Mr. Chairman, I do not have any further questions. I would 
just again for the record state, Mr. Chairman, that you and I 
and others on this committee had planned for this children's 
study. It was passed in 2000. A lot of planning went into this 
and forethought went into it to set up this long-term study, 
and I just cannot believe that we are just going to just stop 
it at this point in time.
    So we have just got to do everything we can to mandate, if 
we have to, mandate--I do not know if there is anyone here from 
OMB, but mandate--that this funding go forward this next year.
    Thank you very much.
    Senator Specter. Thank you. Thank you, Senator Harkin.
    I thank all of you. We are fighting. We put up a Specter-
Harkin amendment and added $7 billion to the budget in the 
Senate. Unfortunately, that has not been accomplished in the 
House. We have added from that $7 billion $2 billion for the 
National Institutes of Health.
    But this is a battle that really has to be engaged in by 
110 million Americans who are suffering directly or indirectly 
from the kinds of illness which we have heard about here today.
    We thank you for coming in. This has been an impressive 
hearing because it puts a face on these ailments. They are sort 
of abstractions. They are not abstractions if your wife is 
suffering from them or a close relative or a close friend or 
you are suffering from them. They are not abstractions at all. 
But there has to be a very intense advocacy effort. We call it 
lobbying around here. It is really advocacy. Your organizations 
are very, very important in this advocacy effort. We thank you 
for what you are doing. But you have to contact your 
counterparts everywhere.
    The amendment which Senator Harkin and I sponsored won 73 
to 27, but there were 27 Senators who voted no and you ought to 
identify them and you ought to march on them in their cities, 
in their States, seriously, very, very seriously. It is a 
little hard, with all that Senator Harkin and I have to do--he 
has got to bounce out of here and go to Iowa for a meeting 
later today and I have got to conduct a hearing on campus 
violence in Philadelphia at 2 o'clock. I have not been in my 
office all week. I have been on the floor managing the 
immigration bill. Before that I was fully occupied with the 
Supreme Court nominations.
    But your groups are advocates and I would like to see that 
million person march. But it has got to be done. We are a 
democracy and people in Washington pay attention to people in 
their home States. If I get seven letters, I have got 12 
million constituents, I think it is significant. You have 
really got to be more politically active, not Democrat or 
Republican active, but active for these issues, active for NIH, 
active for stem cells.
    I am convinced there are cures for all of these ailments 
and we have the resources to do it. It is a question of how 
many doctors and hospitals and research scientists and 
dedicated people you have. It is not a matter of how many 
dollars you have. It is a matter of what your resources are. 
The money flow comes out of Washington to a large extent, also 
out of your State capitals.

                     ADDITIONAL COMMITTEE QUESTIONS

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

              Questions Submitted by Senator Arlen Specter

                     LIVER DISEASE RESEARCH BRANCH

    Question. Dr. Zerhouni, 3 years ago, the NIDDK established a Liver 
Diseases Research Branch within its Division of Digestive Diseases and 
Nutrition. Please explain the benefits of having a Research Branch 
dedicated to a specific area of research and describe how this Liver 
Disease Research Branch has succeeded in its mission.
    Answer. Research on diseases of the liver is a trans-NIH effort 
involving 19 institutes, centers, and offices. The National Institute 
of Diabetes and Digestive and Kidney Diseases (NIDDK) has lead 
responsibility for liver disease research at the NIH. Within the NIDDK, 
liver disease research is under the purview of the Division of 
Digestive Diseases and Nutrition. The Federal liver disease research 
effort has benefited greatly from the establishment in 2003 of an 
organizational entity within the NIDDK--the Liver Disease Research 
Branch--dedicated exclusively to this very important area. This new 
Branch was formed to focus and coordinate research efforts on critical 
areas relevant to liver and biliary disease, such as hepatitis and 
liver transplantation.
    Following a national search, Jay H. Hoofnagle, M.D., an 
internationally recognized authority in liver disease research, was 
appointed as Chief of this Branch. The NIDDK recruited an additional 
scientific Program Director with expertise in liver diseases to further 
support the efforts of the Branch. The Branch also includes scientific 
experts in the areas of viral hepatitis, clinical trials, epidemiology 
and data systems, genetics and genomics, and research training and 
career development.
    The Liver Disease Research Branch has accelerated research on liver 
disease supported by the NIDDK and has helped to coordinate and 
stimulate liver-related research efforts across the NIH and within 
other Federal agencies, such as the Centers for Disease Control and 
Prevention, the Department of Defense, the Bureau of Prisons, the Food 
and Drug Administration, and the Department of Veterans Affairs. An 
initial important task set for the Branch was to prepare the trans-NIH 
Action Plan for Liver Disease Research. The Plan provides an overview 
of the current burden of liver disease in the United States, the 
current level of NIH research funding in liver disease, and recent 
research advances. Importantly, the Plan also summarizes challenges to 
advancing liver disease research and delineates the major goals for 
future research. Specific goals for the next 10 years are defined for 
each of 16 topic areas in liver disease research.
    One mission of the Branch is to oversee the conduct of the Plan, 
which includes annual Progress Reviews to aid in its implementation 
through an ongoing assessment of progress and the need for further 
efforts to promote liver and biliary disease research. The Progress 
Review for 2005, the first year following release of the Action Plan, 
is available at: http://www.niddk.nih.gov/fund/divisions/ddn/ldrb/
Progress_reviews.htm. The Branch also develops and coordinates future 
NIH efforts in liver disease research aimed at reaching the goals 
defined in the Plan.
    Thus, the Branch is succeeding in its mission to plan and direct 
the NIH program of liver research, as evidenced by an impressive array 
of initiatives that include major clinical trials and special program 
announcements in the areas of proteomics of the liver, biomarkers for 
liver disease, non-invasive tests for diagnosis and staging of liver 
disease, and ancillary studies linked to specific clinical trials, 
databases and cohort studies on liver disease (http://
www.niddk.nih.gov/fund/program/DDN-list.htm#Liverprograms).

                  UROLOGY RESEARCH STRATEGIC PLANNING

    Question. Our conference report last year ``urged the NIDDK to 
continue to support and develop the `Urologic Diseases in America' 
report and to include urological complications as well as diabetes and 
obesity research initiatives.'' This language was included in response 
to concern that the NIH-wide Obesity Strategic Plan did not address 
urological issues such as, stress urinary incontinence or erectile 
dysfunction (ED), two conditions highly associated with obesity. These 
conditions severely affect quality of life and result in high medical 
costs. How do you ensure that all disciplines are represented in 
strategic planning?
    Answer. The NIH acts to ensure that its strategic planning efforts 
for research are comprehensive, inclusive, and evidence-based. 
Currently, strategic planning is conducted by the individual 
Institutes, Centers, and Offices of the NIH, as well as through trans-
NIH and interagency mechanisms, as appropriate. The NIH Office of 
Portfolio Analysis and Strategic Initiatives, which I established 
recently, will have an instrumental role in facilitating both 
individual and trans-NIH strategic planning efforts through its planned 
activities.
    To ensure effective planning processes, the NIH seeks input from a 
wide array of stakeholders, including scientific experts, 
representatives from professional organizations, and patient advocates. 
For example, most strategic planning for urologic diseases research is 
conducted by the National Institute of Diabetes and Digestive and 
Kidney Diseases (NIDDK). In two major planning efforts, the NIDDK 
assembled large, multidisciplinary groups of scientists and medical 
professionals prominent in their fields and active in patient and 
professional societies related to bladder disease in 2002, and in 
pediatric urology in 2006. These groups were thus able to bring 
multiple perspectives to bear when reviewing progress in bladder 
disease and pediatric urology research, and to provide broad-based 
assessments of research needs and recommendations for future action, 
including recommendations regarding the impact of obesity and diabetes 
on certain urologic diseases. As a result, these groups' 2002 and 2006 
reports have served as a model for NIH planning for urologic diseases 
research and for trans-NIH collaborations in this area. Moreover, the 
NIDDK has continued to gather multidisciplinary expert groups to assist 
in more focused areas of research planning, such as prostate disease, 
and urologic diseases in women. All of these efforts are bolstered by 
the Urologic Diseases in America report, which has provided significant 
information related to major urologic diseases. The NIDDK is strongly 
committed to maintaining this program, and a research solicitation is 
being developed for the next phase of Urologic Diseases in America that 
will include assessment of the impact of diabetes and obesity on 
urologic diseases. Additional, ongoing assessments of research progress 
in urologic diseases through advisory group meetings, scientific 
conferences, and stakeholder input allow flexibility, capitalization on 
new research advances, and the opportunity to strategically address 
research gaps and barriers that may emerge or become evident over time.
    The Strategic Plan for NIH Obesity Research, developed by the NIH 
Obesity Research Task Force, similarly drew upon a broad base of 
scientific expertise within and external to NIH. The plan focuses, in 
part, on goals and strategies to break the link between obesity and its 
associated health conditions. Recommendations from this and other plans 
and from ongoing strategic planning efforts are reflected in NIH 
action. For example, the NIDDK has funded the Program to Reduce 
Incontinence by Diet and Exercise (PRIDE) study, which is examining the 
impact of weight loss on urinary incontinence in overweight and obese 
women. The benefits of considering multiple disciplines in research 
planning can be seen in research results. For example, the NIH-funded 
Diabetes Prevention Program recently found that weight loss improves 
bladder control in women with prediabetes. This new knowledge, that an 
intervention proven to reduce risk of type 2 diabetes can also reduce 
episodes of urinary incontinence, has the potential to improve health 
and quality of life for the large number of older American women who 
have both prediabetes and bladder control problems. The NIH has also 
been supporting a similar study in patients with type 1 diabetes who 
are participating in the Epidemiology of Diabetes Interventions and 
Complications study, to determine whether intensive control of blood 
sugar levels--an intervention proven to reduce risk of developing eye, 
kidney, nerve, and cardiovascular complications of diabetes--also 
reduces risk of urologic complications.

                    OPASI TRANS-NIH FUNDING PROGRAM

    Question. Dr. Zerhouni, you have initiated a new trans-NIH funding 
program, which requires each Institute and Center to contribute a fixed 
portion of their appropriations for cross-cutting research initiatives. 
Can this program move forward as planned in an environment of no real 
increases in NIH funding?
    Answer. The Administration has focused resources on our highest 
priority: protecting the citizens and our homeland. This underscores 
the importance of being as strategic as possible with NIH dollars to 
catalyze high-impact research. The time is right for NIH to take a more 
coordinated approach to the development and funding of trans-agency 
initiatives by asking each IC to pool a very small proportion of their 
appropriation in a Common Fund for shared needs. This is true not only 
because of the difficult budgets, but also because many of the most 
exciting scientific opportunities and pressing public health challenges 
we now face cut across the mission areas of multiple institutes and 
centers. Thus, the creation of this new trans-NIH funding stream will 
actually enable the NIH to be more proactive in addressing emerging 
scientific needs and opportunities; to fund high-risk, high-impact 
science; and to incubate and launch pilot efforts that have 
transforming potential for all of science.

                       THE HEART TRUTH ROAD SHOW

    Question. As a member of the Congressional Heart and Stroke 
Coalition, I am concerned that heart disease remains the leading cause 
of death of women in the United States, but many women do not realize 
this fact. I know that for the past several years, the NIH has been 
working with the fashion industry in your Heart Truth Campaign to 
increase women's knowledge about their No. 1 killer and that the Heart 
Truth Road Show stopped in Pittsburgh recently. Please explain to the 
Committee about the progress of this initiative?
    Answer. The National Heart, Lung, and Blood Institute's (NHLBI) The 
Heart Truth campaign continues to flourish, extending the reach of the 
campaign in a variety of ways.
  --As the campaign ambassador, First Lady Laura Bush is leading the 
        federal effort to give women a personal and urgent wake-up call 
        about their risk of heart disease, participating in more than a 
        dozen Heart Truth events around the nation over the past 3 
        years.
  --Corporate partners, including General Mills, Minute Maid, and 
        DermaDoctor, have featured the campaign's Red Dress (emblematic 
        of the message ``Heart disease doesn't care what you wear; it's 
        the killer of women'') on more than 60 million product 
        packages. Johnson & Johnson, L'eggs hosiery, Benecol, Starkist 
        Tuna, and Celestial Seasonings have promoted The Heart Truth 
        campaign and Red Dress logo in newspaper advertising inserts, 
        resulting in a combined circulation of 370 million.
  --The Red Dress Collection 2006 Fashion Show took place on the third 
        annual National Wear Red Day--Friday, February 3, 2006. People 
        throughout the country participated in the day's celebration to 
        increase awareness of women's heart disease.
  --The Heart Truth Road Show visited shopping malls in Pittsburgh, 
        Memphis, and Washington, DC, in the spring of 2006 to raise 
        awareness about women and heart disease by helping participants 
        learn about risk factors; providing free health screenings 
        including blood pressure, body mass index, total blood 
        cholesterol, and blood glucose; and disseminating educational 
        materials.
  --The campaign launched ``Know The Heart Truth'' in April 2006, an 
        initiative that is recruiting and training health advocates and 
        educators in local communities to increase awareness about 
        women and heart disease. The Heart Truth has also formed 
        partnerships with leading organizations representing women of 
        color to engage in national and local activities, including a 
        faith-based initiative, to help women reduce their risk for 
        heart disease.
    The impact of The Heart Truth campaign is already becoming 
apparent. Awareness of heart disease as the leading cause of death 
among American women increased from 34 percent in 2000 to 46 percent in 
2003 to 55 percent in 2005. A 2005 survey commissioned by WomenHeart 
found that 60 percent of U.S. women agreed that the Red Dress makes 
them want to learn more about heart disease. Twenty-five percent of 
women recalled the Red Dress as the national symbol for women and heart 
disease awareness and 45 percent agreed that it would prompt them to 
talk to their doctor and/or get a check-up. A Lifetime Television 
Women's Pulse Poll released in February 2006 showed that women are 
increasingly aware of the dangers of heart disease. Thirty-nine percent 
of survey participants recognized the Red Dress as the national symbol 
for women and heart disease awareness, up from 25 percent in 2005.

                                 STROKE

    Question. Following up on language from last year's congressional 
report, please provide this Committee with highlights of implementation 
progress on the Stroke Progress Review Group report.
    Answer. In 2001, the NINDS convened the first meeting of the Stroke 
Progress Review Group (SPRG) to identify and prioritize scientific 
opportunities and needs in stroke research. One hundred forty prominent 
scientists, clinicians, patient advocates, and industry representatives 
participated and developed a set of scientific and resource 
recommendations that the NINDS assembled in a Report of the SPRG in 
2002. In 2003, the chairs of the SPRG meeting reprioritized their 
recommendations and identified a subset of high priorities for stroke 
research in an Implementation Report. Many of the following research 
activities address the scientific research and resource priorities 
identified by the SPRG in its 2002 Report and 2004 Implementation 
Report.
    The NINDS is funding a wide range of studies on the basic biology 
of stroke, including the role of the blood-brain barrier (BBB; the 
cellular barrier that controls the exchange of substances between the 
blood and the nervous system) and the neurovascular unit (NVU; the 
functional ``unit'' comprised by brain blood vessels, glial support 
cells, and neurons). Understanding the function of the NVU and the BBB 
in stroke is critical to developing strategies for treating and 
preventing stroke and related conditions such as vascular cognitive 
impairment (VCI). NINDS is supporting a variety of stroke-related 
studies focused on the roles of the NVU and the BBB under two recent 
Program Announcements with set-aside funding. To more fully understand 
the biological basis of VCI, the Institute held a workshop in June 2006 
to discuss the cell biology of VCI and develop recommendations to 
accelerate research in this area.
    To facilitate the translation of basic research findings into the 
clinical setting, NINDS is planning to expand its Specialized Programs 
of Translational Research in Acute Stroke to include seven programs 
across the country participating in clinical trials, training of 
research fellows, and translational research on stroke. In addition, 
NINDS released two new grant solicitations to address barriers to 
translational research in stroke.
    The NINDS also continues to fund many clinical trials involving 
potential interventions and preventive strategies for stroke. To 
improve outcomes for stroke patients in emergency-room settings, the 
NINDS is developing a Neurological Emergencies Treatment Trials (NETT) 
Network of emergency medicine physicians, neurologists, and 
neurosurgeons, and plans to fund the clinical coordinating center 
component of the NETT in fiscal year 2006. The Institute is also 
supporting research on the causes of stroke among high risk groups, 
improved methods for diagnosing stroke, and a range of educational 
outreach programs to increase awareness of stroke risk factors and 
symptoms.
    In September 2006, the NINDS will sponsor another meeting of the 
SPRG to assess research progress in stroke, evaluate current 
priorities, and identify new opportunities for advancing stroke 
research. Prior to the meeting, 16 working groups will assess progress 
and develop recommendations for future priorities on topics ranging 
from genetics of stroke to recovery and rehabilitation. NINDS solicited 
information from the stroke research community on research progress and 
remaining needs and research gaps, and will provide this feedback to 
the SPRG participants prior to their deliberations. Following the 
September meeting, the SPRG will produce a mid-course implementation 
report that reflects the current status of stroke research and 
identifies new priorities.

               CLINICAL AND TRANSLATIONAL SCIENCE AWARDS

    Question. You have announced that by the year 2010, the GCRC 
program will have been phased out and the funding transferred to a new 
program. How are you going to assure that the CTSAs maintain or enhance 
services currently provided by the GCRCs including specialty nursing 
care, patient facilities, laboratory testing, and specialized 
monitoring and diagnostic capabilities?
    Answer. Applicants for the Clinical and Translational Science 
Awards (CTSAs) are asked to propose a center, department, or institute 
for clinical research that will transform the clinical and 
translational research environment at their institution. Up to $6 
million additional funds may be requested in addition to certain 
National Center for Research Resources (NCRR) and NIH Roadmap awards 
held by the institution at the time of application. These additional 
funds may be used to transform the local, regional, and national 
environment for clinical and translational science, thereby increasing 
the efficiency and speed of clinical and translational research. By 
introducing CTSAs as an increase in support, NIH is allowing applicants 
to retain such services as are currently provided by the General 
Clinical Research Centers (GCRCs) that they deem needed for their 
clinical research, such as inpatient and outpatient facilities, 
laboratory testing, and specialized monitoring and diagnostic 
capabilities.
    Question. You have announced that by the year 2010, the GCRC 
program will have been phased out and the funding transferred to a new 
program. How will you monitor the impact on the vitally important 
clinical research support currently provided to patients and 
investigators through the GCRCs?
    Answer. NIH staff review GCRC Annual Reports, communicate 
frequently with grantees, and attend annual meetings with Center 
grantees in Washington, DC. Clinical and Translational Science Awards 
likewise will submit Annual Reports and will establish Steering 
Committees on which NIH will be represented. These various tools and 
forums provide opportunities to assess the impact of the Clinical and 
Translational Science Awards and General Clinical Research Centers and 
will assure NIH of the requisite monitoring for impact on clinical 
research support.
    Question. You have announced that by the year 2010, the GCRC 
program will have been phased out and the funding transferred to a new 
program. Will institutions that lose their existing GCRC funding and do 
not receive CTSA awards be able to support patient-oriented research 
facilities and services?
    Answer. The 60 CTSAs that NIH plans to award could support over 90 
percent of the institutions that currently have GCRCs. Researchers that 
perform patient oriented research at institutions that do not receive 
CTSAs may apply for investigator-initiated NIH research supported by a 
variety of NIH grant mechanisms including Research Project and Research 
Program Projects and Centers grants. Additional sources of research 
support for investigators may come from Research Foundations, 
partnerships with industrial sponsors and institutional funds.
    Question. You have announced that by the year 2010, the GCRC 
program will have been phased out and the funding transferred to a new 
program. Will researchers in these institutions have to cancel planned 
patient-oriented research projects because of inadequate facilities? 
Certainly, the NIH budget is too constrained to provide this support 
through other competitive mechanisms.
    Answer. Researchers in the institutions that do not receive 
Clinical and Translational Science Awards may apply for investigator 
initiated NIH research supported by numerous NIH grant mechanisms 
including Research Project and Research Program Projects and Centers 
grants. Research Foundations, partnerships with industrial sponsors, 
and institutional funds may also provide additional sources of research 
support for investigators.
    Question. The K12 training mechanism is required for the CTSA 
award. Why isn't the GCRC M01 mechanism required? The RFA appears to 
marginalize the GCRCs and their functions, and I am concerned about 
that. Why not require the M01 mechanism in the CTSA award RFA in 2007?
    Answer. Applicants for a CTSA are required to include a Mentored 
Clinical Research Scholar Award (K12) component in their proposal so as 
to promote clinical and translational research as a distinct 
discipline. There is no requirement for applicants to be K12 awardees 
for them to apply for a CTSA. NCRR has not made an M01 award an 
eligibility requirement for a CTSA application in the expectation that 
certain new affiliations amongst institutions that do not currently 
hold an M01 award would be strong enough to compete successfully. CTSAs 
will support the discipline of clinical and translational science and 
the needs of its researchers, so applicants are encouraged to look 
beyond the constraints of M01 awards and to propose novel concepts, 
methodologies, and approaches that could be integrated into a 
comprehensive, effective, and efficient researcher-, trainee-, and 
participant-centered clinical research program.
    Question. Could NIH maintain a GCRC or mini-GCRC program for 
institutions that have had strong GCRCs, historically, but do not 
receive CTSA awards.
    Answer. NCRR has received wide support for the new CTSA program, so 
we believe that the purposes of clinical research will best be served 
by a smooth and uninterrupted transition. Several new consortia are 
expected to apply for CTSAs and clinical research at those sites that 
compete well in the peer review process should not be delayed by 
prolongation of the GCRC program. Retaining the GCRC program would 
limit the funding available for the CTSA program and NIH believes that 
this would be detrimental to the needs and interests of the majority of 
clinical investigators.
    Question. Have you considered the possibility of a ``pause'' after 
the second year of implementation to evaluate the effectiveness and 
impact of the new CTSA program before proceeding with additional 
awards?
    Answer. The combination of Annual Reports with Clinical and 
Translational Science Award Steering Committees will assure NIH of the 
requisite evaluation opportunities during their implementation. In the 
event that changes are required to optimize the award functionality, 
they can be made without the delays that would be incurred through a 
``pause'' in making awards.
    Question. Do you have a fall-back plan if the budget is not 
sufficient to accommodate the implementation of the CTSA program as you 
envision it?
    Answer. Transformation of Clinical Research infrastructure programs 
from GCRCs to CTSAs will be funded principally by NCRR appropriated 
funds, with additional funds from the NIH Roadmap for Medical Research. 
The project period for CTSA grants is 5 years, and NIH is planning for 
an additional 5-year competitive renewal of these awards. The fiscal 
year 2006 funding level for the combined CTSA/GCRC program is 
$322,740,000 and their estimated fiscal year 2007 funding level is 
$361,200,000. NIH plans to award four to seven CTSAs in fiscal year 
2006, to increase the number of awards annually, and to have 60 CTSAs 
in place by 2012. While changes in Congressional Appropriations would 
affect both the GCRC and CTSA programs in parallel, the transformation 
of the GCRC program to CTSAs is occurring in response to user demand.

