[Senate Hearing 107-404]
[From the U.S. Government Publishing Office]



                                           S. Hrg. 107-404, Pt. 1

  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2002

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

                                HEARINGS

                                before a

                          SUBCOMMITTEE OF THE

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                      ONE HUNDRED SEVENTH CONGRESS

                             FIRST SESSION

                                   on

                           H.R. 3061/S. 1536

 AN ACT MAKING APPROPRIATIONS FOR THE DEPARTMENTS OF LABOR, HEALTH AND 
  HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES, FOR THE FISCAL 
         YEAR ENDING SEPTEMBER 30, 2002, AND FOR OTHER PURPOSES

                               __________

                         Part 1 (Pages 1-572)

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

                               __________

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                      COMMITTEE ON APPROPRIATIONS

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

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

                 ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi            TOM HARKIN, Iowa
JUDD GREGG, New Hampshire            ERNEST F. HOLLINGS, South Carolina
LARRY E. CRAIG, Idaho                DANIEL K. INOUYE, Hawaii
KAY BAILEY HUTCHISON, Texas          HARRY REID, Nevada
TED STEVENS, Alaska                  HERB KOHL, Wisconsin
MIKE DeWINE, Ohio                    PATTY MURRAY, Washington
                                     MARY L. LANDRIEU, Louisiana
                                     ROBERT C. BYRD, West Virginia
                                       (Ex officio)

                           Professional Staff

                            Bettilou Taylor
                             Mary Dietrich
                              Jim Sourwine
                              Mark Laisch
                        Ellen Murray (Minority)
                      Adrienne Hallett (Minority)
                         Erik Fatemi (Minority)

                         Administrative Support

                             Correy Diviney
                       Carole Geagley (Minority)




                            C O N T E N T S

                              ----------                              

                         Tuesday, March 6, 2001

                                                                   Page

Work Safety and the Ergonomics Rule..............................     1

                       Wednesday, April 25, 2001

Department of Health and Human Services: Office of the Secretary.    27

                        Thursday, April 26, 2001

Ergonomics.......................................................    65

                         Wednesday, May 2, 2001

Department of Labor: Office of the Secretary.....................   201

                         Thursday, May 10, 2001

Department of Education: Office of the Secretary.................   251

                        Wednesday, May 23, 2001

Department of Health and Human Services: Office of the Secretary.   293

                       Nondepartmental Witnesses

Department of Education..........................................   417
Department of Health and Human Services..........................   448
Related agencies/general testimony...............................   684
  

 
  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2002

                              ----------                              


                         TUESDAY, MARCH 6, 2001

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 9:39 a.m., in room SD-192, Dirksen 
Senate Office Building, Hon. Arlen Specter (chairman) 
presiding.
    Present: Senator Specter.

                  WORK SAFETY AND THE ERGONOMICS RULE


               OPENING STATEMENT OF SENATOR ARLEN SPECTER

    Senator Specter. Good morning, ladies and gentlemen. The 
Appropriations Subcommittee on Labor, Health and Human 
Services, and Education will now proceed.
    The hearing on ergonomics has been convened on very short 
notice, as we have not had much notice that the issue would be 
on the Senate floor, which it is today, and I thought it would 
be useful to hear from parties in the field, the 
representatives of the factions which are in opposition to the 
current ergonomics regulation, representatives in favor of the 
regulation, and from the Associate Solicitor of Labor for OSHA, 
the Agency which had the responsibility for promulgating the 
regulation.
    I had a brief informal meeting with the parties in my 
office. We will proceed now to try to address a number of the 
critical issues. I would start with the question as to the 
views of the witnesses, and I welcome Mr. Joseph M. Woodward, 
Esq., who is Associate Solicitor of Labor for OSHA, and Baruch 
Fellner, Esq., a partner at Gibson, Dunn & Crutcher, practicing 
employment law with emphasis on occupational safety and health, 
and Lynn Rhinehart, Esq., associate counsel of the AFL-CIO. We 
will start with the baseline question as to whether there ought 
to be any regulation at all. Mr. Fellner, let me start with you 
on that first.
STATEMENT OF BARUCH A. FELLNER, ESQ., PARTNER, GIBSON, 
            DUNN & CRUTCHER, LLP
    Mr. Fellner. Based upon the science, the law, and medicine 
as we presently know it, the regulation which OSHA has 
promulgated is beyond the mark and is fatally flawed.
    Whether there should be any regulation of ergonomics will 
and should depend on the proper nonrush to judgment evaluation 
of this extraordinarily complex area, and Secretary Chao in her 
confirmation hearings has emphasized precisely that, and that 
is, these are issues which are inordinately complicated, both 
from an economic as well as a scientific and medical 
perspective, and given that, given the time frame that it took 
between proposal to final in this instance, a time frame which 
the head of the OSHA effort, Marthe Kent, referred to as a 
miracle if OSHA could promulgate this standard in time--and by 
in time, we all know that that meant before the close of the 
last administration.
    Senator Specter. Then you are essentially saying there 
could be a regulation, but it has to be properly formulated. 
What would you recommend as the course to formulate such a 
regulation?
    Mr. Fellner. We would recommend what we recommended to OSHA 
during the course of the hearings, and it was a recommendation 
that was echoed by the Chief Administrative Judge, Judge 
Vittone, and that was, first, given the complexity of the 
issues involved, the medical and scientific issues, it would be 
appropriate, it would be absolutely necessary to get into the 
same room the major medical and scientific minds on both sides 
and let them have, over a period of 2 or 3 days, or however 
long it took, with appropriate overview from the Department of 
Labor, a full and free discussion of what the science shows.
    Senator Specter. Who should those people be?
    Mr. Fellner. We represent the National Coalition on 
Ergonomics and a number of other petitioners in the lawsuit 
against this litigation, or against this regulation. As part of 
that lawsuit, we submitted statements from 21 of the world's 
greatest experts, amongst whom is Alf Nachemson. Alf Nachemson 
from Sweden, is viewed as the greatest authority on low back 
pain, period, full stop. He has submitted a statement into the 
OSHA record indicating that this standard is so ill-advised 
from an economic, a medical and a scientific perspective, that 
it should not be promulgated. Alf Nachemson, N-a-c-h-e-m-s-o-n, 
and there are many others.
    Senator Specter. How many such experts would you recommend 
representing your side of the issue?
    Mr. Fellner. I would suggest, Senator Specter, that it 
might be slightly premature to get into those specifics, but at 
least a half-a-dozen, half-a-dozen to a dozen experts from our 
side I would suggest, respectfully, from the appropriate 
medical side, and I would also remind the chairman that two 
august medical bodies, the American College of Occupational and 
Environmental Medicine, representing over 100,000 occupational 
doctors, supporters of ergonomic principles from day 1, have 
written a specific letter opposing this final standard. They 
should be represented. Two, the American Academy of Orthopedic 
Surgeons submitted a comment into the record opposing this 
proposed regulation. They should be represented, and if the 
other side wants to bring in their ergonomists to represent 
their position insofar as what the medical and scientific 
issues reflect, by all means let them do so, but if I might 
add, when we made that suggestion of a full and free discussion 
with regard to these issues, OSHA declined, and declined in 
writing. That issue has to be redressed.
STATEMENT OF LYNN RHINEHART, AMERICAN FEDERATION OF 
            LABOR-CONGRESS OF INDUSTRIAL ORGANIZATIONS
    Senator Specter. Before taking up, Mr. Fellner, with your 
specific objections to the regulation, let me ask Ms. Rhinehart 
what her view is of such an interchange among experts.
    Ms. Rhinehart. Well, Senator, I think that is a fine idea, 
but in fact it has already happened. It has already happened a 
number of times, the most recently the National Academy of 
Sciences recently issued a comprehensive report, and that was 
ordered by Congress as part of the appropriations process 2 
years ago.
    The NAS issued a comprehensive report after reviewing all 
of the literature on ergonomics, and this was a gathering of 
major scientific minds. As Mr. Fellner put it, this was a 
gathering of major scientific minds, the National Academy of 
Sciences, and they came out with a comprehensive report in 
January that found not only is there a strong association 
between worker exposure to ergonomic risk factors in the 
workplace, and development of ergonomic injuries, but also that 
interventions reducing those exposures was effective at 
reducing worker injuries.
    Senator Specter. Did the National Academy of Sciences 
support this regulation?
    Ms. Rhinehart. The NAS, their job was to look at the 
science and to make conclusions about what the science says at 
this point. They were very explicit that they were not making 
policy recommendations, that their job was to look at science, 
not policy, so they did not take a specific position on the 
ergonomics regulation. However, their findings clearly support 
an ergonomics regulation. They found that, as I said----
    Senator Specter. Well, they clearly support regulation, but 
the focused question is whether they support this regulation.
    Ms. Rhinehart. They were not asked to support this 
regulation, so they did not comment on this regulation.
    Senator Specter. They were not asked to comment about this 
regulation?
    Ms. Rhinehart. Correct. They were asked to look at the 
science, and they did, and they found the science supports 
ergonomic interventions.
STATEMENT OF JOSEPH M. WOODWARD, ASSOCIATE SOLICITOR OF 
            LABOR, OCCUPATIONAL SAFETY AND HEALTH 
            ADMINISTRATION, DEPARTMENT OF LABOR
    Senator Specter. Mr. Woodward, is it true, as Mr. Fellner 
says, that OSHA specifically rejected a convocation of experts 
on both sides?
    Mr. Woodward. I believe he is referring to a letter that 
was written during the course of the rulemaking proceedings for 
this standard. In order to promulgate a standard, we have to 
follow certain procedures, which include public hearings and an 
opportunity for comment. We were engaged in following those 
proceedings at that time, which are all on the record and 
subject to certain requirements, so I believe it is correct 
that at that time we did not take up that opportunity.
    If I could make a few other points, first of all, I am here 
in a technical capacity to try to help describe the rule and 
the issues in the rule. I am not here to advocate a particular 
policy solution here.
    Senator Specter. Well, are you here to advocate the rule?
    Mr. Woodward. I would like to note that the Agency has 
finalized a rulemaking, and that it found on the record that 
the criteria for issuing an OSHA standard, in the agency's 
view, as of last November, were satisfied. Those criteria are: 
is there a significant risk of harm; is the harm material; and 
is there a feasible way to reduce the harm. That was the 
finding that was made in November.
    Any approach to ergonomics, if it is in a regulatory 
approach, would have to follow the criteria that Congress has 
laid down, and also the procedures. Since we issued the rule, a 
number of people have filed lawsuits. Thirty-one lawsuits have 
been filed. A lot of objections have been raised to the rule. 
The Secretary has said that these are very complicated issues 
that she wants to study carefully. We are aware of the fact 
that many people have objected to the provisions of the rule.
    Senator Specter. Well, you give the reasons why you 
rejected the idea of having experts on both sides come in, 
because, as you describe it, you are in the middle of a 
rulemaking process. Do you think that Mr. Fellner's suggestion 
is a good one, if you are going back to the start again?
    Mr. Woodward. We always think it is a good idea to meet 
with different people who have different viewpoints, and hear 
what they have to say, because certainly you can learn 
something that way.
    Senator Specter. Is that a yes answer?
    Mr. Woodward. Yes. A meeting or a discussion is a good 
thing. If the idea is to do a rulemaking, eventually you have 
to go through the procedures I mentioned, and you have to make 
your decision on the basis of the evidence.
    Senator Specter. Do those procedures allow at some stage to 
have the expertise that Mr. Fellner described convened and 
discuss the matter?
    Mr. Woodward. Certainly. There are public hearings where 
people can come in and say what they want and question each 
other.
    Senator Specter. I do not think he is talking about a 
public hearing, although it could be open to the public. Well, 
you can call it a public hearing.
    Mr. Fellner, coming to the substance of this regulation, 
what, in your view, is wrong with it?
    Mr. Fellner. If I may be given a couple of minutes to 
address that, Senator Specter, rather than a relatively brief 
period of time.
    Senator Specter. Take whatever time you need, Mr. Fellner.
    Mr. Fellner. I appreciate it immensely. It is important to 
reflect, obviously, the perspective from which I come. I am an 
attorney. I represent the National Coalition on Ergonomics, and 
some 106 out of 136 petitioners in this matter and, in the 
interest of an open record, it is important to recognize that I 
am an attorney reflecting those clients.
    Having said that, and if you would allow me a personal 
digression, I have been practicing occupational safety and 
health law for 30 years. In my formative years as a lawyer I 
was in charge of OSHA enforcement for a period of approximately 
10 years, and it is with a great deal of sadness and mixed 
emotion that I am here today, speaking against a regulation 
from an agency for which I have enormous respect and an agency 
which I believe has a very, very important task in this 
country. It has gone too far insofar as this particular 
regulation is concerned.
    And let me emphasize, Senator Specter, what we are not 
opposed to. We are not opposed to the voluntary application of 
ergonomic principles in the workplace. Ever since the wheel was 
invented, man has understood that it is preferable to use a 
wheelbarrow to move rocks than it is to do it on his back. That 
is pure, sensible, logical, you want to make the job as 
comfortable----
    Senator Specter. Mr. Fellner, it does not advance the issue 
much to say that you are in favor of voluntary compliance. Of 
course, if it is voluntary, who would have any objection to 
that. The issue moves from that as to whether you need 
something more.
    Mr. Fellner. That is right, and the question is whether 
this--not whether you need, with all due respect, whether you 
need something more, in the context of your first question to 
me, any regulation. The issue before us this morning, with 
respect, is this midnight regulation that we are talking about.
    Senator Specter. Precisely. That is why I am asking you 
what is wrong with it, in your view.
    Mr. Fellner. It is the most intrusive, most far-reaching 
micromanagement of American industry in the history of the 
Department of Labor. It is, to put it bluntly, bad law, bad 
economics, bad science, and bad medicine, and if I could touch 
on all of those four briefly this morning, I can give what I 
would think would be a complete response.
    Senator Specter. That is fine. To the extent you can be 
specific as to what there is in the regulation which is costly, 
which is inefficient, and which does not move to protect worker 
safety, we would appreciate it.
    Mr. Fellner. Thank you. The final standard we are talking 
about, Senator Specter, does a 180 from the proposal. The 
proposal as a result of 2\1/2\ months of hearings in which I 
participated, cross-examined OSHA's witnesses. That proposal, I 
dare say the agency concluded was vague to the point of being 
unconstitutional and, instead of going with the proposal, they 
went with a final standard which was not the logical outgrowth, 
could not be anticipated from that which was proposed, and let 
me give you one or two examples, if I may.
    The final standard contains nine mathematical formulas 
which include basic screening tools and hazard identification 
tools to tell the employer how to act, how to lift, what to 
move, what constitutes repetition. The final standard defines 
repetition as two motions performed within 1 minute over a 2-
hour period of time. One minute is interminable. I would 
challenge----
    Senator Specter. Two motions?
    Mr. Fellner. Within 1 minute, which are repetitive. A 
repetitive cycle is two motions within 1 minute over 2 hours.
    We do not have the time this morning to take out a stop-
watch, and if you take out a stop-watch and determine how slow 
1 minute is, and how few two motions are, that is the stately 
pace that OSHA would want American business to function at.
    Senator Specter. I would like to have Ms. Rhinehart's 
comment. We will come right back to you.
    Ms. Rhinehart. Thank you, Senator. I hesitate to guess 
exactly what Mr. Fellner is talking about, but I believe he is 
talking about the triggers that OSHA included in its final 
rule, triggers which simply tell an employer, hey, your worker 
may be exposed to a hazard here, and you need to do a job 
analysis, fully analyze the job, and see if your worker is 
exposed to a hazard.
    Nowhere in this rule does it say that workers, or that 
employers have to restrict workers to doing a motion less than 
two times a minute. That simply does not appear anywhere in 
this rule.
    Senator Specter. Mr. Fellner.
    Mr. Fellner. Yes. I would like to read page 68848 of the 
Federal Register document.
    Senator Specter. We will include that page in the record at 
this point.
    [The information follows:]
    
    
    Mr. Fellner. This is table W-1, which is the basic 
screening tool. The left-hand column reads, ``risk factors this 
standard covers.'' The first one is repetition. In that first 
definition it says, repeating the same motions every few 
seconds, or repeating a cycle of motions involving the affected 
body part more than twice a minute for more than 2 consecutive 
hours in a work day. That is OSHA's definition of what it calls 
a risk factor this standard covers, which is repetition.
    We always wanted during the course of this hearing for OSHA 
to tell us how much is too much. They have, in their own words. 
This is their definition of repetition, and while we are on 
this page, Senator Specter, it also contains a definition of 
lifting 75 pounds once. It also contains definitions which say, 
if you lift 25 pounds below the knee, above the shoulders, or 
at arm's length more than 25 times per day--25 pounds, 25 times 
a day--that constitutes force, and on and on.
    These are OSHA's definitions of its risk factors. I would 
suggest that economically the impact of these risk factors, 
were these to trigger the kinds of job hazard analyses that Ms. 
Rhinehart indicates, the impact of these risk factors on our 
retrenching economy would be devastating.
    Moreover, there is not a scintilla of scientific evidence 
or medical evidence to support these exercises in false 
precision.
    Senator Specter. Mr. Woodward, how about it? What is your 
view of what Mr. Fellner is arguing?
    Mr. Woodward. I would like to clarify a couple of things 
here. This table here, which we refer to as a screen, its only 
function is to tell an employer whether it needs to take a look 
at a job. There are no limits in here of the kind that would 
say you have to have fewer repetitions than what is in the 
table.
    The function of this table is, if an employee is injured, 
and you, the employer, determine that that injury was because 
of work, then look at this table and determine if there is at 
least that much exposure to risk factors here. The next step is 
to do a job hazard analysis to try to figure out whether there 
is a hazard. You can use any reasonable method to do the hazard 
analysis.
    In other words, if your employee is injured and he has 
acquired, say, carpal tunnel, and you look at the job and yes, 
he does have 2 consecutive hours of repeating the same motion 
over and over again, then you have to go further and look at 
the job in more detail to see whether or not it is actually a 
hazardous job. Put another way, if it is less than that, you 
stop. You do not even inquire. You say, well, if there is less 
than 2 hours of exposure, I clearly do not need to worry about 
this.
    Now, let me qualify that. There are certain provisions of 
the standard, not the control provisions, that are triggered 
when you exceed this amount of exposure. A medical referral for 
a medical evaluation and then possible work restrictions is 
triggered, and training is triggered, but in terms of whether 
controls are triggered: no, the only requirement is to perform 
an analysis to try to determine whether there is a hazard.
    Just to clarify one other point, the definition is not 
twice per minute. It says, repeating the same motions every few 
seconds, or repeating a cycle of motions involving the affected 
body part more than twice per minute, so there are two concepts 
in here. One is, you are doing the same thing every few seconds 
for 2 hours in a row without stopping. The other is a cycle 
that is a combination of body motions, and whether you complete 
that cycle, go through the full cycle more than twice a minute.
    To go back to the other issue that was raised as to whether 
people have an opportunity to comment on this, that is one of 
the issues that will be in the litigation. What the proposal 
said was that if somebody was injured and if they were working, 
if they were exposed for a significant amount of time to 
repetition, for example, then you should look at the job, but 
that phrase, significant amount of time, was not defined in the 
text of the proposal, so I think that is the point he is 
referring to.
    There was some discussion in the preamble about scientific 
evidence indicating that the 2- and 4-hour level is something 
worth looking at, but there was not anything particular in the 
text of the proposal.
    Senator Specter. Let me come back to the basic point here 
on what this means. Risk factors this standard covers, and then 
we have the specifics. Are you saying, Mr. Woodward, that even 
if the employee's activities fall within those definitions, 
that there is not necessarily a violation?
    Mr. Woodward. Correct. This is a tool that is part of a 
process.
    Senator Specter. It is a tool as part of the process, but 
that triggers an inquiry as to whether there is inappropriate 
work required of the person?
    Mr. Woodward. That is correct, whether there is a hazard.
    Senator Specter. Then what comes next to make a 
determination as to whether, if that is done, there is a 
hazard?
    Mr. Woodward. Then what the standard says is that the 
employer should do a hazard analysis.
    Senator Specter. What about a hazard analysis?
    Mr. Woodward. It says if these levels are exceeded, the 
employer must do a hazard analysis, and it says that there are 
several different methods an employer could use to do a hazard 
analysis. One method is to hire a professional, a safety and 
health person who is knowledgeable in the area and knows 
something about ergonomic principles. Another method is to use 
one of the enumerated tools that are listed in the standard, 
and I think Mr. Fellner was referring to these tools as well as 
something that he believes the public needed more opportunity 
to comment on, but these are tools that are in the nature of 
safe harbors. If you want to use any one of these tools to 
conduct a hazard analysis you can do that, that is allowed. 
Finally, you can do any other approach that is reasonable.
    Senator Specter. Mr. Fellner, your point is that these 
factors occur, then a hazard analysis is triggered, and there 
has to be a determination as to whether there is a hazard which 
is unacceptable, is that your point?
    Mr. Fellner. Yes, in part. If I could expand on that a bit, 
Senator Specter, and that is, first of all let me address one 
of the things that Mr. Woodward said insofar as this screening 
out injuries. The word injury is not used in the standard. It 
is a musculoskeletal disorder incident.
    That term is defined in the context of a list in the 
standard of subjective symptoms, including pain, simply pain, 
tingling, cramps. That constitutes an MSD incident. Then 
question is whether any of these screening criteria which we 
refer to in table WD-1 screen anything out. The answer is no. 
That, in turn, triggers a job hazard analysis.
    The job hazard analysis and its consequences, which is the 
mandated use of nine tools that have not been associated in any 
way, shape, or form scientifically with eliminating ergonomic 
risk factors or eliminating MSD incidents, those nine tools 
have to be used, and you have to constantly implement 
engineering controls, reengineer your workplace in compliance 
with these mandated tools, so the process, soup to nuts, is the 
identification of these hazard screens, these action triggers, 
which in turn----
    Senator Specter. I am going to come back to that. Ms. 
Rhinehart has not had a chance to respond, and I see her 
anxiously edging forward toward the microphone. Ms. Rhinehart, 
what is your view?
    Ms. Rhinehart. Thank you. I would just like to back up, if 
I could, and put some of this in a little bit of context. OSHA 
in this ergonomics rule essentially codified an approach to 
ergonomics that many companies are already following, that the 
General Accounting Office has recommended as an effective 
approach to ergonomics, that NIOSH recommends as an effective 
approach to ergonomics, that the NAS in its recent report 
suggests is an effective approach to ergonomics.
    It is a very broad and very flexible approach to ergonomics 
that has employers follow very basic program elements of job 
hazard analysis, hazard identification and control, involves 
their workers in that process, provides some basic training. 
These are elements that have been out there and in use ever 
since at least the 1990's, the late 1980's, the 1990's, when 
the Department of Labor put out its guidelines for addressing 
ergonomic problems in meat-packing plants.
    These basic elements that are in the final rule were part 
of those red meat guidelines. They have been part of settlement 
agreements that OSHA has reached with many companies. Many 
companies have voluntarily adopted ergonomics programs centered 
around these principles, and there is a reason why they have, 
because they work.
    There are countless examples in the rulemaking record, 
Senator Specter, where companies that have implemented 
ergonomic programs centered around these principles have found 
that not only are they able to reduce worker exposure to 
hazards, they have reduced worker injuries, and they have 
reduced the costs associated with those injuries in terms of 
Workers Comp costs, lost productivity, other health costs, not 
to mention the sparing workers and their families the impact 
that these injuries have.
    These are serious, debilitating injuries that occur at a 
rate of about 600,000 serious injuries per year, and the impact 
of these injuries on workers and their families is simply 
devastating.
    There are effective, known measures centered around these 
broad principles contained in the final rule to address this 
problem and to reduce that suffering, and save employers money 
in the process, and that is why we think that it is important 
that we have a final ergonomics standard on the books that 
frankly has been--it has been 10 years in the making. It has 
been a long time coming. It is no rush to judgment. But 
fortunately, finally the time has come, and we do have these 
ergonomics protections on the books that we strongly support.
    Senator Specter. Mr. Fellner, your position is what? What 
about Ms. Rhinehart's statement that these standards represent 
a great many practices which have been accepted in the industry 
and by these other agencies?
    Mr. Fellner. This standard did not receive 10 years of 
scrutiny. It did not receive 10 minutes of scrutiny insofar as 
notice and comment is concerned. This standard as a regulatory 
requirement, which on pain of penalty from compliance officers, 
taking this standard out and enforcing it has not been part of 
anybody's ergonomics program.
    Senator Specter. Is there a pain of penalty if somebody has 
the repetitive motion of more than twice per minute for more 
than 2 consecutive hours in a work day? Is there a pain of 
penalty for some employer who permits that kind of work to go 
forward?
    Mr. Fellner. If some employer permits that kind of work to 
go forward without undertaking the job hazard analysis and the 
mandated tools, in Appendix D-1 the answer is absolutely yes. 
It is those action triggers that start the ball rolling.
    Senator Specter. Now, the job-mandated analysis on 
specified tools, elaborate as to what that means exactly, and 
why you are opposed.
    Mr. Fellner. Job hazard analysis--and we are opposed to 
that because we have seen this in the context of OSHA having 
issued over 550 general duty clauses--citations under its 
omnibus authority for ergonomics issues.
    The job hazard analysis and what OSHA has required pursuant 
to those citations have involved everything from reengineering 
the workplace, slowing the pace of the workplace, hiring more 
workers, reducing the weight, changing the entire configuration 
of conveyer systems.
    There are comments in the record, Senator Specter----
    Senator Specter. Mr. Fellner, what would you recommend, or 
the ancillary question is, do you believe that there is not a 
problem if someone has to do more than twice a minute the same 
activity more than two consecutive hours in the work day? Do 
you think that is not a problem, or an indicator of a problem 
which requires further analysis to decide whether it is a 
hazard?
    Mr. Fellner. That is correct.
    Senator Specter. You do not think that means anything?
    Mr. Fellner. I would suggest, with all due respect, that 
that indicates how far OSHA has gone if they honestly believe 
that repetition is doing something twice a minute, twice a 
minute for 2 hours, and that that triggers--the word they use 
is action trigger, that that triggers action, including the 
worker removal protection, which is independently triggered by 
that.
    Senator Specter. What is the worker removal test?
    Mr. Fellner. The worker removal protection is 90 days at 
90-percent pay if one has a subjective MSD incident that I 
described earlier.
    Senator Specter. 90 days at 90-percent pay in some other 
job?
    Mr. Fellner. No, sitting at home doing no other job. 90 
days at 90-percent pay. We are talking about the most favored 
injury clause. If you compare this with any other injury, an 
amputation would not yield the same----
    Senator Specter. Okay, I understand your point.
    What kind of repetitive activity do your experts think 
would be hazardous?
    Mr. Fellner. That is an extraordinarily complex question, 
as complicated as the human being is, and I would respond----
    Senator Specter. It is up to a man of your experience to 
answer.
    Mr. Fellner. I would respond by saying, with respect, look 
at the answer of sports medicine. Sports medicine teaches you 
that repetition is not bad, but good. Repetition strengthens 
the human body. The basic medical premise on which ergonomists 
have based this standard is that we are a series of ball-
bearings, we human beings, and that we are going to wear out 
over time.
    If anyone has an aged parent, if anyone is dealing with 
recovery from injury, we know that motion is not bad, but 
repetitive motion, and difficult repetitive motion, is good for 
the human body, striking that balance. It is a difficult 
balance.
    Senator Specter. Mr. Fellner I am trying to zero in on 
issues which I think will be of concern not only to me but to 
my colleagues. Are you saying that there is no problem with 
repetition no matter how much repetition there is?
    Mr. Fellner. I am saying that that is a question for free 
and open debate amongst the experts.
    Senator Specter. What do your experts say? You must know 
what they say on the subject. If you are disagreeing with the 
standard, what is the standard?
    Mr. Fellner. Again, we are not in the position to draft a 
standard in this hearing room, and I would not be in a position 
to condense the experts' views in this hearing room.
    Senator Specter. I was thinking of providing 6 to 12 
persons on each side to come into this room and have a 
discussion about it.
    Mr. Fellner. That is not a bad idea.
    Senator Specter. When you come down to this next one, 
lifting more than 75 pounds at any one time, or more than 55 
pounds more than 10 times a day, or more than 25 pounds below 
the knees or above the shoulders or at arm's length more than 
25 times a day, I think about my experience in my father's 
junkyard. At 17, I could lift 100 pounds, but it was tough, and 
we had joints of 2-inch casing, tubing, 25 feet long, which 
three of us threw on a truck, and more than 100 pounds was 
tough.
    What happens with women? Are women called upon to lift 75 
pounds in their jobs? Are they, Ms. Rhinehart?
    Ms. Rhinehart. Absolutely, Senator. One of the industries 
with the highest rate of back injuries and other ergonomic 
injuries is nursing homes. Nurses' aides and other workers in 
nursing homes are required to lift patients who often weigh 
more than 100 pounds, and often they are required to lift these 
patients on their own, and as a result of that, the rate of 
injuries in that industry is rampant.
    Can I just go back for 1 second to the repetitions?
    Senator Specter. Stay with nursing homes for a second. What 
is to be done? Is someone to be with the employee at all times 
to help them lift the patient?
    Ms. Rhinehart. There are a couple of things that were 
discussed extensively in the rulemaking hearings, either that 
you have somebody assist you in lifting a patient, or there are 
actually mechanical devices that are out there and in use in 
hospitals and in nursing homes and in other settings that 
assist a worker in moving a patient, and which takes some of 
the weight and some of the load off of the worker while still 
permitting the patient-handling that needs to be done to occur. 
So those devices are out there.
    Senator Specter. You had another point you wanted to make.
    Ms. Rhinehart. I just wanted to, on the point of repetition 
and how much repetition is too much, I would just refer you--
and I would be happy to provide this for the record--to some of 
the very compelling testimony during the OSHA rulemaking 
hearings from poultry workers, who have birds coming past them 
on a line at a rate of 70 birds per minute, and they have to 
pull these birds down and make motions and cuts on those birds, 
70 birds a minute, every minute, every hour, and I would 
suggest that when you take that repetition and combine it with 
the effect of that repetition on workers, the skyrocketing 
rates of injuries, that is too much.
    Senator Specter. I am trying to figure out how to get there 
from here. I do not know what the repetition standard ought to 
be, and I do not know what the weight-lifting standard ought to 
be, but the question, Mr. Fellner, is how we get there, and you 
do not like what is being done here, and if you convened 
experts in all of these fields who give their testimony, then 
you would leave it up to OSHA to make a judgment as to which 
expert testimony was correct, and they would then make up a 
chart like this one on risk factors this standard covers. Then 
there would be an opportunity for the parties to comment, and 
then OSHA would consider those comments and come to a final 
conclusion. That is what you are suggesting, Mr. Fellner?
    Mr. Fellner. That is--definitely, assuming that the new 
OSHA concludes that one can segregate the physical factors, 
which is what we have talked about, and limited our discussion 
this morning, from the myriad of other factors acknowledged by 
the World Health Organization, the National Academy of 
Sciences, and others, including psychosocial factors, social 
factors, cultural factors, gender, genetics, and a variety of 
other factors, all of which contribute to these MSD incidents 
that we talked about before.
    And assuming that the new OSHA concludes, as well, that it 
is in a position to distinguish that which takes place in the 
workplace from that which is caused outside of the workplace, 
especially since there is so much of a conglomeration, if you 
will, of these factors together.
    Assume that all of these pieces can be appropriately 
understood by the new OSHA, and assume that physical factors 
can be segregated from all of the rest which have been 
acknowledged even by the experts that Ms. Rhinehart relies on. 
Then what you have described is an entirely appropriate way of 
approaching the issue, but the assumptions are not yet well 
understood.
    Senator Specter. Let us go to the issue of cost. What has 
OSHA estimated the cost to be, Mr. Woodward?
    Mr. Woodward. OSHA estimated the cost of this standard at 
roughly $4.5 billion per year. This is an annualized cost; 
there are several components to that estimate. There is the 
cost of the program elements. In other words, you have to train 
employees according to this standard. That takes time. That is 
a cost. There is the cost of the controls that you would have 
to put in if you find that there is a hazard that needs to be 
controlled. There is also the cost of the work restriction 
protection, maintaining an employee's earnings, if you 
determine the employee is injured and that he cannot perform 
his normal duties.
    Senator Specter. How do you come to the figure? What is 
your methodology?
    Mr. Woodward. The biggest single part of it, according to 
OSHA, is the program cost. Those were roughly $2 billion, a 
little more than that.
    Senator Specter. How do you determine that?
    Mr. Woodward. The current standards requires employers to 
do various things. They have to set up a system by which 
employees can report their injuries to them. They have to give 
employees information about these type of injuries. They have 
to train them. They have to do hazard analysis. What OSHA did 
is to list those activities and then try to figure out how much 
time it typically would take an employer to do that. That 
computation was in the final rule largely based on testimony 
about existing ergonomics programs.
    People testified about their ergonomics programs. For 
example, it takes us x hours to train our employees, and other 
people had a different estimate, and they said, it takes us y 
hours. The agency reviewed those estimates and came out in the 
middle. Basically, that was how OSHA calculated the program 
part of the cost.
    For the work restriction protection part, OSHA received 
from BLS an estimate of how many workers are currently off work 
due to this type of injury. Then OSHA made an adjustment 
because they think there is underreporting, and that the real 
number, after this standard goes into effect would be greater 
since more people would be reporting their injuries.
    Then OSHA looked at what BLS says is the median amount of 
time people are out of work because of these injuries. I think 
it is 7 days for musculoskeletal disorders as a whole, although 
it varies depending on which type of disorder you are talking 
about.
    That was how OSHA calculated the number of days, and then 
they looked at the earnings in different industries and 
occupations and made an adjustment for the fact that some of 
this is currently being covered by Workers' Compensation. OSHA 
subtracted that amount from the cost, since that was already 
being borne, and from that they obtained an estimate of $600 or 
$700 million a year. I believe it was an estimated $630 million 
a year.
    Then there was the control cost presented, what OSHA termed 
it, difficult issues related to costing. What OSHA did was 
convene a panel of practicing ergonomists and asked them to 
estimate what they thought, based on their experience, on 
average, it would cost to fix a hazardous job in a particular 
occupational grouping. Based on that, the experts then tried to 
estimate, how many people are in that occupational grouping in 
different industries and obtained an estimate.
    Senator Specter. Was there a calculation as to benefit as a 
result of the regs to offset the cost?
    Mr. Woodward. Yes.
    Senator Specter. What was that figure?
    Mr. Woodward. OSHA estimated 4.6 million disorders would be 
prevented over the first 10 years, and there was a partial 
monetary value assigned to that. In other words, OSHA did not 
try to cost pain and suffering, but they did estimate that 
there was about $9.1 billion of other value from the rule.
    Senator Specter. What is the total value, Mr. Woodward, 
calculated by OSHA?
    Mr. Woodward. $9.1 billion, I believe.
    Senator Specter. What do you think about those figures, Mr. 
Fellner?
    Mr. Fellner. Those figures make this the most expensive 
regulation in OSHA's history, and those figures are minuscule 
compared to what the real figures are. The litmus test for what 
this standard will cost American industry lies in the citations 
that OSHA has issued over the last 10 years on ergonomics. 
These are citations that will be issued by the same compliance 
officers using the same measures, the same tools, and the same 
requirements for fixes.
    We have for a number of clients taken a look at the 
specific recommendations that OSHA has made to fix these risk 
factors that we have talked about earlier, and we put a price 
tag on them. That price tag is anywhere between $100 billion 
and $1 trillion, and lest that be viewed as an exaggeration, we 
must continue, we in industry, under this standard which is the 
subject of this hearing, we must continue to experiment and 
force technology until we are down to the screening tools, so 
that the action triggers are no longer activated, because we 
know we are going to get those MSD incidents. We know we are 
going to get complaints with regard to back pain.
    So consequently the process by which--for example, there is 
a comment filed by Federal Express in the record which, simply 
put, states that next-day delivery will cease if the OSHA 
standard is promulgated. There is testimony in the record, as 
you can well imagine, from funeral directors indicating that 
burials will no longer take place if the precise kinds of 
requirements in this standard are, in fact, effectuated.
    Senator Specter. When you say burials will not take place, 
do you mean they will be delayed?
    Mr. Fellner. No. I am suggesting to you, Senator Specter, 
you cannot lift a human body, unless it is wasted down to below 
75 pounds, and that is what I am suggesting, and that is what 
the testimony in an uncontradicted fashion indicates in the 
record.
    Senator Specter. What about that, Mr. Woodward?
    Mr. Woodward. There is nothing in the rule that says you 
cannot lift a person who is more than 75 pounds. I do want to 
acknowledge that, as the Secretary has said, these are very 
complicated issues. Many issues have been raised about the way 
the current rule is structured, and we acknowledge that, and we 
are in litigation. No briefing schedule has been set, no oral 
argument set, but we acknowledge that a number of issues have 
been raised about it.
    Senator Specter. Mr. Fellner, how do you get to your 
calculation of $100 billion to $1 trillion in cost?
    Mr. Fellner. If one were to take across the vast array of 
American industry the specific requirements, and we are not 
talking about the hours it would take to absorb. I am not sure 
whether Mr. Woodward said it takes 1 hour or 2 to absorb this 
608-page standard, together with its preamble.
    We are not talking about the number of hours that it takes 
to study and understand an incomprehensible regulation. We are 
talking about the nuts and bolts, as I indicated to you 
earlier, that it would take to comply, after the job hazard 
analysis, with this regulation. This is not a matter of putting 
a phone book under a desk, which some of our union friends have 
indicated.
    This is not simply a matter of simple, quick fixes. This is 
experimenting with pace, with employees, with automation, and 
the bottom line here, the great irony here is that our friends 
in the labor movement, who are very, very much behind this 
standard--and I acknowledge the good faith with which they 
approach the arguments favoring this standard, as I did 2 weeks 
ago when Lynn and I were on an ABA/OSHA subcommittee panel 
together discussing the very same issues.
    The issue is not that good faith. The great irony is that 
this standard will push two things, one, jobs going abroad, and 
two, automating employees out of jobs, because robots do not 
complain about low back pain.
    Senator Specter. Mr. Fellner, can you come to grips a 
little more directly with the way you come to the computation 
of cost of $100 billion to $1 trillion?
    Mr. Fellner. The Employment Policy Foundation has submitted 
a detailed document indicating that the range is $100 billion 
without relying on the specific numbers for implementing these 
5(a)1, these general duty clause citations.
    Senator Specter. What is the basis of that computation?
    Mr. Fellner. The basis of that computation is using a more 
realistic analysis of the hours, the time, and the 
implementation of job hazard controls.
    Senator Specter. They say $100 billion?
    Mr. Fellner. They say in excess of $100 billion, and that 
is part of the record.
    Senator Specter. Do they say as much as $1 trillion?
    Mr. Fellner. They do not say as much as a trillion. That 
reflects an extrapolation from specific 5(a)(1) citations, 
which I indicated earlier.
    Senator Specter. Who made that extrapolation?
    Mr. Fellner. We did, in the context of our submissions to 
the OSHA record.
    Senator Specter. Mr. Woodward, what do you think about 
that? Your $4.5 billion compared to their $100 billion?
    Mr. Woodward. OSHA explained its reason in some detail, and 
OSHA concluded that most of these fixes were relatively 
inexpensive, more in the range of $800 to $1,000, to fix a 
hazardous job. That was based largely on testimony of what 
people currently do to abate a hazard. There is a huge range, 
so we are talking about an average. Some people disagreed with 
that.
    One reason some of the other estimates are so high is 
because they interpreted the provisions of the standard 
differently than OSHA interpreted them. For example, one 
requirement is to provide your employees information about 
musculoskeletal disorders--what are they, what they should be 
aware of--so they can report.
    One of the cost estimates was based on the idea that it 
would take 60 hours with each employee to convey that 
information, whereas OSHA's interpretation of the requirement, 
was that you could simply provide a written explanation to the 
employee of what to look for. So I think there are some 
differences in how the standard was interpreted. That is one of 
the factors.
    Because we were in rulemaking, the estimates were directed 
toward the proposed rule, and there were some differences with 
the final rule. I think that also is a factor here.
    Senator Specter. Mr. Fellner, did your computations take 
into account a benefit contrasted or similar to what Mr. 
Woodward has testified to? When he says there were $4.5 billion 
in cost, he says there were $9.1 billion in benefits. Did your 
analysis take into account the benefit factor?
    Mr. Fellner. In point of fact, our analysis indicates that 
the benefits are largely overdrawn. The BLS statistics upon 
which they are based are roundly criticized by the National 
Academy of Sciences, which is seeking properly a much more 
sophisticated analysis of the so-called MSD incidents. The BLS 
statistics are much too rough a tool.
    Senator Specter. Is there no benefit?
    Mr. Fellner. As a matter of fact, the initial--as OSHA 
concedes, the initial stage of this ergonomics standard will be 
iatrogenic, and by that I mean it will increase the number of 
MSD incidents that are reported in the workplace, because to a 
certain extent we are teaching employees how to be sick, and in 
the context of heretofore having coped with musculoskeletal 
pain and discomfort, and overcome it, as all of us do, OSHA 
would turn the tables on that particular point, and so in many 
respects the benefits that OSHA has indicated are illusory, and 
if I may further add, Senator----
    Senator Specter. Is that a no answer?
    Mr. Fellner. No, it is not a no answer. We do acknowledge 
that there may be some benefits, as there would in the so-
called Hawthorne effect. Turning your attention to any problem 
will, from a variety of different perspectives, potentially 
ameliorate those problems, and that is a psychosocial aspect of 
that amelioration.
    But let me, if I may----
    Senator Specter. You may, but first tell me if you have a 
figure on benefits. You say that there may be benefits. Do you 
have a figure on benefits?
    Mr. Fellner. I do not.
    Senator Specter. You were pretty fast on $100 billion to $1 
trillion, but no figure on benefits?
    Mr. Fellner. If I were to accept, which I do not, the $9 
billion number that OSHA has put forth in the context of the 
standard, it is swallowed up by the costs, so as we see them 
and as they are demonstrated clearly in the record, i.e., $9 
billion in benefits, even assuming that were accurate, is more 
than swallowed up by their $100 billion to $1 trillion in 
costs.
    So under the circumstances benefits is a negligible factor 
in this equation, particularly, if I may, if one looks at what 
Mr. Woodward has indicated is one of the methodologies of 
determining benefits, which is getting their selected 
ergonomists in a room with a huge range, insofar as the 
benefits and the costs that they determine of this standard, a 
huge, inconsistent, subjective range, if their way of coming up 
with benefits of interventions is, as one of the case studies, 
quote-unquote, which they rely on, which is a Continental Air 
magazine----
    Senator Specter. I think I have your point.
    Mr. Fellner [continuing]. Which was taken out of a seat. 
That is the way they determine benefits.
    Senator Specter. With $4.5 billion in costs and $9.1 
billion benefits estimated by OSHA, and your figures of $100 
billion in costs ranging up to $1 trillion. I am trying to find 
some basis for rational congressional evaluation of what is 
going on here and it is a swirl. It is an absolute swirl.
    I do not understand much of what Mr. Woodward says as to 
his $4.5 billion in costs, and I understand less from what you 
have said of the range of $100 billion to $1 trillion. That is 
a pretty big range, and if we go through the rulemaking process 
again, how is there going to be an evaluation?
    One of the things I asked in a meeting that I held 
informally that you did not attend, Mr. Fellner, was the 
possibility of bringing the contestants together to see if 
something could be worked out, to see if there could be some 
agreement.
    When the telecommunications bill was passed with all its 
complexities, the parties finally got together, and we do 
facilitate that from time to time. Is there any possibility of 
doing that, Mr. Fellner, so that experts can draw the lines of 
disagreement and compromise?
    Mr. Fellner. In the context of this regulation the answer 
is no.
    Senator Specter. How about the next regulation, if there is 
one?
    Mr. Fellner. The answer is yes, obviously, if there is one.
    Senator Specter. This massive regulation, which I have 
heard described as 300 pages, and then I have heard it further 
described, and correct me if I am wrong, Mr. Woodward, as nine 
pages of regulations, 16 pages of fact sheets in support, and 
the balance of public comments, is that accurate, Mr. Woodward?
    Mr. Woodward. That is correct.
    Senator Specter. Is that accurate, Mr. Fellner?
    Mr. Fellner. That is inaccurate.
    Mr. Woodward. The rest of the package is what we call the 
preamble. It is an explanation of the rule, and it is a 
justification in terms of the evidence, the scientific evidence 
that was presented, and the economics.
    Senator Specter. But you are saying there are only nine 
pages of regulation.
    Mr. Woodward. The regulatory text, yes, that is correct.
    Mr. Fellner. Any employer, if I may interrupt, any employer 
who would attempt to take action based upon 9 pages of standard 
and 16 pages of fact sheets without knowing what is in the 
preamble, given my experience insofar as OSHA standards are 
concerned, with much shorter preambles than this, is engaged in 
a very risky business.
    To understand the standard is to understand OSHA's 
interpretations in its preamble. Indeed, we will not know what 
OSHA means by this standard until it comes out with its 
enforcement directive, which it has declined to do up until 
now, because there is extraordinary confusion as to what this 
standard means.
    Senator Specter. How about that, Mr. Woodward? How about 
the enforcement directives?
    Mr. Woodward. We normally do issue what we call a 
compliance directive. As I said, the Secretary has noted that 
these are complicated issues, and that the entire standard has 
been under review. We have not issued a compliance directive 
yet. The compliance directive does not change the meaning of 
the nine pages of text. It cannot do that. But any of these 
materials can interpret the rule and, to that extent, provide 
guidance.
    Senator Specter. The issue has been raised as to whether 
any new regulation, if this one falls under the Congressional 
Review Act, will be fatally inhibited by the provision in the 
statute which precludes a new rule, if it is reissued in 
substantially the same form. Is there any problem at all, as 
you see it, Mr. Fellner, in having a new regulation which will 
be permitted under the Congressional Review Act, and not 
prohibited by being substantially in the same form by the rule 
prohibiting a regulation: ``reissued in substantially the same 
form''?
    Mr. Fellner. This being the first time that the CRA will be 
tested, we are clearly in uncharted waters as to what 
substantially the same form means, so let me very carefully and 
very gingerly respond to your question, Senator Specter, and 
suggest that a standard that contains the kind of very 
specifically mandated formulae and definitions that this 
standard contains, and would hold employers to those 
definitions and to those requirements, and I am specifically 
talking about W-1, which we talked about earlier, as well as 
appendix D-1, that that kind of standard may very well fall in 
the substantially similar rubric, as outlined by the CRA, but 
we do not know that, and we will not until good lawyers like 
Lynn and hopefully myself test it in the courts.
    Senator Specter. So there is some possibility that there 
might be some litigation?
    Mr. Fellner. After the next standard comes out, that is 
correct, there may very well be.
    Senator Specter. Do you think there is any conceivable 
possibility there would not be enormous litigation?
    Ms. Rhinehart. Two years ago at an ABA meeting I promised--
--
    Senator Specter. Wait a minute. I want to hear his answer.
    Mr. Fellner. Do I think it is----
    Senator Specter. Do you think there is any possibility at 
all, any remote, contingent possibility that there would not be 
litigation that a new regulation is barred by the 
substantiality requirement I just read?
    Mr. Fellner. The answer is, if we all do our jobs, and we 
come up with a consensus, there is a good chance that 
litigation could be avoided.
    Senator Specter. Ms. Rhinehart, you wanted to say 
something.
    Ms. Rhinehart. I did. I just wanted to----
    Senator Specter. I did not want to let you come in before 
Mr. Fellner had a chance to answer.
    Ms. Rhinehart. And the fact that they may not sue OSHA over 
a subsequent standard is welcome news indeed. I just wanted to 
say that the AFL-CIO is very concerned about the impact of 
passage of a resolution of disapproval under the Congressional 
Review Act on the agency's ability to issue a standard in this 
area in the future, and I think what we have just heard from 
Mr. Fellner is evidence as to why we are right to be concerned.
    OSHA made some modifications in this final rule to be a 
little more specific, and to give employers some more guidance 
because the employers asked for it. Now we are hearing from Mr. 
Fellner that they do not like that specificity, and they want 
to go back to a broad, more general standard. Well, that is 
what they had, and they did not like that, either.
    The fact of the matter is that many trade associations and 
a large part of the employer community has vociferously opposed 
any ergonomics regulation, so the notion that if Congress were 
to pass this resolution of disapproval and send OSHA back to 
the drawing board, that there would be a change of heart and 
all of a sudden we would all be collaborating and embracing a 
new rule in the future seems a bit far-fetched, in our view, 
and so we are very concerned about the effect of passage of a 
resolution on OSHA's future ability to act.
    We would like to believe they could act. We obviously are 
very interested in there being a good, strong ergonomics 
standard to protect workers, and we will do everything we can 
toward that end, but we are very concerned.
    Thank you.
    Senator Specter. Does anybody care to comment any further? 
Additional statements for the record will be included at this 
point, including a letter from Secretary Chao.
    [The statements follow:]
                    Prepared Statement of LPA, Inc.
    Mr. Chairman and Members of the Subcommittee: LPA is pleased to 
submit testimony opposing the Occupational Safety and Health 
Administration's (OSHA's) final ergonomics standard, which has been 
estimated by the Employment Policy Foundation to impose annual costs on 
employers of as high as $126 billion, probably making it the most 
expensive workplace regulation in history. The final standard, which 
OSHA completed in less than 11 months, was less an attempt to 
promulgate a sound workplace regulation than the fulfillment of a 
political promise by President Clinton to organized labor. Politics 
should give way to reasonable regulation, and thus Congress should 
invalidate the standard using the Congressional Review Act, allowing 
OSHA to try again.
    LPA, Inc., is an association of the senior human resource 
executives of more than 200 leading corporations in the United States. 
LPA's purpose is to ensure that U.S. employment policy supports the 
competitive goals of its member companies and their employees. LPA 
member companies employ more than 12 million employees, or 12 percent 
of the private sector workforce. If the final ergonomics standard 
remains in effect, it will cover nearly all of our member companies and 
virtually all of their employees.
    In short, LPA supports the application of ergonomic principles to 
the workplace. However, it opposes the final ergonomics standard 
because it covers ergonomics disorders caused by non-work activities, 
is not based on sound science, ensures that most employers will be 
required to set up ergonomics programs, and creates unacceptable 
conflicts with state workers' compensation laws. Instead, LPA supports 
the Senate joint resolution of disapproval sponsored by Sen. Don 
Nickles (R-OK), S.J. Res. 6, which would invalidate the final standard 
and allow OSHA to regulate workplace ergonomics in a more reasonable 
manner.
Final standard covers non-work-related disorders
    OSHA's final ergonomics standard fails to substantially narrow the 
definition of work-related musculoskeletal disorder (MSD). The final 
standard purports to cover workrelated MSDs, but broadly defines that 
term as those that work caused, contributed to, or for pre-existing 
MSDs, significantly aggravated. The Preamble defines ``significantly 
aggravated'' as having an injury already ``but because of the 
employee's exposure to identified risk factors in the workplace, the 
MSD has progressed to the extent that medical treatment is now 
necessary.'' Reading between the lines, this means that if work 
exposure played any role in an employee-reported MSD, then the MSD is 
work-related.
NAS study shows that final standard not based on sound science
    One of the key arguments in opposition to the final ergonomics 
standard is that OSHA has failed to conclusively prove that work 
factors cause MSDs. The National Academy of Sciences (NAS) study 
completed in January 2001 was intended to solve this debate. The study 
reviewed existing scientific literature in order to determine whether 
science has affirmatively linked injuries to workplace exposures. 
However, it only demonstrated that more research was required in this 
complex area.
    The NAS panel concluded that ``[n]one of the common musculoskeletal 
disorders is uniquely caused by work exposures,'' that there are no 
comprehensive national data on medically defined MSDs, and that the 
available data is mostly based on employee reporting, not a diagnosis 
from a health care provider. It cautioned that often it is difficult to 
scientifically distinguish work exposures that may cause MSDs from 
other life exposures that cause them because 80 percent of the 
population works, further complicating research on the issue. The panel 
concluded that significant additional research is needed in this area.
    The NAS panel also noted that MSDs are affected by many non-work 
factors, such as age, gender, healthy lifestyles, and the effect of 
other diseases such as diabetes. The panel spent a considerable amount 
of time discussing how psychosocial factors, such as high perceived 
stress, low job satisfaction, monotony, and low social support increase 
the chances of developing an MSD in the lower back.
    Despite the unspoken preference for unanimity in such reports, the 
NAS panel drew a rare dissent from panel member Dr. Robert Szabo. Dr. 
Szabo criticized the panel for using inaccurate scientific literature, 
particularly regarding carpal tunnel syndrome. He highlighted the 
studies that indicated that personal factors, age, lifestyle and sex as 
more predictive of carpal tunnel syndrome than job exposure. He also 
noted that the cited studies only demonstrate that job controls reduce 
the symptoms of disease but do not address whether they reduce the 
underlying soft tissue disease. Taken as a whole, the evidence cited by 
Dr. Szabo with respect to carpal tunnel syndrome casts doubt on the 
remainder of the NAS conclusions.
Triggers easily met
    Once an employee has reported a work-related MSD, an employer must 
set up a full ergonomics program if the reported MSD meets two 
``triggers'' or tests set under the standard. The first stage of the 
trigger is met if the MSD involves days away from work, work 
restrictions (such as the inability to work scheduled or mandatory 
overtime) or medical treatment beyond first aid. It is also met if an 
employee feels tingling or other MSD symptoms in his or her arm for 
seven consecutive calendar days. Given that it in not unusual for 
employees to experience symptoms or to request work restrictions 
occasionally, the first trigger is often met.
    Once the first stage of the trigger is met, the employer must 
determine whether the employee's job exceeds certain action thresholds. 
In many cases these thresholds are also easy to meet. For example, an 
administrative employee who regularly works steadily at his or her 
keyboard for four hours or more per day would trigger a full ergonomics 
program for all people performing similar jobs, if he or she reported a 
work-related MSD and was unable to work overtime for one day.
    Taken together, the overbroad definition of work-related and the 
low job task thresholds mean that the standard will cause most jobs to 
be covered by the ergonomics standard.
Standard interferes with State workers' compensation laws
    The final ergonomics standard would require employers to provide 90 
days paid leave at 90 percent of an employee's gross earnings to any 
employee who has been determined unable to work by a health care 
professional. This requirement, called ``work restriction protection,'' 
is a blatant violation of section 4(b)(4) of the Occupational Safety 
and Health
    Act (OSH Act), which states that an OSHA standard may not 
``supercede or in any manner affect'' any state workers' compensation 
law.
    The ergonomics standard will interfere substantially with state 
workers' compensation laws in several ways, including:
  --preempting the exclusive remedy provisions;
  --invalidating state standards on injury and causation;
  --undermining the return-to-work incentive; and
  --increasing state costs because of increased claims and benefit 
        duration.
    Although OSHA has proposed and enforced work restriction protection 
provisions in other, narrower standards, it has never attempted to 
apply it in a wide-ranging standard that applied to virtually all 
general industry employees. Because the ergonomics standard would apply 
to most employees of most employers, significant conflict between the 
work restriction protection requirement in the OSHA standard and state 
workers' compensation laws is a virtually certain, and thus, illegal.
LPA urges support for congressional resolution of disapproval
    Mr. Chairman, because OSHA's final ergonomics standard is 
fundamentally flawed, LPA recommends that Congress invalidate the 
current standard by passing S.J. Res. 6, the joint resolution of 
disapproval introduced by Sen. Nickles. If the Senate and the House of 
Representatives both approve the resolution by a simple majority vote, 
and it becomes law, the ergonomics standard is invalidated.
    Contrary to the assertions of organized labor and other opponents 
of the resolution, a successful resolution would not prevent OSHA from 
issuing an ergonomics standard. Rather it would preclude OSHA from re-
issuing the current standard or one that is substantially similar. LPA 
believes this is a reasonable and measured step to take given the great 
costs to the economy, employers, employees and states imposed by the 
existing standard.

                               CONCLUSION
    OSHA's final ergonomics standard is unworkable because it applies 
to disorders that are not related to work, is based on inadequate 
science and would cause a substantial conflict with state workers' 
compensation laws. LPA endorses the attempt to pass a congressional 
resolution of disapproval to rid the country of this flawed standard 
and to allow OSHA to pursue a more reasonable approach.
    Thank you for the opportunity to present our views.
                                 ______
                                 
                   Prepared Statement of the AFL-CIO

NATIONAL ACADEMY OF SCIENCES/INSTITUTE OF MEDICINE REPORT SUPPORTS THE 
                        OSHA ERGONOMICS STANDARD
    The National Academy of Sciences and the Institute of Medicine 
recently released their long awaited report on Musculoskeletal 
Disorders and the Workplace. The report, requested by industry groups 
and conservative Republicans who opposed an OSHA ergonomics standard, 
finds that there is strong scientific evidence showing that exposure to 
ergonomic hazards in the workplace causes musculoskeletal disorders and 
that these injuries can be prevented. Prepared by some of the world's 
top scientific and medical experts in ergonomics, the report calls MSDs 
an important national problem and strongly supports the approach that 
OSHA took in its final Ergonomics Program Standard, released November 
14, 2000.
    This is the third comprehensive review of the scientific literature 
over the past four years that has come to the same conclusions. The 
National Institute for Occupational Safety and Health (NIOSH) published 
a comprehensive review of the data on the relationship between MSDs and 
the workplace in 1997. The NAS also came to similar conclusion in an 
earlier report published in 1998.
    The NAS report puts to rest, once and for all, the claims by some 
industry groups and conservative Republicans that there is no 
scientific evidence that workplace exposures cause musculoskeletal 
disorders. It shows without question that OSHA's new ergonomics 
standard is needed and justified.
Musculoskeletal disorders are an important national health problem
    The NAS report confirms OSHA's estimates of the scope of the 
problem, citing an even larger number of workers losing time from work 
than OSHA. The NAS estimates that one million people lose time from 
work each year due to these disabling injuries, compared with OSHA's 
more conservative estimate of 600,000. The NAS also confirms OSHA's 
estimate that ergonomic problems cost the economy around $50 billion 
each year. The report warns that MSD-related problems are expected to 
increase in the future due to the changing nature of work, the aging of 
the workforce and rising numbers of women entering material handling 
and computer jobs.
    The report also finds that existing national data sources conclude 
that construction and agricultural workers, who were not covered in the 
OSHA standard, also suffer higher rates of work-related MSDs than 
overall industry.

    ``There is no doubt that musculoskeletal disorders of the low back 
and upper extremities are an important and costly national health 
problem . . . In 1999, nearly 1 million people took time away from work 
to treat and recover from work-related musculoskeletal pain or 
impairment of function in the low back or upper extremities. 
Conservative estimates of the economic burden imposed, as measured by 
compensation costs, lost wages, and lost productivity, are between $45 
and $54 billion annually.'' (Page ES-1)
    ``The consequences of musculoskeletal disorders to individuals and 
society and the evidence that these disorders are to some degree 
preventable justify a broad, coherent effort to encourage the 
institution or extension of ergonomic and other preventive 
strategies.'' (Page ES-6)
    ``As the workforce ages and as more women enter the workforce, 
particularly in material handling and computer jobs, evaluation of work 
tasks, especially lifting, lowering, carrying, prolonged static 
posture, and repetitive motion, will be required to guide the further 
design of appropriate interventions.'' (Page 11-2)
Science strongly supports the fact that there is a strong relationship 
        between workplace physical tasks and the risk of MSDs
    The NAS found a strong and consistent pattern of evidence from both 
epidemiologic studies (studies of groups of people experiencing similar 
exposures), as well as ``biomechanical'' evidence (the actual damage 
that ergonomic stress does to muscles, tendons and nerves.) The report 
cites the same workplace risk factors that OSHA cites in its standard--
heavy lifting, repetition, force, frequent bending and twisting 
(awkward postures) and vibration. The report actually goes beyond the 
OSHA standard, including whole body vibration as a risk factor for back 
injuries, where OSHA only regulates hand-arm vibration.
    While more research and better quality studies are clearly 
desirable, the NAS report finds that the consistent overall pattern of 
evidence from existing studies clearly confirms the relationship 
between workplace physical exposures and MSDs.

    ``The basic biology and biomechanics literatures provide evidence 
of plausible mechanisms for the association between musculoskeletal 
disorders and workplace physical exposures.'' (Page ES-6)
    ``The panel's review of the research literature in epidemiology, 
biomechanics, tissue mechanobiology, and workplace intervention 
strategies has identified a rich and consistent pattern of evidence 
that supports a relationship between the workplace and the occurrence 
of MSDs of the low back and upper extremities.'' (Page ES-3)
    ``The panel concludes that there is a clear relationship between 
back disorders and physical load; that is, manual material handling, 
load movement, frequent bending and twisting, heavy physical work, and 
whole-body vibration. For disorders of the upper extremities, 
repetition, force and vibration are particularly important work-related 
factors.'' (Page 11-10)
    ``Occupations that involve repetitive lifting, e.g. warehouse work, 
construction and pipe fitting, particularly when that activity involves 
twisting postures, are associated with an increased risk for the 
complaint of low back pain and, in a few studies, an increased risk for 
lumbar disc hemiation.'' (App. A-6)
    ``Low back disorder risk has been established through epidemiologic 
studies of work that involves heavy lifting, frequent bending and 
twisting and whole body vibration, as well as other risk factors . . . 
. Biomechanical studies reinforce the epidemiologic findings.'' (Page 
ES-3)
    ``The pattern of evidence for upper extremity disorders, as for the 
low back, also supports an important role for physical factors, 
particularly repetition, force and vibration. The most dramatic 
physical exposures occur in manufacturing, food processing, lumber, 
transportation and other heavy industries, and these industries have 
the highest rates of upper extremity disorder reported as work 
related.'' (Page ES-4.)
    ``There is strong support across these bodies of work that high 
force and repetition are associated with musculoskeletal disorder of 
the upper extremities; basic biology data provide evidence of 
alteration in tissue structure.'' (Page ES-4)
    ``These exposure-response associations persist when adjusted for 
individual factors that may increase vulnerability, such as age, gender 
and body mass index.'' (Page ES-4)
    ``The BLS and workers' compensation data are sufficient to (1) 
confirm that the magnitude of the work-related musculoskeletal disorder 
problem is very large; (2) demonstrate that rates differ substantially 
between industries and occupations consistent with the assumption that 
work related risks are important predictors of musculoskeletal 
disorders.'' (Page 2-17)
Science strongly supports the fact that workplace interventions based 
        on ergonomic principles can reduce the risk of MSDs
    The report also confirms the fact that using ergonomic principles 
to reduce exposure to risk factors reduces the risk of MSDs. Changing 
the design of tools and workstations, rotating jobs and other 
ergonomics interventions such as lift tables and vibration dampening 
seating devices that reduce ergonomic risk factors have been shown to 
reduce the risk of MSDs of the low back and upper extremities.

    ``The weight of the evidence justifies the introduction of 
appropriate and selected interventions to reduce the risk of 
musculoskeletal disorders of the low back and upper extremities.'' 
(Page 11-2)
    ``The intervention literature supports the efficacy of tool and 
workstation design changes, job rotation, and other interventions that 
directly address these risk factors with regard to upper extremity 
symptomology.'' (Page ES-4)
    ``Intervention studies have shown how lift tables and lifting 
hoists are effective in mediating the risk of low back pain in 
industrial settings. Since risk is lowered when the load is changed 
from a heavy lift to a light lift, this finding is also consistent with 
the rigorous epidemiologic finding.'' (Page ES-3)
    ``Based on the current evidence, modification of the lifting can 
reduce symptoms and complaints. Specific successful strategies, which 
include ergonomic interventions (such as the use of lift tables and 
other devices and matching the worker's capacity to the lifting tasks), 
administrative controls (such as job rotation), and team lifting, 
appear successful. Despite enthusiasm for their use, there is marginal 
or conflict evidence about lifting belts and education programs in 
reducing low back pain in the population with heavy lifting 
requirements.'' (Page App. A)
The NAS report supports the main elements included in the OSHA standard
    The NAS Report found that employers with effective-ergonomics 
programs use a programmatic approach that OSHA adopted in its standard. 
The OSHA standard requires employers to include several basic program 
elements in approaching ergonomic problems: Management Leadership and 
Employee Participation, Job Hazard Analysis and Control, Training, 
Medical Management and Program Evaluation. These are the same common 
elements that the NAS report found in successful ergonomics programs. 
This programmatic approach provides a framework for employers; it does 
not dictate how employers are to address the problems. The standard 
fully allows and anticipates that employers will tailor their programs 
to meet the own specific needs of their workplace and work 
organization. The NAS report found this approach to be effective in 
small and large companies from a variety of industries.

    ``To be effective, intervention programs should include employee 
involvement, employer commitment and the development of integrated 
programs that address equipment design work procedures and 
organizational characteristics.'' (Page ES-6 and 11-2)
    ``The complexity of musculoskeletal disorders in the workplace 
requires a variety of strategies that may involve the worker, the 
workforce, and management. These strategies fall within the categories 
of engineering controls, administrative controls, and worker-focused 
modifiers. The literature shows that no single strategy is or will be 
effective for all types of industry; interventions are best tailored to 
the individual situation. However, there are some program elements that 
consistent recur in successful programs:
    ``1. Interventions must mediate physical stressors, largely through 
the application of ergonomic principles.
    ``2. Employee involvement is essential to successful 
implementation.
    ``3. Employer commitment, demonstrated by an integrated program and 
supported by best practices review, is important for success.'' (Page 
App. A-6)
    ``These findings are based on a research and development process 
that tailors interventions to specific work and workers conditions and 
evaluates, on a continuing basis, the effectiveness of these 
interventions in the face of changing workplace and worker factors. It 
is therefore neither feasible nor desirable to propose a generic 
solution.'' (Page ES-5)
                                 ______
                                 
       Prepared Statement of the American Health Care Association

  AHCA PRAISES USE OF CONGRESSIONAL REVIEW ACT TO RESCIND ERGONOMICS 
                               REGULATION
    Washington, DC.--The American Health Care Association (AHCA) today 
praised Senator Don Nickles (R-OK) and Senator Mike Enzi (R-WY) for 
invoking the Congressional Review Act in their effort to rescind a 600-
page ergonomics regulation due to become law unless quick action is 
taken by Congress.

    ``Our membership is actively working to help ensure this 
excessively burdensome regulation does not become law, and we're 
pleased to work with Senators Nickles and Enzi on this critical 
issue,'' stated Charles H. Roadman II, M.D., President and CEO of AHCA. 
``This ergonomics rule would impose yet another crushing financial 
burden costing long term care providers $1.2 billion at a time when we 
are being squeezed on many different fronts. We have to be strong 
advocates for our patients by being zealous guardians of the scarce 
resources allocated by the government for long term care.''

    Late last week, Nickles, Enzi and several other Senators introduced 
a ``resolution of disapproval'' under the Congressional Review Act. If 
the resolution is approved by a simple majority in the Senate and 
House, and is signed by the President, the ergonomics rule will not 
become law.
    Dr. Roadman reiterated AHCA's position that reducing work-related 
injuries and protecting employees is best accomplished not through 
costly new federal regulations, but through ongoing voluntary efforts 
that are already working. AHCA has supported, created and promoted 
ergonomic programs to improve workplace safety for the caregivers in 
long term care for nearly a decade.

    ``We believe the proposed rule will actually reverse the positive 
trend toward lower rates of workrelated injuries because it will divert 
limited resources away from further improvements,'' said Dr. Roadman. 
``Just as the federal government has started to correct the errors made 
in the implementation of federal Medicare cuts, the last thing 
providers need is a new federal regulation that will drain $1.2 billion 
of scarce resources out of facilities to implement on a nationwide 
basis.''
     copy of the letter sent to all u.s. senators and house members
                                                     March 1, 2001.
[Each Letter was Personally Addressed and Signed to Individual Members 
        of Congress]
    On behalf of the American Health Care Association (AHCA), a 
federation representing over 12,000 non-profit and for profit nursing 
home, assisted living, subacute and ICFMR providers of long term care 
nationwide, I am writing to urge your strong support of the 
Congressional Review Act and your vote for the resolution of 
disapproval of the OSHA Ergonomic regulation.
    Let me state up front that AHCA has supported, created and promoted 
ergonomic programs to improve workplace safety for the caregivers in 
long term care for a decade. As caregivers our primary mission is to 
treat our patients and provide them with a high quality of life. This 
can only be successfully accomplished if our employees work in a safe, 
secure, and healthy environment.
    The fact of the matter is that the incidences of musculoskeletal 
disorder (MSD) injuries in long term care have been in decline, and 
continue to decline. Bureau of Labor Statistics (BLS) data show that 
from 1993 to 1997 sprains and strains numbers (the number one problem 
for health care employees) declined by 16.7 percent. BLS data released 
in December 1999 shows the decline to be continuing. Clearly, current 
programs and voluntary efforts to reduce MSDs are working. Indeed, AHCA 
believes that the ergonomics final rule will actually retard and even 
reverse this positive trend toward lower rates of work-related 
injuries.
    Long term care employers are in a box with no way out with respect 
to the resources available to them to help pay for this new standard. 
Medicaid or Medicare pays for the medical care for nearly 80 percent of 
residents in nursing facilities today. AHCA has estimated that the 
first year's cost for long term care facilities is almost $1.2 billion. 
The reality is that there is no way to increase prices to pay for the 
costs of this standard. The $1.2 billion will have to come from 
existing patient care resources, with questionable employee safety 
benefit from the rule's implementation.
    We strongly urge you to prevent this regulatory attack on caregiver 
resources, and allow a more reasoned approach to intelligent safety 
programs. Thank you for your attention to this critical vote.
            Sincerely yours,
                                 Charles H. Roadman II, MD,
                                                 President and CEO.
                                 ______
                                 
                  Letter From Secretary Elaine L. Chao
                                        Secretary of Labor,
                                         Washington, March 6, 2001.
Hon. Arlen Specter,
Chairman, Subcommittee on Labor, Health and Human Services, Education, 
        Committee on Appropriations, U.S. Senate, Washington, DC.
    Dear Chairman Specter: It is my understanding that the Senate will 
soon consider a Joint Resolution of Disapproval pertaining to the 
Occupational Safety and Health Administration's (OSHA) ergonomics 
standard. As you are aware, the Congressional Review Act of 1996 gives 
Congress the authority to vitiate this standard and permanently prevent 
OSHA from promulgating a rule in substantially the same form.
    Let me assure you that, in the event a Joint Resolution of 
Disapproval becomes law, I intend to pursue a comprehensive approach to 
ergonomics, which may include new rulemaking, that addresses the 
concerns levied against the current standard. This approach will 
provide employers with achievable measures that protect their employees 
before injuries occur. Repetitive stress injuries in the workplace are 
an important problem. I recognize this critical challenge and want you 
to understand that the safety and health of our nation's workforce will 
always be a priority during my tenure as Secretary.
    I look forward to working with you throughout the entire 107th 
Congress.
            Sincerely,
                                            Elaine L. Chao,
                                                Secretary of Labor.

                          SUBCOMMITTEE RECESS

    Senator Specter. Thank you very much, Mr. Woodward. Thank 
you, Mr. Fellner. Thank you, Ms. Rhinehart.
    Thank you very much, that concludes the hearing. The 
subcommittee will stand in recess until 9 a.m., Wednesday, 
April 25, when we will meet in room SD-192 to hear from HHS 
Secretary Thompson.
    [Whereupon, at 12:15 p.m., Thursday, March 6, the 
subcommittee was recessed, to reconvene at 9 a.m., Wednesday, 
April 25.]


  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2002

                              ----------                              


                       WEDNESDAY, APRIL 25, 2001

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

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                        Office of the Secretary

STATEMENT OF TOMMY G. THOMPSON, SECRETARY OF HEALTH AND 
            HUMAN SERVICES

               OPENING STATEMENT OF SENATOR ARLEN SPECTER

    Senator Specter. This meeting of the Subcommittee for 
Labor, Health, Human Services and Education will now convene.
    We are pleased to have the distinguished Secretary of the 
Department of Health and Human Services, former Governor of 
Wisconsin, the Honorable Tommy Thompson. This is your first 
appearance before our subcommittee on a formal basis, but both 
Senator Harkin, the distinguished ranking member, and I have 
had opportunities to meet with you and talk about priorities, 
your plans, and our inputs into the very very important 
Department which you are heading.
    The Department has discretionary funding under the 
administration's budget this year for $51.5 billion, which is 
approximately $2.5 billion above the fiscal year discretionary 
allowance for the year we are in now. There are a great many 
very, very, important programs which your Department is 
administering. You have come up with increases in some very 
important areas, and there have been some decreases in some 
important areas which we will want to discuss with you.
    In the interest of time, I am going to ask that my full 
statement be included in the record. As I told the Governor 
yesterday and again this morning, these days are all busy, and 
we appreciate you coming over early for a 9 a.m. session. The 
judiciary committee has a session at 10 a.m., which I expect to 
Chair shortly after it is convened for Senator Hatch, and I 
know Senator Harkin has commitments, so we will move right 
along. I am now delighted to yield to my partner, Senator Tom 
Harkin.

                OPENING STATEMENT OF SENATOR TOM HARKIN

    Senator Harkin. Thank you very much, Mr. Chairman, and 
again, it is always a pleasure to work with you in your 
capacity as chairman of this very important subcommittee. It is 
my pleasure also to welcome Secretary Thompson today to testify 
about the 2002 budget.
    First of all, Mr. Secretary, I am pleased to see that both 
NIH and community health centers have received significant 
increases in the budget. Kudos to you and to the President for 
that.
    I am also glad that you have continued funding for the 
construction of new laboratories at the Center for Disease 
Control and Prevention, Atlanta. I understand you visited there 
yourself and saw how important this work is and how those old 
buildings need to be upgraded----
    Secretary Thompson. Thank you very much, Senator.
    Senator Harkin. So I am really happy that you did that.
    I am also encouraged that the administration has shown 
strong support for the real choice system change grants by 
including them in the President's new freedom initiative for 
people with disabilities. The chairman and I worked hard to 
include funds for these grants in last year's bill, and we look 
forward to working with you on this and other Medicaid reforms 
that will allow people with disabilities and the elderly to 
live at home in the community.
    I might just paraphrase as an aside here, Mr. Secretary, 
when the President came and met with the Democratic caucus, we 
had a Democratic group meeting here a month or two ago or 
something, and he came and visited us. He said that money ought 
to follow an individual, not a program. You ought to focus on 
the individual, and the President is right on that.
    When it comes to people with disabilities, that the money--
--
    Secretary Thompson. That's true.
    Senator Harkin [continuing]. Ought to follow the person 
with the disability rather than a program, and if the person 
wants to live in the community, they ought to be able to do 
that. And so I said, we need some changes in Medicaid. He took 
notes on that, so I know that it registered with him. I am glad 
to see that you are continuing this program and hopefully we 
will be able to help get the funds for it.
    On a little other down note, though, I am disappointed that 
there are some other public health programs and a number of 
programs for children that did not fare as well, Mr. Secretary. 
A few weeks ago on the budget debate, Senator Specter and I 
worked on an amendment that was passed, that shifted money from 
the tax cut, mostly to education, but there was also money in 
there to make sure that kids could get ready to learn.
    In 1989, President Bush, then Governor Bush and the 
Nation's Governors met in Charlottesville, West Virginia.
    Secretary Thompson. That is correct.
    Senator Harkin. And they came up with some national goals 
for schools, education. The first goal was that every child 
should be ready and able to learn by the year 2000. Last year 
has come and gone and we have not gotten there. Well, I do not 
think that we ought to give up on it, we ought to just recommit 
ourselves to it. So I guess what I'm talking about is Head 
Start, an early learning fund, and quality child care, programs 
that come under your purview at your department. There were 
monies in the amendment to fully fund the Head Start program, 
and to fund the early learning fund at the authorized level.
    Now I have got to tell you that I am disappointed that the 
budget eliminates the early learning fund, and I hope we can 
work to get that back in, Mr. Secretary.
    The budget also cuts child care funding for infants and 
toddlers, and there is no expansion for Head Start. Now I am 
not going to say that this is absolutely certain, but from our 
initial read of the Head Start funding for next year, it looks 
as though about 2,500 kids are going to be cut out of Head 
Start under the budget. Now, if I am wrong, I would like to be 
proven wrong on that, but from the initial run that we have 
seen on that, with all of the quality programs and stuff built 
in there, the discretionary money that is left over will 
actually serve 2,500 kids less next year.
    Take a look at that please. I am not certain that is true, 
but that is the first kind of run we took. If that is the 
direction we are going, we have to do more under your purview 
on that.
    So these are priorities that I hope to work with you and 
other members of the subcommittee on, to do.
    Now, one last note, Mr. Secretary.
    Secretary Thompson. Yes.
    Senator Harkin. In Iowa and in Wisconsin and in a lot of 
other States, our people are paying as much in for Medicare as 
any other State in the Nation, but what we get back, our 
reimbursement rate in Iowa is $2,900, and in Louisiana it is 
$7,000. I do not know where Alaska falls, but I bet it is down 
there somewhere.
    And so, what I am saying, there is such a huge disparity in 
our reimbursement rates, I think Wisconsin is probably right 
down there with us someplace too, I think, so it is unfair to 
seniors in Iowa and those who live in rural States. If we just 
looked at the average for the United States and take where Iowa 
is in that average, we are losing a billion dollars a year that 
we have by rights coming in to take care of our elderly.
    Secretary Thompson. Senator, when I was Governor of 
Wisconsin, I would have changed our reimbursement rate for 
Iowa. We got treated even worse.
    Senator Harkin. You were worse than Iowa? Well, we are next 
to last, and I know you are not the last now, so you must be up 
above us somewhere right now, but you know what I am talking 
about.
    Secretary Thompson. I know.
    Senator Harkin. And we are going to introduce legislation 
to address this and try to get a better national average, and I 
hope to work with you on this issue. Thank you, Mr. Secretary.
    Secretary Thompson. Thank you, Senator.
    Senator Specter. Thank you very much, Senator Harkin. We 
are joined today by our distinguished chairman of the full 
committee, Senator Stevens.

                OPENING STATEMENT OF SENATOR TED STEVENS

    Senator Stevens. Thank you very much, Mr. Chairman. Mr. 
Secretary, we are delighted you are taking on this task and 
with your background we are even more delighted, because we 
know what you have done in your own State. I am really pleased 
that you have stopped by to visit me, and I am sure you are 
visiting everyone else to talk over the future of your area.
    I want you to know that I am concerned about the progress 
of keeping our commitment to double NIH funding. I really 
commend Senator Specter and Senator Harkin for their initiative 
in carrying this forward. Baby boomers are coming at us fast 
and if we do not get this science completed in order to deal 
with their problems in a different way than we have dealt with 
our generation, I think it is going to be extremely costly for 
the United States. The investment that we are going to make in 
health care research I think will pay off great dividends.
    I do support your efforts and the administration's 
efforts--I think Senator Bond has been the leader up here on 
this concept--to double funding for community health centers. 
However, I have to tell you that until this year, my state 
received only $7 million out of the total of $1.1 billion for 
community health centers. I found that the authorizing 
legislation and the regulations in your department hinder 
smaller rural isolated communities like those we have in our 
state from participating in that program. I hope that the 
community health center legislation that we develop to 
reauthorize this program will eliminate those barriers to the 
participation of frontier communities in America in the 
community health center program.
    Your budget eliminates the funding for what we call our 
Denali Commission, to build clinics in remote Bush communities 
in Alaska. There are 271 of those, Mr. Secretary. I hope to get 
you up to see our state soon, not just to the capital and our 
major city, but out to the Hooper Bays and the Scammon Bays, 
and the various areas that have tremendous problems.
    Forty percent of the 271 native villages do not have water 
and sewer systems. And these are communities that have no tax 
base, they are completely surrounded by federal property. They 
have unemployment rates in excess of 80 percent on a structural 
basis. There is no way that they can develop their own funds 
for health services.
    We developed the Denali commission so it could handle funds 
from several different agencies, merge them together, and do a 
comprehensive development in each village, instead of going 
into one village with water and sewer one year, and into 
another one the next year, and having different concepts coming 
in from HUD or from EPA. We have tried to put them all together 
so that when they go to the village, they do a comprehensive 
job that is less expensive and more productive in terms of 
producing good benefits.
    It is one of the things I hope you really look at, because 
we put an overhead ceiling of 5 percent on the Denali 
commission. The overhead at your department is 30-plus percent 
on monies that go to rural areas. There is just no reason to 
handle money that way, particularly when several departments 
are needed to deal with the problems of one single small rural 
village.
    I think if you take the time to come up, we can show you 
how you can be of great help and save money in the long run.
    The one really sad thing I want to discuss with you, and 
Senator Harkin has already mentioned that, and that's the 
initiative I developed which was called the Early Learning 
initiative. Your budget eliminates $20 million for that. It is 
not a lot of money, and I do support the first lady's reading 
program. There is no reason not to have them both.
    But the early learning initiative is a comprehensive 
approach to preparing children for school and I think it is 
absolutely essential in these times. We listened to the 
Secretary of Education yesterday concerning the problems of 
reading throughout the country, and it seems that no matter how 
much money we put into the Department of Education, the reading 
levels are not going up. This is one small amount that will, we 
believe, bring those reading skills up more rapidly than much 
of the billions of dollars that have been spent in the past, so 
I urge you to take a look at that.
    But again, I welcome you and look forward to working with 
you, and I am sure that it is going to be an interesting time 
for you. I appreciate your service. Thank you very much.
    Secretary Thompson. Thank you very much, Senator Stevens.
    Senator Specter. Thank you very much, Senator Stevens.
    Our practice, Mr. Secretary, is to put your full statement 
in the record and ask you to hit the highlights and summarize 
it as you see fit, so the floor is yours.
    Secretary Thompson. Senator Stevens, before you leave, I 
would just like to say thank you, and I will be looking forward 
to traveling to Alaska this summer and discussing it with you, 
and I hope to be working with you on the Denali Commission.
    Senator Stevens. Let me see if I can develop some of your 
other skills.

              Summary statement of Hon. Tommy G. Thompson

    Secretary Thompson. I am not very good at it but I will 
certainly try, and if the chairman asks me to do it, I will do 
it.
    Good morning, Chairman Specter, and thank you for your kind 
introduction and your friendship for many years and I 
appreciate that. And Senator Harkin, thank you for doing the 
wonderful job you do in the neighboring State of my home State. 
I have watched you with a great deal of interest and support 
for many years, and I apologize to you for not being able to 
get to see you personally, but I will be making every attempt 
to do so very quickly. I want to meet all the Senators in their 
office, and I look forward to that.
    I am honored, Senators, to appear before you today to 
discuss the President's fiscal year 2002 budget for the 
Department of Health and Human Services. I will make this very 
short, because I know both of you have to leave and I know you 
want to ask questions and I want to answer them.
    But several weeks ago I appeared before the colleagues of 
the Senate Budget Committee to discuss the President's fiscal 
year 2002 budget framework. Since that time, much has been 
written and said about selected portions of our budget. Some 
unfair and some inaccurate charges have been leveled against 
it. That is why I am so very pleased today to have this 
opportunity to appear before you to discuss our detailed budget 
proposal. I am confident that a review of the full details of 
our budget will demonstrate that we are proposing a balanced 
responsible approach to building a strong and healthy America.
    The budget before you today keeps the promises the 
President has made. It proposes new and innovative solutions 
for meeting the challenges that face the nation. Our proposal 
increases support for America's children and families, enhances 
the ground breaking research being sponsored by the National 
Institutes of Health, and I want to thank both senators for 
being so supportive of the NIH.
    Again, the modernization of Medicare expands access to 
health care and reforms the way the department operations are 
managed. Mr. Chairman, the total HHS request for fiscal year 
2002 is $468 billion. The discretionary component totals $55.5 
billion, and the amount before this committee totals $300 
billion in budget authority, of which $52 billion is 
discretionary.
    I know, Mr. Chairman, you have been very interested in NIH, 
as I have. I want to tell you that there is just some wonderful 
things going on up at NIH. And as you know, and you have been 
up there several times, and we are so close in so many areas, 
it is truly an exciting time to be Secretary of this Department 
and be involved.
    Senator Harkin, I appreciate your support of CDC. I have 
been down there. I do not know if you know this, but we are 
currently renting 22 buildings all over the city of Atlanta. I 
went down there and looked at it, and it is a crazy way to run 
it. We have land there, we have got an opportunity to build 
something that everybody in America can be proud of. And I 
pushed very hard to get the money of $150 million for new 
laboratories there. I would like to consolidate the 22 areas 
into one beautiful college campus that is going to do the 
things necessary for CDC, and I appreciate your support.
    Senator Harkin. I will back you any way I can.
    Secretary Thompson. I know that, and I appreciate that.
    In regards to women's health, we have put in a great deal 
of additional money for women's health because it is so 
important. We also have put a lot of money into children.

                           PREPARED STATEMENT

    I could go on, but I think I would much rather stop at this 
time, Senators, and Senator Murray, it is a pleasure to be in 
front of you as well. I know you have lots of questions, and I 
would just as soon answer your questions, and I will leave the 
rest of my written remarks for you to put in the record if that 
would be okay.
    Senator Specter. That is fine, Mr. Secretary. We appreciate 
that.
    [The statement follows:]

              Prepared Statement of Hon. Tommy G. Thompson

    Good Morning, Chairman Specter, Senator Harkin, and members of the 
Subcommittee. I am honored to appear before you today to discuss the 
President's fiscal year 2002 budget for the Department of Health and 
Human Services.
    Several weeks ago, I appeared before your colleagues on the Senate 
Budget Committee to discuss the President's fiscal year 2002 budget 
framework. Since that time, much has been written and said about 
selected portions of our budget, and some unfair and inaccurate charges 
have been leveled against it. This is why I am so pleased to have the 
opportunity to appear here today to discuss our detailed budget 
proposal. I am confident that a review of the full details of our 
budget--not selected pieces of it--will demonstrate to one and all that 
we are proposing a balanced, responsible approach to building a strong 
and healthy America.
    Part of this approach involves taking another look at the way we do 
things on the national level. We must no longer be content to do things 
a certain way because ``that's how we've always done it''; but must 
instead be willing to reform our business practices and seek innovative 
ways to manage our programs. And while we know that the Federal 
Government has an important role to play, we must also recognize that 
we must look to others--to State, local, and tribal governments, to 
community and faith-based organizations, to the private sector, and to 
academic institutions--for new and creative approaches to solving 
public problems. The President and I share this view, and I am proud to 
say that it is manifested in the budget he has put forward.
    The budget I present to you today keeps the promises the President 
has made and proposes new and innovative solutions for meeting the 
challenges that face the nation. Our proposal increases support for 
America's children and families; enhances the groundbreaking research 
being sponsored by the National Institutes of Health and protects 
public health; begins the modernization of Medicare and expands access 
to health care; and, invests in infrastructure and reforms the way the 
Department's operations are managed. The HHS budget also reflects the 
President's commitment to a balanced fiscal framework that puts 
discretionary spending on a more reasonable and sustainable growth 
path; protects Social Security, Medicare, and other priority programs; 
continues to pay down the national debt; and, provides tax relief for 
all Americans.
    Mr. Chairman, the total HHS request for fiscal year 2002 is $468.8 
billion (outlays). The discretionary component totals $55.5 billion 
(budget authority). The amount before this Committee totals $300.7 
billion in budget authority, of which $51.4 billion is discretionary. 
Let me now discuss some of the highlights of the HHS budget.
         increasing support for america's children and families
    The HHS budget substantially increases our investment in children. 
Overall, the President's budget provides nearly $3 billion in increased 
spending for children's programs in this Department. The budget 
includes both increases for existing programs and investments in a 
number of new programs designed to fulfill President Bush's commitment 
to making sure that no child is left behind. This administration 
recognizes that America's children and families are its strength, and 
this budget reflects our commitment to helping them thrive and prosper. 
Our budget also increases support for the charitable organizations that 
can make such a difference in people's lives.
After School Certificates
    One of the lessons I learned during my years as Governor of 
Wisconsin was that for people to move from dependency to success in the 
workforce, you had to be willing to invest in programs that support 
working families. One of the most important things that we as a 
government can do to help working families is to assist them in 
obtaining high-quality child care. Last year the Congress voted to 
provide a substantial increase in child care funding, and this year we 
are asking you to take another step to help working parents and their 
children be successful. The President has requested a total of $2.2 
billion for the Child Care and Development Block Grant and has proposed 
to specifically dedicate $400 million for After School Certificates 
within the block grant. These certificates would help low-income 
working parents to pay for the costs of after school care for up to 
500,000 children who are less than 19 years old. We expect these after 
school activities to also have a strong educational component, helping 
children to achieve success in school.
Promoting Safe and Stable Families and Independent Living
    Our budget takes a number of steps to help protect our most 
vulnerable and at-risk children and to help them live safe and 
productive lives. First, we propose to create a new $67 million 
discretionary program within the Promoting Safe and Stable Families 
program to mentor children of prisoners. This initiative will provide 
grants through States, to assist faith and community-based groups in 
providing a range of activities to assist children of prisoners and 
probationers, including family-rebuilding programs that will help to 
reunite children and parents once the parent is released from prison if 
it is in the best interests of the child. Our budget also proposes a 
$200 million increase in mandatory funding for the Promoting Safe and 
Stable Families program, which supports State and Tribal child welfare 
agencies in carrying out family preservation and support services and 
adoption promotion and support programs. We also propose an additional 
$60 million for the Independent Living program. These funds would be 
used to provide vouchers, worth up to $5,000, to youths who are aging 
out of foster care so that they can obtain the education and training 
they need to lead productive lives. Funds could be used to pay for 
either college tuition or vocational training.
Maternity Group Homes
    One of the toughest problems we face in trying to end the cycle of 
dependency is children having children. These teenage mothers have 
often suffered abuse or neglect and may not have a safe and supportive 
family environment in which to raise their babies. To begin removing 
the obstacles to success that these mothers and their children face, we 
are proposing $33 million for a new Maternity Group Homes program. This 
program will support efforts to work with organizations that operate 
community-based, adult-supervised group homes for teenage mothers and 
their children, as well as to provide certificates to young mothers to 
obtain supportive services. These homes will provide a safe and 
nurturing environment for young mothers while offering the support 
necessary to help them and their children to improve their lives.
Promoting Responsible Fatherhood
    Helping young mothers is an important part of our program to assist 
America's families, but it is also important that we recognize the 
critical role that fathers play in the lives of their families. The 
unfortunate reality is that nearly 25 million children do not live with 
their fathers, and studies show that these children are far more likely 
to experience poverty and suffer problems in school than children who 
live with both parents. Our budget framework includes $64 million to 
begin an initiative to promote responsible fatherhood by providing 
competitive grants to faith-based and community-based organizations 
that work to strengthen the role that fathers play in their families' 
lives. These funds will be used to support programs that help low-
income and unemployed fathers and their families to avoid dependence on 
welfare, and to fund programs that promote successful parenting and 
marriage. Of these funds, $4 million will be used for special projects 
of national significance.
Compassion and Charitable Giving
    The President has been a leader in recognizing the important role 
that charitable organizations play in delivering services to the 
public, and we are proposing a number of steps to increase Federal 
support for these groups. First, we are requesting $89 million to 
establish a Compassion Capital Fund. Through public and private 
partnerships, these resources will be used to provide start-up capital 
and operating funds to qualified charitable organizations so that they 
can expand or emulate model social services programs. Funds will also 
support research on ``best practices'' among charitable organizations. 
Our budget also includes $3 million to establish a Center for Faith-
Based and Community Initiatives in the Department in accordance with 
the President's recent Executive Order. Finally, we have included a 
proposal to encourage States to provide tax credits for contributions 
to designated charities that work to address poverty. Under this 
proposal, States would be allowed to use Federal funds provided through 
the Temporary Assistance for Needy Families program to partially offset 
revenue losses that resulted from the tax credits.
Head Start
    Head Start is the Nation's largest early childhood education 
program. The Head Start program helps to ensure that low-income 
children start school ready to learn and, to that end, provides a range 
of comprehensive child development and health services. The President 
proposes to revitalize Head Start by making school readiness skills 
such as pre-reading and numeracy the program's top priorities. For 
fiscal year 2002, the budget proposes a total of $6.3 billion for Head 
Start, an increase of $125 million. These funds will allow Head Start 
to serve 916,000 children, including 55,000 in Early Head Start, and to 
maintain a competitive salary for teachers.

         ENHANCING SCIENTIFIC AND HEALTH CARE QUALITY RESEARCH
    Advances in scientific knowledge have provided the foundation for 
improvements in public health and have led to enhanced health and 
quality of life for all Americans. Our fiscal year 2002 budget enhances 
support for scientific research as well as for research to improve the 
quality of the Nation's health care system.
Biomedical Research Sponsored by the National Institutes of Health
    The National Institutes of Health (NIH) is the largest and most 
distinguished biomedical research organization in the world. The 
research that is conducted and supported by the NIH, from the most 
basic research on biological systems to the successful mapping of the 
human genome, offers the promise of breakthroughs in preventing and 
treating any number of diseases. A top priority for this Administration 
is ensuring that the NIH continues to have the resources necessary to 
help turn these promises into a reality.
    This budget keeps the President's commitment to double NIH's fiscal 
year 1998 funding level by fiscal year 2003. For fiscal year 2002, we 
are proposing an increase of $2.75 billion, which will be the largest 
dollar increase ever for NIH. This funding level will enable NIH to 
support over 34,000 research project grants, the highest level in the 
agency's history. NIH will expand its focus on four research areas that 
show the greatest potential for yielding new scientific breakthroughs: 
genetic medicine, clinical research, interdisciplinary research, and 
health disparities.
    With any large increase in resources, there also comes the 
increased challenge of making sure that those resources are managed 
properly. I take this responsibility very seriously, and NIH will be 
working to develop strategies to ensure that we are managing taxpayer 
dollars in the most efficient and effective way.
Patient Safety and Health Care Quality
    The Agency for Healthcare Research and Quality (AHRQ) is the 
Federal agency with primary responsibility for research on the Nation's 
health care system and is HHS's lead agency for improving patient 
safety and the quality of everyday health care. The fiscal year 2002 
budget provides a total program level of $306 million for AHRQ, an 
increase of $36 million or 13.5 percent over fiscal year 2001.
    AHRQ will devote a total of $53 million to continue the work this 
Committee first funded in fiscal year 2001 to identify ways to reduce 
medical errors. These funds will support activities to research the 
causes of medical errors, develop and test new technologies to reduce 
medical errors, test reporting strategies, and improve training. 
Earlier this week, I announced the establishment of a new Patient 
Safety Task Force within the Department in which AHRQ will collaborate 
with FDA, CDC, and HCFA to improve existing reporting systems on 
patient safety. HHS seeks to develop a robust, anonymous database of 
information on errors and adverse events that can be used to find new 
and better ways to improve patient safety.
    Our request includes a $26 million increase for research on health 
care quality and cost-effectiveness. Like you and many others, we are 
reviewing the recent recommendations by the Institute of Medicine for 
research to improve the quality of health care. Once that review is 
complete, I expect that an appropriate portion of these resources will 
be directed toward the recommendations that we conclude should be given 
the highest priority. I also expect the findings of this and other 
research on patient safety, which have emphasized the importance of 
encouraging and rewarding the development of health care systems that 
encourage safer and higher-quality care, to guide our efforts to 
improve Medicare, Medicaid, and other government health programs.

     IMPROVING MEDICARE AND EXPANDING ACCESS TO QUALITY HEALTH CARE
    Of all the issues confronting this Department, none has a more 
direct effect on the well-being of our citizens than the quality of 
health care. Our budget proposes to improve the health of the American 
people by taking important steps to improve Medicare, including the 
addition of a prescription drug benefit, and by directing funds to 
various initiatives aimed at expanding access to health care.
Modernizing Medicare
    The Medicare program has been the center of our society's 
commitment for ensuring that all of our seniors enjoy a healthy and 
secure retirement. Honoring this commitment means not only making sure 
that the program is financially prepared for the wave of new 
beneficiaries that the aging of the baby-boom generation will bring, 
but also ensuring that current beneficiaries have access to the highest 
quality care. As an interim step, the President has put forward an 
Immediate Helping Hand (IHH) prescription drug proposal. This proposal 
provides $46 billion over 5 years to help States provide prescription 
drug coverage immediately to beneficiaries with limited incomes or high 
drug expenses. This proposal, which will sunset in fiscal year 2005 or 
as soon as legislation to strengthen Medicare including a prescription 
drug benefit is enacted, would provide immediate coverage for up to 9.5 
million beneficiaries.
    We also believe, along with many members of Congress who have 
supported and continue to support bipartisan efforts to strengthen 
Medicare, that we must take steps to improve Medicare as soon as 
possible. Inadequate prescription drug coverage is only the most 
obvious gap in Medicare benefits. Today, Medicare covers only 53 
percent of the average senior's annual medical expenses, and the 
options available to seniors to help them limit these expenditures are 
declining. In addition, Medicare is facing a looming fiscal crisis. A 
full assessment of the health of both the Part A and Part B Trust Funds 
reveals that spending exceeds the total of tax receipts and premiums 
dedicated to Medicare and that financing gap is expected to widen 
dramatically. Even without the financing problem, Medicare 
modernization would be necessary to ensure beneficiaries get high 
quality health care. President Bush proposes to devote $156 billion 
(including funding for Immediate Helping Hand) over the next 10 years 
to a set of improvements in Medicare that are urgently needed. These 
Medicare modernizations include taking steps to make better coverage 
options available, to assure that all seniors have affordable access to 
prescription drugs, to provide better options for high out-of-pocket 
expenses, particularly for low-income seniors, and to ensure that 
Medicare has greater overall financial security.
Expanding Community Health Centers
    Our budget also proposes steps to strengthen the health care safety 
net for those most in need. Community Health Centers provide high 
quality, community based care to approximately 11 million patients, 4.4 
million of whom are uninsured, through a network of over 3,000 centers 
in rural and urban areas. The President has proposed to expand and 
increase the number of health center sites by 1,200 by fiscal year 
2006, and to double the number of individuals without alternative 
coverage who are served by the centers. As a first installment of this 
multi-year initiative, we propose to increase funding for Community 
Health Centers by $124 million. We will also be looking at ways to 
reform the National Health Service Corps so as to better target 
placement of providers in areas experiencing the greatest shortages of 
health professionals.
Increasing Access to Drug Treatment
    The problems caused by substance abuse affect not only the physical 
and mental condition of the individual, but also the well-being of 
society as a whole. Nationwide, approximately 2.9 million people with 
serious substance abuse problems are not receiving the treatment they 
desperately need. To help close this treatment gap, we propose to 
increase funding for substance abuse treatment by $100 million. Of 
these funds, $60 million will be used to increase the Substance Abuse 
Block Grant, the primary vehicle for funding State substance abuse 
efforts, and $40 million will go to increase the number of Targeted 
Capacity Expansion grants, which seek to address the treatment gap by 
supporting strategic and rapid responses to emerging areas of need, 
including grants to organizations that provide residential treatment to 
teenagers.
Organ Donation
    Our budget supports an initiative very close to my heart. 
Approximately 75,000 patients are awaiting organ transplants, far above 
the number of available donors. In fact, organ transplants in 2000 
totaled 22,827, an increase of 1,172 over the 21,655 transplants that 
occurred in 1999. The number of living donors rose from 4,747 in 1999 
to 5,532 in 2000, an increase of 16.5 percent, the largest 1-year jump 
ever recorded. While I am encouraged by the progress that has been made 
in the last year, there is still a very long way to go. To tackle this 
problem, I launched a new national initiative, on April 17th, to 
encourage and enable Americans to ``Donate the Gift of Life''. I am 
beginning a national ``Workplace Partnership for Life'', in which 
employers, unions and other employee organizations can join in a 
nationwide network to promote donation. I released a model organ and 
tissue donor card, incorporating proven elements from today's donor 
cards and have ordered an immediate review of the potential of organ 
and tissue registries where donors' wishes could be recorded 
electronically and made available to families and hospitals when 
needed. I have also made a pledge to create a national medal to honor 
the families of organ donors and will create a model curriculum on 
donation for use in driver education courses, to be offered to states 
and counties nationwide. And, let me tell you, this is just the 
beginning. I intend to do everything I can to increase organ donation 
throughout America and to create the most comprehensive effort ever in 
our nation regarding donation and transplantation.

          INVESTING IN INFRASTRUCTURE AND REFORMING MANAGEMENT
    For any organization to succeed, it must never stop asking how it 
can do things better, and I am committed to seeking new and innovative 
ways to improve the management of our programs. But we must also 
recognize that we do a disservice to all who rely on this Department if 
we do not provide the resources necessary to effectively administer our 
programs. In preparing our budget, we began the process of evaluating 
the programs and business practices of this Department and identifying 
the areas where we can do a better job of managing taxpayer resources, 
as well as those areas where new investments are required if we are to 
successfully administer our operations.
HCFA Management Reform
    One of the most important management reforms we will pursue is the 
improvement of the Health Care Financing Administration (HCFA). I have 
often referred to HCFA as the agency people love to hate; and I 
recognize that patients, providers, and States have legitimate 
complaints about the scope and complexity of the regulations and 
paperwork that govern the Medicare, Medicaid, and State Children's 
Health Insurance programs. At the same time, we must recognize that in 
the last few years HCFA has been tasked with implementing several 
pieces of major legislation and its responsibilities have grown more 
complex with each new major healthcare law or budget reconciliation.
    Concerns about HCFA's management capabilities have been raised in 
several General Accounting Office reports, including the High Risk 
Series: An Update (January 2001) and Financial Management: Billion in 
Improper Payments Continue to Require Attention (October 2000). HCFA 
management reform is an Administration priority. HCFA will undertake a 
major effort to modernize and streamline its operations to effectively 
manage current programs and implement new legislation. In particular, 
HCFA's role in a modernized Medicare program needs to be carefully 
considered. This may require substantial changes in HCFA's mission and 
structure. My goal is to assure that HCFA's resources are focused as 
effectively as possible on improving quality and limiting costs for 
Medicare beneficiaries, limiting burden for providers, and increasing 
efficiency for taxpayers.
    The budget proposes an increase of $109 million, or 5 percent, for 
HCFA program management. Included in the HCFA program management budget 
is an increase of $36 million, for a total of $53 million, to support 
the development of the HCFA Integrated General Ledger Accounting System 
(HIGLAS). HCFA currently relies on several financial management systems 
to account for the hundreds of billions of dollars spent on Medicare 
benefits, and most contractors do not use double entry accounting 
methods or claims processing systems with general ledger capabilities. 
This system requires financial statements to be imputed manually, 
increasing the risk of administrative and operational errors and 
misstatements. HIGLAS will provide a uniform Medicare accounting system 
that will help to detect and collect money owed to the Medicare Trust 
Funds, retain a clean opinion on financial statements without more 
expensive, alternative efforts, and comply with financial management 
statutory requirements.
    I am also committed to reforming HCFA's antiquated and inefficient 
contracting system. We are considering a number of options in this area 
including: allowing carriers who are not health insurance organizations 
to become Medicare contractors; allowing the Secretary (as opposed to 
the Part A provider) to contract for and assign fiscal intermediaries 
to perform claims processing, claims payment, communications, audit 
functions, renewing contracts, and transferring functions; and 
replacing current special provisions for terminating contracts with 
more standard terms and conditions embodied in the Federal Acquisition 
Regulation (FAR). In addition, I am including in the budget $115 
million in new proposed user fees for duplicate and paper claims 
processing. We will work hard to enact these fees, which will help to 
improve the efficiency and lower the cost of processing Medicare 
claims.
Revitalizing Laboratories and Scientific Facilities
    It is critical that we invest in the modernization of the 
laboratories and scientific facilities, for obsolete facilities affect 
our scientific readiness and compromise our ability to retain the top 
scientists. Our budget includes funds to continue the revitalization of 
key facilities at the Centers for Disease Control and Prevention and 
the National Institutes of Health. We are requesting $150 million for 
buildings and facilities at the Centers for Disease Control and 
Prevention, which will support construction of a laboratory facility 
dedicated to handling the most highly infectious pathogens, such as 
Ebola, and construction of an Environmental Toxicology Lab. The budget 
also requests $307 million for intramural buildings and facilities at 
the National Institutes of Health to support projects such as the 
construction of the John Edward Porter Neuroscience Research Center and 
a centralized, multi-level animal facility.
Enhancing Coordination and Reducing Duplication of Operating Systems
    The only way that this Department can effectively serve its many 
clients is if we commit to making the necessary investments in our 
management and infrastructure. One of the challenges in a large, 
decentralized Department such as HHS is finding ways to bring together 
diverse activities and to develop coordinated systems for managing our 
programs. Our budget provides the resources necessary to begin the 
process of streamlining our financial management and information 
technology systems so that we can enhance coordination across the 
Department and eliminate unnecessary and duplicate systems.
    For financial management, we propose to invest $50 million, which 
includes funding for the new HCFA accounting system, to move toward a 
unified financial accounting system. The Office of Inspector General 
has cited problems with the Department's current system structure, 
which involves five separate accounting systems operated by multiple 
agencies. We plan to replace these antiquated systems with unified 
financial management systems that will increase standardization, reduce 
security risks, allow HHS to produce timely and reliable financial 
information needed for management decision-making, and provide 
accountability to our external customers.
    In the information technology arena, we are proposing $30 million 
for a new Information Technology Security and Innovation fund. 
Currently, the Department's information technology systems are highly 
decentralized, heterogeneous, and vulnerable to exploitation. Funds 
would be used to implement an Enterprise Infrastructure Management 
approach across the Department that would minimize our vulnerabilities 
and maximize our cost savings and ability to share information. With 
this approach, we will be able to reduce duplication of equipment and 
services and be better able to secure our systems against viruses and 
network intrusion.
    As the largest grant-making agency in the Federal Government, this 
Department will also continue to play a lead role in the government-
wide effort to streamline, simplify, and provide electronic options for 
the grants management processes. As part of the Federal Grant 
Streamlining Program, we will work with our colleagues across the 
government to identify unnecessary redundancies and duplication in the 
more than 600 Federal grant programs and to implement electronic 
options for all grant recipients who would prefer to apply for, 
receive, and close out their Federal grant electronically.
Redirecting Resources and Enhancing Flexibility
    Being a wise steward of taxpayer resources means not only 
recognizing where you need to invest but also where resources can be 
redeployed to more effective uses. In preparing our budget, we 
carefully reviewed each agency, identified areas where funding could be 
redirected, and made targeted reductions in selected programs. The 
fiscal year 2002 budget eliminates $475 million in earmarked projects 
and $155 million in funding for activities that were funded for the 
first time in fiscal year 2001. In addition, the budget shifts $597 
million from programs that are duplicative, or whose goals are better 
met through other avenues, to higher priority activities. And, to 
assist in financing other high priority activities, the budget expands 
the use of Public Health Service Evaluation funds. These decisions 
helped to meet our goal of moderating the large increases in 
discretionary spending that have occurred over the last few years and 
putting the budget on a more sustainable growth path for the future.
    This Administration is also committed to giving States greater 
flexibility to manage public health grant programs. Our budget proposes 
to give States expanded authority to transfer funds among public health 
grants, thereby enabling them to make more efficient and effective use 
of Federal resources and to target and reallocate funds to public 
health priorities identified at the State and local levels.
    In addition to giving the States greater flexibility, I am seeking 
to increase my transfer authority from one percent to six percent, to 
eliminate the restriction that the transfer may not increase an 
appropriation by more than three percent, and to make it Department-
wide. I believe this transfer authority is a valuable tool for managing 
the Department's resources and will allow me to respond to emergency 
needs or unforeseen events that would otherwise adversely effect a 
program or agency.
Continuously Evaluating and Improving Program Performance
    The Government Performance and Results Act serves as an important 
tool for making sure that this Department is not only doing the right 
things but that we are doing them well. As in previous years, our 
budget request is accompanied by the annual performance plans and 
reports. The performance measures and targets in these reports touch 
nearly every aspect of the Department's multi-faceted mission and 
detail a number of notable achievements, including:
  --HCFA met its fiscal year 2000 target of reducing the Medicare error 
        rate to 7 percent.
      Auditors estimated improper payments at $11.9 billion, compared 
        with $13.5 billion in fiscal year 1999. The error rate has 
        fallen to roughly half of what it was in fiscal year 1996, and 
        HCFA is pursuing increasingly rigorous goals for fiscal year 
        2001 and fiscal year 2002.
  --The Administration for Children and Families (ACF) reported that 
        42.9 percent of adult recipients of TANF became employed in 
        fiscal year 1999. This is a primary indicator of success in 
        moving families toward self-sufficiency. It improves on the 
        fiscal year 1998 baseline of 38.7 percent and exceeds the 
        target of 42 percent.
  --CDC reported a reduction of perinatal Group B streptococcal 
        disease--the most common cause of severe infections in 
        newborns--by 70 percent from 1995 to 1999, exceeding the goal.
    These are just a few of the dozens of impressive success stories 
found in the 13 performance plans and reports. GPRA has been and will 
continue to be an important part of our effort to improve the 
management and performance of our programs.

         WORKING TOGETHER TO BUILD A STRONG AND HEALTHY AMERICA
    Mr. Chairman, the budget I bring before you today contains many 
different proposals; but, the common thread that binds them all 
together is the desire to build a strong and healthy America and to 
improve the lives of the American people. All of our proposals, from 
enhancing scientific research to modernizing Medicare, from expanding 
access to care to increasing support for the Nation's children and 
families, are put forward with these simple goals in mind. I know these 
are goals we all share.
    As you begin to consider our proposals, let me leave you with one 
final thought. Senator Everett Dirksen said of the legislative process: 
``You start from the broad premise that all of us have a common duty to 
the country to perform. Legislation is always the art of the possible. 
You could, of course, follow a course of solid opposition, of 
stalemate, but that is not in the interest of the country.'' Starting 
from this premise, I am prepared to work with each of you to ensure 
that we develop a budget for this Department that effectively serves 
the national interest. I would be happy to address any questions you 
may have.

                 CENTERS FOR DISEASE CONTROL PREVENTION

    Senator Specter. As is our practice, we will commence with 
5-minute rounds for each Senator.
    I begin, Mr. Secretary, with the issue of the Centers for 
Disease Control. The Centers have deteriorated just 
tremendously, and it is a matter of some concern to me that 
there had not been action by the last administration and a very 
competent Secretary of Health and Human Services in alerting 
this subcommittee to the deplorable conditions. I made a trip 
down there about a year ago, and this subcommittee took the 
lead in putting in $170 million because the situation was so 
catastrophic.
    My recent meeting with the representatives of the Center 
found that they want $240 million. You have----
    Secretary Thompson. $150 million.
    Senator Specter [continuing]. $150 million, which is $25 
million down from our figure last year. And my question to you 
is, how do you calculate $150 million, and is that really 
enough, or are the people at the Center really on the right 
track in asking for about $240 million?
    Secretary Thompson. Well, I think you can make that 
argument, Senator, but the truth of the matter is, there are 22 
buildings that we're renting, and I think it makes very good 
fiscal sense as well as scientific sense to be able to 
consolidate those into one campus.
    Senator Specter. I went down there, and there is no doubt 
about the consolidation. Let me ask you to do this. Let me ask 
you to have your department take a look at the overall program, 
which is a big one, in excess of a billion dollars as I 
understand it, and give us a projection as to what we are going 
to have to spend next year, the year after, so that we can make 
an evaluation of priorities as to whether we think we need to 
shift some money.
    Secretary Thompson. Okay. Well, Senator, I have already 
done that, and that is why we put in $150 million. It is going 
to have to be an ongoing $150 million in order to modernize and 
do it correct. If you want to accelerate it, you could do it at 
$175 million. We cut back on some planning for the next 
building and we felt we could do that in the next fiscal year, 
and we put some labs and so on in this year.
    Senator Specter. Let us take a look at your specific 
projections and compare that with what the Center has in mind.
    Secretary Thompson. Fine.
    Senator Specter. And with what the other advocates have in 
mind.
    Secretary Thompson. My projections are not much different 
than the Center's.
    Senator Specter. Well, the figures are a fair amount lower, 
but let us take a look at the specifics.
    Secretary Thompson. Absolutely.

                           STEM CELL RESEARCH

    Senator Specter. There is not a whole lot of time, so let 
me move to the issue of stem cells, which is a very important 
topic, and note just very briefly for the record that when this 
issue broke in November of 1998, this subcommittee had a 
hearing within a couple of weeks. We have had seven hearings on 
the subject and I think it is a fair assessment that the 
subcommittee, I know that Senator Harkin and I are convinced 
that the stem cells which come from embryos are vital for 
medical research.
    A point which I think has to be emphasized, and you and I 
have talked about this informally but just a word or two on the 
record, is that these embryos are created for in vitro 
fertilization, there are more created than necessary, and they 
are going to be discarded. If there were any possibility that 
these embryos would turn into human life, I would be the last 
to countenance using them for stem cells. But when they are 
going to be destroyed, then the alternative is to use them or 
lose them, in effect.
    I know that there is another evaluation of the legal 
opinion issued by general counsel for the Department of Health 
and Human Services, which concluded that Federal funds may be 
used for research on the stem cells, once they are extracted, 
but Federal funds may not be used to extract the stem cells 
from the embryos. And speaking as one lawyer to another, 
lawyers' opinions are not too hard to obtain on any given 
proposition.
    My yellow light is up and so I will conclude the issue by 
asking you for your perspective and what your plans are on 
handling this stem cell matter.
    Secretary Thompson. Thank you very much, Senator. You know 
this is a very contentious issue and one in which I have been 
very much involved in from my prior life as the Governor of the 
State of Wisconsin.
    Stem cells are being evaluated by the Department, both by 
the general counsel, and other legal opinions are being 
discussed, but also scientific review is being done by NIH. 
Both of those reviews will be to me, hopefully, by the first 
week in June. And as regards to the process that is already in 
place, there are two applications, and those applications are 
being reviewed, even if the hearing was not postponed in April, 
they would not have been able to be funded until next April. 
That still is possible, if in fact both reviews come back 
consistent with your point of view, or if in fact Congress 
decides to change the law, Senator.
    Senator Specter. My red light is on, so we turn now to 
Senator Harkin.

                      REGULATION OF TOBACCO BY FDA

    Senator Harkin. Thank you very much, Mr. Chairman.
    Mr. Secretary, I have been pleased to hear your comments 
about the need for FDA to regulate tobacco. Stick with it.
    Secretary Thompson. I notice when I looked around, there 
were not too many people behind me, except you, Senator.
    Senator Harkin. Well, stay out there, you are right on that 
issue and you are going to get a lot of support because people 
are on your side on this issue.
    The tobacco companies, for example, you know that 
nitrosamines for example, are highly carcinogenic. They have 
the technology to reduce that, they are not doing that. That is 
one of the things that FDA could do. But, I just want to say 
that, you know, we had--the FDA issued in 1996 these 
regulations, and the Supreme Court said they didn't have the 
legislative authority with which to do that.
    But they said, the tobacco companies said they were going 
to voluntarily not market to kids, that they were going to not 
do that. Well, they have been saying that for a long time. A 
recent Federal Trade Commission report showed that in the first 
year after the settlement, tobacco marketing expenditures went 
up 22 percent to a record $8.24 billion per year, and much of 
the increase was in marketing efforts that reached kids. Two 
for one discounts that reduced cigarette prices, payments to 
stores for high visibility shelf displays, et cetera.
    So I tell you, I personally believe the FDA needs to have 
the ability to rein in the industry and protect our kids. That 
is what FDA is supposed to do, supposed to protect us are from 
unwarranted drugs, unsafe foods, and cigarettes.
    The regulations that FDA issued included a number of 
restrictions, including banning of outdoor advertising within a 
thousand feet of schools, it would have allowed only black and 
white text appearing in publications with youth readership.

                         TOBACCO ADVERTISEMENTS

    Senator Harkin. I am going to ask Sabrina to hold this up. 
This was in Cosmopolitan. 1,463,000 teenagers, they say mostly 
girls read it, and that is the ad for Virginia Slims, and that 
is what these young girls are reading. There is no question in 
my mind now why lung cancer now has overtaken breast cancer as 
the most pervasive cause of death among women in America today.
    Secretary Thompson. Very true.
    Senator Harkin. It is true. And we are finding out more and 
more that the tobacco companies have been targeting women and 
young girls, getting them hooked young.
    Well, I do not know that I have so much of a question, 
except just to say, Mr. Secretary, I urge you to continue your 
efforts, and I do not mean to put you on the spot or anything 
like that, but I just want to know how you feel about the FDA 
having that kind of authority to restrict this kind of 
advertising, to restrict where they can put tobacco on store 
shelves, all the things that were in the regulations that FDA 
issued in 1996 which the Supreme Court took out, and which I 
hope we in Congress are going to address.
    Secretary Thompson. This is a big issue, Senator Harkin, 
for me and obviously for you, and I appreciate that. It is 
amazing that 165,000 women died last year which was directly 
caused by tobacco smoking, and 30 percent of our teenagers in 
high school have tried cigarettes--32 percent of our teenagers 
have tried a cigarette or tobacco in the last 30 days.
    Senator Harkin. How many?
    Secretary Thompson. Thirty two percent. And the record 
shows that if in fact you are able to prevent teenagers from 
smoking, that there is an 80 percent chance that people will 
not smoke after they reach age 21. So it is obvious that we 
have to address this problem.
    In regards to regulation, really it is going to be up to 
Congress if they can pass the bill. FDA should have some 
regulation, should be able to do it, and I would welcome that 
opportunity, Senator.
    Senator Harkin. I appreciate your forthright statement.
    Secretary Thompson. Thank you.
    Senator Harkin. My yellow light is on too. I have one 
question about Medicaid and managed care for disabled, but I 
guess I will have to wait for my second round.
    Senator Specter. Senator Murray.
    Senator Murray. Thank you very much, Mr. Chairman, and 
thank you, Mr. Secretary.
    Secretary Thompson. How are you, Senator?
    Senator Murray. I am doing great. Good to see you here at 
our committee, and I look forward to working with you on this 
very very important piece of our budget.
    I have a first question today about the nursing shortage, 
and I think everyone of us have heard----
    Secretary Thompson. It is a real problem.

                            NURSING SHORTAGE

    Senator Murray. There is a real shortage, I am very 
concerned about it, and I see that the President proposed to 
redirect health profession funds from physician education to 
professions like nursing, which is one step, but in talking to 
a number of our technical schools and community colleges that 
do a lot of the initial training on this, they are telling me 
that the impact has come from welfare reform, which has changed 
the emphasis and only gives 1 year credit for education, so 
that there is not an incentive for women and men on welfare to 
go into nursing, because they don't get the exemption long 
enough to get the training that they need. I think it is really 
important to have some flexibility in the welfare program to 
provide that education and training, and I just wanted to find 
out if you would support extending that current 12-month 
education work standard in order to meet the growing nursing 
needs in our hospitals and nursing homes.
    Secretary Thompson. If I could just broaden the question a 
little bit, I would appreciate it, Senator Murray. Nursing 
shortage is a severe problem in America and it is going to get 
worse, especially for the nursing home industry.
    Currently, we are 90,000 short for registered nurses, 
250,000 short on CDNs, and it is very important that we address 
it, and I applaud you for your leadership. It is also a big 
concern of mine and the Department so we want to do something 
about it.
    In regards to welfare reform, TANF is not going to be 
reauthorized until next year, and I will be more than happy to 
work with you to find ways on how we can encourage it, but I do 
not think welfare reform is the cause for the nursing shortage. 
The nursing shortage is caused by long hours and shortage, in 
the fact that the working conditions have not been the best for 
nurses. What we have to do as a Congress, and as an 
administration, we have to look at ways to encourage that.
    I think we also have to consider the possibility, and I 
know this is not popular, but you are asking my opinion, so I 
think we are also going to have to look at seeing how we might 
be able to encourage immigration avenues to encourage people 
that want to come to the United States to go into the health 
professions.
    I am very concerned about the future of nursing home 
industries unless we get more CNAs. Projections are that the 
CNA shortage is going to go from 250,000 possibility up to 
400,000 in the near future and that's going to be a very 
serious problem for you, for me, and for America.
    Senator Murray. Well, I really appreciate the fact that you 
understand this and I want to work with you on this.
    Secretary Thompson. I really want to work with you too. It 
is an issue that is very near and dear to me.
    Senator Murray. I agree that wages, long hours is a 
contributing factor, but in talking to many of the facilities 
in my home State that train and educate, particularly women 
obviously, into these professions, there are not women 
applying, and one of the----
    Secretary Thompson. They are not, and we have to encourage 
people to do that.
    Senator Murray. And I think one way to encourage that and 
help promote that would be to extend that education work 
standard for 2 years specifically for a nursing program.
    Secretary Thompson. I would be more than happy to work with 
you on that, and I am very supportive of issues like that, and 
how we can encourage more young people to go into the nursing 
profession.

                               CHILD CARE

    Senator Murray. Very good, okay.
    Another quick question. In the President's budget he 
increases funds for child care for older children, which I am 
pleased to see, but I also notice that he cuts Federal support 
for child care for younger children by $200 million, which 
seems to go against the welfare reform standards that have been 
advocated, which require that even women with young children 
need to be in the work force earning wages. Was there a study 
that showed that there was a drop in the national needs for 
child care for younger children?
    Secretary Thompson. No, but I have to dispute your 
conclusion. I do not want to be in a position of being 
confrontational, but the baseline was $2 billion, and the 
discretionary money. We are putting in 200 million more, or a 
10 percent increase, to $2.2 billion for child care in the 
discretionary fund. And out of that discretionary fund of $2.2 
billion, the President says instead of just having a block 
grant going back to the State, he wants to earmark $400 million 
of that $2.2 billion, or the 10 percent increase plus the 
additional $200 million, to allow for children between the ages 
of 13 and 19 to be able to have after school care. He thinks it 
is a real serious problem. Instead of a cut, it is going to 
allow for 500,000 additional students to be taken care of under 
the program.
    The second thing is, there also is the mandatory side of 
child care, and that is a $150 million increase. So instead of 
a cut, there has been a $350 increase in child care, a 10 
percent, and a total of $4.9 billion totally, and that is $350 
million over what it was last fiscal year 2001.
    Senator Murray. Thank you for that, and I know my time is 
up. I do want to talk to you at some point about the SCHIP 
program.

                                 SCHIP

    Secretary Thompson. Sure, I would love to talk about it.
    Senator Murray. My question is one that is penalized for 
where we have gone with that, and I would like to talk to you 
about some flexibility in that program so my state and others 
that have been trying to do the right thing are able to fall 
into that program.
    Secretary Thompson. Your Governor, I think, has been in to 
see me on it.
    Senator Murray. Good, thank you.
    Senator Specter. Thank you, Senator Murray. Senator 
Landrieu.

                              HEALTH CARE

    Senator Landrieu. Thank you. And Mr. Chairman, this is my 
first meeting and I want to tell you how pleased I am to be on 
the committee and to serve with our ranking member and my 
wonderful friend and colleague, and Mr. Secretary, it is a 
pleasure to be with you this morning.
    Secretary Thompson. Thank you, Mrs. Landrieu.
    Senator Landrieu. Let me follow up on what Senator Murray 
was highlighting and just associate myself with her remarks, 
because the issue of health care and child health and the 
nursing shortage is on everyone's mind and really is at the 
heart of our efforts to deliver a quality health care system 
for this nation.
    Secretary Thompson. Absolutely.
    Senator Landrieu. I mean, without nurses it cannot be done, 
with all due respect to doctors and the other health 
professionals----
    Secretary Thompson. You are absolutely correct.
    Senator Landrieu [continuing]. That nurses are really the 
heart of that whole enterprise, and we have a real, I would 
almost say crisis in this Nation regarding that, and it is 
going to take a bipartisan sort of multifaceted effort to try 
to come up with some immediate solutions.
    But, I want to follow up on this additional child care 
piece that Senator Murray brought out, because I was looking at 
the numbers too, and want to work with you to increase our 
investment in child care, recognizing that the current budget 
underserves millions and millions of communities. And without 
the child care dollars, particularly for young children, but of 
course as you mentioned, there are needs for children of all 
ages after school, targeted to those communities of working 
families where both spouses are usually having to work not one 
job but two jobs, child care becomes essential to that family 
being able to work their way out of poverty, and to build the 
wealth and assets necessary to provide for their children.
    So if the Government fails to meet them halfway on this 
issue, we are really not living up to, I would say, the minimum 
that we should do. And I wanted just to point out that the way 
we have added the numbers, it does seem like there is a cut in 
this area as opposed to a real increase, because although you 
are increasing the overall number, you are earmarking a certain 
percentage for older children, and the only place it can come 
is from the younger children's discretionary portion.
    So, I do not want to argue those numbers this morning, but 
just to say that I would like to try to get some clarification 
at a later date if that is not the case, then, because it seems 
to us that that most certainly is the case.
    The second point is the area of foster care and stable 
families. I want to work with you on that.
    Secretary Thompson. So do I.

                              FOSTER CARE

    Senator Landrieu. Because as you know, governments do a lot 
of things well, but one thing we do not do very well is raise 
children, and children are best raised in families, in 
permanent stable relationships with either one responsible 
caring adult, preferably two parents, but one responsible adult 
can and in many instances do beautiful jobs. So we need to try 
to support children in the biological families to which they 
are born but if that cannot take place, to try then to find 
them a real family, not an orphanage, not an institution, not a 
group home, but a real family.
    And so I would just say that throughout the budget, I am 
going to be focused on all of the programs that encourage 
reunification where possible, but then a permanency for 
children to be placed into a family. So with your prisoners 
initiative, I just wanted to ask and make a point that we want 
to make sure some of these children can be reunited with 
parents who spent long time in prison, but if it is not 
possible for the reuniting, that we should really work to 
provide another home for children and not take that opportunity 
away from them to have a family.
    I just want to raise that and look forward to working with 
you on adoption and foster care issues particularly.
    Secretary Thompson. You have raised several things and I 
would like to respond to all of them, if I might, Senator 
Landrieu.

                            NURSING SHORTAGE

    It is really heartening for me to hear, both from you and 
Senator Murray, about your passion for increasing nursing. It 
is something, we really have a problem facing us as a country, 
and if we are going to have a quality health care, we are going 
to have to find ways to increase the number of people applying 
for nursing school. I do not know how much more I can tell you 
than I want to work with you.
    It is a very important thing for the department because 
with all the additional rules and regulations we are imposing 
upon nursing homes for more nursing care, and we do not have 
the nurses to staff it, we are going to cause severe problems 
to that industry as well as taking care of our elderly 
citizens, our mothers and our fathers, so it is a problem we 
have to take care of.

                               CHILD CARE

    In regards to the dollars, there is a block grant of $2 
billion in discretionary funds for fiscal year 2001. We put an 
additional $200 million, which is a 10 percent increase; it 
goes from $2 billion to $2.2 billion.
    Now we earmarked $400 million for after school children, 
because we found, and I found as a governor that we could not 
use this money to take care of a real serious problem. And 
those are the freshmen and sophomores, and juniors, seniors 
could care less, but they should be taken care of as well, but 
they were not as interested. But the boys and girls schools, 
the clubs, the opportunities to have athletic programs and 
educational programs after school is so important. And that's 
why the President felt that this was something really needed.
    So there is a 10 percent increase in it, but $400 million 
has been earmarked, there is no question about that, I am not 
trying to hide that. So, I mean, it is a block grant.
    Then on top of that, we added an additional $150 million on 
the mandatory side for child care. You are talking to somebody, 
you know, when I was a Governor, I went from $12 million to 
$300 million my last year for child care. And I have told this 
Senate and I have told the House many times when I was a 
governor, if you are going to have welfare reform, you have to 
take care of the children, you have to be able to have child 
care. We did not have any waiting lists when I left as governor 
in the state of Wisconsin.
    Senator Landrieu. You did an excellent job.
    Secretary Thompson. And so that is a passion of mine, and I 
want to work with you in the reauthorization of TANF on that, 
but I really think the figures speak for themselves. There is 
an increase of $350 million for child care, and there is an 
attachment, that the money goes for that, but it actually takes 
care of 500,000 additional children.

                              FOSTER CARE

    In regards to foster care and adoption, all I can say is I 
agree with you. I mean, we need to do it. But the President has 
also recognized that the fathers are very important. That is 
why we have a fatherhood initiative, and you know that. We have 
to have fathers being reintegrated back into the family, and 
that is why we put an additional, a new program, $67 million, 
for fathers to come back in, also $64 million for prisoners to 
be reintegrated. And prisoners are going to get out of jail, 
and we want them somehow to have the skills necessary to be 
reintegrated back into that family.
    And so those are two new programs that I think and hope 
that you would support.
    Senator Landrieu. Well, I know my red light is on, but let 
me just say that you have been really one of the leaders in 
this area, and I want to applaud you. If our Federal budget 
would reflect the kind of priorities and investments that you 
made as Governor, we would be a heck of a lot better off in 
this nation, so God bless you and thank you for all your good 
work.
    Secretary Thompson. Thank you, ma'am.

                             YOUTH VIOLENCE

    Senator Specter. Mr. Secretary, moving to a number of other 
subjects, this subcommittee took the lead 2 years ago in 
allocating almost a billion dollars to the subject of youth 
violence from existing programs, and we did it in not a low key 
way, but a no key way, just had working sessions with the three 
Departments for which we provide appropriations, yours, Labor, 
and Education, and also the Department of Justice was involved.
    I call this program to your attention specifically, 
although I know you're aware of it. The administration's 
funding reduced the programs which we have designated here by 
more than $250 million. I had called Miss Margaret Lamontaine, 
the domestic counselor, and I mention it at this time for the 
purpose of asking for your staff review and your review with a 
view to implementing this program. It has a lot of facets and 
what we really need to do is to see that these monies are being 
well spent in the areas to which they are directed, and we will 
be following up with you.
    Secretary Thompson. I appreciate that, Senator. As a new 
Secretary that has been here for 75 days, how can we interact 
with your office better to develop a coordinated effort in 
regards to this thing? How can we use your abilities and 
intellect in this, Senator Specter, as a prosecutor and as a 
Senator, to do something in the area of youth values and to 
make sure that the dollars are being well spent to accomplish 
what you and the other Members of Congress have rightly set up?
    Senator Specter. Mr. Secretary, I believe that we ought to 
do it at the highest level with our chiefs of staff and 
Bettilou Taylor, who is my key executive on the subcommittee, 
and who is very very experienced, and have a monitoring 
program. We have to include the domestic advisor to the 
President, Miss Lamontaine, and what I think we really ought to 
do is have the three Secretaries and Senator Harkin and myself 
sit down, and perhaps invite the Attorney General, because the 
Department of Justice is involved, and really give it that kind 
of high level treatment. Because as you well know, when youth 
violence breaks, then everybody is aghast, and we have not----
    Secretary Thompson. We have not had a coordinated effort.
    Senator Specter. There is, as I say, no publicity, it is 
very quiet, with working sessions, but the way to carry forward 
would be at the top level and devise monitoring programs with 
very high ranking people in our offices.
    Secretary Thompson. Could you call a meeting such as that?
    Senator Specter. I will. I want to work through, as I say, 
Miss Lamontaine to get the White House involved in it.
    Secretary Thompson. Fine.

                        FAITH-BASED INITIATIVES

    Senator Specter. Because there is going to have to be a 
fair amount of their oversight and supervision on it 
ultimately.
    With respect to the faith-based initiatives, Mr. Secretary, 
with some $89 million for the compassion capital fund in your 
department, $67 million for supporting children of prisoners 
and $64 million to promote responsible fatherhood, how do we 
carry these programs forward respecting the important 
separation of church and state?
    Secretary Thompson. We just have to be very diligent, we 
have to make sure that our programs are set up in such a way 
that they will not violate the Constitution, and that we have 
to monitor them on a regular basis to make sure that that 
doesn't happen. I think Head Start is a prime example. I do not 
think many people realize this, but almost two-thirds of the 
funds in Head Start go into faith based organizations, and they 
do a wonderful job and I do not think there has been any 
criticism of the Head Start program of money going into faith 
based organizations. I use that only as an example of one that 
really is working, and that is the kind of model that I think 
we should probably try to emulate.
    Senator Specter. Do you anticipate issuing any regulations 
to establish the guidelines?
    Secretary Thompson. Absolutely, sir.

                         ALTERNATIVE MEDICINES

    Senator Specter. All right. We will look forward to seeing 
those.
    On the subject of alternative medicine, that is a matter 
where Senator Harkin and I have been keenly interested and have 
had a number of hearings on over the course of the past decade. 
The funding has been increased from $7 million to about $100 
million, and I would like to call your attention this morning 
to a specific program by Dr. Herbert Benson, who is the 
president of the Mind Body Medical Institute. He has developed 
some really remarkable research on the benefits of releasing 
stress through medication and other approaches, and the impact 
on children.
    The red light is on, so I will conclude my portion now by 
just saying that I am going to be sending over some material to 
you from Dr. Benson because I think this is worthy of 
consideration at your level.
    Secretary Thompson. Fine, thank you. I will be looking 
forward to receiving it and reading it.
    Senator Specter. Good. Senator Harkin.
    Senator Harkin. Thank you, Mr. Chairman. I ask a point of 
personal privilege to ask a question that Senator Byrd wanted 
to ask, and not be deducted from my time.
    Senator Specter. Certainly.
    Senator Harkin. Senator Byrd apologizes that he could not 
be here, but he wanted me to ask this question, Mr. Secretary.
    Secretary Thompson. Yes.

                             OBESITY RATES

    Senator Harkin. Why at a time when obesity rates are 
skyrocketing to the point that two-thirds of adults and a 
quarter of children are overweight or obese, is the 
administration cutting funding to the Centers for Disease 
Control and Prevention's nutrition, physical activity and 
obesity program by 10 percent, when you should be expanding the 
program, and what specifically does the administration plan to 
do to help reduce obesity rates among adults and children?
    Secretary Thompson. I wish I had an answer to that, and I 
really do not. It is a problem facing America but it is also a 
problem facing the whole world. People down at CDC, I went down 
there to talk to them about diabetes, which is a growing 
problem, skyrocketing. And the people at CDC tell me, Senator, 
that 75 to 80 percent of the diabetic conditions can be 
challenged or changed by two things, watching our diet and 
exercising.
    And I am going to make prevention a real cause for the 
Department of Health and Human Services, and we are already 
putting in place and I hope you pass that on to Senator Byrd, 
and people tell me that diabetes impacts on the Medicare budget 
by about 4.9 percent. And I do not know if that is correct, and 
I do not know of the 75 to 80 percent, those were the figures 
given to me, I think they are both very high, but even if they 
are close, what we could do for health care, health budgets, 
and improved quality of life by doing this is something that I 
want to address.
    Now I did not get involved in the budget until very late, 
and prevention is a cause that I want to pursue, and I am not 
going to make any other apologies other than I think we have to 
address it, we have to address obesity because it is a growing 
concern in America, and I think the Department of Health should 
be the real model of trying to change that and improve it, and 
I would solicit your help and that of Senator Byrd in 
accomplishing that, and hopefully we can.
    Finally, I would like to say that the Department is going 
to do everything possible to put in an initiative, hopefully 
with the co-chairmen, Senator Specter and you, Senator Harkin, 
on this sometime this year. We have no ideas yet, but we are 
working on it, and we would like to come to you after we bring 
something together and talk to you about it.
    Senator Specter. Senator Harkin, I think Senator Byrd's 
time is up.
    Senator Harkin. I am going to take off on that now with my 
time. But Mr. Secretary, one thing I suggest, or I hope that 
you will work with us on, putting on another hat, I am also 
ranking on the Agriculture Committee of Senator Lugar.
    Secretary Thompson. Yes, sir.

                           NUTRITION PROGRAMS

    Senator Harkin. Our farm bill is up next year. One big part 
of that is the nutrition program, school lunch, school 
breakfast, all the feeding programs. And quite frankly, we have 
to do something about our school lunch programs out there. 
These kids are getting too much fat in their diets, and the 
difference between that and the school breakfast program is 
like night and day.
    Secretary Thompson. I think we need to add more milk, 
cheese, and corn.
    Senator Harkin. Skim milk, low fat cheese, and Soy, do not 
forget Soy, you have to get Soy in there, healthy for the heart 
and all that.
    Also the vending machines problems that we have in schools, 
things like that. Now that may be out of your purview, but you 
are a leader in this area, and I thought we had it fixed before 
about keeping the vending machines off until after the last 
meal is served in school, but we have to address that problem 
too, so I hope we can work with you in sort of a cross-track on 
this with the Agriculture Department on this too in the feeding 
and the food programs, but I didn't mean to go off on that.
    Secretary Thompson. No, no, I appreciate it. I think it is 
something we should do.
    Senator Harkin. We should work together on that.
    Secretary Thompson. Absolutely. I do not think there is 
enough cooperation in the Federal Government in regards to this 
thing, and I would like to see what I can do as a leader.
    Senator Harkin. That is one area where you and Ann Veneman 
could really work together on that nutrition program.
    Secretary Thompson. Appreciate that.

                            MEDICAID PROGRAM

    Senator Harkin. In 1997 Congress made changes to the 
Medicaid program allowing States to mandate that Medicaid 
beneficiaries be enrolled in managed care plans, and they 
included people with disabilities. But we also required that 
there is a basic set of protections. As a result, HCFA issued 
guidelines and the guidelines went out, they are critical, 
especially for people with disabilities, to get the quality of 
care that they deserve. These regulations lay out standards, 
continuity of care, all that kind of stuff. In February, the 
administration announced the delay of this regulation.
    I know it was caught up in all these things they delayed. I 
do not know about the other ones, but on this one I think it is 
unwarranted. President Bush has called for a patient's bill of 
rights for those who have private health insurance. How about 
the Medicaid people that are being put into the managed care 
plans, especially those people with disabilities, and I just 
hope that you will push to get this regulation out and get the 
delay off. I think it was just caught up in all those, but I am 
asking you to look at it.
    Secretary Thompson. I appreciate that, and I will. I will 
look at it before the end of the week and get back to you, 
Senator.
    Senator Harkin. I would really appreciate that very much.
    Lastly, on restraints. We have all these studies that show 
that a lot of adults and children with disabilities have died 
as a result of restraints, there have been lots of stories on 
it. We just had recently two deaths in Iowa of young people 
being restrained, and these are now being investigated of 
course, but there are some regulations, again regulations that 
were supposed to have come out, to provide guidelines for the 
appropriate use of restraints in Medicaid funded facilities. 
They were supposed to be effective by March 23, and they are 
not there yet. The regulations were going to prevent the types 
of deaths that I just described, the two that just happened in 
Iowa.
    The GAO in September 1999 reported on restraint and 
seclusion and found conclusively that children are especially 
vulnerable to this unsafe practice. What is done, it is being 
used a lot of times just as a means of the caretakers in those 
facilities, if some kids act up and they do not have time to 
take care of it, put them in restraints, and it is used as 
punishment a lot of times too, and those regulations would 
address that.
    And again, second, I hope you take a look at it and see why 
they are not getting out there.
    Secretary Thompson. You know, there was an order put out 
that all these rules and regulations were going to be delayed 
for 60 days and the one on Medicaid is all wrapped up in the 
60-day review period, Senator.
    Senator Harkin. Have all these people that work for you 
take a look at them.
    Secretary Thompson. I will, thank you.
    Senator Harkin. Thank you, Mr. Secretary.

                            FAMILY PLANNING

    Senator Specter. Mr. Secretary, one final subject, and that 
is the issue of family planning, birth control, and abstinence 
only education. This subcommittee has taken the lead in 
appropriating funds in the past for abstinence only education. 
The controversy exists that to talk about abstinence only is 
unrealistic, because facts of life being what they are, unless 
birth control devices are provided simultaneously, that the 
abstinence education will not work.
    My own view has been that there is room in our budget, room 
in our society, for both efforts, family planning with their 
approach, which may include birth control as they protect their 
programs, but separate programs for abstinence only education, 
where a large part of our society which feels so strongly that 
birth control ought not be made available, and ought to have an 
opportunity with abstinence only education to see if that will 
provide an answer.
    Obviously, this is one of the most contentious issues 
facing our society with all the ramifications that come from 
these issues, and I would be interested, the subcommittee would 
be interested, to know what the administrations plans and your 
Departments' plans are on family planning and abstinence only 
education.
    Secretary Thompson. The President has taken a very strong 
position that they should be treated equally, and currently 
there is an underfunding on the abstinence side, about $93 
million compared to $135 million on the birth control side. And 
there is a movement afoot to evaluate our programs to try and 
make them equal, and this is something that the President feels 
very strong about, Senator, and we are working on that.
    Senator Specter. Mr. Secretary, that is a fair amount of 
ground, that cannot be comprehensive. And I was just about to 
sound the gavel until our very distinguished colleague, Senator 
Herb Kohl arrived.
    Secretary Thompson. You can never sound the gavel when the 
distinguished Senator from Wisconsin is here, plus the fact 
that his Bucks are doing a great job in the championship, and 
we are pulling for them, and I hope the people in Iowa and 
Pennsylvania are as well.
    Senator Specter. I see the ruling of the Chair has been 
challenged?
    And the ruling of the Chair has been defeated, so we will 
hear from you, Senator, as we always do.
    Senator Kohl. What do you want?
    Thank you very much, Senator Specter.
    Senator Specter. Senator Kohl and I have worked together 
very closely, most noteworthy on the Ruby Ridge hearings, and I 
have been trying to get him to autograph my copy for 5 years. 
That is what I want.
    Senator Kohl. Done.
    Well, it is good to see you.
    Secretary Thompson. Good seeing you, my friend.
    Senator Kohl. Mr. Secretary, Governor.
    Secretary Thompson. Thank you.

                          CHILD SUPPORT REFORM

    Senator Kohl. Mr. Secretary, you visited my office before 
your confirmation hearing and we talked about our shared 
interest in reforming the child support distribution system.
    Secretary Thompson. Right.
    Senator Kohl. At that time you were just beginning your 
current job, but now that you have had a few months and a 
budget under your belt, I would like to discuss it just a 
little bit further. As you know, under current law, a lot of 
child support money never actually reaches the child. Instead, 
the state and Federal Governments keep it as reimbursement for 
their expenses. In Wisconsin, thanks to your leadership, Mr. 
Secretary, our State----
    Secretary Thompson. And your support, Senator.
    Senator Kohl. That is right. We have a successful waiver 
program to send more child support money directly to families. 
I have introduced legislation to give all states the option to 
follow Wisconsin's example. The bill is included in the 
bipartisan Strengthening Working Families Act, which includes 
several other administration supported initiatives to help 
families succeed.
    Given your long history on this issue and the bipartisan 
support that we have had, can you tell us if the administration 
will support this initiative?
    Secretary Thompson. I know I do. I have not talked to the 
President about it, I am confident that he will, and if you 
want me to find out how the administration feels, I will be 
more than happy to, but I strongly support it because it is the 
right thing to do.
    We pioneered that in Wisconsin, and the beauty of it is it 
gets more money to the mother and to the children and it just 
makes, you know, common sense. And so I am, I cannot say 100 
percent that the administration is in favor of it, but I am, 
and I will do everything I possibly can to convince them if 
they are not, but I would dare to say if we can get your bill 
introduced, you are going to find this administration fully 
behind you support of it, Senator, and I hope that you push it 
hard and I would love to be able to be called to testify on it 
if and when there is a hearing on it.
    Senator Kohl. Thank you, that is very encouraging.
    Secretary Thompson. And I also want to thank you again for 
the great job you are doing with the Bucks. It is great.

                        NURSING HOME INITIATIVE

    Senator Kohl. Thank you very much, Mr. Secretary. I would 
like to ask a question on nursing home enforcement. I have been 
fighting for several years to increase funding for nursing home 
inspections. Although most nursing homes do a good job, we 
still have way too many nursing homes with serious problems, 
including malnutrition, dehydration and bed sores.
    In response to these problems, the Clinton administration 
launched a nursing home initiative which has had bipartisan 
support. This included mandates on State inspecters to make 
their inspections less predictable, to respond more quickly to 
complaints, and to refer deficiencies for immediate sanctions.
    The Federal Government is the primary source of funding to 
the states to carry out these duties. Unfortunately, the 
President's budget flat lines this funding. If we know that 
substandard care is a serious problem in our country and if we 
are all serious about improving care, and I am sure you are, 
then we really have to invest in the inspection process. We 
have to give states the money they need to protect their 
residents. How do you expect States to carry out these critical 
duties if we do not have an increase in funding? In other 
words, as you well know, the inspections often times get 
nursing homes to do a better job, and if we do not increase our 
ability to do inspections, how can we expect nursing homes to 
do a better job?
    Secretary Thompson. We are reviewing all those rules and 
regulations, Senator. I have no definite answer for you at this 
point in time. I think that sometimes we waste money and time 
continuing to inspect the good homes, and should be spending 
more time on the ones that have had violations in the past, got 
complaints, and so on and so forth, and accentuate the surveys 
and inspections there, and also do them at different time 
intervals so that nobody knows that they are coming, and see if 
in fact we can improve the quality of nursing care for our 
senior citizens all over.
    And so, we are looking at that, and that is the best answer 
I have for you at this point in time, but I will be more than 
happy to sit down with you in the future to discuss it in 
further detail.
    Senator Kohl. Okay. Again, I would just make the comment 
which, I would like to hope you would at least partially agree 
with, that to the extent that we inspect, we can expect to have 
some improvement; to the extent that we inspect less, we are in 
greater peril. And as I said, the money for the inspections 
comes from us here in Washington, so I think it is something 
that deserves attention.
    Secretary Thompson. Okay.
    Senator Kohl. Last question. As you know, Mr. Secretary, 
for the past 7 years, Wisconsin's nursing homes have been using 
trained single task workers to help feed residents during busy 
mealtime hours. This frees up more time for other nurse aides 
to provide other critical services. Unfortunately, last year 
HCFA informed Wisconsin that this practice does not comply with 
federal law. I am concerned that the immediate removal of all 
single task workers would only worsen the staffing shortages 
that our nursing homes are already facing.
    I have introduced legislation to allow Wisconsin to 
continue using single task workers as part of an eight-state 
demonstration project. These workers would have to be trained 
and supervised at all times, and a thorough evaluation of the 
project would be done to determine their impact on quality of 
care.
    Would the administration support this kind of demonstration 
project, Mr. Secretary?
    Secretary Thompson. Without a doubt, yes, and 
enthusiastically, I might add, and it is a problem, and I think 
the rules that were interpreted, the law needs to be changed, 
so that HCFA can make the right interpretation. And I will be 
very supportive of it. I know exactly what you are talking 
about. It is causing a problem not only in Wisconsin, but 
nursing homes, especially in the midwest and I presume across 
America, and it is something that needs to be changed, the law 
needs to be changed, and let us push forward with it as fast as 
we possibly can.
    Senator Kohl. Well, I thank you, that is great to hear, and 
you are a great guy and I have always felt that way, and since 
you have been here in Washington, I increasingly feel that way 
and I look forward to working with you.
    Secretary Thompson. My privilege, sir, and thank you very 
much for your kind words, and I feel the same about you.
    Senator Kohl. Thank you, Mr. Secretary.
    Senator Specter. Mr. Secretary, I have been involved in a 
few of these hearings, none has surpassed all of the 
complimentary comments about you. You got a lot of praise and a 
very high standard to live up to.
    Secretary Thompson. I certainly do.

                     Additional committee questions

    Senator Specter. And I join all of the complimenters in 
saying that we are confident that you will do it.
    Secretary Thompson. Thank you very much, Senator.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]

              Question Submitted by Senator Arlen Specter

                        faith-based initiatives
    Question. President Bush's Faith-Based plan created five faith-
based centers. One of the centers in located in HHS. What will be the 
role of the center? How will this center be funded? How will this 
center interact with the White House Office of Faith Based Programs?
    Answer. Established by Executive Order on January 29th, 2001, the 
Center for Faith-Based and Community Initiatives within the Department 
of Health and Human Services will coordinate departmental efforts to 
eliminate regulatory, contracting, and other programmatic obstacles to 
the participation of faith-based and other community organizations in 
the provision of social services. To maintain coordination with the 
White House Office of Faith Based and Community Initiatives (OFBCI), 
HHS has designated a Center employee to serve as the liaison and point 
of contact with the White House OFBCI, cooperate with the White House 
OFBCI, and provide such information, support, and assistance to the 
White House OFBCI as it may request, to the extent permitted by law.
    The President's budget includes $3 million within the 
Administration for Children and Families to fund the Center for Faith-
Based and Community Initiatives in 2002.
    Question. President Bush's Faith-Based initiative calls for the 
expansion of Charitable Choice. What areas of Health and Human Services 
would benefit from this proposed action?
    Answer. Beginning in 2001, the HHS Center for Faith-Based and 
Community Initiatives will (a) conduct a comprehensive review of 
policies and practices affecting existing funding streams governed by 
so-called ``Charitable Choice'' legislation to assess the department's 
compliance with the requirements of Charitable Choice; and (b) promote 
and ensure compliance with existing Charitable Choice legislation by 
the department, as well as its partners in State and local government, 
and their contractors.
    Question. How will this expansion comport with the Constitutions 
Establishment clause?
    Answer. Charitable choice is often portrayed as a source of new 
federal financial assistance made available to--indeed earmarked for--
religious charities. It is not. Rather, charitable choice is a set of 
grant rules altering the terms by which federal funds are disbursed 
under existing programs of aid. As such, charitable choice interweaves 
three fundamental principles, and each principle receives prominence in 
the legislation.
    First, charitable choice imposes on both government and 
participating FBOs the duty to not abridge certain enumerated rights of 
the ultimate beneficiaries of these welfare programs. The statute 
rightly protects these individuals from religious discrimination by 
FBOs, as well as from compulsion to engage in sectarian practices 
against their will.
    Second, the statute imposes on government the duty to not intrude 
into the institutional autonomy of faith-based providers. Charitable 
choice extends a guarantee to each participating faith-based 
organization [FBO] that, notwithstanding the receipt of federal grant 
monies, the organization ``shall retain its independence from Federal, 
State, and local governments, including such organization's control 
over the definition, development, practice, and expression of its 
religious beliefs.'' In addition to this broadly worded safeguard, 
there are more focused prohibitions on specific types of governmental 
interference such as demands to strip religious symbols from the walls 
of FBOs and directives to remake the governing boards of these 
providers. A private right of action gives ready means of enforcement 
to these protections of institutional autonomy.
    Third, the statute reinforces the government's duty to not 
discriminate with respect to religion when determining the eligibility 
of private-sector providers to deliver social services. In the past, an 
organization's ``religiosity,'' obviously a matter of degree not 
reducible to bright-lines, was said to disqualify providers found to be 
``pervasively sectarian.'' That inquiry was always fraught with 
difficulties. Now, rather than probing into whether a service provider 
is thought to be ``too religious'' as opposed to ``secular enough,'' 
charitable choice focuses on the nature of the desired services and the 
means by which they are to be provided. Accordingly, the relevant 
question is no longer ``Who are you?'' but ``What can you do?'' So long 
as a provider is prepared to operate in line with all statutory and 
constitutional parameters, then an organization's degree of 
``religiosity'' is no longer relevant.
    When discussing Establishment Clause restraints on a government's 
program of aid, a rule of equal-treatment or nondiscrimination among 
providers, be they secular or religious, is termed ``neutrality'' or 
the ``neutrality principle.'' Charitable choice is consistent with 
neutrality, but courts need not wholly embrace the neutrality principle 
to sustain the constitutionality of charitable choice.
    The U.S. Supreme Court distinguishes, as a threshold matter, 
between direct and indirect aid. For any given program, charitable 
choice allows, at the government's option, for direct or indirect forms 
of funding, or both. Indirect aid is where the ultimate beneficiary is 
given a coupon, or other means of free agency, such that he or she has 
the power to select from among qualified providers at which the coupon 
may be ``redeemed'' and the services rendered. In a series of cases, 
and in more recent commentary contrasting indirect aid with direct-aid 
cases, the Supreme Court has consistently upheld the constitutionality 
of mechanisms providing for indirect means of aid distributed without 
regard to religion. The Child Care and Development Block Grant Program 
of 1990, for example, has been providing low income parents indirect 
aid for child care via ``certificates'' redeemable at, inter alia, 
churches and other FBOs. The act has never been so much as even 
challenged in the courts as unconstitutional.
    In the context of direct aid, the Supreme Court decision that has 
most recently addressed the neutrality principle is Mitchell v. Helms. 
The four-Justice plurality, written by Justice Thomas, and joined by 
the Chief Justice, and Justices Scalia and Kennedy, embraced, without 
reservation, the neutrality principle. In the sense of positive law, 
however, Justice O'Connor's opinion concurring in the judgment is 
controlling in the lower courts and on legislative bodies.
    Before proceeding in greater detail, the controlling principle 
coming from Mitchell v. Helms can be briefly stated: A government 
program of aid that directly assists the delivery of social services at 
a faith-based provider, one selected by the government without regard 
to religion, is constitutional, but real and meaningful controls must 
be built into the program so that the aid is not diverted and spent on 
religious indoctrination.
    Based on Justice O'Connor's opinion, when combined with the four 
Justices comprising the plurality, it can be said that: (1) neutral, 
indirect aid to a religious organization does not violate the 
Establishment Clause; and (2) neutral, direct aid to a religious 
organization does not, without more, violate the Establishment Clause.
    Question. The President's budget shows new faith-based budget items 
under Health and Human Services and proposes the expansion of others. 
Please share with the subcommittee the details of the following policy 
items:
  --Compassion Capital Fund
  --Supporting Children of Prisoners
  --Promoting Responsible Fatherhood
    Will these programs need new authorization? If not, what is the 
existing authorization?
    Answer. The new proposed discretionary initiatives represent a new 
Federal commitment in providing social services to those in need. 
Through these initiatives, the Administration wants to spur new 
community-level approaches to working with low-income families. The 
Administration will look to all successful sources of support for those 
in need--faith-based organizations, charities, and community groups. 
These groups do not replace Government, but partner with it.
    The Compassion Capital Fund will provide start-up capital and 
operating funds to qualified charitable organizations that wish to 
expand or emulate model social service programs. The program will also 
promote research on ``best practices'' among charitable organizations. 
Another new program, Mentoring Children of Prisoners, will help 
children through the time their parents are imprisoned, including 
efforts to keep children connected to a parent in prison, and increase 
the chances that the family can come together successfully when the 
parent is released. The President also proposes a program to Promote 
Responsible Fatherhood. To strengthen the role of fathers in the lives 
of families, this initiative will provide competitive grants to faith-
based and community organizations that help unemployed or low-income 
fathers and their families avoid or leave cash welfare, as well as to 
programs that promote successful parenting and strengthen marriage.
    The President's fiscal year 2002 budget proposes to fund both the 
Compassion Capital Fund and the Mentoring Children of Prisoners program 
under existing authority within the Administration for Children and 
Families. The Administration is proposing new legislation for the 
Responsible Fatherhood Initiative, and looks forward to working with 
the Congress on how to best structure this new program.

                        COMMUNITY HEALTH CENTERS
    Question. You propose an increase of $124 million for community 
health centers. This is less than the increase Congress provided last 
year, yet the budget justification says that this is the first step in 
a multi-year strategy that will eventually double the number of 
patients seen at community health centers. Could you explain your 
strategy?
    Answer. The President's fiscal year 2002 budget for HRSA includes 
nearly $1.3 billion for Health Centers program, an increase of $124 
million above the fiscal year 2001 appropriation. These additional 
funds in fiscal year 2002 will allow Health Centers to create 200 new 
and expanded access points and serve up to 1 million additional 
patients, almost half of them uninsured. The added funds represent the 
first installment of the Administration's multi-year initiative, which 
will eventually increase or expand health center access points by 1,200 
over five years and eventually double the number of people served.

                          RYAN WHITE PROGRAMS
    Question. Why are there no increases for the Ryan White programs, 
not even for inflation?
    Answer. The President's fiscal year 2002 budget includes over $1.8 
billion for Ryan White activities, the same level as fiscal year 2001. 
Ryan White activities have increased by over 81 percent, or $812 
million, in the last 5 years. By maintaining funding at this level, 
grantees will be able to manage these significant increases and address 
the changes included in the reauthorization of the Ryan White CARE Act.

                               HEAD START
    Question. The President's budget increases for Head Start is $125 
million--an increase that only accounts for inflation. Last year's 
budget increase allowed Head Start to serve 60,000 additional children. 
This year's budget will not allow any additional children to receive 
Head Start services. Can you explain the rational for this budget?
    Answer. The President's budget provides $6.3 billion for Head Start 
in fiscal year 2002, $125 million increase above the fiscal year 2001 
funding level. This funding level will serve 916,000 children, the same 
number that was served in fiscal year 2001. The program has received 
significant funding increases in the past few years and has undergone 
considerable expansion. In fiscal year 2002 we will work to ensure that 
the program has the opportunity to absorb this dramatic growth while 
focusing on strengthening pre-literacy and reading skills of the 
children.
    Question. With the Head Start increase only accounting for 
inflation, can you tell us how many eligible children will not be 
served in fiscal year 1902?
    Answer. In 2002, Head Start will provide preschool services to 
916,000 children (including 55,000 children in Early Head Start), or 
approximately 60 percent of the eligible population of 1.425 million 3- 
and 4-year old children nationwide.

                 CHILD CARE AND DEVELOPMENT BLOCK GRANT
    Question. You have set-aside $400 million for use by the States to 
provide certificates for low-income parents to help defray the costs of 
after-school programs with an educational focus. With only a $200 
million increase in the child care block grant, isn't this an effective 
cut of $200 million in the block grant? Can you explain how this 
program differs from the Department of Education's 21st Century 
Learning Centers.
    Answer. The President's budget supports child care services for 2.6 
million children. This includes child care services for approximately 
2.1 million children--the same number supported in 2001--and 
certificates for up to 500,000 additional children to help parents 
defray the costs of after school child care programs which have a high-
quality educational focus. The certificates will be available for 
children who are less than 19 years of age.
    The block grant is only one portion of the total funds for the 
Child Care Development Fund. The fiscal year 2002 ACF budget includes 
$4.917 billion in Federal resources for the child care services. This 
funding represents a $350 million increase to the fiscal year 2001 
level of $4.567 billion.
    The After School Child Care Certificate set-aside is designed to 
help pay the costs of high-quality after school child care by putting 
money in the hands of parents who need it. As we understand it, the 
21st Century Learning Center program provides funds to support after 
school programs at schools. The After School Child Care Certificate 
set-aside is directed to assist parents in paying for after school 
care, whether in a school or other settings.

                             YOUTH VIOLENCE
    Question. In January the Surgeon General issued a report on youth 
violence which this subcommittee funded. The report was basically a 
review of existing literature and contained no new research. I continue 
to be concerned with the troubling outbreaks of violence by our 
teenagers. Do you plan to conduct new research to help us understand 
the causes of violent behaviors and ways to prevent and treat it?
    Answer. The National Institute for Child and Human Development 
(NICHD) will support research to understand how interactions between 
the brain, hormones, and environmental stimuli lead to changes in teen 
behavior, including youth violence. Researchers will also examine how 
these processes interact with external factors as peers, family and the 
community.
    The National Institute of Mental Health (NIMH) has learned that 
prevention programs must target multiple risk factors for youth 
violence, for example, poor adult supervision, associations with 
deviant peers, lower verbal intelligence, family conflict, impulsive 
behavior, depression, social isolation, school failure, and substance 
abuse. NIMH will continue and expand etiological and risk factor 
studies and will expand research on youth violence interventions.
    Question. Does the Administration have plans to address the role of 
media in contributing to youth violence?
    Answer. From a public health perspective, the Surgeon General's 
Report on youth violence noted that the role of the media in 
contributing to youth violence is largely uncharted territory. Few 
preventive efforts have been studied systematically. Furthermore, not 
enough research has been done to form a basis for the design of many 
experimental interventions. Although many violence prevention programs 
address a complex array of risk and protective factors in the lives of 
young people, they have not yet addressed the role of the media.
    Question. Mr. Secretary, given the unacceptably high rate of youth 
violence in the United States and the reductions proposed in the 
budget, how will the HHS fiscal year 2002 budget request support 
programs that address youth violence?
    Answer. The fiscal year 2002 request for HHS Youth Violence 
activities totals $103 million. Of this amount $90 million is for the 
Substance Abuse and Mental Health Services Administration (SAMHSA). 
With these funds SAMHSA will provide grants to schools and community 
organizations with the goal of building coalitions, establishing 
prevention programs, and developing curriculum. Also included in the 
fiscal year 2002 request is $11.6 million for the Centers for Disease 
Control (CDC). This funding will allow CDC to develop and implement 
multi-disciplinary research, develop and evaluate collaborative 
prevention interventions, and develop a training curriculum. Funding in 
the amount of $1 million for the Office of Minority Health will be used 
to expand the Family and Community Violence Prevention Program and 
$400,000 for the Office of Surgeon General will fund a series of 
community listening sessions on topics highlighted in the Surgeon 
General's Report.
                                 ______
                                 

               Question Submitted by Senator Ted Stevens

        special health needs of children with mental retardation
    Question. On March 5, 2001, at the hearing in Anchorage, the 
Special Olympics officially released the special report on The Health 
Status and Needs of Persons with Mental Retardation. Specifically, the 
Health Report found that (1) Although persons with mental retardation 
need health and health financing programs that are responsive to their 
particular needs, too often they are forced into general programs that 
actually can compromise their health. People with mental retardation 
may not be receiving health services because they are under-insured; 
(2) The majority of health professional who are otherwise qualified to 
treat persons with mental retardation fail to do so. This is largely 
the result of a lack of appropriate, specific training, inadequate 
reimbursement policies, fear, and prejudice; (3) Existing federal, 
state and voluntary programs to meet the health needs of persons with 
mental retardation are inadequate.
    Mr. Secretary, what role can you play in training health 
professionals to address the needs of person with mental retardation?
    The report states that the health care system in this nation 
provides financial disincentives for physicians and other health care 
providers to work with patients with mental retardation. What can be 
done to rectify this situation?
    Answer. People with special health care needs have been of 
particular concern to the Department for decades. Within HRSA's 
Maternal and Child Health Bureau, our concern with mental retardation 
has been a heightened priority for 50 years. Currently, the MCH 
Leadership Education in Neurodevelopmental and Related Disabilities 
(LEND) program improves the health and quality of life of children who 
have, or who are at risk for developing neurodevelopmental or related 
disabilities by preparing trainees from a wide variety of professional 
disciplines to assume leadership roles to ensure high levels of 
clinical competence. By providing interdisciplinary long-term training, 
by developing exemplary clinical service models, and by reaching out to 
the community through consultation, technical assistance, and 
continuing education, the LEND program has made and will continue to 
make significant strides towards developing comprehensive, coordinated 
services for infants and children with the potential to have, or having 
developmental disabilities and for their families. For fiscal year 
2001, MCHB is providing $18.3 million through 35 grants in support of 
the LEND program.
    In addition, the Administration on Developmental Disabilities, ACF, 
administers a national network of University Centers for Excellence in 
Developmental Disabilities Education, Research, and Service (formerly 
known as University Affiliated Programs). There are 61 Centers that 
receive 5-year grant awards, for fiscal year 2001 the level of funding 
for each Center is $347,000. These Centers provide for 
interdisciplinary training, community services, research and technical 
assistance and information/dissemination activities. The University 
Centers are affiliated with medical schools, health care centers and 
hospitals. They are committed in furthering the health care needs of 
this population. For example, University Centers must now report on the 
progress they have made on increasing the number of health care 
providers trained to meet the needs of people with developmental 
disabilities as a result of program intervention. The interdisciplinary 
training programs cover such areas as: medicine, nursing, nutrition, 
physical therapy, speech pathology, social work, audiology, bio-
statistics, psychology and education. They also provide community 
services on behalf of persons with developmental disabilities, 
including individual assessments through clinical service programs and 
physician referral programs.
                                 ______
                                 

               Questions Submitted by Senator Tom Harkin

                     federal mental health funding
    Question. Secretary Thompson, President Bush has expressed his 
interest in increasing Federal support for people with disabilities, 
including those with mental illness, with the announcement earlier this 
year of his New Freedom Initiative. How do you reconcile those 
expressed good intentions with a budget proposal that level-funds and 
even cuts Federal mental health funding?
    Answer. The Department of Health and Human Services is just one of 
several agencies participating in the New Freedom Initiative, which 
will help increase access for and integrate individuals with 
disabilities into the community through assistive technologies, 
expanded educational opportunities, greater opportunities to enter the 
workforce, increased access to community-based care and housing, and 
other strategies. Increasing support for mental health services by 
leveraging federal mental health dollars through better coordination is 
one of many components of this initiative.
    Other investments in HHS are also furthering the goals of the New 
Freedom Initiative. For example, the fiscal year 2002 budget for the 
Office for Civil Rights (OCR) will support an increase in its efforts 
to work cooperatively with states to implement the Supreme Court's 
Olmstead decision. OCR, the Health Care Financing Administration 
(HCFA), the Administration on Aging, the Assistant Secretary for 
Planning and Evaluation, the Substance Abuse and Mental Health Services 
Administration, the Administration for Developmental Disabilities and 
other components within HHS are working together with states to help 
them ensure that individuals with disabilities, including persons with 
mental disabilities, are provided with services in the most integrated 
setting appropriate to their needs. As states implement plans to 
provide such services, they will be offering individuals with 
disabilities more opportunities to move from institutional settings to 
community-based options when community-based care is appropriate.
    We are also encouraging States to consider special initiatives for 
persons with mental illness as they take full advantage of some of the 
new opportunities from HCFA. These include the grants and the Medicaid 
Buy-In newly available under the Ticket to Work legislation. They also 
include the $70 million new ``Systems Change'' grants announced on May 
18, 2001 that Senators Harkin and Specter were instrumental in 
crafting.
    As you know, Medicaid is one of the most important programs for 
people with a mental illness. As an entitlement program, Medicaid 
continues to expand as more people need assistance. We look forward to 
working with you and focusing the attention of the President's National 
Commission on Mental Health to determine if there are additional things 
we could do to make Medicaid even more responsive to people with mental 
illnesses.
    The Substance Abuse and Mental Health Services Administration 
budget includes $766 million for mental health services, a reduction of 
$16 million primarily for one-time projects which will end in fiscal 
year 2001. Even with this reduction, the Programs of Regional and 
National Significance will have $39 million available for ``new 
activities'' as other projects conclude in fiscal year 2001. In 
addition, two-thirds of the individuals with substance use problems 
also have a mental illness and many of these individuals will benefit 
from the President's budget request for an additional $100 million to 
support a Drug Treatment initiative.
                   center for mental health services
    Question. The $16 million cut in funding for the Center for Mental 
Health Services would significantly impact the agency's Best Practices 
or Knowledge, Development, and Application activities. Could you 
discuss how the Administration is proposing to address the need to 
disseminate research findings on best practices in mental health 
service delivery to practitioners and providers in the field so that 
the federal dollars devoted to this very important research are not 
squandered?
    Answer. The President's budget includes $55 million in the Center 
for Mental Health Services to support Best Practices or Knowledge, 
Development, and Application activities. Within this amount, SAMHSA 
will have $39 million to award in new and competing grants and 
contracts for Programs of Regional and National Significance for mental 
health best practices in fiscal year 2002. The Center for Mental Health 
Services has a strong commitment to disseminating to state and local 
communities, providers, consumers and other key stakeholders findings 
from the evaluation of its knowledge development programs. The Center 
is also dedicated to encouraging the adoption of those practices that 
will benefit persons with serious mental and emotional health and 
substance abuse problems. To achieve this mission, the Center has 
funded several grant programs and contracts that use health 
communication and other social marketing strategies that increase 
awareness of evidence-based practices and encourage the incorporation 
of these practices into everyday service delivery. Specific activities 
include national training conferences, workshops, reports, technical 
assistance meetings, toolkits, mentorship programs, policy and 
leadership academies and the use of advanced computer technology for 
dissemination and education.
              president's fiscal year 2002 budget proposal
    Question. The Community Access Program would be eliminated under 
the President's budget. This program was designed to link uninsured and 
low-income individuals with health care services in their communities, 
including mental health services. The budget summary document points to 
increases in funding for community health centers (CHCs) as a more 
efficient approach to the problem of the low-income and uninsured not 
receiving services for which they are eligible. However, the budget 
dedicates this increased funding for CHCs to increasing the number of 
facilities in existence, with a goal of 1,200 new centers. How much of 
this funding increase will actually be used to address the 
fragmentation of public health services for the uninsured and under 
insured and to help providers link their uninsured patients with the 
services they need. Through the Community Access Program, 76 
communities received assistance with improving coordination of care for 
the uninsured and under insured. How many communities will receive this 
kind of assistance under the President's proposal?
    Answer. The Administration is committed to identifying programs 
that are carefully designed and proven to bring more Americans who may 
not have good access to care into the health care safety net. HHS will 
focus on the President's commitment to expand direct health care 
services to the uninsured through Community Health Centers (CHC), to 
which we are adding $124 million, for a total request of approximately 
$1.3 billion. This multi- year Presidential Initiative will increase or 
expand Community Health Center and Migrant access points by 1,200 over 
5 years and eventually double the number of people served. By targeting 
our resources to expand CHCs, millions more Americans will have access 
to high quality health care.
    The CAP program was created to provide short term assistance to 
local communities in order to transition to innovative service delivery 
approaches in order to ultimately be competitive within their own 
markets. Grantees were required to demonstrate that they were able to 
sustain the delivery of services and funding through other public and 
private sources on a longer term basis. There are existing funding 
resources that would enable communities to achieve similar goals as 
CAP. For example, CHC funding already supports the Integrated Service 
Delivery Initiative, which provides funding to CHCs to support their 
efforts to integrate functions with other centers and safety net 
providers in their community. The budget also includes $15 million to 
support grants to States to develop designs for providing access to 
health insurance coverage to all citizens of the State.
                     national health service corps
    Question. The Administration has proposed no funding increases for 
the National Health Service Corps (NHSC), citing that there is no 
longer a physician shortage. Instead, the proposal is for target 
reforms to better address the mail distribution and to increase 
available funds by eliminating the tax on scholarships and loan 
repayments. Eliminating the taxation and working on better distribution 
is all well and good, but the Administration appears to have overlooked 
the fact that the Corps provides funds for nurse practitioners, 
physicians assistants, dentists, psychologists and other mental health 
provider. The nation, especially Iowa and the other rural states 
continue to experience shortages of all of these providers. In Iowa, 
there remains a shortage of all of these providers. For example, the 
Corps is only able to meet less than 7 percent of the dental and mental 
health care needs in Iowa. Furthermore, the nurses in Iowa are going 
out into the communities to deliver primary care, but we need more of 
them.
    How can the Administration rationalize not proposing a substantial 
increase in funding for the National Health Service Corps by citing the 
lack of a physician workforce? How are the Administration's reforms 
going to meet the needs of the uninsured and most vulnerable Americans?
    Answer. The National Health Service Corp Presidential Management 
Reform Initiative will improve the NHSC's service to America's neediest 
communities. The initiative will examine several issues, including the 
ratio of scholarships to loan repayments and other set-asides, and will 
consider amending the Health Professional Shortage Area definition to 
include non-physician providers and J-1 and H-1C visa providers 
practicing in communities. These efforts will enable the NHSC to more 
accurately define shortage areas and target placements to areas of 
greatest need. The NHSC reform initiative will also encourage more 
primary health care professionals to participate in the NHSC by making 
scholarship funds tax free.
    The President's budget includes a request of $126 million, in 
increase of $1.05 million over fiscal year 2001. These funds support 
NHSC clinicians serving communities, as well as outreach and 
development efforts in these communities. The funds will also provide 
for recruitment efforts: 265 Federal Scholarships, 286 Federal Loan 
Repayment agreements, 350 Federal Loan Repayment extensions, and 217 
State Loan Repayment agreements. Since the program's inception, more 
than 22,000 clinicians have been providing services to millions of 
people in underserved areas. Currently, there are nearly 2,400 NHSC 
clinicians practicing in Health Professional Shortage Areas.
                        community health centers
    Question. On April 12, 2000, Governor Bush toured the Grace Hill 
Community Health Center in St. Louis. He used that occasion to propose 
increasing the number of new community and migrant health centers by 
1,200 over 5 years in an effort to double the number of people served 
by these centers. The administration budget proposal, however, calls 
for 1,200 new ``and expanded'' centers and there is no longer a mention 
of doubling the number of people served. Moreover, the proposed 
increase of $125 million for fiscal year 2002 falls well short of the 
mark needed to increase funding by $3.6 billion over 5 years.
    Is the Administration still committed to caring for the uninsured 
and most vulnerable Americans? How is the Administration proposing to 
reach its budget goal of $3.6 billion over 5 years?
    Answer. The President's fiscal year 2002 budget for HRSA includes 
nearly $1.3 billion for the Health Centers program, an increase of $124 
million above the fiscal year 2001 appropriation. These additional 
funds will allow Health Centers to create 200 new and expanded access 
points and serve up to 1 million additional patients, almost half of 
them uninsured. The added funds represent the first installment of the 
Administration's multi-year initiative, which will eventually increase 
or expand health center access points by 1,200 over five years and 
eventually double the number of people served.
    The Administration has also proposed a refundable tax credit to 
make health insurance more affordable for individuals and families not 
covered by an employer plan nor eligible for public programs.
    Finally, the Administration is developing ideas to improve the 
insurance options available to lower-income individuals. We are working 
with States to more efficiently utilize Medicaid and SCHIP funding to 
increase the number of individuals with access to affordable insurance, 
encouraging the availability of private group health plan insurance 
coverage where possible.
                   real choice systems change grants
    Question. Last year, the Appropriations bill included $50 million 
for Real Choice Systems Change Grants. These grants had originally been 
included in MiCASSA (Medicaid Community Attendant Services and Supports 
Act) to help states reform their long term care systems to allow people 
with disabilities to live in their own homes and communities. In 
addition, another $20 million for demonstration projects to achieve 
this same goal.
    HCFA announced the Real Choice funds should be used to develop 
public-private partnerships to increase services and supports to people 
with disabilities. Will HCFA ensure that people with disabilities, 
their representatives and their families are members of the grant-
funded state task forces? Answer. We have tried to be very clear that 
Congress expressed its intent for States to develop their proposals 
jointly with a consumer task force of broad representation. We will 
honor that intent, while simultaneously affording states with 
sufficient flexibility in the methods of involvement that they can get 
the job done. For example, some states have asked if their existing 
ADA/Olmstead planning committee could be used. Where such committees 
include broad-based consumer representation, we have answered 
affirmatively. HCFA also made the involvement of consumers an important 
aspect of its review criteria for the grants. Finally, we made $50,000 
``Starter Grants'' available to states in February in order to help 
defer some of their initial planning expenses, particularly expenses 
associated with stronger efforts to involve people with a disability. 
We hope these efforts are successful in helping states achieve a robust 
level of consumer involvement.
    Question. Would you endorse the continuation of these dollars for 
the purpose of funding similar grants -and demonstration projects in 
2002?
    Answer. No. These grants were designed to be one-time grants to 
assist States in their effort to allow people with disabilities to live 
in their own homes and communities. We believe that the funding 
provided in fiscal year 2000 is sufficient to achieve this goal.
               community attendant services and supports
    Question. Secretary Thompson expressed strong support for 
community-based services for people with disabilities and the elderly 
during his confirmation hearing. In Wisconsin, he championed the 
FamilyCare program to provide comprehensive long term care services to 
people with disabilities and the elderly. In Iowa there has also been 
an effort to provide more community-based services to people with 
disabilities and the elderly. Just last week, the Iowa Department of 
Human Services released a draft of the State's Olmstead plan. And, the 
state is implementing the Ticket to Work and Work Incentives 
Improvement Act.
    Both of these initiatives reflect a strong policy consensus--both 
nationally and in Iowa--that people with disabilities should have the 
opportunity to live in the community and go to work.
    In order to provide people with a real choice to live in the 
community, however, many individuals with disabilities and the elderly 
need access to attendant services and supports. Many states provide 
such services through waiver programs, but they are often not Statewide 
or comprehensive in coverage. As a result, people remain inside 
institutions or are on long waiting lists for appropriate community 
services.
    There is a strong policy consensus that our long term care system 
is in need of reform. Senator Specter and I are in the process of 
drafting a revised version of Medicaid Community Attendant Services and 
Supports Act that would provide states increased resources for 
community attendant services and other activities that would ultimately 
remove the institutional bias of the current Medicaid program.
    Is HCFA willing to work with us on this issue? How can the federal 
government help states create a Medicaid long term care system that 
allows people with disabilities and the elderly the opportunity to live 
at home and in the community? Answer. We believe that the stimulus 
provided by the Congress in the form of ``Systems Change'' grants to 
States in fiscal year 2001, coupled with Department's work to more 
expeditiously process and approve waiver applications, will allow 
States the opportunity to make additional investments in home and 
community-based services. Additionally, we anticipate that this work 
will support the emergence of effectively working systems that provide 
States the ability to provide cost-effective long-term supports.
                                 ______
                                 

               Questions Submitted by Senator Harry Reid

                    chronic disease tracking system
    Question. Fallon, a small town in my home State of Nevada, is 
facing a terrible tragedy. In the last 4 years, 12 children have been 
diagnosed with leukemia, eight of them in a single year (2000), 
significantly more than would be expected in this small community. The 
families are angry and scared and have very real concerns that there 
may be some connection between this cluster of cancer and the 
environment, but currently neither the Environmental Protection Agency 
nor the Centers for Disease Control or other involved Agencies in the 
Department of Health and Human Services can offer any answers. Two 
weeks ago the Committee on Environment and Public Works held a field 
hearing in Fallon, and the witnesses, including representatives of the 
Centers for Disease Control, Agency for Toxic Substances and Disease 
Control and Environmental Protection Agency, and many State officials, 
supported my call for comprehensive disease tracking and rapid response 
capability.
    We had report language in last year's bill that requested CDC put 
together a plan for a chronic disease tracking system that looked at 
environmental factors. I look forward to receiving and considering 
CDC's report on this in the near future. And, I especially want to 
ensure that, as CDC moves toward implementation of its plan, it will do 
so in an integrated manner, not parcel the disease tracking network up 
into separate silos. I do not want this to become a battle between 
fiefdoms, but rather a comprehensive health tracking system to protect 
the nation's health.
    How are you going to make sure that this tracking system is put 
together in a strategic way and establishes a coordinated and 
comprehensive network?
    Answer. In the fiscal year 2001 appropriations report, CDC was 
asked to report back to this committee on plans to respond to the 
findings of the Pew Commission. In response, CDC's National Center for 
Environmental Health formed three CDC workgroups with membership from 
across CDC. The workgroups are in the midst of their work. One 
important next step is to begin a dialogue with our federal, state, 
local and public partners to further define the core functions of what 
a tracking system would do and how it would be implemented. A second 
step would be to begin planning to develop guidance and protocols for 
responding to disease clusters that may be related to the environment. 
CDC will work closely with State and Local Health Departments, 
professional organizations, e.g. CSTE, ASTHO, to develop these 
protocols and guidance.
    Question. Is this a priority? I heard at the hearing last week that 
Fallon is not alone, that there are many other communities in the 
country that are facing unexplained disease clusters.
    Answer. CDC is working diligently with existing funds to define 
core functions and develop guidelines so that CDC can provide 
leadership to the main organizations who would be involved in this 
effort.

                          subcommittee recess

    Senator Specter. Thank you very much, that concludes the 
hearing. The subcommittee will stand in recess until 9:30 a.m., 
Thursday, April 26, when we will meet in room SH-216 to hear 
from the Secretary, Department of Labor, Elaine L. Chao.
    [Whereupon, at 10:08 a.m., Wednesday, April 25, the 
subcommittee was recessed, to reconvene at 9:30 a.m., Thursday, 
April 26.]


  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2002

                              ----------                              


                        THURSDAY, APRIL 26, 2001

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

                               ERGONOMICS

               OPENING STATEMENT OF SENATOR ARLEN SPECTER

    Senator Specter. Good morning, ladies and gentlemen. The 
Hearing of the Appropriations Subcommittee on Labor, Health, 
Human Services and Education will convene. This special hearing 
has been set on the subject of ergonomics.
    Preliminarily, I want to note that we had an enormous group 
in the corridor. I have not seen a line that extends so far to 
Constitution Avenue since Bill Gates Junior came to a hearing 
here a couple of years ago. And I was a little mystified to 
walk in and see the seats empty here and all of the taxpayers 
in the corridor.
    And I asked why people hadn't come in and I was told you 
were looking for an invitation. Well, let the record show you 
don't need an invitation to come to a public hearing. You don't 
even have to show your tax receipts.
    I'll just take judicial notice or senatorial notice that 
you are all taxpayers.
    Today's hearing is on a very complicated subject. It has 
been convened to try to move the process forward as 
expeditiously as possible. I had thought that the issue of 
ergonomics was resolved in our conferences on this subject, 
which go back many years where we delayed the promulgation of a 
regulation and had an enormous number of arguments until the 
regulation was supposed to have been final.
    But as George Schultz once said, nothing is final in 
Washington. And we have what I consider to be an area of 
necessary governmental action.
    We held an ergonomics hearing when the matter was listed 
for revocation. Those Senate floor proceedings came up on short 
notice, so we had a hearing with a number of witnesses and 
found that the subject was very, very complicated and required 
a lot more inquiry.
    We have a great many witnesses today. What we are going to 
try to do is focus in on questions, with concise testimony from 
panelists. We welcome the new Secretary of Labor, Secretary 
Elaine Chao. My distinguished colleague Senator Harkin has 
arrived, so I will turn to him for an opening statement.

                Opening statement of Senator Tom Harkin

    Senator Harkin. Thank you very much, Mr. Chairman and 
Secretary. It is good to see you again. I am glad to see we 
have a good turnout here today for this hearing because this is 
an extremely important hearing. And I thank you, Mr. Chairman, 
for holding this hearing.
    I want to thank also AFL-CIO and the National Academy of 
Sciences and all who are here from the science and labor 
community for coming to testify today.
    First, I want to make as clear as I possibly can how 
disappointed I was that Congress and the President took the 
extreme action of repealing this very important worker safety 
standard.
    More than 2 million American workers each year report work-
related MSDs and half of them lose time because of these 
injuries. The ergonomic standards would have cut those numbers 
drastically. And we are talking about cashiers, nurses, 
cleaning staff, assembly workers in manufacturing and 
processing plants, computer users, clerical staff, truck 
drivers, and meat cutters.
    And this is not just a labor issue, it is a women's issue 
because women are the hardest hit. Women make up 47 percent of 
the workforce. But in 1998, they accounted for 64 percent of 
the repetitive motion injuries and 71 percent of reported 
carpal tunnel syndrome cases.
    A good example is Gloria Boyd from Waterloo. She worked 9 
years on the assembly line in a pork processing plant. She has 
got carpal tunnel so bad she can hardly pick up anything 
heavier than a cup of coffee. Tell her, tell her that we do not 
need an ergonomic standard. Someone tell her and tell her 
family that, would they.
    This is a 15-page rule. And I have seen pictures of people 
waving huge stacks of paper around. I have seen pictures of 
them holding up big stacks of paper saying, Oh, this is how 
burdensome this was; when this is it, 15 pages; 15 pages, not 
200.
    Second, this was a complaint-based rule and very flexible 
according to each workplace and job as a result of exhaustive 
studies we know of over a decade. Some of my colleagues kept 
calling for more studies of ergonomics and repetitive stress 
disorders.
    What did we do? We kept authorizing more studies. Another 
National Academy of Science has studies in 1997, after two more 
before that. Then we continued to want to delay the rule. Well, 
the NAS study of the studies, the study of the studies came out 
in January.
    Once again, the National Academy of Science has found there 
is strong scientific evidence that workplace exposures cause 
musculoskeletal disorders and they can be prevented. So I am 
glad that the National Academy of Science is here today to 
present these findings.
    What more do we have to do to prove that America's workers 
are suffering from these repetitive stress disorders and that 
there are reasonable ways to prevent them.
    With the attitude that seems to be prevalent around this 
town today, I doubt if we could get a hard hat rule through 
like we did 30 years ago, no, 40 years ago, 30-something years 
ago, get a hard hat rule through. Probably could not even get 
that today.
    Well, yesterday, Madame Secretary, I understand you 
received a petition signed by labor unions, civil rights 
organizations, women's groups, occupational health and safety 
groups, that urged the Administration to make it a priority to 
issue a new ergonomics standard.
    It should not be that hard. We have studied it for over a 
decade. We have got all the scientific basis on it. The work 
has been done.
    Madame Secretary, I am told that you yourself said that 
work-related repetitive strain injuries account for more than a 
third of job injuries. And I think this is a quote from you. I 
did not hear it but I read it, that we need a solid 
comprehensive approach to new ergonomics rules.
    Well, that is an encouraging statement. I want to know why 
the standard that was issued was not solid and was not 
comprehensive. And I would like to know what you are going to 
do and how soon you are going to do it.
    It is not enough, I do not think, to say that we are going 
to look at this some more. I would like to know a deadline. I 
would like to know when. And that is a question I am going to 
be asking you is when are you going to set a deadline for 
having a new rule.
    We have gone long enough. Many of our women, our workers, 
are suffering lifetime injuries because we delay and we delay 
and we delay and we delay. And we shove it under the carpet, 
refuse to deal with it.
    So if there are some things wrong with the last rule, I am 
more than willing to listen, more than willing to take into 
account any problems that may have been in it. But I do not 
want to see this as an excuse to delay and delay and delay 
longer.
    If things need to be fixed, let us fix them. I know the 
chairman. He believes in worker health and safety as much as 
anyone around here. And I know that we would work together. I 
think we could work bipartisanly up here, but not if it just 
means we are just going to dribble along year after year after 
year and not get anything done.
    If we have a deadline and you have got solid suggestions, 
we are more than willing to take a look at it. It is 2001. It 
is time to put this sad chapter, this very sad chapter in 
ignoring the legitimate rights of our people to have a rule 
that will protect them, that will encourage businesses to make 
the modest minor changes necessary to cut down on repetitive 
motion disorders, musculoskeletal disorders in the workplace.
    With that, I thank you very much, Mr. Chairman.
    Senator Specter. Thank you, Senator Harkin.
    Let us refrain from applause. Let us not have any displays 
here. Let us approach this hearing on a scientific basis and 
try to figure out what the facts are and what the public policy 
ought to be.
    Let us not have any teams on one side or another. Secretary 
Chao, we welcome you here. We are going to limit very strictly 
the witnesses because we have enough to occupy more than the 
day. Our general rules are 5 minutes. We look forward to what 
you have to say.
STATEMENT OF ELAINE L. CHAO, SECRETARY, DEPARTMENT OF 
            LABOR
ACCOMPANIED BY JOSEPH WOODWARD, ASSOCIATE SOLICITOR, OCCUPATIONAL 
            SAFETY AND HEALTH ADMINISTRATION
    Secretary Chao. Thank you, Mr. Chairman and Senator Harkin, 
and other members of the subcommittee. Thank you for inviting 
me to testify about the need to reduce musculoskeletal 
disorders in America's workforce.
    With me today is Joseph Woodward. He is the Associate 
Solicitor for OSHA, the Occupational Safety and Health 
Administration.
    When I testified before the Senate Health, Education, 
Labor, and Pensions Committee at my confirmation hearing about 
3 months ago, I spoke about the challenges of preparing 
America's workforce for the emerging realities of the 21st 
century workplace.
    The Department of Labor must remain in step with the 
dramatic changes in our economy to fulfill its responsibilities 
to our workforce. And to meet this goal, I have established 
five priorities for the Department.
    One, is to ensure the safety of every workplace; Two, to 
guarantee an honest day's pay for an honest day's work; Three, 
to fight discrimination; Four, to protect workers from coercion 
and intimidation; and Five, to make sure that workers' 
compensation and pensions are protected.
    That first goal listed above, to ensure the safety and 
health of every workplace, is my top priority. And it will 
remain so throughout my tenure as Secretary of Labor.
    But I am also committed to bringing the workforce of the 
21st century in step with the needs and realities of our modern 
economy. And it is clear that the workplace of today is very 
different from the workplace as it existed when the Department 
of Labor was created in 1913.
    Today's employees are better compensated, better treated 
and work fewer hours. They are also better trained, more 
productive and more knowledgeable. And we must continue 
training a more productive workforce in order to continue 
producing a better compensated workforce.
    And so in that vein, I cannot resist a brief commercial for 
the Department's upcoming 21st Century Workforce summit to be 
held at the MCI Center on Wednesday, June 20 of this year. You 
are all invited to join us as what is supposed to be and what 
promises to be an extremely productive and rewarding day to 
talk about training and development for the 21st century 
workforce.
    The workforce of the 21st century today is not only better 
off financially than it was a century ago, it is also far 
better off from a safety perspective. In 1913, the year the 
Department was founded, the Bureau of Labor Statistics, part of 
the Department of Labor, documented 23,000 industrial deaths 
among a workforce of 38 million people. This is equivalent to a 
shocking 61 deaths per 100,000 workers.
    In 1999, the latest year for which figures are available, 
the Bureau of Labor Statistics reported 6,023 deaths among a 
workforce of 134 million people or fewer than 5 deaths per 
100,000; fewer but still too many.
    These numbers demonstrate that we have made great strides 
in improving worker safety over the last century. And the 
Department of Labor as well as our Nation as a whole should be 
commended for its commitment to improving worker safety.
    But these improvements also demonstrate that the new 
century and the new workforce require a new approach to the 
safety needs of the American workforce, an approach based on 
collaboration and prevention rather than the antiquated 
adversarial approach of years past.
    OSHA has a finite budget of $425.4 million in fiscal year 
2001. Securing the cooperation of employers and employees can 
help us to leverage the effectiveness of our resources.
    For example, several employers recently shared with us how 
they have implemented their own ergonomics programs in 
collaboration with their workers, and some with the assistance 
of OSHA's consultative services.
    The administration asks that OSHA place a greater emphasis 
on preventing injuries through compliance, assistance and 
cooperation, such as education, training and technical 
assistance programs, rather than relying on command-and-control 
enforcement.
    Because we are in a new century and facing a new kind of 
workforce issue, it is very important that the Department of 
Labor proceed carefully on the ergonomics question. As we begin 
this new century, it is important to bring the stakeholders 
together, work on creating a common knowledge base and a clear 
recognition of the need for a consensus approach to this issue.
    Since the Department has seemingly been looking into this 
issue for so long, I think it might be helpful to lay out some 
of the history to give everyone a sense of the time line, and 
the controversy.
    Senator Specter. Madame Secretary, we are interested in the 
history but the time is very short. The red light has been on. 
Could you summarize. Your full statement will be made a part of 
the record.

                           prepared statement

    Secretary Chao. My full statement will be made a part of 
the record, as you requested. And I will be more than happy to 
answer any questions you have.
    [The statement follows:]
               Prepared Statement of Hon. Elaine L. Chao
    Mr. Chairman, Members of the Subcommittee, thank you for inviting 
me to testify about the need to reduce musculoskeletal disorders in 
America's workforce. With me today is Joseph Woodward, Associate 
Solicitor for Occupational Safety and Health.
    When I testified before the Senate Health, Education, Labor, and 
Pensions Committee at my confirmation hearing three months ago, I spoke 
about the challenges of preparing America's workforce for the emerging 
realities of the 21st Century workplace. The Department of Labor must 
remain in step with the dramatic changes in our economy to fulfill its 
responsibilities to our workforce.
    To meet this goal I have established five priorities for the 
Department:
  --to ensure the safety of every workplace;
  --to guarantee an honest day's pay for an honest day's work;
  --to fight discrimination;
  --to protect workers from coercion and intimidation; and
  --to make sure workers' pensions are protected.
    That first goal listed above, to ensure the safety and health of 
every workplace, is my top priority; it will remain so throughout my 
tenure as Secretary of Labor. But I am also committed to bringing the 
workforce of the 21st century in step with the needs and the realities 
of our modern economy. It is clear that the workplace of today is so 
very different from the workplace as it existed when the Department of 
Labor was created in 1913. Today's employees are better compensated, 
better treated, and work fewer hours. They are also better trained, 
more productive, and more knowledgeable. We must continue training a 
more productive workforce in order to continue producing a better-
compensated workforce. In that vein, I cannot resist a brief commercial 
for the Department's upcoming 21st Century Workforce summit, to be held 
at the MCI Center on Wednesday, June 20 of this year. You are all 
invited to join us at what promises to be an extremely productive and 
rewarding day.
    The workforce of the 21st century is not only better off 
financially today than it was a century ago; it is also far better off 
from a safety perspective. In 1913, the year the Department was 
founded, BLS documented 23,000 industrial deaths among a workforce of 
38 million people--equivalent to a shocking 61 deaths per 100,000 
workers. In 1999, the latest year for which figure are available, BLS 
reported 6,023 deaths, among a workforce of 134 million people, or 
fewer than 5 deaths per 100,000. Fewer, but still too many.
    These numbers demonstrate that we have made great strides in 
improving worker safety over the last century. The Department of Labor, 
as well as our nation as a whole, should be commended for its 
commitment to improving worker safety. But these improvements also 
demonstrate that the new century, and the new workforce, require a new 
approach to the safety needs of the American labor force, an approach 
based on cooperation and prevention, rather than the antiquated, 
adversarial approach of years past.
    OSHA has a finite budget of $425.4 million in fiscal year 2001. 
Securing the cooperation of employers and employees can help us to 
realize a substantial return on our resources. For example, several 
employers recently shared with me how they have implemented their own 
ergonomics program--some with the assistance of OSHA's consultative 
services. The Administration asks that OSHA place a greater emphasis on 
preventing injuries through compliance assistance and cooperation, such 
as education, training and technical assistance programs, rather than 
relying on command-and-control enforcement.
    Because we are in a new century and facing new kinds of workforce 
issues, it is very important that the Department of Labor proceed very 
carefully on the ergonomics question. As we begin this new century, it 
is important to bring the stakeholders together, work on creating a 
common knowledge base and a clear recognition of the need for a 
consensus approach to this issue.
                                timeline
    Since the Department has seemingly been looking into this issue for 
so long, it might be useful to lay out some of the history, to give 
everyone, the Congress and the American people a sense of the timeline, 
the controversy, and the activities over the last twenty years. As you 
all know, last month, under the Congressional Review Act, Congress 
repealed OSHA's ergonomics standard. In signing the repeal, the 
President emphasized that this Administration supports activities that 
will address the critical challenge of reducing musculoskeletal 
disorders.
    The repeal is only the latest action in the Department's two-decade 
history with this issue, dating back to the hiring of the Department's 
first ergonomics specialist back in 1979. You may be interested to know 
that that individual remains a valued Department of Labor employee.
    Since then, OSHA has been working steadily to determine the best 
possible position for the Department of Labor to adopt in order to 
ensure the health and safety of the American worker. As the history 
shows, the Department and Congress have been operating on a collision 
course for a number of years now, and this movement forward without a 
consensus has put us in the predicament we are in today. At this point 
it would be appropriate to submit into the record a timeline covering 
some of this history.
    The timeline I have just submitted is very useful in laying out the 
history of the ergonomics standard. This history helps demonstrate why 
the original standard failed--the rush to action, the lack of 
consensus, and the continual forward movement despite repeated 
congressional expressions of disapproval. This history makes it clear 
why we need to take our time and to achieve a greater level of 
consensus before proceeding.
                         why ergonomics failed
    It is vitally important that we avoid a repeat of the last 
ergonomics standard. It would be wise to consider the factors that 
preceded last month's vote by Congress before charting a new course. 
OSHA should not rush when producing a new, comprehensive approach to 
ergonomics.
    Last year, OSHA was asked to complete promulgation of the previous 
standard in an unreasonable period of time. Many have stated that this 
was a standard that began in the late 1980's under former Secretary of 
Labor Elizabeth Dole. Now, we know that the Department actually began 
looking at this issue in 1979. We also know, however, that the new 
proposed rulemaking was announced in November 1999 and made final in 
November 2000. Within that same 12-month period, OSHA received over 
11,000 written comments on this rule, making up 188,547 pages. Piled on 
top of each other, these comments and supporting documents would be 78 
and a half feet high. In fact, standing on top of this stack without a 
safety harness would probably constitute an OSHA violation.
    These thousands of pages of documents include complex scientific 
and mathematical analyses that only experts can understand. As you can 
see, this display illustrates just how complex this issue really is, 
and how much interest was generated by the last proposal. The rush to 
make the standard final, however, forced OSHA to rely heavily on 
contractors to assist in the review of these documents. The government 
has a responsibility to listen to the people, especially the regulated 
community.
    Cost, scope of coverage and state jurisdiction were also concerns 
of the previous standard. The disparity between OSHA and private sector 
cost estimates approached $100 billion. As a result, the Department 
will consider having future cost estimates reviewed by an independent 
entity. The previous standard attempted to cover a large number of 
businesses. The Department could help lower the overall cost by 
focusing on high-risk occupations. State jurisdiction should also be 
preserved by permitting States to administer workers' compensation 
programs without Federal intervention by OSHA.
                    department activities since cra
    In determining how best to proceed from this point, it is best to 
take advantage of the expertise and experience of all parties involved 
in the issue. Since becoming Secretary, representatives of unions, 
employers, safety and health professionals, Congress, and members of 
the medical and scientific communities have all come to the Department 
to share their thoughts on how to develop an effective strategy to 
further reduce--and eventually eliminate--these injuries. The OSHA 
career staff also provided a brief on the tools currently available 
under the Occupational Safety and Health Act. I look forward to 
continuing discussions about the best method for balancing the needs 
and concerns of management and labor while improving the health and 
safety of America's workers.
    Some of the groups with whom we have met regarding this issue 
during my short tenure as Secretary of Labor include:
  --The president & workers from the United Commercial and Food Workers 
        Union
  --The AFL-CIO
  --The Service Employees International Union
  --The United Brotherhood of Carpenters & Joiners
  --The United Brotherhood of Teamsters
  --The Hotel Employees & Restaurant Employees International Union
  --The Frozen Food Association
  --The American Occupational Therapy Association
  --The Food Marketing Institute
  --The American College of Occupational and Environmental Medicine
  --The American Society of Safety Engineers
    In addition, we have also had extensive and multiple briefings with 
the dedicated career staff at OSHA to discuss the Department's 
activities and options on ergonomics.
    Finally, I would add that I am especially pleased to appear here 
before you today. I consider meeting with Congress to be an important 
part of listening and learning process on this subject.
    One thing is clear from these meetings: there is no consensus on 
the ergonomics issue. The stakeholders who have come to the Department 
of Labor to discuss ergonomics are coming from completely different 
positions, ranging from those who want no action to those who thought 
that the previous rule did not go far enough. In fact, after my 
testimony, you will hear from a number of other witnesses who I expect 
will demonstrate the full range of these widely divergent points of 
view. And therein lies the problem. This diversity of opinion suggests 
that precipitous action is not the wisest course at this time. If we 
want to find more common ground on this issue, we will need to engage 
in more discussion and analysis, and we will need more data.
                               principles
    That said, we still do know a lot, and enough to begin thinking 
about the kinds of approaches that could work, and more importantly, 
the starting point from which we want to launch further activities. If 
we are to find common ground, it is important that there is at least 
general agreement on certain facts and philosophies before we reengage 
in the process that was reversed last month with the passage of the CRA 
resolution. A great deal of resources, both in and outside the 
Department, went into creating the ergonomics standard. Under the CRA, 
the Department is now precluded from producing any standard that would 
be ``substantially the same.'' Before we expend valuable--and limited--
resources on a new effort, we should agree on general principles that 
the Department will follow in creating a new ergonomics approach that 
fits the new 21st century workforce. These principles will provide a 
vital starting point for common understanding, a point from which we 
can hope to find common ground:
    1. Prevention.--Everyone can agree that reducing occupational 
injuries is our top priority. Fortunately, there is good news on this 
front. Recently, the Bureau of Labor Statistics (BLS) released new data 
on job-related injuries and illnesses for 1999. The data show that 
there has been a continuing decline in musculoskeletal disorders that 
result in employees missing time from work. Employers reported 582,300 
such injuries in 1999, down from 592,500 in 1998 and from more than 
763,000 in 1993. This 25 percent decline has occurred even though more 
Americans were in the workforce. While I'm encouraged by this progress, 
I also recognize that musculoskeletal disorders remain nearly one-third 
of all work-related injuries. The Department should examine why these 
rates continue to decline, even in the absence of a specific ergonomics 
standard and while the number of annual OSHA inspections remains 
steady.
    Clearly, more needs to be done to address the hazards that cause 
these injuries. My goal is for the Department to develop an approach 
that will focus efforts on preventing injuries before they occur, 
rather than simply reacting after workers are hurt. We would much 
rather prevent an injury than fine an employer in the aftermath of that 
injury.
    OSHA has a finite budget of $425.4 million in fiscal year 2001. It 
is impossible to inspect every workplace with this limited budget. This 
money is more effectively spent, and protects more workers, if it is 
focused on prevention efforts. Prevention, education and training are 
the most effective methods for providing the maximum amount of 
protection to the greatest number of workers.
    2. Sound Science.--Any Departmental action should be based on the 
best available science and research. In the previous Administration's 
rush to issue an ergonomics standard, they acted before the completion 
of a National Academy of Science study that would have provided all 
stakeholders with more information on the ergonomics standard. In the 
future, the Department should make sure that it makes determinations 
based on the best available science.
    3. Incentive-Driven.--OSHA has stated that 95 percent of employers 
are acting in good faith. Employers understand that best safety 
practices are good for business and are in the best interests of their 
workers. Any approach should be centered on cooperation between OSHA 
and employers, rather than an adversarial relationship.
    OSHA's efforts with the meatpacking industry over the last 10 years 
demonstrate how successful a voluntary approach to ergonomics can be. 
In 1990, OSHA published ergonomics guidelines for the red meat 
industry, ``Ergonomics Program Management Guidelines for Meatpacking 
Plants.'' One of the reasons the Agency chose to publish guidelines for 
this industry was the unacceptably high injury rate to its workers--
20.2 cases per 100 employees. Many of these injuries were 
musculoskeletal disorders.
    Many firms in the meatpacking industry used these guidelines and 
voluntarily implemented programs in an attempt to decrease ergonomic 
injuries and lower their annual workers' compensation premiums. Over 
the last 10 years, the case rate of total recordable injury cases 
dropped 39 percent, from 20.2 cases per 100 full time workers in 1989 
to 12.3 per 100 full-time workers in 1999. The case rate for injuries 
involving days away from work also dropped substantially over this 
period, from 6.5 per 100 full-time workers to 2.0--a decrease of 70 
percent.
    Although these guidelines initially arose from an OSHA enforcement 
action, this experience does demonstrate the potential effectiveness of 
voluntary, industry-specific ergonomics suggestions, especially in 
industries where the prevalence of musculoskeletal disorders is 
greatest.
    4. Flexibility.--We must recognize the unique nature of individual 
workplaces--avoiding an unworkable one-size-fits-all approach. The 
comments DOL has received demonstrate that one of the biggest 
weaknesses of the failed standard was its universal nature. Every 
workplace is different and will need different tools and approaches to 
prevent ergonomic injuries.
    5. Feasibility.--Small businesses complained that the cost of the 
previous standard, estimated by the Department at upwards of $4 
billion, and by private sources at up to $100 billion, would have 
imposed a crushing burden on them. Small businesses need the Department 
to recognize the costs of compliance and the economic constraints faced 
by small business.
    6. Clarity.--The ergonomics standard took up over 600 pages, 
including preambles and appendices in the Federal Register. While the 
standard represented only a portion of these, small business owners 
faced with the entire 600 pages of supporting documents were 
understandably frightened. Small business owners lack the legal 
resources to understand what is required to comply with complex 
regulations. As a result, any approach to ergonomics must include 
short, simple, and common sense instructions for employers and their 
employees.
                              what's next?
    The Department of Labor understands that there is some 
Congressional interest in addressing ergonomic injuries through 
legislation. We ask for your patience. This is a new Administration. We 
have made it our priority to review and understand this issue by taking 
the time to meet with stakeholders, listen carefully to their concerns 
and construct principles that guide us to a comprehensive resolution. 
While the Department is making significant progress, it will take time 
for us to effectively complete our goal.
    Defining the best, comprehensive approach for ergonomic injuries is 
not a simple process. Occupational physicians explain that ergonomics 
involves soft tissue--including tears, scarring or inflammations, which 
can all be generated in places other than the workplace. While the 
Department is focused on addressing ergonomic injuries acquired on the 
job, determining where a worker developed a tissue strain is still 
subject to much debate. There is no set formula. No table exists. There 
is no equation that permits us to simply plug in a worker's injury and 
instantly determine its history. Because of the great difficulty of 
identifying many ergonomic injuries and establishing causality, these 
kinds of cases can require more investigative resources than 
traditional workplace injury cases.
    The Department of Labor wants to work with Congress in charting the 
best course of action. The Department is here today because it is 
committed to providing necessary protections to workers against 
ergonomic injuries. We applaud you, Mr. Chairman, for holding this 
hearing, and look forward to working with you and hearing any 
suggestions you have for providing a sufficient remedy.

    Senator Specter. Well, in the interest of brevity and to 
move on to the substantive witnesses, I am just going to ask 
you one question with two parts. When do you anticipate having 
a regulation finished, and what are the appropriate monitoring 
steps during the course of the time line from now until the 
date you expect to conclude?
    Secretary Chao. Mr. Chairman, I would love to give you a 
time line and a deadline. A time line we have a better handle 
over. A deadline I do not think would do any one of us any 
particular good in trying to accomplish the goal of reducing 
ergonomic injuries.
    We have seen in the past an artificial deadline 
unreasonably imposed would in fact not bring about the result 
that we all share. We are all in favor of reducing injuries. I 
totally agree with you----
    Senator Specter. Well, can you give us a time line? You say 
you have a handle on a time line but cannot give a deadline.
    Secretary Chao. Well, I think any regulation that goes 
through OSHA depending on the scope, the complexity, whatever 
the particular----
    Senator Specter. Secretary Chao, would you take a look at 
the scope and complexity and the history and give us a deadline 
or a time line.
    Secretary Chao. I am not able to do that, sir. I am sorry. 
I am unable to do that. I don't think that is a responsible way 
to proceed.
    Senator Specter. Senator Harkin?
    Senator Harkin. Madame Secretary, I guess what I am hearing 
is that this is just going dribble on for another 10 years. Is 
it going to be 10 years or 5 years?
    Secretary Chao. No, I do not have that kind of plan in 
mind.
    Senator Harkin. 2 years?
    Secretary Chao. Sir, with all due respect, I know that you 
would like for me to say a specific deadline. I would be more 
than glad to do that if that were a responsible course of 
action.
    Unfortunately, that is not a responsible course of action 
in my eyes. I want to do what is right. And the Department is 
unable to come to a definitive deadline. And maybe what we can 
do is I will ask, if I could, and I hate to put him on the 
spot, but Mr. Joe Woodward is the Associate Solicitor.
    Senator Specter. We do not want to put anybody on the spot 
and we do not want to have a protracted debate about it.
    Secretary Chao. Fine.
    Senator Specter. There is a deadline on my term. It is 6 
years. There is a deadline on the President's term. It is 4 
years. And I do not think it is asking too much when this 
subcommittee asks you for a deadline.
    What I want you to do, if you will not interrupt me, Madame 
Secretary, is to go back to the drawing boards and see if you 
can give us some estimate as to when it is going to be 
concluded.
    Secretary Chao. I will do that. May I just add a few words 
please?
    Senator Specter. Of course.
    Secretary Chao. In my testimony, and I wish that people 
would read the testimony, because the testimony was put 
together with a great deal of thought and care, not for the 
purpose of delaying. Because this testimony really lays out in 
depth our concern with the subject, our desire to move forward 
in a responsible fashion.
    I think one of the problems that has occurred in the past 
is that there has not been consensus. And despite repeated 
appeals from Congress to the Department on acting in a way that 
is responsible to them, those steps have not been taken. And I 
am not saying anything bad about the department professionals. 
I am saying that there were other forces at work.
    And so I think if we were to proceed again without due 
consideration of all the various interest groups that are 
involved, I do not think we are going to be crafting something 
that will be sustainable and that will be longstanding.
    Senator Specter. Madame Secretary.
    Secretary Chao. We are going to end up exactly where we 
were prior to March 20. And that is not what I want. I want to 
do what is right.
    But I think a consensus of some sort has to be brought 
together. I have met with all different kinds of groups. And 
the diversity of opinions is truly vast. We have people on one 
spectrum who do not want to do anything.
    Senator Specter. Madame Secretary.
    Secretary Chao. I do not agree with that.
    Senator Specter. You are repeating yourself. And we do not 
have time for that. Consensus is fine, if you can get it. 
Consultation is what you have to do. That can be accomplished 
in a time frame.
    Around here, we all work under time pressures. We work on a 
budget under a time pressure, and we work late, and we have a 
vote-a-rama, and we have a schedule on appropriations, and we 
have a fiscal year, and we have to meet deadlines.
    And consensus is great if you can get it, but there are 
many regulations. Most regulations are issued without 
consensus. If you could come to consensus, you would not need 
to have a Department of Labor or a subcommittee or proceed with 
these hearings.
    I want to proceed to call the first panel of witnesses. 
Senator Harkin, you want one more question. OK.
    Senator Harkin. Madame Secretary, since you say you are 
going to pursue this----
    Secretary Chao. Yes, of course.
    Senator Harkin. I had my staff look at your budget.
    Secretary Chao. Yes.
    Senator Harkin. How much is in your budget that you have 
devoted to this effort?
    Secretary Chao. We have a total OSHA budget of $425 
million.
    Senator Harkin. I know what your total budget is. I want to 
know how much you have devoted to an expeditious review of and 
culmination of the effort to issue a new standard.
    Secretary Chao. I do not have that number with me. I will 
be more than glad to get it for you.
    Senator Harkin. And would you submit that to this 
Appropriations Committee.
    Secretary Chao. I certainly will.
    Senator Harkin. I would like to see how much money and 
resources you are devoting to this specific effort.
    Second, I have read your statement over. And what I do not 
see in your statement, I do not see anything in your statement 
that says here is what was really wrong with the rule that was 
promulgated, point by point, and here is how we fix it.
    Now, could you submit that also for the record. I want to 
know precisely what it is in this 15 pages of rules that you 
think are wrong and that need to be corrected. Could you submit 
that for the record?
    Secretary Chao. The Congressional Review Act was the action 
that nullified the rule making.
    Senator Harkin. I understand that. I understand that.
    Secretary Chao. That is not our department. We did not 
nullify the rule making. In fact----
    Senator Harkin. But you are supporting that. And you are 
saying that that was the correct course of action to take. You 
are saying it was correct to have thrown this rule out. That is 
what you are saying.
    Secretary Chao. Well, the rule has been deemed null and 
void.
    Senator Harkin. Yes.
    Secretary Chao. That does not mean that a new rule----
    Senator Harkin. But you are saying you support that, do you 
not? You support that.
    Secretary Chao. The administration supports that and I 
support that. Yes. Because I think a consensus, some kind of 
consensus is necessary for us to be able to move forward. 
Because if we do not find some commonality of interests, the 
Congressional Review Act will once again be invoked. And any 
new rule will be void and nullified.
    Senator Harkin. I think----
    Secretary Chao. I am concerned about the workers. If we 
want to really find a solution to reduce the injuries, we have 
to be able to find----
    Senator Specter. I regret interrupting but we have a lot of 
witnesses. And I think you have asked an appropriate question 
as to what the Secretary disagrees with in the regulations.
    We all know what the Congress did. If you would care to 
respond to that, we would appreciate it. But we are not going 
to have a political debate here.
    Secretary Chao. You are right.
    Senator Specter. That is what we are not going to do. What 
we are going to do is try to identify what can be done to 
protect workers. And we have experts here on a wide variety of 
subjects that is just staggering, including: work-related 
musculoskeletal disorders, work-related MSDs and interventions, 
cost benefits and feasibility of economic standards and options 
for new ergonomics standards.
    You have expressed yourself on consensus, Madame Secretary. 
We understand that. Speaking only for myself, if you can get 
consensus, that is wonderful. If you cannot, you are going to 
have to make a decision as the Secretary of Labor, and then 
Congress is going to review that. Those are our procedures.
    I would like to call the second panel now: Mr. Fellner, Dr. 
Bigos, Dr. Hadler, Miss Seminario, Mr. Evanoff and Ms. 
Eberhardt.
    Let us begin, Mr. Fellner, with a question as to what are 
musculoskeletal disorders, if any, which require Department of 
Labor regulation.
STATEMENT OF BARUCH A. FELLNER, ESQ., PARTNER, GIBSON, 
            DUNN & CRUTCHER, LLP
    Mr. Fellner. Senator Specter, it is a pleasure to be before 
the committee this morning and to participate in this important 
hearing. If I may, before I get to your question, may I put it 
in the context of the 5-minute statement that it was my 
impression we all had an opportunity to give this morning. And 
with respect----
    Senator Specter. Yes, you may.
    Mr. Fellner. I will certainly respond.
    Senator Specter. It would be the committee's preference 
that you focus on the subject matter for Panel 1 which I have 
just articulated.
    Mr. Fellner. And with pleasure. I will focus on that, but I 
would like to put it in the context of my statement with your 
kind permission, sir.
    Senator Specter. I have already given you that. Proceed.
    Mr. Fellner. On March 6, the distinguished chairman 
convened a special hearing to examine the issues surrounding 
OSHA's now rescinded ergonomics standard.
    During the course of that hearing, I suggested that the 
next step in determining what course the Department of Labor 
should take should be an open and honest and exhaustive debate 
on the science and economics, a course of action rejected by 
OSHA in the prior administration.
    We are delighted, we are honored to participate in the 
beginning of that process and to be part of such a 
distinguished panel of experts.
    Given the scope of the issues, this process obviously 
cannot begin and end in a single day. We expect that this open 
dialogue and hopefully consensus will continue in the 
Department of Labor under the able leadership of Secretary 
Chao. We do not expect the answers to be easy.
    The more one becomes familiar with these issues and their 
complexity, the more difficult it becomes to find areas of 
common ground.
    And I would like to introduce this debate, Mr. Chairman, by 
outlining some of the many issues about which there is 
considerable disagreement first.
    The nature of the problem broadly referred to as 
musculoskeletal disorders or MSDs is poorly defined. And 
Senator Specter, if I may, the problem and its definition runs 
the gamut from the definition of the National Academy of 
Sciences of disorder, and that is what we are talking about 
today, Senator, musculoskeletal disorders which is an 
alteration in an individual's usual sense of wellness. That is 
the NAS definition. That is their amorphous definition.
    OSHA, on the other hand, has defined musculoskeletal 
disorders as injuries and illnesses that affect muscles, 
nerves, tendons, ligaments, joints or spinal disks. There is 
not even an agreement on how to define the problem much less to 
cure it.
    Number 2, you will hear extraordinary numbers today from 
the non-medical witnesses representing the other side, 1.8 
million, 650,000 annually. I agree with those numbers, Senator.
    If we are talking about an alteration in a sense of 
wellness, there are millions of those. If we are talking about 
illnesses, injuries, there are very, very few of those.
    Number 3, even the strongest proponents of ergonomics 
recognize that work and non-work factors contribute to MSDs. 
Let me suggest in the interest of time that if a picture is 
worth a thousand words, then I invite the attention of this 
committee to two pictures, once again from the National Academy 
of Sciences; two pictures which describe the complexity of the 
factors and the risk factors that go into musculoskeletal 
disorders that include the physiology of the human being, the 
psychology of the human being, the mechanical factors to which 
he is exposed, the socioeconomic factors that the human being 
finds himself into.
    And to suggest that one can pluck one factor, the physical 
factor out of this kaleidoscope of shards and regulate that one 
factor is with all respect, Senator Specter, an impossible task 
based upon the science that we presently know.
    And speaking of that science, we do indeed have a 
distinguished panel. We have brought four eminent medical 
doctors and researchers, not representatives of the National 
Association of Manufacturers, not representatives of the 
Chamber of Commerce, not individuals who are after sound bytes, 
but rather the folks that know the science and will address the 
science. And the science is insufficient to support an 
ergonomic standard as we presently sit.

                           prepared statement

    Moreover, and with this I will conclude, when one is 
dealing with the single-most expensive regulation in the 
history of the Department of Labor, and may I suggest with 
respect the greatest example of microengineering of the 
workplace in the history of this republic, the science better 
be sound before we proceed.
    Senator Specter. Thank you very much.
    Mr. Fellner. With that, Senator Specter, I will conclude.
    [The statement follows:]
                Prepared Statement of Baruch A. Fellner
    Distinguished Chairman and members of the Subcommittee, I am a 
partner with the firm of Gibson Dunn & Crutcher. Since OSHA's inception 
almost 30 years ago, I have practiced safety and health law, having 
shaped OSHA's enforcement policy in the Solicitor's Office for its 
first decade and settled over 1,000 OSHA citations in private practice. 
I am firmly committed to a strong OSHA--one which is actively engaged 
in preventing accidents, illnesses and injuries in the workplace. On 
March 6, the Chairman convened a special hearing to examine the issues 
surrounding OSHA's now-rescinded ergonomics standard. During the course 
of that hearing, I suggested that the next step in determining what 
course of action the Department of Labor should take should be an open, 
honest and exhaustive debate on the science and economics--a course of 
action rejected by OSHA under the prior administration. We are 
delighted and honored to participate in the beginning of that process 
and to be part of such a distinguished panel of experts.
    For the past eight years, OSHA has committed enormous resources 
with a predisposition toward promulgating an ergonomics standard and 
without objectively evaluating the underlying science, the costs, or 
the benefits of such a standard. In the recent rulemaking, OSHA hired 
more than 20 outside consultants to aggressively advocate its position 
and to criticize dissenting comments. The resulting ergonomics standard 
was perhaps single greatest experiment in social engineering in the 
history of the Department of Labor. The costs of the rule would have 
been staggering, and it had no clear scientific support. That standard 
is now rescinded.
    But now we look to the future. This hearing is the first time there 
has been open and honest dialogue regarding the scientific foundations 
and economic implications of an ergonomics rule. Given the scope of 
these issues, this process obviously cannot begin and end in a single 
day. We expect that this open dialogue will continue in the Department 
of Labor under the able leadership of Secretary Chao.
    We do not expect that answers will be easy to find. The more one 
becomes familiar with these issues and their complexity, the more 
difficult it becomes to find ``areas of common ground.'' I will 
introduce this debate by outlining some of the many issues about which 
there is considerable disagreement.
  --The nature of the problem--broadly referred to as musculoskeletal 
        disorders or MSDs--is poorly defined. MSDs encompass a variety 
        of perceived maladies and complaints that are not even 
        described with consistent medical terminology. Some define MSDs 
        as objectively diagnosed ``injury.'' The National Academy of 
        Sciences characterizes MSDs as ``disorders'' that result in 
        ``an alteration in an individual's usual sense of wellness or 
        ability to function.''
  --Efforts to quantify the problem are hampered by the inherent 
        difficulty of categorizing such diverse conditions and 
        complaints. According to the Bureau of Labor Statistics, the 
        bedrock of the claims that an MSD epidemic exists are 
        principally based on 6 million employers interpreting one 
        amorphous category: ``sprains, strains and tears.'' That is a 
        category that encompasses the traumatic and the cumulative, the 
        objective and subjective symptoms, the disabling pre-existing 
        condition that has nothing to do with the workplace and the 
        workplace incident that aggravates but does not injure. And 
        almost all of these judgments are made by laymen. This is the 
        stuff of soundbites, not science, as to the catastrophic state 
        of ergonomic injuries.
  --Even the strongest proponents of a standard agree that work and 
        non-work factors contribute to MSDs. This NAS table is 
        particularly helpful in showing the complex web of suspected 
        influences. There is sharp disagreement, however, about the 
        relative importance and contribution of these factors. The 
        conclusions of scientific studies are inconsistent and 
        difficult to assimilate because they involve so many different 
        aspects of this multi-faceted issue.
  --No single, scientifically validated ``exposure-response'' 
        relationship exists to provide a quantitative basis for a 
        standard. This is not lead or asbestos, where relative 
        scientific certainty suggests a permissible exposure limit. 
        Without this grounding, would-be regulators struggle between 
        two equally unpalatable alternatives: a vague standard based on 
        general goals such as a ``material reduction'' or making sure 
        MSDs are not ``reasonably likely to occur,'' and a more 
        specific standard based on quantitative goals that lack 
        scientific support.
  --Those who espouse the benefits of ergonomics rely largely on 
        anecdotal evidence. However, there is a dearth of 
        scientifically supportable evidence--particularly 
        scientifically reliable randomized controlled trials--on the 
        effectiveness of ergonomics programs. When we were all in fifth 
        grade, we learned the importance of the scientific method; we 
        seem to abandon that method when we are engaged in social 
        policy or social engineering. Anecdotal evidence of employee 
        complaints is unreliable because it may be tainted by factors 
        unrelated to safety or health. Research must focus on 
        objectively diagnosed medical outcomes.
  --Although the benefits of ergonomic controls are speculative, the 
        costs are very real. Even the prior Administration estimated 
        annual costs of more than $4.5 billion, making ergonomics the 
        second most expensive regulation since OMB began its systematic 
        review of regulatory impact. OSHA's estimate, moreover, was 
        based on broad-brush estimates that ergonomic interventions 
        will cost around $150 per job, when the agency had a long track 
        record of seeking interventions costing many times that amount. 
        Industry estimates suggested that the true total cost may 
        exceed $100 billion, perhaps by many multiples.
    As we set about for the first time to conduct an objective analysis 
of the science and economics of ergonomics, it is necessary to proceed 
without pre-formed notions as to the proper outcome. We hope that the 
Department of Labor will produce a detailed formal agency analysis that 
objectively and thoroughly considers all the evidence and comes to a 
conclusion about the appropriate government response, whether that be a 
comprehensive standard, a more narrowly targeted enforcement structure, 
a set of guidelines, or no action at all. The complete analysis and 
determination could then be published in the Federal Register and 
subjected to the open notice and comment process necessary to establish 
it as final agency action. When this process is complete, we believe 
that OSHA will find the current state of scientific knowledge woefully 
inadequate to support anything approaching the type of comprehensive 
standard-setting exercise recently rejected by Congress.

    Senator Specter. Thank you very much Mr. Fellner. Proceed 
now to Dr. Stanley Bigos, Professor of Orthopedics, University 
of Washington. Dr. Bigos, the floor is yours.
STATEMENT OF DR. STANLEY BIGOS, PROFESSOR OF 
            ORTHOPEDICS, UNIVERSITY OF WASHINGTON
    Dr. Bigos. Thank you. It is an honor to be here today to 
participate in an open examination of a federally mandated 
ergonomics rule. As a practicing orthopedic surgeon who deals 
with pain, a researcher and medical school professor, I have 
studied musculoskeletal problems for years and have engineered 
some of the principle studies regarding their causes.
    Simply, I believe there is no scientific basis for a 
mandatory ergonomic intervention at the workplace to prevent 
these nebulous things that have been termed musculoskeletal 
disorders and we refer to them as MSDs.
    The best science regarding musculoskeletal disorders 
suggests ergonomic proposals would actually be detrimental to 
the health of American workers by medicalizing many of the 
undiagnosable things that we in medicine cannot treat 
specifically. And if you cannot diagnose it, how do you prevent 
it.
    Problems at work are a concern for all of us. We would all 
like to make them go away. Unfortunately, there is very little 
consensus about how to define these MSDs and have virtually no 
reliable data regarding the prevalence.
    If we were to rely upon the statistics that OSHA cited in 
the final ergonomics rule, we would find that the vast majority 
of MSDs consist of discomfort or pain, generally unavoidable 
back pain that is a part of life.
    I am not saying that this discomfort is imaginary. It is 
real. It is very real for the people who experience it. I am 
merely pointing out that when we speak about MSDs we generally 
are not referring to physical injuries that are associated with 
tissue damage that can be prevented or medically altered.
    This point was recognized in the World Health Organization 
meeting on January 14, 2000, in a scientific group where all 
the participants agreed that we cannot continue to include 
aches and pains as categorized as injury, arthritis or disease 
because it keeps us away from the real goal of helping our 
patients.
    My point is that many MSDs are nothing more than symptoms 
without observable tissue damage. We are limited in medicine. 
And because there is no reliable data regarding the prevalence, 
it is not at all clear exactly what problem it is we are trying 
to regulate.
    Even if we could identify the nature and scope of the 
problem, there is no clear-cut science to support an ergonomics 
intervention. The ergonomics hypothesis is that many MSDs are 
caused by certain kinds of repetitive motions in the workplace 
and this can be alleviated by ergonomic controls alone. The 
problem with this hypothesis is that it is contrary to the best 
science available today.
    The ergonomic hypothesis relies heavily upon studies that 
only generate clues of association without actually studying 
the clues to see if there can be an effective mechanism by 
which the problem can be prevented.
    In light of the overwhelming potential cost of an ergonomic 
intervention, no rule should proceed without some evidence of 
successful intervention such as based on randomized control 
trials. No prospective RCTs at this point can guide us in 
altering the physical work conditions as an ergonomic remedy to 
the problem.
    In fact, the best science available does not support an 
ergonomic hypothesis. This is especially true for back 
problems.
    I directed the award-winning Boeing study that was 
summarized in the publications in 1991 and 1992. The study was 
of 3,020 aircraft workers at the Boeing factory over a 4-year 
period to look at the report of back problems.
    We started with a retrospective study that provided us with 
clues, and then we studied those clues to see about their 
impact on the reported back problems. The non-physical factors 
outweighed the physical factors in predicting back problems. 
The study found no correlation between heavy lifting and work 
activities increasing the report of problems.
    In fact, the study found that some employees who routinely 
performed heavy lifting jobs in the paint shop, lifting 50 
pounds with their arms outstretched like this, totally against 
everybody's ergonomic recommendation, and actually found that 
because of their--probably because of their high job 
satisfaction, they were among the least likely to report 
problems.
    I also chaired the HCPR Guideline Panel which found no data 
through a methodologic process that would support what is being 
recommended in the rule.
    In conclusion, I believe it is imperative for regulators to 
recognize the past ergonomic proposals are not supported by the 
best science available.
    Let us pretend for a moment that the Food and Drug 
Administration has suddenly prescribed a specific drug 
mandatory for the treatment of all patients with a particular 
problem. Further imagine that the FDA did not know the correct 
dosage of the drug as we are stuck with, and does not know what 
side effects it might have, and never subjected it to a single 
randomized trial. Doctors would then guess the dose or just 
accept the strong data----

                           prepared statement

    Senator Specter. Dr. Bigos, your full statement will be 
made a part of the record. If you summarize the conclusion, we 
would appreciate it.
    Dr. Bigos. My point is I doubt that we would do that in 
medicine. And the whole point is why should an expensive, 
unproven, potentially damaging approach be permitted simply 
based upon unfound hypotheses because we are dealing with OSHA 
science about the work site rather than the FDA science about 
our clinics and our hospitals.
    If we had the solutions, they would already be taken.
    [The statement follows:]
               Prepared Statement of Dr. Stanley J. Bigos
    It is a pleasure to be here today to participate in an open 
examination of the scientific basis for a federally mandated ergonomics 
rule. An open discussion of this nature is long overdue. As a 
practicing orthopedic surgeon, a researcher, and a medical school 
professor, I have studied musculoskeletal disorders for many years and 
have engineered some of the principal studies regarding their causes. 
Based on my extensive experience in this area, I believe that there is 
no scientific basis for mandatory ergonomic interventions in the 
workplace. To the contrary, the best science regarding musculoskeletal 
disorders suggests that the ergonomic proposals we have seen in the 
past would actually be detrimental to the health of American workers.
    Presumably, ergonomics regulation in the workplace is intended to 
prevent musculoskeletal disorders (MSDs). Unfortunately, there is very 
little consensus about how to define MSDs, and as a result there is 
virtually no reliable data regarding the prevalence of MSDs in this 
country. If we were to rely on the statistics that OSHA cited in its 
final ergonomics rule, we would find that the vast majority of MSDs 
consist of discomfort or pain--generally unavoidable back pain--that is 
a part of life and not accompanied by any observable tissue damage. I 
am not saying that this discomfort is imaginary; it is very real to the 
people who are experiencing it. I am merely pointing out that when we 
speak about MSDs, we generally are not referring to physical 
``injuries'' that are associated with tissue damage.
    This point was recognized at the January 14, 2000 ``Scientific 
Group'' meeting of the World Health Organization, when the whole 
conference of 450 participants agreed that musculoskeletal pain is not 
equivalent to injury, arthritis or disease.
    Because many MSDs are nothing more than symptoms rather than 
observable tissue damage, and because there is no reliable data 
regarding the prevalence of MSDs, it is not at all clear exactly what 
the problem is that we are trying to regulate.
    Even if we could identify the nature and scope of the problem, 
there is no clear scientific support for ergonomic interventions. The 
ergonomics hypothesis is that many MSDs are caused by certain kinds of 
repetitive motion in the workplace, and thus can be alleviated by 
ergonomic controls alone. The problem with this hypothesis is that it 
is directly contrary to the best science that is available today.
    The proponents of the ergonomics hypothesis generally rely on 
studies that are useful in generating clues about associations, but 
that cannot establish the causes of MSDs sufficiently to prevent it. In 
light of the overwhelming potential costs of ergonomic intervention, no 
rule should proceed without some true evidence of successful 
intervention such as a based on randomized controlled tests (RCTs). No 
prospective RCTs have ever been conducted to assess the effectiveness 
of altering physical work conditions as an ergonomic remedy.
    In fact, the best science available regarding the causes of MSDs 
suggests that the ergonomics hypothesis is wrong. I directed The award 
winning Boeing Study, ``termed sentinel science'' that was summarized 
in publications in 1991 and 1992. The Boeing study was a prospective 
cohort study of the reporting of back injury claims (not merely 
complaints) among 3020 aircraft workers at the Boeing facility over 4 
years following a retrospective analysis of back injury claims. That 
study found that non-physical factors outweighed physical factors in 
predicting the report of back problems at work. The study found no 
correlation between heavy-lifting work activities and increased 
reporting of back problems at work. In fact, the study found that some 
of the employees who routinely performed heavy lifting (paint shop) but 
who had high job satisfaction were among the least likely to report 
back problems at work.
    I also chaired the panel of experts that produced the Agency for 
Health Care Policy & Research (AHCPR) Guidelines for Low Back Problems, 
which was published in 1994. The AHCPR Guidelines were produced by a 
panel of experts brought together under the direction of the U.S. 
Department of Health and Human Services to conduct an exhaustive 
methodological review of the existing literature on the back problems. 
The panel evaluated more than 10,000 abstracts and obtained more than 
4,600 studies for methodological evaluation. Based on that review, the 
evidence suggested that continued activity rather than decreased 
activity would be helpful in alleviating many types of back problems--a 
finding that is directly contrary to the ergonomics hypothesis--and the 
panel found no valid evidentiary support for the use of ergonomics 
interventions to treat or prevent back pain. The AHCPR Guidelines have 
since been followed and updated in over 45 countries, including the 
United Kingdom, Australia, and Israel. Subsequent research has only 
strengthened many of the key findings of the AHCPR panel.
    In conclusion, I believe it is imperative for regulators to 
recognize that the ergonomic interventions that have been proposed in 
the past are not supported by the best science available, and there is 
a considerable body of evidence which suggests that certain ergonomic 
interventions may actually be physically harmful to American workers 
and slow their return to productive life.
    Let us consider for a moment the Food and Drug Administration, 
which is explicitly charged with evaluating healthcare interventions. 
Imagine that evidence-based medicine had demonstrated no support for an 
expensive experimental class of drugs designed to treat heart disease. 
Imagine that, nevertheless, the FDA suddenly prescribed a specific drug 
as the mandatory treatment for all patients. Further imagine that the 
FDA did not know the correct dosage of the drug, did not know what side 
effects it might have, and never subjected it to a single randomized 
control trial. Doctors would guess the dose and accept opinion that 
strongest data about the issue is wrong? I doubt it! The medical 
community would never be permitted to do this. Why should an expensive 
unproven and potentially damaging approach be permitted simply based 
upon unfounded hypotheses because we are dealing with OSHA's science 
about the worksite rather than the FDA's science about the clinic or 
hospital?

    Senator Specter. Thank you very much, Dr. Bigos. Dr. Nortin 
Hadler, Professor of Medicine and Microbiology/Immunology, 
University of North Carolina, Chapel Hill.
STATEMENT OF DR. NORTIN M. HADLER, PROFESSOR OF 
            MEDICINE AND MICROBIOLOGY/IMMUNOLOGY, 
            UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL
    Dr. Hadler. Good morning. I want to express my gratitude to 
the members of the subcommittee for the opportunity to address 
you today on issues with which I have grappled as a clinician 
and clinical investigator for over 25 years.
    I am a rheumatologist and therefore committed to caring for 
patients with musculoskeletal disorders. As an academician and 
clinical investigator, I was drawn early on to improve our 
understanding of the plight of those amongst us who are 
otherwise well but in the course of our usual life activities 
face compromised function because a particular anatomical 
region such as our low back or arm is painful to move.
    I coined the term ``regional musculoskeletal disorders'' to 
denote this morbidity nearly 20 years ago. Gainful employment 
is one realm in which function is placed at risk by a regional 
disorder. That is the so-called MSD in OSHA's terminology.
    But the illness of work incapacity is not the only 
morbidity, nor is the workplace the only context relevant to 
the regional disorders. The fact the working capacity from the 
regional disorders has engendered ergonomic-based regulatory 
efforts is a social construction that bears very close 
scrutiny.
    We have access to a compelling science that suggests such a 
social construction deprives the hurting worker of insights 
that could lead to substantive relief. Hopefully, such an 
understanding will emerge during the course of today's hearing.
    In this, the first of my two presentations, I will focus on 
the following aspects of the epidemiology of the regional 
disorders: Who is at risk, how common is the morbidity, what 
are the options for coping, and what drives the choice amongst 
the options.
    Notice that I continue to use the term regional 
musculoskeletal disorder. I am willing to specify the region, 
the knee or low back or neck or shoulder and the like, but 
seldom am I willing to apply a label that suggests I know what 
is hurting.
    For nearly all the regional disorders, there is no way 
today to general confidence that any anatomically exact label 
is valid. Nearly always there is nothing to see or feel. All 
our wonderful techniques for imaging anatomy seldom shed any 
light. Either no pathology is demonstrated or that which is 
demonstrable is nonspecific.
    It is commonly found in age matched individuals who are not 
hurting, is likely to have been present in the person who is 
hurting before the onset of pain, and likely to persist when 
the pain has remitted.
    Regional musculoskeletal pain is an intermittent and 
remittent predicament of life for all of us. It is distinctly 
unusual to live a year without having had to cope with a 
backache or 3 years without having to cope with arm pain.
    We know this from surveys where volunteers keep diaries of 
the morbidity they experience each day and from surveys where 
recall of the disorders is elicited. The response varies 
depending on how the questions are asked, but the message is 
inescapable. Regional musculoskeletal pain is an intermittent 
and remittent predicament of life.
    In the past decade, there have been a number of 
investigations which explore the fashion in which people cope 
with these episodes. Coping does not occur in a vacuum. Common 
wisdom and advice abounds, as do many purveyors of putative 
remedies.
    For most of us, most of the time, we can and do cope 
according to our fashion. For most of us, most of the time, the 
predicament passes and it is not even memorable. What makes it 
memorable. What causes us to seek care from a provider. If you 
think the answer relates simply to the severity of the pain, 
you need to be disabused.
    Aspects of life that confound coping render the 
musculoskeletal disorders more memorable and less tolerable. 
Measures of feeling undervalued, of being undervalued, of 
feeling disaffected, and of self-reported health status 
associate with the likelihood of remembering and seeking care 
for back, knee or arm pain. We have known for decades the 
measures of the severity of the pain itself correlates less 
well or not at all.
    No doubt there is the exceptional person who is faced with 
a regional disorder of such intensity and persistence that it 
overwhelms all attempts to cope. Such a person deserves the 
empathetic care that we would offer anyone with any other of 
life's morbid challenges such as a severe case of the flu. But 
these are unusual circumstances.
    Most people either on their own or with guidance discover 
ways to circumvent the painful use of the region that is 
hurting until in days, occasionally weeks, rarely months, the 
disorder remits sufficiently that life goes on and the episode 
is soon to be forgotten.
    When someone finds the disorder insurmountable or even 
unforgettable, it is likely that coping was confounded by the 
psychosocial context in which the morbidity was suffered. These 
psychosocial aspects of life operate to render the episode 
memorable, to cause one to register the complaint to a health 
officer inside or outside the workplace.
    This is not to dismiss the backache or the regional arm 
pain as trivial or to belittle the effort involved in coping. 
We will all face such challenges and hopefully we will all have 
the wherewithal to cope effectively. But I can assure you, if 
you are trying to cope with a backache and your life is not in 
order, if there are coincident challenges at home or work, then 
the backache will seem the last straw.

                           prepared statement

    Senator Specter. Dr. Hadler, your full statement will be 
made a part of the record. Can you summarize in conclusion 
please.
    Dr. Hadler. Yes. The conclusion will come in my second 
statement. There is absolutely no information as to whether we 
can alter the likelihood that we will suffer our regional 
disorder. There have been attempts to alter the likelihood that 
we will not cope on our own. And the best data we have say such 
attempts are ineffective. Thank you for your attention.
    [The statement follows:]
               Prepared Statement of Dr. Nortin M. Hadler
    When I was a medical student, epidemiologists observed that the 
risk for Down's Syndrome, trisomy 21, was not uniform in sibships. The 
youngest child was more likely to be afflicted with this congenital 
disorder. That lead to hypotheses and research as to what was it about 
the multiparous uterus that caused the fertilized egg to divide 
abnormally.
    Several years later, epidemiologists returned to this issue to test 
whether they had missed the real association. The younger the child, 
the older the mother. Could it be that the likelihood of bearing a 
child with Downs's syndrome associated more with maternal age than 
birth rank? The answer proved to be yes. The old hypothesis was 
superseded and research shifted to the biology of the aging ovary.
    Several years after that, epidemiologists again returned to this 
issue to test whether they had missed the real association. The older 
the mother, the older the father. Could it be? The answer was yes and 
no. The likelihood of bearing a child with Down's syndrome associated 
with both maternal and paternal age. The old hypothesis was superseded 
and research shifted to the biology of the aging ovary and testis.
    Such is the scientific method. We learn from the old hypotheses and 
the old false starts. And we move on. Today, no one would consider 
studies of the microenvironment of the multiparous uterus as relevant 
to the pathogenesis of Down's syndrome.
    For over 60 years science has sought associations between the 
physical demands of tasks and the likelihood of suffering disabling 
regional back pain. For 30 years, there have been parallel studies 
between physical demands of tasks and disabling arm pain. Associations 
have been found, but they are inconsistent and weak. There were hints 
30 years ago,\1\ but science has really risen to the challenge in the 
past decade, the challenge of asking whether a more important 
association was being ignored. I have reviewed this transition in a 
lengthy editorial in the Journal of Occupational and Environmental 
Medicine last fall \2\ titled ``Comments on the ``Ergonomics Program 
Standard'' proposed by the Occupational Safety and Health 
Administration'' which I have submitted with the written version of 
this statement. I review the number of cross-sectional and longitudinal 
studies that have attempted to probe for associations between disabling 
regional back or arm pain and aspects of BOTH the physical content of 
tasks and psychosocial context of work. Designing such studies is 
demanding. How do you measure either physical or psychosocial exposures 
given the enormous temporal variability and individual differences? You 
do the best you can. The result of these multivariate studies is that 
the associations with the physical content of tasks are weaker and even 
more inconsistent. The associations with the psychosocial context of 
work are also weak, but they are more consistent and generally subsume 
the associations with the physical content of tasks.
---------------------------------------------------------------------------
    \1\ Hadler, NM. Workers with disabling back pain. N Engl J Med 
1997;337:341-3.
    \2\ Hadler, NM. Comments on the ``Ergonomics Program Standard'' 
proposed by the Occupational Safety and Health Administration. J Occup 
Environ Med 2000;42:951-969.
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    I could belabor this new literature; it deserves scrutiny. However, 
I can not applaud the insistence on relying on the older literature in 
the systematic reviews that are promulgated by NIOSH and the NRC. Any 
study that considers only the association between the physical demands 
of tasks and the likelihood of a disabling regional musculoskeletal 
disorder is out of date, even if it is on-going or proposed. The state-
of-the-science has moved beyond the testing of that hypothesis to newer 
hypotheses that promise to be more informative.
    Let me illustrate first with two small area analyses. There are 
large companies that have multiple work sites each with similar 
facilities and similar demographics of the workforce. The incidence of 
disabling back or arm pain varies from site to site, sometimes 
dramatically. That offers the opportunity to explore whether measurable 
differences in task content, demographics or psychosocial context 
associate best with the variability in the incidence of disabling 
regional musculoskeletal disorders. Independently, investigators from 
NIOSH and I performed such a small area analysis in US West directory 
assistance operations.\3\ \4\ \5\ Neither the NIOSH investigators nor I 
could explain the site-to-site variability in the incidence of 
disabling arm pain by any aspect of task content. However, multiple 
aspects of the psychosocial context of work did associate, fear of 
redundancy, work pressure, and lack of decision authority to mention a 
few. Interestingly, the more overtime and the more hours spent at the 
computer, the LESS likely the operator was to have found arm pain 
disabling.
---------------------------------------------------------------------------
    \3\ Hadler NM. Arm pain in the workplace: a small area analysis. J 
Occup Med 1992;34:113-9.
    \4\ Hales RR, Sauter SL, Peterson M, et al. NIOSH health hazard 
evaluation report (HETA 1989-299-2230, U.S. West Communications). 
Washington, DC: Department HSS, PHS, CDCP, NIOSH.
    \5\ Hales T, Sauter SL, Peterson MR, et al. Musculoskeletal 
disorders among visual display terminal users in a telecommunications 
company. Ergonomics 1994;37:1603-21.
---------------------------------------------------------------------------
    Another small area analysis was performed by UPS. The results were 
submitted as part of the rules making process regarding OSHA's 
``Ergonomics Proposed Standard'' last year. A detailed ergonometric 
analysis was performed at a number of UPS hubs where the tasks involve 
the sorting of parcels. There is not even a hint of an association 
between physical task demands and the likelihood of recorded disabling 
arm or back pain.
    What do I mean by impugning the psychosocial context of work? What 
is the human implication of these small area analyses and nearly all 
multivariate cross-sectional and longitudinal studies that detect 
associations with the psychosocial context of working \6\ \7\ \8\ \9\ 
\10\ \11\ and the likelihood of reporting to a health officer in the 
workplace that your regional arm or back pain is disabling? I do not 
mean to impugn the veracity or the motivation of any worker so 
afflicted. Nor am I suggesting that the inflammatory social 
construction, ``It's in your head'' pertains. I believe they hurt and I 
am saddened that their pain is insurmountable. I know that the remedies 
offered by the providers of today are no matches for this dilemma; \12\ 
\13\ at best they are minimally helpful, most are useless and offer the 
specter of iatrogenesis. However, the science of today forces me to 
conclude that their back or arm pain is rendered incapacitating because 
elements of the psychosocial context in which they work impede coping. 
The frontier for epidemiology is to further define ``psychosocial 
context.'' That's a daunting exercise.\14\ Some of the common threads 
emerging from studies in the workplace include aspects of job 
``stress,'' \15\ ``strain,'' \16\ ``allostatic load'' and motivational 
``flow.'' \17\ These measures are sampling such complex psychological 
functions as satisfaction, autonomy and security on the job as well as 
perceived psychological demand, motivation, collegiality, and the like. 
No wonder, associations with ``psychosocial'' variables are weak, even 
inconsistent. There may be much that is idiosyncratic. However, that 
does not diminish the implications. The sad fate of the hurting 
worker(s) is predetermined if he or she, or they are trapped in a 
malignant psychosocial milieu.
---------------------------------------------------------------------------
    \6\ Linton SJ. A review of psychological risk factors in back and 
neck pain. Spine 2000;25:1148-56.
    \7\ Marmot M. Importance of the psychosocial environment in 
epidemiologic studies. Scand J Work Environ Health 1999;25(suppl 4):49-
53.
    \8\ Heliovaara M. Work load and back pain. Scand J Work Environ 
Health 1999;25:385-6.
    \9\ Krause N, Ragland DR, Fisher JM, Syme SL. Psychosocial job 
factors, physical workload, and incidence of work-related spinal 
injury: a 5-year prospective study of urban transit operators. Spine 
1998;23:2507-16.
    \10\ Burton AK. Back injury and work loss. Biomechanical and 
psychosocial influences. Spine 1997;22:2575-80.
    \11\ Papageorgiou AC, Macfarlane GJ, Thomas E, Croft PR, Jayson 
MIV, Silman JA. Psychosocial factors in the workplace--do they predict 
new episodes of low back pain? Spine 1997;22:1117-1142.
    \12\ Hansson TH, Hansson EK. The effects of common medical 
interventions on pain, back function, and work resumption in patients 
with chronic low back pain. Spine 2000;25:3055-64.
    \13\ Van Tulder MV, Koes BW, Bouter LM. Conservative treatment of 
acute and chronic nonspecific low back pain. A systematic review of 
randomized controlled trials of the most common interventions. Spine 
1997;22:2128-56.
    \14\ Davis KG, Heaney CA. The relationship between psychosocial 
work characteristics and low back pain: underlying methodological 
issues. Clin Biomechanics 2000;15:389-406.
    \15\ Israel BA, Baker EA, Goldenhar LM, Heaney CA. Occupational 
stress, safety and health: conceptual framework and principles for 
effective prevention interventions. J Occup Health Psychol 1996;1:261-
86.
    \16\ Karasek RA, Theorell T. Healthy Work. New York:Basic Books, 
1990.
    \17\ Guastello SJ, Johnson EA, Rieke ML. Nonlinear dynamics of 
motivational flow. Nonlinear Dynamics, Psychology, and Life Sciences 
1999;3:259-73.
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    There are 4 cohort studies that bear witness. Two are ``natural'' 
experiments in that a captive workforce was followed through an 
interval when the psychosocial environment was purposely perturbed: In 
the early 1990's, the Finnish economy suffered a considerable setback 
lasting several years. Many workers were dismissed. The effect of 
impending downsizing on the local-government employees in one small 
city was monitored.\18\ The rate of absenteeism escalated, most 
markedly for sick leave ascribed to regional musculoskeletal disorders, 
particularly among employees over the age of 50.
---------------------------------------------------------------------------
    \18\ Vahtera J, Kivimakl M, Pentti J. Effect of organisational 
downsizing on health of employees. Lancet 1997;350:1124-8.
---------------------------------------------------------------------------
    The ``Whitehall'' studies are cohort studies of British civil 
servants that long ago documented an inverse relationship between civil 
service grade and mortality rate, particularly mortality from 
cardiovascular disease. In recent years it has become clear that the 
association with grade paled next to the association with psychosocial 
job ``stress'', particularly job ``control'', regardless of grade.\19\ 
Similar relationships with job ``stress'' pertain to sickness absence 
from disabling regional back pain.\20\ The ongoing nature of Whitehall 
studies made it possible to take scientific advantage of a natural 
experiment.\21\ In 1988, the British government announced a major 
restructuring. The Property Services Agency was to be ``privatized'' to 
which end its function was ``outsourced'' in 1992. These Orwellian 
terms fool no one, particularly the thousands of bureaucrats whose jobs 
were at risk. They realized that many of them would be without jobs, as 
was the fate of 41 percent in 1992, and that employment in the private 
sector was predictably insecure. What they couldn't have foretold was 
that their health would deteriorate during the 3 years anticipating 
``downsizing'' and sick leave would escalate. None of the trends could 
be ascribed to health-adverse behavior. Impending downsizing wreaks 
havoc on the psychosocial context of work inflicting ``stress'' and 
``strain'' on all.\22\ Downsizing accelerates that noxious, 
insalubrious, and lethal process we are denoting as an adverse 
``psychosocial'' work context. And it does so without regard for prior 
station in life.
---------------------------------------------------------------------------
    \19\ Bosma H, Peter R, Siegrist J, Marmot M. Two alternative job 
stress models and risk of coronary heart disease. Am J Public Health 
1998;88:68-74.
    \20\ Hemingway H, Shipley MJ, Stansfeld S, Marmot M. Sickness 
absence from back pain, psychosocial work characteristics and 
employment grade among office workers. Scand J Work Environ Health 
1997;23:121-9.
    \21\ Ferrie JE, Shipley MJ, Marmot MG, Stansfeld SA, Davey Smith G. 
An uncertain future: the health effects of threats to employment 
security in white-collar men and women. Am J Public Health 
1998;88:1030-6.
    \22\ Reissman DB, Orris P, Lacey R, Hartman DE. Downsizing, role 
demands, and job stress. J Occup Environ Med 1999;41:289-93.
---------------------------------------------------------------------------
    Even without the inflammatory influences of downsizing, an adverse 
psychosocial context works its harm. Slowly it will deprive one of 
favorable ``self-rated health'' (SRH). Like socioeconomic status, SRH 
is a powerful predictor of all-cause mortality, let alone the 
likelihood that one will seek care for regional musculoskeletal 
disorders.\23\ In a cohort of 5,001 Danish workers, adverse 
``psychosocial'' work context was shown to erode SRH over the 5 years 
of observation.\24\ A similar association has emerged from analysis of 
the nurses' health study; a perception that psychosocial work 
conditions were unfavorable predicted declining functional status among 
some 21,000 nurses followed for 4 years.\25\
---------------------------------------------------------------------------
    \23\ Croft P, Schollum J, Silman A. Population study of tender 
point counts and pain as evidence of fibromyalgia. BMJ 1994;309:696-9.
    \24\ Borg V, Kristensen TS, Burr H. Work environment and changes in 
self-rated health: a five year follow-up study. Stress Med 2000;16:37-
47.
    \25\ Cheng Y, Kawachi I, Coakley EH, Schwartz J, Colditz G. 
Association between psychosocial work characteristics and health 
functioning in American women: prospective study. BMJ 2000;320:1432-6.
---------------------------------------------------------------------------
    There are many lessons from the century of disabling regional 
backache.\26\ \27\ Most germane to our discussion today, there is no 
ergonomic solution. Ergonomics has a role in designing workplaces that 
are comfortable when we are well and accommodating when we are ill or 
aging. But ergonomic interventions will not decrease the likelihood 
that a worker will find his or her next episode of regional 
musculoskeletal pain disabling. And an ergonomic regulation of the kind 
recently proposed by OSHA will certainly prove harmful: Such a 
regulation will medicalize the workforce; no longer will it seem 
reasonable to cope with back or arm pain without demanding remedies 
that, for the moment, do not exist. It will perpetuate the sophism that 
task content is the culprit, and thereby inflame resentment. It will 
lead to task modifications that have never been shown to be helpful. 
And most importantly, the regulations enforce a sophistical social 
construction so that progress in science or policy is impeded.
---------------------------------------------------------------------------
    \26\ Hadler NM. Laboring for longevity. An annotated poem. J Occup 
Environ Med. 1999; 41:617-21.
    \27\ Hadler NM. Occupational Musculoskeletal Disorders. Second 
Edition. Philadelphia, Lippincott Williams & Wilkins. 1999. Pp. 1-433.
---------------------------------------------------------------------------
    We know better.
    Thank you for your attention.

    Senator Specter. Thank you, Doctor. Turn now to Ms. Peg 
Seminario, Director of the Department of Occupational Safety 
and Health, AFL-CIO.
STATEMENT OF PEG SEMINARIO, DIRECTOR, DEPARTMENT OF 
            OCCUPATIONAL SAFETY AND HEALTH, AFL-CIO
    Ms. Seminario. Good morning, Mr. Chairman and Senator 
Landrieu. Thank you for the invitation to testify today. I am 
Peg Seminario, Director of Safety and Health for the AFL-CIO.
    A couple of points. Work-related musculoskeletal disorders 
are a huge problem in the workplace today. We have heard the 
statistics referred to earlier today, one-third of all serious 
workplace injuries.
    The latest Bureau of Labor Statistics' survey showed 
582,000 of these cases that were serious enough to result in 
time off the job. Those come from employer reports. Those are 
not the AFL-CIO's numbers. Those are not even the Department of 
Labor's numbers. Those come from employer reports.
    And I think if you talk to individual employers, they would 
confirm that is what they see. I believe a statement was 
submitted to the record of this hearing by ALCOA by the 
steelworkers in ALCOA which said that for ALCOA that one third 
of all of their workplace injuries are musculoskeletal 
disorders. And in some sectors such as the auto industry and 
meat packing, it is even greater. And what we have also found 
is that these numbers really underestimate the problem.
    We did a comparison looking at Workers' Compensation data 
and Bureau of Labor Statistics' data thinking that we would 
find more cases on the OSHA log. What we found is there were 
more cases compensable, even though the criteria for 
compensation are much greater. We found twice as many cases in 
compensation than even under OSHA.
    So this is a huge problem for workers across the United 
States. It is a huge problem for employers. And I am always 
struck by coming to a forum such as this and all the work we 
have done over the last 10 years that what I hear from Mr. 
Fellner, Dr. Bigos and Dr. Hadler, it does not bear any 
relationship to the world that we know, the workplaces we know.
    There are a number of workers who have come to this hearing 
today who were with us yesterday as well. These people love 
their jobs. I mean, they really care about their jobs.
    Cindy Wright is a nurse's aid who was with us yesterday, 
suffered a very, very serious injury, rotator cuff problem, 
neck problem, from lifting a very heavy patient in a nursing 
home.
    She is crushed that she cannot go back to work. This is not 
about coping. She is injured. She is in pain. She needs help.
    This injury could have been prevented if they had used a 
mechanical lifting device. But Dr. Hadler would have you 
believe that, no, she just needs to cope better or she needs to 
like her job better.
    This is not the case. These are very significant serious 
injuries to workers. Again, they occur throughout all sectors 
of the economy. They are upper extremity problems, which as you 
have heard are a particular problem for women workers.
    They are problems of the low back, heavy lifting, 
repetition, awkward postures, vibration. We know the exposures 
that cause these problems. And what we have seen is that when 
employers put in place programs that evaluate these hazards, 
reduce exposure, yes, indeed, we see reductions in injuries. 
That is what we see. That is the real world.
    You can talk about whether there is consensus on this. 
Clearly as you have heard this morning there is not. But we 
would agree with Senator Specter that if we had waited for 
consensus on whether asbestos caused cancer, whether benzine 
caused leukemia, whether cotton dust caused byssinosis, we 
would still have workers in this country dying and being 
exposed today of these very, very serious hazards. And so there 
may not be consensus but there is evidence.
    I think if the committee looks at the reports of the 
National Academy of Sciences done in 1998, the recent report 
concluded in 2001, you will see that they are very 
comprehensive documents that involved a lot of folks, a lot of 
experts. The experts in the country, over 50 experts involved 
in the developments of those reports, they came to some very 
firm conclusions. And we would encourage you to look at those 
conclusions.
    Let me just say that there are approaches to dealing with 
these problems which we will talk about later today, but just 
to make the point that these are very real injuries. They are 
significant injuries. They disable a lot of workers in this 
country.

                           prepared statement

    This problem really needs a national response. And we are 
glad that Senator Specter is having this hearing to examine 
this issue so completely and that both Senator Landrieu and 
Senator Specter are on legislation directing the Department of 
Labor to issue a standard. Thank you.
    [The statement follows:]
                  Prepared Statement of Peg Seminario
    Mr. Chairman, members of the committee, my name is Peg Seminario. I 
am Director of Safety and Health for the AFL-CIO, a federation of 65 
national and international unions representing 13 million working men 
and women and their families. I appreciate the opportunity to testify 
at this special hearing on ergonomics and to present our views on why 
an OSHA ergonomics standard is urgently needed to protect workers in 
this country.
    The AFL-CIO has a long and deep interest and involvement in the 
ergonomics issue. Musculoskeletal disorders (MSDs) caused by exposure 
to ergonomic hazards are a major safety and health problem for our 
members and for all workers. In all economic sectors and in most 
industries, musculoskeletal disorders are the major source of workplace 
injury and illness. Workers in meatpacking, poultry, auto assembly, 
nursing homes, transportation, warehousing, construction, agriculture 
and data entry are among those at risk.
    For more than two decades, unions have been working hard to prevent 
these injuries through research, joint efforts with employers, union 
training programs, and by requesting OSHA enforcement actions under the 
general duty clause.
    Since the late 1980's, we have been seeking an OSHA standard to 
prevent unnecessary musculoskeletal disorders and to control ergonomic 
hazards. It has been ten years since former Secretary of Labor 
Elizabeth Dole committed the Department of Labor to ``taking the most 
effective steps necessary to address the problem of ergonomic hazards 
on an industry-wide basis'' and to develop an ergonomics standard. But, 
due to fierce industry and political opposition to any mandatory 
ergonomics standard, today workers have no legal protection against 
these hazards. During the past decade millions of workers have suffered 
unnecessary injury, illness and disability while an ergonomics standard 
has been delayed. More than 4,900 workers are injured each day that 
protections are further delayed. Since the OSHA ergonomics standard was 
repealed on March 21, 2001, more than 170,000 workers have suffered 
work-related musculoskeletal disorders.
  work-related musculoskeletal disorders are the nation's leading job 
                             safety problem
    Work-related musculoskeletal disorders are the leading type of 
occupational injury and illness in America today. These disorders 
include upper extremity disorders such as carpal tunnel syndrome, 
tendinitis, tenosynovitis, and rotator cuff injuries, and disorders of 
the low back.
    The Bureau of Labor Statistics (BLS) reports that over 582,000 
musculoskeletal disorders involving days away from work were reported 
by private sector employers in1999, accounting for more than one in 
three of all injuries and illnesses involving recuperation away from 
work. (Appendix A) The National Academy of Sciences, in its January 
2001 report, found that approximately one million people lose time from 
work each year due to musculoskeletal disorders.
    While the total number of lost-time MSDs reported by the Bureau of 
Labor Statistics has declined since 1992, the problem of workplace MSDs 
is still great. Despite the downward trend in total numbers of reported 
cases, MSDs have consistently accounted for more than one-third of 
total lost worktime cases since 1992. More disturbing, the downward 
trend seems to be reversing in some areas. According to the most recent 
BLS survey, the rate of injuries associated with repetitive motion rose 
from 1998 to 1999 in every industrial sector except finance, and 
increased over 9 percent nationally. The rate of injuries caused by 
overexertion increased in construction and mining in 1999, and the rate 
of illnesses caused by repeated trauma increased from 14.8/10,000 
workers to 17.6/10,000 workers in transportation.
    These large numbers of injuries reported by the BLS and NAS, 
however, do not represent the total scope of the problem. These cases 
represent only those injuries and illnesses which result in more than 
one day of lost time from work. Based upon the ratio of non-lost work-
time injuries to lost work-time injuries which occur in the workplace, 
(2 to 1), the Department of Labor has estimated that a total of 1.8 
million MSDs are reported by employers to the Bureau of Labor 
Statistics each year.
    But even this number understates the magnitude of the problem. The 
BLS survey only reports injury and illness data for the private sector. 
The injury experience of the more than 16 million state, county and 
local public sector workers, and 2.8 million Federal sector workers, 
including postal workers, is not reflected in the survey (Employment 
and Wage Annual Averages, 1997, BLS, 1998). While comprehensive and 
detailed injury data for these groups of workers is not collected, the 
data that is available shows that MSDs are a major problem for these 
workers as well. For the 28 states and territories where injury and 
illness data is collected for state and local public employees, in 
1998, the BLS reported 63,374 musculoskeletal disorders that resulted 
in lost work days.
    There is also extensive evidence that the BLS survey understates 
the extent of the MSD problem for private sector workers. More than 16 
studies submitted to the record of OSHA's rulemaking on ergonomics 
demonstrated significant under recording and under reporting of 
workplace injuries. Based on this evidence OSHA found that ``that for 
every reported MSD, another MSD goes unreported. Thus, the total number 
of work-related MSDs estimated by OSHA to occur in the United States 
annually is 3.6 million.'' (OSHA, 2000) This estimate does not include 
MSDs suffered by state, local or Federal employees.
    A comparison of data from the BLS survey, workers' compensation 
data and surveillance data for several states confirms that the BLS 
data under-represents the extent of work-related MSDs. A review by the 
AFL-CIO of available BLS data and state workers' compensation data on 
musculoskeletal disorders for three states--Massachusetts, Oregon and 
Washington--for a several year period in the 1990's found that the 
numbers of cases of MSDs reported to BLS were significantly less than 
the number of MSD cases accepted for workers' compensation--in many 
instances 50 percent less. These differences are even more significant 
since the criteria for compensation are much more restrictive than the 
recording and reporting criteria under the BLS survey (i.e. 
compensation for MSDs required 4 or 5 days off the job, compared to one 
day of lost time for reporting to BLS). See Appendix B.
    Recent studies have demonstrated that only a small percentage of 
workers suffering from work-related back injuries, carpal tunnel 
syndrome and other musculoskeletal disorders are filing workers' 
compensation claims for these injuries. A study published in the 
January 2000 ``Journal of Occupational and Environmental Medicine'' 
found that only 25 percent of the group of Michigan auto workers 
studied with diagnosed work-related musculoskeletal disorders filed for 
workers' compensation (Rosenman et al, 2000). A similar study of 
Connecticut workers found that only 10 percent of workers with 
musculoskeletal disorders filed workers' compensation claims (Morse et 
al, 1999).
    Based upon these studies, it appears that the under reporting of 
MSDs may be far greater than found by OSHA in its ergonomics rulemaking 
and the true magnitude of work related MSDs far greater than 3.6 
million cases a year.
    Work-related MSDs are among the most severe injuries facing 
American workers. The BLS reports that among major disabling injuries 
and illnesses, median days away from work are highest for carpal tunnel 
syndrome (27 days). This is significantly higher than the median days 
away from work for fractures or amputations.
    While MSDs occur in every sector and industry across the economy, 
some sectors have been hit harder than others. Over one quarter of all 
MSDs involving time away from work occur in the service sector and over 
one quarter in manufacturing. Nursing aides, orderlies, and attendants, 
along with registered nurses, accounted for almost 10 percent of all 
lost time work-related MSDs in the U.S. in 1999. Sixty-five percent of 
injuries and illnesses involving days away from work for nursing aides, 
orderlies and attendants are due to sprains and strains, while 60 
percent of Registered Nurses' injuries and illnesses are due to sprains 
and strains.
    BLS data show that for many types of MSDs involving the upper 
extremities, including carpal tunnel syndrome, women workers suffer a 
disproportionate number of injuries. In 1999, women suffered 67 percent 
of reported carpal tunnel syndrome cases (18,651) and 61 percent of 
reported tendinitis cases (10,127) even though women comprise about 46 
percent of the workforce and accounted for 33 percent of total 
workplace injuries (BLS, 1999). As with other musculoskeletal 
disorders, the number of cases of carpal tunnel syndrome, tendinitis 
and other repetitive motion injuries reported by BLS understates the 
extent of the problem found among these workers.
    Workers in meat packing plants have a repetitive trauma disorder 
incidence rate of 912 per 10,000 full time workers. Motor vehicle and 
car bodies have a rate of 685.5 and numerous textile and apparel 
sectors have rates exceeding 200.
    Ergonomic hazards are also a significant problem for workers in 
construction, maritime and agriculture. These sectors should be covered 
by an OSHA ergonomics standard just as they are currently covered by 
standards in the states of California and Washington. According to the 
BLS survey, in 1999 there were 52,800 reported cases of lost-time 
injuries resulting from overexertion and repetitive motion in these 
sectors. These types of injuries accounted for 23 percent of all 
reported lost work-time injuries in construction, 21 percent of 
reported lost time injuries in maritime (SIC Codes 44 and 373), and 18 
percent of reported lost work-time injuries in agriculture. A large 
percentage of construction workers suffer from back injuries, shoulder 
injuries and other musculoskeletal disorders.
  the toll of musculoskeletal disorders on workers and the economy is 
                                 great
    Musculoskeletal disorders are painful, disabling, costly injuries. 
According to the National Academy of Sciences, a conservative estimate 
of the costs imposed by MSDs on the American economy is between $45 and 
$54 billion every year (NRC/IOM, 2001). These figures only include the 
actual monetary losses that result from MSDs, but do not account for 
the enormous pain, suffering and disability that these preventable 
disorders cause.
    The pain and toll of these injuries was described by dozens of 
injured workers who testified at OSHA's ergonomic hearings on why a 
standard was so important--workers like Ron Kline, an auto worker from 
Maryland, Carol Py, a clerk typist from Pennsylvania and Nancy Foley a 
newspaper reporter from Massachusetts, all who developed serious work-
related MSDs.

    ``Starting with my right elbow, the illness became so severe, I 
could not lift the air gun. As this was occurring, my reaction was to 
start using my left hand to complete my assignment.
    ``As the pain worsened, even with local treatment from the 
dispensary, it required surgery.
    ``The time away from work for my right arm required 13 weeks away 
from work with less than complete recovery, leaving me with 15 percent 
permanent loss of full use of my right arm.
    ``I also endured one year of physical therapy for my right arm.
    ``Subsequently, I required surgery on my left arm with seven weeks 
away from work.'' (Oral testimony of Ron Kline at OSHA Ergonomics 
Hearings, Tr. 7950)
                                 ______
                                 
    ``I developed cumulative trauma disorder which is like multiple 
muscular injuries due to repetitive motion, DeQuervains disease in my 
thumb here, cubital tunnel syndrome which is the ulnar nerve, 
compression of the ulnar nerve the elbow and trigger finger.
    ``During the next 12 months, the pain in my hand was so unbearable 
that I had to have repeat surgery on my right hand. I have trouble 
turning the pages. I never returned to work as my medical restrictions 
were so limited that my company could not find me a job.
    ``Last year, I had surgery on my other hand because my thumb would 
not move.
    ``Today, I have difficulty driving, cleaning, cooking, and food 
shopping. And my husband, he mostly does all my shopping for me. And my 
grandchildren do a lot of the cleaning for me, too. The yard work is 
out of the question since I cannot rake or mow the lawn. I had to give 
up the things that I used to love like sewing and gardening. Before I 
was injured, I even had a green belt in karate. My arms are so weak now 
that I can barely take care of my three grandchildren.'' (Oral 
testimony of Carol Py at OSHA Ergonomics Hearings, Tr. 6321-6322).
                                 ______
                                 
    ``By the time I left the newspaper I was so severely injured that 
my recovery has been very slow. I may never fully recover. I live with 
chronic pain every day. Sitting still triggers pain. I have trouble 
carrying groceries into my house and doing simple housekeeping tasks. I 
am trying to retrain to be a school teacher, but my injuries make the 
retraining difficult. I do my school work by lying in bed and talking 
into a voice-activated computer.
    ``I loved my job. I remember thinking how lucky I was to have a job 
that was so much fun. It was a great disappointment to me to have to 
give it up...I have suffered from severe depression as a result of 
losing my career and living with chronic pain. I have lost thousands of 
dollars in income. I had hoped to have children some day, but I cannot 
pick up and carry my eight-month old niece.'' (Oral testimony of Nancy 
Foley at OSHA Ergonomics Hearings, Tr. 7321-22).

    The pain and disability caused by musculoskeletal disorders is 
widespread. Dr. Robin Herbert of the Mt. Sinai Medical Center, an 
occupational physician who testified at the OSHA's ergonomics hearings 
reported that 25 percent of her patients with musculoskeletal disorders 
have permanent disabilities, and of those 25 percent, ten percent are 
never able to return to work (Oral testimony at OSHA Ergonomics 
Hearings, Tr. 1736-37). Preliminary results of one study showed that 15 
percent of all patients with MSDs of the upper extremities are 
characterized as disabled (Oral testimony at OSHA Ergonomics Hearings, 
Tr. 1738). In New York State, between 1993-1995, 86 percent of workers 
with carpal tunnel syndrome were deemed to be permanently disabled by 
workers' compensation judges (Herbert, 1999). A study of workers' 
compensation claims for ergonomic injuries in North Carolina found that 
19.4 percent of the injuries resulted in permanent partial disability; 
22 percent of the claimants were unable to return to work (Waldorf and 
Snow, 1996).
    The financial and social consequences of these injuries on workers 
are significant. Many injured workers receive no workers' compensation. 
Their injuries and disabilities destroy or severely limit their ability 
to make a living. Financial burdens created by these injuries result in 
workers losing their homes, cars and health insurance. Injured workers 
are often unable to lead a normal life experiencing great difficulty 
performing routine activities such as writing, cleaning, caring for 
children, bathing and driving a car. The effects of these injuries on 
injured workers' well-being is also significant. Workers suffering MSDs 
report higher levels of depression, anxiety and stress at home.
    the scientific evidence in support of an ergonomics standard is 
                          extensive and strong
    A broad, extensive, and overwhelming body of scientific evidence 
firmly establishes that musculoskeletal disorders are caused by 
exposures to workplace ergonomic risk factors--force, repetition, 
awkward postures and vibration. This conclusion is strongly supported 
by evidence obtained from epidemiological studies of worker 
populations, laboratory findings, and the clinical experience of 
physicians and health care professionals.
    Three recent authoritative and comprehensive reviews of the 
scientific literature conclude that exposure to ergonomic hazards in 
the workplace causes musculoskeletal disorders. These are a 1997 report 
by the National Institute for Occupational Safety and Health, 
``Musculoskeletal Disorders and Workplace Factors,'' and two 
congressionally-mandated reports by the National Academy of Sciences, 
``Work-Related Musculoskeletal Disorders,'' completed in 1999, and 
``Musculoskeletal Disorders and the Workplace,'' completed in 2001.
    In evaluating the extensive body of scientific literature, 
comprising over 800 research studies and references, the January 2001 
NAS report concluded that:
  --``The panel's review of the research literature in epidemiology, 
        biomechanics, tissue mechanobiology, and workplace intervention 
        strategies has identified a rich and consistent pattern of 
        evidence that support a relationship between the workplace and 
        the occurrence of MSDs of the lower back and upper 
        extremities.''
  --``The basic biology and biomechanics literatures provide evidence 
        of plausible mechanisms for the association between 
        musculoskeletal disorders and workplace physical exposures.''
    The research literature has identified the biomechanical risk 
factors in the workplace that pose a hazard to workers of developing a 
musculoskeletal disorder affecting the lower back and upper 
extremities. Workplace biomechanical risk factors that can cause MSDs 
include force, repetition, vibration, awkward postures, and heavy 
lifting. As the 2001 NAS report summarized:
  --``The panel concludes that there is a clear relationship between 
        back disorders and physical load; that is, material handling, 
        load movement, frequent bending and twisting, heavy physical 
        work, and whole-body vibration. For disorders of the upper 
        extremities, repetition, force and vibration are particularly 
        important work-related factors.''
  --``Low back disorder risk has been established through 
        epidemiological studies of work that involves heavy lifting, 
        frequent bending and twisting, and whole body vibration, as 
        well as other risk factors.''
  --``The pattern of evidence for upper extremity disorders, as for the 
        low back, also supports an important role for physical factors, 
        particularly repetition, force and vibration.''
    As noted above, the 1998 and 2001 National Academy of Sciences 
studies on work-related musculoskeletal disorders were the result of 
Congressional requests for a review of the scientific evidence on work-
related musculoskeletal disorders. Both of these reviews concluded that 
there is a strong body of evidence that musculoskeletal disorders are 
associated with exposure to workplace ergonomic risk factors and that 
there are effective interventions to reduce the risk of these 
disorders. The Congress and the Bush Administration should endorse 
these findings and support the issuance of a new ergonomics standard to 
protect workers.
     an osha ergonomics standard is needed to protect workers from 
                       musculoskeletal disorders
    The key finding motivating Congress to enact the Occupational 
Safety and Health Act in 1970 was the fact that ``personal injuries and 
illnesses arising out of work situations impose a substantial burden 
upon, and are a hindrance to, interstate commerce in terms of lost 
production, wage loss, medical expenses, and disability compensation 
payments,'' 29 U.S.C. Sec. 651(a). The purpose of the Act was to assure 
so far as possible every working man and woman in the nation safe and 
healthful working conditions and to preserve the country's human 
resources.
    As the major source of job injury and illness in the nation today 
costing more than $45-$50 billion a year, work-related musculoskeletal 
disorders are precisely the type of problem that the Act was intended 
to address. Just as the Congress acted in 1970 and passed the 
Occupational Safety and Health Act to address the high toll and cost of 
workplace injuries and illnesses, it is imperative that OSHA promulgate 
an ergonomics standard to address the toll and cost of musculoskeletal 
disorders.
    The severity of the problem of MSDs and the need for government 
action was recognized more than 10 years ago by Secretary of Labor 
Elizabeth Dole when she committed to taking the most effective steps 
necessary to address the problem of ergonomic hazards. The need for 
such action was reaffirmed in 1992 by Secretary of Labor Lynn Martin 
when she initiated rulemaking on an OSHA ergonomics standard in 
response to a petition from the United Food and Commercial Workers, 
AFL-CIO and many unions.
    Unfortunately ideological opposition to government action by 
industry groups and some in Congress has delayed and blocked these 
needed protections. More than 10 years after government action was 
promised, workers still lack legal protection against ergonomic 
hazards.
    In the aftermath of the recent action by Congress and the Bush 
Administration to repeal OSHA's November 2000 ergonomics standard, 
Secretary of Labor Elaine Chao committed the Department of Labor to 
developing a comprehensive approach to address musculoskeletal 
disorders. The AFL-CIO supports and has long advocated a comprehensive 
approach to addressing MSDs. But any approach to addressing MSDs must 
have as its core and foundation a mandatory protective OSHA standard. 
Voluntary compliance assistance, outreach, education and further 
research can and should complement and supplement regulatory action. 
But voluntary approaches alone are insufficient to provide workers the 
protection they need and deserve.
    Indeed, the major advances in protecting workers from MSDs and 
implementation of workplace ergonomic programs have come as a result of 
mandatory action required by OSHA enforcement under the general duty 
clause. Ergonomic programs in auto manufacturing, meatpacking, poultry, 
and garment industries all have their roots in the settlement 
agreements that stemmed from OSHA enforcement actions. It is necessary 
and appropriate to extend these same protections by regulation to all 
sectors and workplaces where workers face a significant risk of 
musculoskeletal disorders.
    The AFL-CIO has long advocated that an OSHA ergonomics standard be 
based on the good employer practices that have been demonstrated to be 
effective at reducing the incidence and severity of work-related MSDs. 
As the National Academy of Sciences (NRC/IOM, 2001) and General 
Accounting Office (GAO, 1997) have both reported, these effective 
practices implement ergonomic principles and follow a programmatic 
approach which includes employer commitment and employee participation, 
job analyses and control, training and medical management.
    These basic elements form the foundation of OSHA's 1990 Meatpacking 
Guidelines and settlement agreements that have been implemented 
successfully in key industries. These basic elements also form the 
basis of many employer ergonomic programs that have been effective at 
reducing MSDs. They also form the basis of the voluntary standard on 
MSDs which is being developed by the Z 365 ANSI standard setting 
committee. These basic elements were also the backbone of the November 
2000 ergonomics standard issued by OSHA.
    To be effective at preventing injuries and consistent with the 
OSHAct, the AFL-CIO believes that an OSHA ergonomics standard should 
also do the following:
  --Cover all sectors and all workers at significant risk of injury. 
        OSHA's November 2000 ergonomic standard was limited to general 
        industry and excluded construction, maritime, agriculture and 
        railroads. MSDs are a major source of injury and illness for 
        workers in all sectors. State ergonomic standards in California 
        and Washington apply to all employers and workers. Any Federal 
        OSHA ergonomics standard should cover workers in all sectors as 
        well.
  --Be pro-active and preventive. OSHA's November 2000 standard was 
        triggered only in response to worker reports of MSD injuries or 
        persistent symptoms, when workers also had significant exposure 
        to identified ergonomic risk factors. In the absence of any 
        injury, no action was required, even if the employer had 
        knowledge that serious hazards were present. All other OSHA 
        standards are triggered by worker exposure to hazards, not 
        reports of injuries. To be preventive an ergonomics standard 
        should respond to hazardous exposure, whether or not an injury 
        has occurred.
  --Provide for early detection of MSDs and early intervention. MSDs 
        are cumulative progressive injuries that become more serious, 
        disabling and costly with continued exposure. One of the keys 
        to a successful ergonomics program is the early detection of 
        these injuries, so interventions can be made before damage is 
        serious and permanent. Early detection and intervention is also 
        key to reducing the cost of these injuries.
  --Encourage reporting of MSDs and hazards and participation by 
        workers and their representatives. The early detection of MSDs 
        is only possible if workers feel free to report MSDs and MSD 
        hazards. Any standard must prohibit discrimination and 
        retaliation against workers who make such reports and prohibit 
        practices or policies that discourage worker reports. Such 
        provisions were appropriately included in OSHA's ergonomics 
        standard. To encourage early reporting and participation in any 
        medical management program, employees should not have to face 
        loss of wages for making these reports. This was the purpose of 
        the work restriction protection provision of OSHA's ergonomics 
        rule. The standard mandated that an employer follow a health 
        care provider's medical determination for job restriction of 
        injured workers. It also provided that on a temporary basis 
        when such restrictions were required, workers should not have 
        to lose wages or benefits.
      This work restriction protection was not a workers' compensation 
        system. It's purpose was to encourage early reporting, not 
        after the fact compensation. It, in no way changed or altered 
        workers' compensation laws or benefits. Similar provisions have 
        been included in OSHA standards since 1978 when medical removal 
        protection was included in OSHA's lead standard. Such 
        provisions have been upheld by reviewing courts as permissible 
        and appropriate protective measures under the OSHAct. Such a 
        provision should be included in an OSHA's ergonomics standard.
  --Provide for the reduction of exposure to ergonomic hazards to the 
        extent feasible. The reduction of exposure to ergonomic risk 
        factors--force, repetition, awkward posture, and vibration--
        must be the heart of any ergonomics standard, just as it is the 
        heart of all OSHA standards. An ergonomics standard must 
        require employers to reduce exposures to ergonomic risk factors 
        so they no longer pose a hazard, or if that is not possible, 
        reduce them to the extent feasible.
    As stated earlier, some employers have already taken action and 
implemented measures similar to those outlined above to protect 
workers. Many countries around the globe have implemented ergonomic 
standards or manual handling standards. These include British Columbia, 
Canada, Australia, Sweden and the member states of the European 
Community which have adopted regulations to implement the European 
Community directive on manual handling (Council Directive 90/269/EEC, 
May 29, 1990) and directive on video display terminal use (Council 
Directive 90/270/EEC, May 29, 1990).
    The only reason why a mandatory ergonomics standard is not in place 
in the United States today is because of the fierce ideological 
opposition by some business groups, including the U.S. Chamber of 
Commerce and the National Association of Manufacturers, and others to 
any government intervention on this issue.
    For 10 years these business groups have opposed any and every 
attempt to regulate ergonomics at the state and Federal level. They 
opposed state standards in California, North Carolina and Washington. 
They opposed efforts by states and Federal OSHA to enforce against 
ergonomic hazards under the general duty clause. They are now 
challenging longstanding OSHA regulations that require musculoskeletal 
disorders to be recorded on the OSHA log. They are even trying to block 
a voluntary ANSI standard on MSDs that is now close to being finalized.
    The misrepresentation by these groups of the facts and the science 
and their fierce opposition to any ergonomic protections is directly 
responsible for the serious and preventable injury to millions of 
workers in this country. Unfortunately this past March, a majority in 
the Congress and President Bush decided to side with these opponents of 
protections and acted to repeal OSHA's ergonomics standard.
    We believe that it is time that Congress, elected to be the 
people's representatives, and the Bush Administration started doing the 
people's business. The Department of Labor should act immediately to 
issue--and the Congress should support--a new ergonomics standard to 
protect the working men and women of this country.




           Appendix B--MSD Data Comparison From Three States

                              WORK-RELATED CARPAL TUNNEL SYNDROME IN MASSACHUSETTS
                         [Massachusetts SENSOR Program vs. Massachusetts BLS, 1993-1996]
----------------------------------------------------------------------------------------------------------------
                                                                    Massachusetts SENSOR
                                                          ----------------------------------------   CTS cases
                                                                          Additional     Total      reported by
                           Year                             All workers   physician      unique    Massachusetts
                                                           compensation    reported      SENSOR         BLS
                                                               cases      only cases     cases
----------------------------------------------------------------------------------------------------------------
1993.....................................................         1,076          281        1,357           379
1994.....................................................         1,156          185        1,341           627
1995.....................................................           885           86          971           321
1996.....................................................           915          104        1,019           431
----------------------------------------------------------------------------------------------------------------
Source: The Commonwealth of Massachusetts, Executive Office of Health and Human Services, Department of Public
  Health, January 20, 1999.


                                       MUSCULOSKELETAL DISORDERS IN OREGON
                         [Number of Injuries by Event that Caused the Injury, 1992-1994]
----------------------------------------------------------------------------------------------------------------
                                                                  1992              1993              1994
                                                           -----------------------------------------------------
                                                             WC \1\  BLS \2\     WC      BLS       WC      BLS
----------------------------------------------------------------------------------------------------------------
Repetitive Motion.........................................      545      950    1,038      857    1,521    1,156
Overexertion..............................................   12,325    7,966   11,786    7,752   11,697    7,315
                                                           -----------------------------------------------------
      Total...............................................   12,870    8,916   12,824    8,609   13,218    8,471
----------------------------------------------------------------------------------------------------------------
\1\ There are time-loss-claims with 4 or more days away from work. Private insurers accounted for 49 percent of
  the claims, the SAIF Corporation for 31 percent, and self-insured companies for 20 percent.
\2\ Number of private industry nonfatal occupational injuries and illnesses involving three or more days away
  from work. Days-away-from-work cases include those which result in days away from work with or without
  restricted work activity.

Source: BLS State data for 1992, 1993, 1994 and ``Oregon Workers' Compensation Characteristics Calendar Year
  1995,'' Research & Analysis Section, Oregon Department of Consumer & Business Services, June 1997.


                                        MUSCULOSKELETAL DISORDERS RESULTING FROM OVEREXERTION IN WASHINGTON STATE
                                                  [Industrial Insurance Claims vs. BLS Data, 1992-1994]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               BLS data \1\                       Industrial insurance claims \2\
                                                                 ---------------------------------------------------------------------------------------
                              Year                                  1 or more days      3 or more days       Total # MSD \3\      Total # time-loss MSD
                                                                  away--overexertion  away--overexertion  claims--overexertion  Claims \4\--overexertion
--------------------------------------------------------------------------------------------------------------------------------------------------------
1992............................................................           17,107              13,258               48,019                  21,575
1993............................................................           16,488              12,514               46,970                  20,578
1994............................................................           14,345              11,046               45,747                  19,768
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Reflects both State fund and Self Insured employers.
\2\ The term claims refers to accepted claims only. Data reflects both State fund and Self Insured employers.
\3\ MSDs can include strains/sprains, joint inflammation, lower back pain and nerve compression syndromes. 93 percent of all MSD claims were coded
  overexertion.
\4\ Washington State defines time loss claims as those claims with 4 or more days away from work and includes claims where the employee is kept on
  salary, has loss of earning power or provisional time loss.

Source: ``Work-Related Musculoskeletal Disorders: Washington State Summary 1992-1994,'' State of Washington Dept. of Labor and Industries, Oct. 1996 and
  data from the State of Washington Dept. of Labor and Industries, Jan/Feb 1999.

    Senator Specter. Thank you very much. Dr. Bradley Evanoff 
of Washington University School of Medicine.
STATEMENT OF DR. BRADLEY EVANOFF, ASSISTANT PROFESSOR 
            OF MEDICINE, WASHINGTON UNIVERSITY SCHOOL 
            OF MEDICINE
    Dr. Evanoff. Mr. Chairman, Senator Landrieu, as a general 
internist and occupational health physician, I diagnose and 
treat patients with both work-related and nonwork-related 
illnesses and carry out research on musculoskeletal disorders. 
Thank you for the opportunity to address the committee today. I 
will attempt to answer the specific questions which are posed 
to our panel.
    What types of injuries occur? The term musculoskeletal 
disease is not a single diagnosis but represents a group of 
well-recognized injuries and diseases which affect the bones, 
joints, muscles, tendons, and nerves. Examples of these 
conditions include hand/wrist tendonitis, epicondylitis, low 
back pain, and carpal tunnel syndrome.
    Specific objective criteria exists for the diagnosis of 
these musculoskeletal disorders. For example, the American 
College of Occupational and Environmental Medicine has issued 
practice guidelines containing specific diagnostic criteria 
from more than 50 distinct musculoskeletal disorders which may 
be related to work.
    These diagnoses are based on patients' symptoms and on 
physical examination findings by a treating clinician, and when 
appropriate, laboratory and radiographic tests. Musculoskeletal 
disorders are routinely diagnosed by physicians all over the 
world.
    Who suffers these injuries? Musculoskeletal disorders are 
seen in a variety of patients and have a variety of causes. 
Factors such as age, gender, and coexisting diseases all 
influence the probability that a person will suffer from an 
MSD. However, workplace exposures are among the most important 
determinants of musculoskeletal disorders in many working 
populations.
    Physicians who evaluate working people with a 
musculoskeletal disorder routinely evaluate whether their 
patient's condition is work-related or not by considering both 
work- and nonwork-related factors. In evaluating work 
relatedness, physicians can rely on a large body of literature 
showing that certain musculoskeletal disorders are seen much 
more frequently in workers whose jobs involved repeated 
forceful use of the hands and arms, repeated heavy lifting or 
bending of the back, or exposure to vibration.
    When taken as a whole, the medical literature shows that 
increased exposure to these physical factors is associated with 
a greater risk of an injury.
    Worker groups at increased risk include nurses and nurses' 
aids, garment workers, construction workers, meat packers and 
other food processing workers, and workers in manufacturing and 
agriculture.
    How many suffer MSDs and what is their severity? 
Musculoskeletal disorders are clearly the most common group of 
occupational diseases and injuries and account for the majority 
of lost time, lost productivity and workers' compensation 
costs.
    Data from the Bureau of Labor Statistics indicate that 
there are almost 600,000 lost workday cases due to repetitive 
trauma and overexertion annually. The National Academy of 
Sciences estimates that almost 1 million lost workday cases 
occur annually.
    It is important to know that these figures are 
underestimates. They do not include cases for which no lost 
workdays occurred. And a number of studies show that employers 
and workers routinely under report the occurrence of these 
disorders.
    Musculoskeletal disorders represent an enormous burden to 
our country in terms of lost productivity and personal 
suffering. Conservative estimates of national costs for 
musculoskeletal disorders are around $50 billion annually.
    The National Academy of Sciences estimated that the cost 
may exceed 1 percent of our gross domestic product.
    The personal cost to workers are much harder to quantify. 
Many of my patients are unable to perform not only work duties 
but simple daily activities such as carrying groceries, opening 
a jar or lifting a child. While many patients recover quickly 
from these disorders, others have prolonged disabilities.

                           prepared statement

    In summary, musculoskeletal disorders are commonly accepted 
conditions which can be confidently diagnosed. The personal and 
economic costs of this disorders are high, and workplace 
physical exposures are a prominent and preventable risk factor.
    In my opinion, an adequate scientific basis exists to 
support a standard. Thank you.
    [The statement follows:]
               Prepared Statement of Dr. Bradley Evanoff
    My qualifications to testify: I am a physician and researcher with 
over ten years of experience in treating and studying occupational 
musculoskeletal disorders (MSDs). I am currently an Assistant Professor 
of Medicine at Washington University School of Medicine, where I am 
Chief of the Division of General Medical Sciences and the Richard and 
Elizabeth Henby Sutter Chair of Occupational, Industrial, and 
Environmental Medicine. As a medical researcher, I have published more 
than two dozen peer-reviewed journal articles, dealing primarily with 
the diagnosis and treatment of musculoskeletal disorders and the 
prevention of work-related injuries. I have also presented findings of 
my research at numerous scientific meetings, and have served as the 
chairperson of sessions at scientific meetings devoted to the 
prevention of occupational musculoskeletal disorders. I serve as a 
reviewer for several medical and public health journals. I have been 
involved in the national debate concerning ergonomics and work-related 
musculoskeletal disorders through my participation as an invited 
speaker at the 1998 National Academy of Sciences meeting on ``Work-
Related Musculoskeletal Disorders: A Review of the Evidence.'' I have 
also served as a member of the American National Standards Institute, 
Accredited Standards Committee on Control of Cumulative Trauma 
Disorders.
    My interests in musculoskeletal disorders were shaped by my 
clinical experiences in treating injured workers. I was originally 
interested in occupational cancer research, but as I spent more time in 
the field of occupational health, I realized that musculoskeletal 
disorders were by far the largest preventable cause of morbidity and 
disability among the working populations which I treated. As a treating 
physician, I diagnose and treat patients every week who have work-
related musculoskeletal problems such as back pain, tendonitis, and 
carpal tunnel syndrome. Over the course of my career, I have treated 
several thousand workers with musculoskeletal disorders related to 
their work. Many of these disorders could have been prevented or 
subsequent disability reduced through better job design and more timely 
medical treatment which took work factors into account.
    I feel that I am fortunate to be involved in many aspects of work-
related musculoskeletal problems--I treat individual workers, I advise 
employers on programs to prevent musculoskeletal problems, and I engage 
in research on the causes of these disorders and the effectiveness of 
interventions aimed at reducing their number and severity. There is no 
question that a great deal of suffering, job displacement, and economic 
loss is due to musculoskeletal disorders. It is also clear that many of 
these disorders are preventable, and that appropriate action can reduce 
this disease burden.
    I have based my opinions on my professional background and 
training, which includes clinical experience treating patients with 
MSDs, research experience in performing and analyzing studies of work-
related MSDs, and work on intervention programs to reduce MSDs in 
working populations. Based on the existing scientific evidence and my 
own professional experiences, I conclude that there is strong evidence 
that certain work exposures are causally related to carpal tunnel 
syndrome, tendonitis, back pain, and other MSDs among workers. This 
conclusion takes into account the strengths and limitations of existing 
studies, including issues of confounding, bias, and research design. 
The existing research base is also consistent with my clinical 
experience, where I have seen thousands of workers with clinically 
diagnosed musculoskeletal disorders associated with the same physical 
risk factors described in the scientific literature. Existing research 
and my own clinical and administrative experiences have demonstrated 
that ergonomic interventions can prevent injuries in a cost-efficient 
manner, and that improved medical treatment programs can prevent 
disability from work-related MSDs.
adequate scientific and clinical basis exists to support an ergonomics 
                                standard
    The workforce of our nation incurs a large number of 
musculoskeletal illnesses and injuries which are caused by or related 
to workplace exposures. Many of these disorders are preventable. Both 
my academic and my clinical experiences indicate that MSDs can be 
reliably diagnosed using accepted clinical guidelines, that a 
substantial proportion of MSDs are related to exposure to workplace 
physical factors, and that a significant part of this burden is 
preventable.
    Acute and chronic work-related musculoskeletal disorders (MSDs) 
affect an estimated 19 million persons per year in the United States 
and account for the majority of workers' compensation costs nationwide 
(Bernard 1997, Webster and Snook 1994). Over the past two decades, 
there has been considerable evidence presented in the scientific and 
medical literature which supports a causal relationship between work 
activities and musculoskeletal disorders, including back pain, carpal 
tunnel syndrome, and tendonitis. The available literature when taken as 
a whole strongly supports the presence of a causal association between 
exposure to certain workplace physical activities and the development 
of specific MSDs. The actions of health and safety professionals all 
over the country reflect the knowledge that workplace exposures should 
be reduced in order to reduce injuries and disability.
    The evidence for a causal association between work exposures and 
musculoskeletal disorders has been well summarized by researchers at 
the National Institute for Occupational Safety and Health (Bernard 
1997) as well as by international scientific panels and by regulatory 
agencies in other countries. (Kourinka and Forcier 1995) The National 
Academy of Sciences convened a multidisciplinary international expert 
panel in 1998 to review available evidence on work-related 
musculoskeletal disorders. I was one of the invited participants in 
this process. After thorough review of available scientific evidence, 
including conflicting points of view, the National Academy of Sciences 
concluded that musculoskeletal disorders were a major source of 
disability and economic loss, that workplace physical exposures were an 
important cause of these disorders, and that interventions to reduce 
workplace physical exposures could reduce the number of musculoskeletal 
disorders. Multiple expert panels and individual scientists reviewing 
the scientific evidence have arrived at these same conclusions, as has 
a second review completed by the National Academy of Sciences, released 
earlier this year.
    The conclusions of this second panel report by the National Academy 
of Sciences unambiguously support important arguments in favor of an 
ergonomics standard. The panel found strong and consistent evidence 
from both epidemiologic studies and biomechanical studies to support a 
relationship between workplace physical exposures and the occurrence of 
MSDs of the low back and upper extremities. The panel found that 
existing research demonstrated the effectiveness of appropriate 
ergonomic interventions in reducing the risk of low back pain and upper 
extremity symptoms. The panel found that work-related musculoskeletal 
disorders are a major source of costs and morbidity, and that some of 
this burden to society and to individuals is preventable.
    A number of non-governmental groups have taken actions based on the 
evidence available. After concluding that sufficient evidence existed 
to promote a standard intended to protect worker health and safety, the 
American Conference of Governmental Industrial Hygienists (ACGIH) 
recently announced exposure limits for physical exposures in order to 
reduce musculoskeletal disorders. The ACGIH is a respected and 
authoritative non-governmental body which publishes exposure limits for 
chemical and physical hazards which are widely used in industry. The 
American College of Occupational and Environmental Medicine has 
published practice guidelines which clearly link workplace physical 
exposures to musculoskeletal disorders. The American National Standards 
Institute has a committee charged with creating a national industrial 
standard to reduce work-related musculoskeletal disorders. These and 
other groups have acted because of the scientific evidence showing that 
MSDs are a serious problem, that workplace exposures are related to 
many MSDs, and that the risk of harm to employees can be diminished by 
reduction in physical exposures.
    My own reviews of the scientific literature (Evanoff 1999, Evanoff 
and Rempel 1998) have found that musculoskeletal disorders have been 
studied in a variety of work settings. Numerous studies have shown that 
higher rates of these disorders are seen among workers whose jobs 
demand repetitive or forceful movements, or who are subject to 
vibration or prolonged awkward postures. Systematic review of the 
medical and scientific literature shows that there is evidence of a 
causal relationship between work factors and carpal tunnel syndrome, 
tendonitis of the hand and wrist, epicondylitis, neck disorders, 
shoulder disorders, and low back disorders.
    Opponents of an ergonomics standard have attacked the scientific 
basis of the standard by suggesting that MSDs do not represent 
``objectively'' diagnosed entities, and consist only of worker-reported 
aches and pains. On the contrary, most MSDs fall into well recognized 
and commonly accepted diagnostic classifications which utilize both 
symptoms and specific signs detected on physical examination by a 
health care provider. It must be recognized that ``MSD'' is not a 
diagnosis itself, but a term used to group many different diagnoses 
affecting different body parts. For example, the practice guidelines 
promulgated by the American College of Occupational and Environmental 
Medicine list ``Diagnostic Criteria'' for more than fifty separate 
musculoskeletal disorders. These conditions include such diagnoses as 
lateral and medial epicondylitis, ulnar and radial nerve entrapment, 
shoulder impingement, rotator cuff tear, wrist tendonitis/
tenosynovitis, DeQuervain's tenosynovitis, trigger finger, and carpal 
tunnel syndrome. These diagnostic criteria include mechanism of injury, 
patient symptoms, physical examination maneuvers, and for some 
disorders, diagnostic test results. The described mechanisms of injury 
for over two dozen listed disorders include repetitive use, chronic 
overuse, or repeated trauma.
    Good quality epidemiologic studies have used definitions of MSDs 
which require combinations of symptoms and physical examination 
findings which are similar or identical to the information used to 
diagnose patients in clinical practice. Many of the MSD definitions 
used in the epidemiologic studies are the same definitions of MSDs 
described in medical textbooks and in practice guidelines. The work 
exposures described in the scientific literature are reflected in the 
work exposures reported by my patients with musculoskeletal disorders, 
and by the work exposures which I have observed on visits to workplaces 
with high rates of musculoskeletal disorders. These same work exposures 
are the ones cited by the American College of Occupational and 
Environmental Medicine in their practice guidelines and by the ACGIH in 
their threshold limit values for physical exposures.
 the importance of early recognition and appropriate treatment of msds
    The proposed OSHA ergonomics standard required early access to 
appropriate medical treatment, evaluation of workers' jobs when there 
has been a MSD, and the provision of limited or modified work duties 
when necessary, including when recommended by a health care provider. 
Each of these individual provisions is supported by current research 
and clinical practice. In addition, there is good evidence that 
comprehensive programs which integrate ergonomic changes and medical 
treatment are effective in reducing the incidence and severity of work-
related musculoskeletal disorders.
    Early recognition and treatment of musculoskeletal disorders is 
essential because it allows earlier treatment of affected workers, at a 
time when treatment can prevent progression to a more severe condition. 
Workers who are treated in the early stages of a disorder have a better 
prognosis, and are less likely to have prolonged disability, than 
workers who receive appropriate medical attention only after prolonged 
duration of symptoms. The medical literature consistently supports the 
observation that conservative management is most effective when begun 
in the early stages of these disorders, and that patients who are 
treated only after a prolonged symptomatic period are less likely to 
respond favorably than those treated earlier (Gelberman et al., 1980; 
Dellon, 1989; Stern, 1990; Rystrom & Eversman, 1991). With some 
disorders, such as carpal tunnel syndrome, patients can often be 
treated conservatively in the early stages of disease, while surgery is 
often necessary when patients present with advanced disease. Early 
detection is necessary to ensure that signs and symptoms of work-
related MSDs are recognized and treated appropriately through medical 
management, administrative controls, and job evaluation.
    Both healthy and injured workers can potentially benefit from 
evaluation of their workplace for identification of physical stressors 
that can be eliminated. Simple modifications can often be made to a 
workplace which enable the work to be done with less effort on the part 
of the worker. Such modifications, where possible, can prevent injury 
and can enable injured workers to safely return to their usual jobs 
more quickly. Clinical experience demonstrates that ergonomic 
evaluation and intervention is effective in the treatment of workers 
being treated for a work-related MSD, since earlier safe return to work 
is facilitated when clinicians have more information about a patient's 
job demands and exposures, and when worksite modifications reduce 
physical exposures. A number of authors have advocated the importance 
of ergonomic changes in treating workers with work-related 
musculoskeletal disorders (Melhorn 1996, Higgs and Mackinnon 1995, 
Norris 1993, Feuerstein et. al. 1993, Halpern 1992, Travers 1992, 
Herbert 2000).
    Comprehensive ergonomic programs which incorporate primary 
prevention of MSDs through ergonomic changes in jobs, early detection 
of MSDs through surveillance, and early treatment of MSDs with an 
emphasis on early return to modified work have been endorsed by many 
corporations and by medical professionals. The American College of 
Occupational and Environmental Medicine, the world's largest group of 
Occupational Health physicians, has recently released ``Occupational 
Medicine Practice Guidelines'' which describe what the College 
recommends as best medical practice in the diagnosis and treatment of 
work-related disorders. These practice guidelines explicitly recommend 
many of the elements which are contained in OSHA's proposed regulation 
as representing best medical practice. These include endorsement of the 
application of ergonomic principles to job design in order to prevent 
MSDs, and the use of workstation or tool adjustment to avoid further 
aggravation of a disorder once it has begun. Return of workers to 
modified work which has reduced physical exposures is strongly 
recommended as part of treatment--the guidelines note that the best 
success with return to work is seen when workers go back to their 
original job with modifications to reduce physical exposures. The 
guidelines list ``substantive associations'' between physical risk 
factors and a variety of MSDs including shoulder tendonitis, hand/wrist 
tendonitis, carpal tunnel syndrome, neck muscle tension, and low back 
pain. Specific job modifications are recommended for these and other 
disorders. The guidelines also note that delayed presentation (not 
receiving early recognition and treatment) is a risk factor for delayed 
functional recovery in patients with a MSD.
    My own experiences from over ten years of treating injured workers 
have shown me the importance of early treatment and the importance of 
modifying job duties to facilitate return to work. The proposed 
ergonomics standard addressed these important aspects of disability 
prevention. While the main focus of prevention efforts should be on 
primary prevention--the reduction or elimination of workplace risk 
factors--it is also important to ensure that workers have access to 
appropriate and timely medical care if they do become injured. The 
goals of a medical management program should be to reduce or eliminate 
symptoms, prevent progression of MSDs, reduce the duration and severity 
of functional impairment, and prevent or reduce the severity of 
disability. Important elements to such a program include surveillance, 
timely access to appropriate health care providers, job evaluation of 
injured workers, and the availability of appropriate job modification. 
Follow-up of treated workers and coordination with primary prevention 
efforts are also important.
    My clinical experience clearly indicates that effective treatment 
of work-related musculoskeletal disorders frequently requires a 
reduction in workplace physical exposures for the affected employee. 
The vast majority of injured employees are able to return to productive 
work very quickly, as long as their work is modified to reduce physical 
exposures to the affected body part. Job modifications which reduce 
physical exposures are frequently inexpensive and simple, and can help 
an employee safely return to work sooner, as well as preventing risk of 
future injury. Examples of job modifications include training or 
retraining, simple job changes to prevent awkward postures (such as a 
step stool or tilted work surface), changes in tool design or 
maintenance, or changes in procedures (such as job rotation). Where 
there is no simple fix for a physical exposure which is causing or 
exacerbating a musculoskeletal condition, temporary job transfer or 
restrictions are important to allow the patient's injury to heal. 
Examples of temporary restrictions include reduction in pace or 
quantity of work, restriction of certain tasks, or limitation of hours 
worked. If an employee is to be transferred to a different job, the new 
job should be assessed by the employer and the healthcare provider to 
be sure that the employee will not be exposed to relevant physical risk 
factors When this cannot be accomplished, temporary removal from work 
will allow time for healing. In most cases, I feel that keeping an 
injured employee at work in an appropriate modified position is 
preferable to time loss. What OSHA is requiring in the standard is 
common medical practice among occupational health professionals.
    In my experiences of treating patients and advising the 
administration of employee health programs, I have found that choice of 
a healthcare provider for injured workers is important. Ideally, 
healthcare providers should have training or experience in ergonomics 
and the role of work modifications in the treatment of work-related 
musculoskeletal disorders. Effective diagnosis and treatment requires 
knowledge of specific job duties. The best way for a healthcare 
provider to get knowledge of job duties is through a worksite visit. 
Since this is impractical in some clinical settings, information about 
exposures and job duties can also be obtained through a written work 
description, or a videotape of the job task. Employers should have a 
contact person with knowledge of job activities and the ability to 
coordinate appropriate job placement during a recovery period. Working 
knowledge of the industry and the specific workplace is also needed in 
order to make appropriate recommendations regarding temporary or 
permanent job modifications. In my experience, some employers readily 
provide detailed information about job duties and physical exposures to 
the treating physician. It is more difficult to provide optimal care 
for injured workers when this information is not available.
    The medical literature has examples of successful programs which 
have decreased the length or severity of disability resulting from 
injuries through integrating ergonomic interventions as part of medical 
treatment of injured workers. One such study evaluated work-related 
back pain among workers from a variety of industries who had been away 
from work for more than four weeks due to their back injuries. (Loisel 
et. al. 1997). Workers were randomly assigned to receive an ergonomics 
intervention, an intensive clinical and rehabilitation intervention, 
neither, or both. The ergonomics intervention consisted of a worksite 
ergonomics evaluation that included labor and employer representatives 
in determining the need for job modification. After observation of a 
worker's tasks in conjunction with a trained ergonomist, these parties 
determined the need for modifications to improve the worksite. 
Implementation of the recommended solutions remained the employer's 
responsibility. The clinical and rehabilitation intervention consisted 
of patient education (``back school''), referral to a back pain 
specialist, and a multidisciplinary work rehabilitation intervention. 
Combination of the rehabilitation intervention along with the 
ergonomics intervention was the most successful in returning injured 
workers to work. The ergonomics intervention was the most successful 
element of this program, resulting in more than a two-fold increase in 
the rate of return to usual work. By facilitating return to usual work, 
the ergonomics intervention appeared to reduce progression to long term 
disability. In this study, the intensive clinical and rehabilitation 
intervention did not significantly reduce the time of absence from 
regular work when applied separately from the ergonomics intervention.
    Another example of an integrated program was reported among sheet 
metal workers at an aircraft manufacturer. This program combined pre-
placement evaluations of workers with ongoing surveillance for symptoms 
and signs of upper extremity musculoskeletal disorders in order to 
ensure early medical evaluation of affected workers. Job modification 
was implemented for those with signs of early disorders, through 
restriction of work hours and restriction of use of vibrating hand 
tools. This program reported decreased workers' compensation costs, 
decreased time loss, and decreased severity of injury following the 
implementation of this program for screening, surveillance, early 
medical evaluation, and job modification. (Melhorn JM 1999)
    Other authors have described comprehensive initiatives to manage 
the incidence and cost of occupational injuries that included an 
ergonomics component directed specifically toward injured workers. One 
such program has been described among hospital employees at an academic 
health center (McGrail et. al. 1995). This study showed decreases in 
musculoskeletal injuries, time loss (change from 10.4 days to 6.6 days 
average time loss), and total case costs (18 percent reduction) 
following the implementation of a comprehensive intervention that 
included case management, treatment by physicians experienced with work 
injuries, and the use of ergonomic worksite evaluation and 
modification. A later report from this group described elements of the 
program aimed at the early diagnosis and treatment of work-related 
upper extremity MSDs. The program included ergonomic assessment and 
abatement of the affected employees' work areas, and close coordination 
between the treating physicians and the ergonomists. The program 
resulted in pronounced decrease in the number of work-related upper 
extremity MSDs and a virtual elimination of cases which required 
surgery. The authors concluded that a coordinated program of medical 
care, ergonomic assessment, and intervention can be effective in the 
prevention of MSDs. (Bernacki 1999)
    These and other peer-reviewed studies clearly indicate that a 
multi-element program can reduce the cost and burden of MSDs in 
different working populations. There are also numerous industry case 
reports where the introduction of ergonomic or medical management 
interventions have reduced costs and injury rates. Most major 
corporations have ergonomics programs, in recognition that such 
programs are effective in reducing injuries. Successful approaches have 
most often used a combination of ergonomic principles for prevention, 
as well as improved recognition and management of those disorders which 
have occurred.
    I have also studied the effects of ergonomic assessments and 
interventions as part of the care of workers with WRMSD. As the result 
of a ``natural experiment,'' we have collected pilot data on cost 
outcomes of ergonomic intervention in active workers' compensation 
patients employed by a local educational institution. Prior to 
September of 1996, ergonomic evaluations requested by the treating 
physician were not covered by the workers' compensation insurance 
carrier and requests for this service were denied. This policy changed, 
and ergonomics evaluation and intervention was then allowed under 
workers' compensation when ordered by the treating physician. These 
cases were predominantly neck and upper extremity disorders among 
office employees; the ergonomic interventions consisted of changes in 
workstation layout. We compared 11 consecutive cases referred by the 
treating physician to the ergonomist prior to the administrative change 
with 20 consecutive cases after coverage was allowed. These cases were 
all ones in which the treating physician thought that work factors were 
important in causing disease or retarding healing. Comparison of total 
workers' compensation costs for these cases showed a median cost of 
$5,130 among the patients referred for ergonomic evaluation who did not 
receive it, compared to a median of $4,082 among patients who did 
receive the physician recommended ergonomic evaluation. Costs included 
medical treatment, time loss, and permanent disability payments. Cost 
in the intervention group included the cost of the ergonomic evaluation 
and intervention, which averaged $280. Although these data do not come 
from a randomized study, they represent a series of cases from the same 
workplace referred by the same group of treating physicians, differing 
only in the fact that the ergonomic intervention was denied to the 
first group and given to the second. Based in part on this study, we 
are currently conducting a randomized trial funded by NIOSH to assess 
the effectiveness of an integrated ergonomics and case management 
intervention on cost and disability outcomes among injured workers.
              the effectiveness of ergonomic interventions
    Review of the scientific literature demonstrates that workplace 
ergonomic interventions can prevent injuries and reduce days lost due 
to injuries. This evidence comes from a number of studies published in 
the peer-reviewed literature which show the effectiveness of ergonomic 
interventions at various worksites and employers. The 1998 report by 
the National Research Council stated that ``The literature provides 
evidence that interventions, of various types and complexity, can 
prevent the development of musculoskeletal disorders in specific 
industries and occupational groups.'' The NRC report concluded that 
``Research clearly demonstrates that specific interventions can reduce 
the reported rate of musculoskeletal disorders for workers who perform 
high-risk tasks. No known single intervention is universally effective. 
Successful interventions require attention to individual, 
organizational, and job characteristics, tailoring the corrective 
actions to those characteristics.'' Examples of published intervention 
studies familiar to me are given below; the background information 
provided by OSHA gives over 100 examples of successful ergonomic 
interventions.
    The effectiveness of ergonomic interventions in the prevention of 
musculoskeletal disorders was shown by a study in a telecommunications 
equipment manufacturing plant, where workstations were re-designed to 
reduce postural stress on workers. Following this intervention, time 
loss was reduced by over 40 percent and employee turn-over was reduced 
by 75 percent. Cost-benefit analysis showed that the return on 
investment for the ergonomic interventions was 9 to 1. (Aaras 1994). 
Another study in telecommunications manufacturing sought to control the 
incidence and severity of repetitive trauma disorders associated with 
hand tool operations in a manufacturing facility with 6,600 employees. 
Repetitive trauma disorders were the leading cause of lost time and 
workers' compensation expenses at this plant. The incidence rate of 
OSHA reportable repetitive trauma disorders was 2.2 cases per 100 full-
time equivalent workers (FTE) and resulted in 1,001 lost workdays in 
1979. In the spring of 1981, the plant safety and health committee 
undertook a control program that included creation of a task force, a 
training program, improvements in the design of workstations and 
tooling, and management of restricted workers. During 1982, the 
incidence rate of repetitive motion disorders has decreased to 0.53 
cases per 100 FTE and resulted in only 129 lost workdays. (McKenzie 
1985)
    A study at Gold Kist poultry (Jones 1997) reported results of an 
intervention undertaken due to high rates of upper extremity MSDs--47.7 
per 1,000 workers in 1990. This plant instituted a corporate ergonomics 
program which utilized ergonomic committees at each facility. Key 
program elements included training, worksite analysis and task design, 
and the implementation of medical management procedures. This 
combination of worksite task analysis and medical management is similar 
to the program elements proposed by OSHA. This program resulted in a 46 
percent decrease in upper extremity MSD rates over a five year period.
    Another study evaluated a back injury prevention program undertaken 
in municipal workers in California. The program consisted of a 
combination of worker education, training in safer work practices, 
physical fitness activities, and ergonomic interventions including 
making safety equipment more available and improving the design of work 
facilities (through such measures as safety flooring, improved 
furniture, and rearranging storage space to minimize transport 
distances). Comparison of an intervention group and a control group of 
employees who did not receive the intervention showed a decline in back 
pain prevalence and a reduction in injuries among the intervention 
group. This study evaluated cost savings due to the intervention as 
well as documenting the reduction in back pain and injuries. Cost-
benefit analysis showed a net savings of over $160,000 resulting from 
decreased workers' compensation and medical claims, and reduction in 
sick days. Return on investment was estimated at 179 percent. (Shi 
1993)
    One of my own studies (Evanoff 1999) examined work injuries and 
other outcomes before and after the implementation of a participatory 
ergonomics team among hospital orderlies, a group at high risk for 
injuries of the back, shoulder, and knee. This team designed and 
implemented changes in training and work practices, which included 
standardization of lifting procedures, an apprenticeship program for 
new workers, and use of mechanical lifting and transfer aids. The two 
year post-intervention period was marked by a 50 percent decrease in 
OSHA recordable work injury, a 74 percent decrease in lost time injury, 
and an 81 percent decrease in injuries with three or more days of time 
loss. Total lost days declined from 136.2 to 23.0 annually per 100 
full-time worker equivalents (FTE). Annual workers' compensation costs 
declined from $237/FTE to $139/FTE. The proportion of workers with 
musculoskeletal symptoms declined as well. Other researchers using 
participatory ergonomics teams have demonstrated the abilities of such 
teams to work effectively to address musculoskeletal hazards (Moore and 
Garg 1996, Moore and Garg 1997).
    I have directed a second study which has been presented as an 
abstract but not yet published. This was an ergonomics intervention 
among 117 workers employed in a hospital billing office, who were 
offered an educational session and individual workstation evaluations, 
with changes in workstation layout where appropriate. Changes included 
adjustments in computer keyboard and monitor setup, adjustments in 
seating, and changes in desk layout. Lost work days and total costs for 
workers compensation decreased dramatically in the two years following 
this intervention, compared to the two preceding years. Annual lost 
work days declined from a rate of 51 days per 100 full-time equivalents 
(FTE) to a rate of 25 days per 100 FTE. Annual workers' compensation 
costs declined from a high of $578 per FTE to a low of $120 per FTE. 
The total cost of the intervention was $255 per FTE; return on 
investment over 18 months following the intervention was over 2 to 1.
    Other studies (Kukkonen 1983, Ohara 1976, Parenmark 1988, Oxenburgh 
1985, Lutz 1987) have also demonstrated reductions in symptoms, signs, 
or lost time following the implementation of interventions to reduce 
exposure risk factors for musculoskeletal disorders. Ergonomic job 
design clearly offers great potential for preventing musculoskeletal 
disorders of the low back and upper extremities. (Garg & Moore 1992).
    My personal experience agrees with the literature cited above. I am 
personally aware of many local worksites where ergonomic analysis and 
job changes have led to improvements in symptoms or reductions in 
injury rates among workers. I have seen dozens of case reports of 
industries where the implementation of ergonomics programs have 
resulted in reductions in injury rates or lost time. These industry 
case reports offer important additional information to the peer-
reviewed scientific literature, given the daunting logistical and other 
barriers to performing true ``experimental'' studies of workplace 
ergonomic interventions. I have served as the medical director of an 
ergonomics program aimed at reducing injuries among the 23,000 
employees of a large health system. Musculoskeletal injuries and lost 
days have declined since the implementation three years ago of a 
system-wide ergonomics program. A NIOSH funded project within five 
nursing homes in our health system has demonstrated a marked decline in 
lifting injuries following an ergonomics intervention which consisted 
of training and the purchase of mechanical patient hoists.
    My personal experiences with research studies of ergonomic 
interventions, as well as my experience with ergonomic programs in 
industry, have convinced me that appropriately designed ergonomics 
programs can reduce injuries and disability in many workplace settings.
                                summary
    Based on my knowledge of the relevant scientific literature, my 
observations of best practices among employers and physician groups, 
and my own clinical and administrative experiences, I conclude that 
there is ample evidence to support specific program elements proposed 
by OSHA. Physical exposures in the workplace are clearly a significant 
cause of musculoskeletal disorders. Reduction in physical exposures 
through training, workplace design, or change in practices can reduce 
disability due to musculoskeletal disorders. Appropriate medical 
treatment early in the course of work-related musculoskeletal disorders 
can lead to better functional outcomes and reduced disability. Though 
future research findings will no doubt refine and better inform our 
actions, we need not wait to begin action. Effective solutions are 
available now, and a large burden of disability can be prevented by 
using what we currently know.
  Appendix--Refutation of Some Common Arguments Against an Ergonomics 
                                Standard
    Critics of the conclusion that work activities are causally related 
to musculoskeletal disorders raise a number of arguments which are not 
convincing on closer examination. Four common arguments are addressed 
below.
    Argument 1: Epidemiology or observational studies cannot 
demonstrate causation; only randomized prospective studies can do 
this.--While experimental studies where humans are randomly assigned to 
receive or not receive some treatment provide the strongest evidence 
for a health effect, it is obviously impossible to perform this type of 
study for exposures we think may cause harm. There are well-established 
ways to link observational data to a decision about causation of 
illness which can be valid in the absence of experiemental data. For 
example, the vast majority of the scientific community concluded that 
tobacco smoking caused a number of health problems based on 
observational studies which showed much higher rates of some diseases 
among smokers. It was not necessary to do an experiment where people 
were randomly assigned to smoke or not smoke. Data on the health 
effects of most occupational exposures such as lead or asbestos also 
rely on observational studies, which can demonstrate causality in a 
scientifically acceptable fashion.
    Argument 2: Work can't be the cause of MSDs since some workers get 
these disorders and other workers doing the same job don't have any 
problems.--This argument is specious. People vary in their 
susceptibility and resistance to disease and injury, and people with 
identical exposures frequently have different health effects. Exposures 
clearly interact with personal factors to produce disease in some but 
not others--this does not change the importance of the exposure in 
causing the disease. A minority of heavy smokers die from lung cancer, 
yet we readily accept that smoking causes lung cancer because heavy 
smokers are much more likely to get this disease than non-smokers. 
Though genetic makeup and other personal factors are clearly important 
in determining which smokers die from lung cancer, in the absence of 
smoking the vast majority of these cancers would never have occurred.
    Argument 3: Work can't be a major cause of MSD since there are so 
many other conditions which contribute to MSD risk.--As with most 
diseases, MSDs are multifactorial in origin. It is nonetheless possible 
to study the effects of risk factors in isolation. Consider, for 
example, heart disease. There are many risk factors for heart disease 
which cannot be changed, including age, gender, and genetic makeup. 
There are other risk factors that can be changed, such as high blood 
pressure, blood lipids, exercise, and smoking. Most individuals have 
more than one risk factor, yet we can study the amount of heart disease 
that is caused by smoking, or hypertension, or lack of exercise. We can 
also direct interventions at reducing heart disease risk by targeting 
one or more of these risk factors. Changes (positive or negative) in 
one risk factor can significantly alter the risk of disease, even if 
other risks do not change. Similarly, in MSDs, personal risk factors 
such as obesity, age, gender, and other medical conditions account for 
some fraction of the total disease burden. In many workers, however, 
workplace exposures are the primary determinant or cause of the 
disorder. Comparisons of working populations which do not differ 
substantially in non-work risk factors have shown substantial 
differences in MSD rates linked to workplace exposures. The 
intervention studies cited above show that prevention efforts targeted 
at workplace physical exposures can reduce the risk of MSDs.
    Argument 4: Research shows only that work may cause some symptoms 
of discomfort, but does not show that work causes diagnosable 
diseases.--High quality studies of work-related MSDs have defined these 
disorders through the same methods used by clinicians to diagnose 
MSDs--a combination of history, physical examination findings, and, in 
some cases, nerve conduction studies. The NIOSH review (Bernard 1997) 
only considered studies where clinical case definitions included the 
use of physical examinations as well as symptoms. The case definitions 
used in much of the research on musculoskeletal disorders are similar 
to the diagnostic methods used every day by clinicians.

    Senator Specter. Thank you very much, Dr. Evanoff. Turn now 
to Ms. Heidi Eberhardt, international trade specialist.
STATEMENT OF HEIDI EBERHARDT, INTERNATIONAL TRADE 
            SPECIALIST
    Ms. Eberhardt. Good morning. My name is Heidi Eberhardt. I 
am from Boston, Massachusetts, and I want to thank you for 
inviting me to testify today.
    Two and a half years ago, when I was 30 years old, I was 
injured at my job from working on the computer. I was working 
40 hours a week at a dot com internet publishing company. I was 
an international trade specialist and my job consisted of using 
the computer keyboard most 8 hours a day for writing, editing 
and researching about Latin American countries, surfing the web 
and e-mailing with foreign officials.
    As an undergraduate at Dartmouth College, I majored in 
Spanish and studied in Latin America. When I started this job 6 
years ago, I was thrilled to have found work where I could put 
my education to use. I was excited to be working in a cutting-
edge industry with the advanced computer technology that 
allowed me to be more productive and perform my job more 
efficiently.
    I had never heard about repetitive strain injuries. I did 
not know I could be injured from working on the computer. I did 
not know what workers' compensation was.
    I was a healthy and happy individual in all respects and 
exercised regularly. I had no hobbies that were repetitive in 
nature.
    My company provided no education or training about 
ergonomics or working safely on a computer. Our computer work 
stations were not set up properly.
    There was another young employee in our department who 
after only working 3 months with us had already begun to 
experience symptoms of repetitive strain injury from working at 
the computer. I was diagnosed with bilateral tendonitis, 
tenosynivitis, thoracic outlet syndrome and De Quervain's 
thumb.
    At first, my symptoms were merely annoying. My wrists would 
ache and my hands felt clumsy. Then I started to notice 
tingling and pain that persisted even at rest, even on the 
weekends.
    My pain and loss of dexterity became so severe that I could 
no longer type or do anything on the computer, let alone 
perform any hand-related tasks outside of work.
    My doctor sent me out of work for 4 months, and I had to 
file for workers' compensation. I was returned to light duty 
for 12 hours a week, but my symptoms had not completely gone 
away and I was still working in pain.
    I since have switched to a job where I do not use a 
computer, but even writing, looking through files or even 
holding the phone still hurts my hands. So now at age 32, 2\1/
2\ years after being injured, I am still on workers' 
compensation and still working only 12 hours per week. I am 
greatly hindered in my ability to contribute in a productive 
way to the workforce and am not paying taxes.
    After college, I had spent several years mastering research 
and writing skills. I was building a career, one that was 
satisfying, productive and seemed to be full of potential.
    I am now sitting before you, a young person faced with 
having to find a new career that does not require a computer or 
even much use of my hands. I am faced with reduced income and 
increased medical expenses. I am faced with chronic pain which 
affects my work productivity.
    I have a restricted personal life and am unable to perform 
daily chores outside of work without pain. I have had to endure 
the stigma of being injured and on workers' compensation.
    Doctors can tell me what my injury is. My tendons and 
ligaments are damaged because of repetitive hand use of the 
computer. No doctor can tell me if I will fully recover.
    I am worried about my future and about whether I will ever 
regain complete use of my hands. I am a single person and do 
not have anyone to assist me with daily living, nor do I have 
the financial resources to pay someone to help me.
    I would like to get married and have children some day and 
am worried about not being able to physically raise children.
    Here are a few simple things I used to take for granted but 
I now have difficulty with: Squeezing shampoo bottles, 
toothpaste tubes, turning on and off faucets, clipping finger 
and toe nails, driving, shifting gears, holding the steering 
wheel, carrying groceries, cooking, carrying heavy pots, 
opening cans, cutting things, putting away dishes, cutting my 
food, opening milk cartons, making coffee, holding coffee, 
getting ice cubes out of the ice tray, dressing myself, 
buttoning my pants and my shirts, pulling things on, hanging up 
clothes, doing laundry, carrying clothes to the laundromat, 
pulling clothes in and out of the washer and dryer, folding 
clothes, cleaning house, writing letters, writing checks for 
bills, opening mail, opening doors and windows, turning my 
house key in the lock or my car key in the ignition; in short, 
almost anything you need your hands to do. And this list does 
not include anything I might want to do for fun.
    In March of last year, I testified at the public hearings 
that OSHA held on its then proposed ergonomics standard. When 
the ergonomics standard was issued last November, I was proud 
of our government for recognizing and acting to prevent what I 
now know is the Number 1 injury in the workplace, an injury 
that I know about firsthand and have been trying to recover 
from for 2\1/2\ years, an injury that has profoundly altered my 
life and left me unable to work on the computer.
    So when both houses of Congress voted to repeal the very 
standard that would have prevented millions of devastating 
injuries, I was deeply dismayed.
    What was most disturbing was the manner in which it was 
done. The votes were rushed through without any input from the 
workers it would have protected. This action seemed only to put 
the interests of corporations above the safety and health of 
workers in this country. Millions of workers have suffered 
ergonomic injuries over the past decade while waiting for 
protections.
    Senator Specter. Ms. Eberhardt, I have to remind you that 
the time is up. If you could summarize, we would appreciate it.

                           prepared statement

    Ms. Eberhardt. I know that companies who have put into 
place ergonomic programs have been successful. They have 
reduced costs. And I know that these ergonomics programs which 
include simple education and training can prevent the kind of 
injury that I have sustained and I strongly urge you to 
continue your hard work.
    [The statement follows:]
                 Prepared Statement of Heidi Eberhardt
    My name is Heidi Eberhardt. I am an international trade specialist 
from Somerville, Massachusetts. I am here today to tell you about an 
injury that has changed my life.
    In the Fall of 1998, when I was 30 years old, I was injured at my 
job from working on the computer. I was working 40 hours a week at a 
.com Internet publishing company. There were 8 employees in the 
company, and I was working in the department responsible for 
researching and writing about international trade issues.
    My job as an international trade specialist consisted of writing, 
researching, and editing which was performed 8 hours a days, 5 days a 
week on the computer using a keyboard and a mouse. This included 
typing, cutting and pasting, formatting, scrolling through 20 page 
documents, surfing the web and corresponding via email with customers 
and information providers. We had a heavy workload with weekly, 
sometimes daily, deadlines. We were always behind. There was so much to 
do, I stopped only for breaks to go to the restroom and to get my lunch 
to eat at my desk while I was working.
    As an undergraduate at Dartmouth College, I majored in Spanish and 
studied in Latin America. When I started this job six years ago, I was 
thrilled to have found work writing about Latin American countries 
where I could put my education to use. I had never heard about 
repetitive strain injuries. I did not know I could be injured from 
working on the computer. I did not know what worker's compensation was. 
I was a healthy and happy individual in all respects and exercised 
regularly. I had no hobbies that were repetitive in nature.
    In January of the same year I was injured, my company had switched 
from Windows 3.1, with no internet or e-mail access, to Windows 1995 
and a direct connection to the Internet, internal and external email, 
and websurfing capabilities. I was happy that we could work faster and 
perform more job tasks on the computer at once. With these new computer 
programs there is no need to pause between tasks.
    My company provided no education or training about ergonomics or 
working safely on a computer. I've since learned that our computer 
workstations were not set up properly. There was another young employee 
in our department who, after working only three months with us, had 
already begun to experience symptoms of repetitive strain injury from 
working at the computer. Since being injured, I have received extensive 
ergonomics education from occupational therapists. This education came 
too late to prevent my injury, and it is information that most workers 
will never hear without the types of workplace programs that OSHA tried 
to put in place.
    At first my symptoms were merely annoying. My wrists would ache and 
my hands felt clumsy. Then I started to notice tingling, and pain that 
persisted even at rest, even on the weekends. My pain and loss of 
dexterity became so severe that I could no longer type or do anything 
on the computer, let alone perform any hand-related tasks outside of 
work.
    At my doctor's and occupational therapists' insistence, I filed for 
Worker's Compensation. My doctor, who had diagnosed me with bilateral 
tendonitis, tenosynivitis and DeQuervain's syndrome, prescribed rest 
and abstaining from work. After being out of work for 4 months, I 
returned to light duty for 12-hours a week. But, my symptoms had not 
completely gone away, and I was still working in pain. I since have 
switched to a job where I do not use the computer, but even writing, 
looking through files, or even holding the phone, still hurts my hands. 
Now, at age 32, two and a half years after being injured, I am still on 
worker's compensation, and still working only 12 hours per week. I am 
greatly hindered in my ability to contribute in a productive way to the 
workforce, and I am not paying taxes.
    After college, I spent several years mastering research and writing 
skills. I was building a career, one that was satisfying and productive 
and seemed to be full of potential. I am now sitting before you, a 
young person faced with having to find a new career that does not 
require a computer or even much use of my hands--please imagine that if 
you can. I am faced with reduced income and increased medical expenses. 
I am faced with chronic pain which affects my work productivity. I have 
a restricted personal life and am unable to perform daily chores 
outside of work without pain. I have had to endure the stigma of being 
injured and on worker's compensation. And I have suffered depression as 
a result of dealing with the pain and uncertainties about my future.
    Doctors can tell me what my injury is--my tendons and ligaments are 
damaged because of repetitive hand use at the computer. No doctor, 
however, can tell me when I will be fully recovered. I am worried about 
my future and about whether I will ever regain complete use of my 
hands. I am a single person and do not have anyone to assist me with 
daily living, nor do I have the financial resources to pay someone to 
help me. I would like to get married and have children someday and am 
worried about not being able to physically raise children.
    Here are a few simple things that I used to take for granted, but I 
now have difficulty with:
  --squeezing shampoo bottles, dishwashing detergent and toothpaste 
        tubes
  --turning on and off faucets
  --clipping finger and toe nails
  --driving, shifting gears, holding the steering wheel
  --carrying groceries
  --cooking, carrying heavy pots, opening cans, cutting things, putting 
        away dishes
  --cutting my food
  --opening milk cartons, bottles, cans
  --making coffee, holding coffee
  --getting ice cubes out of the ice tray
  --moving anything heavy
  --dressing myself (buttoning pants and shirts and pulling things on)
  --hanging up clothes
  --doing laundry (carrying clothes to laundromat, pulling clothes in 
        and out of washer/dryer, folding clothes)
  --cleaning house (washing counters, bathrooms, vacuuming)
  --writing letters, grocery lists, etc.
  --writing checks for bills
  --opening mail
  --opening doors and windows
  --turning my house key in the lock, or my car key in the ignition
  --picking up my 2-yr old nephew
    In short, almost anything you need your hands to do, and this list 
does not include anything I might want to do for fun, nor does it 
include computer or work activities.
    In March of last year I testified at the public hearings that OSHA 
held on its then proposed ergonomics standard. When the ergonomics 
standard was issued last November, I was proud of our government for 
recognizing and acting to prevent what I know is the number one injury 
in the workplace today. An injury that I know about first hand and have 
been trying to recover from for two and a half years. An injury that 
has profoundly altered my life and left me unable to work on the 
computer. So when both houses of Congress voted to repeal the very 
standard that would have prevented hundreds of thousands of serious 
injuries, I was appalled. What was most outrageous was the manner in 
which it was done. The votes were rushed through without any input from 
the workers it would have protected. The action taken by Congress and 
the President seemed only to put the interests of corporations above 
the safety and health of workers in this country.
    Millions of workers have suffered ergonomic injuries over the past 
decade while waiting for protections. How many more workers need to 
suffer these crippling injuries before this problem is addressed?
    When I was first injured, I went to the Massachusetts Coalition on 
New Office Technology (CNOT) because they offer resources to injured 
workers. Now I work for CNOT part time, providing training on 
ergonomics and injury prevention. Part of my work involves evaluating 
employees' workstations. What I see in my work validates the 
overwhelming need for a Federal ergonomics standard. More often than 
not, workers are sitting in improperly set up workstations, with little 
knowledge of the impact that this can have on their health, and as I 
know first hand, their entire lives. What is even more frightening is 
that close to 25 percent of the people I see already have symptoms of 
injury.
    These injuries can be prevented with programs that include 
appropriate workstations and training for workers. Once an injury sets 
in it is difficult, if not impossible, to reverse the damage. I implore 
you to pass legislation that requires OSHA to issue a strong ergonomics 
standard that covers workers in all industries and emphasizes 
prevention of repetitive strain injuries. I am only 32, but I know 
people who are in their early twenties, working in Internet companies 
or as software engineers, who are injured.
    Workers in this country desperately need an ergonomics standard to 
prevent even more debilitating injuries from occurring. Too many 
companies will not act to protect their employees unless required to by 
law. I sincerely hope that my testimony today gives you a better idea 
of what can happen to workers, including very young workers, in today's 
computer-driven workplaces and how these injuries are affecting our 
lives. Your work to pass this bill can prevent this story from being 
told over and over again, by injured worker after injured worker. Thank 
you for this opportunity to tell you my story.

    Senator Specter. Thank you very much, Miss Eberhardt.
    Mr. Fellner, do you think that it is realistic to expect a 
consensus on the issues that are involved in ergonomics based 
on the testimony we have heard here in this first panel?
    Mr. Fellner. I think that we will not know the answer to 
that question until a much more exhaustive analysis of the 
issues that are touched on this morning has been had at the 
Department of Labor.
    Senator Specter. Dr. Bigos, you say there is no scientific 
basis. You cannot diagnose and you cannot prevent. In the 
absence of a scientific basis, your testimony is pretty plain 
that from your professional expertise and in the absence of a 
scientific basis and the cost of a regulation simply cannot 
have one. Isn't that right?
    Dr. Bigos. Well, I guess I am not sure I understand the 
question you are asking me.
    Senator Specter. Well, let me repeat the question. You 
testified that there was no scientific basis for an ergonomics 
regulation, did you not?
    Dr. Bigos. Yes, I did.
    Senator Specter. So how can you have an ergonomics 
regulation without a scientific basis as you view this entire 
issue?
    Dr. Bigos. I do not think you can.
    Senator Specter. That is my point. You do not think we can.
    Dr. Bigos. No. Without knowing the dose and without knowing 
how high or how much or some guidance in some way, I do not see 
any way that we can really do that.
    Senator Specter. Well, I understand your point. I was just 
making sure that I understand it. You cannot have an ergonomics 
regulation. Ms. Seminario?
    Ms. Seminario. Seminario.
    Senator Specter. In the absence of a scientific basis, 
which Dr. Bigos testifies to, what basis do you have for 
postulating a regulation besides, if anything, all of these 
reports of work-related injuries?
    Ms. Seminario. A couple of things, Senator. First, we do 
think there is a scientific basis that is fairly extensive and 
quite strong and certainly sufficient to regulate. There is 
also the experience that employers and unions and others have 
had dealing with these problems in the workplace which again is 
quite extensive.
    And we had encouraged the Labor Department and we would 
still encourage the Labor Department to look to that experience 
of employers in addressing these problems as the approach that 
they should take to regulation.
    I would also point out that this issue has been regulated. 
There are regulations on manual handling, ergonomics, video 
display terminal use that have been in place in the European 
community for more than a decade. Many of the same employers 
that obviously operate----
    Senator Specter. Are they in place in Workman's 
Compensation laws in the State level?
    Ms. Seminario. Not the preventative aspects. Obviously 
these injuries are----
    Senator Specter. The diagnosed aspects?
    Ms. Seminario. Yes. The diagnosed aspects certainly are and 
the criteria in some of the states are quite similar to the 
criteria and definitions laid out by OSHA.
    Senator Specter. When I listened to the testimony of Dr. 
Evanoff and Dr. Hadler, diametrically opposed, we have quite a 
number of witnesses to hear, and I will reserve judgment; but 
from what I have heard on this panel, Mr. Fellner, I do not see 
a consensus emerging at all.
    When you talk about, as Dr. Bigos does about nonphysical 
factors outweighing physical factors on back pain, we have all 
had some experience with lifting and pack pain.
    My dad had a junk yard in Russell, Kansas. And it did not 
take me a whole lot of time to figure out that lifting a 30-
foot joint of 3-inch tubing that weighed 300 pounds, and I was 
lifting half of it, and maybe we do not need an ergonomics 
regulation when my older brother one day told me to throw a 
rock bed on top of a load of junk which weighed about 80 
pounds, and I simply refused, having in mind the sciatica nerve 
which he had injured and could not lift junk anymore.
    He was smart enough to sustain an injury so he could avoid 
the lifting. But we will wrestle through the problems. I would 
like to call the second panel now. Dr. Burton, Dr. Punnett and 
Dr. Mirer. I am sorry. Before the panel leaves, Miss Landrieu.
    Senator Landrieu. The panel can go. The new panel can come. 
But I will just make a brief statement, if I could.
    Senator Specter. Okay. Fine. Pardon me Senator Landrieu, 
for not noticing you.
    You took a seat so far to the right.
    There are at least two attributes about your appearance I 
should have noted, and I will not specify them for the record.
    Senator Landrieu. And I wore this bright red jacket so it 
is hard to not notice me today. But I thank you, Mr. Chairman.
    Senator Specter. It is hard not to notice you in the 
absence of a red jacket.
    Senator Landrieu. Thank you, Mr. Chairman. If the new panel 
would just come forward, I do not want to stop you all from 
moving forward. I do want to just make a couple of comments 
though.
    Senator Specter. Senator Landrieu, while you are making the 
comments, I am going to excuse myself for a moment. We have 
Secretary Manetta testifying in Transportation. I am going to 
be gone for a very brief period of time. Senator Landrieu has 
the floor and I shall return momentarily.

             Opening statement of Senator Mary L. Landrieu

    Senator Landrieu. Thank you, Mr. Chairman. I have a 
statement I would like to submit to the record. And I would 
like to ask unanimous consent. Since I am the only one here, I 
am going to give myself unanimous consent to submit this to the 
record.
    But I would just want to make a few points, and then 
unfortunately I am going to have to slip out for another 
meeting myself, and some responsibilities on the floor.
    I want to thank the chairman first of all for calling this 
very important hearing because we need the chairman and our 
ranking member to help us stay focused on this very important 
issue so it does not slip off the radar screen.
    I was briefed at some of the comments earlier made about 
how important it is to develop a consensus. And we try very 
hard to do that here in Washington on a number of different 
issues, whether it has to do with health or transportation, 
environmental issues. It is always desirable I think to build 
consensus, but it is not necessary. What is necessary is a 
majority, a majority to vote, to take an action.
    We do not need a unanimous vote. We do not need always a 
consensus. And many of the most important issues that have 
moved through Congress in the history of this Nation have not 
necessarily moved by consensus but they have in fact moved by a 
majority.
    And I wanted to just show up this morning to say to the 
labor and business leaders and to the workers here that I 
believe there is a majority of Republicans and Democrats today 
that recognize that this is a serious problem in the United 
States, that in fact these injuries are real. They are 
affecting real people in real ways. And we heard some of that 
testimony.
    With all due respect to the scientists and to those 
academics that would argue otherwise, I think we have passed 
that point; that this is real and that there are a majority. We 
do not have everyone. We do not need everyone. But there is a 
majority of votes in the Senate and in the House to actually 
produce a rule that will work to prevent, to try to prevent 
these injuries.
    What the challenge is, and I think what the question is 
which is reflected in the vote that was cast just last week, is 
that the rule that was presented before us either basically had 
to be completely adopted or none of it could be adopted. The 
procedure did not allow for us to sort of reshape that rule.
    And so the vote occurred to reject it. But I hope there is 
no one here in this room or around the country that would 
interpret that vote as meaning that there are not a large 
number of Republicans and Democrats, the majority here, to have 
a rule that will help prevent these injuries and to address it.
    There is a majority that agrees that this cannot be 
voluntary, that while voluntary actions can in fact help, that 
this needs to be, it is proper rule for government. It needs to 
be mandatory. Workers have a responsibility themselves in this 
regard as well as employers.
    And so I want to commend the chairman for calling this 
hearing to say that the challenge is now about how to present 
to the country a new rule, one that will address some of the 
concerns that were raised. But we are not going to go 
backwards. We are going to continue to move forward.
    And I hope because of the bill that I have introduced with 
Senator Breaux and Senator Specter that that time frame could 
be short, perhaps coming back with something in about 18 months 
for the Congress to act on.
    And let me say although I missed your testimony and I have 
the greatest respect for our new Secretary and think that she 
most certainly can do a wonderful job, I was somewhat 
disappointed to hear that she was not more enthusiastic about 
moving forward with a new rule.
    And I hope that this bill that we have introduced is going 
to encourage her in very direct ways to move forward with a new 
rule within a short period of time, one that many employers 
could embrace and many workers. We do not need all employers 
but we need many of them.
    And many that came to my office against the old rule said, 
Senator, we are not opposed to the Government having mandatory 
rules. We just want to make sure that we can understand it, we 
can comply with it, that the workers have responsibilities as 
well as we have responsibilities.
    So I am going on their word, all the employers that came 
into my office to testify to me in that regard. And I am going 
to do everything I can as a Senator to insist that we move 
forward way past the discussions about whether this is true or 
not.
    The American people understand these injuries are 
happening. They are happening to them and their own families. 
We can hear all the scientific testimony. We are past that 
point. We are now about how to draft a good rule that works for 
big employers, for small employers, that prevents these 
injuries and gives real relief without perhaps overlapping too 
much with what some states are doing to recognize the specific 
role of States.
    So I am sorry I do not have a whole list of questions. I 
do, but I do not have the time for them. But I wanted to get 
that statement into the record. And I thank you all.
    If the staff will help me to continue to conduct this 
meeting while the chairman is going, because I am going to have 
to slip out in just a moment. But on behalf of Senator Murray 
who could not be here, she did want me to recognize Dr. Bigos 
from Washington, from the University of Washington, and to 
welcome you in her absence because you are a constituent of 
hers and she wanted me to mention that this morning.
    But whoever would like to proceed with their testimony, and 
then I think if other members show up they will have questions 
or comments. Who should we begin with?
    It has been recommended that we just take a 5-minute recess 
until the chairman comes back. Thank you.
    Senator Specter. We'll resume the hearing now with Dr. Kim 
Burton, director of Spinal Research Unit, University of 
Hudderfield, United Kingdom. Welcome.
STATEMENT OF DR. KIM BURTON, DIRECTOR, SPINAL RESEARCH 
            UNIT, UNIVERSITY OF HUDDERFIELD, UNITED 
            KINGDOM
    Dr. Burton. Thank you, chairman. It is indeed a pleasure 
and an honor to address this body on the controversial topic of 
ergonomics. Recently in the United Kingdom, experts giving 
evidence in litigation cases need to sign declaration that 
their duty is to the Court rather than to the party instructing 
them. It is in that spirit that I address my views to you.
    My background encompasses both clinical science and 
ergonomics. And as you said, currently I am the director of the 
Spinal Research Unit at the University of Huddersfield. I am 
also a registered European Ergonomist, and have prepared 
reports and guidance for the Health and Safety Executive in the 
United Kingdom.
    It is vitally important to distinguish between the various 
manifestations of musculoskeletal disorders. That is, they may 
present as reports of symptoms, the filing of an injury claim, 
the need for sick leave, the development of chronicity and 
irreparable damage.
    Each of these components is unique. And it is somewhat 
unhelpful to talk about them as if they are fully 
interchangeable.
    Because low back pain is the area of my expertise and is 
such a prominent target of OSHA's recent regulation, I will use 
this as an example. Low back pain is not a discrete disease 
entity or even a single clinical syndrome. It is a symptom, a 
symptom experienced by most people during their lifetimes, 
irrespective of employment.
    General adult population surveys find a lifetime prevalence 
of low back pain of around 60 percent, a 12-month prevalence of 
over 40 percent, and a point prevalence of approximately 20 
percent. The lifetime prevalence in adolescents, at just over 
50 percent, is only slightly lower than that for working-age 
adults. In the face of such figures, attribution of the bulk of 
the symptoms to work, in my view, is untenable.
    Nonspecific low back pain can be occupational in a sense 
that it is common in adults of working age, frequently affects 
capacity for work, and often prompts referral for occupational 
health care. The common assumption that this means that low 
back pain is necessarily caused by work, however, overlooks the 
complex and inconsistent relationship between physical and 
other influences.
    The review that I coauthored with Professor Waddell last 
year concluded that on the balance of the scientific evidence 
that it showed physical demands of work can precipitate 
individual attacks of back pain. Certain individuals may be 
more susceptible and certain jobs may be at higher risk. But 
viewed overall, physical demands of work only account for a 
modest proportion of the total impact of back pain.
    The development of chronic pain and disability, however, 
depends more on individual or work-related psychosocial issues 
than on physical or clinical features. People with physically 
or psychologically demanding jobs may have more difficulty 
working when they have low back pain and so lose more time from 
work. But that can be the effect rather than the cause of their 
back pain.
    It is unrealistic to think that we can expect to prevent 
all low back pain. What I understand to be OSHA's apparent 
concept of making all work physically undemanding is not only 
unsupported but may well have adverse effects. There is strong 
chance of raising the profile of the attribution concept among 
workers, their advisors and managers, which in turn could lead 
to an exacerbation of the overall impact of low back pain on 
society, rather than a reduction.
    The state-of-the-art evidence assessing reductions in 
physical exposures as a prescription for ergonomic concerns is 
a comprehensive review from Linton and van Tulder. These 
authors systematically searched the literature for studies 
involving subjects not seeking treatment. One third of the 
studies considered educational approaches, often including 
training in lifting techniques, finding strong evidence that 
they were ineffective. Much of the remaining literature studied 
lumbar supports and back belts, again, negative findings.
    The most telling finding of this review, however, is the 
lack of control trials that consider job controls modifying so-
called risk factors such as force of repetition. We simply do 
not have the scientific evidence yet that these measures are 
effective.
    I am not convinced that there is reliable evidence 
supporting blanket ergonomics programs as a remedy for 
musculoskeletal disorders. In fact, a regulation not dissimilar 
to the issued proposal was introduced in Europe in the early 
1990s.
    This has had no discernible influence on disability due to 
back pain. It may well be better to target our resources 
towards appropriate management of the symptomatic worker, 
taking steps to remove obstacles to recovery, both physical and 
psychosocial, thus facilitating that worker's continued 
comfortable performance of normal job duties.

                           prepared statement

    Senator Specter. Dr. Burton, your time has expired and we 
have to be very close on that with so many witnesses. Your full 
statement will be made part of the record. And if you would 
summarize, we would appreciate it.
    Dr. Burton. That was it. I have finished, sir.
    [The statement follows:]
                  Prepared Statement of Dr. Kim Burton
    It is a pleasure to address this body on the very controversial 
topic of ergonomics. Recently in the United Kingdom, experts giving 
evidence in litigation cases need to sign a declaration that their duty 
is to the Court rather than to the party instructing them. It is in 
this spirit that I present my views to you. My background encompasses 
both biomedical science and ergonomics. Currently, I am Director of the 
Spinal Research Unit at the University of Huddersfield in the United 
Kingdom and I serve as Editor-in-Chief of Clinical Biomechanics, a 
biomedical journal listed in Index Medicus. I am also a registered 
European Ergonomist, and have prepared reports and guidance for the 
Health & Safety Executive in the United Kingdom. Last year, in 
collaboration with Professor Gordon Waddell, I produced what 
commentators have called the most comprehensive and current review of 
the evidence related to occupational aspects of low back pain.\1\
---------------------------------------------------------------------------
    \1\ Occupational Health Guidelines for the Management of Low Back 
Pain at Work, Evidence Review and Recommendations (March 2000) 
(available at www.facoccmed.ac.uk).
---------------------------------------------------------------------------
    The first question posed in this hearing is the nature of the 
problem, including: ``What types of injuries?'' and ``Who suffers these 
injuries?'' This very articulation, however, oversimplifies the 
enquiry. It is vitally important to distinguish between reports of 
symptoms, reports of alleged but medically untested ``injuries'' such 
as filing an injury claim, sick leave, chronicity, and irreparable 
damage--all of which are brought together under the same umbrella. It 
is also important to recognize that the term ``musculoskeletal 
disorders'' or ``MSDs,'' as discussed by OSHA, includes a nearly 
innumerable body of reported conditions, some of which involve a 
discrete pathology whilst others are characterized only by their 
symptoms. Each of these components is unique, and it is somewhat 
unhelpful to talk about them as if they are fully interchangeable. 
There is one common thread, however, and that is the compelling 
evidence of multifactorial influences, including those which are 
unrelated to work.
    Because low back pain is the area of my expertise and is such a 
prominent target of OSHA's recent regulation, I will use this as an 
example. Low back pain is not a discrete disease entity or even a 
single clinical syndrome; it is a symptom. Low back pain, in fact, is a 
symptom experienced by most people during their lifetimes, irrespective 
of employment. General adult population surveys find a lifetime 
prevalence of low back pain of around 60 percent, a 12-month prevalence 
of over 40 percent and a point prevalence of approximately 20 percent. 
The lifetime prevalence in adolescents, at just over 50 percent, is 
only slightly lower than that for working-age adults. In the face of 
such figures, attribution of the bulk of the symptoms to work is, in my 
view, untenable. It becomes exceedingly difficult to identify any 
specific causative agents.
    Non-specific low back pain can be occupational in the sense that it 
is common in adults of working age, frequently affects capacity for 
work and often prompts referral to occupational health care. The common 
assumption that this means low back pain is caused by work, however, 
overlooks the complex and inconsistent relationship of physical and 
other influences. Workers in heavy manual jobs do report somewhat more 
low back symptoms and jobs with greater physical demands commonly have 
a higher rate of reported low back injuries, but most of these 
``injuries'' are associated with normal everyday activities such as 
bending and lifting and there is usually little if any objective 
evidence of tissue damage. The review I coauthored with Professor 
Waddell, which considered 34 existing systematic reviews, 28 narrative 
reviews, 52 individual scientific studies, 22 additional weaker 
scientific studies and 17 previous guidelines. We concluded that the 
balance of the evidence showed that physical demands of work can 
precipitate individual attacks of back pain, certain individuals may be 
more susceptible and certain jobs may be higher risk but, viewed 
overall, physical demands of work only account for a modest proportion 
of the total impact of back pain occurring in workers.
    Whether low back symptoms are attributed to work, are reported as 
``injuries,'' or lead to requests for health care or time off of work 
depends upon a complex combination of individual psychosocial and work 
organisational factors. The development of chronic pain and disability 
depends more on individual and work-related psychosocial issues than on 
physical or clinical features. People with physically or 
psychologically demanding jobs may have more difficulty working when 
they have low back pain and so lose more time from work, but that can 
be the effect rather than the cause of their pain.
    It is unrealistic to think, therefore, that we are even close to 
the point at which we can expect to prevent low back pain. What I 
understand to be OSHA's apparent concept of making all work physically 
undemanding is not only unsupported, but may well have adverse effects 
by exacerbating the psychosocial influences that are now known to be 
important determinants of MSDs in the workplace. There is a strong 
chance of raising the profile of the ``attribution'' concept among 
workers, their advisors and managers, which in turn would likely lead 
to an exacerbation of the overall impact of low back pain on society 
rather than a reduction.
    The state-of-the-art evidence assessing reductions in physical 
exposures as a prescription for ergonomic concerns is a comprehensive 
review from Steven J. Linton and Maurits van Tulder entitled 
``Preventive Interventions for Back and Neck Pain Problems: What is the 
Evidence?'' \2\ The authors of this review systematically searched the 
literature for investigations that specifically considered a 
preventative intervention using randomized or non-randomized controlled 
trials involving subjects not seeking treatment. Twenty-seven such 
studies were found, none of which focused on the physical workplace 
environment. One-third of the studies considered educational approaches 
(often including training in lifting techniques), finding ``strong 
evidence'' that these ``back schools'' are ineffective. Much of the 
remaining literature studied lumbar supports such as back belts, 
yielding consistently negative findings. Exercise programs aimed at 
improving conditioning showed stable positive evidence of relatively 
moderate utility, but issues such as compliance and individual need 
suggest they are not justified for use as a universal remedy. The most 
telling finding, however, is the lack of any controlled trials--
randomized or otherwise--that consider ``job controls'' modifying so-
called ``risk factors'' such as force or repetition. We simply do not 
have the scientific evidence yet that these measures are effective.
---------------------------------------------------------------------------
    \2\ Institute for Research in Extramural Medicine, Free University, 
Amsterdam, Netherlands.
---------------------------------------------------------------------------
    Such evidence, in my opinion, is essential. Anecdotal evidence of 
ergonomic ``successes'' is often cited, but these claims raise more 
questions than they answer. It is difficult to determine in many cases 
exactly what the employer has done and how that can be translated into 
a regulation. Another important issue is that such studies have used 
different measurements by which ``success'' is claimed (e.g. absence, 
injury reports, prevalence rates). Interventions may be said to have 
some effect on absence rates, but in most cases these appear to be the 
outcome of organisationally-based factors such getting all the players 
on one side, rather than the product of reductions in physical demands. 
Without any way to separate out and test these influences, which 
requires carefully designed controlled trials, it becomes impossible to 
determine the optimal strategy.
    Scientists have likewise been unable to develop any reliable 
quantified relationships between exposure to ``risk factors'' and 
negative health outcomes. We are simply not at the point yet where we 
can offer a legitimate work-damage model to guide employer conduct, and 
we are unlikely to reach that point anytime soon. Ergonomics 
researchers face particularly difficult challenges: measuring exposures 
in diverse workplaces, accurately diagnosing the response for outcomes 
such as low back pain that do not manifest objective tissue damage, and 
selecting interventions that might offer benefit for substantial 
numbers of workers. Science, after considerable effort, has failed to 
identify any instances where exposure-response relationships are 
universally agreed to be positively and accurately quantified. It is 
difficult to conceive how a workable standard could be applied in the 
absence of such guidance.
    I am not convinced that there is reliable evidence supporting 
blanket ergonomics programs as a remedy for ``MSDs.'' It may well be 
proper to target resources toward appropriate management of the 
symptomatic worker, taking steps to remove obstacles to recovery (both 
physical and psychosocial) by facilitating that worker's continued 
comfortable performance of normal job duties. Even then, it is 
imperative that physical measures be temporary and not a permanent 
crutch that will impede the worker's return to full function. Helping a 
worker get back to the job in this fashion, however, is a far cry from 
using mandatory and potentially permanent job modifications to prevent 
injuries. The latter alternative, in my opinion, is scientifically 
unsupported and dangerously counterproductive. Whatever OSHA does as a 
next step, therefore, I would hope it will not fall into the trap of 
continued fixation on physical exposures as the key to solving the 
problem.

    Senator Specter. Thank you. We should have begun with Dr. 
Jeremiah Barondess, chairman of the MSD Panel, National 
Research Council, IOM, and president of the New York Academy of 
Medicine. Thank you for joining us, Dr. Barondess. And the 
floor is yours.
STATEMENT OF DR. JEREMIAH A. BARONDESS, CHAIRMAN, PANEL 
            ON MUSCULOSKELATAL DISORDERS AND THE 
            WORKPLACE, AND PRESIDENT OF THE NEW YORK 
            ACADEMY OF MEDICINE
    Dr. Barondess. Thank you very much, Senator. It is a 
privilege to be here. On behalf of the panel, my statement is 
before you and it will be included in the record. And I wish to 
emphasize a few points in it in the course of this 
presentation.
    This study was conducted by a panel put together by the 
National Academy of Sciences and it consisted of 19 nationally-
recognized experts in the relevant scientific fields. The study 
took 2 years and was requested. It was requested of us at the 
outset that it take 2 years. We had then ample opportunity to 
be comprehensive.
    I wish to emphasize that what is presented in this report 
is not the personal opinion of anyone.
    Senator Specter. They gave you a deadline?
    Dr. Barondess. They requested that we not hurry. I would 
put it that way. Two years was the request.
    Senator Specter. But they gave you a deadline?
    Dr. Barondess. Yes, sir. Yes, sir. Once again, this report 
represents the synthesis of the best thinking of people expert 
in the relevant fields. We were essentially asked to look only 
at the science, not policy, and to answer two questions. The 
first is, does the scientific evidence support the contention 
that the workplace adds incremental risk of musculoskeletal 
disorders of the low back and upper extremities; not is it the 
entire cause of all such syndromes but is there incremental 
risk.
    The second question was: Is there a scientific basis for 
the contention that interventions of some sorts and some 
circumstances are effective. The answer to both questions is 
yes, in the view of the committee.
    I would like to emphasize that this review was rigorous, as 
it had to be. A lot of the literature in this field is weak. 
Some of it is easy to dismiss on scientific grounds.
    The Commission reviewed more than 3,600 studies and reviews 
relevant to the fields of mechanobiology, biomechanics and 
epidemiology as well as some clinical literature, and culled 
from those papers some 25 percent so that there was a 
significant filter in the literature that was reviewed.
    In addition to the literature reviews, we had numerous 
informed presentations by representatives of industry, of 
labor, and various others.
    The committee went to two heavy industry plants, kindly 
given access by the Ford Motor Company, and visited those for a 
full day. And finally, there were open fora for the expression 
of opinions by industry, labor and professional bodies.
    The conclusions of the 2-year study of the scientific basis 
that we were asked to review can be very quickly summarized.
    The first conclusion is as you have heard this is a very 
important national health problem. It accounts for some 70 
million office visits to physicians annually, not all of it 
obviously specifically work-related. And it costs something of 
the order of 1 percent of the gross domestic product of the 
nation.
    Second, the question of whether it is possible to compare 
the incidents in the workforce to the incidents in the general 
population cannot be approached. Because more than 80 percent 
of American adults are in the workforce.
    Third, the committee took the position that workplace 
disorders and individual risk and outcomes are inextricably 
bound, and therefore these disorders should be approached in 
the context of the whole person rather than strictly the 
injured structure. It is the structure that gets injured, it is 
person who gets disabled.
    Additionally, the committee concluded that the weight of 
the evidence does justify the evidence, the identification of 
certain work-related risk factors for the occurrence of 
musculoskeletal disorders. For the low back these include heavy 
lifting, that is significant physical loads, load moment, which 
is the distance from the person at which the load to be lifted 
is positioned, frequent bending, twisting and whole body 
vibration; and for the upper extremity, repetition, force and 
vibration.
    The committee concluded that psychosocial factors are in 
fact also very important in addition to the physical factors. I 
appreciate Mr. Fellner putting up two of our illustrations 
demonstrating the complexity of human beings. The complexity of 
humans in these regards does not mean, however, that the 
problem cannot or should not be approached.
    The committee concluded also that the weight of the 
evidence justifies the introduction of appropriate and selected 
interventions, that the scientific basis is there. It is not as 
robust as we would like but it is sufficient for action.
    Some of these interventions should apply ergonomic 
principles to reduce physical as well as psychosocial 
stressors. These things have to be applied carefully in a 
sharply selective manner, should be scientifically based and 
should be periodically evaluated.
    There is no generic solution to these problems. They must 
be tailored to the specifics of the workplace and the tasks 
involved in the job.

                           prepared statement

    The committee also concluded that the entire field would 
benefit from an enhanced information base. There is no science 
base anywhere that is complete. That includes this one. And 
additional research would help in the nuancing of responses. I 
thank you for your attention, Mr. Chairman.
    [The statement follows:]
            Prepared Statement of Dr. Jeremiah A. Barondess
    Good morning, Mr. Chairman and members of the Committee. My name is 
Dr. Jeremiah Baroness. I am the President of the New York Academy of 
Medicine and Chairman of the Panel on Musculoskeletal Disorders and the 
Workplace. I am accompanied by committee member Dr. David Wegman, 
Professor and Chair of the Department of Work Environment at the 
University of Massachusetts at Lowell.
                           panel composition
    The Panel on Musculoskeletal Disorders and the Workplace was 
established by the National Research Council (NRC) and the Institute of 
Medicine (IOM) in January, 1999, to conduct a two-year study of the 
contribution of workplace physical and psychosocial factors to the 
occurrence of musculoskeletal disorders of the low back and upper 
extremities and to examine the effectiveness of various prevention 
strategies. The panel is composed of 19 experts representing the fields 
of biomechanics, epidemiology, hand surgery, human factors engineering, 
internal medicine, nursing, occupational medicine, orthopedics, 
physical medicine and rehabilitation, physiology, psychology, 
quantitative analysis, and rheumatology.
                                impetus
    The impetus for the study was a request from Congress (including 
your subcommittee) to examine the causation, diagnosis, and prevention 
of musculoskeletal disorders (House Report 105-635). The congressional 
request was presented in the form of seven questions. The charge to the 
panel, prepared by the NRC and the IOM, was stated as a series of tasks 
designed to provide a comprehensive review of the science base and to 
address the issues outlined in the congressional questions. A complete 
statement of the panel's charge, approach, conclusions, and 
recommendations is found in the first attachment: the Executive Summary 
of the final report. Attachment App. A provides the panel's response to 
the congressional questions.
                                approach
    The panel approached the complex of factors bearing on the risk of 
musculoskeletal injury in the work setting from a whole-person 
perspective, that is, from a point of view that does not isolate 
disorders of the low back and upper extremities from physical and 
psychosocial factors in the workplace, from the context of the overall 
texture of the worker's life, including social support systems at work 
and in the community and physical and psychosocial stresses outside the 
workplace, or from personal responses to pain and individual coping 
mechanisms. The focus of the study was on work-related factors. 
Individual factors and activities outside of the workplace were 
considered as context and were accounted for in the literature reviews. 
Our task was to determine the incremental effect of work-related 
factors on the occurrence of musculoskeletal disorders.
    The panel applied a set of rigorous scientific criteria in 
selecting the research studies for its review. Because the literature 
includes both empirical and theoretical approaches and covers a wide 
variety of research designs, measurement instruments, and methods of 
analysis, the quality selection criteria varied somewhat among 
disciplines. At one level, there are highly controlled studies of soft 
tissue responses to specific exposures using cadavers, animal models, 
and human subjects. At another level, there are surveys and other 
observational epidemiologic studies that examine the association among 
musculoskeletal disorders and work, organizational, social, and 
individual factors. At yet another level, there are experimental and 
quasi-experimental studies of human populations designed to examine the 
effects of workplace interventions. Studies at each level have 
attendant individual strengths; each also has limitations when 
considered in isolation. When taken together however, they provide a 
rich basis for understanding the causes and prevention of 
musculoskeletal disorders.
                       dimensions of the problem
    The first conclusion reached by the panel is that musculoskeletal 
disorders of the low back and upper extremities are an important 
national health problem, resulting in approximately 1 million people 
losing time from work each year. These disorders impose a substantial 
economic burden in compensation costs, lost wages, and productivity. 
Conservative cost estimates vary, but a reasonable figure is about $50 
billion annually in work-related costs--a figure representing 
approximately 1 percent of GDP.
    The panel found that estimates of incidence in the general 
population, as contrasted with the working population, are unreliable 
because more than 80 percent of the adult population in the United 
States is in the workforce. Nevertheless, the magnitude of the problem 
of work-related musculoskeletal disorders can be gleaned from the 
Bureau of Labor Statistics data. These data suggest that 
musculoskeletal disorders are a problem in multiple industrial sectors; 
they are not limited to the traditional heavy labor environments 
represented by agriculture, mining, and manufacturing. It was reported, 
for example, that the service sector is also importantly involved, 
accounting for 26 percent of sprains/strains, carpal tunnel syndrome, 
or tendinitis; the manufacturing sector accounted for 22 percent. 
Another data base, National Center for Health Statistics, using self 
reports, provided estimates for back pain among those whose pain 
occurred at work (approximately 11.7 million) and for those who 
specifically reported that their pain was work-related (5.6 million). 
In this survey, the highest-risk occupations among men were 
construction laborers, carpenters, and industrial truck and tractor 
equipment operators; among women, the highest-risk occupations were 
nursing aides/orderlies/attendants, licensed practical nurses, maids, 
and janitor/cleaners. Other high-risk occupations were hairdressers and 
automobile mechanics.
     relationship among work factors and musculoskeletal disorders
    A second major conclusion is that the weight of the evidence 
justifies the identification of certain work-related risk factors for 
the occurrence of musculoskeletal disorders of the low back and upper 
extremities.
  --The panel concludes that there is a clear relationship between back 
        disorders and physical load; that is, manual material handling, 
        load moment, frequent bending and twisting, heavy physical 
        work, and whole-body vibration. For disorders of the upper 
        extremities, repetition, force, and vibration are particularly 
        important work-related factors. That is, physical workplace 
        activities have been shown to be responsible for a significant 
        increment in the occurrence of musculoskeletal disorders of the 
        low back and upper extremities.
  --Work-related psychosocial factors recognized by the panel to be 
        associated with low back disorders include rapid work pace, 
        monotonous work, low job satisfaction, low decision latitude, 
        and job stress. High job demands and high job stress are work-
        related psychosocial factors that are associated with the 
        occurrence of upper extremity disorders.
                  the value of workplace interventions
    A third major conclusion is that the weight of the evidence 
justifies the introduction of appropriate and selected interventions in 
the workplace to reduce the risk of musculoskeletal disorders of the 
low back and upper extremities. These include, but are not confined to, 
the application of ergonomic principles to reduce physical as well as 
psychosocial stressors. To be effective, intervention programs should 
include employee involvement, employer commitment, and the development 
of integrated programs that address equipment design, work procedures, 
and organizational characteristics.
    There is no generic solution. To be effective interventions must be 
tailored to the specific work and worker conditions and must be 
evaluated on a continuing basis to account for changing workplace and 
worker factors.
    Cost and effectiveness of various intervention strategies are a 
major concern for public and private policy makers, managers, and other 
leaders facing the practical challenges of allocating limited 
resources. Despite the availability of cost benefit analysis techniques 
they have not been systematically applied to the study of workplace 
interventions designed to relieve or prevent musculoskeletal disorders. 
Outcome measures generally include relief from pain and loss of 
function and reductions in worker's compensation claims and time away 
from work. Although there are individual studies that demonstrate 
favorable outcomes following the introduction of an intervention, the 
conditions under which the data are collected make it difficult to 
determine which of several specific factors are responsible for the 
outcome. On the other side of the equation are the costs associated 
with the design and implementation of the interventions. Some 
interventions require minor changes in procedures or layouts for 
specific work spaces while others may involve developing large-scale 
design modifications or instituting new work practices or ways to 
organize work. Here again, some scattered individual studies exist. 
What is needed to resolve these issues is careful research to develop a 
methodology to facilitate both cost and benefit comparisons across 
alternative interventions in a range of workplaces.
           the need for data collection and reporting systems
    To extend the current knowledge base relating both to risk and 
effective interventions, the Bureau of Labor Statistics should continue 
to revise its current data collection and reporting system to provide 
more comprehensive surveillance of work-related musculoskeletal 
disorders. Specific attention should be given to revising the illness 
and injury coding system, refining the quantification of risk, and 
developing denominator data for job-specific demographic features. 
Reporting should also be enhanced to include details on musculoskeletal 
disorders that do not involve lost workdays. Enhanced resources are 
needed to address these recommendations.
    The National Center for Health Statistics and the National 
Institute for Occupational Safety and Health should include measures of 
work exposures and musculoskeletal disorder outcomes in ongoing Federal 
surveys (e.g., the National Health Interview Surveys, the National 
Health and Nutritional Examinations), and NIOSH should repeat, at least 
decennially, the National Occupational Exposure Survey. NIOSH should 
develop both a passive surveillance packages for use by a broad range 
of employees and a model for an active surveillance program for 
interested employers.
    The National Institute for Occupational Safety and Health should 
take the lead in developing uniform definitions of musculoskeletal 
disorders for use in clinical diagnosis, epidemiologic research, and 
data collection for surveillance systems. These definitions should (1) 
include clear and consistent endpoint measures, (2) agree with 
consensus codification of clinically relevant classification systems, 
and (3) have a biological and clinical basis.
                           a research agenda
    The panel recommends a research agenda that includes developing (1) 
improved tools for exposure assessment, (2) improved measures of 
outcomes and case definitions for use in epidemiologic and intervention 
studies, and (3) further quantification of the relationship between 
exposures and outcomes. Also included are suggestions for studies in 
each topic area: tissue mechanobiology, biomechanics, psychosocial 
stressors, epidemiology, and workplace interventions. In addition, the 
panel recommends (1) expanding research and research training, (2) 
promoting collaboration among industry, labor, and academia, and (3) 
expanding education and training in utilizing workplace interventions 
to employers. In order to accomplish these objectives, the panel 
recognized that funding for NIOSH would have to be significantly 
increased. Broader support for these research programs should also be 
sought from relevant NIH Institutes.
                              the dissent
    The conclusions and recommendations provided in the panel's report 
were supported by 18 of the 19 panel members. The dissenting member, a 
hand surgeon, prepared a statement that was limited to a very narrow 
concern--the relationship between carpal tunnel syndrome and 
keyboarding. Unfortunately, he uses this case to question the 
scientific basis for the panel's review and interpretation of all of 
the literature. Essentially, he asserts that because the relationship 
between low force, high repetition activities and muscusloskeletal 
disorders is weak, the relationship between any work and the occurrence 
of a musculoskeletal disorder may not be sound.
    Some key points in the dissent assert that the panel used an 
unscientific approach to the literature review, that it over-reached in 
interpreting the literature on the relationship between keyboarding and 
carpal tunnel syndrome, and that it recommends ergonomics as an 
exclusive remedy for musculoskeletal disorders. All of these assertions 
are countered in the panel's response to the dissent (see Attachment 
App. C). It is important to note that many of the research studies 
cited by the dissenting member in his discussion of the epidemiology of 
carpal tunnel syndrome and work did not meet the rigorous review 
criteria established by the panel and were rejected for inclusion in 
the full report. Furthermore, one of the 18 panel members is a leading 
and highly regarded hand surgeon and an enthusiastic supporter of the 
panel's conclusions and recommendations.
    Mr. Chairman, I want to thank you for the opportunity to provide 
testimony on this important topic. I will be happy to answer any 
questions.
    Musculoskeletal Disorders and the Workplace--Low Back and Upper 
                              Extremities
                           executive summary
    There is no doubt that musculoskeletal disorders of the low back 
and upper extremities are an important and costly national health 
problem. Musculoskeletal disorders account for nearly 70 million 
physician office visits in the United States annually and an estimated 
130 million total health care encounters including outpatient, 
hospital, and emergency room visits. In 1999, nearly 1 million people 
took time away from work to treat and recover from work-related 
musculoskeletal pain or impairment of function in the low back or upper 
extremities. Conservative estimates of the economic burden imposed, as 
measured by compensation costs, lost wages, and lost productivity, are 
between $45 and $54 billion annually. There is some variation in 
estimates of occurrence and cost as a result of inconsistencies within 
and across existing databases. The ability to better characterize the 
magnitude of the problem and formulate targeted prevention strategies 
rests on improved surveillance and more rigorous data collection.
    There is also debate concerning sources of risk, mechanisms of 
injury, and the potential for intervention strategies to reduce these 
risks. The debate focuses on the causes, nature, severity, and degrees 
of work-relatedness of musculoskeletal disorders as well as the 
effectiveness and cost-related benefits of various interventions. None 
of the common musculoskeletal disorders is uniquely caused by work 
exposures. They are what the World Health Organization calls ``work-
related conditions'' because they can be caused by work exposures as 
well as non-work factors. There are a number of factors to be 
considered: (1) physical, organizational, and social aspects of work 
and the workplace, (2) physical and social aspects of life outside the 
workplace, including physical activities (e.g., household work, sports, 
exercise programs), economic incentives, and cultural values, and (3) 
the physical and psychological characteristics of the individual. The 
most important of the latter include age, gender, body mass index, 
personal habits including smoking, comorbidities, and probably some 
aspects of genetically determined predispositions. In addition, 
physical activities away from the workplace may also cause 
musculoskeletal syndromes; the interaction of such factors with 
physical and psychosocial stresses in the workplace is a further 
consideration. The task herein is to evaluate the significance of the 
risk factors that result from work exposure while taking into account 
the different types of individual and non-work factors. The complexity 
of the problem is further increased because all of these factors 
interact and vary over time and from one situation to another. Research 
is needed to clarify such relationships, but research is complicated by 
the fact that estimates of incidence in the general population, as 
contrasted with the working population, are unreliable because the two 
overlap: more than 80 percent of the adult population is in the 
workforce.
    The panel approached the complex of factors bearing on the risk of 
musculoskeletal injury in the work setting from a whole-person 
perspective, that is, from a point of view that does not isolate 
disorders of the low back and upper extremities from physical and 
psychosocial factors in the workplace, from the context of the overall 
texture of the worker's life, including social support systems and 
physical and psychosocial stresses outside the workplace, or from 
personal responses to pain and individual coping mechanisms (see Figure 
ES.1). The size and complexity of the problem and the diversity of 
interests and perspectives--including those of medical and public 
policy professionals, behavioral researchers, ergonomists, large and 
small businesses, labor, and government agencies--have led to differing 
interpretations of the evidence regarding the work-relatedness of 
musculoskeletal disorders of the low back and upper extremities and the 
impact of interventions. As a result, Congress requested a study by the 
National Research Council and the Institute of Medicine covering the 
scientific literature on the causation and prevention of these 
disorders. The congressional request was presented in the form of seven 
questions, which are addressed in Appendix A of this report. The 
funding for the study was provided by the National Institute for 
Occupational Safety and Health (NIOSH) and by the National Institutes 
of Health (NIH).



    Figure ES.1.--A conceptual model of the possible roles and 
influences that various factors may play in the development of 
musculoskeletal disorders. The dotted box outline on the right indicate 
the possible pathways and processes that could occur within the person, 
including the biomechanical load-tolerance relationship and the factors 
that may mediate the load-tolerance relationship, such as individual 
factors and adaptation. Outcomes may be a result of this relationship 
and may be influenced by individual factors, such as conditioning or 
psychological state. The dotted box on the left indicates the possible 
influences of the workplace on the sequence of events that can lead to 
musculoskeletal disorders in the person. Arrows between ``the 
workplace'' factors and ``the person'' box indicate the various 
research disciplines (epidemiology, biomechanics, physiology, etc.) 
that have attempted to explain the relationship. For example, 
epidemiology typically searches for associations between external 
loading characteristics and reported outcomes, whereas the relationship 
between external loads and biomechanical loading are usually explored 
via biomechanical studies (adapted from National Research Council, 
1999b).



                panel charge, composition, and approach
    The charge to the panel from NIOSH and NIH, which appears in Box 
ES.1, was to undertake a series of tasks that would lead to a detailed 
analysis of the complex set of factors contributing to the occurrence 
in the workplace of musculoskeletal disorders of the low back and upper 
extremities and that would provide the information necessary to address 
the questions posed by Congress. The panel viewed this charge as an 
opportunity to conduct a comprehensive review and interpretation of the 
scientific literature, with the goal of clarifying the state of 
existing knowledge concerning the roles of various risk factors and the 
basis for various efforts bearing on prevention. The focus of the study 
was on work-related factors. In this context, individual risk factors, 
such as age, body mass index, gender, smoking, and activities outside 
the workplace, were considered as sources of confounding and were 
accounted for in the research reviews.
    The panel was composed of 19 experts representing the fields of 
biomechanics, epidemiology, hand surgery, human factors engineering, 
internal medicine, nursing, occupational medicine, orthopedics, 
physical medicine and rehabilitation, physiology, psychology, 
quantitative analysis, and rheumatology. The panel's work was guided by 
two underlying principles. The first, noted above, was to approach 
musculoskeletal disorders in the context of the whole person rather 
than focusing on body regions in isolation. The second was to draw 
appropriate scientific inferences from basic tissue biology, 
biomechanics, epidemiology, and intervention strategies in order to 
develop patterns of evidence concerning the strength of the 
relationship between musculoskeletal disorders and the multiplicity of 
work and individual factors.
    The panel applied a set of rigorous scientific criteria in 
selecting the research studies for its review. Because the literature 
includes both empirical and theoretical approaches and covers a wide 
variety of research designs, measurement instruments, and methods of 
analysis, the quality selection criteria varied somewhat among 
disciplines (see Chapter 1 for details). At one level, there are highly 
controlled studies of soft tissue responses to specific exposures using 
cadavers, animal models, and human subjects. At another level, there 
are surveys and other observational epidemiologic studies that examine 
the association among musculoskeletal disorders and work, 
organizational, social, and individual factors. At yet another level, 
there are experimental and quasi-experimental studies of human 
populations designed to examine the effects of workplace interventions. 
Each level provides a different perspective; together they provide a 
complementary picture of how various workplace exposures may contribute 
to the occurrence of musculoskeletal disorders. Although each level has 
its attendant strengths and limitations when considered alone, together 
they provide a rich understanding of the causes and prevention of 
musculoskeletal disorders.
    The wide and diverse body of literature addressing the work-
relatedness of musculoskeletal disorders suggests various pathways to 
injury. Figure ES.1 summarizes the analytic framework used by the panel 
to organize and interpret these various strands of research. This 
framework is central to the panel's assessment, and it is used to 
orient and structure the panel's report. The factors are organized into 
two broad categories: workplace factors and characteristics of the 
person that may affect the development of musculoskeletal disorders. 
Workplace factors include the external physical loads associated with 
job performance, as well as organizational factors and social context 
variables. A person is the central biological entity, subject to 
biomechanical loading with various physical, psychological, and social 
features that may influence the biological, clinical, and disability 
responses. The rationale underlying the figure is that there may be 
many pathways to injury, and the presence of one pathway does not 
negate nor suggest that another pathway does not play an important 
role. The various pathways simply represent different aspects of the 
workplace-person system.
                          patterns of evidence
    The panel's review of the research literature in epidemiology, 
biomechanics, tissue mechanobiology, and workplace intervention 
strategies has identified a rich and consistent pattern of evidence 
that supports a relationship between the workplace and the occurrence 
of musculoskeletal disorders of the low back and upper extremities. 
This evidence suggests a strong role for both the physical and 
psychosocial aspects of work. There is also evidence that individual 
factors, such as age, gender, and physical condition, are important in 
mediating the individual's response to work factors associated with 
biomechanical loading.
Back disorders and the workplace
    Low back disorder risk has been established through epidemiologic 
studies of work that involves heavy lifting, frequent bending and 
twisting, and whole body vibration, as well as other risk factors. The 
relative risks have been derived from a rigorous evaluation of the 
literature and have been found to be strong and consistent. Strong 
points in this research include control for confounding, temporal 
association, and characterization of dose-response relationships; the 
principal limitation is that a number of the studies are based on self-
reports of injury. The epidemiologic literature that specifically 
quantifies heavy lifting shows the greatest risk for injury when loads 
are lifted from low heights, when the distance of the load from the 
body (moment) is great, and when the torso assumes a flexed, asymmetric 
posture. Biomechanical studies reinforce the epidemiologic findings. 
Studies in basic biology also describe the mechanisms involved in the 
translation of spinal loading to tissue injury within the 
intervertebral disc. In addition, the basic science literature has 
described pathways for the perception of pain when specific structures 
in the spine are stressed. Intervention studies have shown how lift 
tables and lifting hoists are effective in mediating the risk of low 
back pain in industrial settings. Since risk is lowered when the load 
is changed from a heavy lift to a light lift, this finding is also 
consistent with the rigorous epidemiologic findings.
    In epidemiologic studies, psychosocial factors in the workplace 
have also been found to play a role. Specifically, there is evidence 
for a relationship between low back disorders and job satisfaction, 
monotonous work, work pace, interpersonal relations in the workplace, 
work demand stress, and the worker's perceived ability to work. In 
addition, recent evidence from biomechanics studies points to a 
mechanism whereby psychosocial stress contributes to increases in spine 
loading. There is also evidence that exposure to psychosocial stressors 
may result in greater trunk muscle activity independent of 
biomechanical load. Some part of the variance in response described in 
the biological and biomechanical literature appears to be explained by 
individual host factors, such as age, gender, and body mass index. For 
example, age and gender appear to play a role in determining the 
magnitude of load to which a person's spine may be exposed before 
damage would be expected.
Upper extremity disorders and the workplace
    The pattern of evidence for upper extremity disorders, as for the 
low back, also supports an important role for physical factors, 
particularly repetition, force, and vibration. The most dramatic 
physical exposures occur in manufacturing, food processing, lumber, 
transportation, and other heavy industries, and these industries have 
the highest rates of upper extremity disorders reported as work 
related. Psychosocial factors were found to play a role in upper 
extremity disorders as well, particularly high job stress and high job 
demands. In addition, several epidemiologic studies of physical 
exposures (force, repetition) and psychosocial exposure (perceived 
stress, job demands) have documented an elevated risk of upper 
extremity disorders among computer users. Nonwork-related anxiety, 
tension, and psychological distress are also associated with upper 
extremity symptoms. Biomechanical studies have shown that extraneural 
pressure in the carpal tunnel is increased with hand loading and 
nonneutral wrist postures. Basic science studies demonstrate that 
extraneural pressures may lead to intraneural edema and fibrosis, 
demyelination, and axon degeneration. These changes in nerve structure 
may cause impairment of nerve function. The findings in the 
intervention literature are congruent with those in the basic biology 
and epidemiology literatures. There is strong support across these 
bodies of work that high force and repetition are associated with 
musculoskeletal disorders of the upper extremities; basic biology data 
provide evidence of alteration in tissue structure. The intervention 
literature supports the efficacy of tool and workstation design 
changes, job rotation, and other interventions that directly address 
these risk factors with regard to upper extremity symptomology.
    Although the upper extremity literature is less well developed than 
the literature on low back pain, an analogous set of themes emerges, 
lending further support to the conclusion that external loads and 
psychosocial factors associated with work influence outcomes. These 
exposure-response associations persist when adjusted for individual 
factors that may increase vulnerability, such as age, gender, and body 
mass index. The basic biology and biomechanics studies provide a 
plausible basis for the exposure-response relationships. The evidence 
related to the efficacy of ergonomic interventions further supports 
these relationships.
Interventions
    Data from scientific studies of primary and secondary interventions 
indicate that low back pain can be reduced under certain conditions by 
engineering controls (e.g., ergonomic workplace redesign), 
administrative controls (specifically, adjusting organizational 
culture), programs designed to modify individual factors (specifically, 
employee exercise), and combinations of these approaches. Multiple 
interventions that actively involve workers in medical management, 
physical training, and work technique education can also be effective 
in controlling risk. Similarly, with respect to interventions for 
musculoskeletal disorders of the upper extremities, some studies of 
engineering controls for computer-related work (reducing static 
postural loads, sustained posture extremes, and rapid motions, and 
changing the designs of workstations and tools) have resulted in a 
decrease in upper extremity pain reports. Studies of administrative 
controls (modifying organizational culture by an emphasis on 
participatory team involvement) have also reported success. For such 
interventions, the commitment of management and the involvement of 
employees have been important to success.
    These findings are based on a research and development process that 
tailors interventions to specific work and worker conditions and 
evaluates, on a continuing basis, the effectiveness of these 
interventions in the face of changing workplace and worker factors. It 
is therefore neither feasible nor desirable to propose a generic 
solution. The development and application of effective interventions 
requires an infrastructure that supports (1) gathering data, through 
surveillance and research, about the engineering, administrative, and 
worker factors that affect the effectiveness of interventions; (2) 
using these data to refine, implement, and assess alternative 
interventions; and (3) translating knowledge from research to practice. 
These efforts will benefit from cooperation and information exchange 
among researchers, practitioners, and workers and managers in industry 
and labor, government, and academia. These practices should be 
encouraged and extended.
                              conclusions
    Based on a comprehensive review and analysis of the evidence, as 
described above, the panel has reached the following conclusions:
    1. Musculoskeletal disorders of the low back and upper extremities 
are an important national health problem, resulting in approximately 1 
million people losing time from work each year. These disorders impose 
a substantial economic burden in compensation costs, lost wages, and 
productivity. Conservative cost estimates vary, but a reasonable figure 
is about $50 billion annually in work-related costs.
    2. Estimates of incidence in the general population, as contrasted 
with the working population, are unreliable because more than 80 
percent of the adult population in the United States is in the 
workforce.
    3. Because workplace disorders and individual risk and outcomes are 
inextricably bound, musculoskeletal disorders should be approached in 
the context of the whole person rather than focusing on body regions in 
isolation.
    4. The weight of the evidence justifies the identification of 
certain work-related risk factors for the occurrence of musculoskeletal 
disorders of the low back and upper extremities.
  --The panel concludes that there is a clear relationship between back 
        disorders and physical load; that is, manual material handling, 
        load moment, frequent bending and twisting, heavy physical 
        work, and whole-body vibration. For disorders of the upper 
        extremities, repetition, force, and vibration are particularly 
        important work-related factors.
  --Work-related psychosocial factors recognized by the panel to be 
        associated with low back disorders include rapid work pace, 
        monotonous work, low job satisfaction, low decision latitude, 
        and job stress. High job demands and high job stress are work-
        related psychosocial factors that are associated with the 
        occurrence of upper extremity disorders.
    5. A number of characteristics of the individual appear to affect 
vulnerability to work-related musculoskeletal disorders, including 
increasing age, gender, body mass index, and a number of individual 
psychosocial factors. These factors are important as contributing and 
modifying influences in the development of pain and disability and in 
the transition from acute to chronic pain.
    6. Modification of the various physical factors and psychosocial 
factors could reduce substantially the risk of symptoms for low back 
and upper extremity disorders.
    7. The basic biology and biomechanics literatures provide evidence 
of plausible mechanisms for the association between musculoskeletal 
disorders and workplace physical exposures.
    8. The weight of the evidence justifies the introduction of 
appropriate and selected interventions to reduce the risk of 
musculoskeletal disorders of the low back and upper extremities. These 
include, but are not confined to, the application of ergonomic 
principles to reduce physical as well as psychosocial stressors. To be 
effective, intervention programs should include employee involvement, 
employer commitment, and the development of integrated programs that 
address equipment design, work procedures, and organizational 
characteristics.
    9. As the nature of work changes in the future, the central 
thematic alterations will revolve around the diversity of jobs and of 
workers. Although automation and the introduction of a wide variety of 
technologies will characterize work in the future, manual labor will 
remain important. As the workforce ages and as more women enter the 
workforce, particularly in material handling and computer jobs, 
evaluation of work tasks, especially lifting, lowering, carrying, 
prolonged static posture, and repetitive motion, will be required to 
guide the further design of appropriate interventions.
                            recommendations
    1. The consequences of musculoskeletal disorders to individuals and 
society and the evidence that these disorders are to some degree 
preventable justify a broad, coherent effort to encourage the 
institution or extension of ergonomic and other preventive strategies. 
Such strategies should be science based and evaluated in an ongoing 
manner.
    2. To extend the current knowledge base relating both to risk and 
effective interventions, the Bureau of Labor Statistics should continue 
to revise its current data collection and reporting system to provide 
more comprehensive surveillance of work-related musculoskeletal 
disorders.
  --The injury or illness coding system designed by the Bureau of Labor 
        Statistics should be revised to make comparisons possible with 
        health survey data that are based on the widely accepted ICD-9 
        and ICD-10 coding systems.
  --The characterization of exposures associated with musculoskeletal 
        disorders should be refined, including enhanced quantification 
        of risk factors. Currently, exposure is based only on 
        characterization of sources of injury (e.g., tools, 
        instruments, equipment) and type of event (e.g., repetitive use 
        of tools) derived from injury narratives.
  --Information collected from each employer should contribute to 
        specificity in denominators for jobs including job-specific 
        demographic features in the workplace, such as age, gender, 
        race, time on the job and occupation.
  --Injury and illness information should include, in addition to the 
        foregoing demographic variables, other critical variables, such 
        as event, source, nature, body part involved, time on job, and 
        rotation schedule. Combining these with the foregoing variables 
        would, with appropriate denominator information, allow 
        calculation of rates rather than merely counts or proportions, 
        as is now the case for all lost-workday events.
  --Resources should be allocated to include details on non-lost-
        workday injuries or illnesses (as currently provided on lost-
        workday injuries) to permit tracking of these events in terms 
        of the variables now collected only for lost-workday injuries 
        (age, gender, race, occupation, event, source, nature, body 
        part, time on job).
    3. The National Center for Health Statistics and the National 
Institute for Occupational Safety and Health should include measures of 
work exposures and musculoskeletal disorder outcomes in ongoing Federal 
surveys (e.g., the National Health Interview Surveys, the National 
Health and Nutritional Examinations), and NIOSH should repeat, at least 
decennially, the National Occupational Exposure Survey.
  --To upgrade and improve passive industry surveillance of 
        musculoskeletal disorders and workplace exposures, the National 
        Institute for Occupational Safety and Health should develop 
        adaptable surveillance packages with associated training and 
        disseminate these to interested industries.
  --To provide more active surveillance opportunity, the National 
        Institute for Occupational Safety and Health should develop a 
        model surveillance program that provides ongoing and advanced 
        technical assistance with timely, confidential feedback to 
        participating industries.
    4. The National Institute for Occupational Safety and Health should 
take the lead in developing uniform definitions of musculoskeletal 
disorders for use in clinical diagnosis, epidemiologic research, and 
data collection for surveillance systems. These definitions should (1) 
include clear and consistent endpoint measures, (2) agree with 
consensus codification of clinically relevant classification systems, 
and (3) have a biological and clinical basis.
    5. In addition to these recommendations, the panel recommends a 
research agenda that includes developing (1) improved tools for 
exposure assessment, (2) improved measures of outcomes and case 
definitions for use in epidemiologic and intervention studies, and (3) 
further quantification of the relationship between exposures and 
outcomes. Also included are suggestions for studies in each topic area: 
tissue mechanobiology, biomechanics, psychosocial stressors, 
epidemiology, and workplace interventions. The research agenda is 
presented in Chapter 12.
                       additional considerations
    Because of the importance of continued data collection and research 
to further elucidate the causes and prevention of musculoskeletal 
disorders of the low back and upper extremities, the panel believes it 
would be useful for relevant government agencies, including the 
National Institute for Occupational Safety and Health, the Occupational 
Safety and Health Administration, and the National Institute of 
Arthritis and Musculoskeletal and Skin Diseases to consider the 
following program initiatives.
    1. Expanding research support and mechanisms to study 
musculoskeletal disorders in terms of risk factors at work, early 
detection, and effective methods of prevention and their cost 
effectiveness. Some examples include:
  --Developing new mechanisms and linkages among funding agencies 
        (e.g., the National Institute for Occupational Safety and 
        Health, the National Institute of Arthritis and Musculoskeletal 
        and Skin Diseases) to expand ongoing basic research on relevant 
        tissues (e.g., skeletal muscle, tendon, peripheral nerve) to 
        promote study of those parameters that are directly relevant to 
        work-related musculoskeletal disorders.
  --Creating mechanisms to stimulate collaboration and cross-training 
        of researchers in the basic and applied sciences directly 
        relevant to work-related musculoskeletal disorders.
  --Developing mechanisms to promote research jointly conducted by 
        industry and the relevant academic disciplines on work-related 
        musculoskeletal disorders.
    2. Expanding considerably research training relevant to 
musculoskeletal disorders, particularly with relation to graduate 
programs in epidemiology, occupational health, occupational psychology, 
and ergonomics, to produce additional individuals with research 
training.
    3. Expanding education and training programs to assist workers and 
employers (particularly small employers) in understanding and utilizing 
the range of possible workplace interventions designed to reduce 
musculoskeletal disorders. In addition, consideration should be given 
to expanding continuing education (e.g., NIOSH Education and Research 
and Training Projects) for a broad range of professionals concerning 
risk factors that contribute to musculoskeletal disorders inside and 
outside the workplace.
    4. Developing mechanisms for cooperative studies among industry, 
labor unions, and academia, including:
  --Establishing a database of and mechanism for communicating ``best 
        practices.''
  --Providing incentives for industry and union cooperation with due 
        regard for proprietary considerations and administrative 
        barriers.
  --Encouraging funding for such studies from industry, labor, 
        academia, and government sources.
    5. Revising administrative procedures to promote joint research 
funding among agencies.
    6. Encouraging the exchange of scientific information among 
researchers interested in intervention research through a variety of 
mechanisms. Areas that could benefit include the development of (1) 
research methodologies, especially improved measurement of outcomes and 
exposures, covariates, and costs and (2) uniform approaches, allowing 
findings to be compared across studies. In addition, periodic meetings 
should be considered to bring together individuals with scientific and 
``best practices'' experience.
    In order to implement these suggestions, the scope of research and 
training activities of the National Institute for Occupational Safety 
and Health would have to be expanded and funding significantly 
increased. In addition, other Federal agencies (e.g., the National 
Institute of Arthritis and Musculoskeletal and Skin Diseases, the 
National Institute of Mental Health) would have to broaden their 
support of research programs examining musculoskeletal disorders and 
the workplace. In the panel's view these steps deserve serious 
consideration.
          Appendix A.--Answers to Questions Posed by Congress
    The questions below provided the impetus for the study. The charge 
to the panel, prepared by the NRC and the IOM was to conduct a 
comprehensive review of the science base and to address the issues 
outlined in the questions. The panel's responses to the questions 
follow.
     Question. What are the conditions affecting humans that are 
considered to be work-related musculoskeletal disorders?
    Answer. The disorders of particular interest to the panel, in light 
of its charge, focus on the low back and upper extremities. With regard 
to the upper extremities, these include rotator cuff injuries (lateral 
and medial) epicondylitis, carpal tunnel syndrome, tendinitis, 
tenosynovitis of the hand and wrist (including DeQuervains' stenosing 
tenosynovitis, trigger finger, and others) and a variety of nonspecific 
wrist complaints, syndromes, and regional discomforts lacking clinical 
specificity. With regard to the low back, there are many disabling 
syndromes that occur in the absence of defined radiographic 
abnormalities or commonly occur in the presence of unrelated 
radiographic abnormalities. Thus, the most common syndrome is 
nonspecific backache. Other disorders of interest include back pain and 
sciatica due to displacement and degeneration of lumbar intervertebral 
discs with radiculopathy, spondylolysis, and spondylolisthesis, and 
spinal stenosis (ICD 9 categories 353-357, 722-724, and 726-729).
     Question. What is the status of medical science with respect to 
the diagnosis and classification of such conditions?
    Answer. Diagnostic criteria for some of the musculoskeletal 
disorders considered to be work-related and considered in this report 
are clear-cut, especially those that can be supported by objective 
ancillary diagnostic tests, such as carpal tunnel syndrome. Others, 
such as work-related low back pain, are in some instances supported by 
objective change, which must be considered in concert with the history 
and physical findings. In the case of radicular syndromes associated 
with lumbar intervertebral disc herniation, for example, clinical and 
X-ray findings tend to support each other. In other instances, in the 
absence of objective support for a specific clinical entity, diagnostic 
certainty varies but may nevertheless be substantial. The clinical 
picture of low back strain, for example, while varying to some degree, 
is reasonably characteristic.
    Epidemiologic definitions for musculoskeletal disorders, as for 
infectious and other reportable diseases, are based on simple, 
unambiguous criteria. While these are suitable for data collection and 
analysis of disease occurrence and patterns, they are not appropriate 
for clinical decisions, which must also take into account personal, 
patient-specific information, which is not routinely available in 
epidemiologic databases.
     Question. What is the state of scientific knowledge, characterized 
by the degree of certainty or lack thereof, with regard to occupational 
and nonoccupational activities causing such conditions?
    Answer. The panel has considered the contributions of occupational 
and nonoccupational activities to the development of musculoskeletal 
disorders via independent literature reviews based in observational 
epidemiology, biomechanics, and basic science. As noted in the chapter 
on epidemiology, when studies meeting stringent quality criteria are 
used, there are significant data to show that both low back and upper 
extremity musculoskeletal disorders can be attributed to workplace 
exposures. Across the epidemiologic studies, the review has shown both 
consistency and strength of association. Concerns about whether the 
associations might be spurious have been considered and reviewed. 
Biological plausibility for the work-relatedness of these disorders has 
been demonstrated in biomechanical and basic science studies, and 
further evidence to build causal inferences has been demonstrated in 
intervention studies that show reduction in occurrence of 
musculoskeletal disorders following implementation of interventions. 
The findings suggest strongly that there is an occupational component 
to musculoskeletal disorders. Each set of studies has inherent 
strengths and limitations that affect confidence in the conclusions; as 
discussed in Chapter 3 (methodology), when the pattern of evidence is 
considered across the various types of studies, complementary strengths 
are demonstrated. These findings were considered collectively through 
integration of the information across the relevant bodies of scientific 
evidence. Based on this approach, the panel concludes, with a high 
degree of confidence, that there is a strong relationship between 
certain work tasks and the risk of musculoskeletal disorders.
     Question. What is the relative contribution of any causal factors 
identified in the literature to the development of such conditions in 
(a) the general population, (b) specific industries, and (c) specific 
occupational groups?
    Anwer.
Individual Risk Factors
    Because 80 percent of the American adult population works, it is 
difficult to define a ``general population'' that is different from the 
working population as a whole. The known risk factors for 
musculoskeletal disorders include the following:
    Age.--Advancing age is associated with more spinal complaints, hand 
pain, and other upper extremity pain, e.g., shoulder pain. Beyond the 
age of 60, these complaints increase more rapidly in women than men. 
The explanation for spinal pain is probably the greater frequency of 
osteoporosis in women than in men. The explanation for hand pain is 
probably the greater prevalence of osteoarthritis affecting women. 
However, other specific musculoskeletal syndromes do not show this 
trend. For example, the mean age for symptomatic presentation of lumbar 
disc herniation is 42 years; thereafter, there is a fairly rapid 
decline in symptoms of that disorder.
    Gender.--As noted above, there are gender differences in some 
musculoskeletal disorders, most particularly spinal pain due to 
osteoporosis, which is more commonly found in women than in men, and 
hand pain due to osteoarthritis, for which there appears to be a 
genetic determinant with increased incidence in daughters of affected 
mothers.
    Healthy lifestyles.--There is a general belief that the physically 
fit are at lower risk for musculoskeletal disorders; there are few 
studies, however, that have shown a scientific basis for that 
assertion. There is evidence that reduced aerobic capacity is 
associated with some musculoskeletal disorders, specifically low back 
pain and, possibly, lumbar disc herniations are more common in 
cigarette smokers. Obesity, defined as the top fifth quintile of 
weight, is also associated with a greater risk of back pain. There 
currently is little evidence that reduction of smoking or weight 
reduction reduces the risk.
    Other exposures.--Whole-body vibration from motor vehicles has been 
associated with an increase in risk for low back pain and lumbar disc 
herniation. There is also evidence that suboptimal body posture in the 
seated position can increase back pain. Some evidence suggests that 
altering vibrational exposure through seating and improved seating 
designs to optimize body posture (i.e., reduce intradiscal pressure) 
can be beneficial.
    Other diseases.--There is a variety of specific diseases found in 
the population that predispose to certain musculoskeletal disorders. 
Among the more common are diabetes and hypothyroidism, both associated 
with carpal tunnel syndrome.
Work-Related Risk Factors
    Chapter 4 of this report explores the enormous body of peer-
reviewed data on epidemiologic studies relevant to this question. 
Detailed reviews were conducted of those studies judged to be of the 
highest quality based on the panel's screening criteria (presented in 
the introduction and in Chapter 4). The vast majority of these studies 
have been performed on populations of workers in particular industries 
in which workers exposed to various biomechanical factors were compared 
with those not exposed for evidence of symptoms, signs, laboratory 
abnormalities, or clinical diagnoses of musculoskeletal disorders. A 
small number of studies have been performed in sample groups in the 
general population, comparing individuals who report various exposures 
with those who do not.
    The principal findings with regard to the roles of work and 
physical risk factors are:
  --Lifting, bending and twisting and whole-body vibration have been 
        consistently associated with excess risk for low back 
        disorders, with relative risks of 1.2 to 9.0 compared with 
        workers in the same industries without these factors.
  --Awkward static postures and frequent repetitive movements have been 
        less consistently associated with excess risk. For disorders of 
        the upper extremity, vibration, force, and repetition have been 
        most strongly and consistently associated with relative risks 
        ranging from 2.3 to 84.5.
    The principal findings with regard to the roles of work and 
psychosocial risk factors are:
  --High job demand, low job satisfaction, monotony, low social 
        support, and high perceived stress are important predictors of 
        low back musculoskeletal disorders.
  --High job demand and low decision latitude are the most consistent 
        of these factors associated with increased risk for 
        musculoskeletal disorders of the upper extremities.
  --In addition, in well-studied workforces, there is evidence that 
        individual psychological factors may also predispose to risk, 
        including anxiety and depression, psychological distress, and 
        certain coping styles. Relative risks for these factors have 
        been generally less than 2.0.
     Question. What is the incidence of such conditions in (a) the 
general population, (b) specific industries, and (c) specific 
occupational groups?
    Answer. There are no comprehensive national data sources capturing 
medically defined musculoskeletal disorders, and data available 
regarding them are based on individual self-reports in surveys. 
Explicitly, these reports include work as well as nonwork-related 
musculoskeletal disorders without distinction; therefore, rates derived 
from these general population sources cannot be considered in any sense 
equivalent to rates for background, reference, or unexposed groups, nor 
conversely, as rates for musculoskeletal disorders associated with any 
specific work or activity. There are no comprehensive data available on 
occupationally unexposed groups and, given the proportion of adults now 
in the active U.S. workforce, any such nonemployed group would be 
unrepresentative of the general adult population. According the 1997 
report from the National Arthritis Data Workgroup (Lawrence, 1998), a 
working group of the National Institute of Arthritis and 
Musculoskeletal and Skin Diseases, 37.9 million Americans, or 15 
percent of the entire U.S. population, suffered from one or more 
chronic musculoskeletal disorders in 1990 (these data cover all 
musculoskeletal disorders). Moreover, given the increase in disease 
rates and the projected demographic shifts, they estimate a rate of 
18.4 percent or 59.4 million by the year 2020. In summary, data from 
the general population of workers and nonworkers together suggest that 
the musculoskeletal disorders problem is a major source of short- and 
long-term disability, with economic losses in the range of 1 percent of 
gross domestic product. A substantial portion of these are disorders of 
the low back and upper extremities.
    The Bureau of Labor Statistics (BLS) data, while suffering a number 
of limitations, are sufficient to confirm that the magnitude of work-
related musculoskeletal disorders is very large and that rates differ 
substantially among industries and occupations, consistent with the 
assumption that work-related risks are important predictors of 
musculoskeletal disorders. BLS recently estimated 846,000 lost-workday 
cases of musculoskeletal disorders in private industry. Manufacturing 
was responsible for 22 percent of sprains/strains, carpal tunnel 
syndrome, or tendinitis, while the service industry accounted for 26 
percent. Examining carpal tunnel syndrome alone, manufacturing, 
transportation, and finance all exceeded the national average, while 
for the most common but less specific sprains and strains, the 
transportation sector was highest, with construction, mining, 
agriculture, and wholesale trade all higher than average. These data 
suggest that musculoskeletal disorders are a problem in several 
industrial sectors, that is, the problems are not limited to the 
traditional heavy labor environments represented by agriculture, 
mining, and manufacturing.
    The National Center for Health Statistics (NCHS) survey data 
provide added information on self-reported health conditions of the 
back and the hand. This survey presents estimates for back pain among 
those whose pain occurred at work (approximately 11.7 million) and for 
those who specifically reported that their pain was work-related back 
pain (5.6 million).
    The highest-risk occupations among men were construction laborers, 
carpenters, and industrial truck and tractor equipment operators, and 
among women the highest-risk occupations were nursing aides/orderlies/
attendants, licensed practical nurses, maids, and janitor/cleaners. 
Other high-risk occupations were hairdressers and automobile mechanics, 
often employed in small businesses or self-employed.
    Among men, the highest-risk industries were lumber and building 
material retailing, crude petroleum and natural gas extraction, and 
sawmills/planing mills/millwork. Among women, the highest-risk 
industries were nursing and personal care facilities, beauty shops, and 
motor vehicle equipment manufacturing.
    Questions from the NCHS survey on upper-extremity discomfort 
elicited information about carpal tunnel syndrome, tendinitis and 
related syndromes, and arthritis. Carpal tunnel syndrome was reported 
by 1.87 million people; over one-third of these were diagnosed as 
carpal tunnel syndrome by a health care provider and half were believed 
to be work-related. Tendinitis was reported by 588,00 people, and 28 
percent of these were determined to be work-related by a health care 
provider. Over 2 million active or recent workers were estimated to 
have hand/wrist arthritis. The survey did not report these conditions 
by either occupation or industry.
     Question. Does the literature reveal any specific guidance to 
prevent the development of such conditions in (a) the general 
population, (b) specific industries, and (c) specific occupational 
groups?
    Answer.
Development and Prevention in Working Populations
    Because the majority of the U.S. population works, the data for the 
population as a whole apply to the 80 percent who are working. There is 
substantial evidence that psychosocial factors, in addition to the 
physical factors cited above (see response to Question 4), are 
significant contributors to musculoskeletal disorders. Relevant factors 
are repetitive, boring jobs, a high degree of perceived psychosocial 
stress, and suboptimal relationships between worker and supervisor.
    The weight and pattern of both the scientific evidence and the very 
practical quality improvement data support the conclusion that primary 
and secondary prevention interventions to reduce the incidence, 
severity, and consequences of musculoskeletal injuries in the workplace 
are effective when properly implemented. The evidence suggests that the 
most effective strategies involve a combined approach that takes into 
account the complex interplay between physical stressors and the 
policies and procedures of industries.
    The complexity of musculoskeletal disorders in the workplace 
requires a variety of strategies that may involve the worker, the 
workforce, and management. These strategies fall within the categories 
of engineering controls, administrative controls, and worker-focused 
modifiers. The literature shows that no single strategy is or will be 
effective for all types of industry; interventions are best tailored to 
the individual situation. However, there are some program elements that 
consistently recur in successful programs:
    1. Interventions must mediate physical stressors, largely through 
the application of ergonomic principles.
    2. Employee involvement is essential to successful implementation.
    3. Employer commitment, demonstrated by an integrated program and 
supported by best practices review, is important for success.
    Although generic guidelines have been developed and successfully 
applied in intervention programs, no single specific design, 
restriction, or practice for universal application is supported by the 
existing scientific literature. Because of limitations in the 
scientific literature, a comprehensive and systematic research program 
is needed to further clarify and distinguish the features that make 
interventions effective for specific musculoskeletal disorders.
Development and Prevention in Specific Occupations
    Occupations that involve repetitive lifting, e.g., warehouse work, 
construction, and pipe fitting, particularly when that activity 
involves twisting postures, are associated with an increased risk for 
the complaint of low back pain and, in a few studies, an increased risk 
for lumbar disc herniation.
    The prevalence of osteoarthritic changes in the lumbar spine (disc 
space narrowing and spinal osteophytes) is significantly greater in 
those whose occupations require heavy and repetitive lifting compared 
with age-matched controls whose occupations are more sedentary. Despite 
these radiographical differences, most of the studies show little or no 
difference in the prevalence of low back pain or sciatica between those 
with radiological changes of osteoarthritis and those with no 
radiological changes. Based on the current evidence, modification of 
the lifting can reduce symptoms and complaints. Specific successful 
strategies, which include ergonomic interventions (such as the use of 
lift tables and other devices and matching the worker's capacity to the 
lifting tasks), administrative controls (such as job rotation), and 
team lifting, appear successful. Despite enthusiasm for their use, 
there is marginal or conflicting evidence about lifting belts and 
educational programs in reducing low back pain in the population with 
heavy lifting requirements. Some examples of positive interventions 
include:
    Truck drivers.--Vibration exposure is thought to be the dominant 
cause for the increased risk for low back pain and lumbar disc 
herniation. There are some data to support the efficacy of vibrational 
dampening seating devices.
    Hand-held tool operators.--Occupations that involve the use of 
hand-held tools, particularly those with vibration, are associated with 
the general complaints of hand pain, a greater risk of carpal tunnel 
syndrome, and some tenosynovitis. Redesign of tools is associated with 
reduced risks.
    Food processing.--Food processing, e.g., meat cutting, is 
associated with a greater risk of shoulder and elbow complaints. Job 
redesign appears to reduce this risk, but this information is largely 
based on best practices and case reports.
     Question. What scientific questions remain unanswered, and may 
require further research, to determine which occupational activities in 
which specific industries cause or contribute to work-related 
musculoskeletal disorders?
    Answer. The panel's recommended research agenda is provided in 
Chapter 12 of the report.
                 Appendix C.--Panel Response to Dissent
    Dr. Szabo's dissent focuses on whether the panel was consistent in 
evaluating the literature relevant to this report. His dissent deals 
almost exclusively with only one of the musculoskeletal disorders 
considered in the report; specifically he ascribes to the panel 
overstatements about the research findings relating carpal tunnel 
syndrome to work exposures of a variety of types.
    Dr. Szabo states correctly that criteria for the inclusion of 
studies in the report differed for the analysis of biomechanical 
exposures and for the analysis of epidemiologic associations. The four 
bodies of literature reviewed-tissue mechanobiology, biomechanics, 
epidemiology, and workplace interventions-have differing study designs, 
measurement techniques, and outcome variables. The selection criteria 
used in determining the quality of particular studies necessarily 
varied among these literatures (see Chapter 1, pp. 22). These criteria 
were set early in the panel's deliberations. Specifically, the 
biomechanics papers required detailed measures of biomechanical 
exposure, while the epidemiologic studies did not require that same 
kind of detail. Similarly, the epidemiologic papers had to meet 
criteria for epidemiologic inference that were not required of the 
biomechanics papers. The panel discussed the distinction carefully 
before agreeing to adopt it. The distinction would be problematic only 
if the panel made epidemiologic inferences from studies included in the 
biomechanics section that failed to meet criteria for epidemiologic 
studies. We did not do that.
    Dr. Szabo contends that the panel concluded that interventions 
examined in this study prevented carpal tunnel syndrome; this misstates 
our report, which clearly states otherwise (see Chapter 8, pp. 313). 
The report states that interventions influenced pain reports and not 
the occurrence of specifically defined disorders of the upper 
extremities. The studies are summarized in Table 8.3. The report does 
not state that interventions prevent carpal tunnel syndrome or, indeed, 
any other upper-extremity disorder. The emphasis, rather, is on 
amelioration of symptoms, which is the end point in the relevant 
literature. Furthermore, the comments on upper extremity interventions 
carefully state that interventions influence symptoms, not the 
incidence of specific disorders (Chapter 8, p. 313):

    ``Studies of engineering interventions for computer-related work 
that reduce static postural loads, sustained posture extremes, and 
rapid motions have demonstrated decreases in upper extremity pain 
reports. Further study of these interventions is needed to determine 
the amount of pain reduction possible, the duration of salutary effect, 
and which upper extremity clinical conditions could benefit from these 
interventions.''