                       POLYCYSTIC KIDNEY DISEASE

    Question. The Food and Drug Administration has granted ``Fast 
Track'' designation for Tolvaptan, a promising drug therapy designed to 
retard disease progression in polycystic kidney disease (PKD) and thus 
prevent kidney failure. What does the NIH plan to do to make the most 
of this discovery and foster the development of further PKD therapies?
    Answer. The NIH is committed to research that will pursue 
opportunities to combat polycystic kidney disease (PKD)--a serious, 
burdensome, and costly disease. Within the NIH, the National Institute 
of Diabetes and Digestive and Kidney Diseases (NIDDK) supports a 
diverse portfolio of basic and clinical research into the underlying 
biology of and possible therapies for PKD. The Interdisciplinary 
Centers for Polycystic Kidney Disease Research are important components 
of this research portfolio. The NIDDK recently renewed funding for four 
Centers for five additional years. Three of the Centers focus on the 
more common autosomal dominant PKD (ADPKD), and will explore 
extensively the basic and clinical functional changes seen in ADPKD. 
The fourth is a Research and Translational Core that focuses on 
autosomal recessive PKD (ARPKD) and will make available to 
investigators in the field a broad range of model research systems and 
reagents for the study of ARPKD.
    The Institute also has two other major research projects related to 
PKD--the HALT-PKD trial network, and the Consortium for Radiologic 
Imaging Studies of PKD (CRISP) cohort study. CRISP was established to 
develop innovative and standardized imaging techniques and analyses 
that would allow clinicians to reliably follow disease progression of 
ADPKD. This four-year study followed 240 PKD patients with annual 
glomerular filtration rate evaluation (a measure of kidney function), 
and magnetic resonance imaging to assess changes in kidney volume over 
time. The first phase of CRISP was recently completed, and the primary 
study results were published in the New England Journal of Medicine in 
May 2006 (NEJM 354: 2122-2130, 2006). Although the preliminary findings 
show promise for use of imaging methods and structural endpoints for 
tracking progression of ADPKD, the NIDDK has extended the CRISP cohort 
study for another five years, in order to collect additional structure 
and function data on enrolled subjects. Additional data from CRISP II 
will enable investigators to assess how reliably structural changes can 
predict functional kidney changes over time in ADPKD. The CRISP II 
investigators are currently developing the protocol for the next phase 
of the study.
    The Polycystic Kidney Disease Clinical Trials Network, co-funded by 
the PKD Foundation, is conducting two phase III-type studies in the 
HALT-PKD trial--one in patients with early kidney disease and another 
in patients with more advanced disease. HALT-PKD is testing whether 
blockade of the renin-aldosterone-angiotensin system, with angiotensin-
converting enzyme inhibitor monotherapy or combination angiotensin-
converting enzyme inhibitor and angiotensin receptor blocker, will slow 
the progression of ADPKD. A partnership was also negotiated with 
industry to provide medications for testing in these studies. The HALT-
PKD trial in subjects with early kidney disease is novel in that it is 
implementing the CRISP imaging methods in order to determine how 
reliable the methods are for interventional studies in ADPKD. The 
ability to reliably implement imaging methods for trials of ADPKD will 
have a significant impact on planning future interventional studies of 
new therapeutics in this disease. The HALT-PKD studies began enrolling 
patients in January 2006, and will be the largest interventional trial 
ever conducted in ADPKD.

                    NATIONAL PRIMATE RESEARCH CENTER

    Question. The fiscal year 2006 Labor-HHS-Education Appropriations 
bill provided the NIH Office of AIDS Research with up to $4 million to 
spend for construction or renovation necessary to expand a breeding 
colony for non-human primates for AIDS research, which is intended to 
be collaborative effort amongst the National Primate Research Centers. 
What progress has been made on that effort, and what is the expected 
completion date?
    Answer. Although the fiscal year 2006 bill allows the Office of 
AIDS Research (OAR) to utilize funds for construction for the national 
breeding resource facility, funds will not be used for that purpose in 
fiscal year 2006. In late fiscal year 2005, the Tulane National Primate 
Research Center successfully competed for the first phase of a national 
breeding resource facility project. However, construction capability in 
this region has been limited in the aftermath of Hurricane Katrina. 
Thus the second phase of this project has not proceeded as scheduled. 
Consequently, OAR cannot use this provision of the fiscal year 2006 
appropriations bill this year. Instead, OAR provided funds to NCRR to 
support AIDS-related research infrastructure needs and increased 
operating expenses, such as unanticipated high energy costs, at the 
National Primate Research Centers (NPRCs). A timeline for completing 
the national breeding resource facility project is being reassessed.
                                 ______
                                 
               Questions Submitted by Senator Tom Harkin

                     COLLABORATION AMONG INSTITUTES

    Question. Dr. Zerhouni, one of the most common complaints I hear 
from advocacy groups is that they can't get multiple NIH institutes and 
centers (ICs) to work together on common goals. Consider diseases like 
scleroderma, neurofibromatosis or epilepsy, all of which fall under the 
jurisdictions of more than one IC. In each case, one IC might be 
designated as taking the lead on the disease, but other ICs also share 
the responsibility for conducting research on it. Too often, 
unfortunately, patients complain that the ICs don't collaborate. 
Sometimes the patients themselves practically have to drag a researcher 
from one institute into a meeting with a researcher from another 
institute, just to get them to talk.
    I know you're well aware of this problem. It's an issue that the 
National Academies addressed in its report on NIH's structure in 2003. 
What are you doing to improve the situation?
    Answer. In 2002, I began a process called the Roadmap for Medical 
Research that was designed to identify major opportunities and gaps in 
biomedical research that no single institute at NIH could tackle alone 
to make the biggest impact on the progress of medical research. A 
primary accomplishment of the Roadmap was internal ``functional 
integration'' of the 27 institutes and centers (IC) to plan, implement 
and fund initiatives that go beyond the mission of any one IC. These 
accomplishments led to creation of the Office of Portfolio Analysis and 
Strategic Initiatives (OPASI) which has begun to institutionalize these 
processes. The establishment of OPASI represents a major organizational 
change at NIH aimed primarily at addressing challenges in the 
coordination of biomedical research of benefit to every IC. Using a 
combination of approaches such as agency-encompassing portfolio 
analysis and establishment of a common fund for shared needs, OPASI 
will synergize diverse components of the NIH toward the attainment of 
common goals more efficiently. Continuing the tradition of the NIH 
Roadmap, this office will also support well-developed initiatives that 
address areas of science which do not clearly fall within the mission 
of any one IC or program office. This makes OPASI a natural space for 
NIH ICs to work together on broad-reaching opportunities which will 
impact multiple aspects of public health and disease intervention.

                         CONFLICTS OF INTEREST

    Question. Last August, NIH announced the final ethics rules on 
conflicts of interest. What impact are they having on employee 
retention and recruitment, and on interactions between NIH scientists 
and outside associations, such as trade groups and scientific 
associations?
    Answer. Regarding Employee retention and recruitment. In the 
preamble to the final rule (published in August 2005), we stated that 
we would review the rule to ``evaluate continued adequacy and 
effectiveness in relation to current agency responsibilities.'' We are 
particularly interested in learning about any effects that the 
prohibited holding and outside activities provisions of the rule have 
had on hiring and retention. We are currently in the process of 
conducting a survey of current NIH employees, collecting their feedback 
related to the new regulations. In separate surveys in the coming 
months, we intend to ask former employees (those who left the NIH after 
January 1, 2005) and potential employees their opinions as well.
    Interactions between NIH scientists and outside associations, such 
as trade groups and scientific associations. The regulations do not 
affect official duty interactions that scientists may have with trade 
groups or scientific associations.

                              PANDEMIC FLU

    Question. We are all concerned about how long it would take between 
the time that we detected a pandemic flu virus in the United States and 
when we could create a vaccine for it. Right now, if a pandemic were to 
occur, I understand that it would take almost six months to produce a 
vaccine, using our current egg-based methods.
    HHS recently invested $1 billion in the development of new cell-
based technologies to produce a pandemic vaccine. We're all looking 
forward to the results. But even if successful, a cell-based vaccine 
would not be immediately available at the time of a pandemic.
    The current methods of vaccine development are commonly referred to 
as the ``one drug, one bug'' philosophy--develop a vaccine for each flu 
strain or strains. But that means that you have to identify the ``bug'' 
or flu strain before you can begin to manufacture a vaccine. However, I 
have heard that there is work being done to develop a vaccine that 
would address all strains of the flu--a ``one drug, many bugs'' plan. 
Is NIH supporting this type of research? Does it have promise?
    Answer. The National Institute of Allergy and Infectious Diseases 
(NIAID) is supporting research and development of alternate approaches 
to dealing with the threat of emerging and re-emerging infectious 
diseases such as influenza.
    For example, NIAID is pursuing the development of a ``universal 
vaccine'' that protects against multiple virus strains such as those 
resulting from antigenic drift associated with seasonal influenza and 
antigenic shift associated with pandemic influenza. As influenza 
viruses circulate, the genes that determine the structure of their 
surface proteins undergo small changes. Sometimes the change in the 
genes results in a slight change in the antigenic properties of the 
protein, a process commonly referred to as ``antigenic drift.'' 
Antigenic drift is the basis for the changes in seasonal influenza 
observed during most years, and is the reason that we must update 
influenza vaccines annually. Influenza viruses also can change more 
dramatically. For example, viruses sometimes emerge that can jump 
species from natural reservoirs, such as wild ducks, to infect domestic 
poultry, farm animals, or humans. When an influenza virus jumps species 
from an animal, such as a chicken, to infect a human, the result is 
usually a ``dead-end'' infection that cannot readily spread further in 
the human population. However, mutations in the virus could develop 
that allow human-to-human transmission. Furthermore, if an avian 
influenza virus and another human influenza virus were to 
simultaneously co-infect a person or animal, the two viruses might swap 
genes, possibly resulting in a virus that is readily transmissible 
between humans, and against which the population would have no natural 
immunity. These types of significant changes in influenza viruses are 
referred to as ``antigenic shift.'' When an ``antigenic shift'' occurs, 
a global influenza pandemic can result. Historically, pandemic 
influenza is a proven threat. In the 20th century, influenza pandemics 
occurred in 1918, 1957, and 1968.
    The NIAID is supporting a number of research projects to develop a 
vaccine that induces a potent immune response to the common elements of 
the influenza virus that undergo very few changes from season to season 
and from strain to strain. Although this is a difficult task, such a 
``universal'' influenza vaccine would not only provide continued 
protection over multiple seasons, it might also offer protection 
against a newly emerged pandemic influenza virus and thus substantially 
reduce the susceptibility of the population to infection by any 
influenza virus--making the country far less vulnerable to influenza 
viruses emerging from avian and other animal sources.
    One relatively stable element of the influenza virus is a protein 
called M2. The external portion of the M2 protein is very similar in 
influenza viruses from year to year and from strain to strain. A 
``universal'' influenza vaccine targeting the M2 protein, or other 
conserved elements, could be protective against a range of influenza 
strains. NIAID-supported researchers have demonstrated that vaccines 
made with bioengineered versions of M2 can protect mice from lethal 
influenza virus. The scientists now are testing cross-reactivity 
between different species and strains of influenza, examining how long 
the immunity provided by these vaccines lasts, and evaluating whether 
the influenza viruses can evade these vaccines by developing mutations 
in their M2 proteins.
    In addition, researchers at the NIAID Vaccine Research Center (VRC) 
are developing and testing gene-based influenza vaccines that will 
protect against multiple strains of influenza. As a first step, initial 
candidate vaccines, each containing the gene encoding the hemagglutinin 
(H) surface protein of an influenza virus isolated from a recent human 
outbreak of influenza (H1N1, H3N2 or H5N 1), have already shown promise 
in animal studies. VRC researchers plan to develop additional gene-
based vaccines for all common variants of hemagglutinin, as well as 
other influenza viral proteins, such as nucleoprotein and the M2 
protein. In the future, the VRC will incorporate both conserved and 
variable genes from multiple influenza strains into DNA and adenovirus 
vectors that can readily be produced by existing manufacturing 
processes.
    A second approach, while not technically a vaccine, is an immune 
enhancer which specifically targets a component of the immune system 
and enhances one's ability to respond to a broad range of microbial 
threats. Studies of the human innate immune system, which is comprised 
of ``first responder'' cells and other defenses that provide a first 
line of defense against a wide variety of pathogens, have been moving 
forward rapidly. These advances suggest it may be possible to develop a 
relatively small set of fast-acting, broad-spectrum countermeasures 
that can boost innate immune responses to many pathogens or toxins, 
including influenza. The capability to boost the innate immune system 
also could lead to the development of more powerful vaccine additives, 
called adjuvants, that can increase vaccine potency. The concept of 
immune enhancers has been demonstrated in early. stage clinical 
studies, but requires further research and development to be applied to 
pandemic influenza vaccination.
                                 ______
                                 
            Questions Submitted by Senator Daniel K. Inouye

                     TRADITIONAL HEALING PRACTICES

    Question. Last year, at my request, Dr. Donald Lindberg, Director 
of the National Library of Medicine, visited one of our Native Hawaiian 
Healing programs at Papa Ola Lokahi for the purpose of conducting 
``listening circles'' to discuss the needs for preservation and 
documentation of traditional cultural healing practices. I am very 
interested in a report of his findings from this visit. I am most 
appreciative of the National Library of Medicine's continued interest 
and support of Native Hawaiian issues.
    Answer. Early this year NLM convened a working group to examine 
both the feasibility of an exhibition on Native health and healing, and 
NLM's role in collecting and preserving information about traditional 
medicine. As a result of this working group, NLM has reviewed its 
collection to develop policies, as well as examined its collection in 
these areas. Subsequently, the Library has made an effort to collect 
modern publications such as all the items in the Bishop Museum's 
(Honolulu, HI) current catalog as well as their out of print materials.
    In addition to purchasing standard published materials, NLM is also 
obtaining input from Native American (including Native Hawaiian) 
healers, leaders, educators, and others, on appropriate collection and 
preservation policies. Over the past year, since the series of 
Listening Circles the NLM participated in with different Native 
Peoples, NLM staff have met with many such individuals to gain insight 
into the issues of collecting and preserving information about 
traditional healing practices. For example, in February, NLM staff met 
with librarians and curators from the Bishop Museum, Hawaiian 
Historical Society, The Hawaiian Mission Children's Society Library, 
and the University of Hawaii to gather information to planning a larger 
follow-up meeting.
    This meeting, to include NLM staff, occurred in July 2006, and a 
report of findings from this visit will be prepared.

                      DEVELOPING NURSE RESEARCHERS

    Question. A long-standing supporter of the National Institute for 
Nursing Research, I am pleased with the extensive array of research 
initiatives that have been undertaken by the Institute. I am 
particularly pleased with those endeavors that are directed at 
developing the pool of nurse researchers who also become nurse faculty. 
Another important initiative is training support for fast-track 
baccalaureate to doctoral program participants. I welcome news of the 
Institute's progress in facilitating research projects in rural areas 
that serve minority students via community colleges.
    Answer. NINR considers the development of nurse researchers and 
nurse faculty to be a fundamental component of its research mission. 
Indeed, developing nurse investigators will be an overarching goal in 
the Institute's new strategic plan for 2006-2010.
    Approximately 7 percent of NINR's budget supports the Institute's 
Centers programs, which are used to develop the nursing research 
infrastructure and train new investigators. In addition to our ten Core 
and nine Exploratory Centers, we have co-sponsored a joint initiative 
with the National Center on Minority Health and Health Disparities that 
supports partnerships between established, research-intensive 
institutions and growing, minority-serving institutions. These Nursing 
Partnership Centers on Reducing Health Disparities, involving 17 
schools of nursing, will increase health disparities research and 
broaden the diversity of the nurse scientist pool. Several of these 
Centers are located in rural areas or serve rural and other underserved 
populations. These Centers represent a major investment aimed at 
expanding the cadre of nurse scientists involved in health disparities 
research.

                   BACCALAUREATE TO DOCTORAL PROGRAMS

    Question. A long-standing supporter of the National Institute for 
Nursing Research, I am pleased that the Administration has continued 
funding of this program. However, what impact will the $1 million 
reduction have on the National Institute of Nursing Research's 
development of initiative that supports fast-track baccalaureate-to-
doctoral programs? These programs were proposed to help increase the 
number of nursing faculty and in turn decrease the number of qualified 
nursing school candidates who were turned away in prior years.
    Answer. The overall reduction of $792,000 in the fiscal year 2007 
budget request of $136.6 million for the National Institute of Nursing 
Research (NINR) will have no impact on its programs that fast-track 
baccalaureate-to-doctoral nurses to increase the number of nursing 
investigators. These programs are supported within the Research 
Training mechanism in NINR, and the fiscal year 2007 President's Budget 
maintains the current level of support of this activity. NINR remains 
committed to developing the next generation of nurse scientists. NINR 
encourages and supports strategies to change the career trajectory of 
nurse scientists. The Institute emphasizes early entry into research 
careers, including fast-track baccalaureate-to-doctoral programs, and 
supports pre-doctoral and postdoctoral nurses who are the future 
researchers and nursing faculty.

                             CANCER CENTERS

    Question. The National Cancer Institute has had great success and 
demonstrated value in its system of cancer centers across the country. 
When awarding core grants for cancer research, is attention paid to 
geographic and ethnic diversity to ensure that results will capture the 
often significant differences in outcomes among various ethnic groups 
and lifestyles?
    Answer. The NCI-designated Cancer Centers are vital parts of a 
national strategy to reduce the suffering and death due to cancer. The 
NCI Cancer Centers Program provides critical infrastructure for 
academic and research institutions throughout the United States that 
provide broad based, coordinated, interdisciplinary programs in cancer 
research. These institutions are characterized by scientific excellence 
and a capacity to integrate various research approaches focused on the 
problem of cancer. Generally, in order to become an NCI-designated 
Cancer Center, an institution must have a large cancer-relevant grant 
funding base; substantial institutional commitment in the form of 
space, resources, and authorities provided to the Center Director; a 
synergistic organization of transdisciplinary research across all 
scientific areas of the institution; and, specifically for 
comprehensive centers, community outreach, education, and training 
activities.
    While the NCI designation is based solely on an evaluation of the 
science, Centers deliver medical advances to patients and their 
families; provide state-of-the-art care and access to clinical trials; 
serve as the major training ground for new clinicians and researchers; 
and have the strong links with national, state, and local agencies and 
advocacy groups needed to address cancer issues most relevant to their 
communities.
    Examples of strategies focused on the geographic reach of Cancer 
Center services include:
  --Minority Institution/Cancer Center Partnership Programs (MI/CCP).--
        The MI/CCP, which partner Minority-Serving Institutions (MSIs) 
        with existing NCI-designated Cancer Centers, was established in 
        2000 to take maximum advantage of their respective expertise 
        and experience. The program is designed to foster development 
        of independent cancer research programs and minority career 
        scientists in MSIs and to improve minority-focused outreach and 
        training efforts in NCI-designated Cancer Centers. 
        Participation in this program better positions MSIs to compete 
        for independent NCI designation and/or to form equal and 
        permanent research alliances with existing NCI-designated 
        Cancer Centers. These partnerships are expected to enable the 
        NCI-designated Cancer Centers to realize substantial progress 
        in their efforts to implement effective research, outreach, and 
        education programs that truly benefit minority populations.
  --Affiliations and Consortia.--Realizing that many institutions 
        serving minorities may not have the research capability or the 
        desire to apply for NCI designation independently, NCI revised 
        the Cancer Center guidelines to encourage the development of 
        affiliations and consortia. We specifically encourage 
        consideration of partnerships that address cancer in minority 
        and other underserved populations.
  --Emphasized Integration.--Through NCI's ``Discovery, Development, 
        Delivery'' continuum, we expect the continued development of 
        links between existing Cancer Centers, their affiliates and 
        partners in research; as well as state, municipal, and 
        community-based private organizations. NCI is actively seeking 
        mechanisms to foster both vertical integration (i.e., from the 
        Cancer Centers through the community layers they serve) and 
        horizontal integration (i.e., across Cancer Centers and a 
        nationwide network of public and private partners) of the 
        benefits of cancer research. This integration provides a more 
        unified approach to reducing cancer and cancer risk, and more 
        uniform delivery of the benefits of cancer research into all 
        communities.
    NCI recognizes that the Cancer Research Center of Hawaii is unique 
in the community it serves. NCI program staff regularly consults with 
existing NCI-designated centers on approaches for enhancing 
representation of underserved populations, and provides support and 
direction to Center and institutional leadership on how to maintain NCI 
designation; the latter activities are viewed as particularly critical 
for Centers with. significant minority and other undeserved 
populations.
    NCI continues to pay close attention to the Cancer Centers 
geographic placement. The latest planning grants for NCI Cancer 
Research Centers (an initial step to gaining designation) have gone to 
areas without an NCI-designated Center (University of Louisville, 
University of Oklahoma, Emory University, Medical University of South 
Carolina, and Howard University). The University of New Mexico, a 
former planning grant recipient, received Cancer Center designation 
last year. NCI also continues to advise emerging centers in a number of 
other underrepresented areas around the country on an informal basis.
    Additionally, the Cancer Centers themselves are increasingly 
establishing their own networks with community hospitals and private 
oncology practices and extending the benefits of care and clinical 
trials further into communities not previously reached.

                         CONSULTATION PROTOCOL

    Question. I am pleased that the National Library of Medicine and 
the National Cancer Institute have made substantial efforts to 
incorporate, within their program areas, resources to address Native 
Hawaiian health issues and concerns. The Secretary's latest directive 
on consultation directs the Intra-Department Council on Native American 
Affairs to incorporate Native Hawaiian health needs and concerns within 
the consultation framework for agencies within the Department of Health 
and Human Services similar to that afforded American Indians and Alaska 
Natives.
    Would the National Institutes of Health be willing to engage in 
discussions with Papa Ola Lokahi (Native Hawaiian Health Board) on how 
best the lessons learned working with the National Library of Medicine 
and the National Cancer Institute can be incorporated within all the 
Institutes of the National Institutes of Health to develop an agency-
wide consultation protocol for the National Institutes of Health and 
Native Hawaiians similar to that afforded to American Indians and 
Alaska Natives?
    Answer. The NCMHD has established a trans-NIH Committee to work on 
the NIH implementation of the Department of Health and Human Services' 
tribal consultation policy. As the committee prepares the NIH-wide 
tribal consultation protocol, it will look at various best practice 
models among the Institutes and Centers, including the National Library 
of Medicine and National Cancer Institute's models for lessons learned 
that could be incorporated into the protocol and be beneficial to Papa 
Ola Lokahi and other Native Hawaiians. The NIH recognizes the 
importance of listening, dialoguing, and developing relationships prior 
to developing programs and services, and would be willing to hear the 
suggestions of Papa Ola Lokahi.
                                 ______
                                 
               Questions Submitted by Senator Harry Reid

                     CHRONIC FATIGUE SYNDROME (CFS)

    Question. How many Chronic Fatigue Syndrome (CFS) specific grant 
applications were received, reviewed and funded for fiscal year 2004 
and fiscal year 2005?
    Answer. In fiscal year 2004, 17 CFS-specific grant applications 
(R01) were received and reviewed; 2 were awarded. One P50, a 
specialized center, was received and awarded. One R13, a conference 
grant, was received and awarded. In fiscal year 2005, eight CFS-
specific grant applications (R01) were received and reviewed; one was 
awarded. One K12, Physician Scientist Award, was received but not 
awarded.
    Question. Please provide a detailed list of the studies, 
institutions, lead researchers and individual grant amounts for all CFS 
studies funded in fiscal year 2004 and fiscal year 2005.
    Answer. The information requested is included in the following 
tables compiled by the OD Budget Office.

                                                      NATIONAL INSTITUTES FOR HEALTH--FUNDING FOR CHRONIC FATIGUE SYNDROME FISCAL YEAR 2004
                                                                                         [Whole dollars]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
              IC                    Project number         Principal investigator                Institution             State                       Project title                       Amount
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
NHLBI.........................  5 RO1 HL045462........  COLLINS, TUCKER O...........  CHILDREN'S HOSPITAL (BOSTON)....  MA.....  TRANSCRIPTIONAL REGULATION OF E-SELECTIN............   $177,750
NHLBI.........................  5 R01 HL054926........  ISCHIROPOUL OS, HARRY.......  CHILDREN'S HOSPITAL OF            PA.....  REACTIVE SPECIES IN VASCULAR DISEASE-INJURY             170,000
                                                                                       PHILADELPHIA.                              MECHANISMS.
NHLBI.........................  5 R01 HL055591........  LOMASNEY, JON W.............  NORTHWESTERN UNIVERSITY.........  IL.....  MOLECULAR BASIS FOR PROTEIN-PHOSPHOLIPID INTERACTION    148,500
NHLBI.........................  5 R01 HL056850........  CLEMMONS, DAVID R...........  UNIVERSITY OF NORTH CAROLINA      NC.....  MECHANISMS BY WHICH IGF-I STIMULATES SMOOTH MUSCLE      203,694
                                                                                       CHAPEL HILL.                               CELLS.
NHLBI.........................  5 R01 HL059459........  FREEMAN, ROY................  BETH ISRAEL DEACONESS MEDICAL     MA.....  ORTHOSTATIC INTOLERANCE IN CFS......................    392,186
                                                                                       CENTER.
NHLBI.........................  2 R01 HL061388........  CRANDALL, CRAIG G...........  UNIVERSITY OF TEXAS SW MED CTR/   TX.....  HEAT STRESS AND CIRCULATORY CONTROL.................     61,066
                                                                                       DALLAS.
NHLBI.........................  5 R01 HL066007........  STEWART, JULIAN M...........  NEW YORK MEDICAL COLLEGE........  NY.....  CIRCULATORY DYSFUNCTION IN CHRONIC FATIGUE SYNDROME.    252,000
NHLBI.........................  5 R0l HL067422........  CRANDALL, CRAIG G...........  UNIVERSITY OF TEXAS SW MED CTR/   TX.....  SKIN COOLING TO IMPROVE ORTHOSTATIC TOLERANCE.......    131,500
                                                                                       DALLAS.
NHLBI.........................  5 RO1 HL070215........  CALDWELL, ROBERT W..........  MEDICAL COLLEGE OF GEORGIA......  GA.....  ENDOTHELIAL CELL DYSFUNCTION IN OXIDATIVE STRESS        125,562
                                                                                                                                  MODELS.
                                                                                                                                                                                      ----------
      TOTAL, NHLBI............  ......................  ............................  ................................  .......  ....................................................  1,662,258
                                                                                                                                                                                      ==========
NINDS.........................  1R13NSO47105-01.......  HORTOBAGYI, TIBOR...........  EAST CAROLINA UNIVERSITY........  SC.....  INTERNATIONAL SYMPOSIUM ON MOTOR CONTROL USING TMS..      2,250
NINDS.........................  5Z01NS002979-06.......  GOLDSTEIN, DAVID............  NINDS...........................  MD.....  CLINICAL NEUROCARDIOLOGY: CATECHOLAMINE SYSTEMS IN      531,506
                                                                                                                                  STRESS AND DISEASE.
                                                                                                                                                                                      ----------
      TOTAL, NINDS............  ......................  ............................  ................................  .......  ....................................................    533,756
                                                                                                                                                                                      ==========
NIAID.........................  1 R01 AI05601401A1....  SULLIVAN, PATRICK F.........  UNIVERSITY OF NORTH CAROLINA      NC.....  MICROARRAYS & PROTEOMICS IN MZ TWINS DISCORDANT FOR     255,301
                                                                                       CHAPEL HILL.                               CFS.
NIAID.........................  5 RO1 AI042403-07.....  BARANIUK, JAMES N...........  GEORGETOWN UNIVERSITY...........  DC.....  MECHANISMS OF RHINITIS IN CFS.......................    232,800
NIAID.........................  5 R01 AI049720-05.....  JASON, LEONARD..............  DE PAUL UNIVERSITY..............  IL.....  ACTIVITY INTERVENTION FOR CHRONIC FATIGUE SYN- DROME    266,169
NIAID.........................  5 R01 AI051270-03.....  TAM, PATRICIA E.............  UNIVERSITY OF MINNESOTA TWIN      MN.....  VIRAL DSRNA AS A MEDIATOR OF CHRONIC MUSCLE DISEASES    334,125
                                                                                       CITIES.
NIAID.........................  2 RO1 AI054478-02.....  NATELSON, BENJAMIN H........  UNIV OF MED/DENT NJ NEWARK......  NJ.....  SLEEP AND CYTOKINES IN CHRONIC FATIGUE SYNDROME.....    334,904
                                                                                                                                                                                      ----------
      TOTAL, NIAID............  ......................  ............................  ................................  .......  ....................................................  1,423,299
                                                                                                                                                                                      ==========
NICHD.........................  R01HD043301-02........  TAYLOR,RENE E R.............  UNIVERSITY OF ILLINOIS AT         IL.....  CHRONIC FATIGUE SYNDROME IN ADOLESCENTS.............    267,009
                                                                                       CHICAGO.
                                                                                                                                                                                      ----------
      TOTAL, NICHD............  ......................  ............................  ................................  .......  ....................................................    267,009
                                                                                                                                                                                      ==========
NIAMS.........................  5-R01-AR-47678-03.....  BUCHWALD DEDRA S............  UNIVERSITY OF WASHINGTON........  WA.....  ARE FIBROMYALGIA AND CHIARI I MALFORMATION RELATED?.    146,712
                                                                                                                                                                                      ----------
      TOTAL, NIAMS............  ......................  ............................  ................................  .......  ....................................................    146,712
                                                                                                                                                                                      ==========
NIMH..........................  5K23MH001961-04.......  FRIEDBERG, FRED.............  STATE UNIVERSITY NEW YORK STONY   NY.....  PSYCHIATRIC COMORBIDITY IN CHRONIC FATIGUE SYN-         148,923
                                                                                       BROOK.                                     DROME.
                                                                                                                                                                                      ----------
      TOTAL, NIMH.............  ......................  ............................  ................................  .......  ....................................................    148,923
                                                                                                                                                                                      ==========
NINR..........................  R01-AI049720-05.......  LEONARD, JASON..............  DE PAUL UNIVERSITY..............  IL.....  ACTIVITY INTERVENTION FOR CHRONIC FATIGUE SYN-          100,000
                                                                                                                                  DROME.
                                                                                                                                                                                      ----------
      TOTAL, NINR.............  ......................  ............................  ................................  .......  ....................................................    100,000
                                                                                                                                                                                      ==========
NCRR..........................  2M01RR000037-44.......  SMITH, MARK.................  UNIVERSITY OF WASHINGTON........  WA.....  THE EFFECT OF PARENTAL CHRONIC FATIGUE SYNDROME ON       29,494
                                                                                                                                  OFFSPRING.
NCRR..........................  3P41RR002305-20S1.....  MCCULLY, KEVIN..............  UNIVERSITY OF PENNSYLVANIA......  PA.....  CHRONIC FATIGUE SYNDROME............................      5,742
NCRR..........................  5M01RR000039-44.......  PAPANICOLA OU, DIMITRIS A...  EMORY UNIVERSITY................  GA.....  EFFECTS OF CORTICOTROPIN-RELEASING HORMONE INFUSION     179,251
                                                                                                                                  IN NORMAL FEMALES.
NCRR..........................  5M01RR000042-44.......  WILLIAMS, DAVID A...........  UNIVERSITY OF MICHIGAN AT ANN     MI.....  SUBJECT REGISTRY: INTERDISCIPLINARY STUDIES OF            9,149
                                                                                       ARBOR.                                     CHRONIC MULTI-SYMPTOM ILLNESSES.
NCRR..........................  5M01RR000046-44.......  LIGHT, KATHLEEN C...........  UNIVERSITY OF NORTH CAROLINA      NC.....  FACTORS IN ARTHRITIS, CFS, FIBROMYALGIA &                74,144
                                                                                       CHAPEL HILL.                               TEMPOROMANDIBULA R DISORDERS.
NCRR..........................  5M01RR000052-43.......  ROWE, PETER C...............  JOHNS HOPKINS UNIVERSITY........  MD.....  DISORDERED RESPONSES TO ORTHOSTATIC STRESS IN . . .       7,991
                                                                                                                                  GULF WAR SYNDROME SYMPTOMS.
NCRR..........................  5M01RR000052-43.......  SCHWARTZ, CINDY.............  JOHNS HOPKINS UNIVERSITY........  MD.....  MOVEMENT RESTRICTION AND FATIGUE IN CANCER SURVIVORS        157
NCRR..........................  5M01RR002635-20.......  ADLER, GAIL.................  BRIGHAM AND WOMEN'S HOS- PITAL..  MA.....  IMMUNONEUROENDOC RINE RESPONSE TO TETANUS  TOXOID...      4,821
NCRR..........................  5MO1RR010710-07.......  FRIEDBERG, FREDRICK.........  STATE UNIVERSITY NEW YORK STONY   NY.....  PSYCHIATRIC COMORBIDITY IN CHRONIC FATIGUE SYNDROME.    159,869
                                                                                       BROOK.
NCRR..........................  5M01RRO10710-07.......  FRIEDBERG, FREDRICK.........  STATE UNIVERSITY NEW YORK STONY   NY.....  WHY DO PEOPLE DROP OUT OF SUPPORT GROUPS FOR CHRONIC      6,401
                                                                                       BROOK.                                     FATIGUE SYNDROME?.
NCRR..........................  5M01RR016587-03.......  HURWITZ, BARRY..............  UNIVERSITY OF MIAMI-MEDICAL.....  FL.....  RBC MASS/AUTONOMIC NERVOUS SYSTEM/INTEGRITY/SY NCOPE    142,237
                                                                                                                                  IN CHRONIC FATIGUE SYNDROME.
NCRR..........................  5P20RR011145-10.......  FRIEDMAN, THEODORE C........  CHARLES R. DREW UNIVERSITY OF     CA.....  USE OF VIAGRA TO ALTER SYMPTOMS IN PTS WITH CFS.....    118,851
                                                                                       MED & SCI.
NCRR..........................  5P41RR008119-12.......  TARASOV, SERGEY G...........  UNIVERSITY OF MARYLAND BALT PROF  MD.....  SPECT & DNA BINDING OF NAPHTYLIMIDO IMIDAZOACRIDONE      43,966
                                                                                       SCHOOL.                                    WMC79 & RELATED COMPOUND.
NCRR..........................  5P51RR000168-43.......  MADRAS, BERTHA K............  HARVARD UNIVERSITY (MEDICAL       MA.....  MOLECULAR TARGETS OF THE ANTI-NARCOLEPTIC DRUG           14,843
                                                                                       SCHOOL).                                   MODAFINIL.
NCRR..........................  5R13RR017508-03.......  LAKOWICZ, JOSEPH R..........  UNIVERSITY OF MARYLAND BALT PROF  MD.....  CFS COURSE ON FLUORESCENCE SPECTROSCOPY: MICROSCOPY,      4,084
                                                                                       SCHOOL.                                    DATA ANALYSIS, FLUOROMETRY.
                                                                                                                                                                                      ----------
      TOTAL, NCRR.............  ......................  ............................  ................................  .......  ....................................................    801,000
                                                                                                                                                                                      ==========
OD............................  1R01HD43301-02........  TAYLOR, RENEE...............  UNIVERSITY OF ILLINOIS, CHI-      IL.....  CFS.................................................    400,000
                                                                                       CAGO.
                                                                                                                                                                                      ----------
      TOTAL, OD...............  ......................  ............................  ................................  .......  ....................................................    400,000
                                                                                                                                                                                      ----------
      GRAND TOTAL.............  ......................  ............................  ................................  .......  ....................................................  5,482,957
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