    Dr. Szabo uses the case of carpal tunnel syndrome with regard to 
low-force, high-repetition exposures (primarily the use of computer 
keyboards) as the causal factor to suggest that the relationship of 
musculoskeletal disorders to work exposure may not be sound. The panel 
has recognized that the evidence for low-force, high-repetition 
exposures is weaker than for other relationships among risk factors and 
musculoskeletal outcomes; however, strong evidence for causal 
relationships between physical work and musculoskeletal disorders is 
provided throughout the report.
    The epidemiology section as it relates to the upper extremity was 
carefully written. We discuss the cross-sectional designs of most 
studies and possible implications for causal inference, including the 
potential for the ``healthy worker'' effect. In 9 studies, carpal 
tunnel syndrome was defined by a combination of a history of symptoms 
and physical examination or nerve conduction testing. In these studies 
there were 18 estimates of risk based on various specificities of 
carpal tunnel syndrome diagnosis and varying degrees of work exposure. 
Of these, 12 showed significant odds ratios greater than 2.0 (range 2.3 
to 39.8), 4 showed nonsignificant odds ratios of greater than 2.0 and 2 
showed nonsignificant odds ratios of between 1.7 and 2.0. The 
epidemiology section, however, does not draw specific conclusions 
regarding carpal tunnel syndrome. The report points out that just three 
articles dealt with keyboard work; indeed, keyboard work is not a major 
consideration or focus in the report.
    Dr. Szabo's dissent provides an incomplete view of a study 
published in the ``Journal of the American Medical Association'' 
(Atroshi, 1999). He states: ``In the general population the prevalence 
of Carpal Tunnel Syndrome is the same whether people perform repetitive 
activities or not.'' In the panel's view, the nature of the design in 
that study and its survey instruments were such that the power to 
demonstrate this association was not high. The study, however, did show 
a significant risk for carpal tunnel syndrome for blue-collar work, use 
of excessive force of the hands, working with excessively flexed or 
extended wrist, or the use of hand-held vibratory tools; these findings 
are not mentioned by Dr. Szabo.
    Dr. Szabo cites the paper of Greenland and Robins (1988) to suggest 
that without knowledge of cofactors which contribute to carpal tunnel 
syndrome, ``estimates offered by Hagberg as well as the ones used in 
the NAS report must be interpreted with caution.'' In fact, the thrust 
of the Greenland and Robins argument is that such attributable risk 
calculations may severely underestimate (not overestimate, as implied 
by Dr. Szabo) the proportion of cases in which the etiologic factor is 
important because of possible interactions between that factor and the 
cofactors. Greenland and Robins cite numerous examples in which a small 
excess risk masks a much larger effect of a primary study factor.
    Several articles cited by Dr. Szabo in his discussion of the 
epidemiology literature on carpal tunnel syndrome did not meet the 
quality criteria (insufficient participation and inadequate exposure 
measures were common problems) used by the panel in selecting articles 
for the epidemiology review and so are not included in the report.
    In his dissent, Dr. Szabo states, ``More importantly, reliance on 
ergonomics to the exclusion of medical and health risk factors can have 
adverse consequences for the patient.'' Nowhere in its report does the 
panel suggest the exclusive use of ergonomic interventions.
    It is important to reemphasize the fact that we made a major effort 
to base our conclusions on literature that met accepted scientific 
criteria and that the report represents consensus of all of the panel 
members except for Dr. Szabo. At the same time, the report makes plain 
the panel's view that the literature about musculoskeletal disorders is 
incomplete, as all clinical and scientific literatures are, and also 
emphasizes the importance of continuing research on a variety of 
fronts. There is, however, sufficient basis in the research to date to 
support our conclusions and recommendations.

Jeremiah A. Barondess, Chair
Mark R. Cullen
Barbara de Lateur
Richard A. Deyo
Sue K. Donaldson
Colin G. Drury
Michael Feuerstein
Baruch Fischhoff
John W. Frymoyer
Jeffrey N. Katz
Kurt Kroenke
Jeffrey C. Lotz
Susan E. Mackinnon
William S. Marras
Robert G. Radwin
David Rempel
David Vlahov
David H. Wegman

    Senator Specter. Thank you very much. Dr. Jane Derebery, 
occupational physician, Concentra Medical Services.
STATEMENT OF DR. JANE DEREBERY, VICE PRESIDENT OF 
            MEDICAL AFFAIRS, CONCENTRA MEDICAL SERVICES
    Dr. Derebery. Thank you, Mr. Chairman. I am an occupational 
medicine physician. I serve as the vice president of Medical 
Affairs of Concentra Health Services which is the largest 
occupational health group in the country. We treat over 500,000 
injured workers each year.
    I am neither an academician nor a researcher, and had not 
met Drs. Bigos, Hadler and Burton prior to this, but know them 
very well through their work, which has aided me in my own 
practice for many, many years. It also aids me in physician 
training with my company.
    In my early training in occupational medicine, of all the 
courses I took I was most excited by the ergonomic courses. It 
made logical sense to me that repetitive, awkward and forceful 
activities of my patients could potentially cause them 
problems. And it also made sense to apply the principles of 
ergonomics as a solution.
    However, once I got into private practice, I quickly saw 
that there was no consistency between the amount and type of 
activities that my patients were performing and whether or not 
they developed musculoskeletal problems.
    Those ailments that are believed to be caused by repetitive 
motion such as tendonitis and carpal tunnel can and do occur 
with no provocation, no known cause; are also associated and 
even caused by many, many medical conditions.
    What in actual practice the ergonomics standards simply do 
not help me with those patients. Instead, I found that dealing 
with external factors such as underlying medical conditions or 
health problems and psychosocial stressors coupled with the 
sports medicine approach seemed to be more effective.
    In my concern about the ergonomic standard as it was 
proposed, was that it is asking me as a physician to treat my 
patients as if the primary and only cause of their complaint 
was due to their physical activities at work. To wrongly 
classify something as work-related not only increases 
disability likelihood, it misdirects medical care, and it can 
inappropriately exclude a patient from a job. In addition, it 
is an unnecessary drain to the workers' comp system.
    At my company we have the largest clinical outcome database 
in the country. And that has facilitated our ability to study 
and improve our outcomes. In an analysis of work-related, 
nontraumatic musculoskeletal disorders, we have demonstrated 
that the treatment strategy when it is focused predominantly on 
patient issues rather than the physical job factors, that we 
get substantially improved outcomes.
    In one regional analysis, the physicians were given 
training that promoted demedicalization and early activation in 
patients that had musculoskeletal problems. And in most of the 
cases the patients were kept at full duty during treatment.
    In the treatment, the extraneous contributing health 
problems and psychosocial stressors were investigated for, and 
when appropriate, addressed. A conditioning exercise program as 
well as stress management principles generally predominated as 
treatment recommendations. While appropriate job problem-
solving and ergonomics suggestions were given, they were very 
seldom a primary part of our treatment.
    And what we found was the clinical outcomes comparing this 
treatment strategy with other regional providers substantially 
reduced the lost time, restricted duty, disability and cost 
with no increase in recurrences and with high patient 
satisfaction.
    We found similar findings with our low back pain change 
strategy and in which our physicians were encouraged to adhere 
to the evidence-based treatment guidelines such as those of the 
Agency for Health Care Policy Research in the United Kingdom.
    And once again, we found with those patients the majority 
were kept at full duty. And with that strategy, we had a 
substantial improvement over those patients who were treated 
the traditional way.
    The cause of musculoskeletal disorders are multifactorial 
involving as many psychosocial and medical and health 
conditions as physical. And my concern as a physician is if we 
focus on the physical and the ergonomics, it may result in 
increased morbidity and in disability for my patients and at 
great cost to industry as well.

                           prepared statement

    Dr. Evanoff in the last panel mentioned the American 
College of Occupational Medicine Guidelines in his endorsement 
of the ergonomics standard. I am a fellow of the American 
College of Occupational Environmental Medicine. And for the 
record, we did not come out, we did not endorse the ergonomic 
standards for the same reason that I did not. Thank you.
    [The statement follows:]
                Prepared Statement of Dr. Jane Derebery
    I am Dr. Jane Derebery, a board certified occupational medicine 
physician and the vice president of medical operations for the Southern 
Region of Concentra Health Services, the largest occupational medicine 
group in the United States. Each year over five million patients are 
seen at our clinics, and 500,000 new patients with work-related 
injuries are treated.
    I am neither an academician nor a researcher, but rather a 
practicing clinician within the private sector. Although I had not met 
Drs. Bigos, Hadler and Burton previously, I know them through their 
work and publications, which have aided me in my own practice as well 
as in physician training. Their work is especially appreciated, as 
there are widespread misinformation, half-truths, and even myths on the 
subject in both medical and lay literature.
    Since the advent of OSHA in 1970, work places have become safer, 
material handling reduced, and improved ergonomics implemented in many 
industries--yet low back disability has continued to escalate, as have 
complaints of musculoskeletal pain in general. This trend would support 
what the few high quality studies performed have demonstated: there is 
not evidence that ergonomic job design will prevent musculoskeletal 
disorders and pain.
    When I first began in occupational medicine in the eighties, I 
found that the ergonomics courses were the most exciting ones that I 
took. It made logical sense that the more a worker was exposed to 
repetitive, awkward or forceful activity, the more likely he was to 
incur injury. Learning and applying principles of ergonomics seemed 
like the logical solution for my patients.
    Once I was in actual clinical practice, however, I quickly 
discovered that there appeared to be little consistency regarding 
amount and type of activity of patients and whether or not they 
developed musculoskeletal problems. The principles of ergonomics that I 
had been taught didn't seem to aid me in the real world, particularly 
with my more difficult patients--instead, identifying external 
contributors such as underlying medical conditions and psychosocial 
stressors, and using a sports medicine approach seemed to be more 
effective.
    There are inherent risks in allowing politics and public policy 
rather than science to decide what causes disease. Musculoskeletal 
aches and pains are common among all of us regardless of our work and 
leisure activities. Many ailments attributed to repetitive, forceful or 
awkward activity can and do occur with no identifiable provoking cause 
and can also be caused by systemic medical conditions. In the workers 
compensation arena, physicians are being asked to treat muscloskeletal 
pain as if the predominant and only cause is the physical aspect of 
work. Musculoskeletal disorders generally are multifactoral in origin, 
just as are many other medical maladies such as heart disease or 
headaches. To wrongly classify a musculoskeletal illness as work-
related increases the likelihood of disability developing, misdirects 
medical care, can inappropriately exclude an individual from his 
regular job, and places an unnecessary drain on the workers 
compensation system.
    Concentra has the largest clinical outcome database of any medical 
organization in the country, and having outcome data has greatly 
facilitated our ability to study and improve clinical outcomes. 
Analysis of Concentra outcome data has indicated that when dealing with 
nontraumatic musculoskeletal disorders, a treatment strategy focusing 
predominantly on patient issues rather than physical job factors 
results in substantially improved outcomes.
    In one Concentra study, seven physicians in Austin were given 
training that promoted keeping most patients with upper extremity non-
traumatic complaints at their regular jobs during treatment, under the 
presumption that since the job had caused no problems for the worker 
previously, it was likely that non-work factors were predominant causes 
of the symptoms.
    The physicians are advised to give the patient reassurance that the 
problem isn't serious, and to prescribe an appropriate program to 
increase strength, flexibility and endurance. Stress reduction 
techniques such as regular aerobic exercise, relaxation, etc. are also 
prescribed. Extraneous contributions such as underlying health problems 
and psychosocial stressors are investigated and when necessary 
addressed. While appropriate job problem solving and ergonomic 
suggestions are made, these are usually not a primary focus of the 
treatment.
    The clinical outcomes of these providers have been followed and 
compared to 92 other providers in other cities in the southern region. 
The change in treatment strategy have resulted in substantial, 
statistically significant improvements in cost of care and disability 
with no reduction in patient satisfaction. Interestingly, as physicians 
have experienced good outcomes among their patients, they have 
gradually become even more assertive in their management of patients, 
as evidenced by continued improvement from 1997 through 2000.
    Between 1997 and 1999, the seven providers had reduced their 
percentage of patients on restricted duty from 74 percent to 30 percent 
for an average of 22 days, as compared to the other 92 providers, who 
placed 82 percent on restricted duty for 26 days. In addition, in 1999, 
the 367 Austin patients had no lost time, compared to a lost time rate 
of 3 percent in other cities. Only 6.5 percent of the Austin patients 
required specialty referral, compared to 21 percent by the other 
cities' providers. The cost of care in Austin dropped substantially 
because the patients required fewer physical therapy visits and doctor 
visits, with the average cost in Austin being $730 per case compared to 
$959 per case among the other providers.
    We have also had similar findings regarding low back pain by 
encouraging our physicians to adhere to evidence-based low back pain 
treatment guidelines such as those from the Agency for Health Care 
Policy and Research and from the United Kingdom. Specifically, the 
guidelines encourage maintenance or resumption of normal activity, 
including work, in patients with low back pain. The physicians 
achieving the best outcomes typically and consistently place only 15-35 
percent of their back pain patients on restricted duty during the 
treatment course, compared to an overall national average approaching 
90 percent.
    There are strong cultural beliefs and influences that play 
predominant roles in shaping expectations about the ability of 
repetitive physical activity to cause musculoskeletal disorders. This 
has rendered us susceptible to the misinformation and myths being 
widely published not only in the lay literature but even in the medical 
literature.
    For example, there is no scientific evidence to support that carpal 
tunnel syndrome can be caused or aggravated by prolonged keyboard use; 
yet I have repeatedly seen that reported as fact in such widely read 
periodicals as TIME, Newsweek, and the New York Times. Two years ago, 
when a hand surgeon from Columbia University testified as an expert 
witness in a products liability class action suit against a keyboard 
manufacturer, he rendered his medical opinion that keyboarding caused 
the claimants' carpal tunnel syndrome. When pressed to cite what 
scientific article he had read to justify his opinion, he finally 
stated that he had read it in TIME magazine! In actuality in the almost 
fifty cases of products liability suits against keyboard manufacturers 
not one claimant has ever been awarded a cent, so strong is the 
scientific evidence that use of a keyboard does not cause carpal tunnel 
syndrome. Yet, the myth that it does prevails in our society--with 
profound influence.
    The cause of the current spate of CTD disorders is multifactoral, 
involving as many psychosocial and medical factors as job-related ones. 
To focus exclusively on the physical and ergonomic aspects of the 
problem may result in increased morbidity and disability at great cost 
to the patient and to society. Addressing the problem as it is 
perceived by the patient or the public, contributes to the problem 
rather than to its resolution.

    Senator Specter. Thank you very much, Dr. Derebery. We now 
turn to Dr. Laura Punnett.
STATEMENT OF DR. LAURA PUNNETT, PROFESSOR, DEPARTMENT
            OF WORK ENVIRONMENT, UNIVERSITY OF 
            MASSACHUSETTS
            LOWELL
    Dr. Punnett. Thank you very much, Senator. I think perhaps 
there are a few things that almost everyone in this room could 
agree upon. One is that some musculoskeletal disorders are not 
work-related. Some I think the rest we may be in disagreement 
about, but certainly there is an important amount of morbidity 
which arises in relation to non-occupational factors is really 
not in dispute by anyone.
    Another important point is that some amount of physical 
activity is essential to maintaining good health. And the key 
question then for us is how much activity or effort or motion 
is too much. And I would add what kind and under what 
conditions.
    People who are employed full-time spend----
    Senator Specter. So where there is agreement is that some 
ailments are not related to work and some exercise is good?
    Dr. Punnett. Yes, Senator.
    Senator Specter. And that is where you stop your testimony 
on the area of agreement?
    Dr. Punnett. Correct. I am not sure I am going to be able 
to offer you much more----
    Senator Specter. That is not a whole lot of agreement, Dr. 
Punnett, but it is not inaccurate from what I have heard. Go 
ahead.
    Dr. Punnett. I am trying to help you find some consensus.
    Senator Specter. Trying to help me find what?
    Dr. Punnett. Some consensus.
    Senator Specter. I would not call it consensus to say that 
it is 11:15, which is about what you have said. Go ahead.
    Dr. Punnett. People who are employed full-time spend more 
waking hours at our jobs than anywhere else. But I think of 
equal importance to the hours we spend at work is that while we 
are at work we do not have the same freedom to choose how we 
spend our time as we do for example when we are gardening or 
playing tennis.
    A stenographer in a courtroom has to keep up with an expert 
witness who is giving testimony. A mail carrier has to complete 
a route and return to the post office within a specified period 
of time.
    A nurse's aid has to move a disabled patient from the 
wheelchair to the commode when the patient's needs dictate, 
even if there is no one else nearby to help.
    So the way the work is organized, the tasks designated to 
each individual, the equipment or tools provided determine both 
the physical load, how fast you are working, how hard, what 
body postures are necessary, as well as what we call the 
psychosocial factors, meaning psychological demands such as 
time pressure, opportunity to decide what to do when, factors 
that are generally under the employer's control as well as the 
physical load factors are.
    These psychosocial factors are established to be associated 
with the subjective experience of stress. They are related to 
risks of some diseases such as cardiovascular disorders.
    The scientific literature on their effect on 
musculoskeletal disorders is quite more recent and still very 
limited, while in contrast the literature on physical factors 
is voluminous.
    And we have already heard from the NAS that there are 
literally hundreds of studies with a variety of study designs 
and methods, different samples of the population conducted in 
many different countries all showing risk of musculoskeletal 
disorders to be proportionate to the level of exposure to 
physical load.
    These kinds of exposure response examples are numerous. 
Just two very quick examples, a German study showing that new 
back pain among male construction workers was associated with 
the amount of handling of concrete blocks and other heavy 
paving items, and a British study of nurses showing that the 
incidence of new back pain was proportionate to the number of 
patients handled per day.
    So the literature is voluminous. There have been dozens of 
reviews of this literature as well. Like both of the NAS 
reports, virtually all of the reviews, not all but the vast 
majority, agree that some studies are better than others, that 
not every question has been answered yet but that there is a 
very substantial evidence showing the relationship of physical 
workload to musculoskeletal disorders.
    The better studies include a variety of, meet a variety of 
scientific and methodologic criteria including the fact that 
they address the role of non-occupational factors. If someone 
has a history of a wrist injury or goes bowling every Thursday 
night or has been diagnosed with diabetes, we have statistical 
methods of removing the influence of these individual factors 
and making sure that or evaluating whether the association is 
still there when they are taken out of the picture.
    If we limit ourselves to the cream of the crop, the few 
dozen studies rather than the few hundred which are most 
rigorous, we still have at least ten times as many studies as 
OSHA had to rely on in rule making on benzine for example or 
setting a permissible exposure limit for lead in air or rule 
making on formaldehyde.

                           prepared statement

    Of course not every question has been answered, but again 
standards have been passed without every ``I'' being dotted and 
every ``T'' crossed. We had no animal model for asbestos or for 
benzine effects at the time that those OSHA standards were 
passed. And I respectfully submit that while we need more 
research, we also have ample evidence in hand now to begin to 
prevent the many unnecessary disorders that are occurring.
    [The statement follows:]
                Prepared Statement of Dr. Laura Punnett
Qualifications and experience
    I am an occupational epidemiologist and ergonomist with a Doctor of 
Science degree in epidemiology and occupational health and safety from 
the Harvard School of Public Health and two years of specialized post-
doctoral training in occupational ergonomics at the Center for 
Ergonomics, The University of Michigan (Ann Arbor). I am a founding 
faculty member of the Department of Work Environment at the University 
of Massachusetts Lowell (UML), where I now hold the rank of Professor. 
The Department combines a traditional occupational health and safety 
approach to the identification of workplace hazards with a more 
innovative focus on the development and evaluation of engineering 
control measures for those hazards. I am also Co-Director of the Lorin 
Kerr Ergonomics Institute for Occupational Injury Prevention at UML. 
The Institute conducts research and provides technical assistance 
throughout the region on the health, safety, and productivity 
consequences of the failure to design jobs to fit human needs. We take 
a multi-disciplinary approach to the study of work-related 
musculoskeletal disorders, injuries and psychosocial stress, their 
impact on employers, workers, and society, and their prevention through 
changes in work organization and equipment.
    My primary research areas are the epidemiology of work-related 
musculoskeletal disorders; the effect of ergonomic stressors on other 
health endpoints, such as pregnancy outcomes and acute injury; and 
methods for workplace measurement of ergonomic exposures, including the 
validity of worker self-assessments. Since 1981, I have investigated 
these issues in a wide variety of manufacturing and service 
occupations, including the automobile industry, garment assembly and 
other light manufacturing, clerical work, retail food stores, 
hospitals, small farms, sawmills and wood products processing, and 
highway construction. I have also studied the factors influencing the 
effectiveness of ergonomic intervention programs and joint labor-
management health and safety committees in industry. I am the author or 
co-author of about 40 articles in peer-reviewed scientific journals, as 
well as numerous book chapters, technical reports, and papers and 
abstracts in peer-reviewed conference proceedings. My research has been 
funded by the National Institute for Occupational Safety and Health 
(NIOSH), the Centers for Disease Control Center on Injury Prevention, 
the UAW-Chrysler Joint National Committee on Health and Safety, the 
March of Dimes, and the Massachusetts Centers of Excellence 
Corporation.
    Since 1993 I have been a Visiting Lecturer in Occupational Health 
at the Harvard School of Public Health, in Boston. I am a member of the 
Research Committee on Musculoskeletal Disorders of the International 
Commission on Occupational Health. In 1996, I was in residence as a 
Visiting Scientist in the Division of Ergonomics, National Institute of 
Working Life, Sweden; since that time I have had continuing 
collaborations with several researchers at the Institute and have 
returned for several working visits. I have served by invitation on the 
NIOSH Mine Health Research Advisory Committee (U.S. DHHS), two NIOSH 
research review panels, and advisory boards for the Massachusetts 
Department of Public Health Occupational Disease Surveillance (SENSOR) 
Project, the Center for VDT and Health Research, Johns Hopkins School 
of Hygiene and Public Health, the Occupational and Industrial 
Orthopedics Center (Hospital for Joint Diseases, New York NY), and the 
Ergonomics Technology Center of the University of Connecticut 
(Farmington CT). I have consulted on environmental and occupational 
epidemiology to the World Health Organization. I serve on the Editorial 
Boards of the peer-reviewed journals, Applied Ergonomics, New 
Solutions: A Journal of Environmental and Occupational Health Policy, 
and Salud de los Trabajadores (``Workers' Health,'' published in 
Venezuela). I have served as a peer reviewer to 12 scientific journals 
and several private and public research funding agencies.
    Both as an individual consultant and through the Kerr Ergonomics 
Institute, I have conducted training programs in occupational 
ergonomics for engineers, supervisors, medical and safety personnel, 
and labor representatives in a wide variety of workplaces. Consulting 
clients have included General Motors, Ford Motor Company, Digital 
Equipment Corporation, General Electric, Millipore, Herman Miller, Jim 
Walters Paper, CBS/Fox Video, and the U.S. Army Environmental Hygiene 
Agency. I have lectured internationally on occupational health, 
ergonomics and epidemiology and presented seminars and professional 
short courses for professional associations (e.g., American Industrial 
Hygiene Association, American Society of Safety Engineers, Nordic 
Institute for Advanced Training in Occupational Health and Safety, 
International Commission on Occupational Health, Israeli Ergonomics 
Society) as well as at institutions of higher education in the United 
States, Canada, The Netherlands, Spain, Chile, and Sweden.
    In 1998, I was invited to participate on the panel that reviewed 
the epidemiologic evidence on work-related musculoskeletal disorders 
for the National Academy of Sciences (National Research Council), in 
response to a mandate from the U.S. Congress. In 1999, I was a member 
of the committee that drafted the new Threshold Limit Values (TLVsR) on 
Hand Activity Level of the American Conference of Governmental 
Industrial Hygienists--a set of quantitative exposure limits intended 
to aid in preventing or reducing the occurrence of upper extremity 
musculoskeletal disorders.
Issues addressed in this testimony
    This testimony primarily addresses the epidemiologic literature on 
work-related MSDs, including the basis for concluding that there is a 
causal relationship with occupational physical ergonomic stressors and 
that reductions in harm to workers can be anticipated by reductions in 
exposure to these stressors. Exposure-response relationships have 
repeatedly been demonstrated, and the evidence is at least 
qualitatively consistent across sectors of the economy and around the 
world, wherever the problem has come to light. There are unresolved 
questions regarding the nature and role of psychosocial factors and 
more research is needed to clarify diagnostic dilemmas and to elucidate 
pathomechanisms. There is striking evidence that MSDs are greatly 
under-reported in many workplaces and that therefore, however high the 
frequency and costs of MSDs may seem, the true magnitude is undoubtedly 
greater than statistics show. Although formal intervention studies are 
difficult to conduct successfully, there is substantial experience of 
the feasibility and benefits of workplace ergonomics interventions 
(training and engineering controls) implemented by employers.
Scientific evidence regarding physical exposures and the occurrence of 
        MSDs
    There is an extensive scientific literature documenting that 
physical job features can cause musculoskeletal disorders. These 
hazards can occur in a multitude of forms, depending on the specific 
nature of the work; the characterization of ergonomics exposures thus 
often depends on the sector of employment and even the specific 
occupation. Nevertheless, a common set of occupational exposures has 
been associated generically with adverse musculoskeletal health 
effects.
    The scientific evidence for the work-related occurrence of 
musculoskeletal disorders among occupationally exposed individuals 
includes both epidemiologic studies and basic science (biomechanical 
and patho-physiological laboratory experiments). The combination of the 
two is important because together they demonstrate the biological 
plausibility of the epidemiology and the coherence and complementarity 
of the findings. For example, tendon strain and cell damage have been 
shown to occur experimentally as a function of work pace (the frequency 
and duration of mechanical loading), the level of muscular effort, and 
recovery time between exertions.
    The basic science pertaining to mechanisms by which physical load, 
in its various forms, can damage soft tissues was reviewed by Rempel et 
al., Ashton-Miller, and Radwin and Lavender for the National Academy of 
Sciences (NAS) in 1998 (1), as well as by others (e.g., 2-7). The 
preamble to the OSHA Ergonomics Standard (Section V., ``Health 
Effects'') also summarized the literature, illustrating how repeated or 
forceful efforts, sustained static loading, anatomically non-neutral 
postures, accelerated movements, externally applied compressive forces, 
and vibration are understood to affect musculoskeletal, nerve, and 
circulatory tissues.
                niosh review of msd epidemiology in 1997
    The authoritative review of the epidemiology in this field is that 
published by the National Institute for Occupational Safety and Health 
(NIOSH) in 1997 (8). This literature review was conducted according to 
standard, accepted epidemiologic principles and gave greatest weight to 
studies in which the results could be shown to be relatively unaffected 
by selection bias or information bias. Almost all of the studies 
considered in the review had been published in peer-reviewed scientific 
journals, meaning that they already had been through the standard 
quality control process and found to be scientifically valid prior to 
their publication. The review document itself was evaluated prior to 
publication by 27 scientists with research, teaching, and consulting 
expertise in the field of occupational ergonomics.
    The NIOSH review concluded that there is ``a consistent 
relationship between MSDs and certain physical factors, especially at 
higher exposure levels.'' Although some specific exposure-response 
relationships have not been demonstrated and more research is needed in 
several areas, there is evidence that exposure to each of these 
ergonomic factors causes MSDs in one or more body regions: repetitive 
upper extremity motion patterns; forceful exertions, whether manual 
only or whole-body (e.g., heavy lifting); non-neutral body postures; 
and vibration. The risk is especially pronounced when a job includes 
exposure to a combination of two or more of these risk factors.
    The odds of finding so many positive studies, using so many 
variations on study design and methods, in so many countries, would be 
extremely small if ergonomic exposures were not truly hazardous to the 
musculoskeletal system. Even were we to restrict ourselves to the 13 
investigations that were the most rigorous and convincing, these would 
represent a larger body of evidence than has been used for OSHA rule-
making on many other workplace hazards.
    These strongest studies also demonstrate that physical job factors 
cause MSDs independently of any other factors, such as medical history, 
age, or psychosocial strain, that might also be associated with MSDs in 
the general population. In other words, while MSDs have a background 
rate in the general population that is above zero, there is a marked 
additional increase among people whose jobs expose them to excessive 
physical demands.
                   epidemiologic evidence since 1997
    In addition to those studies relied upon by NIOSH in the 1997 
review, other investigations are continuously being carried out. The 
studies published since 1997 are too numerous to catalogue them all 
here; some notable examples have been selected to highlight the ever-
expanding knowledge base. These are chosen, in particular, to fill in 
gaps that NIOSH identified with regard to particular exposure-response 
combinations, and to illustrate how newer studies, many of them 
longitudinal, are adding to the evidence confirming earlier conclusions 
that were based primarily on cross-sectional studies. Longitudinal 
investigations are particularly important because they are less 
ambiguous with regard to cause preceding effect than other study 
designs, so the resulting evidence is inherently stronger. In addition, 
they can provide evidence regarding the progression (``natural 
history'') of MSDs, the latency period from exposure to effect, and the 
factors affecting prognosis or outcomes after MSD onset.
    For example, the NIOSH review concluded that there was 
``evidence,'' but not ``strong evidence,'' that postural stress and 
repetitive work cause shoulder disorders, and ``insufficient evidence'' 
to draw conclusions about the effects of forceful work or vibration on 
the shoulder. More recently, at least two new studies have provided new 
evidence regarding the effects of these exposures on the shoulder. 
Frost and Andersen (9) followed a closed cohort of 1,591 workers from a 
slaughterhouse and a chemical factory over a seven-year period. The 
slaughtering and meat processing tasks were videotaped and analyzed in 
detail and shown to involve pronounced postural stress, with the upper 
arms elevated to an included angle of 30 degrees or more for about one-
half of the work day. Shoulder impingement syndrome, defined as a 
combination of shoulder symptoms lasting at least 3 months within the 
past year plus a positive sign of impingement on clinical examination, 
was more common among slaughterhouse workers than among the chemical 
workers. The risk increased with number of years of exposure to meat 
processing work and was particularly high among former slaughterhouse 
workers. The age-adjusted prevalence ratio showed a steep slope in the 
first 5 to 6 years of exposure and then another steep increase after 
about 25 years of cumulative exposure, providing evidence that risk 
increases with duration of exposure to postural stress and heavy work, 
even after many years of employment.
    My colleagues and I conducted a case-control study of shoulder 
disorders reported to the in-house medical department of an automobile 
assembly plant (10). All cases and a random sample of non-case workers 
from the same production departments were evaluated by interview and 
physical examination. Shoulder disorders (on combination of medical 
report and interview) were associated with severe flexion/abduction 
(above 90 degrees) of the shoulder. The risk of incurring a shoulder 
MSD increased with the proportion of the work cycle that workers were 
exposed to severe flexion/abduction. The exposure-response 
relationships were similar for cases with and without physical 
findings. Forces exerted through the shoulder did not confound these 
results; peak torques at the shoulder were rather low for all workers. 
Use of hand-held tools further increased the risk and also interacted 
with postural stress.
    Relevant evidence regarding the effect of ergonomic exposures on 
the neck is also found in a report on persistent neck disorders 
associated with use of a now obsolete grinding machine in a Swedish 
steelworks (11). Use of this machine had ``caused heavy static load to 
the arms, shoulders, and neck, vigorous impacts and vibrational forces 
being transmitted upwards via the out-stretched arms.'' The authors 
located the last 15 workers who had performed this work, all of whom 
had left the occupation 11-29 years earlier because of continuous neck-
shoulder pain, and 6 of whom were on total disability pension. Even 
after so many years, all still had persistent neck pain, stiffness, 
reduced range of motion, joint degeneration, widespread numbness and 
tingling and reduced sensation.
    A number of new studies have addressed the effects of repetitive 
manual work on upper extremity disorders (12-15). Nordander et al. (16) 
examined a set of fish processing jobs that were all highly repetitive, 
with fast, restricted movements and only light lifting demands. 
Compared with people with more varied jobs, the fish processing workers 
had triple the risk of neck/shoulder and elbow/hand diagnoses by 
physical examination. There were 5 cases each of wrist tendonitis and 
carpal tunnel syndrome (CTS) among the fish processing workers, 
compared with 0 and 1, respectively, in the other workers. Work 
processes changes in another fish processing plant increased the 
repetitiveness and stereotypy of the physical motion patterns, which 
led to increased risk of elbow, wrist and finger symptoms (17). In a 
study of CTS patients and prognosis after medical treatment, the 
performance of hand-intensive work prior to onset was associated with 
less complete relief of CTS symptoms after surgery, which in turn 
predicted failure to return to work due to CTS (18). Thus, NIOSH's 
findings of ``evidence,'' but not ``strong evidence,'' that repetitive 
and forceful work cause CTS can also be updated from these more recent 
findings.
    A series of papers by Nathan and colleagues on median nerve 
neuropathy (MNN), an indicator of CTS, has purported to show that the 
only ``important'' causes are individual, non-occupational factors such 
as age and obesity (e.g., 19-22). This on-going cohort study suffers 
from a number of serious methodologic flaws, as noted by NIOSH (see 
summary in Table 5a-5 of (8)) and others (23). However, it should also 
be noted that the authors' ranking scheme for physical work demands 
(repetition and force) was cross-sectionally associated with MNN (19) 
and predicted the 5-year incidence of slowed nerve function (20). Other 
reviewers of this paper have concurred in finding these data to show a 
positive association (24). The question as posed by Nathan and 
colleagues, whether occupational or non-occupational causes of CTS are 
``more important,'' is misleading (and is not appropriately answered by 
statistical testing such as p-values). Rather, the appropriate policy 
question is whether, among persons exposed to ergonomic stressors at 
work, an important proportion of CTS (and other disorders) could be 
prevented by workplace improvements. The data published by Nathan et 
al., in fact, support rather than argue against this conclusion.
    With regard to back disorders, the NIOSH document also concluded 
that there was evidence, but not strong evidence, regarding the effect 
of ``heavy physical work'' on back disorders. Since then, a German 
research group published a three-year prospective study of 571 male 
construction workers, who participated in ``comprehensive interview and 
physical examination surveys'' at baseline and again at follow-up (25). 
The proportion of the population followed up was 86 percent, and only 
exposure information shown to be reproducible was used in the analyses. 
After adjustment for age, height, and body mass index, the risk of new 
low back pain was increased among workers whose work tasks included 
scaffolding, sawing, erecting roof structures and laying large 
sandstones. After further adjustment for trade, to account for tasks 
performed only by carpenters or bricklayers, for example, additional 
exposure-response relationships were found for two different indices of 
cumulative exposure to handling heavy stones or concrete blocks.
    A prospective investigation of nurses in Great Britain (26) was 
remarkable for the intensity of its follow-up procedures; the nurses 
were asked to complete a standardized questionnaire every 3 months for 
a two-year period. Among those who had been free from low back pain for 
at least one month at baseline, the risk of new pain was predicted by 
the frequency of manual transfer of nurses' patients under various 
conditions. The authors noted, as have others previously, the 
additional effect of prior back pain, which in itself may be a marker 
for prior occupational loading on the back. Another recent study of 
heavy work and back disorders involved a five-year follow-up of a 
random sample from the general population in Finland (27), in which the 
outcome was defined as moderate or severe back pain with functional 
impairment. The study concluded that, ``heavy occupational 
musculoskeletal loading and high general occupational physical demands 
predicted future back pain.'' A six-year follow-up of dock workers 
showed that very heavy work was associated with a higher rate of 
increase in musculoskeletal disorders on examination of the back, neck, 
shoulders, hands and feet (28).
    Other cohort studies have examined the risk of disorders in the 
musculoskeletal system overall. A Dutch study reported increased 
frequency of musculoskeletal symptoms among male employees who 
performed heavy physically demanding work, especially in the young and 
middle-aged subjects (29). Long-term disability, especially that due to 
musculoskeletal disorders, was predicted by the number of years worked 
in piece-rate garment manufacturing in Canada (30). In a sample of the 
French population after retirement, the cumulative incidence of 
disorders of the back, upper or lower limb joints was higher among 
those who had performed heavy physical work for longer than ten years 
(31). Another recent study of my own found a strong cross-sectional 
relationship between upper extremity disorders and combined ergonomic 
exposures, with the same exposure index prospectively predicting both 
the incidence of new disorders after one year and the persistence of 
upper extremity problems from baseline (32, 33).
                        other literature reviews
    Other epidemiologic reviews of workplace exposures and MSDs, by 
experts in various countries, have been published in the peer-reviewed 
scientific literature. Although they have varied somewhat in their 
inclusion and exclusion criteria and review procedures, the majority of 
these reviews have drawn similar conclusions regarding the causal 
importance of repetitive motion, forceful manual exertions, non-neutral 
postures, and segmental vibration for upper extremity disorders and of 
heavy lifting, non-neutral trunk postures and whole-body vibration for 
disorders of the back and lower limbs (2, 24, 34-60).
    NIOSH's review and basis for these conclusions was itself 
subsequently endorsed, both methodologically and substantively, by the 
National Academy of Sciences in 1998. The first NAS study was publicly 
discussed by about 75 scientists and other workshop participants, the 
overwhelming majority of whom agreed that ``There is a higher incidence 
of . . . injury . . . and disability among individuals who are employed 
in occupations where there is a high level of exposure to physical 
loading than for those employed in occupations with lower levels of 
exposure'' (page 23 in (1)). (The second NAS study is not described 
here because it will be discussed separately at this hearing.)
    In 1997, the Swedish National Institute of Working Life (NIWL) 
commissioned a review of the epidemiologic literature specifically 
limited to occupational use of video display units (VDU) and upper 
extremity musculoskeletal disorders. This review covered 72 reports 
from 56 different epidemiologic studies, primarily peer-reviewed 
scientific journal articles (61). The NIWL endorsed the conclusion that 
use of a VDU was a direct causative agent of hand and wrist disorders, 
mediated primarily through repetitive finger motion and sustained 
muscle loading across the forearm and wrist. The risk was particularly 
pronounced for those in more keyboard-intensive jobs, such as data 
entry, which are more stereotyped and involve more continuous exposure 
with fewer alternative tasks or rest breaks.
    In 1999, Dr. Barbara Silverstein and I re-considered the 
epidemiologic literature on work-related MSDs, at the request of the 
American Conference of Governmental Industrial Hygienists (ACGIH), in 
order to assess the nature of the guidance that could be obtained as a 
basis for establishing one or more Threshold Limit Values 
(TLV) for occupational exposure to physical ergonomic stressors (62). 
From the most rigorous epidemiologic studies, we extracted data on 
dose-response relationships and on exposure levels at which there was a 
significant increase in risk of upper extremity MSDs and which could be 
operationalized in the form of a TLV; for example, there was 
quantitative evidence to justify a TLV of 1-2 hours per day of exposure 
to repetitive wrist bending or twisting, 1 hour per day of highly 
forceful manual work, and 1 hour per day of shoulder flexion or 
abduction (work with the arm above shoulder height). Four different 
studies showed an increased risk of shoulder disorders when such 
postural stress is experienced for only 1 to 2 hours per day (see Table 
6). We also confirmed the findings of Bernard et al. (8) that exposure 
to multiple ergonomic risk factors in the same job has at least an 
additive effect, if not much greater, and recommended that a TLV for 
any one dimension of physical load should take account of whether other 
forms of exposure are also present in the job. A new report by the 
European Agency for Safety and Health at Work (63), an office of the 
European Union, has concluded that, ``The scientific reports, using 
defined criteria for causality, established a strong positive 
relationship between the occurrence of some WRULDs [work-related neck 
and upper limb musculoskeletal disorders] and the performance of work, 
especially where workers were highly exposed to workplace risk 
factors.'' The risk factors identified as particularly requiring 
preventive reductions by the European Agency were a familiar list: non-
neutral postures of the shoulder and wrist, force applications at the 
hand, hand-arm exposure to vibration, direct mechanical pressure on 
body tissues, cold, and work organization factors.
                    exposure-response relationships
    A large number of investigations have demonstrated exposure-
response relationships between physical ergonomic exposures and the 
risk of MSDs, and a number of reviewers have cited this evidence in 
concluding that there were causal relationships (e.g., 2, 8, 41, 43, 
58, 64). An exposure-response relationship means, in general terms, 
that as the amount (intensity, frequency or duration) of a risk factor 
increases, so does the probability, or risk, of an adverse health 
effect. An exposure-response relationship, when present, is considered 
to strengthen the evidence of a causal relationship because it is 
believed to be a characteristic of cause-effect situations, in general, 
absent evidence to the contrary. In addition, it is thought that it 
would be more difficult for many or most forms of bias or confounding 
to produce an artifactual exposure-response relationship than to bias a 
simple association such as an odds ratio.
    Some have argued that the lack of comprehensive exposure-response 
data represents a level of scientific ignorance that prohibits any 
preventive action. However, it is not a sine qua non, in that an 
epidemiologic study can provide valuable information even if both 
exposure and outcome are dichotomous. Furthermore, the lack of an 
exposure-response relationship is not necessarily evidence against a 
causal effect, since not all pathomechanisms would produce such trends.
    More importantly, there is substantial evidence of interactions 
among physical exposures, so that (for example) jobs requiring both 
repetitive and forceful motions have a higher risk than jobs requiring 
either exposure alone (65-67). The multifactorial nature of these 
relationships must be taken into account in interpreting research 
findings. A ``low'' level of muscular exertion would seem to be safer 
than a ``high'' level of force, everything else being equal; but if the 
low force must be sustained for an excessive period of time, then the 
prolonged duration of the exertion may render it as hazardous as a 
brief but more strenuous exertion (6). Thus, the exposure-response 
curve for each exposure should ideally be described as a function of 
the level of each other exposure that might also be present in the same 
job. There are obviously an enormous number of possible exposure 
combinations, and not all have yet been rigorously studied by 
epidemiologic methods.
    Two misconceptions that have arisen during debate on this 
literature are that (1) if an exposure-response relationship existed, 
it would necessarily be linear or monotonic; and (2) that it would 
necessarily indicate an exposure level that could be used to 
differentiate between background risk of MSDs and an occupationally 
elevated risk. First, an exposure-response relationship need not take 
the form of a straight line through all data points; it may conceivably 
be better described as a logistic curve, or as a step-function, or as 
any other of a variety of mathematical functions. As only one example, 
the analyses described above by Frost et al. (9) clearly showed a non-
linear exposure-response trend with cumulative exposure to repetitive 
and loaded shoulder flexion. A non-linear relationship specifically 
accommodates the likelihood that some physical activity is beneficial 
and that only at more extreme levels do adverse health effects occur, 
another point advanced in supposed disagreement with the evidence 
summarized here.
    Secondly, an exposure-response trend does not necessarily indicate 
a single exposure level that unambiguously differentiates risk from no 
risk. On the contrary, a perfectly linear relationship would by 
definition not provide a clear threshold level. This is especially true 
if exposure is treated as continuous and the relationship fits a 
straight line through the origin, in which case each small increment in 
exposure increases the probability of an adverse health outcome and, 
extrapolated downward, there may be no discernable point without excess 
risk above the zero exposure level.
    When epidemiologic data indicate a good fit with a continuous 
exposure-response relationship (rather than a step function, for 
example), the designation of a permissible exposure level is a policy 
decision rather than a judgment following inevitably from the 
scientific data. Several authors have called attention to the 
complexity of this process of utilizing exposure-response data for 
quantitative risk assessment in the multi-dimensional domain of 
physical ergonomics (e.g., 2, 58, 64, 68, 69). It is reasonable to 
conclude, as these experts have done, that there is a need for 
continuing study of those relationships and interactions, and at the 
same time that it is appropriate to implement the scientific knowledge 
in hand in order to prevent at least part of the work-related morbidity 
that is presently occurring within the American workforce.
                     psychosocial factors and msds
    Another type of stressor that has received increasing interest with 
respect to MSDs is that of psychosocial factors. The term 
``psychosocial'' is used in a variety of ways by different authors, 
which has led to tremendous confusion both in the scientific literature 
and in public discussion. It is critical to distinguish between 
psychological attributes of individuals--such as personality, coping 
skills, motivation or mood states--and the strain imposed on 
individuals by features of their work environment resulting from the 
organization of production activities. Work organization factors--task 
structure, the division of labor, and skill utilization--are partial 
determinants of physical load as well as of psychological job content 
and constraints that may cause workers to experience ``stress.''
    According to one widely used, internationally standardized 
measurement approach (Job Content Questionnaire), there are three key 
measures of psychosocial job characteristics: psychological job 
demands, decision latitude, and social support (70-72). Decision 
latitude is based on the worker's decision authority and the worker's 
discretion over skill use, i.e., the worker's ability to control his/
her own work process and to decide which skills to utilize to 
accomplish the job. Psychological job demands reflect both physical 
pace of work and mental work load, especially time pressure in 
processing or responding to information. In this model, high 
psychological job demands in combination with low decision latitude 
result in residual job strain and, over time, chronic adverse health 
effects such as cardiovascular disease.
    Clearly, these psychosocial features of the work environment are 
under the control of the employer just as much as are physical factors 
such as work pace and tool attributes. In fact, there is a recognized 
overlap between some physical and psychosocial exposures; the 
experience of performing a repetitive, monotonous task on a machine-
paced assembly line can be described equally well in terms of 
stereotyped, repetitive motion patterns with rigid pacing and few rest 
breaks, and as ``poor'' psychological job content, with few 
opportunities to make decisions, work collaboratively with coworkers, 
utilize existing skills or learn new ones. The relationship of work 
organization factors with psychosocial strain has also been 
demonstrated by intervention studies showing that increasing worker 
participation in decision-making can resolve physiological strain 
linked to high levels of demands over which the worker had no control 
(72).
    The occupational psychosocial stressor most consistently associated 
to date with musculoskeletal disorders is lack of decision latitude or 
autonomy (73). However, the evidence regarding a causal relationship 
with MSDs is still quite limited, and several reviews have concluded 
that the epidemiologic evidence is relatively weak. On the other hand, 
the known physiological effects of psychosocial strain at work include 
several plausible mechanisms by which the musculoskeletal system could 
also be affected: adverse circulatory patterns; high levels of 
sympathetic nervous symptom arousal with general central nervous system 
consequences as well as endocrine system impacts on circulating 
hormones; tonic activation or ``psychogenic'' muscular tension; and 
interference with normal muscle and tendon repair processes (e.g., 74-
79). These postulated mechanisms deserve further study, but in the 
meantime the literature on these associations should not be regarded 
less critically than the literature on physical risk factors.
                      summary of the epidemiology
    In summary, the epidemiologic evidence linking physical ergonomic 
exposures at work with risk of MSDs is extensive, biologically 
plausible, and methodologically adequate to inform primary prevention. 
Numerous reviewers have concluded that ergonomic exposures such as 
repetitive work, heavy lifting, forceful manual exertions, vibration, 
and postural stress are causally related to the occurrence of 
musculoskeletal disorders affecting neck, shoulder, hand/wrist, and 
back. New research has strengthened the evidence supporting these 
conclusions. There is substantial evidence of increasing risk with 
increasing exposure, and of interactions among physical exposures. 
These relationships have been found in studies of specific workplaces 
as well as in samples of the general population. The available 
longitudinal evidence generally confirms, in general terms, the 
conclusions previously drawn from cross-sectional studies regarding the 
etiologic association between working conditions and UE MSDs. The 
impact of physical exposures at work cannot be explained away by 
demographics (e.g., age or gender), medical history, or other 
attributes of individuals.
    There is an international near-consensus that effective prevention 
of these disorders necessarily involves, among other measures, 
reduction of workplace exposure to ergonomic risk factors, and several 
eminent scientific reviewers have specifically called for regulatory 
action, even given imperfect epidemiology and understanding of 
pathomechanisms to date (e.g., 57, 69). Research agencies of the 
European Union have endorsed ergonomics standards and presumptive rules 
for identifying work-related MSD cases (63, 80). Among the U.S. 
organizations reaching similar conclusions are NIOSH (1997), the 
National Academy of Sciences (1998, 2001), and ACGIH (1999).
Costs of work-related MSDs
    In addition to the human pain and suffering associated with MSDs, 
other losses are externalized to workers, with adverse financial and 
psychosocial impacts. There are also costs to employers through 
workers' compensation claims, scrap and decreased production quality, 
medical insurance premiums, labor turnover, and adverse impacts on 
labor relations, although many of these are not linked by traditional 
accounting methods to ergonomic problems per se. The proportion of 
these injuries and illnesses that are work-related are by definition 
preventable, as are their costs to employers, to workers, and to 
society. Several have estimated that the real costs to employers, 
including ``indirect'' or ``hidden'' costs, of workplace injuries and 
MSDs can range from 2 to 3.5 times the amount paid in workers' 
compensation cases (81-84).
    However, it cannot be assumed that market-driven cost-benefit 
calculations will be sufficient to motivate worker protection, because 
firms typically emphasize short-term costs over long-term and because a 
large proportion of these costs are not identified by traditional 
accounting methods as due to ergonomic problems in the work process 
(82). Furthermore, fundamental work organization features are rarely 
questioned; on the contrary, modifications to increase productivity and 
profitability, such as just-in-time systems, lean production and total 
quality management or continuous improvement, appear to have 
intensified job demands for workers (85).
    Workers experience other financial losses--some covered by 
compensation and others not--including the cost of medical care and 
lost work time, lost future earnings and fringe benefits, reduced job 
security and career advancement, lost home production and child care, 
and home care costs provided by family members (81, 86). Non-monetary 
losses include pain and suffering, family relations, sense of self-
worth and identity, social and community relationships, and 
recreational activities (84, 87). These costs may accrue for many 
years, because of the long duration of many MSDs; the 5-year rate of 
increase in joint pain after retirement was higher among French 
subjects who had held jobs with heavy physical work load (31). More 
generally, disability retirement is disproportionately likely when 
people work in ergonomically stressful jobs such as heavy physical 
labor or repetitive tasks (30, 88).
Underreporting of MSDs in the workplace
    The magnitude of MSD under-reporting through administrative data 
bases has been noted repeatedly. For example, in one automobile 
assembly plant, more than one-half of workers selected at random had 
unreported back or shoulder disorders on interview or examination (10, 
89). However, only about 20 percent of workers with a serious episode 
of musculoskeletal pain appear to have sought in-plant medical 
attention (83). Less than one percent of medical visits for MSDs were 
flagged as workers' compensation cases, although 17 percent had work 
restrictions, almost 8 percent resulted in lost work time, and 5 
percent required outside medical treatment. Many workers reported 
seeking medical care from outside providers.
    Others have also shown that the frequency (and therefore the cost) 
of work-related MSDs is severely underestimated, by as much as 60 
percent, when relying on traditional administrative data sources such 
as workers' compensation records and OSHA logs of recordable injury and 
illness (90, 91). Even among unionized auto manufacturing employees, 
who should perceive higher job security than many other workers, only 
25 percent of those with work-related MSDs filed a compensation claim 
or applied for benefits (92). The reasons for under-reporting by 
employers and by workers likely include failure to recognize work-
relatedness; concern about job security; workplace incentives for 
supervisors to discourage reporting; employee preference to avoid the 
workers' compensation system and obtain medical care coverage through 
private insurance, anticipated rejection of the claim, and even denial 
of the injury itself because of financial need or a sense of self-worth 
contingent on providing for oneself and one's family (92-98).
    Under-estimation of MSD frequency also results from injured workers 
leaving the workplace, i.e., the ``healthy worker effect,'' also 
referred to as a survivor or selection bias. Not surprisingly, workers 
who develop musculoskeletal disorders in ergonomically stressful jobs 
are disproportionately more likely to transfer to less exposed 
positions or to leave the workplace altogether (18, 99-103). In the 
automobile assembly plant studies cited above (10, 89), almost 75 
percent of both the back and shoulder cases reported difficulty in 
doing their current or past jobs, and about one-third had voluntarily 
transferred out of previous job assignments because of pain and 
impaired performance.
    The significance of this survivor effect is that it artificially 
reduces the risk measures that can be determined from the population, 
because the most exposed and affected individuals are missing from the 
data set. Such a bias masks evidence of exposure-response 
relationships, meaning that positive associations found in these 
studies would likely have been even stronger if those subjects could 
have been included.
Effectiveness of Ergonomics Intervention Programs
    The potential to reduce MSD occurrence by reductions in 
occupational ergonomic exposures is demonstrated in principle by the 
occurrence of attributable morbidity itself. The proportion of musculo-
skeletal injuries and illnesses that are work-related are by definition 
preventable, as are their costs to employers, to workers, and to 
society. For example, it has been estimated that at least 50 percent of 
all work-related musculoskeletal disorders among the working population 
could be prevented by appropriate ergonomic job design (104, 105). 
Policy-making on other occupational hazards has not required separate 
intervention studies; if higher exposures lead to higher prevalence or 
incidence, then it follows that reductions in exposure would lead to 
reductions in morbidity.
    Some scientific evaluations of ergonomic programs have been 
undertaken, and these have shown mixed results. A key problem is that 
any workplace is a highly dynamic institution. Rather large and 
expensive studies are needed to address all possible risk factors for 
MSDs in a rigorous manner, and yet the scientific investigator has no 
control over external or internal events that might occur during the 
study period. After the study has been initiated, the employer might 
reverse a decision to implement fully a set of ergonomics 
recommendations, or a facility might be closed or downsized, or new 
national legislation on disease reporting might be introduced (106).
    Nevertheless, the scientific literature contains numerous examples 
of intervention studies that document the practical and economic 
feasibility of workplace ergonomic programs. Effective abatement 
measures range from well-designed training programs to workstation 
redesign (107). Reductions in frequency and/or severity of work-related 
MSDs have been demonstrated in manufacturing as well as in other 
economic sectors. For example, in motor vehicle manufacturing, 
ergonomic control measures have been effectively implemented both at 
the level of the job and in the organization of the production process 
(e.g., 108-110). Decreases in MSDs among VDU operators can similarly be 
achieved by provision of adjustable furniture, training sessions to 
facilitate workers' knowledgeable adjustment of workstations and work 
schedules, and early reporting systems that aided employers in 
assisting individual workers before they became too severely injured to 
benefit from workplace measures (61).
    The most effective ergonomics programs appear to be those with 
multiple, coordinated activities, including workstation improvements, 
provision of adjustable furniture, training to facilitate workers' 
knowledgeable adjustment of workstations and work schedules, and 
enhanced medical surveillance and management systems that aid employers 
in assisting individual workers before they became too severely injured 
to benefit (111-120). Shannon et al. found that, in general, lower 
injury rates are consistently associated with workplace characteristics 
such as workforce empowerment and top management's active leadership 
plus delegation of decision-making authority regarding occupational 
safety (121).
    The economic benefits of such improvements should be taken into 
account when attempting to estimate the cost of ergonomic 
interventions. It has been reported that tasks identified by workers as 
having the highest physical demands were far more likely than other 
tasks to result in quality defects that were not detected until the 
final inspection stage (122), and that an automobile assembly system 
designed on the basis of ergonomic principles reduced through-put and 
idle time, improved car quality, enhanced production flexibility and 
operator competence in handling a varied mix of vehicle options, and 
reduced production space requirements (109). Pay-back periods could be 
substantially less than one year if full-cost accounting methods were 
used to assess comprehensively both the costs and benefits of ergonomic 
programs (123).
Conclusions
    Many employers voluntarily utilize ergonomic principles to improve 
working conditions, and they often report economic and other benefits 
from such programs. Nevertheless, work-related musculoskeletal 
disorders still occur with high frequency. Thus we must conclude that 
existing incentives are not sufficient.
    Not all MSDs occur in relation to work demands, but individuals 
with high exposures to ergonomic stresses are at substantially 
increased risk. The considered opinion of many scientists, 
internationally, is that the scientific literature on work-related MSDs 
overwhelmingly demonstrates a causal relationship between occupational 
physical ergonomic stressors and musculoskeletal disorders.
    The fundamental principles of public health practice emphasize the 
prevention of injury and illness. While there may be debate about the 
specifics of what an ergonomic standard should contain, there should no 
longer be any debate that some MSDs can be prevented. Workplace 
ergonomic programs, including early reporting, training, and job 
redesign, are a feasible and effective means for reducing the 
occurrence and severity of MSDs. Public policy measures are required to 
ensure prevention of unnecessary injury, illness and disability.

    Senator Specter. Thank you very much, Dr. Punnett. We turn 
now to Dr. Franklin Mirer, Director of Health and Safety, 
United Auto Workers.
STATEMENT OF DR. FRANKLIN E. MIRER, DIRECTOR, HEALTH 
            AND SAFETY, UNITED AUTO WORKERS
    Dr. Mirer. Thank you very much, Senator, for the privilege 
of testifying here. And I can tell you that in the auto 
industry we do have a consensus. We have a consensus that there 
are work-related musculoskeletal problems. It is our leading 
cause of injury and illness.
    Senator Specter. Employers agree with that?
    Dr. Mirer. Yes, they do. And we have consensus on how to 
measure it using pretty much the same measures across three 
auto companies. We have consensus on how the program ought to 
be structured. That is our ergonomics program. And we arrive at 
that under a deadline which is the end of the auto contract.
    Each round of auto bargaining, we improve the ergonomics 
program. Now, we do not have a consensus that a standard is 
needed, although I think we would be pretty close to a 
consensus that the rest of the industry, including our parts 
suppliers, ought to be doing a better job. And we are 
continuing in the effort to do that, both the UAW and with some 
limited support from management. So this is kind of a--some of 
this argument is alien to us.
    Now, yesterday, I was called by one of our several hundred 
hourly ergonomics reps, local union reps, this one from a parts 
plant in Flint. She was preparing an invited presentation to a 
symposium at the American Industrial Hygiene Association in New 
Orleans.
    She is their local expert on the workings of government, 
having been one of 20 UAW local union witnesses who testified 
on the standard in Washington, Chicago and Portland. And she 
had the pleasure of being cross-examined by Mr. Fellner at time 
to clarify her answers. She told me as recently as----
    Senator Specter. I'm sorry. I didn't hear that. She had the 
what?
    Dr. Mirer. She had the pleasure of being cross-examined by 
Mr. Fellner.
    Senator Specter. I thought that is what you said.
    Dr. Mirer. She told me that as recently--never laid a glove 
on her.
    She told me that as recently as this Tuesday, a member 
approached her on the plant floor to ask if they were going to 
lose ergonomics because of the vote in Congress. She says that 
fear has been raised in local union meetings repeatedly on the 
plant floor the day after the Senate vote.
    And I submit that as evidence that the real experts, the 
hourly people doing ergonomics in the plant, the engineers, the 
shop floor workers all know what it is about and all think it 
is needed.
    And her answer was, do not worry, we have ergonomics in the 
contract with UAW. We are never going backwards.
    But her problem is, and everyone's problem is it is hard to 
get upfront money to fix problems in good economic times, in 
the recent good economic times. Now that it is getting harder, 
preventive maintenance even to keep production running smoothly 
is hard to come by.
    I am afraid we are going to be doing some sideways 
stepping. Our major employers foresaw no changes required in 
their ergonomics programs as a result of the new standard. And 
we are moving to enhance it.
    But we all know that we sought that standard as a safety 
net against future cutbacks and as a floor for building on in 
other facilities. So we fear that we might end up with the 
safety net gone in free-fall or climbing on air.
    Now, very quickly in terms of effectiveness of programs, 60 
percent of the injuries in the auto sector are musculoskeletal 
disorders. Practical ergonomics programs became fully effective 
in 1994 really, and since then we have shown a 35 percent 
reduction averaged over the whole three sectors in injuries.
    But that is an average. Some places are doing better than 
others. Our methods for relieving ergonomic stresses and 
procedures for carrying out practical ergonomics are 
established. We teach that scientific basis using some of these 
researchers to local union representatives.
    We have funded research. A lot of this research has been 
conducted in the auto industry including some joint funding and 
NIOSH funding of Dr. Punnett's work. It is pretty 
straightforward.
    So the consensus in manufacturing, on how to go forward, 
how to design equipment, how to measure stresses, how to 
retrofit problems, some of this information is on open web 
sites of the industry.
    Where we do not have consensus and where as you have heard 
here, actually, it might be close to consensus but they are 
demanding unanimity, we do not have consensus on the need for a 
standard or some of the fine details of the standard.

                           prepared statement

    But everybody is doing this more or less the same way than 
are trying to take care of their workers and get a product out 
the door, a quality product out the door on time. And we need 
that codified, the practices of the industry leaders codified 
so we can pull along the followers, the laggards and the 
outlaws. Thank you very much.
    [The statement follows:]
              Prepared Statement of Dr. Franklin E. Mirer
    This testimony is on behalf of the International Union, United 
Automobile, Aerospace and Agricultural Implement Workers of America, 
UAW and its 1.3 million active and retired members. Equally 
importantly, this testimony is on behalf of tens of millions of 
American workers exposed to ergonomic hazards who are not represented 
by a labor union.
    UAW members assemble vehicles and make parts for the Big 3 auto 
makers, and also produce 18-wheelers, construction equipment, 
locomotives and the Space Shuttle. Their employers are industrial 
giants. We also represent nearly 300,000 employees of 1,500 private and 
public employers in 2,800 bargaining units whose average size is 100. 
In addition, our units include warehouses, schools, cafeteria workers, 
health care and social service agencies. These statistics demonstrate 
the depth and range of the UAW's experience with ergonomics programs in 
both manufacturing and non-manufacturing sectors.
    The UAW's extensive experience with ergonomics programs holds 
answers to all the questions the members of this Subcommittee pose: Is 
an OSHA ergonomics standard needed? Is there sound science to support 
an ergonomics standard? Is an ergonomics standard consistent with 
industry practice? Is an ergonomics standard feasible? Is an ergonomics 
standard applicable and feasible in all sectors of the economy? The 
answer to each of these questions is a resounding ``yes.'' The actions 
such a standard would require are not only feasible, they are already 
commonplace in hundreds of UAW-represented workplaces.
    The UAW appreciates that this Subcommittee is interested in hearing 
the current state of the debate on ergonomics. We would have preferred 
that this debate had been more fully aired before the Senate voted on, 
and the President signed, the Resolution of Disapproval of OSHA's 
ergonomics program standard.
    The UAW strongly supported OSHA's ergonomics program standard as a 
modest, but critical, first step toward abating the largest single 
cause of injury and disability among American workers generally, and 
UAW members in particular. The OSHA rulemaking provided an oasis of 
science amid a desert of lobbying and sound bites. Then, the logic of 
power overwhelmed the power of logic, and the rule in place was 
repealed. We are not here to re-debate the disapproval resolution, 
however. We are here to argue that Congress, having eliminated the 
protections afforded by the ergonomics standard, should mandate that 
OSHA issue another enforceable ergonomics standard regulation by a time 
certain.
    The purpose of Federal standards is to codify the practices of 
industry leaders so that industry followers can adopt those practices 
while exposing industry laggards and outlaws for what they are. There 
are literally thousands of consensus safety standards, set by industry 
to regulate itself. The large majority of OSHA standards are actually 
outdated, 1970's vintage consensus standards. OSHA standards, adopted 
through an open, evidence-rich process, may stretch the industry 
leaders, but they are particularly hated by the laggards because 
management has to comply, rather than merely being invited to comply.
    The UAW testimony today will emphasize the following key points:
    1. Ergonomics programs are the only means to prevent the majority 
of injuries suffered by American workers in the automobile industry, 
and the manufacturing sector generally. Approximately 60 percent of 
injuries in the auto sector are muskuloskeletal disorders.
    2. Practical ergonomics programs are in place in hundreds of 
worksites and have set the stage for major progress.
    3. The Bureau of Labor Statistics 1998 and 1999 surveys show the 
effectiveness of UAW-negotiated ergonomics programs.
    4. Methods for measuring and relieving ergonomic stresses and 
procedures for carrying out practical ergonomics programs have been 
developed and verified over the last decade. The science is well 
established.
    5. The principal need over the next decade is accelerating 
abatement of exposure to physical stresses.
    6. The UAW has developed and implemented an ergonomics model for 
small manufacturing suppliers and office and professional facilities 
which demonstrates that ergonomics is necessary and feasible in such 
facilities. These programs also establish industry recognition of MSD 
risk factors and the elements of a program needed to protect employees.
    7. The OSHA rulemaking process was itself a massive data collection 
and analysis effort that collected information not previously available 
to support an ergonomics standard.
    8. Both the second National Academy of Sciences 2001 review and the 
new ACGIH standard for Hand Activity Level limit demonstrate a 
scientific consensus in support of ergonomics interventions.
    9. In conclusion, the ergonomics standard is necessary, feasible 
and appropriate.
    Each of these points is discussed in detail below:
    1. Ergonomics programs are the only means to prevent the majority 
of injuries suffered by American workers in the automobile industry, 
and the manufacturing sector generally. Approximately 60 percent of 
injuries in the auto sector are muskuloskeletal disorders.
    The need for ergonomics abatement is most clearly shown in the 
Bureau of Labor Statistics (BLS) Disabling Injury reports.\1\ These 
studies compile employer-supplied data on the types and causes of 
injuries and illnesses that result in days away from work. The employer 
data are a sample of OSHA 101 forms for cases with days away from work.
---------------------------------------------------------------------------
    \1\ Most recent detailed industry data available are for 1998. 
These analyses are for the 1997 database, which is not materially 
different.
---------------------------------------------------------------------------
    OSHA relied on this same database. We concur with OSHA that these 
employer-supplied data probably under-report musculoskeletal disorders. 
However, the data portray the full extent of the problem.
    In the motor vehicle parts sector (SIC 3714), the employment 
category of in the auto industry with processes most common to other 
manufacturing industry and with the most small establishments, 54 
percent of disabling conditions are identified by management as strain 
or sprain injuries and various cumulative trauma diagnoses which are 
properly grouped as MSD's. In addition, about 20 percent of disabling 
injuries were in the ``other'' category, which includes some MSD's. 
Therefore, the large majority of disabling conditions are MSD's. For 
auto parts, 40 percent of injuries were coded as arising from 
repetitive motion or overexertion, with an additional 11 percent in the 
``other'' category. Back injuries are the largest single diagnosis in 
this sector, 22 percent, and shoulder injuries are 7 percent. Back and 
shoulder injuries are almost entirely of ergonomic origin. In short, 
injuries preventable by ergonomics programs dominate the disabling 
injuries in the motor vehicle parts sector, and manufacturing in 
general.


    These data demonstrate that the biggest problems now faced by 
safety specialists and suffered by workers are hazards that can be 
abated only by ergonomics programs.
    2. Practical ergonomics programs are in place in hundreds of 
worksites and have set the stage for major progress.
    Every UAW-represented location in the Big 3 auto companies has a 
labor-management ergonomics committee in addition to a labor-management 
health and safety committee. These approximately 300 facilities employ 
about 350,000 hourly workers and additional salaried personnel, and 
represent a substantial fraction of the U.S. Gross National Product. 
The two UAW-represented international transplant assembly plants use 
the same structure. Labor and management representatives on these 
committees are trained to analyze injury and illness data to identify 
high injury jobs; to conduct risk factor analyses; and to identify 
solutions to reduce ergonomic stresses. Dozens, if not hundreds, of 
smaller UAW-represented parts suppliers have adopted this model as 
well. UAW members in the service, clerical and public sectors have been 
able to implement similar programs. These programs are described in 
more detail below.


    The common ergonomic abatement process used by these committees is 
shown in the accompanying flowchart. Ergonomics is a continuous 
improvement process with no clear endpoint. In fact, participants 
believe that ergonomics improvement is integral to a high performance 
manufacturing system, just as quality improvement is.
    Initially, these UAW ergonomic programs grew from massive penalty 
OSHA citations for failure to record injuries and illnesses, and from 
citations under the General Duty Clause. The programs were later 
codified in labor contracts. Labor and management representatives argue 
about the best way to do things and whether change is fast enough, but 
the need for an ergonomics process on this model is no longer in 
dispute. Our ergonomics programs have been shown to reduce worker 
injuries and to increase productivity.
    Ergonomics program activity goes well beyond the vehicle assembly, 
stamping, parts manufacturing and parts distribution facilities of the 
Big 3 auto makers. Similar but less elaborate programs following the 
same model, including job analysis methods and labor management 
structure, have been implemented in many smaller UAW represented 
workplaces. Ergonomics committees at these facilities are often trained 
by UAW professionals. We have done this in parts plants, bicycle 
plants, a health maintenance organization, in clerical settings and 
among public employees. 


    3. The Bureau of Labor Statistics 1998 and 1999 surveys show the 
effectiveness of UAW-negotiated ergonomics programs.
    Analysis by the UAW of the most recent government statistics shows 
that safety and ergonomics programs prevented over 69,000 occupational 
injuries and illnesses in 1998 in the vehicle assembly and parts 
sectors. Of these, at least 41,000 were musculoskeletal problems 
prevented by ergonomics programs.
    These data are derived from the Bureau of Labor Statistics' annual 
injury and illness survey data for 1998, released in December 1999. 
Reductions in injury rates reported for key UAW workplaces give strong 
evidence for the effectiveness of UAW safety and health programs 
generally, and especially for the value of our ergonomics programs.
    The UAW believes that the motor vehicle assembly (SIC 3711), motor 
vehicle parts (SIC 3714) and automotive stamping (SIC 3465) sectors 
have gone farther than most others in implementing ergonomics programs. 
My testimony concentrates on the auto parts sector. We selected 1994 as 
the baseline, because that is when ergonomics programs were first 
likely to be fully implemented, and also to obtain a five year period. 
For the auto parts sector, the total case rate dropped 12 percent over 
one year and 33 percent over five years, while the occupational illness 
rate fell 17 percent over one year and 34 percent over five years. 
Cumulative trauma disorders declined 13 percent and 24 percent 
respectively.
    Over this same period the total case rate, injury rate and CTD rate 
fell slightly for all private employment, while the illness rate 
increased by a small amount. The vehicle assembly rate however, dropped 
5.5 times as fast as the national average over five years, while auto 
parts dropped 4.5 times as fast. Percentage reductions were 40 percent 
greater in vehicle assembly and 70 percent greater in parts 
manufacturing compared to all employers combined.
    The 1999 data, which did not become available until December 2000, 
show an additional 5 percent drop in total rate across the three main 
auto-related sectors. This evidence of continuing improvement was not 
included in the record of the OSHA hearings.
    These data show that ergonomics programs decrease the number of 
worker injuries, with attendant savings to employers as well.
    4. Methods for measuring and relieving ergonomic stresses and 
procedures for carrying out practical ergonomics programs have been 
developed and verified over the last decade. The science is well 
established.
    The important technical developments for effective ergonomics 
programs emerged two decades ago, and the broad outline is now largely 
in place. The driving force was combining the engineering and 
biomechanics disciplines with medical science and epidemiology. The 
University of Michigan and NIOSH are the key institutions that have 
established the United States at the forefront of the science of 
ergonomics. The technical developments include:
  --Development of consistent methods to measure the physical stresses 
        on the human body. Stress is determined by the force exerted on 
        a body part, the frequency of the motion, and the posture of 
        the joint. The Force-Frequency-Posture paradigm is common to 
        both expert and checklist approaches to ergonomic analysis;
  --Acceptance of expert ergonomic analysis for measurement of risk 
        factors according to these methods;
  --Development of simplified non-expert approaches to measurement of 
        risk factors (checklists);
  --Formulation of the NIOSH lifting guide and related biomechanical 
        models which take into account the weight of an object, 
        distance from the body, and motion of the body in lifting;
  --Validated semi-quantitative risk factor checklists for hand, arm 
        and shoulder (upper extremity) cumulative trauma disorders;
  --Diagnostic criteria for upper extremity CTD's;
  --Standardized physical examination protocols for upper extremity 
        CTD's;
  --Validation of symptom surveys and discomfort surveys 
        (psychophysical measures) as risk factor identification tools;
  --Validation of risk factor checklist and symptom survey by workforce 
        personnel to identify high risk jobs and propose abatement 
        methods;
  --Acceptance of the plant ergonomics committee model, especially lay 
        analysis of risk factors using standardized checklists.
    These scientific developments rest on an enormous body of published 
work as well as practical experience. In 1997, NIOSH published a 
massive compilation of ergonomics studies. The UAW believes that the 
NIOSH compilation and analysis of virtually all available studies of 
work-related musculoskeletal disorders settles the question whether 
there is sufficient science underlying ergonomics. The studies show 
exposure-response relationships for ergonomic stress factors and 
musculoskeletal disorders of each body part. NIOSH did an excellent 
evaluation of hundreds of reports to show the weight and strength of 
the evidence for cause and effect relationships, and conclusively 
confirmed that increased stress causes increased injury.
    Nonetheless, Congress subsequently funded a review of this issue by 
the National Academy of Sciences.\2\ A steering committee was 
established in May 1998, under the auspices of the NAS Committee on 
Human Factors.
---------------------------------------------------------------------------
    \2\ The NAS ergonomics report responds to seven questions posed by 
Congressman Livingston: 1. What are the conditions affecting humans 
that are considered to be work-related musculoskeletal disorders? 2. 
What is the status of medical science with respect to the diagnosis and 
classification of such conditions? 3. What is the state of scientific 
knowledge, characterized by the degree of certainty or lack thereof, 
with regard to occupational and non-occupational activities causing 
such conditions? 4. What is the relative contribution of any causal 
factors identified in the literature to the development of such 
conditions in (a) the general population; (b) specific industries; and 
(c) specific occupational groups? 5. What is the incidence of such 
conditions in (a) the general population; (b) specific industries; and 
(c) specific occupational groups? 6. Does the literature reveal any 
specific guidance to prevent the development of such conditions in (a) 
the general population; (b) specific industries; and (c) specific 
occupational groups? 7. What scientific questions remain unanswered, 
and may require further research, to determine which occupational 
activities in which specific industries cause or contribute to work-
related musculoskeletal disorders?
---------------------------------------------------------------------------
    NAS studies typically consist of literature reviews and 
presentations at open meetings, followed by a report drafted by the 
expert committee and reviewed by the Academy members and other peer 
reviewers. The ergonomics study involved an open workshop attended by 
66 leading technical experts. The UAW participated in this workshop 
\3\, presenting evidence of our experiences with ergonomics programs. 
The NAS issued a report on the study in 1999. The summary conclusion 
was: ``Scientific research clearly demonstrates that effective work 
place interventions are available which can reduce ergonomic hazards 
and prevent musculoskeletal disorders. There is evidence that 
interventions are cost-beneficial for employers.'' The report thus 
validated the scientific conclusions cited by OSHA as the basis for its 
decision to move forward with an ergonomic standard.
---------------------------------------------------------------------------
    \3\ Lida Orta-Anes, Ph.D., ergonomist, UAW Health and Safety 
Department, was invited to present a discussion paper on UAW 
experiences and her views of the scientific evidence.
---------------------------------------------------------------------------
    In 1998, Congress commissioned a second NAS study of the same 
issues.
    This section has summarized the state of knowledge when the 
ergonomics standard was proposed and the hearings began. Below we 
discuss subsequent scientific developments that further support the 
need for an ergonomics standard.
    5. The principal need over the next decade is accelerating 
abatement of exposure to physical stresses.
    Many case histories show improved health outcomes on jobs where 
risk factors had been reduced. Many facilities report reduced injury 
rates after implementing ergonomics programs. Scientific studies show 
reduced injury rates and symptom complaints after job changes. These 
case studies were reported in the NIOSH conference and are regularly 
presented at professional meetings. The data presented above show 
sector-wide reductions in MSD rates in the sector with the most 
advanced ergonomics activities. These successes are reasons for 
government to keep pressure on employers to abate ergonomic hazards.
    The principal problem plant ergonomics committees report is not 
being able to get high-risk jobs fixed in a timely fashion. High-risk 
jobs are jobs where injuries have already been recorded. Solutions are 
usually identified directly from the risk factor analysis: the job task 
must be changed to reduce the force, limit the number of repetitions of 
the same motion, or allow the worker to do the job in a neutral 
posture.
    Routine solutions include raising loads off the floor with lift 
tables, adjusting the height of work, reducing the reach to get or 
place parts, damping vibration, placing the tool or the work in a 
fixture, reducing or counterbalancing tool weight. Many tricks of the 
trade are known to engineers and workers alike. People from the 
workplace know job changes that will allow the work to be done and 
reduce the stresses. Virtually all these solutions improve quality and 
efficiency and therefore increase productivity.
    Nevertheless, to solve ergonomics problems and to reduce injury 
rates in the long term, an employer has to invest time and money up 
front. Unless pressure for job improvement is maintained, employers 
will resist accepting their responsibility.
    The principal improvement in ergonomics programs achieved in the 
1999 round of auto contract negotiations was adoption of specific time 
limits for the job improvement cycle. In all three auto agreements, 
management committed that a job will be analyzed within two months of 
the report of a work-related musculoskeletal disorder and modified to 
abate identified risk factors within six months of completion of the 
analysis. In addition, design criteria for new equipment are 
incorporated into the joint new equipment safety reviews. Some of these 
criteria are available to suppliers over the internet.
    6. The UAW has developed and implemented an ergonomics model for 
small manufacturing suppliers and office and professional facilities 
that demonstrates that ergonomics is necessary and feasible in such 
facilities. These programs also establish industry recognition of MSD 
risk factors and the elements of a program needed to protect employees.
    The UAW has implemented ergonomic interventions at approximately 45 
smaller UAW-represented worksites over the past five years. The optimal 
intervention involves all the elements of the OSHA standard, except 
that MSD management typically falls short of the OSHA proposal.
    The essential element of the intervention is training a worksite 
ergonomics committee to analyze jobs and suggest interventions. In UAW-
represented facilities, this training is primarily conducted by peer 
trainers, called Local Union Discussion Leaders (LUDL's). LUDL's are 
full-time employees at UAW-represented facilities. They are shop floor 
employees who move into a trainer position because of their interest 
and demonstrated training skills. These persons are released from work 
on union leave at UAW request to conduct training-related activities. 
LUDLs assigned to ergonomics training are usually ergonomics committee 
members at their home facility. They have all taken at least a 40-hour 
course, conducted job analyses, received training technique instruction 
and been fully evaluated by UAW Staff and University of Michigan 
training evaluation staff.
    Our experience with this training method indicates that because it 
is based on hands-on activities, it ensures retention of information. 
The small group discussion and problem-solving allows for direct 
learning from peers with experience in the topic. The training includes 
extensive case studies through the use of videos. In addition, it is 
delivered at the site. It includes a component where participants 
evaluate real jobs on the shop floor, in real time.
    The UAW has implemented successful ergonomics programs using this 
training at numerous small businesses, including Jaquith Industries 
(Local Union 1128) in Syracuse, New York. With the completion of a 
recent 40-hour Practical Ergonomics Training (PET) program, Jaquith 
workers are now able to evaluate problem jobs and develop solutions. 
Some jobs in this shop are presently being re-engineered to eliminate 
job hazards. In a recent letter to the UAW Health and Safety Department 
from Jaquith's owners, they praised and credited UAW's Health & Safety 
Department grant staff for a professional job in helping them to assess 
their ergonomics concerns and offering solutions to the problems they 
faced.
    Other small employers who have worked with the UAW to establish 
successful ergonomics programs include: Recycle Ann Arbor (Local Union 
157) in Ann Arbor, Michigan; Bosch Braking Systems (Local Union 2155) 
in Johnson City, Tennessee; United Defense Systems (Local Union 683) in 
Minneapolis, Minnesota; Sidler Corporation (Local Union 417) in Madison 
Heights, Michigan; and AP Parts (Local Union 12) in Toledo, Ohio.
    7. The OSHA rulemaking process was itself a massive data collection 
and analysis effort that collected information not previously available 
to support an ergonomics standard.
    The Subcommittee should take note of the remarkably open nature of 
an OSHA standard hearing. Prior to a hearing, OSHA issues the proposal 
and explanation, and invites written comments. The hearing starts with 
the OSHA team that wrote the standard appearing on stage taking 
questions from all comers, industry and labor, explaining and defending 
the proposal on the record. Then, OSHA presents experts who appear and 
face questioning by all parties under the same ground rules.
    After OSHA has laid out its proposal and its evidence, anyone with 
an opinion can submit evidence and present oral testimony. However, the 
price of appearing before the team that will write the standard is 
taking questions from participants from industry, labor and OSHA, also 
on the record. For questioning of witnesses during the ergonomics 
hearings, labor and OSHA relied principally on subject matter experts 
rather than on lawyers. United Parcel Service, the main opponent of the 
ergonomics rule, requested two and a half days of testimony, then 
dropped nearly all its witnesses and took just a couple of hours, 
thereby crowding out other evidence and limiting the time of other 
witnesses.
    The ergonomics standard had been under consideration for ten years, 
initiated by then-Secretary of Labor Elizabeth Dole. OSHA invited 
stakeholders to participate in many meetings to discuss key issues in 
the rule before a proposed standard was issued. NIOSH held an open 
invitation national conference to present best practices. OSHA held a 
series of regional open invitation best practices conferences. There 
was every opportunity for pre-proposal input to all interested parties. 
The UAW participated in many of these events. Participation included 
several joint labor-management presentations of facility experiences.
    A working draft of the ergonomics standard was reviewed by small 
business representatives under the SBREFA process, beginning in 
February, 1999. OSHA, together with the Office of Management and Budget 
and the Small Business Administration created a panel to review and 
comment on a working draft of the standard. The panel sought the advice 
and recommendations of potentially-affected small entity 
representatives, consulting with 21 persons. This included a face-to-
face meeting on March 24-26, 1999. The UAW notes with concern that 
small business representatives were given special status and access to 
rulemakers to ask questions and make comments before workers and the 
public had an opportunity for similar input. Nevertheless, in 
accordance with law, the SBREFA panel submitted a report to OSHA on 
April 30, 1999.
    The SEBREFA panel made 36 recommendations to OSHA concerning the 
ergonomics standard. OSHA responded to each one of them, as detailed in 
the preamble of the proposed rule. Some comments resulted in 
modifications to the cost estimates of the standard. Others resulted in 
clarifications or changes to the explanation of the regulatory text. 
Finally, several changes in the regulatory text were made in response 
to recommendations. These changes included: removing a provision that 
employers must analyze jobs with ``known hazards;'' providing a step-
by-step incremental abatement process; and modifying the medical 
management program to reduce potential cost to employers.
    The UAW notes that some of the changes made in response to small 
business recommendations--in particular the incremental abatement 
process--later became the basis for criticism by business 
representatives.
    The OSHA hearings spanned 44 full days of testimony and questioning 
in Washington, Chicago, Portland, and Atlanta, involved about 900 
witnesses, and generated 18,833 pages of transcript. The full 
transcripts were posted on OSHA's website to be downloaded and 
reviewed, as well as lists of exhibits. This open access to the 
complete record had no precedent in previous rulemaking.
    The UAW presented testimony at three sites. Presenters included 11 
local union representatives from automobile industry facilities; nine 
local union representatives from other sectors, including parts 
suppliers, agricultural implement, truck, appliances, joint ventures, 
private sector clerical and public employees; the UAW co-project 
manager for ergonomics from each of the three auto collective 
bargaining departments presenting the joint program at that company; 
and three Health and Safety Department representatives. The UAW also 
submitted about 200 pages of written testimony and commentary as well 
as training materials and ergonomics manuals developed by the joint 
UAW-company programs. (The UAW notes that the jointly developed and 
validated UAW-GM Risk Factor Checklist was recognized by OSHA as a 
valid means of evaluating ergonomic risk factors.)
    The UAW points out that the experiential data presented by local 
union representatives and staff are rarely available to an agency or to 
the public through the published literature. Yet, this evidence is 
crucial to the practical validation and application of biomechanical 
and epidemiological analyses in the real world. The OSHA process thus 
created a large and valuable new base of data.
    Additionally, OSHA presented several panels of leaders in 
occupational medicine, ergonomic analysis, engineering and regulatory 
analysis applied to ergonomics programs. These were all published 
authorities whose work was available in the open literature. However, 
the invited testimony made these persons available for questioning on 
the specific points that management and labor stakeholders thought to 
be material to a standard. The dialogue in the hearing transcripts 
provides an additional large new base of data on which to develop 
ergonomic knowledge.
    The OSHA team that had drafted the proposed standard sat through 
each of these hearings, as did the key labor and management 
representatives.
    8. Both the second National Academy of Sciences 2001 review and the 
new ACGIH standard for Hand Activity Level limit demonstrate a 
scientific consensus in support of ergonomics interventions.
    On January 18, 2001, the National Academy of Sciences (NAS) and 
Institute of Medicine (IOM) released their long-awaited report on 
Musculoskeletal Disorders and the Workplace (``NAS II''). The report, 
requested by Congress, confirms yet again that there is strong 
scientific evidence that exposure to ergonomic hazards in the workplace 
causes musculoskeletal disorders and that these injuries can be 
prevented by ergonomic interventions.
    The study was not an ivory tower effort. The study committee 
traveled to Detroit, heard a presentation on the state of the art in 
the auto industry, toured auto plants accompanied by UAW and Ford 
staff,\4\ and heard from local ergonomics committee members, labor and 
management, who do the work every day.\5\
---------------------------------------------------------------------------
    \4\ Dr. Bradley Joseph and Dr. Gordon Reeve, Ford Motor Company, 
and Dr. Franklin E. Mirer, UAW Health and Safety Department.
    \5\ Ford Livonia Transmission Plant and UAW Local 182, and Ford 
Michigan Truck Plant and UAW Local Union 900.
---------------------------------------------------------------------------
    The NAS II report confirms that the exposures addressed by the OSHA 
standard--heavy lifting, awkward postures, repetition, force and 
vibration--cause back injuries and/or upper extremity injuries like 
carpal tunnel syndrome. It also found that a programmatic approach 
tailored to individual workplaces, such as that set forth in the OSHA 
standard, is the most effective means to reduce MSDs. Specific major 
findings of the study include the following:

    ``There is no doubt that musculoskeletal disorders of the low back 
and upper extremities are an important and costly national health 
problem . . . In 1999, nearly 1 million people took time away from work 
to treat and recover from work-related musculoskeletal pain or 
impairment of function in the low back or upper extremities. 
Conservative estimates of the economic burden imposed, as measured by 
compensation costs, lost wages, and lost productivity, are between $45 
and $54 billion annually.'' (Page ES-1)
    ``The panel's review of the research literature in epidemiology, 
biomechanics, tissue mechanobiology, and workplace intervention 
strategies has identified a rich and consistent pattern of evidence 
that support a relationship between the workplace and the occurrence of 
MSDs of the low back and upper extremities.'' (Page ES-3)
    ``The panel concludes that there is a clear relationship between 
back disorders and physical load; that is, manual material handling, 
load movement, frequent bending and twisting, heavy physical work, and 
whole-body vibration. For disorders of the upper extremities, 
repetition, force and vibration are particularly important work-related 
factors.'' (Conclusion 3, Page 11-10)
    ``The weight of the evidence justifies the introduction of 
appropriate and selected interventions to reduce the risk of 
musculoskeletal disorders of the low back and upper extremities.'' 
(Page 11-2)
    ``To be effective, intervention programs should include employee 
involvement, employer commitment and the development of integrated 
programs that address equipment design work procedures and 
organizational characteristics.'' (Conclusion 8, Page ES-6 and 11-2)

    Opponents of an ergonomics regulation promptly issued press 
releases stating that this report discredited the scientific basis for 
the OSHA standard. We ask the members of this Subcommittee to judge for 
yourselves.
    Equally compelling was action by the American Conference of 
Governmental Industrial Hygienists (ACGIH) on December 10, 2000. The 
ACGIH is the dominant private entity that issues occupational health 
standards. ACGIH standards are internationally recognized and given 
deference by many governmental authorities outside of the United 
States.
    The ACGIH preface states:

    ``ACGIH recognizes work related musculoskeletal disorders (MSDs) as 
an important occupational health problem that can be managed using an 
ergonomics health and safety program--Some of these disorders fit 
established diagnostic criteria such as carpal tunnel syndrome or 
tendinitis. Other musculoskeletal disorders may be manifested by 
nonspecific pain. Some transient discomfort is a normal consequence of 
work and is unavoidable, but discomfort that persists from day to day 
or interferes with activities of work or daily living should not be 
considered an acceptable outcome of work.''

    The ACGIH adopted a Threshold Limit Value (TLV) for hand activity 
level and issued a notice of intended change to adopt a TLV for 
lifting.
    Hand Activity Level is a numerical function of peak hand force, 
frequency and duration of exposure. The TLV includes an action level, 
below the exposure limit. The standard notes that:

    ``Professional judgment should be used to reduce exposures below 
the action limits recommended in the HAL TLV's if one or more of the 
following factors are present:
  ``--Sustained non-neutral postures such as wrist flexion, wrist 
        extension, wrist deviation, or forearm rotation;
  ``--Contact stresses;
  ``--Low temperatures; or
  ``--Vibration.
    ``Employ appropriate control measures anytime the TLV's are 
exceeded or an elevated incidence of work-related musculoskeletal 
disorders is detected.''

    9. In conclusion, the ergonomics standard is necessary, feasible 
and appropriate.
    The underlying premise of any OSHA standard is that an employer who 
knows a job has injured an employee must take feasible steps to make 
the job safer. Few would disagree with the propriety of this premise. 
This applies equally to ergonomics. The UAW, our auto industry 
employers, and many smaller employers have demonstrated that ergonomics 
programs are a ``win-win'' for both management and employees. In many 
of our worksites, ergonomic risk assessment techniques are applied 
predominantly by hourly workers who, in turn, have been trained by 
other rank-and-file workers. These methods both measure hazard and 
validate abatement.
    Ergonomics programs works. It is time to get down to the business 
of applying ergonomics.

    Senator Specter. Dr. Mirer, from what you have said, then, 
does the auto industry, UAW and manufacturers need an 
ergonomics regulation or have you not pretty much solved the 
problem yourself?
    Dr. Mirer. No. The problem is never solved and we bargain 
over it actually every 3 years. It is a continuous improvement 
process. And we need the standard as a safety net for when 
times get hard.
    Senator Specter. The standard as a safety net. But on an 
ongoing basis you are pretty well working it out from what I 
hear in your testimony.
    Dr. Mirer. We have been making progress in good times. We 
are going into bad times now and things----
    Senator Specter. Well, your experience is obviously not 
determined in there for all of the industry. You have a very 
mature industry in automobiles. And you have good bargaining 
power. And the UAW and the employers, when you say consensus, 
that is nice to hear, even though it is limited. But you would 
still like to have an ergonomics regulation from a Federal 
Government, but as you say from a safety net.
    Dr. Mirer. For the three car companies, for the IPS sector, 
for the supplier sector, the small plants sector, we absolutely 
need that standard as a floor that we can build on and move 
forward.
    Senator Specter. You need a standard forum from some of the 
suppliers. Well, has the UAW not been successful on your 
bargaining strength to get a reasonable result from that group?
    Dr. Mirer. We are far from where we ought to be in that 
group.
    Senator Specter. How do you account for the difference 
being far from where you ought to be in that group in contrast 
to where you are in the industry generally?
    Dr. Mirer. It is a contrast of combination of collective 
bargaining, technical resources and the ability of suppliers to 
turn over their workforce and run away.
    Senator Specter. Well, I think that the model that you have 
described though from the most of the industry of the UAW is a 
good one to be followed. Maybe it needs some sharpening up on 
it, but it is a lot better to hear that you need a safety 
standard than you are on each other's throats and cannot agree 
to anything.
    Dr. Mirer. Absolutely.
    Senator Specter. Dr. Hadler, what do you think of Dr. 
Punnett's testimony that musculoskeletal pain is proportionate 
to physical work? I do not have her exact words. They were too 
complicated and too long and I could not write them all down 
but that is the thrust of it.
    Dr. Hadler. When I was a medical student, epidemiologists 
observed that the risk for Down's Syndrome, trisomy 21, was not 
uniform in sibships. The youngest child was more likely to be 
afflicted with this congenital disorder.
    Senator Specter. Does this turn out to be responsive to my 
question?
    Dr. Hadler. It is a direct response.
    Senator Specter. I am not sure about that. I disagree with 
that already.
    But if it is indirect, I will take it.
    Dr. Hadler. We are working on consensus. Give me about 
another two paragraphs.
    Senator Specter. Okay.
    Dr. Hadler. That leads to the hypothesis and research----
    Senator Specter. Chairman gets very impatient when you have 
got about 40 witnesses.
    Dr. Hadler. I hear you. I will be within my 5 minutes.
    Senator Specter. I am not necessarily giving you 5 minutes, 
Dr. Hadler. I want you to respond to my question. You have had 
5 minutes.
    Dr. Hadler. The answer is, if I need to respond directly, 
and the analogy would help understand it, is that----
    Senator Specter. Go ahead with your analogy. It will be 
shorter than my interruptions.
    Dr. Hadler. That lead to hypotheses and research as to what 
was it about the multiparous uterus that caused the fertilized 
egg to divide abnormally.
    Several years later, epidemiologists returned to this issue 
to test whether they had missed the real association. The 
younger the child in the sibship, the older the mother. Could 
it be that the likelihood of bearing a child with Down's 
Syndrome associated more with the mother's age than the birth 
rank. The answer proved to be yes. The old hypothesis was 
superseded and research shifted to the biology of the aging 
ovary.
    Several years later, epidemiologists returned to this issue 
to test whether they had missed the real association. The older 
the mother, the older the father. Could it be? The answer was 
yes and no. The likelihood of bearing a child with Down's 
Syndrome was associated with both maternal and paternal age. 
The old hypothesis was superseded and research shifted yet 
again.
    That is the scientific method. We learn from the old 
hypotheses and the old false starts and we move on. Today no 
one would consider studies of the microenvironment of the 
multiparous uterus as relevant to the pathogenesis of Down's. 
For 60 years, science has sought associations between physical 
demands of tasks and the likelihood of suffering----
    Senator Specter. Which paragraph are you on now?
    Dr. Hadler. That is the direct answer. The physical demands 
of task and the likelihood of suffering disabling regional back 
pain. For 30 years, there have been parallel studies between 
physical demands of tasks and disabling arm pain.
    Associations have been found, but they are inconsistent and 
weak. There were hints 30 years ago, but science has really 
risen to the challenge in the past decade, the challenge of 
asking whether a more important association was being ignored.
    A number of cross-sectional and longitudinal studies have 
attempted to probe for associations between disabling regional 
back or arm pain and aspects of both, the physical content of 
tasks and the psychosocial context of work.
    The result of these multivariate studies is that the 
associations with the wide range of physical content of tasks 
that has been studied are weaker and even more inconsistent. 
The associations with the psychosocial context of work are also 
weak but they are more consistent and generally subsume the 
associations with the physical content of tasks.
    I could belabor this new literature. It deserves scrutiny. 
However, I cannot applaud the insistence on relying on the 
older literature in the systematic reviews that are promulgated 
by NIOSH and the NRC and Dr. Punnett in her statement.
    Any study that considers only the association between the 
physical demands of tasks and likelihood of a disabling 
regional musculoskeletal disorder is out of date, even if it is 
ongoing or proposed. The state-of-the-science has moved beyond 
the testing of that hypothesis to newer hypotheses that promise 
to be more informative.
    That is my direct answer, sir. Can I elaborate on it? 
Because I had planned to.
    Senator Specter. I do not know whether it is possible to 
elaborate on it.
    I have just been reading the six paragraphs and I would 
have to study and dissect it to understand it. Dr. Punnett, 
there are two questions for you. First, did you understand the 
analogy to Down's Syndrome?
    Dr. Punnett. Well, Senator, I think what Dr.----
    Senator Specter. I have not asked the second question yet. 
But go ahead.
    Dr. Punnett. I think I guess the very short answer is I 
think I might have understood it.
    Senator Specter. Well, when Dr. Hadler disagrees with your 
conclusion of muscular pain proportionate to physical work, I 
am going to have to study his statement so that I can 
understand his reasoning on it.
    Dr. Hadler. Can I illustrate with an example?
    Senator Specter. No. No. You cannot. All right. Go ahead.
    Dr. Hadler. Let me tell you briefly about two small area 
analyses, since they are very easy to follow. There are large 
companies that have multiple work sites, each with similar 
facilities and similar demographics of the workforce. The 
incidence of disabling back or arm pain varies from site to 
site, sometimes dramatically.
    That offers the opportunity to explore whether measurable 
differences in task content, demographics, or psychosocial 
context associate best with the variability in the incidence of 
the disabling regional disorders.
    Independently, investigators from NIOSH and myself perform 
such a small area analysis in U.S. West directory assistance 
operators. Neither NIOSH nor I could explain the site-to-site 
variability in the incidence of disabling arm pain by any 
aspect of the content of the task.
    However, multiple aspects of the psychosocial context of 
the work did associate: Fear of redundancy, work pressure, lack 
of decision authority, to mention a few.
    Dr. Mirer. That will go over real well in Flint.
    Senator Specter. Well, I have the statement and I am going 
to have to study it candidly to understand it.
    Dr. Punnett. Senator Specter, could I just elaborate a 
little bit on my earlier very quick response?
    Senator Specter. Just a little bit.
    Dr. Punnett. I believe that what Dr. Hadler was trying to 
say was that he thinks that the hypothesis regarding physical 
load factors is out of date. He just actually cited a rather 
old study himself.
    But I think that the reviewing process which has gone on in 
the scientific peer-reviewed literature, Dutch reviewers, 
British reviewers, German reviewers, Japanese investigators 
really are increasingly coming together very much in line with 
the NAS conclusions. And the evidence is in fact that even 
taking account of psychosocial factors, the evidence in favor 
of physical load factors is consistent and continues to be 
strong.
    Senator Specter. Dr. Bigos, have you had an opportunity to 
examine this report that Dr. Barondess referred to?
    Dr. Bigos. Yes, I have.
    Senator Specter. And Dr. Barondess articulated the issue 
better than I had, which would not necessarily take a whole 
lot, when he said it adds incremental risk. So it is not a 
causative factor but an incremental factor. Do you disagree 
with that?
    Dr. Bigos. I think that the data is not strong enough to 
make that particular association in a way that we can act on it 
specifically. I think incremental risk is kind of like 
cardiovascular disease. It is a U-shaped phenomena that we see 
all throughout the physical aspects of nature.
    That is, people who do not and people who do participate in 
something seem to do poorer than people who do things in 
moderation, whether it be exercise or alcohol as we are finding 
out.
    What I would like to talk about a little bit is the science 
because that is what this session is about. And if I could just 
have a second, I think that I can make clearer----
    Senator Specter. Well, if you would be brief. We have two 
more panels and it is 11:35.
    Dr. Bigos. No problem. I chaired the HCPR guideline panel 
for back problems. That was under the direction of the U.S. 
Department of Health and Human Services. Because of the recent 
Dopper decision at that time, we decided we had to do it not on 
consensus or opinions but based on the actual data that was 
available in the literature.
    We went through a methodologic process of more than 10,000 
abstracts and 4,600 studies putting them on paper so that you 
could solve for x; better, no better, the same, with different 
aspects.
    The long and short of it is we also applied that within the 
same process to the occupational literature as it relates to 
back problems. The conclusions are that we found no evidence in 
the reliable literature, not the literature that gives you a 
hint that something might be there but the reliable literature 
that lets you act.
    Senator Specter. How did you determine what was reliable? A 
little bit of subjective determination there?
    Dr. Bigos. No, sir. I refer to Holly and Cummings who 
basically have laid out there are certain studies that provide 
you with evidence because you have looked at clues. There are 
certain studies that only provide you with clues.
    Retrospective cross-sectional studies provide you with 
clues that have to be studied to see if the clues are correct. 
Standing on top of a building and doing a 360 in Kansas would 
lead you to the determination that the world is flat. But you 
have to have a better measuring tool and it has to be subjected 
to some scientific rigor.
    Senator Specter. Dr. Bigos, do you disagree with what Dr. 
Barondess said also, that there is, well, I know the answer to 
this but I will ask it anyway, scientific basis for 
intervention?
    Dr. Bigos. I thought I saw that there was a call for more 
research because we didn't have enough information to be able 
to be specific, especially on the back pain----
    Senator Specter. Did I quote you incorrectly, Dr. 
Barondess? You said there was a scientific basis for 
intervention?
    Dr. Barondess. I did say that.
    Dr. Bigos. I think that was for the upper extremity. I do 
not think it was there for the back, was it?
    Dr. Barondess. Yes, it was. In fact it is stronger for the 
back.
    Senator Specter. Dr. Barondess, when you say it is a 1 
percent issue on the gross national product, I want to be sure 
I have got my zeroes in order here, on a $10 trillion gross 
domestic product, that would be $100 billion in losses?
    Dr. Barondess. There have been estimates that high, 
Senator. Actually, I wrestled with the zeroes myself and was 
operating from a smaller estimate of the gross domestic product 
when these figures were put together.
    Senator Specter. What estimate were you working on?
    Dr. Barondess. $5 trillion.
    Senator Specter. $5 trillion. Looks like the tax cut is 
going to have to be reduced then.
    Dr. Barondess. That is the difference between a scientist 
and an economist. We are here to help.
    Senator Specter. This hearing I think has reached a new 
milestone in very heavy competition on disagreement. The 
economists go over the gross national product and the tax cut 
and the surplus and cannot agree on anything. And 
notwithstanding Dr. Punnett's testimony, I think witnesses 
today have agreed on less.
    I guess that is impossible but that is the way it seems to 
me listening. Dr. Barondess, do you have a formula beyond your 
conclusions on adding incremental risk and a scientific basis 
for intervention as to what the intervention ought to be and 
how you ought to tackle these various lines?
    Dr. Barondess. Yes, sir. This is complex territory and the 
committee's view is that multiple interventions need to be 
applied when interventions are applied. They need to include 
not alone efforts to ameliorate physical load but need to 
involve also the workforce in their design, need to involve a 
commitment from management, need to have something to do with 
administrative alterations as well as mechanical alterations.
    When Dr. Hadler says something about physical factors as 
exclusive causes, that is not at all the conclusion the group 
came to. And I agree with him that psychosocial factors are 
extremely important. As I said earlier, humans are complex and 
reactive on a number of levels.
    Senator Specter. Thank you all very much. We are going to 
move to Panel 4, Cost Benefits and Feasibility of Ergonomic 
Programs. Mr. Dean Sparlin, Dr. Burton, Dr. Derebery, Mr. David 
Alexander, Mr. Eric Frumin and Mr. Doug Bonacum.
    Let me start with you, Mr. Sparlin, if we may. And thank 
you for joining us and look forward to your testimony.
STATEMENT OF DEAN SPARLIN, ESQ., GIBSON, DUNN & 
            CRUTCHER, LLP
    Mr. Sparlin. Thank you, Mr. Chairman. We are here today to 
discuss economic issues with six panelists, none of whom is an 
economist. I am a lawyer having represented clients in safety 
and health matters during more than 14 years of practice.
    The reason we do not have an economist here is that we have 
not reached the point where one would be useful. So far we have 
had a battle between big numbers and mind-numbingly huges ones.
    OSHA told us last year that its ergonomic standard would 
cost $4.5 billion per year. Employers countered with cost 
estimates exceeding $100 billion. Any disagreement of that 
magnitude has to be more than mathematics.
    What we have here is a basic different vision between the 
two sides. The key to resolving that difference is a clear 
understanding of what a standard would entail, educated by 
OSHA's own history of enforcing similar requirements.
    With all due respect, I do not believe that testimonials 
from ergonomists and safety and health personnel provide the 
answer. These individuals work on ergonomics programs all the 
time and they freely offer reports of their success.
    The extent to which these claims represent hard facts as 
opposed to salesmanship from people who make their living 
promoting ergonomics is open to debate, but that debate is 
largely academic.
    The question is not what employers spend on ergonomics 
under the status quo, but what they would be forced to spend 
under a standard that would change the status quo.
    My distinguished co-panelist, David Alexander, is an 
articulate and passionate proponent of the mantra that 
ergonomic controls are inexpensive. He has written numerous 
books that promote the cost justification of ergonomics. And he 
testified at the hearing that ergonomic interventions almost 
always pay for themselves by ratios approaching 10 to 1.
    His views and similar opinions from two other ergonomic 
consultants were the sole basis for OSHA's cost estimate. 
OSHA's role, however, is not to tell employers how to improve 
productivity and save money but to protect safety and health.
    If those two goals were as closely aligned as some like to 
claim, then a standard would be unnecessary because employers 
would be rushing to get their 10-to-1 pay backs.
    But more than a decade of OSHA ergonomics activity pursued 
on the advice of many of these same ergonomists, paints a very 
different picture. There is a reason employers are almost 
universally resisting OSHA regulation. And that reason is not 
ignorance of economic benefits. It is the reality of what an 
ergonomic standard would entail.
    This stack of paper beside me, which is very high, is just 
a partial compilation of more than 550 ergonomic citation 
issued under the so-called General Duty Clause. Each of these 
citations lists measures that OSHA believed to be necessary 
abatements of alleged recognized hazards.
    Over and over again, OSHA sought burdensome and costly job 
controls such as the ones you see on the board that was just 
posted. When employers argued that these citations should be 
used as a measure to measure a final standards cost, OSHA could 
not have backpedaled any faster.
    OSHA claimed that its new standard would not necessarily be 
enforced in the same way, even though the standard described 
what was expected in language that was basically 
indistinguishable from the citations. All the while, OSHA 
refused to reveal exactly what its new enforcement policy would 
be.
    The agency also asserted that the abatements were merely 
recommendations. But the one employer who actually litigated in 
favor of a less expensive alternative was greeted with a parade 
of OSHA experts insisting on the listed measures.
    The reason OSHA is so afraid of its own history is that the 
cost of these measures are an entirely different universe. Many 
employers use these same citations to produce their own cost 
estimates which added up to more than $179 billion. Taking into 
account the employers who were not even represented, the 
projection of more than $100 billion in total costs is not at 
all unreasonable.
    Now, if OSHA decides to try again, regardless of its chosen 
approach, it will need to do a far better job of confronting 
the most fundamental question in any cost analysis.
    What does the standard actually require. In the last round, 
OSHA's entire estimate of cost per job control was developed 
before the proposed standard was even drafted. And that 
estimate was never revisited even after major changes in the 
final standard.
    Now, I will not repeat OSHA's mistake of estimating a new 
standards cost before I have seen the new standard. But I will 
tell you that any future cost analysis must begin from a very 
different base line.

                           prepared statement

    OSHA should either use its own enforcement history as a 
guide or should identify exactly what is different about the 
new approach. If the agency continues to ignore its own 
history, it will be doomed to repeat it, once again producing 
cost estimates that seriously misrepresent reality.
    [The statement follows:]
                   Prepared Statement of Dean Sparlin
    Mr. Chairman and members of the Subcommittee: We are here today to 
discuss the economics of an ergonomics standard with an engineer, a 
health and safety director, a spine surgeon, and a lawyer. I am the 
lawyer, having represented clients in occupational safety and health 
matters, including ergonomics, during more than 14 years of practice 
with Gibson, Dunn & Crutcher LLP.
    The economic discussion to date has been characterized by a battle 
between big numbers and mind-numbingly huge ones. OSHA told us last 
year that its ergonomic standard would cost $4.5 billion per year but 
would save approximately twice that amount. Employers countered with 
analyses showing that costs could easily exceed $100 billion. When 
there is a disagreement of that magnitude, it is safe to say that the 
discrepancy is more than mathematical. There is a very basic difference 
in vision between the two sides performing the calculations.
    That, more than anything, explains why it is just as well that an 
economist is not here to address these issues. Before anyone can opine 
on the economic impact of a standard, there must be a clear 
understanding as to what the standard would entail. The key to that 
question lies not in economic theory, but in a practical understanding 
of burdens that would be imposed in light of OSHA's own history of 
enforcing similar requirements.
    With all due respect, I do not believe that testimonials from 
ergonomists and safety and health personnel provide an appropriate 
perspective. It is true that these individuals work together on 
ergonomics programs all the time, and they freely offer reports of 
their successes. The extent to which these claims represent hard facts, 
as opposed to salesmanship from people who make their living promoting 
ergonomic interventions, is open to debate--but that debate is largely 
academic. The question before us is not what employers spend on 
ergonomics under the status quo, but what they would be forced to spend 
under a standard that presumably would change the status quo.
    My distinguished co-panelist, David Alexander, is an articulate and 
passionate proponent of the mantra that ergonomic controls are 
inexpensive. He has written numerous books on the subject, including 
one entitled Selling Ergonomics To Management, which teaches readers 
how to convince skeptical bosses to sign off on ergonomics programs. He 
testified at the hearing that ergonomic interventions almost always pay 
for themselves, by ratios that in his opinion can exceed 10 to 1.\1\ He 
supported that view with descriptions of his experience advising 
clients and anecdotes he has heard from colleagues in his profession. 
His views, and similar opinions from just two other ergonomic 
consultants, were the sole basis for OSHA's cost estimate.
---------------------------------------------------------------------------
    \1\ Transcript, Mar. 20, 2000, at 2183.
---------------------------------------------------------------------------
    It is not OSHA's role, however, to tell employers how to improve 
productivity and save money. OSHA's role is to protect safety and 
health. If the agency's safety and health vision were as closely 
aligned with productivity as some like to claim, then a standard would 
be unnecessary because employers would voluntarily rush to get their 
10-to-1 paybacks. But more than a decade of OSHA ergonomics activity, 
pursued on the advice of the same ergonomists who testified in favor of 
a standard, paints a very different picture. There is a reason 
employers are almost universally resisting OSHA regulation, and that 
reason is not ignorance of the economic benefits. It is the reality of 
what an ergonomics standard would entail.
    The impressive stack of paper beside me is just a partial 
compilation of more than 550 ergonomics citations that OSHA has issued 
under the so-called ``general duty clause.'' Each of these citations 
lists measures that OSHA believed to be necessary abatements of alleged 
``recognized hazards.'' Most of these recommendations never show up on 
ergonomists' lists of ``inexpensive'' controls. Over and over again, 
OSHA compliance officers cited safety and health concerns as a 
justification for slowing work pace, mandating rest breaks, adding 
expensive hoists or automated devices, and micro-managing work 
processes.
    When employers argued during the rulemaking that these citations 
should be used to measure a final standard's cost, OSHA could not have 
backpedaled any faster. OSHA claimed that a standard would not 
necessarily be enforced the same way, even though the standard 
described what was expected of employers in language that was basically 
indistinguishable from the citations. All the while, OSHA refused to 
discuss exactly what its new enforcement policy would be. The agency 
also asserted that the abatements were mere recommendations from which 
employers could vary. But the one employer who actually litigated in 
favor of a less expensive alternative approach in response to a general 
duty clause citation--Pepperidge Farm--was greeted with a parade of 
OSHA experts insisting that the agency's ``recommendations'' were 
gospel.
    The reason OSHA is so afraid of these general duty clause citations 
is not hard to figure out. The costs they entail are in an entirely 
different universe from OSHA's official estimate. Abatement measures 
from these citations formed the essence of many employer estimates 
submitted during the hearings, which added up to more than $179 billion 
in anticipated costs. There is some overlap in the employer estimates 
and some differences in their assumptions, but it is also true that a 
very large portion of affected industry is not represented. It is not 
at all unreasonable to expect, in light of this evidence, that costs 
could exceed $100 billion--perhaps by a very wide margin.
    Theoretically, OSHA could design a new standard or guideline--
assuming appropriate scientific support--that meaningfully departs from 
past general duty clause excesses. This, however, will require more 
than hollow assurances that enforcement will concentrate on inexpensive 
remedies. Unfortunately, it is extraordinarily difficult to draft 
concrete limitations that would enforceably confine control 
obligations. Certainly the proposed standard's vague language does not 
meet this objective. Nor does the final standard, whose ``action 
triggers'' and ``hazard identification tools'' serve primarily to 
underscore just how far OSHA expected employers to go in retooling 
their workplaces.
    If OSHA does decide to try again, regardless of its chosen 
approach, it will need to do a far better job of confronting the most 
fundamental question in any cost analysis: What does the standard 
actually require? In the last round, OSHA's entire estimate of cost per 
job control was developed before the proposed standard was drafted--by 
individuals who afterwards could still not describe the standard's 
provisions. The estimate was never revisited, even after major changes 
in the final standard.
    I will not repeat the mistake of estimating a new standard's cost 
before I have seen it. But I will tell you that any future cost 
analysis must begin from a different baseline. OSHA should either use 
its own enforcement history as a guide or should identify exactly what 
is different about the new approach. If the agency continues to ignore 
its own history, it will be doomed to repeat it, once again producing 
cost estimates that seriously misrepresent the true picture.

    Senator Specter. Thank you very much, Mr. Sparlin. Mr. 
David Alexander, certified professional ergonomist.
STATEMENT OF DAVID C. ALEXANDER, PRESIDENT, AUBURN 
            ENGINEERS, INC.
    Mr. Alexander. Thank you very much. Good morning. I welcome 
the opportunity to join the panel and share my experience on 
ergonomics. My name is David Alexander. I am president of 
Auburn Engineers, a leading applied ergonomics consulting 
company.
    My 25 years of private sector ergonomics experience spans a 
range from small employers to the largest companies in the 
world. I want to address the feasibility of ergonomic solutions 
and the cost benefits of their interventions.
    It has been widely stated that ergonomic problems are not 
solvable or that the solutions are simply too expensive. That 
information is wrong. With 25 years of professional experience, 
I have yet to see a job that could not be improved with the 
application of ergonomic principles.
    I personally developed thousands of solutions to ergonomic 
problems and my colleagues have told me of many more. The 
solutions range from simple workplace changes to complex 
factory redesigns. For window and door manufacture I was able 
to reduce ergonomic risk factors by 90 percent while increasing 
productivity by 300 percent. For chemical manufacture I was 
able to reduce ergonomic risks by 80 percent while increasing 
productivity by 50 percent. For an auto components manufacture 
I reduced loss time by 80 percent while saving a million 
dollars in operating cost. For a telecommunications company, 
reduced lost time cases by 80 percent and demonstrated 
productivity savings as high as 15 percent. These ergonomic 
projects, while notable, are not uncommon. Similar results have 
been reported by other practicing ergonomists.
    The practice of ergonomics is not limited to experts, 
however. Many organizations are using employee teams to resolve 
problems and necessarily this drives the cost down rapidly. 
Fifty percent of ergonomic problems in my opinion can be solved 
locally using local resources and local workers and their 
supervisors.
    Many trade associations have developed solution databases 
for ergonomic problems. They've shared these widely. I've 
participated and worked with those in textiles, apparel, food 
distribution, paper chemicals, petroleum, and I know other 
industries have done the same.
    These guidelines get passed from plant to plant. They 
become more refined, they become more effective and they become 
cheaper to implement, thus some of the cost from yesteryear do 
not reflect the cost of tomorrow.
    There are thousands and thousands of good examples of 
interventions out there. OSHA has developed lists of these and 
shared them, as have insurance companies and many universities. 
In summary, I find that ergonomic problems are typically easy 
to identify and rarely require sophisticated techniques to 
resolve. I have a promotional poster, if I could put that up, 
that illustrates a simple case of ergonomics. It involves some 
visiting dignitaries we White House during the last Bush 
administration as a story. Could you put the--it is a cartoon 
poster, I am sorry.
    As the story unfolds, several shorter dignitaries have 
difficulty speaking from a podium adjusted for a much taller 
President Bush. After several near falls, this team of 
ergonauts uses our simple problem solving process to develop a 
cost-effective solution to the problem. As the story 
illustrates, ergonomics works.
    Now, let me turn to the topic the cost benefits. Cost of a 
dollar spent to implement solutions, benefits were the savings 
that the organization achieves. The benefits are attained by 
controlling worker injuries and saving the dollars currently 
being lost from medical treatment, workers compensation, lost 
time, replacement workers, overtime, lost production, reduced 
quality.
    All of these have benefits or a number of these have been 
outlined by OSHA. But that is not the whole story. There are 
substantial benefits which are not reflected by the OSHA cost 
calculations. These are the business level improvements that 
typically result from ergonomic projects. Mr. Sparlin referred 
to these.
    Here gains can be made that increase the operating 
performance above baseline performance and these are 
substantial, in some cases approaching ten times the cost. A 
common problem with cost calculations is under-reporting. 
People do not do a good job. Common problem with benefits is 
under-reporting. We do not calculate those well. In one case in 
the printing industry we were able to document ten times more 
benefits than what had been initially perceived.
    Project costs are frequently inflated. Overdesign is a 
common problem with an emerging industry and that is what it is 
with ergonomics. As we gain more experience, cost go down. I 
also find that some industries have not modernized. They are 
using out of date processes and unfortunately they lump the 
cost of modernization along with the cost of ergonomic 
compliance, thus grossly inflating prices.

                           prepared statement

    When we look at ergonomics, we have to recognize that costs 
will drop as experience goes on. I've chaired in a flight 
ergonomics----
    Senator Specter. Mr. Alexander, your time is up. If you 
would summarize your full statement, it will be made a part of 
the record.
    Mr. Alexander. Thank you very much. Ergonomics works. Good 
ergonomics is good business.
    [The statement follows:]

                Prepared Statement of David C. Alexander

                     credentials and qualifications
    Good morning. My name is David Alexander. I have been practicing 
ergonomics in the private sector for over a quarter of a century. I 
hold two degrees in engineering, the second a Masters degree with a 
specialty in ergonomics. I have continued my professional development 
throughout my career with extensive academic work, short courses, 
conferences, peer discussions, and professional exchanges.
    I am licensed to practice engineering as a registered Professional 
Engineer in Alabama and Tennessee, and have been for more than two 
decades. Furthermore, I have authored many questions on ergonomics used 
to test professional engineering candidates. The exam is required for 
registration as a Professional Engineer.
    I am a Certified Professional Ergonomist, and have been for many 
years. For the past 4 years, I have served as an officer on and member 
of the Board of Certification in Professional Ergonomics (BCPE). I 
assist with the CPE test development process, and have worked to 
increase the number of Certified Professional Ergonomists in the United 
States and the world. I am currently Vice-President of BCPE.
    My peers in the field of industrial ergonomics have recognized me 
as one of their outstanding practitioners. I received the Ergonomics 
Award from the IIE in 1986. I was awarded Fellow status in the 
Institute of Industrial Engineers in 1990. I received the Industrial 
Ergonomics Award from the Industrial Ergonomics Technical Group of the 
Human Factors and Ergonomics Society in 1993. I am the only ergonomics 
professional to be recognized by both of these two leading professional 
societies.
    I hold two patents for the design of ergonomics inventions. The 
first is a revolutionary new tool handle design, and the second is for 
an ergonomically designed piece of equipment used for decorating cakes 
and other baked goods.
    I speak routinely on ergonomics and its application in industry. I 
have been invited to speak for groups in engineering, health care, 
safety, health, legal and all other professions related to ergonomics. 
My presentations have included invited keynote speeches as well of 
papers, workshops and tutorials. I have taught thousands of people my 
techniques and practices.
    Currently, I am President of Auburn Engineers, Inc., an ergonomics 
consulting company. I have many Fortune 100 companies as clients. My 
staff and I provide a wide range of ergonomics services and have since 
1988. During my tenure in ergonomics, I have worked with many 
organizations, both large and small, representing many different 
industries. I have worked with labor unions and with management, with 
safety and health professionals, with engineers and health care 
practitioners, with production workers and their supervision.
    Prior to my work with Auburn Engineers, Inc., I was an engineer, an 
ergonomist, and an ergonomics program manager for Eastman Kodak 
Company, and performed hundreds of ergonomics projects in all facets of 
their operations.
    During my quarter century of professional ergonomics practice, I 
have worked in many different industries. A listing of recent clients 
includes: Chemicals, Forest Products, Petroleum, Food Production, 
Health Care, Medical Equipment, Hospitality, Government, Food Service, 
Electronics, Plastics, Aerospace, Paper and Pulp, Metals Refining, 
Distribution and Delivery, Printing, Auto Assembly, Metal Processing, 
Consumer Products, Telecommunications, Missiles and Space, Textiles, 
Apparel, Appliances, Auto Parts, and Mining. Over the years, I have 
worked with more industries, provided training for their staffs, 
visited and toured others, and have spoken with ergonomists and 
engineers from yet even more.
                         does ergonomics work?
    During my years of experience with ergonomics, I have yet to find a 
job that cannot be improved with the application of ergonomics 
principles. I would like to share some examples of the outcomes of 
ergonomics when it is applied in business:
  --This company builds automotive equipment for a major auto assembly 
        manufacturer. It must provide components in a just-in-time 
        environment to an assembly plant a few miles away. We were 
        initially identified as a source of assistance by a state 
        agency whose mission it is to help state manufacturers that are 
        in distress or are having significant problems with 
        productivity, environment, safety or other major issues. This 
        company employs approximately 300 people at this site. When we 
        were first introduced to this company, they told us that their 
        injury rate was overwhelming, that their costs from these 
        injuries were approaching $1,000,000 annually, and that they 
        felt an OSHA citation was possible since OSHA was investigating 
        other issues at the plant. We worked collaboratively with them 
        to plan, then implement, an effective ergonomics program. The 
        work included identification of jobs with risks, development 
        and implementation of engineering and administrative controls, 
        training, and the use of job hazard analysis for all jobs. 
        Within a 6-month period, there was an 83-percent reduction in 
        workers compensation costs, and a drop in the OSHA recordable 
        rate from over 50 to less than 4. There was also a 100-percent 
        placement of workers with restrictions into normal production 
        jobs with no ``make work'' jobs being performed. This company 
        was recently awarded the PACE award in the automotive industry 
        for innovation management practice. So not only have they made 
        substantial gains in business performance, they have been 
        recognized by their peers for this accomplishment and the way 
        in which it was made.
  --This company produces wood products in the mid-West, and had a 
        significant ergonomics problem. We helped reduce their 
        compensation costs from over $720,000 per year to $25,000 per 
        year, and dropped their injury rate from 180 per year to less 
        than 5 per year. We did this with a combination of engineering 
        and administrative controls, training, management support, and 
        other ergonomics program measures.
  --This company produces pre-hung doors and windows. It was 
        experiencing excessive back injuries from manually handling the 
        doors and from poor work positions. We reviewed their jobs, and 
        developed a number of job enhancements including supported 
        tools, better work tables, guides and fixtures, and a new 
        conveyor line. When we were done, the result was a 300 percent 
        increase in productivity and a 90-percent reduction in 
        ergonomics risk. The plant was now able to produce 900 doors 
        rather than 300 doors per shift with no additional personnel.
  --On a chemical bag filling operation, we were asked to provide 
        improvements for a bag filling and sealing operation. We did a 
        careful analysis and made recommendations that permitted a 50-
        percent increase in productivity along with an 82-percent 
        reduction in ergonomics risk. The number of bags that could be 
        filled went from 960 per shift to 1,400. The changes included 
        an alternate method of moving bags on a conveyor, changing work 
        heights, and altering the methods of feeding bags into a heat 
        sealer.
    I share these with you because they make the point I wish to leave 
with you--Ergonomics works!
    There are hundreds and thousands of successful ergonomics 
interventions out there. Ergonomics works, and works well. These 
successes range from simple changes to work methods to complete 
reorganizations of factories and workplaces. Many of these successes 
can be found by talking with practitioners in industry and business, or 
by reviewing the many case studies found in the scientific and trade 
press publications.
    what are the tangible benefits to the application of ergonomics?
    To answer this question, it is helpful to understand the types of 
benefits one can expect from ergonomics applications. They fall into 
several categories: avoided costs, and performance improvements.
    Avoided costs begin with the avoidance of direct injury/illness 
costs by controlling or eliminating the injury/illness. As this occurs, 
then one also avoids the indirect costs of injury/illness such as 
replacement workers, the manufacture of off-quality products, time for 
the investigation of incidents, implementation of necessary corrective 
actions, and so on. Essentially these are unplanned losses, or costs, 
or expenses, which take profits away from the bottom line of the 
organization.
    Besides avoiding losses, there is a great opportunity to achieve 
performance improvements. Performance improvements occur when 
ergonomics improvements permit one to achieve breakthrough performance 
that exceeds the current baseline. These improvements are most often 
reflected as traditional business measurements such as enhanced 
productivity, less downtime, product quality, delivery, fewer 
bottlenecks, and so on. They may also include lower costs for workers' 
training or employment as jobs become less stressful. The best way to 
think of these items is that they improve upon your expected level of 
operation and permit you to operate better than planned. The result is 
increased profits to the business.
    Ergonomics benefits are measured in at least 17 different ways, 
according to my research, but one of the most common is benefit/cost 
ratios. These calculate a ratio of the benefits associated with an 
ergonomics project relative to the costs required for implementing the 
project. The benefit/cost ratio should be greater than 1.0 for an 
economical, value added project. The benefit/cost ratio can be impacted 
in two ways: one, increase the level of benefits for the project, or, 
two, decreases the costs associated with the project.
    The benefits can be increased by identifying and reporting more 
benefits (a common problem with cost justification is that economic 
benefits are chronically underreported). The costs can be reduced by 
lowering the cost of the project, perhaps by using administrative 
controls or with less sophisticated engineering controls.
    The cost of ergonomics projects is highly variable. Solutions range 
from low cost administrative controls (work methods, job redesign) to 
very expensive mechanical equipment. Often, for a single set of risk 
factors, as many as 5-10 different solutions can be developed and 
implemented. The choice of the solution has a great impact on the 
overall cost of the project. For many projects that report high costs, 
the problem is that an overly expensive solution has been chosen, when 
in fact, a lower cost solution would work just as well.
    In my work, I found that about half of the ergonomics projects cost 
less than $500, and can be done on a standard work order without the 
need for detailed justification. And only a third of the projects cost 
more than $1,000. In other words, an ergonomics project is likely (two 
times out of three) to cost less than $1,000, and usually can fit 
within most operating budgets. Hugh budgets for the implementation of 
widely expensive ergonomics program simply do not occur.
    At the request of one of our clients, we examined these benefits 
with the goal of developing ``multipliers'' which could be used to 
determine the value of the benefits relative to workers compensation 
costs. For ergonomics, the benefits multiplier was found to be from 0.5 
to 2.0 for the ratio of direct to indirect costs. We also looked at the 
benefits attained from improved performance, and found them to be very 
large. This multiplier was found to range from 2 to 10 times the cost 
of workers compensation.
    One real opportunity, and one that is commonly overlooked, is the 
savings that can occur from better design practices. We have measured 
the costs associated with design for ergonomics, and find them to be a 
highly attractive investment. In fact, this is how we characterize 
these costs. They are an investment in the design, which should provide 
a payback later on. The cost of design goes up substantially as the 
project progresses. The difference between ``doing it right the first 
time'' at the initial design stage and waiting until injuries occur 
during normal operations, is ten-fold. The costs will be ten times 
higher when retrofits are utilized rather than having ergonomics 
designed in from the start. Similar figures have been reported by 
others practitioners, especially those in the auto industry. What this 
means is that costs for ergonomics interventions for current operations 
cannot and should not be extrapolated into the future. When workplaces, 
tools, equipment, vehicles, assembly lines, and factories are designed 
properly from the start, the ergonomics costs should be one-tenth of 
the current estimates.
                      trends in applied ergonomics
    I founded the Applied Ergonomics Conference Series and last month 
we held our 4th Annual Conference, with almost 800 people in 
attendance. They represented industry and business from virtually every 
employment sector, as well as organized labor, trade and professional 
groups, and government. We heard 100 presentations on ergonomics 
programs and interventions.
    There is widespread use of ergonomics in the private sector for 
both injury/illness control and business performance improvements. 
During the four conferences I have chaired since 1998, we have had some 
300 presentations on successful applications of ergonomics, dozens of 
workshops and seminars, and keynote speakers from industry, labor and 
government. Many of these presentations are documented in our printed 
volumes of ergonomics case studies, and more recently in electronic 
form on the internet.
    And we have had 2,500 attendees representing virtually every state 
in the union, our NAFTA partners Mexico and Canada, and a number of 
European countries. The attendees represent 500 companies, universities 
and Federal and State governments.
    The Applied Ergonomics Conferences have been sponsored by a diverse 
list of professional organizations and agencies including:
  --Institute of Industrial Engineers
  --Department of Labor Occupational Health & Safety Administration
  --National Institute for Occupational Safety and Health
  --American Association of Occupational Health Nurses
  --American Industrial Hygiene Association
  --American Society of Safety Engineers
  --Association of Canadian Ergonomists/L'Association Canadienne 
        d'Ergonomie (ACE)
  --Board of Certified Safety Professionals
  --Board of Certification in Professional Ergonomics
  --Ergonomic Assist Systems and Equipment--a product council of 
        Material Handling Industry of America
  --International Labour Organization
  --Risk and Insurance Management Society
  --Society for Risk Analysis
  --Society for Work Science
  --Voluntary Protection Programs Participants' Association
    At these conferences, I have been able to listen to many 
presentations and to talk with dozens of participants about their on-
going work on ergonomics. I found the following trends:
  --Ergonomics is being applied in increasingly diverse settings. We 
        have examples of ergonomics in food distribution, health care, 
        government, petroleum, meatpacking, retail, construction, 
        agriculture, distribution, and other industries.
  --More and more people are involved with the application of 
        ergonomics. We have many examples of shop-floor teams, most 
        including supervision or staff, but some with just production 
        workers. There is normally involvement with nurses and health 
        care providers for root cause determination, and with 
        maintenance and engineering for equipment alteration.
  --There are many examples of shop floor improvements leading to 
        injury/illness reduction and to productivity and quality 
        improvements. Most teams will report benefits for both safety 
        and health, and for productivity or quality.
  --Training is becoming more commonplace and less burdensome. Some 
        teams develop skills with a few hours of training, and then are 
        ready to develop and implement successful ergonomics 
        improvements.
  --There is extensive sharing of solution ideas. This sharing is 
        occurring within companies, within industries, and even across 
        industry sectors.
  --There is a clear trend toward the use of design to prevent problems 
        rather than just to fix problems. Several major auto 
        manufacturer touted their successful work in the design of 
        manufacturing cells, production lines, and even in vehicle 
        design in order to prevent ergonomics injuries and illnesses 
        before they occur. A couple of important points about this:
    --They use risk factors as their guide, not injuries. This 
            indicates a high level of maturity with the surveillance 
            and ergonomics problem identification part of their 
            programs.
    --They do this design work for business reasons. Ergonomics is good 
            business, and it is economical to spend millions of dollars 
            in this way. For a new model change-over, the costs may run 
            into the millions of dollars, yet create savings equal to 
            10 times that number.
    --They report that the majority of these changes result in other 
            positive business improvements like productivity (77 
            percent of the time), quality (50 percent of the time) and 
            reduced vehicle weight (10-15 percent of the time).
  --Many who originally opposed ergonomics now support it! There are 
        many examples of companies who came to learn about ergonomics 
        from an OSHA citation, but who now tout its benefits. 
        Originally, they bemoaned ergonomics as a burden to their 
        business and unnecessary for the protection of their workers. 
        How time and experience can dramatically alter one's viewpoint.
                           if you go forward
    I have worked with industry for many years, and I find that 
ergonomics programs are more effective when they include the following:
  --Involve employees in solving ergonomics problems. Ergonomics 
        solutions are not usually difficult to identify. In my 
        experience, 50 percent can be handled at the worker/supervisor 
        level, and most of the others are resolved with an in-plant 
        team.
  --Use trade groups, sister plants and other organizations to both 
        identify and resolve ergonomics problems.
  --Have a sound health care program and treat injuries both quickly 
        and with respect.
  --Have management leadership on ergonomics, just like it provides 
        leadership on safety, health, production and quality issues.
  --Provide training where necessary to ensure effective performance. 
        JHAs are necessary in modern industry.
  --Prevent ergonomics problems by reviewing new jobs, tools, and 
        equipment.
  --Review the ergonomics program to ensure its effectiveness.
    There are clear differences between effective programs and 
ineffective ones. Effective programs contain certain elements and work 
in certain ways.
                               in closing
    Finally, in closing, let me say that ergonomics is tool that is 
already used in industry. It is not a new tool, it is not difficult to 
use, and it is not burdensome. It is part of continuous improvement 
programs used in many organizations to improve safety and health, 
quality, productivity, and cost.
    Thank you for your attention. I look forward to providing 
additional clarification with your questions and on-going deliberation 
on ergonomics.

    Senator Specter. Thank you. We turn now to Mr. Eric Frumin, 
director of Safety and Health, Union of Needle Trades, 
Industrial and Textile Employees Mr. Frumin.
STATEMENT OF ERIC FRUMIN, DIRECTOR, SAFETY AND HEALTH, 
            UNION OF NEEDLE TRADES INDUSTRIAL AND 
            TEXTILE EMPLOYEES
    Mr. Frumin. Good morning, Senator. First I just want to 
submit for the record a slightly corrected version of the 
written testimony I submitted.
    Senator Specter. It will be made a part of the record in 
full.
    My name is Eric Frumin. I am the health and safety director 
of UNITE. On behalf of our members in Pennsylvania and 
Philadelphia and throughout the Nation, we very much appreciate 
the opportunity to testify here today.
    The arguments about costs and benefits have generated much 
sound and fury and from some quarters like Mr. Alexander, 
actual enlightenment. From other quarters, however, there's 
been nothing but fury and active disinformation. Today UNITE is 
confident in stating the following. First, the cost of these 
injuries are huge to employers, workers and taxpayers alike.
    Second, the requirements of the OSHA ergonomic standard are 
eminently feasible. The potential cost of those requirements 
are sensible in business investments, and the benefits of 
ergonomic programs to workers, employers and society are 
substantial.
    The arguments you have heard today and before about the 
feasibility, costs and benefits have degenerated into a virtual 
warfare and as the saying goes, the first casualty of war is 
the truth. It is been obstructed, the argument, has by what we 
would call a big lie campaign orchestrated by the most rabid 
opponents of reasonable worker safety rules who misled and 
frightened employers large and small.
    The Stanley company, as you know, is one of the nations 
largest makers of tools. Their sales of ergonomically designed 
tools depend heavily on employer confidence that ergonomics 
works. But as one of their senior managers told Business Week 
magazine, we're competing against ignorance. How much do these 
injuries cost? As Dr. Barondess pointed out, between $45 and 
$54 billion annually, about 1 percent of the gross domestic 
product.
    The cost of these injuries is the very reason why this 
Congress passed the Occupational Safety and Health Act. But 
actual industrial experience shows that ergonomics programs are 
technically feasible and are cost-effective and I want to take 
you, Senator, to Lewistown, Pennsylvania to the Leer 
Corporation.
    Repeatedly before both the Senate Labor Committee and the 
OSHA rulemaking record local union officers have testified 
about the OSHA citation at that plant, about the benefits of 
the ergonomics program which the management implemented as a 
result of that citation. That citation and the program the 
employer implemented did exactly the same things that Mr. 
Sparlin is listing on his chart here this morning and I am 
curious why Mr. Sparlin hasn't pointed to the Leer Corporation. 
That company came out strongly in support of OSHA enforcement 
of the general duty clause and we know that that ergonomic 
injuries in that plant have been seriously reduced to virtually 
no disabling injuries anymore in that plant. And Senator, we 
would invite you to come and visit that plant.
    The auto parts industry is highly competitive. Good jobs 
like this in central Pennsylvania are not easy to find. But the 
management and these workers have nothing to fear from 
ergonomics and everything to gain.
    The OSHA rulemaking record is replete with examples like 
this from large and small employers alike. The Xerox 
Corporation submitted, Mr. Senator, a formal cost benefit 
analysis to the OSHA rulemaking record. They spent $3.4 million 
on the ergonomics program in 1999. They said the resulting 
savings was $7 million in that year for avoided workers 
compensation claims. These kinds of benefits are achievable 
throughout the economy and OSHA reviewed hundreds of studies 
and scientific evaluations and case studies which came to the 
same conclusion.
    Senator Specter. What company was the last one you referred 
to?
    Mr. Frumin. Xerox Corporation and that is in my prepared 
statement.
    Unfortunately, Senator, with rare exception it appears that 
these and other well-meaning companies were not present at the 
OSHA hearing. They did not show up to testify. You've heard 
about the auto companies. Where were the Big Three companies at 
the OSHA hearings. Where were the individual grocery chains, 
where were the nursing homes? Seems like they were all in 
hiding to avoid admitting the truth about their actual 
investments in ergonomics and the returns that they enjoyed.
    What OSHA did here instead largely with speculation about 
possible compliance problems but the testimony of one 
participant was most revealing, the United Parcel Service, the 
single most active employer never showed up at the hearing to 
testify. None of their managers came. Only later did OSHA 
receive a corporate memo from UPS, UPS corporate memo, March 
10th, the year 2000, from the corporate industrial engineering 
department entitled Ergonomic Endeavors clearly identifies the 
capital investments and operating investments they've made to 
improve the ergonomics in their work force.
    Never once did any of their representatives at that hearing 
provide this kind of information to OSHA or identify the cost 
that--the investments that UPS was making or the savings that 
UPS was enjoying. Why? We cannot answer for them. Maybe they 
can answer for themselves. But the real question to UPS and to 
the other employers who have opposed this in the way that they 
have, what are you now spending on it? Why don't you tell us 
what the truth is, how much are you saving and why are you 
making these investments.

                           prepared statement

    Senator Specter. Mr. Frumin, your time has expired, your 
full statement will be made a part of the record so if you 
would now summarize, please.
    Mr. Frumin. We have heard, and as Congress unfortunately 
has heard, a figure of $120 billion as the cost of this 
standard. We reject that as a total fabrication. We call upon 
the Congress to look at the findings of previous OSHA 
rulemaking such as the OTA, the Congressional Office of 
Technology Assessment has shown OSHA's rulemakings to be 
feasible, to be economically achievable and we urge the 
Congress to immediately compel the Secretary to issue a new 
standard forthwith. Thank you very much.
    [The statement follows:]
                   Prepared Statement of Eric Frumin
    Good morning. Mr. Chairman, members of the Committee, my name is 
Eric Frumin. I am Health and Safety Director of the UNITE. I am also 
the chairman of the Advisory Committee on Occupational Safety and 
Health Statistics to the U.S. Bureau of Labor Statistics, and a member 
of the Board of Scientific Counselors to NIOSH.
    I am here to address several key questions regarding the OSHA 
standard on ergonomics:
  --the actual feasibility of the standard's requirements
  --potential costs of those requirements, and
  --likely benefits to employers, workers and society.
                 the first casualty of war is the truth
    I want to state initially, however, that as with the so-called 
debate about the underlying science of ergonomics, the discussion of 
feasibility, costs and benefits has been obstructed by a Big Lie 
campaign. This campaign was orchestrated by the most rabid opponents of 
reasonable worker safety rules, who misled and frightened employers 
large and small with their fabrications. This of course contributed to 
the misinformation feeding the Congressional debate earlier this year, 
and adds another unfortunate chapter at today's hearing.
    This campaign of lies and distortion is truly shameful. Not only 
has it irreparably harmed OSHA's ability to issue cost-effective 
standards to prevent the biggest job-safety problem in the American 
economy. It has also sowed confusion and fear of essential preventive 
activities in the minds of America's managers and workers--the very 
people who must understand clearly that ergonomics works, that 
ergonomics both protects workers and saves money for employers and 
workers alike.
    actual industrial experience shows that ergonomics programs are 
              technically feasible and are cost-effective
    On June 21, 1995, President Rick Treaster of UNITE Local Union 2400 
from Lewistown, PA, testified before the Senate Committee on Labor and 
Human Resources. About OSHA's intervention at his plant--the Masland 
Co. auto carpet plant in (now owned by the Lear Corp.), which employs 
200 workers. Mr. Treaster described in detail how OSHA's strict 
enforcement of the general duty clause for ergonomic hazards 
accomplished two things: first, it helped both the management and the 
workers focus on real solutions to a serious safety problem. And 
second, it prompted the company and the union to work together on new 
joint efforts to improve wages, quality and productivity. At that 
hearing, the management wrote to Chairman Kassebaum stressing its 
strong support for strict enforcement of OSHA rules.
    Attached to my testimony are the actual numbers of worker injuries 
at the Lewistown, PA plant as of 1995.
    During the OSHA rulemaking hearing on the proposed standard, Rick's 
successor Greg Wakefield testified again about the continuing success 
of the ergonomics program in the plant. Wakefield reported, as was 
confirmed by the management, that serious ergonomically-related 
injuries had been virtually eliminated in the plant due to an 
aggressive comprehensive program which virtually mirrored the core 
elements of the OSHA standard: worker education, early reporting, job 
interventions and when needed intensive job and equipment redesign. 
This resulted in substantially lower costs to the company, which 
accompanied substantial boosts in productivity and quality. The auto 
parts supply industry is highly competitive, and good jobs like these 
in central Pennsylvania are not easy to find. But this management, and 
these workers, have nothing to fear from ergonomics, and everything to 
gain.
    Mr. Chairman, as is revealed in both OSHA's final standard and the 
testimony today of Dr. David Alexander, the OSHA rulemaking record is 
replete with similar examples from large and small companies alike.
    One company--Xerox Corp.--actually submitted a formal cost-benefit 
analyses regarding its ergonomics program (Exh.#30-1963). According to 
Xerox, their total 1999 ergonomics program investment of $3.4 million 
yielded a

    ``. . . resulting benefit . . . of more than a $7 million reduction 
in the annual cost of ergonomic-related workers compensation claims 
from the 1992 peak.''

    In other words, it shows that a corporate ergonomics program is a 
net cost-savings measure when accounting even if one relies solely on 
workers compensation costs. Moreover, such an analysis does not begin 
to take into account the many other ergo-related cost types (such as 
other disability and Human Resource costs, reduced productivity from 
poor job design, limited quality due to bad job engineering, etc.).
    A few other industry groups, such as the textile and apparel 
industry associations, acknowledged that ergonomics programs were cost-
effective and a necessary part of a competitive business strategy in 
today's economy.
    Indeed, whenever anyone has looked seriously at actual industrial 
experience with ergonomic principles and interventions, for those few 
cases of failure or frustration there are many more cases of clear and 
cost-effective success.
    This includes the hundreds of detailed case studies reported 
previously by corporate personnel, OSHA, NIOSH, labor unions and 
ergonomics consultants. Others were performed directly by OSHA's expert 
witnesses, including Dr. Alexander and others. These reports and 
studies were done at the most recognizable names in American industry: 
General Motors, Ford and Chrysler; Compaq Computer Co.; Allied Signal, 
Coca-Cola, Kellogg Foods, Nabisco, Proctor and Gamble, Scott Paper, and 
literally hundreds of other companies large and small.
    Not surprisingly, in its Final Economic Analysis, OSHA specifically 
cited 7 examples from the rulemaking record of well-documented, cost-
effective comprehensive ergonomics programs, including, Dow Chemical, 
Consolidated Edison, US Defense Department, and Levi Strauss, in 
addition to the company-specific programs in both large and small 
businesses provided by three labor unions in the auto, food and apparel 
sectors.
    OSHA also cited in its Final Economic Analysis the large number of 
both scientifically-designed evaluations of ergonomic interventions and 
individual ``case studies'' on specific workplaces or occupations, some 
of which clearly identified the employers in question.
    Some of the same hundreds of companies which were also undoubtedly 
included in the last-minute, biased survey by the Employment Policy 
Foundation (EPF). This so-called claimed to indicate that the annual 
costs to employers would approach $120 billion. Notwithstanding the 
fact that this ridiculous estimate was submitted too late to be subject 
to serious critical evaluation by OSHA or anyone else, it is 
instructive how vastly different are the EPF estimates from those of 
the real-world experiences of America's employers and workers.
    Indeed, what surprised many observers at OSHA's hearing last year 
was the utter absence of significant reports of actual ``bad'' employer 
experience with ergonomics program, especially from the multiple 
companies which had implemented ergonomics programs in the past.
    Unfortunately, with rare exception, it appeared that these 
otherwise well-meaning employers--companies which knew that ergonomics 
works and saves money--were avoiding the OSHA hearing like the plague.
    Where were the representatives from the Big Three auto companies 
who had invested millions of dollars in ergonomics program far beyond 
anything OSHA had required in its ergonomic citations?
    Where were the individual grocery chains who had already spent 
millions on improved checkstands?
    Where were the nursing homes chains which are grappling with 
unsupportable workers compensation costs and turnover rates because of 
the epidemic of disabling back injuries among nurses aides?
    They were all in hiding. We can only assume that they were avoiding 
the prospect of embarrassing or frankly undermining their customers or 
the know-nothing companies in the same industries. It seems they had to 
avoid admitting the truth about their actual investments in ergonomics 
activities, and about the returns they enjoyed on those investments 
through the reduced costs for workers compensation or the improved 
productivity of their operations.
    Those skeptical or pessimistic estimates which OSHA did hear, 
instead, was almost exclusively speculation about possible compliance 
problems. Much of this speculation came from companies which had not 
made serious efforts to prevent ergonomic injuries among their 
employees. And given the campaign of fear which emanated from the 
National Association of Manufacturers and Chamber of Commerce, it is 
not surprising that the uninformed would attack ergonomics programs in 
this way.
    But the testimony of one participant was most revealing. Judging by 
the number of lawyers present at any moment, the United Parcel Service 
was the single most active participant in the entire rulemaking. They 
initially requested an opportunity for over 20 witnesses to appear. 
Most were supposedly independent medical personnel, but several UPS 
managers were included. However, when UPS' turn came, almost all their 
witnesses disappeared, including all participation by their corporate 
managers.
    Only later did OSHA receive--from the Teamsters union--the actual 
evidence of UPS' views on the feasibility of ergonomics programs. 
Attached to my testimony is the March 10, 2000 internal UPS memorandum 
from the Corporate Industrial Engineering Department entitled 
``Ergonomic Endeavors''. This memo clearly identifies substantial 
capital and operating investments which UPS has made to implement an 
ergonomics program throughout the company. It reveals that UPS has 
invested significantly in new trucks, ergonomic tools for drivers, new 
warehouse equipment, new computer software and hardware, new office 
equipment and extensive training of management personnel.
    This is the company which claims there is no science underlying 
ergonomics, but that under the heading ``Comprehensive Self 
Evaluation'' apparently has ``trained over 500 UPS people (including 
some hourly) in ergonomic principles . . .''
    This is the company that claims that ergonomics interventions do 
not prevent lifting-related injuries, but that under the heading 
``Ergonomics Awareness'' had run ``over 20 workshops . . . at 
districts, regions across the country to convey importance of ergonomic 
principles, job set-up and methods, and workplace design. . . .''
    Mr. Chairman, UPS' lawyers attended the OSHA hearing virtually day, 
and never once did they give OSHA any inkling of the extensive nature 
of UPS' activities on ergonomics. Never once did they admit to UPS 
having spent significant corporate resources to established an 
ergonomics program. Never did they offer an actual UPS manager with the 
authority to speak or answer questions about the company's engineering 
investments in labor-saving equipment or the savings which UPS enjoyed 
from that investment.
    It is easy to understand why: because if UPS managers had revealed 
officially the company's activities comparable to the very same 
measures included in the proposed standard, OSHA or someone else might 
have challenged them to say how UPS ever justified that investment. 
What were the costs of the injuries that these investments were 
designed to prevent? How large was the company's savings by the 
avoidance of these costs? And how much more did the company save in 
productivity improvements as a result of these investments?
             $120 billion: a figure virtually from thin air
    Mr. Chairman, those questions linger today even as the Employment 
Policy Foundation's phony $120 billion cost figure continues to 
reverberate around the Congress and throughout the media.
    We completely reject this absurd, trumped-up fabrication. 
Notwithstanding their complaints about OSHA's rush to judgment, EPF and 
their presumptive allies at the NAM and UPS waited until March 2000 to 
begin to collect data about employers' costs of compliance. They did 
not make any of their data available until June 26, well after their 
witnesses appeared at OSHA's actual hearing to answer questions. They 
then reported the summary version of their actual economic estimates on 
August 9, including their reference to their computer modeling which 
generated the infamous $129.5 billion first-year cost figure.
    This estimate purportedly relies on survey data from an unspecific 
number of Fortune 500 companies with about 1.7 million workers in 
nearly 20,000 separate establishments (averaging over 500 
establishments per company).
    However, despite that extensive direct line of communication with 
the largest corporate entities in the entire world, the EPF survey did 
not identify the actual compliance costs for a single specific high-
risk job or operation. Not for a single truck driver, or grocery 
warehouse or retail checkstand, or nursing home, or paint booth, or 
parts assembler.
    Furthermore, their survey itself was not submitted for the record, 
only portions of it dealing with the employers' estimates of time 
allotments. And the actual methodology for the conduct of the survey 
was never revealed--only the summary results.
    (At the same time, they acknowledged that the benefits would be 
significant--albeit less than OSHA estimated in the proposed rule. But 
they failed utterly to provide any accounting of the derivation of the 
benefits, nor to report the experiences of individual employers 
regarding the returns on ergonomic investments which such employers 
have enjoyed.)
    We may contrast this with the extensive and detailed examination 
which OSHA gave to specific industry sectors in both the proposed and 
final standards, as required by the OSH Act and the Regulatory 
Flexibility Act. OSHA made multiple analyses to confirm the legitimacy 
of its approach. OSHA ultimately derived a cost-estimate which began 
with job-specific estimates covering nearly half the reported MSD's in 
the entire economy. In addition, OSHA dealt specifically in the final 
standard with the criticisms of its opponents, including UPS and EPF, 
regarding OSHA's cost estimates for individual jobs or operations.
    All of this analysis would be reviewable by the Court of Appeals. 
As in the past, OSHA's opponents would have detailed opportunities to 
challenge OSHA's methods and conclusions, and request a stay of the 
proceedings if needed.
    But OSHA's opponents had no sincere interest in legitimate analysis 
or discussion. Their only interest, it is now evident, was to quash any 
real evaluation of the facts about workplace injury or effective job 
safety investments, and destroy OSHA's ability to ever regulate these 
hazards.
           history of industry misrepresentations about costs
    But this is by no means the first time that an industry coalition 
or trade association has sought to undermine the basic functioning of 
the Occupational Safety and Health Act by vastly overestimating the 
potential technological or economic problems of compliance with a 
proposed OSHA standard. Virtually every time that OSHA has proposed to 
substantially improve worker, the affected industries have cried wolf 
about the supposed costs, and threatened to close up shop. And time 
after time, the actual costs have been within OSHA's estimate--or 
indeed far less.
    In 1995, the Congressional Office of Technology Assessment reviewed 
this sordid history of industry obstructionism, and tried to identify 
the actual costs. OTA, no captive of the labor unions or environmental 
activists, concluded, among other things:
    1. The agency's findings and estimates on hazard control options 
and regulatory impacts are often the subject of vigorous review and 
challenge by stakeholders and various experts on all sides of 
rulemaking issues. But this reaction does not generally indicate 
underlying agency analytical neglect. The agency's rulemakings are 
often lightning rods for controversy and are conducted in a politically 
polarized setting.
    2. The agency's findings and estimates on hazard has generally 
performed this task with workable accuracy--that is, standards 
determined by OSHA to be ``feasible'' in the course of its analytical 
deliberations have usually proved to be so when industries took the 
necessary steps to comply. Nonetheless, the agency's demonstrations of 
feasibility are often based on conservative assumptions about what 
compliance responses will predominate across affected industries. As a 
result, there are often sizable disparities between OSHA's rulemaking 
projections of control technology adoption patterns, compliance 
spending, and other economic impacts, and what actually happens when 
affected industries respond to an enacted standard. In a good number of 
the cases that OTA examined, the actual compliance response that was 
observed included advanced or innovative control measures that had not 
been emphasized in the rulemaking analyses, and the actual cost burden 
proved to be considerably less than what OSHA had estimated.
    3. . . . OSHA's rulemakings are not generally imposing unworkable 
compliance burden on industry. In six of the eight cases considered 
industry stakeholders and their representatives argued in the course of 
the rulemaking (modestly to vigorously, depending on the case) that 
compliance would pose unworkable problems. . . .
    For the most part, the post-promulgation reality observed in this 
project's case study standards proved much the opposite of these 
representations. [footnote omitted] In almost all these cases . . ., 
the industries that were most affected achieved compliance 
straightforwardly, and largely avoided the destructive economic effects 
invoked by their rulemaking arguments. Very few companies left the 
industry chiefly because of the new compliance requirements. And, in a 
good many of the cases, the actual cost burden of compliance proved 
considerably less than OSHA's final estimate--about one-quarter the 
estimate in Vinyl Chloride, one-third in Cotton Dust, and one-half in 
Formaldehyde (metal foundries). Furthermore, in half of the eight cases 
examined, the standard stimulated changes in the production technology 
of affected industries that yielded benefits beyond a means for health 
and safety hazard compliance.
    In Vinyl Chloride, several of the principal industry members 
capitalized on the altered business and regulatory setting to 
commercialize innovative processes for polyvinyl chloride 
polymerization, which enhanced manufacturing productivity, better 
rationalization of material inputs, largely eliminated the need for 
manual reactor cleaning (a prime source of high exposures for the 
workforce), and provided a new source of income to the technology's 
developers through licensing arrangements.
    In Cotton Dust, OSHA's mandate for greater dust control, combined 
with a strong need for more competitive production capacity, drove much 
of the textile industry to accelerate investments in modern production 
equipment--this modernization yielded improvements in manufacturing 
productivity and product quality while providing a more cost-effective 
means to bring dust levels within the terms of compliance.
    Other aspects of this persistent problem are described in the 
attached analysis of the OTA report from the New York Times.
    We have witnessed this year probably the most catastrophic example 
of this unscrupulous behavior. It remains up to the Congress heed the 
conclusions of the Office of Technology Assessment, and to set the 
record straight: OSHA's work has benefited the American people, and 
deserves our support even in the face of an hysterical political 
juggernaut like that opposed to the ergonomics standard. To do 
otherwise is to tell America's workers that they are simply expendable.
                            cost of injuries
    American workers are currently paying the price for these injuries, 
and the costs to them, their employers and society are immense. The 
recent review by the National Academy of Sciences concluded that the 
total bill to the U.S. economy for Workers Compensation and other 
medical/disability costs, and for lost productivity, amounts to between 
$45 and $54 billion annually, or about 1 percent of our Gross Domestic 
Product. This is an immense sum.
    The Liberty Mutual company, the nation's largest workers 
compensation insurance carrier, has repeatedly called attention to the 
high costs of back injuries and other disabilities related to ergonomic 
hazards. Their data on disability costs figured prominently in OSHA's 
estimate that each disabling injury prevented by a reasonable 
ergonomics program would yield injury-related cost savings averaging 
$22,000.
    Who is paying these costs now? Billions of dollars of these costs 
are now paid by employers. Many of these employers should know better--
and invest in the simple equipment to prevent injuries. But they 
unfortunately are not willing to make even these small investments for 
worker safety and require an OSHA standard to simply get their 
attention.
    Other costs--often great than employers pay--are paid by workers 
and their families. The daily pain and agony of back pain or carpal 
tunnel syndrome. The inability to pick up a child or a frying pan. The 
depression from severe disability and the fear of family economic 
survival.
    Other costs are paid by the taxpayer, as workers tossed overboard 
are washed ashore as recipients of Social Security Disability benefits 
and Medicaid.
    In addition there are substantial benefits to employer from 
ergonomic investments that improve productivity. Whether it is a simple 
shelf or conveyor in a warehouse, or redesigning an entire assembly 
line to reduce lifting of parts and tools, the improvements in 
productivity which OSHA identified during the rulemaking hearing are 
common, sensible and often quite impressive.
                               conclusion
    These costs--and benefits--are immense. They are the very reasons 
that the Congress passed the OSHAct in the first place.
    The benefits are achievable, and are exactly what's needed to 
preserve real jobs for working families in a period when so many 
working families are left behind.
    We urge the Congress to immediately restore OSHA's authority to 
adopt an Ergonomics Program Standard, and to compel OSHA to issue such 
a standard with all deliberate speed.

  UNION OF NEEDLE TRADES INDUSTRIAL AND TEXTILE EMPLOYEES, DISABLING WORKER INJURIES AND ILLNESSES, 1987-1994,
                          LEAR CORP. (FORMERLY MASLAND INDUSTRIES INC.), LEWISTOWN, PA
----------------------------------------------------------------------------------------------------------------
                                                                      Injuries           Repetitive motion cases
                                                             ---------------------------------------------------
                                                                 Number     Lost days      Number     Lost days
----------------------------------------------------------------------------------------------------------------
Pre-OSHA inspection:
    1987....................................................           76          460           37          462
    1988....................................................          110          955           31          608
    1989....................................................           49          887           35          527
Post-OSHA:
    1990....................................................           48          473           17          324
    1991....................................................           21           33           15          206
    1992....................................................           20          202            9            1
    1993....................................................           29          209            9          188
    1994....................................................           29           64           19           75
----------------------------------------------------------------------------------------------------------------


    Senator Specter. Thank you. Mr. Doug Bonacum, director of 
Patient Safety, Kaiser Permanente.
STATEMENT OF DOUG BONACUM, DIRECTOR, PATIENT SAFETY, 
            KAISER PERMANENTE
    Mr. Bonacum. Thank you for the opportunity to testify here 
today. I am the director of Patient Safety and Environmental 
Safety for Kaiser Permanente, the largest private nonprofit 
provider of health care services in the United States, with 
approximately 8.2 million members in 9 States and the District 
of Columbia.
    Our mission is to provide high quality health care services 
to improve the health status of our members in the communities 
we serve. In support of this mission, the organization strives 
to provide a safe, healthy and supportive work environment for 
our employees, our physicians and our members. We believe an 
important component of this objective is to identify, evaluate 
and mitigate ergonomic risk factors that challenge our work 
force.
    I am here today to discuss strategies for minimizing and 
preventing work injuries and illnesses related to risks 
associated with musculoskeletal disorder and will highlight one 
particular ergonomics-based application of this approach at 
Kaiser Permanente. Kaiser Permanente's occupational injure and 
illness reduction strategy is based upon a multifaceted 
approach that begins far upstream of worker injury illness and 
ends with the safe and efficient return to work program.
    Our focus is on engineering controls, safe work practices 
and injury response and recovery in that order while our 
current OSHA recordable case rate is about average for our 
industry, we are confident that the program elements we have 
put in place will measurably improve our safety record.
    We are initially focusing our energies in two primary 
areas, housekeeping and patient handling. For injuries 
occurring during 2000 alone this constituted approximately 30 
percent of our workers compensation cases and costs. The 
majority of injuries in both areas result from overexertion.
    As our nursing work force is aging with the demand for new 
nurses exceeding the current supply, our inpatient population 
is becoming sicker and often heavier. As a result, we are 
particularly concerned about the back safety of our nursing 
staff. For this reason we have begun implementing an aggressive 
back safety program, targeted patient handling, that is now in 
its second year of a 2 year project to demonstrate the efficacy 
of patient handling equipment, training and monitoring in 
significantly reducing back injuries to our patient care staff.
    There are, of course, numerous reasons for lifting and 
transferring patients in the course of care. For example, 
ambulating a patient after surgery may be a significant part of 
the healing and recovery process or lifting a wheelchair 
dependent patient to an exam table provides the caregiver with 
an appropriate opportunity to facilitate a more through and 
complete physical examination. Without the right equipment, 
training and patient--without the right equipment and training, 
patient repositioning, lifting and transfer tasks that seem to 
go without hitch on TV can result in musculoskeletal strains 
resulting in painful, life-changing injuries to our precious 
work force.
    With 27 of our 29 owned and operated hospitals located in 
the State of California, we are currently focusing our patient 
handling ergonomic interventions there first. At the core of 
this program is patient handling equipment.
    The patient handling equipment we have selected includes 
vertical lifts, pivot transfer aids, special patient chairs and 
lateral transfer devices. The selection process was performed 
with input and hands on evaluation from employee user groups, 
expert advice from consultants and discussions with other 
health care organizations using similar equipment.
    There are three primary methods for utilizing the patient 
handling equipment with the most preferred option being full 
time staff dedicated to the use of the equipment and associated 
tasks. The dedicated patient handling lift team is recruited, 
trained and assigned accountability for identified high-risk 
tasks. On average, there may be two patient lift teams per 250 
hospital beds. They generally conduct lifts in pairs and 
depending upon the hospital's accident experience and 
resources, may be staffed during one shift or around the clock.
    Prior to joining Kaiser Permanente the individual leading 
our program implemented a patient handling lift team in another 
health system in California and achieved a reduction of back 
injuries of over 80 percent during a 3 year period. We are 
looking to do the same.
    Employee participation has taken place on all back safety 
interventions and many are sponsored by local management 
partnership committees that typically include employee 
representation. Kaiser Permanente's labor management 
partnership is about engaging our work force from problem 
solving through strategic planning in order to attain our 
mission of providing high quality care to our members. In 
short, worker safety is part and parcel to our partnership.
    While the primary focus of our early efforts on back safety 
have been on the worker, we recognize there are linkages to and 
synergies with other critical performance areas including 
patient safety, facilitating adequate path for our members with 
disabilities and compliance with state OSHA requirements.

                           prepared statement

    In other words, we feel the appropriate application of 
ergonomic interventions at Kaiser Permanente will have far-
reaching, positive impact well beyond our primary goal of 
ensuring worker safety. For Kaiser Permanente, a healthy work 
force operating in a safe workplace is part of our commitment 
to providing high quality affordable care. Thank you.
    [The statement follows:]
                   Prepared Statement of Doug Bonacum
    Chairman Specter and Committee Members: Thank you for the 
opportunity to testify here today on the very important issue of 
ergonomics. I am Doug Bonacum, the National Director of Patient Safety 
and Environmental Health and Safety for Kaiser Permanente in Oakland, 
California. I would like to take a few minutes to discuss some of the 
efforts Kaiser Permanente is undertaking to improve ergonomics in our 
workplaces.
                           kaiser permanente
    The Kaiser Permanente Medical Care Program is a predominantly 
prepaid, group practice health maintenance organization that is 
committed to providing excellence in both quality of care and quality 
of service. In each region in which it operates, Kaiser Permanente is 
composed of three closely cooperating organizations: Kaiser Foundation 
Health Plan, Inc., a California nonprofit corporation that is a 
federally qualified HMO; or one of its regional health plan 
subsidiaries; Kaiser Foundation Hospitals, a California public benefit 
corporation, which provides or arranges for hospital services to our 
members; and the Permanente Medical Groups, which are multi-specialty 
physician group practices organized as partnerships or professional 
corporations and which provide or arrange for all medical services our 
members require.
    Founded in 1945, Kaiser Permanente is the largest private, non-
profit provider of health care services in the United States, with 
approximately 8.2 million members in 9 states and the District of 
Columbia. We operate 29 acute care medical centers and 423 medical 
offices in which we employ approximately 90,000 people. More than 
11,000 physicians practice within the Permanente Medical Groups.
    The mission of Kaiser Permanente is to provide affordable, high 
quality health care services to improve the health status of our 
members and the communities we serve. In support of this mission, the 
organization strives to provide a safe, healthy, and supportive work 
environment for our employees, physicians, and members. We believe an 
important component of this objective is to identify, evaluate, and 
mitigate ergonomic risk factors that challenge our workforce.
        addressing ergonomic issues in the health care workplace
    While significant media attention has more recently been focused on 
patient safety, the healthcare industry is not without its fair share 
of worker health and safety risks as well. These include potential 
exposures to bloodborne pathogens and infectious diseases, high-level 
disinfectants, sterilants, anesthetic gases, and laboratory chemicals, 
and occupational injury and illness from such activities as patient 
lifting and transport. I am here today to discuss strategies for 
minimizing and preventing worker injuries and illnesses related to 
risks associated with musculoskeletal disorders, and will highlight one 
particular ergonomics-based application of this approach at Kaiser 
Permanente.
    For the purposes of this discussion, ergonomics means the practice 
of adapting the physical environment and implementing safe work 
practices consistent with a human being's capabilities and limitations, 
resulting in optimal individual health and productivity. While the 
overall goal of an ergonomics program should be to ultimately eliminate 
occupational injuries and illnesses caused by ergonomic stressors, our 
guiding principles include trying to put the least amount of stress on 
the body's framework, requiring the least amount of physical work by 
tissues and joints to maintain safe postures and positions while 
providing high quality care. We look to minimize or prevent the 
cumulative application of biomechanical stress to tissues and joints by 
identifying and controlling the following risks: (a) The frequency of 
specific physical motion or exertion known or believed to potentially 
cause harm, (b) The force or physical exertion /pressure applied to 
vulnerable parts of the body during specific motions, and (c) The 
duration or length of period in which an activity occurs that leads to 
the risk of an ergonomic injury.
    Kaiser Permanente's occupational injury and illness reduction 
strategy is based upon a multi-faceted approach that begins far 
upstream of worker injury or illness, and ends, in the event of an 
injury or illness despite best efforts to avoid it, with a safe and 
efficient return-to-work program. It is based on a safety hierarchy 
that addresses risk in the following fashion: (1) Eliminate, (2) 
Mitigate, (3) Administrate, (4) Educate, and when necessary, (5) 
Remediate. In other words, the focus is on engineering controls, safe 
work practices, and injury response and recovery, in that order. While 
our current OSHA Recordable Case Rate is about average for our 
industry, we are confident that the program elements we have put in 
place will measurably improve our safety record. These elements 
include:
    (1) Mandatory design and construction standards for casework, 
furnishings, and the work environment, as well as mandatory purchasing 
requirements for ergonomic accessories. Multi-functional teams develop 
these standards with representatives for our physicians, nursing staff, 
other caregivers, and administrators. Because Kaiser Permanente is an 
Integrated Delivery System, we can ensure that each of our newly 
constructed or renovated facilities is designed with adherence to our 
internal standards, and products and materials are purchased from 
contracts that include ergonomically correct equipment.
    (2) Training and education efforts that include new employee 
orientation, an on-line refresher course addressing basic ergonomic 
principles and procedures, and task or job specific training for high 
risk areas (e.g., patient handling).
    (3) The application of on-the-job hazard recognition and control 
principles principally applied to patient handling and housekeeping 
operations, as well as repetitive laboratory and back-office 
procedures.
    (4) An active medical management program that has been instrumental 
in getting injured employees back to the workforce in a safe and 
efficient manner.
    (5) Performance monitoring and internal reporting systems based 
upon workers' compensation case rates, as well as program evaluation to 
assess and report compliance with internal standards, best management 
practices, and various State regulations.
    We are initially focusing our energies in two primary areas: 
Housekeeping and Patient Handling. For injuries occurring during 2000, 
these two areas alone constituted approximately 30 percent of our 
workers' compensation cases and costs. The majority of injuries in both 
areas result from overexertion. As our nursing workforce is aging, with 
the demand for new nurses exceeding the current supply, our in-patient 
population is becoming sicker and often heavier. As a result, we are 
particularly concerned about the back safety of our nursing staff. For 
this reason, we have begun implementing an aggressive back safety 
program targeted at patient handling.
    We are currently in the second year of a two-year project to 
demonstrate the efficacy of patient handling equipment, training, and 
monitoring in significantly reducing back injuries to our patient care 
staff. We have benchmarked with other healthcare organizations and 
partnered with a recognized industry expert in formulating our approach 
and expect to achieve significant reductions of back injuries in 
targeted areas well in excess of 50 percent.
    Anyone who watches one or more of the popular television hospital 
dramas will often see a team of people manually, and seemingly, 
comfortably transferring a patient from gurney to bed or bed to 
wheelchair, for example. These types of lifts or transfers occur 
repeatedly in the course of diagnosis, treatment, and recovery, both in 
the hospital environment, and across the continuum of care. 
Unfortunately, patient handling is seldom comfortable and often done 
without the aid of a large team of people. This has resulted in 
significant back issues for nursing workforces.
    There are numerous reasons for lifting and transferring patients in 
the course of care. For example, ambulating a patient after surgery may 
be a significant part of the healing and recovery process; transferring 
a patient from gurney to procedure, exam or radiology table may be 
required to ensure the patient receives the appropriate examination or 
follow-up care; and aiding patients in unexpected situations such as 
assisting a patient who has fallen to the floor. Lifting a temporarily 
disabled or disabled wheelchair-dependent patient from a wheelchair to 
an exam table provides the caregiver with an opportunity to facilitate 
a more thorough and complete physical examination. Without appropriate 
equipment, training, and feedback, these patient repositioning, lifting 
and transfer tasks that go without hitch on TV, can result in 
musculoskeletal strains, resulting in painful, life changing injuries 
to the workforce.
    With 27 of our 29 owned and operated hospitals located in the State 
of California, we are focusing our patient handling ergonomic 
interventions here first. We are piloting an approach which provides 
flexibility in individual hospital implementation, but, at its core, 
consists of the following four main elements:
  --The identification, selection, and implementation of lift equipment 
        to take strain off the backs and shoulders of our workforce and 
        place it instead on the mechanical arms of engineering 
        controls.
  --Development of expected practices and protocols for utilizing the 
        equipment and lifting patients.
  --Training and education for the affected work force on basic 
        ergonomic principles, the mechanics of safe lifting, 
        utilization of the equipment, and the application of safe work-
        practices.
  --Program monitoring, modification, and back-injury reduction 
        tracking and reporting.
    The patient handling equipment we have selected includes vertical 
lifts, pivot transfer aids, special patient chairs, and lateral 
transfer devices. The selection process was performed with input and 
hands-on evaluation from employee user groups, expert advice from 
consultants, and discussions with other healthcare organizations using 
similar equipment. The patient care team develops consensus on the 
application and utilization of the lift equipment including who will 
use the equipment, how to use it, and when it will be used.
    There are three primary methods for utilizing the patient handling 
equipment, including: (1) Training current staff how and when to use 
the equipment, (2) Designating select staff members to use the 
equipment as patient handling specialists, or (3) Hiring full time 
staff dedicated to the use of the patient handling equipment and 
associated tasks (preferred strategy). The dedicated staff patient 
handling ``lift-team'' is recruited, trained, and assigned 
accountability for identified high-risk tasks. On average, there may be 
2 patient lift team members per 250 hospital beds for any eight hours 
of hospital coverage. They generally conduct lifts in pairs, and, 
depending upon the hospital's accident experience and resources, may be 
staffed during one shift or around-the-clock. Prior to joining Kaiser 
Permanente, the individual leading our program implemented a patient 
handling lift-team in another health system in California and achieved 
a reduction of back injuries of over 80 percent during a 3 year period. 
We are looking to do the same at Kaiser Permanente. The initial 
estimated cost for purchasing the lift equipment averages approximately 
$100,000 per center. At an estimated average cost of $20,000 per back 
injury, even the strictly financial return on investment from the 
appropriate selection and implementation of lift equipment can be as 
short as one year.
    To date, we have fully implemented patient handling projects in 9 
medical centers, three of which are piloting the lift team 
intervention, and we are on track to have full implementation in the 
remaining medical centers by year-end. We will monitor the Program's 
success through quarterly workers' compensation case rate reports, as 
well as using an internal audit program to ensure compliance with 
relevant Kaiser Permanente Standards and Federal and State regulatory 
requirements.
    Employee participation has taken place on all back-safety 
interventions and many are sponsored by local Labor-Management 
Partnership committees or Local Safety Committees that typically 
include employee representation. Kaiser Permanente's Labor Management 
Partnership is about engaging our workforce, from problem solving 
through strategic planning, in order to attain our mission of providing 
high quality care to our members. The objective of the Partnership is 
to create a culture of consultation within the organization, in which 
labor and management routinely collaborate to address issues of 
operations, the quality of patient care, and the quality of work life 
at Kaiser Permanente. In short, worker safety is part and parcel to our 
Partnership.
    While the primary focus of our early efforts on back safety have 
been on the worker, we recognize there are linkages to and synergies 
with other critical performance areas including Patient Safety, 
facilitating adequate care for our members with disabilities, and 
complying with California OSHA requirements for reducing occupational 
injuries and illnesses. An example of the Patient Safety connection is 
recognition that a member who is routinely and safely ambulated after 
surgery has potentially less chance of falling, acquiring bed sores, 
contracting a respiratory illness, or suffering an increased hospital 
length of stay due to slower than expected recovery. The linkage to 
providing appropriate care for our disabled community is as simple as 
ensuring that a wheel chair bound patient can be safely transferred 
from their wheel chair to an exam table for a complete and thorough 
examination. In other words, we feel the appropriate application of 
ergonomic interventions at Kaiser Permanente will have far reaching, 
positive impact well beyond our primary goal of ensuring worker safety. 
In short, a healthy workforce, operating in a safe workplace is part of 
our commitment to provide easier access and delivering high quality, 
affordable care.
    Thank you for your time. I would be happy to answer any questions 
you may have.

    Senator Specter. Thank you, Mr. Bonacum. I had hoped that 
Secretary Chao will stay for the entire hearing. She was unable 
to do that. I know she has representatives here and I think 
that there have been some illustrations here where employers 
and employees have come very close and I am impressed with what 
you said, Mr. Bonacum, as to what Kaiser Permanente has done. 
And the testimony of the auto industry is also a model where 
they are getting pretty close. And I think what Mr. Sparlin 
said about the OSHA bureaucratic response is understandable 
too. May not be so much the regulations, but the way OSHA 
enforces them or interprets them which really requires a lot 
more supervision so that you get to the important spots but you 
do not create a climate where there's so much resistance 
because of excesses.
    So Mr. Fruman's testimony I think is important in 
identifying companies which have gone along a way and I'd be 
interested to find out why some of those companies didn't come 
in to testify.
    I have a lot of questions but it is now past noon and we 
have another panel, so I am going to thank you all very much.
    Mr. Sparlin. Mr. Chairman, before we adjourn it is 
unfortunate that this forum was used as a means to impugn this 
particular company, UPS, but may I be afforded an opportunity 
to briefly respond.
    Senator Specter. Sure. I do not know that we've impugned 
them, but go ahead.
    Mr. Sparlin. Well, there was an accusation about UPS and--
--
    Senator Specter. Well, it was said they didn't come in to 
testify.
    Mr. Sparlin. Well, it was said that they--I believe it was 
a little stronger, but the record will speak for itself.
    Senator Specter. That is okay, if you want to reply, go 
ahead.
    Mr. Sparlin. Yes. UPS has never made a secret from anyone 
that it is engaged in ergonomic programs and having a great 
deal of success. But what Mr. Frumin and many others seem to 
fail to appreciate is that any time you use the E word, it 
doesn't necessarily mean the same thing.
    UPS does not vigorously oppose an ergonomic standard simply 
because it likes to pay lawyers to engage in a big battle. It 
is opposing the ergonomic standard because it does not believe, 
and I believe your observations are very much on point, that 
the direction that OSHA is taking is a proper one and moreover, 
it is very concerned that this is not frankly something that 
can be articulated. I mean, you've articulated the goals as to 
what we might want to accomplish.
    But frankly you have two paradigms. One is the proposed 
standard where OSHA basically went to employers and said if you 
find a problem, go forth and fix it and they didn't give much 
guidance. And so employers didn't know what to do. So they 
complained about that and OSHA gave us a final standard which 
they didn't give us a right to comment on which gave eight 
specific hazard identification tools.
    Senator Specter. They did not give you a right to comment--
--
    Mr. Sparlin. On the final standard, that is correct. And 
the problem there was those particular tools lacked scientific 
support, were inconsistent with one another, and frankly did 
not achieve the goal of backing away from the excesses that we 
believe are apparent here. So that is the problem we're faced 
with and frankly, it is a very difficult challenge but from the 
economic perspective what we need to do is get away from just 
the notion of coming up with anecdotes and, you know, anything 
that we can label ergonomic we make claims about it and we put 
a price tag on and even as we change the standard we do not 
change the price tag. We have got to be very specific about 
what it is we are expecting from employers, what we expect to 
gain from it, what we expect it to cost, be honest about doing 
the calculations and do them very carefully and with hard data 
support.
    Senator Specter. Well, Mr. Sparlin, you made some valid 
points. It may be that the input from a lot of companies which 
have had success will be very helpful in formulating a standard 
and then it may be that the application and supervision of the 
standard really ought to have representatives of all sides, 
business and labor, so that you do not have just OSHA doing it. 
Too often, and this is not a reflection on the Federal work 
force, the agencies become excessive in their application. 
Happens all the time. Lots of lawsuits go up on the 
administrative process. Maybe we need some umpires from 
business, from labor, to take a look at it and try to put some 
balance in the implementation of the regulations.
    Mr. Frumin, I see you moving forward in your chair. Having 
had a reply to you, would you like a surrebuttal?
    Mr. Frumin. I would appreciate the opportunity, Senator.
    Senator Specter. Go ahead.
    Mr. Frumin. Mr. Sparlin's comments regarding a good faith 
effort by UPS flies in the face of their lack of participation 
in any constructive form in this process. We did not, OSHA did 
not, receive the benefit of UPS's detailed cost analysis of 
their own ergonomics program during the rulemaking hearing or 
during the years and years and years of earlier discussions, 
debates, stakeholder meetings, committee meetings, et cetera, 
et cetera.
    What are the actual costs of the employers who have 
implemented ergonomics programs? OSHA begged industry and their 
representatives to provide that information repeatedly since 
1991 and companies like UPS and others preferred to sit on the 
sidelines, withhold their real world information and shoot at 
OSHA for doing the wrong thing. Other companies which had spent 
the money, most of them unfortunately did not provide that 
information.
    Senator Specter. Mr. Frumin, the subcommittees will make an 
inquiry on the UPS, what you've suggested. If you have other 
companies, let me know.
    Mr. Frumin. Well, we invite you to come to Lewistown and 
meet one.
    Senator Specter. Okay, I go to Lewistown with some 
frequency. I'll do my best to stop in.
    We're moving now to panel five. It says Mr. Fellner again. 
It couldn't be true that it is Mr. Fellner again, could it?
    Mr. Sparlin, we have Ms. Seminario again and Jacquelin 
Nowell and Jerry Wood. Ms. Nowell, let's begin with you, if we 
may.
STATEMENT OF JACQUELINE NOWELL, DIRECTOR, SAFETY AND 
            HEALTH, UNITED FOOD AND COMMERCIAL WORKERS 
            INTERNATIONAL UNION
    Ms. Nowell. Thank you very much.
    Senator Specter. Director of Safety and Health, United Food 
and Commercial Workers International Union.
    Ms. Nowell. Thank you Mr. Chairman. United Food and 
Commercial Workers represents 1.4 million workers in the United 
States and Canada, primarily in the retail trades and food 
processing industries.
    The UFCW strongly supported the repealed OSHA ergonomic 
standard because it contained the basic core elements that we 
helped develop with our companies over the last 10 years, 12 
years, the same elements that OSHA saw was working in 
companies, those of medical management, job analysis and 
control, worker involvement, training and surveillance. We had 
hoped that a standard would get this beyond just our industries 
and the industries that other panelists have talked about where 
this is working so that all workers would be protected.
    We have been involved in this issue for 20 years. We know 
that controlling exposure to ergonomic hazards worked. We've 
seen it happen. Our members were being hurt in record numbers. 
Ergonomics really was the answer.
    I want to raise a couple of issues, one is the issue of 
guidelines. I brought with me a copy of the red meat guidelines 
that Secretary Chao has referred to in her submitted testimony.
    Contrary to her testimony, these must be taken in context. 
These came out in 1990 right in the middle of intense 
enforcement activity by the agency in this industry. There were 
record numbers of injuries in here, rampant medical 
mismanagement of workers. There was major enforcement activity, 
very high fines for lack of record keeping, for example, for 
not treating workers medically.
    In that context, these guidelines were developed and they 
were developed in the context of OSHA moving forward on a 
standard. They would not work in a vacuum. They only were 
successful because they were part of that whole picture, so 
that needs to be in this record. We have participated in these 
types of programs over the years, including the corporate-wide 
settlement agreements that came out of this massive enforcement 
effort that was done in the meat packing industry.
    Let me get at a few of the statistics which are very real, 
not only from the Bureau of Labor Statistics but from the 
industries themselves. The Bureau of Labor Statistics, if you 
look at their statistics from 1991 to 1996 there was a 38 
percent reduction in the rate of MSDs, right at the heart of 
again, enforcement, the red meat guidelines and a push for a 
standard from the agency and the department itself.
    The AMI itself testified during the hearings that there was 
in 10 years since the enforcement and guidelines reduced levels 
of injuries and illnesses by a third and half of the lost time 
injuries had been reduced.
    The Food Marketing Institute, one of the trade groups that 
was foremost in trying to trash this whole process of a 
standard states that there was a 30--there has been a 33 
percent reduction in the number of injuries and illnesses 
caused by ergonomic hazards in the course of their work trying 
to reduce them.
    One meat packing plant reports a 75 percent reduction in 
turnover and having recouped all of their investment, economic 
investment over a 2-year period of first putting in this 
program. Another over 10 years reports a 78 percent reduction 
in MSDs.

                           prepared statement

    I want to speak to the injuries themselves. Senator Harkins 
spoke of Gloria Boyd this morning. Not only was she injured on 
the job but when she had to move off a job that the company 
refused to fix, so that all workers could work it, she lost 
about $100 a week. That is not only a physical injury but a 
financial injury to these workers. Workers need protection 
programs that--programs work but only in the context of 
enforcement. We must have a standard for all workers. Thank 
you.
    [The statement follows:]
                Prepared Statement of Jacqueline Nowell
    Good morning, my name is Jacqueline Nowell and I'm the Director of 
the Occupational Safety and Health Office, the United Food and 
Commercial Workers International Union, UFCW.
    The UFCW is the largest private sector union in North America, 
representing 1.4 million workers in the retail food, warehousing, 
healthcare, garment and textile, footwear and chemical industries. We 
are the largest organization of food processing workers in the United 
States. We put breakfast, lunch and dinner on the table for America's 
families. To feed America's families, thousands of food processing 
workers are needlessly crippled and maimed each year. Meatpacking and 
poultry processing have some of the highest incidences of repetitive 
motion injuries in the country.
    The UFCW strongly supported OSHA's ergonomics program standard. We 
have been actively involved in this issue for nearly 20 years, since 
the early 1980s. Our members were being hurt in record numbers. We 
began by educating them about the problems of musculoskeletal 
disorders, MSDs, and the lack of programs and fixes for them in our 
industries. We filed OSHA complaints in the meatpacking, poultry and 
cat fish industries. We pressed Labor Secretary Elizabeth Dole for a 
standard to address the workplace hazards causing MSDs. We worked 
closely with the Department of Labor and Secretary Dole in developing 
the Red Meat Guidelines, issued in 1990. In 1991, the UFCW, AFL-CIO and 
29 other unions petitioned OSHA for an Emergency Temporary Standard. In 
1992, under Secretary Lynn Martin, the Department of Labor agreed with 
the unions that available information supported initiation of Section 
6(b)(5) rulemaking under the OSH Act to address ergonomic hazards. The 
OSHA ergonomics standard was 10 years in the making, begun by a 
Republican administration, and long overdue. This standard that was 
designed to prevent crippling MSDs, the nation's number one job safety 
problem, was debated in the Senate for 10 hours, while the House gave 
the issue one hour of consideration. It was finally killed when the 
President signed the repeal on March 20, 2001, two months after it had 
gone into effect.
    My testimony today will focus on why a standard is needed, through 
worker stories and successful ergonomics programs in our industries. I 
would be remiss, however, if I did not take this opportunity to let you 
know how disappointed our members were with the elimination of the 
ergonomic standard. By using the Congressional Review Act, a previously 
unused and untested legislative tool, the ergonomic standard was 
obliterated. Workers now feel, with some justification, that the 
Federal government has turned it's back on their ergonomic injuries. I 
would like to submit for the record a copy of a letter that was sent by 
our International President, Doug Dority, to Members who killed the 
worker safety standard. At the same time, we feel nothing but gratitude 
to those who stood up when workers needed it most.
    MSDs are real injuries--they often lead to disability and can have 
a lifetime affect on workers lives. Caroline Shebora is a cashier in a 
grocery store in Alexandria, Virginia. She's had bilateral carpal 
tunnel surgeries and is fearful that it's coming back. Her company 
fought her worker's compensation claim for over 1\1/2\ years, and she 
feels devastated by that after working for this one company for 27 
years. Jan Garrett works in a poultry plant in Kentucky, where she 
worked salvage, until she started having problems with her hands. She's 
also had bilateral carpal tunnel surgeries. Her job, at a line speed of 
140 birds per minute, was to cut off broken wings, broken legs, cut 
skin off that had gall stains, cut tail gland if the machine missed it, 
anything USDA sent down because they knew Jan would wash, cut, trim and 
vacuum trying to salvage any of the bird at all. Her life has been 
completely changed, both at work and home. She can't hang out her 
laundry, can't clean her house, especially using cleaners that come in 
spray bottles. Her family bought their first home last summer and her 
husband and sister had to clean it. To this day, she still hasn't been 
able to wash the windows. She is afraid, now that she's back on a knife 
job at the plant, that she won't be able to keep up, and the plant will 
tell her they have no work for her. Gloria Boyd has worked at the IBP 
pork processing plant in Waterloo, Iowa for nine years. She was 
diagnosed with carpal tunnel syndrome as a result of the job she did, 
cutting bone from picnic hams. She couldn't do anything, couldn't 
especially grip a knife. She was off the job, on light duty for six 
months. Getting injured was a real financial as well as physical 
hardship. She lost her incentive, her pay was reduced $100 a week. She 
was never able to go back to the higher paying knife job, because every 
time she tried, the CTS would come back.
    The UFCW has many ergonomics programs with full union participation 
in our represented industries that are working to reduce MSDs. Many 
industries we represent have recognized the problem for more than 15 
years, and have developed ergonomics programs. These include meat, cat 
fish, retail and boot and shoe. One meatpacking company reduced its 
worker's compensation costs by nearly 60 percent, reduced turnover by 
75 percent and recouped all of their investment in the first two years 
of the program. In the first two years of the program, the number of 
diagnosed cases of MSDs was halved and the number of surgeries in the 
plant fell by 40 percent. Another collectively-bargained ergonomics 
program in meatpacking has a worker doing most of the ergonomic changes 
in the plant. That plant has reduced the number of MSD cases in the 10 
years of the program by over 78 percent! In a boot and shoe plant, MSD 
cases were reduced by 70 percent in two high-hazard departments after 
the company began an ergonomics program. The standard was programmatic 
rather than specification-based, meaning it was a flexible set of 
requirements that business would have been able to adapt to its 
establishments. And it was based on the experience of companies like 
our, ones that have developed and implemented successful ergonomic 
programs.
    The retail industries have recognized the problem of poor ergonomic 
design for years. One chain, Stop and Shop Supermarket Company, has a 
joint program with the UFCW that addresses the high hazard areas of the 
stores and provides training for the Safety and Ergonomics Committees 
in each store. The Food Marketing Institute, a trade group for the 
industry, has educated themselves and their members about the issue of 
MSDs and back injuries related to job design as well as commissioned 
and gathered scientific data on the issue. As well, they claim that the 
injury rate has declined 33 percent in 10 years of voluntary grocery 
industry efforts to reduce worker injuries. Unfortunately, this same 
trade group made exaggerated claims about the ergonomics standard, 
telling its members that they would suffer greatly from a mandatory 
standard, including that they would have to hire baggers, that 
customers would have to bag their own groceries and that the price of 
groceries would increase as a result of the standard. They also claimed 
that baggers, according to the standard, would be prevented from 
lifting more than 15 pounds. These scare tactics we believe aimed at 
generating opposition to the standard rather than concrete criticism of 
the standard itself, which would have been far more useful for all 
parties.
    Workers are being hurt--Jan, Gloria and Caroline are but examples 
of the hundreds of thousands of workers--you can see these workers when 
you go into your own neighborhood grocery store--in the United States 
who are developing MSDs. They come from small plants and large ones; 
union ones and non-union ones. The point is it doesn't matter where 
they work, they need protection. We've been working to get those 
protections for them. We think an ergonomic standard is the answer.
    Thank you for the opportunity to speak to you about this important 
issue for workers.

Attachment:

                   United Food & Commerical Workers
                        International Union, AFL-CIO & CLC,
                                    Washington, DC, April 12, 2001.
Hon. ____,
U.S. Senate, Senate Office Building, Washington DC.
    Dear Senator ____: The more than 600,000 workers who are injured 
and crippled each year from ergonomic hazards in the workplace feel 
betrayed by the congressional vote on the ergonomics standard. Hundreds 
of thousands more workers will now suffer preventable pain and injury 
as well as needless job and income loss. In addition, thousands of 
employers will face additional costs in health care, workers' 
compensation, and reduced productivity.
    The campaign waged against the ergonomics standard was marked by 
misstatements, distortions, and lies. There were no congressional 
hearings, no public forums, and no opportunities for workers to share 
their real-life experiences either as casualties of ergonomic hazards 
or as participants in programs that have successfully eliminated such 
hazards. We believe that many votes against the standard were the 
direct result of the misinformation campaign.
    On behalf of the 1.4 million members of the United Food and 
Commercial Workers International Union (UFCW), I extend to you an 
invitation to meet with workers, and to visit workplaces that will give 
you a broader understanding, and allow you to make a more informed 
judgement of both the problems and solutions regarding ergonomic 
hazards. UFCW has nationally recognized model programs that have both 
significantly reduced injuries and decreased costs for employers.
    UFCW is happy to arrange the meetings with workers and the 
workplace visits to meet your schedule.
    Secretary of Labor Elaine Chao took the opportunity to meet with 
workers on March 14, 2001, at UFCW headquarters. We believe that her 
willingness to hear from workers can be an important step in building a 
consensus on a solution to ergonomic hazards. As Secretary Chao noted, 
Congress must be part of the consensus-building process.
    We hope you wilt take this opportunity to gain a firsthand 
understanding of this issue, and to see the devastation of workers' 
lives that comes with ergonomic hazards. Please contact the UFCW 
Legislative and Political Affairs Department at your earliest possible 
convenience to discuss a workplace visit.
    America's workers are counting on you to hear their concerns and 
act on their needs for safe workplaces. We hope to hear from you soon.
            Sincerely,
                                         Douglas H. Dority,
                                           International President.