                                                      NATIONAL INSTITUTES FOR HEALTH--FUNDING FOR CHRONIC FATIGUE SYNDROME FISCAL YEAR 2005
                                                                                         [Whole dollars]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
              IC                      Project number         Principal investigator              Institution             State                       Project title                       Amount
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
NHLBI.........................  5 R01 HL045462...........  COLLINS, TUCKER O........  CHILDREN'S HOSPITAL BOSTON......  MA.....  TRANSCRIPTIONAL REGULATION OF E-SELECTIN............   $177,750
NHLBI.........................  5 R01 HL054926...........  ISCHIROPOUL OS, HARRY....  CHILDREN'S HOSPITAL OF            PA.....  REACTIVE SPECIES IN VASCULAR DISEASE-INJURY             170,000
                                                                                       PHILADELPHIA.                              MECHANISMS.
NHLBI.........................  5 R01 HL055591...........  LOMASNEY, JON W..........  NORTHWESTERN UNIVERSITY.........  IL.....  MOLECULAR BASIS FOR PROTEIN-PHOSPHOLIPID INTERACTION    148,500
NHLBI.........................  5 R01 HL056850...........  CLEMMONS, DAVID R........  UNIVERSITY OF NORTH CAROLINA      NC.....  MECHANISMS BY WHICH IGF-I STIMULATES SMOOTH MUSCLE      209,541
                                                                                       CHAPEL.                                    CELLS.
NHLBI.........................  5 R01 HL059459...........  FREEMAN, ROY.............  BETH ISRAEL DEACONESS MED- ICAL.  MA.....  ORTHOSTATIC INTOLERANCE IN CFS......................    403,952
NHLBI.........................  5 RO1 HL061388...........  CRANDALL, CRAIG G........  UNIVERSITY OF TEXAS SW MED......  TX.....  HEAT STRESS AND CIRCULATORY CONTROL.................     47,164
NHLBI.........................  5 R01 HL067422...........  CRANDALL, CRAIG G........  UNIVERSITY OF TEXAS SW MED......  TX.....  SKIN COOLING TO IMPROVE ORTHOSTATIC TOLERANCE.......    131,500
NHLBI.........................  5 R01 HL070215...........  CALDWELL, ROBERT W.......  MEDICAL COLLEGE OF GEORGIA (MCG)  GA.....  ENDOTHELIAL CELL DYSFUNCTION IN OXIDATIVE STRESS        125,562
                                                                                                                                  MODELS.
                                                                                                                                                                                      ----------
      TOTAL, NHLBI............  .........................  .........................  ................................  .......  ....................................................  1,413,969
                                                                                                                                                                                      ==========
NINDS.........................  5Z01NS002979-07..........  DAVID, GOLDSTEIN.........  NINDS INTRAMURAL RESEARCH         MD.....  CLINICAL NEUROCARDIOLOGY: CATECHOLAMINE SYSTEMS IN      559,424
                                                                                       PROGRAM.                                   STRESS AND DISEASE.
NINDS.........................  9L30NS054198-02..........  FRANTOM, CATHERINE G.....  LOAN REPAYMENT..................  .......  NEURO-REHAB MEASUREMENT.............................      3,058
                                                                                                                                                                                      ----------
      TOTAL, NINDS............  .........................  .........................  ................................  .......  ....................................................    562,482
                                                                                                                                                                                      ==========
NIAID.........................  5 R0l AI051270-04........  TAM, PATRICIA E..........  UNIVERSITY OF MINNESOTA TWIN      MN.....  VIRAL DSRNA AS A MEDIATOR OF CHRONIC MUSCLE DISEASES    349,860
                                                                                       CITIES.
NIAID.........................  5 R01 AI054478-03........  NATELSON, BENJAMIN H.....  UNIV OF MED/DENT OF NJ-NJ         NJ.....  SLEEP AND CYTOKINES IN CHRONIC FATIGUE SYNDROME.....    673,289
                                                                                       MEDICAL SCHOOL.
NIAID.........................  1 R01 A1055735-01A2......  JASON, LEONARD A.........  DE PAUL UNIVERSITY..............  IL.....  RISK FACTRORS ASSOCIATED WITH CFS AND CF PRO- GNOSIS    541,703
NIAID.........................  5 R01 AI056014-02........  SULLIVAN, PATRICK F......  UNIVERSITY OF NORTH CAROLINA      NC.....  MICROARRAYS & PROTEOMICS IN MZ TWINS DISCORDANT FOR     518,667
                                                                                       CHAPEL HILL.                               CFS.
                                                                                                                                                                                      ----------
      TOTAL, NIAID............  .........................  .........................  ................................  .......  ....................................................  2,083,519
                                                                                                                                                                                      ==========
NICHD.........................  R01HD043301-03...........  TAYLOR, RENE E R.........  UNIVERSITY OF ILLINOIS AT         IL.....  CHRONIC FATIGUE SYNDROME IN ADOLESCENTS.............    268,159
                                                                                       CHICAGO.
                                                                                                                                                                                      ----------
      TOTAL, NICHD............  .........................  .........................  ................................  .......  ....................................................    268,159
                                                                                                                                                                                      ==========
NIAMS.........................  5-RO1-AR-47678-04........  BUCHWALD DEDRA S.........  UNIVERSITY OF WASHINGTON........  WA.....  ARE FIBROMYALGIA AND CHIARI I MALFORMATION RELATED?.    127,983
                                                                                                                                                                                      ----------
      TOTAL, NIAMS............  .........................  .........................  ................................  .......  ....................................................    127,983
                                                                                                                                                                                      ==========
NIMH..........................  5K23MH001961-05..........  FRIEDBERG, FRED..........  STATE UNIVERSITY NEW YORK STONY   NY.....  PSYCHIATRIC COMORBIDITY IN CHRONIC FATIGUE SYNDROME.    157,316
                                                                                       BROOK.
                                                                                                                                                                                      ----------
      TOTAL, NIMH.............  .........................  .........................  ................................  .......  ....................................................    157,316
                                                                                                                                                                                      ==========
NCRR..........................  1M01RR020359-01..........  BARANIUK, JAMES N........  CHILDREN'S RESEARCH INSTI-  TUTE  DC.....  RHINITIS IN CHRONIC FATIGUE SYNDROME (CFS)..........      3,236
NCRR..........................  2M01RR000052-44..........  SCHWARTZ, CINDY..........  JOHNS HOPKINS UNIVERSITY........  MD.....  MOVEMENT RESTRICTION AND FATIGUE IN CANCER SURVIVORS      1,246
NCRR..........................  2P20RR011145-11..........  FRIEDMAN, THEODORE C.....  CHARLES R. DREW UNIVERSITY OF     CA.....  USE OF VIAGRA TO ALTER SYMPTOMS IN PTS WITH CFS.....     19,782
                                                                                       MED & SCI.
NCRR..........................  2P41RR002305-21A1........  MCCULLY, KEVIN...........  UNIVERSITY OF PENNSYLVANIA......  PA.....  CHRONIC FATIGUE SYNDROME............................     16,453
NCRR..........................  5M01RR000037-45..........  SMITH, MARK..............  UNIVERSITY OF WASHINGTON........  WA.....  THE EFFECT OF PARENTAL CHRONIC FATIGUE SYNDROME ON        6,418
                                                                                                                                  OFFSPRING.
NCRR..........................  5M01RR000042-45..........  WILLIAMS, DAVID A........  UNIVERSITY OF MICHIGAN AT ANN     MI.....  SUBJECT REGISTRY: INTERDISCIPLINARY STUDIES OF           77,197
                                                                                       ARBOR.                                     CHRONIC MULTI-SYMPTOM ILLNESSES.
NCRR..........................  5M01RR000046-45..........  LIGHT, KATHLEEN C........  UNIVERSITY OF NORTH CAROLINA      NC.....  FACTORS IN ARTHRITIS, CFS, FIBROMYALGIA &                17,907
                                                                                       CHAPEL HILL.                               TEMPOROMANDIBUL AR DISORDERS.
NCRR..........................  5M01RR000048-44..........  TAYLOR, RENEE............  NORTHWESTERN UNIVERSITY.........  IL.....  A PROSPECTIVE STUDY OF CHRONIC FATIGUE SYNDROME IN       26,247
                                                                                                                                  ADOLESCENTS.
NCRR..........................  5MO1RR000071-42..........  MATHEW, SANJAY...........  MOUNT SINAI SCHOOL OF MEDICINE    NY.....  MRS NEUROMETABOLITE S IN CHRONIC FATIGUE SYNDROME,       10,871
                                                                                       OF NYU.                                    GENERALIZED ANXIETY DISORDER.
NCRR..........................  5MO1RRO10710-08..........  FRIEDBERG, FREDRICK......  STATE UNIVERSITY NEW YORK STONY   NY.....  PSYCHIATRIC COMORBIDITY IN CHRONIC FATIGUE SYNDROME.     48,251
                                                                                       BROOK.
NCRR..........................  5MO1RRO10710-08..........  FRIEDBERG, FREDRICK......  STATE UNIVERSITY NEW YORK STONY   NY.....  WHY DO PEOPLE DROP OUT OF SUPPORT GROUPS FOR CHRONIC     42,683
                                                                                       BROOK.                                     FATIGUE SYNDROME?.
NCRR..........................  5M01RR016587-04..........  HURWITZ, BARRY...........  UNIVERSITY OF MIAMI-MEDICAL.....  FL.....  RBC MASS/AUTONOMIC NERVOUS SYSTEM/INTEGRITY/SYNCOPE      28,827
                                                                                                                                  IN CHRONIC FATIGUE SYNDROME.
NCRR..........................  5P41RR008119-13..........  NOWACZYK, KAZIMIERZ......  UNIVERSITY OF MARYLAND BALT PROF  MD.....  CFS COMPUTERS.......................................     20,687
                                                                                       SCHOOL.
NCRR..........................  5P51 RR000168-44.........  MADRAS, BERTHA K.........  HARVARD UNIVERSITY (MEDICAL       MA.....  MOLECULAR TARGETS OF THE ANTI-NARCOLEPTIC DRUG          120,481
                                                                                       SCHOOL).                                   MODAFINIL.
NCRR..........................  5R13RR017508-04..........  LAKOWICZ, JOSEPH R.......  UNIVERSITY OF MARYLAND BALT PROF  MD.....  CFS COURSE ON FLUORESCENCE SPECTROSCOPY: MICROSCOPY,      4,207
                                                                                       SCHOOL.                                    DATA ANALYSIS, FLUOROMETRY.
                                                                                                                                                                                      ----------
      TOTAL, NCRR.............  .........................  .........................  ................................  .......  ....................................................    444,493
                                                                                                                                                                                      ==========
OD............................  1R01HD43301-03...........  TAYLOR, RENEE............  UNIVERSITY OF ILLINOIS AT         IL.....  CFS.................................................    300,000
                                                                                       CHICAGO.
OD............................  1R01AI055735-01A2........  JASON, LEONARD...........  DE PAUL UNIVERSITY..............  IL.....  CFS.................................................    100,000
                                                                                                                                                                                      ----------
      TOTAL, OD...............  .........................  .........................  ................................  .......  ....................................................    400,000
                                                                                                                                                                                      ----------
      TOTAL, NIH..............  .........................  .........................  ................................  .......  ....................................................  5,457,921
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Question. NIH is expected to announce later this month the awards 
made in response to the 7/14/05 RFA for CFS. Will the studies funded 
under this RFA yield a true increase in the level of NIH research 
funding for CFS?
    Answer. Yes. The 7 new grants funded will infuse an additional 
several million dollars into the bottom line for CFS funding that has 
remained relatively constant in the $5.5-$6 million range over the past 
years. A projected $2 million is derived from the redirected funds of 
the ORWH budget to fund and co-fund studies through the ICs. The 
remainder will be provided by the NIAAA, NIAMS, NIEHS, and NINDS. 
Additionally, individual letters sent from the Tans-NIH Working Group 
for Research on Chronic Fatigue Syndrome encouraged the unsuccessful 
applicants to revise and submit their proposals under the standing CFS 
Program Announcement. Many have been in touch for advice and plan to 
resubmit. The announcement resulted in increased interest from many 
researchers who had not previously conducted research on CFS. They are 
now aware that NIH interest in CFS is broad based and that many 
disciplines can contribute. It is expected that this RFA, information 
on the new website, and contacts established with members of the CFSWG 
will lead to. a further increase in investigator initiated submissions.
    Question. You have been a strong advocate for more centralized 
power and discretion within the NIH Office of the Director for the 
Roadmap Initiative to identify major opportunities and gaps in research 
that no single institute at NIH can tackle alone but that the agency as 
a whole must address. CFS is a complex illness that affects the brain 
and multiple body systems and thus is an example of a condition that 
must be addressed by multiple institutes. The CDC is expected to 
announce that CFS affects more than four million adults in the United 
States. In 1999, responsibility for CFS was moved to the Office of the 
Director. What progress in NIH's approach to the study of CFS has been 
made since this move?
    Answer. Tremendous progress has been and will continue to be made 
in pursuing and further stimulating CFS research. This is accomplished 
through a trans-NIH Working Group for Research on CFS (CFSWG) that is 
chaired by the Office of Research on Women's Health (ORWH) in the 
Office of the Director and includes members from 13 different ICs. The 
CFSWG was established in April 2001 to develop an action plan to 
enhance the status of CFS research at the NIH and among the external 
scientific community. The Working Group first issued a program 
announcement based on recommendations from the Chronic Fatigue 
Syndrome, State of the Science Conference held in October 2000 that 
encouraged innovative and interdisciplinary CFS research. The CFSWG 
updated and reissued this announcement in 2005 based on the results of 
a second NIH-sponsored scientific workshop. This workshop, Neuro-Immune 
Mechanisms and Chronic Fatigue Syndrome: Will understanding central-
mechanisms enhance the search for the causes, consequences and 
treatment of CFS?, was held in June 2003. Its proceedings were 
published in 2004 (NIH Publication No. 04-5497) and disseminated widely 
among the scientific community. The first issue of the new ORWH Science 
Series for the Public, informational fact sheets, is also derived from 
these proceedings. Also based on these proceedings, the ORWH and the 
CFSWG developed a request for applications (RFA) to explicate how the 
brain, as the mediator of the various body systems involved, fits into 
the schema for understanding CFS (RFA OD-06-002). This RFA specifically 
solicited proposals from multidisciplinary teams of scientists to 
develop an interdisciplinary approach to the mechanisms involved in CFS 
in men and women across the life span. Twenty-nine applications were 
received and are in process. All documents mentioned above as well as 
complete information about the NIH CFS program are available at http://
orwh.od.nih.gov/cfs.html. All of the above demonstrate concerted trans-
NIH efforts coordinated by an OD program office that is the focal point 
for research on women's health, ORWH, to engage the scientific 
community in addressing the many aspects of and increasing knowledge of 
CFS.
    Question. Has the move to the Office of the Director led to any 
real progress in multidisciplinary research? If so, what specifics can 
you point to?
    Answer. Yes. Collaborative achievements that include the 
development of an action plan to enhance the status of CFS research at 
the NIH and the products of this plan, such as trans-NIH Program 
Announcements, Requests for Applications, Scientific Workshops would 
not have been possible without the formation of a trans-NIH CFSWG 
chaired by the ORWH in the Office of the Director. The ORWH has had a 
long and successful track record for developing and leading 
interdisciplinary research and training initiatives on women's health 
and sex and gender factors in human health through its Coordinating 
Committee for Research on Women's Health (CCRWH), which brings together 
representatives from every institute and center to facilitate 
collaborative efforts. Similarly, the CFSWG, supported and led by the 
ORWH, is composed of representatives from 13 NIH institutes and centers 
with an interest in facilitating collaborative efforts to invigorate 
CFS research at the NIH.
    Question. How does the current status of CFS research within the 
NIH serve as a model for progress, based on more centralized authority 
within the Office of the Director or as a model for multidisciplinary 
approaches and the Roadmap.
    Answer. NIH has made steady progress towards an interdisciplinary 
approach to CFS through the efforts and function of an OD program 
office that was established to serve as the NIH focal point for the OD 
on women's health research. Therefore, the OD, through ORWH, was able 
to bring together diverse institutes to collaborate effectively in a 
trans-NIH initiative to enhance research on CFS. The ORWH also 
contributed staff and budget to these expanded research activities. 
This ORWH effort for CFS serves as an example of how an office within 
the OD can facilitate trans-NIH scientific initiatives that manifest 
real progress in research.
                                 ______
                                 
                Questions Submitted by Senator Herb Kohl

                          ALZHEIMER'S DISEASE

    Question. In April, the National Center for Health Statistics 
reported that the life expectancy of Americans has risen to 78 years--
the highest it has ever been. However, they also reported that the 
death rate from Alzheimer's disease is increasing among the top 10 
causes of death in the United States. In light of the fact that the 
Baby Boom generation is entering the age of highest risk for 
Alzheimer's, shouldn't NIH be increasing, rather than reducing, its 
investment in Alzheimer's research?
    Answer. It should be noted that our fiscal year 2007 funding level 
for Alzheimer's disease is an estimate and reflects a reduction that is 
comparable to the reductions in the total budgets of the NIH ICs 
supporting research in this important area. At this time, it is not 
possible to be precise as to where available funding will be allocated. 
Funding decisions will be based on public health need, scientific and 
technological opportunity, and the peer review of research 
applications.
    As the Senator points out, with current trends, Alzheimer's disease 
will become an increasingly critical public health concern over the 
coming decades. To reverse this trend, it is critical that we explore 
all promising avenues of discovery and promote the translation of 
research results into interventions for the successful prevention, 
detection, diagnosis, and treatment of Alzheimer's disease. Alzheimer's 
disease research continues to be a high priority for NIH, and 
scientific opportunities in this area will be actively pursued within 
available resources.

                                EPILEPSY

    Question. As you know, for years I have pushed NIH to work harder 
to develop better treatments and a cure for epilepsy. I have supported 
efforts by the National Institute of Neurological Disorders and Stroke 
to fund epilepsy research. However, many experts think we need a 
broader approach, with greater collaboration between NINDS and the 
National Institute on Mental Health, the National Institute on Child 
Health and Human Development, and other Institutes. What are you doing 
to guarantee that multi-Institute studies on epilepsy are developed and 
funded in the coming year?
    Answer. As the lead NIH Institute for epilepsy research, the 
National Institute of Neurological Disorders and Stroke (NINDS) 
coordinates epilepsy research efforts through the InterAgency Epilepsy 
Working Group. The Epilepsy Working Group is composed of scientific 
program staff from the NINDS, eight other Institutes, including the 
National Institute of Mental Health (NIMH) the National Institute of 
Child Health and Human Development (NICHD), and staff members from the 
Centers for Disease Control and Prevention. The Working Group 
facilitates coordination and collaboration among NIH Institutes. For 
example, NINDS and NIMH Epilepsy Working Group members collaborated 
with the American Epilepsy Society to sponsor an international workshop 
in May 2005 on treatment of nonepileptic seizures (NES), a 
neuropsychiatric seizure disorder. As a result of this meeting, the 
NIMH and the NINDS issued a request for applications on ``Collaborative 
Research on Mental and Neurological Disorders.''
    This initiative focused on co-morbidities between mental health and 
neurological disorders, including epilepsy.
    The NINDS and the NICHD have a long history of collaboration on 
epilepsy research. The NICHD funds the Mental Retardation Research 
Centers Program, a network of regional centers developed for research 
on mental retardation and related aspects of human development, 
including epilepsy. Many of the Centers also provide infrastructure for 
NINDS-supported epilepsy research projects. Both Institutes fully 
expect this successful collaboration to continue in the future.
    The NIMH, NICHD, and NINDS also collaborate in funding the Autism 
Research Network (ARN). The ARN is made up of eight collaborative 
research centers that focus on the causes, diagnosis, early detection, 
prevention, and treatment of autism. One of the network studies, ``A 
Longitudinal Assessment of Behavior Problems, Puberty, and Epilepsy'' 
is designed to investigate which children with autism develop seizures 
and whether there are changes in behavior that either precede or follow 
the development of seizures.
    Question. As you know, NINDS held a successful epilepsy conference 
in 2000, where research benchmarks were developed and used to create a 
research agenda in epilepsy. It's my understanding that NINDS is 
planning a follow-up conference on Curing Epilepsy in March 2007. Will 
you ensure that representatives from other Institutes participate in 
the 2007 conference? What steps will you take after the conference to 
ensure that collaborative research is pursued in order to have the 
greatest impact for epilepsy patients?
    Answer. The NINDS has invited all the organizations represented on 
the InterAgency Epilepsy Working Group (IAEWG) to participate in 
planning and co-sponsoring the Curing Epilepsy 2007 conference. Co-
morbidities, such as cognitive and psychological issues in children and 
adults with epilepsy, will be one of the major themes of the 
conference. Epilepsy co-morbidities often include behavioral problems, 
learning and memory difficulties, and depression. The NINDS expects 
that the conference will draw attention to the importance of these 
issues and will stimulate interdisciplinary investigation into the 
causes, treatment and prevention of epilepsy and its co-morbidities. 
The IAEWG will also consider the potential for collaborative activities 
in response to any recommendations that result from the Curing Epilepsy 
2007 conference.

                    AGE-RELATED MACULAR DEGENERATION

    Question. You have publicly cited as an NIH ``breakthrough'' the 
discovery of a gene strongly associated with age-related macular 
degeneration (AMD). As you know, AMD is the leading cause of blindness 
in the United States, especially among our seniors, robbing them of 
their independence and quality of life. What does this finding mean for 
new treatments to stop or reverse this blinding eye disease? How will 
the National Eye Institute follow up on this exciting breakthrough when 
the President's budget proposes to cut NEI funding?
    Answer. National Eye Institute-sponsored investigators have made 
considerable progress since the recent discovery of the complement 
factor H (CFH) gene in age-related macular degeneration (AMD). NEI 
intramural researchers are initiating a phase I clinical trial to 
evaluate anti-inflammatory agents that may inhibit damaging immune 
responses potentially resulting from alterations in the CFH gene. NEI 
extramural and NIH intramural scientists discovered that alterations in 
a second gene in the inflammatory pathway, complement factor B, are 
also associated with AMD. Variations in these two genes can predict the 
clinical outcome in 74 percent of individuals with AMD. In addition, 
the NEI launched a new research initiative to further investigate the 
role of inflammation in AMD and other common eye diseases such as 
diabetic retinopathy and uveitis.

                        IRRITABLE BOWEL SYNDROME

    Question. For the last several years, the Appropriations Committee 
has asked the National Institute of Diabetes and Digestive and Kidney 
Diseases to develop a strategic plan for research into Irritable Bowel 
Syndrome. NIDDK has explained that the Institute [is] creating an 
overall digestive disease action plan and that IBS will be a 
significant part of it. Can you update us on NIDDK's progress on the 
digestive disease plan and explain how much attention IBS will receive?
    Answer. The NIH established a National Commission on Digestive 
Diseases in August 2005, based on the shared interest of the NIH and 
the Congress in advancing research on digestive diseases. One of the 
Commission's primary purposes is to develop a Long-Range Research Plan 
for Digestive Diseases, which will include plans for stimulating 
research on functional gastrointestinal (GI) and motility disorders 
such as irritable bowel syndrome (IBS). Within the NIH, the NIDDK has 
lead responsibility for digestive diseases research and supports a 
research portfolio in IBS and other types of functional GI and motility 
disorders. The NIDDK is providing leadership and support for this 
federally chartered Commission.
    As NIH Director, I appointed members of the Commission after a 
broad call for nominees with diverse scientific, professional, and 
personal experiences related to digestive diseases from within the 
academic and medical research and practice communities, patient and 
patient advocacy community, and the NIH and other Federal health 
agencies. The perspective of individuals with personal or professional 
interest in IBS and other types of functional GI and motility disorders 
is represented within the Commission.
    Commission members recently convened for their first meeting on 
June 12, 2006, and are currently finalizing topics for chapters of the 
Research Plan, one of which is expected to focus on IBS and related GI 
motility disorders research. The ultimate goal of the Commission's 
Research Plan is to improve the nation's health through advancing 
research on digestive diseases, such as IBS. The Research Plan will 
include: (1) information on the burden of disease on individuals and 
society; (2) examples of research advances that are generating new 
knowledge vital to understanding, treatment, and prevention; and (3) 
compelling opportunities for future NIH-funded research, which offer 
promise for reducing the burden of disease. This Research Plan will 
recommend promising research directions relevant to IBS and other types 
of functional GI and motility disorders, which will help guide the 
NIDDK, the NIH, and the investigative and lay community in the pursuit 
of the most productive research avenues.
    The Commission will rely on broad stakeholder input from members of 
the digestive diseases community to inform the Research Plan throughout 
its development. For example, Commission members are currently 
establishing Working Groups composed of individuals with expertise 
related to specific areas of digestive diseases research, who will 
provide input necessary for crafting a well-informed Research Plan. One 
of these Working Groups is expected to focus on functional GI and 
motility disorders, such as IBS, in addition to potential overlapping 
and synergistic efforts in this area on the part of other Working 
Groups. Other opportunities for broad stakeholder input into the 
Commission's activities will include public Commission meetings and an 
open comment period for public input on the draft Research Plan. 
Additional information on the Commission's ongoing activities can be 
found on its website at: http://NCDD.niddk.nih.gov.

                         CONCLUSION OF HEARINGS

    Senator Specter. So thank you for what you are doing. We 
appreciate your thanks to us, and we are going to do more and 
we ask you to do more. That concludes our hearings.
    [Whereupon, at 10:14 a.m., Friday, May 19, 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, EDUCATION, AND RELATED 
              AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2007

                              ----------                              

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

                          DEPARTMENT OF LABOR

                        Office of the Secretary



    [The following questions were submitted to be answered for the 
record:]

              Questions Submitted by Senator Arlen Specter

                              MINE SAFETY

    Question. Congress has now passed bi-partisan mine safety 
legislation that contained many of the provisions in a bill I 
introduced on February 16, 2006. Congress has also passed a pending 
supplemental appropriations bill containing $35,600,000 to augment 
inspections of coal mines and to expand research to develop mine safety 
technology. How do you intend to implement these authorization and 
appropriation measures? What additional appropriations are necessary to 
fully implement the new authorization?
    During the hearing this Subcommittee held on January 23, 2006, on 
the Sago Mine disaster, I questioned the policy of the requiring mine 
representatives to be present during accident investigation interviews 
with miners. Although the legislation I introduced would prohibit this 
practice, it was not included in the consensus bill reported last week. 
Do you support such a provision?
    Answer. $25.6 million of the $35.6 million contained in the 
supplemental appropriation was appropriated to MSHA. The supplemental 
appropriation contains a provision requiring MSHA to submit a spending 
plan for these funds to the appropriations committees by July 15, 2006, 
and MSHA will comply with this provision. The remaining $10 million in 
supplemental funding was appropriated to NIOSH for expansion of 
research and mine safety technology, therefore NIOSH is the appropriate 
entity to answer questions regarding their plans for the use of those 
funds. With regard to additional appropriations necessary to fully 
implement the MINER Act, the MINER Act contains authorization for new 
grant programs but no funding for these programs has been appropriated. 
Many of the new MINER Act provisions do not require any additional 
funding. For example, the increase of the maximum civil penalty for 
flagrant violations and the implementation of minimum penalties for 
unwarrantable citations and orders, as well as the provision requiring 
every mine to have an Emergency Response Plan do not require any 
increases in funding.
    With regard to MSHA accident investigations, the Mine Act gives 
MSHA discretion to determine who may be present during accident 
investigation interviews with miners and other persons who may have 
relevant information. As you are aware, MSHA's longstanding past 
practice regarding interviews has generally included participation by 
the mine operator and the representative of miners. However, we have 
come to the conclusion that this process should be changed to conform 
to the process used by virtually all other law enforcement 
investigative agencies. We believe that witness interviews should be 
conducted with only federal, and where applicable, state authorities. 
Of course, witnesses would continue to have the option of having a 
personal representative of their choosing present during the interview. 
We believe that the time proven technique of interviewing witnesses 
separately and without additional persons present is the best method of 
eliciting useful information without fear of intimidation, and 
minimizes the ability of witnesses to modify their testimony in light 
of the knowledge gained from other witnesses. In fact, recent 
experience has demonstrated that the presence of third-parties could 
compromise the investigation, make witnesses less likely to cooperate, 
and result in premature release of information before all witness 
interviews are complete. Thus, we agree that participation in 
interviews by non-government personnel should be limited to a personal 
representative of the witness. Of course, MSHA will continue its 
practice of releasing all witness transcripts, except those requested 
under the Mine Act to be confidential, once the investigation has 
reached a stage where release would not impede or interfere with the 
investigation.

                           JOB CORPS FUNDING

    Question. It has been more than 45 calendar days of continuous 
session of the Congress since the President proposed rescinding $75 
million of Job Corps construction and renovation funds. Have these 
funds now been released as required by the Congressional Budget and 
Impoundment Control Act?
    Answer. The $75 million in Construction, Rehabilitation, and 
Acquisition funds were not withheld from obligation, as noted in our 
May 30, 2006 letter to GAO on this matter, and remain available for 
obligation by the Office of Job Corps.
    Question. Your budget proposed to cut $62,578,000 from the Job 
Corps budget for program year 2007, which would result in 3,614 fewer 
students enrolled than in 2005. This would reduce funding, on 
inflation-adjusted basis, 8.5 percent below the level in 2005. How far 
below capacity would this put the 122 existing Job Corps centers?
    Answer. With the requested 2007 operating budget of $1,401,602,000, 
Job Corps will be able to maintain 42,863 year-around training slots, 
which represents 95.5 percent of the peak level that could be 
accommodated by our physical infrastructure.

                  REINTEGRATION OF YOUTHFUL OFFENDERS

    Question. Your budget once again zeroes out the program I was 
instrumental in creating, for training and employing of youthful 
offenders. Even after last November's conference agreement restored $49 
million for this program, the Administration immediately offered it up 
as an offset to help pay for December's Katrina supplement. Do you 
think this was an appropriate way to respond?
    Answer. The impacts of the Katrina and Rita hurricanes were 
unprecedented and the Administration carefully prioritized the use of 
available resources across government to fund relief and recovery 
efforts. The Youth Offender appropriation was only one of many offsets 
the Administration presented to Congress, and this is consistent with 
the Administration's proposal in the fiscal year 2007 and previous 
budgets to replace the Responsible Reintegration of Young Offenders 
program with the Prisoner Reentry Initiative, thereby increasing the 
program's overall scope and reach.

                  ELIMINATION OF MIGRANT JOB TRAINING

    Question. Both the House and the Senate appropriations committees 
have repeatedly rejected your proposal to eliminate the Migrant and 
Seasonal Farmworkers Program under the Workforce Investment Act. I 
think it's fair to say that Congress recognizes that it is unrealistic 
to expect states and localities to be responsible for a unique and 
difficult-to-serve migratory population that, from their point of view, 
is ``here today and gone tomorrow.'' It is also unfair to shift this 
burden to states when you are proposing to reduce the already limited 
job training resources that states have to serve their eligible local 
residents. If Congress understands this, why doesn't the Department?
    Answer. The Administration's fiscal year 2007 Budget proposal seeks 
to tap the workforce investment system's potential to serve more 
migrant and seasonal farmworkers by providing job training services to 
them through the One-Stop Career Center system, and turning to other, 
appropriate agencies to provide supportive services, housing, and other 
related assistance. Currently, the section 167 program provides 
employment and training services to only 10,000 of an estimated two 
million farmworkers, which demonstrates the need for a wider system 
approach.
    The Administration believes that providing services to farmworkers 
through the One-Stop system will increase the number served and have a 
positive employment and earnings impact on those who receive services.

                      IMPACT OF JOB TRAINING CUTS

    Question. Your budget is based on the assumed enactment of a new 
Workforce Investment Act reauthorization proposal calling for Career 
Advancement Accounts, to be run through a consolidated workforce 
system, cutting nearly $700 million. Until the authorization 
legislation is changed, this Committee acts on the basis of extending 
current law. In the absence of law change, what impact will your budget 
proposals have on existing programs for youth, adults, dislocated 
workers, and the Employment Service? For example, the Pennsylvania 
Association of Workforce Investment Boards estimates the President's 
Budget would result in a 17 percent cut from current levels for the 
youth, adult and dislocated worker block grants. Do I have your 
assurance that you will not proceed administratively to implement 
proposals such as consolidated Career Accounts without Congressional 
approval?
    Answer. The President's Budget request does assume enactment of the 
Career Advancement Account (CAA) proposal, which would reduce overhead 
and administrative costs and focus more funding on training, thereby 
tripling the number of individuals receiving job training through the 
workforce investment system.
    In the absence of any legislation passed by Congress, states will 
continue to operate Workforce Investment Act programs and the 
Employment Service as currently authorized. The appropriation level 
provided by Congress is a separate issue from job training reform. We 
feel that CAAs are a more effective approach than the current workforce 
investment system, regardless of the funding level provided by 
Congress.
    Several states and local areas have expressed interest in piloting 
CAAs. We will work with these areas to develop a limited pilot that can 
be carried out under current law. However, statutory changes are 
necessary to achieve all of the reforms envisioned under the CAA 
proposal.

                        WORKFORCE TRAINING CUTS

    Question. Your budget for workforce programs contains cuts of $506 
million for state grant programs, while increasing funding under 
national control by $107 million. How does this square with your 
legislative proposal to shift greater control of resources to the 
States?
    Answer. The President's fiscal year 2007 Budget proposes a minimal 
increase for programs under ``national control.'' The only activity 
that falls under this category that is proposed for additional funding 
is Unemployment Insurance National Activities, whereby an increase of 
$600,000 is requested to pay for activity related to processing 
separation documents and unemployment claims of former military service 
personnel.
    Furthermore, the fiscal year 2007 Budget request proposes 
initiatives that give greater control of funding to states and local 
areas. The Career Advancement Account proposal promotes state and local 
flexibility by streamlining and strengthening the One-Stop Career 
Center system and removing or simplifying statutory requirements that 
create rigidity and hinder flexibility in providing education and 
training opportunities to American workers. Also, the Administration 
included a streamlined program structure in its Older Americans Act 
reauthorization proposal, which would give states greater control over 
the Senior Community Service Employment Program (SCSEP) funds.

                           ASBESTOS EXPOSURE

    Question. Madame Secretary, the fiscal year 2006 appropriation 
contained $2 million for the Employment Standards Administration to 
facilitate the expeditious startup of a system to resolve the claims of 
injury caused by asbestos exposure. How are these funds being used to 
shorten the lead-time for implementation of pending asbestos 
legislation?
    Answer. If the Asbestos legislation is enacted as currently 
written, the Department of Labor will be expected to manage a new and 
very substantial national benefits program involving the disbursement 
of billions of dollars in compensation to hundreds of thousands of 
individual asbestos claimants. The proposed time frame for implementing 
this legislation is extremely short, requiring immediate preparatory 
work and the up-front expenditure of resources to ensure that payments 
can begin being made to compensable claimants as quickly as possible.
    Given the status of the pending legislation, the $2 million is 
being used to analyze the proposed legislation and plan how to 
implement it in the event that it is passed. In the next phase, funding 
will be used for initial program start-up expenses in the areas of 
program design, acquisition of specialized expertise, technology, and 
infrastructure.

                 OSHA PENALTIES FOR ASBESTOS VIOLATIONS

    Question. I have introduced legislation (S. 668) to subject 
employers who willfully violate OSHA asbestos standards to fines at 
levels set by the Uniform Criminal Code as well as imprisonment of up 
to five years, or both. Currently OSHA provides for criminal penalties 
only in those cases where a willful violation of standards results in 
the death of a worker within six months after the violation is 
discovered. Do you agree that stronger enforcement action is needed 
against parties that violate OSHA asbestos enforcement rules?
    Answer. Currently, the OSH Act provides for criminal fines and 
imprisonment of up to six (6) months against an employer only where the 
employer's willful violation of a standard caused the death of an 
employee. In addition, criminal penalties exist against employers who 
make false statements to OSHA investigators or who unlawfully interfere 
with OSHA investigations. S. 668 provides that any willful violation of 
a standard issued under OSH Act section 6 with respect to control of 
occupational exposure to asbestos is punishable by fines under section 
3571 of Title 18, United States Code, and imprisonment in the case of a 
first offense, of up to five years. While we agree that occupational 
exposure to asbestos is a very serious health issue, we believe the 
current OSH Act and penalty structure provide the means and flexibility 
to address instances where penalties are warranted.

                            IMMIGRATION BILL

    Question. The Senate passed immigration legislation, S. 2611, 
contains a provision requiring the Secretary of Labor to certify that 
no United States workers are available for a specified position before 
employers can hire an alien for the job. Do you support this provision, 
and does your Department have sufficient resources to administer it?
    Answer. The Department supports the need to enact comprehensive 
immigration reform that creates a guest worker program and enhances the 
security of our borders. In his various speeches on immigration reform, 
the President has repeatedly noted that foreign workers should be 
allowed to take only those jobs that no U.S. worker is willing or 
available to perform. To implement this important program design 
feature, the Department will need to either establish a labor market 
test for domestic worker interest or create a mechanism whereby 
employers can attest that they have tested the labor market and been 
unable to find a U.S. worker to fill the job. If an attestation system 
is created, the Department would randomly audit employer attestations 
to ensure program integrity. We agree that the S. 2611 provision is 
consistent with the President's position and we support it accordingly. 
The administration will work with Congress as immigration legislation 
moves forward to ensure that the need for resources is addressed.
    Question. Your Department has the responsibility to prevent 
employer exploitation of undocumented workers, by enforcing minimum 
wage and overtime laws. To what extent is this effort discouraging 
illegal immigration?
    Answer. The strong enforcement of basic labor standards for all 
employees weakens the incentive to hire undocumented workers. Although 
it is difficult to quantify the extent to which labor standards 
enforcement deters or dissuades employers from hiring undocumented 
workers, most studies on the impact of illegal immigration acknowledge 
the importance of such enforcement as a key component in an overall 
strategy for addressing the problem.
    Question. What actions do Labor Department inspectors take when 
they come across evidence that a business unlawfully employs illegal 
immigrants?
    Answer. When the Wage and Hour Division (WHD) performs an 
investigation a complaint-based investigation, it does not seek 
evidence of the complainant's immigration status. WHD instituted this 
policy to avoid discouraging complaints from undocumented workers who 
might otherwise be reluctant to complain to WHD because of their 
immigration status.
    However, WHD investigators do perform directed investigations (non-
complaint cases) to determine employers' compliance with their 
employment eligibility verification obligations (Forms I-9). In cases 
where it appears that violations have been committed, WHD refers the 
matter to DHS pursuant to a Memorandum of Understanding.

                         MEDICAL LEAVE PROGRAM

    Question. At your last appearance before this Committee on March 
15, 2005 you stated no final decision has been made with respect to 
revising regulations implementing the Family and Medical leave Act. 
What progress has been made addressing concerns of workers and 
employers that have resulted in so many lawsuits on the interpretation 
of when employers are eligible for leave under the law?
    Answer. The Department continues to review the issues raised by the 
Supreme Court's decision in Ragsdale v. Wolverine World Wide, Inc., as 
well as other court decisions, and the possibility of revisions to the 
FMLA regulations remains an item on the Department's regulatory agenda. 
No final decisions have yet been reached as to what, if any, changes 
might actually be proposed. If changes are proposed, the public will be 
provided ample opportunity to comment through the formal notice and 
comment rulemaking process.

                     RE-ALLOCATION OF UNSPENT FUNDS

    Question. Your budget proposed bill language that would take money 
away from states that have more than 30 percent unspent job training 
funds, yet you do not propose applying this principle to Dislocated 
Worker national reserve funds, which currently have unspent funds 
exceeding 50 percent. What is your justification for this?
    Answer. The Department always obligates all National Reserve monies 
to states during the program year for which such money was 
appropriated. Any unspent funds are unspent at the state and local 
level, not at the national level. This indicates that even more funds 
are available for expenditure by states and grantees.

                          RAPID RESPONSE FUNDS

    Question. Currently, states use rapid response funds to provide 
immediate service to workers affected by a mass layoff, often before 
the workers are even laid off. Under your legislative proposal, states 
will need to apply to the Employment and Training Administration for 
rapid response funds as events occur. What are the reasons for keeping 
these funds at the national level, and having states apply for them 
each time they are faced with mass layoffs?
    Answer. The Department does not contemplate that a state would have 
to apply for funds each time there is a mass layoff or to only 
sporadically fund a state rapid response coordinator. Early 
intervention to provide information and assistance to workers to 
decrease the amount of time between actual layoff and re-employment is 
a key principle of the dislocated worker program. Rapid response is a 
key element of this early intervention strategy.
    States could demonstrate need and apply for rapid response funds at 
the beginning of the program year or throughout the program year. We 
will not propose that a state be required to submit an application for 
funding each time a dislocation event occurs.
    In spite of all the good work that has been done over the past 
fifteen years with dislocated worker rapid response funds, the 
Department has found that most company executives do not know about the 
type and quality of assistance available to them and their employees 
when closures or layoffs are contemplated. They have also reported that 
where they have layoffs in several states simultaneously, the levels 
and quality of assistance varies dramatically. ETA, in collaboration 
with state and local partners, has undertaken several initiatives in 
the auto, textile and defense industries recently to try to integrate 
services and develop more consistency. We believe a nationally-
coordinated approach to delivering rapid response assistance by states 
can help bring the services to more workers and employers.
    The proposed mechanism will assist both the Department and the 
states to better manage scarce taxpayer resources by directing the bulk 
of the funds to the areas of need. For example, not all states 
experience major layoffs every year. Analyses of dislocated worker 
program expenditures reported by states have shown that the funds 
reserved for rapid response are consistently under-expended. In the 
aggregate, the rapid response carry-in funds from program year 2003 to 
2004, and from 2004 to 2005, was $136.7 million and $166 million, 
respectively. Through March 31, 2006, states reported accrued 
expenditures of just over $176 million of a total available of more 
than $342.5 million, or 51.4 percent of the total funds available. 
States are not required to retain the up to 25 percent authorized to be 
reserved for rapid response activities. They may include a portion of 
the funds in the amount allocated to local workforce investment boards 
for core, intensive and training services for dislocated workers, or 
they may award additional funds from the reserved amount to local areas 
that experience disasters, mass layoffs, plant closings or other events 
that precipitate substantial increases (defined by the state) in the 
number of unemployed workers.

                  COMMENTS ON CECIL ROBERTS TESTIMONY

    Question. Mr. Cecil Roberts, President of the United Mine Workers 
of America, testified to this Committee that the penalties assessed by 
the Labor Department are designed to insure that mining remains 
profitable, even if the conditions are so hazardous the mine should be 
shut down. Do you believe that keeping a mine operating is more 
important than the safety of the miners?
    Answer. No, we do not believe that keeping a mine operating is more 
important than the safety of the miners who work in that mine. The Mine 
Act states in its opening section that ``the first priority of all in 
the coal or other mining industry must be the health and safety of its 
most precious resource--the miner.'' That is the premise on which the 
Mine Act is based and the reason for the existence of MSHA. The Mine 
Act contains provisions to withdraw miners until the hazard or 
violation is abated when there is an imminent danger to the health and 
safety of miners or an unwarrantable failure of an operator to comply 
with a mandatory health and safety standard. MSHA uses its withdrawal 
authority vigorously and appropriately.
    Under the Mine Act, MSHA has the authority to propose penalties for 
violations of the Act. MSHA does so in accordance with the six 
statutory criteria enacted by Congress in the Mine Act, including 
consideration of the effect of the proposed penalty on the operator's 
ability to stay in business. Consistent with the Administration's last 
three budget requests, Congress included a provision in the MINER Act 
to increase the maximum civil penalty for flagrant violations of the 
Mine Act to $220,000. Minimum penalties were also included for 
unwarrantable failure violations. The Department has announced that 
MSHA will be revising its regulations and proposing a new penalty 
formula to raise penalties for mine safety and health violations across 
the board. These higher penalties should provide a greater incentive to 
mine operators to comply with MSHA's safety standards.