    Senator Specter. Thank you Ms. Nowell. We now turn to Jerry 
Wood, legislative chairman, Local 7800, Communication Workers 
of America.
STATEMENT OF JERRI WOOD, LEGISLATIVE CHAIRMAN, LOCAL 
            7800, COMMUNICATION WORKERS OF AMERICA
    Ms. Wood. Good afternoon, Senator Specter, Mr. Chair. I am 
Jerry Wood, the legislative chair for the Communication Workers 
of America Local 7800 in Seattle and I am also a customer 
communications technician with over 28 years of service for 
Qwest Communications, formerly US West and Pacific Northwest 
Bell.
    I really appreciate the opportunity to testify before you 
and your committee today. I would like to address two important 
issues regarding workplace ergonomics, the first involves 
achieving economic--excuse me, ergonomic changes in the 
workplace. I will illustrate this concern by presenting a 
success story between my union, the Communication Workers of 
America and our employer of record at that time, US West which 
is now known as Qwest. The second deals with what still needs 
to be accomplished regarding workplace ergonomics.
    Mr. Chairman, in 1990 when our company was US West, we had 
a work group known as the centralized mail remittance center 
that processed all incoming payments for our--from our 
company's customers. The job entailed the following procedures: 
workers loading mail into a machine that sliced the envelopes 
open, removing the mail like the bills, checks, cash from the 
envelopes, keying in the payment information and processing the 
received checks and cash and then finally collecting and 
bundling the paper documents.
    The performance of this work involved extensive repetitive 
motions performed in very hot and extremely dusty and dirty 
working conditions. In turn, these conditions laid to the 
occurrence of a high rate of employee repetitive motion 
illnesses, cases of skin rash and resultant Workers 
Compensation claims and awards. In addition, worker morale and 
productivity were extremely low. It was not a very pretty 
picture.
    Initially my union attempted to resolve these issues with 
US West through our collective bargaining process. For an 
extended period of time, affected employees complained to the 
management and to the local union stewards of the inadequate 
ergonomic working conditions and the related health problems.
    In turn without success, the union utilized the contract's 
grievance process. However, lacking--excuse me--lacking 
agreement from the employer to provide safe and healthful 
working conditions necessary to minimize or eliminate the 
identified repetitive motion problems, CWA filed a complaint 
with WISHA, which is our Washington State Industrial Safety and 
Health Administration for relief.
    In 1992 after citing the company under the general duty 
clause of the Occupational Safety and Healthy Act for 
violations regarding inadequate ergonomic working conditions, 
WISHA and the employer negotiated a settlement agreement 
intended to resolve the identified areas of concern.
    Mr. Chairman, the settlement agreement resulted in US West 
providing ergonomic and safe and helpful working conditions for 
all affected employees in that workroom. Components of the 
settlement agreement included the establishment an ergonomic 
task force, the development of a workplace ergonomics training 
program--excuse me--program. Subsequently initial and refresher 
training was provided to all current and new employees. 
Training topics included the principles of ergonomics, 
appropriate body postures, the proper positioning of your 
hands, your wrists, your legs, illumination and glare, and the 
use of physical exercises and stretch breaks and the reporting 
of occupational injuries and illness.
    The creation of an ergonomics program. This program 
included the conducting of periodic work site inspections. In 
turn, short and long-term recommendations for improvements in 
working conditions remains. The implementation of lighting 
fixtures and the provision of appropriate workplace 
illumination. The provision of appropriate physical workplace 
accommodation such as foot rests, wrist rests and back supports 
and I'll hurry up as I see the yellow light is lit.
    All of these topics are important components of a 
comprehensive ergonomics program and standard and since the 
negotiation and implementation of this settlement agreement, 
our members have not experienced any complaints of pain, 
discomfort or illness associated with repetitive motion or 
cumulative trauma and that is been for almost 8, 9 years now. 
No one has had a problem in this work group.
    Mr. Chairman, when this problem was identified nearly 
everyone in this work group had suffered some form of 
musculoskeletal or cumulative stress disorder. And what does 
that mean? For business it means money. The return on 
investment is great. With fewer illnesses and injuries the 
productivity is up. Less money is spent on medical management 
and Workmans Compensation. For the employees, they can come to 
work and not worry about being injured. There is no loss of 
earnings and they are able to have a pain free life both on and 
off the job.
    It is a dollars and cents issue. Unfortunately this is not 
the----
    Senator Specter. The time is up. If you could summarize, 
please.

                           prepared statement

    Ms. Wood. What I would like to say is that we need a 
Federal standard. In our State, in Washington State where I 
live and work, we have a proactive ergonomics work rule that 
was adopted in May of 2000 and we're in the process of that 
now. But US West, Qwest as we're now known, we do not have an 
ergonomic standard that is a 14 state wide standard. We have 
individual work groups that negotiate agreements with managers 
based on personal relationships or, you know, how the business 
is in that area.
    Senator Specter. I think we have your point.
    Ms. Wood. The point is we really do need this standard. 
Once the pain starts, it doesn't stop.
    [The statement follows:]
                    Prepared Statement of Jerri Wood
    Good Morning Mister Chairman. I am Jerri Wood, the legislative 
chair for the Communications Workers of America, Local 7800 in Seattle, 
Washington and a customer communications technician with over 28 years 
of service for Qwest Communications, formerly US WEST and Pacific 
Northwest Bell Telephone.
    I appreciate the opportunity to present testimony before the 
Subcommittee on Labor, Health and Human Services, Education of the 
Senate Appropriations Committee. I would like to address two important 
issues regarding workplace ergonomics. The first involves achieving 
ergonomic changes in the workplace. I will illustrate this concern by 
presenting a success story between my union, the Communications Workers 
of America, and Qwest. The second deals with what still needs to be 
accomplished regarding workplace ergonomics.
    Mr. Chairman, in 1990, when our company was US West, we had a work 
group, known as the Centralized Mail Remittance Center, that processed 
all incoming payments from the company's customers. The job entailed 
the following procedures:
  --workers loading mail into a machine that sliced the envelopes open,
  --removing the mail, i.e., bills, checks, and/or cash, from the 
        envelopes,
  --keying in the payment information,
  --processing received checks and cash, and, finally,
  --collecting and bundling the paper documents.
    The performance of this work involved extensive repetitive motions 
performed in very hot and extremely dusty and dirty working conditions. 
In turn, these working conditions led to the occurrence of a high rate 
of employee repetitive motion illnesses, cases of skin rash, and 
resultant workers' compensation claims and awards. In addition worker 
morale and productivity were extremely low. It was not a pretty 
picture. Initially my Union attempted to resolve these issues with US 
West through the collective bargaining process. For an extended period 
of time, affected employees complained to management and Local union 
stewards of inadequate ergonomic working conditions and related health 
problems. In turn, without success, the Union utilized the contract's 
grievance process. However, lacking agreement from the employer to 
provide safe and healthful working conditions necessary to minimize or 
eliminate the identified repetitive motion health problems, CWA Local 
7800 filed a complaint with WISHA (i.e., the Washington State 
Industrial Safety and Health Administration) for relief. In 1992, after 
citing the company under the General Duty Clause of the Occupational 
Safety and Health Act for violations regarding inadequate ergonomic 
working conditions, WISHA and the employer negotiated a settlement 
agreement intended to resolve the identified areas of concern.
    Mr. Chairman, the settlement agreement resulted in US West 
providing ergonomic and safe and healthful working conditions for all 
affected employees. Components of the settlement agreement included:
  --The establishment of an ergonomics task force;
  --The development of a workplace ergonomics training program. 
        Subsequently, initial and refresher training was provided to 
        all current and new employees. Training topics included the 
        principles of ergonomics; appropriate body postures; the proper 
        positioning of hands, wrists, arms, and legs; illumination (and 
        glare); the use of physical exercises and stretch breaks; and 
        the reporting of occupational injuries and illnesses;
  --The creation of an ergonomics program. This program included the 
        conducting of periodic worksite inspections. In turn, short and 
        long-term recommendations for improvements in working 
        conditions were made;
  --The implementation of appropriate lighting fixtures and the 
        provision of appropriate workplace illumination levels;
  --The provision of appropriate physical workplace accommodations such 
        as foot rests, wrist rests, and back supports. (US West made 
        sure to have an ample supply of these items so as to eliminate 
        delays in providing them to affected employees);
  --The development of procedures that called for the rotation of job 
        functions within affected work groups;
  --The establishment of a medical management program. In part, this 
        involved the medical surveillance of workers and a review of 
        ongoing employee cumulative trauma disorders. In addition, 
        affected occupational and management employees were provided 
        education materials regarding the causes and early symptoms of 
        repetitive motion illnesses; and
  --The introduction of equipment that would eliminate or significantly 
        minimize the amount of paper dust within the workplace.
    All of these topics are important components of a comprehensive 
ergonomics program and standard.
    Since the negotiation and implementation of the settlement 
agreement, our members have not experienced any complaints of pain, 
discomfort, or illness associated with repetitive motion or cumulative 
trauma. In addition, exposure to paper dust has been greatly minimized.
    Mr. Chairman, when this problem was identified, nearly every 
employee in the centralized mail remittance center work group suffered 
from some form of musculoskeletal or cumulative trauma disorder. Today, 
there are no reported cases of repetitive motion illness. What does 
that mean?
    For the business it means money. The return on investment is great. 
With fewer illnesses and injuries, productivity is up. Less money is 
spent on medical management and workers' compensation. For the 
employees, they can come to work and not worry about being injured. 
There is no loss of earnings. They are able to have a pain free life 
both on and off the job. They can participate fully in their family 
life, without limitations. These things cannot be measured in dollars 
and cents. This is a success story that CWA and US WEST learned a lot 
from.
    Unfortunately, this is not the case in all corporations, and even 
at Qwest, some lessons need to be revisited. We still have work groups 
where ergonomics and work place safety are unheard of. As we sit here 
today, many of our members will be hurt and continue hurting after 
their workday is finished because the emphasis is on the bottom line, 
the all-mighty dollar. For some reason, we as a nation are willing to 
play the game of chicken, pitting the financial health of our 
businesses and the physical, emotional and financial well being of 
their employees against this mighty bottom line.
    If you can prevent an injury from happening, you save money in lost 
time wages, doctors and therapy visits, prescriptions, hospitalization 
and so on. Dollars spent in this manner produce no positive return on 
the employer's investment. In fact, they actually take money away from 
the bottom line. If employers spend money, as US WEST did in 1992, 
creating a safer work place, educating their employees to work safer 
and smarter, and providing the necessary accommodations to lessen the 
impacts of repetitive motion, the employer will experience an increase 
in productivity, morale, and employee and customer retention. These are 
items necessary for successful employers and a healthy, thriving, and 
growing economy.
    Mr. Chairman, why do we need a Federal OSHA ergonomics standard? 
This question is particularly important for employers with multi-state 
operations, such as Qwest. A Federal standard would provide for 
consistent policies and procedures within all states. On the other 
hand, the establishment of different standards among different states 
such as Washington, California, and others would present employers with 
burdensome policy and economic scenarios. In addition, with the 
establishment of consistent workplace ergonomics policies and 
procedures, workers would prefer a Federal standard knowing that they 
have a greater opportunity to be provided ergonomic and safe and 
healthful working conditions.
    As stated in the success story that I described, US WEST was not 
fully motivated by a collective bargaining agreement or by some sense 
of doing the right thing in correcting their problems. An outside 
governmental agency, i.e., the Washington Industrial Safety and Health 
Administration, with the authority to inspect, issue citations, and 
levy disciplinary action was needed to convince the company to take the 
necessary protective action. However, WISHA was limited insofar as they 
could only use the OSHA General Duty Clause to investigate, issue 
citations, and take the necessary corrective action. The establishment 
of a Federal OSHA ergonomics standard would allow state OSHA plans that 
do not have an ergonomics standard to more efficiently and effectively 
respond to complaints and resolve inadequate workplace ergonomics.
    Mr. Chairman, I have first hand knowledge of the ergonomics and 
repetitive motion illness problem. I suffer from carpal tunnel and 
tendonitis in both of my arms due to my job function at Qwest. I know 
that if my manager had accommodated my need for an ergonomic keyboard, 
I would not be suffering to the extent that I am today. For the lack of 
this $25 keyboard, my employer spent over $45,000 in lost time wages, 
orthopedic and therapy appointments, prescriptions and braces and 
independent medical examinations, not to mention significant 
administrative costs. My family lost my ability to help them at some 
crucial times in their development. My customers lost my service to 
them. I am a great technician. However, due to my repetitive motion 
illnesses, my co-workers had to work harder; some working overtime to 
cover for my absence. My company lost money, because I wasn't there to 
help them make money.
    Unfortunately, once the pain and suffering associated with 
inadequate workplace ergonomics and the occurrence of repetitive motion 
illness starts, it never stops.
    Mr. Chairman, I urge you to help ease the pain and suffering of 
millions of American workers who, as a result of inadequate workplace 
ergonomics, have developed repetitive motion illnesses by working to 
have a comprehensive Federal OSHA Ergonomic Standard established.
    Thank you for your consideration of this matter.

    Senator Specter. Thank you. Thank you very much. Going now 
to panel number five, Mr. Fellner, Mr. Sparlin, Ms. Seminario. 
When you have 26 witnesses, you get sort of repetitive.
    Mr. Fellner, it is your turn. I see you are marked down 
here for 3 minutes, I do not suppose you will need that long, 
will you?

                     STATEMENT OF BARUCH A. FELLNER

    Mr. Fellner. Well, as a matter of fact, I may surprise you, 
Senator Specter, and during the course of my----
    Senator Specter. I am just kidding, Mr. Fellner, take all 3 
minutes.
    Mr. Fellner. I appreciate that, but during the course of--
the reason that I may surprise you is because I think that the 
search for the Holy Grail of consensus this morning may breed 
more success than you had initially predicted or thought. But 
before I indicate to you where that consensus might be I'd like 
to correct the record.
    In response to the distinguished chairman's question 
directed to Dr. Barondess as to whether interventions are 
effective in addressing MSDs and to the NAS's conclusion with 
regard to that, he said yes. Dr. Barondess misrepresented his 
report. In Appendix C, which is the panel response to the 
single descent, the NAS reports states, and I quote in its 
entirety, this is at page 458, the report states that 
interventions influenced pain reports and not the occurrence of 
specifically defined disorders of the upper extremities. The 
studies are summarized in table 8.3. The report does not state 
that interventions prevent carpal tunnel syndrome or indeed any 
other upper extremity disorder. The emphasis rather is on the 
amelioration of symptoms which is the end point in the relevant 
literature.
    Furthermore, the comments on upper extremity interventions 
carefully state that interventions influence symptoms, not the 
incidence of specific disorders. With that proposition we 
agree, and that means if we return, Senator Specter to where I 
began, the NAS defines disorders as an interruption in a human 
being's sense of wellness. If that is what this morning's 
hearing is about, Senator Specter, we can all agree that the 
workplace does have some influence on individual sense of 
wellness. Come Monday morning I suspect even you, Senator 
Specter, are reluctant to come to the Senate. I know I am 
today.
    If that is what ergonomics regulation is about, if OSHA has 
the authority, if we are entering 1984 Orwellian period where a 
Federal agency has the authority to regulate an individual's 
sense of wellness, then we have come very far. Before we do so, 
Senator, I think that the Department of Labor must take a good, 
long look at the process and at the science and I appreciate 
it.
    Senator Specter. We'll take a close look at the voluminous 
report and contrast Dr. Barondess statement with your challenge 
and see if your challenge is well-founded.
    Ms. Seminario, I have you down for 3 more minutes.
STATEMENT OF PEG SEMINARIO, DIRECTOR, DEPARTMENT OF 
            OCCUPATIONAL SAFETY AND HEALTH, AFL-CIO
    Ms. Seminario. Just to make a couple of points, Mr. 
Chairman, as I've said earlier we've long advocated an OSHA 
standard. We have recommended that such a standard be based on 
the good employer practices that have worked. Those practices 
are the ones that are incorporated into the red meat 
guidelines. They are the practices that are in place in the UAW 
program, they are the practices that were in the settlement 
agreement at Qwest. They are the practices that are in the 
settlement agreements in meat packing.
    If you line up all of these documents and all of these 
programs, they have very common elements. Most of them take a 
programmatic approach that include employer commitment, 
employee involvement, identification of problem jobs, 
development of controls, training and education, and 
appropriate medical management, and that is the practice. And 
the risk factors that are addressed, the exposures that are 
addressed again are the similar common exposures that workers 
have with respect to the development of MSDs.
    They are exposure to excessive reputation, force, awkward 
postures, vibration, jobs involving a lot of manual handling as 
Dr. Barondess indicated. So there is commonality when you look 
at the practice in the workplace and our advice to the 
Department of Labor in developing their rule is to look at that 
practice and to codify that into a regulation.
    Does that mean that every employer do exactly what the UAW 
does or what's done at Qwest or, you know, in the meat packing 
industry? No, there are, you know, obviously real differences 
in risk. There are real differences in operations, but the 
programmatic approach, the basic elements are the same and then 
within that, the control measures are obviously ones that are 
tailored to a particular workplace.
    But at the heart of all this has got to be the reduction in 
exposure. If you just have a program on paper, if you have a 
program and a process that is not resulting in reductions and 
exposure, you are still going to have injury.
    Now, much has been said about the fact that there are not 
only physical factors but psychosocial and organizational 
factors and we agree with that. But when you look at OSHA's 
authority to regulate, the physical factors resulting from the 
jobs are the ones that they are best able to deal with. If OSHA 
got into trying to deal with management structures in the 
workplace, they got into dealing with management relationships 
that have--that are at the heart of the psychosocial work 
organizational factors in the workplace, you would hear much 
greater screams from the employers than you have already heard. 
And when we asked them about this at the hearing, should OSHA 
then address the work organization and psychosocial factors, 
they said no.
    So OSHA tried to deal with what was in its purview and what 
really was the focus of its effort. Was dealing with all risk 
factors? No. It was attempting through the standard to deal 
with those risk factors that they felt could be regulated 
related to the workplace and related to hazards.
    So that is our recommendation is to look at these practices 
and then to codify them into a regulatory approach to reduce 
injuries.
    Senator Specter. Thank you very much, Ms. Seminario and 
thank you all. In my experience having been here for some time, 
this has been a very unusual hearing and the subcommittee has 
gone into a lot more detail to try to understand this problem 
because of our determination to see something done.
    We labored long hours on conferences on this issue, year 
after year after year after year and the process that has 
brought us to where we are today with the regulation having 
been rescinded and we have a statement by the new Secretary of 
Labor that, quote, I intend to pursue a comprehensive approach 
to ergonomics which may include a new rulemaking that addresses 
the concern levied against the current standard. The word may 
leaves latitude for not.
    We intend to press on the time frame. What I hear today is 
not likely to lead to consensus but is very adversarial and I 
am not unused to the adversarial process and I can see the 
adversarial process at work to try to influence the decision 
maker. That is not unusual either.
    You take an extreme position, you may end up closer to 
where you want to be than if you take a conciliatory position. 
That is sort of par for the course in adversarial litigation 
which I think we have here. But through all of it there's been 
a lot of progress through ergonomics with the companies and 
we've heard employers who have come to terms.
    And a big part of the problem is the administration by OSHA 
of which we hear complaints everywhere and this subcommittee 
has defended OSHA's budget trying to look more for 
reconciliation and prevention than for adjudication and 
punishment and what is going to have to happen really in the 
long run is that the OSHA administration is going to have to be 
populated by people who understand the concerns on both sides.
    Business is going to have to put one of your high, your 
really well qualified people into a key OSHA position to see to 
it that OSHA doesn't overstep the bounds.
    The employees at OSHA do not earn what some of the 
witnesses do have testified here today and there has to be a 
safety check from labor having someone there who will see to it 
that they do not go too far in either direction. But the 
governmental administration is a monumental task. But this is a 
really very--I do not have to say this, it is been said by 
everybody, an extraordinarily important program this and this 
subcommittee intends to pursue it and it is my hope that we can 
find some information from some of these companies which 
haven't come forward and try to find some standard to address 
the concerns on all sides because I think at bottom there is a 
good faith effort to try to deal with workers problems, biggest 
impacts on corporate profits, we know that. We all have to live 
together on the planet earth.
    It is exactly 12:30. That is the longest hearing this 
subcommittee has had. It is over.

                          subcommittee recess

    Thank you all very much for being here. The subcommittee 
will stand in recess until 9:30 a.m., on Wednesday, May 2, when 
we will meet in room SH-216 to hear from Department of Labor 
Secretary Elaine L. Chao.
    [Whereupon, at 12:30 p.m., Thursday, April 26, the hearing 
was concluded and the subcommittee was recessed, to reconvene 
at 9:30 a.m., Wednesday, May 2.]


  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2002

                              ----------                              


                         WEDNESDAY, MAY 2, 2001

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 9:33 a.m., in room SH-216, Hart 
Senate Office Building, Hon. Arlen Specter (chairman) 
presiding.
    Present: Senators Specter, Harkin, and Murray.

                          DEPARTMENT OF LABOR

                        Office of the Secretary

STATEMENT OF ELAINE L. CHAO, SECRETARY OF LABOR
ACCOMPANIED BY JAMES McMULLEN, DEPUTY ASSISTANT SECRETARY, BUDGET

               Opening statement of Senator Arlen Specter

    Senator Specter. The Subcommittee, of the Appropriations 
Committee on Labor, Health and Human Services, and Education 
will now proceed.
    We welcome Secretary of Labor, Elaine Chao, to this first 
hearing on her Department's budget.
    I note at the outset that the administration's 
discretionary budget request for fiscal year 2002 for the 
Department of Labor is $11.338 billion, which is a decrease of 
some $562 million below the current budget, noting that the 
total funding for the Department including mandatory programs 
is $44.4 billion.
    There are some increases including funding for the 
disability employment policy, somewhat in excess of $20 
million; for the consumer price index improvements, a little 
over $8 million; and for the unemployment insurance work load 
program, an increase of $65 million.
    But there are some major decreases in the area of youth 
activities, dislocated workers, training programs for incumbent 
workers, the safe schools healthy students program, youth 
offenders, and international labor affairs.
    In preliminary staff inquiries, we have been advised that 
some of these cuts, may be accommodated by the fact that States 
have spending levels at a lower rate than expected.
    But there is a real concern here. Earlier this week, I 
visited a Healthy Start Center in Harrisburg, which is devoted 
to trying to deal with youngsters who are at risk and may be 
predisposed to criminal activity.
    I was really startled to hear that the time for dealing 
with at-risk children is when they are 16 months old. It seemed 
fanciful to me until I heard their approach.
    They say that at 16 months, children start to learn which 
space is theirs, not to be aggressive and pushing other 
children, learn scheduling so they have some structure in their 
life. And that conduct begins at that age.
    And they were very much concerned about the programs in 
Healthy Start, which has had enormous improvement. Although it 
is not funded by this Department, but funded by the 
subcommittee, the Healthy Start staff were concerned as to what 
is going to happen in the summer programs. That is a question 
which the Congress has faced repeatedly and this subcommittee 
has taken a very strong position trying to provide for summer 
jobs for young people.
    And the issue was raised as to daycare. What is going to 
happen to daycare in the summer. So when I look at these cuts, 
I am really concerned.
    I talk about 16-month-olds, because I think that is a bit 
of information which is sufficiently startling to take just a 
few minutes this morning to tell you what the avant garde 
thinking is on this subject.
    Well, Madam Secretary, we do not have 25 witnesses behind 
you today, which will give us a little more of a chance to 
discuss matters. And we look forward to--I was about to say we 
look forward to your statement, but timing is everything.
    And, Senator Harkin, among his many, many talents, has a 
way of arriving at precisely the right moment.
    My distinguished partner, Senator Harkin.
    Senator Harkin. Thank you very much, Mr. Chairman. And I 
will just ask my statement be made a part of the record. You 
are so gracious. I will just put it in the record and let us 
move ahead.
    Senator Specter. Oh, I see that statement. It is too long. 
We cannot afford all of that on the record. We are going to 
have--you will have to summarize that for----
    Senator Harkin. We will have to get a new appropriation 
just to print all this stuff, right?
    Senator Specter. By the time we finish talking, I think we 
will need several new appropriations.
    [The statement follows:]
                Prepared Statement of Senator Tom Harkin
    Thank you, Mr. Chairman. And thank you Secretary Chao for coming 
here today. It's nice to see you again so soon. Now you know that when 
this Committee says that we want to work closely with you, we're not 
kidding!
    Budgets are about priorities. In America, where we spend our money 
reveals a great deal about what we value. The discretionary funding in 
this year's Department of Labor budget is down $600 million. In a year 
of unprecedented surplus, it is shocking that we are sitting here 
discussing deep cuts to an agency whose mission is to protect our 
Nation's workers--the very people who worked so hard to produce a 
surplus.
    Before I get into the concerns I have, I do want to note a positive 
step made in this budget. I am pleased to see that the Department has 
requested a doubling in the funding for the Office of Disability 
Employment Policy, which we created last year. This office will focus 
on integrating individuals with disabilities into worker training 
programs, improving access to one-stop centers and coordinating with 
other agencies to ensure that people with disabilities have 
transportation and community-based attendant services. In many cases, a 
small amount of assistance is all that is required to give these 
individuals the independence that a job affords.
    Aside from that shining star, I believe this budget is simply 
short-sighted. First and foremost, I am confounded by the logic of 
making large cuts in worker training programs just as the country 
experiences rising unemployment rates. Week after week, we see news 
reports about lay-offs at major companies, yet your budget calls for a 
$200 million cut from training programs for dislocated workers.
    If we are to encourage innovation in the marketplace, industry 
NEEDS highly skilled workers and it is in our best interests to provide 
those workers here in America. I am disappointed to see that, out of 
the $600 million cut in overall Department of Labor funding, $473.9 
million of that comes from Employment and Training Programs. That is 79 
percent of the total decrease in the Department!
    Another example of the short-sightedness of this budget is this 
Administration's proposal to cut the Bureau of International Labor 
Affairs by 65-75 percent. In this era of globalization, American 
workers are now pitted against workers throughout the global economy in 
tough, hard-nosed competition as never before. Their jobs and living 
standards are at unprecedented risk.
    Now I am not worried about the productivity of American workers to 
compete and win on a level playing field. But the sad truth is there 
are many trading countries that deliberately refuse to enforce their 
own national laws to respect basic worker rights and labor standards, 
let alone meet their international legal obligations.
    I am deeply concerned that this administration is proposing such 
drastic cuts in the part of the Federal Government which has the 
greatest expertise in labor standards and international worker rights 
issues, such as abusive child labor. These cuts could not come at a 
worse time: U.S. policy-makers need ILAB help more than ever including 
President Bush, who says there are legitimate trade-related worker 
rights issues that must be addressed in the impending fast-track 
debate.
    Finally, I am disturbed by the reductions in worker safety and 
health standards. In the last year, workforce data has illustrated that 
Americans are working more hours than ever before. There is a $1.2 
million reduction in safety and health standards, a $3 million cut in 
training grants, cuts in state programs, technical support and a 
reduction of 94 full-time staff!
    Cutting support for worker training, global workforce and basic 
safety and health standards for our workers--these actions are classic 
examples of cutting off your nose to spite your face. The surplus was 
built on the backs of America's workers and if we as a Nation want to 
prosper in the 21st century, we will need a workforce that is well-
trained, highly-skilled, and does not have to fear being injured due to 
hazardous working conditions. To do any less is to put America's 
prosperity in danger.

                Summary statement of hon. Elaine L. Chao

    Senator Specter. Well, in a very unusual move, Secretary 
Chao, Senator Harkin has deferred to you. I do not think he 
would have done it to anybody else.
    Senator Harkin. You are in rare form this morning.
    Senator Specter. The floor is yours.
    Secretary Chao. Thank you very much. And, of course, to the 
ranking member, I appreciate that courtesy.
    Mr. Chairman, now that I know what the lights are for, I 
have made my statements very short to fit into the time frame. 
And I do have a written record--statement that I would like to 
be submitted for the record.
    Senator Specter. The full statement will be made a part of 
the record. Madam Secretary, with only one witness, we do not 
use the lights.
    Secretary Chao. Oh, okay. Thank you.
    I do want to address your issues because they are important 
as well. I do have a little summary.
    As you mentioned, the Department's overall fiscal year 2002 
budget request is $44.4 billion. It is up from $39.2 billion 
from the previous year. It is about a 13.27 percent increase. 
The FTE's is approximately 17,483. The discretionary request is 
$11.3 billion.
    I think it is important to point out here that the 
Department of Labor's budget is part of the entire 
administration's budget, prepared with the assistance of all 
the Cabinet Secretaries and under the guidance of the President 
and the Office of Management and Budget.
    The President's budget, which will grow about 4.1 percent 
per year, protects Social Security and Medicare, pays down the 
national debt and provides working families with meaningful, 
needed tax relief.
    At my confirmation hearing 3 months ago, I identified five 
key areas for the Department that are reflected in the budget 
that we have submitted today.
    And these priorities are obviously: One, to ensure the 
safety and health of every workplace; to guarantee an honest 
day's pay for an honest day's work; to fight discrimination; to 
protect workers from coercion and intimidation; and to make 
sure workers' pensions are protected.
    And, of course, there is the overriding theme that I have 
worked a great deal on, and that is workforce training and 
development.
    The Department of Labor has done a great deal to protect 
workers, but needs to do more to prepare workers for the new 
economy, for dislocations that result from trade, and for 
changes in skill needs.
    And so to bring focus and drive to this mission, a new 
Office of the 21st Century Workforce has been created within 
the Department. It is funded out of existing resources.
    The Department will hold a summit on the 21st Century 
Workforce on June 20 of this year, where leaders from business, 
labor unions, government, and academia will address the 
fundamental changes affecting our country's workforce and 
economy.
    Let me comment a bit about the five goals. The first goal 
is to ensure the safety and health of every workplace. There is 
no question that the Department needs to be in the business of 
assisting workers through employers before an accident occurs.
    Enforcement is a critical part of the Department's job. I 
am fully committed to that. And OSHA, indeed, has issued about 
38 fines of over $100,000 in the last year. But what I have 
tried to emphasize also is that after-the-fact enforcement is 
not going to ease a family's grief when a loved one is injured 
or killed.
    And so I would like to put more emphasis on compliance 
assistance, so that we can truly help workers, to protect them 
before an accident occurs. OSHA's budget request is $426 
million for the 2002 fiscal year. MSHA's is $246 million.
    The second goal, of course, is to guarantee an honest day's 
pay for an honest day's work. And the Department needs to 
enforce our common sense laws about labor practices, and not 
just a reflexive one-size-fits-all approach.
    The Department's request maintains our worker protection 
agencies at 2001 levels. We are expanding our efforts in 2002 
on compliance assistance activities. And if I can just point 
out, since 1996, the Department has realized a 36 percent 
increase in worker protection programs.
    The Employment Standards Administration, which includes the 
Wage and Hour division, has a fiscal year 2002 budget of $284 
million.
    The third goal was to fight discrimination. And we are 
thankful to the ranking member to have helped in the 
establishment of the Office of Disability Employment Policy.
    Mr. Harkin, I know how strongly you feel about that, and we 
look very much forward to working with you in making sure that 
the mission of this office is totally fulfilled.
    We have allotted $20 million extra on top of last year's. 
And we expect to have ten FTE's for this office in 2001. And as 
you well know, the President feels strongly about this as well, 
because of his new freedom initiative.
    The Department also has an important role in worker 
protection abroad. And as the chairman mentioned, we do have 
the Department's Bureau of International Labor Affairs.
    This Department's program has increased 77 percent over 
fiscal year 1999. And for fiscal year 2002, the Department is 
requesting a smaller amount of $72 million, but 100 FTE's for 
international labor activities. And I will speak more to that, 
I am sure, as we go on this.
    The fifth goal is to make sure that workers' pensions are 
protected. And I have recently met with Attorney General 
Ashcroft to ensure that the Departments of Justice and Labor 
will work together and to protect our workers' pension funds. 
And Pension Welfare Benefits Administration, which guards the 
integrity of our Nation's pension funds has a budget request of 
$108 million.
    This pretty much is an overview of the plans for the 
Department of Labor. I emphasize once again how important it is 
for the Department not just to react to change, but try to 
anticipate them.
    We want to help workers adjust to a 21st Century workforce. 
And that is why we are spending a great deal of time on 
training and development.
    There are concerns about the 5 percent reduction in the 
budget. And as the chairman has pointed out, a great deal of 
that decision was based on the overhang of unexpended funds.
    We do have an unexpended fund balance of $1.7 billion. 
Usually, the unexpended funds balance is about $1 billion. So 
this year, we have well over $700,000,000.
    So while the budget has been cut back, $542 million, that, 
again, is more than taken care of by the larger than usual 
excess from the previous year.
    We are also spending $80 million on new technology to 
ensure that the Department is up to speed. We are spending 
another, I believe, $40 million on BLS to ensure that the 
Bureau of Labor Statistics is providing up-to-date and truly 
relevant information. And it is a wonderful organization.

                           prepared statement

    But I am kind of rambling on, so I will stop here and be 
happy to answer any questions.
    Senator Specter. Thank you very much, Secretary Chao.
    [The statement follows:]
               Prepared Statement of Hon. Elaine L. Chao
    Mr. Chairman, and distinguished Members of the Subcommittee, thank 
you for the opportunity to appear before you today to present the 
Department of Labor's fiscal year 2002 Budget.
    The President's 2002 budget moderates the Federal Government's 
recent rapid growth in spending while funding national priorities, 
paying down the debt, and providing tax relief. The Department of 
Labor's budget request for 2002 follows this responsible approach and 
will serve as the foundation for us to become a 21st Century Department 
of Labor.
    Before I discuss the specifics of the Department's 2002 request, I 
would like to highlight a new addition to the Department of Labor. We 
at the Department of Labor need to provide a beacon of hope, finding 
solutions for the problems facing our Nation's workers and the economy 
as a whole. Thanks to the bipartisan work of Congress, we have a new 
road map--the Workforce Investment Act--to lead us toward this goal. 
Along with states and localities, the professionals in our Employment 
and Training Administration are diligently implementing this new 
legislation. But we need even more fresh ideas, fresh approaches, and 
new partnerships to help us succeed in this journey. That is why I am 
creating within the Department a new Office of the 21st Century 
Workforce to bring focus and drive to this mission.
    This Office will be funded out of existing resources and its first 
responsibility will be to hold a Summit on the 21st Century Workforce 
on June 20, 2001. At the Summit, I will call on leaders from business, 
labor unions, government, and academia to address the structural 
changes affecting our workforce and our economy.
    We need to review every aspect of this Department's work to ensure 
that we are helping, not hindering, the development of a workforce that 
is ready for the future. We want to give workers the flexibility to 
custom-design their work to fit their lives--and not the other way 
around. But I want to make clear that this focus on the 21st Century 
workforce is about a lot more than just making sure Silicon Valley has 
enough engineers. Every worker should have the opportunity for a 
fulfilling and financially rewarding career.
    Given everything we are setting into motion with our 2002 budget 
request, our mission at the Department of Labor must not be just to 
react to changes, but to anticipate them and help the Nation's 
workforce adapt to them. Better yet, the workforce should be able to 
take advantage of those changes. We need to recognize that the 21st 
Century economy is not the same one we grew up with and that America's 
21st Century workforce has to adjust. To help people do that--to give 
workers constant hope in a changing world--we need to become a 21st 
Century Department of Labor.
    At the Department of Labor, it is about making sure that no worker 
is left behind--like those who have been laid off from jobs because 
their company could not keep up with technological changes or foreign 
competition, those who did not get a full education, or those who made 
a wrong turn at some point in their lives and are trying to make it 
back. And, as the President has insisted, we must reach out to those 
who have been denied the opportunity for a productive, meaningful work 
life because of a disability. At the Department of Labor, we are 
prepared to do just that.
    As for our fiscal year 2002 budget, the Department's overall 
request is 17,483 Full-Time Equivalents (FTE) and $44.4 billion in 
budget authority, of which $13.6 billion is subject to the annual 
appropriations process and is now pending, Mr. Chairman, before your 
Subcommittee. The request for discretionary programs is $11.3 billion 
in budget authority, which is $564 million less than 2001--with a net 
reduction of 184 FTE. In a country experiencing a current skills gap 
and a long-term worker shortage, this is a budget request that will 
allow America to achieve its full potential while still maintaining a 
responsible fiscal approach with precious taxpayer resources.
                    employment and training programs
    The Department's fiscal year 2002 budget for Employment and 
Training Programs is $6.8 billion. Included in this total is $2.3 
billion, which is targeted for employment and training programs for 
adults--including $1.4 billion for employment and training activities 
for dislocated workers. In addition, $2.7 billion is requested for 
youth employment and training programs--including $1.4 billion for Job 
Corps--to help young people make a successful transition to the world 
of work and family responsibility.
    This budget represents a net decrease of $474 million from 2001, 
which is largely due to decreases of $359 million in formula grants 
related to the availability of large amounts of State unexpended 
carryover which can be used in lieu of new budget authority. I want to 
be clear, Mr. Chairman: there will be no diminution of service. We are 
prepared to serve the same number of participants as in 2001. It is 
estimated that $1.6 billion in unexpended youth, adult, and dislocated 
worker funds will be carried into 2002--approximately $600 million more 
than what is typically realized, which is due largely to the 
implementation of the Workforce Investment Act.
                      disability employment policy
    The 2002 budget provides $43.2 million and 67 FTE to fund the 
Department's work toward eliminating policy barriers that impede the 
employment of people with disabilities.
    A particular highlight for the Department is the new Office of 
Disability Employment Policy (ODEP). The 2002 budget includes $40.6 
million and 57 FTE for ODEP, an increase of $20.3 million and 10 FTE 
over 2001, to support key elements of the President's New Freedom 
Initiative in areas that focus on integrating Americans with 
disabilities into the workforce.
    The increase includes $6 million and 3 FTE to expand one-stop 
accessibility grants and support the process of ticket-to-work through 
One-Stop Career Centers; an additional $6 million and 3 FTE to build on 
the Youth-to-Work Grant program and ensure that young people with 
disabilities benefit from youth programs under the Workforce Investment 
Act; and $8.3 million and 4 FTE for an Olmstead grant program to assist 
persons with significant disabilities in making the transition from 
institutional settings to the community and employment.
    The Task Force on the Employment of Adults with Disabilities will 
continue its efforts to create a coordinated and aggressive national 
policy to bring adults with disabilities into gainful employment. The 
Task Force will deliver its fourth and final report to President Bush 
by July 26, 2002, the twelfth anniversary of the Americans with 
Disabilities Act. The 2002 budget includes $2.6 million and 10 FTE for 
the Task Force to complete its mission.
                worker protection/compliance assistance
    The Department's 2002 request maintains our worker protection 
agencies at 2001 levels, and we are expanding our efforts in 2002 for 
compliance assistance activities. An example of prior rapid growth in 
spending can be found in our worker protection programs. Since 1996, 
the Department has realized a 36 percent increase for worker protection 
programs, which significantly outpaced inflation. From providing for 
the safety of every worker's pension, to ensuring the safety of every 
workplace, and from ensuring that Federal contractors provide equal 
opportunities to their workers, to ensuring that all employers comply 
with the Nation's wage and hour laws, a responsible fiscal approach 
will allow us to moderate recent growth in Federal spending while still 
realizing the same levels of worker protection.
    I want to be clear on what we wish to achieve: we will continue to 
make administration of labor laws a top priority, but with an eye 
toward a common sense, flexible approach that aims to protect workers 
and help employers comply with the law. To more effectively and 
efficiently administer our laws, our worker protection agencies will be 
emphasizing more--and better--compliance assistance as our initial 
strategy in preventing workplace injuries and illnesses and violations 
of labor laws.
    One example of more and better compliance assistance is the 
Occupational Safety and Health Administration's approach to 
implementing its new ``Needlestick'' rule. We have a proactive strategy 
to ensure that employers understand this new rule--which includes 
extensive outreach and educational efforts before rule enforcement. 
This approach will allow everyone involved--the Department, employers, 
and workers--to focus on the prevention of needlesticks and other 
similar injuries to workers.
    Worker protection laws are only as effective as the degree to which 
they are understood and followed. By emphasizing compliance assistance, 
we help both employers and workers understand not only a rule's 
requirements but also how best to avoid the injury or illness the rule 
is designed to prevent. Each time I hear about safety violations that 
were discovered after an accident that cost the life of an employee, I 
cannot help but feel great sadness. After-the-fact enforcement cannot 
ease a family's grief when a loved one is injured or killed on the job. 
If we really are going to protect workers, we must put more emphasis on 
prevention. By enforcing laws before injuries or illnesses occur, and 
by helping employers provide the necessary levels of protection and 
meet their compliance obligations, we can and will save workers' lives.
                            labor statistics
    The 2002 request includes $25 million in additional funding for the 
Bureau of Labor Statistics, including $8.1 million and 40 FTE for a key 
step in fundamentally changing the manner in which the Consumer Price 
Index (CPI) is revised and updated. For some time, the Bureau has 
worked to improve the accuracy and timeliness of the CPI. The 
additional funds requested in 2002 are critical to the continuation of 
this effort, which has as its goal the production of a more up-to-date 
CPI and should substantially reduce the need for large periodic 
increases like those historically requested.
                      international labor affairs
    The Department requests $71.6 million and 100 FTE for international 
labor activities in 2002. This request recognizes the importance of 
promoting international labor standards and reducing abusive child 
labor throughout the world. I believe the Administration's request 
helps us to effectively balance our priorities on these critical issues 
while maintaining sensible spending policies.
    Our 2002 request preserves the Bureau of International Labor 
Affairs' (ILAB) core responsibilities and allows the Department to 
integrate activities in ILAB with the overall foreign policy of the 
Administration. In this budget, ILAB continues its work on the global 
HIV/AIDS initiative begun in fiscal year 2001 and continues bilateral 
and multilateral projects to assist developing countries in 
establishing basic labor protections, enabling more and more workers to 
enjoy fundamental employee rights.
                         unemployment insurance
    The fiscal year 2002 budget includes a request of $2.4 billion for 
Unemployment Insurance administration. This is an additional $50 
million above the fiscal year 2001 appropriation level, to reflect the 
increased unemployment insurance claims workload under the President's 
economic assumptions. The increase reflects an average weekly insured 
unemployment (AWIU) rate of 2.622 million compared with the 2.396 
million level set in the fiscal year 2001 appropriations.
    energy employees' occupational illness compensation program act
    The Department's budget includes $136 million and 413 FTE for 
administration of the Energy Employees' Occupational Illness 
Compensation Program. In addition, $597 million will provide 
compensation and medical benefits to eligible workers and survivors.
                         advance appropriation
    The Administration proposes to reverse the budget practice of using 
advance appropriations simply to avoid spending limitations. 
Accordingly, the amount requested to be appropriated for the 2002 
budget is sufficient to provide normal funding, and no advance 
appropriation is requested. In order to avoid overstating discretionary 
budget authority in fiscal year 2002, language is proposed to designate 
the Department's advance appropriation budget authority of $2.463 
billion as direct spending. The Administration is committed to 
resolving this issue in the fiscal year 2002 Budget.
               veterans' employment and training service
    For 2002, the Department requests $211.7 million for the Veterans' 
Employment and Training Service (VETS), the same funding level as for 
2001. This request includes 250 FTE to accomplish the VETS mission of 
providing employment and training opportunities for veterans through 
the public employment service and other employment and training 
programs, as well as protecting veterans' employment and re-employment 
rights. The 2002 request continues the funding of the Homeless Veterans 
Reintegration Project at $17.5 million. This program, as authorized by 
the Stewart B. McKinney Homeless Assistance Act and title 38, will 
provide employment and training assistance to homeless veterans, with 
expected job placements of approximately 10,000.
                         information technology
    A total of $80 million--an increase of $43 million over 2001--is 
requested for the centralized Information Technology (IT) account to 
fund the Department's IT investments within four cross-cutting areas: 
$40.5 million for Enterprise Architecture; $10.6 million for a Common 
Office Automation Suite; $19.7 million for Security and Privacy; and 
$9.1 million for Common Administrative Systems. This request will 
support the second year of our efforts to replace duplicative and 
disparate systems with a coordinated approach to provide centralized 
information technology investments managed by the Department's Chief 
Information Officer. These IT resources will help ensure program 
effectiveness among DOL programs and are key to my renewed commitment 
to compliance assistance through maximum use of technology.
                 government performance and results act
    There is a small--but important--amount of $5 million in our 2002 
request for a centralized fund to finance program evaluations, 
primarily in the Department's worker protection agencies. These funds 
will be used to improve overall program effectiveness and data quality 
pursuant to the Government Performance and Results Act (GPRA) of 1993. 
The Department has made significant strides in implementing the 
provisions of GPRA and we believe that funding for program evaluations 
will provide data that can be used to further evaluate and improve 
program effectiveness and data quality. In addition, the Budget request 
for the Employment and Training Administration includes $9 million to 
evaluate job training programs, including an evaluation of the 
Workforce Investment Act's performance management system.
                          grant accountability
    $1.8 million is requested to improve the Department's 
administration of grant funds to improve the timeliness, accuracy, and 
usefulness of financial and performance information. $1.5 million of 
this increase would go to the Employment and Training Administration to 
increase its financial management capacity and strengthen program 
management through specialized oversight and assistance to states and 
other grantees. The Office of the Chief Financial Officer will use the 
remaining $300 thousand to develop financial tools for grant programs 
and provide added oversight to grantee cost reporting.
             federal employees' compensation act surcharge
    The President's 2002 budget includes a proposal to amend the 
Federal Employees' Compensation Act (FECA) to provide for a surcharge, 
to be paid by each agency, to finance the administration of the FECA 
program. The surcharge will replace the $80.3 million in budget 
authority to finance fiscal year 2002 program administrative costs and 
will be based on the amount of the workers' compensation benefits paid 
by each agency. The purpose of this surcharge is to boost Federal 
agency incentives for improving safety in their respective workplaces.
 trade adjustment assistance (taa)/north american free trade agreement-
             transitional adjustment assistance (nafta-taa)
    For fiscal year 2002, $415.7 million is requested for the 
Employment and Training Administration's Federal Unemployment Benefits 
and Allowances. Legislation will be proposed at a later date to 
reauthorize the TAA and NAFTA-TAA programs, which expire on September 
30, 2001.
    Mr. Chairman, this is an overview of what we have planned at the 
Department of Labor for fiscal year 2002. While the President's 2002 
budget presents a responsible approach to meet the needs of America's 
workers--including funding national priorities, paying down the debt, 
and providing tax relief--it will also ensure that our Nation's workers 
are prepared for the 21st Century workplace.
    I will be happy to answer any questions you may have about the 
Department of Labor's budget request.

    Senator Specter. The balances, which are higher than 
expected, would not cover--or would it cover the Youth 
Offenders, where there is a reduction of $55 million?
    Secretary Chao. The Youth Offenders has been combined with 
another program. And I have Jim McMullen, and Jim is the Deputy 
Assistant Secretary for Budget and----
    Senator Specter. That would be fine. We would be glad to 
hear his response.
    Secretary Chao. Okay. Basically $20 million has been 
injected. The whole program is $75 million over 2 years. That 
is the short answer.
    Senator Specter. Well, to sharpen my question----
    Secretary Chao. I was afraid of that.
    Senator Specter. Will the Youth Offenders--we have 5 
minutes for Senators. We do have lights for Senators. That is 
true.
    Secretary Chao. It is an important program.
    Senator Specter. Will the program have less money for 
fiscal year 2002 than 2001?
    Secretary Chao. Yes.
    Senator Specter. And----
    Secretary Chao. But over a 2-year period, there will be 
more. So this has been--the Youth Offender program has been 
consolidated with another program, so that over a 2-year 
period, there will be more money and there will be no 
compromise in the quality of the program.
    Senator Specter. What is the other program with which it is 
consolidated?
    Secretary Chao. May I ask Jim McMullen to take it?
    Senator Specter. Yes. That is fine. If----
    Secretary Chao. Okay. Jim.
    Senator Specter. We are moving into a lot of technical 
information and we would be glad to have Mr. McMullen 
supplement your answers, Madam Secretary.
    Mr. McMullen. What we have pending before you right now, 
Mr. Chairman, is a reprogramming request in fiscal year 2001 to 
move $20 million out of the Incumbent Worker program into the 
Youth Offender program, to make it a program totaling $75 
million over the 2-year period, between 2001 and 2002.
    Senator Specter. Well, so are you saying that with the 
reprogramming, if it is approved, that there will, in fact, be 
no cut in the Youth Offender program for fiscal year 2002?
    Mr. McMullen. No. That is not what we are saying. What we 
are saying is that we are proposing to increase the amount that 
you appropriated in 2001 to spread it over a 2-year period. But 
there is no new budget authority request for the Youth 
Offenders in 2002. That is correct.
    Senator Specter. Well, is the program eliminated or simply 
cut by $55 million in 2002?
    Mr. McMullen. It is not eliminated. It is continued through 
2002 by this reprogramming request.
    Senator Specter. And what happens after 2002?
    Mr. McMullen. We will address that in the 2003 budget.
    Secretary Chao. I understand your concern.
    Senator Specter. Well--so I am not following. Will the 
Youth Offender program have less money in 2002 than in 2001?
    Mr. McMullen. Yes.
    Senator Specter. How much?
    Mr. McMullen. Well, the $75 million is for a 2-year period. 
So you had appropriated $55 million. So if you----
    Senator Specter. Could you skip the----
    Mr. McMullen. If you assume----
    Senator Specter [continuing]. The reasons and tell me how 
much?
    Mr. McMullen. If you assume the $75 million equally spread 
over 2 years, it would be $37.5 million.
    Senator Specter. It's $37.5 million less?
    Mr. McMullen. No. That is a total----
    Secretary Chao. No. That is a total----
    Senator Specter. Well----
    Mr. McMullen. No. That is a total over----
    Secretary Chao. Right.
    Mr. McMullen. $37.5 million each year----
    Secretary Chao. Right.
    Mr. McMullen. [continuing]. 2001 and 2002. So----
    Senator Specter. Is that the appropriation, or is that the 
reduction?
    Mr. McMullen. That----
    Senator Specter. This is the sixth time I have asked the 
question.
    Mr. McMullen. The appropriation was $55 million in 2001. 
And we are proposing to move $20 million more into it to make 
it a $75 million program to be operated over a 2-year period. 
If you assumed even----
    Senator Specter. So $75 million divided by two is $37.5 
million----
    Mr. McMullen. $37.5 million, right.
    Senator Specter [continuing]. And if it had been at $55 
million, that is a $17.5 million cut.
    Mr. McMullen. That would be about a--that is correct.
    Senator Specter. Which is about a third.
    Mr. McMullen. That is correct.
    Senator Specter. Well, okay. We have the standing to make 
some modifications in it, obviously, but----
    Mr. McMullen. That is correct.
    Senator Specter [continuing]. That is a danger signal.
    And how about the youth activities at $102 million, which 
is being reduced in 2002 compared to 2001?
    Secretary Chao. If I can ask Mr. McMullen to take a look at 
that also.
    Mr. McMullen. Yes, sir. We are proposing a reduction in the 
youth area, assuming that the reprogramming that we have 
pending before you be reduced by about 13 percent from 2001 to 
2002.
    Senator Specter. So is the figure accurate as provided by 
my staff to me, that youth activities will be decreased--second 
time I am asking this question--by $102 million in 2002, less 
than 2001?
    Mr. McMullen. Yes.
    Senator Specter. Well, Madam Secretary, on a priority 
public policy matter, what is the justification for that?
    Secretary Chao. I think the President was trying to ensure 
a budget that had fiscal discipline, that was able to meet the 
key priorities of our Nation, protect Social Security and 
Medicare, and hopefully also put some money back into the 
pockets of working men and women in--of America.
    Senator Specter. You are not going to tell me that the tax 
cut is taking this money. That is going to very materially 
weaken the case for the tax cut.
    Secretary Chao. Well, this is the beginning of a dialogue 
that I am having with the committee. And so what I am learning, 
obviously, is the concerns and the priorities of the committee. 
And so I appreciate the opportunity to learn about this.
    Senator Specter. Well, I really do not think that these 
cuts do impact on the tax cut. I just made that comment, when 
you say putting money back into the pockets of the taxpayers, 
which I think is a good idea.
    And we are really looking at an overall budget. And my red 
light is on, so I will just make this brief comment and turn to 
my colleague Senator Harkin.
    We are looking at a decrease in budget which is very 
material, $562 million, and when you have an overall increase 
that the President has proposed by four percent--and that may 
be adjusted upward.
    I do not know what is going to happen. The Budget Committee 
has not yet concluded its work. And I realize that you have to 
negotiate with the Office of Management and Budget. And that is 
the executive branch and these figures have to be worked out.
    Our interest on the subcommittee level is to try to get, to 
the extent we can, the administration's thinking, as we try to 
establish a total budget for our subcommittee, which was at 
about $108 billion last year; and then how we make the 
allocations to all the departments.
    But as I take a look at some of these cuts, I think we will 
have some suggestions for you.
    Senator Harkin.
    Senator Harkin. Thank you, Mr. Chairman.
    Madam Secretary, several years ago, the Department of 
Labor, at my urging and Senator Specter's, began to--began a 
process of taking a look at the use of child labor around the 
globe and how that was impacting our country and impacting 
world trade.
    The Department of Labor, U.S. Department of Labor, has put 
out five volumes. I recommend them to you. You do not have to 
read every one of them, but I recommend you at least take a 
cursory look at those.
    Five volumes over the last--how many years? Seven years, 
maybe--about 7 years, on various aspects of child labor around 
the globe, including child labor in this country. As that 
process moved forward, we began on this committee to take a 
look at our obligations in the international labor organization 
and what we might do to help a program called IPEC, the 
International Program for the Elimination of Child Labor.
    I felt at that time, and I think a lot of people felt that 
the United States ought to stand as a leader, as a beacon to 
the rest of the world in terms of eliminating child labor, that 
we should not just get along and go along, but that we ought to 
take concrete action to help reduce the incidents of child 
labor around the globe.
    To that extent, this committee and, along with the House, 
began to increase funding for that program that is called the 
IPEC, the International Program for the Elimination of Child 
Labor. And so we started putting money into it. And that went 
up to--the final appropriation last year was $45 million for 
that, up from $30 million the year before.
    Concurrently, along with that, one of the problems that I 
have seen as I have traveled around the world and looked at the 
issue of child labor in other countries, is the problem of 
education, that you cannot just take these kids and take them 
out of some of these factories and plants and--surgical 
instruments and clothing and things like this, most of whom are 
girls, women, young girls, and dump them out.
    So the--there is a program that was started that was an 
educational aspect of this program to provide support for 
educational programs for these children who were taken out of 
these plants and out of these factories in some of these 
countries.
    And so we began a bilateral program with other countries 
for education. Now, I have, on my own, seen the results of this 
in some other countries and what has happened.
    And it really has been startling to see these young girls, 
some of them 10, 11, 12 years old, and they have been working 
in these plants for 2, 3, or 4 years, since they have been 8 
years old. They do not know how to read. They do not know how 
to write. They do not know basic arithmetic.
    They have been taken out of these plants. They have been 
sent to school. They have been given materials. The families 
have been given a little bit of a stipend to replace some of 
the lost wages.
    And if you ever want to have an uplifting experience, go to 
one of these countries--I do not need to name them all here--
and just see some of these young girls, who are now 13 years 
old. And they can read. And they can write. And they can do 
basic arithmetic and math. What has happened to them just in 
the last 2 or 3 years has been remarkable.
    And so the United States is now taking a lead in this; and 
I think for good cause and for good outcomes and to help end 
the discrimination that we see around the globe on child labor.
    Well, we put $45 million in it last year, into IPEC. We 
added $37 million for the education program. Your budget cuts 
the IPEC program by, considerably, from $45 million to $30 
million, and you eliminate the educational aspect that we put 
$37 million in last year. And it cuts 17 FTE's in that program.
    Well, Madam Secretary, I think this is a vitally important 
program. It is one that we have been making slow progress on 
over the last several years through the Department of Labor. I 
think the Department of Labor has moved to the forefront of 
this.
    I believe in the international community, as I have met 
with international labor organizations and others, they are now 
looking upon the United States as being a leader in the 
elimination of child labor and the promotion of educational 
benefits for these kids.
    I think it really is a step backward for us to try to zero 
this out and to reduce the funding for it. And I would just 
like to have your comments on it.
    Secretary Chao. I would be pleased to. You mentioned 
visiting countries in which these child labor practices occur. 
I have visited them. I have been with the Peace Corps, and I 
have visited many countries. There is no doubt that this is a 
serious issue, and we all care deeply about it.
    I think the larger issue is whether an office such as 
International Labor Affairs Bureau, is able to absorb the money 
because in 1996, the budget of the ILAB was about $9 million. 
In 2000, the funding was increased to about $76 million. And in 
2001, the funding was increased to about $147 million.
    That is beyond the capacity of one office to absorb. And 
one way obviously to absorb that money is to contract out $70 
million of it.
    I do not know whether that, indeed, is a responsive way of 
doing it, and certainly you can contract out $170 million or 
whatever to organizations overseas.
    So please be assured that we are not differing at all in 
terms of the goal. We want to work with you on this. The issue 
is how best to do so, and how we can work and how ILAB can 
absorb all this money in such a short period of time. But the 
commitment, I assure you, is absolutely there. And we look 
forward to working with you on that.
    Senator Harkin. Well, I will work with you on it.
    All the indications I have is that this money is well 
utilized and they could absorb this increase.
    I would be delighted if you want to give me some written 
documents to show that this money is not being utilized well.
    Every indication I got was that it was well utilized and 
that they were able to handle this. If you are telling me it 
was not, I would like to have some information on that.
    I just think to go from $37 million to zero is really 
turning it--I mean, obviously they could do more than zero on 
education.
    Secretary Chao. But the budget of the whole office is the 
International Labor Affairs Bureau. I think I was asking for 
clarification as to the difference between ILAB and IPEC.
    ILAB, itself, under which this program falls, has a budget 
of $74 million that went up to about $140 million. So that is a 
lot. And I think that was the absorption issue.
    Senator Harkin. Over 3 years. That is because of IPEC and 
the education.
    Secretary Chao. Yes.
    Senator Harkin. So----
    Secretary Chao. And so a large part of that was just 
contracted out. And if you want to build the infrastructure, 
internally, that will take some time.
    Senator Harkin. But my staff just said--you are talking 
about ILAB, but the IPEC program is something that has been 
going on for years.
    Secretary Chao. Yes.
    Senator Harkin. This is not something new. It has been 
going on for many years.
    Secretary Chao. This is part of ILAB though. And the funds 
are fungible.
    Senator Harkin. The program, IPEC----
    Secretary Chao. Yes.
    Senator Harkin [continuing]. International Program for the 
Elimination of Child Labor has been going on for a long time. 
This is not something new.
    Secretary Chao. I have been told it is new. Let me look 
into it for you, and clarify that.
    Senator Harkin. Well, okay. Just----
    Staff. The education part is----
    Senator Harkin. Yes. The education part was new. That is 
what we started. I look forward to working with you. I just 
think it is not right to be backing off on that right now.
    Let us see. I just had one other area. According to the 
OSHA strategic plan, you specifically cite the Susan Harwood 
training grants as one of the main tools your Department 
intends to use in OSHA's mission, which is improving workplace 
safety and--and health.
    These grants provide funding to non-profit organizations to 
conduct safety and health training and education in the 
workplace.
    Yet on March 29, you sent a letter to the 2001 awardees, 
informing them that you rescinded the funding, citing budgetary 
reasons. One of the grantees, Kirkwood College in Cedar Rapids, 
Iowa, had received a $381,000 award. These grants were funded 
through the fiscal year 2001 money that this committee 
appropriated last year.
    Secretary Chao. Yes.
    Senator Harkin. So, again, I wonder: What are the budgetary 
circumstances that necessitated taking this funding away? If, 
in fact--you also said that you specifically cited the Susan 
Harwood training grants as one of the main tools. Then you send 
a letter out saying that you are going to rescind the funding.
    Secretary Chao. Let me backtrack a little bit. These grants 
were given on a 3- to 5-year basis. And so the grants were 
given basically on the basis of an old budget. In our going 
through the budget this time, we found that there was not 
enough money.
    So let me just also say I have heard a great deal of 
concern expressed on this, not only from you, but from other 
people. I have received lots of letters. And so that is another 
area that I will be looking at.
    These grants will not be terminated. We are asking for new 
solicitations for a 1-year term. So those grants will go 
forward. Instead of the 3- to 5-year time frame that was being 
talked about, we are going to go for 1-year grants and take a 
look at receiving applications for 1 year.
    We are encouraging people, in fact, to reapply. Although, 
it will be a 1-year term instead of 3 to 5 years.
    Senator Harkin. These grants that went out were not 1-year 
grants.
    Secretary Chao. No. They were not. They were 3 to 5 years. 
And we did not have the funding at that time, which is why we 
are going out with a new process.
    Senator Harkin. Okay, explain--let's take Kirkwood College 
in Cedar Rapids. They had received a $381,000 award. We put the 
money into it. We appropriated the money for that program 
there.
    Now, you write a letter saying ``We are rescinding that 
money.'' Why?
    Secretary Chao. Yes. Because it was for a commitment of 3 
to 5 years that this administration was not ready to commit to 
at this point. So we would like to start the program anew and 
go out with a 1-year application process.
    Senator Harkin. But I mean at least the money that went 
out----
    Secretary Chao. Yes.
    Senator Harkin [continuing]. Why did you rescind that 
money? If you want to do something else next year, come in and 
do something this year. But as I understand it, you are trying 
to rescind this money.
    Secretary Chao. Well, people are just restructuring the 
program from a commitment of 3 to 5 years to 1 year.
    Senator Harkin. So----
    Secretary Chao. We are encouraging people to apply.
    Senator Harkin. So Kirkwood is going to receive their 
$381,000 then?
    Secretary Chao. I do not know whether that is a 1-year or a 
3- to 5-year commitment, but we encourage them to apply again 
for a 1-year grant. And I certainly would understand your 
concern with that.
    Senator Harkin. My staff tells me that Kirkwood got 1-year 
money with the possibility that it could be extended beyond 
that.
    Secretary Chao. Well, they are, again, invited to apply 
again for the 1-year grant.
    Senator Harkin. Well, I do not really understand that.
    Secretary Chao. Instead of making a commitment for 3 to 5 
years, we are saying: This is a new administration. We would 
like to have the opportunity to review some of these grants. 
But please apply for a 1-year timetable, instead of a 3 to 5. 
So that gives us some time to evaluate some of these grants.
    And it is not a political process. I mean, the same people 
will be going through it, the same career professionals. So we, 
in fact, would like people to apply for a new grant, but just a 
1-year grant.
    Senator Harkin. Well, I will take a look at that. I do not 
know. I----
    Secretary Chao. And I appreciate your bringing that up to 
me. Clearly, you are concerned about that one.
    Senator Harkin. Yes. We have got to take a----
    Secretary Chao. I am very much aware of that.
    Senator Harkin. We have to take a look at that.
    Can we go back to ergonomics here for a second?
    Secretary Chao. Yes.
    Senator Harkin. Last week, I asked how much of the budget 
would be dedicated to reviewing the--this whole issue of 
ergonomics with this--I--and as I understand, what you are 
doing is you are moving ahead to develop a new standard.
    You said that there was some problems in the rule. It 
needed to be more thoroughly reviewed. Okay. Fine. That is 
certainly that is your power to do that as Secretary and this 
administration, because the old rule was done away with.
    But as I understand from your statements that you want to 
move ahead with a new rule, with looking at a new rule and--and 
getting information on looking at the problems of the old one.
    Okay. If you are going to do that, then it is my 
understanding that the budget for the development and 
evaluation of Occupational safety standards is cut by $1.2 
million. So, again, given your statements that, ``The rule was 
problematic. We need to thoroughly review it and come up with a 
new rule,'' how can we cut the budget by $1.2 million?
    I was asking you also last week how much funding does your 
budget allow for review of this issue?
    Secretary Chao. Right. The OSHA standards budget is 
approximately $14 million. Now, not all of that will be for 
ergonomics, because it has not been earmarked. But potentially 
all of that can be available. So that is the--the overall pot.
    We have an overlay--you know, an overhang of $1.7 billion. 
So a lot of that overlay is going to be funding. Because the 
cut in the budget is only $562 million, the larger-than-usual 
increase in the overhang of unexpended funds is over $700 
million.
    So that is why I was saying that enforcement will not be 
compromised, that none of these programs will be compromised, 
because, again, we have this overhang of unexpended funds.
    Senator Harkin. My staff informs me that all of that 
unspent money is in training, not in OSHA.
    Secretary Chao. You are right. I stand corrected.
    Senator Harkin. So what--okay. Then we come back to OSHA 
again.
    Secretary Chao. The OSHA also--some of the decrease also is 
because of the cost of living adjustments in terms of FTE's.
    Senator Harkin. Well----
    Secretary Chao. So that took up some parts of the budget.
    Senator Harkin. Again, Madam Secretary, I want to ask you 
again, with all due respect, you know, if we are moving--I am 
taking you at your word. And I am taking the administration at 
its word, since you represent the administration, that you had 
problems with the old ergonomics rule, that you want to look at 
the problems that were in it, and you want to come up with a 
new rule.
    Is that my understanding, or am I wrong in understanding 
that?
    Secretary Chao. No. I have not committed to any course of 
action. So I have not committed to a rule.
    Senator Harkin. Well----
    Secretary Chao. I wanted the opportunity to take a 
comprehensive look at this whole issue.
    Senator Harkin. So you are not committed to coming up 
with--because I--we got into a little bit of a debate a week 
ago about a time frame. So now you are telling me you are just 
going to look at it.
    Secretary Chao. No. I never said that I was coming up with 
a rule.
    Senator Harkin. So you are not coming up with a rule.
    Secretary Chao. I am not dismissing it either. But I have 
never said that I was going to come out with a rule.
    We have been in office basically since February--or January 
20. The C.R.A. did not occur until March 20. So until the 
C.R.A., there was an existing rule. So we have had less than a 
month.
    Senator Harkin. Well, I just--your statement here on March 
28 said--you say in your own statement is that, ``However, 
musculoskeletal injuries accounted for nearly one-third of all 
the injuries. This finding demonstrates the need for a solid 
comprehensive approach to ergonomics.''
    Secretary Chao. I totally agree with that.
    Senator Harkin. But that does not mean a rule?
    Secretary Chao. Well, I have not decided yet. I am not 
saying there will not be a rule either. I think the responsible 
way to approach it is that there is a new team in town. And I 
think we have to feel comfortable with taking the appropriate 
course of action. And we need to talk with the administration.
    Senator Harkin. Well, unfortunately, I wish I knew what 
that course of action was going to be. I mean, I have just----
    Secretary Chao. Well, I cannot----
    Senator Harkin. I mean----
    Secretary Chao. I wish I knew as well. But if I did, I 
would be working out of a preconceived position. And I said 
that I would keep an open mind and that I would talk to 
stakeholders, that we would review the past record, that we 
would talk to all different groups.
    And, in fact, in my previous testimony, I had talked about 
certain principles that we would have going forward. And that 
was basically to go from a basis of prevention. We all agree 
that reducing occupational injuries and musculoskeletal 
injuries is our goal. And the question is how best to do that.
    And I listed six principles. One is prevention. Two is some 
program based on sound science. Three that it be incentive 
driven, so employers would really embrace it as well. Four, 
some flexibility.
    Senator Harkin. Well----
    Secretary Chao. ``One size fits all,'' I do not think does 
it. Five is feasibility; and six, clarity. So at this point we 
have not made a decision.
    Senator Harkin. Well, that is fine, but----
    Secretary Chao. We are proceeding in good faith to address 
this issue.
    Senator Harkin. Fine. And every time you are here, I am 
going to ask you the same question.
    Secretary Chao. I understand that.
    Senator Harkin. I am going to try to find out when we are 
going to start moving on this.
    And, fine, if you do not have a timetable now, well, we 
will ask it the next time. And we will see when we are going to 
get some timetable and move ahead on this.
    Secretary Chao. I understand, yes. I would love to have a 
timetable. I think that would be very comforting.
    But what we have seen on this issue is that when artificial 
time lines are imposed, workers do not benefit. None of us 
benefit because----
    Senator Harkin. Well, Madam----
    Secretary Chao. I----
    Senator Harkin. Madam Secretary, also workers do not 
benefit when this dribbles along year after year after year, 
and nothing is ever done.
    Secretary Chao. But we are not talking about years, 
obviously.
    Senator Harkin. More injuries continue to happen. More 
people suffer. And so if I get my druthers, I would rather have 
a time line because it forces people to do something and get 
something done by a certain time. But if you do not have time 
lines, it just dribbles on year after year after year.
    Secretary Chao. I understand exactly what you are saying. I 
am very concerned about it. If I may just add one last thing, 
we had a time line before with the previous administration and 
it did not work. So I want to make sure there is not a repeat 
of any action that can be reversed.
    Senator Harkin. Mr. Chairman.
    Senator Specter. Thank you very much, Senator Harkin.
    Madam Secretary, on the worker protection line, the 
President's budget maintains the activities at last year's 
dollar level, but as a result of inflation, there will be a 
reduction in staff enforcement.
    That leaves less staffing than is in effect for this fiscal 
year for OSHA enforcement, mine, safety and health 
administration, and employment standards administration.
    Is it not, simply stated, a bad idea to reduce staff on 
those very important lines of enforcement?
    Secretary Chao. I said before--I am trying to answer the 
question directly. There is no question that we are for 
enforcement. And in looking over this budget, there is no 
compromise to the quality nor the intensity of enforcement. We 
are going through all of these reductions through attrition.
    And also I think one has to make the assumption--one has to 
look at whether these positions were the right numbers to begin 
with. And so we are committed to going through, looking at the 
numbers to see whether this, indeed, is the enforcement that we 
need, but there is no lack at all in commitment--in backing 
down in commitment on enforcement.
    Senator Specter. Well, Madam Secretary, when you say you 
are committed to enforcement, there is no showing that there 
are too many people in these enforcement lines. And if you 
reduce the number, the enforcement is, simply stated, going to 
suffer. Well, we will take a look at that too, but that is a 
big problem.
    We have already gone over the cuts in the job training 
programs, the youth program, the Workforce Investment Act, and 
the dislocated worker programs. We will review those here.
    Let me take up a different subject with you on medical 
resident work hours. The Federal Government limits the number 
of hours that truck drivers and airplane pilots can work, among 
others. And there is a big issue on medical resident work 
hours, where physicians work up to 80 hours a week, without a 
day off, and sometimes more than that.
    And there is a good bit of evidence accumulating about 
sleep deprivation associated with these long hours resulting in 
automobile accidents, depression, and giving birth to premature 
infants. I am reading a list of the factors, which have been 
called to the subcommittee's attention.
    And then you have the basic problem of people who are being 
treated by these residents who are, simply stated, groggy, and 
simply cannot perform.
    There was a petition filed on April 30 to OSHA from 
healthcare professionals seeking a Federal limit on the number 
of hours medical residents can work. What do you think?
    Secretary Chao. I just learned about the petition on 
Monday, so I have not had an opportunity to review it. 
Obviously, if the Chairman is concerned about it, I am 
concerned about it. And I will take a----
    Senator Specter. Well, perhaps we ought to have a hearing 
on that specifically. I realize that it has just been filed and 
there is always a reluctance to increase Federal jurisdiction. 
Especially when you talk about hospitals with the Balanced 
Budget Act, their economies and sort of an unwritten code that 
if you want to be a high and mighty doctor, you have got to 
suffer a lot going through on the resident process, and the 
argument is made that they make up for it later.
    But this is a real problem for those who are going through 
it. And it is a real problem for people who are in hospitals 
that received their services.
    Secretary Chao. I might also add, probably we have to talk 
to HHS about this as well.
    Senator Specter. Turning to still another subject, there 
has been a long-standing problem with the Amish--a good many of 
whom are in Lancaster County and are constituents of mine--on 
an effort to have Amish youth, 14 to 18, work in sawmills.
    The House of Representatives has twice passed legislation 
to allow that. We have had legislation pending in the Senate, 
which I have introduced. What I would like you to do is to take 
a look at that.
    It is a fairly involved and fairly technical subject, 
unless you already have a view on it. Tell us what you think 
about that.
    Secretary Chao. I am very sympathetic. And, obviously, as I 
have said before, concerns by members resonates strongly with 
me. I will take another look, but the preliminary response that 
I have gotten from Wage and Hour is that this has to be a 
legislative fix.
    Senator Specter. It has to have a legislative fix?
    Secretary Chao. Yes, and that they do not have very much 
flexibility in reinterpreting that.
    But on the other hand, I do not have my solicitor in place 
or lots of other people in place. I will take another look.
    Senator Specter. Well, take a look. It is a little early 
for you to really be expected to have a comprehensive view of 
that, but it would not be unkind to say that it may be a 
bureaucratic response to say there has to be a legislative fix.
    Secretary Chao. Well, I am hoping that, you know, as I get 
my team staffed up, that we will be more responsive, and we 
will be able to answer a whole host of questions.
    Senator Specter. The President has a lot of discretion. And 
he has delegated that discretion to the Secretary of Labor, so 
let us take a look.
    Secretary Chao. I will do so.
    Senator Specter. I think administratively would be a much 
better way to handle that.
    My red light is on again. So I am going to yield to my 
colleague.
    Senator Murray.
    Senator Murray. Thank you very much, Mr. Chairman.
    And, Secretary Chao. Welcome. It is good to have you here, 
and I am--let me just say at the beginning, I am encouraged by 
what I see in your Department's proposed budget.
    Increasing funding for the Department by $5.2 billion, I 
think, is a positive sign in providing adequate resources for 
programs like Job Corps and funding for the Office of 
Disability Employment Policy and other critical assistance 
programs, I think, is essential.
    I am concerned, however, about some of the decreased 
investments for job programs that help at-risk youth and funds 
employment and training activities for dislocated workers.
    And let me start by asking you about at-risk youth. I think 
we all know that the job requirements, the education 
requirements, the training requirements for our work force have 
changed dramatically in the last decade. And today, more than 
ever, our workers need more education and training to develop 
the skills they need for the--the jobs that are out there 
today.
    And I am really very concerned that your budget provides 
$222 million less for youth employment and training programs. 
We cannot leave young people out of our country as we move 
forward. And I would appreciate it if you would address that 
cut in your budget.
    Secretary Chao. There is no commitment, obviously, to 
backing away from helping youths at risk. It is an issue that I 
feel strongly about, and I have worked with in the past.
    I mentioned before that there was about $1.7 billion in 
unexpended funds. And the usual carryover is about $1 billion. 
So we have an extra $700 million. The cuts from the budget is 
only about $562 million. So the carryover still takes care of 
the overall reduction.
    The youth carryover is about $480 million, so we can 
maintain the service levels.
    Senator Murray. The carryover from last year's budget?
    Secretary Chao. So we, again, do not expect any diminution 
of service or commitment, obviously. But that we believe that 
we can maintain the service levels.
    Senator Murray. Were those funds that were appropriated and 
not spent?
    Secretary Chao. Yes.
    Senator Murray. I hope then that you have a commitment to 
make sure that those grants and opportunities move out there 
for our young people. There is a high increasing demand for 
that.
    Secretary Chao. We will do so.
    Senator Murray. Okay.
    Secretary Chao. And there is also a reprogramming request 
of $20 million that makes for a 2-year budget request of $75 
million. So we went over that a little earlier. But 
participants will not go down because, again, the number of 
participants will not go down and the quality of the program 
will remain undiminished.
    Senator Murray. I think it is--good. Yes. I think it is 
really important that we emphasize that we do not want to see 
our kids on the street with no skills.
    Secretary Chao. Yes.
    Senator Murray. Second, I am very concerned about 
dislocated workers. In my end of the country, we have seen a 
lot of dislocation, unexpected, in the last year or two, 
particularly with the current energy crisis that has shut down 
some of our mills and aluminum companies and threatens more, 
very--in the very near future. We have seen over 2,000 layoffs 
at this point and we will be seeing more.
    Boeing has had some layoffs. Our high-tech industries are 
not employing and--and having layoffs. And I am very concerned 
that your budget has decreased adult employment and training 
programs by $257 million.
    I think the demands for these dislocated workers are 
increasing. And if you could address that, I would appreciate 
it.
    Secretary Chao. There is also some talk about a softening 
economy, so this is obviously an area that we are concerned 
about. We want people to be able to find assistance.
    The dislocated workers program, again, is one of those 
programs that we do not expect any diminution of service nor 
quality, because of excess funds from the previous years.
    I know that in your particular State, you have got special 
concerns. And I will be more than glad to work with you on 
those concerns, as well.
    Senator Murray. Okay. I would really appreciate your doing 
that, because we are seeing a lot of dislocation. We are going 
to see more. And we want to make sure that these people land. 
So I would very much like to work with you on that.
    In a place where we are seeing a lack of workers is the 
nursing shortage that we are currently seeing that I am very 
concerned about. Our healthcare facilities, our long-term 
facilities are very concerned about the lack of healthcare 
workers that are coming into--into that.
    And we are currently working in the Senate now on 
legislation to provide $500 million a year for the next 3 years 
in grants to States to promote the nursing profession and to 
help long-term care providers, to recruit and train and retain 
caregivers at all levels.
    Would you be supportive of that kind of an approach?
    Secretary Chao. I have talked a lot about the skills gap. I 
think this is clearly one example. So I have set up a new 
office called the 21st Century Workforce. And this is one of 
the areas that we are going to address, for example, at the 
summit that we are holding on June 20, and as we go forward as 
well.
    Senator Harkin. Okay. Well, Secretary Thompson testified 
before the committee last week that part of the solution might 
be tied to allowing more foreign nurses and healthcare workers 
to immigrate to the United States to help fill that void.
    Would you be willing to work your Agency with his to talk 
to the Department of Justice and Immigration and Natural 
Service to try and enact something like that?
    Secretary Chao. We would be interested in exploring this 
option further with him.
    Senator Murray. Okay. I think it is important that we look 
at all ways to meet that need.
    Secretary Chao. Right.
    Senator Murray. So I encourage you to do that.
    On an entirely different topic, I want to talk about 
asbestos for a minute. Most people in this country think that 
asbestos has been banned and they do not have to worry about 
it. But asbestos has not been banned in this country and in 
some cases, it is still being used to manufacture automotive 
brakes and roofing materials.
    And we are seeing it show up in consumer products like 
crayons, garden fertilizers and insulation. Because asbestos is 
a contaminant found in deposits of other minerals, that is why 
we are seeing that.
    Evidence has suggested that workers have died from 
exposure. The case in Libby, Montana, where 192 people have 
died has been very prominent in the news. And 375 people are 
currently suffering from fatal diseases caused by that 
exposure.
    I was curious whether you were familiar with the Inspector 
General's report on MSHA's handling of inspections in the mine 
in Libby and with the recommendations that are in that report.
    Secretary Chao. The I.G. has handed that report to me 
about, I would say, 3 weeks ago. We are in the process of going 
through that.
    I do not have an MSHA administrator yet. He has been 
announced and nominated. We hope that he will be confirmed 
soon, so that he can tackle this issue as well.
    Senator Murray. Well, when he is in place or even before, I 
would like to work with your Agency to make sure that we 
address that and implement the recommendations that require 
rule--rule-making as quickly as possible.
    And I see that my time is up. Thank you.
    Senator Specter. Thank you very much, Senator Murray.
    Senator Harkin, do you have one more question or----
    Senator Harkin. Just one more question.
    Just picking up on what Senator Murray was talking about on 
the employment and training money that you said there was this 
carryover. First of all, I understand that the amount--that 
even though you have a large carryover, the amount varies per 
State.
    Secretary Chao. Yes.
    Senator Harkin. And so dislocated worker funds go to States 
on a formula basis.
    Secretary Chao. Right.
    Senator Harkin. Therefore, every State will take the same 
percentage cut even though some States may have a big carryover 
and some States may not have much carryover.
    Well, here is the point I am getting to: My staff at my 
direction requested an analysis, because I wanted to know what 
was happening in Iowa, obviously, my State. I wanted an 
analysis of the unexpended carryover funds in employment 
training programs by State. About a month ago, my staff 
requested this breakdown by State.
    They were told by your staff that a table--there was a 
table. We have asked repeatedly as late--as late as yesterday 
to get this, but your Department will not release it. So I am 
asking: Will you release to me the information that will allow 
us to understand the impact on the cut to my State--and our 
States?
    Secretary Chao. I see no reason why you cannot have that at 
all. So I am not aware of that request. But you will have it.
    Senator Harkin. If you can get that, because I would like 
to see, because it does vary State by State.
    Secretary Chao. Sure.
    Senator Harkin. And if you are going to take a cut that is 
percentage, some States may be fine. Some States may not be 
fine. And I think we, as appropriators, need to take a look at 
that. And I would appreciate it.
    Secretary Chao. I think that is a very reasonable request.
    Senator Harkin. I appreciate it. Thank you very much, Madam 
Secretary.
    Thank you.
    Senator Specter. Thank you. Thank you, Senator Harkin.
    Madam Secretary, the hearing that we had on last Thursday 
on ergonomics showed a very, very deep split between some 
segments of the business community and those representing the 
workers.
    And I know your schedule precluded you from attending the 
full hearing, but we have given you the transcript. We ordered 
expedited transcripts so that we could take it up today.
    Do you think that there is any realistic likelihood that 
there can be a consensus on an ergonomics rule?
    Secretary Chao. No, I do not; 100 percent consensus, no. 
But I think there has to be some critical mass upon which to 
move forward because without that critical mass, I do not think 
any program is going to be successful.
    So I am keeping an open mind and I do not have any 
preconceived notions. I am keeping all options open. As I 
mentioned in my letter, it may include rulemaking. I have not 
ruled anything out. I have not made a final decision.
    We have only had since March 20 when the C.R.A. was pleased 
to take a look at this. And I can assure you that we are 
proceeding with full speed and with absolute seriousness and 
intent to try to address the ergonomics and musculoskeletal 
injuries.
    Senator Specter. When you say that you are proceeding at 
full speed, precisely what are you doing?
    Secretary Chao. We are meeting with--well, this is a new 
team also. And I think we need to be given time to, No. 1, meet 
with the shareholders, and go through the past record.
    In terms of making up a new rulemaking, we cannot go back 
to the previous record and draw--well, there is some question 
as to whether--and you know better than me. There is some 
question as to whether we can go back to the previous record 
and just utilize the information of the previous record, 
because there were issues expressed about, not only the 
substance, but also the process.
    So I think at the very start, we need to go back and talk 
with all the stakeholders. I think we have done a good job. We 
have met with multiple groups in an effort to listen to 
everyone, first of all, and then try to craft some program for 
moving forward that will not be stymied right from the outset.
    Senator Specter. Well, Madam Secretary, I think it is 
reasonably clear that you can go back and look at the 
information which was compiled before.
    Secretary Chao. Yes.
    Senator Specter. You are going to have to satisfy yourself 
as to an evaluation of it and to have an opportunity for people 
to comment about it. But you can take a look at what has been 
presented in the past.
    Secretary Chao. That is true.
    Senator Specter. This subcommittee wants to, in its 
oversight capacity, monitor what you are doing on a time line.
    I take it from your response to Senator Harkin's question 
that when I asked you to go back and take a look to see if you 
could give us a time line or a concluding date, that you have 
thought about that but do not think you can give us a target 
date.
    Secretary Chao. I would love to, if I could, but I just do 
not think I can. I do not think that is a responsible way to 
approach it. I am not going to drag this out. I can assure you 
of that. But I think for me to come out with a deadline would 
be very irresponsible.
    Just to let you know, we have met with United Commercial 
Food Workers. This was in my testimony last time. We have met 
with the AFL-CIO, Service Employees International Union, United 
Brotherhood of Carpenters and Joiners. We met with a lot of 
labor groups, a lot of--American Occupational Therapy 
Association, Food Marketing Institute, certainly on the other 
side, American College of Occupational Environmental Medicine.
    So we are conducting our due diligence in meeting with 
these various groups. We are going back to the record. There 
were 11,000 comments on the old rule in just a 12-month period. 
We are not obviously going to go through the whole thing, but 
there have been criticisms of the process.
    And while we can go back, obviously, and take a look at the 
previous record, there has been some criticism as to whether 
that record is inclusive of other types of information.
    And also there have been concerns about--comments were 
submitted by citizens, you know, that were farmed out, paid 
outside consultants. I mean, this is pretty--this is a very 
complicated issue. It is very complex.
    I am not interested in slowing it down, but I do want to do 
it right. And, again, I want to do it right because we have got 
to do the right thing; otherwise, another overturned action can 
occur. And I am not so sure that benefits anyone.
    Senator Specter. Well, I daresay that something that the 
Bush administration comes up with is not likely to be 
overturned. The action by the Congress was highly unusual. And 
I supported overturning the regulation, because I thought it 
was excessive and others did too, where there were some 
expressed commitments made by legislators, by Senators that 
there would be a new rule.
    Now, they do not bind you, but this is something we will be 
talking about within the Senate, where we have a lot of 
experience on this issue. And the people who were strenuously 
opposed the rule were able to persuade a number of us to vote 
to overturn that rule on the representation that there would be 
a new rule.
    Now, I understand the articulation you have made. And they 
do not bind you, but we are all players in the process, and we 
all have a role in the process. And those who made those 
representations to secure votes on the Senate floor have some 
impact and some weight.
    Let me raise a question as to your use of the term 
``irresponsible'' to come up with a----
    Secretary Chao. Well, let me answer the previous point. If 
other people have made representations, then those are the 
people that should--that should be--that this matter should be 
discussed with.
    I stated very plainly in my letter that I was not ruling 
out rulemaking, but I was not committed to it either. So, 
again, if there are other people who made other 
representations, then they should be talked to.
    Senator Specter. Well, you can bet they are being talked 
to. You can be sure of that.
    I have already made it abundantly clear that I understand 
they do not bind you. There is this doctrine called 
separation----
    Secretary Chao. I am very interested in having a good 
relationship with this committee and especially with the 
chairman and the ranking, so I hope you will realize that I 
will--I am looking at this from a long-term point of view. I 
would never play any short-term games or anything like that. 
And I hope that you understand that.
    Senator Specter. Well, I was about to say I understand the 
doctrine of separation of powers and that you are an Article II 
officer, and we are Article I officers. And we do not really 
rate very high anyway.
    Secretary Chao. That is not true at all, not----
    Senator Specter. Since----
    Secretary Chao. You rate very high in my book.
    Senator Specter. Since Marbury v. Madison, neither Article 
I nor Article II officers rate very high. The Court decides 
everything these days.
    But I was starting to raise a question about the use of the 
word ``irresponsible.'' To say that it would be irresponsible 
to accept a time line when the subcommittee is pressing for a 
time line, I question that characterization.
    I do not think we are asking for something which is 
irresponsible. There is----
    Secretary Chao. I think that it is irresponsible on my 
part. It is not to say that there is any--that is not to 
attribute that to anybody else but me.
    Senator Specter. Well--but if the subcommittee is asking 
for a time line, and a time line is irresponsible, somebody 
might raise the inference that we are asking for something 
which is irresponsible. So I just----
    Secretary Chao. And I certainly did not imply--I did not 
mean to imply that.
    Senator Specter. I just question the use of the word 
``irresponsible.'' Unrealistic, impossible, difficult--
``irresponsible'' is a word that has a lot of----
    Secretary Chao. I will use one of the other words from now 
on.
    Senator Specter. I know you are familiar with Senate bill 
598, which proposes legislation to establish a time limit of 2 
years for the enactment of a rule. What do you think about 
Congress telling you that you have 2 years to make a rule?
    Secretary Chao. I know that you are a co-sponsor of that.
    Senator Specter. Senator Harkin is not, though. He is still 
safe.
    Secretary Chao. I know that you are a co-sponsor of that 
and, obviously, we are very cognizant of the amendment. We are 
working with--we would like to work with Senator Breaux and the 
sponsors on this.
    A 2-year time frame, as told to me by the career 
professionals in the Department, is unrealistic. It is very 
hard to say pro forma how long a particular rulemaking would 
take. But 2 years for this kind of rule seems overly ambitious. 
But, again, we want to be in discussion on this issue.
    Senator Specter. Well, okay. I mentioned the bill, because 
the Breaux bill does set a time limit. And it is possible that 
bill could be enacted.
    And my preference would be not to have the time limit come 
from the Congress. My preference would be to have the time 
limit come from the Secretary.
    So I would ask you, on behalf of the subcommittee and the 
committee and the Senate and the Congress to take another look 
at this issue to see if you cannot give us some idea as to how 
long it is all going to take.
    Secretary Chao. I will certainly do that. Let me also say, 
you know, given all the pressure that I am under, it would be a 
lot easier for me just to give a deadline. It would make my 
life a lot easier. It would make a lot of--certainly, would 
make my life a lot easier.
    But I have been there for, again, for 3 months. I want to 
do the right thing. I do not have an OSHA administrator yet. I 
have only got two people that are confirmed in the Department.
    You know, Mr. Harkin was talking about responsiveness from 
the Department. The career professionals are wonderful. I 
devote a great deal of time cultivating the relationship with 
them. But we are a new team. We want to be responsive. We are 
not there yet. I fully understand that.
    But as we get staffed up, as we get more familiar with some 
of these issues, I hope that you will think that we are 
responsive as well.
    But, again, let me say, from a personal pressure point of 
view, it would be so much easier for me to say, ``I can give 
you a deadline.'' But, again, I do not think that that is 
something that will benefit any one of us in promulgating a 
truly good program.
    So let--and as I have said before, I want to work with you 
and also Senator Breaux on this amendment. And so my staff, I 
believe, has been talking to all of you. And I would hope that 
that will continue.
    Senator Specter. Madam Secretary, we have taken a look at 
the plans at Levi Strauss, Xerox, Consolidated Edison, United 
Auto Workers, all of which have put ergonomics programs into 
effect with very beneficial results.
    One of them, Xerox, had a 24 percent decline in the number 
of worker's compensation cases. So we would commend to you what 
is going on in the private sector as a model.
    Secretary Chao. Yes.
    Senator Specter. And we understand UPS also has done some 
good work. And we have written to UPS. And the point was made 
that some of the companies have not responded to the Department 
of Labor, like UPS, on giving them the benefit of their 
thinking and their successes. And this subcommittee is in a 
position to help you. Do you----
    Secretary Chao. Well, I appreciate that.
    Senator Specter. Do you know if you have the subpoena power 
to compel, say, a company to come forward and tell you what 
their experience has been?
    Secretary Chao. No, I do not. But I think that is a pretty 
bad example, if we have to compel them. I am not so sure their 
results were--what--are ones that I want to hear.
    Senator Specter. Well----
    Secretary Chao. We are looking at best practices and we are 
interested obviously in finding out what the private----
    Senator Specter. Well, if a company does not respond to 
what their experience has been, the Congress is not reluctant 
to issue subpoenas. And I do not know what----
    Secretary Chao. I will certainly find out if we do have the 
authority to do that.
    Senator Specter. I do not know whether you do, but this 
subcommittee would have no reluctance to find out what 
companies are doing.
    Secretary Chao. I have no reluctance either. I was making a 
little bit of a--of levity, which was probably not appropriate. 
But I was going to say that if they did not want to share their 
results, I am not so sure they are worthy to be shared. But 
your point is a very good one about the subpoena.
    Senator Specter. Well----
    Secretary Chao. And I will find that out.
    Senator Specter. Well, I do not know that UPS has not 
responded. That representation was made. Whether it is so or 
not, I do not know. We are making an inquiry.
    Secretary Chao. And we are talking to other companies on 
best practices.
    Senator Specter. Okay. But these companies which have 
experience, which would be useful to the Department of Labor, I 
expect them to make it available.
    Secretary Chao. Yes.
    Senator Specter. And if they do not, this subcommittee has 
subpoena power. And I have had some experience at issuing 
subpoenas----
    Secretary Chao. Yes.
    Senator Specter [continuing]. And effectively. So I want to 
help you.
    Secretary Chao. Thank you.
    Senator Specter. Madam Secretary, we are going to give you 
some questions from Senator Stevens for response in the record.
    My final question to you--or let me not put it in the form 
of a question.
    I would like for you to give this subcommittee a periodic 
report as to what you are doing, since we have not gotten to 
the point of a time line. I would like you to let us know every 
90 days, if that is not too burdensome. I was thinking about 60 
days, but let us make it 90 days, if you could give us a brief 
summary as to what you have done on the ergonomics issue.
    Secretary Chao. I would be delighted to.
    Senator Specter. Okay.
    Secretary Chao. Let me--may I also add one last thing?
    Senator Specter. Sure.
    Secretary Chao. Going back to the Youth Offenders program, 
let me also take another look at that, because my understanding 
was that the participants would not go down because of the 
carryover funds. And so if that is not the case, then I will 
take a look.
    But that--my understanding was that the quality of the 
program was not going to be diminished, and number of 
participants will not go down--again, because we had this 
excess funds. But if that is not the case, I will get----
    Senator Specter. Well, that is an especially important----
    Secretary Chao. I will get back to you on that.
    Senator Specter [continuing]. Important program. When you 
talk about rehabilitation, if we do not do it with the Youth 
Offenders, it is just a revolving door and recidivism. And that 
is a critical point of intervention.
    Secretary Chao. Right.
    Senator Specter. So I appreciate your taking another look 
at it.
    Anything you care to add, Secretary Chao?
    Secretary Chao. I think that is it. Thank you for having 
me.
    Senator Specter. Mr. McMullen, I will give you more of a 
speaking part here.
    Mr. McMullen. Nothing to add, sir.

                     Additional committee questions

    Senator Specter. Thank you very much. There will be some 
additional questions which will be submitted for your response 
in the record.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]
              Questions Submitted by Senator Arlen Specter
                         companionship services
    Question. What is the Labor Department's plan regarding the Clinton 
Administration proposal to change the rule on ``companionship 
services'' under the Fair Labor Standards Act, specifically regarding 
an analysis as to the impact on the elderly and the disabled?
    Answer. The rulemaking proposal was published on January 19, 
inviting comments for 60 days. Because of the continuing interest 
expressed in the proposal and in response to requests, on April 23 the 
Department reopened and extended the public comment period for 90 
additional days (until July 23). The background and history to the 
statutory provisions covered by this rulemaking, as well as its 
perceived impact on recipients of companionship services, will be 
carefully reviewed. In addition, all public comments received on the 
proposal during the extended comment period will be given very careful 
consideration before reaching any final decision in this matter.
    Question. Regarding the proposed rule on companionship services, 
has the Department given full consideration to the impact of the change 
on Federal and State programs that pay for much of the care that will 
be affected by the proposal? If the costs to provide the care go up, 
will the costs go up to the Federal and State programs that pay for 
these services?
    Answer. HCFA previously estimated that the proposed rule would have 
a negligible effect on Medicare costs, as this service is not a 
significant component of Medicare. Annual Medicaid program expenditures 
may increase somewhere within a $30 million to $40 million range, of 
which 57 percent would be the Federal share. Assuming an equivalent 
magnitude of increase in the private sector would suggest the maximum 
possible combined (public and private) increase of no greater than $75 
million. (See preamble of regulatory proposal, at 66 Fed. Reg. 5486, 
January 19, 2001.)
    Question. If this rule is implemented, will it exacerbate the 
shortage of this workforce as workers may be restricted to less than 40 
hours per week to avoid obligations for overtime compensation?
    Answer. Implementing the proposed rule is not expected to 
exacerbate any workforce shortage in this industry. To the contrary, 
improving the wage structure to include minimum wage and overtime 
protections may contribute to attracting additional workers to this 
industry.
    Estimates from the home care industry indicate that most workers in 
this industry are not working overtime hours, on the average. The data 
also indicate that there are many low-wage workers in this industry.
                             harwood grants
    Question. I am troubled by your Department's recent decision to 
withdraw a number of OSHA's ``Susan Harwood'' Grants. This action will 
have a significant negative impact upon efforts nationwide to curb 
devastating workplace injuries. Particularly, I am advised that the 
Graphic Communications International Union Locals within Pennsylvania 
will lose a grant for $296,000 per year for five years and would be 
forced to stop offering their members training via the safety and 
health program that is now being funded by this grant. Please provide 
me with your justification for withdrawing these grants.
    Answer. I can appreciate that there are disappointed groups in your 
State. The Pennsylvania Foundry Association in Plymouth Meeting, 
Pennsylvania, was affected by the decision to rescind the grants. 
However, the funding for the Graphic Communications International Union 
Locals is unaffected. They were not one of the 19 groups whose grants 
were rescinded.
    In reference to the decision affecting the 19 groups: we did not 
believe that we should commit to higher cost long-term grants of 3 to 5 
years. These grants, which were approved during the last month of the 
previous Administration, are larger and longer-term grants than have 
typically been awarded under this Program. In choosing among many 
competing priorities for funding, the Department concluded that it was 
preferable to provide targeted, short-term grants and maintain 
Departmental flexibility to respond to emerging safety and health 
issues. Therefore, OSHA will revert back to one-year grants in targeted 
subject areas.
    We published a new solicitation under the Susan Harwood Training 
Grants program on April 18, 2001. Grants will be tailored to provide 
short-term targeted training in: (1) construction; (2) bloodborne 
pathogens; (3) ergonomics; (4) electrical power generation; and (5) 
training programs for hard to reach workers. We have specifically asked 
prior applicants to reapply for grants under the new solicitation. I 
will ensure that, in fiscal year 2001, OSHA awards fully the $11.2 
million available for training and education grants. These grants will 
be geared to our team's strategic plan and new approach to safety and 
health of the Nation's workers.
    As I stated when I was sworn in, ``If we are going to protect 
workers, we must put more emphasis than ever before on prevention and 
compliance assistance--rather than just after-the-fact enforcement.'' 
As you know, the Harwood Training grants are but one of many compliance 
assistance tools used by OSHA. Others include on-site consultation, 
training provided by the OSHA Training Institute and its affiliates, 
and easy-to-use interactive electronic tools to help employers and 
workers understand and comply with OSHA standards.
                  office of the 21st century workforce
    Question. Tell us about your plans to create, with existing funds, 
a new ``Office of the 21st Century Workforce''. Where will the funds 
come from to create this new office? What do you anticipate this new 
office will accomplish?
    Answer. The mission of the Office of the 21st Century Workforce is 
to ensure that every worker has the opportunity to pursue fulfilling 
and financially rewarding careers and to make sure that no worker 
becomes a casualty of the global economy of this new millennium. Its 
initial mission is to address our current skills gap and worker 
shortage. Funding for the permanent staff of the Office is from the 
Office of the Secretary's Departmental Management account.
                      transitional living program
    Question. You are requesting $8.3 million for a new grant program 
to assist persons with significant disabilities in making the 
transition from institutional settings to the community and employment. 
This sounds very much like the $50 million program of the Health Care 
Financing Administration at the Department of Health and Human 
Services. Are there are any differences?
    Answer. Yes, the two programs are different in that they would be 
focused on providing different types of services even though they are 
focused on the same target group--individuals with disabilities who are 
making the transition from institutional settings to the community. The 
two programs would be designed to complement, not duplicate, each 
other.
    The Department of Health and Human Services' (HHS) $50 million 
grant program is for support services. These grants will promote the 
design and delivery of home and community-based services that support 
people with a disability or long-term illness to live and participate 
in their communities. The HHS grants will focus on meeting housing 
needs, personal assistance, expanding public-private partnerships to 
meet long-term needs, technology, and technical assistance. The United 
States Supreme Court's Olmstead decision, which is the basis for the 
HHS grants, clearly holds many implications and opportunities with 
respect to employment opportunities for people with disabilities. 
However, the HHS grants do not specifically target the employment and 
vocational needs of individuals transitioning from institutions to 
their communities.
    The proposed $8.3 million for a DOL Olmstead grant program would 
support the educational and professional development of individuals 
with disabilities. The grant program would provide funds to build 
professional competence within the workforce system to be able to 
effectively partner with other systems so that movement of people from 
institutions to the community includes planning for their employment. 
We plan to work closely with HHS and other relevant agencies, such as 
the Department of Education and the Department of Housing and Urban 
Development, to coordinate with and complement their efforts.
              information technology (it) cross-cut budget
    Question. You have requested more than double the funding of 
information technology at the Department of Labor from $37 million to 
$80 million. What do you anticipate that increase in funding will 
accomplish? Is this increase in funding to be expected in subsequent 
budgets?
    Answer. The central IT fund comprises cross-cutting initiatives to 
comply with laws like the Clinger-Cohen Act and which benefit the 
entire Department. These initiatives fall into four categories:
    Security and Privacy.--This necessary component includes security 
planning and plan implementation, risk management and mitigation, 
contingency planning, installing firewalls and intrusion detection 
systems, and related support contracts.
    Enterprise Architecture.--This focuses on upgrading the 
Department's outdated core infrastructure, a necessary step to 
implement the Department's IT Architecture. Investments will be made in 
Local Area Networks (LANs), software, cabling, and telecommunications 
equipment.
    Common Office Automation Suite.--This moves the Department to a 
single suite of office automation tools (word processing, spreadsheet, 
graphics, e-mail, database) to permit full interoperability among DOL 
agencies.
    Common Administrative Systems.--We must also address applications 
that are used by most or all DOL agencies, such as Human Resources, 
Payroll, Travel, and inventory management functions.
    Together, these initiatives are designed to ensure an integrated, 
Department-wide approach to IT investments in support of the 
Department's missions, goals, and objectives. Compliance with Section 
508 of the Rehabilitation Act also has been built into the IT cross-cut 
budget. The initiatives are managed in accordance with DOL's IT capital 
planning and investment control process.
    The increase in funding will support an IT infrastructure capable 
of supporting E-government objectives, the implementation of our common 
office automation suite strategy, a more secure IT environment in 
accordance with the Government Information Security Reform Act, and 
implementation of applications supporting enterprise-wide 
administrative functions such as financial and human resources. The 
only department-wide IT fund, this approach has been identified as a 
``best practice'' by the Office of Management and Budget (OMB).
    These IT improvements are ongoing initiatives and are essential to 
help the Department be as responsive as possible to the needs of 
workers and to secure its data and IT resources. We have not, however, 
made decisions on future budgets.
                  osha, msha and esa staff reductions
    Question. Your budget request would maintain funding for OSHA, the 
Mine Safety and Health Administration, and the Employment Standards 
Administration at essentially current levels. Due to the impact of 
inflation, this would reduce staffing at OSHA by 94 full-time 
equivalent positions, 47 mine safety positions, and 93 jobs at the 
Employment Standards Administration. Is this justifiable? Are these 
agencies currently overstaffed? Is it your intention not to hire the 
additional enforcement staff approved by Congress for fiscal year 2001?
    Answer. Worker protection budgets have increased significantly 
during the last 5 years. While worker protection continues to be a high 
priority for the Department, we have, in the interest of responsible 
budgeting, carefully reviewed each agency's FTE needs with an eye to 
eliminating unnecessary management layers and inefficient work 
processes. The budget proposes to redirect these resources to higher 
priority areas like front-line service delivery.
    OSHA, for example, has reviewed its current organizational 
structure to look for completed activities or those functions which are 
better integrated into the front-line work of the agency. Overall, the 
fiscal year 2002 budget reflects a reduction of 94 FTE--42 management 
FTE and 52 FTE associated with the previous Administration's re-
invention initiatives. Since OSHA is not reducing safety and health 
compliance officer staffing, the agency plans on hiring all of the 
additional enforcement staff approved by Congress in fiscal year 2001.
    The three ESA enforcement programs anticipate a slight reduction in 
enforcement staff in fiscal year 2002. Approximately 60 percent of the 
reduction in the enforcement programs will be taken in overhead staff, 
which comprises about one-third of the total enforcement program 
staffing. A reduction of 93 FTE amounts to approximately a 2 percent 
reduction in staffing and most, if not all, of that can be absorbed 
without negative consequences for enforcement. Within ESA, the Office 
of Workers' Compensation Programs anticipates employing the same number 
of claims examiners in fiscal year 2002 as in fiscal year 2001 for the 
Federal Employees' Compensation, Longshore and Harbor Workers' 
Compensation, and the Black Lung Compensation Programs.
    With respect to MSHA, during the past five years, the number of 
coal mine enforcement FTE remained roughly level even as the number of 
coal mines decreased by 19 percent. Given this situation, the Agency 
believes that it can absorb the 47 position reduction in FTE in the 
coal program without compromising worker safety. MSHA fully intends to 
hire the additional 40 FTE approved by Congress for the metal and 
nonmetal enforcement program in fiscal year 2001.
                       cuts in workforce programs
    Question. You have proposed reductions for programs authorized 
under the Workforce Investment Act due to the slow expenditure of funds 
in the first year of implementation. Do you think it is possible that 
demand for those funds may increase in the next fiscal year since many 
States and communities are now planning and implementing programs based 
on that funding? If so, is it wise to scale back these programs at this 
time?
    Answer. In projecting expenditures for the remainder of Program 
Year (PY) 2000 and PY 2001, and budget needs for PY 2002, DOL assumed 
that State Workforce Investment Act (WIA) programs would be fully 
implemented by June 30, 2001. DOL also projects State expenditures in 
succeeding years will be greater than would have been possible had 
unexpended balances not increased last year and during the first six 
months of this year. There will be no scaling down of programs 
nationally as a result of the reduced request for PY 2002. In fact, 
total spending for WIA State programs is estimated to be $174 million 
more in PY 2001 and in PY 2002 than the PY 2001 budget authority.
    Question. How would the proposed cuts affect those States and 
communities that are fully spending their funding allocation? Have you 
heard from any of these groups since your budget proposal was released?
    Answer. DOL staff regularly and routinely speak with States, local 
communities and their representatives. There is widespread 
acknowledgment that spending has been lower than expected and that the 
causes are many. In fact, through mid PY 2000, only two States 
(Delaware and Vermont) had spent more than 50 percent of the funds 
available to them in PY 2000. Federal, State and local partners have 
joined forces to review the causes and work together to propose policy 
changes and assistance that would address the issues.
    A few communities might find themselves with fewer resources as 
allotments are reduced and they do not have as large an unspent balance 
as others have. However, we believe that underspending is widespread 
and the number of communities that are fully using funding are few. 
Most communities will find themselves with sufficient carry-over from 
earlier years to offset reduced allocations. For those few that do not 
have substantial carry-in, we would hope the impact of the proposed 
reductions can be ameliorated, in part, through reprogrammed monies to 
the youth formula program in 2001, State reallocation of funds among 
local areas, State targeting of funds available for Statewide 
activities, and Federal award of National Emergency Grants.
    With respect to the latter, Dislocated Worker funding is provided 
to States and local communities by formula; the Secretary maintains a 
reserve of 20 percent of total Dislocated Worker funding, most of which 
is used for National Emergency Grants. These grants are available to 
States and local communities which have fully spent their formula funds 
and find themselves needing additional allocations for Dislocated 
Worker assistance. As a result, we do not expect dislocated workers to 
be denied services as a result of the small reduction requested for the 
program.
                             worker layoffs
    Question. In light of the recent sluggish economy, what kinds of 
worker layoffs do you expect in the next fiscal year?
    Answer. There were 1,445 mass layoff actions in April 2001 as 
measured by new filings for unemployment insurance benefits during the 
month, according to data from the Bureau of Labor Statistics. Each 
action involved at least 50 persons from a single establishment, and 
the number of workers involved totaled 175,064. In January 2001 through 
April 2001, the total number of events, at 5,995, and initial claims, 
at 719,781, were higher than in January-April 2000 (4,889 and 535,327, 
respectively).
    In April 2001, manufacturing industries accounted for 42 percent of 
all mass layoff events and 44 percent of all initial claims filed. A 
year earlier, layoffs in manufacturing accounted for 34 percent of 
events and 32 percent of initial claims. Manufacturing industries with 
the highest number of initial claimants were transportation equipment 
(12,583, mostly in motor vehicles and car bodies), electronic and other 
electrical equipment (11,552, largely in semiconductors), and 
industrial machinery and equipment (11,312, primarily in farm machinery 
and equipment). Services accounted for 25 percent of events and 28 
percent of initial claims filed during the month. Layoffs in services 
were highly concentrated in business services (particularly in help 
supply services, which accounted for 12 percent of the total number of 
initial claimants). We also have seen a significant upswing in trade 
petitions for last five months.
    With the slow economy, we expect this trend to continue through 
part of the next fiscal year.
    However, the unemployment rate remains low, meaning that many 
dislocated workers are able to find new employment with little or no 
governmental assistance because they have transferrable job skills. 
Those who are permanently laid off with little opportunity to return to 
their previous occupation or industry often need assistance to find or 
prepare for new jobs.
    Under the Workforce Investment Act, Dislocated Worker services are 
provided through the One-Stop system. Dislocated workers who require 
assistance in finding new jobs can access a range of services at their 
local One-Stop Career Centers, ranging from job search assistance to 
assessment, counseling and retraining.
    Question. In your opinion, will a $207 million reduction in the 
Dislocated Worker program hurt the chances of those dislocated workers 
finding new jobs?
    Answer. The requested level for the Dislocated Worker program will 
allow our State and local partners to meet the employment and training 
needs of the affected workers. As a result of efficiencies in 
administration and service delivery as well as carry-in funds from 
prior years' appropriations, Dislocated Worker programs will have 
levels of resources comparable to previous levels. States and local 
areas whose needs exceed available resources may request assistance 
through National Emergency Grants to provide additional Dislocated 
Worker funding for workers affected by economic downturns.
                         one-stop coordination
    Question. One of the cornerstones of the Workforce Investment Act 
was the coordination of resources at the One-Stop, particularly those 
provided under that Act and the Wagner-Peyser Act. Are the One-Stops 
coordinating resources with the State Employment Service? Are those two 
offices often located in the same building? If not, what are your 
thoughts on how we could improve that coordination?
    Answer. The clear intent of WIA is that State employment services 
authorized by the Wagner-Peyser Act be delivered solely as part of the 
locally designed One-Stop systems. In addition, Wagner-Peyser 
employment and information services, including labor exchange services, 
employment statistics and labor market information, are critical core 
services that make One-Stop systems responsive to the universal 
population. Wagner-Peyser re-employment services are also critical to 
the linkage of unemployment insurance claimants to both employment 
services and more specialized services available within One-Stop 
centers/systems.
    Nationwide, State employment services are entering into memoranda 
of understanding regarding how services will be delivered in One-Stop 
systems. WIA allows for different physical configurations within a One-
Stop system. Each local area must have at least one physical location, 
a comprehensive One-Stop center, which provides core services and where 
access to all ``required'' One-Stop partner services is available. In 
addition, the law permits affiliated sites with specialized services as 
long as the sites are part of the broader One-Stop system. The design 
of One-Stop systems varies as it relates to Wagner-Peyser employment 
services. There are three primary options for configuring how 
employment services fit in a One-Stop system: (1) the employment 
service office is the location of the comprehensive One-Stop center; 
(2) employment service staff are fully integrated into the 
comprehensive One-Stop center which is operated by another entity; or 
(3) an employment service office is an affiliated office with staff 
assigned to the comprehensive center.
    It is the position of the Department of Labor that Wagner-Peyser 
services must be integrated as closely as possible within a One-Stop 
system. Therefore, we are working with our State partners to promote 
integration in a number of ways including, but not limited to:
  --developing policy guidance flowing from WIA and the regulations on 
        the role and ``fit'' of Wagner-Peyser employment services 
        within One-Stop systems;
  --developing and providing technical assistance to State employment 
        service agencies, local boards, and One-Stop operators to help 
        facilitate the integration of Wagner-Peyser employment 
        services; and
  --identifying best and promising practices and models for integration 
        to share among the States and local areas.
    Question. The justification for flat-funding Job Corps assumes that 
costs in the Job Corps program may have risen at the economy-wide rate 
of inflation in the 2001 budget year, and that substantial funds will 
be carried over into 2002. However, Job Corps centers are currently 
experiencing inflation rates that are significantly higher than the 
economy-wide rate of 2.1 percent. If, as a result of higher costs in 
2001, the carryover anticipated for 2002 were not available, what would 
be the impact on the quality of Job Corps operations?
    Answer. Job Corps' ability to continue current services without an 
inflationary increase is due primarily to savings from unplanned delays 
in new center openings. These savings, combined with some cost 
containment efforts, will adequately address our resource needs in PY 
2003. Flat funding Job Corps in fiscal year 2002 will not impact the 
quality of Job Corps operations.
    Question. What would be the impact on the three new centers 
scheduled to open in 2002? Would Job Corps have to close centers or 
reduce the number of students served?
    Answer. As indicated above, Job Corps' ability to continue current 
services without an inflationary increase is due primarily to savings 
from unplanned delays in new center openings. We will submit a report 
to Congress detailing the status of those center openings and the 
reasons for the current delays. Let us be clear that these center 
opening delays are the result of a variety of unplanned events that are 
in no way related to the fiscal year 2002 Budget level. Job Corps will 
not close centers or reduce the number of students served.
                    additional youth program funding
    Question. DOL proposes to revise the fiscal year 2001 appropriation 
for the youth program by adding $45 million to it from funds 
reprogrammed from other WIA programs. What is the rationale for adding 
funds for 2001, then cutting funding in fiscal year 2002?
    Answer. For fiscal year 2001, DOL proposes to reprogram the $25 
million increase in 2001 from Youth Opportunity Grants and the initial 
$20 million from the Safe Schools/Healthy Students initiative to move 
funds from targeted programs to core job training programs, as 
described in President Bush's Blueprint for New Beginnings. The 
Workforce Investment Act was enacted to establish the core youth, 
adult, and Dislocated Worker programs, and we believe our emphasis 
should be on ensuring the success of these programs. The increase in 
Youth Opportunity Grants in 2001 would have resulted in additional 
sites that our fiscal year 2002 budget would not be able to sustain, as 
would also be the case for the Safe Schools/Healthy Students 
initiative. We are confident that, with the unexpended funds available 
from previous years, our fiscal year 2002 request of $1 billion for 
Youth Activities will be sufficient to serve the same number of young 
people in need of WIA services as are projected to be served in 2001.
                     fiscal year 2002 funding level
    Question. Does the fiscal year 2002 request reflect a one time 
adjustment in funding as a result of lower than expected levels of 
expenditures (due to the amount of time it is taking States to 
implement WIA)? If so, does the Administration expect to request funds 
in fiscal year 2003 to restore the cuts it is proposing in fiscal year 
2002?
    Answer. Yes, our fiscal year 2002 request does take into 
consideration the fact that unexpended balances are roughly $600 
million greater than the traditional level. Any fiscal year 2003 
request will consider expenditure data between now and when PY 2003 
funding levels are finalized, as well as the Administration's 
assessment of the relative size of unspent balances carried into PY 
2003.
                  state flexibility for training needs
    Question. By decreasing funds, which effectively will decrease 
carry over, is the Administration reducing the flexibility States have 
to meet unexpected training needs that might occur if the economy 
continues to weaken and more laid off workers need training to obtain 
jobs?
    Answer. As previously indicated, the Department and its State 
partners will continue to address the needs of laid off workers through 
awards of formula funds, supplemented, where necessary, by National 
Emergency Grants.
                    funds reverting to the treasury
    Question. Given the level of spending by States, would you expect 
any fiscal year 2000 funds to revert to the Treasury if funding were 
not reduced for the formula grant programs in fiscal year 2002?
    Answer. States have the Program year of Federal award and the two 
succeeding Program years to spend funds under WIA. Because of this, we 
do not expect that these unspent funds will revert to the Treasury. 
They will remain in the grant and carried over for use in future years.
               unspent funds listed by state and by grant
    Question. Could you please provide to this committee a list of the 
amount of unspent grants expected for fiscal year 2000 and fiscal year 
2001 for each State by formula grant program? If you have information 
on projected unspent funds based on data more recent than December 
2000, would you provide them to this committee?
    Answer. The Department does not have projected end of year 
carryover by State or program; the attached table shows aggregate 
estimates by State for expenditures through December 2000 and is 
submitted for the record. Our assumptions about expenditures for PY 
2001 and PY 2002 are not State-by-State. Estimates may not be accurate 
if applied to individual States given differences in State plans and 
spending rates.

                              EMPLOYMENT AND TRAINING ADMINISTRATION STATE REPORTING OF FORMULA SPENDING WIA YOUTH ADULTS AND DISLOCATED WORKERS PROGRAMS COMBINED
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               PY 2000 allotments                                   Expenditures 7/1/00-12/31/00  (& PY       Unexpended balance as of 1/1/01
                                              ---------------------------------------------------                       2000 Youth:  4/1/00-6/30/00)     ---------------------------------------
                                                                                      Total       Total available ---------------------------------------
                                 Unexpended                                         allotments      7/1/00-12/31/
            State             carry-in  to PY  PY 2000 portion                      (includes      00  (& PY 2000
                                    2000          excluding     FY 2001 advance  advance funding  Youth:  4/1/00-                     % of        % of         Total          % of        % of
                                               advance funding      funding         available         6/30/00)          Total      allotments  available                   allotments  available
                                                                                  beginning  FY
                                                                                      2001)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Alabama.....................       $7,204,025      $21,569,576      $18,435,358      $40,004,934      $47,208,959     $12,944,260       32.4       27.4       $34,264,699       85.7       72.6
Alaska......................          453,000        6,220,665        6,804,719       13,025,384       13,478,384       2,734,243       21.0       20.3        10,744,141       82.5       79.7
Arizona.....................        6,170,133       22,265,696       18,050,796       40,316,492       46,486,625      10,087,539       25.0       21.7        36,399,086       90.3       78.3
Arkansas....................        8,941,265       17,060,263       15,813,292       32,873,555       41,814,820       7,910,502       24.1       18.9        33,904,318      103.1       81.1
California..................       50,370,517      310,532,858      319,358,288      629,891,146      680,261,663     136,440,050       21.7       20.1       543,821,613       86.3       79.9
Colorado....................        3,804,877       11,133,399       10,794,033       21,927,432       25,732,309       5,900,041       26.9       22.9        19,832,268       90.4       77.1
Connecticut.................        3,620,292       12,391,413       11,276,123       23,667,536       27,287,828       7,063,815       29.8       25.9        20,224,013       85.5       74.1
Delaware....................        1,694,396        3,603,138        2,887,440        6,490,578        8,184,974       4,167,507       64.2       50.9         4,017,467       61.9       49.1
District of Columbia........        1,384,000        9,011,879       10,103,668       19,115,547       20,499,547       6,051,585       31.7       29.5        14,447,962       75.6       70.5
Florida \1\.................       65,279,463       62,533,829       56,846,081      119,379,910      184,659,373      86,121,969       72.1       46.6        98,537,404       82.5       53.4
Georgia.....................       11,966,905       32,680,141       29,305,954       61,986,095       73,953,000      13,874,807       22.4       18.8        60,078,193       96.9       81.2
Hawaii......................        5,462,399       11,851,140       13,166,154       25,017,294       30,479,693       5,058,091       20.2       16.6        25,421,602      101.6       83.4
Idaho.......................        3,697,810        7,068,503        6,933,051       14,001,554       17,699,364       4,665,156       33.3       26.4        13,034,208       93.1       73.6
Illinois....................        6,425,117       62,507,353       54,649,207      117,156,560      123,581,677      28,274,929       24.1       22.9        95,306,748       81.3       77.1
Indiana.....................        7,134,777       17,145,854       14,928,500       32,074,354       39,209,131      16,609,855       51.8       42.4        22,599,276       70.5       57.6
Iowa........................        2,717,190        5,718,570        5,734,756       11,453,326       14,170,516       3,501,904       30.6       24.7        10,668,612       93.1       75.3
Kansas......................        2,346,659        6,217,232        6,430,585       12,647,817       14,994,476       4,065,239       32.1       27.1        10,929,237       86.4       72.9
Kentucky....................       34,811,212       23,190,724       19,259,988       42,450,712       77,261,924      18,029,020       42.5       23.3        59,232,904      139.5       76.7
Louisiana...................       12,202,135       34,855,558       31,745,279       66,600,837       78,802,972      13,427,930       20.2       17.0        65,375,042       98.2       83.0
Maine.......................          100,000        5,918,650        5,323,098       11,241,748       11,341,748       3,940,588       35.1       34.7         7,401,160       65.8       65.3
Maryland....................       11,977,850       22,762,126       21,383,922       44,146,048       56,123,898      14,054,255       31.8       25.0        42,069,643       95.3       75.0
Massachusetts...............        3,070,000       20,596,131       18,433,727       39,029,858       42,099,858      15,477,068       39.7       36.8        26,622,790       68.2       63.2
Michigan....................       10,625,065       43,150,489       35,227,909       78,378,398       89,003,463      25,246,367       32.2       28.4        63,757,096       81.3       71.6
Minnesota...................        4,862,114       12,661,947       11,192,310       23,854,257       28,716,371      11,136,597       46.7       38.8        17,579,774       73.7       61.2
Mississippi.................        7,545,109       19,849,458       17,445,585       37,295,043       44,840,152       8,407,897       22.5       18.8        36,432,255       97.7       81.2
Missouri....................        9,220,801       22,537,168       20,531,057       43,068,225       52,289,026      11,812,901       27.4       22.6        40,476,125       94.0       77.4
Montana.....................          874,719        7,330,069        7,429,328       14,759,397       15,634,116       4,751,724       32.2       30.4        10,882,392       73.7       69.6
Nebraska....................        1,562,920        3,843,427        3,370,955        7,214,382        8,777,302       1,593,856       22.1       18.2         7,183,446       99.6       81.8
Nevada......................        1,023,781        6,236,289        6,052,345       12,288,634       13,312,415       3,126,560       25.4       23.5        10,185,855       82.9       76.5
New Hampshire...............          352,571        3,796,677        3,276,886        7,073,563        7,426,134       1,695,816       24.0       22.8         5,730,318       81.0       77.2
New Jersey..................       18,918,820       39,764,126       38,034,164       77,798,290       96,717,110      27,749,286       35.7       28.7        68,967,824       88.6       71.3
New Mexico..................          888,554       16,388,725       21,437,086       37,825,811       38,714,365       9,060,603       24.0       23.4        29,653,762       78.4       76.6
New York....................      163,730,964      148,728,129      156,225,476      304,953,605      468,684,569      42,802,149       14.0        9.1       425,882,420      139.7       90.9
North Carolina..............       13,648,284       23,561,472       21,935,374       45,496,846       59,145,130      15,529,729       34.1       26.3        43,615,401       95.9       73.7
North Dakota................          735,455        3,522,617        2,725,413        6,248,030        6,983,485       2,234,580       35.8       32.0         4,748,905       76.0       68.0
Ohio........................       18,566,094       61,982,728       50,847,933      112,830,661      131,396,755      15,795,680       14.0       12.0       115,601,075      102.5       88.0
Oklahoma....................        3,965,403       15,582,047       13,092,549       28,674,596       32,639,999       5,553,484       19.4       17.0        27,086,515       94.5       83.0
Oregon......................        7,288,406       28,275,038       30,992,014       59,267,052       66,555,458      14,705,981       24.8       22.1        51,849,477       87.5       77.9
Pennsylvania \1\............       43,473,437       55,552,160       51,169,069      106,721,229      150,194,666      39,674,951       37.2       26.4       110,519,715      103.6       73.6
Puerto Rico.................       82,022,985      103,556,318      111,940,940      215,497,258      297,520,243      51,195,386       23.8       17.2       246,324,857      114.3       82.8
Rhode Island................          732,708        4,082,645        3,811,684        7,894,329        8,627,037       2,536,074       32.1       29.4         6,090,963       77.2       70.6
South Carolina..............        5,651,400       18,242,679       15,239,431       33,482,110       39,133,510       8,681,128       25.9       22.2        30,452,382       91.0       77.8
South Dakota................        1,524,676        3,541,195        2,762,797        6,303,992        7,828,668       2,434,662       38.6       31.1         5,394,006       85.6       68.9
Tennessee...................       11,326,551       27,717,111       23,061,871       50,778,982       62,105,533      12,670,648       25.0       20.4        49,434,885       97.4       79.6
Texas.......................       67,300,071      134,094,193      111,733,955      245,828,148      313,128,219     119,541,113       48.6       38.2       193,587,106       78.7       61.8
Utah........................        3,219,027        5,433,280        4,965,519       10,398,799       13,617,826       3,497,324       33.6       25.7        10,120,502       97.3       74.3
Vermont \1\.................          590,542        3,455,742        2,590,847        6,046,589        6,637,131       4,657,829       77.0       70.2         1,979,302       32.7       29.8
Virginia....................        7,300,000       20,744,067       17,994,165       38,738,232       46,038,232       8,246,066       21.3       17.9        37,792,166       97.6       82.1
Washington..................       12,731,724       35,864,208       34,182,597       70,046,805       82,778,529      20,479,984       29.2       24.7        62,298,545       88.9       75.3
West Virginia...............       10,000,000       20,886,759       23,332,050       44,218,809       54,218,809      13,094,672       29.6       24.2        41,124,137       93.0       75.8
Wisconsin...................        2,688,907       15,799,916       14,706,901       30,506,817       33,195,724      14,471,966       47.4       43.6        18,723,758       61.4       56.4
Wyoming.....................        2,688,907        3,688,545        3,059,298        6,747,843        9,436,750       2,819,580       41.8       29.9         6,617,170       98.1       70.1
                             -------------------------------------------------------------------------------------------------------------------------------------------------------------------
      Total Formula.........      765,894,017    1,636,703,922    1,558,031,527    3,194,735,449    3,960,629,466     925,604,946       29.0       23.4     3,035,024,520       95.0       76.6
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Revised/corrected expenditures for Florida and Vermont; corrected carry-in for Pennsylvania.

               Questions Submitted by Senator Tom Harkin
  energy employees occupational illness compensation program (eeoicpa)
    Question. In a televised interview (McLaughlin's ``One on One'' 
from 3/23/01) I understand you said the DOL has ``no capability, no 
infrastructure'' to carry out the nuclear workers compensation program. 
I am surprised at this statement given the history of Office of 
Workers' Compensation Programs in administering the Federal Employees' 
Compensation Act, as well as compensation for coal mine workers and 
longshore and harbor workers. What capability and infrastructure do you 
need to build?
    Answer. My comments centered on the statutory deadline for the 
Department to implement this large new program. This reality poses 
significant challenges, thus warranting my public concern. While the 
Energy Employees Occupational Illness Compensation Program bears some 
resemblance to ESA's other compensation programs, its size, covered 
population, and unique requirements have necessitated the establishment 
of a new claims processing and adjudication infrastructure. The 
Department has created a unit within ESA, with its own dedicated staff, 
to handle the large number of expected claims. This unit will be 
responsible for accepting and adjudicating claims under the program, 
which will include such tasks as determining the probability that an 
individual's cancer was as likely as not due to radiation exposures and 
adjudicating all disputes arising from the claims process.
    Question. Given your concerns, what are your plans to bring in 
expertise to start the program?
    Answer. Since EEOICPA's enactment, the Department has been working 
with the Departments of Energy, Health and Human Services, and Justice 
to implement this program in a fair and equitable manner. We have 
utilized private-sector contractors to a great extent. In our efforts 
to build the organizational structure to administer this program, we 
are reaching out in a very broad way to recruit the staff necessary to 
operate this program. This will include staff to adjudicate claims and 
those with technical expertise in areas such as radiation measurements 
and exposures. Simply put, we are utilizing every available resource to 
assure the timely and effective implementation of this program.
    Question. Would you consider setting up an outside advisory 
committee to help address some of the issues? Could you use the 
Department of Energy's Office of Environment, Safety and Health Public 
Advisory Committee, which already has dealt with this program, for this 
purpose?
    Answer. As you know, the EEOICPA established an Advisory Board on 
Radiation and Worker Health. In addition, as you note, the Department 
of Energy's Office of Workers' Advocacy has also established an 
advisory committee. We have been engaged with, and will continue to 
participate in, the DOE Advisory Committee and will participate in the 
Advisory Board on Radiation and Worker Health when it is established. 
We will use these forums as well as continuing to meet with 
stakeholders in a variety of other settings to get input on 
administering this program. These avenues for obtaining input have 
seemed most beneficial at this point, especially given the July 31 
implementation deadline the Department must meet. In light of this 
deadline, we have had to focus our efforts on ensuring that eligible 
claimants receive benefits as soon as possible after this date. At a 
later date, we will consider whether there is a need to establish 
another advisory body.
    Question. Last year the DOL proposed some amendments to the 
EEOICPA, including adding an option of providing a sick worker with 
lost wages. Do you support these proposed changes?
    Answer. In January of this year, the previous Administration 
forwarded a set of proposed amendments to the EEOICPA to Congress. The 
extremely short deadlines for publishing regulations and implementing 
this program have required DOL to focus exclusively since then on 
efforts to promulgate regulations and create procedures and systems 
necessary to undertake our responsibilities under EEOICPA and Executive 
Order 13179. Thus, consideration of possible legislation must await our 
completion of the initial implementation of the program. We will 
consult with the Office of Management and Budget and other agencies 
with responsibility under EEOICPA to assess the need for a legislative 
proposal.
    Question. I understand you recently recommended to OMB that ``the 
Administration support technical legislation that will soon be 
introduced to remedy some of the remaining deficiencies in the 
EEOICPA.'' What are these deficiencies, what amendments to EEOICPA will 
you recommend, and when you do expect the legislative proposal to be 
introduced?
    Answer. EEOICPA contains virtually no provisions concerning 
administration of the program or review of decisions made on claims for 
benefits. In drafting EEOICPA, Congress recognized that the statute did 
not create a comprehensive compensation system when it directed 
submission of further legislation to implement the program. In addition 
to the almost total lack of administrative and review provisions, it 
also contains ambiguous or unclear provisions and certain provisions 
that appear to have adverse consequences that may not have been 
intended. As noted in the previous response, however, extremely short 
deadlines for implementing EEOICPA have required DOL to focus on that 
task. We do intend, however, to further review this legislation and 
consult with the Office of Management and Budget and other agencies 
with responsibility under EEOICPA to determine the appropriate nature 
and timing of a legislative proposal.
    Question. I understand you said that DOL could not meet the 
statutory deadline to begin accepting applications. When do you expect 
to be ready to accept applications, and when should workers who qualify 
expect to begin receiving compensation?
    Answer. As a result of the extraordinary effort and dedication of 
DOL's career staff, interim final regulations were published on May 25, 
2001 and will take effect 60 days thereafter. This will allow us to 
begin officially accepting applications on July 31, 2001, the date that 
the legislation provides for the statute to take effect. For 
straightforward cases, we expect to begin paying EEOICPA benefits by 
early fall.
    However, it must be recognized that there will be a surge of claims 
filed in the first days of this program for illnesses and deaths 
occurring over more than a half century. While we are making every 
effort to address this up-front claims workload, it will be very 
difficult to process this volume of cases immediately. Based on our 
knowledge of this population, we expect that many claims will require 
significant work on the part of DOL, DOE, and HHS to piece together 
decades-old work history and exposure data. Claimants whose cases will 
require complex adjudication--especially of those for whom HHS must 
complete an individual radiation dose reconstruction--will need to 
realize that it may take many months for all aspects of their case to 
be fully reviewed.
    Question. How do you expect to handle workers with covered 
radiogenic cancers for whom dosimetry records do not exist? How will 
they be considered for inclusion in a Special Exposure Cohort?
    Answer. The Department of Health and Human Services' National 
Institute on Occupational Safety and Health (NIOSH) has been assigned 
responsibility for developing methodologies for ``reconstructing'' 
reasonable estimates of radiation doses received by individuals, and 
for carrying out individual dose reconstructions in each case where the 
claimant is determined by DOL to be a covered employee, but is not a 
member of a Special Exposure Cohort. In the absence of complete 
dosimetry data, these estimates will be used by DOL to determine the 
probability that an individual's cancer was as likely as not due to 
occupational radiation exposure. In addition, HHS is developing a 
process for designating additional members to the Special Exposure 
Cohort, with the advice of the Advisory Board on Radiation and Worker 
Health. These issues will be addressed in the regulations being 
developed for EEOICPA by HHS.
    Question. How do you expect to coordinate with the Department of 
Energy for workers whose illnesses may have been caused by radiation or 
by hazardous substances?
    Answer. The EEOICPA does not preclude filing for benefits under 
both EEOICPA and State workers' compensation. EEOICPA provides for 
assisting workers in obtaining State workers' compensation benefits 
through the DOE Office of Worker Advocacy. We anticipate that 
individuals who were exposed to both radiation and other toxic 
substances will file claims under both programs. We are coordinating 
with DOE in many areas, but particularly through the establishment of 
joint DOE/DOL resource centers near nine major DOE nuclear sites, where 
claimants will be able to get direct assistance in filing under either, 
or both, programs.
    Question. Does the budget include sufficient funds for timely 
implementation of the program?
    Answer. The funding for EEOICPA is sufficient and will not affect 
our ability to meet the established time frames. The difficulties in 
meeting the time frames are related to the tremendous amount of work to 
be done, and the lack of lead time available to acquire and gear up the 
staff and other resources necessary to be at peak capacity at the 
inception of the program. Establishing the organization structure, 
acquiring office space, purchasing equipment, hiring and training 
staff, developing essential data, communications, and financial 
systems, and developing detailed procedures for administering such a 
complex program these are all major undertakings. I assure you that we 
are doing everything possible to stay on schedule.
                           staffing shortages
    Question. What is the Labor Department's strategy in addressing the 
existing shortage of female-dominated jobs, such as nursing, day care 
and teaching?
    Answer. Within a few decades, some demographic experts believe the 
American workforce simply will not be large enough to meet the demands 
of a continually growing economy. Nurses, day care providers, and 
teachers are a large part of this ``incredibly shrinking workforce.''
    These professions are of tremendous value to our communities. Every 
day they care for our neighbors and educate our children. The President 
has begun the process of elevating the appreciation for the individuals 
in these careers. We must show consideration for the value of these 
professions not only in dollars and benefits, but also in respect.
    The Department will continue to evaluate the Nation's current 
skills gap and worker shortage and identify methods, including those 
that cross Departmental lines, that allow us to address this problem--
both short- and long-term. We are, in fact, already working to address 
some of these shortages. For example, under the Workforce Investment 
Act of 1998, our locally-driven workforce investment boards may certify 
occupations that are in demand in their area in which an eligible 
individual may select training. For example, Certified Nursing 
Assistants (CNAs) represent an occupation that is very much in demand 
in most local areas. Therefore, an individual who goes to a One-Stop 
Career Center and becomes eligible for training will likely see CNA 
training offered as a response to one of the occupational choices. Many 
One-Stop Career Centers also offer access to training in advanced 
skills that require certification, such as medical laboratory 
technicians, operating room technicians, and inhalation therapists.
              bureau of international labor affairs (ilab)
    Question. Madame Secretary, in this era of globalization, American 
workers are now pitted against workers throughout the global economy in 
tough, hard-nosed competition as never before. Their jobs and living 
standards are at unprecedented risk. Why are you proposing such drastic 
cuts in the Bureau of International Labor Affairs? This is the office 
of the Federal Government that has the greatest expertise in 
international worker rights issues (i.e. abusive child labor), and 
labor standards at a time when President Bush is requesting trade 
authority and even says there are legitimate trade-related worker 
rights issues that must be addressed in the impending fast-track 
debate.
    Answer. The President's fiscal year 2002 request for ILAB preserves 
the Bureau's core responsibilities and recognizes the importance of 
eradicating all forms of abusive child labor and promoting 
international labor standards throughout the world. Funding for these 
programs has multiplied dramatically over the past years. The proposed 
spending levels help us to effectively balance our priorities while 
maintaining management controls and sensible spending policies that are 
crucial to our domestic well-being.
    The budget request includes funding for ILAB's core mission, and 
provides $30,000,000 to support projects that remove children from 
exploitative work and provide them with an education and their families 
with viable economic alternatives; $10,000,000 to support work on an 
HIV/AIDS through workplace-based prevention and education programs and 
technical assistance to improve the working environment of employees 
living with AIDS; and approximately $19,000,000 to continue 
multilateral and bilateral projects to help developing countries 
establish labor protections so that workers everywhere can enjoy 
fundamental rights and principles at work and help strengthen the 
ability of developing countries' to implement social safety net 
policies and programs to foster economic growth.
    Question. Madame Secretary, I am troubled by reports I've heard 
that no appointment for the position of Deputy Undersecretary of Labor 
for International Affairs is expected before this coming fall. Is this 
true and, if so, how can you leave this important position vacant for 
so long and still claim to be giving priority treatment to child labor, 
enforcing worker rights law on the books, advancing trade-linked worker 
rights issues and promoting greater respect for internationally-
recognized worker rights?
    Answer. We plan to fill this position as soon as we have identified 
a person with the qualifications and expertise we seek. In the 
meantime, the Bureau is in the capable hands of experienced career 
professionals.
              pension and welfare benefits administration
    Question. Last year, I worked with the Pension and Welfare Benefits 
Administration to expand the assistance program through which they help 
retirees understand their rights under the Employee Retirement Income 
Security Act of 1974 (ERISA). I am disappointed to see that your budget 
for this activity under the Policy, Regulation and Public Services 
Account is cut by $1 million.
    The retirement of the baby boom generation doesn't just affect 
Social Security, it also creates a large influx of retirees that need 
to understand their pension rights. In addition, the volatility of the 
stock market rightly has all concerned, acutely affects retirees with 
defined contribution and 401K plans. Given the increasing demand for 
retiree assistance and the increasing importance of that assistance in 
light of the changing economy, how do you justify cutting the one 
Federal service that counsels retirees about their pension rights?
    Answer. We have not reduced the request levels for benefit advisors 
that counsel retirees and other participants about their pension 
rights, nor have we reduced the levels of advisors that provide 
assistance to employers in plan operations. The Pension and Welfare 
Benefits Administration (PWBA) is committed to providing participant 
assistance. There are currently 105 FTE dedicated to participant 
assistance--16 in the national office and 89 in the field offices. In 
fiscal year 2000, these Benefit Advisors assisted over 150,000 
participants. Also in fiscal year 2000, PWBA adopted--for the first 
time--a Strategic Plan for Outreach, Education and Assistance. The plan 
includes specific performance measurements. PWBA also is beginning a 
pilot project to implement an 800 number. Assisting participants in 
health and retirement plans to make sure they understand their rights 
and receive the benefits to which they are entitled is a priority for 
me and the Department. PWBA will continue to fulfill this mission to 
the fullest extent possible.
               disparity in wia budget request reductions
    Question. This budget requests a $473.9 million cut in employment 
and training programs, claiming that unexpended carryover funds from 
last year will allow States to maintain service levels while taking 
that large of a cut. Madame Secretary, although large amounts of 
carryover may exist in some States, the amount varies per State. 
Dislocated Worker funds go to States on a formula basis. Therefore, 
every State will take the same percentage cut in funding, regardless of 
the amount of carryover they have.
    First, how do you deal with the disparity between States with small 
amounts of carryover and large cuts in fiscal year 2002 funds? Doesn't 
this method of cuts actually punish States who have implemented the new 
Workforce Investment Act quickly and efficiently?
    Answer. Information received to date indicates very few States are 
without significant carry-over available to maintain 2001 projected 
service levels through 2002. The Department is prepared to assist these 
States however possible. For example, the Department maintains a 
sizable reserve for National Emergency Grants where Dislocated Worker 
formula funds are insufficient to meet worker needs. As always, we will 
move quickly to make these awards where the need is demonstrated.
    Question. Second, these cuts will not go into effect until July of 
2002 and your analysis of unexpended carryover is as of January 1, 
2001. Do you not expect WIA to be fully implemented and working as 
planned in the next 18 months?
    Answer. The Department expects WIA to be fully implemented by June 
30, 2001, and program spending to have resumed to levels commensurate 
with amounts appropriated. As you indicate, the spending projections 
are based on unspent balances as available December 31, 2000 and what 
we believe to be reasonable estimates of increased spending through the 
remainder of this program year. Based on these estimates and our 
expectation that the WIA implementation issues that limited program 
spending will be resolved and the program fully implemented, we have 
projected an amount available on June 30, 2001 that, when added to 
available PY 2001 funds and the amounts requested for PY 2002, will 
allow spending, nationally, at levels greater that what was provided by 
the Congress for 2001.
                     personal protective equipment
    Question. Another important standard has been developed that 
clarifies who pays for personal protective equipment that is required 
by the employer. Some employers actually charge workers for ear plugs, 
rubber boots and protective gloves, even though this is the primary 
means of protection that the workers have, for example, from the 
hazards of noise, slippery floors, and sharp knives. The OSH Act 
requires the employer to pay for engineering controls, such as 
ventilation and machine guards. When employers require workers to pay 
for PPE, they are passing along the economic burden of controls to 
workers, often those in the lowest paying jobs, such as poultry 
processing. It is our hope that you would examine this issue, look at 
the regulatory record, and urge final approval. This is not a major 
regulation, and it is not a major issue to most employers. However, it 
is a major cost to many low-wage workers who have to spend an 
additional portion of their hard won paychecks in order to do their 
jobs.
    Can you tell me the status of the proposed regulation? Can you give 
me a timetable on when it might be completed?
    Answer. As discussed below, the new Administration has not 
completed its review of OSHA's regulatory agenda. Until that review is 
completed, I am unable to give you a timetable for this proposal.
                     lump sum pension distributions
    Question. Please provide me with a detailed explanation of where 
DOL and Treasury are regarding taking actions on the lump sum issue 
discussed [in my request] and what the Pension and Welfare Benefits 
Administration is doing to improve its ability to ferret out 
significant broad failures of plans to properly inform plan 
participants of their rights or to properly provide benefits.
    Answer. I am familiar with the concerns raised in your January 2000 
letter to Secretary of Labor Herman and Secretary of the Treasury 
Summers concerning the information disclosed to pension plan 
participants about their benefit distribution options. I believe that 
pension plan participants need and deserve sufficient information about 
their plan and benefits, including distribution options, to make 
informed decisions about their retirement. We are reviewing this issue 
and will respond more comprehensively when we have reached any 
conclusions.
                    fair labor standards act (flsa)
    Question. As you know, the Fair Labor Standards Act provides the 
most basic labor standards for working Americans, including child 
labor, minimum wage and overtime protections. In recent years, 
enforcement of the Act has suffered from lack of funding for 
investigators that are far too few in number to adequately enforce the 
law in the many thousands of workplaces across the country.
    Will you ensure that wage-hour enforcement gets the priority, and 
the funding that it needs to protect the workers' wages?
    Answer. I am committed to enforcement of worker protection laws. 
One of my goals is to ensure an honest day's pay for an honest day's 
work. While it is true that the number of investigators in the Wage and 
Hour Division declined throughout the early 1990s, the number of 
investigators steadily increased beginning in 1996 and is now at its 
highest level. There is sufficient funding in the fiscal year 2002 
budget to maintain the current level of investigators. In addition to 
enforcement, compliance education is another strategy for protecting 
workers' wages. I am encouraging the Department's enforcement agencies 
to undertake a renewed emphasis on compliance assistance.
    Question. While there have been slight increases, there are still 
significantly fewer investigators than 15 years ago for more 
workplaces. Will you press for and will you support funding for more 
investigators?
    Answer. At the end of fiscal year 2000, the number of investigators 
in the Wage and Hour Division was equal to the number of investigators 
in fiscal year 1985. Wage and Hour currently has 21 percent more 
investigators than at the end of fiscal year 1996. While I appreciate 
the fact that there are now more employers covered by the laws 
administered by the Wage and Hour Division than there were 15 years 
ago, I am not at this point seeking additional funding for 
investigators. Rather, I believe that providing compliance assistance 
to this increased number of employers is an important factor in the 
equation to improve compliance with worker protection laws.
    Question. In September 1999, the General Accounting Office issued a 
report to the House of Representatives which found that many of the 
nation's low-income workers were being illegally misclassified as 
exempt from overtime, often by conferring on those workers fancy titles 
that disguise the true nature of their work. For example, a cook paid a 
salary of $200 per week may be called an Executive Chef and 
misclassified as exempt from overtime.
    Are you willing to use the resources of your office to stop this 
kind of illegal exploitation of low-income workers by (a) increasing 
enforcement, and (b) providing education to employers about their 
responsibilities and providing information to workers about their 
rights?
    Answer. The primary goal of the Wage and Hour Division is to 
increase compliance with labor standards laws and regulations, 
including those affecting young workers, and workers in low-wage 
industries. To increase compliance, Wage and Hour has adopted a multi-
prong strategy of compliance education, enforcement and partnerships.
    Compliance education includes such activities as seminars for 
employers and employer associations; town hall meetings for workers; 
and distribution of a variety of compliance materials, including fact 
sheets, compliance manuals and wallet-sized cards. In addition, the 
Department has developed Elaws Advisors, an interactive internet-based 
tool which provides easy-to-understand expert advice on the basic 
requirements of the Fair Labor Standards Act and the Family and Medical 
Leave Act. A separate module covers the Federal child labor 
requirements. In September 2000, Wage and Hour began operation of the 
first phase of the Technology for Excellent Customer Service program, a 
national toll-free number to answer questions and refer callers to the 
appropriate office for service.
    The enforcement component of the strategy includes the use of 
traditional enforcement tools like investigations; the assessment of 
civil money penalties; targeted strike forces, particularly in low-wage 
industries; and the use of the ``hot goods'' provision of the FLSA that 
prohibits the shipment in interstate commerce of goods produced in 
violation of the Act.
    Establishing various partnerships leverages Wage and Hour's limited 
resources and broadens the impact of the other strategies. Wage and 
Hour enters into partnerships with employers and employer associations 
to urge proactive steps to help ensure current and future compliance, 
as well as with non-profit and community-based organizations, and 
States and other Federal agencies to help reach low-wage employees and 
make them aware of their rights.
    Question. The GAO Report also found that the primary cause of this 
type of exploitation was that regulatory minimum salary levels for 
workers to qualify for overtime-exempt status had not kept pace with 
inflation since they were last adjusted in 1975, a quarter of a century 
ago. For example, in 1975 about 30 percent of the full-time work force 
would have been automatically entitled to overtime because their pay 
did not exceed these minimum salary levels. However, in 1998, because 
of the failure of these levels to keep pace with inflation, only 1 
percent of this workforce would be automatically entitled to overtime.
    Will you support raising the minimum salary levels to account for 
the effects of inflation over the last 25 years?
    Answer. In May 2000 the House Subcommittee on Workforce Protections 
of the Committee on Education and the Workforce, U.S. House of 
Representatives, held a hearing in connection with the GAO's report and 
received testimony from business and labor representatives, as well as 
from the Department of Labor. Witnesses at the hearing confirmed GAO's 
assessment that the ability to move forward with constructive and 
appropriate changes to the regulations has proven extremely difficult 
because of the strongly-held views of the many affected and interested 
parties and the significant impact of possible changes. After that 
hearing, the Department of Labor began a modest research effort to 
identify areas in which we would need additional information to analyze 
the evolution of the overtime-exempt categories of workers and how they 
are classified by their employers. The regulations are currently 
scheduled on the Department of Labor's regulatory agenda for upcoming 
review and possible future revisions. However, there is much more to be 
learned before we will be fully positioned to offer specific regulatory 
changes.
                            osha ergonomists
    Question. How many ergonomists does OSHA currently employ? Do you 
have plans to hire more?
    Answer. There is no Federal job classification titled 
``ergonomist.'' However, OSHA currently has two certified professional 
ergonomists; approximately six field compliance officers with advanced 
degrees in disciplines in industrial engineering, with concentration in 
ergonomics; between 20 and 30 field people who have extensive training 
in ergonomic intervention in specific industries, such as meat packing 
and textiles; and three individuals with extensive ergonomics expertise 
with the Salt Lake City Health Response Team.
                       underreporting of injuries
    Question. OSHA's research and the information collected at the 
recent hearings show that there is extensive underreporting of MSDs. In 
fact, based on the record compiled in the recent rulemaking process, 
OSHA concluded ``that for every reported MSD, another MSD goes 
unreported.''
    What do you plan to do to correct this problem of underreporting? 
Are you dedicating any additional resources to addressing this problem?
    Answer. The Department is developing a comprehensive approach to 
addressing ergonomics. One of the many issues we will investigate is 
the underreporting of MSDs that OSHA asserted during the recent 
rulemaking. While it is too early to say for certain, I believe that 
lack of awareness of MSDs and an inability to universally define such 
injuries are plausible reasons for underreporting. Furthermore, I 
believe raising awareness of MSDs on the part of both employers and 
employees will help to prevent MSDs before they occur. I intend to use 
what I find from looking at the reasons for underreporting to create 
systems that will disseminate information to employers and employees on 
the best ways of preventing MSDs.
    During the month of July, the Department will hold three forums to 
address, among other issues, the definition of what constitutes an 
ergonomics injury. The Department plans to publish a report, based on 
the information collected from the forums, that will address the issue 
of underreporting.
                                ergo ii
    Question. You have repeatedly asserted that ergonomics is a 
priority for this Administration's Department of Labor. Yet, the 
Administration has indicated that it will nominate Mr. Eugene Scalia 
for Solicitor General. As Solicitor General, Mr. Scalia would oversee 
all standard setting or enforcement of ergonomics, yet Mr. Scalia has 
repeatedly opposed any ergonomics standard, going so far as to call 
ergonomics, ``a questionable science.'' In fact, Mr. Scalia has written 
extensively in opposition to any ergonomics standard setting or 
enforcement by OSHA.
    Have you discussed with him the importance of ergonomics in this 
Administration and is it your sense that he will actively pursue a new 
ergonomics rule?
    Answer. As Secretary, I have pledged to take a comprehensive 
approach toward ergonomics. I have met with numerous stakeholders and 
experts to discuss the issue during my short tenure, including 
representatives of workers, industry, and safety and health 
professional, and I have outlined certain key principles that will 
guide the Department's approach toward ergonomics under my leadership. 
Eugene Scalia, the President's nominee for Solicitor of Labor, has a 
broad range of experience in labor and employment law and a 
distinguished record of service in past administrations. I have 
emphasized to him the importance of the issue of ergonomics to this 
Administration and to the Congress. I am confident that, as Solicitor, 
he will faithfully discharge his responsibility to legally represent 
whatever ergonomics policy we establish.
                        osha enforcement budget
    Question. There is a $3 million increase for OSHA's enforcement 
budget, there is also a cut of 64 FTEs. The budget indicates that OSHA 
will conduct 36,400 Federal enforcement inspections in fiscal year 
2002, the same as fiscal year 2001. How will the agency conduct the 
same number of inspections with fewer enforcement officers?
    Answer. None of the FTE being cut are compliance safety and health 
officers. As a result, the agency will be able to conduct the same 
level of inspections as in fiscal year 2001. The staffing cuts reflect 
reductions in management and FTE associated with reinvention, not front 
line inspector positions.
                             osha standards
    Question. You have laid out a very ambitious health and safety 
standard setting program and I commend you for that. OSHA expects to 
issue 15 proposed standards in fiscal year 2002, versus only one in 
fiscal year 2001, and 6 final standards in fiscal year 2002, versus 5 
in fiscal year 2001. Can you give me the status of the following 
standards and whether you will publish them in final form in fiscal 
year 2002?
  --Tuberculosis
  --Employer payment for personal protective equipment
  --Glycol ethers
  --Signs, signals and barricades
  --Exit routes update
  --Personal fall protection systems
    Answer. The new Administration is still reviewing the regulatory 
agendas of the Federal agencies, including OSHA. Until that review is 
complete, it would be premature to specify OSHA's regulatory priorities 
or timetables for specific projects.
                     wia budget request reductions
    Question. We are currently in the midst of the first year of 
implementation of the Workforce Investment Act, and people throughout 
the country are working hard to change our systems to accommodate the 
new Act. Many areas have had slow rates of expenditures over the first 
6 months of the program, but as they get their systems up and running, 
the expenditure rates are increasing every day.
    However, the effect of these proposed cuts will not be felt until 
July 2002, when all systems should be running smoothly.
    I am concerned about making cuts which are based on projections 
made only 6 months into the new Act. Can you discuss the implementation 
of the Act and reassure me that these cuts will not result in cuts in 
service?
    Answer. The transition from the Job Training Partnership Act 
structure to the new Workforce Investment Act has resulted in much 
slower spending than originally projected. While many jurisdictions 
jump started partnership- and system-building activities during PY 
1999, July 1, 2000 marked States' and local communities' transition to 
WIA and its many reforms. Because of the nature of these reforms, full 
implementation of WIA by States and local communities is taking longer 
than originally expected, and the current lower than expected 
expenditures reflect this one-time phenomenon. While fewer participants 
will be served in PY 2000 than were served in PY 1999, States and local 
communities will be able to serve many more participants in PY 2001 and 
PY 2002 because of the availability of the carry over funds.
    Major reasons for slower than anticipated activity include:
    Implementing Fundamental WIA Changes Takes Time.--WIA requires 
fundamental system-wide changes in service delivery, the make-up of 
eligible service providers, and new customer service requirements. In 
addition, there also were major changes to State and local governance 
structures.
    Workforce Investment System Access to Other Funds.--State and Local 
Workforce Investment Boards are encouraged to think strategically about 
how to use WIA and other funds most effectively in order to address 
labor market needs of the broad population served by WIA. They have 
used other funds available such as JTPA carry in dollars or Pell grants 
for low-income, college-ready adults before drawing down PY 2000 WIA 
funds.
    More Emphasis on Universal Labor Exchange.--States and local 
communities have spent much energy and time on making the One-Stop 
Center networks under WIA work so that customers can access information 
about core job training, education, and employment services at a single 
location.
                                 ______
                                 
               Questions Submitted by Senator Ted Stevens
    Question. I am concerned that the Labor Department budget proposes 
a workers' compensation surcharge that would cost the Defense 
Department an additional $36.7 million--and all Federal agencies a 
total of $80.3 million. What is the rationale for including this 
legislative proposal in an appropriations bill? If Congress denied this 
request, where would you suggest making cuts elsewhere in your budget 
to restore the funds needed to administer workers' compensation 
programs?
    Answer. Ensuring the safety of American workers is a priority of 
the Department of Labor. In the Federal arena, we see an urgent need to 
focus the actions of the employing agencies on increasing worker 
safety, in part, by highlighting for them the full cost of worker 
injuries, including the cost of administering the Federal Employees' 
Compensation Act (FECA) program. As you know, Federal agencies are 
billed each year for cash and medical benefits that have been paid to 
their employees under FECA, while DOL bears the cost of administering 
the program. The fiscal year 2002 Budget proposes to integrate benefit 
and administrative costs by allowing DOL to add an administrative 
surcharge to the annual bill DOL now sends to Federal agencies for FECA 
benefits. Because the surcharge is based on an agency's FECA benefits, 
we believe this proposal would provide an additional incentive for 
agencies to control FECA costs by preventing injuries and cooperating 
in return-to-work efforts.
    We believe that an appropriations bill is the most efficient 
vehicle for establishing an appropriate funding mechanism that both 
ensures adequate funding for the administration of the FECA and 
enhances the safety of Federal workers by demonstrating the real cost 
of injuries. Our budget proposal provides for a surcharge that 
accomplishes this purpose and establishes guidelines and limitations 
for its use. Further, as the cost of Federal workers' compensation is a 
budget issue for the Federal agencies, we believe an appropriations 
bill is the best vehicle for addressing the issue.
    Clearly DOL cannot administer FECA absent Federal resources. If 
Congress decides not to enact this proposal, the Administration will 
work with Congress to identify alternative resources for the 
administrative costs of the FECA program.
                              mass layoffs
    Question. Mass layoffs are increasing. In January alone, employers 
announced 1,522 mass layoffs, involving the projected loss of more than 
200,000 jobs. In the last year, 647,000 workers who lost their jobs due 
to mass layoffs filed for unemployment compensation. Wouldn't it be 
better to increase funding for Dislocated Worker training, instead of 
paying out longer unemployment benefits?
    Answer. Under the Workforce Investment Act, dislocated workers 
receive services designed to meet their individual needs for assistance 
to help them return to work as quickly as possible. Individualized 
assessment of worker needs in One-Stop Career Centers helps to 
distinguish those dislocated workers who might return to work with 
minimal reemployment assistance from those who require more extensive 
help. Workers in the latter category include those with obsolete 
skills, with limited English proficiency, and workers in some 
communities that lack a diverse economic base.
    Services for dislocated workers include a full range of activities, 
beginning with computerized job matching and resume posting, and 
extending to in-depth assessment and occupational skill training. 
Although many workers' training costs can be supported through Pell 
Grants and other resources, adequate funding for Dislocated Worker 
training is critical to meeting basic program goals. Our fiscal year 
2002 budget request, combined with State unspent funds, will ensure 
that services to dislocated workers will not decrease from PY 2001.
    For Dislocated Worker programs to achieve their goals of timely 
reemployment at good wages, the choice is not necessarily between 
longer unemployment benefits and increased funding for Dislocated 
Worker programs. Because workers who need additional skills to achieve 
quality reemployment must devote time to acquiring those skills in lieu 
of working, training for dislocated workers cannot stand alone. It must 
be supplemented by Unemployment Insurance (UI) benefits which provide 
needed partial wage replacement so that individuals can meet current 
living expenses while receiving training. The UI benefit helps reduce 
the financial hardship caused by loss of employment for individuals 
while at the same time helping to automatically stabilize the economy. 
For those workers who continue in training after their UI benefits are 
exhausted, needs-related payments are an available resource.
                                 ______
                                 
              Questions Submitted by Senator Patty Murray
    Question. Secretary Chao, what is the Administration prepared to do 
for aluminum workers and other workers in the Pacific Northwest who 
lose their jobs due to the energy crisis?
    Will your budget request provide sufficient resources to help 
workers who find themselves suddenly unemployed given the 
Administration's expressed concerns about a potential recession?
    Answer. The Department's discretionary National Emergency Grant 
(NEG) program is designed to provide reemployment services, supportive 
services and retraining activities in response to mass layoffs and 
plant closures affecting large numbers of aluminum workers and other 
industries. Additionally, all communities have funds available to them 
through formula grants to serve dislocated workers. For example, in PY 
2000 the State of Washington received $28.2 million in formula funds to 
assist communities in the State in serving dislocated workers, a 103 
percent increase over the previous year's funding under the Job 
Training Partnership Act. Oregon received $30.4 million, a 72 percent 
increase.
            exposure of miners to asbestos in libby, montana
    Question. Are you familiar with the Inspector General's recent 
report on MSHA's handling of inspections of the mine in Libby, and with 
the recommendations contained in the report? Do I have your commitment 
that the Department will make it a top priority to implement the 
recommendations that require rulemaking as quickly as possible?
    Answer. Yes, I am familiar with the Office of the Inspector 
General's (OIG's) report of March 22, 2001, Evaluation of MSHA's 
Handling of Inspections at the W.R.Grace & Company Mine in Libby, 
Montana. We are extremely pleased that the Senate has confirmed Mr. 
David Lauriski as the new Assistant Secretary of Labor for Mine Safety 
and Health. Both he and I are committed to protecting miners' safety 
and health, including preventing their exposure to harmful contaminants 
such as asbestos.
    I have asked Mr. Lauriski to review the facts and the OIG's 
recommendations and consult with the affected parties to develop a 
course of action.
    energy employees occupational illness compensation program act 
                               (eeoicpa)
    Question. Secretary, I believe you have said (McLaughlin's ``One on 
One'' taped on March 23, 2001) the Labor Department has ``no 
capability, no infrastructure'' to carry out the nuclear workers 
compensation program.
    What are your plans to develop the infrastructure so you can get 
this program running?
    Answer. My comments centered on the statutory deadline for the 
Department to implement this large new program. This reality poses 
significant challenges, thus warranting my public concern. We have been 
working diligently to develop the necessary regulations, organization, 
systems, and procedures for carrying out the Energy Employees 
Occupational Illness Compensation Program Act (EEOICPA) in as timely a 
manner as possible. In doing this, we have been utilizing our 
experiences in administering the workers' compensation systems for 
Federal employees, longshore and harbor workers, and miners suffering 
from black lung. As I have explained in response to questions from 
other members of the Subcommittee, while the EEOICPA has some features 
similar to parts of each of the programs mentioned, its provisions are 
sufficiently different from any of those programs that is necessary for 
us to develop a separate infrastructure. Furthermore, the substantial 
number of claims that we expect to be filed in the first few years also 
requires a separate organizational unit, with dedicated staffing. This 
unit will be responsible for accepting and adjudicating claims under 
the program, a responsibility which will include determining the 
probability that an individual's cancer was as likely as not due to 
radiation exposures and adjudicating disputes. We have been working 
with the Departments of Energy, Health and Human Services, and Justice 
to implement this program in a fair and equitable manner. We will be 
utilizing private sector contractors as well as reaching out in a very 
broad way to recruit the necessary staff to adjudicate claims and 
supply the necessary technical expertise in areas such as radiation 
measurements and exposures.
    Question. On March 9, you wrote to Mitchell Daniels, Director of 
OMB, that you recommended that ``the administration support technical 
legislation that will soon be introduced to remedy some of the 
remaining deficiencies in the EEOICPA.'' What are these deficiencies 
and how do you see them remedied? What is the status of this 
legislative proposal?
    Answer. As enacted, the EEOICPA contains few provisions concerning 
administration of the program or review of decisions made on claims for 
benefits. In addition, the Act also contains ambiguous or unclear 
provisions, some of which may have unintended consequences. The 
extremely short deadlines for implementing this program have required 
DOL to focus exclusively on efforts to promulgate regulations and 
create procedures and systems necessary to undertake our 
responsibilities under EEOICPA and Executive Order 13179. Thus, 
consideration of possible legislation must await our completion of the 
steps needed for the initial implementation of the program. We do 
intend, however, to further review this legislation and consult with 
the Office of Management and Budget and other agencies with 
responsibility under EEOICPA to determine whether and what type of 
legislative proposal is warranted.
                        women's bureau equal pay
    Question. The previous administration make bridging the wage gap a 
priority. What specific steps will the Bush Administration take to 
solve this serious problem?
    Answer. In 1963 the Equal Pay Act was passed, and since then women 
have continued to make tremendous advancements in the labor force. 
Today, women earn more than half of all college degrees, and nearly 
half of all graduate degrees. With this increased education comes 
increased earning power for women, and the pay gap has narrowed 
significantly over time.
    The Department of Labor, through the Women's Bureau, will continue 
to pursue a vigorous program of outreach to increase women's awareness 
of new opportunities for education, training, and employment. In 
addition, we will continue to inform employers of their 
responsibilities under the Equal Pay Act and to fight gender 
discrimination.
                             youth programs
    Question. The 21st Century is rapidly approaching and the skills 
that will be most valuable in our country are ever changing. The 
workforce must, therefore, have the ability to adjust to the times. 
Currently, too many Americans are left behind in this sweeping change. 
The days when one could easily earn a living wage with a high school 
education are rapidly diminishing. Today, workers need more education 
and training to develop skills that reflect our changing economy. I am 
concerned that your budget provides $222 million less for youth 
employment and training programs. We should be increasing not 
decreasing our investments that focus on one of our most vulnerable 
sectors of the workforce, young people.
    Fewer resources for programs like the Youth Opportunity Grants 
program will ensure less children are making productive transitions 
from school to work.
    I must point out that your proposed funding request for the 
Rewarding Youth Achievement Program is on the right track by focusing 
on children in high poverty areas and providing them with employment 
opportunities they wouldn't normally receive. It is very important that 
the Department of Labor is a valued partner in providing young people 
opportunities to receive needed job skills to be competitive in the 
modern workforce.
    Secretary Chao, what specific measures will you take to ensure 
these youth are provided with opportunities to learn needed job skills?
    Answer. Although the fiscal year 2002 budget request provides $222 
million less for youth employment and training programs, this request 
does not diminish our investment in one of the country's most valuable 
resources, America's youth. In fact, the request for WIA youth 
activities allows the Department to serve the same level of youth as 
will be served in 2001--721,000 youth. The transition from the Job 
Training Partnership Act has resulted in significant underspending as 
State and local programs gear up to fully implement the numerous 
structural changes in the workforce investment system under WIA. As 
these unspent funds are carried forward and States become fully 
operational, service levels will increase creating more opportunities 
for America's young people. The Department will work vigorously with 
State and local communities to ensure that systems are in place to 
provide opportunities for young people to learn the needed job skills 
and receive the necessary support to achieve academic success.
                         shortage of caregivers
    Question. This past week, HHS Secretary Thompson testified before 
this Subcommittee on the need to address the current shortage of 
caregivers nationwide, particularly in our Nation's nursing homes and 
assisted living facilities where there's a shortage of 250,000 CNAs and 
60,000 RNs. This Subcommittee would like to work closely with you in 
the effort to address this serious problem to ensure that the nation's 
frail elderly receive quality care.
    I am interested in your thoughts on ways to address this shortage 
of caregivers?
    Answer. The Department of Labor is cognizant of the need for more 
caregivers at all skill levels and is working to address this issue. 
For example, under the Workforce Investment Act of 1998, an eligible 
individual may select training in high-demand occupations certified by 
their local workforce investment board. Certified Nursing Assistants 
(CNAs) represent an occupation that is very much in demand in most 
local areas. Therefore, an individual who goes to a One-Stop Career 
Center and becomes eligible for training will likely see CNA training 
offered as a response to one of the occupational choices. Many One-Stop 
Career Centers also offer access to training in advanced skills that 
require certification, such as medical laboratory technicians, 
operating room technicians, and inhalation therapists.
    In addition, a substantial number of the 190 Welfare-to-Work 
competitive grantees (representing an investment of nearly $700 million 
dollars over six years) offer welfare recipients and other low-income 
individuals training and work experience opportunities to gain 
employment as a CNA or in other health occupations.
    Finally, the H-1B Technical Skills grant program provides 
specialized, high skill training to American workers desiring to 
upgrade their skills to fill occupations that are now filled 
temporarily by foreign workers. In 2001, we expect to have 
approximately $180 million available for the H-1B Technical Skills 
grants. Through this program, the Department has recognized health care 
occupations, particularly registered nursing, as a specialty 
occupational area in high demand.
    Some H-1B Technical Skills grants have focused specifically on 
health care training, in particular nursing training. In New York, the 
League/Service Employees International Union (SEIU) 1199 Training and 
Upgrading Fund received an award that proposed to train 675 employed 
and unemployed health care workers for high demand nursing positions. 
Under another grant, the State of Vermont and the Vermont Human 
Resources Investment Council will work together to provide a mix of on-
the-job training and on-site instruction for critical care nurses to 
place workers in 16 hospitals. Workforce Essentials, an H-1B Technical 
Skills grantee in Clarksville, Tennessee is training registered nurses.
                 legislation for long-term care givers
    Question. In the Senate, work is now underway on legislation that 
would provide $500 million a year for the next three years, in grants 
to States, to promote the nursing profession and to help long term care 
providers recruit, train, and retrain caregivers at all levels. Would 
you be supportive of this approach to addressing the caregiving 
shortage?
    Answer. The Department of Labor is very interested in efforts to 
address employers' demand for skilled workers while also providing 
opportunities for unemployed and underemployed individuals to increase 
their skills and advance in their careers. The Administration is 
particularly concerned about communities that lack access to care and 
plans to reform the National Health Service Corps to better define 
shortage areas and target placements of non-physician providers 
practicing in communities.
    The Administration will carefully review and consider legislation 
to address this issue. Once the legislation has been reviewed, we will 
be happy to share our views with you.
                immigration of health care professionals
    Question. HHS Secretary Thompson testified before this committee 
last week that part of the solution might be tied to allowing more 
foreign nurses and health care workers to immigrate to the United 
States to help fill the void. Would the Labor Department be willing to 
work directly with HHS, the Department of Justice, and the Immigration 
and Naturalization Service to create an immigration program that can 
help meet this need?
    Answer. The Department currently is administering the H-1C 
nonimmigrant nurses program, which is intended to address nursing 
shortages in areas where there are spot shortages. It previously 
administered the now-expired H-1A nonimmigrant nurses program. The 
Department of Labor would be, of course, willing to work directly with 
HHS, the Department of Justice, and the Immigration and Naturalization 
Service to develop creative ways to address this problem over the long-
term.
                                 ______
                                 
               Question Submitted by Senator Thad Cochran
            migrant and seasonal farmworker housing program
    Question. In the past, this subcommittee has included 
appropriations report language directing the continuation of a small, 
but important program that assists farmworkers in gaining better 
housing. Since at least 1983, I have worked with the Department to 
ensure a network of local organizations, including one in my State, 
receives funding to plan, develop, and manage housing for migrant and 
seasonal farmworkers. There is a well established network of local 
housing organizations that receive these funds.
    In the fiscal year 2001 Labor Appropriations report, language was 
included to provide $4 million in funding for this network. This amount 
was an increase of $1 million over the fiscal year 2000 level. I am 
hopeful that the Department of Labor will continue to support increased 
funding for this important program.
    I look forward to working with you and the Department in the 
future. Thank you.
    Answer. The Department of Labor will provide a total of $4 million 
for competitive and non-competitive farmworker housing grant activities 
in Program Year (PY) 2001. Grants totaling $3.6 million will be awarded 
competitively to fund housing and housing development activities for 
migrant and seasonal farmworkers. The Department is also funding on a 
non-competitive basis the Hope Migrant Rest Center for $333,000. The 
Center provides overnight and temporary lodging to over 40,000 migrant 
farmworkers and their families who criss-cross the country in search of 
and en route to seasonal agricultural jobs.
    Grants to the National Farmworkers Jobs Program authorized under 
WIA section 167 will total $72 million for PY 2001. These programs also 
provide for direct assistance to eligible farmworkers for transitional, 
temporary, or emergency housing in support of job training activities, 
or agricultural employment.
    Senator Specter. Okay. Thank you all very much.
    Secretary Chao. Thank you.

                          SUBCOMMITTEE RECESS

    Senator Specter. The subcommittee will stand in recess to 
reconvene at 9:30 a.m., Thursday, May 10, in room SD-192. At 
that time we will hear testimony from Dr. Roderick Paige, 
Secretary, Department of Education.
    [Whereupon, at 10:47 a.m., Wednesday, May 2, the 
subcommittee was recessed, to reconvene at 9:30 a.m., Thursday, 
May 10.]


  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2002

                              ----------                              


                         THURSDAY, MAY 10, 2001

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 9:37 a.m., in room SD-192, Dirksen 
Senate Office Building, Hon. Arlen Specter (chairman) 
presiding.
    Present: Senators Specter, Harkin, Reid, and Murray.

                        DEPARTMENT OF EDUCATION

                        Office of the Secretary

STATEMENT OF DR. RODERICK R. PAIGE, SECRETARY OF 
            EDUCATION
ACCOMPANIED BY THOMAS P. SKELLY, DIRECTOR, BUDGET SERVICE

               OPENING STATEMENT OF SENATOR ARLEN SPECTER

    Senator Specter. Good morning, ladies and gentlemen of the 
subcommittee on Labor, Health, Human Services and Education. 
The Appropriations Committee will now proceed.
    This is the first hearing where we have an opportunity to 
welcome the distinguished Secretary of Education, Dr. Paige. He 
brings to this Cabinet position a very distinguished record; a 
bachelor of science from Jackson State University; a master and 
Ph.D. degrees from the University of Indiana. He had been the 
superintendent of the Houston Independent School District, a 
job of enormous responsibility, where he was innovative and 
very accomplished. He previously served as Dean of Education 
and Athletic Director at Texas Southern University.
    In addition to the widespread praise and reputation, he has 
been awarded the 1999 Richard R. Green Award by the Council of 
Great City Schools, the 2000 Harold W. McGraw, Jr. Prize in 
Education from the McGraw-Hill Companies, and the 2001 National 
Superintendent of the Year Award from the American Association 
of School Administrators.

                        Education Budget Issues

    Dr. Paige, you come to present the administration's budget 
request on a day when, as you know, the Senate is considering 
the Education bill.
    Secretary Paige. Right.
    Senator Specter. A very complicated matter. We have set it 
aside, briefly, to take up the budget. There are nine pending 
amendments. To say it is a quagmire would be an understatement. 
But I have seen, in the time I have been here, that 
institutionally the Senators are a lot smarter than any of the 
individual Senators. I would not say that for secretaries, but 
for Senators and--and the Senate has a way of working through 
the problems.
    There are a great many subjects that we want to ask you 
about today; the allocations, some of the additional programs, 
some of the programs which have been cut, the problem of campus 
crime, the Youth Violence Initiative which this subcommittee 
put into operation, the issues on class size, more teachers, 
and the school construction.
    And I turn now for an opening statement from my 
distinguished colleague, Senator Harkin.

                OPENING STATEMENT OF SENATOR TOM HARKIN

    Senator Harkin. Thank you very much, Mr. Chairman. And I 
cannot think of a more timely time to have this hearing than 
right now, when we are involved in a debate on the Senate floor 
on the Elementary and Secondary Education Act reauthorization.
    We welcome you, Mr. Secretary, for this very important 
budget hearing. We can talk all we want to about education and 
how we all love it and how we want to make education better, 
but if the resources are not there, it is just more of the same 
old rhetoric.
    Now, Mr. Secretary, I have a great deal of admiration for 
you and for your background and what you have done for 
education. So, I hope that what I am about to say you do not 
take personally----
    Secretary Paige. I will not take it personally.
    Senator Harkin [continuing]. But take it policy-wise.
    Secretary Paige. Yes. Thank you.
    Senator Harkin. And I had great hopes earlier this year 
when President Bush was talking about leaving no child behind. 
When he picked you to be his Secretary of Education, I thought 
we are going to be on our way. And quite frankly, my hopes, I 
think, have been dashed. The budget this year is just 
incredibly inadequate, in terms of education.

                       Special Education Funding

    Now, I am going to just start, first of all, by reading an 
article that was in the paper this morning. Now, I do not know 
if it is true or not, but I am going to read it to you.
    It said--it is talking about the education plan. It said, 
``The administration indicated it was particularly upset--
particularly upset--by a vote last week to increase funding for 
schooling disabled students and to lock it into the Federal 
budget for the next 10 years by shielding it from the annual 
appropriations process. Officials described the proposal as 
`costly and unwarranted.'''
    I hope that official was not you, Mr. Secretary.
    Well, after all these years, on both sides of the aisle, 
talking about getting the Federal Government up to its 40 
percent of the average per pupil expenditure for kids with 
disabilities--and you and I have talked about this personally 
in my office--the Senate finally, on a unanimous vote--
unanimous, which means when we offered the amendment, we did 
not even ask for a vote; it was unanimous, because no one 
objected--unanimously said, ``We are going to appropriate, not 
just authorize, but we are going to appropriate about $181 
billion over 10 years to meet this need.''
    And now, the administration says they are upset about it; 
that it is costly and unwarranted. I beg to differ.

                 Tax Cut package and Education funding

    Second--or third, I guess, Mr. Secretary, the Senate 
adopted an amendment that both of us supported, that would have 
shifted $250 billion out of the $1.6 trillion tax cut, and put 
it into education. Well, the House had passed the 
administration's $21.3 billion for 10 years.
    Well, you would think, when it went to conference, they 
might have compromised someplace in the middle. The budget we 
got back is zero. The budget that we have, that we are going to 
vote on today on the Senate floor, has zero increase above 
baseline for education for the next 10 years. They did not even 
put in the President's $21.3 billion, let alone the $250 
billion that we had supported in the Senate.
    And so, I would like to have your thoughts on that and find 
out, well, why is not the administration saying something?

                       School Renovation Funding

    I am disappointed that they have eliminated the $1.2 
billion fund for school modernizations.
    The American Society for Civil Engineers recently issued a 
report--they gave our schools a D-minus. The lowest grade of 
all of the facility infrastructure in America was our schools.
    Finally, the Senate and the House, last year, began the 
process of reaching out to help modernize our schools, and the 
administration has zeroed that out.
    Well, I know that money alone will not improve schools. I 
have heard that all the time, but tell me how you are going to 
repair a roof, if you do not have some money; how you are going 
to build an extra classroom, if you do not have some money.
    Sure, we want accountability, testing--I can work my way 
through all of those, but if we do not have the resources in 
there to build decent schools for kids, I am sorry, I am out of 
here. And I just do not understand where the administration is 
on this.

                  Strategic Review of Education Budget

    Well, lastly, I just say this: Next week Defense Secretary 
Donald Rumsfeld will announce the results of a strategic review 
of the Defense budget. And then, the President plans to submit 
a new budget request based on those results. And the rumors I 
am hearing around here were on Defense appropriations, we are 
going to commit an additional $20 billion to $30 billion per 
year.
    Why can we not do that for schools? Why would not the 
President have a strategic review of the education budget, and 
ask the question, are all our kids ready to learn when they 
enter school?
    In 1989, President Bush, the Governors, we all decided on 
Goals 2000. We are going to meet Goals 2000 in education. First 
goal, every child ready and able to learn by the time they 
enter school. 2000 was last year, and we are not even anywhere 
near it.
    Are our classes small enough to promote learning? Are our 
schools in good repair? Are teachers well trained?
    Well, if the answers are no, why do we not have a strategic 
review and come back with a budget that will meet these needs? 
But no, what I read is they cannot even support what we finally 
decided on a bipartisan basis to do. And that was to meet the 
needs of special education.
    So, Mr. Secretary, I have great respect for you.
    Secretary Paige. Thank you.
    Senator Harkin. And I mean that, personally. Your 
background speaks well. But I am telling you, this budget is 
awful, when it comes to education. And I just hope that you 
will speak up and fight as hard as you can, as a Secretary, to 
say that this is unacceptable to everyone.
    I am sorry to be so emotional about it, but my gosh, we 
have got to do something about this education budget.
    Thank you, Mr. Chairman. I am sorry.
    Senator Specter. Well, so much for the level playing field, 
Mr. Secretary.
    Well, Senator Harkin never minces words. We know exactly 
where he stands.
    In the end, we have had a record for coming together in a 
collegial way. And I am optimistic we will do the same thing 
here.

            Education 302(b) Congressional Budget Allocation

    I might just add one more word before you begin your 
testimony. We are trying to get an allocation for this 
subcommittee which will accommodate the points that all sides 
are making, the points the President is making, the points the 
Secretary is making, what Senator Harkin has in mind, what his 
caucus has in mind.
    Without giving you the bitter experience of last year, this 
subcommittee set a mark at $106 billion, which was President 
Clinton's figure, which was candidly more than my caucus wanted 
to set, but with a lot of effort, that was established. And we 
re-allocated some of the priorities. And then we had a dispute, 
and at one point it looked like we were going to $114 billion 
instead of $106 billion. And we finally ended up at a little 
over $107 billion.
    And this year I am concerned that when we go to the floor, 
there will be add-on amendments. And 13 republicans, last year, 
voted with the democrats to add the funds. And as the manager 
of the bill, I stuck with the figure and cast more bad votes in 
3 days than I passed in the past 19 years on my own preferences 
for allocations.
    So, if we get an allocation which can accommodate at the 
start, I think we will make some headway. Some in my caucus 
say, ``Well, the President will veto a bill which is too 
high.'' Okay. But then it comes back to the Congress. And what 
do you do from there? With a 50-50 split, my very strong 
conviction is we ought to come to terms at the outset on a 
total figure, and then work on the priorities as to how we meet 
it, as opposed to taking one amendment after another, which 
will ultimately run the severe risk of leading to gridlock.
    With that overly long introduction, Mr. Secretary, we look 
forward to your testimony.

               Summary Statement of Dr. Roderick R. Paige

    Secretary Paige. Mr. Chairman, thank you so much. And I 
actually benefitted from those comments. And I appreciate them. 
I even appreciate the comments of Senator Harkin. I especially 
appreciate his passion because I know he means that very 
deeply. We have some points of disagreement on emphasis, but I 
assure you that I really respect your interests in the children 
of America, as I do the other members of this fine committee.
    Thank you for the opportunity to testify on behalf of 
President Bush's 2002 budget for the Department of Education. 
As you know, the President has made education his highest 
priority, and has reflected that in his budget request.

               Excellence in Education must be Nationwide

    The reason for this is simple. There is no part of our 
interest more important to the future of our Nation than the 
education of our children. And fortunately, in pockets and 
corners around the country, dedicated teachers in our 
exceptional schools are safeguarding our future by fixing and 
giving children rich and exciting experiences in learning. And 
we congratulate them, because we know of their dedication and 
commitment. And the children who attend those schools are not 
being left behind.
    Those schools do not represent the norm. Basically, our 
system is going to be required to be fixed in order to achieve 
the goal of educating all of our children. And no society has 
ever attempted that before.
    Most societies have even gone so far as to assign or 
designate those children who should be educated and those who 
should not. To say that no child should be left behind is a 
pretty aggressive goal. That requires the system to work. So 
pockets of excellence will not work here.
    And even as we congratulate those schools that are great 
and those teachers and principals and parents and PTA members 
who are causing that greatness, we congratulate them, we say it 
is insufficient and we need to fix the system.

                       Excellence Requires Change

    And so, the emphasis in the President's budget is about 
reform, about changing things. We do not think continuing on in 
the way we are going will accomplish this. If things do not 
change, they stay the same. And we know that the same is not 
satisfactory.

             NAEP Testing Results--4th Grade Reading Scores

    Last month I had the dubious distinction of participating 
in the announcement of the latest results from the National 
Assessment of Educational Progress in reading for our 4th grade 
students. And any caring person who heard those results will 
agree that we cannot keep doing the same. I call it dubious, 
because the only news that I had to comment on after the press 
conference was that the average reading performance of our 
fourth graders had been flat. This is shown in this chart 
showing NAEP reading test scores for 4th graders from 1984-
1999.


                        Flat Reading Performance

    Now, if you bear down inside that statement that the 
average performance is flat, you find that that result is from 
the better students getting better and the worst students 
getting worse. The net result being flat reading scores.
    But if you look at it from a deeper perspective, even, the 
students who are doing worse are exactly the students who this 
bill was created to help. That is even more devastating.
    So, flat performance is not good enough. And so, it 
requires change.
    The results of that reading assessment are even more 
disconcerting when we look at it from the point of view of our 
disadvantaged students.
    I am sorry to tell you that among students taking the 4th 
grade reading exam, ethnically, they are dividing themselves; 
economically, they are dividing themselves. Despite Federal 
programs designed to help the disadvantaged students, that is 
exactly the group that is doing worst.
    There is a decade of historic increases in funding that 
supports this. We are not doing the right things or we are not 
doing things right.

            ESEA Spending and 4th Grade Reading Achievement

    The story of our investment in education can be illustrated 
by this graph which shows 4th grade NAEP reading test scores 
for 1984-1999 and the Federal ESEA investment over the same 
period. It speaks for itself. Now, promoting the continuation 
of that seems to me to be inappropriate.



              ESEA Spending and 4th Grade Math Achievement

    The story of our student performance in mathematics can be 
illustrated by this graph.



            Federal ESEA Investment and Student Achievement

    The charts make powerful arguments to stopping, to pausing. 
Let us stop and take a look at what kind of results we are 
getting and think about doing something different.
    I want to say here that I know that everybody shares my 
passion, the Senators' passion, and all our passion about 
fixing these things, but I am just trying to call your 
attention to what is happening.
    The story of our students' performance tells the story. 
Perhaps the most powerful one is the chart showing reading 
achievement for the 4th graders as measured by NAEP test scores 
and compared to the Federal ESEA investment. The blue is the 
spending. The red is the performance. The connection between 
those points do not seem to connect. It argues, for me, to let 
us take another look.

                   Creating a culture of achievement

    I give everybody credit for wanting to do things to improve 
student performance. Federal funds have been forthcoming. To 
understand this better, I went back and read the arguments for 
and against the ESEA bill in 1965 and each reauthorization 
thereafter. I read the Congressional Records, the reports and 
looked at those who argued for and against various points of 
views. I can tell you, from that reading, that we are circling 
and making the same arguments and getting the same results.
    While Federal funds have been forthcoming, student 
performance has stagnated on the average and declined among the 
hardest to reach students. The students who we are supposed to 
be reaching through Title I and other Federal programs are 
precisely the kids that are hurting.
    Our system is a system that has allowed elementary and 
secondary student performance to stagnate, while in the last 
few years, the spending increase has averaged 17 percent. And 
when we spend, we think that we have conquered. When we spend, 
we think we have had victory. And we measure success by how 
much we spend.
    And I am not telling you things that are new. These things 
have been said before. The General Accounting Office in 1998 
said, and I quote, ``The clearest evidence about a lack of 
positive effect from Federal expenditures comes from one of the 
largest programs, Title I. Title I of the Elementary and 
Secondary Education Act is the largest Federal elementary and 
secondary education grant program. Children in high-poverty 
schools began school academically behind their peers in low 
performance schools and could not close these gaps as they 
progressed through school. In addition, when assessed according 
to high academic standards, most Title I students failed to 
exhibit the reading and mathematics skills expected of their 
respective grade levels.''
    This is the goal we said we were going to accomplish in 
1965. I can say that from reading the history.
    Now, what should we take away from this lesson? Simply put, 
we know that spending more on the same thing is not the answer. 
We need to do things differently to adopt a culture of 
achieving in our schools and school systems, and to demand 
results from our growing investment. We also need to continue 
to invest in those enterprises that work.

                 Guiding Principles of Education change

    And I am proud to appear before you on behalf of the 
administration's budget to make the point about some principles 
that work. I know they work. I personally participated in them.

                   Houston Independent School System

    I used them to improve the seventh largest public school 
system in the United States that resides in the fourth largest 
city in the United States that is populated by poor children. 
The school district that has converted itself from a district 
with minorities to a district of minorities; a district with 73 
percent free and reduced lunch eligible students. These simple 
principles----
    Senator Reid. I did not understand that. Seventy-three 
percent of what?
    Secretary Paige. Seventy-three percent of the 210,000 to 
215,000 students are eligible for free and reduced priced 
lunches, which is a criterion or indication of being poor.
    And by the way, it is probably higher than that, because we 
know that middle school students and high school students, 
traditionally, do not register for free and reduced priced 
lunches, even though they are eligible in many cases.

                          ESEA Reauthorization

    You and your colleagues are in the midst of a critical 
debate over the reauthorization of the Elementary and Secondary 
Education Act and the substitute to be offered by Senator 
Jeffords, the Better Education of Students and Teachers Act. 
That is pending before us, now.

                    Principles of Educational Change

    I will not bore you with these principles, because I know 
that you have heard them before. I will just briefly list 
them--accountability, flexibility, allowing the principals at 
the--the principal and the other people, not just the leader of 
the school--but all the people at the site to make decisions 
and to have control over matters, doing things that work, not 
funding failure.
    Many people are doing the same thing over and over again. 
When I became superintendent of the Houston Independent School 
District and looked at the Title I programs, we had to call a 
moratorium on doing the same thing, and to say, ``If you did 
this last year and this is your results, we are not going to 
allow you to do it this year.''
    And so the momentum of this continue-to-do-the-same-thing 
is so powerful, that it takes effort to stop it and put 
something new there. And this is not about money. It is okay to 
spend all the money in the world we have got, but it is about 
our children, who are not gaining with this principle. That is 
the point.
    The budget is the argument, but the point is our students 
are not growing. And we need to figure out a way to deal with 
that.
    Reading is a particularly difficult problem. It is the 
foundation of learning. And when students cannot read, the rest 
of it is all of no value.
    Expanded parental options. We could argue politically about 
this. And there is no reason to beat a dead horse, but nobody 
has answered the question, what do you intend to do with 
students who are failing in a failing school? If a school has 
failed and failed and failed, what do you intend to do about 
the students?
    The only answer I have heard is: Continue to fix the 
school. Favor the system over those kids. I argue passionately 
against that--I do not think any principle is more important 
than fixing the kids.

         Failing Schools--Cumulative Effect of Achievement GAPS

    When we look at the Sanders' study, it tells us that these 
kinds of gaps are cumulative, which means the student who has 
an ineffective teacher for 1 year, and then the second year has 
a very effective teacher, still the gaps created by the 
ineffective teachers cannot be covered up. This gap is 
continuing. So, we go through 2, 3 years of ineffectiveness? 
What do we intend--what do we do with the students who are not 
growing in this environment? It seems to be the most important 
question we could ask.
    You know the numbers better than I. So, I will not bore you 
with these numbers. I will quickly bypass them and go to the 
end of this presentation.

           Debate Reform and Principles of Reform, Not Budget

    I know the President has provided in his budget expanded 
funds. And I believe that he is amenable to increasing the 
spending of funds, but the question is not allowing the 
discussion to be switched from reform. Reform is the issue. 
Funding is not the issue. If funding were the issue, we would 
not be arguing now. Reform is the issue. The debate is about 
reform, not about funding.
    I am about finished. Overall, you know the numbers in the 
President's budget better than I, but I do want to emphasize 
that the President has put terrific emphasis on the critical 
skill of reading. And we intend to make that work.
    I referred, already, to the charts that you saw before you, 
but I want to do so, again, because I want to underscore that 
if money alone were the answer to our education dilemma, we 
would not be here today.
    You are considering this budget in the context of a debate 
about reform. And that will make all the difference in the 
world for our children. The same is not true for other 
Department of Education programs, other than elementary and 
secondary programs. Money alone will not result in a system 
change. And no matter how much we spend, we cannot measure 
success that way.
    I urge you to give the President's reform proposals very 
careful consideration. And I will end by making this 
observation--and I apologize, at first, for continuing to refer 
to myself as a Houston public school administrator. I was 
drafted for that job. I did not ask for it. But once I had 
accepted the responsibility for the management of that system, 
the seventh largest public school system in the world, I was 
intent on making it work.
    And it was disconnected from the public. By that, I mean 
the public had very little confidence in this system. And for 
3--no, 4 straight years, we did not go back to the public, we 
decided not to ask the public for additional funds. So, there 
was no tax increase at all, although we grew, the public 
schools student population grew.
    I want to make the point that we can reform the system 
without going back for additional dollars; using inside funds; 
redistributing these funds, and using them in a more effective 
way.
    And after 4 years of that--each year, coming back and 
showing improvement as we went--when we did have to go back to 
the public to build buildings, we were successful in raising 
the funds. The public had turned down a $391 million bond issue 
3 years earlier, which was the greatest lesson in my life, 
because if they had passed that bond issue, I would have spent 
3 years building buildings.
    They defeated that bond issue and I spent that next 3 years 
building the confidence of the public in the public school 
system. I spent 3 years building relationships. And I spent 3 
years building productivity and efficiency inside the system.
    And 3 years later, I went back to the public with a bond 
issue twice that size, with $678 million, the largest ever in 
the history of our State, and said, up front, ``It will cost 
you 5.5 cents on the tax rate.'' And in Texas, you do not say 
``taxes.'' We stood out, publicly, and said it loud.
    Seventy-three percent of the public voted to support that 
bond issue. All segments of the public; people who did not have 
children in our schools; from both sides of the political 
spectrum; from labor and from management, every segment 
supported it, because they had confidence in what we were 
doing.

            Houston School System Reforms and Public Opinion

    Senator Specter. Mr. Secretary, what reforms did you 
initiate in the interim to lead to that change in the public 
attitude?
    Secretary Paige. The first reform, Senator, was to accept 
responsibility for student learning. It was to hold people 
accountable and to administratively arrange a relationship 
between the leaders of our schools--the managers, the 
principals--and connect in that way to increase their 
productivity; rearranging their contracts, so each had 
contracts just like I had, which almost was a public service--a 
public sector contract, because the board could change it at 
any moment. They did not have the political cover of going to 
their board members or other people like that. That was the 
first one.
    The second one was to set real clear, crisp standards and 
continue to remind them of those standards. In every school 
that you went to, there was a graph on the wall saying, ``Here 
is where you are, now. And here is where you are going to be 4 
years from now. And here is what annual progress means, where 
you will be next year.''
    So, we listened to the public, talking to the community 
groups, the business community, the faith-based community, the 
ethnic groups, NAACP, LULAC, all of those, getting all of these 
people involved.
    I do not mean to imply that we licked this thing. I am just 
saying that we had progress and the progress was built on the 
common practice of listening. We stopped talking about money, 
started talking about productivity, and showed the results to 
the public.
    And by the way, even when we made mistakes, we would go to 
the public and say, ``We made this mistake.'' We stopped making 
excuses about mistakes. When something went wrong, we stood up 
in front of them and said, ``We did this wrong. We will do it 
better.''
    We did a lot of different things, like simply taking 
responsibility, setting high standards, measuring results, 
reporting those results to the public, calling our 
administrators in and letting them know feedback on how they 
were performing.

                           Prepared Statement

    Senator Specter. Mr. Secretary, your full statement has 
been received by the committee and has been studied and fully 
made a part of the record, if it is acceptable to you.
    Secretary Paige. It is.
    [The statement follows:]

              Prepared Statement of Dr. Roderick R. Paige

    Mr. Chairman and Members of the Committee: Thank you for this 
opportunity to testify on behalf of President Bush's 2002 budget for 
the Department of Education. As you know, the President has made 
education his highest priority, and this priority is reflected in his 
2002 budget request.
    The reason for this is simple: there is nothing more important for 
the future of this great Nation than the education of our children. 
Unfortunately, our system of education is failing too many of those 
children. Earlier this month, the latest results of the National 
Assessment of Educational Progress (NAEP) showed that the average 
reading performance among our fourth graders has not improved since 
1992. And when 37 percent of our 4th-graders--and nearly half of inner-
city 4th-graders--are unable to read at even the NAEP Basic level, our 
education system is broken and needs repair urgently.
    President Bush and I are especially concerned about the persistent 
gaps in achievement between poor and minority students and their more 
advantaged peers. For example, the NAEP results showed that in 4th 
grade reading, 73 percent of white students performed at or above the 
basic level, compared with just 42 percent of Hispanic students and 
only 37 percent of African American students.
    This disappointing performance comes after nearly two decades of 
national attention on education reform and a dozen years of rapidly 
increasing Federal spending on elementary and secondary education. 
Simply spending more money in the same way is not the answer. We need 
to do things differently, to adopt a culture of achievement in our 
schools and school systems, and to demand results for our growing 
investment in education.
    That's why I'm especially proud of the President's 2002 budget 
request for education. It provides a budget authority increase of $4.6 
billion, or 11.5 percent--the largest increase of any cabinet-level 
agency--and a $2.5 billion or almost 6 percent increase over the 2001 
program level. This increase is particularly impressive in the context 
of the President's overall effort to restore discipline to 
discretionary spending over the next decade while delivering an across-
the-board tax cut benefiting all American families.
    Even more important, these new dollars are focused on changing the 
culture of our education system and closing the achievement gap. Our 
budget reflects the principles put forward in No Child Left Behind: 
high standards; annual testing of all students in grades 3-8 in reading 
and math; increased accountability for student performance; a focus on 
research-based practices--particularly in teaching reading; reduced 
bureaucracy and greater flexibility for States, school districts, and 
schools; and expanded options for parents to make choices for their 
children's education.
                      closing the achievement gap
    President Bush believes that the Federal government can, and must, 
help close the achievement gap between disadvantaged students and their 
peers. The primary means toward this goal is the Title I Grants to 
Local Educational Agencies program. We are requesting $9.1 billion for 
this program, an increase of $459 million, to give States and school 
districts financial support to turn around failing schools, improve 
teacher quality, and ensure that all students meet State academic 
standards before advancing to the next grade.
    No Child Left Behind provides a new framework of accountability for 
ensuring that the Federal investment in Title I is well-spent and 
delivers the results intended when it was first authorized 36 years 
ago: closing the achievement gap between poor children and their more 
advantaged peers. The foundation of this new accountability framework 
is annual State assessments in reading and math for all students in 
grades 3-8, instead of the current law requirement for testing only 
twice during these critical formative years. The President's budget 
provides $320 million to help States develop and implement these 
additional assessments.
    I know many in Congress have concerns about these new assessments, 
but I can tell you from my own experience that there is no substitute 
for annual information on how well students and schools are performing. 
Children in good schools make remarkable progress during these early 
grades, and we cannot afford to wait three or four years to find out 
that some students have fallen behind. Where there are problems, they 
must be discovered and addressed immediately, an approach that can only 
be accomplished with the information provided by annual testing.
    Moreover, these tests are essential if we are to set clear goals 
for performance and help our schools get the job done. The alternative 
is to continue to rob millions of poor and disadvantaged young 
Americans of their futures by failing to provide them an effective 
education.
    The important thing about testing, of course, is what we do with 
the results. We would start by helping teachers learn to use data 
effectively. Secondly, we would require schools to report assessment 
results for all students to parents and the public. School districts 
would use these results to make sure that all schools and students are 
making adequate yearly progress toward State content and performance 
standards, and that no groups of students are left behind.
    Under No Child Left Behind, schools would be identified for 
improvement after just one year of failing to meet State standards. And 
unlike the current system, where about half of schools identified for 
improvement receive no additional assistance from their State or 
district, we would require States and school districts to provide these 
schools with technical assistance grounded in scientifically-based 
research. The $9.1 billion request for Title I Grants to Local 
Educational Agencies includes $400 million, an increase of $175 million 
or 78 percent, to help pay for these efforts to turn around low-
performing schools.
    If the school still has not improved after two years, it would be 
identified for corrective action and subjected to more comprehensive 
measures, such as implementation of a new curriculum, intensive 
professional development, or reconstitution as a public charter school. 
While such measures are underway, students would be given the option of 
attending another public school not identified for improvement or 
corrective action.
    Only after all these efforts, and following three full years of 
poor performance--during which time a student may well have fallen 
behind a grade or two--would we use Federal funds to help that student 
find a better education at a private school. We are proposing to permit 
the use of Title I funds to help students transfer to a higher 
performing public or private school, or to obtain supplemental 
educational services from a public- or private-sector provider. I know 
there are disagreements about methods of reform, but surely everyone 
can agree that no child should be trapped in a persistently failing 
school.
    Taken as a whole, these proposals reflect what I believe is a 
strong consensus, both within the Congress and among the American 
people, that States, school districts, and schools must be accountable 
for ensuring that all students, including disadvantaged students, meet 
high academic standards. At the same time, we recognize that it is 
unfair to demand accountability without enabling success. This is why 
the 2002 budget supports other proposals in No Child Left Behind that 
would give States, school districts, schools, teachers, and parents the 
tools and flexibility to help all students succeed.
    For example, the President's Reading First program would help 
States and school districts implement comprehensive reading instruction 
grounded in scientifically-based reading research for children in 
kindergarten through third grade. The budget includes $900 million for 
Reading First State grants, more than triple the 2001 level for reading 
instruction. The request also would provide $75 million for Early 
Reading First, an initiative that would complement Reading First State 
Grants by supporting model programs to develop the academic readiness 
of preschool-aged children. Over 5 years, the President would invest 
more than $5 billion to ensure that every child in America can read by 
the 3rd grade.
    We also are requesting $846 million for 21st Century Community 
Learning Centers to support a State formula program that provides high-
quality extended learning opportunities after school and during the 
summer, particularly for children in high-poverty and low-performing 
schools. And a $30 million request for our Transition to Teaching 
proposal would help school districts recruit, prepare, and support a 
wide range of talented career-changing professionals as teachers, 
particularly in high-poverty schools and in high-need subject areas.
                    empowering parents with choices
    President Bush and I believe that one of the best ways to improve 
accountability in our schools is to give parents the information and 
options needed to make the right choices for their children's 
education. This is why, for example, the accountability proposals in No 
Child Left Behind include school-by-school report cards and give 
students in failing schools the option of transferring to a better 
school. In addition, the 2002 budget request includes the following:
    The President is proposing to increase the choices available to 
parents through a new $175 million Charter Schools Homestead Fund. The 
program dollars will be used to provide grants to leverage funds to 
build, lease, purchase, or renovate facilities for use by charter 
schools. A $200 million request for the regular Charter Schools 
programs, an increase of $10 million, would support approximately 1,780 
new and existing charter schools that offer enhanced public school 
choice and have the flexibility to offer innovative educational 
programs in exchange for greater accountability for student 
achievement.
    The President is also proposing a tenfold increase in the annual 
contribution limit for education savings accounts, from $500 to $5,000. 
Parents would be able to make tax-free withdrawals from these accounts 
to pay for elementary, secondary, college, and after-school program 
expenses at both public and private schools.
             expanding flexibility and reducing bureaucracy
    The Administration believes that it is possible to achieve better 
results by reducing regulations, paperwork, and bureaucracy and giving 
States and communities the flexibility to create their own innovative 
solutions to challenges in education.
    For example, the $2.6 billion State Grants for Improving Teacher 
Quality proposal would combine funding from several existing education 
programs, including the Class Size Reduction and Eisenhower 
Professional Development State Grants programs, into performance-based 
grants. The proposal would provide a $375 million or 17 percent 
increase over the antecedent programs to help States and local 
educational agencies (LEAs) fund their own needs and priorities in 
developing and supporting a high-quality teaching force.
    Similarly, the $817 million Educational Technology State grants 
proposal would consolidate all of the Department's current educational 
technology programs into a single, performance-based grant program to 
ensure that schools use technology effectively to improve teaching and 
learning. And our $472 million request for Choice and Innovation State 
grants would combine overlapping and duplicative programs into one 
flexible grant program to help States and school districts implement 
their own innovative strategies, including school choice, for improving 
student achievement.
              other key elementary and secondary proposals
    The President's budget includes a $1 billion increase for the 
Special Education Grants to States program, for a total of $7.3 
billion. This is the largest increase in this program ever requested by 
a President, and would provide an estimated $1,133 for each child with 
a disability. That is approximately 17 percent of the national average 
per-pupil expenditure--the highest level of Federal support ever under 
the Individuals with Disabilities Education Act.
    We also are requesting $644 million for Safe and Drug-Free Schools 
State grants to provide students with more effective drug- and 
violence-prevention programs and to implement strategies to improve 
school safety. No Child Left Behind includes proposals designed to 
strengthen the ability of schools and teachers to prevent violence in 
our schools, and our budget proposal would provide flexible Federal 
resources to help make our schools safe and drug-free.
    The President's Budget also supports a significant increase in the 
Impact Aid program, which provides financial assistance to school 
districts afffected by Federal activities. The $137 million increase 
for Impact Aid Construction would greatly expand support for the 
renovation and repair of schools that serve large proportions of 
military dependent students and students residing on Indian lands.
    In addition to our discretionary request, the President's budget 
includes tax proposals that would significantly benefit elementary and 
secondary education. I have already mentioned our plan to expand tax-
free Education Savings Accounts to increase the educational choices 
available to parents. Another key proposal would allow States to issue 
tax-exempt private activity bonds for constructing public elementary 
and secondary schools. Current law does not exclude from income the 
interest on such bonds used to finance school construction. Private 
entities would construct, own, and maintain the schools.
    We also would allow teachers and other elementary and secondary 
school professionals to treat up to $400 in out-of-pocket classroom 
expenses as a non-itemized, above-the-line deduction beginning in 2002. 
Expenditures for books, supplies and equipment related to classroom 
instruction and for professional training programs would qualify for 
this deduction.
                        postsecondary education
    No Child Left Behind is focused on elementary and secondary 
education, but the 2002 request also demonstrates the President's 
commitment to preparing low-income and minority students for 
postsecondary education, strengthening financial aid programs that help 
students and families pay rising college costs, and building the 
capacity of postsecondary institutions serving large proportions of 
minority students.
    For example, we are proposing a $1 billion increase for Pell Grants 
to support a maximum grant of $3,850--the highest ever--and to improve 
access to postsecondary education for economically disadvantaged 
students. Overall, the President's budget would support a total of more 
than $49 billion in student financial aid, an increase of $2.2 billion 
or 4.6 percent over the 2001 level, for an estimated 8.2 million 
students and parents.
    To help low-income students prepare for, enroll in, and complete a 
college education, we are requesting a $50 million increase for TRIO 
outreach and support services. We also are seeking a $15 million 
increase for Historically Black Colleges and Universities and a $4 
million increase for postsecondary institutions that serve largely 
Hispanic populations.
    We would encourage more college students to pursue teaching careers 
in high-need areas by expanding loan forgiveness for math and science 
teachers serving low-income communities from $5,000 to a maximum of 
$17,500.
    We also would permit tax-free distributions from Qualified State 
Tuition Plans (QSTPs) to pay higher education expenses, including room 
and board, tuition and fees, and certain expenses for books, supplies, 
and equipment. In addition, private educational institutions would be 
permitted to establish qualified prepaid tuition plans, provided they 
are eligible to participate in Federal financial aid programs under 
Title IV of the Higher Education Act of 1965.
                               conclusion
    The President's 2002 budget request for education, in tandem with 
the education reform proposals contained in No Child Left Behind, 
support a comprehensive vision for closing the achievement gap and 
improving the quality of education for all Americans. I urge you to 
give these proposals careful consideration, and I stand ready to answer 
any questions you may have.

    Senator Specter. I would like to begin, now, the round of 
questioning by the Senators.
    Secretary Paige. Thank you.
    Senator Reid. Mr. Chairman, if the chairman yields, I would 
ask consent of the subcommittee that I be allowed to submit my 
statement for the record and questions. I am going to have to 
depart for other places.
    Senator Specter. Your statement will, without objection, be 
made a part of the record. Are you asking to question out of 
turn?
    Senator Reid. No. I do not want to question out of turn. I 
will submit some questions in writing.
    Senator Specter. Of course. Of course, Senator Reid. That 
will be acceptable. And I am sure the Secretary will respond in 
writing.
    [The statement follows:]

                Prepared Statement of Senator Harry Reid

    I want to thank Chairman Specter and our distinguished Ranking 
Member, Senator Harkin for holding this hearing on the Department of 
Education's budget.
    Education is so vitally important--it impacts every aspect of our 
lives. There are, therefore, many issues I could discuss with you 
today, but I will focus on only a few.
    I am troubled by the fact that the budget that President Bush sent 
to us--and the budget that he has asked Secretary Paige to defend--
      --has nothing for school construction,
      --has no increase for after school programs,
      --has no targeted class size reduction funding, and
      --has nothing for dropout prevention.
    Senator Bingaman and I have long supported a national dropout 
prevention program. Last year, Congress recognized the importance for 
such a program and we included funding in the appropriations bill. This 
year, we have again introduced our bill, S. 102, the Dropout Prevention 
Act.
    The aim of this bill is to encourage innovative thinking by the 
States and local school districts regarding dropout prevention, and to 
provide the funds if schools wish to start a similar program in their 
school. To help restructure the schools with the highest dropout rates 
in each State, this legislation would create a coordinated national 
dropout prevention program.
    Over half a million high school students drop out each year, 
joining almost 4 million young Americans who lack a high school degree 
and are not in the process of getting one. Unemployment rates of high 
school dropouts are more than twice those of high school graduates.
  --The probability of falling into poverty is three times higher for 
        high school dropouts than for those who have finished high 
        school.
  --If we do not address the dropout problem in this country now, we 
        will be faced in the future with a weak and uneducated 
        workforce.
  --By keeping kids in school, we are attacking much larger social and 
        economic issues.
    Earlier this year, I was pleased to learn from Secretary Paige that 
he supported a similar program when he was in Houston.
    The Education bill that we have on the floor right now authorizes 
$250 million for the dropout prevention program. I urge the Committee 
to fund this program and I urge the Secretary and the President to 
support such funding.
    Thank you.

                      School Construction funding

    Senator Specter. Mr. Secretary, let me begin the round of 
questions. We do not have the lights on, which is a little 
difficult, because--not for you, Mr. Secretary, but for the 
members that cannot see when it is turning to yellow and when 
it turns to red. So, we will hand members slips when we come to 
4 minutes and when we come to the end of the time. And as is 
our practice, I, as Chair, will begin the round of questioning.
    And let me start with the issue of school construction, 
which is going to be a matter to be voted upon by the Senate. 
And there are differences of opinion, different gradations. And 
the National Center for Education and Statistics, in a 1999 
study, found that $127 billion was needed for repairs, 
renovation, and modernization of America's schools.
    Now it is true that the lion's share of responsibility is 
on the State and local government, but the prior administration 
had a program for school construction. It ended up, last year, 
differently from my preference. My preference was to direct the 
funds, about $1.3 billion, for school construction, but if the 
local boards met certain standards, then to have flexibility 
and allow the local boards to do what they chose with that 
money and not use it for school construction.

                  Federal Role and School Construction

    Now, I have a two-point question for you, Mr. Secretary, on 
this subject. If the Federal Government is not to take a 
leadership role in school construction, and knowing that the 
States and local governments have allowed the school buildings 
to deteriorate, where will we find some relief? Let me start 
with that question, without adding a second.
    Secretary Paige. Mr. Chairman, I have to agree with you 
that the condition of our buildings across the United States is 
really deplorable in the main. And I guess at some point we 
would be benefited by a great debate about what the Federal 
role is in public education. I am not taking any particular 
position on that, now.
    In fact, when President Kennedy--I mean, President Clinton 
proposed the legislation on school construction several years 
ago, as a big city superintendent I came to testify in favor of 
the bill, because that----
    Senator Specter. Is that still your position?
    Secretary Paige. No, it is not. And it was because I had a 
construction problem in Houston. And we had calculated that we 
would get somewhere in the neighborhood of $200 million, or 
something like that which would have been there to help us. We 
needed it badly. And it was my position, then, that that was 
something that we should do.
    So, I can understand, clearly, people arguing both sides of 
this, but----
    Senator Reid. Mr. Chairman, but he is not for or against it 
at this stage. Is that what he said?
    Senator Specter. He is against it. He had been for it, as 
superintendent of the schools of Houston, but as Secretary of 
Education, he is against it.
    Now, why, Mr. Secretary? Because you think it is not the 
Federal role?
    Secretary Paige. Well, that is--that is one thing, Mr. 
Chairman. I think that we need to examine to determine where 
the Federal role starts and ends, because I do not know if the 
Federal Government is capable of managing this one.
    Here is my rationale. The $1.2 billion that was allocated 
for this purpose, under the previous administration, would not 
have repaired the buildings in the Houston Independent School 
District 3 years ago. So, today, it would cover, maybe, 75 
percent of them.
    Senator Specter. Well, how about the leadership role of the 
Federal Government, Mr. Secretary? If we--my idea in the 
current bill is to have an allocation for school construction, 
but if the local boards decide that they have some greater 
need, to give them the flexibility.
    So, in effect, it is a rebuttable presumption. And it 
provides some continuity, even though we do not have the 
Clinton administration, we have the Bush administration, but to 
meld the two on some central ground and say, ``We would like to 
continue this, but it is up to you, if you think you need the 
money somewhere else more urgently.'' Why not that approach, 
Mr. Secretary?
    Secretary Paige. Well, Mr. Chairman, I am not prepared to 
debate that approach, because I think there is some thought 
behind that. And I think there is great merit there. However, 
it differs a little bit from my point of view, because my point 
of view is about managing the construction issue from this 
level. And it is going to be extremely difficult.
    How do we choose among these great needs all the way across 
the United States?
    Senator Specter. Well, we certainly have the--let me move 
to the other question, because I have got 20 seconds left, and 
that will be time for me to state the question and you can give 
the answer, but not on my time.

             Flexible Teacher Fund and Class size reduction

    Teachers. The same thing. $1.3 billion last year. Class 
size. Senator Murray has offered an amendment. And I have made 
what we call a second-degree amendment to make it presumptive, 
yes, for teachers, but again, if the districts decide something 
else, they can do as they choose.
    My red light is on. I am nine seconds over. Now, we will 
listen to your answer, Mr. Secretary.
    Secretary Paige. Okay. Was that last point about the 
teachers? Class size reduction was to increase more teachers?
    Senator Specter. Yes.
    Secretary Paige. Allow me, once again, to rely on my 
experience. Okay. When we looked at that from Houston's point 
of view, the first thing we found out was that we had no space 
to add additional classrooms for the additional teachers.
    The next thing we found out was the funds would only pay 
salaries of first-year teachers. So, that further handicapped 
us. The district and the State had already reduced class sizes. 
So, we were handicapped in that regard.
    We wanted to use those dollars to ensure improved student 
achievement, but the regulations were so stringent that the 
flexibility to do that was difficult.
    Now, I will confess, now, that we got around it, but the 
way we got around it, I would say, was dubious. We went around 
by using a very crisp understanding of what the regulations 
said and getting ready to debate that at some point, because we 
thought that we might get it done that way, but the regulations 
tied our hands. We found a way to use the money, but the 
regulations tied our hands.
    We would have been better off if it had come to us the way 
that it is packaged in the President's budget now, with $2.6 
billion for teacher quality, which allows the district to make 
decisions about how to increase teacher quality. We should not 
just take the concrete, specific, limited concept that if you 
have more teachers, the situation is better.
    It is much more complicated than that. And it is tied 
almost exclusively with teacher quality. Are the additional 
teachers better, or are they worse? Can you get better 
teachers?
    We would like to use the money, maybe, to take the teachers 
we have and send them off to be trained. Or we may like to take 
some of the money to go to Mexico and to recruit more teachers 
who have dual language capabilities. You cannot know that. Only 
we could know that.
    So, the flexibility to use those dollars, as it is packaged 
in the President's budget, is much preferable to all of the big 
city superintendents that I have talked to and all of the rural 
superintendents that I have talked to.
    Senator Specter. Senator Harkin.

                      School Construction Funding

    Senator Harkin. Thank you very much, Mr. Chairman.
    Mr. Secretary, permit me, a little, to tarry along the 
construction situation.
    Secretary Paige. Okay.
    Senator Harkin. I first started proposing this in 1991, and 
then in 1992, and then in 1993. And finally, in 1994, when I 
held the chair that Senator Specter does now, and he was 
ranking member, I got through $100 million in appropriations to 
put out a pilot program for construction. That was 1994.
    In 1995, the Clinton administration rescinded it. So, there 
you go. You can say now you agree with the Clinton 
administration. He rescinded it. I was furious. Furious. It was 
not the Republicans that did it. It was the Clinton 
administration that rescinded it. You know that as well as I 
do.
    So, I tried again, year after year, to get this thing going 
again. Finally, dragging, kicking and screaming, we got the 
administration to support it last year. And we got $1.2 billion 
into school construction. And I have got a list of how much has 
gone out to the States.
    That is just a little bit of the background for you, where 
this is coming from.
    In the meantime, after the President rescinded that in 
1995, I said, ``Well, I believe this will work. There is a 
great need, and it will work.''
    So, for 3 years in a row, we got money through the 
Appropriations Committee to go to my State of Iowa for 
construction grants. It went to the State Department of 
Education with broad guidelines. We did not give them every jot 
and tell them exactly how to do it.
    We just said, ``Here is the money. Broad guidelines. Target 
the poorest school districts.'' That is all we said. So, it 
went out to the Iowa State Department of Education.

         Leveraging Federal Funds--School Construction in Iowa

    Now, Mr. Secretary, $28 million has gone out to Iowa for 
that. Now, hang on to your hat. That $28 million leveraged $311 
million on the State and local level.
    One of the things that we know about the Federal Government 
is, sometimes money can leverage money. And anytime you get 10 
to 1 leverage on Federal dollars, something is happening out 
there.
    What the State Department of Education said was, ``We will 
do matching on it. And you can raise money through a bond 
issue, sales tax.'' We have local option sales tax for plant 
and equipment, the different things that local units of 
government can do in the State of Iowa.
    With that little bit of money--with that little bit of 
money, they stepped forward and did it, and leveraged it over 
10 to 1. And I have got the data to prove it.
    You said two things. The Federal Government is not capable 
of administering this.
    Secretary Paige. No. I mean----
    Senator Harkin. Well, I wrote it down.
    Secretary Paige. Yes. I probably did say that, but I mean 
solving this problem. I did not mean administering.
    Senator Harkin. Oh, well, you said ``administering.'' I 
just want you to know, we did not administer it in Iowa. We let 
the State Department of Education in Iowa do it.
    Secretary Paige. Yes.
    Senator Harkin. And the legislation that we have now, the 
same thing; that would be our guideline. It is going to go out 
to the State Departments of Education in Pennsylvania and 
Washington and every other place. And we are just going to give 
them a broad guideline, target it to the poorest districts----
    Secretary Paige. Yes.
    Senator Harkin [continuing]. And let each State do it in 
their own way. So, we do not have a problem of administering 
it. It is administered in Iowa by the Iowa Department of 
Education. And it has made a huge difference. Go out and ask 
those school districts out there what it has done in terms of 
leveraging that money.
    So, when you talk about $1.2 billion will not repair three 
of your schools in Houston, when it all factors out, that is 
probably true, if you are talking about the totality, but think 
about it in terms of how much it leverages out there. If we can 
just get two-thirds of that leveraging nationwide, from $1.2 
billion, you are talking about $7 billion, $8 billion, $9 
billion. Now that makes an impact.
    So, there is a history here to this. And there is some 
proof of concept out there that we have gone through. And that 
is why I hope that your initial support of this, you would 
revisit, and come back again, Mr. Secretary.
    Secretary Paige. Well, that is what I want to do, Senator, 
to put emphasis on our education situation.
    And by the way, I would like the record to show that, if I 
am permitted to, I do not mean administering. I used the wrong 
word there. What I mean was solve it. I meant that this problem 
is so vast it is going to need the locals to address it, as you 
have indicated that they are doing.
    Senator Harkin. They do have to address it, obviously, but 
we are going to give them a little bit of help to move them 
along. That is the leveraging aspect of that money that goes 
out there.

                        Impact aid Construction

    Secretary Paige. But there is a place where we have the 
direct responsibility. And I think the Federal Government has a 
direct responsibility for school districts that are impacted by 
military enrollment of our students. I think that is a primary 
direct responsibility of the Federal Government in terms of 
construction.
    And when we look at the conditions of the buildings in 
those locales, I think that we find that we have an even 
greater problem there.
    And the second one would be on Indian reservations. It is 
those areas, where I would agree that we need to have a 
specific Federal focus on the construction of buildings.
    So, there is not that much difference here in the argument. 
There are places where we have direct responsibility that I 
think we should take care of first.
    Senator Harkin. Well, I agree that we need to do something 
in those areas, but--on the school districts in the military 
and stuff, why should that not also come out of the Defense 
budget? Why do we have to take that out of the Education 
budget? Put it in the Defense budget. That is where it ought to 
be done. That is my response to that.
    We have got an obligation. You are right. But I think this 
is a military obligation that they have.
    Thank you, Mr. Secretary.
    Secretary Paige. Thank you.
    Senator Specter. Thank you very much, Senator Harkin.
    Secretary Paige. Thank you for your passion in this matter. 
I know it is important to you.
    Senator Harkin. Yours, too. Yours, too. You have got good 
passion, too.
    Senator Specter. Senator Murray.
    Senator Murray. Thank you, Mr. Chairman.
    And clearly, Secretary Paige, you have a passion for making 
sure that all of our students get a good education. And I 
really commend you on that. And I have spoken to you a number 
times on this, both in my capacity on this committee and on the 
Authorizing Committee. And I appreciate your being here today 
and showing us, once again, your passion.
    I have to just quickly add on school construction--that I 
am delighted to hear you say that we should be funding military 
impacted schools, because I have been fighting to help some 
impacted schools in my State and cannot get anything from the 
Defense Department on this. They absolutely say it is hands-
off. And I agree with Senator Harkin that this is an issue we 
need to deal with, but it is an issue we need to deal with for 
all children.
    Let me go back to the issue of class size. The Chairman 
began this hearing with a question on this, and I heard your 
response about hiring only first-year teachers. The only 
requirements within the class size bill is that teachers hired 
are fully qualified, not that they are first-year teachers.
    So, I am not certain where you were coming from on that, 
but I can certainly tell you if there is a misunderstanding 
with that, then we need to deal with the language. Let us not 
throw the program out. Let us figure out what the language 
needs to be.
    And second, we have worked very hard with Senator Specter, 
Senator Harkin, and a number of people on both sides of the 
aisle to develop language for the very successful class size 
program, to assure that it is flexible; that if a school 
district has met their class size goals in first, second and 
third grade, then the money can be used for teacher training 
and for other purposes.
    And I want to thank Senator Specter, publicly, for his 
interest in this. I have seen his second-degree amendment. And 
I hope we can work something out on this, because I think that 
as we see the studies that come to us, we see the progress that 
has been made on class size, we see that this is a way to 
leverage Federal taxpayer dollars to actually make a difference 
in students' achievement; in their math, in their science, in 
their reading scores.
    We have seen, through various studies, that smaller classes 
make a difference in dropout rates and the number of students 
going on to college, and even teen pregnancy rates, even if it 
is just in those first, second and third grades, where our kids 
are just beginning to learn the basics, that they get the 
individual attention they need. And yes, it is the 
responsibility of the Federal Government to be a partner, to 
make sure that our local school districts have the ability to 
create smaller classes.
    In fact--I have to say, I am sort of baffled by your 
conversion, as Secretary of Education, from where you stood on 
this issue were as Superintendent of Houston schools, because I 
know that in presentations by your advisor, Susan Sclafani, 
about how Houston closed the achievement gap, certainly setting 
out the goals and where you wanted kids to be--and telling 
people they had to be accountable was part of it.
    But clearly, she has said that targeting assistance to low-
performing schools was important--and she specifically has 
said, that adding teachers to lower pupil-teacher ratio was a 
critical part of making sure that those students achieve.
    We believe that closing the achievement gap is a laudable 
goal, and one that many districts are struggling to reach. The 
class size dollars that we have put in place over the last 3 
years have come back to us, triple-, quadruple-fold from 
results in districts where teachers and parents and students 
are saying what a tremendous difference smaller classes have 
made for them.
    Because I have been on a school board, I know how hard it 
is to find the funds for long-term commitments like hiring more 
teachers. I know how many demands there are when it comes to 
budget time.
    The Federal class size dollars go directly to these school 
districts with the least amount of paperwork and the most 
flexibility, ensuring that students are able to get the kind of 
help they need. And we want to continue to leverage that. And 
we want to continue to build on that success. And I hope that I 
can work with you to make that happen, because I think it is 
absolutely critical to our children's success.
    And I hope you can comment on that really quickly, because 
I do have a very important question about the chart that you 
have.
    Secretary Paige. Well, Senator, you make a very powerful 
argument. I find very little in your comments to disagree with. 
My only point is the categorical nature of the way the dollars 
are provided for the system.
    I believe the people on the scene should be able to make 
the decision on how those dollars are used. And we should 
provide them with the total flexibility to----
    Senator Murray. I know you have said that before. And I 
appreciate that, but I would remind all of us that there are a 
number of targeted funding streams in the President's education 
reform proposal, including Reading First, Technology, After 
School Programs, and Charter Schools. This is where the 
Administration has said, ``We do believe targeted funds make a 
difference.''
    I am passionately telling you I believe that there are 
other areas, as well, including class size.
    Secretary Paige. That I think has an important role to 
play. We are talking about how broad or how narrow it is. And I 
thought that the teacher class size reduction legislation, the 
previous legislation, was too narrow.
    I thought that it was too restrictive. And I would have 
preferred, as an administrator, the flexibility of using my 
judgment on the scene, on determining how I could improve 
teacher quality. But the broadness of the teacher quality is--
--
    Senator Murray. We would disagree on that.
    Secretary Paige [continuing]. What we are talking about. I 
think that, clearly, you know that I agree with the--that 
smaller is better, given just that--if you just think of that. 
But it is not that narrow. It is much more complicated than 
that.
    Senator Murray. Well, I disagree.
    Secretary Paige. So, I am just arguing about the narrowness 
of the legislation. I'm arguing for a broader teacher quality 
package that will allow the people on the scene to make those 
decisions.
    Senator Murray. Well, I agree. Teacher quality is 
important, too, but so is class size.
    And before I yield my time, I just want to ask you a 
question about the chart that you have here, because you show 
that between 1984 and 2002, the increase in funding has gone up 
significantly and the red line representing NAEP reading 
scores, age nine, has been level.
    But is it not true that since 1984, when we had a little 
over 39 million students, our public schools have grown to 
serve 47 million students? And that chart is a little bit 
misleading, because we are actually educating a lot more kids 
in our public schools than we were in 1984. And those demands 
on the school system are not considered in that chart.
    Secretary Paige. Yes.
    Senator Murray. I just wanted to make that clear.
    Secretary Paige. You are correct. That is correct. What 
that says is our challenge is broader, our task is more 
difficult, but the----
    Senator Murray. Sure.
    Secretary Paige [continuing]. But the scores are still 
flat.
    Senator Murray. But you cannot say that we have increased 
funding and test scores have stayed the same to make the 
correlation that individual students are getting more money, 
because we are clearly educating more students in our schools.
    I understand my time is up. And I would yield back to the 
Chair.
    Secretary Paige. Yes.
    Senator Specter. Thank you very much, Senator Murray. We 
are sticking very close to the time. There is a Judiciary 
Committee meeting. And I have just been informed that they have 
nine Senators and need a tenth for a quorum.
    So, we are going to take Solomon's approach and split the 
Senator down the center, so he can be in two places at one 
time.
    Let me proceed to ask you a number of questions, Mr. 
Secretary, and either to have abbreviated answers, so I can 
cover them rapidly, or you can put them in writing. And then I 
am going to defer to Senator Harkin, who has one more question. 
And then I am going to excuse myself.

                       Vouchers and school choice

    On the question of vouchers, the President's program 
provides that if certain standards are not met within a third-
year point, there will be vouchers issued.
    As I understand it, in the past, you have opposed vouchers 
to private schools.
    Secretary Paige. Well, no, I have not.
    Senator Specter. That is not so?
    Secretary Paige. I have been a passionate supporter of 
cooperating with private schools and had a very broad private 
school program in Houston I operated for 4 years.
    Senator Specter. Well, there is considerable concern in the 
Congress about vouchers. As you know, they were defeated in the 
House and----
    Secretary Paige. I am aware of that.
    Senator Specter [continuing]. My instinct is that while it 
will be a close vote, it will probably not succeed. And I would 
like for you to submit, in writing to the committee, because it 
is a complicated subject----
    Secretary Paige. Yes, it is.
    Senator Specter [continuing]. And you cannot deal with it--
--
    Secretary Paige. Right.
    Senator Specter [continuing]. In a few minutes, your 
philosophical grounding. We have great respect for your views, 
because of your experience. Also, please deal with the question 
which is raised so consistently about what will happen to the 
public school system if vouchers do become the order of the 
day. And also, to comment on the amendment to be offered by 
Senator Carper, vouchers for use in public schools.
    Secretary Paige. Yes, sir.
    Senator Specter. The program of Youth Violence was adopted 
by this subcommittee 2 years ago, really utilizing the same 
philosophy that you have approached, and that is by taking 
$1.45 billion from other programs and directing it to Youth 
Violence. And I would appreciate it if you would take a look at 
the program we have coordinated with the Department of Health, 
Human Services and Labor and Department of Justice, and give us 
your evaluation of that.
    It is my hope to have a meeting coordinated with the 
President's domestic advisor. We would be interested in your 
evaluation there, and your further suggestions on how we deal 
with youth violence.
    We have made this proposal without any news conferences, 
any public attention, but with a whole series of workshops 
where Senator Harkin and I personally participated for hours on 
end, bringing in the people who really know--the technicians in 
the field. And we would appreciate it if you would take a look 
at it----
    Secretary Paige. I will.
    Senator Specter [continuing]. And give us your advice.

                              Campus crime

    Next, there is the issue of campus crime, where legislation 
was enacted more than a decade ago, after a brutal rape-murder 
at a Pennsylvania college, and the parents, Mr. Howard and Mrs. 
Connie Clery, came forward.
    Now, there has been a problem with respect to the 
Department's implementation of the Clery Act. The guidance from 
the Department on reporting standards has been hard to get. And 
when there are violations, it is difficult to secure 
investigation and corrective action. I had introduced that 
legislation and later produced amendments to toughen it up.
    And this is something which is very, very important; the 
essence of which is to tell people what is happening on the 
campus, so they know what the risks are. And that has the 
therapeutic effect of colleges and universities not wanting to 
report campus crime, so acting to prevent it and a great many 
efforts to circumvent it by not counting the sidewalks through 
the university campus as part of the university or not counting 
university leased premises as part of the university.
    So, we would appreciate your review and comment on that.
    Secretary Paige. I thank you for that legislation, Mr. 
Chairman. And I will tell you, you have my commitment that we 
are going to have a strong look at this, because this is the 
right thing to do. You have our support.

           Budget increases to be tied to reform and results

    Senator Specter. Well, I appreciate that comment. I only 
want to ask you one question for the record. I wrote down what 
you said, when you said, ``I think that the President is 
`amenable to increasing the spending of funds.'''
    By that, do you mean that if the Congress comes in somewhat 
higher or a little higher or reasonably higher than the 
President's budget, we might get him to sign the bill?
    Secretary Paige. I meant by that, that the President 
appears to me, from my interaction with him, willing to fund 
reform. And dollars that are tied to making things work better, 
he seems to be more willing to support.
    So, the connection would be funding reform. What he objects 
to is funding failure.
    Senator Specter. Well----
    Secretary Paige. I think he would be willing to spend 
whatever amount is necessary to reform the system, assuming 
those two things are connected.
    Senator Specter. Well, that is a fair challenge. If we tie 
our spending to reform, we may then look for the President's 
concurrence.
    Mr. Secretary, thank you very much for coming in.
    Secretary Paige. Thank you.
    Senator Specter. Again, I think we have covered the subject 
matter, although we have subverted on you to respond in 
writing, because of limitations of time. And I am going to turn 
the gavel over to Senator Harkin, who says he has one more 
subject matter. It is that hot newspaper article that he is 
indifferent to that he wants to ask you about.
    Thank you, Mr. Secretary.
    Secretary Paige. Thank you. And thank you, Mr. Chairman, 
for your leadership.
    Senator Harkin. Thank you. I have actually got two 
questions, but one basically that covers----
    Senator Specter. You can answer only one of them. You take 
your source. He said he only had one question.
    Senator Harkin. Then I will adjourn it, Mr. Chairman.
    Senator Specter. Thank you.
    Senator Harkin [presiding]. Mr. Secretary, again, back to 
the construction thing. Again, it is my understanding that your 
department has written a new guidance, alerting States that 
they might be able to spend school renovation grants in a way 
that Congress did not intend.
    Under current law, 75 percent of this money had to be used 
for school renovation; 25 percent could be, if they wanted to, 
used for IDEA, Individual Disabilities--doing things that meet 
their needs for special education and technology for special 
education.
    I am understanding that your new guidance is telling the 
States they do not have to do this, because Congress might 
eliminate the fund. First of all, what is the status of this 
guidance?
    Secretary Paige. Mr. Chairman, let me find out more about 
that. I am not equipped to answer that question, but I promise 
this----
    Senator Harkin. Yes.
    Secretary Paige [continuing]. Administration supports 
administering it so that congressional intent is carried out. 
So, I will look into it and get right back to you on that one.
    Senator Harkin. I would like to know that, because I just 
heard this, and I was just going to urge you to not issue this 
guidance, because----
    Mr. Skelly. Well, Senator Harkin, we have not issued the 
guidance, yet. We have drafted it. And we shared the content of 
the guidance with some of the staff on your committee just to 
see what they would think about it.

       President's proposal and use of school construction funds

    What it says is that although the current law does allow 
States considerable flexibility in using money for IDEA or 
technology, in addition to school renovation, the President's 
budget has made a proposal that would allow them even more 
flexibility to use that; not just 25 percent, but maybe 50 or 
100 percent for special education or technology, if they chose 
to do that.
    It is a proposal that was in the President's budget. The 
Congress would have to accept that proposal, pass it, and the 
President would have to sign it into law for that to take 
effect. And the guidance merely reiterates that the President's 
budget made that proposal.
    Senator Harkin. I understand what you are saying is that 
you would take the 2001 money, the money we already 
appropriated, and change how they could spend it, but you 
cannot do that on your own. You have to get us to do that.
    Mr. Skelly. That is exactly right. The guidance says----
    Senator Harkin. Well, I can tell you right now, forget it.
    Mr. Skelly. All right.
    Senator Harkin. Forget it. It is not going to happen. I 
cannot speak for the Chairman, but I think I can on this one. 
Forget it.
    Mr. Skelly. Okay.
    Senator Harkin. Because what that would do, I think, would 
create a lot of turmoil out there. We will fight the other 
battles next year and beyond, but on this one, I think it might 
confuse a lot of school districts out there and say, ``Well, we 
want to apply for the money. Why apply for it, if we cannot use 
it and they are going to change it?''
    As long as it is there, the money is--goes out July 1st. 
School districts, I know, all over the country, are thinking 
about applying for this. There are State Departments of 
Education. I do not think it would be fair to confuse them on 
it at this point.

         Funding for special education and idea reauthorization

    But what I really wanted to ask--now I am going to run out 
of time here--is that the administration indicated it was 
particularly upset by a vote last week to increase funding for 
schooling disabled students and lock it into the Federal budget 
for the next 10 years by shielding it from the annual 
appropriations process, which is exactly what we did.
    We put it on the mandatory side. It had broad-based 
bipartisan support. Senator Hagel was my co-sponsor on it; 
Senator Jeffords, Senator Specter. I mean, broad. It passed by 
unanimous consent and no one objected to it. And officials 
described the proposal as costly and unwarranted.
    Can you please respond to that, because this is very, very 
disturbing?
    Secretary Paige. Well, Senator, I have not read that. This 
is the first time I have heard that language. I do not have 
anything to add to what is written there, because I have not 
ever seen the article.
    Senator Harkin. Okay. So, it did not come out of your shop, 
then.
    Secretary Paige. I do not know.
    Mr. Skelly. That is from the Statement of Administration 
Policy, which is issued by the Office of Management and Budget. 
It was part of a longer piece. And it mentioned the IDEA 
amendment.
    Senator Harkin. Is that a correct quote, then, from it; 
that it is costly and unwarranted?
    Mr. Skelly. Those are adjectives used in the statement, 
yes.
    Senator Harkin. By OMB. That meeting our 40 percent 
obligation was costly and unwarranted.
    Mr. Skelly. I think the argument is that the--making it 
mandatory at this time, as a floor amendment to the ESEA, 
without a longer review of the IDEA--the IDEA, you know, was 
reauthorized in 1997. It will come up again in another 18 
months.
    It would be good to have a more thorough review of the 
IDEA, I think, is what the administration's position is, rather 
than making a change now as part of a floor amendment on ESEA.
    Senator Harkin. Well, okay. I can accept that as an 
argument. I just would point out that we are not changing any 
of the underlying law in IDEA. We are not--we are not changing 
it. We just simply are appropriating money to meet the 
underlying 40 percent requirement. That is all.
    I do not--I cannot see any--any indication out there at all 
that we want to reduce that 40 percent. I think that would run 
into a firestorm around here.
    Mr. Skelly. I think there is one other change in the basic 
law that would change the fiscal relief provision from 20 
percent, which was enacted in 1997, to 55 percent. In other 
words, of the additional funds that are made available for 
IDEA, Part B, State grants, some of the--if States are 
providing services to children with disabilities already, they 
could use some of that money for fiscal relief, use it for 
other purposes. So----
    Senator Harkin. But we can do that when we reauthorize 
IDEA. What we did, putting it on the mandatory side, has no 
effect on that. I mean, we can--we can do that. If that is the 
will of the Congress and the administration to do that, we can 
do that at that time.
    Mr. Skelly. It was in--it was just in the same amendment.
    Senator Harkin. Well, I understand, but--but I do not--
reauthorizing IDEA does not have anything to do with the 
funding. We are just funding it. If we want to change the mix 
and stuff, we can do that any time we want on the 
reauthorization end of it, 2 years from now.
    But I just think--the choice of words as being costly and 
unwarranted, I think, is a poor choice of words from OMB on 
that. And I hope that there might be some clarification put out 
from the administration on this.
    Mr. Secretary, do you have anything else to add before I--
--
    Secretary Paige. I would just like to thank you for the 
opportunity to come and for the stimulating discussion about 
that. And although we have some differences in point of view, I 
have great respect for your interests in improving education in 
America.

                       Testing and accountability

    Senator Harkin. Well, we will work together on this. I know 
that there are a lot of things we have got to do together. See, 
I want to--just for the record, make it clear, I am not opposed 
to what you are trying to do, in terms of testing and 
accountability and to try to model what you did in the Houston 
school system. I have no problem with that.

                         Cost of annual testing

    I think there has got to be a broader approach and other 
things that we have got to do beyond that. And fine. I can 
support your proposals on that, but funding, I guess, maybe we 
look at it, as appropriators--the National State Boards of 
Education estimated that all this additional testing would cost 
$2.7 to $7 billion extra. Now, I cannot verify that. That is 
what I heard from the State Boards of Education.
    Well, if we are going to require them to test, we ought to 
help them with some of the funding, too. I mean, I do not know 
if that is a proper amount of money or not. But somehow we are 
going to have to think about getting some additional funds out 
there for helping them with this testing and stuff.
    Secretary Paige. May I just make one observation about 
that, Mr. Chairman? The President is proposing $320 million to 
help States with the development of tests. The actual 
implementation of tests, the cost of that varies with the 
effectiveness of the management of the various test 
implementors.
    In Houston, it cost--we had to spend--for nine administered 
grades, 1 through 11, we implemented that at the cost of about 
$10 per child. And that was because it was very finely managed 
and carefully controlled. That cost could vary from what I 
think to be our very effective cost of $10 per child to $50 a 
child. It would depend on the effectiveness of the organization 
and how much the people who administer it want to save dollars 
there.
    So, it is a figure that we really cannot get our arms 
around. And besides, the 1994 reauthorization required 
administering tests to all the students at least three times 
through the pipeline. And there was no argument, then, about 
paying for those tests that they imposed on school districts at 
that time.
    So, what we are talking about is simply just adding tests, 
but we do see a need to help with the development of these 
tests. We know that this is going to be a process, not an 
event. And we will grow, in terms of learning about the costs.

                            Closing remarks

    Senator Harkin. Fair enough. Well, thank you very much, Mr. 
Secretary----
    Secretary Paige. Thank you.
    Senator Harkin [continuing]. For your dedication to 
education. I am sure we will have an opportunity to meet 
repeatedly, between now and whenever we get our budget through 
and our appropriations bills through, to work out our problems 
on this.
    Secretary Paige. Thank you, Senator.

                     Additional committee questions

    Senator Harkin. Thank you very much. There will be some 
additional questions which will be submitted for your response 
in the record.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]
              Questions Submitted by Senator Arlen Specter
                        private school vouchers
    Question. Please provide your philosophical grounding for your 
support of vouchers and explain what you think happens to the public 
school system. Also, please provide your view of Senator Carper's bill 
and its impact on the public school system.
    Answer. In the broadest sense, we believe that just as market-based 
competition works throughout our economy to maximize the efficient use 
of resources and provide high-quality goods and services at low cost, 
greater competition is good for our system of public education. This is 
why, for example, the President is such a strong supporter of charter 
schools, which encourage innovation that not only leads to better 
options for parents and students, but also brings pressure on regular 
public schools to improve their own educational offerings.
    We also support the limited use of vouchers because we believe that 
parents and students alike benefit greatly from the ability to choose 
the school that best meets their educational needs. And when parents 
choose the school their child attends, they are more likely to actively 
support the school. I can tell you from personal experience that when 
parents get involved in our schools, good things happen.
    More specifically, it cannot be denied that there are too many 
schools that are failing our children, denying them the opportunity to 
reach their full potential as citizens and human beings. Vouchers and 
other forms of choice can help ensure that no child is trapped in a 
failing school--one of the central goals of No Child Left Behind.
    As for the impact of vouchers on our public schools, I have two 
answers. One is that for the foreseeable future the vast majority of 
our children will continue to attend public schools, even if in limited 
circumstances vouchers are available. In my view, vouchers present very 
little in the way of a threat to our long tradition of public 
education. In large part this is because of my second answer, which is 
that in general public schools compete very well with private schools. 
This was my experience in Houston, and I believe it would be the 
experience nationwide if voucher systems were more widely adopted.
             amendment proposed by senator thomas r. carper
    Senator Carper's proposed amendment would authorize competitive 
grants to States or school districts to support the implementation of 
universal public school choice programs. As you know, President Bush 
and I support the expansion of choice and educational options for 
parents and students, and I believe Senator Carper's proposal would be 
a step in the right direction in this area. In particular, the Carper 
proposal would support the creation of meaningful choice by helping to 
pay for the cost of transporting students to the schools they choose to 
attend, and by helping to expand capacity at the high-quality, high-
demand schools that students will want to attend.
                             youth violence
    Question. Please look at the programs included in the youth 
violence prevention initiative that we have coordinated with other 
agencies and evaluate what has been done and provide further 
suggestions on how to deal with the issue of youth violence.
    Answer. A number of the programs included in this initiative are 
demonstrating an impact on fostering youth violence prevention 
activities in communities across the country. For example, the Safe 
Schools/Healthy Students initiative the Department of Education has 
funded jointly with the Departments of Justice and Health and Human 
Services is supporting collaborations between schools, mental health 
providers, and law enforcement that promote healthy child and youth 
development and safer schools. In fiscal year 2000, some Safe Schools/
Healthy Students communities reported decreases in arrests and 
detentions for violent acts at school. They also reported increases in 
the provision of mental health assessment and treatment services to 
students.
    The Department's 21st Century Community Learning Centers program is 
helping to provide safe and stimulating after-school environments for 
students in supervised settings in which they can receive homework 
support, mentoring, drug and violence prevention counseling, and 
college preparation services. One grantee has reported a 40 percent 
drop in juvenile crime in the neighborhood surrounding the Learning 
Center's after-school program. Another has reported that the program 
led to a substantial drop in student use of drugs, alcohol, and 
tobacco.
    Several States are reporting that their Character Education 
programs are having a positive influence on student behavior. For 
example, an independent evaluation of the first year of Maryland's 
program found that students were perceived to be more likely to solve 
conflicts without fighting, insults or threats; to respect others' 
personal rights; and to treat classmates with respect. In Utah, 
participating schools reported a decrease in discipline referrals, 
fewer student fights and confrontations, decreased vandalism, less 
tardiness, and an increase in positive behaviors such as interacting 
more kindly and respectfully with students and teachers, better 
attendance, improved achievement, and greater student involvement in 
extracurricular activities.
    One of the strongest suggestions I can offer for addressing the 
problem of youth violence is to hold schools accountable for school 
safety. That is why the Administration's No Child Left Behind proposal 
would require States to develop a definition for a ``persistently 
dangerous school'' and to provide victims of serious, schoolbased 
crimes and students trapped in persistently dangerous schools the 
option to transfer to a safe alternative.
                        clery act implementation
    Question. I have some concerns about the Department of Education's 
implementation of the Clery Act. Please review and comment on the 
implementation of this Act.
    Answer. The Department has made a good faith effort to implement 
the Clery Act. Last year, for example, the Department collected crime 
statistics as required by the Act. In collecting these statistics, the 
Department used a web-based data collection tool through which 
statistics were publicly available as the data were collected. This 
approach--combined with the Department's aggressive enforcement of the 
requirement--resulted in a 100 percent response rate to this data 
collection.
    In addition to collecting the campus crime statistics, the 
Department has successfully investigated allegations that institutions 
were misrepresenting their crime statistics. Generally, we have been 
successful in bringing institutions into compliance with the 
requirements of the Act. When appropriate, the Department has imposed 
fines for non-compliance.
                       education funds for reform
    Question. You stated during your oral remarks that you believe the 
President would be ``amenable to increased funding.'' Please elaborate 
on this remark.
    Answer. As I said earlier, the question is really not about 
funding, but reform. I believe the President is willing to fund serious 
reform efforts, such as those proposed in No Child Left Behind and 
included in our 2002 budget request. He is not willing to continue 
funding failure in our education system.
         school renovation grants--guidance for implementation
    Question. What is the status of the Department's guidance for 
implementation of the School Renovation grants program enacted in the 
fiscal year 2001 Labor-HHS Education appropriations conference report?
    Answer. The Department distributed guidance for the School 
Renovation grants program to State coordinators on May 17, 2001.
    Question. What statutes, rules or regulations (internal Department 
or government-wide) govern when and how the guidance may be issued?
    Answer. The School Renovation program guidance is non-regulatory. 
Nonregulatory guidance is not subject to the Administrative Procedures 
Act, as is the case with regulations. Furthermore, other statutes or 
regulations do not generally govern the issuance of guidance.
    The guidance for the school renovation program is designed to 
explain, using plain language, the provisions of the legislation to 
help grant recipients understand the requirements in the legislation. 
The Department conducts an internal review of guidance to ensure 
consistency with legislation before it is issued.
    Question. Will the guidance package be wholly consistent with 
congressional intent as expressed in the fiscal year 2001 Act, and will 
the purpose of the program be reflected throughout the document 
(including cover notes, supplemental material, guidance, etc.)?
    Answer. Yes, the guidance package is wholly consistent with the 
congressional intent expressed in the Fiscal Year 2001 Department of 
Education Appropriations Act.
    As you know, the Administration's 2002 budget submission proposed 
to amend the 2001 appropriations act to provide States with additional 
flexibility in how they may spend their portion of the $1.2 billion in 
fiscal year 2001 school renovation funds. The Administration proposes 
to allow States to choose how much of the funds may be spent on any of 
the three currently allowable activities: school renovation, activities 
under Part B of the IDEA, and technology activities associated with 
school renovation.
    If Congress enacted the Administration's proposal, we would 
communicate the enactment to the States. The Administration remains 
committed to securing this flexibility for the States whether 
congressional action occurs before or after July 1 of this year.
                21st century community learning centers
    Question. The budget request proposes to consolidate the 21st 
Century Community Learning Centers and Safe and Drug-Free Schools 
programs in a formula driven State grant program so that school 
districts can support drug and violence prevention activities as well 
as after school activities. How will this help improve student safety 
given the findings in the Department's ``Progress in Prevention'' 
national evaluation of the Safe and Drug Free Schools program that 46 
percent of districts would lose their prevention programming without 
its funding and more than 75 percent would reduce them to a great 
extent?
    Answer. The Administration's fiscal year 2002 budget request does 
not propose to consolidate the 21st Century Community Learning Centers 
and Safe and Drug-Free Schools programs into a single formula grant 
program. The request would maintain separate funding streams for the 
two programs.
    The Administration is requesting $644 million in fiscal year 2002, 
the same as 2001, for the Safe and Drug-Free Schools program. However, 
a greater proportion of total funds would flow to States under the 
President's proposal (as compared to the 2001 funding level for State 
Grants) to help ensure that children receive a high-quality education 
in a safe and drug-free environment. The President's No Child Left 
Behind proposal for reform of elementary and secondary education would 
hold States accountable for school safety by requiring States, as a 
condition of receiving a performance-based grant for safe and drug-free 
schools, to: (1) develop a definition for a ``persistently dangerous 
school'' and to report on school safety on a school-by-school basis; 
(2) provide victims of serious, school-based crimes and students 
trapped in persistently dangerous schools the option to transfer to a 
safe alternative; and (3) adopt a ``zero-tolerance'' policy that 
empowers teachers to remove violent or persistently disruptive students 
from the classroom.
    The Administration is also requesting $845.6 million, the same as 
fiscal year 2001, for the 21st Century Community Learning Centers 
program. Program funds would be used to provide students, particularly 
students who attend high-poverty or low performing schools, with high-
quality extended learning opportunities to help them meet challenging 
academic standards.
               unmet need and access to higher education
    Question. ``Access Denied'', a report of the Advisory Committee on 
Student Financial Assistance was released in February 2001 and 
identified three interrelated factors that conspired to produce what is 
fast becoming an access crisis. The first is the increasing cost of 
higher education as a relative percentage of family income only for 
low-income families and the shifting focus of Federal, State, and 
institutional policies toward merit-based programs. Second, is the 
steep rise in unmet need of low-income students. On average, the very 
lowest income students face $3,200 of unmet need at 2-year public 
institutions and $3,800 at 4-year public institutions, even after 
factoring in loans. Third, students, motivated by rational financial 
considerations, make choices that lower the probability of their 
persistence and degree completion significantly. In addition, dramatic 
demographic changes will produce an increase in college enrollment of 
18 to 24 year olds of 1.6 million by 2015.
    Last year's final appropriation included resources to increase the 
maximum Pell Grant by $450. How does this budget reduce the opportunity 
barrier of unmet need and increase access to postsecondary education 
for low-income students?
    Answer. The fiscal year 2002 President's Budget includes a three-
pronged approach to enhancing access to postsecondary education among 
low-income students, which provides: (1) $1 billion in additional Pell 
Grant funding, increasing the maximum grant to a record $3,850 (under 
this proposal, the maximum grant will have grown by nearly 43 percent 
over the five years through 2002, significantly faster than tuition and 
fee increases over the same period); (2) continued support for 
supplemental grant assistance under the TRIO Student Support Services 
program, as well as increased funding for TRIO academic support and 
counseling services to low-income students to better prepare them for 
higher education; and, (3) additional funds to strengthen institutions 
that serve large numbers of minority and low-income students, including 
Historically Black Colleges and Universities and Historically Black 
Graduate Schools, and for Hispanic Serving Institutions.
                         persistence in college
    Question. What does this budget propose to increase persistence for 
students saddled with high levels of debt and significant work 
responsibilities while attending school on a full- or part-time basis?
    Answer. Research on the relationship between persistence and work 
and persistence and debt on several occasions has yielded mixed 
results. Many analysts believe that the decision to depart from 
postsecondary education is related to a student's specific short- and 
long-term plans, the strength of the student's desire to finish, and 
the difficulties associated with adapting to the challenges of college 
life. In this area, the Department's budget includes increased 
assistance to institutions of higher education that serve large 
populations of low-income and minority students to help them meet the 
needs of their students, as well as to programs that directly respond 
to the needs of low-income and first-generation college students. For 
example, the budget includes additional support for Historically Black 
Colleges and Universities (HBCUs) under Title III and Hispanic-Serving 
Institutions (HSIs) under Title V to help these institutions meet the 
growing demand for their services. The budget also includes an increase 
for the TRIO programs, which help to prepare low-income students for 
college and help improve retention and success rates among these 
students once they enter college.
                      growth in college population
    Question. How is the Administration planning to support the 
increasingly diverse needs of the additional 1.6 million college 
students expected by 2015?
    Answer. The fiscal year 2002 budget proposal addresses the short-
term needs for funding for postsecondary education. The 
Administration's long-term strategy for supporting the diverse needs of 
students enrolled in postsecondary education will be developed as we 
prepare for the reauthorization of the Higher Education Act in 2003.
                                 ______
                                 
              Question Submitted by Senator Larry E. Craig
                             trio programs
    Question. Mr. Secretary, in my State, I know that TRIO's Upward 
Bound and Talent Search programs have been very successful in serving 
middle and high school students. These programs are enabling students 
attending under-performing schools to raise their aspirations and 
develop the skills to achieve those goals. How are you including TRIO 
in your Department's overall plan to meet the educational needs of all 
children?
    Answer. TRIO plays an important role in our overall plan by 
ensuring that the needs of students are met all the way through 
college. In particular, the Upward Bound and Talent Search programs 
target disadvantaged middle and high school students, providing 
tutoring, mentoring, counseling, and other services to adequately 
prepare them for success in college. The Student Support Services 
program provides similar services once these students are in college, 
helping them to achieve their higher education goals. The $50 million 
increase requested for the TRIO programs would significantly expand 
these services and increase the number of students who would benefit.
                                 ______
                                 
               Questions Submitted by Senator Tom Harkin
                     access to a college education
    Question. The President's budget would increase the maximum award 
for Pell Grants by just $100, to $3,850. That's $355 less, in real 
dollars, than 25 years ago. In the meantime, college tuition costs have 
skyrocketed. If we really want to leave no child behind, shouldn't we 
do more to help our poorest high school graduates get a college 
education?
    Answer. To help the poorest students and families pay the rising 
cost of attending college, the Administration is proposing an 
additional $1 billion in Pell Grants to increase the Pell Grant maximum 
award to $3,850, the highest award ever. Under this proposal, the 
maximum grant will have grown by nearly 43 percent over the five years 
through 2002, significantly faster than tuition and fee increases over 
the same period. The Pell Grant program is the foundation of the 
Federal student assistance effort and is designed to help low- and 
middle-income students attend college.
    Helping the poorest high school graduates get a college education 
requires more than just providing financial assistance, however, since 
a disproportionate number of low-income and minority students who do 
enter college do so without the academic preparation needed for 
success. The Administration's budget would increase support for the 
Federal TRIO programs to help prepare low-income and minority students 
for postsecondary education. In addition, the Administration is 
proposing to increase assistance to institutions of higher education 
that serve large populations of low-income and minority students to 
help them meet the needs of these students.
           elementary school counseling demonstration program
    Question. Most people agree that school mental health and 
prevention services are critical to creating a healthy and safe 
learning environment. But the President's budget would eliminate $30 
million for the Elementary School Counseling Demonstration Program, 
which provides assistance for hiring school counselors, school social 
workers, and school psychologists. Why does the President oppose this 
program?
    Answer. Neither the President nor I oppose the provision of 
counseling and mental health services for students; we just oppose the 
proliferation of small, categorical Federal programs with narrow 
purposes that limit State and local flexibility to address State and 
local needs. Under the President's 2002 budget request, funding for the 
Elementary School Counseling Demonstration program is consolidated 
under the $471.5 million proposed Choice and Innovation State Grants 
program. School districts would be permitted to use funds under this 
flexible grant program to hire school counselors, social workers, and 
psychologists if they choose. School districts may also use their Safe 
and Drug-Free Schools and Communities State (SDFSC) Grant funds to 
provide counseling and related services for students. The President's 
2002 budget request includes $547.3 million for SDFSC State Grants, a 
$108 million increase over 2001.
                  special education teacher shortages
    Question. There is a tremendous shortage of special education 
personnel throughout the country--second only to math/science. 
Currently there are over 35,000 individuals teaching students with 
disabilities who are not qualified to do so. The Department of Labor 
estimates that schools will need more than 200,000 new special 
education teachers over the next five years. Yet our colleges and 
universities prepare only half that number. We are even beginning to 
document increasing shortages of special education faculty in our 
Nation's universities.
    In addition, with new programs, such as the President's Reading 
First and Early Reading First, there will be even a greater need for 
special education professionals with skills in communications disorders 
and early literacy interventions. The President's budget calls for 
level funding for Personnel Preparation for the Individuals with 
Disabilities Education Act (IDEA). This account has not received an 
increase in over a decade despite these critical shortages. We are 
working hard to fully fund Part B of IDEA, but without qualified 
teachers, we will not get the results we want. What is your plan to 
address these critical personnel shortages, and why didn't you request 
an increase in funding for Personnel Preparation?
    Answer. We believe that if large increases in funding are provided 
over a short period of time for the Grants to States program under Part 
B of IDEA, they may not be used to achieve the improved results we all 
want for children with disabilities. For example, with large increases 
local educational agencies may have more resources to hire special 
education teachers, but may be unable to do so because the supply of 
such teachers is relatively inelastic in the short term.
    However, more gradual increases, such as the $1 billion increase 
proposed in the President's budget, may be used effectively to promote 
improved working conditions, smaller class sizes, retention incentives, 
inservice training, and other activities as well as increased salaries 
that will create greater incentives for college students to enter and 
remain in the field of special education. We believe that the best way 
to recruit and retain special education personnel is through enhancing 
the value of working in that field and not necessarily through 
providing additional funds to institutions of higher education, which 
is the primary activity under the Special Education Personnel 
Preparation program.
    In addition to the funds requested for the Grants to States 
program, funds to address personnel needs are also provided through the 
Special Education State Improvement program, which was authorized by 
the IDEA Amendments of 1997. This program awards grants to States to 
help them to address their particular needs. States must use at least 
75 percent of their grants under this program to address their special 
education personnel needs. Our fiscal year 2002 request for this 
program is $49.2 million, and there was a $14 million increase in 
funding for the program in fiscal year 2001.
    We believe that the combination of increased funding provided for 
the Grants to States program, support for the new State Improvement 
program, and maintenance of support for the Personnel Preparation 
program will begin to effectively address our needs for special 
education personnel.
                    math and science budget support
    Question. The President's budget calls for tripling the spending on 
reading to improve instruction and student achievement in the early 
grades. His education reform plan would require annual testing in 
reading and mathematics. Given that teacher shortages put math and 
science at the top of the list, why is a similar investment in the 
preparation and professional development of teachers in those key 
fields not similarly recommended in the budget for the Department of 
Education?
    Answer. No Child Left Behind reflects the President's commitment to 
improving the quality of our teaching force in all subject areas, 
including mathematics and science, because teacher excellence is vital 
to achieving improvement in student achievement. The Administration's 
fiscal year 2002 budget request reflects this commitment because it 
includes $2.6 billion for the Department of Education for the State 
Grants for Improving Teacher Quality program and $200 million for the 
National Science Foundation for the Math-Science Partnership program.
    The State Grants for Improving Teacher Quality program would 
combine funding from several existing education programs, including 
Class Size Reduction and Eisenhower Professional Development State 
Grants, into performance-based grants that provide sufficient 
flexibility for States and local educational agencies (LEAs) to meet 
their particular needs and to strengthen the skills and improve the 
knowledge of teachers and administrators. Because of the flexibility 
that the President is proposing for this program, States and LEAs would 
be able to use program funds to improve the quality of their 
mathematics and science teaching force, if they believe that would best 
address their needs.
    In return for this flexibility, States and LEAs would be required 
to ensure that program funds are used for professional development that 
is grounded in scientifically based research. States would be held 
accountable for ensuring that all children are taught by effective 
teachers and improving student academic achievement. Professional 
development programs also would be tied to State or local standards, of 
sufficient intensity and duration to affect teaching performance, and 
directly related to the subjects taught by the teachers who are 
participating in the professional development.
    In addition, the Math-Science Partnership program, which the 
President is proposing as a National Science Foundation program, would 
provide funds for States to join with institutions of higher education 
to strengthen mathematics and science K-12 education. These 
partnerships, which could also include LEAs, would provide highquality 
teacher preparation and professional development for mathematics and 
science teachers, help to implement high standards in mathematics and 
science education, and address gaps between the education of advantaged 
and disadvantaged students.
         assistive technology act, title i state grants program
    Question. The State Grants program under Title I of the Assistive 
Technology Act is slated to sunset beginning this year. And the 
President's budget calls for an increase of $25 million for the Title 
III Assistive Technology Loan program. To date, all of the grants that 
have been awarded under Title III have been awarded to the Title I 
State projects. Who will run these loan programs if the Title I 
projects sunset?
    Answer. Under Title III of the Assistive Technology (AT) Act, the 
Secretary is authorized to make grants to States for the administration 
of alternative financing programs. In order for a State to be eligible 
for funding under the Title III Alternative Financing Program, the 
State must receive or have received Title I funding. Therefore, the AT 
Act clearly contemplates that when States apply for Title III funds 
they may no longer be participating in the Title I program. In 
addition, the State is required to enter into a contract with an 
experienced community-based organization to administer the Alternative 
Financing Program.
                      gaann and javits fellowships
    Question. The Department proposes level funding of the Graduate 
Assistance in Areas of National Need (GAANN) and Jacob Javits program 
at $31 million and $10 million, respectively. These programs support 
graduate students who will become the teachers, scholars and 
researchers of tomorrow. Since the stipend level for these two programs 
is tied by statute to the stipend level for the Graduate Research 
Fellowship program at the National Science Foundation (NSF), the 
stipend for both these programs will increase to $18,000 per student in 
the 2001-2002 academic year and to $20,500 in 2002-2003. Because of 
this, the number of new fellowships in the Javits program will decrease 
significantly and there will be no resources available for a GAANN 
competition or new awards this coming year. Knowing that an increase in 
funding, to keep pace with statutory obligations to increase stipends, 
was the only way program integrity could remain intact, why did the 
Administration decide to level-fund both programs?
    Answer. At the time we submitted our fiscal year 2002 budget 
request, the approved NSF stipend level was $18,000. Unfortunately, we 
had no way of knowing that it would be increased for the second time in 
two years to $20,500 for the 2002-2003 academic year. However, knowing 
that it is difficult to predict the average fellow's level of need and 
the maximum stipend level that will be in effect at the time we make 
awards, our estimates were based on all fellows receiving the maximum 
stipend that was in effect at the time we submitted the budget. As 
such, our estimates reflect the minimum number of fellows that would 
have been supported with a maximum stipend of $18,000.
    Under the Administration's request for the Javits Fellowships 
program, even with a stipend level of $20,500, a minimum of 60 new 
fellows would be supported in fiscal year 2002. The request for GAANN, 
even though it would not support a new competition, would maintain 
support for approximately 1,070 continuing fellows. A new competition 
would be held again in fiscal year 2003.
    Question. What will the Administration do in the future to support 
these two small, yet vitally important programs in graduate education?
    Answer. The Administration will continue to work to ensure that all 
low-income students have the resources necessary to complete their 
postsecondary education. The Javits Fellowships and GAANN programs play 
an important role in preparing students for scholarly careers and 
careers in areas of national need, which will remain a critical part of 
our goal to strengthen America's workforce.
                 vocational education programs support
    Question. Career technical education funding has declined 19 
percent, in real dollars, in the past decade. At a time when the Labor 
Department is reporting increasing unemployment, why has President Bush 
level funded and, in some cases, cut programs in the Carl D. Perkins 
Vocational Technical Education Act, a law whose sole purpose is to 
prepare America's students with the skills, education and training they 
will need to pursue employment or higher education? Please address the 
proposed level funding of Basic State Grants, the cut to National 
Programs, and the elimination of the Tech Prep Demonstration Program.
    Answer. The Department's 2002 budget received the largest 
percentage increase of any Cabinet-level domestic agency. The budget 
reflects major increases for the Administration's highest priority 
areas, including $1 billion for Special Education Grants to States, $1 
billion for Pell Grants, and substantial new funding to implement 
changes proposed in No Child Left Behind, the President's framework for 
reauthorization of the Elementary and Secondary Education Act. Under 
the proposal, many programs are eliminated or consolidated, but none of 
the consolidations affect the Vocational Education appropriation. The 
Administration recognizes the importance of the Vocational Education 
State Grants by maintaining level funding for the program.
    The fiscal year 2002 request includes $12 million for National 
Programs, a reduction of $5.5 million. In past years, National Programs 
provided funds to assist in the implementation of new accountability 
requirements and other provisions of the 1998 reauthorization. Now the 
implementation is well underway, and many national activities have 
been, or will be, completed by fiscal year 2002. The request provides 
sufficient funding to support major national initiatives.
    The Administration requests zero funding for the Tech-Prep 
demonstration program, which is consistent with the effort to redirect 
resources to high-priority areas and to eliminate small programs whose 
activities can be funded from other sources. Currently, States can use 
funds they receive from the Tech-Prep State grant program to support 
this kind of activity. In fact, some States are already developing and 
implementing Tech-Prep programs that locate secondary schools on 
community college campuses and that can be disseminated and adopted by 
other States. The Department does not believe that a separate, more 
prescriptively structured, program that specifically focuses on this 
area is needed.
                                 ______
                                 
                Question Submitted by Senator Harry Reid
                     addressing the dropout problem
    Question. Secretary Paige, how do you plan to address the dropout 
problem our nation faces? Please provide the specific, measurable steps 
you plan to implement to address the problem.
    Answer. Research has shown that poor academic performance is the 
best predictor of who will drop out of school. Students who receive low 
grades, perform poorly on tests, are retained in grade, or are absent 
frequently are more likely to drop out before completing high school 
than are their peers. No Child Left Behind, the President's framework 
for reforming elementary and secondary education, would apply proven 
strategies--high State standards, annual testing of students in grades 
three through eight in at least reading and mathematics, increased 
accountability for student performance, reduced bureaucracy and greater 
flexibility for States, school districts, and schools, and expanded 
options for parents to make choices for their children's education--to 
strengthen Federal support for State and local efforts to help improve 
student achievement.
    The most effective strategy for preventing students from dropping 
out is to ensure that they are successful and engaged at school. The 
strategies proposed by the President would help ensure that all 
students have the opportunity to succeed in school. For example, 
research has shown that early intervention for students who show signs 
of academic difficulty or disengagement from school is very important. 
The President's proposal for annual testing of students in at least 
reading and mathematics would provide teachers with current information 
on a child's progress in school, including specific strengths and 
weaknesses, and enable teachers to arrange for the types of support and 
remediation that are most likely to help that child succeed 
academically.
    In addition, research shows that students who fail to read well by 
the fourth grade have a greater likelihood of dropping out and a 
lifetime of diminished success. The Administration's proposed Reading 
First State Grants and Early Reading First programs will help States 
and school districts implement comprehensive reading instruction, 
grounded in scientifically based reading research, to enhance the pre-
reading skills and school readiness of school-aged children and to 
ensure that all children can read well by the end of third grade.
                                 ______
                                 
              Questions Submitted by Senator Mary Landrieu
                         title i budget request
    Question. Like you, I strongly believe that the targeted 
investments we make through Title I Grants are key if we hope to turn 
around low performing schools, improve teacher quality and ensure that 
all students achieve high standards. Although I am extremely pleased by 
the fact that all of the excess dollars included under this section are 
to be allocated through the targeted grants formula, I still have grave 
concerns about how little the President's budget invests in increasing 
Title I.
    In my own State of Louisiana last year, their overall Title I 
allocation was reduced by $16 million because of insufficient funds at 
the Federal level. This year's increase, even if targeted, would bring 
only $2 million in new money for these purposes. This is in a State 
where over 20 percent of the school age kids are in poverty. As a 
Superintendent, you know accountability and reform cost money. Do you 
honestly believe that this amount is sufficient to help achieve the 
goals the President has laid out?
    Answer. I agree that resources are important, but my experience as 
Superintendent showed that how money is spent can be just as important 
as how much is available, and that improving management and 
accountability allow more funds to be used for the instruction of 
students. In any case, the President's budget does include $400 
million, an increase of $175 million or 78 percent, to support State 
and local efforts to turn around low-performing Title I schools. Your 
State of Louisiana will share in these funds in proportion to its 
overall Title I allocation.
    I must point out, however, that Louisiana received a lower Title I 
allocation last year not because of insufficient funding--the Title I 
appropriation rose $660 million or more than 8 percent from 2000 to 
2001--but because its child poverty rate has been declining in recent 
years. It is certainly true that Louisiana remains a poor State, but 
according to Census estimates its percentage of school-age kids in 
poverty fell from almost 29 percent in 1995 to a little over 24 percent 
in 1997. Other States experienced growing poverty rates over the same 
period. The Title I funding formulas are designed to target funds to 
States and school districts that have a growing population of poor 
children, so this shift in poverty rates resulted in lower allocations 
for Louisiana and other States with declining relative shares of poor 
children, and higher allocations for States with rising proportions of 
poor children.
                         transition to teaching
    Question. I am glad to see that the budget includes additional 
resources to address the teacher shortage. I am particularly interested 
in two of the programs you include. First, the Transition to Teaching 
program. Currently, this money is used to support the Troops to 
Teachers Program, which is a wonderful program. I understand that this 
budget gives you the authority to expand on that program to recruit 
other mid-career professionals. Can you tell me what efforts you hope 
to include?
    Answer. For fiscal year 2002, the President is requesting $30 
million for a Transition to Teaching initiative. In addition to funding 
the Troops to Teachers program under this initiative, the Secretary 
would have the authority to reserve some of these funds for a program 
that would be similar to the Transition to Teaching program for which 
Congress appropriated $31 million in fiscal year 2001. Funds could 
support efforts to recruit, prepare, and support a wide range of 
talented career-changing professionals as teachers, particularly in 
high-poverty schools and in high-need subject areas.
    In fiscal year 2001, the appropriation for the Eisenhower National 
Activities program included $3 million to be transferred to the 
Department of Defense for the Troops to Teachers program and $31 
million for Transition to Teaching activities to recruit and support 
mid-career professionals and recent college graduates to become 
teachers.
    The Department has already transferred the $3 million in fiscal 
year 2001 funds to the Department of Defense for the Troops to Teachers 
program. With these funds, the Department of Defense will be able to 
support and expand the highly effective Troops to Teachers program by 
providing high-quality teachers for more students in high-poverty 
schools.
    Also, the Department's competition for the fiscal year 2001 
Transition to Teaching program is underway; applications became 
available in April and must be returned to the Department by June 15, 
2001. The fiscal year 2001 Transition to Teaching program will provide 
support for recent college graduates with outstanding academic records 
to become licensed and successful teachers. The program would also 
provide assistance for mid-career professionals with work experience in 
high-need areas to become successful teachers.
                teacher retention and recruitment grants
    Question. I am also concerned by your decision not to increase your 
efforts in the area of higher education for teachers. In my own State, 
it has been the institutions of higher education that have led the 
efforts to recruit and retain qualified teachers. They also are crucial 
in preparing teachers for the challenges they will face. The budget 
mentions that Title II Teacher Quality money is also available for 
these efforts, but that money is barely enough for professional 
development, recruitment and retention of existing teachers. Would you 
care to comment?
    Answer. The Administration's budget includes $2.6 billion to 
support a new program, State Grants for Improving Teacher Quality, 
which is an increase of $375 million over funding provided in fiscal 
year 2001 for consolidating programs like the Class Size Reduction and 
Eisenhower Professional Development State Grants. Under the President's 
proposal, States may choose to use these performance-based grants for 
the kinds of activities authorized under the Title II program, 
including changes to teacher certification or licensure requirements, 
alternative certification, tenure reform, pre-service teacher 
preparation, professional development, and recruitment and retention 
initiatives.
                        pell grant program costs
    Question. In the area of higher education, this budget includes an 
additional $1 billion to increase the Pell Grants by $100 to a maximum 
of $3,850. Recent program data show that more students are applying for 
Pell Grants, and more of those applying are eligible for these awards, 
than was previously expected. Will some of this money be used to 
address that issue as well, and, if so, how much of the billion will be 
left for the increases in awards?
    Answer. As you note, recent program data indicate that more 
students are applying for Pell Grants, and more of those applying are 
eligible to receive aid, than was previously forecast. This has 
increased the cost of funding awards for the 2001-2002 award year by 
$117 million; this additional prior-year need would be funded from the 
proposed $1 billion increase. In addition, the fiscal year 2001 
appropriation used $319 million in surplus funds from prior years to 
fully fund the maximum award level of $3,750. In the absence of these 
supplemental and surplus funds, $436 million of the proposed $1 billion 
increase for fiscal year 2002 is needed to maintain the previous year's 
funding level, replacing the $117 million and $319 million used in 
fiscal year 2001. An additional $78 million is needed to fully fund a 
$3,750 maximum award in fiscal year 2002. Increasing the maximum award 
by $100, to $3,850, for academic year 2002-2003 requires $312 million, 
with the remaining $57 million of the proposed $1 billion set aside to 
account for possible further growth in program costs.
                             trio programs
    Question. Mr. Secretary, there are almost 9.6 million low-income 
students (from middle school to college) currently eligible for the 
TRIO programs. In the next decade, demographic trends show that this 
number will grow considerably as more low-income students move through 
the education pipeline.
    Although TRIO has a demonstrated record of success, the current 
funding level only allows approximately 6 percent of the eligible 
population to be served. Understanding the importance of these 
programs, many members on both sides of the aisle have voiced their 
support of expanding TRIO so it can serve 10 percent of those eligible. 
Is this a goal you think the Administration will support?
    Answer. The Administration does support an expansion of the Federal 
TRIO Programs. In fact, our fiscal year 2002 budget request would 
expand TRIO to serve 785,000 low-income students, approximately 8 
percent of the eligible population you mention. The $50 million 
increase requested for TRIO would support more than 40 new projects and 
provide a greater intensity of services, high school work-study 
opportunities, and college scholarships to thousands of additional 
students. However, TRIO is just one of many programs in the 
Administration's ``No Child Left Behind'' proposal that reach out to 
low-income and minority students.
    Under our budget request, Gaining Early Awareness and Readiness for 
Undergraduate Programs would provide academic and support services and 
scholarships to more than 1 million students in high-poverty middle and 
high schools. Additionally, substantial increases would be provided for 
Historically Black Colleges and Universities and Hispanic-serving 
Institutions that serve thousands of minority and low-income college 
students. The President's budget also includes an increase of $1.9 
billion for the Department's elementary and secondary education 
programs.
                                 ______
                                 
             Questions Submitted by Senator Robert C. Byrd
                  american history instruction support
    Question. President Bush has stated that he wishes to strengthen 
and reform education, and he has presented Congress and the American 
people with an education proposal that calls for renewed diligence in 
math, science, and reading. History education, however, is ignored. 
History, and specifically, American history, have become stealth 
subjects, transformed and disguised under the labels ``Social Studies'' 
or ``Civics,'' or disregarded. Consequently, our children's knowledge 
of American history is shameful. What do you intend to do to address 
this question?
    Answer. The 2002 budget request for education, in tandem with the 
education reform proposals contained in No Child Left Behind, supports 
the President's comprehensive vision for closing the achievement gap 
and improving the quality of education for all children. It is clear 
that Federal education policy is not accomplishing its goals, despite 
the investment of more than $130 billion and the creation of hundreds 
of categorical programs over the past three decades. The President 
proposes to eliminate many categorical programs to give States and 
communities greater flexibility to use Federal resources for their own 
priorities. While the Administration's proposals do not include a 
separate Federal program to improve history instruction, American 
history is clearly an important part of the overall curriculum. We 
believe that States and school districts are in the best position to 
determine how best to improve history instruction, and our proposals 
provide them with the flexibility to accomplish this improvement.
                teaching american history grant program
    Question. On a related subject, Congress appropriated $50 million 
in fiscal year 2001 to create the Teaching American History Grant 
program, a national program intended to help put the study of U.S. 
history back into the classroom. Apparently, however, the 
Administration intends to save millions of dollars in your Department's 
budget by discontinuing all one-time projects, including the Teaching 
American History Grant program. Is it true that the Administration 
intends to eliminate this program despite our education system's 
glaring failure to teach the history of our Nation?
    Answer. The Administration's budget request supports No Child Left 
Behind, the President's framework for reform of elementary and 
secondary education which proposes to eliminate or consolidate many 
categorical programs to give States and localities greater flexibility 
to use Federal resources for their own priorities. As you are aware, 
the Department is proceeding to use the $50 million Congress 
appropriated in 2001 to make awards under the Teaching American History 
grant program. Department staff have worked with your office, the 
National Endowment for the Humanities, and a variety of organizations 
dedicated to improving the teaching of American history in order to 
ensure that this program is successful.
    So that grantees have sufficient time and resources to implement 
high-quality projects, the Teaching American History Grant program will 
make awards for up to three years from the 2001 appropriation. Grants 
will support programs to raise student achievement by improving 
teachers' knowledge, understanding, and appreciation of American 
history. They will assist local educational agencies, in partnership 
with entities that have extensive content expertise, to develop, 
document, evaluate and disseminate innovative, cohesive models of 
professional development. These grants will offer models that can be 
adopted by other communities to help improve the teaching of American 
history in U.S. schools.
    As noted in response to the previous question, the budget does not 
include funding to continue a separate American history program, but 
States and school districts would have the flexibility to use other 
Federal funds to continue this type of activity.
                      class-size reduction funding
    Question. The President proposed consolidating the Eisenhower 
Professional Development program and the Class Size Reduction program 
into a new teacher quality title under the Elementary and Secondary 
Education Act. Accordingly, his budget provides $2.6 billion for this 
new title. This would be a $375 million increase over the combined 
fiscal year 2001 funding level of these programs. The Class Size 
Reduction program, which has been working to reduce kindergarten 
through third-grade classes nationwide from 25 to 18 students, supports 
the salaries of 37,000 highly qualified new teachers. If we are to stay 
on this program's schedule to hire an additional 13,000 new teachers in 
fiscal year 2002, while also fulfilling our obligation to pay the 
salaries of the 37,000 teachers already hired via this program, we must 
provide additional funding for this program alone in the amount of $700 
million. This is a shortfall of $325 million. At what level does the 
President intend to meet the funding requirements of the Class Size 
Reduction program?
    Answer. The fiscal year 2002 budget supports the Administration's 
proposal, to combine the Class Size Reduction program with the 
Eisenhower Professional Development State Grants program and a few 
other programs into a single, flexible State grant program that 
supports State and local efforts to improve the quality of instruction. 
States and districts would use their funds for such activities as high-
quality professional development, reforming teacher certification or 
licensure requirements, and alternative certification of teachers and 
administrators. In addition, a district that believes that reducing 
class size would be the most effective strategy for improving student 
achievement within the district would be free to use its funds to hire 
teachers to reduce class size, but no district would be compelled to 
use their Federal funds in a manner that is not appropriate for its 
students and teachers.
    This proposal is one of several consolidation proposals in No Child 
Left Behind, the President's framework for reform of elementary and 
secondary education. The President believes that schools will work best 
when administrators, teachers, parents, and other interested parties, 
are given the latitude and support to implement the educational reforms 
that best meet their needs, and then are held accountable for producing 
results. The Administration recognizes that the same strategy is not 
appropriate for all communities, and that is why we are proposing to 
give States and districts greater flexibility in using their Federal 
resources.
    Question. Does the President intend to fulfill the obligation of 
this program to hire 13,000 new teachers and to support the salaries of 
the 37,000 teachers previously hired via this program, or does he 
intend to place the burdens of these teachers' salaries on the local 
school districts, therefore, jeopardizing their continued employment 
and the Federal, State, and local efforts to reduce class sizes in 
grades K-3 to reasonable levels?
    Answer. The Administration believes that every child in America 
deserves to be taught by a high-quality teacher. The $2.6 billion 
requested by the Administration in fiscal year 2002 for the State 
Grants for Improving Teacher Quality program is sufficient to enable 
districts to retain the teachers that were hired previously under the 
Class Size Reduction program and hire additional teachers to reduce 
class size if a district believes that reducing class size would be the 
most effective strategy for improving student achievement.
    As I stated earlier, the Administration believes that schools will 
work best when administrators, teachers, parents, and other interested 
parties, are given the latitude and support to implement the 
educational reforms that best meet their needs, and then are held 
accountable for producing results. Under the Administration's proposal 
for the State Grants for Improving Teacher Quality program, Federal 
funds would be available to support the research-based strategy for 
improving the quality of instruction and student achievement that best 
meets the needs of the district. However, no district would be 
compelled to use its Federal funds in a manner that is not appropriate 
for its students and teachers.
                                 ______
                                 
            Questions Submitted by Senator Dianne Feinstein
                         title i ``shortfall''
    Question. The U.S. Department of Education has concluded that the 
fiscal year 2001 appropriations for Title I may fall short by about 
$165 million, and that States' allocations will have to be reduced as a 
result. Do you support a supplemental fiscal year 2001 appropriations 
bill to cover the shortfall?
    Answer. The Administration completed a budget review earlier this 
year that resulted in a government-wide decision to ``live within our 
means'' and oppose additional requests for funding. This is part of our 
overall emphasis on supporting a more sustainable rate of increase in 
domestic discretionary spending.
                title i allocations--use of updated data
    Question. Title I was created to target funds and provide 
supplemental services to disadvantaged, poor children, and the law 
requires the Department to use updated counts of poor children in an 
effort to ensure that funding reflects changes in the poor student 
population. Do you support funding for this program that is targeted to 
poor children by using the most recent count of poor children possible?
    Answer. Yes, we do support the use of biennially updated Census 
poverty estimates in making allocations under the Title I Grants to 
Local Educational Agencies program.
                         title i hold-harmless
    Question. Do you oppose a Title I hold-harmless provision that 
``freezes in'' funding levels to States despite changes in the poor 
student population?
    Answer. Yes; the President's 2002 budget request for Title I 
assumes the application of statutory hold-harmless provisions and not 
the 100-percent hold-harmless included in appropriations language in 
recent years.

                          SUBCOMMITTEE RECESS

    Senator Harkin. Thank you very much, that concludes the 
hearing. The subcommittee will stand in recess until 9 a.m., 
Wednesday, May 23, when we will meet in room SD-138 to hear 
from the Acting Director, National Institutes of Health, Dr. 
Ruth L. Kirschstein.
    [Whereupon, at 10:45 a.m., Thursday, May 10, the 
subcommittee was recessed, to reconvene at 9 a.m., Wednesday, 
May 23.]


  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2002

                              ----------                              


                        WEDNESDAY, MAY 23, 2001

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 9:04 a.m., in room SD-138, Dirksen 
Senate Office Building, Hon. Arlen Specter (chairman) 
presiding.
    Present: Senators Specter, Cochran, and Harkin.

                 DEPARTMENT OF HEALTH AND HUMAN SRVICES

                     National Institutes of Health

STATEMENT OF RUTH L. KIRSCHSTEIN, M.D., ACTING DIRECTOR
ACCOMPANIED BY:
        DR. RICHARD D. KLAUSNER, DIRECTOR, NATIONAL CANCER INSTITUTE
        DR. CLAUDE LENFANT, DIRECTOR, NATIONAL HEART, LUNG AND BLOOD 
            INSTITUTE
        DR. AUDREY S. PENN, ACTING DIRECTOR, NATIONAL INSTITUTE OF 
            NEUROLOGICAL DISORDERS AND STROKE
        DR. RICHARD J. HODES, DIRECTOR, NATIONAL INSTITUTE ON AGING
        DR. ALLEN M. SPIEGEL, NATIONAL INSTITUTE OF DIABETES AND 
            DIGESTIVE AND KIDNEY DISEASES
        DR. JACK A. McLAUGHLIN, ACTING DIRECTOR, NATIONAL EYE INSTITUTE
        DR. STEPHEN I. KATZ, DIRECTOR, NATIONAL INSTITUTE OF ARTHRITIS 
            AND MUSCULOSKELETAL AND SKIN DISEASES
        DR. ANTHONY S. FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY 
            AND INFECTIOUS DISEASES

               OPENING STATEMENT OF SENATOR ARLEN SPECTER

    Senator Specter. The Appropriations Subcommittee on Labor, 
Health and Human Services, and Education will now proceed. This 
hearing has been advanced from 9:30 to 9:00 o'clock, because of 
other conflicting hearings. We are scheduled to have nominees 
for key positions in the Justice Department and also Secretary 
of Treasury O'Neil will be testifying before the Foreign 
Operations Subcommittee. Since the scheduling was undertaken, 
we have been considering the tax bill, and there has been what 
is called the Filibuster by Amendments.
    We came in at 6 a.m. o'clock expecting on Monday to 
complete the action on the bill fairly promptly. We had 17 
votes, and adjourned shortly after midnight. Yesterday we had 
27 votes, and we are scheduled to reconvene at 9:30 today, so 
we will not have as much time as I would like for this 
important session. We thought it important to proceed with this 
hearing, because we wanted to finish our subcommittee's agency 
hearings to be thorough on examining the Administrations Budget 
requests
    Now, last year, this subcommittee tied a record going back 
to 1976, completing our work on June 30th, and we had the 
conference finished on July 27th, and in an effort to get there 
early when you divide up $2 trillion, it is good to be at the 
head of the line. One of the key reasons that I wanted to be at 
the head of the line was to keep the funding going for the 
National Institutes of Health.
    All of you know what Senator Harkin and I have done in the 
leadership role in increasing the funding for NIH. It has been 
very difficult. When we appeared before the budget committee 5 
years ago and asked for an extra $1 billion, we were turned 
down, so we got a sharp pencil out and established the priority 
for this unit at NIH over many, many others.
    So the next year we went back to the budget committee and 
asked for $2 billion, since we got turned down on $1 billion. 
We were turned down again and we lost many votes, but finally 
this year we won by a very decisive margin. The administration 
has come forward with an increase in funding in excess of $2.7 
billion, but Senator Harkin and I are targeting an increase of 
$3.4 billion for fiscal year 2002.
    We have spent a good deal of our time on the issue of stem 
cells as a potential answer to a great many of the maladies, 
which all of you know. It has candidly been quite an experience 
to chair this subcommittee and to have people come in who are 
devastated by their illnesses or the illnesses of their family 
or friends. No family in the world is untouched by the 
maladies. This room has been overflowing, and we have 
consistent requests from groups to publicize their own 
particular problem, and to prevail on NIH to give them a larger 
share.
    We have had Michael J. Fox coming in on Parkinson's, and we 
have had Jerry Lewis coming in on muscular dystrophy, and the 
breast cancer group, and the amyotrophic lateral sclerosis 
group, the Alzheimer's group and children with Juvenile 
diabetes.
    So we have looked to this committee really almost for 
miracles. Prime Minister David Ben Gurion of Israel, said, ``If 
you do not believe in miracles, you are not a realist,'' and I 
believe that the potential is unlimited for what you can do.
    So that is why I am committed to staying here. It is fairly 
well known that I wanted to move on to another subcommittee 
after battling the Congress for the budget. I thought it would 
be easier to chair foreign operations and deal with the 
Israeli-Palestinian conflict than with the Conference Committee 
on NIH, but then, realized that people were so interested in a 
continued service, so here I am.
    I do not want to focus on the issue of the response to the 
letters that I sent on May 4 on stem cells, but candidly, I am 
very concerned about not getting the answers until yesterday. 
The responses totalled some 70 pages, and we hardly had time to 
digest them. I am even more concerned about what I understand 
may have been rewriting of the letters. I am going to come to 
that in due course, but first, I want to touch on affirmative 
or substantive issues, and we welcome Dr. Kirschstein here 
today, the Acting Director of the National Institutes of 
Health, having served as deputy director from July, 1993, until 
she took over as acting.
    She had served as Director of the National Institute of 
General Medical Sciences, the first woman to hold the position 
at NIH. She came to NIH in 1956 as a medical officer in 
clinical pathology, with a BA magna cum laude from Long Island 
University, and a M.D. from Tulane University.
    Let me express on a personal note to Dr. Kirschstein how 
appreciative I am of your work, and your cooperation, and your 
devotion to your job. So the floor is yours for up to 5 
minutes.

              Summary statement of Dr. Ruth L. Kirschstein

    Dr. Kirschstein. Thank you, Mr. Chairman, for those very 
kind words. Today, I appear before the subcommittee with my 
colleagues, the directors of the NIH's 27 institutes and 
centers. As you said, the President's budget for fiscal year 
2002 reflects the administration's commitment to doubling the 
NIH budget by fiscal year 2003, and requests $23.04 billion, an 
increase of $2.8 billion, or 13.5 percent above the 2002 level.
    NIH is deeply gratified by the support of the American 
public and the Congress, and recently, of the administration. 
Because of this unprecedented growth in our budget, we are 
gaining new knowledge and translating it into new treatments, 
diagnostics, and prevention strategies at a remarkable pace. 
This is a time of extraordinary scientific opportunity.
    As you know, this year we celebrated the mapping of the 
human genome, a remarkable accomplishment, but as we look 
toward next year, and on to the next decade, our work has only 
just begun. The greatest challenges are before us, as are the 
greatest rewards. Turning what we know about genes into new 
approaches for prevention and management of disease will 
require even more intense efforts, and the dedication of our 
best and brightest scientists, as well as the continued support 
of the Congress and the nation.
    To this end, NIH is expanding and developing a variety of 
new initiatives and programs aimed at seizing these new 
opportunities in all aspects of biology and medicine, from 
animal and human molecular studies, and stem cell biology, to 
clinical studies. We are expanding our clinical research 
programs in an effort to attract new young physicians into 
careers in research, so we are supporting several new loan 
repayment programs.
    We are expanding our training programs and research efforts 
in bioinformatics and computational biology, so that we have 
the expert tools and personnel to get the most out of a 
landslide of information emerging from genomics, proteinomics, 
and imaging technologies, and we are using this new technology 
and this new knowledge to reach out to the public and to the 
health-care providers to help ensure that state-of-the-art 
information regarding the prevention, diagnosis, and treatment 
of disease is incorporated into the delivery of care.
    As you know, in this regard, just last week, the National 
Heart, Lung, and Blood Institute issued major new practice 
guidelines on the prevention and management of high cholesterol 
levels in adults, the first major update in almost 10 years, 
and as reported just last Sunday in The Washington Post, the 
statins, originally developed to lower cholesterol levels 
appear to lower the risk of stroke, diabetes, and Alzheimer's 
Disease, as well as the rejection of certain transplants, and 
to affect many other disorders as well.

                          prepared statements

    Mr. Chairman, I have kept my remarks brief, but I and the 
Institutes directors are here to answer your questions, and to 
elaborate, and to assure you that the accomplishments made as a 
result of the research will go on in the future. Thank you.
    Senator Specter. Thank you very much, Dr. Kirschstein.
    [The statements follow:]

             Prepared Statement of Dr. Ruth L. Kirschstein

    Mr. Chairman and Members of the Committee: I am Ruth Kirschstein, 
the Acting Director of the National Institutes of Health. I am honored 
to appear before the Subcommittee, representing my colleagues, the 
Directors of the 27 Institutes and Centers who each have presented a 
written statement related to the President's budget for fiscal year 
2002. I shall present an overall view of the total Administration 
budget for NIH in fiscal year 2002.
    The NIH is deeply gratified that, beginning in fiscal year 1999, 
the support of the American public, the Congress, and the 
Administration produced a commitment to double its funding by 2003. 
Because of that additional funding, progress in the medical sciences is 
advancing at a speed we only dreamed of a few years ago. This is a time 
of extraordinary scientific opportunity.
    Last June, the International Human Genome Consortium completed a 
working draft of the human genome sequence. More than 30 genes for 
human diseases and disorders, including various cancers, deafness, and 
birth defects, have already been identified using this working draft, 
and scientists are now using the information to design better means of 
diagnosing and treating these disorders and of identifying other genes. 
New insights and knowledge in biology and new tools, including advanced 
imaging techniques, computing power, and robotics, allow scientists to 
move from studying a single gene and protein to studying entire sets of 
genes and proteins and understanding their interactions. In all fields 
of medical research, we are now ready to move even more rapidly into 
clinical studies, the means of bringing advances directly to the 
patient.
    The NIH Institutes and Centers have strategically invested the 
increases provided since 1999 to take advantage of the enormous 
scientific opportunities and to address essential health needs. 
Although scientific accomplishments often take many years to unfold 
into new diagnostic tools, treatments, and ways to prevent disease 
before it strikes, we can already see progress stemming directly from 
the increased funding. I will cite a few examples that Institute and 
Center Directors have recorded.
    A new project funded by the National Cancer Institute (NCI) 
supports scientists who are developing detailed profiles, at the 
molecular level, of tumors and cancers of the lymphatic and blood 
system. The scientists used microarray technology to look at how 
thousands of genes are expressed at once, a scale previously 
unimaginable. This new project, looking at approximately 1.8 million 
measurements of gene expression from 96 different samples, revealed 
that there are two distinct subtypes of a malignancy called diffuse 
large B-cell lymphoma (DLBCL). Before this finding, clinical 
researchers had been unable to account for the fact that 40 percent of 
patients with DLBCL respond well to current treatment, yet the 
remainder die of the disease. This is just the first demonstration of a 
technique that promises to revolutionize diagnosis and treatment for 
lymphoma as well as for other cancers.
    The National Institute on Drug Abuse (NIDA) was able, in fiscal 
year 1999, to use its increased funds to jump-start the establishment 
of what has now become a national clinical research infrastructure for 
testing treatments for drug addiction. From past research, we know that 
treatment of drug abuse can be effective, but these treatments had not 
been adequately applied in community treatment centers. The National 
Drug Abuse Treatment Clinical Trials Network (CTN), which was expanded 
in fiscal year 2000, now provides the infrastructure to bring new 
treatments to diverse populations of patients across the country. Since 
the inception of the CTN, rapidly and systematically it has grown to 
include 14 research centers across the country working in partnership 
with over 80 community treatment providers. Patients are already 
participating in the first seven treatment protocols, which use both 
medications that counter addiction and behavioral approaches. Patient 
brochures have been published in English and Spanish, and an additional 
17 new protocol concepts have been submitted to NIDA for review.
    Language impairment is a serious problem that affects about 7 
percent of all school-age children in the United States. It has 
significant consequences for families and for society as a whole, 
particularly in regard to cost of education and vocational training. 
There has never been a good evaluation of the effectiveness of the 
usual interventions for language impairment. A recently developed 
computerized method called Fast For Word has received national 
attention. Scientists supported by the National Institute of Deafness 
and Other Communication Disorders (NIDCD) are conducting a randomized 
clinical study to compare this intervention, which uses acoustically 
modified speech with computer assistance, to computer assistance alone 
and to other individualized interventions. The goal is to determine 
which intervention leads to the greatest improvement in language, the 
greatest gains in being able to converse, and the greatest gains in 
auditory perception, as well as being the most cost effective.
    These examples illustrate some of the ways the Institutes and 
Centers have invested the budget increases since fiscal year 1999. They 
not only show great progress over the short-term, but also illustrate 
what is required today, in terms of technology and infrastructure, to 
take advantage of scientific opportunity and move basic findings into 
the practice of medicine.
    The President's fiscal year 2002 budget reflects the continuing 
commitment to doubling the NIH budget by fiscal year 2003, requesting 
$23.04 billion, an increase of $2.8 billion, or 13.5 percent more than 
for fiscal year 2001.
    Investments have already expanded our knowledge and the practice of 
medicine as they have pushed back frontiers. They have also revealed 
new frontiers-new opportunities to understand diseases, to treat them, 
to prevent them, and even to cure them. As a result, the Institutes and 
Centers have many new research projects underway, all of which will 
continue well beyond 2003. And given the accelerating rate of progress 
and discovery, it is clear that more opportunities will present 
themselves. We must seize these future opportunities. To illustrate, I 
will present examples from four areas of research offering particular 
promise to yield enormous benefits in the form of new knowledge, new 
treatments, and new strategies for prevention of disease and 
disability.
                     genomics and genetic medicine
    Now that a draft of the human genome sequence has been completed 
and is available to all scientists in a public database maintained by 
the NIH, opportunities abound. For example, future large-scale 
sequencing will be aimed at developing data to help scientists 
interpret the human sequence. One of the most efficient ways to do this 
is to obtain the genetic sequences from related organisms. A comparison 
between the genomes of the human and other organisms such as the non-
human primates, mouse, rat, fruit fly, and yeast will help identify 
important features which point scientists toward genes likely to cause 
human disease.
    There are a number of disorders that are primarily due to 
alterations in a single gene. How that disease manifests itself is 
complex and varies greatly among patients. These differences, thought 
to be caused by other genes that influence the disease-causing genes, 
will be a focus of research. Studying these so-called modifier genes 
will help us understand variations in the rate at which disease 
progresses and how individuals respond to therapy. In addition, these 
studies will enable earlier diagnosis and more accurate prognosis, and 
may even provide novel targets for therapy that are more useful than 
the gene primarily involved in causing a disease.
    Together these approaches will help us identify genes involved in, 
for example, heart, lung, and blood disorders; cancer; mental and 
developmental disorders, including Alzheimer's disease and autism; 
diabetes; kidney disease; the muscular dystrophies; and the causes of 
aging; adverse reactions to drugs; and babies born full-term but with 
low weight.
   clinical research: taking basic discoveries into medical practice
    The NIH will continue to expand its emphasis in fiscal year 2002 on 
clinical research, the means by which basic findings relating to 
behavior, to molecules, and to genes, can be tested and translated into 
medical practice and improvements in public health.
    Several Institutes will begin or will expand their clinical trials 
networks located nation-wide, ready to evaluate new prevention 
strategies, drugs, and vaccines in large numbers of patients. Other 
initiatives in clinical research planned for fiscal year 2002 include 
regional centers of excellence for research on rare diseases, research 
on care at the end of life, and the self-management of the chronic 
illnesses which plague our society.
    The NIH is expanding its programs aimed at building the capacity to 
conduct clinical research. For example, the 106th Congress authorized 
several new Loan Repayment Programs (LRPs), which we regard as vitally 
important in recruiting new clinical researchers. Two of these new 
programs, the Extramural Clinical Research and the Pediatric Research 
LRPs will be trans-NIH programs that will be supported by nearly all 
the Institutes and Centers in the fiscal year 2002 President's request. 
In addition, we will support the Clinical Research LRP for Individuals 
from Disadvantaged Backgrounds and the LRP for Minority Health 
Disparities Research. Two programs started in fiscal year 1999, the 
Mentored Patient-oriented Research Career Awards and the Mid-Career 
Investigator Awards in Patient-oriented Research, will be expanded to 
meet the increasing demand for clinical investigators of high quality.
    Participation of patients and other volunteers in clinical research 
is critical to progress. The NIH's national clinical trials database, 
called ClinicalTrials.gov, continues to provide the public with 
enhanced access to new information about clinical trials. In addition 
to learning about NIH-supported clinical trials, the public can gain 
access to information about such trials for serious or life-threatening 
conditions sponsored by other Federal agencies as well as by industry. 
This expanded capacity provides an even greater array of facts about 
which clinical trials are being conducted and whom to contact about 
participating in them.
                infrastructure and enabling technologies
    As medical research generates more and more data, there is a 
pressing need for scientists with expertise in biocomputing and 
bioinformatics. To meet this need, the NIH will significantly expand 
its current program in bioinformatics and computational biology. New 
research initiatives will include: Centers of Excellence in 
Biocomputing and Bioinformatics, grants to institutions to train people 
in these areas of science, and a joint NIH/National Science Foundation 
program to support research in mathematical biology.
    Rapid progress in medical research is more and more dependent upon 
the availability of advanced instruments and other devices that often 
cost well in excess of half a million dollars each. The fiscal year 
2002 President's budget request provides funds so that the NIH can 
support high-end instrumentation for basic and clinical scientists. 
Such instrumentation includes very high-field NMR spectrometers, 
extremely sophisticated imaging systems and electron microscopes, high-
resolution mass spectrometers, and high-performance supercomputers.
    The fiscal year 2002 President's budget also requests $40.2 million 
for the newly legislated National Institute of Biomedical Imaging and 
Bioengineering (NIBIB), the focus of which is to develop new knowledge, 
create new technologies, and train researchers able to integrate fully 
the quantitative sciences with medical research. The programs described 
above are over and above the $1.2 billion the Institutes and Centers 
currently devote extramurally to the physical sciences, including 
mathematics, chemistry and other physical sciences.
                     eliminating health disparities
    We are expanding our commitment to programs focused on the health 
needs of minorities and the medically underserved, as well as programs 
designed to increase the number of minority scientists.
    The new National Center on Minority Health and Health Disparities 
(NCMHD) was established in December 2000 and is leading NIH's efforts 
to plan and coordinate research focused initially on racial and ethnic 
disparities. The Center's mission will expand to include studies 
related to medically underserved populations, including people who live 
in rural settings remote from medical care. The President's budget for 
fiscal year 2002 requests a 20 percent increase to $158.4 million for 
the new Center over the fiscal year 2001 estimate. In addition, the 
budget for the Office of Research on Women's Health would increase by 
about $28 million, to nearly $50 million in total, to support new 
research and career development for women in science.
    The other Institutes and Centers will continue to expand their 
emphasis on health disparities as well. For example, a major clinical 
trial involving African-Americans is designed to identify ways to slow 
the progression of kidney disease due to hypertension. The study 
compares two major classes of drugs used to treat high blood pressure--
beta blockers and ACE inhibitors and, when completed, will enable the 
NIH to provide and disseminate information about the optimal treatment 
of hypertension to prevent end-stage kidney disease in this minority 
group. NIH will also award grants to establish formal partnerships 
between NIH-designated cancer centers and minority-serving institutions 
such as historically black, Hispanic, and tribal colleges and 
universities. These partnerships will support research projects and 
research training in the minority-serving institutions, foster long-
term collaborations between scientists and faculty that examine the 
disproportionate incidence and mortality from cancer in minority 
populations, and improve the effectiveness of cancer research, 
education, and outreach activities.
    This is, Mr. Chairman, only a small sampling of our present and 
future research portfolios. The fiscal year 2002 budget request enables 
the NIH to sustain momentum of research already in progress, to open 
the way to new research opportunities, and to augment both our research 
infrastructure and our human capital. In fiscal year 2002, the NIH will 
fund 36,143 research grant awards, the highest annual total ever 
awarded.
    The budget request includes a total of $135 million for the 
Institutional Development Award (IDeA) program, an increase of $35 
million over fiscal year 2001. This increase will bring our support to 
a total of $75 million for the Biomedical Research Infrastructure 
Network (BRIN) subcomponent of the IDeA program, which has been 
developed to enhance the capacity of institutions located in States 
that have not fully participated in medical research, and are eligible 
for participation in the IDeA program.
    Research and development contracts increase by 20 percent. The 
larger increase in R&D contracts, as compared to other extramural 
mechanisms, includes $28 million to support the two new loan repayment 
programs I described earlier.
    The fiscal year 2002 President's budget also includes an increase 
of 12.5 percent for Research Management and Support (RM&S). As the NIH 
research budget grows, it is important to increase activities under the 
RM&S, so that we can effectively manage our programs. The RM&S includes 
support for the NIH professional staff who guide and monitor research 
activities of the Institutes, for example, those who oversee 
protections for volunteers participating in research, and who design 
and conduct programs to disseminate the results of NIH research to the 
public and to health care professionals.
    This request will provide a 10 percent stipend increase for pre-
doctoral and post-doctoral trainees and will permit us to recruit and 
retain the best and brightest scientists in careers in medical 
research. In the fiscal year 2002 President's budget, Buildings and 
Facilities (B&F) would be funded at $306.6 million. Three projects are 
particularly important to our research plans: The John Edward Porter 
Neuroscience Research Center, the Central Vivarium/Animal Research 
Center, and the Building 10 Revitalization Program to repair and 
renovate the aging facility used for clinical studies. The budget 
request also includes an increase from $75 million in fiscal year 2001 
to $97 million in fiscal year 2002 in programs for construction and 
renovation of extramural research facilities through the National 
Center for Research Resources.
    Consistent with the Administration's initiatives to combat drug 
abuse, the National Institute on Drug Abuse (NIDA) received an increase 
of 16.2 percent in the fiscal year 2002 President's budget request. In 
addition, the request includes funds for the Oravax smallpox vaccine 
contract managed by the Centers for Disease Control and Prevention ($32 
million) and for intra-governmental support for development of anthrax 
vaccine ($5 million) and a vaccine production facility ($5 million).
    Also included in the budget request is $10 million to begin the 
establishment of a system of sanctuaries for chimpanzees to provide 
lifetime care when they are no longer needed in research supported by 
Federal agencies. This system of sanctuaries was authorized by law in 
2000.
    Mr. Chairman, this concludes my opening statement. I would be glad 
to respond to any questions.
                                 ______
                                 

    Prepared Statement of Duane Alexander, M.D., Director, National 
            Institute of Child Health and Human Development

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2002 President's budget request for the National 
Institute of Child Health and Human Development (NICHD) of 
$1,096,650,000, which reflects an increase of $117,744,000 over the 
comparable fiscal year 2001 appropriation.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) Of 1993. 
Prominent in the performance data is NIH's second annual performance 
report which compares our fiscal year 2000 results to the goals in our 
fiscal year 2000 performance plan. As performance trends on research 
outcomes emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
    The mission of the NICHD extends over much of the human life span, 
from the time a single egg is fertilized and develops into an infant, 
through the childhood and teenage years, through the young adult and 
reproductive years, to the health concerns of mature men and women. Our 
research seeks to answer questions important to everyone: How can 
parents have children at the times they want them? How can all children 
be born healthy and mothers avoid the adverse consequences of 
pregnancy? How can every child reach adulthood free of disease and 
disability, able to achieve his or her full potential? How can we ease 
the burden of physical or mental disability to enable all individuals 
to participate in society as fully as possible?
    Since the Institute was established almost 40 years ago, we have 
made enormous strides in answering these questions and improving the 
lives of millions of Americans. Through research, we have identified, 
and eliminated or reduced, many of the causes of mental retardation and 
as a result, far fewer children and adults have mental disabilities. 
Through research, we have reduced infant mortality and as a result, 
many more infants have grown into healthy children and adults. Through 
research, we have found ways to reduce the transmission of the HIV 
virus from mother-to-infant and as a result, AIDS in children has 
markedly declined in this country. And through research, we have 
demonstrated cost-effective methods of significantly reducing the rate 
of HIV transmission in developing countries.
    We faced formidable scientific challenges in achieving these 
advances, and we face many challenges today. Yet these challenges are 
dwarfed by the excitement and hope of soon finding answers to questions 
we have wondered about for decades.
          new technology to help answer a fundamental question
    For many years the answer to a critical scientific question has 
eluded us: what actually triggers labor in a pregnant woman, at term or 
at preterm? We know many things that correlate with a woman going into 
labor, but we have never identified the mechanism that triggers labor. 
This is an important question. Preterm birth is the leading cause of 
infant sickness and death among African American babies and the second 
leading cause of infant death among all races. Despite some wonderful 
and heartwarming stories that occasionally appear in the media about a 
premature infant surviving, the long-term outlook faced by very 
premature infants can be bleak.
    Now, for the first time, the human genome project has provided us 
with the basis for a new technology called microarrays that will allow 
us to compare the active genes from pregnant women who begin labor 
prematurely with active genes from those who are not in labor or who 
deliver their babies after the full nine months. This comparison will 
help us to identify the gene products that are responsible for 
initiating labor. Armed with this knowledge, we can learn how to stop, 
postpone, or, if needed, induce labor. So we have within our reach the 
hope of addressing the single biggest cause of infant mortality, 
premature birth. And in the process of answering this important 
question, we can help eliminate the significant racial disparity in 
infant mortality.
       new collaborations to eliminate racial disparities in sids
    As you know, we have had extraordinary success in reducing another 
cause of infant mortality, Sudden Infant Death Syndrome or SIDS. Since 
the Institute initiated the Back to Sleep campaign in 1994 to reduce 
the risk of SIDS, the death rate from SIDS has declined by 40 percent. 
Yet this decline has been less pronounced among African American 
infants. In fact, the SIDS rate among African American infants is 
greater than twice that of white infants. So in collaboration with 
several national African American organizations, we have initiated an 
outreach program to reduce the risk of SIDS among African American 
infants. The organizations, which include the National Black Child 
Development Institute, the Women of the NAACP, the Alpha Kappa Alpha 
sorority, and 100 Black Women, among others, are conducting one-to-one 
training sessions in communities throughout the country to inform 
African American parents and care givers about back sleeping and other 
ways to reduce the risks of SIDS.
              behavioral interventions to improve learning
    Education is a cornerstone of healthy behavior and reading provides 
the foundation for education. Children who have difficulty reading are 
at risk for failure in school, failure at work, and failure at the many 
activities required to navigate successfully as an adult in our 
society. NICHD research has demonstrated that using teaching techniques 
based on phonemic awareness results in most children being able to read 
by the end of the third grade. As you recall, in collaboration with the 
Department of Education, as directed by Congress, the Institute 
convened a National Reading Panel in 1998 to review the evidence from 
reading research and make recommendations for the most effective 
methods of teaching children to read. In the largest and most 
comprehensive evidence-based review of research on how children learn 
reading ever conducted, the Panel reviewed more than 100,000 
experimental and quasi-experimental research studies. The Panel report 
strongly endorsed the findings and instructional approaches from 
NICHD's research. We are now collaborating with the National Institute 
for Literacy to disseminate the Panel's findings to administrators, 
teachers, and parents.
             improving the environment for children to grow
    Compared to adults, children are at increased risk from 
environmental influences. Children are not just small adults. Yet their 
developing bodies are often exposed to the same level of contaminants 
as are adults. In some instances, such as ingesting lead from peeling 
lead-based paints, children may be exposed to greater contaminants than 
are adults. What happens to a child before birth and early in life will 
affect the child's subsequent growth, development, and well being
    For this reason, the President's Task Force on Environmental Health 
and Safety Risks to Children recommended a longitudinal cohort study of 
environmental impacts on children to identify and quantify the risks 
that children face. Several Federal agencies, among them, the NICHD, 
the National Center for Environmental Health of the CDC, and the 
Environmental Protection Agency, are participating in planning this 
study. The study will enroll 100,000 children, beginning from before 
birth, and will gather information on environmental influences and 
outcomes until the children reach at least age 21. Methodological and 
pilot studies are planned for fiscal year 2001 to 2003 and the full 
study will be initiated in 2004. This planning phase will also allow us 
to answer key questions about the administration of the study. This is 
the largest such prospective study ever undertaken in this country and 
we look forward to working with this committee in addressing these 
exciting and challenging issues.
                reducing hiv and aids among adolescents
    The advent of highly active antiretroviral therapy, or HAART, in 
the mid 1990s dramatically improved the outlook for many people living 
with HIV infection. But for adolescents infected with HIV, HAART posed 
a great promise and a greater challenge. The therapy holds the promise 
of converting HIV infection into a chronic but manageable condition 
that gives young people time to benefit from emerging therapies. The 
challenge is that many HIV positive adolescents have little experience 
with medications, therapeutic regimens, or adherence to therapy. In the 
absence of a strong social support system, many HIV positive 
adolescents on HAART do not recognize the importance of taking 
medications consistently, on time, every day, without fail. The stakes 
are high because if the drugs are taken for short bursts or erratically 
over long periods, the probability of drug resistance increases. To 
help treat HIV positive adolescents and to develop effective prevention 
strategies, the NICHD established the Adolescent Medicine HIV/AIDS 
Research Network. By providing training, reinforcement, and a strong 
social support system, the Network has demonstrated that adolescents 
can be motivated to remain on an exacting medication regimen. Moreover, 
the adolescents have been trained in peer counseling techniques and 
they are providing a strong prevention message to friends and 
classmates in their social network.
                            autism research
    In our autism research, we continue to make important discoveries 
that help us understand this condition in the hope of finding more 
effective treatments. Recently researchers funded by NICHD and other 
NIH Institutes identified a gene that may predispose people to 
developing autism. The gene, known as HOXA1, plays a crucial role in 
early brain development. This finding strongly suggests that a gene 
controlling early brain formation may underlie the development of 
autism in a large number of cases. Together with other NIH Institutes, 
we are also actively implementing the provision of the Children's 
Health Act of 2000 that calls for the establishment of the Centers of 
Excellence on Autism Program. As an initial step toward establishing 
the Centers, we are issuing Requests for Applications for Center 
Development grants which will allow potential Centers of Excellence to 
marshal the resources necessary to submit strong proposals when we 
request applications for the actual centers.
                             women's health
    Research in women's health continues to be a high priority for the 
Institute. We are supporting research to develop effective treatments 
for uterine fibroids, the number one reason for hysterectomies and a 
leading cause of infertility, particularly among African American 
women. With the Office of Research on Women's Health, we are conducting 
research to understand, treat, and reduce conditions such as pelvic 
organ prolapse and incontinence that can develop as a result of 
childbirth or the aging process. We are also conducting research to 
diagnose and treat vulvodynia, a particularly painful condition that 
affects the reproductive, sexual, and physical health of women. We have 
also initiated gender specific-research to understand how women's 
unique reproductive physiology influences the transmission and 
progression of HIV-1. This research will lay the foundation for new 
prevention and treatment strategies to reduce AIDS among women. And 
because some conditions such as uterine fibroids, ectopic pregnancies, 
and preterm births disproportionately affect African American women, 
NICHD has helped establish a collaborative partnership between 
reproductive scientists at minority institutions and NICHD-funded 
programs. The new Reproductive Science Centers at Minority Institutions 
are designed to increase the number of minority investigators trained 
to study reproductive health issues, particularly those relevant to 
racial and ethnic populations.
    In closing Mr. Chairman, I look forward to working with you and the 
subcommittee and will be happy to provide answers to any questions you 
have.
                                 ______
                                 
   Prepared Statement of Dr. James F. Battey, Jr. Director, National 
        Institute on Deafness and Other Communication Disorders
    Mr. Chairman and Members of the Committee, I am pleased to present 
the President's budget request for the National Institute on Deafness 
and Other Communication Disorders (NIDCD) for fiscal year 2002, a sum 
of $336,757,000 which reflects an increase of $35,631,000 over the 
comparable fiscal year 2001 appropriation. The NIH budget request 
includes the performance information required by the Government 
Performance and Results Act (GPRA) of 1993. Prominent in the 
performance data is NIH's second annual performance report which 
compares our fiscal year 2000 results to the goals in our fiscal year 
2000 performance plan. As performance trends on research outcomes 
emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
    The United States recently celebrated the 10th Anniversary of the 
signing of the Americans with Disabilities Act, a law enacted in 1990 
to promote integration, equal opportunity, and inclusion of millions of 
Americans with a disability. Even with this legislation, individuals 
affected by a communication disability may still find it difficult to 
enter the labor force and live a productive life because of the daily 
challenges they face. It is often impossible for them to perform the 
simple acts of speaking, listening, or otherwise making their wants and 
needs understood. Disorders of hearing, balance, smell, taste, voice, 
speech, and language exact a significant economic, social, and personal 
cost for many individuals. The NIDCD supports and conducts research and 
research training in the normal processes and the disorders of human 
communication that affect approximately 46 million Americans. Human 
communication research now has more potential for productive 
exploration than at any time in history. With substantive 
investigations conducted over the past decades, the advent of exciting 
new research tools and new highly trained scientists, the NIDCD is 
pursuing a more complete understanding of the scientific mechanisms 
underlying normal communication and the etiology of human communication 
disorders. Examples of this research are highlighted in this statement 
for the record.
    The Speed of Sound: Rapid Motor Protein of Inner Ear Identified.--
Millions of Americans, especially middle-aged and older individuals, 
suffer from mild to moderate hearing loss. It is likely that a defect 
in the most sensitive cell types in the inner ear, the hair cells, 
causes this type of hearing deficit. The hair cells of the inner ear 
are sensory receptor cells that give humans and other mammals the 
remarkable ability to hear. As sound travels to the ears, down the ear 
canal, through the bones of the middle ear and into the inner ear, the 
outer hair cells amplify the mechanical vibrations produced by the 
sound through a process known as electromotility. These electrical 
changes in the cell allow it to rapidly change its length and 
stiffness. The length changes amplify the vibrations, which are sensed 
by the other hair cells (inner hair cells) that send auditory 
information to the brain. NIDCD-supported scientists have recently 
identified the gene that codes for the motor protein responsible for 
outer hair cell electromotility as well. Prestin (from the musical term 
presto, indicating a rapid tempo) was selected as the name of the gene 
to emphasize one of the most interesting features in the cellular motor 
process, its speed in changing the length of outer hair cells. Outer 
hair cells can elongate and contract at rates close to 100,000 times a 
second! Future research on Prestin should lead to significant advances 
in understanding the auditory system, and may lead to the development 
of new therapeutic measures for hearing impairment.
    Genes Responsible for Hereditary Hearing Impairment.--NIDCD-
supported scientists continue to make impressive scientific progress in 
mapping and cloning genes responsible for hereditary hearing 
impairment. Over the past few years, the chromosomal location of over 
60 genes whose mutation results in hereditary hearing impairment have 
been identified. In the past three years, nearly 20 genes have been 
identified whose mutations cause hereditary hearing impairment. The 
identification of these genes enables scientists or clinicians to 
rapidly identify individuals carrying the defective gene even if the 
hearing loss has a delayed onset and is not yet evident. In addition, 
the identification and isolation of genes responsible for hereditary 
hearing impairment immediately provide a powerful tool to determine how 
the mutation results in deafness by targeted gene mutations or 
deletions in an animal model. The animal model can provide information 
on which structures of the ear are affected, as well as the molecular 
and physiological defects that result in hearing impairment, and 
provide a system to test potential new therapies.
    Gene Cloned for Syndrome That Causes Deafness and Blindness.--Usher 
syndrome type 1 is an inherited sensory defect involving profound 
deafness, balance disorders and eventual progression to blindness. It 
is the most common genetic cause of a syndrome leading to blindness and 
deafness in Americans. Studies of affected families in the U.S. and 
abroad indicate that there are more than six distinct genes whose 
mutations result in this devastating inherited disease. NIDCD-supported 
scientists are collaborating with researchers from France, Germany, 
Lebanon, and Japan to identify the defective gene responsible for one 
form of this disorder, USHER1C. They identified the defective USHER1C 
gene in unrelated families in the U.S., Lebanon, and Europe. The 
finding will allow for genetic-based diagnosis of Usher syndrome before 
a deaf individual begins to lose sight. Early diagnosis will permit the 
study of the complete progression of retinal degeneration and provide 
opportunities in the future for possible treatment before the retinal 
degeneration begins.
    An Animal Model for Pendred Syndrome.--Individuals with Pendred 
syndrome have sensorineural deafness and goiter (enlargement of the 
thyroid gland). In a collaboration between National Human Genome 
Research Institute and NIDCD intramural scientists, genetic analysis 
revealed that mutations in the Pendrin gene occur in deaf individuals 
without thyroid disease, indicating that the gene is responsible for a 
much broader spectrum of deafness than only those individuals with 
Pendred syndrome. To determine the cause of this disorder, the Pendrin 
gene was deleted in mice and analysis of this mouse model was 
conducted. The mutant mice were found to be deaf and have a variable 
spectrum of balance problems similar to symptoms of individuals with 
the syndrome. The scientists observed swelling in parts of the 
developing inner ear in the mutant mouse embryos. The resulting fluid 
imbalance within the inner ear subsequently leads to the destruction of 
the sensory hair cells necessary for hearing. This mutant mouse model 
provides important clues about inner ear pathology associated with the 
human syndrome.
    Otitis Media is Linked to a Strong Genetic Component. Otitis media 
(OM), or middle ear infection, is the most common reason why a sick 
child visits a physician, and is the most common reason that children 
receive antibiotics or undergo surgery. Previous anatomical, 
physiological, and epidemiological studies have raised the question of 
whether the likelihood of having multiple bouts of this common disease 
has a hereditary component. Studying twins and triplets to determine 
the extent to which this common disease might be due to genetic 
factors, NIDCD-supported scientists have determined that there is a 
strong genetic component to the rate of occurrence of otitis media in 
children. The implications of these findings are numerous for both 
immediate and future improvements in treatment of OM. For example, 
primary care physicians can follow siblings and offspring of affected 
children as potentially high-risk cases. These children could be 
monitored more closely for early detection and treatment of disease, 
reducing the risk of hearing loss. In addition, identification of the 
genetic factors that cause this disease could eventually result in 
genetic diagnostic tests to identify individuals with enhanced risk. 
Finally, studies of the molecular basis for the increased risk and 
frequency of otitis media could lead to new approaches for intervention 
and treatment of this disease.
    Molecular Biology of Taste Signal Transduction.--A long history of 
NIDCD-supported research has shown that taste perception involves four 
basic taste qualities: sweet, sour, salty, and bitter. In a recent 
study, a fifth taste has been recognized and its taste receptor 
identified--umami--the taste of monosodium glutamate or the taste 
associated with protein-rich foods. From this finding, scientists have 
determined that each taste quality appears to be mediated by a distinct 
biochemical pathway. Salty and sour substances activate specialized ion 
channels in the membrane of the taste receptor cells in the taste buds 
in the tongue. In contrast, umami-, sweet-, and bitter-tasting 
substances activate another pathway involving G-protein-coupled 
receptors. Scientists recently characterized the diverse structure, 
function and expression of a large family of mammalian G-protein-
coupled receptors, called T2Rs, which are selectively expressed in a 
subset of taste receptor cells of the tongue and palate. T2R receptors 
were shown to mediate bitter taste perception in humans and mice.
    The Genetics of Stuttering.--Stuttering is a speech disorder in 
which the normal flow of speech is disrupted by frequent repetitions or 
prolongations of speech sounds, syllables or words. Currently, there is 
no cure for the 3 million Americans who stutter. The precise causes of 
stuttering have not been identified but there is evidence that it is 
genetically determined. NIDCD intramural scientists have been 
conducting a large study that involves individuals who stutter and 
their families. From this group, the scientists have recently 
identified a single region of the genome that may contain one or more 
genes involved in stuttering. Understanding the genetic causes of 
stuttering will eventually lead to treatment for this age-old disorder.
    Language Impairment in Autism.--NIDCD-supported scientists were the 
first to investigate the language profiles on a large sample of 
children with autism. One cardinal feature of autism is the delay or 
absence of spoken language. In the study, the researchers found 
significant differences in language skills, although articulation 
skills (or how the sounds of the language are produced) remained normal 
in all the children. Different subgroups of children with autism were 
identified on the basis of their performance on the language measures. 
Some children with autism have normal language skills, while others 
have language skills significantly below their age expectations. The 
scientists also observed that the performance profile across the 
standardized measures for the language-impaired children with autism 
was similar to the profile of children with specific language 
impairment (SLI). These findings suggest that there may be overlapping 
or shared characteristics among families with SLI and autism. Future 
studies will need to investigate the mechanisms underlying language 
processing in children with SLI, autism and perhaps other disorders, in 
order to advance the understanding of language disorders in children.
    Expanding Efforts to Identify Hearing Impairment in Newborns.--As 
efforts increase in many States to screen all newborn infants for 
hearing impairment before discharge from the hospital, more infants 
will be identified with hearing impairment at an early age when 
appropriate intervention can be started that will optimize their long-
term speech and language skills. NIDCD-supported scientists have 
examined the importance of age at enrollment in intervention programs 
and subsequent language outcomes for a group of deaf and hard-of-
hearing children. Significantly better language scores were associated 
with early enrollment, and high levels of family involvement correlated 
with positive language outcomes. These results provide further evidence 
that children will benefit when early identification of hearing loss is 
combined with an early intervention strategy that actively involves 
family participation.
    Advances in the genetics of hereditary hearing impairment and in 
the early identification of hearing impairment have now converged, 
leading some clinicians to suggest genetic testing/evaluation be 
performed on all infants who are identified with a hearing loss at 
birth. In consideration of these developments, the NIDCD is planning a 
study to address the clinical relationship between genetic and 
audiologic/otologic information, as well as to assess the clinical 
validity, value and utility of genetic testing in the diagnosis, 
treatment and management of hearing impairment.
    Cochlear Implants Are Cost Effective.--Over 20,000 Americans with 
profound hearing impairment have received cochlear implants with 
approximately one-half of the recipients being children. This device 
converts sound into electrical impulses on an array of electrodes 
surgically inserted into the inner ear, bypassing the hair cells and 
stimulating the auditory nerve directly. NIDCD-supported studies have 
shown that children with cochlear implants exhibit improvements in 
speech perception, speech production, and better language and reading 
performance. In addition, a recent analysis showed that cochlear 
implants improve the children's quality of life, and result in a net 
saving to society. The cost benefit is in the form of fewer demands on 
special education and greater wage-earning opportunities for implant 
recipients.
                                 ______
                                 

  Prepared Statement of Dr. Marvin Cassman, Ph.D., Director, National 
                 Institute of General Medical Sciences

    Mr. Chairman and Members of the Committee, good morning. I am 
pleased to present the President's budget request for the National 
Institute of General Medical Sciences (NIGMS) for fiscal year 2002, a 
sum of $1.720 billion, which reflects an increase of $180 million over 
the comparable fiscal year 2001 appropriation.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
Prominent in the performance data is NIH's second performance report, 
which compares our fiscal year 2000 results to the goals in our fiscal 
year 2000 performance plan. As performance trends on research outcomes 
emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
    The NIGMS mission is to support basic biomedical research in 
disciplines ranging from genetics, chemistry, and cell biology to 
trauma and burn research. These studies, often carried out in organisms 
such as yeast, fruit flies, and bacteria, yield a fundamental 
understanding of the biological processes that underlie all of the 
functions of life. Insights into the basic behavior of living systems 
provide the underpinning for subsequent discoveries regarding the way 
these processes go awry and lead to disease.
    It is becoming increasingly clear that research started with the 
goal of understanding unknown or poorly understood processes can 
immediately lead to insights about the mechanisms underlying diseases. 
One example is a research effort focused on a rather esoteric protein 
that is involved in the way cells process the instructions from DNA. As 
part of this study, the NIGMS-supported investigators closely examined 
the makeup of the protein. From its somewhat unique structure, they 
inferred that the protein could trigger diseases that result from the 
body's reaction to its own materials, a process known as autoimmunity. 
Interestingly, this discovery was entirely incidental to the original 
investigations. When the scientists tested this hypothesis, they found 
a strong correlation between high levels of immune response to this 
protein and the occurrence of a disease called systemic lupus 
erythematosus. This suggests that the occurrence of lupus is a 
consequence of some aberrant event that results in the accumulation of 
this protein or in the body's response, or both. We anticipate that 
this discovery will provide a major tool to allow accurate diagnosis of 
lupus as well as a clue to possible cures.
    Another example of the rapid conversion of a basic understanding of 
biology to an understanding of disease processes is found in studies 
being done on copper. Although copper is most often associated with 
pennies or the pipes used in plumbing, the metal is also an essential 
component of biological systems. However, when free in cells and 
organisms, even a small amount of copper can be very toxic. How does 
the body process copper in a way that does not cause irreversible 
damage? NIGMS grantees discovered proteins that ``chaperone'' copper 
and protect it from interacting with other cellular components until it 
reaches its proper destination. These proteins are called 
``metallochaperones.'' Some are specific for transporting copper, and 
some are specific for transporting other essential metals. There are 
several known hereditary diseases that are the result of defective 
copper metabolism, and these diseases frequently cause 
neurodegenerative disorders. It is important to understand just what is 
going wrong in individuals with these problems. Recent detailed studies 
on the mechanism of copper transport have shown how the chaperones that 
carry copper are implicated in the events leading to these diseases.
    Finally, a major thrust in modern medicine is the attempt to 
understand individual responses to drugs based on a person's genetic 
make-up. For example, certain drugs used to treat cancer can have 
widely variable effects in patients, and many of these treatments have 
serious toxicities. On occasion, patients are literally poisoned 
because their bodies cannot get rid of, or ``clear,'' a drug. For 
example, patients given the same dose of a commonly used chemotherapy 
drug, docetaxel, can have wide variations in the amount of time it 
takes to clear the medication. A solution to this problem may come from 
many years of basic studies on the behavior of a drug-metabolizing 
protein nicknamed ``CYP3A4.'' This protein chews up many different 
drugs, including docetaxel. An NIGMS grantee has developed a simple 
breath test to measure the activity of CYP3A4, and a small clinical 
study has shown that patients who exhibit low activity of the protein 
suffer the greatest docetaxel toxicity. Since blood tests have 
previously failed to predict docetaxel toxicity, the breath test may 
offer a promising tool to help physicians administer this drug more 
safely.
                      recent research initiatives
    NIGMS has recently begun a number of major research initiatives, 
and I would like to describe our progress in three of them. The first 
is in the area of pharmacogenetics, an example of which is the 
docetaxel toxicity research I just described. The goal of this research 
initiative is to identify the genetic basis of individual variations in 
drug response, and ultimately to develop tools that will allow 
individual differences to be determined before drugs are prescribed. We 
have funded 9 research groups for a total of $12.8 million in the first 
year. NIGMS leads the research initiative, and five other NIH 
components are cofunding projects. The other NIH components are the 
National Heart, Lung, and Blood Institute; the National Cancer 
Institute; the National Human Genome Research Institute; the National 
Library of Medicine; and the National Institute of Environmental Health 
Sciences. The centerpiece of the program is the development of a 
database that will link gene variations to their cellular and molecular 
consequences, and ultimately to their physiological outcomes. Because 
many of these studies will initially be on defined populations we have 
established a Populations Advisory Group to provide advice on how to 
best proceed with such research. We established a second advisory group 
to provide a liaison to the pharmaceutical industry. Although this 
industry is doing a great deal of work in pharmacogenetics, much of it 
is proprietary. However, there are opportunities for mutually 
beneficial interactions, and this advisory group has been established 
to identify those areas.
    The second major research initiative is in the area of structural 
genomics. The goal is to determine the three-dimensional structures of 
all proteins in nature, through a combination of direct experiments and 
theoretical analysis. Proteins are the worker molecules in every living 
thing. By determining the structures of proteins, we are better able to 
understand how each protein functions normally and how faulty protein 
structures can cause disease. Scientists can use the structures of 
disease-related proteins to help develop new medicines and diagnostic 
techniques.
    The project was begun in September 2000 through funding nearly $30 
million worth of awards to seven consortia that total 41 participating 
institutions. These are pilot programs to determine the most effective 
approaches that will result in rapid production of detailed protein 
structures. It is important to note that the NIGMS research initiative 
is part of a world-wide activity in structural genomics that also 
includes several industrial participants. Together with the Wellcome 
Trust in the United Kingdom, NIGMS organized an international 
structural genomics meeting that was held in England in April 2000. A 
second international meeting was held in the Washington, DC area in 
April 2001.
    The third Institute research initiative provides support to ``glue 
together'' groups of investigators working on significant problems that 
could not be solved if the scientists worked independently. Like the 
other two research initiatives, it involves the formation of a network 
of researchers who collaborate and share their results to speed 
progress toward a major goal. All of these projects reflect changes in 
how biomedical research is done today. There is an increased emphasis 
on large-scale and collaborative approaches to important scientific 
questions. These include studies of complex systems that involve the 
interaction of many components, such as all of the activities that go 
on within a single cell and the ways that cells and organs ``talk'' to 
each other.
    Studying complex systems requires the contributions of more than 
just biological scientists. It requires the expertise and approaches of 
physicists, mathematicians, computer scientists and engineers, all of 
whom are in a unique position to organize and analyze the vast amounts 
of data generated by studies of complex systems. To address this need, 
NIGMS has started programs to encourage these scientists to join their 
expertise and interests with those of biomedical researchers.
                           research training
    NIGMS remains committed to preparing ``a cadre of versatile 
scientists and engineers for research and teaching careers,'' investing 
in ``an educational system that creates a reservoir of flexible talent 
for the work force,'' and ensuring ``opportunities for the 
participation of all groups in science and engineering.'' These goals, 
which are quoted from a 1998 Office of Technology Assessment report on 
the objectives of Federal training programs, mirror the Institute's 
interests. We accomplish these goals through a variety of mechanisms, 
two of which I will mention. The first is our predoctoral training 
programs, which have been widely recognized as a means of identifying, 
stimulating, and rewarding quality research training. They encourage 
interdisciplinary training, which is a central requirement of all of 
our training programs. Two recent reports, one by the National Academy 
of Sciences and one an internal NIH study tracking the career 
progression of former trainees, have noted the value of these programs 
in generating a highly qualified group of investigators.
    In order to encourage ``opportunities for the participation of all 
groups in science and engineering,'' we require that our training 
programs make active efforts to recruit and retain underrepresented 
minorities. Additionally, our Minority Access to Research Careers 
(MARC) Program has a strong focus on research training, primarily at 
the undergraduate level. In fiscal year 2000, we supported 644 students 
at 62 institutions through this program. Although this is a program of 
very long standing, since 1975, we have several other programs focusing 
on the training of underrepresented minorities in science, a number of 
which have been initiated in the past few years. These programs are 
coupled to intensive outreach efforts that are designed to improve the 
capabilities of institutions to participate in Federal programs and to 
identify new approaches to bring underrepresented minorities into 
biomedical research.
                           health disparities
    NIGMS has several special activities in the area of health 
disparities. One is a new collaboration with the Indian Health Service 
to enhance the capacity and skills of tribal organizations and Native 
American researchers to conduct high-quality biomedical and behavioral 
health research and to apply successfully for competitive research 
grants.
    By its very nature, our pharmacogenetics research initiative will 
likely reveal new information linking differences in response to 
medicines with genes that are more common in certain population groups. 
Such knowledge could contribute to a reduction in health disparities by 
improving doctors' ability to identify and treat individuals who have 
these genes. Beyond these general benefits, we are planning to offer 
research grant supplements for studies that are specifically related to 
health disparities in response to medicines.
    Finally, a proposed NIGMS health disparities initiative would focus 
on differences between various population groups in the physiological 
response to traumatic injury. New information about such differences 
could improve doctors' ability to anticipate how trauma patients are 
likely to fare, especially which patients are at higher risk of 
developing a potentially fatal complication called systemic 
inflammatory response syndrome.
                               conclusion
    In conclusion, NIGMS sustains and develops programs that provide 
the research and research personnel required to ensure the continued 
progress of biomedical research. Our many accomplishments attest to our 
success in this endeavor, and our recent research initiatives should 
help us make even more significant contributions to the biomedical 
research enterprise in the years ahead.
    Thank you, Mr. Chairman. I would be pleased to answer any questions 
that you may have.
                                 ______
                                 

 Prepared Statement of Dr. Francis S. Collins, M.D., Ph.D., Director, 
                National Human Genome Research Institute

    Mr. Chairman and Members of the Committee: During fiscal year 2000, 
Human Genome Project scientists capped the achievements of the last 
decade with a historic milestone--the complete initial reading of the 
text of our genetic instruction book. At present, roughly 93 percent of 
the 3.1 billion bases of the human genome are freely available in 
public databases. This is an awesome step toward a comprehensive view 
of the essential elements of human life, a perspective that inaugurates 
a new era in medicine where we will have a more profound understanding 
of the biological basis of disease and develop more effective ways to 
diagnose, treat, and prevent illness.
    Between March 1999 and June 2000, the production of human genome 
sequence skyrocketed. During this time, the international collaborators 
in the Human Genome Project sequenced DNA at a rate of 1000 bases per 
second, 7 days a week, 24 hours a day. After completing the working 
draft of the human genome sequence in June of 2000, Human Genome 
Project scientists and computational experts began to scour the 
sequence for insights. They reported the first key discoveries in the 
February 15, 2001 issue of the journal Nature. Among the findings were 
the following:
  --Humans are likely to have only 30,000 to 35,000 genes, just twice 
        as many as a fruit fly, and far fewer than the 80,000 to 
        150,000 that had been widely predicted.
  --Genes are unevenly distributed across the genomic landscape; they 
        are crowded in some regions and spread out widely in others.
  --Individual human genes are commonly able to produce several 
        different proteins.
  --More than 200 human genes arrived to the genome of some ancestor 
        directly from bacteria.
  --The repetitive DNA sequences that make up much of our genome, and 
        commonly regarded as ``junk,'' have been important for 
        evolutionary flexibility, allowing genes to be shuffled and new 
        ones to be created. The repetitive DNA may also perform other 
        important functions.
                  finishing the human genome sequence
    Because of the enormous value of DNA sequence information to 
researchers around the world, in academia and industry, NHGRI has 
always been committed to the principle of free, rapid access to genomic 
information through well-organized, annotated databases. Databases 
housing the human genome sequence are being visited an average of more 
than 50,000 times a day. In fiscal year 2002, NHGRI will increase the 
usefulness of the human genome sequence to the world's researchers by 
finishing the sequencing to match the project's long-standing goals for 
completeness and stringent accuracy. More than a third of the draft 
sequence already has been finished into a highly accurate form--
containing no more than 1 error per 10,000 bases. Finished sequence for 
the entire genome is expected by 2003. Finished sequence is already 
available for the entire lengths of chromosomes 21 and 22. Genes on 
chromosome 21 are involved in Down syndrome, Alzheimer disease, certain 
cancers, and manic depressive illness, while those on chromosome 22 are 
implicated in the workings of the immune system, in congenital heart 
disease, schizophrenia, mental retardation, and several cancers, 
including leukemia. Researchers can now study the molecular bases of 
the conditions linked to these chromosomes systematically and 
comprehensively, and the same high standard of completeness will be 
achieved for the other 22 human chromosomes over the next two years.
                 genome sequences of non-human species
    In the coming year, NHGRI and its partners will sequence the 
genomes of important model organisms, including the mouse and rat. The 
Human Genome Project's goals always included the analysis of the 
genomes of species that have been important to laboratory research. 
Having genome sequence from additional species is one of the most 
efficient tools for interpreting the human sequence, because many of 
the most important elements in our genome--including genes and the 
regions that regulate their expression--are conserved in the genomes of 
other species. Genome sequences from the well-studied laboratory mouse 
and rat will be especially useful because, as mammals, their genomes 
are relatively similar to the human genome and because they have long 
provided insights into the molecular basis of disease.
    The Mouse Sequencing Consortium formed in October 2000 and in April 
2001 produced a publicly accessible draft sequence covering 95 percent 
of the mouse genome, a result of the collaborative efforts of three 
private companies, six institutes of the NIH, and a British charity, 
the Wellcome Trust. The Consortium will now go through the more arduous 
process of filling in gaps in the draft and will produce high-quality 
finished sequence no later than 2005. Already, the mouse data is saving 
researchers a great deal of time. For example, researchers at Merck 
recently found a mouse relative of a human gene implicated in 
schizophrenia by scanning the newly available mouse genome sequence. 
Alterations in the human gene were found in a large Scottish family 
where schizophrenia correlates with a chromosomal rearrangement. 
Researchers had searched without success for years for the related gene 
in mouse, but the mouse genome sequence readily revealed the 
corresponding mouse gene in a computer search taking only seconds. The 
researchers can now test the effects of inactivating the gene on the 
mouse brain, perhaps giving clues to the molecular basis of 
schizophrenia in humans.
    Meanwhile, the laboratory rat, long used for a wide range of 
medical research, including studies on high blood pressure, cancer, and 
drug metabolism, is getting its share of attention. In February, NHGRI 
and the National Heart, Lung and Blood Institute announced a plan for 
sequencing the rat genome. The institutes will fund private companies 
as well as academic labs; all have agreed to release data weekly into 
public databases.
    Other model organisms' genomes are undergoing study as well. NHGRI 
is funding scientists at the University of California at Berkeley and 
the Baylor College of Medicine to close the gaps in the fruit fly 
genome sequence and to ensure that the finished sequence meets quality 
standards for finished sequence data. In fiscal year 1999, NHGRI and 
the National Cancer Institute, leading 15 other NIH institutes, 
launched the Mammalian Gene Collection, whose goals are to develop 
analysis tools and to produce a collection of full-length copies of 
genes, which can be sent to researchers on demand. So far, nearly 
20,000 full-length gene copies have been identified and are slated for 
sequencing.
                        human genetic variation
    For understanding the basis of common diseases with complex 
origins, like heart disease, Alzheimer disease, and diabetes, it is 
important to catalog genetic variations and how they correlate with 
disease risk. Among any two people, an average of one DNA spelling 
variation--or SNP--exists in every 1000 bases. With a draft of the 
human genome sequence in hand, the pace of SNP discovery has increased 
dramatically. In fiscal year 1999, NHGRI organized the DNA Polymorphism 
Discovery Resource consisting of 450 DNA samples collected from 
anonymous American donors with diverse ethnic backgrounds. NHGRI has 
funded studies looking for SNPs in these samples. The non-profit SNP 
Consortium came into being in April 1999, with the goal of developing a 
high-quality SNP map of the human genome and of releasing the 
information freely. Consortium members include the Wellcome Trust, a 
dozen companies (mostly pharmaceutical companies), and three academic 
centers; they have looked for SNPs in DNA from a subset of the samples 
in the DNA Polymorphism Discovery Resource. In July 2000, the NHGRI and 
The SNP Consortium announced a collaboration that has allowed the 
contribution of 5 times more SNPs to the public domain than the 
consortium originally planned. As of March 28, the public database that 
serves as a central repository for SNPs has received 2,840,707 SNP 
submissions.
    With the increased knowledge about human variation, the genetic 
underpinnings of various diseases, including diabetes, are being 
discovered. The recent discovery of a gene, calpain-10, whose 
disruption contributes to diabetes, resulted from studies linking 
diabetes with genetic variations across the whole genome and then in a 
specific part of chromosome 2. The newly-discovered gene suggests that 
a previously unknown biochemical process is involved in the regulation 
of blood sugar levels. Diabetes is also one of the areas of focus for 
intramural research at NHGRI.
    Investigators from Howard University and NHGRI are engaged in a 
project looking for genetic risk factors for diabetes in West Africans. 
This is part of a wider collaboration between the two institutions to 
study the genetic basis of diseases that disproportionately affect 
African-Americans. The diabetes study focuses on West Africans since 
they are thought to be the population from which modern African-
Americans are largely descended, and the Africans are not exposed to 
the same dietary risk factors as Americans. Study recruitment centers 
were opened in Nigeria and Ghana; in the fall of 2000, researchers met 
their goal of recruiting 400 pairs of siblings affected with diabetes. 
Genetic typing of the collected tissue samples is in progress at 
NHGRI's Center for Inherited Disease Research in Baltimore to search 
for genetic variations that increase susceptibility to diabetes.
    Meanwhile, other intramural investigators are part of a consortium 
where researchers pool a wide range of data about the genetic factors 
underlying diabetes. One of the studies, called FUSION (Finnish U.S. 
Investigation Of Non-insulin dependent diabetes mellitus) has collected 
DNA samples and clinical data from 5000 Finnish people who have 
diabetes; many of the individuals are related. A genome-wide search 
among these people for genes related to diabetes risk has so far 
identified two areas on chromosome 20 that are likely to contain 
crucial genes.
                            gene expression
    The new-found abundance of genomic information and technology is 
propelling scientists out of the pattern of studying individual genes 
and into studying thousands at a time. Large-scale analyses of when 
genes are on or off (gene expression) can be used, for example, to 
study the molecular changes in tumor cells. This exciting new approach 
combines recombinant DNA and computer chip technologies to produce 
microarrays or DNA chips. Classifying cancer on a molecular level 
offers the possibility of more accurate and precise diagnosis and 
treatment. Intramural researchers at NHGRI have used large-scale 
expression studies to discover genetic signatures that can distinguish 
the danger from different skin cancers and that can distinguish between 
hereditary and sporadic forms of breast cancer.
              protein structure, function, and interaction
    With a global view of human genes now possible, scientists are 
eager to obtain a similarly comprehensive view of human proteins, a 
field called proteomics in analogy to genomics. Researchers want to 
know the functions of proteins and how the proteins work together in 
cells. Only a subset of all possible proteins are present in any given 
cells at any given time. To study protein function on a wide scale, 
various groups of researchers plan to identify the locations of 
proteins, their levels in different cells, their structures, the 
interactions among different proteins, and how they are modified. NHGRI 
is contributing to this field by developing technologies for efficient, 
large-scale analyses, particularly for determining protein interactions 
and measuring protein abundance in different cells.
                centers of excellence in genomic science
    In fiscal year 2001, NHGRI will award the first grants under a new 
program to bring cross-disciplinary teams of researchers together with 
shared resources and a unified goal. The Centers of Excellence in 
Genomic Science are designed to develop new genomic approaches for 
analyzing the molecules of life systematically, to integrate technical 
developments into biomedical research, and to expand training 
opportunities. Additional centers will be funded in fiscal year 2002 to 
develop new ways of undertaking genome-wide analyses in areas like the 
regulation of gene expression, protein expression and interaction, 
human genetic variation, and the storage and analysis of the flood of 
new data. These centers are expected to be a source of creative 
approaches addressing previously unanticipated questions. As training 
centers, they will give high priority to the training of people from 
racial or ethnic minority groups, women, and people with disabilities.
               promise for new treatments and prevention
    Genetic testing will become increasingly important for assessing 
individual risk of disease and prompting programs of prevention. An 
example of how this may work involves the disease hereditary 
hemochromatosis (HH), a disorder of iron metabolism affecting about one 
in 200 to 400 Americans. Those with the condition accumulate too much 
iron in their bodies, leading to problems like heart and liver disease 
and diabetes. The gene causing the condition has been identified, 
allowing early identification of those in whom HH may develop. Once 
people at risk are identified, they can easily be treated by 
periodically removing some blood.
    Genetic testing is also being used to tailor medicines to fit 
individual genetic profiles, since drugs that are effective in some 
people are less effective in others and, in some, cause severe side 
effects. These differences in drug response are largely genetically 
determined. Customizing medicine to a patient's likely response is a 
promising new field known as pharmacogenomics. A recent publication in 
the journal Hypertension showed how pharmacogenomics applies to high 
blood pressure. Researchers found a variation in a particular gene that 
affects how patients respond to a commonly used high blood pressure 
drug, hydrochlorothiazide. Other recent studies reveal that doctors 
should avoid using high doses of a common chemotherapy treatment (6-
mercaptopurine) in a small proportion of children with leukemia. 
Children with a particular form of a gene (TPMT) suffer serious, 
sometimes fatal, side effects from the drug.
    Genomics is also fueling the development of new medicines. Several 
drugs now showing promising results in clinical trials grew out of 
genomics-related studies. One example is Glivec (previously called 
STI571), produced by Novartis for treating chronic myelogenous leukemia 
(CML). In CML, an abnormal gene fusion creates an abnormally activated 
protein. Novartis designed a small molecule that specifically 
inactivates the protein. In phase I clinical trials, this drug caused 
favorable responses in 53 of 54 patients, while side effects were 
minimal no matter how high the dosage. Meanwhile, Bayer and Millennium 
announced the development of another cancer drug born of genomics in 
January 2001. GlaxoSmithKline is testing a new genomics-derived heart 
disease drug that targets a protein involved in fat metabolism. Johnson 
& Johnson is testing a drug targeting a brain receptor involved with 
memory and attention. Human Genome Sciences has four clinical trials in 
progress to test gene-based drug candidates.
                ethical, legal, and social implications
    From its inception, NHGRI recognized its responsibility to address 
the broader implications of having access to genetic information and 
technology. Since 1991, it has committed 5 percent of its budget to 
studying the ethical, legal, and social implications (ELSI) of genome 
research. Study of human genetic variations raises many ELSI issues. 
The case of hemochromatosis brings up some of these issues. Given the 
devastating complications from HH and the simple treatment, some have 
proposed widespread genetic testing to find those predisposed to HH. 
But considerable uncertainty remains about how strong the link is 
between particular gene variants and the presence and severity of HH 
disease. In fiscal year 2000, NHGRI and the National Heart, Lung and 
Blood Institute began a 5-year, $30 million epidemiological study among 
100,000 adults to gauge, among other things, the prevalence and the 
genetic and environmental causes of HH. NHGRI is funding an examination 
of the ethical, legal, and social issues related to implementing a 
widespread screening program. Information from the study should yield 
insights not only for HH but also for other treatable adult-onset 
genetic disorders.
    Many ELSI issues raise policy implications; one is how to deal with 
potential employment discrimination. Two years ago, a Time/CNN poll 
showed that 95 percent of those polled thought employers should not 
have access to genetic information about employees without their 
permission. A recent case, involving the Burlington-Northern Santa Fe 
railroad, shows what can happen. In March 2000, BNSF added testing for 
a gene (PMP22), which may be the cause of carpal tunnel syndrome in a 
small population of people with the disorder, to the medical evaluation 
of employees who file workers' compensation claims for carpal tunnel 
syndrome, to test whether the carpal tunnel syndrome was ``work-
related.'' Employees were not told that their blood would be submitted 
for a genetic test. In February, the Equal Employment Opportunity 
Commission and the workers' union filed suit against BNSF. The company 
has now stopped genetic testing and agreed to seek approval from the 
union before doing any genetic testing in the future. While this is a 
happy ending for this particular case, comprehensive public policy will 
be required as genetic tools become more widespread. The ELSI program 
at NHGRI will continue to form policy recommendations that balance the 
need to protect individuals with the needs of the research community 
and the healthcare industry.
    Finally, as part of its mission of education, NHGRI produced a free 
educational kit, ``The Human Genome Project: Exploring our Molecular 
Selves,'' that was released when the human sequence analysis was 
published in February. The kit includes a multimedia CD-ROM, an award-
winning video documentary, and an informational brochure. The kit is 
designed to give science teachers and classrooms, particularly at the 
high school level, better access to the latest information about genome 
science and its implications, but it is expected to be used more 
broadly, by college students, voluntary health organizations, and the 
general public. Backing from Howard Hughes Medical Institute and 
Pharmaceutical Research and Manufacturers of America (PhRMA) insured 
that the kit, sponsored by the NIH and DOE, would be available for 
free. Nearly 40,000 kits have been requested in just two months.
    I am pleased to present the President's budget request for the 
National Human Genome Research Institute (NHGRI) for fiscal year 2002, 
a sum of $426,739,000, which reflects an increase of $44,627,000 over 
the comparable fiscal year 2001 appropriation. The NIH budget request 
includes the performance information required by the Government 
Performance and Results Act (GPRA) of 1993. Prominent in the 
performance data is NIH's second annual performance report which 
compares our fiscal year 2000 results to the goals in our fiscal year 
2000 performance plan. As performance trends on research outcomes 
emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
                                 ______
                                 

 Prepared Statement of Donna J. Dean, Ph.D., Acting Director, National 
           Institute of Biomedical Imaging and Bioengineering

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Institute of Biomedical 
Imaging and Bioengineering (NIBIB) for fiscal year 2002, a sum of 
$40,206,000, which reflects an increase of $38,231,000 over the 
comparable fiscal year 2001 appropriation.
    At the outset, I should note that the NIBIB is the newest of NIH's 
Institutes, having been established on December 29, 2000 by Public Law 
106-580, the National Institute of Biomedical Imaging and 
Bioengineering Establishment Act of 2000. I am excited by the challenge 
afforded me to help guide the formation and early development of this 
newest member of the NIH family. In the past four months, we have begun 
to consider the new opportunities in biomedical research that NIBIB can 
foster and have articulated the basic principles upon which we will 
build NIBIB. It is my privilege to share with you the philosophy under 
which the NIBIB will operate and our initial steps toward fulfilling 
the promises embodied in the legislation.
                          a mission of promise
    The foundations of tomorrow's medicine will continue to be built on 
the emergence of discoveries in basic science and development of new 
technologies. The mission of NIBIB is to apply the principles of 
engineering and imaging science to biological systems. Advances in the 
imaging sciences could change the face of medicine, making it possible 
to non-invasively detect, diagnose, and guide therapy for a large 
variety of diseases. Bioengineering is unique in its ability to 
integrate principles from diverse fields, and to cross the boundaries 
of academia, science, medicine and industry. The focus of NIBIB will be 
on developing fundamental new knowledge, creating potent new 
technologies, and nurturing researchers to be able to fully integrate 
the quantitative sciences with biomedical research.
    Bioengineering and the imaging sciences are rooted in physics, 
mathematics, chemistry, materials sciences, computer sciences and the 
life sciences. The application of these systematic, quantitative, and 
integrative ways of thinking about and approaching the solutions to 
problems will be important to biology and medical research. The 
biological scientist often seeks to answer such questions as ``Why do 
things work the way they do?'' and ``How do these organisms function?'' 
The engineer or imaging scientist may ask questions such as ``How can I 
create something that has never existed before?'' or ``Can I develop a 
solution to this seemingly intractable problem?'' The excitement of 
bringing together new research constituencies, perspectives and 
collaborations is a particular challenge and a unique opportunity for 
NIBIB.
    In support of its mission, NIBIB will support an integrated and 
coordinated program of research and research training that can be 
applied to a broad spectrum of biological processes, disorders and 
diseases and across multiple organ systems. Strong coordination will be 
fostered with biomedical imaging and bioengineering programs of other 
NIH Institutes and other agencies so as to support imaging and 
engineering research with potential medical applications. These 
partnerships will facilitate the translation of fundamental discoveries 
into research on and applications for specific diseases, disorders, or 
biological processes.
    Most of the revolutionary changes in biology and medicine over the 
past decades were rooted in fundamental discoveries in many different 
fields, such as the role of nuclear physics in producing radioisotopes 
essential for much of modern medical science. Engineering and physics 
were central in the development of key tools of common clinical 
practice today--x-rays, computed tomography (CT) scanning, fiber optic 
viewing, laser surgery, echocardiography and fetal sonograms. Materials 
science is helping to develop new joints, heart valves, and other 
tissue mimetics. Understanding of nuclear magnetic resonance and 
positron emissions was required for the imaging study of the location 
and timing of brain activities that accompany thought, motion, 
sensation, speech, or drug use. Now, as never before, the boundaries 
are disappearing between biology and biomedical engineering, resulting 
in increasing and expanding opportunities for new scientific and 
technological approaches and new clinical tools and devices.
             identifying productive new research directions
    The creation of programs on the cutting edge of research and 
innovation will pose complex scientific challenges and require 
multidisciplinary strategies. A critical component of the Institute's 
inaugural year will be the formulation of a strategic plan for research 
in biomedical imaging and bioengineering. This activity will be 
undertaken in cooperation with the NIBIB Advisory Council and with 
broad representation from the research community. An outstanding 
opportunity exists to recruit scientists, engineers and physicians to 
new areas of biomedical research through the research programs to be 
developed by NIBIB.
    NIH has provided important groundwork that is of invaluable aid to 
NIBIB as it formulates an emerging research agenda. Key areas of future 
research in biomedical imaging and bioengineering have been highlighted 
by four symposia sponsored by NIH in the last three and a half years. 
At these meetings, the country's leading engineers, scientists, and 
physician-scientists have addressed areas of opportunity in 
bioengineering, biomedical imaging, nanotechnology, and reparative 
medicine or tissue engineering.
    Since one of NIH's highest priorities is the funding of medical 
research through research project grants, NIBIB will emphasize this 
mechanism to promote fundamental discoveries, design and development, 
and translation of technological capabilities in biomedical imaging and 
bioengineering, enabled by relevant areas of information science, 
physics, chemistry, mathematics, materials science, and computer 
sciences. The research supported by NIBIB will be multidisciplinary in 
nature and strongly synergistic with NIH's other research Institutes 
and Centers. NIBIB will expand the principles embodied in NIH's 
development of the Bioengineering Research Partnerships and 
Bioengineering Research Grants--that creation, development, and 
implementation of technology are worthy goals.
               developing a new generation of researchers
    NIBIB will meet the challenge of training a new generation of 
investigators with a vision transcending narrow disciplines. Training 
and career development programs will be central to NIBIB's approach to 
its mission. Increasing the pool of individuals uniquely positioned to 
bring innovative concepts and approaches to research in biomedicine and 
health will benefit the entire NIH. The changing nature of biomedical 
research in the future points strongly toward the need to train our 
young physicians and engineers to succeed in facets of biomedical 
research that are not yet imagined.
                               conclusion
    NIBIB's leadership in developing crosscutting research and training 
in biomedical imaging and bioengineering will be fostered by strong 
partnerships and collaborations with other Institutes and Centers of 
NIH, all with the ultimate goal of improvement in human health and 
well-being. NIBIB is poised to identify challenges in biomedical 
research that can benefit from bioengineering approaches, facilitate 
interinstitute cooperation, and promote transdisciplinary training. 
NIBIB will strengthen and complement, not substitute for or subtract 
from, the already robust research programs of NIH's other Institutes 
and Centers. We look forward to the challenges of the next year in 
creating a new and enriched focus at NIH for bioengineering and imaging 
sciences.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
Prominent in the performance data is NIH's second annual performance 
report which compares our fiscal year 2000 results to the goals in our 
fiscal year 2000 performance plan. As performance trends on research 
outcomes emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
    The budget request for fiscal year 2002 for the National Institute 
of Biomedical Imaging and Bioengineering is $40.2 million.
    Mr. Chairman, I will be happy to answer your questions.
                                 ______
                                 

                 Prepared Statement of Anthony S. Fauci

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Institute of Allergy 
and Infectious Diseases (NIAID) for fiscal year (FY) 2002. Including 
the estimated allocation for the acquired immunodeficiency syndrome 
(AIDS) of $1,192,855,000, total support requested for NIAID is 
$2,355,325,000, an increase of $292,317,000 over the fiscal year 2001 
appropriation. The portion of the budget not related to AIDS is 
$1,162,470,000, which reflects an increase of $162,054,000 over the 
comparable fiscal year 2001 appropriation. The NIH budget request 
includes the performance information required by the Government 
Performance and Results Act (GPRA) of 1993. Prominent in the 
performance data is NIH's second annual performance report which 
compares our fiscal year 2000 results to the goals in our fiscal year 
2000 performance plan. As performance trends on research outcomes 
emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
                           overview of niaid
    NIAID, the third largest NIH Institute, supports and conducts 
research to better understand, treat and prevent infectious, 
immunologic, and allergic diseases. The scope of the NIAID research 
portfolio is expanding continually in response to new challenges, such 
as the emergence of AIDS and other newly recognized diseases, and 
because of scientific opportunities facilitated by new technologies and 
progress in the core NIAID scientific disciplines of microbiology, 
immunology, and infectious diseases. Advances in these key fields, 
including progress in relatively new areas such as pathogen and human 
genomics, are driving the development of new treatments, vaccines, 
diagnostic tests, and technologies that improve the health of people in 
the United States and around the world.
    In order to meet the many health challenges of the new millennium 
and take advantage of unprecedented scientific opportunities, the 
Institute has developed a strategic research plan for the 21st century 
centered around four major areas: (1) Global health and emerging 
infectious diseases; (2) HIV/AIDS; (3) Immune-mediated diseases, 
including allergy and asthma; and (4) Vaccines. The complete NIAID 
Strategic Plan is available on the World Wide Web at http://
www.niaid.nih.gov/strategicplan2000.
             global health and emerging infectious diseases
    NIAID has a long history of supporting research into diseases that 
transcend national boundaries and hence fall under the rubric of global 
health. Examples of such diseases include newly recognized conditions 
such as AIDS and liver disease due to hepatitis C virus; diseases that 
have spread to new geographical settings, such as West Nile fever and 
dengue; and resurgent endemic diseases such as malaria and 
tuberculosis, which are increasingly resistant to antimicrobial drugs. 
In addition, we now face the specter of a new kind of emerging disease: 
one deliberately spread by bioterrorists. These emerging and re-
emerging diseases are superimposed on other major health problems such 
as acute respiratory infections, diarrheal diseases, and measles, which 
remain leading causes of illness and death worldwide.
    To mitigate the burden of these diseases, NIAID supports numerous 
laboratory, field-based, and clinical research projects related to 
global health, both domestically and abroad. Among many projects, 
NIAID-supported studies on malaria in Mali, pneumococcal disease in the 
Gambia, tropical diseases in the International Centers for Tropical 
Disease Research, and HIV prevention through the HIV Prevention Trials 
Network, have achieved important results through coordinated 
partnerships with local governments and other agencies and 
organizations. Building on NIAID's longstanding commitment in global 
health, the Institute this month released a new ``Global Health 
Research Plan for HIV/AIDS, Malaria, and Tuberculosis'', which outlines 
NIAID goals and plans for fighting infectious diseases by building 
sustained research capability domestically and internationally and 
enhancing international partnerships.
    Many of the challenges posed by emerging infectious diseases lend 
themselves to research in a relatively new field: genomics. The 
sequencing of the entire human genome and the anticipated assignment, 
over the next few years, of function to the estimated 30,000 to 60,000 
human genes will have an enormous impact on all of medicine, including 
our understanding of the host response to microbial pathogens. In 
addition, the genomic sequencing of microbial pathogens will be a 
critical component of 21st century strategies for the development of 
diagnostics, therapeutics, and vaccines for infectious diseases. NIAID 
has funded projects to sequence the genomes of more than 50 medically 
important pathogens, a dozen of which have been completed. These 
include the bacteria that cause tuberculosis, gonorrhea, chlamydia, and 
cholera, as well as individual chromosomes of the malaria parasite, 
Plasmodium falciparum. Most recently, investigators have reported the 
complete genomic sequence of Streptococcus pyogenes, a bacterium that 
causes diseases ranging from strep throat to the flesh eating disease 
known as necrotizing fasciitis, as well as that of Escherichia coli 
O157:H7, a worldwide public health threat that has triggered scores of 
recent outbreaks of hemorrhagic colitis and numerous fatalities from 
kidney failure. In the interest of global scientific cooperation, 
NIAID-supported scientists deposit pathogen sequence data in 
specialized public databases such as GenBank, where investigators 
around the world can access it via the World Wide Web.
                                hiv/aids
    AIDS, caused by the human immunodeficiency virus (HIV), has claimed 
22 million lives since the disease was recognized 20 years ago. More 
than 36 million people are living with HIV infection, including 
approximately 800,000 to 900,000 individuals in the United States. In 
the United States and other western countries, potent combinations of 
anti-HIV drugs (highly active antiretroviral therapy or ``HAART'') have 
dramatically reduced the numbers of new AIDS cases and AIDS deaths. 
NIAID-supported investigators conducted research that was pivotal to 
the development of these drugs, and have helped define how best to use 
these medications in different clinical settings. Ongoing research 
promises to yield a new generation of drugs that may improve upon 
existing medications in terms of cost, effectiveness, and tolerability.
    Until recently, expensive HAART regimens were considered to be 
beyond the reach of developing countries, where 95 percent of the 
world's HIV-infected people live. Now, with dramatic reductions in the 
price of antiretroviral drugs for developing nations and the commitment 
of world leaders to address the AIDS problem in southern Africa and 
other poor regions of the world, AIDS therapies will begin to reach 
more of the people in poor countries who could benefit from them. 
Building on the research infrastructure that NIAID has helped establish 
in Africa and elsewhere in the developing world, we intend to work with 
our international colleagues to link the provision of anti-HIV therapy 
to ongoing efforts in prevention research, with the goal of 
facilitating a comprehensive approach to the AIDS pandemic in poor 
countries. Two recently launched NIAID programs will be key to this 
effort: the HIV Prevention Trials Network (HPTN) and the HIV Vaccine 
Trials Network (HVTN), which have research sites in the United States, 
Latin America, Europe, Africa, Asia and the Caribbean.
    The HPTN focuses on several key areas of prevention research, 
including behavioral modification, interventions to prevent mother-to 
infant transmission of HIV, and the development of topically applied 
microbicides that women could use to protect themselves against HIV and 
other sexually transmitted pathogens. The HVTN will conduct all phases 
of clinical vaccine trials, from evaluating candidate vaccines for 
safety and the ability to stimulate immune responses, to testing 
vaccine efficacy. In pre-clinical and clinical studies, NIAID-supported 
investigators are testing a diverse range of vaccine strategies, 
several of which in recent months have shown remarkable promise in 
tests in non-human primates. The best candidates will be moved rapidly 
into HVTN trials. We remain optimistic that a safe and effective 
vaccine can be found that will prevent HIV infection and/or slow the 
progression of disease in people who are already infected with the 
virus.
                        immune-mediated diseases
    Immunologic diseases cause a considerable burden of illness and 
death and lead to medical costs that exceed $100 billion annually in 
the United States. Many immune-mediated diseases disproportionately 
affect women and members of minority groups. Autoimmune diseases such 
as type-one diabetes, rheumatoid arthritis, systemic lupus 
erythematosus, and multiple sclerosis collectively afflict 
approximately five per cent of the U.S. population. More than seven 
percent of American children are asthmatic, with poor children in inner 
city areas disproportionately affected by this serious disease. In 
addition, immune-mediated graft rejection remains a significant 
obstacle to the successful transplantation of potentially life-saving 
organs.
    NIAID-funded research in basic and clinical immunology has led to 
many promising approaches for treating individuals with these and other 
immunologic conditions. For example, researchers are developing novel 
ways of selectively blocking inappropriate or destructive immune 
responses, while leaving protective immune responses intact. This 
approach, called tolerance induction, holds great promise for the 
treatment of many immune-mediated conditions, including autoimmune 
diseases and asthma and allergic diseases. The induction of tolerance 
to transplanted organs or tissues ultimately may allow transplant 
patients to forego long-term regimens of broadly immunosuppressive 
drugs. These drug regimens are costly and dampen not only destructive 
immune responses, but protective ones as well, thereby increasing a 
patient's risk of malignancies and infections. Among many projects in 
the field of immune tolerance, the Institute established the Immune 
Tolerance Network (ITN), an international consortium of more than 70 
research groups. The ITN is implementing clinical trials in four areas: 
transplantation of islets (the insulin-producing cells of the 
pancreas), kidney transplantation, autoimmune diseases, and asthma and 
allergic diseases. The first ITN trial is testing a new approach to 
transplanting islets in diabetics who are unable to properly control 
their blood sugar levels. This international study builds on 
groundbreaking research at the University of Alberta that has resulted 
in long-term insulin independence for nearly 20 patients.
    For more than a decade, NIAID has worked to reduce the burden of 
asthma, particularly among inner-city children. Investigators of 
NIAID's National Cooperative Inner-City Asthma Study developed a 
successful behavioral and educational intervention that substantially 
reduced asthma severity in these pediatric populations. Building on 
this success, NIAID and the Centers for Disease Control and Prevention 
(CDC) are collaborating to implement this proven intervention in a new 
four-year program that will reach 6,000 children in 23 inner-city 
health care delivery sites throughout the U.S. An ongoing NIAID 
intervention study, involving approximately 1,000 children nationwide, 
is testing the effectiveness of environmental control measures and 
physician education in reducing the burden of asthma. Preliminary 
results are showing substantial reductions in asthma symptoms and 
emergency room visits. In both of these studies, recruitment has 
exceeded the targeted levels and retention of patients has been 
extraordinarily high compared to other studies of other inner-city 
pediatric populations. Because of these successes, NIAID-supported 
inner-city asthma programs are now recognized as models for conducting 
clinical research in the inner city and have attracted partners in the 
public and private sectors to collaborate with NIH-funded researchers. 
These collaborations promise to bring new asthma interventions to 
minority populations whose access to such therapies might otherwise be 
diminished or delayed.
                          vaccine development
    Vaccination has been recognized as the greatest public health 
achievement of the 20th century, and vaccine research has long been a 
cornerstone of the NIAID research portfolio. NIAID-supported research 
has led to the development of many new and improved vaccines now widely 
used, such as those against Haemophilus influenzae type b, pertussis, 
chickenpox, pneumococcal disease, and hepatitis A and B. The rapidly 
evolving science base in pathogen genomics, immunology and microbiology 
will facilitate further progress in developing new and improved 
vaccines. In particular, the availability of the genomic sequences of 
major microbial pathogens will facilitate the identification of a wide 
array of new antigens for vaccines. Because many pathogens gain entry 
to the body via mucosal sites, NIAID-supported scientists are 
developing new vaccines that target mucosal surfaces such as those in 
the intestine or respiratory tract. Vaccines that are easy to 
administer--orally, nasally, or trans-dermally--will have great utility 
in resource-poor setting and for mass immunization programs. In 
addition to the development of vaccines against classic infectious 
diseases, NIAID is working to develop vaccines against chronic diseases 
with infectious origins, as well as potential agents of bioterrorism, 
and autoimmune diseases and other immune-mediated conditions.
                               conclusion
    In the 21st century, NIAID is poised to exploit unprecedented 
scientific opportunities in immunology, microbiology and infectious 
diseases. As has been the case for more than 50 years, a commitment to 
the best possible research--basic science as well as clinical trials--
will drive our efforts to improve health in this country and abroad. 
With a strong research base, the commitment of talented investigators, 
and the availability of powerful new research tools, we are confident 
that our initiatives will help solve seemingly intractable clinical and 
public health problems and improve global health in the 21st century.
                                 ______
                                 

Prepared Statement of Stephen A. Ficca, Associate Director for Research 
                                Services

    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 2002, a sum of $306,600,000, which reflects an 
increase of $152,810,000 over the comparable fiscal year 2001 
appropriation.
                      role in the research mission
    The annual Buildings and Facilities (B&F) Appropriation is the only 
means by which the public supports the crucial physical infrastructure 
required to carry out the in-house component of the biomedical research 
mission of the National Institutes of Health (NIH). As approaches to 
basic and clinical research evolve, the demands for, and on, research 
facilities change as well. Properly planned and equipped, safe, and 
flexible research facilities are important resources in the formula for 
achieving the next scientific advance or biomedical breakthrough.
    The fiscal year 2002 Buildings and Facilities budget request is the 
product of a deliberate, corporate facilities planning process that 
addresses the NIH's immediate and longer range facility requirements of 
the entire agency. The goal of the planning process is to optimally 
meet the changing facility needs of the NIH research programs in the 
Washington, D.C., region and across the NIH field stations with a mix 
of owned and leased facilities.
    The B&F appropriation funds a continuing, multi-year program that 
supports NIH facilities throughout their life-cycles. The construction 
program supported by the proposed fiscal year 2002 request strikes a 
balance among three critical facility priorities: the creation of new 
facilities for new and expanding scientific opportunities, the 
upgrading of existing facilities to keep pace with the changing 
requirements of ongoing NIH programs, and the responsible stewardship 
of the entire NIH real estate portfolio. The specific projects included 
in the proposed fiscal year 2002 request are on the critical path of a 
larger rolling five-year plan. Thus, the investments in fiscal year 
2002 are predicated on previous investments and the timely investment 
in the future. For example, the Building 6 modernization is the last 
project in a series of projects that began in the 1980's to renovate 
the original NIH research buildings. The upgrade of the mechanical 
system at the National Institute of Environmental Health Sciences is 
the first phase of a two-phase modernization of the mechanical and 
electrical systems at the Research Triangle, North Carolina, field 
station.
    Safe, modern facilities, including the appropriate building systems 
and utility infrastructure, are a basic requirement to effectively 
carry out NIH's intramural research program, as well as stewardship of 
the extramural research programs. For the intramural research program, 
they are necessary to enable NIH's expansion into new areas of 
investigation, to house an expanding cadre of researchers and trainees, 
to attract the best and the brightest investigators, and to help retain 
staff who are being courted by the burgeoning biomedical industry.
    The B&F request for each budget year strives to optimize the 
distribution of resources among the programs activities so that, year 
to year, the continuity of the individual projects and the B&F Program 
as a whole is maintained.. Within this balanced mix of new 
construction, essential safety and health improvements, repair and 
improvement projects, renovations, and equipment and system upgrades, 
three projects are particularly important to the NIH's research plans: 
the John Edward Porter Neuroscience Research Center, the Central 
Vivarium/Animal Research Center, and the Building 10 Revitalization 
Program.
    The John Edward Porter Neuroscience Research Center will enable the 
integration of the neuroscience research community at the NIH. The 
Center is conceived as a place where the best and brightest scientists 
from many disciplines will collaborate in state-of-the-art laboratories 
to develop and evaluate therapies for some of the most complex problems 
in biomedical research. The Center will house researchers from nine 
institutes and multiple disciplines under one roof. It will be designed 
to support high priority research initiatives using innovative 
strategies in cell biology, neuroimaging and bio-informatics to better 
describe the link between biochemistry and behavior, to elucidate the 
nerve cell degenerative processes, and to explore other lines of 
inquiry that are emerging from the genetic mapping of the brain.
    New facilities are needed to support this vision because nearly all 
of the space that houses NIH neuroscience research is substandard. 
Current facilities for cellular and molecular neuroscience on campus 
are inadequate to meet the challenges of high-quality, high-risk 
research projects.
    The Central Vivarium/Animal Research Center is a vital part of the 
NIH research infrastructure. Animal models continue to be one of the 
most valuable means of elucidating basic biology and more complex 
mechanisms of disease. The multi-level facility will include state-of-
the-art animal holding, receiving and quarantine areas; procedures and 
specialized laboratories and administrative support spaces. It will 
replace facilities that are crowded and only marginally suitable to the 
support of many of the most promising animal models with AAALAC-
compliant facilities specifically designed to humanely house non-
mammalian species, genetically altered rodents, chimeras, and non-human 
primates.
    The soon to be completed Mark O. Hatfield Clinical Research Center 
(CRC) will be one major milestone in a continuing effort to maintain 
the physical research infrastructure of the Agency. It will house 
state-of-the-art patient-related research and laboratory research 
facilities for the clinical programs. The Building 10 Revitalization 
Program is the next phase in the renaissance of the critical 
infrastructure for the clinical research program at the NIH described 
in the 1994 Marks-Cassell report. The Building 10 Revitalization 
Program is a multi-phased approach that will renovate and renew the 
portions of the clinical program that remain in Building 10 when the 
CRC is occupied. The purpose of this effort when completed, is to 
accommodate all the research programs in the entire Clinical Center 
Complex in modern, safe, state-of-the-art hospital, research and 
support facilities. The fiscal year 2002 request for the Building 10 
Revitalization Program consists of three program activities. The 
Building 10 Transition Program includes projects required to sustain 
functionality between the old and new buildings. The Building 10 
Interim Renovation provides the necessary space and infrastructure 
reconfiguration to allow continued operation of the building during the 
phased renewal. Finally, the Phase I Renovation of Building 10 includes 
the renovation of the central core as clinical research space and the 
renovation and interconnections of the hospital and facilities support 
systems between the buildings.
                    fiscal year 2002 budget summary
    As in prior and future years, the funding request for fiscal year 
2002 is a part of a long range plan. The fiscal year 2002 request for 
Buildings and Facilities is $306.6 million. The B&F request totals 
$105.1 million for new construction composed of $26 million for the 
continued construction of the John E. Porter Neuroscience Research 
Center; $10.6 million to fund the design of the second phase of the 
Center; $53 million to complete the design and start the construction 
of the Central Vivarium/Animal Research Center; $14 million to design 
and construct the Northwest Parking Facility; and $1.5 million to 
initiate the Concept Development Studies program. There is a total of 
$99.9 million for essential safety and health improvements composed of 
a combined sum of $36 million to begin the Building 10 Revitalization 
Program through a plan of Interim Renovations to provide temporary 
space, and the initiation of the Phase I Renovation; $19.7 million in 
funding to complete the modernization of Building 6; $10 million for 
the continued support of the rehabilitation of animal research 
facilities; $10 million for the continuing upgrade of fire and life 
safety deficiencies of NIH buildings; $3 million for the phased removal 
of asbestos from NIH buildings; $1 million to systematically remove 
existing barriers, to persons with disabilities, from the interior of 
NIH buildings; $2 million to address indoor air quality concerns and 
requirements at NIH facilities; $12.2 million as a second phase to 
improve and upgrade utilities at the NIH Animal Center; $7.2 million to 
replace the mechanical systems in Building 6B; $5 million to initiate a 
four-year program to upgrade elevators in various buildings on the 
Bethesda and satellite campuses; and $1 million to allow for 
environmental remediation activities at NIH sites. In addition, the 
fiscal year 2002 request includes $65 million for the continuing 
program of repairs, improvements, and maintenance that is the core of 
the B&F program. The fiscal year 2002 request also includes: $14.1 
million for the Building 10 transition program; $3.6 million to upgrade 
mechanical systems at NIEHS; and $11.7 million to complete the 
construction and installation of Boiler 7 on the NIH campus in 
Bethesda.
             government performance and results act (gpra)
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
Prominent in the performance data is NIH's second annual performance 
report which compares our fiscal year 2000 results to the goals in our 
fiscal year 2000 performance plan. As performance trends on research 
outcomes emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
    My colleagues and I will be happy to respond to any questions you 
may have.
                                 ______
                                 

 Prepared Statement of Enoch Gordis, M.D. Director, National Institute 
                    on Alcohol Abuse and Alcoholism

    I am pleased to present the President's budget request for the 
National Institute on Alcohol Abuse and Alcoholism (NIAAA) for fiscal 
year 2002, a sum of $381,966,000, which reflects an increase of 
$41,288,000 over the comparable fiscal year 2001 appropriation.
    Alcohol-use disorders impose an enormous toll on society. They cost 
the Nation $185 billion each year, one-and-one-half times as much as 
all illegal drugs combined,\1\ and 100,000 people die of alcohol-
related causes annually.\2\ These figures reflect only the toll imposed 
by the 14 million adult Americans who are physically dependent on 
alcohol or who abuse it to the point that it disrupts their lives, but 
who aren't dependent on it.\2\ Still others add to the burden when they 
occasionally drink to excess and, temporarily impaired, injure or kill 
themselves or others, or damage property.
---------------------------------------------------------------------------
    \1\ Updated figures from Lewin Group, 1998.
    \2\ IAAA epidemiology data.
---------------------------------------------------------------------------
                           alcohol is unique
    Among substances of abuse, alcohol is unique in a number of ways. 
It is a toxin that can cause damage to any tissue in the body. The 
resulting diseases range from certain kinds of cancer to liver and 
heart disease. Alcohol also is unique in the pervasiveness of its 
actions in the nervous system, the body's command center, through which 
alcohol exerts its behavioral effects. Rather than affecting only one 
or a few neurotransmitter systems--that is, the crucial chemical 
systems through which components of the nervous system communicate with 
each other and with the outside world--alcohol affects every 
neurotransmitter system that we have studied to date.
    Alcohol also affects parts of the membrane that surrounds nerve 
cells, the ``point of entry'' for substances of abuse, that illegal 
drugs do not appear to affect. These factors greatly complicate the 
search for alcohol's sites of action in the nervous system.
    Policy and legal issues--as well as social ones--also confer unique 
status on alcohol. For example, alcohol raises the need for laws on 
minimum drinking age, maximum allowable blood levels for driving, and 
zoning and licensing. Alcohol raises the issue of revenue, since it is 
associated with a tax-paying industry, an industry that promotes 
alcohol's use through advertising. Alcohol also raises the issue of 
warning labels on beverage containers.
    Another of the ways in which alcohol is unique among substances of 
abuse is that it is a food, since it has caloric value. The brain 
regulates appetite for food through neuropeptides, pieces of protein. 
Evidence suggests that, to some extent, craving for alcohol might be 
driven by the same or similar biochemical pathways that drive appetite 
for food.
         neuroscience holds the key to behaviors of alcoholism
    Some people can drink lightly and occasionally and never develop 
problems with alcohol, while at the opposite end of the spectrum of 
alcohol use, it takes over people's lives and they become physically 
dependent on it. Between these two scenarios lie varying degrees of use 
and misuse. What accounts for these differences in how people respond 
to alcohol, differences that may decide whether or not it destroys 
their lives?
    Environmental factors--family and peers, for example--play a role, 
but variations in our nervous systems constitute the largest part of 
the differences in our behaviors toward alcohol. It is here that 
alcohol affects a multitude of biologic events that determine our 
propensity for drinking and our vulnerability to the biologic process 
of becoming dependent on alcohol. Before we have taken our first drink, 
the genetic and molecular make-up of our brains influences, largely, 
how we will respond to alcohol once we are exposed to it.
    Substances ultimately stimulate the same major reward pathways of 
the brain. However, various substances first stimulate other, different 
biochemical pathways before they ``light up'' these major reward 
pathways. Thus, substances differ in the mechanisms, and in the 
complexity of those mechanisms, that lead to reward. The routes of 
alcohol's actions appear to be particularly pervasive.
    Alcohol's effects on the nervous system vary throughout the life-
span, from the uniquely devastating damage it causes in the fetus, to 
disruptions in development of the adolescent brain, to the patterns of 
biologic risk and damage we see in adults. Among substances of abuse, 
alcohol is, by far, the greatest inducer of neurologic and other birth 
defects.
                          the answers we seek
    Alcohol research seeks to answer these questions: What are the 
genetic and molecular factors in the brain that determine these 
differences in how we respond to alcohol? How does alcohol change 
``hardwired'' functions of the brain to cause physical dependence? What 
role do environmental factors play in alcohol dependence? Can we design 
interventions that disrupt these biologic and environmental pathways, 
to prevent alcohol's harmful effects? In each of these areas and 
others, we are making advances.
                      advances in alcohol research
    Our neuroscience research is aimed at understanding how a multitude 
of biologic factors combine to form neural circuits--networks of nerve 
cells and the thousands of biochemical activities associated with 
them--that mediate alcohol's actions. Our research links these biologic 
events with alcohol-related behaviors and the impact that environmental 
influences have on them.
    We have made major advances. For example, we are closing in on 
specific regions of the nerve-cell membrane where alcohol initiates its 
effects. This kind of information raises possibilities for design of 
medications that block such sites. Among our priorities is to develop 
medications that will be effective in a wider range of people with 
alcoholism than are current medications. For example, our research on a 
nervous-system protein (protein kinase C) has resulted in a 
treatment-development project by a pharmaceutical company.
    Animal and clinical neuroscience findings are guiding our efforts 
to develop medications for alcoholism that target optimal molecular 
sites in the nervous system. For example, naltrexone, approved for 
alcoholism treatment by the FDA in recent years, targets a specific 
neurotransmitter system--the opioid system--and is among the more 
promising pharmaceuticals currently in use.
    In the genetics arena, we have found several chromosomal regions 
likely to contain genes that influence our susceptibility to 
alcoholism. Our challenge is to pinpoint their exact locations. Because 
alcoholism is a genetically complex disease--that is, multiple genes 
influence it--the search for these genes is complex. Our Collaborative 
Study on the Genetics of Alcoholism addresses this issue and has 
generated data used by other disciplines with an interest in addiction 
and by the scientific community.
    We are conducting studies in rodents in which we either ``knock 
out'' or enhance the activities of genes, to see how this affects 
behaviors toward alcohol. These studies are providing us with 
information about biologic mechanisms that contribute to the risk of 
becoming alcoholic. Another genetics technology (microarray technology) 
is telling us which genes appear to be active under various scenarios 
of alcohol use. This technology enables us to scan much of the human 
genome for changes in gene activity that occur with physiologic states 
associated with alcohol; for example, alcohol dependence.
    Our research is revealing mechanisms that mediate alcohol's damage 
to the fetus and evidence that adolescent brains are vulnerable to 
alcohol-induced damage. New NIAAA research also links stress-induced 
hormonal changes in infancy with risk of alcohol problems later in 
life.
    Ultimately, these kinds of studies can guide us to points for 
pharmaceutical intervention in the biochemical pathways through which 
alcohol exerts its effects. We are capturing the potential of 
neuroscience through collaboration. Alcohol research covers the 
spectrum from genetics to behavior and all of the intricate molecular 
biology that lies between. However, so many areas of expertise now 
exist in neuroscience that integrating research and results relevant to 
alcohol investigations is difficult. To ensure that we do not miss 
opportunities, our Integrative Neuroscience Initiative on Alcoholism is 
encouraging investigators from different fields to integrate their work 
and their findings. We expect this major initiative to speed the 
translation of new findings into clinically useful data.
                          beyond basic science
    Our research on social and policy issues extend far beyond 
questions of legislation. For example, drinking among college students 
is a complex problem entrenched in campuses and communities. Evidence 
suggests that intentional and unintentional injury, including death, 
associated with this problem is much greater than previously suspected. 
Our investigators are pursuing estimates of alcohol-related death rates 
among this vulnerable age group, and avenues for prevention. Minority 
groups provide another example. Certain minority groups appear to 
respond differently to alcohol, physically and behaviorally, than does 
the general population. Our epidemiology research identifies these 
kinds of public-health issues, and these findings lead to basic and 
behavioral research that investigates root causes and potential 
interventions.
    We bring our research findings to the public in a variety of ways. 
Our Research to Practice Initiative is an excellent example. In 
collaboration with the Substance Abuse and Mental Health Services 
Administration's Center for Substance Abuse Treatment, we arrange with 
States to meet with treatment providers and administrators. After 
exchanging information about our current research findings and the 
practitioners' obstacles to providing treatment, we place experts in 
temporary residencies in treatment programs that have identified 
specific areas of need.
    We bring our findings to the public via Alcohol Screening Day, a 
nationwide event that enables people to receive free screening for 
alcohol problems and, if needed, referrals. Last year, almost 1,500 
sites across the country participated, more than 370 of them college 
campuses. We also are dealing with the difficult issue of college 
drinking through our Advisory Council's Subcommittee on College 
Drinking. The Subcommittee, a collaboration between researchers and 
college presidents, has been meeting since 1998 and has commissioned 
major papers and panel reports to guide efforts to prevent drinking by 
students.
    Drinking by youth is not limited to college students, and we are 
reaching children and adolescents through our Governors' Spouses 
Initiative. Spouses of governors in 28 States have joined this project 
to reduce drinking by young people; a crucial effort, given our 
findings that early initiation of drinking portends dramatically higher 
risk of alcoholism later in life. These efforts will be accompanied by 
public service announcements on underage drinking.
                 government performance and results act
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) Of 1993. 
Prominent in the performance data is NIH's second annual performance 
report, which compares our fiscal year 2000 results to the goals in our 
fiscal year 2000 performance plan. As performance trends on research 
outcomes emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
                                 ______
                                 

    Prepared Statement of Dr. Patricia A. Grady, Director, National 
                     Institute of Nursing Research

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Institute of Nursing 
Research (NINR) for fiscal year 2002, a sum of $117,686,000, which 
reflects an increase of $12,508,000 over the comparable fiscal year 
2001 appropriation.
    This year, as NINR celebrates its 15th anniversary, it is 
encouraging to reflect on the progress made so far. Nursing research on 
a broad range of issues has been stimulated, developed, funded, 
published, and integrated into practice, where patients and the public 
are already reaping the benefits of improved health care. Studies 
include improving management of symptoms and quality of life for the 
increasing population of patients with longstanding chronic illnesses; 
smoothing the transition of advanced technologies into people's lives, 
such as genetic screening and telehealth; reducing health disparities 
among minorities and those without adequate access to the healthcare 
system; and improving care at the end of life. Yet nursing research is 
a young science. It must continue to grow to help meet urgent national 
health needs, expectations of our nation's people, and requirements of 
2.7 million registered nurses for well-tested, effective interventions. 
NINR research is central in supplying empirical evidence that expands 
the scientific base for care affecting people's physical, psychosocial, 
and cultural needs.
   translating research findings into practice at the community level
    Let me illustrate how nursing research can influence public and 
private organizations at the community level--and in so doing, help 
eliminate health disparities. NINR study findings addressed an 
important health issue--low birthweight and preterm births--and 
supported research that promoted lower incidence while decreasing costs 
to the healthcare system. According to the National Center for Health 
Statistics, the United States is a disappointing 26th among 
industrialized nations in the number of babies per 1000 dying before 
their first birthday. The national rate is over 7 deaths per thousand. 
For African-Americans it is over 14 per thousand. In North Carolina, 
where the study took place, investigators targeted low-income African 
American pregnant women and Caucasian women at particular risk for low 
birthweight, including pregnant teens. This five-year project involved 
a home visit followed by low-cost, low-tech phone calls by registered 
nurses to monitor health and address problems of the women. Results 
showed that the low birthweight rate for the treatment group was 10.9 
percent, compared with 14 percent for controls. For African Americans 
19 years and older, the results were even more pronounced--11 percent 
in the treatment group versus 17 percent for controls. For this group, 
cost savings to the hospital were $277 per pregnancy. Extended savings 
also resulted from a reduction in long-term problems related to low-
birthweight.
    Investigators expanded the intervention to four programs that 
included Hispanics, African-Americans and Caucasians--three programs 
focusing on low-income women and one on women of all income levels 
nationwide. The results equaled or bettered the original study 
findings. All four programs are continuing today without Federal 
research funding--having been adopted by private sector organizations, 
including a national HMO.
        improving daily living for alzheimer's disease patients
    This anniversary year presents the opportunity to recognize some 
notable nursing science advances. For example, with respect to 
Alzheimer's disease patients, an important goal is preserving their 
functional capacity as long as possible so that they can bathe, dress 
and feed themselves. Researchers studied nursing home residents with 
Alzheimer's disease--the most disabled group in these establishments. 
Their disabilities were found to be caused by cognitive deficits, but 
also by the staff's inability to encourage independence. This can cause 
disability beyond what can be expected of cognitive impairment alone. 
The study involved nursing home staff instituting one-to-one 
interventions to improve the residents' abilities to bathe and dress. 
First, the residents were examined to determine which skills they 
retained. Then the physical and social environment was restructured to 
reactivate those skills. Findings indicate that the intervention 
improved residents' bathing and particularly dressing capabilities, and 
disruptive behaviors were reduced. Improvements were realized within 
five days' time and were maintained by the end of three weeks. To 
achieve this, however, staff time with each resident increased. 
Investigators hypothesize that the amount of time can be reduced if the 
goal is to maintain the residents' skill levels, rather than to raise 
them.
                  end-of-life/palliative care research
    Another issue predominantly affecting seniors, but also affecting 
people of all ages, is how to retain quality of living during life's 
final phase. NINR has a special interest in this area and is the 
Institute that coordinates end-of-life research at the NIH. A major 
issue is that, while capable of enhancing life, technologies and 
treatments can also involve burdensome procedures that may be futile 
and prolong discomfort and pain. The decision whether or not to 
withdraw life support, usually made by family members or friends on 
behalf of the dying patient, is a difficult decision to make. NINR 
researchers measured family member stress levels and found them to be 
twice as high as those due to other serious crises, such as 
construction disasters, or losing a home to fire. This study is one of 
the first to show that existence of an advance directive eases stress 
on the family when life-sustaining treatment is withdrawn. When an 
advance directive existed to guide decisions, the families were better 
able to focus on patients' quality of life and less likely to choose 
prolonging life at all costs.
               factors influencing obesity in adolescents
    Obesity can decrease quality of life and shorten life span. 
According to the Centers for Disease Control and Prevention, 13 percent 
of children and 14 percent of adolescents are overweight, continuing 
the pattern of the past two decades. These young people are at risk for 
cardiovascular disease later in life. In a study of 2000 adolescents, a 
nurse investigator found that for both males and females, the influence 
on obesity of ethnicity and socioeconomic status was greater than the 
influence of watching TV or playing video games. African-American teens 
and low-income female teens were at special risk, which suggests where 
the emphases of prevention programs should be placed. The study also 
indicated that participation in high-intensity exercises, such as 
basketball or swimming, may protect boys against obesity. School 
physical education and community recreation programs that feature high-
intensity physical activities could help lower the obesity rate. 
Further research is needed, however, before programs can be developed 
for girls.
                      new and expanded initiatives
    Turning to the immediate future, next year NINR plans an increased 
emphasis on chronic illness. The rise in chronic illness creates an 
escalating demand for strategies that enable people to live as normal 
lives as possible, even while they are dealing with chronic illness. 
Another key factor is caregiving for family members at home. This 
practice is increasing in importance as an essential ingredient of the 
Nation's healthcare system.
    The chronic disease of cancer has special urgency for minorities, 
because it is they who bear an unequal burden for this disease. The 
Healthy People 2010 report states that African Americans are 34 percent 
more likely to die of cancer than are Caucasians. New ways must be 
found to reverse this disturbing trend. NINR plans to concentrate on 
culturally-sensitive prevention research that focuses on lifestyle 
factors, such as alcohol, poor diet, and exposure to environmental 
toxins. We will also develop and test innovative approaches to increase 
screening for cancers in minorities, which should help reduce disease 
or bring balance to the present unevenness of disease expression among 
populations.
    Chronic pain, prevalent throughout our society, is frequently the 
reason people visit doctors and hospitals, and it can significantly 
influence recovery from illness. Imagine, however, being in severe pain 
but not able to tell the nurse or doctor about it. Many people are in 
this position, which makes pain treatment all the more difficult. 
Examples include those who may be cognitively impaired, or cannot speak 
English, or are infants unable to talk yet. Next year NINR plans a new 
emphasis on pain. Researchers must discover cues that indicate the 
presence and degree of pain so that adequate treatment can be provided 
for those who cannot speak for themselves. Research is also needed to 
address other barriers to the effective treatment of chronic pain, 
including under-reporting of pain and underutilization of analgesics.
    Frequently accompanying chronic illness is cachexia, a condition 
signaled by muscle wasting and weight loss. Patients with cancer, 
cystic fibrosis, AIDS, and chronic lung disease are at risk for 
cachexia. The impact on quality of life stems from fatigue, weakness 
and susceptibility to other complications. Despite promising 
opportunities, there has been limited research attention to this 
condition. The urgent needs of patients with long-standing illnesses 
dictate that cachexia must be addressed.
    Those who care for ill family members are sometimes overlooked in 
the overall battle against chronic illness. Yet according to the Center 
for Advancement of Health, nearly one in four families in our country 
are involved not only with physical care of their relatives, but also 
in dealing with behavioral or cognitive problems. Yet many caregivers 
must still shoulder their other responsibilities of daily life. The 
combination of these demands can put them at risk for poor health, 
caused in part by the stress of caregiving and perhaps their own 
advanced years. NINR plans to increase research in this area, including 
studies to promote learning and refining caregiving skills to benefit 
the patient, and strategies to safeguard caregivers' own health and 
quality of life.
              building the capacity to do nursing research
    NINR must also ensure that the nation maintains a sufficient, well-
prepared supply of nurse researchers to provide the empirical evidence 
necessary for clinical nursing practice. NINR offers a variety of NIH 
training opportunities, including those emphasizing patient-oriented 
research and research conducted by and involving minorities. We must 
also address the concerns of the recent report of the National Research 
Council on the needs for biomedical and behavioral scientists. The 
report recommended that NINR emphasize research training that 
facilitates earlier entry into research careers. To address this 
concern, NINR has designed several innovative programs to attract 
students to early research careers and to shorten the entry time into 
research. We also plan to continue our successful Summer Genetics 
Institute to fill the need for expert nurses prepared to address the 
many issues raised by genetic advances.
    In closing, contemporary and future biomedical and behavioral 
research will continue to emphasize many aspects of what nurses do 
well--such as ethnic and culturally sensitive approaches, health 
promotion, and symptom management--all strong research emphases of 
NINR. NINR must continue to build good science in these critical areas.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
Prominent in the performance data is NIH's second annual performance 
report which compared our fiscal year 2000 results to the goals in our 
fiscal year 2000 performance plan. As performance trends on research 
outcomes emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
    I would be pleased to answer any questions the Committee may have. 
    
    
                                 ______
                                 

                 Prepared Statement of Richard J. Hodes

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Institute on Aging 
(NIA) for fiscal year 2002, a sum of $879,961,000, which reflects an 
increase of $93,509,000 over the comparable fiscal year 2001 
appropriation. The NIH budget request includes the performance 
information required by the Government Performance and Results Act 
(GPRA) of 1993. Prominent in the performance data is NIH's second 
annual performance report which compares our fiscal year 2000 results 
to the goals in our fiscal year 2000 performance plan. As performance 
trends on research outcomes emerge, the GPRA data will help NIH to 
identify strategies and objectives to continuously improve its 
programs.
    Evidence suggests that older Americans are living longer, healthier 
lives. Life expectancy in the United States has dramatically improved 
from an average of 49 years in 1900 to 76 years at the turn of the 21st 
century.\1\ The results of several national surveys also suggest that 
older Americans are experiencing better health and a declining rate of 
disability. Despite this promising news, we know that good health is 
not a universal reality for all older Americans -especially for aging 
minority groups. Thus, the NIA is committed to supporting high quality 
research to address the conditions and diseases affecting the elderly 
population, such as Alzheimer's disease (AD), osteoporosis, 
cardiovascular disease, cancer, diabetes, and physical frailty.
---------------------------------------------------------------------------
    \1\ National Center for Health Statistics, National Vital 
Statistics Report, United States Life Tables, 1998, February 2001.
---------------------------------------------------------------------------
                     conquering alzheimer's disease
    AD, the most common cause of dementia among older persons, 
tragically affects as many as four million Americans who are 
predominately 65 years and older. There has been an explosion of recent 
findings that are yielding important clues about AD risk factors and 
disease pathology and, as a result, are suggesting targets for 
treatment and prevention.
    In the past year, scientists have identified a number of genetic 
and non-genetic AD risk factors. Separate studies concluded that a gene 
or genes on chromosome 10 may be risk factors for late onset AD-the 
most common form of AD. Prior to these findings, the apolipoprotein E 
(APOE) gene was the only widely recognized genetic risk factor in late 
onset AD. Examples of possible non-genetic risk factors uncovered 
recently include poor socioeconomic status, low-educational level, 
absence of extensive social networks, and history of serious head 
trauma. Evidence from these and other studies suggests that early life 
course events may play a role in AD development and could lead to novel 
interventions.
    While research is ongoing to explain how AD develops, scientists 
are also working to translate information about risk factors and 
underlying disease mechanisms into effective AD treatments. The public 
and scientific community are particularly excited about an emerging, 
potentially promising AD vaccine. In a breakthrough experiment last 
year, which was based upon NIH-supported advances in basic research, 
pharmaceutical company scientists announced they had developed a 
vaccine that in mice appears to slow production of amyloid. Amyloid is 
the substance, or peptide, that forms the senile plaques in the brains 
of AD patients. Their research showed that repeated long-term 
injections of an amyloid vaccine can stimulate an immune response in 
test mice, nearly eliminating amyloid plaques and associated 
neuropathology. (Chart#1) A number of NIH-funded scientists have since 
confirmed and extended these observations. Other NIA-supported studies 
have shown that the vaccine is effective in preventing cognitive 
decline in mice. Human trials being conducted by pharmaceutical company 
researchers are now beginning to test both the safety and efficacy of 
these vaccines as a possible therapy for AD. The NIA is discussing 
potential ways in which the public and private sectors can collaborate 
to facilitate the success of these critical trials.
    The NIA is currently supporting 17 AD clinical trials, seven of 
which are large-scale cognitive impairment and AD prevention trials. 
These trials are testing agents, such as estrogen, anti-inflammatory 
drugs, and anti-oxidants, for their effects on slowing progress of the 
disease, delaying AD's onset, or preventing the disease altogether. 
Other intervention trials being supported by the Institute are 
assessing the effects of various compounds on the behavioral symptoms 
(agitation, aggression and sleep disorders) in people with AD. The NIA 
is also supporting studies that are testing interventions for improving 
AD patient care delivery and alleviating caregiver burden.
                    reducing disease and disability
    Besides AD, many other chronic diseases and disabling conditions 
can compromise the quality of life for older people. Osteoporosis, a 
skeletal disorder characterized by compromised bone strength, is one of 
the seven most common causes of disability in older people, especially 
older women. According to the National Institute of Arthritis and 
Musuloskeletal and Skin Diseases, one out of every two women (as 
opposed to one in eight men) over 50 will have an osteoporosis-related 
fracture in her lifetime. Large observational studies have determined 
that the use of thiazide diuretics, an inexpensive treatment for high 
blood pressure, is associated with higher bone density and about a 30 
percent lower risk of hip fracture. To directly test the effects of 
low-dose hydrochlorothiazide on bone density in men and women with 
normal blood pressure, investigators completed a recent clinical trial. 
The trial found that the agent preserved bone density at the hip and 
spine. The modest effects observed over three years, if accumulated 
over 10-20 years, may explain the 30 percent reduction in hip fracture 
risk associated with thiazides in the earlier observational studies. 
The results of this trial suggest that low-dose thiazide therapy may 
have a role in preventing osteoporosis.
    Diabetes is another one of the seven major debilitating diseases 
affecting older people. Adult onset diabetes, or type 2 diabetes 
mellitus (DM), is caused by an inability of the beta cells of the 
pancreas to compensate for increasing insulin demands; consequently, 
blood glucose levels rise. GLP-1, a glucagon-like gut peptide, can 
stimulate beta cells to produce more insulin even in type 2 DM; 
however, its biologic half-life is short and its effects quickly 
diminish. Exendin-4, a newly studied peptide analog of GLP-1, is long-
lived and more potent than GLP-1, and has been shown to reduce blood 
glucose levels in rodents. A recent study with small numbers of 
diabetic and non-diabetic humans demonstrated Exendin-4's efficacy in 
inducing insulin and normalizing blood sugar, even in diabetics. 
(Chart#2) In the near future, an exendin-like drug possibly may become 
an effective treatment for type 2 DM.
    Research has shown that many of the disabling conditions affecting 
older people could be diminished through regular exercise. The evidence 
was enhanced this year by findings that found 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. Findings like these motivate the NIA to continue its 
ongoing campaign to encourage older people to exercise. Since the 
campaign was launched in 1998, the NIA has distributed over 350,000 
copies of its exercise guide and over 15,000 copies of its companion 
video to the public.
                            biology of aging
    In keeping with its mission, the NIA supports research on diseases 
and conditions affecting the elderly as well as on the normal aging 
process. To understand the aging process, it is important to identify 
those factors that affect the overall life span of an organism. Toward 
this end, NIA supports and promotes research on the biochemical, 
genetic, and physiological mechanisms of aging and the onset of age-
related disease. Experiments in a number of animal models, such as 
mice, fruit flies, and nematodes (roundworms), are providing valuable 
insights.
    Understanding factors that contribute to longevity in animal 
models, and how these factors may apply to humans, are of major 
interest to the NIA. The role that oxidative stress, for example, may 
play in the aging process continues to be explored. In the last year, 
investigators announced that they had extended the average life span of 
nematodes via pharmacological intervention targeting oxidative stress. 
Using an artificial compound, EUK-134, which mimics enzymes that reduce 
oxidative damage, researchers extended the life span of nematodes by 
about 50 percent. The intervention also reversed premature aging in a 
nematode strain subject to elevated damage. These results strongly 
suggest that oxidative stress is a major factor in the rate of aging in 
the nematode and may be slowed by pharmacological intervention. It may 
be that similar compounds could lessen oxidative stress in humans and 
delay or reduce age-related pathology.
    Caloric restriction, which entails a diet that includes all of the 
necessary nutrients but fewer calories, has been shown to slow the 
intrinsic rate of aging and to delay and reduce the onset of diseases, 
such as cancer. In rodents, it was demonstrated recently that caloric 
restriction can also increase resistance of neurons to age-related and 
disease-specific stresses, suggesting that it may be an effective 
approach for reducing neuronal damage and neurodegenerative disorders 
in aging. Although the effects of caloric restriction on humans have 
not been evaluated, this year, the NIA announced an initiative to begin 
studying the effects in humans of sustained caloric restriction on 
physiology, metabolism, body composition, risk factors for age-related 
pathologies, progression of age-related changes (where feasible), and 
its potential adverse effects. Results of these studies could be 
valuable in the development of better methods of preventing multiple 
age-related diseases.
                     behavioral and social research
    Behavioral and lifestyle factors have a profound impact on health 
throughout the life span. Thus, the NIA supports behavioral and social 
research, including demographic research, to elicit information about 
the health of older people, their socioeconomic status and the social 
and behavioral influences that affect their lives.
    Demographers reported some of the most promising news of the last 
decade related to the health status of older Americans. In a landmark 
study, researchers used the 1982 disability rates from the National 
Long Term Care Survey (NLTCS) for people aged 65 and older to estimate 
the numbers of disabled persons in each future year using census bureau 
projections. They then used subsequent waves of the NLTCS to determine 
the actual numbers of disabled persons and compared that to their 
estimates. Using this method, they observed 1.6 million fewer disabled 
older people in the U.S. in 1998 than there would have been if the 
disability rate had not changed since 1982.\2\ (Chart #3) These 
decreases in disability have been confirmed using several independent 
databases and have been shown to benefit both men and women, and 
minority as well as non-minority populations. The latest preliminary 
findings from the 1999 NLTCS suggest that the rate of decline in 
chronic disability is continuing and may even be accelerating. Research 
is ongoing to understand the potentially significant long-term economic 
and social consequences of disability decline, including its effect on 
health care costs and the American workforce. Importantly, research has 
also begun to identify the factors contributing to the decline so that 
specific interventions and behavioral changes can be designed that 
might sustain or accelerate trends in improved function and quality of 
life among older Americans.
---------------------------------------------------------------------------
    \2\ National Long Term Care Survey 1982-1994 (Kenneth Manton, 
Ph.D.)
---------------------------------------------------------------------------
    NIA encourages research with the aim of not only extending life, 
but also improving the quality of life. One factor contributing to a 
higher quality of life in later years may be a positive outlook. A 
recent study demonstrated that emotional vitality is associated with 
decreased mortality and is correlated with slower progression of 
disability in disabled older women (aged 65 years and older). Using 
data from the Women's Health and Aging Study, a longitudinal study of 
disabled women, researchers found that women who were classified as 
emotionally vital (i.e. upbeat and positive) at the beginning of the 
study maintained better physical function over time than women who were 
not emotionally vital. Although more research is necessary to elucidate 
the possible role of emotions in protecting against health decline, 
these results suggest that helping older people maintain a high level 
of emotional vitality may help prevent or slow physical decline.
                               conclusion
    Many people have assumed that old age is always associated with 
increased disability. As little as five years ago, researchers could 
not conceive of an approach to preventing Alzheimer's disease (AD). 
However, through research advances, the nation has renewed hope that 
scourges, like AD, may be treated or prevented one day. Americans can 
also foresee the possibility of living a long, satisfying life free of 
major disability. To continue its trajectory of recent success, the NIA 
recently released its five-year strategic plans for aging research and 
research into health disparities. The goals are ambitious. However, 
these documents provide a framework that the Institute will be using to 
continue the tremendous progress made in the last century. By 
continuing and intensifying research, NIA can move forward in meeting 
the promise of extended life by improving the health and well-being of 
older people in America. 