                    OLDER WORKER EMPLOYMENT PROGRAM

    Question. The Department has launched another national grant 
competition process for the Senior Community Service Employment Program 
despite not having the essential performance data that will not be 
available for new performance goals until September 2006. Since the 
current law directs that re-competition be conducted for non-
performance by a grantee, on what basis do you deem this new round of 
competition to have sound data for assessing current or future grantee 
performance or capacity?
    Answer. The Department has been collecting performance data since 
the inception of the program, and has been collecting additional data 
on the new common performance measures since July 2004.
    Furthermore, according to the Title V of the Older Americans Act, 
competition is not limited to when grantees fail performance measures. 
Section 514(a) limits the award of SCSEP grants to no more than three 
years, thus requiring a selection of grantees within three years of the 
first competition. The issue of whether the Department can compete the 
SCSEP grants has also been addressed by the courts. The U.S. District 
Court of the District of Columbia held recently in Experience Works v. 
Chao, 267 F.Supp. 2d 93 (D.D.C. June 17, 2003), ``[t]he use of 
competitive procedures is a time-honored method for obtaining the most 
highly qualified awardees of government funds, for allowing new and 
innovative ideas and organizations to receive those funds, and for 
assuring public confidence in the integrity of the process to 
distribute government funds.''
    Finally, the current Solicitation for Grant Applications (SGA) 
clearly identifies the criteria against which applicants are assessed. 
All applicants will be rated using a ranking criterion based on points. 
This SGA requires that responses be thoughtful and reflect a strategic 
vision.
    The SGA evaluation criteria are as follows:
    1. Design and Governance--15 points
    2. Program and Grant Management Systems--10 points
    3. Financial Management System--10 points
    4. Program Service Delivery--40 points
    5. Performance Accountability--25 points
    Question. When the program was competed in 2003, this whole 
competition process--application, grading and transition--took almost 6 
months--including over 6 weeks for transitioning the participants 
affected. This time the new competition rules are much more complex, 
yet the whole process has been shortened to 4 months, leaving barely 3 
weeks for transition of these vulnerable participants--why the rush to 
get this done this way this year?
    Answer. This year's competition is not rushed. Applicants were 
given nearly the same amount of time this year as in the 2003 
competition to respond to the Solicitation for Grant Applications 
(SGA). In 2003, grantees were given 90 days to respond to the SGA, a 
time period which included Christmas. This year, the competition was 
announced in the Federal Register on March 2, and grantees were given 
until May 26 to respond, or 85 days.
    Further, once grants are awarded, grantees have 2 months in which 
to transition participants among grantees, a longer transition period 
than in 2003. As specified in the SGA, the transition period follows a 
1-month extension of current grants and will take place August 1-
September 30, 2006. This means that the period from publication of the 
SGA (March 2) until the transition period ends (September 30) is 
approximately 7 months, 1 month longer than the 2003 competition.
    Question. The cost of transitioning thousands of participants 
nationwide among old and new sponsors will be significant. Subsequent 
to publication of the SGA in the Federal Register, the DOL website was 
amended to say, ``Transition cost should be submitted as an integral 
part of the budget and reflected on the other' cost category with a 
narrative explanation. Can you assure the Committee that services to 
enrollees will not be diminished as a result of incurred transitions 
costs?
    Answer. All current grantees were required to build transition 
costs into their budgets in the 2003 competition, and all applicants 
under the 2006 competition have also budgeted for transition costs. 
Further, the Department is prepared to assist grantees with additional 
costs associated with the transition, as it did following the 
transition after the 2003 competition. Program Year 2004 recaptured 
funds are available for this purpose.
    At the time of the 2003 competition, many participants and grantees 
were concerned about the transition effects upon participants. The 
Department can say with authority that every single participant was 
transitioned successfully. Competition does not need to cause any 
disruption among services participants receive.
    DOL has identified specific responsibilities for itself, national 
grantees and state grantees to ensure a smooth transition. DOL will 
provide orientation to all national grantees to provide information on 
program administration and management. DOL will begin regular 
conference calls between federal and regional DOL staff and national 
grantees to quickly address any transition issues. DOL will also 
provide assistance through a national call center, and provide on-site 
technical assistance as needed.
    Question. Your budget proposes to save $44 million in the Community 
Service Employment for Older American program through ``efficiencies 
related to program streamlining.'' What exactly is being proposed to 
save this amount?
    Answer. The Administration proposes that reauthorization of the 
Title V SCSEP program be based on five key reform principles: (1) 
helping meet employers' demands for skilled workers by attracting more 
older workers into the labor force, encouraging others to remain in the 
workforce, and by offering opportunities for older workers to update 
their skills; (2) making the One-Stop Career Center system effective 
for older individuals seeking to work or upgrade their skills, 
including better integrating services for older workers and assisting 
more older workers, regardless of income, to gain skills that are in 
demand; (3) tailoring services to meet the needs of individual older 
workers by providing a range of training experiences, including 
community service employment, on-the-job training and classroom 
training, depending on the individual's background and experience; (4) 
targeting SCSEP resources to those older workers most in need 
(primarily low-income older workers who lack the basic skills for 
private sector employment), while ensuring that others receive services 
through the One-Stop Career Center system; and (5) streamlining the 
program to make it easier to administer in order to improve program 
performance, serve more participants, and receive a return on 
investment for the federal taxpayers' dollar.
    In fiscal year 2007, savings from streamlining administration and 
other reforms will amount to an estimated $44 million in the first year 
of implementation. Specifically, we expect that savings will be 
achieved from the following reforms:
  --Revamping the SCSEP program structure so that states conduct a 
        competition every three years to run the program in the state, 
        which will simplify administration, eliminate duplication, and 
        create a more comprehensive program.
  --Eliminating fringe benefits for program participants (except 
        accident insurance or benefits that may be required by law) to 
        reinforce the training aspect of the program.
  --Allowing SCSEP funding to be used for training (as opposed to 
        wages) and allowing more flexible training options in addition 
        to community service work experience.
    In addition to savings from reforms through reauthorization, 
savings will also be realized through the current grant competition. 
The current Solicitation for Grant Applications encourages a regional 
service delivery architecture that will reduce redundancy and 
fragmentation of service delivery areas by requiring that applicants 
apply to serve an entire county instead of a portion, and generally 
requiring that applicants apply to serve contiguous counties if 
multiple counties are served.
    It is important to note that the fiscal year 2007 request will 
continue to support 92,300 low-income elderly individuals, the same 
level as fiscal year 2006.

                     ADMINISTRATION AND MANAGEMENT

    Question. Provide appropriations and full time equivalent staff for 
each of fiscal years 2003 through 2005 enacted, fiscal 2006 comparable, 
and fiscal 2007 budget request, for each of the components of the 
Administration and Management activity within the Departmental 
Management account, including: Department Budget Center; Center for 
Program Planning and Results; Human Resources Center; Information 
Technology Center; Civil Rights Center; Office of Security and 
Emergency Management and Business Operation Center. Provide the source, 
by Department of Labor agency and activity, of the FTE and funding for 
Working Capital Fund Programs, comparing fiscal year 2006 comparable 
with the fiscal year 2007 request.
    Answer. The information for Administration and Management follows:

                               ADMINISTRATION AND MANAGEMENT BUDGET ACTIVITY DEPARTMENTAL MANAGEMENT SALARIES AND EXPENSES
                                                                  [Amount in thousands]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              Fiscal year 2003      Fiscal year 2004      Fiscal year 2005      Fiscal year 2006      Fiscal year 2007
                                                   enacted               enacted               enacted             comparable              request
                  Agency                   -------------------------------------------------------------------------------------------------------------
                                               AMT        FTE        AMT        FTE        AMT        FTE        AMT        FTE        AMT        FTE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Program Planning and Results...     $6,352          4     $6,076          9     $5,537          8     $5,438          8     $5,562          8
Human Resources Center....................      3,650         23      3,473         23      3,502         24      3,445         24      3,573         24
Information Technology Center.............     12,414         60     12,954         56     11,624         50      9,346         37      9,755         37
Business Operation Center.................      2,652         16      2,026         14      1,959         11      1,778         11      1,825         11
Office of Security and Emergency Mgmt.\1\.  .........  .........  .........  .........      6,944  .........      6,875  .........      1,893  .........
Department Budget Center \2\..............  .........  .........      1,776         15      2,362         19      2,056         18      2,116         18
Library...................................        714          2        719          2        754          1        754          1        782          1
Federal Executive Board...................        170          2        173          2        176          2        206          2        210          2
Assistant Secretary for Administration and      4,239          5      5,956          5      6,500         10      7,590         10      7,923         10
 Management...............................
Civil Rights Center \3\...................      5,930         48      6,144         48      6,237         46      6,451         46      6,735         46
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Represents funding for Frances Perkins Building security enhancements. The fiscal year 2007 Request includes a comparative transfer of $5 million
  from this budget activity to the Working Capital Fund for upgrading security and continuity of operations capabilities for the Department.
\2\ Department Budget Center was transferred to Administration and Management budget activity from the Chief Financial Officer budget activity in fiscal
  year 2004.
\3\ CRC is funded from the Civil Rights Activity, rather than the Administration and Management Activity.

    The information for Working Capital Fund follows:

               DOL AGENCY WORKING CAPITAL FUND ASSESSMENTS
                        [In thousands of dollars]
------------------------------------------------------------------------
                                                       Fiscal year
                                               -------------------------
                                                    2006         2007
                                                  estimate     request
------------------------------------------------------------------------
ETA...........................................       14,987       17,942
ETA/TES.......................................        9,326        9,922
ESA...........................................       37,620       44,021
OSHA..........................................       22,851       25,235
EBSA..........................................       10,054       11,463
BLS...........................................       16,009       19,353
OIG...........................................        4,097        4,685
OSEC..........................................       14,458       16,730
VETS..........................................        2,832        3,207
SOL...........................................        6,396        6,646
ILAB..........................................        1,984        2,228
MSHA..........................................       11,237       13,564
ODEP..........................................        1,250        1,305
FPB repairs...................................          915          833
                                               -------------------------
      Total...................................      154,016      177,134
------------------------------------------------------------------------

                           PROGRAM DIRECTION

    Question. Provide appropriations and full time equivalent staffing 
for each of fiscal years 2003 through 2005 enacted, fiscal 2006 
comparable, and fiscal 2007 budget request, for each of the following 
components of the Program Direction and Support activity within the 
Departmental Management account: Office of the Secretary; Office of the 
Deputy Secretary; Office of Public Affairs; Office of the Assistant 
Secretary for Policy; Office of Congressional and Intergovernmental 
Affairs; Office of Small Business Programs; Office of Public Liaison; 
Office of the 21st Century Workforce; and the Center for Faith-Based 
and Community Initiatives.
    Answer. The information for Program Direction follows:

                                                              PROGRAM DIRECTION AND SUPPORT
                                                                  [Amount in thousands]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              Fiscal year 2003      Fiscal year 2004      Fiscal year 2005    Fiscal year 2006 \1\    Fiscal year 2007
                                                   enacted               enacted               enacted              comparable             request
              PDS components               -------------------------------------------------------------------------------------------------------------
                                               AMT        FTE        AMT        FTE        AMT        FTE        AMT        FTE        AMT        FTE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Office of the Secretary...................     $3,669         17     $3,015         12     $4,639         21     $4,859         17     $5,068         20
Office of the Deputy Secretary............      1,173          8      1,270          8      1,260          9      1,234          8      1,293          9
Office of Small Business Programs.........      1,021          9      1,097          9      1,289          8      1,344          7      1,659          8
Office of Public Liaison..................        840          8        895          7        949          6      1,004          6      1,072          6
Office of Congressional and                     4,232         32      4,456         32      4,420         27      4,651         24      5,258         27
 Intergovernmental Affairs................
Office of Public Affairs..................      4,003         26      5,861         35      3,612         28      3,772         26      4,812         28
Office of the Assistant Secretary for          10,423         53      8,975         46      8,903         40      7,222         35      8,741         40
 Policy \2\...............................
Office of the 21st Century Workforce......      1,019          8      1,049          8      1,041          6      1,040          6      1,092          6
Center for Faith-Based & Community          .........  .........        593          5        605          6        633          6        800          6
 Initiatives..............................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ $28.5 million was appropriated in ETA Program Administration for Job Corps program salaries and expenses. These funds have been allotted to the
  Office of the Secretary to be used for the Job Corps program in accordance with Section 102 of Public Law 109-149.
\2\ Includes ASP drug-free workplace funds.

                      BUILT-IN AND PROGRAM CHANGES

    Question. Provide a table for each discretionary appropriation 
account, identifying by line-item, the built-in changes from the fiscal 
year 2006 adjusted level, and each program increase, to arrive at the 
fiscal year 2007 budget request level.
    Answer. The attached table reflects built-in increases and 
decreases, program increases and decreases, and finance changes, 
affecting each discretionary appropriation account from the fiscal year 
2006 adjusted level to the fiscal year 2007 budget request level.

                                                                   DEPARTMENT OF LABOR
                                                                [In thousands of dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Fiscal year         Built-In                 Program                               Fiscal year
                                                              2006    ------------------------------------------------             Finance   2007 budget
           Discretionary Appropriation Account              adjusted                                                    Transfer   changes     request
                                                             level     Increases   Decreases   Increases   Decreases                         current Law
--------------------------------------------------------------------------------------------------------------------------------------------------------
EMPLOYMENT & TRAINING ADMIN:
    TRAINING AND EMPLOYMENT SERVICES:
        Adult Employment and Training Activities........      857,079  .........  ...........  .........     -145,079  .........  .........      712,000
        Dislocated Worker Employment and Training           1,337,553  .........  ...........  .........     -222,971  .........  .........    1,114,582
         Activities.....................................
        Youth Activities................................      940,500  .........  ...........  .........     -100,000  .........  .........      840,500
                                                         ===============================================================================================
    Job Corps:
        Operations......................................    1,450,400      1,282  ...........  .........      -50,080  .........  .........    1,401,602
        Construction and Renovation.....................      106,920  .........  ...........  .........       -6,920  .........  .........      100,000
                                                         -----------------------------------------------------------------------------------------------
          Subtotal--Job Corps...........................    1,557,320      1,282  ...........  .........      -57,000  .........  .........    1,501,602
                                                         ===============================================================================================
    Responsible Reintegration for Young Offenders.......       49,104  .........  ...........  .........      -49,104  .........  .........  ...........
    Prisoner Re-entry...................................       19,642  .........  ...........  .........  ...........  .........  .........       19,642
    Native Americans....................................       53,696  .........  ...........  .........       -2,238  .........  .........       51,458
    Migrants and Seasonal Farmworkers...................       79,252  .........  ...........  .........      -79,252  .........  .........  ...........
                                                         ===============================================================================================
    National Programs:
        Pilots, Demonstrations and Research.............       29,700  .........  ...........  .........      -12,000  .........  .........       17,700
        Evaluation......................................        7,857  .........  ...........  .........       -2,936  .........  .........        4,921
        Denali Commission...............................        6,875  .........  ...........  .........       -6,875  .........  .........  ...........
        Other...........................................        1,980  .........  ...........  .........       -1,980  .........  .........  ...........
        Community College Initiative....................  ...........  .........  ...........    150,000  ...........  .........  .........      150,000
                                                         -----------------------------------------------------------------------------------------------
          Subtotal--National Programs...................       46,412  .........  ...........    150,000      -23,791  .........  .........      172,621
                                                         ===============================================================================================
    Job Corps Construction Balances Cancellation........  ...........  .........  ...........  .........      -75,000  .........  .........      -75,000
                                                         -----------------------------------------------------------------------------------------------
      Total--Training and Employment Services...........    4,940,558      1,282  ...........    150,000     -754,435  .........  .........    4,337,405
                                                         ===============================================================================================
    COMMUNITY SERVICE EMPLOYMENT........................      432,311  .........  ...........  .........  ...........  .........  .........      432,311
                                                         ===============================================================================================
    STATE UI & ES OPERATIONS:
        Unemployment Compensation (Trust Funds):
        State Operations................................    2,497,770    101,905  ...........     40,000  ...........  .........  .........    2,639,675
            AWIU........................................       41,580  .........      -41,580  .........  ...........  .........  .........  ...........
            National Activities.........................        9,900  .........  ...........        600  ...........  .........  .........       10,500
                                                         -----------------------------------------------------------------------------------------------
              Subtotal--Unemp Comp......................    2,549,250    101,905      -41,580     40,600  ...........  .........  .........    2,650,175
                                                         ===============================================================================================
        Employment Service:
            Grants to States:
                Federal funds...........................       22,883  .........  ...........  .........         -867  .........  .........       22,016
                Trust funds.............................      693,000  .........  ...........  .........      -26,247  .........  .........      666,753
            National Activities (Trust Funds)...........       33,428  .........  ...........  .........         -510  .........  .........       32,918
                                                         -----------------------------------------------------------------------------------------------
              Subtotal--Employment Service..............      749,311  .........  ...........  .........      -27,624  .........  .........      721,687
                                                         ===============================================================================================
            One Stop Career Centers /ALMIS..............       81,662  .........  ...........  .........      -17,807  .........  .........       63,855
            Work Incentives Grants......................       19,514  .........  ...........  .........      -19,514  .........  .........  ...........
                                                         -----------------------------------------------------------------------------------------------
              Total--State UI & ES Operations...........    3,399,737    101,905      -41,580     40,600      -64,945  .........  .........    3,435,717
                                                         ===============================================================================================
    Program Administration:
        Adult Services..................................       43,360      1,716  ...........  .........  ...........  .........       -288       44,788
            Trust Funds.................................        7,846  .........  ...........  .........  ...........  .........        288        8,134
        Youth Services..................................       38,565      1,410  ...........  .........  ...........  .........  .........       39,975
        Workforce Security..............................        6,225      2,616  ...........  .........  ...........  .........     -2,415        6,426
            Trust Funds.................................       72,113  .........  ...........      6,000  ...........  .........      4,688       82,801
        Apprenticeship Training, Employer and Labor            21,538        800  ...........  .........  ...........  .........       -923       21,415
         Services.......................................
        Executive Direction.............................        6,956        320  ...........  .........  ...........  .........     -1,120        6,156
            Trust Funds.................................        2,090  .........  ...........  .........  ...........  .........       -231        1,859
                                                         -----------------------------------------------------------------------------------------------
              Total--Program Administration.............      198,693      6,862  ...........      6,000  ...........  .........         -1      211,554
                                                         -----------------------------------------------------------------------------------------------
              Total--ETA................................    8,971,299    110,049      -41,580    196,600     -819,380  .........         -1    8,416,987
                                                         ===============================================================================================
EMPLOYEE BENEFITS SECURITY ADMINISTRATION:
    Enforcement & Participant Assisstance...............      111,604      3,794          -98      5,000  ...........  .........  .........      120,300
    Policy & Compliance Assistance......................       17,358        642  ...........  .........  ...........  .........  .........       18,000
    Executive Leadership, Program Oversight &                   5,044        229  ...........  .........  ...........  .........  .........        5,273
     Administration.....................................
                                                         -----------------------------------------------------------------------------------------------
      Total--EBSA.......................................      134,006      4,665          -98      5,000  ...........  .........  .........      143,573
                                                         ===============================================================================================
EMPLOYMENT STANDARDS ADMIN.:
    Enforcement of Wage & Hour Standards................      166,408      5,170  ...........      6,000  ...........  .........  .........      177,578
    Office of Labor Management Standards................       45,912      1,974  ...........      4,520  ...........  .........  .........       52,406
    Federal Contractor EEO Standards....................       81,645      3,012  ...........  .........       -1,000  .........  .........       83,657
    Federal Programs for Workers' Comp..................       99,593      4,581  ...........  .........  ...........  .........  .........      104,174
    Trust Funds.........................................        2,034         42  ...........  .........  ...........  .........  .........        2,076
    Program Direction & Support.........................       17,253        550          400       -677  ...........  .........  .........       17,526
                                                         -----------------------------------------------------------------------------------------------
      Total--ESA........................................      412,845     15,329  ...........     10,920       -1,677  .........  .........      437,417
                                                         ===============================================================================================
OCCUPATIONAL SAFETY & HEALTH:
    Safety & Health Standards...........................       16,462        430  ...........  .........  ...........  .........  .........       16,892
    Federal Enforcement.................................      173,430      6,503  ...........  .........  ...........  .........  .........      179,933
    State Programs......................................       91,093  .........  ...........  .........  ...........  .........  .........       91,093
    Technical Support...................................       21,435        957  ...........  .........  ...........  .........  .........       22,392
    Compliance Assistance:
        Compliance Assistance--Federal..................       72,545      1,396  ...........      2,616  ...........  .........  .........       76,557
        Compliance Assistance--State....................       53,357  .........  ...........  .........  ...........  .........  .........       53,357
        Training grants.................................       10,116  .........  ...........  .........      -10,116  .........  .........  ...........
                                                         -----------------------------------------------------------------------------------------------
          Subtotal--Compliance Assistance...............      136,018      1,396  ...........      2,616      -10,116  .........  .........      129,914
                                                         ===============================================================================================
    Safety and Health Statistics........................       24,253        521  ...........      7,500  ...........  .........  .........       32,274
    Executive Direction.................................       10,591        578  ...........  .........  ...........  .........  .........       11,169
                                                         -----------------------------------------------------------------------------------------------
      Total--OSHA.......................................      473,282     10,385  ...........     10,116      -10,116  .........  .........      483,667
                                                         ===============================================================================================
MINE SAFETY & HEALTH ADMIN:
    Coal................................................      117,463      2,932  ...........  .........  ...........  .........  .........      120,395
    Metal/Nonmetal......................................       68,227      1,879  ...........  .........  ...........  .........  .........       70,106
    Standards Development...............................        2,485        173  ...........  .........  ...........  .........  .........        2,658
    Assessments.........................................        5,405        161  ...........  .........  ...........  .........  .........        5,566
    Educational Policy and Development..................       31,749      1,177  ...........  .........  ...........  .........  .........       32,926
    Technical Support...................................       25,609        804  ...........      1,000  ...........  .........  .........       27,413
    Program Eval & Info Resources.......................       15,532        203  ...........  .........  ...........  .........          1        5,735
    Program Administration..............................       11,938      1,099  ...........  .........  ...........  .........  .........       13,037
                                                         -----------------------------------------------------------------------------------------------
      Total--MSHA.......................................      278,408      8,428  ...........      1,000  ...........  .........  .........      287,836
                                                         ===============================================================================================
BUREAU OF LABOR STATISTICS:
    Employment & Unemployment Statistics................      165,683      5,373  ...........  .........  ...........  .........  .........      171,056
    Labor Market Information (Trust Funds)..............       77,066      1,960  ...........  .........  ...........  .........  .........        7,026
    Prices and Cost of Living...........................      173,515      5,566  ...........      8,000  ...........  .........  .........      187,081
    Compensation and Working Conditions.................       81,052      2,808  ...........  .........  ...........  .........  .........       83,860
    Productivity and Technology.........................       10,777        341  ...........  .........  ...........  .........  .........       11,118
    Executive Direction & Staff Services................       30,235        912  ...........  .........  ...........  .........  .........       31,147
                                                         -----------------------------------------------------------------------------------------------
      Total--BLS........................................      538,328     16,960  ...........      8,000  ...........  .........  .........      563,288
                                                         ===============================================================================================
DEPARTMENTAL MANAGEMENT:
    Program Direction and Support.......................       25,759      1,320         -152      2,868  ...........  .........  .........       29,795
    Departmental IT Cross Cut...........................       29,462  .........  ...........  .........          -57  .........  .........       29,405
    Departmental Management Cross Cut...................        1,683  .........  ...........  .........         -575  .........  .........        1,108
    Legal Services......................................       80,416      3,246  ...........      1,204  ...........  .........  .........       84,866
    Trust Funds.........................................          308         14  ...........  .........  ...........  .........  .........          322
    International Labor Affairs.........................       72,567        651          -26  .........      -60,829  .........  .........       12,363
    Administration & Management.........................       30,613      1,237           -4  .........         -100  .........  .........       31,746
    FPB Security Enhancements...........................        1,875         18  ...........  .........  ...........  .........  .........        1,893
    Adjudication........................................       27,243      1,700          -12  .........  ...........  .........  .........       28,931
    Women's Bureau......................................        9,763        456          -71  .........         -800  .........  .........        9,348
    Civil Rights Activities.............................        6,451        284  ...........  .........  ...........  .........  .........        6,735
    Chief Financial Officer.............................        5,340        239  ...........  .........  ...........  .........  .........        5,579
                                                         -----------------------------------------------------------------------------------------------
      Total--DM S&E.....................................      291,480      9,165         -265      4,072      -62,361  .........  .........      242,091
                                                         ===============================================================================================
OFFICE OF DISABILITY EMPLOYMENT POLICY..................       27,695        558  ...........     -7,934  ...........  .........  .........       20,319
VETERANS EMPLOYMENT AND TRAINING:
    State Administration Grants.........................      160,791        427  ...........  .........  ...........  .........  .........      161,218
    Federal Administration..............................       30,211      2,206  ...........  .........  ...........  .........  .........       32,417
    Nat'l Veterans Training Institute (NVTI)............        1,964          5  ...........  .........  ...........  .........  .........        1,969
    Homeless Veterans Program...........................       21,780         58  ...........  .........  ...........  .........  .........       21,838
    Veterans Workforce Investment Program...............        7,425         20  ...........  .........  ...........  .........  .........        7,445
                                                         -----------------------------------------------------------------------------------------------
      Total--VETS.......................................      222,171      2,716  ...........  .........  ...........  .........  .........      224,887
                                                         ===============================================================================================
OFFICE OF INSPECTOR GENERAL:
    Program Activities..................................       65,744      2,329  ...........  .........  ...........  .........  .........       68,073
    Trust Funds.........................................        5,552        136  ...........  .........  ...........  .........  .........        5,688
                                                         -----------------------------------------------------------------------------------------------
      Total--OIG........................................       71,296      2,465  ...........  .........  ...........  .........  .........       73,761
                                                         ===============================================================================================
Working Capital Fund....................................        6,168         16  ...........     13,954       -6,184  .........  .........       13,954
                                                         -----------------------------------------------------------------------------------------------
      Total--DM.........................................      618,810     14,920         -265     10,092      -68,545  .........  .........      575,012
                                                         -----------------------------------------------------------------------------------------------
      Total--Department of Labor........................   11,426,978    180,736      -41,943    241,728     -899,718  .........         -1   10,907,780
--------------------------------------------------------------------------------------------------------------------------------------------------------

                        WOMEN IN APPRENTICESHIP

    Question. The conference agreement on the fiscal year 2006 Labor 
Department appropriations legislation specified $982,000 for carrying 
out Public Law 102-530, the Women in Apprenticeship and Non-Traditional 
Occupations Act.
    What action is being taken to issue grants to community based 
organizations to encourage employment of women in apprenticeable 
occupations and nontraditional occupations?
    Answer. The Employment and Training Administration and the Women's 
Bureau have worked collaboratively to develop a Solicitation for Grant 
Applications (SGA). The SGA is currently going through Departmental 
clearance and we expect a notice announcing the SGA to be published in 
the Federal Register in August 2006.