                                 ______
                                 

    Prepared Statement of Steven E. Hyman, M.D., Director, National 
                       Institute of Mental Health

    Mr. Chairman and Members of the Committee, I am pleased to present 
the President's budget request for the National Institute of Mental 
Health (NIMH) for fiscal year 2002, a sum of $1,238,305,000, which 
reflects an increase of $131,576,000 over the comparable fiscal year 
2001 appropriation.
               mental disorders are enormously disabling
    Mr. Chairman, mental disorders constitute extraordinarily 
significant causes of disease burden in the United States and 
worldwide, with their greatest contribution to that burden resulting 
from their disproportionate impact on disability. According to the 
World Health Organization (WHO), major depression is the leading cause 
of disability in the United States and, indeed, throughout the 
developed world, and four mental illnesses rank among the top ten 
causes of disability. In recognition of this fact, the WHO has 
designated mental health as the topic of the World Health Assembly to 
be held in May in Geneva, which will be attended by Secretary Thompson 
and health ministers from all member nations within the U.N. In 
addition, mental health will be the sole topic of WHO's World Health 
Report for 2001, which should provide a significant platform for 
improved understanding worldwide. The World Health Report will 
complement the extremely well-received Surgeon General's Report on 
Mental Health issued by Surgeon General David Satcher in December 1999 
in the United States. The NIMH takes great pride in having served as 
the critical advisor to both the United States and World reports.
           co-occurring mental and general medical disorders
    The impact of mental illness on disability is well known. Less well 
known, but increasingly well documented, is the fact that mental 
illness can have a significant impact on the incidence and course of 
general medical disorders. In March, NIMH sponsored a conference in 
Pittsburgh that was attended by a member of this panel, Congressman 
Kennedy, and a member of the Senate, Senator Arlen Specter, which 
focused on this issue of co-occurrence, or comorbidity. Scientists 
presented overwhelming evidence for a physiologic role of depression in 
the progression of heart disease, including a contribution to heart 
attacks and death. Of course, depression may interfere with a person's 
ability to engage in rehabilitation or to adhere to diets and complex 
medical regimens. But that is far from the whole story. Depression 
causes excessive release of stress hormones, such as cortisol and 
adrenaline that can have negative effects on metabolism and on the 
heart. Depression may also make the heart more prone to abnormal 
rhythms, and may alter the stickiness of platelets. There is strong 
evidence that the fundamental pathologic processes leading to 
Parkinson's disease often also lead to severe depression, which, in 
turn, can markedly exacerbate this disabling and tragic disorder. And 
research points to the role of depression as a contributor to mortality 
in cancer and AIDS. Some treatments for general medical illnesses may 
also cause depression by altering brain chemistry. Treatment of cancer 
with high dose interferon--is often limited--indeed, often terminated--
as a result of interferon-induced depression. Early treatment with 
antidepressant medication was shown this year to minimize depression 
and facilitate cancer treatment. Separation of ``mind'' and ``body'' in 
medicine is folly. Mental disorders are illnesses of the brain. By 
themselves these disorders cause enormous suffering and disability, but 
in addition, by altering hormone release, appetite, sleep, and other 
somatic systems, mental illnesses have a deleterious--and often 
preventable--impact on organs outside the brain.
           strategic research planning targets mood disorders
    The conference on depression co-occurring with other medical 
illnesses was held in conjunction with an exciting effort to engage the 
Nation's leading mood disorder researchers in our ongoing strategic 
planning process. The effort, entitled ``Breaking Ground, Breaking 
Through: A Strategic Plan for Depression and Bipolar Disorder 
Research,'' will identify scientific areas that offer significant 
opportunities for progress or in which there are currently significant 
gaps. Participants analyzed the state-of-the-science in nine areas, 
ranging from genetics, to the neural and behavioral substrates of mood 
regulation, to an assessment of barriers to care for patients at all 
points across the lifespan and in all of our racial and ethnic minority 
groups. These reports will be published in a leading scientific journal 
later this summer, and will provide the grist for updates to our NIMH 
Strategic Plan. This plan, which is publicly discussed by our National 
Advisory Council on a regular basis, plays a critical role in our 
engagement with the scientific community as well as with other 
stakeholders. We believe that accountability to the Congress and to the 
American people demands that we publicly state our goals for the 
advancement of diagnosis, treatment, and ultimately cure and even 
prevention of mental illnesses.
        molecular genetics tools benefit mental illness research
    In the foregoing, I have highlighted the enormous public health 
need created by the current realities of mental illness, and have 
alluded to the way in which NIMH plans to address that need. Of course 
the best intentions in research can go nowhere without scientific 
opportunities--opportunities based in a well-trained scientific 
community, powerful technologies, and good scientific leads. 
Fortunately for individuals with mental illness and their families, 
there are now unprecedented scientific opportunities to address these 
terrible disorders , and it is this conjunction of public health need 
with exciting and forward-looking science that truly justifies our 
budget request.
    At NIMH, a critically important use for new funds is for research 
that can capitalize on the fruits of the genome project. As with most 
of the serious chronic illnesses that affect humanity, the major mental 
disorders have a substantial genetic component. For some of the most 
disabling disorders, including autism, schizophrenia, and bipolar 
disorder, the genetic aspects of risk are extremely potent, greater 
than those observed, for example, for most forms of coronary artery 
disease, type II diabetes, or hypertension. Finding the genes 
implicated in mental disorders is critical to accurate diagnosis, the 
discovery of effective new drugs, and fundamental understanding of the 
disease processes. Mental disorders do not result from the 
deterministic action of a single gene, but rather result from the 
interplay of multiple genes each exerting a small increment of risk, 
together with environmental risk factors. Prior to the human genome 
project it was hard to see how we would succeed in piecing these 
difficult puzzles together. That is all changed now. With the tools of 
the genome project in the offing, NIMH-funded investigators are engaged 
in large-scale collection of DNA samples from people with 
schizophrenia, bipolar disorder, autism, early-onset major depression, 
and other disorders. In addition, in the coming year, NIMH plans to 
begin to collect DNA samples from the well-characterized participants 
in our large-scale clinical trials. In addition to providing 
information about the causes of mental illness, genetics can help us to 
understand why some individuals respond to one treatment and not 
another, helping to usher in an age of individualized treatment. The 
result will be appropriate treatment selection for an individual to 
maximize efficacy and minimize unwanted side effects.
    Modern molecular tools are changing not only genetics, but also 
brain biology. The last 3 years have seen steady progress in the 
development of technologies in which very dense arrays of DNA or 
protein samples are printed on a glass slide or other support. These 
functional genomic and proteomic ``microarrays'' permit us to ask, for 
example, whether a gene or protein is expressed at a higher or lower 
level in diseased tissue versus healthy or in a drug treated sample 
versus a control comparison. With a few such slides we can now look for 
patterns of change in thousands of genes at once. Promising research 
with such microarrays supported by NIMH is underway. In the past year 
we saw the first application of these technologies to post-mortem brain 
tissue from individuals who had suffered with schizophrenia and other 
serious mental disorders. In brains from people with schizophrenia, a 
class of genes governing the function of synapses in the brain were 
expressed at clearly different levels than those observed in the 
comparison brains. This research, published in leading journals, has 
opened a new window on the causation of mental illnesses and the 
effects of treatment on the brain.
          animal models can provide mental disorder phenotypes
    It is often not recognized that genetics creates new opportunities, 
not only for biologists, but for behavioral scientists. Using the tools 
of genetics well demands that we have a greater understanding of the 
symptom clusters and course of illness in people who constitute 
individual diagnostic groupings. At the same time, we recognize that 
the need to understand the precise mechanisms that cause disease 
require animal models. The ability to alter the mouse genome, almost at 
will, with the resulting production of animals with altered behavior 
has revealed a shortage of scientists who can analyze animal behavior 
and who can relate it to its neural or genetic substrates. The need for 
interdisciplinary scientists, individuals who bridge genetics, 
neuroscience, and behavioral science, was highlighted in a report 
released in the past year by the Institute of Medicine. Their 
thoughtful recommendations on training the next generation of 
scientists, scientists who can marshal our new technologies to solve 
critical problems related to mental disorders, are currently being 
implemented.
    In the specific area of animal models aimed at understanding 
disease, we have collaborated with other NIH institutes that support 
brain research to develop centers around the country that will make 
novel mouse mutations and identify neural and behavioral abnormalities. 
An important aspect of this program is that all useful models will be 
shared throughout the research community. While no one expects to 
derive a perfect mouse model of schizophrenia or bipolar disorder, 
there is a great likelihood of finding mutations that model significant 
aspects of mental illnesses. These will be used to understand what goes 
wrong in the brain to produce such disorders, and most important, as 
screening tools to develop new treatments. These powerful approaches to 
biology--large-scale mouse mutagenesis, and high throughput screening 
for behavioral and nervous system phenotypes of interest--span the 
interests of multiple neuroscience-based NIH institutes.
        clinical trials, including child mental disorder studies
    We have also carried out a major expansion of our efforts in 
clinical trials. This expansion relates not only to the numbers of 
needed trials, but also to their intellectual basis. We have expanded 
our trials beyond their usual endpoint-answering the question of 
whether a medication or psychotherapy was safe and effective-to 
questions of whether our treatments will work for ``real world'' 
patients in diverse ``real world'' treatment settings such as primary 
care clinics and neighborhood health centers.
    One important aspect of our clinical trials program is our network 
of Research Units in Pediatric Psychopharmacology (RUPPs). In the last 
month, these units have produced an important result, published in the 
New England Journal of Medicine, showing substantial efficacy and also 
safety of a selective serotonin inhibitor (SSRI) drug in the treatment 
of children with serious anxiety disorders who had not improved with 
behavioral therapy. Given the dire need to establish the safety and 
efficacy of treatments for children with depression, bipolar disorder, 
anxiety disorders, autism, and many other mental disorders, and given 
the initial success of these units, we are delighted that the fiscal 
year 2002 budget request should permit an expansion from 7 to 10 units 
within the network in the coming year.
    The NIH Autism Coordinating Committee (ACC) will work to increase 
emphasis in the area of autism research, including more rapid 
implementation of the centers program mandated under the Children's 
Health Act of 2000.
    Later this month, the National Advisory Mental Health Council Child 
Workgroup is expected to issue a report recommending that NIMH 
strengthen research in this area, including acceleration of 
interdisciplinary and multi-site research to develop new 
interventions--both psychosocial and pharmacologic--for child and 
adolescent disorders and to deploy these treatment strategies to front-
line clinicians. We already are developing fiscal year 2002 initiatives 
that will lay the groundwork for a series of child treatment research 
networks designed to develop new treatments over the next decade. The 
expanded networks will direct resources to research on bipolar 
disorder, autism, depression in prepubertal children, and comorbid 
conditions that adversely affect child development. A parallel research 
network will address the critical question of how we can effectively 
disseminate evidence-based care within different provider practices, 
communities, and service systems.
            john edward porter neuroscience research center
    In collaboration with the National Institute of Neurological 
Disorders and Stroke and seven other NIH institutes, we are moving 
ahead with development of a national Neuroscience Research Center (NRC) 
on the NIH campus, a bold initiative that is essentially dictated by 
the pace of progress in integrative neuroscience. The new center builds 
on the recognition that progress in our science demands that we 
overcome any balkanization that has occurred. Specialized investigators 
working on discrete facets of brain disease have advanced our field 
enormously over the past decade. Now, however, the challenge before us 
is to reintegrate the information we have accumulated: to look at 
single neurons in the context of larger neuronal ensembles, and those 
in the context of brain circuits and systems, all the way up to the 
level of the behavior of living organisms. Throughout this testimony I 
have described the need to build bridges across disciplines. The 
Neuroscience Research Center will serve as a wonderful model for such 
collaborations, which can capitalize rapidly on our exciting new ideas 
and technologies, and translate as rapidly as possible basic 
discoveries into the clinical arena.
    Mr. Chairman, the NIH budget request includes the performance 
information required by the Government Performance and Results Act 
(GPRA) Of 1993. Prominent in the performance data is NIH's second 
annual performance report which compares our fiscal year 2000 results 
to the goals in our fiscal year 2000 performance plan. As performance 
trends on research outcomes emerge, the GPRA data will help NIH to 
identify strategies and objectives to continuously improve its 
programs. I will be pleased to answer any questions.
                                 ______
                                 

                 Prepared Statement of Stephen I. Katz

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Institute of Arthritis 
and Musculoskeletal and Skin Diseases for fiscal year 2002, a sum of 
$443,565,000, which reflects an increase of $46,962,000 over the 
comparable fiscal year 2001 appropriation.
    It is an honor for me to have this opportunity to share stories of 
progress and opportunity in the research within our mission areas. 
Improving daily life is the driving force for the research that we 
support and conduct at the National Institute of Arthritis and 
Musculoskeletal and Skin Diseases (NIAMS). Virtually every home in 
America is touched by diseases affecting bones, joints, muscles, and 
skin. We are committed to better understanding, diagnosis, treatment, 
and prevention of these diseases and disorders that are often chronic 
and disabling, many of which disproportionately affect women and 
minority populations.
                           health disparities
    Research has revealed that many of the diseases within our mandate 
affect groups such as African Americans, Hispanic Americans, American 
Indians, Alaskan Natives, and Asian Americans both in increased numbers 
and increased severity. For example, the prevalence of lupus is higher 
among African Americans and Hispanic Americans, and these groups also 
experience more complications of lupus; African Americans also have 
higher rates of hip and knee osteoarthritis; scleroderma occurs with 
greater frequency in Choctaw American Indians; and African American 
people are also disproportionately affected by overgrowth of scar 
tissue (keloids) and by loss of pigmentation (vitiligo), both of which 
may be severely disfiguring.
    Health Partnership Program. The health of a nation depends on the 
health of its communities. Recognizing this, the NIAMS is launching the 
first phase of its Health Partnership Program--A NIAMS Diversity 
Outreach Initiative, a new program to address the health disparities in 
joint, muscle, bone and skin diseases that exist in minority 
communities. The initial phase of this Program has begun as a model 
community-based program in the African American community in the 
metropolitan Washington, D.C., area, with the focus on rheumatic 
diseases. As a component of this partnership, plans are also underway 
for a new rheumatology clinic to be located in a centrally accessible 
area of Washington, D.C.
    Recruitment to Research Careers. Specific strategies are underway 
and planned to increase the number of underrepresented minority 
investigators in the biomedical research fields related to the diseases 
within our mandate. The Institute, along with many other NIH 
Institutes, has recently issued a Request for Applications for planning 
grants for clinical research training in minority institutions as a 
first phase of this initiative. The second phase will be a five-year 
grant to assist in the actual development of clinical research 
curricula. A successful program will produce well-trained clinical 
researchers who can lead clinical research projects.
                          research in children
    The NIAMS has undertaken a number of programs and activities 
focused on children to enhance our understanding of childhood diseases 
and to develop improved treatments for our younger generation. For 
example, the NIAMS Intramural Research Program launched an exciting and 
promising initiative in the fall of 2000 at the NIH research hospital--
the new NIH Pediatric Rheumatology Clinic. The clinic offers diagnosis, 
evaluation, and treatments for children with arthritis and other 
rheumatic diseases. The clinic will provide children with a place where 
they can be diagnosed and treated in a state-of-the-art facility, and 
researchers can learn much more about rheumatic diseases. In addition, 
treatment for juvenile rheumatoid arthritis has been significantly 
improved with the results of a recent clinical trial that showed 
Enbrel (etanercept) is a safe and effective drug in the 
treatment of children and teenagers with juvenile rheumatoid arthritis 
(JRA). This clinical trial was conducted by researchers at one of the 
NIAMS Multipurpose Arthritis and Musculoskeletal Diseases Centers and 
investigators in the Pediatric Rheumatology Collaborative Study Group. 
The success of this clinical trial is also the culmination of many 
years of basic research supported by the NIAMS and other NIH 
components. These findings offer hope for children with juvenile 
rheumatoid arthritis, hope that they may live their lives as active 
children. In other research involving children, we now understand that 
osteoporosis may actually start in childhood. Research studies in young 
girls revealed that minor variations in a gene for the bone protein 
collagen can lead to lower bone density. These minor variations in this 
gene, while not causing apparent disease, may define a high 
susceptibility group for osteoporosis later in life. Identifying and 
understanding genetic susceptibility to osteoporosis early in life may 
facilitate the targeting of interventions to those who will most profit 
from them.
                     bone biology and bone diseases
    Bone is metabolically a very active tissue, constantly undergoing 
build up of new bone and resorption of old bone. Bone remodeling is a 
normal, but carefully balanced process. Bone diseases like osteoporosis 
can result from an imbalance in this process and osteogenesis 
imperfecta can result from the mutation of bone-producing genes, and 
both diseases result in low bone density, fragile bones, and increased 
susceptibility to fracture. Research has taught us that many factors 
affect bone density and strength, including genetic, nutritional, 
environmental, and others. Basic research has provided the foundation 
for our understanding of bone and has revealed some intriguing and 
potentially important scientific opportunities. For example, 
researchers found that statins, drugs that lower serum cholesterol, 
increase the production of a bone-enhancing molecule. This is leading 
to work on the development of similar drugs that can be directly 
delivered to the bone for maximum effect. Other studies showed us that 
a protein called leptin, which has an established role in controlling 
food intake and other aspects of behavior and physiology, seems to 
inhibit bone formation in animal models. Researchers will pursue this 
finding with the goal of designing drugs to specifically block leptin's 
action on bone and restore lost bone.

                   MUSCLE BIOLOGY AND MUSCLE DISEASES
    There are many forms of muscular dystrophy, and the NIAMS has 
teamed with our colleagues in other components of the NIH, particularly 
the National Institute of Neurological Disorders and Stroke, to bring a 
strong focus to basic and clinical studies of muscular dystrophy. Last 
year we sponsored major scientific conferences in both Duchenne 
Muscular Dystrophy (DMD) and Facioscapulohumeral dystrophy (FSHD), 
issued research solicitations signaling our strong interest in the 
submission of high quality research applications in understanding and 
treating muscular dystrophy, and have funded a research registry for 
FSHD and myotonic dystrophy that will facilitate research by serving as 
a liaison between families affected by these diseases, and researchers 
who want to study these disorders.

                     SKIN BIOLOGY AND SKIN DISEASES
    This has been a particular productive year in research on skin 
biology as well as skin diseases. Highlights of progress include: (1) 
ground-breaking research on impetigo, a common infection among children 
aged 2 to 6. The bacterium Staphylococcus aureus, cause of the common 
skin infection bullous impetigo, produces a toxin that attacks a 
protein highly specific for cell-to-cell binding in the outermost layer 
of the skin. Researchers have reported that breakup of this protein not 
only brings about the characteristic blistering, but also gives the 
bacterium a specific mechanism to circumvent the skin's protective 
barrier and spread further. (2) The gene causing Pseudoxanthoma 
Elasticum has been identified. Pseudoxanthoma elasticum is an inherited 
disorder characterized by progressive calcification of elastic fibers 
in the skin, eye and cardiovascular system. This disease is inherited 
and can have severe manifestations in these organ systems. Work is 
continuing to determine the function of the gene and how mutations in 
the gene result in the clinical disease. This discovery should allow 
for the eventual determination of the cause and, ultimately, allow the 
design of therapeutic interventions for the treatment of this disease. 
(3) Advances in understanding hair development and treating hair 
diseases have been reported. A number of skin diseases affect hair 
cycle resulting in various abnormal types of hair loss as well as the 
hair loss normally associated with aging. An understanding of the 
events in hair development, cycling, and the mechanism of hair loss in 
various diseases will allow for the development of treatments to 
correct these abnormalities. Knowledge of the molecular mechanisms 
involved in the continuously repeated cycle of resting, shedding, and 
regrowth means that hair biology is useful not only as a way to 
understand hair diseases such as alopecia areata, but also for 
understanding of other cycling and regenerating tissues. The research 
advances that have increased our understanding of the hair follicle 
system and the chemicals and signaling molecules involved in its 
cycling will allow the development of specific interventions to treat 
hair diseases, both naturally occurring, such as alopecia areata, and 
those induced by certain cancer chemotherapeutic treatments.

                               CONCLUSION
    The vitality of our bones, joints, muscles, and skin is key to the 
length and quality of our lives. Basic research has taught us much 
about how these components of our bodies function normally and what 
goes awry and causes the enormous number of diseases and disorders 
affecting bones, joints, muscles, and skin. Clinical research helps us 
to understand the nature of disease, and improves our ability to 
diagnose, treat, and prevent disease. Medical research supported by the 
NIAMS has made significant strides in improving health and quality of 
life, and we are committed to pursuing promising research opportunities 
that will continue to improve the health of the American people. We are 
investing in the future health of our nation, and American people of 
all ages and population groups will benefit from these investments.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
Prominent in the performance data is the NIH's second annual 
performance report which compares our fiscal year 2000 results to the 
goals in our fiscal year 2000 performance plan. As performance trends 
on research outcomes emerge, the GPRA data will help NIH to identify 
strategies and objectives to continuously improve its programs.
    I will be happy to answer any questions that you may have.
                                 ______
                                 

Prepared Statement of Gerald T. Keusch, M.D., Director, John E. Fogarty 
     International Center for Advanced Study in the Health Sciences

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the Fogarty International Center for 
fiscal year 2002, a sum of $56,449,000, which reflects an increase of 
$5,967,000 over the comparable fiscal year 2001 appropriation.
    The Fogarty International Center (FIC) plays a unique role in the 
efforts of the United States to improve the health of the American 
people and of those who live in developing regions in Africa, Eastern 
Europe, Asia, and Latin America. The wealth of nations depends upon the 
health of people. A healthy world is a safer world, for our nation and 
for those less fortunate with whom we share this amazing and beautiful 
planet. Virtually all FIC research and training efforts are aimed at 
reducing the disparities in health that exist between the peoples of 
the developing world and those who live in countries that enjoy the 
vast advantages of prosperity.
    FIC was established in 1968 to honor Congressman John E. Fogarty of 
Rhode Island. The Center embodies his vision that because ``disease 
knows no boundaries, so also the benefits of medical research and 
indeed research itself can know no boundaries.'' FIC is carrying this 
vision into the 21st Century. Through its leadership role, program 
initiatives, and analysis of global science and health policy, FIC 
plays a central role in NIH efforts to harness the fruits of science 
for global health. Research advances made abroad often contribute to 
improvements in health in the United States. For example, research in 
Bangladesh establishing the physiological basis and practical use of 
oral rehydration therapy for cholera has led to adoption in the United 
States of this simple and inexpensive treatment of diarrheal disease, 
particularly frequent in infants and children. Research to develop 
diagnostic tests, new drugs, and other therapeutic strategies for HIV/
AIDS, tuberculosis, and other diseases present both in the United 
States and abroad, is beneficial to all, no matter where it is 
undertaken. Adapting biomedical research advances to populations at 
home and elsewhere in the world requires a continuing commitment to 
basic science as well as rigorous clinical research by both American 
and foreign collaborating scientists. Success in these endeavors 
requires the creation of a vibrant research infrastructure and trained 
research staff in collaborating centers internationally. This is what 
FIC does best.
    In carrying out its mandate, FIC supports medical investigators in 
over one hundred twenty U.S. institutions who collaborate with medical 
scientists in more than ninety nations. These efforts are 
multidisciplinary, embracing clinical, epidemiological, basic 
biomedical, and behavioral research. Although FIC acts to foster 
collaborative efforts in all parts of the world, it has placed special 
emphasis on training medical research personnel in those nations with 
the least resources. Such countries bear a disproportionate burden of 
illness and premature death, not only from communicable diseases but 
from non-communicable chronic diseases as well.

                      CHALLENGES IN GLOBAL HEALTH
    FIC efforts to address the challenges in global health research are 
carried out through 20 research and research capacity building 
programs, as well as through policy and coordination efforts. With more 
than 35 million persons worldwide infected with HIV, AIDS is a global 
emergency and has been identified as a threat to our national security. 
In addition to individual tragedy, one person at a time, there are 
profound societal consequences including economic loss, social 
disintegration, and political instability. ``Each man's death 
diminishes me,'' wrote John Donne centuries ago, ``because I am 
involved with mankind.'' AIDS prevention, treatment, care, and 
ultimately cure are universal concerns because the people of the world 
are increasingly connected by trade, travel, and, unfortunately, 
threats to health.
    To address the burgeoning pandemic, FIC launched the AIDS 
International Training and Research Program (AITRP), now in its 13th 
year. AITRP has provided research training for more scientists and 
health professionals from developing countries than any other program, 
fostering collaborative links between research institutions in the most 
affected areas in Africa, Asia, and South America and leaders of 
American medicine. AITRP trainees have been in the vanguard of the most 
successful efforts to reduce new infection and to keep infection rates 
low. Their efforts have contributed to numerous scientific discoveries 
and implementation of programs to reduce HIV transmission. Now that 
antiretroviral therapy may be within the reach of the highly stricken 
poor nations, a massive effort to build organizational infrastructure 
and train the large number of professionals required to assure the safe 
and appropriate use of these complex drugs is the critical bottleneck 
to success. Having developed extensive HIV research and training 
networks among U.S. Schools of Medicine and Public Health and 
counterparts in developing nations, FIC is in a unique position to 
enlarge the pool of professionals necessary to support such an effort. 
We cannot afford not to succeed.
    Malaria, once rampant in the United States, including this capital 
city, has resurged and spread in endemic regions in Latin America, 
Africa and Asia. An added complication is that the malaria parasite has 
developed drug resistance. For these reasons, Americans remain at risk 
when they travel to endemic regions of the world, each year in 
increasing numbers. New strategies are needed to meet this global 
challenge that claims approximately 2.7 million lives annually, largely 
in tropical countries. FIC has implemented a new malaria research and 
training program to link research to control. In addition, FIC efforts 
to create a global coalition to address malaria have resulted in the 
Multilateral Initiative on Malaria (MIM), a new type of international 
collaboration designed to create research capacity among African 
scientists and to generate information in the field. As the current MIM 
Secretariat, FIC has overseen the enlargement of the MIM research 
portfolio, expanded its training activities, and increased the number 
of sponsoring partners. Today, MIM is the essential research 
counterpart for Roll Back Malaria at WHO and together these two 
initiatives represent the major global collaborations to combat 
malaria.
    Well over ten million people in the United States and 2.1 billion 
people worldwide are infected with the tubercle bacillus. This ancient 
infection still results in more than 2 million deaths annually. One 
third of tuberculosis in the United States is attributed to infection 
contracted elsewhere and effective treatment is thwarted by the global 
emergence of TB strains with multiple drug resistance. To meet this 
threat, FIC started the Tuberculosis International Training and 
Research Program that focuses on improving clinical and laboratory 
practices and the training of medical research scientists. Now in its 
5th year, it is an essential component of the global strategy to 
contain the tuberculosis epidemic and has led to important new control 
measures. One product of this research is a rapid, reliable, simple and 
inexpensive diagnostic test, which can be adapted to determine drug 
susceptibility.
    Loss of plant and animal biodiversity is a worldwide phenomenon. 
The medical consequences, though less obvious, are just as serious as 
the effects on ecology. With the loss of plant biodiversity there is an 
irrevocable loss of natural products that have traditionally been the 
source of front line drugs such as quinine for malaria and digitalis 
for heart disease. The FIC-led International Cooperative Biodiversity 
Groups Program is a model for ethical bioprospecting in the search for 
new drugs while it promotes high quality science through multi-purpose 
partnerships between U.S. and developing country universities, major 
pharmaceutical companies, and non-governmental organizations. More than 
6,000 species have been examined for biological activity in 13 
therapeutic areas. Fifty substances of interest have been found and 15 
have been selected for further research because initial studies 
indicate they may prove useful to treat malaria, leishmaniasis, and 
tuberculosis.
    In response to the increasingly complex questions concerning the 
social and ethical dimensions of international research, FIC initiated 
and organized the Global Forum on Bioethics in Research, the first 
international effort to address critical issues related to the 
bioethics of conducting research in developing countries. FIC also 
established the first international bioethics training and research 
program to develop a cadre of qualified ethicists and health 
professionals from the developing world who can work in partnership 
with clinical investigators. They will shape and implement research 
programs and ethical research policies in their home countries to 
insure that human subjects receive equal protection from research 
risks, as do participants in research in the United States.
    In collaboration with the National Science Foundation, FIC 
initiated a research program to study the role of ecological factors 
that influence the emergence of infectious diseases. This program 
addresses a critical need, to predict and prevent an infection from 
emerging rather than confront it after the problem appears. It brings 
together unique research teams composed of climatologists, 
epidemiologists, ecologists, vector biologists, entomologists, and 
microbiologists to develop predictive models of emerging infections. 
For example, the last El Nino preceded an upsurge in diarrheal disease 
in Latin America and malaria in Africa. To be forewarned is to be 
forearmed.
    Under FIC leadership, innovative research is being initiated to 
investigate linkages between investments to improve health and economic 
performance in developing countries. Healthier people living better 
lives remains an elusive dream and the Alma Ata declaration has fallen 
far short of its lofty goal of ``Health for All by 2000.'' Research 
results from FIC's International Studies in Health and Economic 
Development Program will help the U.S. and other nations working to 
enhance economic development in the poor countries of the world 
understand how best to achieve, at lowest cost, the goals of healthier, 
better educated people living better in politically stable nations 
around the world.
    As we look to the future, FIC will both strengthen existing 
programs and respond to needs and opportunities with innovative new 
initiatives.

                      FISCAL YEAR 2002 INITIATIVES
    To address the growing pandemic of tobacco-related illness and 
death, now shifting from the developed to the developing nations, FIC 
will explore how to diminish the initiation of smoking by youth and 
adolescents. The objective of the International Tobacco and Health 
Research and Capacity Building Program is to generate scientific 
information on biological, behavioral, and policy factors that will 
lead to effective control measures to reduce smoking initiation and 
enhance cessation. The results of these efforts will be applicable in 
the U.S.
    New advances in clinical research are needed to translate basic 
research into clinical practice and to develop effective public health 
policy and programs. There are too few well-trained clinical 
researchers in low- and middle-income countries. Even fewer have policy 
experience to deal with research and health care. Clinical researchers 
are needed to address multi-dimensional medical care needs for AIDS 
patients, and the prudent use of antibiotics to deter the further 
emergence of antibiotic resistance. Travelers, refugees, and pilgrims 
spread resistant microbes worldwide with shocking speed. The 
International Clinical, Operational, and Health Services Research and 
Training in Communicable Diseases program will train new clinical 
researchers in developing countries who understand how to translate 
their research into practice.
    Since Biblical times, those afflicted with disfiguring illnesses of 
body and distortions of mind have been shunned and cast aside. Such 
stigma is a burden both to the afflicted and the social compact. 
Stigma, acting through prejudice, diminishes patients' access to care 
and even their participation in research designed to alleviate 
suffering. The Stigma Research Initiative will examine the causes of 
and response to stigmatization of patients with such diseases as HIV, 
mental illness, epilepsy, drug or alcohol addiction, and physical 
disabilities, in the U.S. and abroad. Through epidemiological and 
social science studies on the roots of stigma, its expression and 
outcomes, new strategies can be identified and tested to relieve its 
effects and to enhance the well being of patients, communities, and 
nations.
    Publication of the human genome is an extraordinary achievement 
that creates a wealth of opportunities to identify genetic determinants 
of susceptibility and resistance to disease. New discoveries to prevent 
and treat infectious diseases will stem from this knowledge, aided 
especially by new information on the genomes of microbial pathogens 
(most recently Strep pyogenes, the cause of ``strep throat'', rheumatic 
fever, ``flesh eating'' necrotizing fasciitis, and toxic shock) and 
insect vectors. Now for the first time, scientists can target with 
precision the development of a drug or a vaccine for a specific 
microbe. For example, over a dozen genes have been identified that 
relate to the susceptibility to malaria. Efforts in malaria vaccine and 
drug development are now utilizing this new information.
    From the very beginning of research on the human genome there has 
been concern about ethical issues that relate to medical applications 
and the protection of the individual. To permit the expansion of 
genetics research in developing countries, a new program, Incorporating 
New Genetic Tools into Global Health Strategies, will foster the 
development of ethically responsible international research and 
training in the use of modern genetic technologies. U.S. and foreign 
scientists will forge collaborations to define the genetic influences 
on conditions that affect both populations, and to discover the ways 
and means to improve health and reduce disparities at home and abroad.

                               CONCLUSION
    The pursuit of health through international scientific cooperation 
is an inherently global enterprise and one that ultimately improves the 
public health of our nation. Just as trade and communications have tied 
the world together, advances in biology have demonstrated our social 
and global interdependence. ``Science knows no country'', said Louis 
Pasteur ``because it is the light that illuminates the world.'' The 
genome project, the recognition that improved health is a determinant 
of economic development, and the impact of ecological changes on the 
emergence of infectious diseases all contribute to a deepening 
consensus that individuals and nations share common interests and 
responsibilities. The programs of the FIC advance this vision though 
their support of research and training focused on global health 
disparities and enabling effective collaborations between American and 
foreign scientists. FIC leadership and accomplishments enhance our 
national efforts to achieve better health for Americans and for those 
less fortunate in the developing world.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) Of 1993. 
Prominent in the performance data is NIH's second annual performance 
report which compares our fiscal year 2000 results to the goals in our 
fiscal year 2000 performance plan. As performance trends on research 
outcomes emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
    Thank you Mr. Chairman. I will be pleased to answer any questions.
                                 ______
                                 

               Prepared Statement of Richard D. Klausner

    Mr. Chairman and Members of the Subcommittee: I am Richard 
Klausner, the Director of the National Cancer Institute (NCI). I am 
pleased to appear before you to present a brief review of some of the 
activities supported by the NCI and to present the President's budget 
proposal for fiscal year 2002. The significant budget increases over 
the past several years have allowed the NCI to aggressively implement 
its strategic plans to:
  --Support a broad-based portfolio of superb research to increase our 
        knowledge about all aspects of cancer.
  --Translate basic science to transform all aspects of cancer 
        prevention and care
  --Train the next generation of cancer researchers
  --Address both the quality of cancer care and the disparate burden of 
        cancer experienced in America across the cancer continuum.

                             CANCER TRENDS
    Four years ago, the NCI initiated an annual report to the Nation on 
the burden of cancer. This report is developed in collaboration with 
the American Cancer Society, the Centers for Disease Control and 
Prevention and its National Center for Health Statistics. This spring, 
we will report the latest cancer statistics for the country through 
1998. Total cancer death rates are falling now by 1.1 percent per year 
with black males showing the largest drop of 2 percent per year. For 
breast and prostate cancer, death rates are now falling by 3.5 percent 
per year. Despite overall progress, incidence and/or death rates for 
some cancers are rising. These cancers, which include esophageal 
cancer, liver cancer, non-Hodgkin's lymphoma, acute myelogenous 
leukemia and melanoma, account for about 13 percent of the total cancer 
burden in the U.S. The NCI has convened task forces and directed new 
research to understand these trends.
    The full and accurate assessment of the U.S. cancer rates is at the 
foundation of our ability to define the cancer burden, detect trends 
and pinpoint geographic and demographic variables and disparities. For 
30 years, the NCI's Surveillance, Epidemiology and End Results (SEER) 
Program has been the gold standard for cancer registration worldwide. 
This year, we announced a major expansion including California, 
Louisiana, Kentucky and New Jersey, and SEER now covers 26 percent of 
the U.S. population. We will increase the coverage of the rural 
population by 150 percent, of the population below the poverty line by 
200 percent, of Asian Americans by 200 percent, of non-Mexican 
Hispanics by 70 percent and of Native Americans by 36 percent.
    We have expanded and will continue to expand what we call Rapid 
Response Studies which allow researchers and NCI staff to rapidly 
respond to urgent issues that are revealed by cancer surveillance. We 
have greatly expanded our capacity to monitor, report and evaluate 
geographic differences in cancer burden. This involves a three-pronged 
approach. First, we are continually improving our analyses and 
dissemination of cancer mortality maps so that they are useful to 
researchers, local officials and policy makers. Second, we have 
provided a fund to encourage researchers to propose hypothesis-testing 
studies associated with geographic variations in cancer. Third, we are 
greatly expanding the funding for and management of Geographic 
Information Systems (GISs) to create computer systems that allow 
examination and tracking over time and space of cancer rates with any 
geographically defined factor that might contribute to the cancer 
burden. About 30 applications have been received in response to this 
new initiative.

                        EARLY DETECTION RESEARCH
    New approaches, based on genomics, proteomics and other emerging 
technologies, are being systematically pursued to reach the goal of 
developing effective and reliable tests for the earliest possible 
detection of all cancers and even of pre-cancers. The Early Detection 
Research Network (EDRN) is a major new initiative of the NCI to create, 
for the first time, a national R&D enterprise to discover biomarkers of 
cancer, develop reliable tests and validate them with clinical studies. 
The EDRN is a partnership between NCI, other government agencies, 
industry and academics; in its first year, dozens of potential markers 
are being studied and three are moving towards validation studies. The 
need to develop effective early detection for lung cancer aimed at 
current and former smokers at risk for this deadly disease is clear. We 
are actively pursuing the possibility that low dose, helical Computed 
Tomography might provide a new method to detect early and potentially 
curable lung cancers. A randomized trial to compare standard screening 
mammography with digital mammography for the detection of breast cancer 
is being initiated and we continue to closely monitor the results of 
NCI's large randomized trial to finally determine the clinical value of 
PSA in prostate cancer screening. Even our most successful cancer 
detection tool, the Pap smear, can use improvement. A recent NCI study 
has addressed ways to make the test more predictive of serious findings 
for the large number of Pap smears that are currently read as being of 
uncertain significance and whose evaluation is estimated to cost as 
much as $1 billion per year. A DNA test looking for the virus that 
causes cervical cancer can successfully predict which of these Pap 
smears can be safely ignored and which require follow-up.

                               DIAGNOSIS
    Two years ago, the NCI announced a major new program aimed at 
utilizing the emerging knowledge of the genome to create new approaches 
to the diagnosis of cancer, indeed to potentially change the very names 
and classifications being applied to human cancer. This program, called 
the Director's Challenge, has been responded to by a consortium of 
researchers from around the country who will attempt to redefine the 
classification of leukemia, lymphoma, lung, prostate, breast, 
colorectal, brain, ovarian, childhood and other cancers. Results have 
begun to emerge demonstrating that cancers currently lumped under one 
diagnosis are actually multiple molecularly distinct diseases. For at 
least one group of cancers called diffuse large cell lymphoma, this 
previously hidden heterogeneity may explain why only 50 percent of 
patients can be cured with current therapy. Rather, it now appears that 
this cancer is actually at least two different diseases, one of which 
is almost always cured by current therapy and the other of which is 
almost never cured. This program will accelerate progress towards 
achieving a long-held dream of being able to correctly classify human 
cancer.

   MOLECULAR TARGETS: A NEW ERA IN THE DISCOVERY AND DEVELOPMENT OF 
              PREVENTIVE AND THERAPEUTIC AGENTS FOR CANCER
    Revealing the actual molecular machinery of cancer has long 
promised to bring a new, highly selective approach to both prevention 
and treatment. Examples of molecularly targeted therapy for cancer are 
beginning to emerge. For example, chronic myelogenous leukemia (CML) is 
known to be the result of the breaking and recombination of two 
chromosomes. The fused chromosomes produce a new gene which tells the 
cell to produce a protein called bcr-abl whose uncontrolled activity is 
responsible for the growth of the leukemia cell. A new drug, called 
STI571, developed as a collaboration between Novartis Pharmaceuticals 
and NCI-funded investigators, is highly effective at turning off the 
activity of bcr-abl. In recently published studies, virtually every 
patient with the chronic phase of CML, the disease expressing the 
molecular target, has shown a complete correction of their blood 
abnormalities. This is an oral drug with apparently few and mild side 
effects. We now know that this same drug has activity against two other 
distinct molecular machines present in a variety of cancers. As a 
result, the NCI in collaboration with Novartis is rapidly developing 
numerous clinical trials to test STI571, alone or in combination with 
other drugs, in leukemia, gastrointestinal sarcomas (in which dramatic 
responses have already been seen), brain tumors, lung, prostate, 
breast, ovary and pediatric cancers.
    To expand the discovery, validation and development of more 
molecular targets in cancer, the NCI has initiated a series of funding 
programs including:
    1. Molecular Targets Drug Discovery (MTDD) grants--four new grant 
programs to discover and validate molecular targets for cancer for 
which we have received over 170 applications.
    2. Interdisciplinary Research Teams for Molecular Target Assessment 
(IRT/MTA)--a new approach to the development of clinically useful 
assays to measure and monitor cancer in patients according to the 
actual molecular targets where treatment is directed.
    3. Chemistry/Biology Centers--we have funded six centers of 
excellence to bring chemists and biologists together to discover 
chemicals that report on and can perturb the molecular machinery of 
cancer.
    This year we hope to establish one to three large contract efforts 
called National Molecular Target Laboratories (MTLs). These are 
envisioned as genomic-scale efforts to discover molecular probes for 
all potential cancer relevant molecular targets.
    We hope to expand the Rapid Access to Interventional Development 
(RAID) program, which was established two years ago to take potential 
therapeutics from academic or small business laboratories and turn them 
into drugs ready to be tested in phase I clinical trials. In its first 
two years, RAID is supporting 51 novel agents and we hope that 11 will 
reach the clinic by the end of this year.
    The way scientific discovery eventually leads to advances in 
medical practice is through the clinical trial. Currently, the NCI is 
actively accruing patients (about 25,000 a year) to over 840 clinical 
trials including about 700 early phase trials where we can test the 
safety and possible effectiveness of new agents. In fiscal year 2000, 
261 new trials were opened compared to 177 in fiscal year 1999. Our 
goal is to double the number of new agents entering such clinical 
testing over the next two years. Over the past year, completed clinical 
trials have demonstrated new treatment regimens that show a 50 percent 
increase in survival for resectable gastric cancer and a 40 percent 
increase in survival rates for metastatic renal cancer, to cite just 
two examples.
    Over the past year, we have been implementing our strategic plan to 
address the pressing question of cancer disparities through our Quality 
of Cancer Care initiatives, our newly formed Center to Reduce Cancer 
Health Disparities and our Comprehensive Minority Biomedical Programs. 
Eighteen Special Population Networks for Cancer Awareness, Research and 
Training have been launched as have 12 new partnership programs between 
NCI-funded Cancer Centers and Minority Serving Institutions. These and 
other activities are aimed at increasing our understanding of cancer 
disparities, increasing the participation of minority and underserved 
communities in the cancer research enterprise and finding ways to 
address the disparities in cancer burden.
    I am pleased to present the President's budget request for the 
National Cancer Institute for fiscal year 2002, a sum of 
$4,177,203,000, which reflects an increase of $439,275,000 over the 
comparable fiscal year 2001 appropriation.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) Of 1993. 
Prominent in the performance data is NIH's second annual performance 
report which compares our fiscal year 2000 results to the goals in our 
fiscal year 2000 performance plan. As performance trends on research 
outcomes emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
                                 ______
                                 

                  Prepared Statement of Claude Lenfant

    Mr. Chairman and Members of the Committee: I am delighted to 
address this Committee once again on behalf of the National Heart, 
Lung, and Blood Institute (NHLBI). Let me begin by thanking you for 
your longstanding and generous support of our research programs and 
activities, and highlighting two examples of the benefits that have 
accrued to the American public.

                          SICKLE CELL DISEASE
    As the following illustration indicates, we have made tremendous 
progress in our battle against sickle cell disease since our programs 
began about 30 years ago.
    Patients with sickle cell anemia now live, on average, into their 
mid-forties, and average life expectancy for patients with a related 
condition, SC-hemoglobin disease, has climbed to the mid-sixties. These 
dramatic increases are highly correlated with the development and 
fruition of key NHLBI research programs that have provided an array of 
treatments and preventive regimens for the patients. Care that was once 
fragmented and often administered in an emergency setting is now 
coordinated, beginning with screening of newborns, provision of 
appropriate control of infections, and prevention of stroke in high-
risk children through transfusion therapy.


    Continued progress can be expected as we capitalize on new 
opportunities made feasible by recent increases in the NHLBI budget. 
For instance, we have funded studies of bone marrow transplantation in 
children with sickle cell disease. At least 50 children have undergone 
successful transplants, leading the way for further studies of this 
curative process. We have expanded our studies on the drug hydroxyurea, 
which has been shown to decrease painful crises in adult patients by 50 
percent, to determine whether this may prove safe and effective in 
children, as well. Additional trials are also being initiated to 
determine how best to manage the long-term care of children with sickle 
cell disease who are receiving chronic transfusions.

                CONGENITAL CARDIOVASCULAR MALFORMATIONS
    Congenital cardiovascular malformations are the most common birth 
defect in the United States, affecting nearly one of 100 newborns, or 
about 40,000 infants each year. While these malformations remain 
leading contributors to infant mortality, the chances that an affected 
baby will live to celebrate a first birthday are far better today than 
they were several decades ago. This progress, illustrated in the 
following chart, is testimony to the success of research that has 
greatly improved our ability to diagnose and treat congenital heart 
disease. Whereas a half-century ago, an accurate diagnosis could be 
made only at autopsy, nowadays many heart defects can be diagnosed in 
utero. Doctors no longer sit by helplessly as babies weaken and die, 
because they now have an armamentarium of surgical and medical 
approaches, as well as reliable and effective methods for monitoring 
and supporting these infants.


    Nonetheless, many challenges remain, and we have expanded our 
research programs to meet them. Although we have enjoyed much success 
in treating congenital cardiovascular malformations, their incidence 
has remained quite high and their appearance is often unexpected and 
unpredictable. Effective preventive strategies await a better 
understanding of the genetic and environmental factors that influence 
heart development. In that regard, we are very pleased to have been 
able to increase our program of Specialized Centers of Research (SCORs) 
in Pediatric Cardiovascular Diseases, which provides opportunities for 
basic and clinical scientists to collaborate in unraveling complex 
problems such as this. During fiscal year 1999-the initial year of the 
major expansion in our appropriations-we added two centers, bringing us 
to a total of five.
    During the current fiscal year, we are establishing a Pediatric 
Heart Disease Clinical Research Network to facilitate development and 
refinement of new treatment protocols. This program will allow for 
rigorous evaluation of therapeutic regimens for a wide variety of 
cardiovascular malformations, and promote rapid dissemination of the 
findings to the medical community.

                    UNDERSTANDING HEALTH AND DISEASE
    Over the years, I have emphasized the importance of a comprehensive 
approach that looks at health and disease from a variety of 
perspectives. Good (or ill) health rests on a tripod of genes, 
environment, and behavior. Let me provide some examples of NHLBI 
activities that address each of these issues.

                         GENETICS AND GENOMICS
    The much-publicized sequencing of the human genome has brought with 
it tremendous excitement and opportunity. Coordinated efforts are 
already under way to extend the range of fully sequenced animal models 
so that comparative genomics can be used to identify human genes and to 
determine their functions. In this regard, the NHLBI has made a major 
investment in sequencing the genome of the rat, which has great 
applicability to many of the diseases under our mandate. In addition, 
intensive efforts are already under way to begin translating our 
knowledge of the structure of the genome into a working knowledge of 
its functions. The new NHLBI Programs of Genomic Application, the 
largest Institute initiative in our history, are pursuing this goal 
with vigor and creativity.
    The notion of using gene therapy to cure inherited diseases has 
long been a dream of scientists, and in some areas such as hemophilia, 
we have every reason to believe that it may soon become a reality. Our 
research in this area is gaining additional momentum with funding of 
new Centers of Excellence in Gene Therapy, which are designed to move 
these studies rapidly into the clinical arena within the context of 
careful and appropriate safeguards for patient safety and welfare. 
Although gene therapy is certain to continue to attract considerable 
interest, it is our belief that the biggest public health payoff of our 
emerging genomic knowledge may lie in the ability to understand 
individual differences in disease prognosis and treatment. We are 
already seeing exciting reports of genetic variations that account for 
differences in the manifestations and course of heart failure and 
differences in the effectiveness of asthma medications. The ability to 
predict, for a given patient, whether disease will be benign or severe 
and whether a drug will have beneficial or adverse consequences would 
truly revolutionize the practice of medicine.

                          EXTERNAL INFLUENCES
    It has been said that one's genes load the gun, but the environment 
pulls the trigger; that is certainly true in the case of many chronic 
diseases. Consider, for example, chronic obstructive pulmonary disease 
(COPD). Some smokers develop COPD but many others do not, which 
suggests that genes influence individual susceptibility. However, the 
observation that very few nonsmokers ever develop COPD suggests that 
whether or not the genetic gun is loaded is irrelevant in the absence 
of the environmental trigger-cigarette smoke.
    In the area of asthma we are looking to environmental factors as a 
possible explanation for the startling increases in asthma prevalence, 
which have occurred over too short a period of time for genetic factors 
to be the culprits. Research has produced some evidence that a more 
Westernized lifestyle that includes increased household furnishings, 
humidity, and temperatures; decreased ventilation; and increased time 
spent indoors may result in greater allergic sensitization. A number of 
studies have linked obesity with asthma in both adults and children, 
and burgeoning levels of overweight in the U.S. population are thought 
to be due, in part, to decreased physical activity. Still other work 
has advanced the somewhat counterintuitive hypothesis that modern lack 
of exposure to infections-because of immunization, antibiotic use, or 
generally improved hygiene-may adversely affect immune system 
development and lead to heightened susceptibility to asthma. We are 
avidly pursuing these and other leads in the hope of uncovering some 

MEANS OF STEMMING THIS RISING PUBLIC HEALTH PROBLEM.
                                BEHAVIOR
    Understanding and changing health-related behaviors is critical if 
we are to make the most of the new discoveries of the research 
enterprise. Behavior is, of course, intimately connected with 
environmental exposure; inhaling smoke, consuming food, and taking 
prescription drugs are all behaviors.
    Our national education programs have been quite successful in 
increasing public awareness and control of hypertension and high blood 
cholesterol, for example, but there is still considerable room for 
improvement, especially in certain vulnerable subsets of the 
population. To address this issue, the NHLBI recently established 
Enhanced Dissemination and Utilization Centers (EDUCs) as a means of 
extending the health benefits associated with current clinical 
guidelines and medical information. A total of 13 EDUCs have been 
established in communities at high risk for asthma or cardiovascular 
disease. They are using information generated by the Institute's 
education programs to inform their communities of the public health 
burdens of asthma and cardiovascular disease and to develop, implement, 
and evaluate educational strategies to reduce the burden. We believe 
this new approach will provide a solid foundation for our efforts to 
address Healthy People 2010 performance objectives of eliminating 
racial/ethnic and geographic disparities in underserved high-risk 
populations.
    Our interest in this area encompasses not only the behavior of 
patients and the general public, but also the behavior of health care 
providers who dispense advice and prescribe medications. We are placing 
enormous emphasis on translation of new research results into clinical 
practice. It is of great concern that the results of definitive 
clinical trials indicating, for instance, the proven benefits of lipid-
lowering therapy in patients with high cholesterol or beta-blocker 
therapy for heart attack survivors have not been widely applied to 
patients. We are committed to using every avenue at our disposal to 
close this gap between bench and bedside and reap the greatest public 
health return on our research.

                     AMOUNT OF PRESIDENT'S REQUEST
    I am pleased to present the President's budget request for the 
NHLBI for fiscal year 2002, a sum of $2,567,429,000, which reflects an 
increase of $268,329,000 over the comparable fiscal year 2001 
appropriation.

                 GOVERNMENT PERFORMANCE AND RESULTS ACT
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) Of 1993. 
Prominent in the performance data is NIH's second annual performance 
report which compares our fiscal year 2000 results to the goals in our 
fiscal year 2000 performance plan. As performance trends on research 
outcomes emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
    I would be pleased to respond to any questions that the Committee 
may have.
                                 ______
                                 

  Prepared Statement of Dr. Donald A. B. Lindberg, Director, National 
                          Library of Medicine

    I am pleased to present the President's budget request for the 
National Library of Medicine (NLM) for fiscal year 2002, a sum of 
$275,725,000, which reflects an increase of $29,374,000 over the 
comparable fiscal year 2001 appropriation.
    The Library is a key element in the foundation of the biomedical 
research enterprise. It is said that scientific research begins and 
ends in the library: from learning about the latest that has been 
published before embarking on an experiment, to publishing the results 
of that experiment in a journal that finds its way into an online 
database and onto the library shelf. In the health sciences, the 
institution that plays the role of information collector, organizer, 
and disseminator is the National Library of Medicine. The NLM not only 
maintains two buildings in Bethesda to house this unparalleled resource 
(with treasures dating to the 11th century), but the Library is the 
creator of immense electronic data resources that may be used, free, by 
anyone in the world.
    There is a second aspect of the NLM's infrastructure role as 
creator, nurturer, and backup for national and international medical 
information networks. The U.S. National Network of Libraries of 
Medicine, created by NLM in the sixties, is an organization of 4,500 
member institutions that provide vital information services to American 
health professionals and, increasingly, to the public. NLM is 
encouraging medical libraries to work closely with public libraries and 
other community organizations to provide the public with access to high 
quality health information. The NLM sponsors special programs within 
the network to support improving information services in areas that 
disproportionately affect minority groups, such as HIV/AIDS and 
toxicology and environmental health. There are also special outreach 
programs within the network for Native Americans and Spanish-speaking 
minorities. The Library supports an international medical information-
sharing network so that it can both receive scientific information from 
foreign institutions and also provide their researchers and health 
professionals with access to NLM's electronic information resources.
    Primary among these electronic resources is MEDLINE, the Library's 
immense database of references and abstracts to journal articles. With 
current usage of more than 250 million searches a year, it is the 
world's most-used medical literature resource. An easy-to-use Web-based 
program, known as PubMed, is the popular route of access. It takes only 
a few seconds to search through an ever-expanding collection of 11 
million references and abstracts culled from more than 4,000 journals, 
covering the world-wide literature from 1966 to the present. The PubMed 
system also has links to 1800 participating publishers Web sites so 
that users can retrieve full text versions of articles identified in a 
MEDLINE search. A new feature, introduced in 2001 by the NLM and the 
National Center for Complementary and Alternative Medicine because of 
widespread public interest in the subject, is the ability to search a 
database limited to the literature of alternative medicine ( CAM on 
PubMed ). One unforeseen outcome of making MEDLINE available free on 
the Web was that the database was discovered by the general public and 
quickly became a favorite source of medical information. Today, the 
Library estimates that one third of MEDLINE searching is done by 
consumers.

                         BROADENING THE MANDATE
    The enthusiasm with which the public embraced MEDLINE on the Web 
has altered the traditional role of the NLM, which was to serve the 
nation's health by providing information services through health 
professionals, scientists, educators, and practitioners. The Library 
maintains those time-honored services, but now also serves the public 
directly with information products created specifically for consumers. 
MEDLINEplus and ClinicalTrials.gov are examples of Web-based services 
that the public can access directly. The most broad-based of these is 
MEDLINEplus.
    With help from members of the National Network of Libraries of 
Medicine across the country, the information specialists who maintain 
MEDLINEplus select and organize a variety of consumer health 
information issued by the National Institutes of Health, professional 
medical societies, and voluntary health agencies. MEDLINEplus not only 
has extensive information on more than 425 diseases and health 
conditions, but an extensive medical encyclopedia, detailed information 
about prescription drugs, directories of health professionals and 
hospitals, health-related articles from the daily news media, patient 
education modules, and links to a variety of organizations that 
disseminate information on various health problems. MEDLINEplus also 
makes it easy for the consumer to search MEDLINE for up-to-date 
information from the scientific literature. The Library is working with 
the National Institute on Aging to introduce more information related 
to the health of seniors, such as Alzheimer's disease, and to put the 
information into a format that is easily accessible by that segment of 
our population.
    MEDLINEplus has become tremendously popular and now logs about 5 
million page hits per month. The NLM has also learned that health 
professionals of all kinds are finding it to be an excellent source of 
information. Many physicians use it to keep up-to-date on medical 
subjects outside of their specialty. Others are referring their 
patients to MEDLINEplus for up-to-date and authoritative information 
about their health conditions.
    One of the most useful features of MEDLINEplus is the ability to 
learn about clinical trials. The Web site ClinicalTrials.gov, developed 
by NLM, became publicly available in February 2000 and has already 
proved to be of great help to physicians, patients, and their families. 
ClinicalTrials.gov is a registry of more than 5,000 federally and 
privately funded trials of experimental treatments for serious or life-
threatening diseases or conditions. It is being expanded to include 
more clinical trials sponsored by private companies and some performed 
in other countries. The database includes a statement of purpose for 
each clinical research study, together with the recruiting status, the 
criteria for patient participation in the trial, the location of the 
trial, and contact information. ClinicalTrials.gov is linked closely 
with MEDLINEplus, so that anyone looking for information about a 
particular disease or condition can easily tell it is the subject of 
any clinical trials. There is no registration for either MEDLINEplus or 
ClinicalTrials.gov, and complete privacy is assured to all users.

                            SCIENCE ADVANCES
    The National Library of Medicine's involvement with the 
infrastructure of medicine extends far beyond its collection and the 
services built upon it. NLM is also a leader in providing crucial 
components of medical infrastructure for the 21st century. One aspect 
of this is ensuring that the nation's biomedical research enterprise 
has the trained professionals it needs in computational biology, 
including mathematical modeling in the life sciences, advanced imaging, 
and molecular biology. This role was brought into focus in the NIH 
report, The Biomedical Information Science and Technology Initiative 
(BISTI), which recommends that the NIH invest heavily in computer and 
information technology. As a result of BISTI, the NLM is expanding the 
12 medical informatics training programs it supports at major 
universities to carry out research in general informatics and in 
Medical Genomics.
    The Library also has internationally recognized program in medical 
genomics, organized within the National Center for Biotechnology 
Information (NCBI). The NCBI plays a pivotal role in coordinating, 
integrating, and disseminating the growing body of data currently being 
generated by the sequencing and mapping initiatives of the Human Genome 
Project. These efforts are complemented by the inclusion of individual 
genomic sequences, from over 75,000 organisms, submitted to NCBI from 
scientists worldwide, as well as the data generated through the 
collaborative projects aimed at sequencing the genomes of other model 
organisms. NCBI has also designed a novel system for linking its 
genomic resources to the biomedical literature, a necessary step for 
providing quality assurance, as well as for providing a framework for 
associating the most current and comprehensive biological information 
about a genomic sequence. Hence, NCBI's readily accessible genomic and 
literature databases, as well as their publicly available data analysis 
tools, represent a true international information infrastructure 
designed to facilitate and propel the biomedical research advances that 
will ultimately lead to better health for the American public.
    Because the NLM depends to a great extent on the Internet for 
disseminating its many health information services, it is a supporter 
of the infrastructure initiative known as the Next Generation Internet. 
This is a cooperative effort among industry, academia, and government 
agencies that seeks to provide affordable, secure information delivery 
at rates thousands of times faster than today. Some NLM health 
applications, for example those involving the Visible Humans and 
telemedicine, require more bandwidth and more reliable service than are 
currently available. The Visible Human male and female data sets, 
consisting of MRI, CT, and photographic cryosection images, are huge, 
totaling some 50 gigabytes. They are being used by scientists around 
the world in a wide range of educational, diagnostic, treatment 
planning, virtual reality, artistic, mathematical, and industrial uses. 
Projects run the gamut from teaching anatomy to practicing endoscopic 
procedures to rehearsing surgery. One new project, being carried out by 
NLM scientists, is AnatLine, a web-based image delivery system that 
provides retrieval access to large anatomical image files of the 
Visible Human male thoracic region, including 3D images. Another is the 
collaborative project with other NIH Institutes to develop a super-
detailed atlas of the head and neck. The Visible Human Project is an 
example of a program that requires both advanced computing techniques 
and the capability of the Next Generation Internet if it is to be 
maximally useful.
    The Library also funds innovative medical projects that demonstrate 
the application and use of the capabilities of the Next Generation 
Internet. These projects span the spectrum of medical disciplines, 
geographic areas, and target audiences. One example is to evaluate the 
potential of telemedicine applications on the health care system in 
rural Alaska as a way of improving the quality of health care while at 
the same time containing costs. Another project, in rural Iowa, is 
measuring the effectiveness of video consultations for patients with 
special needs, including children with disabilities and persons with 
mental illness. In addition to supporting such advanced applications, 
the NLM continues its research on evaluating the performance of today's 
Internet pathways between and among health institutions and users. This 
research gives us a glimpse into what the future holds.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
Prominent in the performance data is NIH's second annual performance 
report which compares our fiscal year 2000 results to our goals in our 
fiscal year 2000 performance plan. As performance trends on research 
outcomes emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
                                 ______
                                 

   Prepared Statement of Alan I. Leshner, Ph.D., Director, National 
                        Institute on Drug Abuse

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Institute on Drug 
Abuse, a sum of $907,369,000, which reflects an increase of 
$126,394,000 over the comparable fiscal year 2001 appropriation.
                     nida's comprehensive portfolio
    New scientific discoveries are fundamentally changing how this 
Nation approaches drug abuse and addiction. As we speak, more and more 
diverse patient populations are receiving the best treatments that 
science has to offer as a result of the work of our National Drug Abuse 
Treatment Clinical Trials Network. Promising new medications for 
treating addiction to nicotine, methamphetamine, cocaine, heroin, and 
other drugs are being tested and developed further. And, our increasing 
knowledge about the health and developmental consequences of drugs of 
abuse, particularly emerging drugs like Ecstasy (MDMA), is allowing us 
to rapidly provide communities with the science-based tools to prevent 
and treat drug problems at the local level. It is the tremendous 
advances from science, fueled in part by the very generous increases in 
the past several budget cycles, that have allowed the National 
Institute on Drug Abuse (NIDA) to accomplish these momentous 
achievements and are providing us with renewed hope for a safe and 
healthy drug-free citizenry.
    NIDA supports more than 85 percent of the world's research on the 
health aspects of drug abuse and addiction, including the impact that 
drugs have on other diseases such as AIDS, hepatitis C, and 
tuberculosis. Because NIDA is so central to the entire research 
enterprise, the Institute maintains a very comprehensive research 
portfolio. We focus on all drugs abuse, both legal and illegal, 
including nicotine, with the exception of a primary focus on alcohol. 
NIDA also rapidly translates all of its new findings into formats that 
will be useful and used by a variety of audiences. I will highlight 
some recent accomplishments and mention a few promising directions.
         national drug abuse treatment clinical trials network
    One of the best examples of the impact that science can have on 
local communities is in the treatment arena. Thanks to recent treatment 
advances, NIDA was able in fiscal year 1999 to jump-start and then in 
fiscal year 2000 to greatly expand what has quickly become a national 
clinical research infrastructure for testing science-based drug 
addiction treatments in real-life community-based treatment settings. 
The result is that science-based treatments are now more accessible to 
diverse groups of patients suffering from various addictions. Patients 
from across the country can now participate in the 7 research protocols 
that are already being run through the National Drug Abuse Treatment 
Clinical Trials Network (CTN) with another set of trials nearing the 
implementation stage. Until the establishment of the CTN, researchers 
and treatment providers had to rely on treatment results from studies 
conducted in specialized settings with much restricted subject 
populations. Through this present network of 14 research centers and 
over 80 community treatment programs on the front lines of clinical 
practice across the country, the CTN is engaging much of the drug abuse 
community in a national effort against addiction and its consequences.
    Additionally, the CTN provides a much needed infrastructure to more 
efficiently and rapidly disseminate other kinds of research findings to 
practitioners and patients across the country. The CTN is a major step 
toward achieving NIDA's millennial goal of improving the quality of 
drug addiction treatment in this country using science as the vehicle. 
The network is still not complete, however. Many areas of the country 
are yet to be brought into its auspices. Future plans call for the CTN 
to spread out geographically which will better serve the more than 5 
million individuals that the Office of National Drug Control Policy 
reports are currently in need of treatment. The CTN will also serve as 
a natural vehicle to reach segments of the population that have 
traditionally been the least likely to access medical help, such as 
minority populations, disadvantaged populations, urban and rural 
communities, and others whose health care needs are unmet.
             responding to ever-emerging new drug problems
    Unfortunately, the overall picture of drug abuse in the United 
States is constantly changing. As soon as we get a clear understanding 
of drug use patterns and gain some control over existing drug problems, 
new dangerous substances seem to emerge. Similar to the way a virus 
mutates, both regional and national drug abuse patterns are constantly 
reshaping and rarely remain static. Tried and true prevention and 
treatment approaches may not work with many of the new drugs that are 
emerging on the scene today. For example, newly emergent drugs like 
methylenedioxymethamphetamine (MDMA or ``Ecstasy''), which acts as both 
a hallucinogen and a stimulant, require new prevention and treatment 
approaches, as does the unique stimulant methamphetamine. By having our 
pulse on these constantly changing drug trends, NIDA is poised to use 
the power of scientific research and its application to avert emerging 
drug problems before they become national epidemics. Nowhere is this 
proactive approach better exemplified than with the role that science 
continues to play as our Nation discusses and responds to menacing 
drugs like MDMA and methamphetamine. Because these club drugs were 
identified early on by NIDA as potential health problems, we were able 
to launch our Club Drug Research Initiative, and dissemination effort 
to rapidly inform communities about these drugs. The fact that over 
700,000 people have visited our dedicated website on this topic (http:/
/www.clubdrugs.gov/) since we launched it in late 1999 demonstrates the 
interest that people have in receiving science based information. Not 
only have we come a great distance in educating the public about these 
drugs, but our science has revealed some ground-breaking findings.
    Research shows that ``club drugs'' such as MDMA are far from benign 
substances. MDMA has been found in animals and most recently in humans 
to be neurotoxic, resulting in long-lasting or possibly permanent 
damage to the neurons that release serotonin. MDMA has also been found 
to impair an individual's learning and memory abilities. Accumulating 
evidence shows that chronic heavy use of MDMA is associated with sleep 
disorders, depressed mood, anxiety, impulsiveness and hostility, and 
memory loss. These cognitive effects have been found to last even up to 
six to 12 months after abstinence from the drug. Because of the 
abundance of research findings that continue to emerge on this topic, 
NIDA will bring leading researchers from across the globe to the NIH 
campus this summer to discuss the myriad of findings and determine the 
best future research directions to answer important remaining questions 
about the causes and consequences of MDMA use and how best to deal with 
them.
    Methamphetamine, another popular club drug, has also been found to 
cause neuronal damage to an individual's brain cells, similar to some 
of the damage that occurs from stroke or Alzheimer's. Again, the 
abnormal brain function persists well after drug use has stopped. For 
example, methamphetamine abusers who were drug-free for up to eleven 
months still had significant memory and coordination deficiencies that 
were directly linked to brain changes produced by their prior drug use. 
These alarming results have led NIDA to expand its portfolio in all 
areas, with a special emphasis to look more closely at the potential 
health and developmental consequences that methamphetamine use by women 
of child-bearing years might have on the developing child.
          neuroscience portfolio sets stage for new treatments
    The convergence and application of powerful new tools and emerging 
technologies are accelerating the pace of neurobiological advances and 
allowing researchers to ask and answer questions that were not even 
imaginable five years ago. NIDA has nearly doubled the breadth and 
depth of its basic and clinical neuroscience portfolios. It has also 
allowed us to use basic research as the foundation for the entire NIDA 
portfolio, from prevention efforts to medications development.
    One of the major new areas that NIDA will exploit in the 
neuroscience arena is to build on our knowledge about how specific 
brain circuits are affected by drugs of abuse, so that we can more 
precisely determine how these brain pathways are impacted by chronic 
exposure of drugs and how this can ultimately result in addiction. We 
have learned much, but still do not completely understand what causes 
an individual to make the critical transition from being able to 
voluntarily use and then abstain from drugs to the uncontrollable 
compulsive drug-seeking State that has become the hallmark of 
addiction. An array of new technologies, such as microarrays, which can 
simultaneously analyze the activity of thousands of genes, is allowing 
us to better elucidate the molecular and cellular mechanisms by which 
voluntary drug use can evolve over time into addiction. We will be 
better able to determine what genes are being turned on and off by drug 
exposure and to identify patterns of gene expression that make some 
individuals more vulnerable to addiction than others. For example, 
researchers found that individuals with a genetic deficiency in an 
enzyme that metabolizes nicotine (CYP2A6) are less likely to start 
smoking, and smoke less if they do start, than individuals with normal 
CYP2A6 activity. Building on this knowledge, researchers tested more 
than 200 compounds to decrease CYP2A6 activity and found that one 
compound (methoxsalen) commonly used to treat skin disorders may be 
helpful to people who want to quit smoking. This is just one example of 
the role that genetic research can play in helping us to develop even 
more novel therapeutic approaches to prevention and treatment of 
tobacco smoking.
    Developing new approaches for treating addiction to nicotine is an 
important research endeavor for NIDA. NIDA will work both independently 
and collaboratively to bring more pharmacological and behavioral 
therapies for nicotine addiction to fruition. NIDA is especially 
interested in developing treatments that are specifically tailored to 
adolescent populations. At our Teen Tobacco Treatment Research Center 
in Baltimore, for example, over 60 adolescent patients are 
participating in a 3-month outpatient study that is helping to 
determine the most effective methods for treating tobacco dependence in 
this population. These findings will be used to improve treatment for 
teens across the country.
           science-based principles for drug abuse prevention
    Just as NIDA has declared as our millennial goal to improve the 
quality of drug abuse treatment nationwide using science as the 
vehicle, we are working to do the same in the prevention arena. To 
ensure that science-based prevention principles and protocols can be 
effectively used by a wide variety of populations across the country 
NIDA plans to launch a National Drug Abuse Prevention Trials System in 
fiscal year 2002. Leading prevention researchers will be brought 
together at NIDA's 2nd National Conference on Drug Abuse to discuss the 
latest prevention findings and to help NIDA prioritize the most 
promising prevention programs that should be initially tested in the 
new System.
          blending public health and public safety approaches
    In the same way that we have developed and sent to the field 
general principles that define effective prevention and treatment 
strategies, we are working to lay out standardized principles about 
duration, setting, and detailed protocols that should be used to more 
effectively treat individuals while they are under criminal justice 
control. Given the fact that untreated addicted criminal offenders have 
extremely high rates of post-release recidivism both to drug use and to 
criminality, NIDA's research can play a pivotal role in helping to 
address this public health and public safety issue. As we continue to 
learn about how to improve treatment outcomes and how to reduce the 
risk of relapse for patients undergoing treatment, NIDA will use this 
knowledge to work with the Department of Justice and others to improve 
the treatment of addicted criminals, particularly those with co-
occurring mental disorders.
                  science leads our national discourse
    Scientific advances continue to come at a tremendous pace and are 
not only improving the health and quality of life for our citizens, but 
are changing how we as a Nation view and approach addiction. 
Understanding initial drug use as a voluntary, and thus preventable, 
behavior; and understanding addiction to be a treatable, often chronic 
and relapsing disease of the brain, forces us as a Nation to adopt an 
even more sophisticated approach to dealing with this nation's drug 
problems. Having science set the stage for our course of action, 
including furthering the blending of public health and public safety 
approaches, is clearly the best way to reduce the enormous financial 
and social burden of drugs on our society. There are indicators at all 
levels, Federal, State and local, that this is in fact occurring. NIDA 
will continue to provide the latest science-based information to ensure 
the national discourse on this topic proceeds. We will also continue to 
ensure that new findings rapidly reach local communities. Science 
brings us all renewed hope and confidence for a healthy and prosperous 
future. It is NIDA's role to ensure that this hope for the future is 
fully realized.
             government performance and results act (gpra)
    NIH Budget request includes the performance information required by 
the Government Performance and Results Act (GPRA) of 1993. Prominent in 
the performance data is NIH's second annual performance report which 
compares our fiscal year 2000 results to the goals in our fiscal year 
2000 performance plan. As performance trends on research outcomes 
emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
                                 ______
                                 

  Prepared Statement of Dr. Yvonne T. Maddox, Acting Deputy Director, 
         Office of the Director, National Institutes of Health

    Mr. Chairman, Members of the Committee: I am pleased to present the 
President's budget request for the Office of the Director (OD) for 
fiscal year 2002, a sum of $232,098,000, which reflects an increase of 
$44,552,000 over the comparable fiscal year 2001 appropriation. The OD 
provides leadership and coordination for the research activities of 
NIH, both extramural and intramural. The OD also is responsible for a 
number of special programs and for management of centralized support 
services essential to the operation of the entire NIH.
    The OD guides and supports research by setting priorities; 
allocating funding among these priorities; developing policies based on 
scientific opportunities and ethical and legal considerations; 
maintaining peer review processes; providing oversight of grant and 
contract award functions and of intramural research; communicating 
health information to the public; facilitating the transfer of 
technology to the private sector; and providing fundamental management 
and administrative services such as budget and financial accounting, 
and personnel, property, and procurement management, administration of 
equal employment practices, and plant management services, including 
environmental and public safety regulations of facilities. The 
principal OD offices providing these activities include the Office of 
Extramural Research (OER), the Office of Intramural Research (OIR), and 
the Offices of: Science Policy; Communications and Public Liaison; 
Legislative Policy and Analysis; Equal Opportunity; Budget; and 
Management. This request contains funds to support the functions of 
these Offices.
    The OD also maintains several trans-NIH offices and programs to 
foster and encourage research on specific, important health needs; I 
will now discuss the budget requests for each of these trans-NIH 
offices in greater detail.
                      the office of aids research
    The Office of AIDS Research (OAR) plans, coordinates and evaluates 
the NIH HIV/AIDS research activities; serves as the focal point for 
AIDS policy and budget development; and coordinates NIH involvement in 
international AIDS research activities.
    OAR develops an annual comprehensive AIDS research plan and budget 
for all NIH sponsored AIDS research, based on the most compelling 
scientific priorities that will lead to better therapies and prevention 
of HIV infection and AIDS. These priorities are determined through a 
unique and collaborative process involving the NIH Institutes and non-
government experts from academia and industry, with the full 
participation of AIDS community representatives.
    The OAR also administers a discretionary fund and supports the 
Intramural AIDS Targeted Antiviral Program (IATAP) and the AIDS 
Research Loan Repayment Program (LRP). The budget request includes 
$53.5 million for OAR activities in fiscal year 2002.
                the office of research on women's health
    The Office of Research on Women's Health (ORWH) is the focal point 
for women's health research at NIH and strives to ensure that research 
supported by NIH addresses the health concerns of women, that women are 
appropriately included as subjects in research protocols and clinical 
trials, and that women are encouraged to pursue careers in medical 
research. The science-based activities of ORWH are determined by the 
Agenda for Research on Women's Health for the 21st Century, an agenda 
developed following public hearings and scientific workshops involving 
some 1,500 representatives dedicated to improving the health of women. 
In fiscal year 2002, the OD budget request includes an increase of $28 
million for ORWH to pursue the recommendations within this agenda 
including research on chronic diseases in women, support for 
reproductive health research, research to aid in the prevention and 
detection of cervical cancer and ovarian cancer, studies to develop 
gender-based treatments for diabetes and kidney disease, and studies 
that address prevention and elimination of lung cancer in women. In 
addition, the ORWH, with NIH Institutes and the Agency for Health 
Research and Quality (AHRQ), will support career development programs 
that encourage the pursuit of interdisciplinary research careers 
relevant to women's health and encourage patient-oriented or 
population-based clinical research careers. Finally, ORWH will continue 
to monitor compliance with established policies for the inclusion of 
women and minorities in clinical research.
         the office of behavioral and social sciences research
    As NIH continues its efforts to improve health outcomes, there is 
increasing awareness that many of our most serious health concerns are 
related to individual behaviors and social context. The Office of 
Behavioral and Social Sciences Research (OBSSR) furthers the mission of 
NIH by emphasizing the role that behavioral and social factors play in 
health. The fiscal year 2002 OD budget includes $23.7 million for 
OBSSR, an increase of $3 million, or 15.7 percent, over fiscal year 
2000. OBSSR works to integrate a psychological and social perspective 
across all research programs at NIH and to increase the support for 
behavioral and social science research and training.
    One strategy that OBSSR uses to increase support for behavioral and 
social sciences research is the development of broad trans-NIH 
initiatives that address issues relevant to many Institutes and Centers 
(ICs). OBSSR has addressed one of the Nation's most troubling health 
concerns--youth violence. A special panel of experts found that there 
is a need for interventions to prevent and treat youth violence, as 
well as for studies that would improve service delivery and maintain 
behavioral change. OBSSR, with four Institutes, initiated a Request for 
Applications (RFA) entitled, ``Research on the Development of 
Interventions for Youth Violence,'' to focus on these needed areas of 
research.
    Child neglect is one of the most critical areas of research when 
focusing on the well-being of children, and a topic about which little 
is known. OBSSR authored both a RFA and a Program Announcement (PA) for 
this activity along with six NIH Institutes; the Agency for Children, 
Youth, and Families (ACYF); The Department of Justice (DOJ), and the 
Department of Education. Both the RFA and the PA encourage research to 
enhance understanding of the causes, extent, treatment, management, and 
prevention of child neglect.
    Enhancing opportunities to collaborate and form partnerships is an 
important component of the OBSSR strategic plan. OBSSR is currently 
collaborating with the Association of American Medical Colleges (AAMC) 
to explore the development of a curriculum for behavioral and social 
sciences relevant for medical schools. The OBSSR, with several ICs, 
also supports centers to investigate aspects of the interactions 
between mind and body in health and disease. In addition, OBSSR has 
joined with 12 Institutes to address the problem of inadequate 
adherence to prescribed medications and therapies.

                    THE OFFICE OF DISEASE PREVENTION
    The Office of Disease Prevention (ODP) has several specific 
programs/offices that strive to place new emphasis on the prevention 
and treatment of disease:
  --In fiscal year 2002, the Office of Dietary Supplements (ODS) will 
        continue to promote the scientific study of the use of dietary 
        supplements. The Office will continue to support investigator-
        initiated research through the Research Enhancement Awards 
        Program (REAP) and through PAs with other ICs at NIH. The 
        Office will also stimulate research through conduct of 
        conferences, workshops, and presentations at national and 
        international meetings.
  --In continuing efforts to inform the public about the benefits and 
        risks of dietary supplements, the ODS expanded the 
        International Bibliographic Information on Dietary Supplements 
        (IBIDS) database to include a consumer-oriented search 
        strategy.
  --ODS is nearing completion of public-oriented information pages 
        (Fact Sheets) about specific vitamin and mineral dietary 
        supplements for wide dissemination in print and on the 
        Internet. These are to be followed by a series of Fact Sheets 
        for botanical and herbal supplements which are being developed 
        in conjunction with the National Center for Complementary and 
        Alternative Medicine (NCCAM).
  --To determine the effects and safety of dietary supplements 
        containing ephedra, ODS, with other Federal partners, will 
        conduct an evidence-based review of ephedra efficacy and 
        safety; and will nominate ephedra for study by the National 
        Toxicology Program of the National Institute of Environmental 
        Health Sciences.
    Another component of ODP, the Office of Rare Diseases (ORD), 
supports research activities on rare diseases and conditions, develops 
and disseminates information to health care providers and patient 
support groups, and forges links among investigators with ongoing 
research activities in this area. The ORD continues to support 
workshops and symposia to stimulate research and to identify research 
opportunities related to rare diseases.
    The ORD, with the National Human Genome Research Institute (NHGRI), 
plans to release a Request for Proposals (RFP) to establish an 
information center to respond to requests received by the NIH for 
information about rare and genetic disorders.
    The ORD is also planning to respond to the critical needs of 
patients with rare, life-threatening diseases by establishing a 
diagnostic center of excellence for patients whose previous diagnoses 
have been elusive despite extensive prior efforts to determine the 
exact nature of their illnesses. The center would foster research on 
rare diseases, develop facilities designed specifically for rare 
diseases research, and would eventually support investigator training 
focusing on rare diseases.

                          OTHER OD ACTIVITIES
    The OD also supports a number of additional NIH programs that 
promote research and enhance research career development:
  --The NIH, through the OIR maintains intramural loan repayment and 
        scholarship programs as important instruments for recruiting 
        high quality candidates in basic and clinical research 
        positions. The request contains funds for the NIH Clinical 
        Research Loan Repayment Program and the Undergraduate 
        Scholarship Program, both for individuals from disadvantaged 
        backgrounds, and for the General Research Loan Repayment 
        Program. Each program provides for the payment of educational 
        costs in return for specific commitments of service in NIH's 
        intramural research facilities. The request also contains funds 
        for the implementation and administration of two new NIH 
        clinical loan repayment programs, the Extramural Clinical 
        Research Loan Repayment Program and the Pediatric Research Loan 
        Repayment Program.
  --The Office of Science Policy (OSP) has a role in addressing science 
        policy issues on behalf of NIH and in coordinating NIH's 
        approach to the Government Performance and Results Act (GPRA). 
        In addition, the OSP has developed, with the ICs, curriculum 
        supplements to complement existing science curricula in grades 
        K-12 that benefit both students and teachers and encourage 
        students to consider careers in research.
  --The request also reflects several functional transfers, including 
        the transfer of funding for bioengineering and bioimaging 
        activities to the National Institute of Biomedical Imaging and 
        Bioengineering (NIBIB); funding for the Extramural Loan 
        Repayment Program transferred to the National Center for 
        Minority Health and Health Disparities (NCMHD); funding for the 
        Extramural Associates Program (EAP) and the Extramural 
        Associates Research Development Award (EARDA) Program to the 
        National Institute of Child Health and Human Development 
        (NICHD); and the transfer of the Academic Research Enhancement 
        Award (AREA) funding to the several ICs supporting these 
        awards.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
Prominent in the performance data is NIH's second annual performance 
report which compares our fiscal year 2000 results to the goals in our 
fiscal year 2000 performance plan. As performance trends on research 
outcomes emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
    Thank you for giving me the opportunity to present this statement; 
I will be pleased to answer questions.
                                 ______
                                 

              Prepared Statement of Dr. Jack A. McLaughlin

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request of the National Eye Institute (NEI) for 
fiscal year 2002, a sum of $571.1 million, which reflects an increase 
of $60.5 million over the comparable fiscal year 2001 appropriation.
    Diseases of the eye and disorders of vision can have a profound 
affect on the quality of our lives. Many of them are chronic, disabling 
diseases and conditions that may ultimately lead to visual impairment 
or blindness. The National Eye Institute and the scientists it supports 
are committed to improving the visual health of our citizens. The 
research that they perform in this pursuit touches upon every area of 
scientific endeavor and every facet of the visual system.

                        RETINAL DISEASE RESEARCH
    The retina is the transparent, light-sensitive tissue that lines 
the back of the eye. Diseases and disorders of the retina and its blood 
supply account for much of the blindness and visual disability in this 
country. The most important of these include macular degeneration, 
diabetic retinopathy, retinitis pigmentosa and related disorders, 
retinal detachment, uveitis, and cancer (choroidal melanoma and 
retinoblastoma).
    NEI-sponsored scientists are actively pursuing laboratory and 
clinical studies on the development, molecular and cell biology, 
molecular genetics, and metabolism of the photoreceptor cells that 
capture light; the initial neural processing of information that is 
transmitted to the visual centers of the brain; the pathogenesis of 
diabetic retinopathy; the fundamental causes of and etiologic factors 
responsible for uveitis; the identification of the genes and 
neurodegenerative mechanisms for macular degeneration, retinitis 
pigmentosa, and related disorders; and the cellular and molecular 
events that accompany retinal detachment. The ultimate goal of these 
studies is to develop effective therapeutic or preventive measures 
where none currently exist or to improve those treatments that are 
currently available.

                        CORNEAL DISEASE RESEARCH
    The cornea is the transparent tissue at the front of the eye that 
plays an important role in refracting or bending light to focus visual 
images sharply on the retina. Because the cornea is the most exposed 
surface of the eye, it is especially vulnerable to damage from injury 
or infection. The leading causes of corneal blindness are herpes and 
other infections, corneal opacification or clouding, and inherited and 
degenerative diseases. The NEI supports laboratory and clinical studies 
on a wide range of research topics, including: the regulation of genes 
that express proteins unique to corneal tissue; the characterization of 
specific proteins and cell surface receptors that interact with corneal 
cells, pathogens, and blood-borne cells; the mechanisms that maintain 
corneal hydration and transparency; the physiologic basis for immune 
privilege in the cornea; corneal wound healing; the cellular and 
molecular mechanisms by which corneal transplants are rejected; and the 
role of specific viral genes in the establishment and reactivation of 
corneal herpetic infections. These studies should ultimately improve 
our ability to limit or prevent damage to corneal clarity caused by 
injury, infection, or other disease processes.

                           CATARACT RESEARCH
    A cataract is an opacity of the eye's normally clear lens that 
interferes with vision. Cataract may develop at any time during life, 
although it is most often associated with advancing age. In addition to 
aging, cataract may be a consequence of diabetes and other metabolic 
disorders, trauma, exposure to ionizing radiation, or it may be 
inherited or congenital in nature. Cataract treatment in this country 
is one of the most successful of all surgical procedures. At this time, 
surgery to remove the opaque lens is the only effective way of treating 
cataract.
    The NEI-sponsored research includes: studies of the development and 
aging of the normal lens of the eye; the identification, at the 
cellular and molecular level, of those components that maintain the 
transparency and proper shape of the lens; the control of lens cell 
division and differentiation; the delineation of the structural and 
regulatory sequences of crystallin and noncrystallin lens genes; and 
the impact of continual oxidative insult on the lens. The aim of this 
research is to develop the means to delay or prevent cataract 
formation.

                           GLAUCOMA RESEARCH
    Glaucoma is a group of disorders that share a distinct type of 
optic nerve damage that can lead to blindness. Glaucoma is often 
associated with increased pressure within the eye caused by inadequate 
drainage of aqueous humor, the fluid within the eye that nourishes the 
cornea and lens. Researchers once thought that glaucoma resulted solely 
from increased pressure, but they now know that the elevation in the 
pressure within the eye is only one of the risk factors for the 
disease. Although glaucoma is primarily a chronic disease of aging, it 
may occur at any age. It can occur as a primary disorder or it can be 
secondary to other ocular or systemic conditions. Because glaucoma is a 
major health problem and the number one cause of blindness in African-
Americans, it is a primary focus for NEI's research on health 
disparities. Approximately three million Americans have glaucoma, with 
about half of these unaware that they have the disease. As many as 
120,000 are blind from this disease.
    The NEI supports clinical trials that assess the role of medical 
and surgical therapy in the treatment of the disease. One study, the 
Ocular Hypertension Treatment Study, is attempting to determine the 
benefit of treating people with elevated pressure in their eyes who are 
at moderate risk for developing glaucoma with pressure lowering 
medications to prevent or delay sight-threatening damage to the eye 
from glaucoma. The NEI also supports studies on the identification and 
characterization of genes that are involved in the development of 
glaucoma and the basic mechanisms that control fluid secretion and 
outflow and the design of methods to control these processes and to 
protect the optic nerve from damage.

         STRABISMUS, AMBLYOPIA, AND VISUAL PROCESSING RESEARCH
    Research on strabismus and amblyopia encompasses a broad range of 
clinical and laboratory studies on the structure and function of the 
neural pathways from the retina to the brain, the central processing of 
visual information, visual perception, the control of ocular muscles, 
and refraction. A large number of congenital, developmental, and 
degenerative abnormalities affect the visual sensorimotor system, but 
three disorders are of primary concern: strabismus or the misalignment 
of the eyes; amblyopia, or lazy eye, in which one eye has reduced 
vision due to misalignment or unequal refraction; and refractive 
errors, especially myopia (nearsightedness), hyperopia 
(farsightedness), and presbyopia (difficulty focusing on near objects 
with advancing age).
    As a means of improving the visual health of those afflicted with 
these conditions, the NEI supports a broad range of laboratory, 
therapeutic, and preventative studies that are concerned with the 
development and function of the neural pathways from the eye to the 
brain; the central processing of visual information; visual perception; 
optical properties of the eye; oculomotor function; functioning of the 
pupil; and control of the ocular muscles. Additional emphasis is on 
research on optic neuropathies, eye movement disorders, and the 
development of myopia.

                VISUAL IMPAIRMENT AND ITS REHABILITATION
    Each of the chronic diseases and disorders previously described can 
cause blindness and lesser degrees of visual impairment that may also 
be disabling. As a means of addressing the special needs of those with 
uncorrectable visual impairment or low vision, the NEI supports a 
program of research on visual impairment and its rehabilitation. Some 
individuals require simple optical or mechanical aids to perform daily 
functions adequately, while others may need more specialized devices or 
modifications to their environment. Many face depression as they deal 
with their loss of vision and potentially their loss of independence.
    The NEI supports research to understand the origins of visual 
impairment and assist in the rehabilitation of those who have such 
disabilities. The NEI supports projects aimed at improving the methods 
of specifying, measuring, and categorizing loss of visual function; 
devising strategies to help visually impaired people maximize the use 
of their residual vision; systematically evaluating new and existing 
visual aids; developing an adequate epidemiological base to understand 
the causes of blindness, partial loss of sight, and visual anomalies; 
and studying the optical, electronic, and other rehabilitative needs of 
people with visual impairments.

                   HEALTH EDUCATION AND COMMUNICATION
    The NEI's National Eye Health Education Program (NEHEP) was 
developed to increase awareness among health care professionals and the 
public of scientifically based health information that can be applied 
to preserving sight and preventing blindness. Working through its 
partnership of over 50 professional and voluntary organizations, which 
includes some of the other NIH Institutes, the NEHEP attempts to reach 
select target audiences, informing them of the importance of early 
detection and treatment of eye diseases, particularly glaucoma and 
diabetic retinopathy, and persuading them to make an appropriate change 
in behavior.
    To increase awareness of low vision and its impact on quality of 
life, NEHEP developed the Low Vision Education Program. This program is 
directed toward people with low vision, their families and friends, and 
the health care and service professionals who care for them. It takes 
particular note of the growing population of people over age 65 and 
other high risk populations, including Hispanics and African Americans 
who are likely to develop low vision at an earlier age. As part of this 
education effort, the NEI has developed a public service campaign and a 
mobile exhibit on low vision that is currently traveling to shopping 
malls and centers throughout the United States. The exhibit consists of 
five colorful kiosks designed to attract a cross section of the 
population. It contains an interactive multimedia touchscreen program; 
provides information on low vision services and resources; and displays 
aids and devices that help people with low vision, all available in 
Spanish as well as English. The exhibit and touchscreen program explain 
the causes of low vision; offer personal accounts of people living with 
low vision; and provide a self-assessment to help people determine if 
they or someone they know may have low vision.

                 GOVERNMENT PERFORMANCE AND RESULTS ACT
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) Of 1993. 
Prominent in the performance data is NIH's second annual performance 
report which compares our fiscal year 2000 results to the goals in our 
fiscal year 2000 performance plan. As performance trends on research 
outcomes emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
    Mr. Chairman that concludes my prepared statement. I would be 
pleased to respond to any questions you or other members of the 
committee may have.
                                 ______
                                 

 Prepared Statement of Kenneth Olden, Director, National Institute of 
                     Environmental Health Sciences

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Institute of 
Environmental Health Sciences (NIEHS) for fiscal year 2002, a sum of 
$561,750,000, which reflects an increase of $58,668,000 over the 
comparable fiscal year 2001 appropriation.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
Prominent in the performance data is NIH's second annual performance 
report which compares our fiscal year 2000 results to the goals in our 
fiscal year 2000 performance plan. As performance trends on research 
outcomes emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.

                       GENES AND THE ENVIRONMENT
    Over the past 100 years, advances in biomedical research have led 
to remarkable improvements in the prevention, diagnosis, and treatment 
of human illness. Life expectancy has increased from an average age of 
49 years at the turn of the century to the current average of 76. 
Continued improvements in quality of life and longevity will require a 
better understanding of the development and progression of common 
diseases. Identification of the major determinants of human health is 
one of the major challenges of the 2lst century.
    Scientists in biomedicine, environmental health, and public health 
are working to understand and prevent human diseases. Most chronic 
diseases in humans arise from a complex array of factors which could 
include several genes, environmental conditions or exposures, the age, 
nutritional status or stage of development of a person, and other 
predisposing factors. The relationship between genes and the 
environment can be compared to a loaded gun and its trigger. A loaded 
gun by itself causes no harm; it is only when the trigger is pulled 
that the potential for harm is released. Genetic susceptibility creates 
an analogous situation where the loaded gun is one or a combination of 
susceptibility genes and the trigger is an environmental exposure. One 
can inherit a predisposition to have a disease, but never have the 
disease unless exposed to the environmental trigger. Therefore, most 
chronic diseases will not be fully understood until both the genetic 
and environmental contributions to their etiology are elucidated. 
Unfortunately, the relationship between genes and the environment is 
neither well understood nor extensively studied at the present time. 
Until recently, limited and inadequate knowledge of human genetics had 
hampered progress in this area and had limited scientists to relatively 
simplistic models-models that assume that diseases are caused by 
mutations in a single gene or by exposure to a single environmental 
agent. Interactions between multiple genes, or between genes and 
several environmental agents, have only been rarely considered as the 
cause of human illness. So our knowledge has many information gaps.
    To develop the framework that will allow us to accurately assess 
environmental threats to human health-threats that affect us from 
conception to death-we need to fill in the missing information in at 
least three areas. We need:
  --information relating to toxicity for environmentally significant 
        compounds from well-characterized animal models tested at 
        biologically relevant doses;
  --a comprehensive catalogue of human gene variation that can 
        influence susceptibility to environmental exposures;
  --extensive epidemiological and other population-based studies that 
        can definitely link human disease to environmental exposure.

                 ASSESSMENT OF TOXICITY/CARCINOGENICITY
    Estimates are that 70-75 percent of the high-volume, high-use 
chemicals (15,000) in commercial use in the United States have not been 
assessed for human toxicity or carcinogenicity (National Academy of 
Sciences, 1980; Environmental Defense Fund, 1993). While many, if not 
most, of these may not require testing since they are very similar to 
chemicals already tested, several do need testing. But, given the sheer 
magnitude of the problem, we can never satisfy this testing requirement 
using traditional technologies. For example, the National Toxicology 
Program only recently celebrated the completion of carcinogenicity 
assessments of 500 chemicals after 30 years of operation. The time-
honored way of determining which of the thousands of environmental 
agents are toxic to humans is to expose hundreds of animals to the 
suspected product and observe them for adverse health outcomes (e.g., 
cancer or developmental anomalies). These studies take years to 
complete, cost millions of dollars, use hundreds of animals, and are 
not sufficiently informative.
    Now, however, we have new tools generated by advancements in the 
science of genomics; that is, the study of our genes and what they do. 
These tools offer unprecedented ways to understand biological and 
disease processes at the molecular level. The NIEHS is merging the 
field of toxicology with genomics, creating a science of toxicogenomics 
that identifies toxicant activity at the genetic and molecular level. 
Last November, the NIEHS developed a National Center for Toxicogenomics 
to promote a genomics-based approach for assessing the toxic or 
carcinogenic potential of environmental agents. Using this approach, 
one can survey the entire human genome in just a few days to determine 
the response of various tissues or organ systems to specific 
environmental exposures. Rather than using pathology to identify 
illness, the toxicogenomics approach relies on gene expression profiles 
or signature patterns to determine which agents are toxic or 
carcinogenic. Current experience with this rapidly evolving technology 
has validated its potential usefulness in that various classes of toxic 
agents give rise to unique signature patterns (i.e., gene expression 
profiles) characteristic of specific disease pathways.
    To promote the development and validation of the gene expression 
profiling approach, the NIEHS has established five university-based 
regional centers with the NIEHS intramural program serving as a data 
repository and coordinating center.

             SEARCH FOR ENVIRONMENTAL SUSCEPTIBILITY GENES
    Organisms and species are exposed to hazardous agents in the 
environment on a continual basis. As a result, sophisticated metabolic 
pathways have evolved that can minimize the biological consequences of 
hazardous environmental agents. These pathways constitute the so-called 
``environmental response machinery.'' All human genes, including those 
that encode components of the environmental response machinery, are 
subject to genetic variability, which can be associated with altered 
efficiency of a biological pathway. So a person's risk for developing 
an illness as a result of an environmental exposure might be dependent 
on the efficiency of his or her own unique set of environmental 
response genes. These genes, for example, might determine how a person 
responds to and metabolizes drugs or carcinogenic compounds after 
exposure.
    The Environmental Genome Project was initiated in 1997 to stimulate 
population-based and other research into the role of genetic variation 
in response to environmental exposure. The key objective is to identify 
all the genes in the human genome that confer susceptibility to 
environmental agents. The NIEHS is supporting five university-based 
centers to resequence suspected or candidate environmental 
susceptibility genes to identify genetic variations responsible for 
differences in response to environmental agents leading to specific 
diseases.
    Presently, environmental health regulatory agencies craft rules as 
if ``one-size-fits-all.'' However, we know that individuals can vary by 
more than two-thousand fold in their capacity to repair or prevent 
damage following exposure to toxic agents in the environment. For 
example, several people died after members of the Aum Shinrikya cult 
released potent nerve gas called sarin in a Tokyo subway station about 
six years ago; not all those exposed, however, died. We now know that 
some humans are much more vulnerable to sarin poisoning than others. 
Circulating in the blood of 25 percent of Asians and 10 percent of 
Caucasians is a version of an enzyme called paraoxonase that converts 
sarin to a less toxic chemical about 10 times more quickly than the 
enzyme found in most people. The gene that produces paraoxonase is one 
of dozens that toxicologists think make some individuals more or less 
susceptible to the effects of pollutants and other environmental 
chemicals (e.g., organophosphate pesticides), contributing to adverse 
health outcomes such as cancer, asthma, birth defects, diabetes, 
cardiovascular disease, Parkinson's and Alzheimer's. So, scoring for 
variations in a person's genetic code can help determine the likelihood 
that an individual will have an adverse response from exposure to sarin 
or other environmental agents. Knowledge of the prevalence of 
susceptibility genes would take much of the guesswork out of 
environmental health decision-making.

         GENETIC VARIABILITY, EXPOSURE, AND DISEASE ASSOCIATION
    To study the functional implications of genetic polymorphism or 
variation relative to specific environmental exposures and disease 
development, better exposure data will be required. Exposure monitoring 
is a ``right-to-know'' issue for citizens who are involuntarily exposed 
to environmental pollutants. However, little is known about actual 
human exposure and body burdens of environmental pollutants. This 
knowledge gap hampers regulatory decision making and introduces 
uncertainties in setting exposure limits. It also limits our 
understanding of dose-response relationships and capacity to develop 
effective prevention strategies. Exposure is typically estimated using 
indirect surrogates of environmental quality, such as toxic release and 
production inventories and environmental monitoring. Actual exposure is 
highly variable for individuals and subpopulations. It is really a 
function of individual uptake, metabolism, excretion and behavior. So 
the assumption that all men, women and children living in the same 
geographic area have similar exposure is seriously flawed. What we need 
are direct measures of exposure based on tissue analysis or deposition. 
The NIEHS is spearheading an interagency effort to intensify exposure 
assessment research. We have been working with Centers for Disease 
Control and Prevention to expand the types of toxicants measured in 
samples collected thru National Health and Nutrition Examination Survey 
(NHANES) such as those recently reported in the National Report on 
Human Exposure to Environmental Chemicals. These and future efforts are 
expected to strengthen what is often viewed as the weakest link in the 
risk assessment process.
    The effects of exposure are not just limited to individual 
chemicals. Typically, toxicity and carcinogenicity are assessed in 
animals one chemical at a time, and the risk for each chemical in the 
mixture is added up to get a total risk. Implicit in summing up the 
risks is the assumption of independent, not interactive but additive, 
effects. This assumption is controversial. Also, this contrasts with 
the ``real world'' where humans are exposed to multiple agents-
chemical, physical and biological-at any given time in the form of 
mixtures. We are aware of situations where current assumptions do not 
hold in that components of mixtures behave synergistically. We now have 
the capacity to develop technology to assess the toxicity of mixtures. 
One promising technology being developed with the NIEHS support is the 
DNA microarray gene expression profiling approach described above.

                                SUMMARY
    Much of 20th century medicine focused on managing endstage diseases 
rather than preventing them at the outset. Yet prevention is the most 
cost-effective and life-enhancing means we have to protect human health 
at every life stage. In the past, the environmental health sciences, 
where prevention is the goal, lacked the necessary tools to identify 
important disease triggers. Now, however, the Nation's long-term 
investment in the basic sciences has put us in the position to fill the 
knowledge gaps. We are poised to more efficiently and more precisely 
identify the environmental components that set the stage for disease 
initiation and progression.
                                 ______
                                 

                  Prepared Statement of Audrey S. Penn

    Mr. Chairman and Members of the Committee: I am Audrey Penn, Acting 
Director of the National Institute of Neurological Disorders and 
Stroke. I am pleased to present the President's budget request for 
NINDS for fiscal year 2002, a sum of $1,316,448,000, which reflects an 
increase of $139,428,000 over the comparable fiscal year 2001 
appropriation. The NIH budget request includes the performance 
information required by the Government Performance and Results Act 
(GPRA) Of 1993. Prominent in the performance data is NIH's second 
annual performance report which compares our fiscal year 2000 results 
to the goals in our fiscal year 2000 performance plan. As performance 
trends on research outcomes emerge, the GPRA data will help NIH to 
identify strategies and objectives to continuously improve its 
programs.
    The mission of NINDS is to reduce the burden of neurological 
disorders. Today I will speak briefly about that burden. I will also 
say a few words about the progress so far in treating these diseases 
and the remarkable opportunities presented by recent scientific 
advances. However, I will spend most of my limited time telling you 
what NINDS is doing to ensure that science is translated as quickly as 
possible into help for people with neurological disorders.

                  THE BURDEN OF NEUROLOGICAL DISORDERS
    Disorders that affect the brain, spinal cord, nerves of the body, 
muscles and their control impose an enormous toll on society. 
Neurological disorders can compromise the complex thinking and emotions 
that make us human, the routine perception and movement that we take 
for granted, and even the control of bodily systems that are normally 
beneath our conscious awareness. Trauma, infections, toxic exposure, 
birth defects, degenerative diseases, tumors, gene mutations, systemic 
illness, vascular events, nutritional deficiencies, and adverse effects 
of essential treatments for diseases like AIDS and cancer can all 
disrupt the functions of the nervous system.
    We often think first of neurological disorders that afflict older 
Americans-stroke, Alzheimer's, Parkinson's. But problems like multiple 
sclerosis, brain and spinal trauma usually strike young adults, and the 
list of childhood disorders is enormous-autism, cerebral palsy, 
Duchenne muscular dystrophy, Batten disease, Canavan disease, to name 
just a few. Disorders like epilepsy and brain tumors, which can strike 
at any age, also occur frequently.
    Some neurological disorders are very common. NINDS and American 
Heart Association studies show that more than 700,000 Americans suffer 
strokes each year. The Centers for Disease Control and Prevention 
estimates that head trauma kills more than 50,000 people each year and 
more than five million survivors suffer disabilities. Physicians tell 
us that pain is the most common symptom that brings people to a doctor. 
A recent journal from the American Academy of Neurology, for example, 
suggests that migraine headaches affect about twenty percent of women. 
Diabetic neuropathy commonly accompanies diabetes. Epilepsy, autism, 
cerebral palsy, dystonia, the neurological aspects of AIDS and several 
other disorders also affect many people.
    Collectively the hundreds of rare disorders of the nervous system 
also affect many people and their families. The history of medicine 
teaches us that studying rare diseases often has wide repercussions. 
Creutzfeldt-Jakob disease (CJD) is a terrible disorder that strikes 
about one in a million people. The long tradition of NINDS research on 
this formerly obscure disease is now coming to the forefront because of 
the public health concerns raised by the related bovine spongiform 
encephalopathy (BSE or ``mad cow disease''). In the last year NINDS 
initiated a contract program to develop tests needed for confronting 
the public health and economic threats from BSE. Rare disorders often 
provide clues to more common diseases, and CJD is a good example here 
too. Abnormal aggregation of proteins called prions are at the crux of 
CJD. Abnormal clumps of other proteins have also been implicated in 
common diseases such as Parkinson's, Huntington's, and Alzheimer's.

             PROGRESS AND PROMISE IN NEUROLOGICAL DISEASES
    Perhaps because the brain is so complex and inaccessible, 
neurological disorders have always been among the most difficult to 
treat of all medical problems, but we are making progress. The American 
Heart Association estimates that the death rate from stroke went down 
by 14 percent from 1987 to 1997. NIH is continuing prevention trials 
that have contributed to that decline. In the 1990's NINDS clinical 
trials demonstrated the first acute treatment that improves outcome 
from stroke, the drug t-PA, and the first emergency drug treatment that 
can reduce the disability from spinal cord injury, high dose 
methyprednisolone. Neurosurgeons have developed guidelines that can 
improve outcome from head trauma. The first treatments that reduce 
symptoms and even slow progression of multiple sclerosis have emerged 
from studies of the nervous and immune systems. Several new drugs for 
epilepsy are now available, partly through efforts of the NINDS drug 
development programs. New surgical treatments, such as chronic deep 
brain stimulation, show promise for Parkinson's and other disorders. We 
have new genetic tests that help diagnose inherited neurological 
disorders. Clearly we are making progress, and much of that progress 
rests on the stream of advances from basic neuroscientists which is 
continuing. But each example represents only the first steps toward 
adequate treatments and prevention. We have a long way to go.
    What is most encouraging is the range of new therapeutic strategies 
on the horizon. It may seem peculiar, but one important step in 
learning how to prevent or cure a disease is to first learn how to 
cause it. The striking progress in understanding the nervous system and 
its diseases at the level of genes, proteins, cells and brain circuits, 
is bringing us long sought after animal models of human disorders. 
Animal models enable scientists to follow the course of disease 
progression, refine understanding of causes, and develop therapies. 
Discovery of the genes responsible for inherited disorders such as 
Batten disease, ataxias, spinal muscular atrophy, and muscular 
dystrophy often leads to animal models of these disorders. Finding the 
genes responsible for uncommon inherited forms of Alzheimer's, 
Parkinson's and amyotrophic lateral sclerosis (ALS) has led to animal 
models that will foster progress against the more common non-inherited 
versions of these disorders. Genes are not the only route to developing 
animal models. This year brought new models for neurodegeneration in 
Parkinson's disease through use of a pesticide, rotenone, as well as 
through manipulation of genes; surgical techniques have always been 
important for developing animal models of stroke and trauma; and 
immunological approaches are important in diseases such as multiple 
sclerosis.
    Using animal models, researchers are exploring the potential of 
cell transplantation, gene transfer, natural biochemicals, electrical 
stimulation, and new approaches to drug therapy for treating 
neurological disorders. Researchers using gene transfer vectors to 
deliver the natural neurotrophic (growth and survival) chemical GDNF 
were able to counter some Parkinson's-like effects in animals. Gene 
transfer also has shown promise in mice with the same gene defect as 
boys with Duchenne muscular dystrophy, and strategies to repair 
defective genes also now appear plausible for this disease. Cell 
transplantation in animals has helped repair damage from spinal cord 
injury, restore the myelin insulation of nerve fibers that is lost in 
multiple sclerosis, provide missing enzymes in inherited disorders like 
Tay-Sachs disease, and replenish the chemical dopamine in Parkinson's 
disease. Study of the steps in ``cell suicide'' that occurs as the 
simple nervous system of the worm develops led to the recognition that 
similar cell death mechanisms play out in several neurological 
disorders. Blocking steps in this cell death program has shown benefits 
in animal models of stroke, trauma, Huntington's disease and ALS. This 
is only a sampling, but shows that not far over the horizon are 
possibilities for treating many neurological disorders.

               WHAT IS NINDS DOING TO MOVE TOWARD CURES?
    The genius of the NIH system is its power to engage the collective 
wisdom and ingenuity of the nation's scientific community. We must 
continue to nourish those ongoing efforts and position ourselves 
prudently to continue to support that base upon which all our efforts 
rest. At the same time, the scientific progress compels us to target 
efforts toward translating the scientific potential into real help for 
people as quickly as possible, and the recent funding increases empower 
us to do so. The key is again to rely upon the distributed insight of 
the medical and scientific community.
    NINDS has a multi-tiered planning process to harness that 
collective wisdom to meet our mission. The planning process brings 
together scientists, physicians, the advocacy community, industry, and 
NIH staff in several complementary ways. We began, about two years ago, 
by convening more than 100 leaders from the scientific community, 
together with patient-advocates and NINDS staff, to assess needs, 
opportunities and priorities in several cross-cutting areas, each 
relevant to progress against many disorders. Seven panels focused on 
Neurogenetics; Neurodegeneration; Channels, Synapses, and Circuits; 
Cognition and Behavior; Neurodevelopment; Plasticity and Repair; the 
Neural Environment; and Experimental Therapeutics and Clinical Trials. 
NINDS posted draft panel reports on the internet and solicited comments 
from more than 250 patient advocacy groups and professional scientific 
organizations. This input helped shape the NINDS strategic plan 
``Neuroscience at the New Millenium.'' which serves as a foundation for 
all our planning efforts.
    Building on the strategic goals, we have begun a series of disease 
specific planning efforts, beginning with Parkinson's disease. A 
January 2000 workshop brought together intramural, extramural, and 
industry scientists, Parkinson's disease advocates, and ethicists, 
forming the basis for the ``NIH Parkinson's Disease Research Agenda,'' 
submitted to Congress in March of last year. NIH is vigorously 
implementing the Agenda. We held several workshops focused on specific 
aspects of Parkinson's disease research, such as drug therapies, gene 
therapies, cognitive and emotional aspects, and environmental 
influences. Including solicitations issued shortly prior to the Agenda 
or nearing release, NIH has developed more than a dozen requests for 
grants or contracts that target specific Agenda priorities. Targets of 
opportunity include deep brain stimulation, clinical trials for 
neuroprotective drugs, and proteins implicated in the disease. We have 
supplemented existing grants to expedite work on high throughput drug 
screening, bringing new investigators to the field, and genetics of 
Parkinson's in minority ethnic groups. Working groups or consortia have 
formed in critical areas, such as deep brain stimulation. NINDS is also 
continuing to support the eleven Udall Parkinson's disease research 
centers. The Institute will soon launch a website that will set the 
standard for informing the public about progress in implementing a 
disease specific research plan, and also serve as a resource for 
researchers and caregivers.
    Several other disease specific planning efforts are also underway. 
As a joint undertaking NCI and NINDS brought together a Progress Review 
Group on Brain Tumors. More than 100 experts in several scientific and 
medical disciplines with a bearing on brain tumors presented 
assessments of current understanding and future needs in 14 critical 
areas. NINDS and NCI are working to implement these recommendations. A 
Progress Review Group in Stroke is following a similar process. Last 
spring's landmark conference ``Curing Epilepsy: Focus on the Future'' 
launched efforts that developed ``benchmarks'' for epilepsy research 
which are the first step towards a research agenda. This spring the 
Institute of Medicine of the National Academy of Sciences released an 
assessment of current status of research on multiple sclerosis with 
recommendations for future research. This effort, which included NIH 
researchers, will inform future efforts on this disease. Disease 
specific planning efforts dovetail with the NINDS strategic plan, 
revealing elements in common for many diseases and those unique to each 
disorder.
    Health disparities has also been a focus of specific planning 
efforts at NINDS. Since fiscal year 1999 NINDS, working together with 
NCRR, the ORMH and other Institutes, has expanded its original center 
at Morehouse School of Medicine to eight specialized neuroscience 
research programs at minority institutions and a network of research 
consortia at 28 leading neuroscience research programs. NINDS is 
expanding activities of this program with a parallel development of 
other research as an integral part of the Institute plan for addressing 
health disparities.
    Another aspect of NINDS planning efforts is an active agenda of 
scientific workshops, often held in cooperation with private groups and 
with other components of NIH, such as the Office of Rare Diseases. 
NINDS holds about 40 of these meetings each year. Some focus on 
specific therapeutic strategies or technologies, such as neural 
prostheses, gene therapy, optical imaging, computational neuroscience 
and high throughput drug screening. Others target specific diseases. 
Recent workshops focused on Duchenne muscular dystrophy, 
facioscapulohumeral muscular dystrophy, hereditary spastic paraplegias, 
spinal cord injury, ALS and spinal muscular atrophy, channelopathies, 
neurofibromatosis, and pediatric stroke. At these workshops, in 
addition to the scientific discussions, NINDS solicits advice on how to 
eliminate bottlenecks and encourage progress.
    I could describe many other planned and ongoing activities, and 
certainly more exciting science, but I want to conclude with a simple 
message. Because NINDS has an ``acting'' director does not mean the 
Institute will be less active until a permanent director is appointed. 
Given the burden of neurological disorders, the scientific 
opportunities, and the favorable funding environment, it would be 
unconscionable for the Institute to become passive. I assure you we are 
doing everything we can to move aggressively toward better ways to 
treat and prevent neurological disorders.
    Thank you. I would be happy to answer questions.
                                 ______
                                 

Prepared Statement of John Ruffin, Ph.D., Director, National Center on 
                 Minority Health and Health Disparities

    Mr. Chairman and Members of the Committee: I am honored to appear 
before you as the new Director of the National Center on Minority 
Health and Health Disparities (NCMHD) to present the President's budget 
request for fiscal year 2002, a sum of $158.425 million, which reflects 
an increase of $26.356 million over the comparable fiscal year 2001 
appropriation.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
Prominent in the performance data is NIH's second annual performance 
report which compares our fiscal year 2000 results to the goals in our 
fiscal year 2000 performance plan. As performance trends on research 
outcomes emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
    The Secretary for Health and Human Services approved the NCMHD on 
January 16, 2001, as called for in Public Law 106-525. Within the 
National Institutes of Health, the NCMHD serves as the focal point for 
planning and coordinating minority health and other health disparities 
research. The Center coordinates the development of a comprehensive 
health disparity research agenda that identifies and establishes 
priorities, budgets, and policy that govern the conduct and support of 
all NIH-sponsored minority health and other health disparities research 
and training activities. Significant progress has been made since the 
establishment of the Center; however, considerable work remains to be 
done as the Center transitions from an Office to a Center and assumes 
grant review, funding and financial management functions. The 
development of a comprehensive research portfolio began with the NIH 
Office of Research on Minority Health and will be expanded to include 
the medically underserved and other health disparity groups as 
designated by the Agency for Health Care Research and Quality. As a 
part of its mandate to build capacity for minority health and health 
disparities research, the Center also will expand it's support of 
training and the development of research infrastructure at Minority 
Serving Institutions.
    The complexity of the disparity in health status relates to 
convergence of multiple factors in unsuspecting ways to cause 
differences in disease progression and in health outcomes. If one tried 
to identify a priori all of the factors that could potentially impact 
the overall health of an individual, the results would look something 
like the attached schema. Accordingly, the Center will promote and 
increase participation in minority health and health disparities 
research by expanding the number of investigators involved in such 
research and by providing sustained funding for a wide breadth of 
studies--basic, clinical, and population research; studies on the 
influences of health processes; and research on the societal, cultural, 
and environmental dimensions of health--all aimed at identifying 
potential risk factors for disparate health outcomes.

        LEVERAGING RESOURCES WITH THE NIH INSTITUTES AND CENTERS
    The NCMHD will continue to provide funding support to assist the 
NIH Institutes and Centers (ICs) in the following ways: piloting new 
health disparities programs, improving recruitment and retention in 
clinical trials, and in providing competitive supplements to expand the 
focus of existing programs. The Center also will share in the support 
of selected targeted studies that are supported by the NIH ICs. 
Selected examples of the ways in which the Center leverages its funds 
with the NIH ICs are provided below.
    The Jackson Heart Study (JHS), a targeted study co-supported by the 
National Heart, Lung, and Blood Institute and the NCMHD, is an 
investigation of the causes of the high rate of cardiovascular disease 
in the State of Mississippi. The objectives of the JHS are to: identify 
risk factors for the development and progression of CVD; build research 
capacity in a minority serving institution; and expand minority 
participation in CVD epidemiology research. Initial examinations among 
the JHS cohort began in the fall of 2000 and will take 3 years to 
complete. Some of the newer areas of focus will include early 
indicators of disease, genetics, sociocultural influences such as 
socioeconomic status and discrimination, and physiological relations 
between common disorders such as high blood pressure, obesity, and 
diabetes and their influence on CVD.
    The Diabetes Genes, Treatment, and Prevention in Minorities 
Research program, supported by the National Institute on Diabetes, 
Digestive, and Kidney diseases and the NCMHD, focuses on the following 
groups: Hispanic diabetic adults residing in a rural Texas-Mexico 
border community; centrally obese African-Americans with impaired 
glucose tolerance; obese Hispanic high school students in Colorado; 
African American children, adolescents, and adults with diabetes; and 
Caribbean Latinos with non-insulin dependent diabetes. Its objectives 
include the development of treatment and prevention interventions that 
specifically address diabetes in a range of minority populations and 
elucidation of the genetic basis of diabetes in minority populations 
and the underlying mechanisms controlled by gene expression.
    The National Institute for Nursing Research (NINR) and the NCMHD 
will pilot planning activities for a new partnership initiative in 
NINR's extramural research program. The focus will be on decreasing 
disparities in the burden of illness and mortality experienced by 
racial and ethnic populations and the medically underserved through a 
variety of approaches, which include basic, epidemiological, clinical 
and prevention, control and population research. Cultural and ethnic 
considerations, genetic diversity, and social and economic influences 
on health and health outcomes are potential areas of emphasis. The 
activity will include partnership research, training, and other 
activities between Minority Serving Institutions and research-intensive 
majority institutions in institutions that provide services to the 
rural and urban poor.
    Other potential areas where the NCMHD will leverage its funds with 
the NIH ICs include: the intersection of non-genetic factors and genes 
in health disparities, infectious origins of chronic diseases and 
research training.

                AN INDEPENDENT RESEARCH GRANT PORTFOLIO
    Independent grant-making authority not only increases the Center's 
flexibility in leveraging its funds with the NIH ICs, but it also 
enables the Center to: focus on ``gap areas'' where such research is 
not conducted or supported by the NIH ICs; more effectively build 
research capacity in minority health and health disparities research, 
address barriers to the participation of minority serving institutions 
in the research enterprise, and to develop research capacity among 
community-based organizations.
    With respect to research, the NCMHD recognizes several pressing 
priorities. Our new Division of Research will develop programs to fund 
interdisciplinary teams of biomedical, clinical, and social science 
investigators--teams that are crucial to developing strategies and 
tools for eliminating health disparities. Another priority of the 
Division of Research is to ensure that the power of bioinformatics and 
genomics research, including pharmacogenomics, is brought to bear on 
the health disparity program.
    Our new Division of Community-Based Research and Outreach will 
identify and implement through research, effective and generalizable 
models of health care delivery, disease prevention and intervention, 
and communication that will improve community health outcomes in racial 
and ethnic minority and other health disparities populations. The 
Division will utilize available data generated by other Federal and 
State agencies to identify affected communities and to measure progress 
in outcomes associated with specific interventions. Key areas of focus 
will be to promote research on investigation of health behaviors, 
cultural health beliefs and environmental factors in community health. 
Validated findings will be utilized and incorporated by the Division to 
develop culturally sensitive and appropriate community-based prevention 
messages.

                     CENTERS OF EXCELLENCE PROGRAM
    As mandated in its statutory authorities, the NCMHD also will 
develop and implement a Centers of Excellence Program to support 
minority health research and other health disparities research and 
research training for members of health disparity populations. The 
exploratory grant mechanism will be used to plan for and promote 
interdisciplinary biomedical and behavioral research and to plan for 
the establishment of stable research and training programs. Center 
planning strategies may focus on a specific research theme (e.g., 
diagnosis, therapy, epidemiology) or integrate a broad spectrum of 
research to include the basic, clinical, prevention, and population 
sciences. Partnerships between minority institutions and majority 
institutions will be encouraged.

                       RESEARCH ENDOWMENT PROGRAM
    The Center also will develop and implement a Centers of Excellence 
Endowments Program for certain designated centers and those centers at 
Institutions of Emerging Excellence. Potentially a pilot initiative 
could begin in 2001. The purpose of the program is to provide enduring, 
forward-looking, sustainable support for the Center's minority health 
and health disparities research programs and to provide continuing 
research infrastructure support.

                         LOAN REPAYMENT PROGRAM
    In fiscal year 2001, the NCMHD will develop and implement two 
distinct extramural loan repayment programs recently authorized by the 
Congress: the Clinical Research Loan Repayment Program (LRP) and the 
Health Disparities Loan Repayment Program (HD-LRP). The emphasis of the 
LRP on ``clinical research'' and on individuals from ``disadvantaged'' 
backgrounds is consistent with the objective of building a culturally 
competent cadre of clinical investigators. Such a cadre of clinical 
investigators not only will have the potential of having an influence 
on the medical processes within their communities but can also engage 
in and promote the development of clinical research programs that 
reflect an understanding of the variety of issues and problems 
associated with disparities in health status. The focus of the health 
disparities LRP is specifically on clinical research related to 
diseases and conditions having an increased prevalence among racial and 
ethnic minorities and other designated health disparity groups.

                    OTHER CAPACITY BUILDING PROGRAMS
    To expand the number of investigators participating in minority 
health and health disparities research the NCMHD will promote, assist, 
and support research capacity building activities in the minority and 
medically underserved communities. These activities will focus on 
research infrastructure development, faculty career development, and 
increasing the number of under-represented minority students and 
students from health disparity groups with an interest in careers in 
biomedical and behavioral research.

                    HEALTH INFORMATION DISSEMINATION
    Our health information dissemination activities will be 
multifaceted since professionals and the lay-public obtain information 
from very dissimilar sources. Information will be transmitted to 
professional medical and scientific organizations for dissemination 
among their membership, and also will be made available to the public 
through media that are most likely to reach racial and ethnic minority 
groups.

                               CONCLUSION
    Recognizing that the process of medical discovery occurs in stages, 
the Congress has provided many new opportunities to build upon the 
previous efforts of the Office of Research on Minority Health. Our 
commitment to the research needed to ultimately eliminate health 
disparities will be steadfast and enduring, and we will be ever 
vigilant in our efforts. We are excited about these opportunities and 
greatly encouraged by the strong support the Center has received from 
the Congress, the Administration, our fellow NIH IC Directors and from 
groups and individuals across the Nation.
                                 ______
                                 

   Prepared Statement of Stephen E. Straus, M.D., Director, National 
           Center for Complementary and Alternative Medicine

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Center for 
Complementary and Alternative Medicine for fiscal year 2002, a sum of 
$100,063,000, which reflects an increase of $10,925,000 over the 
comparable fiscal year 2001 appropriation.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) Of 1993. 
Prominent in the performance data is NIH's second annual performance 
report which compares our fiscal year 2000 results to the goals in our 
fiscal year 2000 performance plan. As performance trends on research 
outcomes emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
    The past year, NCCAM's second, has been exciting and productive. 
With your generous support we continued to build a new research 
enterprise dedicated to defining the effectiveness and safety of 
diverse complementary and alternative medical (CAM) practices. Many 
Americans turn to these practices to relieve or prevent disease 
symptoms or the side effects of their treatment, despite a lack of 
clear and compelling data about them. We have the scientific tools, the 
commitment, and the resources to begin to guide their decisions 
regarding these practices. Consistent with our mandate, we have 
identified priority areas that warrant more immediate action due to 
pressing public health needs and either a dearth of valid scientific 
information or sufficient maturation of the science. Allow me to 
provide some examples of our approach.

                    MECHANISMS OF CAM INTERVENTIONS
    Among NCCAM's highest priorities is the conduct of Phase III 
clinical trials of CAM modalities. NCCAM's Phase III clinical trials 
are built upon a substantial body of scientific evidence concerning a 
given modality. While complex enough in design and ambitious enough in 
scope to address critical scientific issues and patient safety 
concerns, these pivotal trials are also well poised to address the 
central question: ``Does this therapy work?'' In collaboration with 
other NIH Institutes and Centers (ICs), NCCAM supports the following 
multiyear, multicenter phase III clinical trials: St. John's wort for 
depression, with the National Institute of Mental Health (NIMH); shark 
cartilage for lung cancer, the National Cancer Institute (NCI); Gingko 
biloba for dementia, the National Institute on Aging (NIA), the 
National Heart, Lung and Blood Institute (NHLBI), and the National 
Institute of Neurological Disorders and Stroke (NINDS); acupuncture for 
osteoarthritis pain, the National Institute of Arthritis and 
Musculoskeletal and Skin Diseases (NIAMS); and glucosamine/chondroitin 
sulfate for osteoarthritis, NIAMS.
    NCCAM also funds 15 specialty research centers, completing the 
research infrastructure platform on which to investigate the mechanisms 
underlying CAM treatments and their health effects. NCCAM-funded 
centers cover CAM approaches for many areas of major public health 
need, including drug addictions, aging and women's health, arthritis, 
craniofacial disorders, cardiovascular diseases, neurological 
disorders, pediatrics, and chiropractic research. These centers 
constitute a major investment of NCCAM's resources and serve as the 
focal point for initiating and maintaining state-of-the art 
multidisciplinary CAM research. They develop core research resources, 
train new CAM investigators, provide community outreach and education, 
and expand the research base through collaborative research and 
outreach to scientists and clinicians.
    While CAM remedies have been employed for centuries, we still 
understand little about them. By studying their underlying mechanisms, 
we could better monitor their actions and develop biomarkers whose 
changes would correlate with beneficial clinical outcomes. Thus, we 
would be better positioned to reveal which CAM modalities work and 
which do not, and inform the public accordingly.
    One prospect is acupuncture, which, after millennia of empiric 
development and widespread use in Asia, has emerged as an exciting but 
still poorly understood tool for pain management. The ancients imagined 
pain as a result of imbalances in energy flow through defined body 
channels, or meridians. By inserting needles at precise points, 
practitioners attempted to correct the pain-provoking energies. In 
contemporary neurobiological terms we understand chronic pain as a 
result of abnormal actions within key nerve-signaling pathways from the 
periphery to the central brain. NCCAM grantees are testing the value of 
acupuncture for pain relief and learning more about its mechanisms of 
action. Studies using remarkably sensitive imaging techniques have 
pinpointed pain processing centers in the brain and showed that the 
activity of these centers is altered when needles are inserted at the 
body sites defined by the ancient Chinese practitioners as affording 
pain control. Acupuncture-mediated analgesia is not imagined, it is 
real. Our clinical trials are exploring the range of conditions for 
which acupuncture may provide effective pain relief. Our largest such 
study of acupuncture involves the pain of osteoarthritis.
    In the largest and most rigorous trial of acupuncture to date, 
cosponsored by the National Institute of Arthritis and Musculoskeletal 
and Skin Diseases (NIAMS), the short- and long-term safety and efficacy 
of acupuncture for the pain of osteoarthritis of the knee are being 
evaluated. In this six-week study, 570 aging Americans are being 
randomly assigned to: (1) true acupuncture; (2) sham acupuncture; or 
(3) standard education and attention. The goal is to determine whether 
patients receiving true acupuncture experience significantly less pain 
and fewer limitation than patients in the other groups. A separate 
follow-up of the patients in this study will evaluate the long-term 
outcomes and cost-effectiveness of the acupuncture intervention.
    Another key area of interest is the use of CAM to treat coronary 
artery disease (CAD), which is the leading cause of mortality for both 
men and women in the U.S. Despite increasingly effective conventional 
treatments for CAD, many turn to alternative approaches including the 
use of ethylenediaminetetraacetate (EDTA) chelation therapy, a popular 
but controversial approach. To date, however, studies of chelation 
therapy for CAD have been few, very small in size, and poorly designed, 
affording few conclusions concerning its true safety and effectiveness. 
To address this important public health issue, NCCAM plans, in 
collaboration with the National Heart, Lung and Blood Institute 
(NHLBI), to fund the first major, multi-site, clinical trial to 
investigate the efficacy and safety of EDTA chelation therapy in 
individuals suffering from CAD, using rigorous trial design and 
validated outcomes measures: a solicitation (RFA) has been released.

                                 CANCER
    NCCAM is applying this same energy and commitment to studies of 
cancer. Our rapidly growing research portfolio encompasses both the 
study of CAM cancer interventions and palliative care. In fiscal year 
2000 NCCAM funded two new Specialty Research Centers dedicated to 
studying the safety and effectiveness of several popular CAM cancer 
therapies. One center is evaluating the mechanisms of action, safety, 
and clinical efficacy of hyperbaric oxygen (oxygen at greater-than-
atmospheric pressures) treatment for head and neck cancers. The other 
center conducts studies of breast cancer as well as the first 
randomized, placebo-controlled clinical trial of a popular mixture of 
eight Chinese herbs, known as PC-SPES, in men with hormone-refractory 
prostate cancer. This latter study will evaluate PC-SPES for disease 
progression, bone pain, and quality-of-life issues, such as changes in 
sexual function, that so often accompany prostate cancers and their 
treatment. (The name PC-SPES means hope for prostate cancer.)
    Some menopausal and postmenopausal women find symptom relief 
through conventional estrogen replacement therapy (ERT). Research has 
also shown that ERT benefits cardiovascular, skeletal, genitourinary, 
and cognitive health. Despite these benefits, less than 20 percent of 
American women use ERT, in part because it seems to be associated with 
an increased risk of breast cancer. This dissuades some women from 
using it and excludes its use for breast cancer survivors. Many women 
explore alternative approaches to estrogen replacement to eliminate the 
risks of conventional ERT, with the hope of reaping its benefits while 
avoiding its potential hazards. Soybeans are rich in naturally 
occurring compounds with estrogen-like activity. Several preliminary 
studies of popular soy-derived phytoestrogens (PEs) yielded unclear and 
contradictory results, leaving open the question of whether soy may 
protect against breast cancer or, like conventional ERT, promote its 
emergence. NCCAM intends to conduct Phase II clinical trials to assess 
the impact of PE supplementation on women's health after a breast 
cancer diagnosis.
    Cancer patients for whom a cure is not an option face not only the 
prospect of death, but also the diminution of quality of life and 
dignity, and intractable pain. Perhaps as many as 70 percent of these 
cancer patients seek complementary and alternative therapies to expand 
options for end-of-life care. NCCAM is soliciting Phase I and II 
clinical trials of CAM modalities for: the prevention and management of 
symptoms associated with the end of life, including secondary side 
effects of chemotherapy and radiotherapy; and the enhancement of the 
patient's well-being.

                               BOTANICALS
    Botanicals, among the most popular CAM therapeutics, are relied 
upon for treatment and prevention of a number of conditions. In 
collaboration with the NIH Office of Dietary Supplements (ODS), NCCAM 
funds four Centers for Dietary Supplement Research with an emphasis on 
botanicals. The Centers identify and characterize botanicals, assess 
their bioavailability and activity, explore mechanisms of action, 
conduct preclinical and clinical evaluations, establish training and 
career development, and help select the products to be tested in 
randomized controlled clinical trials. Our plans include studying 
botanical-drug interactions, the developing standardized botanical 
products, and examining the safety and effectiveness of cranberry 
products in preventing urinary tract infections.

                           HEALTH DISPARITIES
    In conjunction with the trans-NIH effort to address U.S. health 
disparities, we have recruited a director for the NCCAM Office of 
Special Populations and charged him to expand our own research plan in 
this area. We plan to: identify the extent and nature of CAM use among 
special populations; studying the application of CAM therapies to 
reduce disparities; increase participation of underrepresented 
populations in NCCAM-supported clinical trials; and enhance the ability 
of minority institutions to support CAM research. This plan will serve 
through fiscal year 2005 as a guide for developing new initiatives to 
address minority health and health disparities. In the near term, NCCAM 
intends to determine the prevalence of CAM use by different minority 
and underserved populations, initiate studies on the use of magnesium 
sulfate in the treatment of acute asthma, and use the National Research 
Training Award (T32) mechanism to support pre- and post-doctoral 
trainees in CAM research at minority and minority-serving institutions.

               INTEGRATIVE MEDICINE AND RESEARCH TRAINING
    NCCAM has initiated a series of specific activities to facilitate 
the successful integration of safe and effective CAM modalities into 
mainstream medical practice. We conduct research that provides 
compelling evidence of efficacy and safety and publishing these 
findings in peer-reviewed journals, study factors that promote or 
impede integration, support the development of model curricula for 
medical and allied health schools and continuing medical education 
programs, and inform the public in a clear and definitive manner. In 
fiscal year 2001, we launched a new integration initiative to study 
factors that promote or impede integration, determine whether CAM 
research results can be translated to real-world settings, and support 
the evaluation of programs that integrate CAM and conventional care. 
Integrative medicine is also a key component of NCCAM's Intramural 
Research Program and a component of NCCAM's Specialized Research 
Centers.
    NCCAM's ability to achieve its research goals depends on the 
availability of a critical mass of skilled investigators in both CAM 
and conventional communities. It is our goal to increase the knowledge, 
experience, and capacity of CAM practitioners to conduct or participate 
in rigorous research. We also intend to enhance conventional 
practitioners' and researchers' knowledge and experience in specific 
CAM areas. We actively support research training by making awards to 
both institutions and individuals. Likewise, NCCAM supports mentored 
and independent trainees, from the pre-doctoral level through mid-
career and senior faculty members. The research spectrum of these 
trainees is broad, covering the continuum of basic through clinical 
studies. NCCAM supports all of the major training mechanisms offered by 
NIH.

                               CONCLUSION
    As the graying of America progresses, more of our citizens are 
choosing CAM approaches when conventional medicine fails to provide 
complete satisfaction. It is, therefore, imperative that we continue to 
expand our research portfolio, train researchers, and fund research 
studies to scientifically establish critical safety and efficacy 
information for dissemination to healthcare providers and consumers. I 
am confident that the results of our rigorous research will further 
enhance the successful integration of safe and effective CAM modalities 
into mainstream medical practice.
    I am now happy to take your questions about these or any other of 
NCCAM's activities and plans.
                                 ______
                                 

                 Prepared Statement of Allen M. Spiegel

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Institute of Diabetes 
and Digestive and Kidney Diseases (NIDDK) for fiscal year 2002, a sum 
of $1,457,915,000, which reflects an increase of $154,098,000 over the 
comparable fiscal year 2001 appropriation. The NIH budget request 
includes the performance information required by the Government 
Performance and Results Act (GPRA) of 1993. Prominent in the 
performance data is NIH's second annual performance report which 
compares our fiscal year 2000 results to the goals in our fiscal year 
2000 performance plan. As performance trends on research outcomes 
emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
    The NIDDK supports research on a wide range of chronic, 
debilitating diseases including diabetes; hepatitis and other liver 
diseases; inflammatory bowel disease; interstitial cystitis and other 
bladder conditions; prostatitis and benign prostate enlargement; 
several anemias; and polycystic kidney disease and other causes of end-
stage kidney failure. The economic burden of these diseases accounts 
for a major portion of U.S. health care expenditures. Advances in 
biomedical research are critical if we are to mitigate the human and 
economic burden of these diseases. With the generous support Congress 
has provided, NIDDK-supported scientists are well positioned to 
identify the causes of the diseases within our mission, to help 
identify people at risk for development of these diseases, and, 
ultimately, to provide novel approaches to prevention and treatment.

                                DIABETES
    One of the most important health care issues facing our Nation is 
the increasing burden of diabetes. According to the Centers for Disease 
Control and Prevention (CDC), diabetes affects an estimated 16 million 
Americans, one-third of whom are unaware they have the disease and are 
therefore untreated. An estimated 30 million additional Americans have 
a pre-diabetic condition known as impaired glucose tolerance. Within 
the last year, scientists have made tremendous progress in 
understanding and treating both type 1 and type 2 diabetes. Type 1, or 
juvenile diabetes, occurs when the body's immune system destroys the 
insulin-producing beta cells in the islets of the pancreas. Type 2 
diabetes, previously called non-insulin dependent or adult-onset 
diabetes, results from the body's inability to respond to insulin 
effectively--a condition known as insulin resistance--followed by a 
failure of the beta cells to produce sufficient insulin.
    People with type 1 diabetes must take regular insulin injections to 
survive. However, insulin represents only a treatment for type 1 
diabetes, not a cure. Recent advances have created new hope for a cure 
for type 1 diabetes through pancreatic islet transplantation. The NIDDK 
is supporting several clinical trials to expand upon a promising study 
in which islet transplantation permitted a small number of people with 
type 1 diabetes to remain healthy for over a year without daily insulin 
injections. We are also supporting research on many aspects of beta 
cell development and function so that we can address the problem of the 
inadequate supplies of donor pancreatic tissue for transplantation, 
possibly by developing alternative sources of islet beta cells. In 
addition, we are supporting research on alternatives to lifelong 
immunosuppressive drug treatment currently required to prevent 
rejection of transplanted islets. One innovative approach uses a short 
course of therapy to teach the immune system to accept a transplant as 
``self,'' avoiding tissue rejection without global immunosuppression. 
Not only do these novel approaches to educating the immune system 
increase the likelihood of achieving a true cure for type 1 diabetes, 
they also offer hope of preventing the disease in those at risk. Trials 
of innovative prevention measures will be performed as part of our 
newly-created type 1 diabetes TrialNet.
    Type 2 diabetes is a ``complex genetic disease'' with subtle 
changes in the function of several genes contributing to disease 
susceptibility. Despite the technical difficulties in identifying such 
gene changes, researchers studying a population of Mexican Americans 
who are particularly prone to type 2 diabetes identified changes in a 
gene--NIDDM1--that correlate with development of the disease. The 
product of this gene--calpain 10--is present in pancreatic islets, 
muscle, and liver--all tissues that are involved in insulin and glucose 
processing. Scientists have identified at least three other chromosomal 
regions whose products may interact with NIDDM1 to increase 
susceptibility to type 2 diabetes. Knowledge of the genetic basis for 
diabetes susceptibility paves the way to improved prevention and 
diagnosis by identifying individuals at risk, and to improved treatment 
by providing new targets for therapy.
    Obesity is a major risk factor for type 2 diabetes. The alarming 
increase in the number of people who are overweight or obese in the 
U.S. population has led to a coincident increase in type 2 diabetes in 
adults, and even in children and adolescents. Successful control of 
body weight could therefore profoundly diminish the incidence of type 2 
diabetes. In just the past few years, there have been major advances in 
our understanding of how weight is regulated. Scientists have 
identified many of the steps in a complex pathway that controls both 
appetite and metabolic rate. An imbalance in this regulation can lead 
to the accumulation of excessive body fat. Until recently, the precise 
mechanism by which excess fat led to insulin resistance and type 2 
diabetes was unclear. However, several recent advances have changed the 
way scientists view fat, and have underscored that fat--far from being 
an idle repository of excess energy--is in fact a dynamic tissue that 
produces a number of hormones with the potential to influence appetite 
and metabolism.
    Leptin, a protein produced by fat cells that acts on the brain to 
suppress appetite, was discovered just six years ago, but has already 
entered clinical trials in humans. More recently, by ``mining'' mouse 
and human genome sequences, scientists have identified other hormones 
produced by fat cells that act on muscle and liver--the primary sites 
in the body of glucose metabolism and insulin action. For example, 
NIDDK grantees identified a protein produced by fat cells they termed 
``resistin,'' because it promotes insulin resistance. Obesity causes 
increased levels of resistin in blood, thus providing a direct link 
between excess body weight and the diminished insulin sensitivity often 
seen in overweight individuals. Another group of NIDDK-supported 
investigators identified another protein produced by fat cells--called 
Acrp30--that acts to increase fat metabolism in muscle, thereby 
promoting weight loss. Together, these studies indicate that fat cells 
produce hormones that may either promote or inhibit insulin 
responsiveness. Under normal circumstances, these two opposing signals 
keep each other in check. However, in obese individuals, this balance 
may be perturbed, and drugs that block or mimic these hormones may 
prove useful in both prevention and treatment of obesity and type 2 
diabetes.
    In addition to genetic susceptibility, the environment exerts an 
influence on the development of obesity and type 2 diabetes. The NIDDK 
is therefore supporting initiatives on environmental approaches to 
obesity prevention, including educational efforts. We are launching a 
major initiative aimed at prevention and treatment of type 2 diabetes 
in children and adolescents. A major multi-center clinical trial, the 
Diabetes Prevention Program (DPP), is testing the ability of lifestyle 
and drug intervention strategies to prevent type 2 diabetes in 
individuals with impaired glucose tolerance who are at high risk for 
the disease. The results of this trial, slated for completion in 2002, 
may have major public health implications for the prevention of type 2 
diabetes.
    Diabetes is the leading cause of end-stage kidney failure, new 
cases of blindness in adults, and non-traumatic lower limb amputations. 
It also causes increased susceptibility to urinary tract infections and 
a progressive form of fatty liver disease known as non-alcoholic 
steatohepatitis (NASH). Heart disease is the leading cause of death in 
diabetics, and the NIDDK is sponsoring a clinical trial--Look AHEAD--
that will determine whether sustained weight loss in obese people with 
type 2 diabetes can reduce the incidence of cardiovascular 
complications. According to the American Diabetes Association, diabetes 
cost the country $98 billion in 1997, and over half of this expense was 
related to the disability, lost productivity, and early mortality 
associated with the disease. We know that prevention of diabetes, and 
where prevention is not possible, optimal management of the disease, 
not only alleviates human suffering but is cost-effective. For this 
reason, the NIDDK is exploring many avenues of prevention and treatment 
for diabetes and its complications, including basic genetic and 
molecular studies, development of animal models to facilitate testing 
of new drugs, therapeutic gene transfer techniques, and drug 
intervention trials. We are also increasing the resources available to 
our Diabetes Research and Training Centers to enhance efforts in 
diabetes prevention and treatment, and are expanding the National 
Diabetes Education Program (NDEP), which supports community-based 
multi-cultural efforts to increase diabetes awareness, to improve care 
of people with diabetes.

              HEPATITIS C AND OTHER CHRONIC LIVER DISEASES
    The NIDDK supports research on many other serious diseases, 
including liver disease arising from a range of causes. In the U.S., 
infection with the hepatitis C virus is a leading cause of liver 
failure and can lead to liver cancer. The newly-initiated HALT-C trial 
is testing whether long-term antiviral treatment can eliminate the 
hepatitis C virus in patients who fail to respond to conventional 
treatment. We are also initiating a trial of interferon treatment for 
hepatitis C in African Americans, whose disease is often resistant to 
the standard treatment regimen.
    The NIDDK is also studying NASH, a disease characterized by fat 
deposition in the liver that can lead to inflammation, fibrosis, and 
cirrhosis. NASH is most often seen in overweight individuals and is 
associated with diabetes and insulin resistance. NIDDK plans a clinical 
research network to study the natural history, complications, and 
possible therapies for NASH. Whatever the precipitating cause, liver 
failure is ultimately only treatable currently through liver 
transplantation. Unfortunately, the need for donor livers far outstrips 
the supply of available organs. The NIDDK organized a workshop in 
December 2000 to assess recent advances in adult-to-adult living donor 
liver transplantation. An important outcome of this meeting is the 
development of a research initiative for a prospective database to 
further knowledge about the consequences of living donor liver 
transplantation, both for the donor and the recipient.

        INFLAMMATORY BOWEL DISEASE AND OTHER DIGESTIVE DISEASES
    The NIDDK sponsors studies on the inflammatory bowel diseases 
(IBDs), ulcerative colitis and Crohn's disease, including efforts to 
identify their genetic and environmental causes. A contributing factor 
to both conditions is believed to be an inappropriate reaction by the 
body's immune system to the bacterial flora normally present in the 
gut. Previous research on mouse models of IBD led to the discovery of a 
factor responsible for gut inflammation, and ultimately to development 
of an antibody to neutralize this factor that has been shown to be 
effective in treatment of Crohn's disease. In recent studies, NIDDK-
supported investigators have identified a strain of mice that 
spontaneously develop intestinal inflammation remarkably similar to 
Crohn's disease. They have shown that these mice can be efficiently 
used to test new treatments for the disease. In the future, the NIDDK 
plans an IBD Genetics Consortium to facilitate identification of 
susceptibility genes, and a clinical network to accelerate studies of 
prevention and treatment of IBD.

         END-STAGE RENAL DISEASE AND POLYCYSTIC KIDNEY DISEASE
    According to the United States Renal Data System, individuals with 
diabetes account for approximately 45 percent of patients with end-
stage kidney disease. Because of this, the NIDDK is concentrating its 
efforts on preventing diabetic kidney disease and slowing its 
progression. The Institute is expanding the FIND (Family Investigation 
of Nephropathy and Diabetes) consortium to identify genetic loci and, 
ultimately, the specific genes that influence susceptibility to, and 
severity of, diabetic nephropathy. The Institute is also investigating 
the causes and possible new treatments for FSGS (Focal Segmental 
Glomerular Sclerosis), an important cause of kidney failure in children 
and young adults. The Institute plans a multi-center clinical trial to 
study treatment approaches for FSGS.
    NIDDK support is also making a difference in understanding other 
important causes of irreversible kidney failure such as polycystic 
kidney disease (PKD). NIDDK-funded researchers are studying non-
invasive means of assessing PKD progression, which will facilitate a 
planned clinical trial of drug intervention to slow progression. A new 
prospective observational study is aimed at understanding the factors 
responsible for the high incidence of heart disease in patients with 
end-stage kidney disease. Because folate lowers levels of homocysteine, 
a known risk factor for heart disease, we are also planning a clinical 
trial on the use of high doses of this vitamin in the prevention of 
heart disease in renal transplant recipients. We are also launching a 
National Kidney Disease Education Program to address the rising 
incidence of end-stage kidney disease, particularly in various minority 
groups.

                           UROLOGIC DISEASES
    The NIDDK is sponsoring initiatives to promote understanding of a 
range of urologic diseases, including interstitial cystitis, benign 
prostatic hyperplasia (BPH), and chronic prostatitis. The Institute is 
working to organize a compendium of ``Urologic Diseases in America'' 
that will describe the changes in the epidemiology, health economic 
impact, and practice patterns for each of the diseases currently 
included within the scope of urology. The Institute has recently 
organized a Progress Review Group for Bladder Research to develop a 
future research agenda. We are also building on our Medical Therapy of 
Prostatic Symptoms (MTOPS) Trial with a national registry of prostate 
tissue samples that will allow urology investigators to harness genomic 
technology to study BPH and prostate cancer.
    The NIDDK continues to pursue many approaches to combat the serious 
diseases within its mission in order to relieve the burden they place 
on individuals, families, and the Nation. I appreciate the opportunity 
to address the Committee, and I thank you for your attention. I look 
forward to answering any questions you might have.
                                 ______
                                 

 Prepared Statement of Lawrence A. Tabak, Director, National Institute 
                  of Dental and Craniofacial Research

    I am pleased to present the President's budget request for the 
National Institute of Dental and Craniofacial Research (NIDCR) for 
fiscal year 2002, a sum of $341,898,000, which reflects an increase of 
$35,687,000 over the comparable fiscal year 2001 appropriation.
    The first-ever Surgeon General's report on oral health was released 
last year, and the good news was that Americans as a whole have 
benefitted greatly from advances in disease prevention and health 
promotion in recent decades. Improvements in oral health because of 
research have saved the nation an estimated $5 billion a year in dental 
bills-an annual savings amounting to more than the cumulative funding 
for NIDCR since its inception in 1948.\1\ Our work is not finished, 
however. Millions of Americans still experience pain and suffering from 
complex diseases affecting the mouth and face, including oral cancer, 
cleft lip and palate, dental caries (tooth decay), periodontal (gum) 
diseases, and temporomandibular disorders. More research is needed to 
understand the associations between oral infections and conditions such 
as diabetes and low birth weight. We also need new studies to help us 
understand and eliminate oral health disparities in this country. By 
funding cutting edge biomedical and behavioral research, NIDCR strives 
to fulfill our mission of improving oral health for all Americans.
---------------------------------------------------------------------------
    \1\ Brown, L.J., T. Beazoglou and D. Heffley. ``Estimated Savings 
in U.S. Dental Expenditures, 1979-1989''. Public Health Reports, 1994, 
109, 195-203.
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  reducing oral health disparities to improve quality of life for all 
                               americans
    Scientific advances have led to substantial gains in the nation's 
oral health, but not all Americans have shared equally in these gains. 
Disparities in oral health exist at all ages and in many different 
population groups within our society. For example:
  --Cancers of the mouth and throat, which kill about 8,000 Americans a 
        year, take a disproportionate toll on African Americans, 
        particularly men. African American men are one-third more 
        likely than whites to be diagnosed with oral cancer, and their 
        5-year survival rate is only 28 percent, compared to a 53 
        percent survival rate for white men.\2\ 
---------------------------------------------------------------------------
    \2\ Miller, B.A. et al, editors. Racial/Ethnic Patterns of Cancer 
in the United States, 1988-1992. National Cancer Institute, National 
Institutes of Health. NIH pub. No. 96-4104. Bethesda (MD): National 
Institutes of Health, 1996.
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  --Dental caries, or tooth decay, is the most common chronic disease 
        of childhood--five times more common than asthma and seven 
        times more common than hay fever. Children from low-income 
        families suffer twice as much dental decay as their better-off 
        peers, and their disease is more likely to go untreated.\3\ 
---------------------------------------------------------------------------
    \3\ National Center for Health Statistics 9NCHS). Third National 
Health and Nutrition Examination Survey (NHANES III) reference manuals 
and reports. Hyattsville, MD: NCHS, U.S. Department of Health and Human 
Services, Public Health Service, Centers for Disease Control and 
Prevention, 1996.
---------------------------------------------------------------------------
  --African American adolescents are 10 times more likely than white 
        teens to suffer from early-onset periodontitis, a severe and 
        rapidly progressive form of gum disease that destroys the bone 
        supporting the teeth.\4\
---------------------------------------------------------------------------
    \4\ Albandar JM, Brown LJ, Loe H. Clinical features of early-onset 
periodontitis. Journal of the American Dental Association 1997 
Oct;128(10): 1303-9.
---------------------------------------------------------------------------
    The causes of these and other oral health disparities are not fully 
understood, but genetic, environmental, and behavioral factors all 
likely play a role. This year, NIDCR will establish Centers for 
Research To Reduce Oral Health Disparities. The centers will conduct a 
broad range of interdisciplinary research aimed at reducing health 
disparities. Much of this work will be focused on, and conducted in, 
the communities where the disproportionate disease burden is evident. 
The centers will provide ideal environments for training new 
scientists, particularly those from minority groups underrepresented in 
the scientific workforce. Because cross cutting research is essential 
for reducing health disparities, we are using mechanisms designed to 
encourage training in multidisciplinary research. Recognizing the need 
to establish the effectiveness of interventions for different 
population groups, we are also taking steps to ensure that all 
population groups are appropriately represented in clinical trials. 
These steps include providing investigators with the tools to 
facilitate community-based linkages for research. One advance with 
potential for application in community settings is the use of saliva-
based diagnostic tests. Saliva, which is easier and less invasive to 
collect than blood, is already being used in a number of tests, and may 
provide a means of detecting diseases such as oral cancer at an 
earlier, more curable stage.
  chronic infectious diseases: dental caries and periodontal diseases
    The most common oral diseases, and among the most prevalent of all 
chronic infectious diseases, are dental caries (tooth decay) and 
periodontal (gum) diseases. These diseases affect people throughout the 
life span, requiring lifelong attention by both the individual and 
health care providers. The Health Care Financing Administration 
estimates that dental expenditures by 2000 approached $60 billion, most 
of which was spent repairing teeth and periodontal tissues.
    Dental caries and periodontal diseases are infections caused by 
bacteria that accumulate in the form of a ``biofilm'' on the surfaces 
of teeth and soft tissues. NIH and NIDCR recently sponsored a Consensus 
Development Conference on the diagnosis and management of dental caries 
that pointed to the need for earlier detection of dental decay to allow 
for more conservative intervention.
    Long considered localized infections, periodontal diseases are now 
linked to a number of systemic diseases and conditions. For example, 
periodontal disease in pregnant women may contribute to the risk of 
delivering pre-term, low birth weight babies. The destructive 
inflammatory processes that define periodontal disease are also 
intertwined with diabetes. Periodontal diseases are exacerbated in 
individuals with uncontrolled diabetes, and researchers are examining 
the effects of periodontal infections on blood sugar control. These and 
other interrelationships were highlighted at a recent symposium co-
sponsored by the NIDCR entitled ``The Periodontal-Systemic Diseases 
Connection.''

  RESEARCH CREATES NEW MATERIALS FOR REPLACING AND RESTORING DAMAGED 
                                TISSUES
    As people continue to live longer, the demand increases for ``new 
parts'' to repair or replace those lost to disease, injury, and wear-
and-tear. Each year, millions of Americans suffer some type of tissue 
loss or end-stage organ failure, at a cost of more than $400 billion 
annually.\5\ Included in these figures are millions of dental, oral, 
and craniofacial procedures, ranging from tooth restorations to major 
reconstruction of facial tissues.
---------------------------------------------------------------------------
    \5\ Langer, R. and Vacanti, J.P. ``Tissue Engineering'', Science, 
May 14, 1993, 260. 92.
---------------------------------------------------------------------------
    Biomimetics (literally, to mimic biology) and tissue engineering 
are new disciplines that have emerged to meet the challenge of 
rebuilding the body. In the same way that Velcro inventor George de 
Mestral imitated the natural adhesion of burrs, biomimetics researchers 
take cues from nature to design ``bio-inspired'' materials. For 
example, NIDCR-supported scientists have created a biomimetic material 
that promotes bonding of bone-forming cells to artificial surfaces, an 
achievement with tremendous potential for improving dental and 
orthopedic implants. Poor bonding to surrounding bone is one of the 
biggest reasons for dental implant failure. The researchers synthesized 
a material that mimics a natural binding site for bone-forming cells; 
when an artificial surface is coated with the material, bone-forming 
cells respond by building new bone around the surface, creating a 
strong bond.
    Using the new technology of tissue engineering, NIDCR researchers 
are developing an artificial salivary gland that could restore salivary 
flow to patients whose own glands are destroyed by disease or radiation 
therapy for head and neck cancers. Currently no effective treatments 
exist for these patients, whose quality of life is severely compromised 
by difficulties in chewing, swallowing, and speaking and by an 
increased risk of rampant tooth decay and other oral infections. The 
NIDCR scientists are creating a small tube that could be implanted in a 
patient's cheek. The tube will be lined with cells engineered to 
secrete a saliva-like fluid. The artificial salivary gland could be 
ready for clinical testing within 5 to 7 years.

    GENETIC RESEARCH IS KEY TO UNDERSTANDING CRANIOFACIAL DISORDERS
    Genetic research by NIDCR scientists is revealing the basis for a 
number of craniofacial birth defects, offering hope to thousands of 
Americans who suffer pain, dysfunction, and emotional consequences from 
malformations of the mouth and face. Cleft lip, with or without cleft 
palate, is among the most common of human birth defects, affecting 1 in 
1,000-2,500 newborns. Most cleft disorders-in which the lip or palate 
fail to fuse properly-occur alone, although they may also be part of 
birth defect syndromes that affect many organs and tissues. Many cleft 
disorders are caused by single gene mutations. NIDCR-supported 
scientists recently identified a gene called PVRL1 as the cause of one 
form of cleft lip/palate. The gene codes for a cell surface adhesion 
protein called nectin-1. In mice, this protein aids in the development 
of the palate, teeth, and skin--the same tissues that are malformed in 
humans with a mutation in PVRL1. Other NIDCR-funded researchers have 
found that a mutation in a gene called PAX9 results in missing molar 
teeth. Their work may lead to a better understanding of congenital 
disorders in which teeth fail to develop. Approximately 20 percent of 
the population is born unable to develop a full set of permanent teeth.

  INVESTIGATING THE ORAL CAVITY'S CONTRIBUTION TO DEFENDING THE BODY 
                         AGAINST HIV INFECTION
    The specific factors that result in relatively high rates of HIV-1 
transmission by breast milk but minimal rates of transmission by saliva 
are not known. Therefore, studies of oral defense systems may prove 
instructive for development of new preventive strategies for HIV 
infection. One intriguing finding is that saliva consistently exhibits 
anti-retroviral activity, whereas breast milk only displays this 
property when collected during the first three weeks after childbirth. 
The potentially important anti-retroviral activity appears to be lost 
three weeks postpartum. While many factors likely contribute to the 
anti-retroviral activities observed in saliva and breast milk, one 
factor, called secretory leukocyte protease inhibitor (SLPI), is found 
at high levels in saliva. While SLPI levels are high in breast milk at 
birth, this anti-microbial substance virtually disappears from the milk 
three weeks after delivery. Despite the risk of HIV-1 transmission from 
breast-feeding, the risk of death from malnutrition for nonbreast-fed 
children in many parts of the world has resulted in controversial 
recommendations about breast-feeding. Studies on the timing of 
postnatal transmission of HIV-1 and the innate protective correlates 
may provide a better understanding of a ``safer'' window of breast-
feeding and the specific roles of anti-retroviral substances in natural 
secretions that could be exploited as future therapies.

    NEW METHODS NEEDED TO TREAT CHRONIC PAIN AND TEMPOROMANDIBULAR 
                               DISORDERS
    Most people have experienced some form of oral-facial pain. A 
variety of painful facial conditions may interfere with vital functions 
such as eating or speaking. NIDCR scientists are continuing to develop 
novel approaches to selectively block pain receptors in the body. A 
recent study in an animal model makes use of gene therapy to deliver a 
message to cells that ``tricks'' them into producing reduced levels of 
pain receptors on their surfaces. If similar techniques can be designed 
to work in humans, this approach may benefit chronic pain patients.
    Various factors, including trauma, can give rise to pain and 
dysfunction in the temporomandibular joints and surrounding muscles--
conditions collectively called TMD. The multiplicity of factors that 
may cause or contribute to TMD has unfortunately led to an even greater 
number of treatments that have not been validated. NIDCR is conducting 
clinical trials looking at the effects of conservative versus surgical 
interventions, with preliminary findings indicating that surgical 
interventions offer no increased benefits. To address the needs of 
patients who require joint replacement, NIDCR is conducting basic 
research on engineering more biocompatible implants. Given the 
complexity of TMD and the need to approach this condition in a 
multidisciplinary manner, the Institute established the TMD Interagency 
Working Group to facilitate progress in dealing with these disorders 
through cooperation, communication, and collaboration among the many 
Federal agencies that conduct or support TMD-related research and 
direct provision of health care services.

                 GOVERNMENT PERFORMANCE AND RESULTS ACT
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) Of 1993. 
Prominent in the performance data is NIH's second annual performance 
report which compares our fiscal year 2000 results to the goals in our 
fiscal year 2000 performance plan. As performance trends on research 
outcomes emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
    I became Director of NIDCR eight months ago with great enthusiasm 
about the opportunities to make a difference in improving the nation's 
oral health through biomedical research. As NIDCR Director, one of my 
main goals is to accelerate our progress toward relieving the burden of 
the many chronic and costly diseases that affect the mouth and face. 
Having been an NIDCR grantee for many years, I knew before arriving how 
important the Institute is to the scientists who conduct oral, dental, 
and craniofacial research and to the well being of the people of this 
country. Seeing it work from the inside has given me a new appreciation 
for the organization, its talented and dedicated staff, and the role of 
the Institute nationally and internationally.
    Thank you for the opportunity to provide you with information on 
NIDCR's research efforts.
                                 ______
                                 

  Prepared Statement of Dr. Judith L. Vaitukaitis, Director, National 
                     Center for Research Resources

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Center for Research 
Resources (NCRR) for fiscal year 2002, a sum of $974,038,000, which 
reflects an increase of $156,785,000 over the fiscal year 2001 
appropriation.
    It is a pleasure once again to have the opportunity to present the 
accomplishments of NCRR-supported research and future directions for 
NCRR programs. With the human genome and several others essentially 
sequenced, biomedical research is entering a new age. Up until now, 
biomedical science has benefitted greatly from a reductionist 
perspective which examines single genes or their encoded macromolecules 
to determine the cause of disease. But today, new research technologies 
enable scientists to pry ever deeper into the cell to uncover the 
structural and functional secrets of the ribosome which serves as the 
cell's protein factory and also to find hundreds of disease-associated 
proteins. With advanced technologies investigators have discovered 
defective membrane potassium channels responsible for some forms of 
epilepsy or abnormal heart rhythms that may be fatal if the genetic 
abnormalities resulting in altered potassium channel function are not 
detected and treated.
    Sophisticated biomedical research now frequently requires a 
multidisciplinary approach with teams that include physician-
investigators, physicists, bioinformaticists, physical chemists, 
structural biologists, and others. The research team must not only take 
full advantage of existing novel research tools but must also develop 
novel ones to solve new complex research problems.
    To facilitate this new paradigm for research, NCRR's programs need 
to modify or generate new, more sophisticated resources to enable 
research in the 21st century. NCRR provides the critical research 
infrastructure that enables all lines of biomedical inquiry, from the 
molecular level to the whole organism. Specially adapted clinical 
research facilities assure that the fruits of bench research reach the 
patient. The network of NCRR's General Clinical Research Centers 
(GCRCs) require sophisticated core laboratories and bioinformatics 
tools to facilitate research. To foster multisite research 
collaborations, NCRR supports development of web-based research 
networks for clinical trials and research on the molecular and other 
causes of disease.
    To enhance access to costly technologies, NCRR works in partnership 
with other Federal agencies, such as the Department of Energy and the 
National Science Foundation (NSF). For decades, NCRR has funded a 
substantial research effort to improve x-ray crystallography 
techniques. NCRR has been a pivotal player in developing very high 
intensity x-ray sources for biological research at the national 
synchrotron facilities, through cooperative approaches with DOE and NSF 
staff. The nation's synchrotron facilities are critical for 
ascertaining the structures of biological molecules encoded by 
thousands of genes. With the incorporation of robotics, newer imaging 
technologies along with methods to automate data collection and 
processing, an appropriately equipped research resource may conduct 
more than one hundred thousand crystallization experiments per day! 
Using NCRR research resources, studies in the past required years of 
effort, will be accomplished in a week!
    NCRR also supports programs to enhance the research capabilities of 
minority-serving graduate institutions through the Research Centers in 
Minority Institutions (RCMI) program. Separately, through the 
Institutional Development Award (IDeA) program, NCRR provides funding 
for capacity building for biomedical research in those States which 
have not previously participated fully in the research programs of the 
NIH. The current cohort of 23 IDeA-eligible States and Puerto Rico 
receives about five percent of NIH grant funds annually.

                     GENOMICS AND GENETIC MEDICINE
    To determine the genetic causes of diseases, large numbers of 
patients must be screened for specific gene variants. NCRR proposes to 
support national genotyping laboratories to provide a cost-effective, 
high throughput approach. Genotyping attempts to find nucleotide 
substitutions at specific points, or loci, within a gene that may be 
defective and cause disease. In addition, NCRR proposes to expand the 
capacities of its mouse mutant regional resource centers network to 
accommodate a rapidly expanding pool of mouse mutants and to support a 
web-based catalog of their genetic variants and physical 
characteristics or phenotype. The mutant mouse network's catalog will 
facilitate investigator access to mouse mutants needed for their 
research.
    Scientists today urgently need improved or new technologies to 
study the thousands of proteins that interact with one another to make 
a cell function as a tightly controlled unit. This complex research 
requires an integrated or systems approach. In response, NCRR proposes 
to develop and support comprehensive Integrated Biomedical Technology 
Resource Centers, where multiple complementary technologies examine the 
inner workings of both healthy and diseased cells. Research areas that 
can be facilitated through integrative approaches include those for 
proteomics, imaging, structural biology and glycobiology.
    NCRR proposes to develop the rhesus macaque as an nonhuman primate 
model of genetic disease in humans. In collaboration with the National 
Human Genome Research Institute, NCRR will provide support for the 
development of BAC (Bacterial Artificial Chromosome) libraries as well 
as for genetic and radiation hybrid maps. New technologies have made it 
theoretically possible to selectively modify genes of nonhuman primates 
to create defects that mimic human diseases, such as cystic fibrosis. 
Studies will also address how risk factors modulate gene function in 
polygenic disorders such as type 2 diabetes mellitus and hypertension.

             BIOENGINEERING, BIOIMAGING, AND BIOINFORMATICS
    Today's biomedical research depends on sophisticated research 
technologies more so than in the past. NCRR proposes to increase 
support for instruments in the $100,000 to $500,000 range through its 
Shared Instrumentation Grant (SIG) Program. The off-the-shelf 
instruments in greatest demand through the SIG program include confocal 
microscopes, NMR spectrometers, cell sorters, mass spectrometers and 
protein/DNA sequencers. To address the broad research community needs 
of the instrumentation that costs between $500,000 and several million 
dollars, NCRR proposes to initiate a new program to provide advanced 
instrumentation that includes very-high-field NMR spectrometers, 
synchrotron facilities, mass spectrometers, cryoelectron microscopes, 
and high-performance supercomputers.
    To further enhance the national infrastructure for biomedical 
research, NCRR will establish a biomedical imaging research network 
(BIRN) test bed for development of hardware, software, and protocols to 
effectively share and mine data in a site-independent manner for both 
basic and clinical research. For this undertaking, NCRR has teamed up 
with the San Diego Supercomputer Center, one of three National Science 
Foundation-supported centers for advanced computational infrastructure, 
to provide biomedical investigators access to sophisticated modeling 
and computational tools. Other partners include the NSF, University of 
California at San Diego and several NIH Institutes along with seven 
institutions with NCRR-supported general clinical research centers, co-
located with imaging technology centers. The BIRN will include image 
data with high-bandwidth requirements, as well as genomic, structural, 
and gene expression data. The BIRN will be designed so that it can be 
readily expanded to meet the evolving needs of basic and clinical 
investigators across a network of resource centers that provide access 
to specialized research facilities, repositories and regional core 
facilities to enable research nationwide.

               NEW PREVENTIVE STRATEGIES AGAINST DISEASE
    Not all research advances lie in medical genetics. Scientists have 
observed recently that transplantation of insulin-producing human 
pancreas cells, called islet cells, to patients with type I diabetes 
can free them from the need for insulin injections. But to get a 
sufficient supply of these scarce and difficult-to-isolate cells, cell-
harvesting efficiency and islet cell stability need to be optimized. To 
pursue these very promising results, which eventually may provide a 
cure for type I diabetes, NCRR--together with the National Institute of 
Diabetes and Digestive and Kidney Diseases and the Juvenile Diabetes 
Research Foundation International-will establish several Islet Cell 
Resource Centers to optimize the isolation, purification, and function 
of islet cells for transplantation into patients with type I diabetes.
    As clinical research becomes more complex and promising new 
therapies are evaluated, more attention to the safety of research 
subjects must be taken. The NCRR will provide support for a Research 
Subject Ombudsman (RSO) at each General Clinical Research Center (GCRC) 
and RCMI Clinical Research Center to ensure that the research subject 
monitoring plan at these resources is fully implemented and carried out 
according to the Institutional Review Board-approved protocol. The 
Ombudsman will also ensure that investigators report serious adverse 
events within a required time frame to appropriate agencies, offices or 
Boards. Th RSO will also keep patients and volunteers informed about 
the research projects and clinical trials in which they participate.

                           HEALTH DISPARITIES
    To address the health concerns of minority populations, NCRR 
proposes to establish Comprehensive Centers for Health Disparities 
Research at minority-serving medical schools associated with the NCRR-
funded Research Centers in Minorities Institutions. These Centers will 
further develop their medical schools' capacities to conduct basic and 
clinical research on type II diabetes and cardiovascular disease, which 
disproportionately affect minority populations. The Centers will 
support further development of the host institution's research 
infrastructure, including laboratories, faculty recruitment of 
established clinical investigators and development of promising junior 
faculty. Collaboration with nearby research-intensive universities will 
be strongly encouraged. To further strengthen these minority 
institutions, NCRR also proposes to establish a Web-based clinical 
trials network for minority-serving institutions. This new network will 
better position minority-serving medical schools to more fully 
participate in NIH-supported research, including multi-site clinical 
trials that address diseases that disproportionately affect minorities 
and underserved populations.

                RESEARCH TRAINING AND CAREER DEVELOPMENT
    Proper training in research methodology is essential for young 
scientists. NCRR proposes to initiate new mentored programs for medical 
and veterinary students to develop their research skills and pique 
their interests in research careers to enhance the pool of well-trained 
young physicians and veterinarians who will become the independent 
investigators for tomorrow's health-related research.
    In addition to expanding support for the Mentored Patient-Oriented 
Research Career Development Award (K23), NCRR proposes to initiate a 
new career development program for physicians and dentists through a 
mentored institutional Clinical Research Scholars (CRS) program. That 
CRS pilot program will be phased in over several years at approximately 
ten institutions. The flexible program will provide tuition support for 
didactic courses, leading to an M.S., Ph.D. or M.P.H. degree. The CRS 
program support for candidate development of clinical and bench 
patient-oriented research skills in a mentored setting is central to 
this new program. The long term CRS program goal is to enhance the pool 
of high quality independent clinical investigators.

                           RESEARCH CAPACITY
    Adequate, up-to-date facilities are indispensable for biomedical 
research, but according to a 1998 NSF survey, biomedical research 
institutions had to defer $5.6 billion for needed construction and 
renovation projects. The greater biocomplexity of modern research 
requires state-of-the-art research facilities. The NSF survey estimated 
that less than half of existing research facilities could conduct 
sophisticated biomedical research. Through the NIH Research Facilities 
Improvement Program, NCRR will expand its support to help address this 
need.
    Modern research facilities are also needed to provide care and 
housing for chimpanzees that were originally bred for AIDS research. So 
far, chimpanzees have not proven to be suitable models for studies of 
AIDS pathogenesis, but they are essential for studies of respiratory 
syncytial virus, hepatitis, malaria, and possibly for AIDS vaccine and 
gene vector development. To consolidate the NIH-supported chimps into 
just two or three sites, animal housing must be constructed to provide 
cost-effective facilities that will assure the well-being and safety of 
the animals and people who work with them. Funding to construct a 
chimpanzee sanctuary system is also needed to accommodate chimpanzees 
no longer eligible or required for research.
    NCRR proposes to increase the level of support for the Animal 
Facilities Improvement Program. About half of all NIH research grants 
include animal research models and institutions need to build specially 
adapted, modern research facilities to accommodate these genetically 
altered rodents. A special initiative to upgrade the research animal 
facilities of minority graduate and health profession schools will be 
continued to help those institutions meet PHS standards and receive 
accreditation by the Association for Assessment and Accreditation of 
Laboratory Animal Care (International).
    Through the Biomedical Research Infrastructure Network (BRIN), the 
NIH's Institutional Development Award program enhances the educational 
infrastructure and research capacities of institutions within 23 
eligible States and Puerto Rico. The BRINs provide support for 
laboratory renovation and scientific equipment, as well as the 
recruitment and support of faculty at eligible institutions. In fiscal 
year 2002, NCRR proposes to further develop the BRINs that were 
initially established in fiscal year 2001. In addition, those States 
that did not receive a BRIN award in fiscal year 2001 will have a 
special opportunity to compete for this award in fiscal year 2002.
    The NIH budget request includes the performance information 
required by the Government Performance and Results Act (GPRA) of 1993. 
Prominent in the performance data is NIH's second annual performance 
report which compares our fiscal year 2000 results to the goals in our 
fiscal year 2000 performance plan. As performance trends on research 
outcomes emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
    My colleagues and I will be happy to respond to any questions you 
may have.
                                 ______
                                 

Prepared Statement of Jack Whitescarver, Ph.D. Acting Director, Office 
                            of AIDS Research

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the AIDS research programs of the 
NIH for fiscal year 2002, a sum of $2,501 million, an increase of $258 
million above the comparable fiscal year 2001 appropriation. The NIH 
budget request includes the performance information required by the 
Government Performance and Results Act (GPRA) of 1993. Prominent in the 
performance data is NIH's second annual performance report which 
compares our fiscal year 2000 results to the goals in our fiscal year 
2000 performance plan. As performance trends on research outcomes 
emerge, the GPRA data will help NIH to identify strategies and 
objectives to continuously improve its programs.
    The National Institutes of Health (NIH) represents the largest and 
most significant single public investment in AIDS research in the 
world. It supports a comprehensive program of basic, clinical, and 
behavioral research on HIV infection and its associated opportunistic 
infections and malignancies to better understand the basic biology of 
HIV, develop effective therapies to treat it, and design interventions 
to prevent new infections from occurring. This research is conducted 
through intramural and extramural studies in the U.S. and around the 
world, sponsored by nearly all of the NIH Institutes and Centers. Each 
NIH component supports HIV/AIDS-related research activities, consistent 
with its individual mission. It is the role of the Office of AIDS 
Research (OAR) to plan and coordinate this research, setting the 
scientific agenda and the budget necessary for this large and diverse 
NIH AIDS research program.

                         THE EXPLODING PANDEMIC
    The AIDS pandemic is the greatest international challenge of our 
generation. HIV has infected more than 50 million people around the 
world. AIDS already has killed more than 21 million people, surpassing 
tuberculosis and malaria as the leading infectious cause of death 
worldwide, according to data released by the Joint United Nations 
Programme on HIV/AIDS (UNAIDS) in the ``AIDS Epidemic Update: December 
2000'' and the World Health Report 2000 of the World Health 
Organization (WHO). (Chart 1)
    The impact of AIDS on developing nations and many former communist 
countries is staggering, with even greater potential disaster to come. 
AIDS is reversing decades of progress from important public health 
efforts, lowering life expectancy, and significantly affecting 
education, food supplies, and international businesses. Lost 
productivity and profitability, the cost of sickness and death 
benefits, and the decline in a skilled workforce in the developing 
world will have economic effects worldwide. AIDS is affecting the 
military capabilities of some countries as well as the international 
peacekeeping forces. In Africa, the epicenter of the pandemic, AIDS is 
killing ten times as many people as war, sabotaging economic 
development, leading to massive social breakdown, and creating a 
generation of orphans. (Chart 2)
    If the global spread of HIV/AIDS continues unchecked, South and 
Southeast Asia, and perhaps China will follow the disastrous course of 
sub-Saharan Africa. Rapid increases also are occurring in Eastern 
Europe and Central Asia, and AIDS remains a serious threat in Latin 
America and the Caribbean. During the year 2000, more new HIV 
infections were registered in the Russian Federation than in all 
previous years of the epidemic combined.

               THE EVOLVING EPIDEMIC IN THE UNITED STATES
    In the United States, the HIV/AIDS epidemic continues to evolve. 
Although the incidence of new AIDS cases has declined, attributed 
largely to expanded use of new antiretroviral therapies that prevent 
progression of HIV infection to AIDS, the decline in death rates 
observed in the late 1990s has leveled off. Further, according to the 
Centers for Disease Control and Prevention (CDC), the rate of new HIV 
infections has been constant at approximately 40,000 new cases each 
year since 1990, meaning that the overall epidemic is continuing to 
expand. In fact, HIV infection rates are continuing to climb in a 
number of subpopulation groups, such as women, racial and ethnic 
minorities, young homosexual men, individuals with addictive disorders, 
and people over 50 years of age. The appearance of multi-drug resistant 
strains of HIV presents a serious public health concern. These data 
forebode an epidemic of even greater magnitude in the coming years, and 
they shape our most urgent research priorities.

              COMPREHENSIVE AIDS RESEARCH PLAN AND BUDGET
    The OAR develops an annual comprehensive trans-NIH AIDS research 
plan and budget to address these priorities, based on the most 
compelling scientific opportunities that will lead to better therapies 
and prevention for HIV infection and AIDS. The planning process is 
inclusive and collaborative, involving the NIH institutes as well as 
non-government experts from academia, foundations, and industry, with 
the full participation of AIDS community representatives. The plan 
provides objectives and strategies for the five Scientific Areas of 
Emphasis of AIDS research: Natural History and Epidemiology; Etiology 
and Pathogenesis; Therapeutics; Vaccines; and Behavioral and Social 
Science; as well as for key Areas of Special Interest, which cross-cut 
all of the scientific areas: Racial and Ethnic Minorities; 
International Research Priorities; Training, Infrastructure, and 
Capacity Building; and Information Dissemination. This year, the OAR 
also led an NIH effort to develop a strategic plan for microbicide 
research, which will become an integral part of the overall plan. In 
addition, the fiscal year 2003 plan, now underway, will include a new 
section devoted to research priorities for AIDS in Women and Girls. The 
Plan serves as the framework for developing the NIH AIDS budget for 
each Institute and Center, for determining the use of NIH AIDS-
designated dollars, and for tracking and monitoring those expenditures.
    Four major themes frame the fiscal year 2002 NIH Plan for HIV-
Related Research: prevention research to reduce HIV transmission here 
in the United States and around the world; therapeutic research to 
treat those who are already infected; international research 
priorities, particularly to address the critical needs in developing 
countries; and research targeting the disproportionate impact of AIDS 
on minority populations in the United States. All of these efforts 
require a strong foundation of basic science, the bedrock of our 
research endeavor.

                     PRIORITY: PREVENTION RESEARCH
    The transmissible nature of HIV makes it radically different from 
non-transmissible diseases such as heart disease and cancer. The 
transmissibility of HIV--between individuals and across borders and 
populations--is what most defines the global pandemic and makes it 
imperative that the U.S. help address prevention and treatment needs 
worldwide. The transmissibility of the infection means that there is 
the potential for unlimited global spread. But it also means that, with 
the development of appropriate biomedical and behavioral interventions, 
there is the possibility for dramatic reductions in new infections--and 
ultimate control of the pandemic--in a way that will not be possible 
for noninfectious diseases.
    NIH supports a comprehensive approach to HIV prevention research 
that includes contributions from the biomedical, behavioral, and social 
sciences. The OAR prevention science research agenda targets 
interventions to both infected and uninfected at-risk individuals to 
reduce HIV transmission. Our biomedical prevention research priorities 
include the development of topical microbicides, strategies to prevent 
perinatal transmission-including a better understanding of risk 
associated breast-feeding-and management of sexually transmitted 
diseases. NIH also supports behavioral research strategies, including 
prevention interventions related to drug and alcohol use and risky 
sexual behaviors. Efforts continue to identify the most appropriate 
intervention strategies for different populations and sub-epidemics in 
the U.S. and around the world.

                       PRIORITY: VACCINE RESEARCH
    A safe and effective HIV preventive vaccine is essential for the 
global control of the AIDS pandemic. NIH funding for HIV vaccine 
research increased by more than 170 percent between fiscal year 1997 
and fiscal year 2002, resulting in the award of new grants to foster 
innovative research on HIV vaccines, including vaccine design and 
development, and the invigoration and reorganization of the NIH vaccine 
clinical trials effort. (Chart 3) Construction of the new intramural 
Vaccine Research Center has been completed. In February 1999, NIH-
supported investigators initiated the first AIDS vaccine trial in 
Africa. The investment in this area over the past few years will have 
enormous significance, not only for AIDS research but for other 
diseases as well, as progress made in the development of an AIDS 
vaccine will have implications for vaccines against other life-
threatening illnesses.

                      PRIORITY: TREATMENT RESEARCH
    Today, many HIV-infected people are living with the benefits 
resulting from NIH-supported research in this area. The development of 
combination regimens including protease inhibitors has extended the 
length and quality of life for many HIV-infected individuals in the 
United States and Western Europe. Unfortunately, however, highly active 
antiretroviral therapy (HAART) has failed to eradicate HIV, and a 
growing proportion of patients receiving therapy experience treatment 
failure. Some patients find it difficult or impossible to comply with 
arduous treatment regimens, develop toxicities and side-effects, or 
cannot afford their high cost of approximately $15,000 per year. Others 
fail to obtain a satisfactory reduction in viral load even while 
adhering to treatment regimens. In addition, metabolic complications, 
including insulin resistance, and body composition changes such as 
deforming deposits of abdominal adipose tissue, have emerged in 
individuals who have been on long-term antiretroviral regimens. 
Finally, an increasing number of treatment failures are linked to the 
increasing emergence of drug-resistant HIV. Thus, the need for simpler, 
less toxic, and cheaper drugs and drug regimens to treat HIV infection 
and its associated opportunistic infections (OIs), malignancies, and 
other complications, continues to be a high priority. (Chart 4)

                    PRIORITY: INTERNATIONAL RESEARCH
    To address the increasing urgency of the global AIDS pandemic, the 
OAR has established a new initiative and strategic plan for global 
research on HIV/AIDS aimed at slowing the disaster and reversing its 
destruction of communities, economies and nations worldwide. The Global 
AIDS Research Initiative and Strategic Plan reaffirms NIH's long-
standing commitment to international AIDS research and will 
significantly increase research efforts in the coming year to benefit 
resource- and infrastructure-poor nations. NIH supports a growing 
portfolio of research conducted in collaboration with investigators in 
developing countries. Results of this research benefit the people in 
the country where the research is conducted as well as people affected 
by HIV/AIDS worldwide. It is critical to the success of international 
studies that foreign scientists be full and equal partners in the 
design and conduct of collaborative studies and that they have full 
responsibility for the conduct of studies in-country. To that end, NIH 
supports international training programs and initiatives that help to 
build infrastructure and laboratory capacity in developing countries 
where the research is conducted.

                 PRIORITY: RACIAL AND ETHNIC MINORITIES
    Research to address the disproportionate impact of the HIV/AIDS 
epidemic on U.S. racial and ethnic minority communities (Chart 5) 
continues to be a high priority. We are directing increased resources 
toward new interventions that will have the greatest impact on these 
groups. These include interventions that address the co-occurrence of 
other STDs, hepatitis, drug abuse, and mental illness; and 
interventions that consider the role of culture, family, and other 
social factors in the transmission and prevention of these disorders in 
minority communities. NIH is making significant investments to improve 
research infrastructure and training opportunities for minorities, and 
we will continue to assure the participation of minority subjects in 
AIDS clinical trials as well as in natural history, epidemiologic, and 
prevention studies. OAR has provided additional funds to projects aimed 
at: increasing the number of minority investigators conducting 
behavioral and clinical research; targeting the links between substance 
abuse, sexual behaviors and HIV infection; increasing outreach 
education programs targeting minority physicians and at-risk 
populations; and expanding our portfolio of population-based research. 
One of these projects is a series of Training and Career Development 
Workshops for racial and ethnic minority investigators.

                        PRIORITY: BASIC SCIENCE
    Of paramount importance in our fight against HIV/AIDS is 
maintaining a strong commitment to basic research. Tremendous progress 
has been made in understanding the fundamental steps in the life-cycle 
of HIV, the host-virus relationship and the clinical manifestations 
attending HIV infection and AIDS. Groundbreaking research on basic HIV 
biology and AIDS pathogenesis has revolutionized the design of drugs, 
the methodologies for diagnosis, and the monitoring for efficacy of 
antiviral therapies. Thus, OAR will continue to devote a substantial 
portion of NIH AIDS-related research funds to fundamental biomedical, 
behavioral, and social science research.

                                SUMMARY
    The worldwide human and economic toll of this insidious disease is 
profound, and we will never solve the problem of AIDS for our own 
citizens without controlling the epidemic in the rest of the world. The 
nation's investment in AIDS research is reaping even greater dividends, 
as AIDS research is unraveling the mysteries surrounding many other 
infectious, malignant, neurologic, autoimmune and metabolic diseases. 
We deeply appreciate the support of this Committee for our efforts.

                 THE EXPLODING GLOBAL HIV/AIDS PANDEMIC
                              [In millions]
------------------------------------------------------------------------
                                People     People
                                newly      living      AIDS      Total
            Group              infected  with HIV/  deaths in     AIDS
                               in 2000      AIDS       2000      deaths
------------------------------------------------------------------------
Adults......................        4.7       34.7        2.5       17.5
Women.......................        2.2       16.4        1.3        9.0
Children....................         .6        1.4         .5        4.3
                             ===========================================
      Total.................        5.3       36.1        3.0       21.8

------------------------------------------------------------------------
Source: UNAIDS










    Senator Specter. We have been joined by my distinguished 
colleague, Senator Thad Cochran.
    Senator Cochran, do you care to make an opening statement?

               Opening statement of Senator Thad Cochran

    Senator Cochran. Well, Mr. Chairman, thank you. I join you 
in welcoming Dr. Kirschstein thanking her in joining us for 
this discussion of the budget for the fiscal year 2002 for NIH.
    I think she deserves our commendation, too, for her service 
to the National Institutes of Health, particularly during this 
recent transition period, but this budget is a very important 
step toward our goal of doubling the NIH budget by the year 
2003. It addresses very oppressing health needs in our country, 
and around the world, as a matter of fact.
    There are two areas I hope to see the Institutes address 
during this year. We have to deal with the disparities in 
under-served areas of our country, as well as funding 
disparities. The IDeA program is one way of enhancing research 
effort in my part of the country, where NIH research has not 
traditionally been conducted. It is interesting to note that 
these are also some of the same areas with glaring health 
disparities. The IDeA program has the potential to improve the 
health of millions of needy patients in these areas.
    An additional area of concern for me is bio-imaging and 
radiology research. The newly authorized National Institute of 
Bio-Imaging and Bio-Engineering will require a transfer of 
existing radiology and bio-engineering research to this new 
institute. We are looking forward to working with you and 
helping to provide you the benefit of our counsel and advice. 
Thank you again for being here, and for your dedicated work for 
millions of Americans.
    Thanks, Mr. Chairman.
    Senator Specter. Thank you very much, Senator Cochran.
    Dr. Kirschstein, a question which is repeatedly posed to me 
by my colleagues is, are we providing too much money too fast 
to the National Institutes of Health. What are your best 
assurances, as specific as you can be, that this rapid increase 
in your budget is being put to good use?
    Dr. Kirschstein. Mr. Chairman, the scientific opportunities 
are immense, and they have been for some time. The increases 
that the Congress has provided to the National Institutes of 
Health have been put to extraordinarily good use over the last 
several years.
    Programs in clinical research that could not possibly be 
started before have been begun, in drug abuse, in heart 
disease, new testing of vaccines, new testing of therapies for 
HIV AIDS, new studies in cancer. Dr. Klausner can describe 
several new drugs that have been developed, as can all my 
colleagues.
    The momentum is there. What is needed is to continue to 
make progress, because every question that is answered leads to 
several more questions that need to be answered, and this is a 
moment of enormous opportunity.
    Senator Specter. Is $3.4 billion sufficient to utilize and 
follow all of the existing leads?
    Dr. Kirschstein. Mr. Chairman, I think that the increase 
that the administration has given us is very fine, indeed. It 
is 13.5 percent, $3.4 billion would be even more, clearly, but 
I think we could use those funds extremely well. We have 
investigators who are full of burgeoning ideas. We have 
clinical trials that we want to do.
    We need to do some work in the states that Senator Cochran 
is talking about. Our BRIN program has been started, and the 
Senator knows. I came down and saw him last week, and we have 
all sort of wonderful opportunities. I would like to give my 
colleagues a chance to tell you about them, if possible.
    Senator Specter. You pick the first colleague to give us as 
specific an illustration as he or she can as to what this 
additional funding has meant.
    Dr. Kirschstein. Dr. Klausner.
    Senator Specter. We heard from Dr. Klausner 10 days ago, 
and we know his answers.
    Dr. Kirschstein. In that case, I will go to Dr. Lenfant. 
Either way.
    Senator Specter. Go ahead, Dr. Klausner.
    Dr. Klausner. Senator, just in case you forgot, over the 
last couple of years, with the increase in funding, we have 
been able to do a variety of things, including beginning to 
change the entire way cancer is diagnosed, as we talked about a 
few weeks ago, switching from a hundred years of pathologic 
diagnosis alone, to the new molecular diagnosis.
    We are suddenly discovering rapidly that there are new 
types of cancers that we only imagined exist, we now see exist. 
For the first time, with that, we can align therapies to the 
appropriate diagnosis.
    Senator Specter. Dr. Klausner, you testified at the hearing 
on breast cancer about the impact of stem cells. I think it 
would be good for you to summarize that here this morning.
    Dr. Klausner. Yes. What I pointed out is that in cancer we 
believe that there are two types of opportunities in stem 
cells. Of course, in cancer research we have been using stem 
cells to replace organs, generally, the bone marrow, that are 
damaged, either because of disease, or, more commonly, therapy.
    The two areas of promise with stem cell research for cancer 
are, one, understanding the fundamental biology which underlies 
cancer, and that is, how do cells make the decision to either 
keep proliferating, or to differentiate. That fundamental 
switch which underlies stem cell biology is, we believe, 
fundamental to understanding the switches that lead to cancer 
cells.
    The other issue in cancer is the fact that until we have 
better therapies currently, cancer itself, or the therapies, 
are often quite destructive of tissues, or particular organs, 
and stem cells, as they have been used successfully in cancer 
therapy, hold the promise of regenerative approaches to deal 
with the damage due to therapy or the disease.

                       ADULT STEM CELL EXPERIMENT

    Senator Specter. Dr. Lenfant, I am turning to you next. As 
Dr. Kirschstein suggested. Thank you for the response to my 
letter, in which you had pointed out that in the next 5 years 
it's projected that there will be an ability to engineer 
tissues for damage heart valves, muscles, and blood vessels, 
and the delivery of therapeutic genes, and in 10 years, 
projecting complete heart ventricles, regeneration of cardiac 
tissue, and organ growth in infants born with cardiovascular 
malformations. That is very good news, indeed. To what extent 
do the stem cells play a part in that?
    Dr. Lenfant. Well, so far, Mr. Chairman, we have been 
developing a fairly significant experiment in the use of adult 
stem cells and the results have been extraordinarily exciting 
and significant, as to what you were mentioning, the recreation 
of tissues which have been damaged, and quite successfully in 
the formation of new valves, new blood vessels. And in the case 
of, say, heart failure, which is the ultimate complication, so 
to speak, of the repeated heart attack, we can now regenerate 
some heart cells, and restore some of the functionality of the 
myocardium, which has been damaged by a repeated heart attack.
    Senator Specter. Why do you particularize adult stem cells, 
Dr. Lenfant?
    Dr. Lenfant. Excuse me?
    Senator Specter. Why did you specify adult stem cells?
    Dr. Lenfant. Because so far that is the only experience 
that we have, Mr. Chairman.
    Senator Specter. Have you not had stem cells available from 
embryos?
    Dr. Lenfant. No. No. Not in our areas of research. They 
have not been used.

                     EMBRYONIC STEM CELL POTENTIAL

    Senator Specter. We have had expert testimony that 
embryonic stem cells offer a great deal more flexibility and 
ability to differentiate that is much superior to adult stem 
cells. Would you agree with that?
    Dr. Lenfant. Yes, I would agree with that. In my scientific 
opinion, it is something that needs to be explored, but so far 
it has not been done, and all the comments that I can make are 
on the basis of what we have learned from other stem cells.
    Senator Specter. Well, I think it is very good news, 
indeed, to people who have heart disease what you have 
accomplished, and what you have the prospects to accomplish 
beyond.
    My red light went on, so I will turn to my colleague, 
Senator Cochran.
    Senator Cochran. Mr. Chairman, I have some specific 
questions about the IDEA program, and some other issues, which 
I am prepared to submit for the record, and let you move along. 
You have a lot of people here, and I have another commitment 
that requires me to leave now, but I appreciate your conducting 
the hearing, and having everyone here for the committee.
    Senator Specter. Thank you very much for joining us, 
Senator Cochran. I appreciate it.
    The issue of stem cells, I know, has been very much in the 
forefront of Parkinson's. Dr. Audrey Penn, a question that I 
have asked in each of our previous sessions has been ``When,'' 
and we had an estimate within 5 years to conquer Parkinson's. 
In light of all of the money you have gotten for research, how 
far can you advance that completion date?
    That is what you call a leading loaded question, Dr. Penn. 
You can handle it any way you like.
    Dr. Penn. I hope we can advance it. There are two responses 
to your question on record. One was 5 years and one was 10 
years, I will not claim either one, but we feel that we are 
moving very quickly on measures that will control this disease 
much better than we have ever done before. A cure is going to 
be harder, as we know, and it will take a little longer. There 
are several issues.
    In terms of the stem cell question, we have evidence 
already using stem cells or precursor cells in mouse models 
that we can really impact the types of models of Parkinson's 
Disease that we already have, these are chemically induced 
models, but the response is tremendous.
    We have not yet moved beyond that, and there may be another 
way. There may be a way of using the cells already resident in 
the brain to mobilize them. There is already evidence that that 
can be done. We hope that we can do this, because it solves 
things like gene therapy, it solves things like putting special 
factors in that could help those cells that are left to work. 
We very much think that this is a way of approaching the 
problems we are having in really curing this disease.
    Senator Specter. Let me move quickly to a couple of other 
questions----
    Dr. Penn. Yes, sir.
    Senator Specter [continuing]. Dr. Penn. Amyotrophic lateral 
sclerosis, what is the progress there, and to what extent are 
the stem cells implicated there?
    Dr. Penn. I would say, sir, that there is a group organized 
by private donors that are very much involved in doing just 
this, and they are making progress working with some of the 
best investigators in the country.
    Senator Specter. On stem cells----
    Dr. Penn. They are monitoring this. They are working with 
stem cells.
    Senator Specter. And they are private donors?
    Dr. Penn. They are private donors, and they have a very 
specific target, as you can well imagine.
    Senator Specter. What are the prospects for delaying the 
onset of ALS?
    Dr. Penn. I do not know that this approach will delay the 
onset, but it certainly could put back working motor neurons, 
so that this disease could be slowed way down. The whole group 
in the amyotrophic sclerosis community is very much involved in 
doing clinical trials.
    They want to do clinical trials as soon as possible with 
almost anything that will work, so they are organized and 
mobilized. We are still trying to put pertinent factors back in 
the spinal cord, but there is some very interesting evidence 
that stem cells may work.
    Senator Specter. And Alzheimer's comes within your branch 
as well.
    Dr. Penn. Yes, it does. Again, Dr. Hodes and NIA is the 
primary institute dealing with Alzheimer's disease.

                      ALZHEIMER'S DISEASE RESEARCH

    Senator Specter. Well, let me turn to him then, sort of 
spend around the speaking parts, and ask you, Dr. Hodes, for 
your evaluation as to what progress we are making on 
Alzheimer's, and to what extent the research is moving ahead, 
and if stem cells factor in there.
    Dr. Hodes. Thank you for the opportunity. If you will 
remember, we had the chance to speak with you before a hearing 
here not so long ago, during which there was a summary of the 
very dramatic progress in Alzheimer's research over the past 
years. The identification of genetic and molecular 
underpinnings of the disease has very directly been translated 
now into new approaches to treatment.
    They include attempts to actually interfere with some of 
the molecules, enzymes that cause some of the toxic products in 
the disease. You heard in particular about an approach to 
immune therapy, or vaccination, against Alzheimer's peptide, 
that is very exciting.
    In terms of the role of stem cells, there has been very 
exciting news over the past year indicating that in some of the 
areas of the brain that are affected by Alzheimer's, there is, 
indeed, stem cell activity, the sort Dr. Penn referred to, that 
is stem cell activity resident within the brain. One approach 
is to try to trigger differentiation of these very cells in the 
brains of individuals affected, and repair damage caused.
    In addition, there is work that has been occurring in 
animal models in which cells from a variety of sources 
unexpectedly have been shown to have the capacity, for example, 
bone marrow stem cells, to differentiate into stem cells for 
neurons, which can, indeed, repopulate the brain. So these are 
some very recent and exciting findings, which suggest that stem 
cells from a variety of sources may be capable of 
differentiating into functional neurons in the brain, and 
provide relief, or even prevention for Alzheimer's disease.
    Senator Specter. Let me turn now to Dr. Allen Spiegel, 
Diabetes Institute. The question is: I understand that the stem 
cells have been very instrumental in moving ahead on diabetes. 
Can you bring us up to date on that, please?

                  ISLET TRANSPLANTS IN TYPE 1 DIABETES

    Dr. Spiegel. I would be happy to, Chairman Specter. As you 
know, and as we discussed with your colleague, Senator Harkin, 
the Edmonton trial in Canada has demonstrated that islet 
transplantation can be a successful potential cure for type 1 
diabetes. The follow-up for this trial was updated just in 
April in a paper published in the journal Diabetes, which 
indicated that 11 of the 12 people receiving these islet 
transplants are still insulin independent. This is very 
promising.
    This protocol is being replicated in NIH-supported studies 
around the country, and at the NIH Clinical Center there has 
already been experience with four such patients, again, showing 
some success.

                      INADEQUATE SUPPLY OF ISLETS

    This is the good news. However, roughly 1,000 donor 
cadaveric pancreases, from which these islets are harvested, 
are insufficient to ever meet the need for the roughly million 
type 1 diabetics. This is why we are working intensively on 
many, many approaches to providing the supply of islets. Stem 
cell work is very important in this regard.

                           STEM CELL RESEARCH

    I will summarize briefly some of the progress to date of 
which I am aware. Mouse adult stem cells, derived from the 
pancreatic ducts, have been used in an experimental study 
published in Nature Medicine to reverse type 1 diabetes in the 
mouse model. That has not been replicated, and there have been 
some concerns as to whether there are really adequate amounts 
of insulin produced.
    In human efforts for adult stem cells coming from the 
pancreatic duct, investigators at the Joslin Clinic, whom we 
support, have isolated such adult stem cells that can turn into 
islets, but unfortunately, the amounts, to date, are 
inadequate.
    Senator Specter. The amount of what is inadequate?
    Dr. Spiegel. These cells are precursors in the pancreatic 
ducts from adult pancreases that are cadaveric pancreases, 
grown into islet-like clusters, and unfortunately, the amounts 
generated, according to the investigators in that paper, are as 
yet inadequate to be useful.
    Senator Specter. The amount of adult stem cells?
    Dr. Spiegel. That is correct, according to those 
investigators.
    Senator Specter. Do you concur with Dr. Lenfant that the 
embryonic stem cells would be superior?
    Dr. Spiegel. I cannot give you a simple answer to that, but 
I can tell you about work on mouse embryonic stem cells, which 
is what I was coming to.
    The mouse embryonic stem cell work, which can be supported 
by NIH, was actually done intramurally in the National 
Institute of Neurological Disorders and Stroke. Researchers 
demonstrated in a very, very exciting fashion that they could 
differentiate these mouse embryonic stem cells into islet-like 
clusters. Unfortunately, these cells made about a fiftieth of 
the amount of insulin of a normal beta cell, and they were 
inadequate to be able to cure diabetes in a mouse model. This 
is work of Dr. Ron McKay and colleagues, published in Science.
    As far as human embryonic stem cell work, undoubtedly it is 
going on in the private sector, perhaps in foreign countries, 
but because there are no publications that I am aware of, I 
cannot really comment.
    Finally, I would comment on the work with bone marrow stem 
cells. We have heard so much about their plasticity--the fact 
that they can turn into so many other kinds of stem cells. 
However as yet, to my knowledge, there is no evidence that they 
turn into islet cells--liver cells, possibly, but not islets.
    In summary, we just do not know at this very early stage of 
investigation which of the two types of cells--adult stem cells 
or embryonic stem cells--would be superior. I think, as a 
scientist, that one has to be cautious and not make 
pronouncements when there is no sort of adequate data yet.
    Senator Specter. Would you like to have the availability of 
embryonic stem cells to at least find out?
    Dr. Spiegel. That is something that is under review by the 
Administration, and I think we will have to see how that works 
out.
    Senator Specter. Excuse me, but what does that have to do 
with my question, what the administration wants to do? I am 
asking you as a scientist, would you like to have embryonic 
stem cells available.
    Dr. Spiegel. What I can certainly say is that a number of 
scientists, I think there were 80 Nobel Laureates, that I am 
aware of, have articulated the desire to be able to compare 
these. I think scientists around the country in the various 
centers have said exactly that. As a scientist, yes, I think we 
would like to be able to do this.
    Senator Specter. That is what I was looking for, as a 
scientist.
    Dr. Spiegel. Yes, absolutely, as a scientist, that is 
absolutely the case.

                  USE OF STEM CELL IN VISION RESEARCH

    Senator Specter. Let me move quickly before yielding to 
Senator Harkin and get some comments from Dr. McLaughlin, of 
the Eye Institute, with the focus on new cornea studies showing 
promise with stem cells. Dr. McLaughlin, how about that?
    Dr. McLaughlin. Yes, sir. That is probably, in the eye, 
field the most advanced situation for stem cell 
transplantation. In conditions such as alkaline burns, where 
the normal cells that would lead to the clear cover----
    Senator Specter. Speak more directly into the microphone, 
please, Dr. McLaughlin.
    Dr. McLaughlin. The cornea of your eye is covered by a 
single layer of cells, and this is very important. If those 
cells are unhealthy, your cornea will cloud, and you will not 
be able to see. In situations, for example, like an alkaline 
burn, the cells that normally would produce those, that single 
layer of cornea cells, they are destroyed.
    So what investigators are doing, they are taking cells--
this is from adults--that are stem cells, or precursors to 
those cornea cells, growing them up in culture, and then 
transferring them to patients who have these various corneal 
problems, and so far the results are very promising.
    Senator Specter. Let me turn now to Dr. Stephen Katz, 
National Institute of Arthritis, Musculoskeletal and Skin 
Disease, with respect to the stem cell treatment on arthritis, 
which, as I understand it, shows promise on pre-growth of skin, 
what is your view of that, Dr. Katz?
    Dr. Katz. Thank you, Senator. In all of the areas of the 
interest of the National Institute of Arthritis and 
Musculoskeletal and Skin Diseases stem cells have shown promise 
including regenerating cartilage cells in the joint in 
osteoarthritis, which is the most common form of arthritis. In 
the area of osteogenesis imperfecta, stem cells have been shown 
to be effective in regenerating some of the bone-forming cells.
    In the muscular dystrophies, stem cells in work that has 
been supported by the Neurology Institute, as well as our 
institute, have shown promise in what are called satellite 
cells, which are thought to be stem cells of muscle, to 
regenerate those muscle cells. We know also that in skin, stem 
cells are very important, as Dr. McLaughlin said, to regenerate 
epithelium that covers the skin.
    Senator Specter. Let me turn now to Dr. Anthony Fauci, 
Allergy and Infectious Diseases, with respect to the stem cell 
treatment on AIDS.
    Dr. Fauci. Senator--thank you for the question.
    One of the characteristics of HIV/AIDS disease is a rather 
dramatic and catastrophic depletion of immune system functions, 
specifically a very important cell of the immune system. 
Similar to the reconstitution of bone marrow that Dr. Klausner 
alluded to just a few moments ago in patients who are treated 
for cancer, the same would hold true with regard to the 
reconstitution of the human immune system by stem cells. Stem 
cell research is very much at the forefront of the ideas of 
individuals who are planning strategies. Once you get the virus 
under control with anti-retroviral therapy, to help the immune 
system, which might not be able to spontaneously regenerate 
itself, it may be possible to help the immune system to 
regenerate itself by providing it with these precursor cells.
    Senator Specter. Dr. Kirschstein, let me come to this 
question about their letters and the late arrival, and then I 
will turn to my distinguished colleague, Senator Harkin.
    We did not get the responses until yesterday afternoon at 
3:45. There were 42 pages, as I understand it, instead of 70. 
Why such a late return?
    Dr. Kirschstein. Mr. Chairman, the Institute directors 
received your letter on May 4th, and they were assigned for 
completion to the various institutes, to be returned to the 
central focus, the Executive Secretariat of NIH, by May 9th. I 
met you at the event for the Society for Women's Health, and 
told you, as I had told Ms. Taylor, that I was going to send 
those letters for clearance, which is the policy, to the 
department.
    Our responses, except one, which was delayed, were sent to 
the department for clearance on May 14th, and we did it--by the 
way, we always send such responses through the NIH Executive 
Secretariat, from our Executive Secretariat. At that point, the 
work was to be done, whatever, in the department for clearance.
    Senator Specter. Well, I am told that the letters were 
rewritten in the department, is that true?
    Dr. Kirschstein. Yesterday, I was called, and asked whether 
the letters, which had been reviewed, when there was an issue 
as to whether letters from individual Institute directors 
raised issues more broadly than the mission of that institute, 
would the Institute directors consider narrowing their focus to 
their own mission, and talking strictly about the scientific 
aspects, which is what I think we always address.
    I had a meeting with the Institute directors, and asked 
each of them to review what they had said, and see whether they 
wished to, in any way, modify the letters, based on whether 
they thought their letters were more broad ranging. The letters 
were then----
    Senator Specter. Whether their letters were what?
    Dr. Kirschstein. More broad ranging than focusing on the 
particular mission of the Institute. Each of the Institute 
directors then reviewed their letters, and some made changes, 
and some did not.
    Senator Specter. Well, this subcommittee would like to get 
copies of the original letters and a copy of the modifications. 
It has been reported to me that the instructions were given, 
quote, ``The answers and questions based on science, and not on 
political speculation or personal views,'' closed quote. Is 
that accurate?
    Dr. Kirschstein. It was not on speculation, but it was on 
following the mission of the Institute. The term ``personal 
views'' was never told to me; it was never mentioned to me.
    Senator Specter. Mr. Whitaker, Assistant Secretary for 
Legislative Affairs, I understand, is present. Would he step 
forward, please?
    Come up front. We can make a place for you at the head 
table.
    Mr. Whitaker. Okay.
    Senator Specter. Why the long delay, Mr. Whitaker?
    Mr. Whitaker. Honestly, Mr. Chairman, first of all, I want 
to apologize to you for the delay, but I also want to assure 
you that there was in no way an attempt on the Office of the 
Secretary's part to withhold information or control the 
information that was sent to you.

    [Clerk's note.--Page 27-32--Mr. Whitaker's office, 
Assistant Secretary for Legislation, informed ASMB that the 
letters and an explanation concerning the distribution of the 
letters were sent to the Committee the end of May, we were not 
informed of the exact date.]

    Senator Specter. Well, I am interested in your 
conclusions--
    Mr. Whitaker. It was simply----
    Senator Specter [continuing]. But only a little. Let me 
find out what the facts are here. Why the delay? What happened? 
Were those letters submitted on May 14th, as Dr. Kirschstein 
testified? Why the delay?
    Mr. Whitaker. I was told by our Executive Secretariat, 
which is the part of the Department that controls 
correspondence for the entire department----
    Senator Specter. And who is that?
    Mr. Whitaker. Anne Agnew is our executive secretary. Some 
of the letters were received on the 14th, but not all the 
letters, and that she----
    Senator Specter. But not what?
    Mr. Whitaker. Not all of the letters were received on the 
14th from the Institute directors.
    Senator Specter. Is that true, Dr. Kirschstein?
    Dr. Kirschstein. I believe, from what I know, that all of 
the letters, except one, were received on the 14th. The 
National Cancer Institute was working on its letter, and it 
came in 1 day later.
    Senator Specter. So one letter was 1 day late, is that so, 
Mr. Whitaker?
    Mr. Whitaker. That is not what I have been told by the 
Executive Secretariat. I do not control that information. The 
information is only passed on to me. I am told that the final 
letter did not come in until----
    Senator Specter. I want you to pursue that and find out 
whether Dr. Kirschstein is correct or not----
    Mr. Whitaker. Yes.
    Senator Specter [continuing]. And submit a written response 
within a week, please.
    Mr. Whitaker. I will do that, sir.
    Senator Specter. So how about the letters that were 
submitted? Why were they not transmitted to the subcommittee?
    Mr. Whitaker. As a matter of policy, the Secretary has 
asked for the right to review correspondence to Congress, as 
well as testimony to Congress, and those letters were received 
in the Office of Legislation on Thursday night, and on my desk 
on Friday evening.
    Senator Specter. Which Thursday and which Friday?
    Mr. Whitaker. This past Thursday. The date would have been 
the 17th. Then I saw the letters the following Friday evening.
    Senator Specter. What happened to them between Monday and 
Friday?
    Mr. Whitaker. I do not know, sir. The letters were----
    Senator Specter. Would you find out for me?
    Mr. Whitaker. I will find out. My assumption is that the 
letters were at the Executive Secretariat's office, and they 
were probably being compiled so that they had a complete 
package to forward to the Office of Legislation. That is my 
guess as to----
    Senator Specter. Were there any requests made for 
modification by----
    Mr. Whitaker. We made no specific requests to modify any of 
the letters. We simply asked----
    Senator Specter. Aside from a specific request, did you 
make a generalized request?
    Mr. Whitaker. We made a generalized request that we thought 
it would be best that the letters be focused on the science, 
and the science only, and that----
    Senator Specter. Well, what were the letters focused on, 
that these scientists were not writing the letters based on 
science?
    Mr. Whitaker. I believe, and Dr. Kirschstein talked to me 
about this, and to our chief of staff, and Dr. Kirschstein 
agreed, that some of the letters may have gone beyond exactly 
what the mission of each institute was, and based on some non-
scientific speculation, and Dr. Kirschstein----
    Senator Specter. These letters had non-scientific 
speculation.
    Mr. Whitaker. That was my understanding from my 
conversation with Dr. Kirschstein.
    Senator Specter. Would you make available to this 
subcommittee the specifics as to what you are talking about, 
what letters you received, and what you considered non-
scientific speculation?
    Mr. Whitaker. As a general rule, sir, we receive draft 
letters from all agencies, from HCFA, to AOA, to NIH, to CDC, 
for review. These come to us in the form of draft letters for 
us to review, and that is general policy----
    Senator Specter. I am not so much interested in that as I 
am in response to my question. Will you submit to this 
subcommittee the letters which you concluded were based on 
speculation?
    Mr. Whitaker. I will go back and look at those letters, 
sir, and I will get a response to you.
    Senator Specter. Will you submit those letters to this 
subcommittee?
    Mr. Whitaker. I would be happy to do that, sir. I obviously 
would have to clear that with the Secretary.
    Senator Specter. Well, let me be direct in my concerns 
here. This subcommittee is interested in what the potential for 
stem cells may be, and we want the scientific facts. When I get 
a report that the answers to my questions are based not on 
science, but on political speculation and personal views, 
closed quote, I am more than a little concerned. This would be 
an indication of the kind of scientists which we have here, if 
the responses were not based on science.
    If you, top-flight men and women, do not respond to the 
subcommittee based on science, I have a hard time understanding 
why we are appropriating $24 billion for you. You are 
scientists, and I would expect you to submit answers based on 
science, and I would be shocked if you did not, because I know 
your caliber and your qualifications.
    So I want to see what those responses are, whether they are 
based on science, or maybe some of you did not like the 
answers. Then when it goes on to say not on political 
speculation, well there is no place for politics in the work in 
your unit, and I want to know what the facts are on stem cells.
    I have had a discussion with the President of the United 
States on this subject, and he wants to know what the facts 
are, too, and we want them unvarnished. I talked twice to the 
Secretary of Health and Human Services about this matter. I was 
not very happy, at mid-day, the day before this hearing, not to 
have those letters.
    There are other things on my agenda between yesterday 
afternoon and this morning, like voting in the United States 
Senate on the tax bill. So I intend to get to the bottom as to 
what is going on here. Really the basic consideration is what 
is the potential for stem cells.
    There is a political fight brewing over this matter, and it 
is going to be decided in the Congress and by the President. 
When we have these extra embryos created for in vitro 
fertilization, and they create more embryos than necessary. 
Some are going to be destroyed, and there is an argument, a 
theological, philosophical, political argument about whether 
life is in existence. If life were to be created, I would be 
the last one to say let us use these embryos for stem cell 
research, but if they are going to be destroyed, it is another 
matter. But that is something to be decided in the Congress and 
by the President in accordance with our laws.
    We can pass a bill, he can sign it or veto it, and we can 
override the veto, if there are two-thirds necessary. That is 
the way these judgments are made, but from you we would expect 
the facts and the scientific evaluation. And from you, Mr. 
Whitaker, and your department, we would expect the transmission 
without editing and alteration, but we will get the details as 
to what was originally submitted, and whatever objections you 
had, and we will make our own evaluation of that.
    Senator Harkin.
    Senator Harkin. Thank you very much, Mr. Chairman. I will 
just ask that my statement be made a part of the record.
    [The statement follows:]

                Prepared Statement of Senator Tom Harkin

    Thank you, Mr. Chairman. You've been a great champion for medical 
research over the years, and I thank you for holding this hearing.
    Dr. Kirschstein, it's a pleasure to welcome back you and your 
colleagues to testify before this subcommittee. Most people probably 
don't realize how important your work is to their daily lives, and how 
lucky they are that you do it so well. But all of us on this 
subcommittee are grateful for your extraordinary dedication and 
service.
    A lot has happened since we met last spring to discuss the NIH 
budget for fiscal year 2001. Two months after that hearing, NIH 
scientists announced the completion of a draft sequence of the human 
genome--without a doubt, one of the most significant events of our 
lifetime.
    And just two weeks ago, the NIH made another exciting announcement: 
the FDA approval of the most promising cancer drug ever developed. This 
drug, called Gleevec, was given to 54 patients with chronic myelogenous 
leukemia (CML), a disease in which too many white blood cells are made 
in the bone marrow. In 53 of those patients, the disease basically 
disappeared. A year later, 51 of those patients still had a normal 
blood count.
    One thing that's so exciting about this drug is its potential for 
fighting other diseases as well. As I understand it, Gleevec turns off 
the same molecular targets that also cause some forms of cancer in the 
abdomen and brain. It's hard to believe that a single drug could work 
against three cancers that seem so different on the surface, but that 
seems to be a real possibility.
    And if it's true, we might have to re-evaluate the way we think 
about the nature of disease itself. Instead of describing a disease by 
where it shows up in the body--the liver or the brain or the lung--the 
key issue is really what part of the molecule is causing the problem.
    This is exactly the kind of discovery that the NIH is all about. 
First, scientists did basic research about how molecules work; then 
they translated it into a direct application that could save thousands 
of lives.
    And it's an encouraging sign to those of us on this subcommittee 
who have supported the NIH over the years. When I first started talking 
about doubling NIH's budget back in the early 1990s, most people didn't 
take that idea very seriously. Now, thanks to the work of Chairman 
Specter and many others, it's on the verge of happening. Next year, 
fiscal year 2002, will be Year 4 of our five-year effort to reach that 
goal.
    The president has called for a $2.7 billion increase, but Chairman 
Specter and I would like to boost that figure up to $3.4 billion. Of 
course, our ability to do that will depend greatly on what kind of 
appropriations allocation we get; we certainly weren't helped by the 
budget resolution that Congress adopted earlier this month. But I'm 
hopeful we'll prevail.
    And if we do, Dr. Kirschstein, I don't need to remind you that the 
additional money will bring added responsibilities--$3.4 billion means 
a lot more grants to award, a lot more clinics to staff, and a lot more 
employees to manage. It will take a great deal of vigilance to ensure 
that the money is spent wisely.
    Again, Mr. Chairman, I want to thank you for holding this hearing, 
and I look forward to Dr. Kirschstein's testimony.

    Senator Harkin. I want to welcome Dr. Kirschstein and all 
of the other directors, the scientists and administrators who 
are here today.
    First of all, let me just say for the record, Mr. Chairman, 
you have been one of the great leaders in the entire Congress 
in pushing for medical research all the time I have known you, 
and all these years, and I just want you to know that I 
appreciate that, and I thank you for that, and I thank you for 
holding this hearing, and for your strong support of unbiased, 
non-political interference in scientific pursuits, and I want 
to thank you for that.
    I just want you to know, I have just been listening to 
this, and I know a little bit about this. If at any time that 
you would like to issue a subpoena to go back and get those, 
you will have my name on it.
    Senator Specter. Thank you.
    Senator Harkin. I would be glad to support you in that, if 
you would like to do that, if that becomes necessary. If that 
becomes necessary, I will support you.
    I was just thinking, again, Mr. Chairman, that years ago we 
had a lot of political interference in terms of the budget 
coming up, especially from the National Cancer Institute. This 
is a number of years ago, preceding me. So the Congress passed 
a law mandating a by-pass budget. So every year we get a by-
pass budget that we get our hands on directly from the 
Institutes.
    Well, maybe, Mr. Chairman, what we need to do is to ensure 
that any requests for letters from any of the heads of any of 
the Institutes that we request that comes to this appropriation 
subcommittee also has a by-pass that comes here, just like the 
by-pass budget.
    Now, if the political people, in whatever department, and 
whatever administration, want to tinker with it, that is their 
own business, but at least we should get the unvarnished truth 
without going through it, so maybe we ought to think about how 
we--if we ask, if this committee, you as chairman, me ranking 
member, whatever, asks for information from an institute, that 
ought to be transmitted, and it should not have to go through 
other kinds of departments, just like a by-pass budget, and 
maybe we ought to think about----
    Senator Specter. Good point.
    Senator Harkin [continuing]. Changing the law in that 
regard. We have a vote on, and I am sorry, I apologize, we are 
going to have all these votes, and so I assume we are going to 
have to go, right?
    I just want to thank all of you for all of the tremendous 
work you are doing in scientific research, the great leadership 
you have shown. I wish we could have more time to go into a lot 
of these things. I have as much support for stem cell research 
as my chairman does, and we are pretty much in lock step on 
this one.
    A couple of things, and you do not even have to answer 
this, but I perhaps need it in writing, Dr. Kirschstein, is, we 
have been working hard to double the budget, we are going to 
get it done, it is going to happen over the next couple of 
years, but the President's budget, looking in the forward 
years, calls for a 2.2 percent increase in 2004 and a 2.2 
percent increase in 2005.
    Now, that has important implications, because research 
grants run about 4 years, and we want them to run longer than 
shorter periods of time, so new grants that are awarded now 
will require commitments through 2005. But if we come to a 
ledge and we drop off, what is going to happen if, in fact, 
there will not be any money left over for anything new?
    In other words, if we use all that money for all the old 
grants, what happens to the new grants that we want to start 
funding in those out years? I am really concerned about that, 
and I do not--we have to go. I do not know if you can respond 
to that shortly, and----
    Dr. Kirschstein. I can give you a short answer, Mr. Harkin. 
We are concerned, also, and so we are beginning to look at 
this, and, indeed, I am putting together a committee of 
Institute directors. Dr. Lenfant will chair the committee. We 
will have other Institute directors. We will have Dr. Baldwin, 
who handles the day-to-day activities of our extramural 
research program, and we will be working on this steadily, and 
we will have some plans sometime by the summer.
    Senator Harkin. Okay. Two other quick things: The status of 
our labs out there and extramural research. I will not go into 
all of the studies and all of that data, but I am just going to 
say that right now it is authorized at $250 million, and given 
the current situation, would it make sense for the NIH to spend 
more than $97 million out of that $250 million that is 
authorized? So take a look at that, will you, for me?
    Dr. Kirschstein. We will, Senator.
    Senator Harkin. I think we need to look at that a little 
bit longer, closer.
    The last thing is--there are a lot of things I would like 
to get into. Gleevec, what a great breakthrough on cancer 
research on this drug, it seems to me. We have talked about it 
before, but the question I have is: How much of NIH's research 
went into that, supported, NIH-supported research went into 
that?
    Dr. Klausner. The reality is, that a larger amount of the 
underlying research that led to understanding the drug target 
has been supported by NIH-funded research, starting back in 
about 1960.
    Senator Harkin. Now, Rick, you know what my next question 
is. When I talked about--I was in my home state, and we were 
talking about this new drug, and this new candidate, and it 
looks like it has maybe applications for other types of 
cancers, too----
    Dr. Klausner. It does.
    Senator Harkin [continuing]. But then the news reports 
carried the report that it would come in at around $2,000 or 
$3,000 a month, to which one person said, ``That is wonderful. 
I cannot use it. How are you going to pay for it?''
    So I am just wondering about the pricing of this, and 
whether or not there is some recapture, or something like that. 
We have to figure this one out, about what we do about the 
pricing, and if it is that expensive, how much comes back into 
NIH to help us out. I do not know, but I--that is coming down 
the road. If you want to respond to that, fine.
    Dr. Klausner. We, of course, are not involved in the 
pricing of a particular drug.
    Senator Harkin. I understand that. I understand that.
    Dr. Klausner. But we really are very concerned about making 
sure--that individuals, individuals that need drugs, have 
access to those drugs.
    Senator Harkin. Yes. Well, this is something I think we, up 
here, are going to have to figure out on what we want to do on 
that, but I just wanted to mention it. We have 4 minutes left.
    Thank you, Mr. Chairman. Three minutes.
    Senator Specter. Thank you all very much for coming. I am 
always reluctant to take the time of this many distinguished 
scientists who could be back in the laboratory moving ahead. 
America is very fortunate to have such an extraordinary 
organization like the National Institutes of Health.
    You have heard me say on many, many occasions that you are 
the crown jewel of the Federal Government. I stopped saying you 
are the only jewel of the Federal Government--I have had too 
many complaints about that--but we thank you for what you are 
doing.
    Senator Harkin and I will continue to fight hard to bring 
you more resources, and I think you will have the backing of 
the Congress and the President.
    Thank you.
    Dr. Kirschstein. Thank you, Mr. Chairman.

                     additional committee questions

    Senator Specter. Thank you very much. There will be some 
additional questions which will be submitted for your response 
in the record.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]
              Questions Submitted by Senator Arlen Specter
                             ndri expansion
    Question. What have you done to expand NIH support for NDRI?
    Answer. Approximately two-thirds of the National Disease Research 
Interchange (NDRI) enterprise activity is supported by private 
foundations and fees charged to for-profit corporations. The remaining 
one-third of the activity is supported by an NCRR/NIH cooperative 
agreement, now in its tenth year. The National Center for Research 
Resources (NCRR) provided sole support during the first eight years of 
the grant. Currently, four additional NIH components (the National Eye 
Institute (NEI), the National Institute of Allergy and Infectious 
Diseases (NIAID), the National Institute of Diabetes and Digestive and 
Kidney Diseases (NIDDK), and the Office of Rare Diseases (ORD), also 
provide co-funding for the grant.
    Question. More specifically, have you met with each Institute 
Director and encouraged them to work with NDRI to access its human 
tissue resources to meet the special needs and initiatives of each 
Institute?
    Answer. A memorandum was sent to the directors of the various 
Institutes in July of 1999, inviting them to participate with NCRR in 
support of this endeavor. The scope of the NDRI service to the 
biomedical research community has been reviewed by a committee of 
experts and NCRR's National Advisory Council. The level of support 
provided for NDRI reflects the recommendations of the peer review 
process. The total level of NDRI funding would be the same whether NCRR 
alone or NCRR along with several other NIH components supported the 
NDRI award.
    Question. If not, why not?
    Answer. The NDRI user (investigator) list and the NIH institutes or 
Centers relevant to the research areas were systematically reviewed. As 
a result of that analysis, four additional NIH components were invited 
to cofund the NDRI application and all four agreed to participate. The 
other NIH components supported only a very small percent of the user 
activity.
    Question. If so, please report what next steps have been taken by 
each Institute Director.
    Answer. As noted above, the NEI, the NIAID, the NIDDK, and the ORD 
have joined NCRR in cofunding the cooperative agreement entitled 
``Human Tissue and Organ Research Resource (HTOR).''
    Question. When will you begin providing NDRI with supplementary 
funding through the Multi-Institute Initiative?
    Answer. Cofunding by the above-mentioned Institutes and Centers is 
currently in place. As noted above, the total level of funding for the 
NDRI application is independent of the number of NIH components which 
cofund the application. The peer review process provides 
recommendations to NIH staff as to the scientifically and technically 
meritorious aspects of the NDRI application and the applicant provides 
estimated costs for those costs. These same principles hold for the 
peer review and subsequent funding of other meritorious research or 
resource grant applications. Question. How much direct supplementary 
funding will NIH provide NDRI through the Multi-Institute Initiative 
beginning July 1, 2001?
    Answer. The Notice of Grant Award will be augmented by $300,000 
from NIAID in support of the second year of the demonstration pilot 
project to obtain HIV positive tissues. The increased level of support 
reflects additional NDRI activity related solely to NIAID.
    Question. What is your plan to secure supplementary Multi-Institute 
Initiative funding for NDRI beyond June 30, 2003?
    Answer. A memorandum will be sent again to the Institute Directors 
inviting them to support the Human Tissue and Organ Research Resource 
(HTOR) cooperative agreement.
                      ninds stroke strategic plan
    Question. Dr. Penn, I am concerned that stroke remains a leading 
cause of permanent disability and the third largest killer of men and 
women in the United States. Last year this Committee encouraged the 
National Institute of Neurological Disorders and Stroke, as part of 
your strategic planning, to work with the research community, 
clinicians, voluntary health organizations, and patient advocacy groups 
to discuss new avenues of basic and clinical stroke research 
opportunities. Please provide us with an update on this activity.
    Answer. Stroke research is a high priority of NINDS because this 
neurological disorder is the most common cause of disability, and the 
opportunities for progress in both prevention and treatment of stroke 
are very great. The Institute's overall strategic plan, Neuroscience at 
the New Millennium, addresses research questions of importance to 
stroke in its discussion of neural environment, experimental 
therapeutics, funding of research in this area and clinical trials. 
Evidence of the importance of stroke to our Institute's efforts, 
funding of research in this area is supported in both ``Clinical 
Trials'' and ``Neural Environment'' extramural program groups.
          trans-agency conference on heart disease and stroke
    Question. Dr. Lenfant, several years ago this Subcommittee 
encouraged the National Heart, Lung, and Blood Institute to hold a 
trans-agency conference on heart disease and stroke to obtain an 
assessment of progress and opportunities and develop a comprehensive 
research and prevention agenda on heart disease and stroke for the 21st 
Century. I have heard that the report on this conference was released 
in December of 2000. What was the conclusion in the report and how do 
you plan to implement the findings?
    Answer. The report of this conference was published in the December 
19/26, 2000 issue of the journal Circulation. Among the conclusions 
were that, for the United States as a whole, the coronary heart disease 
(CHD) death rate is still declining, but more slowly than it did 
between 1970 and 1990; stroke mortality rates have declined little 
since 1990; striking differences exist in levels and trends of 
cardiovascular disease (CVD) by race/ethnicity, socioeconomic status, 
and geography (for example, rates of CHD death have declined more 
slowly among black men than among white men); and trends in levels of 
risk factors are consistent with the slowing in the decline in the 
death rate (little change since 1990 in smoking prevalence, physical 
inactivity, and hypertension control and striking increases in 
prevalence of obesity and type 2 diabetes). The conference also 
concluded that although there is considerable activity in prevention 
and treatment of CVD, much more needs to be done with respect to 
assessing risk factors and applying proven approaches to treat them. A 
number of recommendations were made with respect to application of 
current knowledge and further research.
    Concerned about data presented at the conference that some 
Americans are not enjoying the improvements in health that can be 
realized by applying existing clinical guidelines and other medical 
information, the NHLBI recently developed and implemented several new 
programs. One, an education initiative, entails Enhanced Dissemination 
and Utilization Centers (EDUCs) in communities with heart disease and 
stroke death rates that far exceed the national average. These centers 
will become the foundation of a network of Healthy People 2010 
performance partners committed to eliminating of racial/ethnic and 
geographic health disparities in underserved high-risk populations. 
Funded centers are using information generated by the national 
education programs of the NHLBI to inform their communities of the 
public heath burden of CVD and are developing, implementing, and 
evaluating educational strategies to reduce the burden through changes 
in behavior of health care providers, patients, and the general public 
related to the prevention and control of CVD. The six current centers 
are located in Arkansas, North Carolina, Virginia, West Virginia (two), 
and Texas. One of the EDUCs, West Virginia Health Right, Inc., in 
Charleston, is a free primary care clinic that serves the uninsured and 
under-insured poor. At the North Carolina EDUC, Wake Forest University 
School of Medicine will collaborate with the Robeson County Partnership 
for Community Health, Columbus County Hospital, and Columbus County 
Healthy Carolinians to reach low-income blacks and Native Americans 
with CVD screening and cardiovascular health education activities. The 
University of North Texas Salud para su Corazon Outreach Initiative 
EDUC is a collaboration among the University, the Dallas Concilio, 
Northside Clinic, Hispanic Health Coalition of Fort Worth, and Harris 
Methodist Hospital to use lay health educators to reach Hispanics with 
cardiovascular health promotion and disease prevention activities.
    EDUCs are one element of a larger heart-health agenda that the 
NHLBI launched as part of its efforts to meet the cardiovascular health 
goals and objectives in the federal government's Healthy People 2010 
Report. On February 1, the NHLBI, several other federal health 
agencies, and the American Heart Association (AHA) signed a Memorandum 
of Understanding (MOU) to speed progress toward heart disease and 
stroke goals set forth in Healthy People 2010. This historic MOU has 
created a working partnership that promises to improve greatly the 
nation's cardiovascular health by the year 2010. The federal agencies 
and the AHA will work to accomplish four cooperative knowledge 
application goals for heart disease and stroke: prevent the development 
of risk factors; detect and treat risk factors; achieve early 
identification and treatment, especially in the acute phases of 
disease; and prevent recurrence and complications. The NHLBI also 
sponsored a workshop in March as the first step in developing an 
ambitious agenda for a new women's heart health education effort. It 
brought together a group of about 60 key researchers, public health 
leaders, women's and minority health advocates, health communicators, 
health care delivery experts, patients, and others who have a stake in 
improving women's cardiovascular health to develop a science-based 
blueprint for a comprehensive health education effort for patients, 
health professionals, and the public. Late this summer an award will be 
made for program support to launch the nationwide education effort. In 
addition, the NHLBI is continuing to collaborate with the National 
Recreation and Park Association to develop and implement a nationwide, 
community-based program to reduce the growing trend of obesity and the 
risk of CHD in the U.S. by encouraging Americans of all ages to aim for 
a healthy weight, follow a heart-healthy eating plan, and engage in 
regular physical activity. The program targets high-risk and 
underserved neighborhoods through community park and recreation 
programs.
    The NHLBI will continue its ongoing projects in African American 
and Latino communities and is now taking steps to implement strategies 
to improve the health behavior of several underserved Asian American/
Pacific Islander (AAPI) groups, including those of Philippine, 
Vietnamese, Native Hawaiian, Samoan, Cambodian, Hmong, and Laotian 
heritage. To begin formulating culturally and linguistically sensitive 
heart health education materials for these AAPI ethnic groups, consumer 
interviews and discussions with community leaders are being conducted 
and efforts to build community-based networks in these underserved AAPI 
communities have begun. So far, 15 community-based network partners 
across the country have been enlisted to assist in the implementation 
of outreach activities in underserved AAPI communities. The NHLBI is 
also beginning the second phase of its three CVD projects in American 
Indian and Alaska Native (AI/AN) communities to develop and implement 
community-based interventions to increase awareness and to expand 
adoption of heart-healthy behaviors and thereby reduce health 
disparities. The three communities are the (1) Ponca Tribe of Oklahoma 
with about 2,500 members, (2) Bristol Bay Area Corporation with 32 
villages in Southwestern Alaska, and (3) Laguna Pueblo in New Mexico 
with about 4,000 members. The NHLBI has joined forces with the Indian 
Health Service to use the tools and materials developed during the 
first phase of the project to implement community-based outreach and 
education activities in the three communities over the next 3 years.
    To continue the dialogue regarding the issues and recommendations 
put forth at the CVD Trends Conference, the NHLBI is sponsoring a 
National Cardiovascular Health Conference, ``Cardiovascular Health for 
All-Meeting the Challenge of Healthy People 2010,'' to be held in 
April, 2002 in Washington, D.C. We expect an onsite attendance of 2,000 
health professionals committed to eliminating the racial/ethnic, 
gender, and geographic disparities reported at the CVD Trends 
Conference. Conference cosponsors include the AHA, the CDC, HCFA, and 
HRSA. The Institute has also developed an innovative NHLBI Healthy 
People 2010 Gateway Web site and integrated Health Information Network 
(HIN) at http://hin.nhlbi.nih.gov. Visitors to the Gateway are offered 
quick access to a wide range of resources that can be used for planning 
and implementing community-based Healthy People (HP) 2010 activities. 
The current NHLBI HP 2010 performance projects are defined, and ongoing 
activities and progress of performance teams are reported through a 
variety of means including Webcasts of major meetings, electronic 
communication memos, and special Web pages that provide details about 
performance partners, major project events, pilot project results, and 
access to the latest NHLBI-developed resources. Visitors are encouraged 
to complete an electronic application to become a HIN partner. Partners 
receive electronic notifications of new NHLBI educational products and 
services, late-breaking news of NHLBI-funded research findings, 
notification of NHLBI conference Webcasts, distance learning 
opportunities, and special Web-based applications such as interactive 
disease mortality maps to assess the magnitude of the public health 
burden of disease by state and Health Service Area. Network membership 
has been increasing on a daily basis-it currently numbers over 11,000 
health care providers, public health practitioners, patients, and other 
interested consumers nationwide as well as a growing international 
representation.
    The Institute is also funding a program of grants to evaluate 
interventions in clinical care settings that are designed to improve 
adherence to medically prescribed lifestyle changes used to treat heart 
disease. This program targets racial and ethnic minorities and/or 
persons living in poverty. In addition, the NHLBI is initiating an 
evaluation of innovative strategies that can be used in clinical 
practice to improve implementation of evidence-based guidelines for 
treatment of heart disease.
                       new cholesterol guidelines
    Question. Dr. Lenfant, I am a staunch proponent of prevention. 
Cholesterol is a major risk factor for heart disease, the leading cause 
of death of Americans, and for stroke, the No. 3 killer in the United 
States. The National Heart, Lung, and Blood Institute's new cholesterol 
guidelines have received a lot of attention. These guidelines are the 
first major revision in about 10 years. Please explain to this 
Committee how these guidelines have changed from the ones published 
nearly a decade ago and how well can you insure that these new 
cholesterol guidelines are implemented.
    Answer. The new cholesterol guidelines developed by the Institute's 
National Cholesterol Education Program (NCEP) Adult Treatment Panel III 
(ATP III) are evidence-based. The ATP III report states explicitly the 
nature and strength of the evidence, derived from a rigorous and 
systematic review, that forms the basis for its conclusions and 
recommendations. Compared with the previous guidelines, which were 
released in 1993, the ATP III guidelines have several new features. 
First, they call for more aggressive lowering of LDL (bad) cholesterol, 
the primary target of therapy, in individuals at high risk for a heart 
attack or death from coronary heart disease (CHD). This high-risk group 
includes those who have CHD itself, diabetes, or multiple (2 or more) 
CHD risk factors and a 10-year risk for CHD greater than 20 percent. 
These high-risk people have the most stringent LDL goal: <100 mg/dL. 
Individuals with multiple risk factors and a 10-year CHD risk of 10-20 
percent are also at substantially elevated risk and often require 
aggressive therapy, but their LDL goal is somewhat less stringent: <130 
mg/dL. The ATP III report provides a risk assessment tool to identify 
individuals who require intensive cholesterol-lowering treatment; based 
on data from the NHLBI Framingham Heart Study, it enables calculation 
of 10-year CHD risk. A second new feature is a more intensive set of 
Therapeutic Lifestyle Changes (TLC) that constitute the mainstay of 
cholesterol-lowering therapy and offer greater potential to lower LDL 
than the previous guidelines. Third, the new guidelines define and 
recommend treatment for a cluster of CHD risk factors known as ``the 
metabolic syndrome,'' which is related to the increasing prevalence of 
obesity and overweight in the United States. Fourth, the ATP III report 
urges greater clinical attention to high triglycerides and low HDL 
(good) cholesterol, both of which are linked to increased risk for CHD. 
Fifth, the guidelines recommend a complete lipoprotein profile (total, 
LDL, and HDL cholesterol and triglycerides) as the preferred initial 
test for detecting cholesterol problems. Sixth, ATP III sets a new 
level at which low HDL becomes a major CHD risk factor (<40 mg/dL, as 
compared with <35 mg/dL in ATP II). Seventh, ATP III recommends ways of 
improving professional and patient adherence to the guidelines and to 
appropriate therapy.
    The new guidelines identify many people who are at higher risk for 
CHD than had previously been recognized and, thus, their application 
will increase the number of people who need cholesterol-lowering 
lifestyle therapy from about 52 million to about 65 million. Of these, 
about 36 million will need to combine drug treatment with lifestyle 
changes to achieve an adequate reduction in CHD risk; the vast majority 
(80 percent) of them are in the two highest categories of CHD risk.
    The results of cholesterol-lowering clinical trials suggest that 
full implementation of ATP III guidelines could produce approximately a 
30 percent reduction in the rate of CHD, which continues to be the 
leading cause of death of women and men in this country and currently 
accounts for almost 500,000 deaths annually. To help ensure 
implementation of the ATP III guidelines, the NCEP has developed an 
array of new products and tools. For professionals, the aids include an 
Executive Summary of the evidence and recommendations that was 
published in the Journal of the American Medical Association (JAMA) 
together with a patient page on cholesterol and an editorial from the 
JAMA editors urging physicians to implement the guidelines. Other tools 
include a PowerPoint slide show for teaching the guidelines to 
professional audiences; an ATP III At-A-Glance Desk Reference that 
outlines the basic action steps in management of LDL, HDL, and 
triglycerides; a Palm OS interactive tool that puts the guidelines at 
the fingertips of physicians for use at the point of care; and a 10-
year CHD risk calculator in online and downloadable (Excel spreadsheet) 
versions. To empower patients to be active partners in their care, the 
NCEP has developed a new patient brochure entitled ``High Blood 
Cholesterol--What You Need to Know,'' a 10-year CHD risk calculator for 
lay audiences, and an updated Web site (``Live Healthier, Live 
Longer'') that reflects the new information in the ATP III report. All 
of these tools are available on the ATP III Web page, which can be 
accessed by going to the NHLBI Web site (www.nhlbi.nih.gov). In 
addition to developing and distributing these new products the NHLBI, 
through the NCEP, has established a strategic partnership with the 
National Committee for Quality Assurance (NCQA) to promote adoption of 
the new guidelines. The NCQA and the NHLBI cosponsored a national 
conference for professionals on ATP III implementation June 3-5, 2001. 
The HEDIS (Health-plan Employer Data and Information Set) performance 
measures of the NCQA can help ensure implementation of ATP III, and 
NCQA involvement will extend the reach of the new recommendations into 
managed care. By these various means, the NHLBI and the NCEP are 
seeking to speed adoption of the ATP III guidelines.

                         RETURN ON INVESTMENTS
    Question. As you know I believe that NIH is the crown jewel of the 
federal government and an institution that deserves our highest 
priority. I am always concerned, however, about the returns we see from 
our investment.
    I realize that establishing deadlines in science such as predicting 
when a certain disease will have a cure is difficult to do, however, 
how do you propose that we measure the return we are getting from our 
investment in NIH?
    Answer. As required by the Departments of Labor, Health and Human 
Services, and Education, and Related Agencies Appropriations Act, 2001, 
the NIH will be addressing the issue of return on NIH investments by 
submitting a report by July 2001 that includes a listing of therapeutic 
drugs which are FDA approved, have reached $500 million per year in 
U.S. sales, and have received NIH funding.

                POPULATION MORBIDITY AND MORTALITY RATES
    Question. Do we see an improvement in morbidity and mortality rates 
as a result of government funded research?
    Answer. It is difficult to attribute the exact share of 
improvements in population morbidity and mortality rates that is due to 
government funded research. Historically, we know that health and 
longevity are influenced by increases in income, education, public 
sanitation and access to care. Of course NIH does not control access to 
care or participate directly in the delivery to care. However, there is 
much evidence from clinical trials that new research-based technologies 
can reduce mortality and morbidity rates when applied appropriately. 
And recent declines in population morbidity and mortality rates for 
specific conditions and disorders can be attributed, at least 
partially, to research-based diagnostic screens, vaccines and other 
preventives and therapies.
    The age-adjusted death rate for all causes fell from 577.0 per 
100,000 in 1979 to 471.7 in 1998 (Use of the age-adjusted rate adjusts 
for increases in deaths due to growth and aging of the population).\1\ 
The corresponding rate for Diseases of the Heart, the leading cause of 
death, fell from 199.5, to 126.6. over the same period. The recent data 
on age-adjusted decline in heart attacks and deaths due to heart 
disease is based on years of research to identify and refine our 
ability to control risk factors for heart disease such as hypertension 
and high blood cholesterol levels. Research confirmed the effectiveness 
of diet and exercise in controlling risk factors and conditions such as 
high cholesterol levels, hypertension, obesity and diabetes. 
Preliminary, unpublished analysis suggests that the majority of the 
reduction in the Cardiovascular Disease mortality rate from 1950 to 
1990 may be attributable to providing this information to the public. 
Information about risk of hypertension, smoking, and high cholesterol 
levels was made available and diffused widely to individuals and to 
physicians throughout the country. In response, people modified their 
diets and exercise patterns, and physicians changed their testing 
protocols and medical advice, according to a Harvard University study.
---------------------------------------------------------------------------
    \1\ National Vital Statistics Reports, Vol. 48, No. 11, July 24, 
2000. Table 7.
---------------------------------------------------------------------------
    The use of the common aspirin, to reduce the risk of heart attack 
and as part of the immediate post heart-attack treatment, is another 
example of an application of research which, at small expense, reduces 
health care costs.
    Another example comes from research on the prevention of stroke 
patients who suffer from atrial fibrillation. The two million Americans 
who have atrial fibrillation are six times more likely to have a stroke 
than people who do not, and this accounts for as many as 80,000 strokes 
a year. A decade long study, by NINDS, carefully examined the best 
strategy for balancing prevention of strokes versus the risk of adverse 
side effects among such individuals. Aspirin was recommended for 
patients with atrial fibrillation in the low risk category and warfarin 
for those with more risk factors for a stroke. This is another 
significant example of careful research to provide a tailored, low-tech 
strategy to prevent a high cost disease.
    Another example of a low-tech alternative therapy was provided when 
research, supported by NIDDK, confirmed the efficacy of a new therapy 
for peptic ulcers using already available pharmaceuticals. Treatment of 
the cause of these ulcers, a bacterium (Helicobacter Pylori), using a 
``triple therapy'' of available drugs--tetracycline, metronidazole, and 
bismuth subsalicylate (Pepto-Bismol)--speeds the cure and cuts the 
recurrence rate of ulcers. Research found the recurrence rate for 
peptic ulcer fell to the 12 percent to 13 percent range, compared to 
the 74 percent to 95 percent recurrence rate with the previous 
conventional treatment using antacid preparations and surgery. The 
resulting annual savings in treatment costs are estimated in the 
hundreds of millions of dollars. Cataract surgery is another example of 
an intervention which extends working life and enhances functioning and 
independence of the retired. Intervention to restore sight is essential 
for human well-being. What once required a long hospital stay including 
days in intensive care, is now performed on an outpatient basis. 
Meanwhile, the National Eye Institute continues to support research 
aimed at understanding and preventing cataracts, as well as other 
vision disorders.
    Another evidence of advance is the reduction in infant deaths from 
all causes from just less than 5 per 100 live births in 1940 to less 
than one per 100 today. The causes are multiple, but many are research 
based. Infant mortality rates from congenital cardiovascular 
malformations, for example, have declined as a result of rapid advances 
in the field of infant heart surgery. Several research projects have 
contributed to improved evaluation and treatment guidelines, the 
development of 3-D imaging techniques, echocardiography, and deep 
hyperthermia surgical technique.
    HIV/AIDS remains a national and international epidemic, but there 
has been research based progress in this area as well. In the U.S. the 
incidence rate of new cases dropped for the first time in 1993 and 
deaths among people with AIDS declined for the first time in 1996, 
dropping 25 percent.\2\ As a result of new, more effective combination 
therapies, people are living longer with HIV and development of 
opportunistic infections are being delayed.
---------------------------------------------------------------------------
    \2\ MMWR. ``HIV and AIDS in the United States'' June 1, 2001/Vol. 
50/No. 21. Figure 1, page 432.
---------------------------------------------------------------------------
    These are but a few examples of where medical research has improved 
health and reduced morbidity and mortality.

                       NEW TECHNOLOGIES IN NIBIB
    Question. I note that you are requesting $40.2 million for a new 
National Institute of Biomedical Imaging and Bioengineering for 
creating new technologies. Is there any thought given by yourself or 
your staff about the cost-effectiveness of these new technologies?
    Answer. We are excited about the new opportunities that the new 
National Institute of Biomedical Imaging and Bioengineering (NIBIB) 
will create for support of fundamental research that applies principles 
of engineering, mathematics, computer science and the physical sciences 
to biological processes, disorders and diseases. NIBIB has great 
potential to promote innovation and discovery that could have a 
significant impact on virtually every area of medical science. We have 
just begun to constitute our research portfolio and identify 
programmatic gaps and prioritize the many scientific opportunities 
before us. As the application of these scientific disciplines to 
medicine is still relatively new, it would be premature to make 
ironclad promises as to their cost-effectiveness. However, we plan to 
conduct technology assessment and outcome studies as authorized by 
legislation. As the science and the NIBIB research portfolio mature, we 
will plan to conduct such evaluations to answer the question you 
propose.
    Question. Are we at risk of developing technology that is 
unaffordable to many people as we are seeing with some of the AIDS 
antiviral drugs?
    Answer. NIBIB will support fundamental research that applies 
principles of engineering, mathematics, computer science and the 
physical sciences to biological processes, disorders and diseases. In 
some respects, such an approach to human health is still relatively 
new. We will support studies that examine incremental changes from 
technologies as they are applied today, as well as new and innovative 
approaches that reject current technologies in favor of completely new 
paradigms. The studies that NIBIB will support will add to 
biomedicine's knowledge base. At this juncture, there is no way to tell 
which as yet undeveloped technologies may make the largest impact on 
health and what the cost of these technologies would be. NIBIB's is 
authorized to conduct technology assessments and outcome studies, and 
such evaluations will address these key issues.

                        RESEARCH PROJECT GRANTS
    Question. I also note that the funding rate for grant applications 
has remained at around 1 in 3. Are the remaining two-thirds of 
significant less quality?
    Answer. Success rates for Research Project Grants (RPGs) represent 
a complex set of factors. They represent the ratio of RPG awards to the 
total RPG applications received for that fiscal year. Success rates 
vary among Institutes, among RPG activities such as single-investigator 
initiated traditional (R01s) grants and multiple investigator program 
projects (P01). Success rates and submission of applications also vary 
among types of grants, such as new grants, first time awardees, and 
competing renewals which depend on the cycling of grants from 
noncompeting to competing status. Furthermore, there is not a linear 
relationship between budget level, number of applications, and number 
of awards. That is, an increase of twice the current budget levels will 
not result in an increase in twice the number of applications or twice 
the number of grants awarded. This is because institute portfolios are 
based on a number of interrelated mechanisms and factors, including the 
balance between intramural and extramural research, investigator 
initiated projects, contracts, centers, as well as the number of grant 
applications, the size of grants, the length of project periods.
    With the recent increases in the NIH budget, we have funded 
research project grants that typically have larger budgets, such as 
clinical trials, epidemiologic studies and various genomic projects. We 
have also witnessed an increase in the number of applications, but not 
to the extent that has significantly affected our success. There are 
always some projects that would ordinarily remain unfunded, but which 
have some particular value and for which we might make a modest award. 
However, our experience is that those applications that are in the 
lower half of all applications received are generally in need of 
significant revision before we would consider funding.

                          MERITORIOUS RESEARCH
    Question. Are we shutting out the majority of meritorious research 
with our current budget?
    Answer. No, we are not shutting out the majority of meritorious 
research with the current NIH budget. While peer review remains a 
highly competitive process, the NIH is firmly committed to funding 
meritorious research. The Institutes and Centers (ICs) have developed 
various strategies to fund applications that are of particular 
significance or importance to public health, e.g., through selective 
pay or bridge grants. In some cases it may be desirable to fund a 
portion of an application or provide seed money to help an applicant 
develop a fuller research plan for re-submission and review at a later 
date.

             CLINICAL RESEARCH CAREER DEVELOPMENT PROGRAMS
    Question. Are the programs in place at the NIH to attract clinical 
researchers sufficient?
    Answer. The NIH launched three new clinical research career 
development programs in fiscal year 1999--Clinical Research Curriculum 
Award (K30), Mentored Patient-Oriented Career Development Award (K23) 
and Mid-Career Investigator in Patient-Oriented Research Award (K24). 
These programs have been successful and continue to attract 
enthusiastic response from the community. Since their inception, NIH 
has funded 278 K23, 158 K24, and 55 K30 awards.
    In addition to these programs, the NIH is currently developing a 
program announcement to provide support to institutions to develop 
degree-granting programs in clinical research. It is anticipated that 
the National Center for Research Resources will take the lead in this 
initiative and launch it in fiscal year 2002. We believe that these new 
programs, along with the other existing clinical career development 
awards, e.g., K08, K12, etc, have gone a long way in addressing the 
need for training more qualified physician scientists.
    Question. Are you seeing an adequate number of clinical research 
grant applications in comparison to basic science?
    Answer. In fiscal year 2000, the NIH funded over 11, 000 clinical 
research awards out of a total of 44,363 awards (26 percent), both new 
and continuing projects. This number of awards includes all types of 
NIH-supported extramural awards, including training grants, fellowship 
awards, construction grants, NLM resource awards, and research and 
development contracts. The percentage of clinical research awards has 
remained relatively stable for the last five years.

                               STEM CELL
    Question. I asked for detailed responses from each of your 
institute directors on the role of stem cells in the mission of their 
respective institute. Most of these reports give overwhelming support 
to the potential of stem cells in their field. I also understand that 
you have only received 3 applications for stem cell grants this year. 
Is this surprising to you?
    Answer. Still in review. Will provide an answer upon completion.

                           CANAVAN'S RESEARCH
    Question. Please explain to the Committee what research is 
currently being conducted at the NIH on Canavan's Disease.
    Answer. Canavan's disease is one of a very large number of 
childhood brain diseases, each caused by inherited defects in a 
different enzyme. In this case, the enzyme affected is called 
aspartoacylase and the disease is very severe. About a decade ago, 
scientists identified the enzyme that was at fault. About five or six 
years ago, the gene causing the defect was identified. Just last year, 
an NIH-funded scientist succeeded in creating a genetically engineered 
mouse model of Canavan's disease. The mouse model of the disease will 
enable researchers to study precisely how the gene defect harm the 
brain and to develop and test possible therapies. More generally, NIH 
supports considerable efforts to develop therapeutic interventions for 
the many inherited enzyme disorders, such as Canavan's, for which the 
gene is now known, but no therapy is available. These potential 
interventions include conventional drugs, gene therapy, use of stem 
cells, and enzyme replacement. NIH is encouraging more research 
concerning these diseases through workshops, solicitations and other 
efforts.
    A recent report indicated that an application that was pending 
before the NINDS was not funded because of the lack of a control group.
    Question. Please provide a detailed description of the problems 
involved in funding a safety trial for persons with Canavan's Disease.
    Answer. As you have noted, an application to study the transfer of 
the aspartoacylase gene to children with Canavan's disease is pending. 
As you can well imagine, the issues and considerations involved in the 
design of a clinical trial to establish the safety of a gene-based 
intervention for children with Canavan's disease are extensive. Such a 
study involves not only gene transfer, but gene transfer to the brain 
by neurosurgical procedures in children. First, the grant application 
must ensure that the preclinical and preliminary clinical data are of 
sufficient strength to support proposing such a trial in children. 
Then, the study design presented must thoroughly address numerous 
safety and ethical issues including concerns about the establishment of 
outcome measures; the use of anesthesia during diagnostic MRIs and 
surgery; safety controls in production of the vector, that is, the 
agent being used to transfer the genetic material; potential immune 
responses to the vector; safety of administration of the vector 
including the number and location of injection sites in the brain and 
the rate of administration; the risks of the neurosurgery itself; the 
plans for post-operative care; the adequacy of the informed consent 
process; the procedures established for the monitoring and reporting of 
adverse events; and the overall plan for data and safety monitoring. In 
addition, the NINDS must ensure that all required reviews and approvals 
for a trial of this nature have been received. These would include not 
only approval of the investigational new drug (IND) application by the 
Food and Drug Administration, but protocol submission to the NIH 
Recombinant DNA Advisory Committee (RAC), and approvals of the research 
protocol, including the informed consent and safety monitoring 
processes, by the local institutional review boards (IRBs).
    I can assure you that members of the NINDS staff have been working 
closely and intensely with the principal investigator of the proposed 
study to which you refer, so that the pending application can be given 
every consideration in accordance with applicable policies and 
procedures. The Institute is committed to advancing research on 
Canavan's disease as well as the other childhood brain diseases caused 
by enzyme deficiencies that result from inherited genetic defects.
                                 ______
                                 
               Questions Submitted by Senator Ted Stevens

                          VARIANT VCJD THREAT
    Question. As you may be aware, Senate Subcommittee on Consumer 
Affairs, Foreign Commerce and Tourism held a hearing on April 4 of this 
year on transmissible spongiform encephalopathies, also known as TSEs. 
One type of this TSE called variant Creutzfeldt-Jakob Disease (vCJD), 
has been a particular problem for our friends in Britain where 97 
people have died from vCJD, presumably from the consumption of prion 
infected beef. In your opinion is vCJD a threat to the United States?
    Answer. We should keep proper perspective since there has not been 
a case of the human disease, vCJD, in the United States, but we must 
remain vigilant to ensure that we take the proper steps to make sure 
that vCJD does not affect people in this country. There is strong 
evidence that the distinctive biological and molecular features of the 
infectious agent isolated from cattle infected with BSE, or mad cow 
disease, are identical to that in the human cases of vCJD, so that 
prevention of the animal disease, BSE, is important for prevention of 
the human disease, vCJD. BSE has not been detected in the U.S., but it 
would be unwise to assume that it can't happen here. We still don't 
know for sure how BSE first arose in Britain-it might have been from 
``rendered'' cattle feed containing remnants from sheep with the 
related disease scrapie, or perhaps BSE arose spontaneously as the form 
of CJD in humans can do. We do have sheep with scrapie in this country, 
as well as other animals such as deer with a closely related disorder, 
chronic wasting disease (CWD). Furthermore, most cattle are slaughtered 
at an age too young to show obvious symptoms of BSE or to be detected 
as infected on currently available tests, so a spontaneous case capable 
of harboring and transmitting the disease could go undetected. So, the 
important thing is that we must make sure that we have procedures in 
place to prevent an isolated case of BSE from spreading if it does 
occur.
    As discussed at the hearing you noted, the U.S. Department of 
Agriculture, the Food and Drug Administration (FDA) and the Centers for 
Disease Control and Prevention CDC) have imposed a series of safeguards 
to protect human and animal health. In Britain, it was later learned 
that the spread of BSE was greatly increased because carcasses of BSE-
infected cattle were used to make animal feed (meat and bone meal), 
resulting in contaminated product that was fed to other cattle. The FDA 
in 1997 published a regulation to prevent this type of spread of BSE, 
should BSE occur in this country. The FDA regulation prohibits the use 
of most mammalian protein to make feed for cattle or other ruminant 
animals. We should also keep brains and spinal cords, which are most 
likely to carry the disease, out of the human food chain.
    We must continue to examine whether our practices are adequate and 
update these measures as new evidence or better scientific 
understanding dictates. Congress has charged the General Accounting 
Office to do just that, and we have briefed the GAO on TSE science and 
research. NIH has played an important role since the 1950's in laying 
the scientific foundation for confronting the public health and 
economic threats from the group of diseases that includes CJD and BSE. 
In the past year, we have increased our efforts, especially those 
towards developing practical tests for early detection that are badly 
needed. We will continue to work with other agencies to make sure vCJD 
does not become a problem in the United States.

                           VCJD ON THE RISE?
    Question. Have we seen the worst of this disease yet?
    Answer. The unsettling truth is that we just don't know. The 
British are monitoring the incidence of vCJD closely. This class of 
diseases has an incubation time that can be as long as decades, so it 
is too early to tell. The numbers of vCJD cases in Britain each year 
from 1995 through 2000 have been 3, 10, 10, 18, 15, and 27. Three 
additional cases have occurred in France and one in Ireland. Great 
Britain, France, and Ireland all have BSE among cattle, unlike the 
United States. The small numbers don't allow any reliable prediction of 
a trend, so we don't know whether 2001 will show the incidence is still 
on the rise, leveling off, or starting to decline. In this country, the 
CDC monitors cases of classical CJD and conducts disease surveillance 
to detect the possible ocurrence of vCJD. So far, no cases of vCJD have 
been detected in this country.

                      ROLE OF NIH IN VCJD RESEARCH
    Question. What do you perceive the role of the NIH to be in 
researching and finding a cure for a disease such as vCJD that has yet 
to infect a single American?
    Answer. Although variant of Creutzfeldt-Jacob disease (vCJD) has 
not affected a single American, the conventional form of CJD kills 
about 250 to 300 Americans each year. We should not forget that if BSE 
were to occur in the United States, it could potentially devastate the 
cattle industry as it did in Britain. This would have major economic 
consequences. We are also quite concerned about the prevalence of 
related diseases such as the spontaneously occurring chronic wasting 
disease (CWD) in deer and elk in the United States.
    NIH has supported pioneering research on CJD and other TSEs since 
the 1950's. This research that has been recognized by the award, to 
U.S. scientists, of two Nobel prizes because of its significance to 
science and medicine. The scientific foundation of the work supported 
by NINDS has been essential for confronting the public health threat of 
vCJD with appropriate safeguards and without panic.
    These are unusual diseases. We would not have been able to detect 
the disease, how it is transmitted, where to focus our future work, and 
what precautions to take, without those years of scientific 
investigation supported by NINDS before BSE and vCJD appeared. We are 
actively engaged in strengthening our broad program of investigation 
into these disorders, including work towards developing diagnostic 
tests and treatments. Last year, we awarded major contracts focused on 
developing tests capable of detecting early stages of the disease, 
tests that at this point, are critical to confront the public health 
and economic threats.
    Finally, rare diseases often show us the way toward understanding 
common diseases, and there are some intriguing suggestions this may be 
so in this case, too. Many scientists, including the Nobel winners I 
noted, believe that the study of CJD may offer clues to more common 
neurodegenerative disorders such as Alzheimer's and Parkinson's.

                           VIRAL SIMILARITIES
    Question. Do you see any similarities between vCJD and the West 
Nile Virus or the AIDS virus?
    Answer. The most significant feature shared by all three of these 
viruses is that they all originated as an infection of a non-human 
species and humans were, or still are, the ``accidental'' hosts. 
Infections such as these are known as ``zoonosis.'' The origin of 
variant Creutzfeld Jacob Disease (vCJD) is thought to be bovine 
spongiform encephalopathy (BSE) or mad cow disease. The mechanism of 
transmission to man is still not understood. Ironically, cows may also 
be an ``accidental'' host probably acquiring the infection from sheep 
infected with scrapie, another related disease.
    West Nile Virus (WNV) is only spread to humans by the bite of a 
female mosquito, usually Culex pipiens. Humans are considered to be 
``accidental hosts'' in a cycle of transmission of WNV, that is 
normally from mosquito to bird and then back to mosquito, when it feeds 
on infected birds. Unfortunately, infected mosquitoes can also spread 
disease to man, horses, cats and dogs.
    Although HIV is now most commonly spread by sexual transmission or 
contact with blood from another infected human, the origin of HIV was 
likely the accidental transmission to humans of a related non-human 
primate virus.
    While the HIV virus, vCJD, and WNV also share certain biological 
properties such as the ability to affect the brain, they are caused by 
different agents, take different paths to infect man, produce different 
symptoms, and differ in other important ways. The agent that causes 
vCJD is believed to be a ``prion'', agent containing protein only and 
without a genome. Its pathology results from a chain reaction when the 
prion initiates a series of repetitive improper folding of a normal 
brain protein. Classic CJD is a ``slow'' disease that may take many 
years between exposure and disease and the course of the disease itself 
is slow, in the range of four to five years. One of the frightening 
features of the new variant vCJD is that the course of disease is more 
rapid, and patients progress from first symptoms to death in about a 
year.
    The West Nile virus is a flavivirus. This is a family of viruses 
whose genome is single-stranded RNA. Unlike vCJD, WNV causes an acute 
infection in that both the incubation period and the time of 
symptomatic infection are short. Most infections are mild but the 
severe form of the infection, encephalitis, may occur if the virus is 
able to migrate from the blood to the brain.
    The genome of HIV is also RNA, but during replication it is 
transformed to a double-stranded DNA copy which integrates into host 
cellular DNA. HIV, like vCJD, causes a chronic infection with disease 
developing long after initial exposure, although some individuals may 
have mild flu-like symptoms within a few weeks of infection.
    These three diseases taken together serve as reminder that we must 
take a global perspective on research and public health. Each of these 
diseases has its origin outside of the United States. Vector-borne 
diseases, such as West Nile Virus infection, which have a complex life 
cycle in nature that involves an animal host that amplifies the 
infection and the mosquitoes that transmit virus, have never respected 
borders, and the reality of commerce and air travel today accelerates 
the spread of such diseases. With modern transportation, a person or 
other carrier with an infectious disease can travel to the United 
States from any part of the world, often during the incubation period 
of a disease--that is after infection begins but before any symptoms 
are apparent. In the future, we will certainly confront other new or 
``emergent'' diseases, like AIDS HIV infection or vCJD, diseases 
previously unseen or rare in the United States, like West Nile or 
Hantavirus, and drug resistant forms of old diseases, like tuberculosis 
and malaria. Thus, we must maintain a broad research base and a 
responsive public health infrastructure so we can deal with the 
unexpected. NIAID has a long-standing commitment to research directed 
toward understanding, identifying, preventing and controlling emerging 
and re-emerging infections (for more information see the website, 
www.niaid.nih.gov/dmid/eid).

                      VCJD AND PRION INFECTED BEEF
    Question. To your knowledge, is the consumption of prion infected 
beef the only way for humans to contact vCJD?
    Answer. The evidence is quite compelling that vCJD is linked to 
BSE, or ``mad cow disease,'' but we are not certain exactly how people 
acquired the disorder from cows. Consumption of beef, especially beef 
products that contain spinal cord and brain tissue, is the most likely 
route. However, the FDA has also been considering potential risks posed 
by the use of drugs, dietary supplements, cosmetics, and processed 
foods derived from cattle. The agent of CJD cannot be destroyed by 
sterilization. Thus, while CJD cannot be transmitted from human to 
human by casual contact, it can be transmitted by brain material on 
contaminated surgical instruments, or by drugs derived from certain 
tissues, so this presents another range of possibilities, though 
probably quite limited if the number of vCJD cases remains low. There 
is a theoretical possibility that CJD might be transmissible by blood 
products, but there is no evidence that this has ever occurred, despite 
several ongoing investigations of blood donors, and specifically, of 
people who received blood or blood products from donors later diagnosed 
with CJD, and hemophiliacs, who are exposed to products derived from 
pooled blood from large numbers of donors. So, in short, there are 
other possibilities through which vCJD might be transmitted, but 
consumption of products from cattle infected with BSE seems the most 
likely.

                             PRION RESEARCH
    Question. Are you aware of any other diseases that may be better 
understood as a result of research in prion diseases like vCJD?
    Answer. Rare disorders often provide clues to more common diseases, 
and scientists have certainly argued that this is the case for prion 
diseases. In particular, prion diseases seem to involve the formation 
of abnormal aggregates of proteins in the brain. Abnormal clumps of 
proteins are also strongly associated with several more common 
neurodegenerative diseases, including Alzheimer's, Parkinson's, 
Huntington's, and the spinocerebellar ataxias. For all of these 
diseases, scientists are actively studying just how the abnormal 
processing of proteins leads to aggregates and how that relates to the 
progression of the disease. All human brains have a normal prion 
protein but we do not know what its function is nor how it becomes 
abnormal and possibly can cause disease. We are beginning to learn 
that, when the normal prion protein and closely related proteins are 
not present, brain dysfunction occurs, and this might be an important 
clue. At this point, it is too soon to speculate as to where such 
research will lead.

                     NIH SUPPORT OF PRION RESEARCH
    Question. If so, does increasing our NIH investment in prion 
disease make sense to you?
    Answer. We are increasing our investment in this area, especially 
in critical areas like the development of diagnostic tests. The 
Department has been coordinating the NIH efforts with those in the FDA 
and CDC. The issues of BSE in cattle and prevention of an vCSD 
infections in the U.S. are of public health significance and the need 
for a useful, reproducible diagnostic test is essential. However, 
scientists with specialized training in prion diseases are needed to do 
productive work in this area. Much of this research requires very 
expensive, high level safety containment facilities, and we are working 
on enhancing that aspect as well. We must also maintain close 
communication with the considerable efforts underway in Europe, so we 
learn from their experience and work together toward the same ends.
                                 ______
                                 
               Questions Submitted by Senator Tom Harkin

                           PANCREATIC CANCER
    Question. Pancreatic cancer is the fourth leading cause of death 
from cancer for men and women, but the amount of research funding per 
mortality that's devoted to it is among the lowest of all cancers. 
What's more, the NCI's Progress Review Group on Pancreatic Cancer found 
that there are only about 9 principal investigators in the United 
States who are focused on this terrible disease. What can be done to 
increase funding for research in pancreatic cancer and to get more 
scientists involved?
    Answer. The NCI is committed to increased resources for pancreatic 
cancer research. The aim of this increase is to catalyze implementation 
of the research priorities recommended in the Pancreatic Cancer 
Progress Review Group (PRG) report.
    The NCI has always funded outstanding research, including research 
focused on pancreatic cancer. The low level of NCI funding for 
pancreatic cancer research, and the limited number of researchers 
focused on this disease, largely reflects the difficulty in studying 
it. For example, pancreatic cancer exhibits a diversity of biological 
properties, and patients exhibit a variety of nonspecific symptoms. In 
addition, as noted in the PRG Report, pancreatic cancer care is 
complicated, and outcomes are nearly always disappointing. 
Nevertheless, the NCI is committed to a leadership role in surmounting 
these difficulties.
    In response to the PRG Report, the NCI is undertaking a 
comprehensive review of its initiatives, activities, and funded 
projects, as they relate to the PRG's recommendations. In July, the NCI 
Director and other NCI staff will meet with the PRG members to identify 
gaps in the NCI research portfolio and discuss strategies for filling 
them. After the conclusion of this meeting, the NCI will prepare a plan 
for implementing the PRG's recommendations. This plan will include 
strategies for addressing recommendations that haven't been addressed 
adequately. It also will include information about ongoing NCI 
activities that address the PRG's other recommendations. The NCI will 
reconvene a meeting of some or all of the members of the PRG in 2-3 
years to discuss and assess progress in advancing scientific knowledge 
and implementing the PRG's recommendations.
    In summary, the NCI will aggressively increase resources for 
pancreatic cancer research, and it will address and implement the PRG's 
recommendations thoroughly and comprehensively. Through these efforts, 
the Institute hopes to increase the number of researchers focused on 
pancreatic cancer, and more importantly, to alleviate the burden of 
pancreatic cancer on U.S. citizens.
    Last August, the general counsel for the Department of Health and 
Human Services said federal funding could be used for research on 
embryonic stem cells as long as the cells met certain NIH guidelines. 
But it's unclear whether any such cells exist. The only group that is 
known to be distributing stem cells in the United States is WiCell, and 
their cells do not meet NIH guidelines. There's an Australian 
researcher who says his cells do meet the guidelines, but this claim 
has not been verified.

                           STEM CELL FUNDING
    Question. Do you know whether there are any stem cells today that 
are eligible for federal funding?
    Answer. Still in review. Will provide an answer upon completion.

                   BIOMEDICAL RESEARCH INFRASTRUCTURE
    Question. The president has requested a nearly 30 percent increase 
in funding for construction of extramural NIH research facilities, for 
a total of $97 million. Even that increase, however, is significantly 
below what's needed to address the current backlog, let alone provide 
adequate lab space for the influx of new research. A 1998 National 
Science Foundation study on the status of scientific research 
facilities at U.S. college and universities identified an estimated 
$11.4 billion in deferred construction and renovation projects, as well 
as a decrease in new construction of health research facilities across 
an array of institutions. Has the NIH collected any data on the extent 
of this problem?
    Answer. In general, the Nation's research infrastructure has served 
the biomedical community well to date, allowing the United States to 
remain a world leader in biomedical science. There is some data that 
suggests that the Nation's biomedical research infrastructure is fast 
becoming outdated or insufficient, for example the NSF report. NIH has 
not collected any data itself on the extent of the problem.
    The need for modern research facilities will become increasingly 
urgent in the coming years. As research becomes more complex, which in 
turn, requires a multidisciplinary research team with complementary 
scientific expertise there are even greater demands on the nation's 
already overburdened research facilities. In addition, entirely new 
types of research facilities are needed to keep pace with today's rapid 
rate of change in the biomedical sciences and the need to accommodate 
high through-put technologies. Many emerging disciplines and 
technologies require new types of specialized facilities, such as 
biocontainment laboratories for handling infectious agents or clean 
rooms for producing clinical-grade gene vectors. As a result, 
facilities once expected to last for two or three decades can become 
technologically obsolete in less than half that time.
    The Acting Director of NIH, Dr. Ruth Kirschstein, appointed a 
Working Group of the Advisory Committee to the Director, NIH, to 
identify some of the factors that limit the construction and renovation 
of biomedical research facilities. The Working Group's primary charge 
was two-fold: (1) To examine the adequacy of current funding mechanisms 
for enhancing the infrastructure of research facilities in the 
biomedical sciences, and (2) To propose Federal actions that might 
bolster needed construction and renovation of such facilities at a 
variety of institutions. The Report of the Working Group was presented 
at the meeting of the Advisory Committee to the Director at the meeting 
this June. Dr. Kirschstein requested that the members of the ACD 
further discuss the recommendations in the Report with colleagues at 
their institutions; the report may be modified as a result of that 
process before the ACD accepts the Report. Question. Extramural NIH 
construction is authorized at $250 million. Given the current 
situation, would it make sense for the NIH to spend more than $97 
million?
    Answer. The fiscal year 2002 Budget provides $100 million for 
extramural construction, a $22 million increase (+28 percent) over 
fiscal year 2001. This funding level will enable the NIH to continue to 
support infrastructure upgrades at biomedical research facilities 
through the Research Facilities Construction grant program.

                           NCCAM SUCCESS RATE
    Question. The success rate for research project grants in the 
National Center for Complementary and Alternative Medicine is projected 
to be just 16 percent in fiscal year 2002, compared with an NIH average 
of 30 percent. Why is it so low? What can we do to bring that number 
up?
    Answer. Success rates for Research Project Grants (RPGs), the ratio 
of RPG awards to the total number of RPG applications received for a 
given fiscal year, represent a complex set of factors. Success rates 
typically vary among Institutes and Centers, among RPG activities, such 
as single-investigator initiated traditional grants (R01s) and 
multiple-investigator program projects (P01s), and among types of 
grants, such as new grants, first time awardees, and competing renewals 
which depend on the cycling of grants from noncompeting to competing 
status.
    Furthermore, there is not a linear relationship between budget 
level, number of applications, and number of awards. That is, an 
increase of twice the current budget levels will not result in an 
increase in twice the number of applications or twice the number of 
grants awarded. This is because the NCCAM portfolio is based on a 
number of interrelated mechanisms and factors, including the balance 
between intramural and extramural research, investigator initiated 
projects, contracts, and centers, as well as the number of grant 
applications, the size of grants, and the length of project periods.
    For the fiscal year 2002 President's Budget submission prepared in 
early April, NCCAM estimated it would receive 220 applications in 
fiscal year 2001, and 245 applications in fiscal year 2002, for an 
estimated success rate of 17 percent and 16 percent respectively.
    It is difficult, however, for NCCAM to predict with certainty the 
number of applications it will receive. Investigator-initiated 
applications reflect the state of a particular arena of science, public 
health need, the maturity of a scientific field, and even the morale of 
the scientific community. While the detailed outcomes of scientific 
discovery cannot be predicted, the current level of enthusiasm 
demonstrated by the research community is expected to continue, and the 
potential of current scientific opportunities and the successes of the 
past lead us to predict that NCCAM's continuing investment in all 
mechanisms of research support will be easily repaid in discoveries 
that will benefit the U.S. public.
     Question. The President's proposed NIH budget for fiscal year 2002 
calls for an increase of $2.74 billion, for a total of $23 billion. But 
he also wants to double the fee for evaluation activities from 1 
percent to 2 percent. Wouldn't that change effectively reduce the NIH 
increase by $230 million?
    Answer. As with most of the Department's other public health 
agencies, NIH contributes its fair share of funds to the Public Health 
Service Evaluation Fund, as authorized under Section 241 of the PHS 
Act. NIH traditionally, provides about 70-75 percent of these funds, 
reflecting the relative size of the NIH budget. These funds have always 
been used to support health statistics surveys by CDC/NCHS, health care 
services and health care quality research by AHRQ, and, as proposed for 
fiscal year 2002, national data collection surveys by SAMHSA and policy 
research by ASPE. NIH receives significant benefits from the projects 
supported through theses funds. By financing them through the PHS 
Evaluation Fund, the President's Budget proposes to more fully reflect 
the cross-cutting value of these health surveys and health care 
research activities of NCHS, AHRQ, SAMHSA, and ASPE. Under the fiscal 
year 2002 request, NIH's evaluation fund share would increase by $189 
million over its fiscal year 2001 contribution. Excluding the 
evaluation fund assessments in the base, as well as in the request, 
NIH's proposed budget would still increase by nearly $2.6 billion, or 
+12.7 percent in fiscal year 2002.
                                 ______
                                 
           Questions Submitted by Senator Ernest F. Hollings

                     RETINAL DEGENERATIVE DISEASES
    Question. Macular degeneration is a major and growing public health 
problem. Macular degeneration, Retinitis Pigmentosa and other retinal 
degenerative diseases can lead to blindness. How is the National Eye 
Institute responding to this challenge?
    Answer. Macular degeneration belongs to a group of retinal 
degenerative diseases that includes retinitis pigmentosa (RP), Usher 
syndrome, Leber Congenital Amaurosis, and allied diseases. As a group, 
these diseases are a major cause of blindness and therefore a priority 
area of research focus for the intramural and extramural programs of 
the National Eye Institute (NEI). Macular degeneration affects the part 
of the retina responsible for sharp central vision. One form of the 
disease, age-related macular degeneration (AMD), is the leading cause 
of irreversible vision loss in the United States among persons over 65 
years of age, the fastest growing segment of the US population. In 
spite of the public health significance of AMD, there is no proven 
treatment for most affected persons and information about its clinical 
course and the factors that predispose to it is limited. NEI-supported 
research on the identification of risk factors for AMD can help provide 
clues about the etiology of the condition and help to develop possible 
strategies for intervention. Two potentially modifiable risk factors, 
smoking and hypertension, have already been associated with the most 
severe form of AMD. The Age-Related Eye Disease Study (AREDS) is an 
ongoing multi-center study of the clinical course of AMD to identify 
additional risk factors for the development of high risk 
characteristics associated with severe vision loss. Another part of 
this study is investigating the effect of antioxidants and zinc on the 
progression of AMD. A major clinical trial is also underway to 
determine whether low intensity laser treatment can prevent the 
development of advanced complications of AMD.
    NEI-sponsored scientists recently reported the results of a gene 
transfer study that restored sight in an animal model of the inherited 
retinal degeneration--Leber Congenital Amaurosis. Continuation and 
expansion of this line of research offers hope for children who are 
afflicted with this blinding condition and may lead to development of 
gene transfer therapy applications for other inherited retinal 
degenerations. Other scientists are actively pursuing laboratory and 
clinical studies on the rescue and regeneration of deteriorating 
neurons; the identification of genes and neurodegenerative mechanisms 
for macular degeneration, RP, and related disorders; and the use of 
growth factors and transplantation, as well as gene therapy, as 
potential therapeutic measures. The goals of these studies are to 
increase understanding of the causes and mechanisms of cell death in 
retinal degenerative diseases, and to accelerate the development of 
innovative strategies to prevent, treat, and cure these diseases.

                               LOW VISION
    Question. Also, many eye diseases leave people with severely 
impaired vision. Is the NEI doing anything to help them cope with their 
impairment and to improve these individuals' quality of life?
    Answer. To address the special needs of those with uncorrectable 
visual impairment or low vision, the NEI supports a program of research 
on visual impairment and its rehabilitation. Some individuals require 
simple optical or mechanical aids to perform daily functions 
adequately, while others may need more specialized devices or 
environmental modifications. The NEI supports research to understand 
the origins of visual impairment and assist in the rehabilitation of 
those who have such disabilities. The NEI supports projects aimed at 
improving the methods of specifying, measuring, and categorizing loss 
of visual function; devising strategies to help visually impaired 
people maximize the use of their residual vision; systematically 
evaluating new and existing visual aids; developing an adequate 
epidemiological base to understand the causes of blindness, partial 
loss of sight, and visual anomalies; and studying the optical, 
electronic, and other rehabilitative needs of people with visual 
impairments.
    Additionally, the NEI established a Low Vision Education Program as 
a part of its National Eye Health Education Program to increase 
awareness of low vision and its impact on quality of life. This program 
is directed toward people with low vision, their families and friends, 
and the health care and service professionals who care for them. It 
takes particular note of the growing population of people over age 65 
and other high risk populations, including Hispanics and African 
Americans who are likely to develop low vision at an earlier age. As 
part of this education effort, the NEI has developed a public service 
campaign and a mobile exhibit on low vision that is currently traveling 
to shopping malls and centers throughout the United States. It contains 
an interactive multimedia touch screen program; provides information on 
low vision services and resources; and displays aids and devices that 
help people with low vision, all available in Spanish as well as 
English. The exhibit and touch screen program explain the causes of low 
vision; offer personal accounts of people living with low vision; and 
provide a self-assessment to help people determine if they or someone 
they know may have low vision.
                                 ______
                                 

          Questions Submitted by Senator Kay Bailey Hutchison

                         FUNDING COLLABORATION
    Question. U.S./Israel Cancer Collaboration. I understand that the 
National Cancer Institute recently funded a workshop to explore the 
feasibility of a U.S.-Israel collaboration on research projects related 
to cancer genetics. Please describe the intention of the NIH/NCI with 
respect to pursuing and funding this collaboration.
    Answer. NCI staff participated in the workshop and related meetings 
in Houston last fall to discuss this topic. The NCI was impressed with 
the list of areas of mutual interest for potential collaborations.
    Since that meeting, the joint group has identified priorities for 
such collaborations. The goal is to facilitate collaborations that 
result in competitive research proposals that succeed in peer review.
    Building toward this goal, NCI is working on two possible 
collaborations, both of which are very preliminary at this time:
  --Ovarian cancer screening study.--Researchers from the Hadassah 
        Medical Organization in Jerusalem have expressed interest in 
        collaborating in a trial of a new screening strategy for women 
        at high risk for ovarian cancer based in the NCI's Cancer 
        Genetics Network (CGN). Israeli collaborators could contribute 
        to this trial through partnership with M.D. Anderson Cancer 
        Center. A pilot study to evaluate the feasibility of this trial 
        is underway.
  --Behavioral research.--Initial discussions between NCI staff and 
        representatives of Hadassah Medical Organization have 
        identified areas of mutual interest in research on the 
        implications of testing individuals and families for genetic 
        risk factors. NCI is inviting Israeli investigators to 
        participate in the CGN Behavioral Research Working Group to 
        develop competitive grant applications for submission in the 
        near future.
    NCI has a strong, continuing interest in facilitating international 
research collaborations to meet research objectives that would be 
otherwise difficult to address using only domestic resources. One high 
priority area is research on the implications for the prevention and 
treatment of cancer posed by interactions between genes and 
environmental exposures. The scarcity of appropriate high-risk 
individuals and families who have a genetic susceptibility and the 
costs associated with the necessary studies has made it clear that 
national and international collaborations will be crucial to the 
success of our research enterprise.
    Existing studies at the Weizmann Institute of Science, Rehovot, are 
aimed at understanding the mechanism of action of the p53 tumor-
suppressor gene in its normal (wild type) and mutated forms. 
Inactivation of the endogenous wild-type p53 gene is associated with 
more than one-half of all cases of human cancer. Studies are focusing 
on the identification and characterization of genes involved in p53 
regulation. Other NCI-supported projects at the Weizmann Institute 
address (a) use of magnetic resonance imaging and spectroscopy as 
noninvasive procedures for early evaluation of breast cancer response 
to hormonal therapy and (b) investigation of molecular mechanisms 
through which the ErbB-2/HER2 oncoprotein contributes to tumorigenesis 
in various adenocarcinomas.
    At Tel Aviv University, NCI currently supports research on the 
neuroendocrine and immunologic mechanisms underlying the modulatory 
effects of the estrous cycle, gonadal hormones, and gender on immune 
competence and tumor development.
    NCI is also supporting an epidemiologic study of ovarian cancer at 
the Chaim Sheba Medical Center, Tel Hashomer, to evaluate a broad range 
of potential risk factors (e.g., reproductive, hormonal, nutritional, 
genetic, and occupational factors). Genetic analysis is also being 
added to the study. Scientists are pursuing the possibility of 
performing a study to assess the role of the BRCA1 and BRCA2 genes in 
prostate cancer risk, and a study of BRCA1 and BRCA2 gene mutations in 
male breast cancer is also under way. In addition, a feasibility 
project is being conducted to ascertain whether ataxia-telangiectasia 
is hereditary in approximately 24 candidate families and to determine 
procedures for a population-based study of cancer risk in these 
families.
    Mutations in the BRCA1 or BRCA2 gene are thought to account for 
about 90 percent of familial forms of breast cancer and ovarian cancer. 
In a study involving more than 5,000 Ashkenazi Jewish volunteers from 
the Washington, DC area, mutations in either BRCA1 or BRCA2 occurred in 
nearly 1 in 40. Collaborators on this project included scientists from 
the Chaim Sheba Medical Center in Israel.

               INTERNATIONAL COLLABORATIONS BY INSTITUTES
    Question. Considering the success of international cooperation on 
the Human Genome Project, do you see advantages to similar 
collaboration with other nations, like Israel, in other research areas, 
like cancer?
    Answer. The NIH participates in a broad range of international 
collaborations with many of the Institutes striving to develop and 
maintain a strong and diverse selection of international collaborations 
and initiatives. For example:
National Cancer Institute (NCI)
    NCI, in cooperation with extramural institutions and the Fogarty 
International Center of the NIH, supports international health research 
through bilateral agreements, grants, and contracts. NCI supports some 
1,000 Visiting Scientists and Exchange Scientists. The work of 
outstanding scientists throughout the world is supported through 
fellowships, cooperative projects, exchanges of personnel and 
materials, workshops and international dissemination of cancer 
information.
    NCI's international effort, coordinated by the Office of 
International Affairs (OIA) within the Office of the NCI Director, 
works in conjunction with programs within NCI's divisions, at other NIH 
Institutes and the Fogarty International Center. Advances in cancer 
research result from NCI support and from support by other U.S. and 
foreign government agencies, industries, private nonprofit institutes, 
and individual philanthropists.
    One way in which NCI fosters joint research between U.S. and 
foreign scientists is by cosponsoring international workshops. The NCI 
workshops program brings together small groups of U.S. and foreign 
scientists who are at the forefront of their fields of research, to 
discuss their newest research that has not yet been published.
    NCI is supporting several projects that are collaborative efforts 
with other countries:
  --NCI supports the work of investigators at Tata Memorial Hospital, 
        Bombay, India, in a community-based randomized-control 
        evaluation of low-cost methods for early detection of common 
        cancers in women. Breast and cervical cancers account for about 
        50 percent of cancer deaths in women in India. Among the 
        diagnostic methods being evaluated are clinical breast 
        examination without mammography, self-examination, and visual 
        inspection of the cervix by trained female health workers. The 
        goal is to reduce mortality by detection and diagnosis of 
        breast and cervical cancer at an early stage. This trial is one 
        of the first of its kind to be conducted in a developing 
        country, and findings may be relevant to other countries and 
        populations with limited resources (e.g., underserved 
        populations in developed countries).
National Institute of Allergy and Infectious Diseases (NIAID)
    NIAID supports a broad research portfolio that encompasses multiple 
infectious diseases including malaria, tuberculosis and HIV/AIDS. 
Because so many of these diseases occur primarily or solely outside the 
United States but have the capacity to emerge as public health threats 
in the U.S., NIH and NIAID have long recognized that programs promoting 
international research efforts and other disease control measures in 
the developing world can help to protect the health of Americans as 
well as the health of people living in countries where these diseases 
have long been endemic. Therefore, strengthening the research 
capability of scientists in their own countries is an important focus 
of NIAID efforts. One of the cores of our international programs is the 
rich network of partnerships--a set of alliances for conducting 
cutting-edge research, fostering good will, and transferring technical 
knowledge and know-how to research institutes and hospitals in regions 
of the world where tropical diseases are endemic. The alliances 
encourage U.S. scientists to work in and obtain expertise on disease 
issues in those regions. They also enable investigators from those 
areas to collaborate on research projects on site and to visit U.S. 
laboratories and attend scientific conferences and workshops to discuss 
with global experts the challenges of studying and combating these 
diseases.
            International Centers of Excellence:
    An important component of the NIAID Strategic Plan is a focus on 
addressing global health disparities. In order to address the 
disproportionate burden of infectious diseases on third world 
countries, NIAID is in the process of setting up International Centers 
of Excellence (ICERs). These research centers will be joint ventures 
between NIAID's intramural and extramural divisions and host nations. 
Extensive infrastructure improvements, equipment procurement and 
personnel and financial resources will be crucial to the success of 
these endeavors. Three sites have been identified by the NIAID:
  --The Tuberculosis Research Center (TRC) in Chennai, India will be 
        the base for an ICER to expand research on tuberculosis, 
        lymphatic filariasis and HIV. Research will initially focus on 
        the interaction between pre-existing helminth infection and 
        mycobacterial infection, studies of chemotherapy of TB in HIV 
        infected patients and the influence of non-HIV infections on 
        HIV expression. Longer term goals include understanding the 
        interaction between allergic disease and helminth infection, 
        the genetics of asthma in a tropical setting, drug resistance 
        in both helminth infection and TB, and possible assessments of 
        vaccines for Plasmodium vivax, TB, HIV or group A 
        streptococcus.
  --The Rakai District in southwestern Uganda will be a base for an 
        ICER to focus on HIV and STDs, including the effects on 
        pregnancy, fertility, infant survival, placental pathology and 
        mother-to-child HIV transmission.
  --The Papua New Guinea Institute of Medical Research will be the site 
        of an ICER to conduct malaria vaccine studies. The development 
        and testing of asexual blood stage malaria vaccines will be the 
        primary focus.
            HIV Networks:
    MAID supports two global research networks, the HIV Vaccine Trials 
Network (HVTN) and the HIV Prevention Trials Network (HPTN). The HVTN 
is a network of clinical sites in the United States and abroad that is 
dedicated to the development of an HIV vaccine through testing and 
evaluating candidate vaccines in clinical trials. The network includes 
11 sites in the United States and eight sites overseas, including sites 
in Africa, Asia, South America, and the Caribbean. The HVTN's global 
capacity will allow for rapid expansion as more vaccine candidates 
enter the pipeline for testing and development, and for carrying out 
larger scale studies of suitable vaccines.
  --The HPTN evaluates the safety and efficacy of non-vaccine 
        prevention interventions, alone or in combination, using HIV 
        incidence as the primary endpoint. Because HIV is transmitted 
        via different routes in different populations, developing a 
        variety of HIV prevention strategies will have a significant 
        impact on reducing transmission rates and slowing the spread of 
        HIV worldwide. Research through the HPTN is carried out through 
        HIV Prevention Trials Units (HPTUs) located at nine sites in 
        the United States and 16 sites overseas in Africa, Asia, Europe 
        and South America.
  --More recently, NIAID released a new grant program called the 
        Comprehensive International Program of Research on AIDS 
        (CIPRA). The goals of CIPRA are to provide long-term support to 
        researchers and institutes in developing countries to (1) plan 
        and implement a comprehensive HIV/AIDS prevention and treatment 
        research agenda relevant to their populations; and (2) enhance 
        the infrastructure necessary to conduct such research.
            International Histocompatibility Working Group (IHWG):
    NIAID is the primary sponsor of IHWG, a multi-national 
collaboration of more than 400 laboratories in 79 countries. The 
collective goal of this large group is to study the tremendous 
diversity of the human leukocyte antigen (HLA) gene complex, the most 
variable region of the human genome, and how this diversity affects 
human health. Genes of the HLA complex control immune responses and 
therefore determine an individual's resistance or susceptibility to 
autoimmune and infectious diseases. The HLA gene complex contains over 
220 identified genes. Each gene may be present in several different 
forms (alleles), and there are over 1,000 different alleles of HLA 
genes. This degree of sequence variability makes the HLA complex a 
uniquely valuable tool in analyzing human diversity and measuring the 
relatedness of distinct geographic, ethnic, and racial populations. 
Another feature of the IHWG that will facilitate its efforts is access 
to large cohorts of diverse ethnic and geographic origins. This 
provides tremendous statistical power for the population-based studies 
of HLA genetics in human diversity, transplantation, autoimmune 
diseases, and immune responses to infectious agents.
National Institute on Deafness and Other Communication Disorders 
        (NIDCD)
    NIDCD continues to support an international consortium with the 
purpose of expediting the discovery of genes responsible for hereditary 
hearing impairment. The consortium encompasses research on nonsyndromic 
and syndromic forms of hereditary hearing loss, such as Waardenburg 
syndrome and Usher syndrome. Scientists from countries including 
Belgium, Colombia, Finland, France, Germany, Israel, Japan, Norway, 
South Africa, and the United Kingdom, as well as scientists throughout 
the United States, continue their efforts to map the genes responsible 
for syndromic and nonsyndromic hereditary hearing impairment. Almost 60 
genes have been identified for recessive and dominant nonsyndromic 
hereditary hearing impairment in families from Colombia, India, 
Indonesia, Israel, Lebanon, Newfoundland, Pakistan, Tunisia, and the 
United States, including Puerto Rico. The collaborative efforts 
fostered by the consortium have been instrumental in identifying a 
large number of the genes responsible for hereditary hearing impairment 
and in advancing the understanding of these disorders.
    The Laboratory of Molecular Genetics established a collaboration 
with the University of Toronto on a study of hereditary deafness in 
Ashkenazi Jews and is actively working on the genetic mapping and 
identification of a novel deafness gene in a large Ashkenazi Jewish 
family. This has already resulted in one publication about the hearing 
status associated with a particular allele (variant) of a known 
deafness gene called connexin 26 (GJB2).
    NIDCD is also collaborating with the Instituto di Genetica 
Molecolare of the Consiglio Nazional delle Recerche (Institute of 
Molecular Genetics, National Research Council), Alghero, Sardinia, 
Italy in a study of inherited deficits in the sense of bitter taste. 
This laboratory has developed a unique study population in the 
Ogliastra region of Sardinia, consisting of a number of genetically 
isolated villages. Such populations provide important experimental 
advantages of the study of common recessive genes, such as those that 
cause deficits in the sense of bitter taste in individuals of European 
origin. The goal of this research is to identify the genes which cause 
this deficit to better understand the molecular mechanisms involved in 
the sense of bitter taste in humans.
    In another collaboration between NIDCD's Laboratory of Cellular 
Biology and the faculty at the Sackler School of Medicine, Tel Aviv 
University, Tel Aviv, Israel an attempt is underway to determine the 
pattern of expression and biological effects of Myosin VI during 
development of the auditory system. Myosin VI has been shown to be 
required for development of hair cells and for hearing, however the 
specific effects of this protein have not been determined.
National Center for Complementary and Alternative Medicine (NCCAM)
    The National Center for Complementary and Alternative Medicine, in 
collaboration with Johns Hopkins University, Johns Hopkins Singapore 
and the National University of Singapore, is co-sponsoring a research 
symposium on traditional Chinese medicine and a workshop on clinical 
methodology and grantsmanship in November 2001. The symposium will 
present state of the art research in traditional Chinese medicine from 
investigators in the region. The goal of the workshop is to train 
potential scientific collaborators in the necessary skills to 
successfully compete for National Institutes of Health grants. 
Scientific data and conclusions from grantees in Southeast Asia, where 
traditional medicine is widely practiced and accepted, will broaden the 
knowledge base of complementary and alternative medicine interventions 
while providing important information on chronic diseases such as 
cancer and cardiovascular disease that can be targeted to reduce health 
disparities in Asian populations in the U.S.
Fogarty International Center (FIC)
    The Fogarty International Center (FIC), the international arm of 
the NIH, promotes and supports international collaborations to advance 
medical research in virtually every area of science on behalf of the 
NIH. In addition, FIC focuses attention on the scientific opportunities 
and needs of low- and middle-income countries and works to reduce 
disparities in global health. Working through over 20 programs and in 
partnership with other NIH components, U.S. agencies and foreign 
counterparts, the FIC tackles global health challenges such as AIDS, 
mental illness, tuberculosis and maternal and children's health. FIC 
works through bilateral and multilateral arrangements, at times 
involving formal intergovernmental discussions and agreements, and more 
frequently through scientist-to-scientist exchanges. Illustrative 
examples of FIC-led programs include:
            Multilateral Initiative on Malaria (MIM):
    Launched in 1997, the MIM brings together countries from around the 
world in an effort to speed discoveries in malaria research while at 
the same time building capacity in countries most affected to employ 
state-of-the-art prevention and control technologies. Among its 
partners are public and private science funding agencies in Great 
Britain, France, Japan and Norway, as well as the World Health 
Organization and the World Bank. Since 1999, FIC has served as the MIM 
Secretariat, and has advanced the MIM agenda in partnership with other 
NIH ICs including NIAID and NLM by: increasing malaria research 
funding, increasing internet access for malaria researchers, expanding 
the numbers of MIM sponsors, improving the sharing of research 
resources for malaria, and establishing new opportunities for the 
training of African scientists in this critical field. In addition, MIM 
has just recently initiated and supported the development of new 
estimates of malaria mortality, now known to be close to 3 million 
deaths per year, primarily in sub-Saharan Africa and in children under 
the age of five, in addition to significant disability and morbidity in 
Africa, Latin America and Asia.
            AIDS International Training and Research Program:
    Working primarily through U.S. universities, FIC supports training 
of scientists and health professionals from the developing world as 
part of international collaborative research programs. This training 
includes Ph.D. or Master's level degrees and is the largest program 
contributing to capacity to confront the AIDS epidemic in countries 
hardest hit. Graduates of this training are now the leaders in their 
country, reaching senior level positions in Ministries of Health, 
including the Minister of Health position. They will be essential to 
the design and conduct of clinical trials to test new AIDS prevention, 
vaccines, and treatment technologies and to ensure that such trials are 
conducted with scientific rigor as well as in accordance with 
international and local ethical norms. FIC's program, which works 
closely with all relevant NIH components, has led to the development of 
scientific infrastructure in countries such as Uganda and Senegal where 
HIV infection rates have been reduced dramatically or held at a low 
level, respectively.
            Pan American Fellowship Program:
    Begun with NIH counterparts in Mexico in 1995, the Pan American 
Fellowship Program brings post-doctoral scientists to the NIH 
laboratories in Bethesda for advanced training in a range of scientific 
areas. Building on mutual strengths and interests, fellows receive 
training under the mentorship of chief NIH scientists in areas such as 
neurobiology, infectious disease, genetics and maternal and children's 
health. Every year, fifteen to twenty trainees participate in this 
program, which is sponsored on a cost-shared basis by both countries. 
Based on the success of the effort with Mexico, FIC expanded the 
program recently to include other Latin American countries such as 
Argentina, Colombia, Chile, Costa Rica, and Uruguay, with additional 
support from the Pan American Health Organization to co-sponsor from 
other countries in the Latin American and Caribbean region.
National Institute of Neurological Disorders and Stroke (NINDS)
    In November 2000, NINDS, on behalf of the United States, signed a 
Memorandum of Understanding (MOU) with the National Institute for 
Physiological Sciences at Okazaki, representing Japan. The purposes of 
this cooperative program are to stimulate studies of the molecular, 
cellular, and integrative mechanisms of mammalian--including human--
brain function. The MOU will establish a cooperative program that will 
be open to all neuroscientists in both countries. Associated activities 
may include collaborative research projects, information sharing 
through workshops and seminars, short-term exchanges of scientists and 
other relevant activities. We believe that new knowledge about the 
brain and the nervous system gained through this agreement will 
favorably impact the health of all populations.
National Institute of Dental and Craniofacial Research (NIDCR)
            Genetics of Cleft Lip and Palate:
    NIDCR supports a project with the World Health Organization to 
serve as the umbrella organization for the development and maintenance 
of a global research network in the area of craniofacial anomalies 
(CFA). Such a network links U.S. and NIH-funded researchers with other 
researchers, and provides access to populations in other parts of the 
world for studies regarding the genetic and environmental causes of 
CFA, the health care systems and treatment methodologies which lead to 
the best outcomes for those children born with CFA, and ways to reduce 
the incidence or prevent these birth defects.
    As a result of this collaboration, significant progress has 
recently been achieved in understanding the genetics of cleft lip and 
palate. An NIDCR-supported research team reported the discovery of the 
gene responsible for cleft lip and palate when it occurs as part of a 
syndrome that also includes defects in the skin, teeth, and hands. The 
gene, called PVRL1, codes for a molecule that is important for cell 
adhesion. Mutations in the PVRL1 gene are responsible for a recessive 
cleft lip and palate syndrome, called CLPED1, which occurs with a high 
frequency among the population of Margarita Island. More recently, this 
research team has found preliminary evidence that individuals carrying 
one copy of the mutated gene have an increased risk for cleft lip and 
palate that is not associated with the other defects of the syndrome. 
These results may lead to the development of early diagnostic tools and 
prevention strategies for cleft lip and palate.
National Institute Drug Abuse (NIDA)
    Pandemics such as drug abuse and HIV/AIDS require that we bring the 
full power of science to bear on these complex public health problems. 
Toward this end, NIDA has several collaborative efforts underway with 
the nations of Thailand and South Africa that will likely have 
advantages to enhance both the U.S. and the participating country's 
research agenda.
    For example, given the extremely high rates of methamphetamine 
abuse in Thailand, and as a follow-up to the Pacific Regional Research 
Conference on Methamphetamine and Amphetamine-Type Stimulants, held in 
November 2000 in Bangkok, Thailand, NIDA has been working with the Thai 
government to determine ways to best prevent and treat addiction to 
this powerful stimulant. Thailand presents some unique opportunities 
for collaborative efforts. For one, the government in Thailand is very 
enthusiastic and committed to focusing on its methamphetamine problem. 
The population of methamphetamine abusers is also unique because of the 
age and symptoms of those who are abusing. Use begins at a very early 
age in Thailand, typically before the teen years. By the age of 12, 
some of these children are being diagnosed with long-term psychosis. 
There is much we can learn by studying this population, especially as 
the drug continues to spread in our own country. Also given that there 
are currently no medications available in the U.S. or elsewhere to 
combat this addiction, there is a behavioral treatment model (MATRIX) 
that has proven successful in the United States. This model is now 
being used in Thailand to help deal with their methamphetamine 
epidemic.
    A second example of a collaborative research effort that will 
likely directly benefit the citizens of both nations is the efforts 
that NIDA has underway with South Africa. NIDA has been working with 
South Africa on an informal basis for over a year, but is interested in 
stimulating more formalized bi-national collaborative drug abuse 
research between the United States and South Africa. South Africa has 
one of the fastest growing rates of the HIV infections in the world. 
Although we have learned much about preventing and treating HIV/AIDS in 
the United States, very little is known about the potential for 
replicating science-based prevention and treatment approaches in 
settings outside of the U.S. Given the many similarities between the 
two countries transmission patterns and the cultural diverse 
populations of its citizenship, there is much the U.S. can learn from 
South Africa as it attempts to prevent HIV/AIDS with lessons learned 
from the U.S.
    Finally, NIDA has also begun a collaborative research initiative 
with the Dutch government that includes efforts to explore areas of 
mutual interest. One important area is the growing use of MDMA, or 
ecstasy, and its short and long term effects on the brain. NIDA is 
hosting a workshop this fall with U.S. and Dutch researchers to review 
the current science and to plan for future collaborative research 
projects.
National Institute of Mental Health (NIMH)
    As the world leader in research on effective behavioral strategies 
to decrease and prevent the spread of AIDS, the National Institute of 
Mental Health is involved in a number of international collaborative 
efforts that provide the opportunity to disseminate and build upon the 
knowledge gained, ease the burden of disease and prevent the 
international spread of a devastating disease. NIMH is supporting the 
first international trial of a U.S. tested model of community-level 
HIV/STD behavioral prevention program. The NIMH Collaborative HIV/STD 
Prevention Trial is a two-arm randomized, community-level trial being 
conducted in six countries--China, India, Peru, Russia, Uganda, and 
Zimbabwe. In addition, research collaborative agreements with the 
research ministries of the governments of India and South Africa have 
resulted in increasing the quality of the HIV behavioral prevention 
studies and helping to develop the research capacity of these 
countries.
    With mental illnesses occupying such a prominent place in the 
global burden produced by disease, the NIMH also supports mental health 
research in over three dozen foreign countries.
National Institute of Child Health and Human Development (NICHD)
    NICHD, in partnership with both other NIH Institutes and the Gates 
Foundation, has developed and implemented a Global Network for Women's 
and Children's Health Research. This large, international collaborative 
effort is essential to addressing the leading causes of morbidity and 
mortality in children and women of child-bearing age in resource-poor 
settings. Through partnerships between leading U.S. researchers and 
senior foreign investigators, interventions to reduce maternal and 
child morbidity and mortality will be tested for efficacy with advance 
planning that will permit the rapid and sustainable implementation of 
interventions judged by rigorous research to be successful.
    The NICHD-sponsored study, The Hyperglycemia and Adverse Pregnancy 
Outcome Study is an epidemiologic investigation to clarify the 
association of various levels of glucose intolerance during the third 
trimester of pregnancy and the risk of adverse outcomes. This 
international collaborative study will enroll 25,000 women in the U.S., 
Australia, Canada, China, Israel, the Netherlands, the Republic of 
Singapore, Thailand, the United Kingdom and the West Indies. The study 
is examining glucose intolerance in a large heterogeneous, 
multinational ethnically diverse cohort of women in the third trimester 
of gestation. This international collaboration has been carefully 
planned and will generate robust data on the global incidence of 
gestational diabetes that will provide definitive international 
reference standards. This cooperative study makes use of state-of-the-
art laboratory and measurement techniques and, via frequent steering 
committee meetings, facilitates the sharing of creative and innovative 
scientific thinking from around the globe. NICHD and NIDDK are acting 
jointly to support this important investigation.
    The Trial to Reduce the Incidence of Type I Diabetes Mellitus in 
the Genetically at Risk will test the hypothesis that a nutritional 
intervention during infancy will reduce the incidence of type I 
diabetes in genetically susceptible infants. This randomized, 
prospective controlled clinical trial will enroll a total of 2,370 
infants in the United States, Australia, Canada, Estonia, Finland, 
France, Germany, Hungary, Italy, Netherlands, Poland, Russia, Spain, 
Sweden, and Switzerland. The public health implications of this 
nutritional intervention will be enormous if proven successful. This 
study represents a collaborative international effort involving funds 
from the NICHD, other NIH Institutes, the Juvenile Diabetes Research 
Foundation, the Canadian Institutes of Health Research, and the 
European Foundation for the Study of Diabetes. Thus, financial 
contributions from both the U.S. and abroad, innovative collaborative 
scientific thought from an international group of diabetologists and 
pediatricians from the nations noted above, and enrollment of a large 
and diverse population will synergistically act to answer a critical 
public health question.
    The NICHD is developing a potentially very promising research 
initiative with India. This initiative will foster joint research on 
the leading causes of morbidity and mortality among women of child 
bearing age and children. It also will support joint HIV/AIDS research, 
particularly on the prevention of HIV transmission from mothers to 
their children, and research on reproductive health and sexual 
behavior. Pursuing these lines of research in India offers great 
opportunities to U.S. scientists because Indian biomedical and 
behavioral scientists are well trained and supported by relatively 
strong scientific institutions. Also, because of the growing AIDS 
epidemic in India and the prevalence of many diseases and conditions in 
Indian populations of women and children, India offers unique 
opportunities to study new ways to improve health in large populations. 
Furthermore, the Government of India is committed to research co-
funding so U.S. Government funding can be multiplied.
    NICHD also sees important opportunities for research collaboration 
in Africa, which has the greatest burden of maternal and child 
morbidity and mortality. Research on HIV/AIDS, infectious diseases 
including sepsis, upper-respiratory diseases and nutrition-related 
disorders are a few examples of areas where research in Africa holds 
great potential for new discoveries. In Africa it also is most cost-
effective to mount programs on a regional basis to maximize the use of 
trained investigators and to assure lessons learned are applied to the 
greatest benefit. Through the Global Network for Women's and Children's 
Health Research, which is co-funded by the Gates Foundation, NICHD 
plans to expand joint research in Africa on critical maternal and child 
health interventions specifically developed for developing countries. 
This promising program is a model for public-private partnership as 
well as international research collaboration.
National Institute of Environmental Health Sciences (NIEHS)
    Among the many reasons for pursuing international collaborations 
are that some phenomena--both tools and conditions--exist in other 
countries that do not exist in the U.S. One is the availability of 
information. NIEHS is initiating a collaborative cohort study with 
scientists and health officials in Norway to study pregnant women and 
their children; this study takes advantage of that country's system of 
socialized medicine both to enroll the women (a very high percentage of 
women obtain early prenatal care) and to follow them and their 
children. Other studies, particularly in the field of environmental 
health, cast a global net to find populations and regions with higher 
exposure levels to pollutants of interest, in which the divisions 
between exposed and unexposed populations are more clearly delineated 
and epidemiological studies are more likely to provide clear 
information of either an association or a lack of an association with 
disease. For instance, most of the information we have used in the U.S. 
to assess risks from mercury exposure have come from studies in the 
Faroe Islands in the North Atlantic and from the Seychelles Islands off 
the coast of Africa, where the people eat a great deal of fish and 
their mercury exposure comes through that route.

                   SUCCESS RATE FOR GRANT SUBMISSIONS
    Question. Mental Health/National Institute of Mental Health. Where 
does the National Institute of Mental Health (NIMH) stand relative to 
other NIH institutes on the rate of grants submitted and funded?
    Answer. In fiscal year 2000 the average success rate (awarded 
grants as a percentage of total grant applications) for research 
project grants was 32 percent NIH-wide. Success rates across the 21 NIH 
Institutes and Centers ranged from a high of 43 percent to a low of 18 
percent. The NIMH ranked 13th from the highest with a success rate of 
29 percent.

                QUALITY OF SCIENCE IN GRANT SUBMISSIONS
    Question. Is the relative quality of science in the grant 
submissions and proposals received by NIMH rising or declining?
    Answer. The striking growth and scientific development of the field 
of neuroscience over the last decade has served to drive a rapid, 
sustained expansion of the number of very high quality research 
programs in the areas of basic and clinical neuroscience. This 
expansion of excellent research programs has meant that the pool of 
outstanding NIH grant applications has grown at a corresponding rate. 
NIMH has ``turned the corner'' in substantially upgrading its research 
portfolio and retargeting research opportunities. This has resulted in 
a much larger pool for these areas of outstanding applications that are 
truly significant for NIMH's mission. Similar NIMH efforts in the areas 
of services and intervention research have been successful in producing 
and expanding a high-quality pool of better-targeted applications.

                          BUDGETARY INCREASES
    Question. Can NIMH efficiently spend the increases enacted by 
Congress in fiscal year 2000 and fiscal year 2001 again in fiscal year 
2002, i.e. will good science continue to keep pace with budgetary 
increases?
    Answer. Yes. The science related to the brain and to behavior is at 
the frontier that now attracts the most talented investigators in the 
country. With the recent budget increases, NIMH has undertaken new 
initiatives in several scientific areas--basic and clinical 
neuroscience, and behavioral science--that are poised for rapid 
development because of technological innovation and dramatic growth in 
our understanding of brain function. In addition, NIMH has targeted a 
significant portion of its funding to initiatives deemed by the public 
and Congress to be health emergencies including research on the use of 
psychotropic medications in children, youth violence in our schools and 
communities, and suicide prevention. Also of note, NIMH recently 
launched several large clinical treatment trials to determine the most 
effective treatments for people with some of the most disabling mental 
illnesses (schizophrenia, bipolar disorder and depression). These are 
areas in which unprecedented advances in our understanding have emerged 
coincident with critical public health needs.
    Judging from peer review ratings and programmatic relevance, the 
quality of the grant applications received in response to the majority 
of these initiatives has been outstanding. The fiscal year 2002 Budget 
level would allow additional initiatives, determined by a selective 
NIMH planning process, to come on-line expeditiously. Initiatives 
recently implemented, and those planned for fiscal year 2002, are 
focused on topics such as development of therapeutics, training 
investigators for clinical research, and genetic/molecular neuroanatomy 
of the brain. Special emphasis is being placed on severe mental 
disorders, including, for example, a major new centers program for 
autism research.

                       INFORMATION DISSEMINATION
    Question. In the last decade, many new treatments and services have 
been developed and proven for severe mental illnesses such as 
schizophrenia. Yet most individuals with these illnesses receive less 
than optimal care. What steps can the NIH/NIMH take to ensure that 
improvements in treatments and therapies can be effectively 
disseminated to providers and patients?
    Answer. NIMH focuses on research that helps to reduce the burden of 
mental disorders for the American public. The Institute's research 
program aims to translate the understanding of basic biological and 
genetic processes, including knowledge of mechanisms underlying 
thought, emotion, and behavior, into effective treatments that reach 
patients with mental illness. NIMH's new generation of ``real-world'' 
treatment effectiveness studies will raise the standard of care for 
several major mental disorders, including schizophrenia and bipolar 
disorder (manic-depressive illness), by determining the best existing 
treatments in thousands of patients across the U.S. The National 
Advisory Mental Health Council (NAMHC) did a study of the effects of 
parity for mental health benefits which helps policymakers and the 
public to have the appropriate information about the costs of providing 
mental health insurance coverage.
    Through its Office of Communications and Public Liaison (OCPL), 
NIMH publishes and disseminates research-based information on mental 
disorders and their treatment for diverse audiences including the 
general public, people with mental disorders and their families, health 
care providers, mental health professionals, scientists, advocates, and 
the media. Materials that cover the wide range of disorders and 
research areas funded by the Institute are available both in print and 
on the Web. At this time, the NIMH Web site (http://www.nimh.nih.gov) 
is receiving approximately 7 million hits each month; and recently it 
received commendation for the quality of its information, especially on 
depression.
    NIMH also supports a continuing Dissemination Research Program 
dedicated to improving communication of research evidence to providers, 
patients, and other stakeholders. A program highlight in the latest 
funding cycle is a new study evaluating a web-based information system 
for families and patients dealing with schizophrenia. Furthermore, 
through the Small Business Innovation Research contract program, NIMH 
is reviewing proposals to develop dissemination tools for schools and 
other community settings. The Institute is collaborating with the 
National Association of State Mental Health Program Directors to 
organize workshops in the coming months to raise the profile of 
dissemination and evidence based treatment for mental health in 
children. NIMH/NIH is also partnering with other HHS agencies (ASPE, 
AHRQ, CDC, HRSA) in an initiative to examine dissemination and 
diffusion of research findings and to focus on dissemination efforts. 
In April 2001 NIMH sponsored a workshop on Implementing Evidence-Based 
Practice in the Public Mental Health Sector.

                         CONCLUSION OF HEARINGS

    Senator Specter. Thank you all very much for being here. 
That concludes our hearing.
    [Whereupon, at 9:55 a.m., Wednesday, May 23, the hearings 
was concluded, and the subcommittee was recessed, to reconvene 
subject to the call of the Chair.]


  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2002

                              ----------                              

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

                       NONDEPARTMENTAL WITNESSES

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

                        DEPARTMENT OF EDUCATION

 Prepared Statement of the American Indian Higher Education Consortium

    Mr. Chairman and Members of the Subcommittee, on behalf of this 
nation's 32 Tribal Colleges and Universities, which comprise the 
American Indian Higher Education Consortium (AIHEC), we thank you for 
the opportunity to share our fiscal year 2002 funding requests for 
programs within the Department of Education.
    This statement will cover two areas (a) background on the tribal 
colleges, and (b) justifications for our funding requests.

                     BACKGROUND ON TRIBAL COLLEGES
    The Tribal College Movement was launched in 1968 with the 
establishment of Navajo Community College, now Dine College, in Tsaile, 
Arizona. A succession of tribal colleges soon followed, primarily in 
the Northern Plains region. In 1972, the first six tribally controlled 
colleges established AIHEC to provide a support network for member 
institutions. Today, AIHEC represents 32 Tribal Colleges and 
Universities in 12 states and one in Canada, created specifically to 
serve the higher education needs of American Indian students. 
Collectively, they serve 25,000 students from over 250 federally 
recognized tribes.
    Tribal colleges offer primarily 2-year degrees, although in recent 
years some institutions have begun to offer baccalaureate and graduate-
level degrees. The vast majority of the tribal colleges are fully 
accredited by independent, regional accreditation agencies.\1\ In 
addition to college level programming, tribal colleges provide much 
needed high school completion (GED), basic remediation, job training, 
college preparatory courses, and adult education. Tribal colleges 
fulfill additional roles within their respective communities 
functioning as community centers, libraries, tribal archives, career 
and business centers, economic development centers, public-meeting 
places, and child care centers. An underlying goal of tribal colleges 
is to improve the lives of students through higher education and to 
move American Indians toward self-sufficiency.
---------------------------------------------------------------------------
    \1\ The Tribal Colleges and Universities are accredited by regional 
accreditation agencies and must undergo stringent performance review on 
a periodic basis. The higher education division of the respective 
regional accreditation agency accredits twenty-seven of the TCUs. Two 
new TCUs are at the Pre-candidate stage as they complete work to attain 
Candidate status; one TCU is at Candidate status. Two TCUs are 
accredited as ``Vocational/Adult Schools by the ``schools'' division of 
the respective regional accreditation agency.
---------------------------------------------------------------------------
    Tribal colleges provide needed access to higher education for 
American Indians and others living in mostly remote, economically 
depressed areas of the country. These institutions are chartered by 
their respective tribal governments and were established in response to 
the recognition by tribal leaders that local, culturally-based 
education institutions are best suited to help American Indians succeed 
in higher education. Tribal colleges combine traditional teachings with 
conventional postsecondary courses and curricula. They have devised 
innovative means to address the needs of tribal populations in 
economically depressed regions and are successful in overcoming long-
standing barriers to Indian higher education. Since the first tribal 
college was established on the Navajo reservation, these vital 
institutions have come to represent the most significant development in 
the history of American Indian higher education, providing access to 
under-represented students and promoting achievement among students who 
may otherwise never have known post-secondary education success.
    Funding of tribal colleges is grossly inadequate. While these 
institutions have successfully negotiated many challenges in the 
history of the Tribal College Movement, adequate funding remains the 
most significant barrier to their ongoing success. Core operational 
funding for 25 tribal colleges is provided through the Tribally-
Controlled College or University Assistance Act (TCCUAA), Public Law 
95-471. Funding was first appropriated through the Act in 1981, and is 
still less than two-thirds of its Congressionally authorized level of 
$6,000 per full-time Indian student. In fiscal year 2001, the Colleges 
received $3,849 per full-time Indian student. Moreover, this amount is 
less than two-thirds of the estimated $6,089 per full-time student 
received by mainstream community colleges. While mainstream 
institutions have a foundation of stable state support, tribal colleges 
must rely on the Federal government for operational funding. Because 
tribal colleges are located on federal trust territories, states have 
no obligation to fund them. In fact, most states do not even fund our 
colleges for the non-Indian state-resident students who account for 
approximately 20 percent of our enrollments.
    Since their inception, tribal colleges have achieved exceptional 
growth and success, yet they are the most poorly funded higher 
education institutions in America. Although conditions at some have 
improved substantially, many colleges still operate in trailers; cast-
off buildings; and facilities with crumbling foundations, faulty 
wiring, and leaking roofs. Sustaining quality academic programs is a 
challenge without a reliable source of facilities maintenance and 
construction funds.
    Today, one in five American Indians live on reservations. As a 
result of 200 years of Federal Indian policy--including policies of 
termination, assimilation and relocation--many reservation residents 
live in abject poverty comparable to poverty found in Third World 
nations. Through the efforts of tribal colleges, American Indian 
communities receive services they need to reestablish themselves as 
responsible, productive, and self-reliant citizens.

                             JUSTIFICATIONS
    Higher Education Act requests.--The Higher Education Act Amendments 
of 1998 created a separate section within Title III, Part A, 
specifically for the nation's tribal colleges (Section 316). The Aid 
for Institutional Development programs, commonly known as the Title III 
programs, support minority institutions and other institutions that 
enroll large proportions of financially disadvantaged students and have 
low per-student expenditures. Tribal colleges clearly fit this 
definition. Tribal colleges are among the most poorly funded 
institutions in America, yet they serve some of the most impoverished 
areas of the country. They fulfill a vital role of providing access to 
quality higher education programs, which are specifically designed to 
focus on the critical, unmet needs of their American Indian students 
and communities. This funding will help the tribal colleges effectively 
prepare their students for the workforce of the 21st Century in a safe 
environment. The President's budget recommendation included increases 
for the Historically Black Colleges and Universities programs, and the 
Hispanic Serving Institutions line item under this program, while the 
tribal colleges' account was level funded. We strongly urge the 
Subcommittee to correct this oversight and fund this section--which is 
critical to the tribal colleges--at $25 million. We ask that $10 
million of these funds be specifically designated for the competitive 
facilities and infrastructure improvement program created in fiscal 
year 2001, also administered under this section.
    The importance of Pell grants to our students cannot be overstated. 
Department of Education figures show that at least half of all Tribal 
College students receive Pell grants, primarily because student income 
levels are so low and our students have less access to other sources of 
aid than students at mainstream institutions. Within the Tribal College 
system, Pell grants are doing exactly what they were intended to do--
they are serving the needs of the lowest income students by helping 
people gain access to higher education and become active, productive 
members of the workforce. We urge you to build upon increase 
recommended in the President's fiscal year 2002 budget.
    Perkins Vocational Education Act.--Section 117 (addressing 
Tribally-Controlled Postsecondary Vocational Institutions) of the Carl 
D. Perkins Vocational and Applied Technology Education Act provides 
core funding for two of our member institutions: United Tribes 
Technical College in Bismarck, North Dakota, and Crownpoint Institute 
of Technology in Crownpoint, New Mexico. We support the $5.6 million 
included in the President's budget request for the Tribally-Controlled 
Postsecondary Vocational Institutions under Section 117. We request 
report language reaffirming that this funding remain specific to these 
two Tribally Controlled Postsecondary Vocational Institutions.
Greater Support of Indian Education Programs Under ESEA
    American Indian Adult and Basic Education.--This section supports 
adult education programs for American Indians that are offered by 
tribal colleges, state and local education agencies, Indian tribes, 
institutions, and agencies. Unfortunately, the section has not been 
funded since fiscal year 1995. The Tribal College Act does not include 
funding for remediation and adult basic education, as it only supports 
those students enrolled in postsecondary programs. Yet, the tribal 
colleges must continue to provide basic adult education classes for 
their communities. Before many individuals can even begin the course 
work needed to learn a productive skill, they first must earn a GED or, 
in some cases, learn to read. According to a 1995 survey conducted by 
the Carnegie Foundation for the Advancement of Teaching, 20 percent of 
the participating students had completed a tribal college GED program 
before beginning formal classes at the tribal college. At some schools, 
the percentage is even higher. Lac Courte Oreilles Ojibwa Community 
College in Hayward, Wisconsin, for example, reports that nearly one-
third of its students had earned a GED through its tutoring and testing 
center. Clearly, the need for basic educational programs is tremendous, 
and tribal colleges need funding to support these crucial activities. 
Tribal colleges need a minimum of $5 million to meet the ever-
increasing demand for basic adult education services. Without this 
minimum commitment, vitally needed services for our adult student 
population cannot be sustained, much less increased to address the full 
need. It is our hope that Congress will rectify this serious oversight 
in fiscal year 2002.
    American Indian Teacher Corps.--American Indians are severely 
under-represented in the teaching ranks nationally. This program, aimed 
at producing 1,000 new teachers for schools serving American Indian 
students, would provide for fellowships to college students majoring in 
education programs and for professional development programs in Indian 
Country to support current teachers. We believe that the tribal 
colleges are the ideal catalysts for this initiative because of our 
current work in this area and the existing articulation agreements 
tribal colleges hold with 4-year higher education institutions. We 
request Congress continue to support this $10 million program, included 
in the President's fiscal year 2002 budget request, to increase the 
number of qualified American Indian teachers in Indian Country.
    American Indian Administrator Corps.--In fiscal year 2001, a new 
program was funded to establish the American Indian Administrator 
Corps. Like teachers, American Indian school administrators are 
severely under-represented in the profession nationally. This program 
will support the recruitment, training, and in-service professional 
development of 500 American Indians and Alaska Natives to become 
effective school administrators in schools with large Native American 
populations. We request Congress continue to support this $5 million 
program, included in the President's fiscal year 2002 budget request, 
to increase the number of American Indian school Administrators in 
Indian Country.

                               CONCLUSION
    Fulfillment of AIHEC's fiscal year 2002 request will strengthen the 
mission of the Tribal Colleges and Universities, and contribute to the 
enormous, positive impact they have on their respective communities. 
Moreover, it will help ensure that American Indians will be properly 
educated and prepared for the workforce of the 21st Century. As the 
1997 Carnegie Report on tribal colleges stated:

    ``Now, as strongly as ever, we repeat our conviction that tribal 
colleges deserve continued support. Their value has been proven, but 
their vision is not yet fulfilled.'' \2\
---------------------------------------------------------------------------
    \2\ Paul Boyer, Native American Colleges: Progress and Prospects. 
Princeton, NJ: Carnegie Foundation for the Advancement of Teaching, 
1997.

    Tribal colleges have been extremely responsible with the Federal 
support they have received over the last 20 years, and have proven 
themselves to be a sound federal investment.
    Thank you again for this opportunity to present our funding 
requests before this Subcommittee. We respectfully ask the Members of 
this Subcommittee for their continued support and full consideration of 
our fiscal year 2002 appropriations request.
                                 ______
                                 

      Prepared Statement of the American Museum of Natural History

              ABOUT THE AMERICAN MUSEUM OF NATURAL HISTORY
    The American Museum of Natural History [AMNH] is one of the 
nation's preeminent institutions for scientific research and public 
education. Since its founding in 1869, the Museum has pursued its 
mission to ``discover, interpret, and disseminate--through scientific 
research and education--knowledge about human cultures, the natural 
world, and the universe.'' It is renowned for its exhibitions and 
collections of more than 32 million specimens and cultural artifacts. 
With nearly five million annual visitors--approximately half of them 
children--its audience is one of the largest, fastest growing, and most 
diverse of any museum in the country. Museum scientists conduct 
groundbreaking research in fields ranging from all branches of zoology, 
comparative genomics, and paleontology to earth, space, and 
environmental sciences and biodiversity conservation. Their work forms 
the basis for all the Museum's activities that seek to explain complex 
issues and help people to understand the events and processes that 
created and continue to shape the Earth, life and civilization on this 
planet, and the universe beyond.
    Today more than 200 Museum scientists with internationally 
recognized expertise, led by 47 curators, conduct laboratory and 
collections--based research programs as well as fieldwork and training. 
Scientists in five divisions (Anthropology; Earth, Planetary, and Space 
Sciences; Invertebrate Zoology; Paleontology; and Vertebrate Zoology) 
are sequencing DNA and creating new computational tools to retrace the 
evolutionary tree, documenting changes in the environment, making new 
discoveries in the fossil record, and describing human culture in all 
its variety. The Museum also conducts graduate training programs in 
conjunction with a host of distinguished universities, supports 
doctoral and postdoctoral scientists with highly competitive research 
fellowships, and offers talented undergraduates an opportunity to work 
with Museum scientists.
    The AMNH collections of some 32 million natural specimens and 
cultural artifacts are a major scientific resource, providing the 
foundation for the Museum's interrelated research, education, and 
exhibition missions. They often include endangered and extinct species 
as well as many of the only known ``type specimens,'' or examples of 
species by which all other finds are compared. Within the collections 
are many spectacular individual collections, including the world's most 
comprehensive collections of dinosaurs; fossil mammals, Northwest Coast 
and Siberian cultural artifacts, North American butterflies, spiders, 
Australian and Chinese amphibians, reptiles, fishes outside of their 
home countries, and one of the most important bird collections. 
Collections such as these are historical libraries of expertly 
identified and documented examples of species and artifacts, providing 
an irreplaceable record of life on earth. They provide vital data for 
Museum scientists as well as more than 250 national and international 
visiting scientists each year.
    In the exhibition halls AMNH scientific knowledge and discovery are 
translated into three dimensions. One of the most exciting chapters in 
the Museum's history culminated just over 1 year ago with the opening 
of the Rose Center for Earth and Space in February 2000. Greeted with 
critical and popular acclaim and record-setting attendance surpassing 
all projections, the Rose Center includes a rebuilt Hayden Planetarium, 
Hall of the Universe, and Hall of Planet Earth. It leads to the Hall of 
Biodiversity, which reveals the variety of Earth's living things and 
expands the Museum's efforts to alert the public to the critical role 
biodiversity plays in sustaining life as we know it. Together, the new 
planetarium and halls provide visitors with a seamless educational 
journey from the universe's beginnings to the formation and processes 
of Earth to the extraordinary diversity of life on our planet.
    The Education Department builds on the Museum's unique research, 
collections, and exhibition resources to offer rich programming 
dedicated to increasing scientific literacy, to encouraging students to 
pursue science and museum careers, and to providing a forum for 
exploring the world's cultures. Each year hundreds of thousands of 
students, teachers, and schools participate in workshops, courses for 
college credit, and Museum visits; more than 500,000 students and 
teachers come on school visits, prepared and supported by curriculum 
resources and workshops. The Museum is also reaching beyond its walls: 
through its National Center for Science Literacy, Education, and 
Technology, launched in 1997 in partnership with NASA, it is exploiting 
new technologies to bring learning and discovery, materials, and 
programs into homes, schools, museums, and community organizations 
around the nation.
 support for department of health and human services mission and goals
    The American Museum shares with DHHS and HRSA a fundamental 
commitment to improving the nation's health and advancing the research, 
training, and facilities that support it. The Museum seeks a 
partnership with the agency to leverage our complementary resources and 
mutually strengthen our abilities to advance shared goals.
Genomic Science
    DHHS is a leader in health-related research and genome science, 
advanced sequencing technologies, instrumentation, and facilities. The 
American Museum, in turn, is home to a preeminent molecular research 
effort. Indeed, natural history and genomic science are intricately 
related. The AMNH molecular systematics program is at the forefront of 
comparative genomics and the analysis of DNA sequences for evolutionary 
research. In its molecular laboratories, in operation now for 10 years, 
more than 40 researchers in molecular systematics, conservation 
genetics, and developmental biology conduct genetic research on a 
variety of study organisms.
    The Museum is also expanding its collection techniques to include 
the preservation of biological tissues and molecular libraries in a 
super-cold storage facility for current and future genetic study. This 
collection is an invaluable resource for worldwide research in fields 
including genetics, comparative genomics, and medicine. Such a tissue 
collection will preserve genetic material and gene products from rare 
and endangered organisms that may become extinct before science fully 
exploits their potential. With nearly 40,000 samples already collected, 
it will be the largest super-cold tissue collection in the world and 
will increase the possibilities for DNA research exponentially.
Parallel Cluster Computing
    Parallel computing is an essential enabling technology for 
phylogenetic (evolutionary) analysis and intensive, efficient sampling 
of a wide array of study organisms. A 256-processor cluster recently 
constructed in-house by Museum scientists is the fastest parallel 
computing cluster in an evolutionary biology laboratory and one of the 
fastest installed in a non-defense environment. It allows Museum 
scientists to examine the effectiveness and computational behavior for 
large real-world data sets, and will be central to all Museum projects 
in evolutionary and genomics research.

                   INSTITUTE OF COMPARATIVE GENOMICS
    The Museum proposes to establish, in partnership with DHHS, an 
Institute of Comparative Genomics so as to contribute its unique 
resources and expertise to the nation's genomic research enterprise. A 
full understanding of the impact of the knowledge we have gained from 
genomics and molecular biology can come from placing genomic data in a 
natural history perspective; comparative work in genomics will enrich 
our knowledge not only of biodiversity, but also of humans, medicine, 
and life itself. The Museum intends to establish the Institute with 
funds from federal as well as nonfederal sources.
    With the advent of DNA sequencing, museum collections have become 
critical baseline resources for the assessment of the genetic diversity 
of natural populations. Genomes, especially those of the simplest 
organisms, provide a window into the fundamental mechanics of life. One 
of the goals of the nation's genomic science research programs is to 
learn about the relevance to humans of nonhuman organisms' DNA 
sequences. This research can yield information that can be applied in 
solving critical challenges in health care. The AMNH comparative 
genomics program could provide vital tools in these endeavors.
    The Museum has already established its parallel computing facility, 
enhanced the molecular labs with state-of-the-art DNA sequencers, and 
built the super cold storage facility. Thus initially equipped, the 
Institute will be one of the world's premier research facilities for 
mapping the genome across a comprehensive spectrum of life forms, 
drawing on comparative methods and biological collections.
    Working cooperatively with New York's outstanding biomedical 
research and educational institutions, the Institute will focus on 
molecular and microbial systematics, expanding our understanding of the 
evolution of life on earth through analysis of the genomes of selected 
microbes and other non-human organisms, and constructing large genomic 
databases for conservation biology applications. Research programs may 
include the study of the utility of genomic information on organismal 
form and function, microbial systematics, the construction of large 
genomic databases for conservation biology applications, and the use of 
broad scale comparative genomic studies to understand the function of 
important biomolecules.
    The Institute's scope of activities will include: an expansion of 
the molecular laboratory program that now trains dozens of graduate 
students every year; the utilization of the latest sequencing 
technologies; employment of parallel computing applications that allow 
scientists to examine the effectiveness and computational behavior of 
large real world datasets; and operation of the frozen tissue 
collection as a worldwide scientific resource, with at least 500,000 
samples accessioned in the first phase alone, an active loan program, 
and ready public on-line access.
    In addition to research, the Museum has already launched an 
ambitious agenda of genomics-related exhibition, conference, and public 
education programming, including the landmark exhibition, ``The Genomic 
Revolution,'' which opens in May 2001. The exhibition, the most 
comprehensive ever presented on genomics, will examine the revolution 
taking place in molecular biology and its impact on modern science and 
technology, natural history, biodiversity, and our everyday lives. In 
conjunction with the exhibition, the Museum may also display a video 
bulletin on genomics in the Hall of Human Biology. The bulletin would 
be modeled after the popular Earth, Bio, and AstroBulletins in the 
newest exhibit halls that display changing science news and link to 
computer kiosks and websites.
    In fall 2000 the Museum hosted ``Sequencing the Human Genome: New 
Frontiers in Science and Technology,'' an international conference 
featuring leading scientists and policymakers. Spring conferences will 
include: ``Conservation Genetics in the Age of Genomics,'' co-sponsored 
by AMNH's Center for Biodiversity and Conservation and the Wildlife 
Conservation Society; and ``New Directions in Supercomputing,'' which 
will explore how parallel computing can make sense of the huge complex 
data sets that genomic science and other fields generate. In September, 
the Museum will convene ``Assembling the Tree of Life: Science, 
Relevance, and Challenges.''
    In establishing the Institute, the Museum plans to expand its 
curatorial range in microbial work; grow the super-cold tissue 
collection; and draw on our exhibition and educational expertise to 
offer enhanced public education and outreach. Plans entail expanding 
and renovating lab space and facilities to accommodate additional 
curators and students. By renovating an area adjacent to one of the 
existing molecular labs and possibly building new space, the Museum 
will add lab and associated office and maintenance space to accommodate 
the new Institute's needs.
    We seek $5 million in fiscal year 2002 to partner with DHHS/HRSA in 
establishing the Institute for Comparative Genomics at the Museum. In 
partnership, the two organizations will be positioned to leverage their 
unparalleled resources to advance shared goals for improving the 
nation's health through research and facilities, education and 
training.
                                 ______
                                 

   Prepared Statement of the Bushnell Center for the Performing Arts

    Mr. Chairman of Members of the Subcommittee, my name is Ronna 
Reynolds, and I am the Interim Executive Director of The Bushnell 
Center for the Performing Arts, located in Hartford, Connecticut. I am 
pleased to have this opportunity to share with you the exciting and 
successful arts-in-education programs being conducted at The Bushnell 
and to urge your support for funding for additional educational 
programs in fiscal year 2002.
    The Horace Bushnell Memorial Hall is an historic and nationally 
recognized performing arts center. After a $34 million renovation and 
expansion project, the 71-year-old Hall has been renamed ``The Bushnell 
Center for the Performing Arts.'' We believe it's an appropriate name 
to describe a center for the arts, a center for the community, and a 
center for education that will all come together--and bring people 
together--at The Bushnell.
    The new Bushnell is more than just a building. It is a facility 
that will enhance Hartford's position as a premier performing arts 
destination. The 90,000 square-foot facility being built adjacent to 
the current Mortensen Hall will include the Belding Theater, a Great 
Hall for receptions and smaller performances, and such amenities as a 
cafe, gift shop, classroom space and more rest rooms and elevators. 
With the current Hall booked to capacity, the expansion will enable The 
Bushnell to present new arts and entertainment options and better 
accommodate local arts organizations in multiple performance spaces. It 
will also give an economic boost by bringing more people to downtown 
Hartford.
    The new Bushnell facility presents the opportunity to link the 
Hall's artistic programming to education and learning. For most of the 
20th Century, education and serving the community has been the central 
focus for The Bushnell as it has dedicated considerable resources and 
leadership to create powerful tools for learning and building 
community. Our educational programs serve as the stable and sustainable 
base from which The Bushnell can continue to expand and deepen its 
education, community service and programming. The result is a 
performing arts center which serves as a classroom without walls; a 
stage ``in and of'' the community.
    The strongest and most visible manifestation of this commitment can 
be found in the The Bushnell's arts education programs. The Bushnell 
Center for Learning is the organization-wide structure through which 
The Bushnell will promote and cause the arts to advance education in 
communities and schools through direct services, training, advocacy, 
and convening. This new Center represents a coalescing of all 
educational activities of The Bushnell under one umbrella. With a focus 
on direct services through classroom programs, teacher and artist 
training, public policy and advocacy and community and educational 
convener, The Bushnell Center for Learning places educational 
programming as central to the organization's day-to-day activities.
    Several programs comprise The Bushnell Center for Learning, 
including direct services and programs for grade school and high school 
students, as well as training programs and teaching seminars. The 
Bushnell has over ten years of experience operating arts-in-education 
programs that use the arts to improve literacy and to increase the 
understanding of diverse cultures for over 6,000 public school students 
in four school districts in Connecticut.

                          THE PARTNERS PROGRAM
    PARTNERS (Partners in Arts and Education Revitalizing Schools) is a 
nationally recognized arts-in-education program that strengthens 
language arts skills and fosters multi-cultural competence in the 
Hartford area schools. Implemented in 1993 in eight schools in 
Hartford, West Hartford and Bloomfield, PARTNERS uses the visual and 
performing arts to spark learning and generate excitement in the 
classroom. Participating in the program provides not only a foundation 
for artistic literacy, but more importantly, it strengthens the core 
educational curriculum while bringing together a great diversity of 
students in a unique educational experience. Since 1996, PARTNERS has 
been active in the Plainville Community Schools in partnership with GE 
Fund of Fairfield and GE Industrial Systems of Plainville.
    The PARTNERS program is made up of five interlocking components: 
curriculum and assessment, artistic resources, staff development, The 
Bushnell Children's Theatre and family events. Curriculum and 
assessment are at the core of all PARTNERS program components. 
Curriculum resources ensure that cross-cultural, hands-on arts 
experiences are integrated into a child's classroom experience through 
multi-cultural children's literature, book-based activity guides, and 
other pertinent materials. Program assessment has been carried out each 
year in an attempt to review and test program components and the goals 
set forth in the initial program design.
    In the PARTNERS program, professional artists take on the role of 
teaching artists who develop and lead classroom-based arts activities. 
Presenting artists who conduct grade level assembly presentation 
further students' understanding of these areas through performances 
delivered at the school site. Classroom and performance experiences are 
also enriched by museum, theatre, and science center field trips 
throughout the year. Through the professional development component, 
PARTNERS provides participating classroom, art and music teachers with 
exposure and hands-on access to the arts-integrated units of study. 
These sessions, held at The Bushnell, offer educators the opportunity 
to use the arts as tools to enhance the learning process for their 
students.

                       OTHER EDUCATIONAL PROGRAMS
    In addition to the PARTNERS program, The Bushnell offers other 
educational programs and services, including:
  --Professional development and support services to educators, 
        artists, contributors, and organizations;
  --Replication and dissemination of the PARTNERS technique and 
        curriculum through building the capacities of institutions, 
        communities and schools; and
  --Integration of programming and education through a collaborative 
        planning process and marketing strategy to be known as ``Great 
        Works''.
    These combined activities enrich the lives of students who are 
involved in the many different Bushnell educational programs, 
including:
  --Living Laboratories in Schools
  --Parent Enpowerment through Early Literacy and Read Aloud
  --The Bushnell Children's Theatre
  --Pre and post performance lectures
  --Arts camps
  --High School lecture series
  --Teachers institutes and seminars and other professional development 
        programs
  --Artist training
    Mr. Chairman, in order to support the expansion of arts-in-
education programs at The Bushnell Center for Learning, we respectfully 
request $1 million through the Department of Education's Fund for the 
Improvement of Education (FIE) account in the Fiscal 2002 Labor/HHS/
Education Appropriations bill. Thank you for your attention to this 
request, and for your support of programs which benefit the children of 
Connecticut and children across the nation.
                                 ______
                                 

 Prepared Statement of the American Council on Education Coalition for 
                        International Education

    Mr. Chairman and Members of the Subcommittee: We are pleased to 
have the opportunity to present the views of the Coalition for 
International Education on the fiscal year 2002 appropriations for the 
Higher Education Act, Title VI and the Mutual Educational and Cultural 
Exchange Act, Section 102(b)(6), commonly known as Fulbright-Hays. The 
Coalition for International Education is an ad hoc group of 28 national 
higher education organizations with principal focus on the 
aforementioned international education, foreign language and exchange 
programs. Together they represent the nation's 3,300 colleges and 
universities, and numerous disciplinary, international exchange groups 
and other international education organizations.
    Over the history of Title VI and Fulbright-Hays, many different 
groups have come to the Federal Government to make their case for these 
programs. This usually has taken the form of small coalitions or 
separate voices arguing for their particular interests. However, the 
sense of urgency about the United States' declining international 
competence against a backdrop of enormous international challenges is 
so strong within the higher education community, that it has drawn our 
different perspectives into a single consensus position.
    We express our appreciation for the Subcommittee's support for 
these programs. Title VI has grown over the last decade, and Fulbright-
Hays in the last year.
    To address new and expanding challenges to the nation's leadership 
capabilities in foreign policy, national security, economic 
competitiveness, and solving global problems, the Coalition recommends 
a 3-year strategic plan for Title VI and Fulbright-Hays. The plan 
proposes increasing the number of experts with in-depth international 
knowledge and highly proficient foreign language skills, as well as the 
number of U.S. citizens with global competence. Our proposed funding 
levels for fiscal year 2002, more fully described below, would be the 
first installment of this plan.

                            PROGRAM OVERVIEW
    At the height of the Cold War, Congress created Title VI in the 
National Defense Education Act of 1958, and Section 102 (b)(6) of the 
Mutual Educational and Cultural Exchange Act of 1961 out of a sense of 
crisis about U.S. ignorance of other countries and cultures. Spanning 
more than four decades, these programs still remain the Federal 
Government's most comprehensive mechanisms for supporting the 
development and maintenance of a higher education infrastructure that 
produces the nation's expertise in foreign languages, and area and 
other international studies, including international business. The 
programs have grown and evolved over this time in response to the 
changing global environment. The fourteen funded Title VI and 
Fulbright-Hays programs support activities to improve our educational 
capabilities, from K-12 through the graduate levels and advanced 
research, with emphasis on the less commonly-taught languages and areas 
of the world. Title VI largely supports the domestic side of training 
and research, while Fulbright-Hays supports an essential overseas 
component.

                              FEDERAL ROLE
    The Federal Government plays a critical role in international and 
foreign language education because of the clear relevance of 
international competence to the conduct of U.S. foreign policy, to the 
national security of the U.S., and to the health and vitality of the 
U.S. economy in a global marketplace. Informed decisions in these areas 
by public and private sectors depend on citizens who have the skills 
and understanding of other nations' languages, cultures and systems to 
function effectively within them. U.S. global leadership depends on 
persons who know how the people of other cultures think and work and 
who can competently assess the political, economic, or social 
implications of decisions and actions. In short, it is a critical 
federal role to ensure the nation is successfully prepared to respond 
to the challenges presented by its relationships with other nations.
    Through Title VI and Fulbright-Hays programs, the Federal 
Government shares this responsibility with institutions of higher 
education, in partnership with the corporate and state/local government 
sectors. State and local governments and the private sector, including 
foundations, will not by themselves focus on long-term national needs 
for international expertise. While these sectors support short-term 
projects from time to time, they do not provide the long-term, 
sustained support for the 10-12 years of study and research needed to 
produce an expert on the Middle East fluent in Arabic, for example. 
Moreover, universities could not bear this responsibility alone. 
Outside resources are essential incentives for developing and 
sustaining interdisciplinary programs, underwriting high cost programs 
in the less common-taught languages and areas, and providing extensive 
outreach and collaboration among education institutions, government 
agencies, and corporations.

                        EXPANDING NATIONAL NEEDS
    There is fresh evidence that the nation's needs for international 
competence continue to expand in the global era, and that the 
government, corporate and education sectors face a dangerously short 
supply of qualified personnel.
    Responding to new demands to protect national security in a broad 
range of arenas throughout the U.S. and the world, virtually every 
federal agency now is engaged globally. One estimate is that over 80 
federal agencies and offices rely on human resources with foreign 
language proficiency and international knowledge and experience. 
Hearings last fall of the Senate Subcommittee on International 
Security, Proliferation, and Federal Services revealed the shortage of 
personnel with the foreign language and area skills required to meet 
national security needs across the defense, intelligence, and foreign 
policy agencies. These agencies report shortfalls in hiring, deficits 
in readiness, and adverse impacts on operations. One federal agency 
estimated its total needs to be 30,000 employees dealing with over 80 
languages, while another identified key shortfalls in Central Eurasian, 
East Asian, and Middle Eastern languages.
    Title VI and Fulbright-Hays are among the few programs the Federal 
Government supports that provide the necessary long-term investment in 
building the language and foreign area capacity that responds to 
national strategic requirements. Regional expertise and language 
ability related to less commonly-taught areas are offered primarily 
through higher education institutions receiving Title VI funding. In 
fact, a recent study funded by the U.S. Department of Education 
revealed that 81 percent of the graduate language enrollments in the 
least commonly taught languages are located at Title VI-funded 
institutions. Because of the high cost per student, these programs 
would not exist without Title VI support.
    National security is increasingly linked to commerce, and U.S. 
business is widely engaged around the world with joint ventures, 
partnerships, and economic linkages that require its employees to have 
international expertise both at home and abroad. A recent study on the 
internationalization of American business education found that 
knowledge of other cultures, cross-cultural communications skills, 
experience in international business, and fluency in a foreign language 
ranked among the top skills sought by corporations involved in 
international business. Despite new efforts to internationalize 
business education in the last decade, U.S. business schools continue 
to fall short of fulfilling the need of businesses for personnel who 
can think and act in a global context.
    Title VI supports important programs that internationalize business 
education and help small and medium-sized U.S. businesses access 
emerging markets, a boost toward reducing the trade deficit and 
creating U.S. jobs. The U.S. Department of Commerce reports that 97 
percent of all U.S. export growth in the 1990s was contributed by small 
and medium-sized companies, and yet only 10 percent of these companies 
are exporting. The most common reason cited by U.S. businesses for not 
pursuing export opportunities is a lack of knowledge and understanding 
of how to function in the global business environment.
    In addition to business, the ubiquitous nature of globalization 
also is driving new demands for globally competent citizens and 
international knowledge in almost all fields of endeavor, such as 
health, the environment, and law. Whether it be in the culturally 
diverse U.S. workplace or on assignment abroad, employers increasingly 
look for candidates who have cross-cultural skills, foreign language 
proficiency, and the ability to meet the international challenges of 
their field. Increasing the pool of underrepresented minorities who 
pursue international careers is a critical dimension as well.
    Title VI and Fulbright-Hays programs support projects to infuse 
foreign language, area and other international studies into the 
curriculum and across disciplines, from K-12 through professional 
education. They support increasing the capacity of predominantly 
minority-serving institutions to produce globally competent graduates 
who enter the international service. Extensive outreach programs serve 
government, education and corporate needs for international knowledge.
    Finally, it does not appear that our education system is positioned 
to produce the increasing numbers of international experts needed, or 
even ordinary citizens who are globally competent. Recent studies and 
surveys suggest that overall our education institutions are falling 
behind in international education:
  --The vast majority of students is being provided with only 
        rudimentary levels of international skills and competencies;
  --Foreign language enrollments in United States higher education fell 
        from 16 percent in 1960 to just 8 percent today and the number 
        of 4-year colleges with foreign language entrance and 
        graduation requirements also declined. On the positive side, 
        foreign language enrollments in community colleges and at the 
        K-12 levels are increasing;
  --There is a shortage of trained teachers and faculty in foreign 
        languages, especially the less commonly-taught languages, and 
        in area and international studies; and
  --Only about 3 percent of United States students enrolled in United 
        States colleges and universities study abroad.
    Title VI and Fulbright-Hays programs support the training of 
teachers and faculty in foreign languages and international education. 
They support overseas research, the development of study abroad 
programs in underrepresented areas, research in the teaching and 
learning of foreign languages, and the application of new technologies 
to all of these efforts.

                   FISCAL YEAR 2002 FUNDING PROPOSAL
    Funding for this account during President Clinton's Administration 
did not keep up with increased national needs for global competence or 
with increases in overall federal education funding. When adjusted for 
inflation, the Department of Education's budget for discretionary 
programs grew by about 50 percent since fiscal year 1994, while these 
programs combined increased by only 14 percent. Despite the increase, 
Title VI and Fulbright-Hays continue to be funded below their constant 
dollar level of the late 1960s. (For example, only half as many Foreign 
Language and Area Studies fellowships are being awarded today, compared 
with fiscal year 1967.) Moreover, funding for the Institute for 
International Public Policy has not been increased since its inception 
in fiscal year 1994.
    Our 3-year strategic plan proposes three policy goals to meet the 
growing national needs described above:
  --Increase the production of the nation's international expertise and 
        knowledge to meet national strategic needs;
  --Enhance the knowledge and skills of our citizens for a global 
        workplace; and
  --Expand education, government and private sector access to 
        international expertise and knowledge (outreach and 
        dissemination)
    To address these goals, we recommend as a first year installment, a 
total of $96.32 million for the International Education and Foreign 
Languages Studies account. This represents an $18.3 million increase 
over fiscal year 2001.
    We recommend our proposed increase be allocated as follows:
  --A $13.5 million increase in Title VI-A & B domestic programs ($80.5 
        million in total). Title VI-A & B programs ensure a national 
        capacity of expertise and knowledge in foreign languages, area 
        and other international studies, including international 
        business education. The proposed increase would strengthen 
        activities addressing national strategic needs and shortfalls 
        in capacity: (1) training the next generation of experts and 
        producing research on the foreign languages, world areas and 
        global/regional issues of emerging economic and security 
        importance; (2) infusing foreign languages and area studies 
        into the professional disciplines; (3) increasing outreach and 
        linkage activities to government agencies, business, the media, 
        and education institutions; (4) accessing and making widely 
        available expensive foreign information resources using 
        innovative applications of technology; and (5) enhancing the 
        knowledge, understanding and skills of our citizens for a 
        global workplace.
  --A $3.3 million increase in Fulbright-Hays ($13.3 million in total). 
        Fulbright-Hays complements Title VI programs by providing U.S. 
        students, faculty and teachers a vital overseas research and 
        training dimension in foreign languages and area studies. For 
        example, in a recent survey of former doctoral dissertation 
        research abroad grantees, nearly all indicated they could not 
        have achieved their level of expertise without this support, 
        and that they utilized the skills gained abroad in teaching and 
        research. Yet under this program in fiscal year 2000, only 88 
        fellowships could be awarded out of an applicant pool of 417. 
        In recent years the average number of fundable applications for 
        all four Fulbright programs has been roughly double the number 
        actually awarded with available funds. An additional $3.3 
        million would enable about 75 more awards for doctoral 
        dissertation, faculty research, group projects and seminars 
        abroad.
  --A $1.5 million increase for the Title VI-C Institute for 
        International Public Policy ($2.52 million in total). The IIPP 
        responds to the national need for a diverse pool of well-
        trained, language-proficient professionals to enter the foreign 
        service and related careers. Students completing this program 
        have earned the distinction of passing the foreign service oral 
        exam on the first attempt. Level funding for the IIPP since 
        fiscal year 1994 has caused a scaling back of several program 
        components. An additional $1.5 million will enable full funding 
        of the graduate fellowships and reinstatement of the 
        institutional capacity--building grants to HBCUs, HSIs, and 
        other minority institutions, in keeping with the program's 
        statutory mandate.
    We consider our request to be a modest one for programs vital to 
our nation's long-term security and economic well being. Thank you for 
your consideration and for the opportunity to express our views.
                                 ______
                                 

       Prepared Statement of the Colonial Williamsburg Foundation

    Dear Mr. Chairman: Colonial Williamsburg Foundation hereby submits 
for the record, testimony regarding an electronic field trip project 
called the ``Outreach Education Initiative.''

                                SUMMARY
    Colonial Williamsburg, the nation's oldest and largest living 
history museum, continues to inspire Americans. Our national history is 
a dramatic story that continues to influence the present. The story of 
America's colonial history and the coming of the American Revolution 
are the heritage of every American. Colonial Williamsburg explores the 
history behind the critical issues that still challenge American 
society--how diverse people, holding different and sometimes 
conflicting personal ambitions, evolved into a union that valued both 
liberty and equality.
    This history that defines us as a nation should be understood by 
all school children. Technology is the means by which this message can 
be clearly delivered to schools across America.
    Each year, one million adults and children from all fifty states 
and several foreign countries, visit Colonial Williamsburg's Historic 
Area in person, including over 160,000 students on school study trips.
    For most students, however, a personal visit to the Historic Area 
is not a realistic option.
    To reach students and teachers throughout the country, Colonial 
Williamsburg launched its Educational Outreach Initiative with the 
electronic field trip project in the fall of 1996. This initiative 
takes the museum's dynamic methods of history education beyond the 
streets and buildings of Williamsburg and transports them directly into 
the nation's classrooms. Electronic field trips replicate, to the 
greatest extent possible, an actual visit to Colonial Williamsburg and 
create a palpable excitement for learning.
    With the best technological communication resources at our command, 
Colonial Williamsburg reaches millions of students and teachers 
throughout the country. Through electronic field trips, this experience 
is taken directly to the nation's classrooms. These programs currently 
reach an estimated one million registered students in forty-six States 
with a total viewing audience of more than five million unregistered 
students and home viewers.
    Colonial Williamsburg's Electronic Field Trips--``lightspeed 
learning'' experiences--are live, interactive television programs, 
linked to comprehensive teacher's guides, and Internet activities and 
discussion groups. Several weeks before each program airs, registered 
schools receive a teacher's packet, which includes an instructional 
videotape and short introduction to Colonial Williamsburg, a 
comprehensive teacher's guide, full-color classroom poster, and links 
to national standards of learning. The teacher's guide includes 
historical background materials, facsimiles of historical documents and 
prints, photographs of Colonial Williamsburg and its costumed 
interpreters, glossaries, timelines, and several suggested lesson plans 
written by classroom teachers.
    Electronic field trips are eight live broadcast events each school 
year. Each field trip consists of two or three historical dramas 
depicting aspects of eighteenth-century life, ranging from a young 
recruit's view of military preparations for the Revolution to a free 
black man's efforts to buy his wife's and children's freedom from their 
owner.
    After each dramatic vignette, students from registered schools can 
speak directly to the historical interpreters on live television, 
asking questions and expressing opinions about the issues presented in 
the programs. Those students that do not make it on air can speak via 
the telephone and the Internet to more than thirty interpreters and 
historians behind the scenes. During an electronic field trip, Colonial 
Williamsburg staff will respond to over 1,300 phone calls in four hours 
and reply to as many as 1,000 email and Internet bulletin board 
inquiries. Students can also vote on issues raised during the program 
to see how their votes compare with others across the country.
    The field trips are also much more than history lessons. History is 
just a starting point for high-tech interdisciplinary learning in 
civics, mathematics, science, art, and government, and an excellent 
venue for honing critical thinking skills--so necessary for creating a 
job-ready work force.
    Through the electronic field trips Colonial Williamsburg is able to 
teach our country's history and encourage the use of technology in the 
classroom for a wider audience. Here's what one California teacher had 
to say about the impact of an electronic field trip on her classroom 
and on one ``at-risk'' student in particular:

    ``One of my boys, who is an at-risk student and who has had lots of 
problems, was able to get on the air with his question and was so 
excited! He was the fifth grade star because the other fifth grade 
classes were also watching the program to hear his question. . . . The 
kids are now primed for our study of the American Revolution.''----
Sally White, Teacher, George White Elementary School, Laguna Niguel, 
California

                            AUDIENCE SERVED
    The target audience for Colonial Williamsburg's electronic field 
trips includes the nation's entire student population, generally 
students from fourth through twelfth grade.
    Extrapolating information from registered schools and the number of 
students asking questions and voting via telephone and the Internet, 
Colonial Williamsburg estimates that at least 500,000 registered 
students actively participated in the 1996-1997 electronic field trips. 
Current estimates predict that approximately 1 million registered 
students will have participated in the 1999-2000 electronic field 
trips, with a total viewing audience of more than 5 million.
    Communities across the country are concerned about studies showing 
the erosion of young people's American history knowledge and the need 
for teacher and student training in the use of educational technology. 
Last year Congress made additional funds available for history 
education programs. Colonial Williamsburg's electronic field trips are 
an important contribution to improving history education and helping 
students become more knowledgeable and excited about the past while 
relating it to their current environment.
    Electronic field trips help students discover positive role models 
from history to which all young people, from gifted to at-risk 
students, can relate. They increase teacher familiarity with technology 
and their understanding of appropriate methods for utilizing it. These 
programs are standards--based in multiple disciplines, providing 
opportunities to engage students in cross-discipline learning. They are 
very low cost and accessible through almost any level of technology 
available to the classrooms. In addition, Colonial Williamsburg staff 
members work with teachers independently to help them get the most out 
of the programs.
    Colonial Williamsburg's electronic field trips provide 
opportunities to integrate technology in the classroom and enhance 
technical skills. Teachers and students in less-advantaged communities 
might have access to communication hardware but don't have the training 
to use those technology resources. Because information tools and 
familiarity in using them are increasingly important to individual 
success, it is essential to correct this imbalance. Technical 
competence is integral to the success of today's students and 
tomorrow's adults and, without such competence, a large portion of the 
nation's citizens will be left behind, unable to compete, and 
increasingly distanced from the means by which many people are 
receiving information, producing work, and participating in their 
communities.

                                METHODS
    Begun in the fall of 1996, Colonial Williamsburg's Electronic Field 
Trips craft comprehensive teacher materials, live interactive 
broadcasts, and Internet activities into an interactive learning 
experience for students. Each field trip follows a similar format 
combining production, educational material, and new media components.
Production
    The main component of each field trip is a live, one-hour, 
interactive broadcast, offered twice on the broadcast day so that 
students in all United States time zones can participate. Each program 
is of broadcast quality and is sent via satellite, as well as via 
public and educational broadcasters, to schools across the United 
States.
    Colonial Williamsburg historical interpreters host each program, 
introduce students to life in colonial America, and are available for 
questions from registered viewers.
    Interaction--the exchange of ideas and opinions--is the heart of a 
Colonial Williamsburg electronic field trip. The intent is to make 
students feel as if they have traveled back to the eighteenth century 
and are active participants in the process of history. Based on the 
responses from teachers and students, this format works extraordinarily 
well.
Traditional Educational Material
    The teacher's guide includes historical background materials, 
facsimiles of historical documents and prints, photographs of Colonial 
Williamsburg and its costumed interpreters, and several suggested 
lesson plans. Colonial Williamsburg's teacher advisors develop these 
teacher guides and lesson plans. Because classroom teachers create 
them, they are practical and useful. Feedback from educators indicates 
that the teacher's guides are excellent resources, particularly the 
primary source documents, which are often difficult for educators to 
find.
Media Components
    The Internet component of the field trips provides another venue 
for the students to engage in interactive, distance learning. Each 
field trip provides a forum that allows students to discuss issues and 
ask questions of each other and of Colonial Williamsburg's historians. 
The forum remains available throughout the school year so those 
educators who wish to revisit the material later in the school year can 
still interact with Colonial Williamsburg. Also, the teacher's guide is 
available on-line along with several participatory student activities. 
Student on-line activities provide an opportunity to explore topics in-
depth, and to extend and amplify the classroom and broadcast lessons.

                              PROJECT NEED
    Colonial Williamsburg believes that Thomas Jefferson was correct: 
an educated populace is essential for the maintenance of a free 
democracy. The fundamental premise of our government is that political 
power derives from the informed consent of the people, which, we 
believe, can come only from knowledge and understanding of the people 
and events that shaped American society. Through historical knowledge, 
Americans come to appreciate their pluralistic society and see other 
racial, ethnic, and religious groups as part of the nation's genius and 
strength. An understanding of the principles on which this country was 
founded is indispensable in the development of an informed citizenry. 
Furthermore, the study of history promotes the critical thinking skills 
that are so necessary for a job-ready work force.
    An increasingly disturbing portrait of American education is 
emerging from research on schools; parents and educators alike are 
concerned about students' lack of knowledge and preparation. Often, in 
the efforts to address deficiencies in language arts and math skills, 
history is virtually left out of the curriculum. Many elementary school 
teachers do not receive enough exposure to the subject during their 
classroom training. Students who can keep pace with state-of-the-art 
computer technology may find little to capture their imagination in 
events that took place decades or centuries ago. As a result, 
youngsters simply do not form a basic understanding of American history 
and, therefore, are not interested in the subject.
    Schools nationwide are finding that resolving the crisis in 
education calls for a new pedagogy. Many schools, particularly those 
that and present the classic profile of a student population at risk, 
are struggling to make instruction both meaningful and effective and 
fun.
    The confluence of several successful Colonial Williamsburg programs 
and the needs of the schools suggests that now is the time to create a 
comprehensive program targeting both teachers and students in our 
nation's school system and promote a renewal of history education.
                                request
    While Colonial Williamsburg currently reaches over one million 
registered students with innovative, state-of-the-art programs, we feel 
we have an obligation to help more schools and students better 
understand the history of our nation. Recently, Colonial Williamsburg 
received a private donation of $5 million to endow the Electronic Field 
Trip programming.
    As stewards of an important segment of our American heritage, we 
are asking for a one-time appropriation of $5 million to leverage with 
the $5 million private endowment. Federal money would allow Colonial 
Williamsburg to do the following:
  --Support distribution of the video program across the country.
  --Support the further development of web casting.
  --Support coordination with the various state standards of learning.
  --Support disadvantaged schools to integrate technology and education 
        in their schools.
    The Colonial Williamsburg Foundation wishes to express its deep 
appreciation to this Committee for permitting us to submit this 
presentation on the ``Outreach Education Initiative.'' Your positive 
response for Colonial Williamsburg's request for support will have a 
positive impact on our nation's education crisis by teaching history to 
our children.
                                 ______
                                 

             Prepared Statement of Florida State University

    Mr. Chairman, I would like to thank you and the Members of the 
Subcommittee for this opportunity to present testimony before this 
Committee. I would like to take a moment to briefly acquaint you with 
Florida State University.
    Located in Tallahassee, the capitol of Florida, FSU is a 
comprehensive Research I university with a rapidly growing research 
base. The University serves as a center for advanced graduate and 
professional studies, exemplary research and top quality undergraduate 
programs. Faculty members at FSU maintain a strong commitment to 
quality in teaching, to performance of research and creative activities 
and have a strong commitment to public service. Among the faculty are 
numerous recipients of national and international honors, including 
Nobel laureates, Pulitzer Prize winners as well as several members of 
the National Academy of Sciences. Our scientists and engineers do 
excellent research, have strong interdisciplinary interests, and often 
work closely with industrial partners in the commercialization of the 
results of their research. Having been designated as a Carnegie 
Research I University several years ago, Florida State University 
currently is approaching $125 million per year in research awards.
    Florida State attracts students from every county in Florida, every 
state in the nation, and more than 100 foreign countries. The 
University is committed to high admission standards that ensure quality 
in its student body, which currently includes some 192 National Merit 
and National Achievement scholars, as well as students with superior 
creative talent. We consistently rank in the top 25 among U.S. colleges 
and universities in attracting National Merit Scholars to our campus.
    At Florida State University, we are very proud of our successes as 
well as our emerging reputation as one of the nation's top public 
universities.
    Mr. Chairman, let me tell you about a project we are pursuing this 
year involving the U.S. Department of Education and distance learning. 
Florida State University is pioneering the use of distance education to 
provide access to baccalaureate degrees for students with Associate of 
Arts degrees who, due to family or work situations, may not be able to 
relocate to a college or university to complete their degree work. FSU 
is currently offering upper-division programs entirely online for 
students to receive their baccalaureate degree in Computer Science, 
Information Studies, and Software Engineering--all areas central to our 
economy. An essential part of this program is the use of mentors, who 
take a proactive stance toward the students, contacting them on a 
regular basis to provide assistance, and are available electronically 
to students as needed. Student mentoring is key to insuring successful 
outcomes in distance courses.
    This program is a model of effective distance learning that can be 
used anywhere at the undergraduate level. Our focus has been on 
Florida, though we have a small number of out-of-state students in our 
distance degree programs. With additional support, additional majors 
can be added and the program can be expanded to serve a wider range of 
students geographically. Front-end development activities are essential 
for quality courses and require significant expenditures to add majors, 
train mentors and offer degree programs on a larger scale.
    Additionally this year, we plan to address the issue of preparing 
students to become K-12 teachers. Governor Bush has stated that he 
would like to see teachers trained both by traditional and alternative 
means and wants skills of current teachers to include the use of 
technology. We will utilize the same articulation we have between the 
AA and the bachelor's degree in Florida to offer first the general 
teacher certification courses online, then begin placing specific areas 
of certification online. In addition, we plan to build on our ``Troop-
to-Teachers'' project and have a robust alternative certification 
program available online. Many qualified people in mid-life or retires 
who may want to become teachers are discouraged by the typical format 
for teacher certification which requires then to return to a campus to 
take undergraduate courses. The state of Florida is pioneering with an 
alternative certification program that allows the local school board to 
certify teacher if they go through a process while employed at the 
school. Florida State has take the first steps in developing an online 
curriculum for alternative certification that could be used by any of 
Florida's 67 school districts, and for that matter anywhere else in the 
country where the alternative certification model is employed. It is 
being piloted in two school districts this year. We will service 
students in Florida and will expand to draw students from other states 
that plan to relocate to Florida. Further, this can serve as a 
demonstration project which if successful could be adopted across the 
nation to help alleviate our teacher shortage. We will do this with the 
guidance of the recent reports--the first, Investing in Teaching, which 
was prepared by a consortium composed of The Business Roundtable, the 
National Alliance of Business, the National Association of 
Manufactures, and the US Chamber of Commerce. The other report, 
Professional Standards for the Accreditation of Schools, Colleges and 
Departments of Education, has been published by the National Council 
for Accreditation of Teacher Education (NCATE).
    Florida State University is heavily invested in new technologies 
and learning and is ideally positioned to provide further leadership in 
student supported high quality distance learning. Last year, FSU 
received $170,000 in fiscal year 2001 to begin its efforts. We are 
seeking an appropriation of $3 million within the Department of 
Education's Fund for the Improvement of Post-Secondary Education 
account to continue and expand this activity in fiscal year 2002.
    Finally Mr. Chairman, I would like to discuss construction needs of 
the FSU College of Medicine. Last year, the State of Florida approved 
the establishment a Medical School at Florida State University. The FSU 
College of Medicine is the first medical school to be established in 
the United States in a quarter of a century. This initiative is a major 
opportunity for FSU and will be a tremendous asset to the State of 
Florida. By establishing this medical education program in a unique 
fashion, which is our plan, we are convinced that its creation can have 
a national impact on medical education. The University is seeking to 
implement this new approach to medical education in extremely 
innovative and nontraditional ways, and we will be doing so in an 
efficient fashion that will meet today's and tomorrow's challenges to 
the practice of primary care matched with Florida's unique 
demographics. The College's focus will not be on centralized campus 
clinical care facilities. We intend to maximize the University's 
statewide visibility to create networks of collaborative relationships 
with public health clinics, hospitals, and other primary health care 
delivery systems throughout the State. We will employ approaches that 
include unique and extensive distance learning technologies, 
telecommunications and telemedicine capabilities; we will focus on 
public, community, and rural health; we will develop expertise and 
interest in health policy issues, health statistics, and demographic 
research; we will focus on an aging population; and we will emphasize 
health professions development. The University will build upon existing 
strengths in many of these areas to create a truly unique medical 
resource of the State of Florida and the nation.
    Florida State University has already received $30 million from the 
Florida legislature over the past two years for a new basic sciences 
building to be used for the College of Medicine. There is another $15 
million requested in Governor Bush's budget pending with the 
legislature at this time. The estimated cost of the medical building is 
$60 million. We are requesting the remaining funding, $15 million, to 
be secured from HRSA, which will allow us move forward with the 
building of this facility, and will ultimately allow FSU's new College 
of Medicine to becomes a reality. This investment will have lasting 
results that will greatly benefit both Florida and the nation.
    Mr. Chairman, these are just a few of the many exciting activities 
going on at Florida State University that will make important 
contributions to solving some key problems and concerns our Nation 
faces today. Your support would be appreciated, and, again, thank you 
for an opportunity to present these views for your consideration.
                                 ______
                                 

  Prepared Statement of the National Military Family Association, Inc.

    Mr. Chairman, the National Military Family Association and the 
families we represent are grateful to this Subcommittee and to the 
United States Senate for its actions on behalf of military children and 
the Impact Aid Program. We thank all Congressional supporters of Impact 
Aid, especially the Members of the House and Senate Impact Aid 
Coalitions, for securing another increased appropriation for the 
program for fiscal year 2001. Your continued support of this program 
translates into better education for approximately 550,000 military 
children and several million of their civilian classmates in school 
districts across the country.

                           THE MILITARY CHILD
    NMFA presents this statement on behalf of military families, or 
more specifically on behalf of military children:
  --Military families move an average of every 2.9 years, three times 
        the rate of their civilian counterparts. Military children 
        attend an average of six different schools during their K-12 
        education. Less than 20 percent of these children attend 
        Department of Defense schools; the overwhelming majority of 
        military children attend civilian schools dependent on Impact 
        Aid.
  --Military children bring a wealth of cultural experiences gained 
        from living in many parts of the world to their new schools. 
        They also frequently come with gaps in their education that 
        their new teachers must quickly fill while moving the rest of 
        the class ahead. Sometimes they are far ahead of their new 
        classmates, adding boredom to the list of reasons why they hate 
        moving to yet another new school.
  --Because of varying course standards, school schedules, and state 
        graduation requirements, military children sometimes lose 
        credits needed for graduation. Currently 18 states have 
        graduation requirements linked to performance on state exit 
        exams; 6 more states are developing exit exams. With the rise 
        of exit exams and increased graduation requirements, transfers 
        in the last year or two of high school are becoming more 
        problematic. A change of schools at any time is traumatic, but 
        a change in the middle of the school year is especially so. A 
        midyear transfer can place some children so far behind that 
        they cannot catch up the rest of the school year.
  --Because of the high operations tempo of today's military, the 
        military child often has to adjust to the new school, face that 
        week of standardized tests, fight for the spot on the newspaper 
        staff, and play the basketball game before a crowd of 
        strangers, all without the support of their military parent. 
        Worry about the safety of a parent in a place far from home 
        where people are shooting at each other makes for a powerful 
        distraction from the business of education.
    Today's military force is an educated force and military members 
have high expectations for their children's education. More are 
accepting or rejecting assignments, or even deciding to leave the 
military, based on perceptions about the quality of education their 
children will receive at prospective duty stations.

               WHY IMPACT AID? THE FEDERAL RESPONSIBILITY
    Military families understand that the Impact Aid program supports 
basic education services provided by their local school districts. They 
understand the impact the federal presence has on the tax base of these 
local districts and their states. They understand the impact their 
children and the transient military lifestyle can have on their local 
schools. What they do not understand is that Impact Aid funds fall 
short of the levels intended by the creators of the program or of the 
amount needed by their children's schools.
    Military families hold the Government, and the citizens they have 
sworn to serve and protect, accountable for living up to their promise 
to provide a quality education for their children. The districts have 
accepted the responsibility to educate military children; the Federal 
Government must provide the resources it has promised to support that 
education. The intent of the original Impact Aid legislation (Public 
Law 81-874) was ``to provide financial assistance for those local 
educational agencies upon which the United States has placed the 
financial burden.'' It originally provided an ``in-lieu-of-tax'' 
payment equal to the local per-pupil costs for students whose military 
parent both lived and worked on a federal installation (these students 
were termed ``military A'' students) and one-half of the local per-
pupil cost for students whose military parent worked on a federal 
installation but lived in the civilian community (termed ``military B'' 
students).
    NMFA thanks this Subcommittee and the Congress for its continued 
funding of Impact Aid for the military children who live off the 
installation, the military Bs. Two-thirds of military families live 
off-base. Although military families living in the civilian community 
pay property taxes to help support local schools, they often do not 
contribute to other sources of education funding. States provide an 
increasingly larger share of local districts' funding. Many military 
members pay no state tax on their military income. They also shop in 
military exchanges and commissaries, thus paying no sales tax. Under 
the provisions of the Soldiers' and Sailors' Relief Act, they are often 
exempt from paying personal property taxes or license fees for 
automobiles if they are on military orders away from their home state. 
Military children, whether living on- or off-base, impose costs on the 
district as they move in and out: records must be prepared, evaluations 
and testing must be done for special programs, transition labs or 
remedial programs may be needed.
    NMFA is grateful to the Congress for recognizing the costs imposed 
on school districts by the military B students and the inadequacy of 
the B's weighting at only one-tenth of the payment made for on-base 
students. The increased weight to two-tenths of the on-base payment 
included in last year's reauthorization of the Impact Aid program was 
an important step in providing districts that serve these children with 
the funding necessary to meet their responsibility for educating them. 
Funding for these children will become even more crucial for school 
districts as the military Services increasingly look to the civilian 
community to provide more housing for military families. Funding for 
military Bs will also be important to districts serving installations 
building privatized housing in civilian communities off-base rather 
than on the installations. Although developers may be paying some 
taxes, these revenues may be inadequate, especially during the early 
years of the privatization contracts.
    The administration's fiscal year 2002 budget proposal included a 
request for Impact Aid basic support at the fiscal year 2001 funding 
level rather than the smaller request we had come to expect from 
previous administrations. We note, however, that the increased weight 
now provided for off-base students will result in smaller payments for 
some districts unless more money is provided for basic support. We 
would hate to see that a much-needed change to help districts educating 
many off-base children would be paid for by districts supporting large 
numbers of on-base military children.
    A well-funded Impact Aid program enables districts serving large 
numbers of military children to approach the level of educational 
opportunity available in neighboring, non-impacted school districts 
even though they do not have access to the same kind of tax base. 
Impact Aid dollars are targeted to districts where the Federal 
responsibility is the greatest under the law. The dollars go directly 
to school districts with no strings attached. The local community, the 
people with the greatest stake in the quality of education in their 
schools, decides how Impact Aid funds will best serve the basic 
education needs of all students.

  FAMILY HOUSING PRIVATIZATION: A CAUTIONARY NOTE ON EDUCATION FUNDING
    NMFA has supported the concept of privatization of military family 
housing as essential for increasing the amount of capital available to 
eliminate the backlog in substandard housing. However, we caution 
installation leaders and wish to inform policymakers of privatization's 
unintended consequences on both family budgets and school district 
funding. The law requires that servicemembers living in privatized 
housing be paid Basic Allowance for Housing (BAH), which is then turned 
over to the developer as rent. Eligibility for safety net programs 
administered by the U.S. Department of Agriculture such as food stamps; 
the Women, Infants, and Children (WIC) nutrition program; and free and 
reduced price school lunches is based on a family's total income. When 
an installation's housing is privatized and servicemembers start 
receiving BAH--which is immediately passed to the developer via an 
allotment--the total income as indicated on the member's Leave and 
Earnings Statement (LES) seems to have increased. Many servicemembers 
then lose eligibility for safety net programs. Press reports state, for 
example, that two-thirds of the families receiving food stamps on Fort 
Carson, CO, lost their eligibility once the housing was privatized. 
When families lose eligibility for free and reduced school lunches, 
their local school can also lose other funding. Federal Title 1 and E-
rate technology funding as well as some state funding is based on a 
school's poverty rate, which in turn is based on the percentage of 
children receiving free and reduced lunches. Fountain-Fort Carson 
District 8, a district of approximately 4,900 children, reports that it 
received $400,000 less in funding from these sources in the year after 
installation housing was privatized and servicemembers on Fort Carson 
began receiving BAH. NMFA urges the Departments of Defense, 
Agriculture, and Education to examine how school funding can be 
protected during the implementation of privatization projects.

                          FIX THE SCHOOLHOUSE
    For a newly-arrived family in a military community, the sight of a 
well-maintained, safe, child-friendly school building can calm many 
anxieties about the latest move. Unfortunately, too many military 
children must deal with those anxieties in a school facility that has 
seen better days. Their military parents see the deteriorating school 
building as perhaps a symbol of a deteriorating respect for their 
service to the country. Although Impact Aid provides much of a heavily-
impacted district's working capital, a district's payment cannot 
usually be stretched to fund the facility maintenance and improvements 
old school buildings need. Military families at many installations 
voice concerns about the repairs needed for these buildings and the 
lack of available funds. Obtaining funding to construct and renovate 
school buildings is a challenge for school districts across the 
country, not just districts receiving Impact Aid; many U.S. school 
buildings were built in the fifties and sixties and need major work to 
meet handicapped accessibility standards and to be able to handle 
modern technology. The reduced tax base of districts dependent on 
Impact Aid often makes it difficult for these districts to float the 
necessary bond issues to construct new schools or renovate existing 
buildings.
    NMFA remains concerned about the inadequate funding to upgrade and 
maintain buildings owned by the Department of Education. The co-
terminous districts--those civilian districts whose boundaries are the 
same as the military installations they serve--have received funds in 
recent years out of the Department of Defense budget to help with 
repair and renovation projects. Some of these districts have school 
buildings owned by the Department of Education. Even with the DOD 
funding, these districts still face difficult prioritization decisions 
on how to address facility shortfalls. Randolph Independent School 
District, serving Randolph Air Force Base in San Antonio, TX, estimates 
that it needs $14 million to meet the facility needs in its Department 
of Education-owned buildings. The district must address safety and 
structural needs before addressing a priority of many military 
families: renovating a room that is too small to accommodate the 
district's award-winning band.
    Other districts, with a mix of schools owned by the district and by 
the Department of Education, have not received the funding they have 
needed to take care of these buildings. They have been forced to use 
district funds to bring the Department of Education-owned buildings up 
to district standards so that the military children attending these 
schools will not fall behind their peers in district-owned buildings. 
NMFA is pleased to note the increased amount requested for construction 
in the administration's budget proposal and urges Congress to allocate 
adequate construction funding in the Impact Aid budget for districts 
that do not have other funding alternatives available.

                        ONE CHILD, MANY SCHOOLS
    The education of a military child is a continuum. As the military 
child moves from school district to district--from a school receiving 
Impact Aid in California, to another Impact Aid school in Texas, to a 
Department of Defense school in Japan, to an Impact Aid school in 
Kansas--the quality of education she receives in one school may well 
affect the education she and her classmates receive in the next. 
Children whose schools are unable to provide the necessary educational 
services could easily fall behind their peers in other districts. 
Schools serving these children could face difficulties in maintaining 
accreditation as tough new standards are implemented in many states. A 
smooth transition into their next school, whether across the state or 
around the world, benefits military children, their classmates, and 
their communities. The Impact Aid program enables districts affected by 
the presence of a military installation to offer not only a quality 
basic education program, but also the support services needed by 
military children as they transition from school to school.
    Recognizing that servicemembers view quality education as an 
important quality of life factor and a retention issue, the military 
services have stepped up their efforts to establish partnership 
programs with local schools, to train installation school liaison 
officers, to provide better information to families about local 
schools, and to study the problems faced by military children as they 
move. The Services are adopting proposals to facilitate parent 
involvement in schools, such as the policy at Fort Hood, TX and other 
installations that states a servicemember's place of duty is the 
scheduled parent-teacher conference. The Army has addressed the 
difficulties students' face when moving in their senior year by 
recently instituting a Senior Stabilization Policy that enables the 
soldier to request a delay in PCS orders so that a rising senior can 
finish high school at the current location. Personnel are working 
across the Services on common issues and are reaching out to military-
related and education organizations. NMFA applauds DOD's creation of 
the Educational Opportunities Directorate to address the needs of all 
military children wherever they go to school. The Directorate has 
established a Special Needs Website (www.mfrc.calib.com/snn) as a 
resource for military as well as for schools and service providers. The 
Directorate is currently conducting a series of roundtables in states 
with high military populations to raise awareness of issues affecting 
the mobile child among parents, state and local education policymakers, 
and installation officials.
    School districts are responding to military families' concerns 
about quality education and to the military Services' desire to develop 
partnerships by devoting resources to training their personnel on 
transition issues and to setting up more transition programs. They 
recognize their interdependence and their shared responsibility for the 
education of military children and are increasing their communication 
with each other to ease children's transition in and out of different 
school systems.
    Military parents view the partnerships between their schools and 
the military Services--from the unit adopting the local elementary 
school to the presence of Service and DOD leadership at educational 
conferences on the military child--as progress toward relieving some of 
the anxieties about their children's education. The educational focus 
of these efforts is a legacy of a successful, well-funded Impact Aid 
program. When the Federal Government fulfills its responsibility to 
provide funding for basic education to districts serving military 
children, the schools can concentrate on providing a high-quality 
education program for all students. We thank you, the Members of this 
Subcommittee, for your leadership in this partnership for the education 
of military children. We ask you to continue this role by meeting the 
Federal obligation to fully fund Impact Aid.
                                 ______
                                 

       Prepared Statement of the United Tribes Technical College

                           SUMMARY OF REQUEST
    For 32 years United Tribes Technical College \1\ (UTTC) has been 
providing postsecondary vocational education, job training and family 
services to Indian students from the Great Plains and throughout the 
nation. Our request for fiscal year 2002 funding for tribally 
controlled postsecondary vocational institutions as authorized under 
Carl Perkins Vocational and Applied Technology Act is:
---------------------------------------------------------------------------
    \1\ The college is owned and operated by five federally-recognized 
tribes situated wholly or in part in North Dakota--Spirit Lake Sioux 
Tribe, Sisseton-Wahpeton Sioux Tribe, Standing Rock Sioux Tribe, Three 
Affiliated Tribes of the Fort Berthold Reservation, and Turtle Mountain 
Band of Chippewa. Control of the institution is vested in a ten-member 
board of directors comprised of elected Tribal Chairpersons and Tribal 
council members.
---------------------------------------------------------------------------
  --$6 million, or $400,000 over the fiscal year 2001 enacted level. 
        This funding is essential to our survival as we receive no 
        state-appropriated vocational education monies.
    In addition we request:
  --Funding for renovation of our facilities, many of which are 
        original to the Fort Abraham Lincoln army installation and are 
        on the National Register of Historic Places. A recent study 
        commissioned by the Department of Education and submitted to 
        Congress shows a facility need for UTTC of $49 million.

                           FUNDING AUTHORITY
    Section 117 of the Carl Perkins Vocational Education and Applied 
Technology Education Act Amendments of 1998 authorizes funding for 
tribally controlled postsecondary vocational technical institutions. 
Under this authority funding is currently provided to UTTC and one 
other tribally controlled postsecondary vocational institution, the 
Crownpoint Institute of Technology. We do not receive funding through 
the Tribally Controlled Community Colleges Act.
             a unique inter-tribal educational organization
    United Tribes Technical College is the only inter-tribally 
controlled, campus-based, postsecondary vocational institution for 
Indian people. Our campus is the site of the Fort Lincoln Amy Post, an 
110-acre area near Bismarck, North Dakota. We currently enroll 371 
students from 32 tribes and 14 states. And we serve 155 children in our 
pre-school programs and 175 children in our elementary school, for a 
direct services population of 701.

           EDUCATING STUDENTS AND CONTRIBUTING TO THE ECONOMY
    We are proud of the education, skills and services provided by UTTC 
for our students and their families. And we are proud that this 
education is taking place in a setting they where can maintain and 
strengthen their tribal heritage. The average age of our students is 
28. 68 percent of our students are female, and 45 percent of student 
are single parents with an average number of dependents of 2.5. We have 
had a sustained job placement rate exceeding 80 percent over the last 
10 years. This success is all the more gratifying in light of the 
background of our students, most of whom come from tribal areas where 
poverty and unemployment are the norm. Many of our students are from 
the 14 tribes in the Dakotas, where unemployment among Indian people is 
chronic. BIA Labor Force data reports the percentage of potential 
Indian labor force on and near reservations in the Aberdeen Area who 
are jobless is 71 percent. Of those persons who are employed 33 percent 
are still living below the poverty guidelines. (Source: Interior 
Department 1999 Labor Market Information On the Indian Labor Force.)
    We believe that a primary reason for UTTC student success is that 
we serve the students' social, academic and cultural needs. Many of our 
students are the first generation in their family to attend college, 
and for many it is their first experience in living away from home. 
Many students are on public assistance and many have families of their 
own. Some of our services are:
  --Early childhood services for 145 children, ages birth to 5 years 
        and an additional 12 elementary children for extended care.
  --Theodore Jamerson Elementary School serving 148 Indian students;
  --A health clinic whose services includes immunization, health 
        education, eye and dental exams, and referrals to other health 
        care providers;
  --Family housing and dormitories for solo parents and for students 
        without children;
  --A local transportation system for students for school activities 
        and necessary appointment e.g., (doctor appointments) outside 
        the campus. Most UTTC students do not have cars.
    UTTC is a major business contributor to the state of North Dakota. 
We undertook a study of the economic impact for 1999 of our institution 
on the state of North Dakota, and found, using only four key dollar 
impact areas, the economic impact created by UTTC was $34 million. This 
study did not encompass all the meetings and conferences that UTTC was 
directly or indirectly responsible for bringing to Bismarck. Thus, the 
economic impact in 1999 was even greater than indicated in our study 
(``Economic Impact by United Tribes Technical College on the Bismarck-
Mandan Community and North Dakota--January 2001'')

                       UTTC NEW COURSE OFFERINGS
    We offer 9 Certificate and 15 Associate of Applied Science degree 
programs. We are very excited about the recent additions to our course 
offerings, and the particular relevance they hold for Indian 
communities. The modest increases in our Department of Education 
funding has helped make these new programs possible. These new programs 
are:
  --Injury Prevention
  --Food and Nutrition
  --Tribal management, including gaming management
  --Computer Support Technician
  --Distance Learning programs
    Food and Nutrition/Diabetes.--UTTC will meet the challenge of 
fighting diabetes through education. As this Subcommittee knows, the 
rate of diabetes is very high in Indian county, and with some tribal 
areas experiencing the highest incidence of diabetes in the world. 
About half of Indian adults have diabetes (``Diabetes in American 
Indians and Alaska Natives, NIH Publication 99-4567, October, 1999).
    The College currently offers a Food and Nutrition Associates to 
increase the number of American Indians with expertise in human 
nutrition and dietetics. Currently, there are only a handful of Indian 
professionals in the country with training in these areas. Future 
improvement plans include offering a Nutrition and Dietary Management 
degree with a strong emphasis on diabetes education and traditional 
food preparation.
    United Tribes Technical College has also established the United 
Tribes Diabetes Education Center to assist local Tribal communities and 
UTTC students and staff in decreasing the prevalence of diabetes by 
providing diabetes educational programs, materials, and training.
    Injury Prevention.--Through our Injury Prevention Program we are 
addressing the injury death rate among Indians which is 2.8 times that 
of the U.S. population (Source: IHS fiscal year 1999 Budget 
Justification). We received assistance through the IHS to establish the 
only degree-granting Injury Prevention program in the nation.
    Computer Support Technician.--High demand exists for computer 
technicians. In the first year of implementation, the program is at 
maximum student capacity. In order to keep up with student demand, UTTC 
will need more classroom space, computers and associated equipment, and 
instructors. Our program includes all of the Microsoft Systems 
certifications which translates into high income potential.
    Distance Learning.--We are bridging the ``digital divide'' by 
providing web-based education from our North Dakota campus to American 
Indians residing at other remote sites, including the Denver Indian 
community. Training is currently provided in the areas of Early 
Childhood Education and Computer Literacy. By the year 2005, students 
will be able to access full degree programs in Computer Technology, 
Injury Prevention, Health Information Technology, Early Childhood 
Education, and Office Technology, and others from these remote sites. 
Online education allows all American Indians an opportunity to overcome 
barriers such as geographic isolation and access to culturally relevant 
education. Through partnership programs, UTTC is meeting the challenge 
of providing technology skills and training to Indian country.
    In addition, UTTC has been a member of the Interactive Video 
Network of North Dakota's colleges, universities, and tribal colleges. 
This allows for collaborative arrangements with other colleges and 
universities, expanding the educational opportunities for our students.

                         OTHER UTTC INITIATIVES
    Northern Plains Bison Research.--UTTC is coordinating reservation-
based field research under the Northern Plains 1862/1994 Land Grant 
Institutions Bison Research Collaborative. The overall project goal is 
to enhance the quality of prairie rangeland conditions that will 
sustain the spiritual and physical well being of Tribal bison herds. 
Research activities are focused on the habitat and nutrition needs of 
bison herds on North and South Dakota reservations.
    Job Training and Economic Development.--UTTC is a designated Indian 
Minority Business Center serving Montana and the Dakotas. We also 
administer a Workforce Investment Act program and an internship program 
with private employers. And we are assisting tribes and tribal members 
in the Aberdeen Area with rebuilding their economies and buffalo herds.
    Coordination with State Welfare-to-Work Efforts.--UTTC is working 
in cooperation with the state of North Dakota and Tribal JOBS programs 
on addressing the effects of welfare reform. The campus Child 
Development Center provides early childhood services for 91 families. 
This includes an Extended Care program so that students are able to 
complete TANF work requirements, complete Cooperative Education 
internships with private employers, and complete other work activities.
    In North Dakota, only 33 percent of state TANF recipients are 
allowed schooling as a work activity. The 12-month statutory limit on 
length of time a TANF recipient can be enrolled in a vocational 
education course of study presents additional barriers for single 
parent families. This limits TANF recipients to taking 1-year 
certificate courses at UTTC. Our experience shows that the students who 
graduate from a 2-year, rather than a 1-year, course of study have 
significantly higher earning power. Many of our students come to UTTC 
planning to take a 1-year course, and then, finding themselves in a 
supportive environment and seeing the economic benefit of the longer 
course, decide to work for the 2-year degree.

                 NEW STUDY DOCUMENTS OUR FACILITY NEEDS
    The 1998 Perkins Act required the Department of Education to study 
the facilities, housing and training needs our institution. That 
report, conducted for the Department of Education by the American 
Institutes for Research, was published in November 2000 (``Assessment 
of Training and Housing needs within Tribally Controlled Postsecondary 
Vocational Institutions, November 2000, American Institute of 
Research'') The report identified the need for $16,575,300 for the 
renovation of existing housing and instructional buildings ($8 million 
if some existing facilities are converted to student housing) and 
$30,475,000 for the construction of housing and instructional 
facilities. Our core facilities range from 90 to 100 years in age. 
Originally the site was a military post built as Fort Abraham Lincoln. 
UTTC acquired its use and eventual ownership in 1968.
    If not adequately addressed, these costs will inevitably continue 
to grow as the buildings age and inflation rises. The following needs 
must be addressed if the College is to remain in existence and increase 
its capacity.
    Housing.--UTTC continues to identify housing as its greatest need. 
UTTC has a huge waiting list of students--some wait from one to 3 years 
for arrival. New housing must be built to accommodate those on the 
waiting list as well as to increase enrollment. Existing housing must 
be renovated to meet local, state, and federal safety codes. In the 
very near future, some homes will have to be condemned which will mean 
lower enrollments and fewer opportunities for those seeking a quality 
education. Single student housing must also be built and expanded to 
meet the College's needs.
    Classrooms & Offices.--This type of space is at a premium. The 
College has literally run out of space. This means that the UTTC cannot 
expand its course offerings to keep up with job market demands. Most 
offices and classrooms that are being used are quite old and are not 
adequate for student learning and success.