           APPALACHIAN COUNCIL/WORKING FOR AMERICA INSTITUTE

    Question. This subcommittee held a hearing on July 22, 2004, on the 
funding of the Appalachian Council and Working for America Institute. 
Despite that hearing, the Labor Department did not renew the contracts 
for these organizations, forcing Congress to earmark $2.2 million and 
$1.5 million, respectively, for their continued operation. I understand 
that funding has now run out, and I urge you to renew the contracts. 
Will you take another look at the organizations, and see what can be 
done to provide renewed funding?
    Answer. On February 1, 2005, the Department of Labor executed a 
$1,500,000 grant to the Working for America Institute (WAI). This grant 
will remain active until February 3, 2007. The Department of Labor 
continues to work closely with WAI to support the deliverables of their 
grant, including developing resources to support a well-skilled 
advanced manufacturing workforce.
    Job Corps funded the Appalachian Council for $2.2 million in 
February, 2005 and then renewed the funding in the amount of $2.2 
million in April, 2006. That funding is through March 31, 2007. An 
evaluation will be done to determine if additional funding will be 
provided based upon performance and funding availability.

                           JOB TRAINING STAFF

    Question. Your budget request for federal administration of 
Employment and Training Administration programs provided for 1,158 
direct full-time equivalent staff, compared to the current level of 
1,194 staff.
    Why are you requesting only a reduction of 14 federal staff when 
you are proposing to consolidate several job training programs into a 
single block grant to states?
    Answer. The Employment and Training Administration (ETA) fiscal 
year 2006 FTE level supported by appropriated funds is 1,180 (with an 
additional 16 FTE supported by fees and reimbursements). The ETA fiscal 
year 2007 Legislative Proposal FTE level (excluding FTE supported by 
fees and reimbursements) is 1,158. Compared with fiscal year 2006 
staffing, ETA's fiscal year 2007 Legislative Proposal represents a net 
reduction of 22 FTE--an addition of 7 FTE within Youth Services to 
support the proposed transfer of Youthbuild from the Department of 
Housing and Urban Development to ETA, and a reduction of 29 FTE in 
Workforce Security in anticipation of the enactment of a Foreign Labor 
Certification Permanent Program fee.
    ETA does not anticipate that the implementation of the Career 
Advancement Accounts (CAA) will have an immediate impact on ETA 
staffing levels. Assuming the passage of authorizing legislation in 
fiscal year 2007, a significant amount of effort by ETA staff will be 
required to transition from the current Workforce Investment Act (WIA) 
structure to a new CAA structure. Moreover, during the transition and 
until it is complete, the same or a similar level of effort that is 
currently provided will be necessary to continue national and regional 
Federal oversight required to administer WIA. The time necessary to 
implement the transition to a new CAA structure will also provide ample 
time for an orderly transition to an FTE level appropriate for the 
level of Federal oversight required to administer CAAs.

                          SAFE PLACES IN MINES

    Question. The Commonwealth of Pennsylvania has begun an analysis of 
locating safe places in the mines for workers to seek refuge in case 
escape routes are blocked. These safe places could be permanent or 
portable. Do you intend to conduct a similar analysis nationwide?
    Answer. Section 13 of the MINER Act requires NIOSH to study various 
refuge alternatives in an underground coal mine environment and issue a 
report not later than 18 months after enactment of the Act. Not later 
than 180 days after the receipt of this report, the Secretary of Labor 
is required to provide a response to the two authorizing committees 
describing what actions, if any, the Secretary intends to take based on 
the report. The Department will comply with this statutory requirement.

                         COMPETITIVENESS AGENDA

    Question. You propose cutting $653 million from workforce 
investment programs and another $27 million from the Employment 
Service, despite the fact that funding for workforce programs is $1 
billion below the funding level than when the President took over and 
there are one million more unemployed workers than there were in 2001. 
Isn't that approach inconsistent with a competitiveness agenda that is 
supposedly going to help America, and its workers, compete in the 
global economy?
    Answer. Although the President's fiscal year 2007 Budget request 
for the Employment and Training Administration is below the fiscal year 
2006 appropriation, it is a responsible budget that reflects the 
competitive demands for very limited resources for domestic programs 
and the need to eliminate waste and redundancy. The proposed reforms 
align with the competitiveness agenda by reforming the workforce 
investment system so that many more workers are trained, equipping them 
with the skills necessary to succeed in the 21st Century.
    The public workforce investment system could be structured to 
better meet the training challenges presented by the increased need for 
skills and competencies by workers. There exists a lack of integration, 
which causes too much money to be spent on competing bureaucracies, 
overhead costs, and unnecessary infrastructure, and not enough on 
meaningful skills training that leads to job growth and economic 
prosperity.
    Career Advancement Accounts, relative to the existing workforce 
investment system, will be more effective and flexible in meeting the 
demands of the global economy and in addressing the nation's workforce 
challenges. Career Advancement Accounts would mean a streamlined 
workforce investment system that gets more training dollars in the 
hands of workers and reduces costs by eliminating duplication across 
employment and training programs and lowering overhead costs. The 
greater efficiency from this redesign of the system will result in cost 
savings that account for much of the reduction in ETA's budget. More 
than triple the number of workers currently being trained would be 
trained under this proposal.

                            VOUCHER PROPOSAL

    Question. You have proposed a new WIA reauthorization proposal 
calling for Career Advancement Accounts, i.e. vouchers, to be run 
through a consolidated workforce system overseen by the Governor, 
allowing him or her to choose to eliminate the local workforce system 
and the One Stop network. This is the third different reauthorization 
proposal you have made to the Congress, your previously two attempts to 
create a block grant for the Governor have been resoundingly rejected 
in both the House and Senate, which have consistently protected the 
local workforce delivery system as essential to helping our workers 
receiving training for jobs in the local economy. Knowing that this 
approach has been rejected twice before, isn't your budget proposal jut 
a smokescreen to provide a rationale for deep budget cuts to the 
workforce system?
    Answer. No. Under the Administration's proposal for Career 
Advancement Accounts, states can maintain One-Stop Career Centers to 
provide employment services to job seekers and employers, as well as 
access to Career Advancement Accounts, at these sites. Career 
Advancement Accounts are a more efficient and effective way to deliver 
job training that will result in more workers getting the skills they 
need with less overhead costs. We believe that with the constraints on 
discretionary spending and the promise of more than tripling the number 
of workers trained with this innovative new approach, Congress will 
take this proposal seriously. This proposal is consistent with the 
``innovation'' agenda that has bi-partisan support in Congress.
    Workforce Investment Act (WIA) reauthorization has been pending in 
Congress for three years. No proposals have been either formally 
accepted or rejected. H.R. 27, which was passed by the House on March 
2, 2005, does consolidate the WIA Adult, WIA Dislocated Worker, and 
Employment Service funding streams, indicating interest on the part of 
Congress in streamlining programs as the Administration proposed.

                    RATIONAL FOR WORKFORCE TRAINING

    Question. You claim that only 200,000 are trained annually by the 
workforce system; however your data provides the smallest data pool 
possible to make your claim, as it only measures participants leaving 
training during a fiscal year. GAO estimates that over double this 
number, 416,000 receive training annually. Your own data provided in 
the Budget Justifications shows that over 15 million participants 
receive an array of training, intensive, or basic employment assistance 
annually through the workforce system. Isn't your budget request 
another example of using selective data to block grant and cut program 
funding?
    Answer. The important point is that 200,000 people complete and 
exit training per year with a $4 billion investment, meaning that too 
much money is being spent on low-cost services with little value to the 
customer. ETA uses actual data collected from the states in referencing 
number of people trained. The GAO study indicates that 40 percent of 
funds are used for training adults and dislocated workers, whereas ETA 
estimates this figure at 26 percent. This discrepancy occurs due to two 
primary differences in the measurements: (1) ETA is measuring exiters, 
or those that have actually completed training, while GAO is measuring 
training costs of all participants receiving training (meaning that 
people are ``double counted'' because their training may have occurred 
over two program years); and (2) ETA includes expenditures, while GAO 
includes both expenditures and obligations--obligations which may not 
result in someone actually being trained. The estimates by ETA and GAO 
are different because they look at distinctly different sets of cost 
estimates and individuals included in the count.
    The question also refers to the number of individuals served by the 
workforce investment system. The large majority of these participants 
are receiving only basic employment services, including self-services. 
The Career Advancement Accounts proposal would increase the number of 
individuals trained through the workforce investment system, while 
still providing basic employment services to job seekers.

                    ELIMINATION OF MIGRANT PROGRAMS

    Question. For the third year in a row, you have proposed 
eliminating the Migrant and Seasonal Farmworker program authorized 
under WIA. You first proposed to work with states and local areas to 
ensure that migrant and seasonal farmworkers could access services 
through One-Stop Career Centers; despite the fact that your 
Department's data show that the program met its performance goals. Now 
you propose to give governors the flexibility to design how individuals 
will access information and Career Advancement Accounts or vouchers. 
How does the Administration propose to ensure that these individuals--
some of America's neediest adults and their families--will be able to 
successfully navigate among service delivery systems that will differ 
from state to state and secure the job training and employment services 
that they need?
    Answer. The Administration's fiscal year 2007 Budget proposal seeks 
to tap the workforce investment system's potential to serve more 
migrant and seasonal farmworkers by providing job training services to 
them through the One-Stop Career Center system, and turning to other, 
appropriate agencies to provide supportive services, housing, and other 
related assistance. Currently, the section 167 program provides 
employment and training services to only 10,000 of an estimated 2 
million farmworkers, which demonstrates the need for a wider system 
approach.
    The Administration believes that providing services to farmworkers 
through the One-Stop system will increase the number served and have a 
positive employment and earnings impact on those who receive services.
    The Administration's fiscal year 2007 budget proposal seeks to take 
advantage of the One-Stop system's potential to better serve more 
migrant and seasonal farmworkers by helping them access the full array 
of employment and training services available from the seventeen 
federal programs delivered through the One-Stop system. While the 
proposal is to increase the amount of funding spent on training 
utilizing Career Advancement Accounts as the vehicle, the proposal also 
includes continued funding for core service delivery, including career 
guidance and job referrals, to any job seeker. Career Advancement 
Accounts can be used for a combination of remedial training leading to 
a diploma or GED in addition to post secondary education. We believe 
this combination of career guidance and training in the context of the 
One-Stop delivery system that connects workers to a wide array of 
services, including supportive services, can result in increased 
services to farmworkers and more positive employment and earnings 
impact on those farmworkers who receive services.

                        EMPLOYMENT SERVICE CUTS

    Question. You propose to cut the Employment Service by about $27 
million in fiscal year 2007 over and above a $96 million reduction in 
fiscal year 2006. You would give states the flexibility to determine 
how to provide basic employment services to America's workers and at 
the same time, absorb other costs that you propose to divest from the 
federal level--in labor market information products and services and 
dedicated professionals to help the disabled obtain employment. Past 
shortfalls in federal support have forced states to close local 
offices. With these deep cuts, states will be forced to shut down many 
more One Stop Career Centers that help match job seekers and employers 
seeking workers. How do you expect governors to be able to help an 
expected 14 million workers who need jobs and the thousands of 
employers looking for workers?
    Answer. The Department proposes to consolidate the Workforce 
Investment Act (WIA) programs for adults, dislocated workers, and 
youth, and the Wagner-Peyser funding stream into a single flexible 
grant that enables governors to utilize these resources strategically 
to both drive their economies and provide maximum training and 
employment opportunities for their citizens.
    The public workforce investment system, as currently constituted, 
is ill-equipped to meet the workforce challenges presented by the 
increased need for advanced skills and competencies in the 21st century 
economy. As one researcher has noted, ``As it now stands, employment 
services (and by extension the One-Stop system) is very far from being 
an effective labor exchange capable of assisting people surmount the 
challenges of today's job market.\1\ This is due, in part, to the lack 
of integration, which causes too much money to be spent on competing 
bureaucracies, overhead costs, and unnecessary infrastructure, and not 
enough on meaningful skills training that leads to job growth and 
economic prosperity. For example, while the Employment Service is 
intended to be the cornerstone of the One-Stop system under WIA, many 
states continue to have a separate network of Employment Service 
offices that offer the same ``core services'' that are available under 
WIA through One-Stop Career Centers.
---------------------------------------------------------------------------
    \1\ Osterman, Paul. ``Employment and Training Policies: New 
Directions for Less Skilled Adults.'' Paper prepared for the Urban 
Institute. October 2005. p.16.
---------------------------------------------------------------------------
    Furthermore, large amounts of state unexpended carryover funds 
still remain. In fiscal year 2004, unexpended funds from the WIA Adult, 
Dislocated Worker, and Youth programs totaled almost $1.2 billion and a 
similar amount is projected for fiscal year 2005, which ends on June 
30, 2006. Therefore, it is the Administration's position that through 
more efficient administration, integration of existing funding, and the 
effective use of currently available resources, states will not face 
the need to reduce services to the citizens generally or to populations 
with barriers to employment.

                         NATIONAL RESERVE FUND

    Question. Your proposal indicates that the Department would retain 
at the national level a portion of funds for a National Reserve Fund 
for unexpected emergencies before allocating funds for Career 
Advancement Accounts. What is the Department's estimate for this fund? 
And how would we distinguish the uses of these funds from the pilot, 
demonstration, and research account?
    Answer. Under the Career Advancement Account (CAA) proposal, the 
Department proposes to set aside funds for a National Reserve in a 
manner similar to the current Dislocated Worker National Reserve 
structure. The Department would reserve 7.5 percent of the 
appropriation provided by Congress for Career Advancement Accounts for 
the National Reserve. The Secretary would have the discretion to use 
this funding to quickly address unanticipated events, such as natural 
disasters, mass layoffs and plant closings, and the impacts of foreign 
trade. The National Reserve would also be used to provide technical 
assistance and for demonstration activities.
    The proposed use of Career Advancement Account National Reserve 
funds for demonstrations in addition to those carried out under pilots, 
demonstration and research budget authority is no different than the 
current structure. Under WIA section 171(d), up to ten percent of the 
National Reserve is used for dislocated worker projects. These 
demonstrations are in addition to the pilots, demonstrations and 
research authorized under WIA section 171(b). As it does now, the 
Department will maintain rigorous financial controls that track fund 
sources for all programs and activities.

                        RAPID RESPONSE SERVICES

    Question. Your consolidation proposal eliminates state resources 
set aside specifically for states to respond rapidly with information 
and services to workers who have received word of pending layoffs. You 
would require states to apply for funds from the National Reserve 
Account to provide such services. What justification do you provide 
states about requiring them to go through extra steps to provide rapid 
response services and gaining their confidence that the Department can 
respond to such requests in a timely manner?
    Answer. The Department does not contemplate that a state would have 
to apply for funds each time there is a mass layoff or to only 
sporadically fund a state rapid response coordinator. Early 
intervention to provide information and assistance to workers to 
decrease the amount of time between actual layoff and re-employment is 
a key principle of the dislocated worker program. Rapid response is a 
key element of this early intervention strategy.
    States could demonstrate need and apply for rapid response funds at 
the beginning of the program year or throughout the program year. We 
will not propose that a state be required to submit an application for 
funding each time a dislocation event occurs.
    In spite of all the good work that has been done over the past 
fifteen years with dislocated worker rapid response funds, the 
Department has found that most company executives do not know about the 
type and quality of assistance available to them and their employees 
when closures or layoffs are contemplated. They have also reported that 
where they have layoffs in several states simultaneously, the levels 
and quality of assistance varies dramatically. ETA, in collaboration 
with state and local partners, has undertaken several initiatives in 
the auto, textile and defense industries recently to try to integrate 
services and develop more consistency. We believe a nationally-
coordinated approach to delivering rapid response assistance by states 
can help bring the services to more workers and employers.
    The proposed mechanism will assist both the Department and the 
states to better manage scarce taxpayer resources by directing the bulk 
of the funds to the areas of need. For example, not all states 
experience major layoffs every year. Analyses of dislocated worker 
program expenditures reported by states have shown that the funds 
reserved for rapid response are consistently under-expended. In the 
aggregate, the rapid response carry-in funds from program year 2003 to 
2004, and from 2004 to 2005, was $136.7 million and $166 million, 
respectively. Through March 31, 2006, states reported accrued 
expenditures of just over $176 million of a total available of more 
than $342.5 million, or 51.4 percent of the total funds available. 
States are not required to retain the up to 25 percent authorized to be 
reserved for rapid response activities. They may include a portion of 
the funds in the amount allocated to local workforce investment boards 
for core, intensive and training services for dislocated workers, or 
they may award additional funds from the reserved amount to local areas 
that experience disasters, mass layoffs, plant closings or other events 
that precipitate substantial increases (defined by the state) in the 
number of unemployed workers.

                          ADULT TRAINING FUNDS

    Question. We need to upgrade the skills of our current workforce, 
including the low skilled on a broad base to increase economic growth 
and incomes. Recent data released from the National Assessment of Adult 
Literacy indicates that 14 percent of American adults had less than 
basic literacy skills--meaning they had a hard time locating easily 
identifiable information on commonplace material or following written 
instructions in simple documents. Your proposal would reduce adult 
training funds and turn the funds that are left into Career Advancement 
Accounts. It appears that low skilled adults who would compete with 
other workers for these vouchers may require combinations of 
assessment, career planning and developmental education services prior 
to being able to benefit from technical training. How will these 
individuals really fare under a system of capped vouchers and high 
pressure sales from many training providers?
    Answer. We agree there is a need to upgrade the skills of our 
current workforce, including those with low skills and literacy. State 
and local workforce systems set service priorities, and this will 
continue to be the case under the CAA proposal. These priorities will 
differ across the country, since demographics, labor markets and 
regional economies differ. By combining funding streams, our proposal 
will allow a more flexible response to these differences. Our proposal 
will triple the number of workers who currently are being trained by 
the workforce investment system.
    Assessment, career planning and developmental education services 
will continue to be accessed through One-Stop Career Centers, provided 
either through Workforce Investment Act funding or One-Stop partner 
programs. States will be responsible for determining eligible training 
providers within the state, as well as determining policies that govern 
those providers, such as policies to prevent false advertising and 
other abuses.

                        ECONOMIC GROWTH EFFORTS

    Question. Your consolidation proposal, combined with sizable cuts 
and program eliminations, ironically puts states in the position of not 
being able to jump start or continue to nurture regional economic 
growth planning and collaboration activities that integrates economic 
development, workforce development and education systems. These 
activities are similar to those you are promoting through your new 
WIRED initiative. What do you say to states that want to move forward 
with such integrated economic growth efforts if they don't qualify for 
funds under federal rules?
    Answer. The proposals for consolidation of workforce programs are 
intended to provide maximum flexibility for states and regional 
economies to implement the type of workforce investment services that 
are needed in that specific region. We believe that our traditional 
thinking about how individual programs are funded is contributing to 
the persistent problem of siloed program services, with excessive funds 
being spent on overhead and bureaucracy, rather than addressing the 
workforce needs of a regional economy. If regional economic needs are 
to be effectively and comprehensively addressed, it will take many 
sources of funding, including funding from economic development 
agencies and educational institutions, and coordination across these 
funding streams. Therefore, the approach of making Federal funding for 
workforce services more flexible will contribute to integrated economic 
development efforts and the maximum leveraging of resources. Finally, 
the transformation of a regional economy is not dependent on Federal 
demonstration funding. What drives transformation is the collaborative 
leadership and strategic planning of economic development, research and 
development, capitalization, entrepreneurship and workforce development 
visionaries.

                  ELIMINATION OF YOUTH TRAINING GRANTS

    Question. Your proposal to redesign the workforce delivery system 
eliminates WIA training grants for disadvantaged youth that are aimed 
at improving their education, employment, and earnings prospects. It is 
difficult to reconcile your proposed request when the President and you 
as well have focused on the need to raise the skills of young people in 
order to maintain our competitive edge in this new global economy. And 
from research--much funded by your Department, we know that an array of 
services is necessary to help disadvantaged youth complete their 
education, mature into solid citizens, and make the successful 
transition to work. By making these young people compete with adults 
for Career Advancement Accounts, aren't you really limiting their 
changes for future success?
    Answer. We agree that there should be an emphasis on raising the 
skills of young people in order to maintain our competitive edge in the 
global economy. Career Advancement Accounts will be available to out-
of-school youth. Furthermore, states and localities will still be able 
to provide career counseling and other services to these out-of-school 
youth, and workforce information will be available to assist them in 
choosing careers in high growth industries and in determining 
appropriate training for those careers.
    Targeted programs and set-asides have led to multiple program 
silos, excessive overhead and bureaucracy, lack of coordination and 
integration, and only a modest number of people trained for the size of 
the workforce system investment. States and local areas will still be 
able to serve targeted groups, such as out-of-school youth, but will 
have more flexibility in using resources and not be subject to the 
often conflicting requirements of multiple programs or funding streams. 
Furthermore, consolidating funding streams will enable states and 
localities to better focus on the needs of their distinct populations, 
since labor force demographics and labor markets vary considerably 
across the country. The substantial number of requests for waivers to 
allow transfer of funds between programs indicates the need for more 
flexibility in this area than the current legislation allows.

                      CAREER ADVANCEMENT ACCOUNTS

    Question. A recent ETR article on the fiscal year 2007 budget 
request noted ``ETA officials said their legislative analysts believe 
this program--the consolidated Career Accounts proposal--can be 
implemented under current authorizing statues, but would be easier for 
states to embrace with program consolidation that would occur under the 
WIA reauthorization package put forward by House Republicans, HR 27.'' 
It's my understanding that HR 27 has passed the House and is awaiting 
conference with the Senate. Please explain how, if the House already 
has a bill that is not consistent with your Career Advancement Accounts 
proposal, how you plan to accomplish this.
    Answer. As you indicate, the House has passed H.R. 27 and the 
Senate recently passed its version of Workforce Investment Act 
reauthorization legislation. H.R. 27 would implement many key 
components of the President's job training reform proposal, such as 
merging funding streams. We believe CAAs can be built upon this piece 
of legislation.

                    ELIMINATION OF JOB BANK PROGRAM

    Question. The elimination of America's Job Bank is particularly 
troubling. It is the backbone for more than 20 state job banks as well 
as the electronic version of a national employment service. Thousands 
of job seekers get their work through AJB and thousands of employers 
use it. By your own Department's last count, over 138 million job 
searches were conducted on AJB for the year ending June 3, 2005 and 
over 9 million resume searches were conducted by employers during the 
same period. There were about 7.8 million job postings originated on 
AJB during that year, over 700,000 new resumes posted, and 55,000 new 
employer registrations. All of these activity counts are increases over 
the prior year. How can the United States have a modern public 
employment service without an electronic exchange?
    Answer. The Department of Labor considered numerous factors in 
coming to the decision to phase out America's Job Bank (AJB), which 
included looking at the larger environment in which AJB is operating 
and weighing the costs associated with running the system. Since the 
launch of AJB, the number of private sector Internet-based job banks 
(Career Builder, Monster, Yahoo! Hot Jobs, etc.) has proliferated, 
calling into question the need for a Federal government-sponsored 
national job bank. These private-sector electronic labor exchange 
systems are continuously improving and most, if not all, of these sites 
offer free services to job seekers. Current trends in the industry seem 
to indicate that some level of free service will also be offered to 
businesses/employers in the future and many employers who currently use 
AJB are already using these other job banks simultaneously to advertise 
their openings.
    In addition, it has been increasingly difficult, if not impossible, 
to keep America's Job Bank updated as technology has advanced. Also, as 
Internet technology and technical resources have become widespread and 
the costs associated with them have declined, state and local areas 
that previously relied on AJB for their Internet self-service labor 
exchange presence have built and operate job banks of their own that 
are not based on AJB and promote them to their job seeker and business 
customers rather than AJB.
    AJB is not the backbone for 20 state job banks, nor is there any 
evidence of widespread job gains as a result of using AJB. In fact, AJB 
is not used in most One-Stop Career Centers across the country.

                     PROPOSED WORKFORCE LEGISLATION

    Question. The Administration plans to introduce legislation to 
reform the workforce investment system and create the Career 
Advancement Accounts (CAAs). If this legislation is not passed before 
fiscal year 2007, what would be the impact on services of the proposed 
15 percent funding reduction for workforce development programs?
    Answer. The President's Budget request assumes enactment of the 
Career Advancement Account (CAA) proposal, which would reduce overhead 
and administrative costs and focus more funding on training, thereby 
tripling the number of individuals receiving job training through the 
workforce investment system. In the absence of CAA legislation passed 
by Congress, the workforce investment system will continue to have 
siloed funding streams that result in duplicative costs.
    While states will be able to continue operating Workforce 
Investment Act programs and the Employment Service at the lower funding 
levels proposed by the Administration, these reduced levels, without 
the accompanying reforms, may result in decreases in the number of 
participants served through these programs, compared to the President's 
proposal.
    Question. States could administer the CAAs through ``community 
career centers'' at community colleges, public libraries, senior 
centers, and other locations, as well as through existing one-stop 
centers. Could this approach lead to the creation of a parallel system 
of job search and career assessment services, that duplicates what is 
already available through the one-stop centers? Could it lead to 
confusion among potential customers of the system, about where to go to 
access services?
    Answer. Under our proposal, states can maintain One-Stop Career 
Centers to provide employment services to job seekers and employers, as 
well as access to Career Advancement Accounts. States and localities 
would have the option of making employment services and access to 
Career Advancement Accounts available at additional sites in the 
community.
    Question. Will the existing state and local workforce boards have 
any role in administering the new program, or will they be disbanded? 
Similarly, will the programs that are currently mandatory partners in 
the one-stop system have any role in administering the CAAs?
    Answer. State and local Workforce Investment Boards will continue 
to exist and retain roles and functions similar to what they have under 
the current Workforce Investment Act. Similarly, the required partners 
will continue to participate in the One-Stop service delivery system, 
and have a role in setting local policy and providing oversight for the 
service delivery system. The specific role of the partner programs in 
administering Career Advancement Accounts (CAA) would be worked out 
under policies set by the state in setting up the CAA system.
    Question. How will the Labor Department calculate the amount of 
funds each state will receive for CAAs? Will there be a formula?
    Answer. There will be a formula for allotting Career Advancement 
Account funds to states, similar to the formulas that have been used to 
allot funds to states under current law. The specific formula proposal 
has not been finalized, but the final formula would be worked out 
between the Administration and Congress.
    Question. The CAA proposal assumes that individuals need minimal 
assessment and case management services to make good decisions about 
whether and how to use training funds. However, in implementing reform 
of the Trade Adjustment Assistance (TAA) program, you have emphasized 
the need to co-enroll TAA participants in WIA for case management, so 
that their training needs can be properly assessed. What is the basis 
for your decision to provide training funds with minimal case 
management funds, in the CAA proposal?
    Answer. The Department's ongoing evaluation of the Individual 
Training Account activity under the Workforce Investment Act shows that 
when an individual is provided more choice in training and counseling 
services, the individual is more likely to use an ITA for training and 
to enter training more quickly. Further, the individual's training 
selection tends to be similar to training programs selected by similar 
individuals who are required to receive counseling services and 
approval.
    We believe that up-front assessment (as contrasted with ongoing and 
costly case management) is what workers need, including those served 
under the TAA program. Assessments can be provided under the CAA 
proposal if needed, with over $700 million set aside for such services 
to complement training (22 percent of the total consolidated resources 
per state, roughly equivalent to the current Wagner-Peyser amount for 
core services). The purpose of such assessments is to properly gauge 
marketable skills and assist workers to reenter employment or identify 
training to fill gaps in marketable skills. Our demonstrations show 
that with this ``informed choice'' more people can receive actual 
training for jobs in the local labor market.
    Question. The new system would be designed based on lessons from 
the implementation of the Individual Training Account and Personal 
Reemployment Account (PRA) programs. What lessons specifically have 
been drawn from the implementation of those programs? What evaluations 
exist to support giving more control over training funds to 
individuals?
    Answer. CAAs provide individuals with increased customer choice and 
flexibility for selecting training and other services that are 
appropriate for them and are based in part on lessons learned from 
Individual Training Account (ITA) and Personal Reemployment Account 
(PRA) demonstrations.
    The ongoing evaluation of the ITA Experiment explored the use of 
increasing customer choice in the delivery of ITAs. Initial analysis 
from eight local boards participating in the experiment showed that 
when an individual was provided more customer choice in training and 
counseling services, the individual was more likely to accept an ITA 
for training, the individual's training selection tended to be similar 
to training programs selected by individuals required to receive 
counseling services and approval of programs, and the individual was 
more likely to enter training quickly. The final report, to be 
completed later this year, will provide a more in-depth analysis of the 
impacts of the three different ITA service approaches.
    The goals of PRAs are to provide individuals who are identified as 
most likely to exhaust Unemployment Compensation with a quicker return 
to work, direct access to training, greater customer choice and 
control, and better economic outcomes. Initial observations from the 
PRA Demonstration show that participating states were able to implement 
the PRAs generally as planned, with the first accounts offered in March 
2005. The evaluation of the PRA Demonstration is underway. An interim 
report, to be completed this year, will provide a more in-depth 
understanding of the implementation process. In the meantime, reports 
from states on best practices show that account mechanisms can be 
implemented, appropriate oversight can be maintained, and individual 
choice can provide greater access to needed services.
    Question. The CAA proposal includes performance measures that are 
similar to those now used to assess the adult and dislocated worker 
programs. However, with CAA funds going directly to individuals, who 
would be held accountable for performance outcomes--states or the local 
community career centers? Does it make sense to apply performance 
measures designed for adults (that focus on employment outcomes) to 
CAAs that are also used by youth? Currently, youth performance measures 
also consider educational goals.
    Answer. States will continue to negotiate performance targets and 
report to the Department of Labor on three primary outcome measures: 
(1) entered employment, (2) retention in employment, and (3) earnings. 
In addition, attainment of a degree or certificate, entry into training 
and education, and literacy and numeracy gains would be tracked as 
intermediate outcomes.

                          RAPID RESPONSE FUNDS

    Question. Currently, states use rapid response funds to provide 
immediate service to workers affected by a mass layoff, often before 
the workers are even laid off. Under your legislative proposal, states 
will need to apply to The Employment and Training Administration for 
rapid response funds as events occur. What are the reasons for keeping 
these funds at the national level, and having states apply for them 
each time they are faced with a mass layoff? What effect will this 
approach have on states' ability to provide immediate rapid response 
services for mass layoffs?
    Answer. The Department does not contemplate that a state would have 
to apply for funds each time there is a mass layoff or to only 
sporadically fund a state rapid response coordinator. Early 
intervention to provide information and assistance to workers to 
decrease the amount of time between actual layoff and re-employment is 
a key principle of the dislocated worker program. Rapid response is a 
key element of this early intervention strategy.
    States could demonstrate need and apply for rapid response funds at 
the beginning of the program year or through the program year. We will 
not propose that a state be required to submit an application for 
funding each time a dislocation event occurs.
    In spite of all the good work that has been done over the past 
fifteen years with dislocated worker rapid response funds, the 
Department has found that most company executives do not know about the 
type and quality of assistance available to them and their employees 
when closures or layoffs are contemplated. They have also reported that 
where they have layoffs in several states simultaneously, the levels 
and quality of assistance varies dramatically. ETA, in collaboration 
with state and local partners, has undertaken several initiatives in 
the auto, textile and defense industries recently to try to integrate 
services and develop more consistency. We believe a national approach 
to delivering rapid response assistance by states can help bring the 
services to more workers and employers.
    The proposed mechanism will assist both the Department and the 
states to better manage scarce taxpayer resources by directing the bulk 
of the funds to the areas of need. For example, not all states 
experience major layoffs every year. Analyses of dislocated worker 
program expenditures reported by states have shown that the funds 
reserved for rapid response are consistently under-expended. In the 
aggregate, the rapid response carry-in funds from program year 2003 to 
2004, and from 2004 to 2005, was $136.7 million and $166 million, 
respectively. Through March 31, 2006, states reported accrued 
expenditures of just over $176 million of a total available of more 
than $342.5 million, or 51.4 percent of the total funds available. 
States are not required to retain the up to 25 percent authorized to be 
reserved for rapid response activities. They may include a portion of 
the funds in the amount allocated to local workforce investment boards 
for core, intensive and training services for dislocated workers, or 
they may award additional funds from the reserved amount to local areas 
that experience disasters, mass layoffs, plant closings or other events 
that precipitate substantial increases (defined by the state) in the 
number of unemployed workers.

                      FOREIGN LABOR CERTIFICATION

    Question. There is an inherent unfairness to having some employers' 
applications from six years ago pending at the BEC and having new 
applications adjudicated in two months. These inordinate delays have 
caused and are causing serious prejudice to employers and employees 
alike. With this as background, please address the following issues:
    Answer. The Department published a final regulation implementing a 
new re-engineered Permanent Labor Certification Program effective March 
28, 2005. This regulation created a new faster and more efficient 
method for employers to have their applications processed. The 
regulation applies to all applications filed after its effective date. 
However, for applications previously filed up until March 27, 2005, 
those applications must be processed under the previous regulation. The 
process prescribed by the previous regulation takes considerably more 
time than the new one, despite efficiency measures we have introduced, 
e.g., technology, to streamline it as much as possible.
    Question. Congress has expressed a clear intention in the Child 
Status Protection Act to prevent government delays from separating 
families by having children turn 21 during the permanent residence 
processing. At the time Congress passed the CSPA, the existing scope of 
the DOL backlog was unanticipated. In light of the clear Congressional 
intention, why has the Department of Labor refused to expedite long-
pending backlogged applications based upon a showing that the impact of 
the delay will forever prevent a child from becoming a permanent 
resident with his or her parents?
    Answer. We understand the Child Status Protection Act applies only 
to cases pending before the Department of Homeland Security. The 
Department of Labor strongly supports efforts to keep families 
together. The Department has determined this goal can best be 
accomplished by minimizing the amount of time it takes to process 
foreign labor certification applications. For this reason, the 
Department has consistently applied a first in/first out (FIFO) policy 
to cases in the Program Electronic Review Management (PERM) program. 
The FIFO policy prevents the need to make subjective decisions 
regarding which, if any, cases merit special consideration for 
expedition, thereby conserving resources and substantially reducing the 
amount of time that is required to process applications. It is ETA's 
longstanding policy to also process cases in the permanent labor 
certification program backlog on a ``First-In/First-Out'' basis within 
that system's various processing categories; for example Reduction in 
Recruitment (RIR) cases are in a separate processing queue from cases 
being handled through the traditional recruitment process (TR), but 
cases in each queue are processed on a ``First-In/First-Out'' basis. It 
has been ETA's established policy never to expedite cases bases on the 
specific circumstances of individual employers or aliens.
    Question. In addition to children aging out, other significant 
detriments to employers and employees exist in specific cases. Examples 
include inability to promote employees, loss of tuition benefits, 
inability to travel, inability for spouses to work, etc. Given that the 
delays are through no fault of the employer or the employee, why has 
the Department of Labor failed to establish a system for expediting 
worthy cases?
    Answer. The Department's policy of not expediting cases saves an 
enormous amount of limited resources since we do not have to evaluate 
the merits of each request to expedite across what potentially could be 
tens of thousands of cases. Furthermore, we believe some of the 
concerns you note arise from visa restrictions over which the 
Departments of State and Homeland Security have jurisdiction and not 
from any DOL permanent labor certification rules or requirements.
    The most equitable response to this complicated issue is to require 
strict adherence to our first-in/first-out policy under which all 
applicants are treated consistently. For every case considered for 
expedited consideration, an older case would be further delayed. Unlike 
the Department of Homeland Security, the Department of Labor does not 
have the legislative authority for a fee structure which allows for 
``premium processing.''
    Currently, employers do not pay a fee to DOL for the processing of 
permanent foreign labor certification applications. Employers benefit 
significantly from the admission of foreign workers, and the efficient 
review of applications they receive under the new, streamlined process. 
The backlog system is not fully automated and therefore continues to 
function through a FIFO process. The Administration has included a 
proposal in the fiscal year 2007 budget to create a fee structure for 
the Permanent Labor Certification Program. We anticipate revenue from 
such fees would permit the assignment of additional staff, such that 
there should be no backlogs in the new PERM system.
    Question. Why has the Department of Labor made it so difficult and 
risky for employers to convert cases from the BEC to PERM? Seemingly, 
DOL has created the most restrictive rules possible to discourage these 
conversions, resulting in an unexpectedly low number of conversions and 
an unexpectedly high number of cases remaining at the BECs? Will DOL 
amend its rules to encourage conversions? Examples of improvements 
include eliminating the risk of the loss of priority date if a case is 
not eventually adjudicated to be ``identical''; eliminating the risk of 
loss of the ability to obtain seventh year H-1B extension if the case 
is not considered to be ``identical''; removing the ``identical'' 
standard entirely; changing present procedures which involve audits of 
most or all of the conversion cases; eliminating the very extensive 
delays in adjudicating PERM conversion cases; and allowing cases at the 
BEC to remain pending until the approval of the PERM case (especially 
since a mere typographical error could result in a PERM case being 
denied).
    Answer. The Department is in the process of reviewing the rate at 
which cases have been converting from the old pre-PERM certification 
system to PERM. Employers currently have the option of re-filing the 
case if it meets the requirements of the PERM regulation. Those who 
wish to have the benefit of the new efficient processing system must 
meet the regulatory requirements of that rule. The Department does not 
have the resources to process identical cases under two different 
regulations implementing the permanent labor certification program, 
i.e., pre-PERM and post-PERM. Removing the ``identical'' standard under 
the PERM regulation would require a new rulemaking process and has the 
potential for trading backlogs between the Backlog Elimination Centers 
and the Department's National Processing Centers. We do not feel that 
this would be in the interests of employers or foreign workers. The new 
PERM system is much more efficient than the old system, but converting 
all old cases into new PERM cases would result in backlogs in PERM.
    Question. What is the plan for dealing with applications for which 
no 45 day letter was received by June 30? Will provisions be made for 
reconstructing lost files? When will employers be notified of these 
procedures?
    Answer. The BECs have taken extensive steps to ensure that all 
applications identified for transfer to the BECs have been shipped and 
received at their designated destination. However, because there may be 
some applications that for various reasons were never identified by the 
state agencies or ETA Regional Offices for shipment to the BECs, we are 
developing a process by which to handle those cases. Within the past 
two weeks, the Department posted a detailed set of Frequently Asked 
Questions (FAQs) on the foreign labor certification website which 
addresses procedures related to the 45-day letters http://
www.ows.doleta.gov/foreign/#whatsnew.
    Due to the high demand for information and time and resource 
constraints, we believe that posting the information on our website is 
the best way for the entire public to have access to the information at 
the same time. These FAQs will provide procedures for employers in the 
event they have had a case closed through the non-receipt of a 45-day 
letter. Additional FAQs to cover these situations may be posted if 
appropriate at a later date.
    Question. What are the realistic expectations for adjudicating all 
BEC cases by September 30, 2007? How are these expectations impacted by 
losses of the top level people at the BEC in Pennsylvania? How has DOL 
factored into these expectations the lack of incentive for BEC 
employees to complete the cases on a timely basis since doing so will 
result in loss of their positions as of September 30, 2007?
    Answer. The Department has plans underway to fill all vacancies, 
both Federal and contractor staff, at the Philadelphia Backlog 
Elimination Center. Since establishing the two (2) backlog centers in 
July 2004, we have logged in all 360,000+ cases transferred to the 
backlog centers from the states, sent 45-day letters to all employers, 
and cleared over (157,473) cases from the centers. We intend to have 
all backlog cases under processing by September 30, 2007.
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