                          OTHER AREAS OF NEED
    Devastating Utility Increases.--Utility costs have skyrocketed due 
to increases in natural gas. UTTC's utility costs have increased by 65 
percent. This has put a major added burden on the school and is causing 
a funding dilemma, since we do not have the option of relying on state 
appropriated resources or other fixed cost revenues.
    Inadequate Salaries.--We were able to provide a cost-of-living 
increase for our employees last year. However, our faculty and staff 
still receive salaries that are lower than any state college system in 
the 50 states. (Source: Integrated Postsecondary Education Data Systems 
Report of the U.S. Bureau of the Census and the Department of Education 
Office of Education Statistics.)
    Course Offerings/Student Services.--We hope to change some of our 
courses to better meet new market demands, e.g. training to increase 
the number of students in the allied health professions, updating of 
technology. We also need to expand our diagnostic capabilities in 
tribal-specific areas and in the areas of literacy and math-science 
background. And, we want to make improvements in our student follow up, 
career development, and job market research efforts.
    Thank you for your consideration of our request.
                                 ______
                                 

             Prepared Statement of the University of Tulsa

    It is proposed that the Department of Education support an 
information technology center for the University of Tulsa. We are 
seeking $13 million for building and equipment needs.
       the university of tulsa center for information technology
    It is a reality that economies are increasingly linked to 
technology. In February 2000, Oklahoma Governor Keating hosted a round 
table discussion of technology, educational, and commerce leaders in 
Tulsa. As a result of that meeting, a Center of Excellence in 
Information Technology and Telecommunications was formed. Participants 
in the Center include the University of Tulsa, Oklahoma State 
University-Tulsa, the University of Oklahoma's Tulsa operations, Oral 
Roberts University, Tulsa Community College and Tulsa Technology 
Center.
    The University of Tulsa is poised to help ensure that the Center of 
Excellence in Information Technology and Telecommunications meets the 
needs of industry and fulfills its mission of advancing the industry 
through research and educational programs. However, we are in need of a 
state of the art technology center to optimize our educational and 
research opportunities.
    There are a number of significant benefits that will flow to the 
State of Oklahoma and the Tulsa community from an investment in a TU 
Center for Information Technology (IT). These include:
  --Attracting and retaining quality students
  --Enhanced educational opportunities
  --Research opportunities for both faculty and students
Attracting and Retaining Quality Students
    TU is committed to quality education. The University of Tulsa 
faculty is nationally recognized. For example, last year the Carnegie 
Foundation honored two University of Tulsa professors for the 
Advancement of Teaching and Learning. One was named a Carnegie 
Professor of the Year and one was named a Pew Scholar. In the past five 
years, The University of Tulsa, MIT and Stanford produced an equal 
number of Goldwater Scholars, tying for seventh place in the nation. 
The TU Center for IT would provide the infrastructure to maximize the 
potential of integrating these quality students with quality faculty. 
However, the Center would prove beneficial even before students arrive 
on campus. The recruiting competition for quality students is fierce. 
Students judge the technology infrastructure of a college or university 
when selecting an institution of higher learning. Students often make 
the decision to stay at a college or university based on opportunities 
for access to state of the art technology. TU wants to educate the 
technology knowledge workers to enter the digital economy work force 
and the Center would allow us to nationally recruit quality students to 
Oklahoma.
Enhanced Educational Opportunities
    The TU Center for Information Technology will enhance educational 
opportunities in three areas:
  --by providing tools/resources to enhance learning in all academic 
        areas and disciplines,
  --by providing an infrastructure for technology based program 
        students (such as management information systems, computer 
        information systems, and computer science) students to 
        complement in class learning by applying their classroom 
        learning, and
  --by enabling TU to deliver education to a broader range of 
        constituents--students in divers geographic regions. It will 
        also enable TU to reinforce the lifelong learning we encourage 
        our alumni to pursue.
Research Opportunities
    The TU Center for Information Technology will provide resource 
opportunities for both University of Tulsa faculty, and graduate/
undergraduate students. Due to the number of industry leaders located 
in Tulsa, TU researchers have access to a significant volume of 
relevant subjects and data. TU's research program for undergraduate 
students (known as TURC--the Tulsa Undergraduate Research Challenge) is 
nationally recognized and acclaimed. Students have won a variety of 
national scholarships and grants from prestigious organizations such as 
the National Science Foundation and the Department of Energy. The 
enhanced research labs available in the TU Center for IT would further 
enhance the success of this program.
    In summary, the combination of quality professor, students, and 
technology infrastructure will result in a win-win proposition for 
students of higher education in Oklahoma and the Oklahoma economy.
                                 ______
                                 

      Prepared Statement of the Crownpoint Institute of Technology

    This testimony addresses appropriations under The Carl D. Perkins 
Vocational Education Act, Section 117 ``Tribally Controlled Vocational 
and Technical Institutions.'' On behalf of the Crownpoint Institute of 
Technology, (CIT), I thank this Subcommittee for providing very 
necessary and deeply appreciated appropriations to Section 117 for 
tribally controlled vocational educational institutions. CIT is aware 
of only two such institutions in the nation. Funding to the U.S. 
Department of Education by this Appropriations Subcommittee for Section 
117 has enabled CIT to provide vocational and technical education and 
training to over 400 students annually. CIT graduates enter our 
nation's workforce with highly marketable employment skills.
    While this appropriation has been greatly appreciated and extremely 
well-utilized for the education of Native American young adults, CIT 
believes the most significant situation relevant to Section 117 
appropriations is that on March 27, 2001 the U.S. Department of 
Education unexpectedly issued new regulations and application 
guidelines that drastically redirect this appropriation. The Department 
ruled that minor changes in the 1998 reauthorization to Section 117 
constituted a ``substantial revision,'' and therefore expanded 
eligibility to tribal institutions already supported under other 
statutes. CIT does not agree that Section 117 of the reauthorization 
law was revised. Attached with this testimony is a side-by-side 
comparison of the 1990 and 1998 ``Tribally Controlled Postsecondary 
Vocational Institutions'' definitions demonstrating that there are no 
substantial revisions to the definitions of eligible institutions. Our 
most important request to this Subcommittee is for assistance and 
intervention in ensuring that the intent of the Congress is carried out 
in the Department's awarding of funds under Section 117 beginning with 
fiscal year 2001 appropriations which this Department of Education 
March 27, 2001 Notice redirects effective May 29, 2001.
    The Title for Tribally Controlled Postsecondary Vocational 
Institutions was enacted to create a stable base of operational support 
for those tribal colleges that were not eligible for the ``Tribally-
controlled Community Colleges Assistance Act.'' That 1978 act followed 
the U.S. Congress policy of Indian Self-Determination, which allowed 
tribes to manage their own institutions, and provides basic operational 
support for tribal colleges through Interior appropriations into the 
present time. The Tribal Colleges Act supports all but two of the 
nation's tribally controlled colleges. The Crownpoint Institute of 
Technology (CIT) is one of these two excluded tribal colleges. The 
reason for the exclusion is a provision in the Tribal Colleges Act that 
limits each Tribe to one college. On its surface this statutory 
limitation may seem reasonable. The average population of tribes having 
tribal colleges ranges between 3,000 and 10,000 members. The Navajo 
tribe is a population anomaly among Indian tribes with 225,298 members 
as verified by the most recent U.S. Census. Dine College, Tsaile, 
Arizona, is the Navajo Tribal College funded under Interior's Tribal 
Colleges Act. Founded in 1969, Dine is the first of the nation's tribal 
colleges. CIT was founded in 1979, one year after enactment of the 
Tribal Colleges Act and even then was originally created as a job 
skills center. The ensuing decade saw CIT's evolution from a job-
training center to a full-fledged vocational technical college. Skilled 
employment opportunities expanded for students graduating with 
credentialed degrees, and CIT earned full institutional accreditation 
from North Central Association of Colleges and Schools in 1987. CIT's 
outstanding success at providing its students with highly marketable 
career skills has enabled over 4,000 Navajo adults to leave the welfare 
roles behind forever. This is how the Navajo Nation came to have a 
second college.
    The size of the Navajo population warrants a second college. 
Throughout our nation, colleges are created to serve population bases. 
The number of tribes is irrelevant. There are sixteen Indian tribes in 
the three States of Montana, North Dakota and South Dakota. Each of 
these tribes has a tribal college supported by Congressional 
appropriations. Yet the combined population of on-reservation, all-ages 
of these sixteen tribes is 72,835. An enrollment base establishes the 
need for any educational institution. It is illogical by any standard 
to erect sixteen colleges for a 73,000 population, while simultaneously 
limiting a 225,000 population to only one college. However 
inadvertently, this is exactly what the Congress did in 1978 with 
enactment of Public Law 95-471, ``The Tribally Controlled Community 
Colleges Act.''
    Geographic access to postsecondary education is another significant 
factor in establishing the need for a college, and was a primary 
consideration for most tribes in founding their own colleges. The 
Navajo Nation is 26,897 square miles extending into three States: 
Arizona, New Mexico and Utah. The Navajo Nation reservation is 2,810 
square miles larger than the State of West Virginia, and only slightly 
smaller than the five New England States of Vermont, New Hampshire, 
Massachusetts, Connecticut and Rhode Island combined. The driving 
distance across this reservation is approximately nine hours. In the 
remote vastness of this reservation in America's Southwest, geographic 
access to postsecondary education for Native people would not exist for 
most citizens without these two tribal colleges.
    The existing tribal colleges adamantly opposed many years of CIT's 
efforts to amend the Tribal Colleges Act to allow a second college in a 
situation of exceptional population. In 1990, Congress enacted the 
``Tribally Controlled Postsecondary Vocational Institutions'' 
provisions to provide federal assistance to tribal colleges not 
eligible for Interior appropriations under the Tribal Colleges Act. At 
that time there were only two such colleges in the nation, and their 
primary mission was and remains vocational/technical education. Thus, 
the provision was included in the Carl D. Perkins Vocational Education 
Act. The second of these anomaly tribal vocational colleges is United 
Tribes Technical College (UTTC) located in Bismarck, North Dakota. The 
four tribes of North Dakota charter UTTC that each already had an on-
reservation tribal college funded under the Tribal Colleges Act. More 
than two decades after their founding, there remain only two tribal 
vocational colleges in the nation, although during these same years 
several new tribal community colleges have been added under the Tribal 
Colleges Act. Each of those colleges is the only college that the 
sponsoring tribe has chartered. The vast majority of tribes have never 
founded a first tribal college. Due to the small populations of most 
tribes, it is highly unlikely that any tribe other than the Navajo will 
ever found a second tribal college. In the situation of the Navajo 
people, remote geography and population uniquely combined to predicate 
this unusual need for a second postsecondary institution.
    The 1998 Reauthorization of the Carl D. Perkins Vocational 
Education Act saw some major revision, but the Tribally Controlled 
Postsecondary Vocational and Technical Institutions provision remained 
essentially intact because the situation it addressed remained 
essentially the same. Because Section 117 contained only minor changes, 
Congressional sponsors did not accompany enactment with a statement of 
the intent of the Congress. The absence of such statement of the intent 
of Congress served as the Department of Education's justification to 
abruptly proclaim on March 27, 2001, more than two and one half years 
after 1998 enactment, that Section 117 definition of eligibility was 
``substantially revised.'' In response, a colloquy by the authorizers 
reiterating the intent of the Congress as to this provision was 
published in the April 26, 2001 Congressional Record and provided to 
the Department. Upon receipt of the requested clarification, the 
Department declined to withdraw the competition, which expands 
eligibility for appropriations to all tribal colleges, which already 
receive their basic operational support under Interior's Tribal 
Colleges Act. A technical amendment is in process. However, it is 
unlikely that this amendment can be enacted in time to affect awards 
under fiscal year 2001 appropriation because the Department's 
unretracted grant application deadline is May 29, 2001 with the fiscal 
year 2001 program year beginning the following month. This Subcommittee 
increased the fiscal year 2001 appropriation from $4.6 to $5.6 Million, 
under which CIT's student count allocation is desperately needed to 
remain in operation. Under the Department's new guidelines, CIT would 
lose at least 70 percent of its operational funding, and in a worst 
case, would not even be one of the institutions selected in the 
competition by the Department at all. In either case, CIT would not be 
able to open its doors for classes in August 2001, and will be forced 
to furlough employees beginning June 2001. Presently, CIT is only able 
to renew faculty contracts provisionally, subject to continued Section 
117 funding. The potential loss of faculty to other more secure 
employment would have a devastating effect on CIT. We urge this 
Subcommittee to do all in its power to intervene and ensure that its 
fiscal year 2001 Section 117 appropriation is spent according to the 
law and the intent of the United States Congress.
    CIT believes it has established its merit as a tribal institution 
worthy of federal assistance. CIT has an eight-year average student 
retention rate of 95 percent, and an average job placement rate of 86 
percent over the same period. CIT's current enrollment is 492 headcount 
or 423 Full Time Equivalency/Indian Student Count, an increase of 
thirty students over academic year 1999-2000. Through tribal HUD 
assistance, CIT has expanded married/family on-campus housing to 
accommodate those students possibly most in need of jobs, students with 
dependant children. CIT is a dormitory-based institution and off-campus 
housing in scarce. Each year, student applications continue to surpass 
capacity and CIT has a waiting list of over 200 otherwise qualified 
applicants.
    CIT offers fully-accredited two year Associate of Applied Science 
degrees and/or one year certificates in high employment demand fields 
including Accounting, Administrative Assistant, Applied Computer 
Technology, Automotive Technology, Building Maintenance, Carpentry, 
Culinary Arts, Electrical Trades, Environmental Technology and Natural 
Resources, Law Advocate, Legal Assistant, Nursing Assistant and 
Veterinary Assistant. For academic year 2001-2002, CIT has prepared to 
offer Dental Assistant and Health Technician in response to a high 
employment demand and shortage of skilled workers in these fields. CIT 
has already secured donated dental training equipment enabling it to 
maximize its use of federal assistance in this program.
    Over 10,000 young adults graduate from Navajo area high schools 
each year. The decennial Indian population increase is 14 percent as 
compared to only 8 percent for mainstream America. Median Native 
American population age is now 27.4 years, 8 years younger than the 
median age for mainstream America. CIT's average student age is 26, 
although the actual range has been 18-64. CIT is open to and welcomes 
all qualified Indian and non-Indian applicants, and as just one example 
has retrained displaced non-Indian uranium workers from neighboring 
towns. However, the primary mission for this institution is to rectify 
the joblessness and hopelessness so prevalent among too many of the 
more than 200,000 on-reservation people. CIT graduates earn an average 
$15,075 average entry-level annual wage upon graduation. Each employed 
graduate pays an average of $2,261 of their earnings to federal taxes 
in the first year of employment alone. While tax contributions vary 
according to number of dependents and other factors, in general wages 
and tax contributions over an average thirty years of employment and 
tax paying. CIT lacks institutional resources to track all of its more 
than 4,000 graduates of the past two decades, but of those tracked, 61 
percent are employed in private industry and do not rely on federal 
appropriations for jobs. In an average lifetime of employment, CIT 
graduates will return to the federal government the cost of its 
investment many times over through tax contributions as well as through 
remaining off the welfare rolls.
    It will have been a tragic loss of the investment of two decades 
that brought CIT to the educational institution it is today if federal 
operational assistance is so abruptly withdrawn. Over the past decade, 
a significant investment of tribal and federal funding has brought CIT 
facilities up to the standards that ultimately result in CIT graduates' 
abilities to succeed in the mainstream American economy. CIT opened its 
state-of-the art Veterinary teaching clinic last year. This teaching 
clinic will greatly enhance the way of life that remains traditional 
for most Navajo people, which relies on livestock yield. Over three 
years, a more than $4 Million EDA grant enabled the replacement of 
trailers with actual classrooms. In addition, this same EDA funding 
repaired dormitories damaged by years of soil contraction, an 
unforeseen construction problem endemic to the Southwest when CIT was 
originally built by the Federal Government. CIT Administrative 
buildings, also damaged beyond repair by this same problem, were 
replaced with new mobile units in order steer maximum facilities 
improvements directly to the students. The Navajo Nation invested their 
HUD funding to increase housing capacity for students with dependent 
children. Sixteen of a projected thirty-two units now have resident 
student families on their way to acquiring life-long employment skills 
to support these families. The Navajo Nation sacrificed much to ensure 
that CIT provides education equal to that provided in mainstream 
America so that our graduates can compete on a level playing field. It 
will be a tragic waste of this investment if federal assistance to CIT 
is withdrawn by the Department's radical new funding interpretations. 
We deeply thank this Subcommittee for all its assistance and urge that 
it take all action possible to ensure that its appropriations reach the 
recipients that the law specifies and that the Congress intended.
                                 ______
                                 

             Prepared Statement of the Alpha One Foundation

    Mr. Chairman and members of the Committee thank you for the 
opportunity to submit testimony for the record on behalf of the Alpha 
One Foundation.

                        THE ALPHA ONE FOUNDATION
    The Alpha One Foundation is a national not-for-profit organization 
dedicated to providing the leadership and resources that will result in 
increased research, improved health, worldwide detection and a cure for 
Alpha1-Antitrypsin (Alpha-1) Deficiency.

                ALPHA-1 IS SERIOUS AND LIFE THREATENING
    Alpha-1 is a genetic disorder that can result in devastating and 
fatal lung and or liver disease that is often misdiagnosed as asthma or 
Chronic Obstructive Pulmonary Disease (COPD). Alpha-1 afflicts an 
estimated 100,000 individuals in the United States with fewer than 
6,000 accurately diagnosed. Alpha-1 is a major cause for lung 
transplantation in adults.
    The pulmonary impairment of Alpha-1 causes disability and loss of 
employment during the prime of life, frequent hospitalizations, family 
disorganization, and the suffering known only to those unable to catch 
their breath. Lung transplantation, with all its associated risks and 
costs, is the most common final therapeutic option. Alpha-1 is the 
primary cause of liver transplantation in infants and an increasing 
cause in adults. Untreated individuals can have their life expectancy 
reduced by 20 or more years.
    Alpha-1 is a progressive and devastating disorder that in the 
absence of proper diagnosis and therapy leads to premature death; in 
spite of the availability of therapeutics and preventative health 
measures that can be life prolonging.
       the medical needs of the alpha-1 community have gone unmet
    Alpha1-Antitrypsin Deficiency is a hidden killer that 
desperately needs new therapies. It masquerades as asthma, chronic 
usual obstructive lung disease and bronchiectasis. There is a lack of 
awareness of the insidious nature of the early symptoms of the lung 
disease associated with this genetic condition by both medical care 
providers and the public.
    Currently, the only specific therapy for Alpha-1 is intravenous 
augmentation therapy produced from pooled human plasma at an average 
annual cost of $50,000.00. This single source therapy, initially 
marketed through the Orphan Drug Act, increases the plasma levels of 
the deficient protein and appears to slow or halt the progression of 
the pulmonary disease described above. Unfortunately, this therapy has 
been in short supply over the past several years. During prolonged 
shortages, individuals on therapy were forced to reduce the dosage of 
drug being administered or prolong the duration of time between 
treatments. No data is available concerning the potential efficacy of 
these untested treatment regimens. As new patients were identified, 
they were unable to obtain drug during these periods.

                          SUPPORT FOR RESEARCH
    The Alpha One Foundation believes that significant federal 
investments in medical research are critical to improving the health of 
the American people and specifically those affected with Alpha-1. The 
Foundation is supportive of the goal set by Congress of doubling the 
National Institutes of Health (NIH) budget by fiscal year 2003. At the 
proposed funding level NIH will be able to support the highest level of 
new and competing research project grants, and the highest level of 
total grants in NIH history.
    It is fair to state that the support of this Subcommittee has made 
a substantial difference in improving the public's health and well-
being. The Foundation requests that the increase in the NIH budget will 
reflect an increase in the Alpha1-Antitrypsin Deficiency 
research portfolio to achieve the following goals:
  --The Promotion of basic science and clinical research related to the 
        AAT protein and AAT Deficiency.
  --The funding to attract and train the best young clinicians for the 
        care of individuals with AAT Deficiency.
  --The support for outstanding established scientists to work on 
        problems within the field of AAT research.
  --The Development of effective therapies for the clinical 
        manifestations of AAT Deficiency.

                      10 SPECIFIC AREAS OF CONCERN
    1. Increase the level of funding for investigator-initiated 
research.--Our best ideas to cure and prevent Alpha-1 come from 
individual scientists working in the laboratory and with patients. We 
recommend that the NIH budget be increased to allow an increased number 
of scientifically meritorious grant proposals that are investigator 
initiated be funded.
    2. Provide significant increases in federal funding to attract, 
educate, and train more clinical and translational researchers.--We 
need continued replenishment of leaders to bring findings from the 
laboratory bench to the bedside. We must recruit new clinicians to 
become involved in clinical research. This is becoming more and more 
difficult as managed care tightens budgets and allows little if any 
time for physicians to engage in research. We must address this issue 
if we are to have the trained personnel needed to prevent and cure 
Alpha-1 in the next 5 to 10 years.
    3. Increase individual grants for scientific conferences and 
workshops.--Increase the number and amount of grants available to 
sponsor scientific conferences and workshops in order to increase the 
promotion and participation in these forums.
    4. Fund targeted screening and detection.--In 1989 the HHS National 
Commission on Orphan Diseases estimated that only 30 percent of the 25 
million patients suffering with rare diseases receive a diagnosis in 
three to five years after the onset of symptoms. That works out to 
about 7.5 million patients who are shuffled from specialist to 
specialist, year after year. Fifteen percent, or 3.7 million people, 
wait seven years or more. The average patient with Alpha-1 sees 5 
physicians over 7 years before they are properly diagnosed. In addition 
only 6 percent of those estimated to have Alpha-1 have been identified. 
A targeted screening and detection plan should follow the 
recommendations of the World Health Organization's report on Alpha-1 
and promote appropriate treatment and positive health interventions. 
Research has shown that early diagnosis and treatment leads to fewer 
long term health complications and a better quality of life.
    5. Establish ``centers of excellence'' to support proactive 
initiatives in Alpha-1 treatment.--We must focus our efforts to further 
reduce smoking, understand and improve dietary habits and undertake a 
national effort to identify and test potential Alpha-1 patients in an 
effort to offer the best therapies and life prolonging preventative 
health strategies.
    6. Initiate health surveillance for frequent plasma recipients.--
Blood carries inherent risks that increase for life-long recipients. 
Although all plasma-derived products are virally inactivated, there are 
concerns about new and emerging pathogens and their ability to be 
transmitted through blood. Targeted surveillance of the Alpha-1 
community would allow for an early warning system should such a threat 
be present in the blood supply. Specifically, the Foundation welcomes 
an evaluation of the experience of this long term and frequent 
recipient cohort of pooled plasma derivatives.
    7. Capitalize on the unprecedented number of opportunities to 
create new therapeutics through increased funding and public-private 
partnerships.--The medical needs of the Alpha-1 community will go unmet 
without the development of new therapies. The final delivery of new 
therapies depends on the overall process of drug development and 
clinical trials, and in the case of therapies for orphan disease this 
process is often burdensome and prohibitively expensive. Academic 
institutions and the private sector carry out these expensive 
processes. To fully leverage the strengths of these sectors and 
validate new therapies there must be resources to fund the expedited 
development of unprecedented and novel public-private partnerships.
    8. Fund programs to improve the quality of life.--Alpha-1 is a 
tragic disease that extracts a great deal in terms of human suffering 
from its victims and their families. We must provide programs that 
address critical issues such as pain and fatigue and end-of-life issues 
for patients and families. Preventative measures, environmental 
effects, psychosocial, economic and ethical issues related to Alpha-1 
should be fully explored.
    9. Fund initiatives that will address research questions dealing 
with disparities in minority, and underserved populations, and 
accelerate programs to ensure early detection, and treatment.--We must 
make every effort to reduce and equalize disease rates across all 
populations. The Foundation supports increased funding for programs 
that ensure that all populations receive the benefit of research and 
that health disparities do not continue among minority populations.
    10. Adequately fund the Office of Rare Diseases.--Finally, the NIH 
needs to ensure that all Americans, not just a select few, have access 
to the incredible work being done at the NIH. Today, only ten cents for 
each and every person suffering with a rare disease is dedicated to 
ORD. We request a significant increase in this funding amount.

                               CONCLUSION
    The Alpha One Foundation supports an increase of $3.4 billion for 
fiscal year 2002, in the hope that this increased investment in the 
National Institutes of Health will translate into an increase in the 
resources dedicate to research and awareness of the devastating 
disorder: Alpha1 Antitrypsin Deficiency.
                                 ______
                                 

   Prepared Statement of the Association of Schools of Public Health

    The Association of Schools of Public Health (ASPH) is the only 
national organization representing the deans, faculty, and students of 
this nation's 29 accredited schools of public health and graduate 
programs seeking accreditation as schools of public health in the 
United States and Puerto Rico. These schools have a combined faculty of 
over 2,500 and educate more than 15,000 students annually from every 
state in the U.S. and most countries throughout the world. The schools 
graduate approximately 5,000 professionals each year. The 29 schools of 
public health constitute a primary source of comprehensively trained 
public health professionals and specialists in short supply to serve 
the Federal Government, the 50 states and the private sector. Yet 
according to the DHHS, public health professionals are in short supply.
    On behalf of the 29 graduate schools of public health in the U.S. 
and Puerto Rico, the Association of Schools of Public Health (ASPH) 
hereby submits a statement for the hearing record on the association's 
fiscal year 2002 appropriations requests for programs of primary 
concern in the U.S. Public Health Service. There is a chart on page 
five that outlines these recommendations. Consideration of these 
requests by the Subcommittee is appreciated.

                   PREVENTION RESEARCH CENTERS (CDC)
    The Congress established the CDC prevention research centers 
program in 1985 to provide grants to academic institutions to fund 
applied research programs designed to develop new and innovative 
strategies in health promotion and disease prevention. Through this 
program, faculty expertise of schools of public health is made 
available to federal, state and local health officials, community-based 
organizations and nonprofit organizations. Additionally, the centers 
serve as sources of education and training for America's next 
generation of public health professionals. Unfortunately, the funding 
level for the program has never reached the level that Congress 
intended when authorizing the program.

                              ASPH REQUEST
    CDC currently funds 24 prevention research centers at schools of 
public health and schools of medicine across the country. Each center 
has a specific prevention research focus, based largely upon its 
faculty expertise and geographic location. However, core funding for 
prevention centers has been decreasing since the program was first 
funded in 1986 from an average of approximately $800,000 per center to 
the current year average of approximately $715,000 per center. ASPH 
requests that the Congress increase the funding for this important 
program from the current year level of $25 million to $40 million. 
These funds will be used for the following purposes: to increase the 
core funding of centers such that the average core award is $1 million 
(as intended by the Congress) which would allow CDC the flexibility to 
provide additional funding to centers which have undertaken a more 
aggressive program; to provide sufficient resources to permit not more 
than six new, competitively-selected centers; and to provide the 
necessary resources for administration of an expanded program at CDC.
    Each prevention research center (PRCs) taps into the long-standing 
links that schools of public health have with their communities and 
regions. Schools of public health faculty work closely with community 
leaders in designing and applying prevention strategies and programs 
that address the public health challenges facing these communities.
    From Appalachia, Harlem, the Deep South, the Midwest, the Northwest 
and the Southwest, the PRCs link diverse and geographically distinct 
areas through a national network that tracks and translates prevention 
research and best practices to applications in community-based public 
health and disease prevention programs. Increasing funds for prevention 
research centers in fiscal year 2002 will enable them to expand 
community-based interventions further into communities, allowing wider 
access to lifesaving research and interventions.

                HEALTH PROFESSIONS TRAINING (HRSA/BHPR)
    The Association of Schools of Public Health respectfully requests 
that Congress provide at least $20 million for public health training 
programs and preventive medicine residencies in the fiscal year 2002 
appropriations bill. Of this amount, $10 million should support public 
health traineeships and preventive medicine residencies and $10 million 
should be dedicated to public health training centers at schools of 
public health.
    The Pew Health Professions Commission, in its 1995 report entitled 
Critical Challenges: Revitalizing the Health Professions for the 
Twenty-First Century, concluded that the demand-driven system in health 
care will result in increased demand for public health professionals as 
managed care organizations seek to hold health care costs down by 
employing public health solutions to community problems.
    Several public health workforce experts in both government and 
academia estimate that as many as 80 percent of individuals currently 
working in state or local health departments have no formal education 
in pubic health. Furthermore, those same experts estimate that less 
than 50 percent of the directors of the local health departments, many 
of whom are MDs, have no public health training. There is a critical 
need to provide these professionals with the most up-to-date public 
health training available.
    DHHS has listed personnel shortages in several public health 
occupations.\1\ Many state/local health department directors have 
reported that the lack of practical knowledge and skills in the core 
sciences of public health and preventive medicine have restricted the 
effectiveness of their agencies. In order to improve the quality of the 
American public health infrastructure, we must provide adequate 
training, education and continuing education to the public health 
workforce.
---------------------------------------------------------------------------
    \1\ There is a large under-trained public health workforce of more 
than 400,000 who have no public health degree, certificate, or 
education in public health. This represents roughly four of every five 
employees in public health. Without well-trained public health 
professionals in various shortage disciplines, communities are left 
vulnerable to increased infectious diseases, toxic environmental 
situations, contaminated food, and other threats to public health. 
Training for public health professionals is critically important in 
medically underserved communities, where serving disadvantaged 
populations is critical. There are only 2,755 physicians trained in 
general preventive medicine and public health in the nation. The number 
of physicians completing a preventive medicine residency has declined 
by 25 percent during the last 5 years leading to major gaps in 
preventive medicine expertise need for clinical prevention, community 
public health, and health services organization/delivery. DHHS programs 
are designed to address the problems identified above. The public 
health traineeships provide support for students in shortage 
disciplines including epidemiology, biostatistics, environmental 
health, toxicology, public health nursing, public health nutrition, 
preventive medicine, behavioral sciences and mental health. The 
preventive medicine and dental public health programs support planning, 
development or maintenance of residency programs and provide financial 
assistance to residency trainees enrolled in these programs.
---------------------------------------------------------------------------
    Many national health groups--especially the maternal and child 
health agencies and state/local health officials--agree that regional 
shortages of adequately trained professionals present the most 
significant barrier to providing population-based prevention 
initiatives, in general, and ensuring the delivery of quality health 
care to underserved individuals and underrepresented populations, in 
particular. Health professionals trained to handle the unique demands 
of rural and inner-city public health issues are in the shortest 
supply.

                              ASPH REQUEST
    The Association of Schools of Public Health (ASPH) is requesting 
that the fiscal year 2002 HRSA budget include $20 million for public 
health workforce training. Specifically, funding should be targeted to:
  --Make public health/preventive medicine education more accessible;
  --Create links between public health/preventive medicine education 
        and future trends in the practice of public health;
  --Continued efforts to promote diversity in student populations;
  --Provide education or training for students and preventive medicine 
        residents in practice-based sites instead of solely in the 
        classroom; and
  --Develop educational methods and distance-based learning 
        technologies that ensure the ability of public health workers 
        to reach underserved populations.

                   RESPONDING TO BIOTERRORIST ATTACK
Public Health Preparedness Centers
    Building upon an fiscal year 2000 investment of $2 million and 
report language urging continuation of the program in fiscal year 2001 
to conduct training for current state and local health department 
employees, the Congress should include $10 million in CDC's budget to 
continue public health education programs using distributed learning 
technologies with the goal of training employees of state and local 
departments of public health and community-based organizations to 
detect, contain and respond to a bioterrorist attack. Such an action 
would also provide critically needed training in the area of infectious 
diseases as well.
    The recent focus on a bioterrorist attack on the United States has 
led many to question the ability of the current public health workforce 
to deal with such an emergency. There has not been a case of smallpox, 
for example, since the early 1970s--and few public health professionals 
are trained to recognize the symptoms of this deadly disease. This lack 
of formal training in infectious diseases extends to other biological 
agents such as anthrax, tularemia, botulinin toxin and plague. In order 
to detect and respond to a bioterrorist attack, the U.S. needs public 
health professionals who:
  --Can conduct epidemiological surveillance;
  --Can design and use the tools to detect terrorist biological 
        attacks; and
  --Understand the principles of containment.

                              ASPH REQUEST
    We respectfully request that the Subcommittee include a total of 
$10 million in the fiscal year 2002 CDC budget to provide for 
professional workforce development services to public health and 
community-based organization employees in order to detect and respond 
to a bioterrorist attack. It is proposed that CDC select not more than 
ten public health preparedness centers based at accredited schools of 
public health to conduct distance learning and professional workforce 
development activities. Outcomes of these programs would include:
  --Offering high-level, in-depth biodefense and infectious disease 
        training to approximately 500 public health professionals in 
        state and local leadership positions (including large cities 
        and state departments of health) using the Internet and other 
        distance learning technologies;
  --Offering basic biodefense and infectious disease training to 
        roughly 1,000 staff-level public health officers (such as 
        surveillance officers) through distance learning;
  --Assessing the skills and readiness of public health workers to 
        respond to bioterrorist and other public health threats;
  --Developing a comprehensive public health training curriculum 
        focused on detection and response to bioterrorist attacks to be 
        delivered through the Internet, or other appropriate mass 
        communication technology.

                  PREVENTION RESEARCH INITIATIVE (PRI)
    Prevention research plays a critical role in reducing the human and 
economic costs of disease. For example, the CDC has estimated that the 
annual cost of cardiovascular disease in the U.S. is approximately $259 
billion, cancer is estimated to cost $104 billion, diabetes is 
estimated at $92 billion, Alzheimer's disease--approximately $80 
billion, and arthritis about $65 billion. However, these costs can be 
reduced through prevention.
    The benefits of population-based prevention are astounding. The 
Journal of the American Medical Association published a widely accepted 
article in 1993 that estimates that ten percent of all early deaths in 
this country can be prevented by medical treatment. By contrast, the 
study found that population-wide public health approaches have the 
potential to prevent up to 70 percent of these early deaths through 
measures that target underlying risks, such as tobacco, drug and 
alcohol use, diet and sedentary lifestyle, and environmental factors.

                              ASPH REQUEST
    The Association of Schools of Public Health respectfully requests 
that the Congress increase the funding for the CDC prevention research 
initiative to $25 million in the fiscal year 2002 Labor, HHS and 
Education appropriations bill. Such a program should focus on 
conducting priority research in the following areas:
  --Investigations into the epidemiology of disease, including 
        identification of social and behavioral determinants of 
        illness;
  --Studies of means to ameliorate personal, social and environmental 
        factors contributing to disease onset or exacerbation;
  --Investigations into the disproportionate disease burden among 
        underserved populations;
  --Studies of vulnerable populations with a high disease burden;
  --Studies on immunization strategies and of methods for and the cost-
        effectiveness of population screening programs; and
  --Studies into the means by which further decline in physical or 
        social functioning can be prevented in people already ill.
    Finally, the program would serve to expand the capacity of CDC to 
bring the benefits of prevention to the millions of Americans at risk 
for unnecessary early death.

                                SUMMARY
    In closing, we are spending billions of dollars on treatment of 
chronic diseases and/or research to find cures for such diseases, while 
at the same time using pennies of our health care dollars to find ways 
to prevent them. For example, the U.S. Government spends approximately 
$50,000 per year/per capita to train medical graduates; by contrast, 
the federal share per year to train graduate public health students in 
the United States is less than ten dollars per student.
    Our training programs in schools of public health are focused on 
prevention of disease and disability; our programs are steeped in the 
basic public health sciences of epidemiology and biostatistics; and our 
curricula have a population-based perspective. In short, our graduates 
will be more likely to approach their jobs with a better understanding 
of disease in populations and with keener sense of a whole spectrum of 
interventions aimed at the environment, human behavior and lifestyle. 
Federal support of these programs is a wise investment in the health of 
the American people.
    In addition to our requests, the ASPH wishes to go on record in 
support of the fiscal year 2002 appropriations recommendations of the 
following groups and coalitions that have or will submit testimony 
before the Subcommittee:
  --Ad Hoc Group for Medical Research Funding
  --CDC Coalition
  --Coalition for Health Funding
  --Friends of AHRQ
  --Friends of NIOSH
  --Friends of Title V (MCH Block Grant)
  --Health Professions and Nursing Education Coalition
  --Injury Control and Research Centers Coalition
  --Friends of NCHS
    In addition, we want to express the support of ASPH for providing 
$250 million to upgrade laboratory facilities at CDC. These facilities 
are in desperate need of renovation.
    ASPH requests, and those outlined by these coalitions, represent 
needs assessments that were derived from the views and expert opinions 
of this country's most respected administrators, scholars, scientists 
and leaders in the public health sector. We know that the Subcommittee 
members will take them into serious consideration when marking-up the 
fiscal year 2002 appropriations bill.
    Listed below are the ASPH fiscal year 2002 funding recommendations 
for programs of primary concern to the academic public health 
community:

                        [In millions of dollars]

CENTERS FOR DISEASE CONTROL AND PREVENTION:
    Prevention Research Centers (PRCs)............................    40
    Prevention Research Initiative (PRI)..........................    25
    Preparedness Centers (PHPCs)..................................    10
HEALTH RESOURCES AND SERVICES ADMINISTRATION:
    Public Health Training Centers, Traineeships, Preventive 
      Medicine and Dental Public Health...........................    20
                                 ______
                                 

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

           Prepared Statement of the University of Cincinnati

    Mr. Chairman and Members of the Subcommittee, my name is Dr. Donald 
Harrison, and I am the Senior Vice President and Provost for Health 
Affairs at the University of Cincinnati. As CEO of the Medical Center, 
I am also administratively responsible for the University's 
participation in the Health Alliance of Greater Cincinnati and for the 
academic programs of the Colleges of Medicine, Nursing, Pharmacy, and 
Allied Health Sciences. I am a practicing cardiologist with an 
international patient base, and I have served as national president of 
the American Heart Association and Vice President of the American 
College of Cardiology.
    I am here today on behalf of a coalition of 20 academic health 
centers across the nation to highlight issues of concern to all 
academic health centers in the United States. We are the institutions 
which conduct a significant portion of the extramural biomedical and 
behavioral research funded through the National Institutes of Health, 
and I welcome this opportunity to comment on the programs and policies 
which seek to strengthen the nation's extramural research enterprise.
    First, I would like to thank all of the Members of this 
Subcommittee for the outstanding support provided to the NIH over the 
past several years. The additional funds clearly have a significant 
impact the causes, prevention and treatment of health problems which 
afflict the citizens of our nation and the world.
    Second, I would like to thank the Subcommittee for successfully 
raising the salary cap imposed on extramural NIH researchers to Level 
One of the Executive Pay Scale, or $161,200 per year. This higher 
salary level allows academic medical centers to attract and retain the 
most talented individuals to biomedical and behavioral research, 
especially clinician-investigators. Further, the higher salary cap 
assures equity between intramural and extramural scientists. Because of 
your leadership, extramural salaries will now be equal to the maximum 
salary level which the NIH can pay its own senior scientists under the 
Senior Biomedical Research Service.
    I would like to take this opportunity to request your support for 
further enhancing the extraordinary partnership that was established 
with great foresight years ago between academic institutions and the 
Federal Government. This partnership has spawned remarkable scientific 
developments over decades. These advances position us--academia, 
industry, and the government--to work together to exploit the golden 
era of biology. Academic institutions across the nation are proud to be 
major players in this partnership.

                       INCREASED FUNDING FOR NIH
    As we look ahead to fiscal year 2002, I would like to begin by 
expressing the support of academic medical centers, and the extramural 
research community, to seek a $3.4 billion or 16.5 percent increase for 
the NIH this year to bring the agency's budget to $23.7 billion for 
fiscal year 2002. This level of support will keep efforts on track to 
double the NIH's budget by fiscal year 2003. This is an incredible time 
in biomedical history as the mapping of the human genome has been 
successfully completed just last month. This extraordinary 
accomplishment presents an exponential number of additional 
opportunities to investigate the causes of disease and will lead to new 
roads of inquiry to developing cures. In addition--and I will repeat a 
statistic that I am sure you are all very aware--the NIH currently 
funds fewer than four of every 10 approved research grants. All of 
these are judged by peer-review to merit funding because of their 
potential for biomedical advance. For these reasons, I urge you to 
continue efforts to increase the NIH's budget toward the goal of 
doubling the agency's budget by fiscal year 2003.
    Having raised the need to continue to increase funding for the NIH, 
I would like to bring to your attention several factors that impact the 
ability of our institutions to carry out the extramural component of 
our nation's expanding and thriving biomedical research enterprise. Our 
institutions bear certain costs for conducting NIH research that are 
not supported by the federal research dollar. In fact, all 
institutions, either public or private, bear a portion of the research 
expense. I am here today to advocate that we further strengthen the 
academic/federal partnership so that the extramural biomedical and 
behavioral research community can operate at optimal capacity and 
efficiency: Specifically, I urge you to:
  --Increase extramural construction funding so that NIH investigators 
        can utilize state-of-the-art facilities to carry out the 
        increasing volume of federally-supported biomedical and 
        behavioral research; and
  --Provide resources to research institutions in order to comply with 
        the increasing costs of federal regulation.
    In addition, I seek your support for increased funding through the 
Agency for Healthcare Research and Quality for technological support to 
combat medical errors. This problem has been highlighted in a review by 
the Institute of Medicine and in numerous media reports.
increase funding for facilities construction, renovation, and equipment
    For the past two years, the NIH has included $75 million in 
extramural construction funding through the NIH's National Center for 
Research Resources (NCRR). These funds are necessary for extramural 
researchers to have adequate laboratories in which to conduct this 
important research. It is vitally important that we have the facilities 
and equipment to fully exploit research opportunities and utilize the 
increased project grant funding. Exciting developments in genomics, 
chemical biology, neurosciences, cancer, and many other fields require 
new kinds of equipment and facilities. Even the best minds cannot 
compensate for outdated equipment and facilities.
    The National Science Foundation (NSF) completed a study in 1998 on 
the status of scientific research facilities at U.S. colleges and 
universities. This analysis generated an estimate of $11.4 billion in 
deferred biomedical research construction and repair or renovation 
projects. In a March 1998 report, the Association of American Medical 
College (AAMC) stated that ``The government should reestablish and fund 
an NIH construction authority, consistent with the general 
recommendations of the Wyngaarden Committee report of 1988, which 
projected at that time the need for a 10-year spending plan of $5 
billion for new facilities and renovation.'' In June 1998, the 
Federation of American Societies of Experimental Biology (FASEB) 
reported that ``Laboratories must be built and equipped for the science 
of the 21st Century. Infrastructure investments should include 
renovation of existing space as well as new construction, where 
appropriate.'' We have reached a period where the useful life of our 
research facilities fail to meet the needs of modern technology and in 
many instances do not meet regulatory standards.
    While the research community commends the Subcommittee for 
providing $75 million for extramural facility construction last year, 
there is a clear and documented need for several billion dollars to 
rectify this situation. For this reason, we urge the Subcommittee to 
provide a funding level of $250 million for extramural construction in 
fiscal year 2002. The funds would be awarded on a peer-reviewed, 
competitive basis--requiring institutional matching funds to leverage 
NIH resources.

         INCREASING COSTS OF COMPLYING WITH FEDERAL REGULATIONS
    Another issue of significant concern to academic medical centers is 
the increased costs to research institutions for complying with 
research-related federal regulations. While extramural researchers have 
always been subjected to certain federal regulations, the increasing 
number of administrative requirements imposed on institutions has 
resulted in escalating costs. In recent years, institutions have been 
required to take additional measures to comply with more frequent 
institutional review boards, privacy regulations, human subject and 
animal protections--to name just a few. Let me reiterate that 
researchers are not opposed to providing these safeguards and do not 
question the necessity of these measures. We are, however, concerned 
about the costs of complying with these mandates, many of which are 
constantly changing. Last year the nonprofit RAND institute published a 
report titled ``Paying for University Research Facilities and 
Administration.'' The report notes that compliance costs affect both 
facilities and administrative components, and further states 
``increasingly sophisticated regulations have required new specialized 
personnel.'' The RAND report further provided the following impact on 
an unnamed institution:

    ``. . . compliance with facilities requirements necessitates so 
many improvement projects for existing facilities that is infeasible to 
undertake them all at once. This university has committed $1.2 million 
per year, indefinitely, for facilities improvements to enhance 
compliance with hazardous waste, occupational safety, animal care, and 
other facilities regulations . . . This is only a partial estimate of 
the costs of compliance. This estimate does not include the costs of 
compliance associated with major building renewal of new construction 
projects that the university undertakes. Neither does it include the 
costs of administrative oversight each year to track compliance, train 
people, and make reports''.

    FASEB, in its recommendations for federal funding for biomedical 
and related life sciences funding for fiscal year 2002, specifically 
advocates ``that NIH, other federal agencies and the biomedical 
research community address growing administrative costs associated with 
increased regulation, such as for human subjects protection and animal 
care. These costs should be fully funded by the sponsoring agency.''
    Researchers at academic medical centers join reiterate the concern 
raised by our colleagues in FASEB that federal agencies sponsoring 
biomedical and behavioral research should provide adequate funds for 
institutions to comply with the necessary regulations associated with 
conducting federal research. In my own institution, we have had to add 
more than five new staff to meet recently enacted regulations. Our 
interaction with federal agencies responsible for these has increased 
several-fold.
         technological infrastructure to address medical errors
    Lastly, I would like to commend the Subcommittee for providing $50 
million in last year's Labor/HHS Appropriations bill through the Agency 
for Healthcare Research and Quality to determine ways to reduce medical 
errors. This funding was provided consistent with S. 2038, the medical 
Error Reduction Act of 2000, which was introduced by Senators Arlen 
Specter, Tom Harkin and Daniel Inouye. This legislation sought to 
establish a competitive demonstration program for health care 
facilities and organizations to test best practices for reducing 
errors. As institutions with large clinical programs, we are, of 
course, interested in reducing the incidents of medical errors within 
our institutions. We seek additional funding for this program to 
provide our institutions with adequate resources to utilize or upgrade 
technological infrastructure to reduce the incidence of medical errors.

                           CONCLUDING REMARKS
    Mr. Chairman, polls conducted by Research!America--including polls 
in my State of Ohio--reflect the fact that the American public strongly 
supports our federal investments in biomedical and behavioral research. 
We believe that NIH's extramural research enterprise would 
significantly benefit if institutions were provided with additional 
resources, including $250 million to upgrade extramural laboratory 
space and instrumentation, and additional funding to address the 
increased administrative costs associated with regulatory compliance. 
In addition, we support additional funding through the Agency for 
Healthcare Research and Quality for technological infrastructure so 
that our institutions can reduce medical errors.
    Each of these steps will increase the productivity and efficiency 
of the academic/government partnership in biomedical and behavioral 
research and research training. On behalf of academic health centers 
across the nation, I thank you for your attention to these needs and 
recommendations. Best wishes to each of you.
                                 ______
                                 

    Prepared Statement of the American Academy of Family Physicians

    The 93,000 member American Academy of Family Physicians is pleased 
to submit this statement for the record on three issues of critical 
importance to family physicians in the United States: (1) funding for 
family medicine training in Section 747 of the Public Health Service 
Act; (2) funding for the Agency for Healthcare Research and Quality 
(AHRQ); and (3) funding for rural health programs. The Academy is the 
professional organization representing practicing family physicians, 
residents and medical students.

                   FAMILY MEDICINE TRAINING PROGRAMS
Recommendation
    The American Academy of Family Physicians supports appropriations 
of $158 million for Section 747 of Title VII of the Public Health 
Service Act for fiscal year 2002. Section 747 authorizes the Primary 
Care and Dentistry cluster, which includes support for family medicine, 
general internal medicine and general pediatrics, physician assistants 
and general and pediatric dentistry. This figure includes $96 million 
for family medicine programs. In fiscal year 2001, Section 747 received 
$91 million, a 17 percent increase over last year's funding level of 
$78.3 million.
    Section 747 is the only program at the federal level that supports 
four family medicine training programs at both the undergraduate and 
graduate level: residency training; academic departments; predoctoral 
programs and faculty development. Section 747 is crucial to training 
the physicians that America needs most; it is the engine that powers 
the growth of this nation's supply of family physicians.
Title VII Grants to Medical Schools Induces Physicians to go into 
        Primary Care
    A recent, unpublished study by the Robert Graham Policy Center for 
Policy Studies showed that the receipt of Section 747 family medicine 
funds by a medical school made a significant difference on whether 
medical students ultimately (1) practiced in family medicine or primary 
care (defined as family physicians, general practitioners, general 
internists or general pediatricians), (2) practiced in a rural area, or 
(3) practiced in a whole county primary care health professions 
shortage area.
  --All three types of grants (departments of family medicine, 
        predoctoral medical education programs, and faculty development 
        programs) made a difference in producing more family 
        physicians, and more primary care doctors.
  --Predoctoral and department development grants made a difference in 
        producing more primary care doctors serving in rural areas, and 
        more primary care doctors serving in primary care health 
        professional shortage areas.
  --Sustained funding during the years of medical school training had 
        more positive impact than intermittent funding.
    Due to Section 747 funding, thousands of physicians are making 
career choices to go into primary care and family medicine and to serve 
millions of patients. Without Section 747 funding, fewer students would 
be making these career choices.
The United States Relies on Family Physicians Unlike any other 
        Physicians
    Another recent study by the Robert Graham Center showed that the 
United States relies on family physicians more than any other physician 
specialty. Specifically, the study looked at counties designated as 
Primary Care Health Professions Shortage Areas, those counties that 
have inadequate numbers of family physicians, general pediatricians, 
general internists or obstetrician/gynecologists. Currently, there are 
3,082 counties in the United States; 784 qualify as Primary Care HPSAs. 
The study found that:
  --If family physicians were to be withdrawn from all 3,082 counties, 
        an additional 1,332 counties would become Primary Care HPSAs.
  --In contrast, if all internists, pediatricians and obstetrician-
        gynecologists were to be taken out of the nation's counties, 
        only another 176 would become shortage areas.
    Without family physicians, counties around the United States would 
not receive essential primary care services.
Turning Around the Shortage of Family Physicians
    There is a shortage of family physicians and other primary care 
physicians (general internists and general pediatricians) in the United 
States. Numerous experts, including the Physician Payment Review 
Commission; the Council on Graduate Medical Education; the Robert Wood 
Johnson Foundation; the Pew Health Professions Commission; the American 
Medical Association and the Association of American Medical Colleges 
have called for increasing the supply of primary care physicians for 
quality, access and cost reasons. Most experts believe a physician 
workforce with a 50/50 ratio between primary care physicians and 
subspecialists would best meet America's health care needs; the ratio 
is currently approximately 30/70.
    Section 747 family medicine grants have helped establish an 
infrastructure throughout the country that has reversed the downward 
trend in primary care. While at one time, the United States physician 
workforce was comprised of more than 50 percent primary care 
physicians, it declined after World War II to approximately 30 percent 
today. The Section 747 family medicine training programs provided funds 
to establish family medicine departments in medical schools; to 
increase the number of faculty to both teach and act as role models, 
and to set up new residencies throughout the country.
Market Demand for More Family Physicians
    The demand for family physicians in the market is greater than our 
nation's current training capacity. Medicare payment policies have 
contributed to the increase in subspecialist physicians and have 
fundamentally skewed the market. These policies have promoted training 
in the expensive inpatient specialties--rather than in family medicine 
and other primary care fields. Moreover, NIH grants, totaling billions 
of dollars, go primarily to subspecialist research in the nation's 
medical education complexes.
Primary Care Doctors are Cost Effective
    Numerous studies show that primary care physicians are more cost-
effective due to their prudent use of hospital services, tests and 
procedures. A September, 1995, study conducted by KPMG Peat Marwick, 
The Role of Primary Care Physicians in Controlling Health Care Costs: 
Evidence and Effects, indicated that Medicare spending could be cut by 
at least $48.9 billion and as much as $271.5 billion over the next six 
years if primary care physicians were 50 percent of the total physician 
workforce.
Community Training Requires Support
    In contrast to other specialties, 80 percent of family practice 
residencies are located in community settings rather than in major 
tertiary care teaching hospitals. These residencies provide more 
ambulatory training than any other residencies. As a result, family 
practice programs do not have access to the considerable resources that 
flow to teaching hospitals. Further, 25 percent of family practice 
residencies are located in public hospitals. These hospitals receive a 
low reimbursement for patient care services, and treat fewer Medicare 
patients. As a result, they do not receive substantial Medicare 
graduate medical education dollars.
Acute Shortage of Faculty
    There is an acute shortage of faculty for family medicine residency 
programs and family medicine departments. The discipline has been 
successful at placing its graduates in practice settings serving 
communities of need rather than in full-time faculty positions. Without 
adequate funding, there is a risk that even the progress that has been 
made so far will be compromised for lack of faculty.
Title VII and Graduate Medical Education
    Title VII health professions programs are separate and distinct 
from graduate medical education (GME). Title VII is a Public Health 
Service program and funding goes to medical schools, universities and 
residency programs to develop a primary care infrastructure. Graduate 
medical education is part of the Medicare program and funds go 
primarily to hospitals to support residency training.
    The Academy has had a long-standing interest in graduate medical 
education because of our commitment to a rational physician workforce 
policy that both discourages an oversupply of physicians and encourages 
increased training of those physician specialties in short supply. Our 
organization has produced and updated a number of policies on physician 
workforce issues, as well as specific GME recommendations. However, 
without a major overhaul of the physician workforce in the United 
States that would address the primary care issues targeted by Title VII 
funding, it is imperative to support these programs.
Innovative Programs
    Title VII funds are used to support innovative new programs that 
help training and teaching programs simply get better, a goal that 
often involves new technologies. Innovative programs can include web-
based technologies to evaluate training programs, or even establish 
links to primary care research networks. Grant recipients are using 
Title VII dollars to leverage dollars not only to meet the traditional 
goals of diversity, outreach to the underserved and rural populations, 
but also to new programs that use key technologies.
Additional Outcomes Data
    There have been several articles that have specifically described 
the value of Title VII family medicine programs.
  --An October, 1994 General Accounting Office (GAO) report indicated 
        that ``students who attended medical schools with family 
        medicine departments were 57 percent more likely to pursue all 
        three primary care disciplines (italics added).'' In addition, 
        the 1994 GAO report indicated that ``students who attended 
        schools requiring a third-year family practice clerkship were 
        18 percent more likely to pursue primary care.''
  --A November/December, 1997, article in the Archives of Family 
        Medicine found a strong relationship between continued Title 
        VII funding and the presence of family medicine departments, 
        which is associated with greater rates of primary care 
        production. (The Impact of Title VII Departmental and 
        Predoctoral Support on the Production of Generalist Physicians 
        in Private Medical Schools, Robert M. Politzer, ScD, et. al.)
  --Family physicians have deep roots in rural communities, where 25 
        percent of all Americans live. About one-quarter of family 
        physicians locate there, as well. The February, 1998, Tenth 
        Report of the Council on Graduate Medical Education (COGME) 
        stated that, ``Programs authorized under Title VII of the 
        Public Health Service Act support family medicine programs with 
        a successful record of training physicians who choose to 
        practice in rural and underserved areas. These efforts should 
        be continued and increased.''
    The goals stipulated by Congress in the Title VII reauthorization 
bill emphasize both the delivery of health services to underserved 
populations and the geographic distribution of health professionals to 
underserved, particularly rural, areas. These congressionally mandated 
goals are fully addressed by the Title VII programs, and for family 
medicine, all four program areas have been extremely successful.
    In addition, another Congressional priority is to enhance the 
diversity of our medical workforce. In 1978, the first year for which 
we have data, the number of minority residents in training in family 
practice residency programs was 9.5 percent. By 1997, that rate had 
increased to 24 percent.
    Finally, over 90 percent of physicians who complete family practice 
residency programs work in direct primary patient care and are able to 
handle a high percentage of their patient's problems.

               AGENCY FOR HEALTHCARE RESEARCH AND QUALITY
Recommendation
    The American Academy of Family Physicians recommends appropriations 
of $400 million for the Agency for Healthcare Research and Quality 
(ARHQ) in fiscal year 2002. We strongly support the Agency because of 
its emphasis on primary care and practice-oriented research. It is the 
only federal agency with this charge. In fiscal year 2001, the Agency 
for Healthcare Research and Quality (AHRQ), received $269.9 million, a 
36 percent increase above the current funding level of $198.76 million.
What is Primary Care Research?
    Primary care research includes (1) research on the conditions that 
affect the majority of the population, and (2) translating biomedical 
research into practice.
    Additional research is needed on conditions that affect most 
Americans. Most medical care is provided in outpatient settings. 
However, ambulatory medicine is the least researched mode of patient 
care. While over 95 percent of all medical conditions have been 
evaluated and treated outside of hospitals over the last 30 years, 
physicians are educated and trained using research that has been 
derived mainly from hospitalized patients, or patients with rare 
conditions. Primary care physicians who diagnose and treat patients 
before they need hospital care operate without the level of research 
available to their subspecialist colleagues.
    It is not enough to develop new treatments; they must also be 
implemented and result in better patient outcomes. American medicine is 
praised worldwide for its excellence in biomedical research. However, 
while we have invested heavily in new technologies, drugs and 
procedures, they are seen increasingly as costly advances for 
potentially modest gains. Greater gains may be possible if we can 
invest more heavily in finding ways to bring state-of-the art medicine 
to community medical practices.
Primary Care Research Agenda
    A primary care research agenda should include at least six basic 
categories for study. (The agenda is further described in the AHRQ 
report, Putting Research into Practice: Report of the Task Force on 
Building Capacity in Primary Care, 1993.) Included in this agenda 
should be research on:
  --the origin of disease and the loss of health;
  --improvements in diagnostic accuracy;
  --appropriate treatments;
  --improvements in the physician-patient relationship;
  --improvements in health care delivery;
  --improvements in patient satisfaction.
Examples of Primary Care Research Needs
    Primary care research is needed to provide information to 
physicians on the most effective treatment plans for patients with 
numerous, serious conditions. An example of this situation is a single 
patient with diabetes, hypertension, depression, low back pain and 
heart disease. Traditional, disease-specific treatment is not useful in 
this situation; treatment for one disease may exacerbate the other 
conditions.
    Research is also needed on differentiating the common headache that 
affects 20 million Americans from one with serious implications. While 
headaches afflict millions of individuals, the primary care physician 
has little information on how to identify the few who suffer from life-
threatening illness.
IOM Recommendation on Funding Needed for Primary Care Research
    According to the 1996 Institute of Medicine (IOM) report on primary 
care, Primary Care: America's Health in a New Era, federal investments 
in primary care research today total between $15 and $20 million 
annually. The IOM report recommended an immediate fourfold increase in 
primary care research.

                         RURAL HEALTH PROGRAMS
    Finally, the Academy supports continued funding for several rural 
health programs. In particular, we support the programs of the Federal 
Office of Rural Health Policy; Area Health Education Centers, two 
programs that are equally important to health care in rural areas and 
in our inner cities; the Community and Migrant Health Center Program 
and the National Health Services Corps. State rural health offices, 
funded through the National Health Services Corps budget, help States 
implement such programs so that they benefit rural residents as much as 
urban dwellers. Continued funding for these rural programs is vital if 
we wish to provide adequate health care services to America's rural 
citizens.

                               CONCLUSION
    Thank you for your consideration of these important requests.
                                 ______
                                 

   Prepared Statement of the American Academy of Physician Assistants

    On behalf of the 41,000 clinically practicing physician assistants 
in the United States, the American Academy of Physician Assistants is 
pleased to submit comments on fiscal year 2002 appropriations for 
Physician Assistant (PA) education programs that are authorized through 
Title VII of the Public Health Service Act.
    A member of the Coalition for Health Funding (CHF), the American 
Academy of Physician Assistants supports the CHF recommendation to 
appropriate $44.285 billion for the Public Health Service in fiscal 
year 2002. The Academy is also a member of the Health Professions and 
Nursing Coalition (HPNEC) and supports the HPNEC recommendation to 
provide at least $440 million to support the Titles VII and VIII 
programs in fiscal year 2002. The Academy believes that the recommended 
increase in funding for the Title VII health professions programs is 
well justified. The programs are essential to the development and 
training of primary health care professionals and contribute to the 
nation's overall efforts to increase access to care by promoting health 
care delivery in medically underserved communities.
    The Academy is very concerned with the Administration's proposal to 
reduce fiscal year 2002 funding for the Titles VII and VIII programs. 
As Members of the Subcommittee are aware, these programs are designed 
to help meet the health care delivery needs of the nation's Health 
Professional Shortage Areas (HPSAs). By definition, the nation's 2,800 
HPSAs experience shortages in the primary care workforce that the 
market alone can't address. We wish to thank the Members of this 
Subcommittee for your historical role in supporting funding for the 
health professions programs, and we hope that we can count on your 
support for these important programs in fiscal year 2002.

             OVERVIEW OF PHYSICIAN ASSISTANT (PA) EDUCATION
    PA programs provide students with a primary care education that 
prepares them to practice medicine with physician supervision. 
Physician assistant programs are located at schools of medicine or 
health sciences, universities, teaching hospitals, and the Armed 
Services. All PA educational programs are intensive education programs 
that are accredited by the Accreditation Review Commission on Education 
for the Physician Assistant.
    The typical PA program consists of 111 weeks of instruction. The 
first phase of the program consists of intensive classroom and 
laboratory study, providing students with an in-depth understanding of 
the medical sciences. More than 400 hours in classroom and laboratory 
instruction are devoted to the basic sciences, with over 70 hours in 
pharmacology, more than 149 hours in behavioral sciences, and more than 
535 hours of clinical medicine.
    The second year of PA education consists of clinical rotations. On 
average, students devote more than 2,000 hours or 50-55 weeks to 
clinical education, divided between primary care medicine and various 
specialties, including family medicine, internal medicine, pediatrics, 
obstetrics and gynecology, surgery and surgical specialties, internal 
medicine subspecialties, emergency medicine, and psychiatry. During 
clinical rotations, PA students work directly under the supervision of 
physician preceptors, participating in the full range of patient care 
activities, including patient assessment and diagnosis, development of 
treatment plans, patient education, and counseling.
    Physician assistant education is competency based. After graduation 
from an accredited PA program, the physician assistant must pass a 
national certifying examination jointly developed by the National Board 
of Medical Examiners and the independent National Commission on 
Certification of Physician Assistants. To maintain certification, PAs 
must log 100 continuing medical education credits over a 2-year cycle 
and reregister every two years. Also to maintain certification, PAs 
must take a recertification exam every six years.

                      PHYSICIAN ASSISTANT PRACTICE
    Physician assistants are licensed health care professionals 
educated to practice medicine as delegated by and with the supervision 
of a physician. In all states, physicians may delegate to PAs those 
medical duties that are within the physician's scope of practice and 
the PA's training and experience, and are allowed by law. Forty-seven 
States, the District of Columbia, and Guam authorize physicians to 
delegate prescriptive privileges to the PAs they supervise.
    PAs are located in almost all health care settings and in every 
medical and surgical specialty. Fourteen percent of all PAs practice in 
rural areas where they may be the only full-time providers of care 
(state laws stipulate the conditions for remote supervision by a 
physician). Approximately twenty percent of PAs work in urban and inner 
city areas. The majority of PAs are in primary care. Nearly one-quarter 
practice in surgical specialties. Seventy percent of PAs practice in 
outpatient settings. In 2000, an estimated 161 million patient visits 
were made to PAs and approximately 202 million medications were 
prescribed or recommended by PAs.
  critical role of the title vii, public health service act, programs
    A growing number of Americans lack access to primary care, either 
because they are uninsured, underinsured, or they live in a community 
with an inadequate supply or distribution of providers. The growth in 
the uninsured U.S. population increased from approximately 32 million 
in the early 1990s to over 42 million today. Simultaneously, the number 
of medically underserved communities continues to rise, from 1,949 in 
1986 to 2,800 today.
    The role of the Title VII programs is to alleviate these problems 
by supporting access to quality, affordable, and cost-effective care in 
areas of our country that are most in need of health care services, 
specifically rural and urban underserved communities. This is 
accomplished through the support of educational programs that train 
more health professionals in fields experiencing shortages, improve the 
geographic distribution of health professionals, and increase access to 
care in underserved communities.
    The Title VII programs are the only federal education programs that 
are designed to address the supply and distribution imbalances in the 
health professions. Since the establishment of Medicare, the costs of 
physician residencies, nurses and some allied health professions 
training has been paid through Graduate Medical Education (GME) 
funding. However, GME has never been available to support PA education. 
More importantly, GME was not intended to generate a supply of 
providers who are willing to work in the nation's medically underserved 
communities. That is the purpose of the Title VII Public Health Service 
Act Programs, which support such initiatives as loans and scholarships 
for disadvantaged students, scholarships for students with exceptional 
financial need, centers of excellence to recruit and train minority and 
disadvantaged students, and interdisciplinary initiatives in geriatric 
care and rural health care.

               TITLE VII SUPPORT OF PA EDUCATION PROGRAMS
    Targeted federal support for PA education programs is currently 
authorized through section 747 of the Public Health Service Act. The 
program was reauthorized in the 105th Congress through the Health 
Professions Education Partnerships Act of 1998, Public Law 105-392, 
which streamlined and consolidated the federal health professions 
education programs. Support for PA education is now considered within 
the broader context of training in primary care medicine and dentistry.
    Public Law 105-392 reauthorized awards and grants to schools of 
medicine and osteopathic medicine, as well as colleges and 
universities, to plan, develop, and operate accredited programs for the 
education of physician assistants and faculty, with priority given to 
training individuals from disadvantaged communities. The funds ensure 
that PA students from all backgrounds have continued access to an 
affordable education and encourage PAs, upon graduation, to practice in 
underserved communities. These goals are accomplished by funding PA 
education programs that have a demonstrated track record of: (1) 
placing PA students in health professional shortage areas; (2) exposing 
PA students to medically underserved communities during the clinical 
rotation portion of their training; and (3) recruiting and retaining 
students who are indigenous to communities with unmet health care 
needs.
    The program works. A review of PA graduates from 1991-1999 reveals 
that 16.5 percent of students graduating from PA programs supported by 
Title VII are from underrepresented minorities, compared to 7.7 percent 
of graduates from programs that did not receive Title VII support. 
Similarly, 13.5 percent of the graduates who attended PA programs 
receiving Title VII support during the 8-year period practice in 
underserved communities, compared to 10.1 percent of graduates of 
programs not receiving such support during the same period.
    The PA programs' success in recruiting and retaining 
underrepresented minority and disadvantaged students is linked to their 
ability to creatively use Title VII funds to enhance existing 
educational programs. For example, a PA educational program in Iowa 
uses Title VII funds to target recruitment efforts to disadvantaged 
students, providing shadowing and mentoring opportunities for 
prospective students, increasing training in cultural competency, and 
identifying new family medicine preceptors in underserved areas. PA 
programs in Texas use Title VII funds to create new clinical rotation 
sites in rural and undersered areas, including new sites in border 
communities, and to establish non-clinical rural rotations to help 
students understand the challenges faced by rural communities. A PA 
program in Kansas has used Title VII funds to provide a significant 
portion of the training for 500 PA students in remote, medically 
underserved communities in the state. Several other PA programs have 
been able to use Title VII grants to leverage additional resources to 
assist students with the added costs of housing and travel that occur 
during relocation to rural areas for clinical training.
    Without Title VII funding, many of these special PA training 
initiatives would not be possible. Institutional budgets and student 
tuition fees simply do not provide sufficient funding to meet the 
special, unmet needs of medically underserved areas or disadvantaged 
students. Nevertheless, the need is very real, and Title VII is 
critical in meeting it.
     need for increased title vii support for pa education programs
    Increased Title VII support for educating PAs to practice in 
underserved communities is particularly important given the market 
demand for physician assistants. Without the Title VII funding to 
expose students to underserved sites during their training, PA students 
are far more likely to practice in the communities where they were 
raised or the communities in which they attended school. Title VII 
funding is a critical link in addressing the natural geographic 
maldistribution of health care providers by exposing students to 
underserved sites during their training, where they frequently choose 
to practice following graduation.
    The supply of physician assistants is inadequate to meet the needs 
of society, and the demand for PAs is expected to increase. A 1994 
report of a workgroup of the Council on Graduate Medical Education 
(COGME), ``Physician Assistants in the Health Workforce,'' estimated 
that the anticipated medical market demand and the estimated workforce 
requirements for PAs would exceed demand. Additionally, the Bureau of 
Labor Statistics projects that the number of available PA jobs will 
increase 48 percent between 1998 and 2008.
    Despite the increased demand for PAs, funding has not 
proportionately increased for the Title VII programs that are designed 
to educate and place physician assistants in underserved communities. 
Nor has the Title VII support for PA education kept pace with increases 
in the cost of educating PAs. A review of PA program budgets from 1984 
through 1999 indicates an average annual increase of 7.2 percent, a 
total increase of 173 percent over the past sixteen years; yet, federal 
support has remained relatively static. The fiscal year 2001 increase 
in appropriations for Title VII's Cluster on Training in Primary Care 
Medicine and Dentistry, which includes funding for PA education, 
represented the first real increase in funding in nearly a decade.

              RECOMMENDATIONS ON FISCAL YEAR 2002 FUNDING
    The American Academy of Physician Assistants urges members of the 
Appropriations Committee to consider the inter-dependency of all the 
public health agencies and programs when determining funding for fiscal 
year 2002. For instance, while it is important to fund clinical 
research at the National Institutes of Health (NIH) and to have an 
infrastructure at the Centers for Disease Control (CDC) that ensures a 
prompt response to an infectious disease outbreak, the good work of 
both of these agencies will go unrealized if the Health Resources and 
Services Administration (HRSA) is inadequately funded. HRSA administers 
the ``people'' programs, such as Title VII, that bring the cutting edge 
research discovered at NIH to the patients--through providers such as 
PAs who have been educated in Title VII-funded programs. Likewise, CDC 
is heavily dependent upon an adequate supply of health care providers 
to be sure that disease outbreaks are reported, tracked, and contained.
    The critically important programs administered by NIH, HRSA, and 
CDC are integral components within the nation's public health 
continuum. One component is not more important than another, and no one 
component can succeed without adequate support from each of the other 
elements. The Academy is particularly concerned that any increase for 
the NIH not be made at the expense of the health professions education 
program or other public health programs, as recommended this year by 
the Senate Budget Committee.
    The American Academy of Physician Assistants is particularly 
appreciative of the increase in funding for PA education programs that 
was appropriated for fiscal year 2001. Yet, the increase is not 
sufficient to meet the increasing demand for PA graduates in the 
growing number of medically underserved communities. Accordingly, the 
Academy respectfully requests that the Title VII health professions 
programs receive a 15 percent funding increase in fiscal year 2002, 
including $10 million to support PA educational programs.
    Thank you for the opportunity to present the American Academy of 
Physician Assistants' views on fiscal year 2002 appropriations.
                                 ______
                                 

Prepared Statement of the American Association for Geriatric Psychiatry

    The American Association for Geriatric Psychiatry (AAGP) 
appreciates this opportunity to present its recommendations on issues 
related to fiscal year 2002 appropriations for mental health research 
and services. AAGP is a professional membership organization dedicated 
to promoting the mental health and well being of older Americans and 
improving the care of those with late-life mental disorders. AAGP's 
membership consists of over 2000 geriatric psychiatrists as well as 
other health professionals who focus on the mental health problems 
faced by senior citizens.
    AAGP would like to thank the Subcommittee for its continued strong 
support for increased funding for the National Institutes of Health 
(NIH) over the last several years, particularly the additional funding 
you have provided for the National Institute of Mental Health (NIMH) 
and the National Institute on Aging (NIA). Although we generally agree 
with others in the mental health community about the importance of 
sustained and adequate Federal funding for mental health research and 
treatment, AAGP brings a somewhat unique perspective to these issues 
because of the aged patient population served by our members.
    There are serious concerns, shared by AAGP and researchers, 
clinicians, and consumers that there exists a critical disparity 
between appropriations for research, training, and health services and 
the projected mental health needs of older Americans. This disparity is 
evident in the convergence of several key factors:
  --demographic projections inform us that, with the aging of the U.S. 
        population, there will be an unprecedented increase in burden 
        of mental illness among aging persons, especially among the 
        baby boom generation;
  --this growth in the proportion of older adults and the prevalence of 
        mental illness is expected to have a major direct and indirect 
        impact on general health service use and costs;
  --despite the fact that effective treatment exists, the mental health 
        needs of many older adults remain unmet;
  --a major gap exists between research and service delivery; and
  --despite recent significant increases in appropriations for support 
        of research in mental health, the allocation of NIMH and the 
        Center for Mental Health Services (CMHS) funds for research 
        that focuses on mental health and aging is disproportionately 
        low, and woefully inadequate to deal with the impending crisis 
        of mental health in older Americans.

   DEMOGRAPHIC PROJECTIONS AND THE DISPARITY IN RESEARCH FUNDING FOR 
                       MENTAL DISORDERS OF AGING
    As shown in Figure 1 (attached), the increase in the number of 
people over 65 years of age, combined with the increasing prevalence of 
psychiatric problems in that segment of the U.S. population, will 
dramatically increase the proportion of older adults with mental health 
disorders relative to younger adults. Furthermore, older adults account 
for health care costs that are disproportionately greater than their 
numbers. This figure also illustrates that the projected proportion of 
NIMH funding for aging research (based on current funding trends) is 
drastically below what will be needed to address the projected increase 
in mental health problems among older persons over the coming decades.


    With the ``baby boom'' generation nearing retirement, the number of 
older Americans experiencing mental problems is certain to increase in 
the future. By the year 2010, there will be approximately 40 million 
people in the United States over the age of 65. Over 20 percent of 
those people will experience mental disorders. A national crisis in 
geriatric mental health care is emerging and has received recent 
attention in the medical literature. Action must be taken now to avert 
serious problems in the near future. While many forms of mental and 
behavioral disorders can occur late in life, they are not an inevitable 
part of the aging process, and continued research holds the promise of 
improving the mental health and quality of life for older Americans.
    Current and projected economic costs of mental disorders alone are 
staggering. For example, the direct medical costs of caring for 
patients with Alzheimer's disease (many of whom are treated by 
geriatric psychiatrists) ranges from $18,000 to $36,000 a year per 
patient, depending on the severity of the disease. In addition, there 
are other expenses associated with caring for an Alzheimer's disease 
patient including social support, care giving, and often nursing home 
care. It is estimated that total costs associated with caring for 
patients with Alzheimer's disease is over $100 billion per year. 
Psychiatric symptoms (including depression, agitation, and psychotic 
symptoms affect 30 to 40 percent of people with Alzheimer's and are 
associated with increased hospitalization, nursing home placement, 
family burden, and over 20 percent greater costs over and above 
Alzheimer's alone. Although NIA has supported extensive research on the 
cause and treatment of Alzheimer's, treatment of these behavioral and 
psychiatric symptoms has been neglected and should be supported through 
NIMH.
    Depression is another example of a common problem among older 
persons. Of the approximately 32 million Americans who have attained 
age 65, about five million suffer from depression, resulting in 
increased disability, general health care service use and costs, and 
increased risk of suicide. Approximately 30 percent of older persons in 
primary care settings have significant symptoms of depression; and 
depression is associated with greater health care costs, poorer health 
outcomes, and increased mortality. Older adults have the highest rate 
of suicide rate compared to any other age group.
    The enormous and widely underestimated costs of late life mental 
illnesses justifies major new investments. The personal and societal 
costs of mental illness and addictive disorders are high, but advances 
in research and treatment will help save lives, strengthen families, 
and save taxpayer dollars. While the funding increases supported by 
this Subcommittee in recent years have been essential first steps to a 
better future, a serious and sustained investment in research is 
necessary to allow continuous progress on the many research advances we 
made to date. Toward that end, we support the professional judgment of 
the mental health research advocacy community that a 16.5 percent 
across-the-board increase in fiscal year 2002 funding for NIH is 
warranted.
    Commendable as recent funding increases for NIH and NIMH have been, 
AAGP would like to call the Subcommittee's attention to the fact that 
these increases have not always translated into comparable increases in 
funding for extramural research on mental health of the elderly. Data 
supplied to AAGP by NIMH indicates that while extramural research 
grants by NIMH increased 59 percent during the 5-year period from 
fiscal year 1995 through fiscal year 2000 (from $485,140,000 in fiscal 
year 1995 to $771,765,000 in fiscal year 2000), NIMH grants for aging 
research increased at less than half that rate: only 27.2 percent 
during the same period (from $46,989,000 to $59,771,000).
    Figure 2 (attached) shows that funding for aging mental health 
research is not keeping pace with that of other adult mental health 
research, and is actually decreasing proportionally when considered in 
the context of anticipated projections in growth of mental disorders in 
older persons. For example, the proportion of total NIMH newly funded 
extramural research grant funding devoted to aging research declined 
from an average of eight percent from fiscal years 1995 to 1999 to a 
low of six percent in fiscal year 2000. It is likely that one reason 
for the decline in funding of new grants is due to the lack of grant 
review committees at NIMH with specific expertise in aging. Grant 
review committees with specialized expertise in geriatrics are needed 
to assure fair review of research proposals that take into account 
knowledge of the unique biological factors associated with the aging 
brain, the universal presence of co-occurring medical disorders, and 
different nature of financing and health service delivery for older 
Americans.


               THE BENEFITS OF RESEARCH ON PUBLIC HEALTH
    The U.S. Surgeon General's Report on Mental Health (1999) and the 
Administration on Aging Report on Older Adults and Mental Health (2001) 
underscore the prevalence of mental disorders in older persons and 
provide evidence that research supports the development of effective 
treatments. These publications by the Federal Government recognize the 
increasing importance of late life mental illness on our society. In 
addition, these reports summarize research findings showing that 
treatments are being developed and tested that are effective in 
relieving symptoms, improving functioning, enhancing quality of life, 
including preliminary findings suggesting that these interventions 
reduce the need for expensive and intensive acute and long-term 
services. However, it is also well demonstrated that there is a 
pronounced gap between research findings on the most effective 
treatment interventions and implementation by health care providers. 
These reports stress the need for translational and health services 
research focusing on identifying the most cost-effective interventions, 
as well as creating effective methods for improving the quality of 
health care practice in usual care settings. A major priority 
(neglected to date) is the development of a research agenda focusing on 
health services research on mental health and aging that examines the 
effectiveness and costs of effective models of mental health service 
delivery for older persons.
    Special attention also needs to be paid to investigations of 
inadequate, or poorly studied, serious late-life mental disorders since 
illnesses such as schizophrenia, anxiety disorders, alcohol dependence 
and personality disorders have been largely ignored by both the 
research community and the funding agencies despite the fact that these 
conditions take a major toll on patients, their care givers, and 
society at large. Many of AAGP's members are at the forefront of 
groundbreaking research on Alzheimer's disease, depression, and 
psychosis among the elderly, and we strongly believe that more research 
funds must be focused in these areas. Improving the treatment of late-
life mental health problems will benefit not only the elderly, but also 
their children, whose lives are often profoundly affected by those of 
their parents.
    Perhaps one of the greatest costs of late-life mental illness is 
the physical and emotional toll on family members, caregivers, and 
friends. AAGP would like to express its appreciation to Congress for a 
new program established and funded for the first time this year: the 
Family Care Givers Program of the Older Americans Act. This new program 
provides funding to the States so that they may assist family care 
givers in obtaining the best, most appropriate care for their loved 
ones, as well as offering care givers limited, but badly needed respite 
from their care-giving responsibilities. First year funding of 
$125,000,000 was authorized and appropriated for fiscal year 2001. AAGP 
expects the need for these services to grow rapidly in the future and 
urges the members of the Subcommittee to be responsive to this need as 
it develops. In addition to caregiver programs and support services, 
research is needed to fill in the gaps in our understanding of the 
psychiatric responses of caregivers to the chronic stresses of taking 
care of older adults with mental illnesses.
    In addition to supporting research activities at the NIMH, AAGP 
supports increased funding for the other institutes at the NIH that 
have some jurisdiction over geriatric mental health, including the NIA 
and the National Institute of Neurological Disorders and Stroke.
    It is also critical that there be adequate funding increases for 
the mental health initiatives under the jurisdiction of the CMHS within 
the Substance Abuse and Mental Health Services Administration (SAMHSA). 
While research is of critical importance to a better future, the 
patients of today must also receive appropriate treatment for their 
mental health problems. SAMHSA provides funding to State and local 
mental health departments, which in turn provide community-based mental 
health services to Americans of all ages, without regard to the ability 
to pay. The Labor-HHS conference agreement for fiscal year 2001 
increased funding for SAMHSA by about 11.5 percent (from $2,651,342,000 
to $2,958,001). AAGP urges the Subcommittee to increase the funds 
available to SAMHSA for these purposes to keep pace with this demand.
    Furthermore, a top priority should be funding for the dissemination 
and implementation of evidence-based practices in ``real world'' usual 
care settings. Despite significant advances in research on the causes 
and treatment of mental disorders in older persons, there is a major 
gap between these research advances and clinical practice in usual care 
settings. The greatest challenge for the future of mental health care 
for older Americans is to bridge this gap between established research 
findings and clinical practice in the community. A specific geriatric 
mental health services initiative is needed to disseminate and 
implement evidence-based practices in routine clinical settings across 
the states.

                               CONCLUSION
    Based on AAGP's assessment of the current need and future 
challenges of late life mental disorders, we submit the following 
recommendations:
  --The current rate of funding for aging grants at NIMH and CMHS is 
        inadequate. Funding for NIMH and CMHS aging research grants 
        should be increased to be commensurate with current need 
        (approximately three times the current funding level). In 
        addition, the anticipated projected future increase in mental 
        disorders among our aging population in terms of dollar amount 
        of grants and absolute number of new grants should be built 
        into the budget process;
  --A fair grant review process will be enhanced by committees with 
        specific expertise and dedication to mental health and aging; 
        and
  --Infrastructure within NIMH and CMHS is needed that supports the 
        development of initiatives in aging research, monitors the 
        quality and number of applicants for aging research grants, and 
        management of those grants. Specifically, AAGP believes that 
        individuals should be designated in the Office of the Director 
        of NIMH and in the Office of the Director of CMHS to oversee 
        the aging research agendas and initiatives for these two 
        agencies.
    AAGP strongly believes that the present research infrastructure, 
health care financing, and healthcare personnel with appropriate 
geriatric training, and the mental health delivery systems are grossly 
inadequate to meet the challenges posed by the expected increase in the 
number of elderly with mental disorders. The economic impact of the 
aging baby boom generation on the Medicare and Social Security systems 
has already become a focus of national dialogue, but that there is 
another challenge that has not received attention. Because of reduced 
mortality in older adults with chronic medical disorders, we can expect 
an unprecedented explosion in the number of people over age 65 with 
potentially disabling chronic mental illnesses. Congress must continue 
to support funding for research that addresses the identification, 
diagnosis, and treatment of mental illnesses, as well as support 
programs that increase the quality of life for those with late life 
mental illness.
    The American Association for Geriatric Psychiatry looks forward to 
working with the members of this Subcommittee and others in Congress to 
establish aging research as a priority at NIMH and at CMHS.
                                 ______
                                 

    Prepared Statement of the American Association of Immunologists

    The American Association of Immunologists (AAI) is a professional 
association of six thousand research scientists and physicians 
dedicated to understanding the immune system, resulting in the 
prevention, treatment, and cure of disease. We appreciate this 
opportunity to submit written testimony for the Hearing Record 
regarding the fiscal year 2002 appropriations bill for the Departments 
of Labor, Health and Human Services, and Education. Our comments will 
be confined to issues involving the Department of Health and Human 
Services, and specifically, the National Institutes of Health (NIH).
 fiscal year 2002 appropriations for the national institutes of health
    AAI is grateful for this subcommittee's and the Congress's strong 
commitment to biomedical research through the ongoing effort to double 
the budget of the National Institutes of Health. In addition to the 
sheer purchasing power of the increased appropriations--allowing for 
the funding of more quality research grants, better lab equipment, and 
training for the next generation of scientists--this national 
commitment has energized researchers around the world who realize that 
many of the scientific achievements and discoveries of recent years--
including the sequencing of the human genome--are just the first 
essential steps toward unraveling the mysteries of the human body and 
the treatments that may prevent or even cure deadly diseases. We urge 
this subcommittee, therefore, to support rapidly unfolding biological 
discoveries by continuing the process of doubling the NIH budget with 
additional appropriations of $3.4 billion for fiscal year 2002, for a 
total budget of $23.7 billion.

                 IMMUNOLOGY AND ITS PROMISING RESEARCH
    While ``immunology'' may not be a discipline that Americans 
contemplate in their daily lives, AAI's members' life's work affects 
every person throughout the world every day. Immunologists study both 
the immune system that helps protect the body from harm and the 
maladies--from the common cold or flu to cancer and AIDS--which can 
invade it. Many of us work to discover the cause of a particular immune 
response--which can range from successfully destroying an invading 
virus or bacteria to fighting one's own body tissues (resulting in an 
``autoimmune'' response and possibly causing an autoimmune disease). 
Others work to find a way to prevent an undesirable immune response, 
i.e., an allergic response to a vaccine or drug treatment. And others 
of us work to find a treatment for a known immune response that leads 
to illness or disease (such as diabetes). So when you read the 
newspaper and see stories about scientists working to develop effective 
vaccines for HIV/AIDS and influenza; to discover new defenses against 
re-emerging infections such as tuberculosis and drug-resistant 
bacterial infections; to regulate autoimmune diseases such as diabetes 
and lupus; to develop treatments to prevent the rejection of 
transplanted organs and bone marrow; and to discover the causes of 
cancer and promising new treatments, you are reading about immunology 
and the budget of the National Institutes of Health.
    To give you an example of the type of research conducted by 
immunologists, let us cite a few examples of some exciting work now 
being done.
  --On March 9, 2001, the Washington Post reported on a new study by 
        immunologists that supports the prospect of an AIDS vaccine. 
        According to the article, ``[i]n a study offering new evidence 
        that AIDS can be controlled by vaccine, inoculated monkeys 
        stayed healthy despite exposure to high levels of virus. . . . 
        The new vaccine is being fast-tracked toward human testing.'' 
        The study was reported in the March 9 issue of the journal 
        Science.
  --Immunologists are studying responses of the fortunate few people 
        who are repeatedly exposed to HIV but don't get the virus, to 
        determine how their immune system appears to fend off active 
        infection of HIV-crucial information for the design of an 
        effective vaccine.
  --Immunologists are also working at understanding how the immune 
        system can recognize cells infected with viruses. Here mice, 
        genetically modified to have only a very simple immune system--
        but one which can recognize a lethal virus infection--are 
        critical to understanding how an immune response is initiated, 
        how the immune system remembers past infection, and therefore 
        how it will respond to future infection. These studies, 
        originally made for a virus infection in mice, have led to 
        clinical trials in cancer immunotherapy (see Time Magazine, 
        January 15, 2001).
  --Immunologists are studying the role of cytokines (hormone-like 
        substances made by cells that regulate immune and other 
        biological functions) in mice to discover their role in 
        protecting their hosts from intestinal parasites such as worms 
        and also to determine their deleterious role in asthma, 
        allergy, rheumatoid arthritis, and lupus. This research might 
        help determine the best way to reduce or prevent the 
        overproduction of cytokines, to prevent these diseases, and to 
        identify and reduce side effects from potential treatments. 
        Earlier research by this same team of scientists helped to 
        determine that cytokines play a critical role in causing 
        asthma.
  --Immunologists are studying how cytokines affect the immune response 
        to self-antigens (molecules already in the body) in the insulin 
        secreting cells in the pancreas. Understanding the immune 
        response is critical because we know that autoimmune 
        destruction of the pancreas is the cause of Type I diabetes, a 
        disease which classically attacks young people. A recent paper 
        has shown that by changing the way the self-antigen is exposed 
        to the immune system, the disease can be prevented in mice 
        genetically predisposed to develop diabetes.
  --Immunologists are studying periodontal disease (gum disease), which 
        is the major cause of tooth loss in the United States. Current 
        work is seeking to understand how the two major bacterial 
        species cause this disease. This involves cloning the bacterial 
        genes necessary for allowing the bacteria to cause disease, and 
        understanding the body's response to the bacteria. Both the 
        bacteria and the response are necessary to cause tooth loss.
  --Immunologists are studying the effect of aging and environmental 
        factors on the development of autoimmune disorders, with a 
        special focus on myasthenia gravis--a disease that causes 
        muscle weakness. In this disease, the immune system responds to 
        a critical molecule necessary for nerve signal conduction. 
        Because this molecule is present only in very low amounts, 
        people (and animals) are able to develop an immune response 
        since immune tolerance was never produced. Immunologists have 
        created a transgenic mouse in which this tolerance does occur. 
        This allows the identification of the major mechanisms of 
        disease to be discovered and ultimately controlled.
  --Immunologists have identified a novel DNA binding protein that is 
        produced only in the thymus and appears to play a role the 
        production of the antigen receptor gene rearrangement. Because 
        aberrant rearrangement of certain genes (oncogenes) has been 
        seen in many lymphomas and leukemias, immunologists are 
        studying the regulatory processes involved. Such studies may 
        offer critical insight into both diseases.
  --Immunologists are studying systemic lupus erythematosus (lupus), an 
        autoimmune rheumatic disorder which can cause arthritis, 
        rashes, kidney failure, central nervous system disease, and 
        other serious medical problems. In studying the antibodies that 
        are made in the disease and the substances to which they bind, 
        a team of immunologists has theorized that the Epstein Barr 
        virus may play a role in causing this disease and is now 
        testing this theory. These immunologists are also working to 
        identify the genes which they believe may predispose people to 
        develop lupus.
    As the above examples show, the work of immunologists is varied and 
relevant to the everyday lives of many American families. Our members 
devote their professional lives to painstaking work that may one day 
cure a disease or contribute on some smaller but significant level to 
better scientific understanding of complex human physiological 
reaction.

                    MAKING SCARCE DOLLARS GO FURTHER
    As this subcommittee struggles with difficult decisions regarding 
the funding level for NIH and other important government agencies and 
programs for fiscal year 2002, we would like to suggest two ways that 
we believe that dollars allocated to biomedical research could be 
stretched further. First, our researchers have found an increasing 
regulatory burden placed on them by various rules and regulations 
promulgated by a variety of government agencies. While our scientists 
appreciate that their work is funded by taxpayer dollars and respect 
their duty to account for the use of those funds, they have often found 
these regulations burdensome and lacking any measurable benefit, taking 
valuable time (and money) away from the research at hand.
    Reducing paperwork and streamlining and simplifying rules would 
certainly help obtain the greatest value from every research dollar.
    Second, as our work described above makes clear, immunologists 
depend heavily on the use of animal models in their research. Without 
the use of animals, theories about immune system function and 
treatments that might cure or prevent disease would have to be tested 
first on human subjects, something our society--and our scientists--
would never countenance. Despite the clear necessity for animal 
research, people and organizations that oppose such research are 
threatening scientists who use animal models. The legal and extra-legal 
methods used by these groups to further an animal-rights/anti-medical 
research agenda is diverting precious resources from our work, 
threatening the personal safety and security of scientists, and 
delaying the progress of important research that is already underway. 
Addressing this ongoing problem is an additional cost that--were it 
relieved--would enable NIH dollars to go further.

            NIH BUDGET PLANS FOR SUPPORTING YOUNG SCIENTISTS
    AAI would like to call to the subcommittee's attention NIH's 
announced plans to increase the level of stipends for post-doctoral 
recipients. AAI has been deeply concerned about the future supply of 
biomedical researchers, and in particular, the plight of post-doctoral 
fellows who are significantly underpaid and under-compensated for their 
work. In early March, the National Academy of Sciences (NAS) held a 
Convocation on Enhancing the Postdoctoral Experience For Scientists and 
Engineers to discuss post-doctoral issues and a report recently issued 
by its Committee on Science, Engineering, and Public Policy (COSEPUP). 
Among the many recommendations of the COSEPUP committee was the need 
for better compensation and employment benefits for post-doctoral 
fellows. NIH responded by releasing on March 22 a statement in response 
to the NAS report (Notice NOT-OD-01-027), in which it indicates its 
plans to increase the stipends for National Research Service Award 
(NRSA) recipients over a period of five years. While AAI believes that 
the urgency of the situation requires a phase-in of higher stipends and 
the offering of basic employment benefits in considerably less than 
five years, AAI applauds NIH for responding to the COSEPUP report 
promptly and greatly appreciates NIH's leadership in beginning to 
address the need for better compensation for post-doctoral fellows. We 
urge this subcommittee and the Congress to support efforts to address 
the immediate need for better compensation and benefits for our 
nation's future biomedical research leaders.

      NIH BUDGET ON RESEARCH MANAGEMENT AND SUPPORT (RMS) FUNDING
    Current funding for management and oversight at NIH is $693 
million, or 3.3 percent of the NIH budget. As funding for NIH has 
increased, allowing for large new numbers of increasingly complex 
grants, there has been an inadequate increase in support for oversight 
to ensure that the funds are used wisely and well. As Congress has 
increasingly asked questions--rightfully so--about what NIH and the 
nation's researchers are doing with these additional funds, NIH is 
hampered by insufficient staff to either answer those questions or to 
ensure fully the proper management and oversight of existing grants.
    Between 1984 and 2000, there was little if any increase in RMS 
funding. In fiscal year 2000 and fiscal year 2001, there were increases 
of 8 percent and 10 percent respectively, raising the RMS to its 
current level. But if NIH is to properly manage taxpayer dollars, 
ensure the continuation of its excellent and highly regarded peer 
review process, provide professional development to staff, manage its 
facilities, provide public education, and undertake the multitude of 
activities supported by the RMS budget, AAI believes that an increase 
in the RMS budget to 4.5 percent of the NIH budget--a level that is the 
historical average--is required. We urge this subcommittee to review 
this important budget category again this year, recognizing that for 
NIH to use well--and account for--the generous funding increases you 
have provided, the RMS budget needs your active support.
    On behalf of AAI, may I express our appreciation for having this 
opportunity to submit our remarks and invite any members of the 
subcommittee who have questions to feel free to contact me for further 
information.
                                 ______
                                 

 Prepared Statement of the American Association of Colleges of Nursing

    The American Association of Colleges of Nursing (AACN) respectfully 
submits this testimony to the Subcommittee with our requested funding 
priorities for nursing research and education programs. This federal 
support will be a critical piece in the nation's effort to overcome the 
nursing shortage. AACN represents over 550 baccalaureate and graduate 
nursing education programs in senior colleges and universities across 
the United States.
    The country is in the midst of an emerging nursing shortage unlike 
any that the nation has experienced over the past 30 years. Since 1994, 
AACN has noted declining enrollments in baccalaureate nursing programs. 
Increasingly, employers are reporting dramatic and crisis level 
shortages of nurses in their health care settings. Hospitals are forced 
to close entire patient care units; ambulances are being diverted to 
other overcrowded facilities; and surgeries are being canceled due to 
the lack of appropriately educated and skilled registered nurses (RNs). 
Nurse vacancy rates are noted in all practice settings including long-
term care, home care, and public health. In addition, an aging 
workforce, with the average age of RNs up to 45.2 years, compounds the 
shortage.
    Although employers are seeking a more highly educated nursing 
workforce for today's complex health care environment, only 41 percent 
of nurses have a baccalaureate or higher degree. The growing shortage 
and the decline in enrollments are accompanied by a number of other 
factors that will affect the ability of the nursing profession to meet 
the demand for professional nursing care. The longitudinal American 
Freshman Study indicates that an extremely small percentage of freshman 
college students are choosing a nursing career. A recent national 
assessment of children's career aspirations by the J. W. Thompson 
Company has found that young children, particularly those who plan to 
seek a college education, also do not see nursing as an attractive 
career option.
    A lack of nursing faculty has had an impact on the shortage. The 
majority of AACN member nursing programs report great difficulty 
filling budgeted faculty positions. The small one percent of doctorally 
prepared nurses in this country and the lengthy completion time of a 
doctoral degree have limited the availability of nurses prepared to 
function in a faculty role. Doctoral nursing students also are more 
often part-time students and have maintained their full-time clinical 
or other positions. Expansion of doctoral enrollments as full-time 
students would facilitate greatly the production of available faculty. 
AACN members also report difficulty recruiting master's prepared 
nursing personnel for faculty roles because of the great disparity 
between clinical salaries and the salaries available as a faculty 
member. Schools would benefit from support initiatives that provide 
resources to augment salaries for specialized faculty needed to support 
the entire program.
    AACN recognizes that strategies to meet the growing nursing 
shortage must encompass private and public sector initiatives. Local 
communities and health care employers are utilizing creative programs 
to recruit middle school students into the nursing profession. States 
are introducing legislation funding scholarships and studies to assess 
statewide workforce need. We are asking the Subcommittee to graciously 
consider these requests and the effect that an unresolved RN shortage 
of this magnitude will have on the future of health care in America.

             NATIONAL INSTITUTE OF NURSING RESEARCH (NINR)
    We thank you and respectfully request a fiscal year 2002 funding 
level of $144.37 million, which reflects an increase of $40 million for 
the National Institute of Nursing Research. At this funding level, NINR 
will support significant new research on health disparities in diseases 
such as diabetes and cardiovascular disease, self management of chronic 
pain, end-of-life research to address weight loss, muscle wasting, 
fatigue, and caregiver issues. Most critical to enhancing research 
within the nursing profession is infrastructure development that 
increases the pool of nurse investigators, expands programs to develop 
partnerships between research-intensive environments and smaller 
colleges and universities, and promotes career development for minority 
researchers.
    In an effort to develop the pool of nurse faculty and researchers, 
NINR directs 8 percent of its budget to research training. Research 
training dollars supported approximately 190 pre-doctoral nurse 
researchers and 70 post-doctoral researchers this year. These numbers 
must be increased in the future to address recent recommendations of 
the National Research Council. Additionally, AACN's 2000 Survey of 
Institutional Data Systems claims 3,338 nurses in doctoral programs, 
indicating that NINR supports less than 6 percent of those nurses in 
doctoral study. In view of the national nurse faculty shortage of 500 
unfilled positions in teaching and research, we recommend this 
significant increase in appropriations for additional stipends and 
training for pre- and post-doctoral researchers.
    NINR provides research findings for the nation's largest profession 
of health care providers: 2.7 million RNs. In light of the increasing 
shortage of qualified professional nurses, the NINR requires a 
significant funding increase for the following reasons:
  --To provide clinically-based research findings that make a 
        difference in the lives of all Americans, from our youth whose 
        health needs must be addressed to our nation's aging population 
        of which many experience chronic, debilitating diseases.
  --To establish the role of nurse researcher, which attracts bright 
        young women and men into a field that provides opportunities to 
        both conduct meaningful research and use important research 
        findings that make a difference in people's lives.
    NINR's fiscal year 2001 funding is at $104.37 million. This is 
$14.83 million or 16.6 percent more than the fiscal year 2000 level. 
Nurses from across the nation are thankful for this increase. It has 
provided resources for 81 new multi-year research grants beginning in 
fiscal year 2000 and an estimated 60 new studies, which begin in fiscal 
year 2001.
    The increase in appropriation for fiscal year 2000 enabled NINR's 
success rate to reach the NIH mean success rate of 32 percent for 
competing research projects for the first time in its 15-year history. 
This is a significant improvement over fiscal year 1999 when the 
success rate was only 14.4 percent. Because of NINR's ability to 
attract important applications for research studies, the success rate 
for fiscal year 2001, despite a good increase in appropriation, is 
estimated to be only 20 percent.
    The fiscal year 2000 research findings from NINR-funded studies 
include 17 reports related to aging, long-term care, or Alzheimer's and 
care giving. More studies are reported in dozens of scientific articles 
in: HIV/AIDS patient care, cardiovascular disease prevention and care, 
child and adolescent health, critical care, diabetes, mental health, 
and the utilization of nurses in the health care system. In addition, 
NINR-funded investigators across the country produced scientific 
advances in maternal-infant care, pain and other symptom management, 
and women's health. These findings together form the research base to 
establish evidence-based practice for registered nurses providing 
direct patient care 24-hours a day, seven days a week, all across the 
country.
    In addition, NINR is the lead institute at NIH to coordinate 
research on end-of-life care, addressing the public's disappointment 
with the current status of care at the end of life. Other groups such 
as the Institute of Medicine, the Robert Wood Johnson Foundation, and 
the Hartford Foundation recognizing this need especially in light of 
our aging population. End-of-life care utilizes many of the skills of 
nurses such as pain and other symptom management, clinical management 
to promote quality of life, and family teaching and counseling. This 
focus helps families to identify and use resources to better cope with 
the stresses at this critical time.
    The Subcommittee investment in NINR is well justified as nursing 
research contributes extensively to wellness and health choices that 
prevent disease. The NINR supports investigators who conduct a broad 
range of clinical research, developing and testing interventions to 
improve patient care, treat disease, manage chronic conditions and 
address the physical and emotional concerns that are important to the 
diverse American public. There is growing evidence of advances made 
possible by NINR research, but I will highlight just four recent 
success stories. AACN believes that based on these and numerous other 
examples, it is clear that nursing research is making a difference in 
health outcomes. For example, NINR research has made a difference by 
identifying interventions or other studies to:
  --Enhance the independence and reduce signs of distress among 
        severely cognitively impaired nursing home residents.
  --Develop new methodologies for investigating ways to reduce breast 
        cancer risk in women who have a genetic predisposition.
  --Reduce the extremely high stress levels experienced by family 
        members who were involved with decisions to stop life-
        sustaining support for a terminally ill loved.
  --Reduce the risk of cardiovascular disease in children from minority 
        backgrounds who are living in rural areas.

                     THE NURSE EDUCATION ACT (NEA)
    We also ask for increased funding of $25 million for the Nurse 
Education Act and additional funding for the nursing student loan 
programs. AACN recommends an increase in the NEA for fiscal year 2002 
to $103.1 million for the NEA and $an additional $20 million directed 
to student loan programs. NEA appropriations for fiscal year 2001 were 
$78.1 million. Central to increasing the availability of a well-trained 
nursing workforce is the availability of educational grants and 
scholarships. Current demand for nursing student loan support exceeds 
significantly the resources available. In addition, scholarship support 
is a major incentive to enter the profession and facilitates full-time 
study.
    Title VIII of the Public Health Service Act (PHSA), the NEA, is the 
major federal statute providing authority for the Department of Health 
and Human Services to fund initiatives to expand or improve nursing 
education. Authorities under Title VIII provide for support of advanced 
practice nursing education, special initiatives for nursing clinics, 
support of innovations in the delivery of nursing care, expansion of 
enrollments in baccalaureate nursing programs, and development of 
initiatives to expand minority nursing enrollments. Several of the 
programs assist schools with their efforts to bring more students into 
baccalaureate nursing programs. In addition, the program for loans to 
nursing students allows students to acquire low interest rate loans 
that can be repaid through service in high need areas.
  --Advanced Education Nursing Grants (Sec. 811).--The initiative 
        provides grants to schools to train advanced practice primary 
        care nurse practitioners and nurse midwives. It also provides 
        grants to educate master's and doctoral students as clinical 
        nurse specialists, public health nurses, nurse administrators, 
        faculty, nurse anesthetists, and non-primary care nurse 
        practitioners. It includes traineeships for master's and 
        doctoral students with a limit of 10 percent of appropriations 
        for doctoral traineeships.
  --Nursing Workforce Diversity Grants (Sec. 821).--To increase 
        opportunities for nursing education for disadvantaged students, 
        including underrepresented minorities, this initiative 
        furnishes scholarships, stipends, pre-entry preparation, and 
        retention activities. Grantees are responsible for 
        accomplishing the objectives of their grants.
  --Basic Nurse Education and Practice Grants (Sec. 831).--This 
        initiative disseminates grants to schools of nursing to 
        strengthen basic nurse education and practice with seven 
        priority areas. The areas are: expanding nursing practice in 
        non-institutional settings to increase access to primary health 
        care, training for care of underserved and high risk 
        populations, education for managed care, developing cultural 
        competency, expanding baccalaureate enrollments, increasing 
        nursing career mobility, and nursing education in informatics 
        and use of distance learning.
  --Nursing Student Loan Program (NSLP) (Sec. 836).--AACN recommends an 
        appropriation of at least $10.3 million for the NSLP for fiscal 
        year 2002. Administered by the Division of Student Assistance, 
        this program was created to address nursing workforce 
        shortages. Academic institutions select students enrolled in 
        nursing programs for participation in the program based on 
        financial need. The program operates on revolving funds 
        received through student loan paybacks and returned funding 
        received from nursing schools that closedown. In fiscal year 
        2001, only 291 out of 1,500 eligible collegiate schools of 
        nursing participate in the program because of reluctance to 
        compete for the limited funding. This loan program has received 
        no new funding since 1983.
  --Nursing Education Loan Repayment Program (NELRP) (Sec. 846).--AACN 
        requests at least an additional $10 million for this program in 
        fiscal year 2002. The NELRP, administered by the Bureau of 
        Primary Health Care, provides loans to registered nurses, nurse 
        anesthetists, and nurse practitioners in exchange for 
        practicing in designated Health Profession Shortage Areas. Due 
        to funding limitations in fiscal year 2000, the Bureau provided 
        loans of 60 percent of the amount authorized to only 50 percent 
        of the nurses applying for program participation. The NELRP has 
        $2 million in fiscal year 2001 funding.
             scholarships for disadvantaged students (sds)
    AACN recommends that SDS be funded at $55.63 million for fiscal 
year 2002, a 25 percent increase. Fiscal year 2001 funding is at $44.5 
million. Scholarships for Disadvantaged Students is a PHSA Title VII 
Program (Sec .737) that provides funds to disadvantaged and minority 
health professions students. The statute directs 16 percent of the 
funds appropriated to nursing students. This program is the major 
federal scholarship source for undergraduate nursing students and 
eliminates or reduces the financial barriers that may prevent these 
students from enrolling. The majority of SDS recipients are minority 
students.

                  NATIONAL HEALTH SERVICE CORPS (NHSC)
    AACN recommends maintaining the 10 percent set aside and increasing 
funds for the NHSC to $300 million. The National Health Service Corps 
Scholarship and Loan Repayment programs (PHSA Title III) seek to 
attract health professionals to practice in Health Professional 
Shortage Areas that lack such providers. Many of those areas are rural, 
and have difficulty attracting and retaining caregivers. Nursing has a 
10 percent set aside that provides funding for certified nurse 
midwives, nurse practitioners, and psychiatric clinical nurses 
specialists.

                               CONCLUSION
    In summary, AACN respectfully recommends the following 
appropriations for fiscal year 2002:

                        [In millions of dollars]

                                                                  Amount

National Institute of Nursing Research............................144.37
Nurse Education Act...............................................103.1 
Nursing Student Loan Program...................................... 10.3 
Nursing Education Loan Repayment Program..........................  12  
Scholarships for Disadvantaged Students........................... 55.63
National Health Service Corps Scholarship/Loan.................... 300  

                                 ______
                                 

     Prepared Statement of the American Association of Colleges of 
                          Osteopathic Medicine

    As President of the Philadelphia College of Osteopathic Medicine 
and Chairman of the Board of Governors of the American Association of 
Colleges of Osteopathic Medicine (AACOM), I am pleased to present the 
views of our nineteen colleges on fiscal year 2002 appropriations for 
health professions education assistance programs under Titles VII and 
VIII of the Public Health Service Act. First, I would like to express 
the American Association of Colleges of Osteopathic Medicine's 
appreciation for the past efforts of this Subcommittee to maintain a 
commitment to health professions education. The Subcommittee's vision 
has enabled health professions schools in general and colleges of 
osteopathic medicine in particular to address the physician workforce 
needs dictated by a rapidly changing health care delivery system.
    However, we are not yet able to say we are in a position to 
completely meet these workforce needs. ``Healthy People 2010,'' a 
document that serves as a blueprint for health care delivery, has 
articulated two overarching goals: Increase Quality and Years of 
Healthy Life; and Eliminate Health Disparities. To achieve these goals 
by 2010, we must begin now to train health professionals who have the 
necessary skills and commitment. More than ever, institutions need the 
support of Titles VII and VIII programs to develop the kind of 
workforce consistent with ``Healthy People 2010.''
    At the same time we recognize the responsibility of the 
Subcommittee to examine all programs in light of their cost 
effectiveness in meeting the health care needs of all Americans. We 
believe colleges of osteopathic medicine measure particularly well 
under such scrutiny. By training and by tradition, osteopathic 
physicians practice ``hands on,'' holistic medicine and value the 
highly close and interactive physician-patient relationship that is 
characteristic of our profession. This philosophy has driven a unique 
educational model in our medical schools. The American Association of 
Colleges of Osteopathic Medicine is especially proud that the model of 
osteopathic medical education is entirely consistent with the Federal 
objectives of addressing physician geographic maldistribution in the 
United States and increasing access to primary care services. Mr. 
Chairman and Members of the Subcommittee, it is important to note that 
this model has not been developed recently in response to Federal 
funding requirements. Rather, it has been at the core of our 
osteopathic medical education for over 100 years.
    The principal vehicle for addressing the specialty and geographic 
maldistribution of physicians has been through primary care education 
and training. The American Association of Colleges of Osteopathic 
Medicine member schools have a long history of dedication to training 
primary care physicians to work in America's smaller communities, rural 
areas and underserved urban areas. Osteopathic physicians represent 5.5 
percent of the U.S. physician workforce, but constitute 15 percent of 
the physicians practicing in communities of fewer than 2,500 
population.
    The mission statement of my own institution reflects this 
commitment: `` Philadelphia College of Osteopathic Medicine is 
dedicated to providing programs of study to educate skilled 
professionals in health and science fields and competent and caring 
osteopathic physicians. The programs of study are built on the 
foundations of primary care, an orientation to the needs of the 
community and are guided by osteopathic tradition, concept and 
practice. The college is committed to the advancement of knowledge and 
encouragement of intellectual growth through research and leadership 
and to the advancement of the community through health promotion, 
education and service.''
    Mr. Chairman and Members of the Subcommittee, all of our 
osteopathic medical schools share similar missions. These missions are 
reflected in the profile of our medical students. Our latest data show 
that over 40 percent of our entering students come from small towns and 
rural areas (i.e. towns of fewer than 50,000).
    The health professions assistance programs under Titles VII and 
VIII of the Public Health Service Act have been valuable in our efforts 
to continue to ensure this commitment. In Public Law 105-392, the 
Health Professions Education Partnership Act of 1998, 44 different 
Federal health professions training programs were consolidated into 
seven clusters. These clusters provide support for training of 
underrepresented minority and disadvantaged students; training of 
primary care and dental providers; the establishment and operation of 
interdisciplinary community-based training activities; health 
professions workforce and analysis; public health workforce 
development; nursing education; and student financial assistance. These 
programs are designed to meet the health care delivery needs of the 
over 2,800 Health Professions Shortage Areas in the country. Many rural 
and disadvantaged populations depend on the health professionals 
trained by these programs as their only source of health care. For 
example, without the practicing family physicians who are currently in 
place, an additional 1,332 of the United States' 3,082 urban and rural 
counties would qualify for designation as primary care Health 
Professions Shortage Areas.
    Titles VII and VIII programs have had a significant impact in 
reducing the nation's Health Professions Shortage Areas. Indeed, a 
recent study estimated that if funding for Title VII programs were 
doubled the effect would be to eliminate the nation's Health 
Professions Shortage Areas in as little as 6 years (Politzer, RM, 
Hardwick KS, Cultice JM, Bazell, C. Eliminating Primary Care Health 
Professions Shortage Areas: The Impact of Title VII Generalist 
Physician Education, The Journal of Rural Health, 1999: 15(1): 11-19).
    A study by the Robert Graham Center showed that the receipt of 
Title VII family medicine grants by medical schools produced more 
family physicians and more primary care doctors serving in rural areas 
and health professionals shortage areas. Over 69 percent of Title VII 
funded internal medical graduates practice primary care after 
graduation. This rate is nearly twice that of programs not receiving 
Title VII funding.
    Among the programs within these clusters that have been especially 
important to enhancing osteopathic medical schools' ability to train 
the highest quality physicians are: General Internal Medicine 
residencies; General Pediatric Residencies; Family Medicine Training; 
Preventive Medicine Residencies; Area Health Education Centers; Health 
Education and Training Centers; Health Careers Opportunities Programs; 
Centers of Excellence Programs; and Geriatric Training Authority.
    Let me give you examples of how Title VII programs have benefited 
not only the osteopathic medical schools receiving the support, but 
also the citizens in the communities and states they serve.
    The Philadelphia College of Osteopathic Medicine (PCOM) received a 
3 year grant, now in its final year, from the Health Resources and 
Services Administration to develop a predoctoral curriculum which 
places significant emphasis on a comprehensive and integrative approach 
to providing health care to medically underserved persons. The three 
major curriculum goals are:
  --To develop, implement and evaluate a teaching module which focuses 
        on preventive medicine for the medically underserved in a 
        managed care environment.
  --To develop, implement and evaluate a teaching module which focuses 
        on understanding the roles of family and community in health 
        care delivery.
  --To develop, implement and evaluate a teaching module which focuses 
        on the application of evidence-based medicine in patient care 
        and on becoming a self-directed learner.
    This program will serve as a model for medical institutions that, 
like the Philadelphia College of Osteopathic Medicine, are interested 
in reaching out to medically underserved populations by training 
doctors to understand the socioeconomic aspects of patients' lives in 
order to provide them with the most appropriate, comprehensive, and 
integrative health care.
    Nova Southeastern University College of Osteopathic Medicine has a 
Model Area Health Education Center (AHEC) Program Grant that serves 
underserved rural and inner-city communities throughout South and 
Central Florida. Nearly 500,000 people reside in the many Health 
Professions Shortage Areas in this nineteen county region served by 
this AHEC program. Among the many special initiatives have been an 
active AHEC Rural Medicine Program, an AHEC Health Careers Camp, a 
Library Without Walls Program, A Practice Opportunities Program, and 
Distance Learning Teleconferences. This AHEC Program has also worked 
closely with three other medical schools in Florida to develop a 
Statewide Florida AHEC Network to cultivate and leverage additional 
state support to maximize overall program scope and effectiveness. In 
1997, this Florida AHEC Network was recognized by its peers across the 
nation for its program excellence in developing an innovative and 
collaborative statewide network of community/academic partnerships, and 
for significantly improving the supply and distribution of primary care 
health professionals in underserved communities of Florida.
    The Chicago College of Osteopathic Medicine of Midwestern 
University is in their third year of funding with an Establishment of 
Family Medicine grant. This grant has allowed for the establishment of 
a new course ``Topics in Family Medicine'' for MSII students. The 
Chicago College of Osteopathic Medicine took material that was 
historically taught the last eight week of the MSII year and developed 
it into a full year course focusing on topics in medicine normally seen 
by primary care physicians and including issues in managed care and 
practice management. A simulated patient program has been incorporated 
that allows students to practice dealing with difficult patient 
situations such as death and dying. Community medicine sites have been 
enhanced and approximately 50 new preceptors have been added. This 
spring, the Chicago College of Osteopathic Medicine will sponsor a 
faculty development program for all new preceptors. There have also 
been great strides in the area of technology and on-line capabilities 
for things such as distance learning with the students.
    Title VII also authorizes student assistance programs that are 
especially important to osteopathic medical students. Our students have 
the highest average debt upon graduation among health professions. 
Congress should be concerned with minimizing the debt load of graduates 
of health professions schools, if they, in turn, can be expected to 
hold down medical costs, practice in primary care, and locate in 
underserved areas.
    Title VII grants have been a crucial factor in the establishment 
and growth of primary care departments and have enabled them to develop 
innovative curricula. These grants represent the only Federal 
initiative that has specifically encouraged students to consider 
careers in primary care, a clearly identified national priority. With 
the exception of fiscal year 2001, appropriations for Titles VII and 
VIII programs have remained relatively flat for a number of years. 
Thus, the ability to meet the workforce needs mentioned earlier becomes 
more difficult.
    Accordingly, Mr. Chairman and Members of the Subcommittee, AACOM 
recommends that the fiscal year 2002 funding level for Titles VII and 
VIII be $440 million. These figures do not include funding for the 
children's hospitals graduate medical education program, which is an 
amount separate from Titles VII and VIII funding. This funding level 
would provide a much needed boost toward ensuring the training of a 
workforce who will be delivering the types of services and providing 
the full access to these services identified in Healthy People 2010.
    Finally, Mr. Chairman and Members of the Subcommittee, the American 
Association of Colleges of Osteopathic Medicine supports the Ad Hoc 
Group for Medical Research Funding request of $23.7 billion for the 
National Institutes of Health for fiscal year 2002. This $3.4 billion 
(16.5 percent) increase represents the fourth step toward the 
bipartisan goal of doubling NIH funding over the 5-year period from 
fiscal year 1999 to fiscal year 2003. Although osteopathic medical 
schools in the past have not engaged in research activities nearly to 
the extent of our allopathic brethren, we have been steadily increasing 
the research capabilities of our institutions.
    Again, I appreciate the opportunity to present our views to the 
Subcommittee. If I can provide you with any additional information, you 
may contact either me at the Philadelphia College of Osteopathic 
Medicine or Michael Dyer, Vice President for Government Relations at 
AACOM (301) 968-4152.
                                 ______
                                 

 Prepared Statement of the American Association of Colleges of Pharmacy

                  RECOMMENDATIONS FOR FISCAL YEAR 2002
                        [In thousands of dollars]
------------------------------------------------------------------------
                                                  Fiscal year
 Public Health Service Act Title VII -----------------------------------
              Programs                                        2002
                                            2001         recommendation
------------------------------------------------------------------------
Health Careers Opportunity Program..            32,800            35,000
Scholarships for Disadvantaged                  44,500            48,000
 Students...........................
Faculty Loan Repayment..............             1,300             2,300
Health Professions Workforce                       826             1,200
 Information and Analysis...........
------------------------------------------------------------------------

    Your past support of the Title VII of the Public Health Service Act 
programs means improved access to care for all Americans. The health 
professions students and schools supported by these programs are the 
mostly likely to offer their services to underserved communities and 
practice in sites like community health centers. With Title VII 
programs facing substantial reductions in the President's fiscal year 
2002 budget, your support for these programs is important again this 
year.
    The leadership and faculty of our nation's colleges and schools of 
pharmacy are committed to educating professional pharmacists capable of 
and comfortable with providing comprehensive pharmacy services to the 
diverse populations they serve. A recent survey of the pharmacy 
services provided at community health centers, conducted by the 
University of Texas at Austin under a grant from the Health Resources 
and Services Administration's (HRSA) Bureau of Primary Care, found that 
the culturally diverse patient populations served by the CHCs benefit 
from improved health promotion counseling by pharmacists with similar 
cultural background.
    Individuals considering pharmacy as a career choice and their 
teachers (pharmaceutical education faculty, and colleges and schools) 
all benefit from the Title VII programs such as:
  --Health Career Opportunities Program (HCOP);
  --scholarships for disadvantaged students (SLD);
  --faculty loan repayment and faculty training fellowships (FLRP); and
  --Centers of Excellence programs (COE).
    Your support of critical Title VII programs is needed since the 
diversity of the current pharmacist workforce, or any other health 
professions workforce, does not mirror the diversity of our society in 
general.
    The fact that we need to educate more pharmacists, in general, is 
supported by a congressionally mandated study that the Department of 
Health and Human Services (HHS) released last December. The Pharmacist 
Workforce: A Study of the Supply and Demand for Pharmacists indicates 
that the demand for pharmacists will remain strong for the foreseeable 
future. Improving the opportunity for students from culturally diverse 
backgrounds is more important than ever. In light of the study, 
targeting funds to pharmacy students and colleges and schools of 
pharmacy could prove beneficial. The health workforce data HRSA 
currently collects through the National Center for Health Workforce 
Information and Analysis (NCHWIA) within the Bureau of Health 
Professions is insufficient to assist policy makers to determine how 
many active pharmacists there are. With increased appropriations NCHWIA 
could establish a health professions database, including pharmacists, 
that is verifiable, reliable, indicative of health professions numbers 
at the state, county and local level, and not merely a repository of 
statistics from professional associations and societies. This database 
could also be used to improve the decision making process for placement 
of National Health Service Corps personnel.
    Your consideration of our recommendations is greatly appreciated. 
Please do not hesitate to contact our office should you require 
additional information.
                                 ______
                                 

   Prepared Statement of the American Association of Pharmaceutical 
                               Scientists

              SUMMARY OF FISCAL YEAR 2002 RECOMMENDATIONS
    AAPS supports the continual efforts to double the National 
Institutes of Health (NIH) budget by providing a 16.5 percent increase 
for fiscal year 2002, to $23.7 billion.
    Basic scientific research conducted at the National Institutes of 
Health or sponsored by NIH has resulted in a better understanding of 
new therapies for many diseases. The American Association of 
Pharmaceutical Scientists (AAPS) represents scientists in academia, 
industry and government. While NIH funding does not support all of our 
members, the impact of scientific discoveries derived from NIH 
sponsored research has broad implications for all who are developing 
new treatments. Pharmaceutical scientists trained in academic 
institutions under the auspices of NIH often become noted academic, 
industrial or governmental researchers. Many of these scientists create 
knowledge in the pharmaceutical sciences that forms the basis for new 
approaches in the treatment of the diseases that bedevil mankind. AAPS 
members develop new methods of drug discovery, drug delivery and 
related technologies, pharmaceutical analysis, new information 
regarding drug metabolism and disposition, clinical evaluation, 
pharmacoepidemiology, and pharmacoeconomics. All areas are important in 
ensuring the safety, efficacy, and availability of new therapeutic 
modalities.
    Currently, pharmaceutical scientists advise the NIH in direct 
collaborations and by participating in many study section review 
boards. Many pharmaceutical scientists have been involved with ``start-
up'' biotechnology companies. A few of these entities are enormously 
successful and have changed the way that some diseases are treated. 
Others are involved in innovative research that may lead to the next 
big breakthrough in the treatment of a number of diseases. With the 
proposed reorganization of the NIH review process, this may be an 
appropriate time for our 11,000 members to expand their involvement in 
the evaluation of research related to the pharmaceutical sciences and 
we stand ready to do so. Because of the importance of the discoveries 
by NIH, AAPS urges Congressional support for funding at or above the 
proposed levels. Continued NIH funding is necessary to continue the 
leadership and reputation of the United States in the fields of 
biomedical research and pharmaceutical sciences. There has been an 
explosion of biomedical and pharmaceutical knowledge in the last few 
years and it is crucial that this knowledge now be used to develop new 
therapies for those in need.
                                 ______
                                 

        Prepared Statement of the American College of Cardiology

                              INTRODUCTION
    The American College of Cardiology (ACC) is a 25,000-member, 
professional medical society and educational institution whose mission 
is to foster optimal cardiovascular care and disease prevention through 
professional education, promotion of research, and leadership in the 
development of standards and guidelines and the formulation of health 
policy. The ACC submits for the record this statement in support of 
fiscal year 2002 funding for the National Heart, Lung, and Blood 
Institute (NHLBI).
    Thanks to the research support of the NHLBI, patients have 
benefited from the emergence of advanced technologies, devices, and 
pharmaceuticals. Medical research has played a major role in a notable 
decline in the number of deaths from cardiovascular disease over the 
past three decades. Yet, cardiovascular disease continues to claim more 
lives each year than the next seven leading causes of death combined. 
This year, it is estimated that nearly one million Americans will die 
as a result of heart and blood vessel/vascular disease. More than 60 
million Americans are living with one or more types of cardiovascular 
disease. Fortunately, many of these individuals are living better and 
more productive lives as a result of new drug and device therapies, 
surgical innovations, prevention initiatives, and educational 
programs--all made possible in part through NHLBI-sponsored research.
    Because cardiovascular disease continues to affect the lives and 
productivity of millions of Americans, and because researchers are on 
the brink of many new and exciting medical discoveries, it is critical 
that the subcommittee maintain its long-standing support for the NHLBI, 
specifically heart-related research.

                       THE COST OF HEART DISEASE
    In 1999, the total economic impact--direct and indirect costs--of 
heart disease was $183 billion, of which $81 billion is attributed to 
lost productivity--people unable to work or care for their families. 
According to the National Institutes of Health (NIH), 450,000 Americans 
age 65 and older require home or hospice care due to cardiovascular 
disease, and congestive heart failure is the largest cause of 
hospitalization for aging Americans. Investments in cardiovascular 
research today will result in future savings to the health care system 
and to society. According to a report issued in May 2000 by the 
congressional Joint Economic Committee, it is estimated that the 
average American has gained a value of $85,000 in increased longevity 
from medical advances in heart disease since 1950, at a cost of $35,000 
per person in research spending--a gross investment return of about 240 
percent of costs.
    Last year, Congress demonstrated its commitment to medical research 
by providing a 15 percent increase in funding to the NIH. The ACC 
recognizes this commitment and hopes Congress will continue to work 
toward doubling the NIH's budget by 2003.

              GROUND-BREAKING HEART RESEARCH ADVANCEMENTS
    In 1991, the NIH launched the Human Genome Project. Innovative 
research in human genetics holds great promise for the prevention, 
diagnosis, and treatment of cardiovascular disease. Today, the NHLBI is 
a leader among other NIH institutes in gene research.
    In September 2000, the NHLBI launched the Programs for Genomic 
Applications. This $37 million initiative is designed to advance 
genomic research in the areas of heart, lung, blood, and sleep 
disorders by deciphering individual genes and functions and then 
applying those findings to what is already known about the mapping and 
sequence of the human genome. The initiative will accelerate progress 
in heart, lung, blood, and sleep research by stimulating investigator-
initiated research and by making information immediately available to 
the research community, thereby allowing other scientists to develop 
separate relevant studies cost effectively. Ensuring investigators have 
the tools necessary to conduct genomic analysis expands the potential 
for medical discovery.
    NHLBI-funded researchers recently grew heart valves in laboratories 
using new tissue-engineering techniques. More than 60,000 patients in 
the United States receive replacement heart valves each year. Although 
the valves' performance has been excellent, problems such as abnormal 
clotting or poor durability limit their effectiveness. Further research 
efforts are needed to improve these new tissue-engineering techniques 
so that heart valves of higher durability and quality can be produced. 
Scientists are hopeful that someday laboratory-grown implantable valves 
will last an entire lifetime, actually growing and maturing with the 
patient.
    With the help of NHLBI research funding, scientists are seeking 
ways for patients to grow blood vessels in the heart to replace the 
ones they have lost as a result of a heart attack. During a heart 
attack, blockage in coronary arteries leaves a portion of the victim's 
heart tissue without oxygen. When this happens, part of the heart 
tissue begins to die. Research has indicated that it is possible to 
grow new blood vessels in the heart; however, this research is still in 
its infancy, necessitating continued funding. This research may yield 
hope that heart attack victims will someday be able to regenerate blood 
vessels and keep damaged tissue alive.

                      SUPPORT FOR CLINICAL TRIALS
    All scientific developments in biomedicine must pass through 
clinical research before they can benefit patients. A critical 
component of clinical research is trials that allow physicians to apply 
the results of research in practice. Clinical trials can also be an 
important tool in identifying early on therapeutic strategies and 
pharmacological agents that have the potential to reduce health care 
costs.
    To alter clinical practice, large-scale randomized trials are 
usually necessary to demonstrate unequivocally the effectiveness of a 
new drug or device or a new application for an existing drug or device. 
Some of these trials require thousands of patients to be studied over 
several years. For example, funding is needed to conduct large-scale 
clinical trials to study heart failure in the elderly. Large trials are 
also needed to examine ways in which heart disease can be treated once 
it is detected. While large-scale clinical trials require a significant 
financial commitment, they hold the potential to improve patient well-
being and to reduce health care spending over time. The ACC believes 
that continued funding increases are needed to significantly increase 
clinical research overall, and large-scale clinical trials 
specifically, while also increasing funding levels for basic research. 
Funding for basic science and clinical trials must go hand-in-hand, and 
there cannot be increased funding for one at the expense of decreased 
funding for the other.
    The ACC asks the subcommittee to ensure that increased funding be 
made available for the training of clinical investigators. Clinical 
investigators, or physician-scientists, are quickly becoming a ``dying 
breed.'' Critical to the advancement of medical science, clinical 
investigators bridge scientific discoveries and their application at 
the patient bedside. Today, young physicians are being forced to choose 
between performing research or practicing medicine. The demands of 
managed care and other health insurance programs have further precluded 
physicians from performing basic research and supervising patient care 
at the same time. Incentives are needed to attract physicians to the 
important field of clinical investigation. Increased resources must 
also be dedicated to train a new generation of clinical investigators 
who are well trained in biostatistics, research protocol designs, 
bioethics, and outcomes analysis. So many of the advances in patient 
care in the last 30 years have come from the research efforts of these 
investigators who bridge the basic and clinical domains. They are a 
vital link in our battle against premature death and disability from 
heart and vascular disease, and their training must be supported.

              HEART RESEARCH INITIATIVES AND OPPORTUNITIES
Congestive Heart Failure Clinical Network
    It is estimated that 4.8 million Americans suffer from congestive 
heart failure and that approximately 400,000 new cases are diagnosed 
every year. Health care costs associated with heart failure are 
estimated at $40 billion annually. More effective treatments are needed 
to address this growing public health problem. The NHLBI plans to 
establish a collaborative network of clinical research centers and a 
data coordinating center to conduct clinical studies in heart failure. 
Clinical networks have been shown to be an effective method for 
translating promising basic research findings into clinical research 
and practice. This initiative will allow for investigations focused on 
women and minorities and on programs to train physicians in clinical 
research.
Bone Formation and Calcification in Cardiovascular Disease
    Evidence suggests that a relationship exists between bones and 
blood vessels. Research, however, is needed to determine whether there 
is a link between bone formation, repair, and breakdown (e.g., 
osteoporosis) and the development of cardiovascular disease. Scientists 
already know that patients who take statin drugs to lower cholesterol 
levels are at a decreased risk of bone fractures. Conversely, studies 
have found that people with low bone mass may have an increased risk of 
developing or dying from cardiovascular disease. Further research in 
this area may lead to strategies to prevent both cardiovascular disease 
and osteoporosis.
Lifestyle Intervention With Stress Management After Heart Attack
    Mental stress has been shown to trigger myocardial ischemia. 
Patients with coronary artery disease who experienced myocardial 
ischemia following mental stress tests had higher than expected rates 
of subsequent cardiac events. Results from rehabilitation and 
prevention programs that included stress management interventions have 
shown that behavioral interventions may improve quality of life and 
reduce morbidity and mortality of patients with coronary artery 
disease. However, because those trials used small sample sizes, it has 
been difficult to accurately assess the effect of stress management 
interventions. The NHLBI has suggested the need for a pilot study of 
behavioral interventions to determine the feasibility of recruiting 
patients, delivering interventions, ascertaining the effects on 
adherence, and assessing the progression of coronary artery disease and 
other clinical outcomes.
Public Access to Defibrillation
    About one fourth of the 300,000 annual deaths from sudden cardiac 
arrest occur outside the home--in public areas. In August 2000, the 
NHLBI launched a nationwide pilot program to test public access to 
automated external defibrillators (AEDs). AEDs are devices that 
automatically analyze heart rhythms and deliver an electric current to 
the heart of a cardiac arrest victim. Survival rates after cardiac 
arrest are low, averaging 4 percent. However, survival rates can be 
increased by shortening the time to defibrillation. The study will 
place AEDs in 24 communities across the Unites States and Canada. 
Researchers already know that AEDs save lives. The purpose of this 
study is to look at the life-saving potential and cost effectiveness of 
AEDs when used by trained lay-individuals. When the study, which will 
be conducted over 30 months, is complete, 1,000 sites will be equipped 
with AEDs. As of March, 850 of those sites had been approved for the 
placement of AEDs.
    Recognizing the critical importance of early defibrillation, the 
ACC asks the subcommittee to support $12.5 million in funding for 
implementation of the Rural Access to Emergency Devices Act, Public Law 
106-505, the Public Health Improvement Act. The funding will be used to 
help rural communities buy AEDs and to train rural emergency responders 
in the use of AEDs.

                  PREVENTION, EDUCATION, AND PRACTICE
    Efforts must be strengthened to prevent the incidence of heart 
attacks, coronary heart disease, heart failure, and high blood pressure 
through increased patient and physician education if we are to win the 
war against heart disease. We know that heart disease is linked 
definitively to hypertension, high cholesterol, obesity, diabetes, 
smoking, and physical inactivity. The NHLBI's public education 
programs--the National High Blood Pressure Education Program, the 
National Cholesterol Education Program, the Obesity Education 
Initiative, and the National Heart Attack Alert Program--make 
information readily available to patients, families, and health 
professionals.
    The earlier that heart disease is detected, the better it can be 
treated to prevent its development. In September 2000, the NHLBI 
launched a 10-year, multi-center study to find new ways of detecting 
heart disease early, before it produces symptoms. The $68 million 
Multi-Ethnic Study of Atherosclerosis involves six centers, which will 
recruit 6,500 participants. The hope is that the study will yield more 
specific predictors of heart disease and will determine which factors 
best predict heart disease in men and woman and in different ethnic 
groups.
    One of the fastest growing public health problems in this country 
is adult and childhood obesity. People who are overweight or obese are 
at greater risk for several major diseases, including heart disease and 
stroke. More than 108 million adults in the United States are 
overweight or obese. Even more startling, an estimated 5 million 
children in this country between age six and 17 are considered 
overweight.
    Just recently, the NHLBI unveiled a new tool for health care 
providers and the public to combat obesity. A ``practical guide'' is 
now available to physicians and other health care professionals. The 
guide includes a 10-step plan and a quick reference tool to help 
physicians assess, classify, and treat patients who are overweight and 
obese. The guide also includes information for patients on diet, 
physical activity, and tools for behavioral change.
    The NHLBI has also funded research targeted at the prevention and 
treatment of obesity. NHLBI-funded researchers have found that in 
overweight individuals, high dietary sodium intake is strongly 
associated with an increased death rate, particularly from 
cardiovascular disease. The average adult in the United States consumes 
well above the recommended daily sodium level of 2,400 milligrams. 
Knowing this, physicians and other health care providers can suggest 
reducing sodium intake as a low-cost intervention for those who have 
difficulty losing weight as a way to help lower their risk of death 
from cardiovascular disease.
    Another NHLBI study has shed new light on genetic predisposition to 
obesity. Additional research is needed to gain a better understanding 
of the leptin receptor gene, the gene linked to fat accumulation. 
Researchers have found that a variation in the leptin receptor gene is 
associated with higher fat levels in middle-age white males, but not in 
black males or in women of either race. This suggests that leptin 
therapy may be effective only in middle-age white males, and that other 
genetic factors influence excess fat accumulation in women and blacks. 
Understanding the leptin receptor gene will be an important step in 
developing effective preventive and therapeutic strategies to fight 
obesity.
    There is much to be done to ensure that preventive and therapeutic 
measures proven effective in the fight against cardiovascular disease 
are adopted by physicians. Cardiovascular drugs, such as anti-
hypertensives and beta-blockers, have played a key role in the decline 
of heart disease-related deaths. Beta-blockers, drugs that are used to 
slow the rate and force of the heart's contractions and to stabilize 
the heart's rhythm, are still underused in treating heart attack 
patients in the emergency room. Funding is needed to gather evidence-
based information that can be used to improve health care practices by 
physicians and other health care providers. The ACC supports increased 
funding to the Agency for Healthcare Research and Quality for the 
purposes of improving health care quality.

                               CONCLUSION
    Beyond better public awareness and the incorporation of research 
advances into practice, reducing the number of cardiovascular-related 
deaths is greatly dependent upon research sponsored by the NHLBI. We 
must intensify our cardiovascular disease research efforts now in an 
effort to prevent an increase in the prevalence of cardiovascular 
disease that will otherwise accompany the aging of the so-called 
``baby-boomer'' generation. The ACC hopes the subcommittee shares its 
optimism about the unique opportunities scientists and clinical 
investigators now have to achieve their long-standing goal of 
conquering this nation's number-one killer. In summary, the ACC 
encourages the subcommittee to provide a funding level of at least 
$2.679 billion for the NHLBI in fiscal year 2002. Furthermore, the ACC 
asks that at least $1.650 billion of that amount be devoted to heart- 
and stroke-related research.
    The ACC hopes the subcommittee will consider this request. It is a 
wise investment in the future health of our nation.
                                 ______
                                 

   Prepared Statement of the American Dental Hygienists' Association

    On behalf of the American Dental Hygienists' Association (ADHA), 
thank you for the opportunity to present testimony regarding fiscal 
year 2002 appropriations for the Department of Health and Human 
Services. I am Stan Peck, ADHA's Executive Director.
    ADHA is the largest national organization representing the more 
than 100,000 dental hygienists across the country. Dental hygienists 
are preventive oral health professionals who are licensed in each of 
the fifty States. As prevention specialists, dental hygienists 
understand that recognizing the connection between oral health and 
total health can prevent disease, treat problems while they are still 
manageable, and conserve critical health care dollars. Dental 
hygienists are committed to improving the nation's oral health, a 
fundamental part of total health. Please visit the ADHA web site at 
<>.

    U.S. SURGEON GENERAL'S MAY 2000 REPORT ON ORAL HEALTH IN AMERICA
    Last May, U.S. Surgeon General David Satcher issued ``Oral Health 
in America: A Report of the Surgeon General.'' This landmark report 
confirms what dental hygienists have long known: that oral health is an 
integral part of total health and that good oral health can be 
achieved. Key findings enumerated in the Report include:
  --Oral diseases and disorders in and of themselves affect health and 
        well-being throughout life.
  --Safe and effective measures exist to prevent the most common dental 
        diseases--dental caries (tooth decay) and periodontal diseases.
  --Lifestyle behaviors that affect general health such as tobacco use, 
        excessive alcohol use, and poor dietary choices affect oral and 
        craniofacial health as well.
  --There are profound and consequential oral health disparities within 
        the U.S. population.
  --More information is needed to improve America's oral health and 
        eliminate health disparities.
  --The mouth reflects general health and well-being.
  --Oral diseases and conditions are associated with other health 
        problems.
  --Scientific research is key to further reduction in the burden of 
        diseases and disorders that affect the face, mouth and teeth.
    The Surgeon General's Report on Oral Health challenges all of us--
in both the public and private sectors--to address the compelling 
evidence that not all Americans have achieved the same level of oral 
health and well-being. The Report describes a ``silent epidemic'' of 
oral diseases, which affect our most vulnerable citizens--poor 
children, the elderly and many members of racial and ethnic minority 
groups. The Surgeon General insists that additional steps be taken to 
address these disparities in oral health status.
    ADHA suggests that one such step is to improve access to the 
preventive oral health care services provided by dental hygienists. 
This is important because unlike most medical conditions, the three 
most common oral diseases--dental caries (tooth decay), gingivitis (gum 
disease) and periodontitis (advanced gum and bone disease)--are proven 
to be preventable with the provision of regular oral health care. 
Despite this prevention capability, tooth decay--which is an infectious 
transmissible disease--still affects more than half of all children by 
second grade. Clearly, more must be done to increase children's access 
to oral health care services.
    While the profession of dental hygiene was founded in 1923 as a 
school-based profession, today the provision of dental hygiene services 
is largely tied to the private dental office. Increased utilization of 
dental hygienists in schools, nursing homes, and other sites--with 
appropriate referral mechanisms in place to dentists--will improve 
access to needed preventive oral health services. This increased access 
to preventive oral health services will likely result in decreased oral 
health care costs per capita and, more importantly, improvements in 
oral and total health.
    ADHA is committed to working with the Congress to improve access to 
oral health care services, particularly for children eligible for 
Medicaid and the State Children's Health Insurance Program (SCHIP).

         NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
    As the Surgeon General's Report on Oral Health so clearly 
demonstrates, the nation's oral health can and must be further 
improved. The National Institute of Dental and Craniofacial Research 
(NIDCR) is the nation's focal point for oral health research and 
NIDCR's work has yielded significant advancements in oral health.
    Moreover, NIDCR's work in dental research has not only resulted in 
better oral health for the nation, it has also helped curb increases in 
oral health care costs. Americans save nearly $4 billion annually in 
dental bills because of advances in dental research and an increased 
emphasis on preventive oral health care. To enable NIDCR to continue 
and to build upon its important research mission, ADHA joins with other 
groups in the oral health community to recommend $370 million for 
NIDCR.

                         ORAL HEALTH INITIATIVE
    ADHA is pleased to see the increasing recognition among federal 
Policymakers of the importance of oral health to overall health and 
well-being. A primary illustration of this appreciation for the link 
between oral health and general health is the Oral Health Initiative at 
the Health Resources and Services Administration (HRSA). The goals of 
HRSA's Oral Health Initiative are to work toward the elimination of 
disparities in oral health status and to improve access to oral health 
services. Regretfully, much work needs to be done in both of these 
areas to help assure that children enrolled in Medicaid and the State 
Children's Health Insurance Program (SCHIP) are provided access to 
necessary oral health services.
    As the General Accounting Office (GAO) confirmed last year in two 
separate reports to Congress, ``dental disease is a chronic problem 
among many low-income and vulnerable populations'' and ``poor children 
have five times more untreated dental caries (cavities) than children 
in higher-income families.'' The GAO further found that the major 
factor contributing to the low use of dental services among low-income 
persons who have coverage for dental services is ``finding dentists to 
treat them.'' ADHA pledges to work with HRSA to achieve the goals of 
the Oral Health Initiative. Increased utilization of dental hygiene 
services--appropriately linked to the services of dentists--is critical 
to addressing the nation's crisis in access to oral health care for 
vulnerable populations.
    Because access to preventive oral health services is vital to 
children's health and wellbeing, ADHA urges a minimum of $20 million 
for HRSA's Oral Health Initiative so that access to oral health 
services for Medicaid and SCHIP children will improve and disparities 
in oral health status will be lessened. A portion of these monies would 
be used to fund important children's health projects authorized in the 
``Children's Health Act of 2000.''
    ADHA further urges that the Oral Health Initiative receive a 
separate line item in the budget. This consolidation into a line item 
will vastly improve coordination of HRSA's various oral health 
activities.

          CENTERS FOR DISEASE-CONTROL DIVISION OF ORAL HEALTH
    ADHA would also like to lend its support to the Division of Oral 
Health within the Centers for Disease Control (CDC). Specifically, ADHA 
joins with other dental groups in urging a budget of $17 million for 
the Division of Oral Health at CDC. This funding level will enable the 
Division of Oral Health to continue its vital work to control and 
prevent oral disease, including its important work in the area of 
community water fluoridation and school-based dental sealant programs 
as authorized in the ``Children's Health Act of 2000.''

            RYAN WHITE HIVAIDS DENTAL REIMBURSEMENT PROGRAM
    Included in the Ryan White CARE Act is a dental reimbursement 
program that assists in meeting the oral health needs of people living 
with HIV/AIDS, most of whose care is not covered under existing federal 
and state assistance programs. The dental reimbursement program 
provides participating institutions with partial reimbursement for the 
cost of providing oral health care services to low income people living 
with HIV and AIDS. In 1999, oral health care was provided to more than 
65,000 patients under the program.
    The ``Ryan White CARE Act Amendments of 2000'' would--for the first 
time--render dental hygiene programs eligible for the dental 
reimbursement program. There are presently 255 accredited dental 
hygiene education programs in the United States. In fact, all States, 
with the exception of Montana, have at least one dental hygiene 
education program. Currently, there are 55 dental schools.
    Federal support for the provision of oral health services through 
dental hygiene programs to HIV positive individuals will not only 
provide greatly needed oral health services, but will also afford 
dental hygiene students important education opportunities. ADHA joins 
with the American Dental Education Association in recommending $15 
million for this important program.

                          CHIEF DENTAL OFFICER
    ADHA further urges that the position of Chief Dental Officer at the 
Health Care Financing Administration (HCFA) be made permanent. While 
this vital position has historically received funding, it is not now 
permanent. Given the increasing recognition of the importance of oral 
health and the key role of HCFA's Chief Dental Officer, it is 
imperative that this position be institutionalized.

                             ALLIED HEALTH
    ADHA joins the Allied Health Roundtable in supporting the important 
work of Title VII of the Public Health Service Act and recommends 521 
million for Allied Health Project Grants. Allied health disciplines 
constitute fully 60 percent of the health care work force. With the 
acknowledged need for cost-effective health care providers, it is time 
to augment funding for and recognition of these important allied health 
programs. ADHA further encourages funding for federal programs in 
HRSA's Minority and Disadvantaged Health Professionals Training 
Cluster. These important programs recruit and retain minority and 
disadvantaged students.

                   MATERNAL AND CHILD HEALTH PROGRAM
    Title V Maternal and Child Health (MCH)/Children with Special 
Health Care Needs programs have had a history of supporting the public 
oral health infrastructure, for providing the population-based 
prevention programs, such as water fluoridation or dental screenings, 
and for providing direct and enabling oral health services when 
necessary. Despite this important work, the Maternal and Child Health 
program has not enjoyed the level of spending growth over the last ten 
years that many other public health programs have realized. ADHA 
strongly supports the MCH programs and urges $850 million for fiscal 
year 2002, which is full funding at the level authorized last year.

                                 CLOSE
    In closing, the American Dental Hygienists' Association appreciates 
the important contributions this Subcommittee has made in improving the 
quality and availability of oral health services throughout the 
country. ADHA is committed to working with this Subcommittee--and all 
Members of Congress--to improve the nation's oral health which, as Oral 
Health in America: A Report of the Surgeon General so rightly 
recognizes, is a vital part of overall health and well-being.
    Thank you for this opportunity to submit the views of the American 
Dental Hygienists' Association.
                                 ______
                                 

   Prepared Statement of the American Lung Association (ALA) and the 
                    American Thoracic Society (ATS)

    The American Lung Association (ALA) and the American Thoracic 
Society (ATS) are very pleased that President Bush has committed his 
Administration to doubling the NIH budget by fiscal year 2002. To keep 
the NIH budget on course towards doubling the budget in 2003 will 
require a 16.5 percent increase in fiscal year 2002. We look forward to 
working with this committee to bring the campaign pledges of President 
Bush to fruition. Mr. Chairman, while our comments today will focus on 
selected parts of the Public Health Service, the American Lung 
Association and the American Thoracic Society are firmly committed to 
appropriate funding for all parts of our nation's public health 
infrastructure.
    There are 3 specific issues that ALA/ATS would like to bring to 
your attention.

                  SHORTAGE OF PHYSICIAN-INVESTIGATORS
    Mr. Chairman while investments in biomedical research at NIH will 
make tremendous strides in the health of our nation, the ALA/ATS feel 
there is a fundamental flaw in the research enterprise. That flaw is 
the shortage of physician-investigators. Physician-investigators are 
MDs or MD/PhDs who devote a significant share of their time to 
conducting research.
    Physician-investigators are essential to the research enterprise 
because they link the worlds of patient care and bench research. 
Physician-investigators are best equipped to translate the needs of the 
patients they serve into research questions. The active presence of 
physician-investigators is essential to keep biomedical research 
focused on the needs of the patient.
    In recent years, the number of new physician-investigators applying 
for NIH grants has diminished. NIH must take action to ensure new 
physician-investigators are entering the field of research.
    Last year, Congress enacted the Clinical Research Enhancement Act. 
This legislation will take a number of steps to address the shortage of 
physician-investigators involved in clinical research. While the 
legislation is an excellent first step, we feel the shortage of 
physician-investigators is not limited to just clinical research but 
extends to shortages of physician-investigators in all disciplines of 
biomedical research.
    The ALA/ATS recommends Congress continue to support activities 
called for in the Clinical Research Enhancement Act, but consider 
extending the support mechanisms to all physician-investigators. We 
also recommend NIH raise the low training stipends paid to students. 
The $35,000 paid to fifth year post-doctoral students is extremely low 
considering the $95,000 average debt physicians have after medical 
school.
National Heart, Lung, and Blood Institute AIDS Budget
    Last year, the Administration's budget proposed to flat fund the 
AIDS Budget at the National Heart, Lung, and Blood Institute. Mr. 
Chairman, as you may know, opportunistic pulmonary illnesses (like 
tuberculosis, pneumonia and influenza) are the leading cause of death 
for people with AIDS. Adequate funding is needed for the NHLBI to 
continue to study the interaction of these illnesses in the lungs of 
people with HIV. We are pleased to report that, with the good help of 
this subcommittee, the National Heart Lung and Blood Institute has 
increased its investment in investigating the interactions between 
tuberculosis and HIV.
    The ALA/ATS want to thank the committee for its help in bringing 
attention to the valuable work done at NHLBI on tuberculosis and AIDS. 
We hope we can count on the Subcommittee to continue that interest in 
this small, but important program.
Fogarty International Center TB Training Programs
    The Fogarty International Center at NIH provides training grants to 
U.S. universities to teach international physicians and researchers 
AIDS treatment and research techniques. The goal of the program is to 
develop a cadre of health professionals in the developing world to 
begin to control the global AIDS epidemic.
    Because of the linkage between AIDS and TB infection, FIC has 
created supplemental TB training grants for these institutions to train 
international health care professionals in the area TB treatment and 
research. This supplemental program has been highly successful in 
beginning to create the human infrastructure to treat the nearly 2 
billion people who have TB worldwide.
    However, we believe TB training grants should not be offered 
exclusively to institutions that have received AIDS training grants. 
The TB grants program should be expanded and open to competition from 
all institutions. The ALA/ATS recommend Congress provide an additional 
$3 million for FIC to expand the TB training grant program from a 
supplemental grant to an open competition grant.

                       MAGNITUDE OF LUNG DISEASE
    This year over 350,000 Americans will die of lung disease. Lung 
disease is third leading cause of death in the U.S., responsible for 
one in every seven deaths. More than 25 million Americans suffer from a 
chronic lung disease. Lung diseases cost the U.S. economy an estimated 
$89.1 billion annually.
    Lung diseases represent a spectrum of chronic and acute conditions 
that interfere with the lung's ability to extract oxygen from the 
atmosphere, protect against environmental or biological challenges and 
regulate a number of metabolic processes. Lung diseases include: 
chronic obstructive pulmonary disease, lung cancers, tuberculosis, 
pneumonia, influenza, sleep disordered breathing, pediatric lung 
disorders, occupational lung disease, sarcoidosis, and asthma. While 
lung disease encompasses many illnesses, these comments will focus on 
two illness, asthma and tuberculosis.

                                 ASTHMA
    Asthma is a chronic lung disease in which the bronchial tubes of 
the lungs become swollen and constrict, preventing air from getting 
into or out of the lung. These obstructive spasms of the bronchi are 
caused by a broad range of environmental triggers that vary from one 
asthma-sufferer to another.
    Asthma is on the rise. A 1998 survey found that an estimated 26 
million Americans (8.6 million children under the age of 18) have been 
told by their doctor they have asthma. Rates are increasing for all 
ethnic groups and especially for African American and Hispanic 
children. While some children appear to out grow their asthma when they 
reach adulthood, 75 percent will require life-long treatment and 
monitoring of their condition.
    Asthma is expensive. The growth in the prevalence of asthma will 
have significant impact on our nation's health expenditures, especially 
Medicaid. Currently, asthma costs the United States over $8.1 billion 
in direct medical expenditures. Hospital inpatient visits account for 
$3.2 billion in asthma expenses. Asthma attacks bring 1.9 million 
people to the emergency room each year.
    Asthma kills. In 1998, 5,438 people in the U.S. died as a result of 
an asthma attack. That is a 209 percent increase from 1979. A 
disproportionate share of these deaths occurred in African American 
families.
Federal Response to Asthma
    The federal response to asthma has three components; research, 
programs and planning. We are pleased to report that, with support from 
the Subcommittee, we are making progress on all three fronts.

                  FEDERAL RESPONSE TO ASTHMA--RESEARCH
    As the prevalence of asthma has grown, so has asthma research. 
Researchers are developing better ways to treat and manage chronic 
asthma. Research supported by National Heart, Lung and Blood Institute 
(NHLBI) has shown that using corticosteroids to treat children with 
mild to moderate asthma is safe and effective. For several years there 
had been concern that corticosteriods would stunt the growth of 
children who used them. The five-year study showed that children had a 
one-year small reduction in their growth rate. But they had normal 
growth rates compared with children who did not use corticosteriods for 
the following 4 years. Children who used corticosteroids did suffer 
fewer asthma attacks and fewer trips to the emergency room.
    Genetic research is also providing insights into asthma. Physicians 
have noticed that while most people respond well to inhaled beta-
agonists--a commonly prescribed drug to treat asthma--some patients do 
not response or have worse asthma using inhaled beta-agonists. 
Researchers in the NHLBI supported Asthma Clinical Research Network 
have discovered that a genetic variation in the beta-adrenegric 
receptor determines how well asthma patients will respond to inhaled 
beta-agonists. This discovery will enable physicians to better target 
the drugs they proscribe to treat asthma.
    Basic research is also learning more about asthma. Researchers 
supported by NHLBI have developed better animal models to allow 
expression of selected asthmatic genetic traits. This will allow 
researchers to develop a greater understanding of how genes and 
environmental triggers influence asthma's onset, severity and long-term 
consequences.

                  FEDERAL RESPONSE TO ASTHMA--PROGRAMS
    Last year, Congress provided approximately $27 million for CDC to 
conduct asthma program and tracking activities. CDC will use these 
funds to conduct asthma outreach, education and tracking activities. In 
Ohio, Case Western University and Rainbow Babies and Children's 
Hospital have been awarded funds to conduct an asthma intervention 
program. However, at the current level of funding, less than half the 
states have funds to respond to asthma. The ALA/ATS recommend that CDC 
be provided $50 million to expand its asthma programs.

                  FEDERAL RESPONSE TO ASTHMA--PLANNING
    Last year, Congress enacted legislation that directs the National 
Asthma Education and Prevention Program (NAEPP) at NHBLI to develop a 
plan for the federal government to respond to the growing asthma 
epidemic in the U.S. The plan will include recommendations on research, 
public health, tracking, education and treatment activities. The ALA/
ATS supports this planning process and looks forward sharing the 
recommendations of the NAEPP Federal Asthma Plan with this Subcommittee 
in the near future.
IOM Report: Ending Neglect--the Elimination of Tuberculosis in the 
        United States
    Mr. Chairman, tuberculosis has been with us since the dawn of time. 
Tuberculosis is an airborne infection caused by a bacterium, 
Mycobacterium tuberculosis (TB). TB primarily affects the lungs but can 
also affect other parts of the body, such as the brain, kidneys or 
spine.
    TB is spread through coughs, sneezes, speech and close proximity to 
someone with active tuberculosis. People with active tuberculosis are 
most likely to spread TB to others they spend a lot of time with, such 
as family members or coworkers. It cannot be spread by touch or sharing 
utensils used by an infected person.
    There are an estimated 10 to 15 million Americans infected with 
latent TB, with the potential to develop active TB in the future. About 
10 percent of these individuals will develop active TB disease at some 
point in their lives. In 1998, over 18,000 cases of active TB were 
reported in the United States.
    The Institute of Medicine (IOM) recently published a report on how 
the United States has responded to tuberculosis. The IOM report 
documents the cycles of attention and progress toward TB elimination, 
the periods of insufficient funding and the re-emergence of TB. The 
ALA/ATS is pleased to report that, at the moment, TB rates in the U.S. 
are on the decline. From a high in 1992 of 26,673 new cases, we have 
seen 7 straight years of decline in TB rates.
    While declining TB rates is good news, the emergence and spread of 
multi-drug resistant TB poses a significant threat to the public health 
of our nation. Continued support is need if the U.S. is going to 
continue progress toward the elimination of TB.
    The IOM report provides the United States with a road map of 
recommendations on how to eliminate TB in the United States. The IOM 
report identifies needed detection, treatment, prevention and research 
activities. The American Lung Association and the American Thoracic 
Society endorse the IOM report and its recommendations. We estimate it 
will cost $528 million for the CDC Tuberculosis Elimination Program to 
implement the IOM report recommendations.
    The National Institutes of Health also has a prominent role to play 
in the elimination of TB. Currently there is no highly effective 
vaccine to prevent TB transmission. However, the recent sequencing of 
the TB genome and other research advances have put the goal of an 
effective TB vaccine within reach. The National Institutes of Allergy 
and Infectious Disease have developed a Blueprint for Tuberculosis 
Vaccine Development. ALA/ATS encourage the Subcommittee to fully fund 
the TB vaccine effort.
NIOSH--Researching and Preventing Occupational Lung Disease
    In 1998, approximately 66,000 Americans died from work-related 
injuries or illnesses; 392,000 newly diagnosed cases of occupational 
illnesses and 5.5 million non-fatal work injuries were reported. 
Workplace illness and injury will cost the U.S. economy $171 billion 
this year.
    To protect the health of our nation's workforce will require 
research, training, tracking and new technologies. The ALA/ATS 
recommend that the Subcommittee provide a $50 million increase for the 
NIOSH budget including $25 million for the NIOSH National Occupational 
Research Agenda (NORA). NORA represents a partnership research plan for 
occupational disease. The NORA agenda was developed with input from 
labor, business and the health community.
    A recent IOM Report--``Safe Work in the 21st Century: Education and 
Training Needs for the Next Decades Occupational Safety and Health 
Personnel,'' identified a growing shortage of trained occupational 
health professionals in the United States. Unlike the majority of 
medical subspecialties, occupational health professionals do not 
receive Medicare training support. We recommend $10 million to increase 
training opportunities for occupational health professionals. The ALA/
ATS believe more funds are needed to track the incidence of serious 
work-related illnesses and injury. We recommend $10 million for 
surveillance data on workplace safety.

                LUNG-DISEASE OPPORTUNITIES AND ADVANCES
    Previously, the ALA/ATS reported that NHLBI-supported researchers 
found that retinoic acid can reverse the effects of emphysema in 
laboratory rats. The ALA/ATS is pleased to report that studies have 
gone from rats to non-human primates and that results continue to be 
encouraging. NHLBI is taking steps to test retinoic acid treatment in 
people. We appear to be one step closer to finding a way to reverse the 
effects of emphysema--what was once considered an irreversible, 
debilitating disease.
    NHLBI and Medicare are continuing to investigate the efficacy of 
the Lung Volume Reduction surgery in the National Emphysema Trial 
(NET). This clinical trial will help evaluate the best combination of 
surgical and rehabilitation therapy for people with emphysema.
    NHLBI is continuing its support for sleep-related research. It has 
been observed that people who suffer from inadequate sleep appear to 
recover more slowly from infections. NHLBI is supporting research to 
better understand the genetic basis of sleep-immune interactions.
    NHLBI-supported researchers have made strides in understanding the 
health effects sleep apnea and have identified genes in dogs that cause 
narcolepsy. The discovery of the narcolepsy gene in dogs will help 
guide further research in humans.
    Researchers have discovered a genetic defect that may cause 
familial primary pulmonary hypertension (PPH) in humans. PPH is a rare 
but serious disease in which blood pressure in the pulmonary artery 
becomes extremely high. Discovering the gene for familial PPH will help 
researchers discover the cause of this rare and fatal disease and 
should lead to improved treatments for PPH.
    In conclusion, Mr. Chairman, lung disease is a growing problem in 
the United States. It is America's number three killer, responsible for 
one in seven deaths. The lung disease death rate continues to climb. 
Overall, lung disease and breathing problems constitute the number one 
killer of babies under the age of one year. Worldwide, TB kills 3 
million people each year, more people than any other single infectious 
agent. Mr. Chairman, the level of support this committee approves for 
lung disease programs should reflect the urgency illustrated by these 
numbers.
                                 ______
                                 

  Prepared Statement of the American Gastrotenterological Association

                       SUMMARY OF RECOMMENDATIONS
    The American Gastroenterological Association (``AGA'') urges 
Congress to increase funding for medical research on digestive diseases 
and disorders through budgetary increases to the National Institutes of 
Health (``NIH''), the Centers for Disease Control and Prevention 
(``CDC''), and the Agency for Healthcare Research and Quality 
(``AHRQ'').
    Specifically, AGA encourages Congress to provide at least a 16.5 
percent increase over fiscal year 2001 for NIH, raising the funding 
levels from $20.3 billion to $23.7 billion, as recommended by the Ad 
Hoc Group for Medical Research Funding. Within NIH, AGA recommends at 
least a commensurate increase for the National Institute of Diabetes 
and Digestive and Kidney Diseases (``NIDDK''), the National Cancer 
Institute (``NCI''), and the National Institute of Allergy and 
Infectious Diseases (``NIAID''), each of which support a considerable 
portfolio of gastrointestinal research. These increases would allow for 
further research on the diagnosis, treatment and cure for debilitating 
and devastating digestive diseases.
    AGA also urges Congress to increase funding over fiscal year 2001 
by 29 percent to $5.0 billion for the CDC as recommended by the CDC 
Coalition, and by 40 percent to $400 million for AHRQ as recommended by 
the Friends of AHRQ.

                    MEDICAL RESEARCH RECOMMENDATIONS
    AGA is the nation's oldest, not-for-profit specialty medical 
society, consisting of over 11,000 gastroenterologic physicians and 
scientists who are involved in research, clinical practice, and 
education on disorders of the digestive system. As the nation's leading 
voice on gastrointestinal research, AGA is uniquely qualified to advise 
Congress on the current status of federally-supported digestive disease 
research programs and the areas in need of further research.
    Each year more than 62 million Americans are diagnosed with 
digestive disorders. Among the more common are obesity, 
gastrointestinal cancers, inflammatory bowel disease, motility 
disorders and foodborne illness. This testimony focuses on these 
serious health problems and makes recommendations on how Congress 
should allocate this country's precious medical research dollars to 
combat digestive diseases.
Nutrition and Obesity
    110 million adults in this country are either overweight (61 
million) or obese (49 million); 31.3 percent of men and 34.7 percent of 
women are considered to be clinically obese; one in five children are 
clinically obese. The number of obese adults in the United States has 
doubled in the last 25 years.
    The costs to society are both direct and indirect, and include 
increased medical expenses, loss of productivity in the workplace, 
disability claims and job discrimination. Approximately 300,000 adult 
deaths in the United States each year are attributable to obesity.
    Obesity is a major health problem in the United States because of 
its marked prevalence, causal relationship with serious medical 
diseases and considerable economic impact. Obesity is a major cause of 
gastrointestinal diseases such as gall bladder disease, liver disease 
(including cirrhosis of the liver), and colorectal cancer. Treatment of 
obesity and diseases directly related to it accounts for 5 percent to 7 
percent of total health care costs annually.
    Despite the fact that obesity is gaining more recent attention, a 
significant amount of ground must be covered before medical research 
catches up with the need to address the problem in a comprehensive 
manner. There are a growing, but inadequate, number of grants being 
funded to examine this disease.
    AGA recommends that Congress urge NIDDK, the National Institute of 
Child Health and Human Development, the Office of Research on Women's 
Health and the Center for Research on Minority Health to increase RO1 
funding for obesity research by 15 percent for fiscal year 2002 and to 
encourage the institutes to consider RFA's on the effects of obesity on 
gene expression, particularly as it relates to GI cancers, including 
colon cancer. Additionally, research into the effect of diet and 
nutrient intake on mucosal function, metabolism and gene function will 
provide insight into how nutrients affect gut function. Furthermore, 
the institutes should increase advanced research training at the basic 
level (KO8) and clinical level (K23) by 25 percent in fiscal year 2002.
Gastrointestinal Cancers
    Approximately 226,600 new cases of gastrointestinal cancers will be 
diagnosed this year. Sadly, 129,800 Americans will die from these 
cancers. The most common cancers involve the colon/rectum, stomach/
esophagus, and pancreas.
  --Colorectal cancer is the second leading cause of cancer-related 
        deaths in the United States and ranks fourth as the most common 
        cancer.--70 percent to 80 percent of colorectal cancer cases 
        involve average-risk individuals. If diagnosed early, this 
        cancer is highly curable. As such, research and early detection 
        through screening remains the key to preventing, treating, and 
        curing this disease. We encourage Congress to require coverage 
        for screening for all Americans. Further, we urge Congress to 
        support additional research on colorectal cancer.
  --Pancreatic cancer will be diagnosed in 28,300 Americans in 2001 
        with 28,200 people projected to die from this disease.--It is a 
        highly lethal form of cancer with the lowest survival rate 
        among all major malignancies.
  --Of increased concern to AGA are esophageal and stomach cancers. 
        These are the second most common gastrointestinal cancers.--It 
        is projected that nearly 34,000 Americans will be diagnosed and 
        more than 25,100 will die in 2001 from these cancers. Of 
        heightened concern to AGA is Barrett's esophagus, a precursor 
        to esophageal cancer, and the relationship between Barrett's 
        and chronic gastroesophageal reflux disease (``GERD'').
    AGA applauds the NCI for its commitment to improving the 
understanding of, and seeking cures to, these and other 
gastrointestinal cancers. However, more research is needed. Congress 
should encourage the NCI to likewise establish a Progress Review Group 
on espohgeal and stomach cancers. Congress also should urge the NIDDK 
to augment its efforts in these areas, and to particularly focus 
resources on the genetic aspects of these cancers, diagnostic tests for 
genetic abnormalities and prevention of these cancers, the modulation 
and understanding of epithelial injury and repair the environmental 
factors relating to the development of these diseases, and the 
development and treatment of Barrett's Syndrome in patients with GERD.
    Most cases of these cancers are detected too late to be effectively 
treated. However, CDC's National Colorectal Cancer Screening Awareness 
program is helping to inform the public that early detection through 
regular screening is important. Congress should support CDC's 
Colorectal Cancer Screening Awareness program with $15 million in 
fiscal year 2002, an increase of $6 million over fiscal year 2001.
Inflammatory Bowel Disease
    It is estimated that 1 million Americans have inflammatory bowel 
disease (``IBD''). Although older and younger people may also develop 
this disease, IBD usually begins between the ages of 15 and 40 and 
persists throughout life with remissions. People with IBD experience 
abdominal pain, fever, bowel sores, intestinal bleeding, anorexia, 
weight loss, fullness, diarrhea, constipation, and vomiting. In severe 
cases, the patient can hemorrhage or contract sepsis/toxemia resulting 
in death.
    Studies on the cause of IBD are desperately needed in order to have 
a better understanding of the disease and work towards more effective 
management and treatment. Specifically, AGA recommends that NIDDK 
support genomic research aimed at identifying abnormal genes in persons 
with IBD and finding the causes of IBD.
Motility Disorders
    It is estimated that up to 30 percent of all Americans may be 
affected at some time during their lives by motility disorders. 
Irritable bowel syndrome (``IBS''), the most common motility disorder, 
is especially troubling because a patient does not present with any 
pathognomonic symptoms or laboratory findings of the disease, making 
diagnosis and treatment extremely difficult.
    Further research is needed in this area both due to the high 
prevalence of this disease as well as the lack of knowledge on how to 
identify, diagnose, and cure the disease. AGA urges Congress to direct 
the NIDDK to focus additional resources on IBS. Specifically, AGA 
recommends that NIDDK support research into the development of 
physiologic tests to characterize the phenotypic subgroups of 
functional gastrointestinal disorders, including non-ulcer (functional) 
dyspepsia, functional constipation, and irritable bowel syndrome 
(motility). Additionally, AGA urges Congress to also encourage the 
Office of Research on Women's Health to devote more of its attention to 
these areas of research in light of the high incidence of IBS among 
women.
Foodborne Illness
    Foodborne illnesses are estimated to cost annually $5 to $6 billion 
in direct medical costs and productivity losses. Due to poor reporting 
of foodborne incidents, experts vary on the number of Americans 
affected annually from a conservative 6 million to over 80 million.
    AGA recommends that Congress encourage the NIH, including NIDDK and 
NIAID, and others conducting foodborne illness research like the United 
States Department of Agriculture (``USDA'') and the CDC to concentrate 
more intensively on research into treatments for foodborne illness. AGA 
thus urges NIDDK and NIAID to support research on (1) intestinal 
diseases caused by combination of luminal (including bacterial), 
environmental, and genetic factors with an emphasis on inflammatory 
bowel diseases, and (2) the reaction of the gut to foodborne pathogens, 
including research on the pathogenesis of the disease, the reaction of 
the gut to infections, the development of animal models to test 
therapies, and the invention of vaccines or substances that bind with 
the toxins to prevent the illness.

                    MEDICAL RESEARCH INFRASTRUCTURE
Digestive Disease Research Centers
    Digestive Diseases Research Core Centers are key to establishing 
strong research networks and advancing medical knowledge. Currently, 
fourteen fully funded centers exist which conduct basic and clinical 
research on a variety of digestive disorders. They have been highly 
successful in expanding medical knowledge on a variety of GI diseases 
and disorders. AGA urges Congress to instruct NIDDK to expand the 
number of centers by adding one new 5-year center in each of the next 2 
years such that sixteen centers are fully supported. These new centers 
should focus on genomic and proteomic approaches to gastrointestinal 
research. Moreover, NIDDK should maintain full funding for those 
centers already in existence.
Small Equipment Grants
    As technology continues to evolve, laboratory research equipment is 
becoming more expensive to purchase and maintain. NIH's current Shared 
Instrumentation Grant Program offers equipment grants for which 
researchers can apply for equipment with a minimum cost of $100,000; 
appropriate for use in replacing pieces of large equipment. However, a 
similar grant program does not exist to assist researchers in replacing 
less expensive ($50,000-$100,000), often highly utilized, pieces of 
equipment. Researchers' small equipment needs are just as critical as 
larger pieces of equipment and the cost of replacing such 
instrumentation can be prohibitively expensive to support on a single 
grant application. Therefore, AGA urges Congress to suggest that NIH 
study the need for a small equipment grant program comparable to the 
existing Shared Instrumentation Grant Program.
Training of Physician-Scientists
    While research has expanded our medical knowledge and enabled 
physicians and other providers to better prevent diseases, diagnose 
disorders, and treat people, there is growing concern that the number 
of physician-scientists (e.g., investigators who have medical degrees) 
is declining and that this decline will negatively impact many key 
future research endeavors. A recent study documenting this decline 
points to the tremendous debt incurred by medical school graduates who 
have more lucrative options outside of research as a primary cause. See 
Tamara R. Zemlo et al., The Physician-Scientist: Career Issues and 
Challenges at the Year 2000, 14 The FASEB Journal 221-230 (2000).
    AGA views this problem as an immediate and serious threat to the 
future of biomedical research generally, and gastrointestinal research 
in particular. To alleviate this growing problem, AGA urges Congress to 
increase funding for the continued expansion of clinical research and 
clinical research training opportunities. To achieve this Congress 
should take the following steps: career support for established 
clinical investigators, especially to enable them to mentor new 
investigators; and appropriate funding to NIH for the implementation of 
the loan repayment provisions of the Clinical Research Enhancement Act.
NIH Budget Doubling Initiative
    Medical research endeavors and America's patients have benefited 
tremendously from the 5-year effort to double the NIH budget. However, 
researchers recognize that there may be ramifications once the NIH 
budget has been doubled, and annual funding increases return to pre-
initiative levels. It is imperative that Congress not permit NIH 
funding to stagnate upon achieving the goal doubling the NIH budget. 
Therefore, in order to prevent a funding crisis that results in a 
retreat from the significant progress that has been made, AGA 
recommends that Congress plan for the post-doubling period accordingly. 
Additionally, Congress should applaud NIH for working to develop a 
funding strategy for post-fiscal year 2003, encourage further budget 
modeling exercises at NIH, and afford NIH the maximum amount of 
flexibility to address post-budget doubling funding levels.

                               CONCLUSION
    The diseases described above continue to take a huge toll on 
America's health and economy. Congress must keep up the momentum it has 
started, and in some cases, devote even more resources. AGA appreciates 
the opportunity to present its views on the fiscal year 2002 
appropriations. Please call Michael Roberts, Vice President of Public 
and Government Relations at AGA, at (301) 941-2618 if you have further 
questions.
                                 ______
                                 

          Prepared Statement of the American Heart Association

    It is highly likely that heart attack or stroke will cause your 
death or disability or that of a loved one. Heart attack, stroke and 
other cardiovascular diseases remain America's leading cause of death 
and a major cause of disability. Cardiovascular diseases account for 
nearly 1 of every 3 deaths in the United States.
    The American Heart Association works to reduce death and disability 
from heart attack, stroke and other cardiovascular diseases. We commend 
this Committee for making fiscal year 2001 funding for the National 
Institutes of Health and for the Centers for Disease Control and 
Prevention a priority. But, we are concerned that our government is 
still not devoting sufficient resources for research and prevention to 
America's No. 1 killer--heart disease--and to our country's No. 3 
killer and a leading disabler--stroke.

                            STILL NUMBER ONE
    Heart attack, stroke and other cardiovascular diseases have been 
America's No. 1 killer since 1919. Nearly 61 million Americans--1 in 
5--suffer from one or more of these diseases. Americans of all ages! 
Also, hundreds of millions of Americans have major risk factors for 
these diseases--about 50 million have high blood pressure, 41 million 
adults have elevated blood cholesterol (240 mg/dL), 49 million adults 
smoke, 107 million adults are overweight or obese and 10 million have 
physician-diagnosed diabetes. As the baby boomers age, the number of 
Americans afflicted by these lethal and disabling diseases will 
increase substantially. Cardiovascular disease costs Americans more 
than any other disease. Americans will pay an estimated $300 billion 
for cardiovascular-related medical costs and lost productivity in 2001. 
These diseases constitute 4 of the top 5 hospital costs for all payers, 
excluding childbirth and its complications, and 4 of the top 5 Medicare 
hospital costs. Heart disease is also the major cause of premature, 
permanent disability of American workers, accounting for nearly 20 
percent of Social Security disability payments.

                     HOW YOU CAN MAKE A DIFFERENCE
    Now is the time to capitalize on a century of progress in 
understanding heart attack, stroke and other cardiovascular diseases. 
According to an expert panel supported by this Committee, America's 
progress in reducing the death rate from cardiovascular disease has 
slowed, suggesting that new strategies against these killers are 
needed. The panel also reported that there are striking differences in 
cardiovascular death rates by race/ethnicity, socioeconomic status and 
geography. But promising, cost-effective breakthroughs in treatment and 
prevention are on the horizon. If you stay the course to double NIH 
funding by fiscal year 2003, the support of heart and stroke research 
and of the translation of that research into effective clinical and 
community initiatives will cut health care costs and improve the 
quality of life. For fiscal year 2002, we urge you to do the following:
  --Appropriate $23.7 billion (a 16.5 percent increase over fiscal year 
        2001 funding) for the NIH--the fourth step toward the 
        bipartisan goal of doubling NIH's budget by fiscal year 2003.--
        NIH research provides new treatment and prevention strategies, 
        cuts health care costs, creates jobs and maintains America's 
        status as the world leader in the biotechnology and 
        pharmaceutical industries.
  --Provide at least a 16.5 percent increase over fiscal year 2001 
        funding for NIH heart and stroke research.--Researchers are on 
        the brink of advances to greatly enhance prevention and to 
        provide new treatments so you and your loved ones can be spared 
        the pain and suffering of heart disease and stroke.
  --Allot $50 million for CDC's Cardiovascular Health Program to expand 
        this initiative to 35 states.--Science must be made applicable 
        through community programs that encourage Americans to make 
        healthful lifestyle choices to prevent heart disease and 
        stroke.
  --Support $12.5 million to continue to help rural communities buy 
        automated external defibrillators (AEDs) and to train rural 
        emergency responders, including police and fire personnel, to 
        use them.--Rural Access to Emergency Devices Act is part of 
        Public Law 106-505, Public Health Improvement Act.

            HEART AND STROKE RESEARCH BENEFITS ALL AMERICANS
    Thanks to advances in addressing risk factors and in treating 
cardiovascular diseases, more Americans are surviving heart disease and 
stroke. Heart disease and stroke research and prevention breakthroughs 
are saving and improving lives. Several examples follow.
  --Stents.--Each year nearly 1 million Americans undergo angioplasty 
        to widen their narrowed arteries to the heart. But, within six 
        months, 35 percent of angioplasties must be repeated because 
        the artery narrows again. In a major change in patient care, 
        stents (wire mesh tubes used to prop open an artery) are now 
        used in nearly 80 percent of angioplasties. The use of stents 
        along with angioplasty has significantly reduced the incidence 
        of artery renarrowing within six months.
  --Surgery to Reduce Risk for Stroke.--In many cases, surgeons can 
        prevent stroke by removing the buildup of plaque when one of 
        the main arteries to the brain is severely narrowed. Research 
        has better defined the group of patients in whom this surgery 
        is most helpful. About 121,000 such procedures are performed 
        each year.
  --State-of-the-Art Life-Extending Drugs.--Research has produced 
        amazing new drugs to help prevent and treat heart disease and 
        stroke. Cutting-edge drugs to control blood pressure and 
        cholesterol are more effective than ever in saving lives and 
        enhancing life quality of millions of Americans. Some of these 
        drugs can prevent both heart attack and stroke. When prevention 
        fails, revolutionary ``clotbuster'' drugs, such as tPA, can 
        reduce disability from heart attack by dissolving blood clots 
        causing the attack. In stroke, the use of tPA, within 3 hours 
        of the onset of symptoms, can restore blood flow and reduce 
        chances of permanent disability by 33 percent, saving health 
        care costs. TPA offers hope for the estimated 1.1 million 
        Americans who will suffer a heart attack and the 450,000 who 
        will have a clot-based stroke this year.
    So Americans can continue to benefit from these types of 
breakthroughs, it is critical that we proceed toward doubling the 
overall NIH budget by fiscal year 2003. We advocate an fiscal year 2002 
appropriation of $23.7 billion for the NIH, the fourth step toward the 
doubling goal. We have a particular interest in individual NIH 
components that relate directly to our mission of reducing heart 
attack, stroke and other cardiovascular diseases. Our funding 
recommendations for these institutes, centers and programs follow.

         HEART RESEARCH CHALLENGES AND OPPORTUNITIES FOR NHLBI
    The above and other advances have been made possible by more than 
50 years of American Heart Association-sponsored research and more than 
a half-century of investment by Congress in the National Heart, Lung, 
and Blood Institute. Thanks to research, more of our patients, our 
families, and our friends survive their heart attack or stroke and with 
a better quality of life. However, while more Americans are surviving, 
heart attack and stroke are still our No. 1 and No. 3 killers, 
respectively, and can cause permanent disability, requiring costly 
medical care and loss of productivity and quality of life. Clearly more 
work is needed if we are to win the fight against heart disease and 
stroke.
    We urge this Committee to double the NHLBI budget, including heart 
initiatives, by fiscal year 2003. As the next step toward reaching this 
goal, we advocate an fiscal year 2002 appropriation of $2.679 billion 
for the NHLBI, with $1.650 billion for heart and stroke-related 
research. A funding level of this amount will allow NHLBI to expand 
existing programs and invest in promising new initiatives. Several 
challenges and opportunities to advance the battle against heart 
disease are highlighted below.
  --Advanced Imaging.--Research has revolutionized imaging technology 
        to diagnose heart disease. About 1.3 million Americans in 1998 
        were hospitalized for an angiogram, an X-ray picture of blood 
        vessels that can demonstrate narrowings in arteries that can 
        lead to heart attacks or strokes. Because angiograms are 
        associated with some discomfort, the risk of infection and 
        bleeding, and in rare cases, heart attack or stroke; there is 
        strong motivation to replace them with easier, safer and 
        cheaper imaging procedures. Considerable progress has been 
        made. The high speed CT scan takes pictures that produce a 
        measure of blockages in arteries to the heart, and helps 
        doctors better tailor treatments. Three-dimensional coronary 
        magnetic resonance angiography uses strong magnets to provide 
        detailed images of the arteries to the heart. In less than an 
        hour, an MRA evaluates heart anatomy and other heart functions, 
        providing an accurate and thorough, non-invasive examination.
  --Bone Formation and Calcification in Cardiovascular Diseases.--
        Calcium is an early marker of atherosclerosis involving the 
        arterial wall. Evidence suggests an association between bone 
        formation, repair and breakdown (e.g. osteoporosis) and 
        development of heart disease and other cardiovascular diseases. 
        For instance, patients who take statin drugs--effective in 
        lowering cholesterol levels and in reducing cardiovascular 
        disease risk--are at decreased risk for bone fractures. 
        Conversely, several studies have reported that people with low 
        bone mass may have an increased risk of developing or dying 
        from cardiovascular diseases. These results indicate that basic 
        research in this area may result in strategies to prevent 
        osteoporosis and cardiovascular diseases.
  --Heart Attack, Stroke and Other Cardiovascular Diseases in Women.--
        Cardiovascular diseases are a major cause of disability and the 
        No. 1 killer of American women, killing more women than the 
        next 14 causes of death combined. About 1 in 5 women live with 
        effects of cardiovascular diseases. The clinical course of 
        cardiovascular disease is different in women than in men and 
        our diagnostic capabilities are less accurate in women than in 
        men. After a woman develops cardiovascular disease, she is more 
        likely than a man to have continuing health problems and is 
        more likely to die. But these diseases are largely unrecognized 
        by both women and their doctors. Extra funding is needed to 
        allow NHLBI to expand cardiovascular disease research in women 
        and to create more educational programs for patients and health 
        care providers on cardiovascular diseases risk factors, as 
        authorized under Public Law 105-340, Women's Health Research 
        and Prevention Amendments.
  --Resuscitation Research.--Some 1,000 Americans die each day from 
        unsuccessful cardiopulmonary and trauma resuscitation. The 
        National Heart, Lung, and Blood Institute, the National 
        Institute of Neurological Disorders and Stroke, the National 
        Institute of Child Health and Human Development, the National 
        Institute of General Medical Sciences, the Department of 
        Defense, and the Food and Drug Administration sponsored a forum 
        to set a broad research agenda on promising and novel life-
        saving therapies and to identify promising new directions in 
        CPR and trauma resuscitation research.

         STROKE RESEARCH CHALLENGES AND OPPORTUNITIES FOR NINDS
    A major cause of permanent disability and a key contributor to 
late-life dementia, stroke is America's No. 3 killer. Many of our 4.5 
million stroke survivors face debilitating physical and mental 
impairment, emotional distress and huge medical costs. About 600,000 
Americans will suffer a stroke this year. Considered a disease of the 
elderly, stroke also strikes newborns, children and young adults.
    We urge a doubling of the NINDS stroke budget by fiscal year 2003. 
An fiscal year 2002 appropriation of $1.371 billion for NINDS, with 
$151 million for stroke initiatives, would be the next step toward the 
goal. This will allow the NINDS to expand studies and start new 
initiatives to prevent stroke, protect the brain during stroke and 
enhance rehabilitation. Some challenges and opportunities follow.
  --Strategic Stroke Research Plan.--As a result of report language 
        provided by this Committee during the fiscal year 2001 
        appropriations process, NINDS is developing a 5-year strategic 
        stroke research plan. Researchers, clinicians, pertinent 
        organizations and advocacy groups will identify existing gaps 
        in knowledge and areas ripe for advances. Expected to be 
        released in fall 2001, the plan will strongly stimulate stroke 
        research.
  --Emerging Stroke Risk Factors.--More Americans are controlling major 
        stroke risk factors, such as high blood pressure and smoking, 
        yet the number of people falling victim to stroke continues to 
        rise. Scientists are defining new stroke risk factors, re-
        examining existing ones and reconsidering the long-held belief 
        that no difference exists in risk between young and older 
        patients with similar risk factors. Researchers are studying 
        heart valve disease, irregular heartbeats, the role of 
        inflammation in clogging of arteries, and the long-term effects 
        of previous high blood pressure. Increased funding to study 
        these areas may lead to new ways to prevent stroke.
  --Therapeutic Strategies for Stroke.--Several major clinical trials 
        have identified new methods for preventing and treating stroke 
        in high-risk populations. However, with the increased number of 
        strokes, and with the disparities evident in the treatment of 
        stroke, new ways to prevent strokes, to raise awareness, and to 
        better treat strokes need to be developed and evaluated. 
        Funding for new clinical studies is crucial for developing 
        cutting-edge stroke treatment and prevention.
  --Stroke Education.--Less than 5 percent of those eligible for tPa--
        the only approved emergency treatment for clot-based stroke--
        receive it. As a member of the Brain Attack Coalition, 
        comprised of organizations committed to fighting stroke, we 
        work with the NINDS to increase public awareness of stroke 
        symptoms and to call 9-1-1. Together, we sponsor and distribute 
        a televised public service announcement and are striving to 
        develop systems to make tPA readily available to appropriate 
        patients. When these measures are fully implemented, stroke 
        treatment will change from supportive care to early brain-
        saving intervention. More funding is needed to educate the 
        public and health professionals about stroke.
        research in other nih institutes benefit heart & stroke
    The National Institute on Aging defines how the aging process 
contributes to cardiovascular diseases, a main disabler and No. 1 
killer of older Americans. An fiscal year 2002 appropriation of $80.675 
million for cardiovascular research will allow continuation of studies 
and expansion into promising areas of investigation.
    The National Institute of Diabetes and Digestive and Kidney 
Diseases studies help in reducing cardiovascular disease death and 
disability. We advocate an fiscal year 2002 appropriation of $1.548 
billion for the NIDDK to advance research to help diabetics, 2/3 of 
whom die from heart disease or stroke.
    The National Institute of Nursing Research studies play a key role 
in promoting self-care and patient education. NINR research is key to 
primary and secondary prevention of heart attack, stroke and other 
cardiovascular diseases. We advocate an fiscal year 2002 appropriation 
of $121.591 million for NINR.
    Animal research and nationally-supported clinical research at the 
local level are critical for heart and stroke research. We support an 
appropriation of $952.358 million for the National Center for Research 
Resources. Increased resources will fortify animal research, help 
correct deficiencies in animal research resources and strengthen 
nationwide General Clinical Research Centers and Biomedical Technology 
and Infrastructure Areas.

               AGENCY FOR HEALTHCARE RESEARCH AND QUALITY
    The lead health care quality agency, AHRQ acts as a ``science 
partner'' with public and private health care sectors in improving 
health care quality, reducing health care costs and broadening access 
to essential services. AHRQ is an active participant in developing 
evidence-based information needed by consumers, providers, health plans 
and policymakers to improve health care decision making. We advocate an 
appropriation of $400 million for the AHRQ to improve health care 
quality, reduce medical errors and expand the availability of health 
outcomes information.

               CENTERS FOR DISEASE CONTROL AND PREVENTION
    Prevention is the best way to protect Americans' heath and ease the 
huge financial burden of disease. Commitment cannot stop at the 
laboratory door. Resources must be made available to bring research to 
places where heart disease and stroke live--the towns and neighborhoods 
of America.
    CDC sets the pace on prevention. It builds a bridge between what we 
learn in the lab and how we live in communities. We advocate an fiscal 
year 2002 appropriation of $5 billion for CDC, with a $350 million 
increase for chronic disease prevention.
    As a result of this Committee's support since fiscal year 1998, 
CDC's Cardiovascular Health Program now covers 25 states. It allows 
states to design and/or implement programs to meet local needs to 
prevent and control heart disease and stroke. CDC's 1997 report 
Unrealized Prevention Opportunities: Reducing the Health and Economic 
Burden of Chronic Disease states ``strong chronic disease prevention 
programs should be in place in every state to target the leading causes 
of death and disability--and their risk factors.'' Until this Committee 
started the Cardiovascular Health Program, CDC's Preventive Health and 
Health Services Block Grant was the only source of federal funding to 
states for targeting cardiovascular diseases, the No. 1 killer in each 
state. An fiscal year 2002 appropriation of $50 million for the 
Cardiovascular Health Program will allow CDC to expand it to 10 more 
states, to total 35 states.
    The Paul Coverdell National Acute Stroke Registry is designed to 
track and improve delivery of care to stroke patients. CDC is working 
with an expert panel to define data points for the registry prototypes. 
An appropriation of $5 million for the registry will allow CDC to 
continue this initiative.
    WISEWOMAN builds on CDC's National Breast and Cervical Cancer Early 
Detection Program to also screen uninsured and low-income women ages 
40-64 for heart disease and stroke risk factors. We laud this Committee 
for providing funding to expand this program up to 15 states. An 
appropriation of $20 million will allow CDC to support up to a total of 
20 states in WISEWOMAN.
    Also, we recommend the following fiscal year 2002 funding levels 
for the following CDC programs:
  --$210 million for the Preventive Health and Health Services Block 
        Grant;
  --$50 million for an extensive nutrition, physical activity and 
        obesity program;
  --$35 million for a comprehensive school health education program; 
        and
  --$130 million for CDC's Office of Smoking and Health to build a 
        national program to prevent tobacco use, including a public 
        education campaign to reduce youth access to tobacco products.
    Coupled with a nationwide comprehensive Cardiovascular Health 
Program, these initiatives will help the fight against heart disease 
and stroke. We urge you to make cardiovascular health a priority.

              HEALTH RESOURCES AND SERVICES ADMINISTRATION
    About 220,000 Americans die each year from sudden cardiac death--
when a heart's electrical rhythms malfunction, causing the heart to 
suddenly stop beating. Only about 5 percent of the victims live. Small, 
easy-to-use devices, AEDs can shock a heart back into normal rhythm and 
restore life. For each minute the heart beat is not restored to its 
normal rhythm, the victim's chance of survival drops as much as 10 
percent. The first responder to a cardiac arrest may not be a medical 
responder, so the Rural Access to Emergency Devices Act, part of Public 
Law 106-505, Public Health Improvement Act, authorizes up to $25 
million over 3 years to help rural communities buy AEDs and to train 
emergency responders to use them. An appropriation of $12.5 million is 
needed to further implement the rural AED component.

                        DEPARTMENT OF EDUCATION
    Physical inactivity is a major risk factor for heart disease and 
stroke. So the grim decline in daily enrollment in physical education 
(PE) classes is a key concern. To address this matter, in fiscal year 
2001 Congress appropriated $5 million for the Physical Education for 
Progress Act. Under PEP, the Education Secretary can award grants to 
start, expand and improve PE for kindergarten through grade 12. Funds 
can be used to buy equipment, develop curriculum, hire and/or train 
staff and support other efforts so students can participate in PE. We 
advocate an appropriation of $70 million for PEP in fiscal year 2002.

                             ACTION NEEDED
    Significantly increasing funding for research and community 
programs will allow us to continue making strides in the battle against 
heart disease and stroke. Our government's response to this challenge 
will help define the health and well being of Americans in this new 
millennium.
                                 ______
                                 

        Prepared Statement of the American Psychological Society

                       SUMMARY OF RECOMMENDATIONS
    As a member of the Ad Hoc Group for Medical Research Funding, APS 
recommends $23.7 billion for NIH in fiscal year 2002 as the 4th 
installment of the 5-year doubling plan.
    APS requests Committee support for increased behavioral and social 
science research and training at NIH in order: to better meet the 
Nation's health needs--many of which are behavioral in nature; to 
realize the exciting scientific opportunities in the fields of 
behavioral and social science research; and to accommodate the changing 
nature of science, in which new fields and new frontiers of inquiry are 
rapidly emerging. Specifically, we ask that you help make behavioral 
research more of a priority at NIH, both by providing maximum funding 
for those institutes where behavioral science is a core activity, and 
by encouraging NIH to advance a model of health that includes behavior 
in deciding its scientific priorities.
    Specific Committee support is requested for behavioral science 
activities at a number of individual institutes and examples are 
provided to illustrate the exciting and important behavioral and social 
science work being supported at NIH.
    Mr. Chairman, Members of the Committee: On behalf of our members, I 
want to thank this committee for your leadership in the bipartisan 
effort to double the NIH budget. As a member of the Ad Hoc Group for 
Medical Research Funding, the American Psychological Society recommends 
$23.7 billion for NIH in fiscal year 2002 as the 4th installment of the 
5-year doubling plan. The rationale for these aggressive increases 
remains as compelling today as it was in fiscal year 1999, the first 
year that you and your colleagues in the House embarked on this path. 
Our Nation's health needs, scientific opportunities, and the changing 
nature of health research all warrant this expansion. I will talk about 
these three areas in terms of the field that I represent, which is 
behavioral and social science research--specifically, psychological 
science research.
    Health Needs.--The effects of behavior on health have been widely 
documented. Behavior is as threatening as any genetic or biological 
condition. When you look at what determines health, you can't help but 
notice behavior. Smoking, drinking, taking drugs--all begin as 
behaviors. And many other leading health concerns are behavioral in 
origin or in their manifestation: Heart disease, lung disease, 
diabetes, mental illness, developmental disabilities, brain injury, 
AIDS, and so many more cannot be fully understood without studying the 
behavioral and psychological factors involved in causing, treating and 
preventing them.
    Scientific Opportunities.--Many of the 15,000 people who belong to 
APS are scientists at our Nation's leading universities and colleges, 
conducting research and training supported by NIH. The behavioral 
research enterprise at NIH spans from theoretical to applied, from 
basic to clinical. Virtually every institute at NIH supports some 
amount of psychological science. Examples include investigations into: 
The connections between the brain and behavior; the basic processes of 
cognition and memory; social interaction in people of all ages; the 
interactions of such things as emotion, stress, and psychophysiology 
and their impact on health; research into how children grow and 
develop; management of debilitating chronic conditions such as diabetes 
and arthritis as well as depression and other mental disorders; and the 
behavioral aspects of smoking and drug and alcohol abuse, to find ways 
people can escape addiction. These topics represent some of the most 
exciting research frontiers today, and our field is poised to make 
significant strides in a number of scientific areas that a few years 
ago didn't even exist.
    Changes in the Nature of Research.--If we didn't know it before, 
the recent publicity surrounding the sequencing of the human genome has 
hit home the notion that we are in a new era of science. In the flurry 
of interviews and opinion pieces that followed the recent publication 
of human genome research articles, leaders of the human genome projects 
and other scientists have repeatedly stressed that genes alone cannot 
explain complex behavior or account for all risks for developing a 
particular physical or mental illness or for behavioral problems. They 
consistently caution against the notion that genes determine behavior. 
As noted by Robert Plomin, a distinguished APS Fellow and pioneer in 
the field of behavioral genetics, the influence of genes on behavior is 
``probabilistic, not deterministic.''
    The implications of mapping the human genome are enormous for 
psychological research. Psychologists and other behavioral scientists 
already are asking such questions as: How do the effects of specific 
genes unfold in behavioral development? How do they interact with 
experience and other environmental factors? In other words, now that we 
have genes, how do they work?
    As just one example of what I mean, psychologists soon may be able 
to use genes to better target behavioral interventions to the people 
who need them most--to tailor our interventions to those at highest 
genetic risk. For example, if we learn that certain genes put children 
at risk for behavioral disorders, say anorexia, depression, or even for 
diabetes, then those are the children for whom we need to develop 
specific prevention strategies. For diabetes, this may mean a much more 
aggressive approach to diet, weight control, and a program to maintain 
compliance with taking medication, an often-ignored but critically 
important and totally behavioral part of managing a disease. What this 
requires, however, is that at the same time we are trying to understand 
how genes influence behavior, we need to more systematically study the 
behavior itself and use that information to develop more targeted 
interventions.
    The emergence of fields such as behavioral genetics draws from the 
progress made both in genetics and behavioral research, and illustrates 
the seamless connection between behavior and biology--a continuum we 
would like to see NIH promote more than it does now. Cognitive 
neuroscience, the combined approach of mapping the brain's 
psychological functioning onto its physical and biological functioning, 
is another such area. Unfortunately, NIH's research and training 
policies sometimes make it appear as if there is an artificial 
distinction between the behavior and biology. There is excellent 
behavioral science work being done at NIH, producing quality knowledge 
and breakthroughs that should be a source of enormous pride for NIH. 
But too often in the NIH model, behavior is ignored, particularly basic 
behavioral research. It isn't until a person gets lung cancer, 
emphysema, heart disease, liver damage, brain damage, that behavior is 
thought of. As important as the molecular and cellular origins of these 
problems are, the behavioral origins are equally important. For 
example, how do the basics of learning, memory, perception, emotion, or 
even social development interact with the biology of various diseases? 
The answer is, there is a great deal of interaction among these 
factors. Almost none of the disorders NIH addresses can be fully 
understood without also understanding their behavioral dimensions.
    Mr. Chairman, I ask you and the Committee to give your fullest 
consideration to these concerns as part of your deliberations on the 
fiscal year 2002 budget for NIH. Specifically, we ask that you help 
make behavioral research more of a priority at NIH, both by providing 
maximum funding for those institutes where behavioral science is a core 
activity, and by encouraging NIH to advance a model of health that 
includes behavior in deciding its scientific priorities.
    Training: A Return on the Investment.--When discussing the budget 
for NIH and other federally-funded science agencies, we often talk in 
terms of investment--putting money into activities where the return 
will be realized somewhere down the road. In providing research grants, 
sometimes we don't know when or even whether there will be a 
significant payoff--we have an extensive review system that helps 
minimize the likelihood of a washout, but still, the outcomes of 
science are unpredictable.
    One part of science where the investment is almost guaranteed to 
payoff is in the area of training. We know that if we provide support 
now for a young investigator, we will have a well-trained, highly-
qualified scientist as a result. We also know that without training, we 
will not have an adequate pool of researchers to pick up where 
preceding generations leave off. Supply is a critical issue in 
behavioral science at NIH. Right now, NIH institutes are competing for 
a comparatively small pool of behavioral science researchers. In fact, 
we are seeing some institutes with new or expanding behavioral science 
programs enticing senior behavioral grantees from sister institutes, 
leaving the ``old'' institutes with critical gaps in their portfolios.
    To address this problem, institutes need to ``grow their own''--the 
responsibility for training behavioral scientists should be shared 
across all of the institutes because of the role of behavior in 
virtually all of the major health issues being addressed by NIH. Toward 
this end, several institutes have established B/START (Behavioral 
Science Track Awards for Rapid Transition) programs of small grants to 
encourage newer behavioral science investigators. This has proved to be 
an effective mechanism and should be used across NIH.
    But training shouldn't be just an issue of supply and demand. As I 
noted earlier, health needs should be the most important factor in 
determining our research and training priorities. In behavioral and 
social science research, training is essential not only to ensure 
future supply of scientists, but also to ensure that our Nation's best 
minds are working on the issues that are most directly linked to 
health.
    Dozens of reports from the National Research Council and the 
Institute of Medicine have recommended increased training for health 
and behavior research. One such report, Bridging Disciplines in the 
Brain, Behavioral and Clinical Sciences, notes that ``newly emerging 
health problems, as well as those that have plagued us over time, are 
proving to be surprisingly complex as scientists and health care 
providers begin to recognize the intricate interplay among environment, 
behavior and disease.'' The report adds that this is ``driving 
disciplines toward each other'' and that ``the next generation of 
scientists must be prepared to integrate the advances of rapidly 
progressing disciplines.'' The report nicely complements the changes in 
the nature of research that I highlighted above.
    Meeting the future needs of research in health and behavior means 
NIH must have a comprehensive training strategy today, a strategy that 
focuses on training young investigators in the core disciplines of 
behavioral and social science research as well as in the 
multidisciplinary perspectives alluded to in the NRC report and 
elsewhere. In addition to encouraging behavioral science training at 
individual institutes, NIH needs an overall plan that will minimize 
unnecessary duplication and will establish an appropriate behavioral 
science training enterprise that can serve the needs that exist 
throughout NIH's institutes and offices.
    We ask the Committee to support the development, in consultation 
with the relevant scientific community, of a comprehensive training 
strategy for behavioral and social science research at NIH. This 
strategy should include all training mechanisms, and should be balanced 
between interdisciplinary research and traditional core disciplines in 
the behavioral sciences.
    National Institute of Mental Health (NIMH).--Translational 
Research--In an effort to more closely link basic and clinical research 
in behavioral science, NIMH is implementing an institute-wide plan to 
expand its ``translational research'' activities that are intended to 
bring knowledge from the lab into practice, and for practice to 
influence what occurs in the laboratory. Responding to recommendations 
from a report conducted under the auspices of its national advisory 
council, NIMH is stimulating new connections between basic and clinical 
research through such mechanisms as: Requests for Application (RFAs); 
providing greater access to clinical populations and collaborators; 
workshops connecting basic researchers with public health and clinical 
investigators; and new peer review procedures that draw on experts from 
both clinical and basic perspectives. NIMH is also considering support 
for translational research centers in behavioral science.
    Basic Behavioral Research.--We applaud NIMH for its efforts to 
promote the transfer of knowledge into application. But basic 
behavioral research at NIMH must continue to receive the same strong 
support it traditionally receives there. This is important not only to 
ensure the foundation of basic knowledge in mental health, but also 
because NIMH is a de facto source of basic behavioral knowledge that is 
tapped by many other institutes. Until other institutes begin to 
support larger amounts of basic behavioral science research connected 
to their mission, it is essential that NIMH's programs of research into 
behavioral phenomena such as cognition, emotion, psychopathology, 
perception, development, and others continues to flourish.
    We ask the Committee to encourage NIMH's continued efforts to 
strengthen the ties between basic and clinical behavioral research, and 
to encourage NIMH's basic behavioral science portfolio in order to 
ensure continued progress in our understanding of the causes, 
treatment, and prevention of mental illness and the promotion of mental 
health.
    National Institute on Drug Abuse (NIDA).--NIDA's dramatic progress 
in addressing the Nation's drug problems (many of which are behavioral 
in nature) has been accompanied by a broadening of its behavioral 
science portfolio. Under the leadership of psychologist Alan I. 
Leshner, NIDA has launched a widescale Clinical Trials Network (CTN) to 
test drug treatment strategies that have proven effective under 
controlled research conditions. Most of the interventions currently 
being tested are based on behavioral treatments, since those have been 
found to be effective. The CTN was recommended by the 1998 Institute of 
Medicine report, Bridging the Gap Between Research and Practice, as the 
single mechanism most likely to improve drug abuse treatment in this 
country. Given the enormous promise of this initiative to improve the 
Nation's drug treatment programs and the urgency of the Nation's public 
health problems associated with drug abuse and addiction, we ask the 
Committee to increase funds for NIDA's Clinical Trials Network in 
fiscal year 2002.
    In addition to the Clinical Trials Network, NIDA's basic behavioral 
research helps treatment providers better understand and address the 
dynamics of addiction. NIDA is placing special emphasis on cognitive 
research because processes such as learning, memory, decision-making, 
and other cognitive factors play a central role in virtually every 
aspect of drug abuse and addiction, including vulnerability, craving, 
relapse, self-regulation, and treatment. The knowledge from NIDA's 
basic behavioral science research has enormous potential for reducing 
demand for drugs at the individual, family and community levels. We ask 
this Committee to increase NIDA's budget as part of an overall policy 
of creating a more balanced and effective drug control strategy for the 
Nation.
    National Institute on Alcohol Abuse and Alcoholism (NIAAA).--
College-age drinking and underage drinking are two behavioral topics of 
enormous concern to the Nation's universities, parents, and 
communities. A subcommittee of the NIAAA national advisory council is 
completing a report addressing various aspects of campus drinking. The 
report, being developed jointly by alcohol researchers and college 
presidents, describes the scope of the problem, examines the 
effectiveness of current interventions, and will recommend priorities 
for developing effective, science-based interventions to reduce college 
drinking.
    NIAAA has made substantial efforts to broaden its behavioral 
science portfolio to understand the underlying psychological and 
cognitive processes that lead people to drink, and the impact of 
chronic alcohol abuse on those processes. As one example, NIAAA 
convened a workshop of national experts on social identification and 
alcohol research to examine ways that peer pressure in groups and group 
norms concerning drinking may influence drinking behaviors. More 
recently, the institute convened a group of experts in cognitive 
research to explore the effects of alcohol abuse on memory, decision-
making, cognitive development, in order to begin looking at issues of 
cognitive rehabilitation.
    Understanding the behavioral origins and manifestations of problem 
drinking and addiction is the key to addressing the Nation's epidemic 
of alcohol-related behavioral health problems, which range from brain 
disease to drunk driving. We ask Congress to increase NIAAA's budget in 
fiscal year 2002 in order to reduce the Nation's alcohol-related health 
problems.
    National Institute of General Medical Sciences (NIGMS).--NIGMS is 
the only national institute specifically mandated to support research 
not targeted to specific diseases or disorders. NIGMS does not now 
support basic behavioral science research, despite the wide range of 
fundamental behavioral topics with relevance to a variety of diseases 
and health conditions. The lack of behavioral science research at NIGMS 
represents is an enormous gap, given the basic behavioral research and 
training that NIGMS should be supporting. Congress addressed this issue 
for the past two years in appropriations reports on the fiscal year 
2000 and fiscal year 2001 budgets for NIH. Specifically, you said: 
``There is a range of basic behavioral research and training that the 
Institute could support, such as the fundamental relationships between 
the brain and behavior, basic cognitive processes such as motivation, 
learning and information processing, and the connections between mental 
processes and health. The Committee encourages NIGMS to support basic 
behavioral research and training, and to consult with the behavioral 
science research community and other Institutes to identify priority 
research and training areas.'' NIGMS has not responded to your 
requests. We continue to believe strongly that NIGMS should develop a 
basic behavioral science research program. Accordingly, we ask the 
Committee to direct NIGMS to develop a plan for basic behavioral 
science research at NIGMS.
    National Cancer Institute (NCI).--NCI has expanded its commitment 
to behavioral research in a comprehensive program that ranges from 
basic behavioral science to research on the development, testing and 
dissemination of disease prevention and health promotion interventions 
in areas such as tobacco use, diet, and even sun protection. 
Recognizing the central role of effective communication in addressing 
issues of health and behavior, NCI has also undertaken a major effort 
to develop science-based communications strategies for disseminating 
information and persuasive messages about cancer prevention and 
treatment to the public. These messages draw from a foundation of basic 
behavioral and social science research into such issues as how people 
learn and remember health information, how they perceive health risks, 
and how they are persuaded to adopt healthy behaviors.
    One of NCI's scientific priorities in fiscal year 2002 is tobacco-
related research. A significant portion of this initiative is devoted 
to behavioral and social science research into such topics as 
identifying populations at risk for tobacco use, formulating effective 
prevention and quitting strategies, and capitalizing on legal, social 
and public policy developments on tobacco use and addiction.
    Other basic behavioral research programs include research to 
develop theoretical models, identify underlying mechanisms of behavior 
change, and to develop and test science-based interventions. For 
example, NCI supports research that examines how stress and 
psychosocial influences on behavior, the central nervous system, the 
immune system, and CNS-immune system interactions affect the 
progression and remission of cancer. Other examples include research 
into the psychophysiological and genetic processes involved in health 
behaviors, and the psychosocial and behavioral consequences of cancer 
risk assessment, including the impact of genetic testing on the 
individual and the family.
    NCI's behavioral research program also supports health promotion 
research, including behavioral science relating to cancer prevention 
and program evaluation. We ask Congress to support NCI's expanded 
behavioral science research and training initiatives.
    National Institute on Aging (NIA).--NIA is a major supporter of 
behavioral and social science research. NIA has reorganized its 
behavioral and social science programs in order to respond to--and 
create--new opportunities in the study of aging processes, how older 
people function in society, and how people change with aging. NIA also 
looks at the social institutions such as family and the health care 
system in terms of their impact on the health of older people. Areas of 
emphasis in NIA's behavioral and social science programs include health 
disparities, aging minds, health expectancy, health, work and 
retirement, behavior change, and the interplay among genetics, 
behavior, and social environment. NIA also supports a significant 
amount of research in cognitive functioning in its neuroscience and 
neuropsychology program, which looks at the effects of aging on memory 
and other brain-based behavioral functioning. We ask the Committee to 
support NIA's commitment to behavioral and social science research on 
aging.
    National Institute on Child Health and Human Development.--Child 
development involves some of the most complex and important questions 
facing behavioral and social science researchers. Understanding the 
interplay among behavior, social and physical environment, and biology 
is central to discovering ways to prevent behavior-based health 
problems ranging from fetal alcohol syndrome to teen pregnancy to 
violence. NICHD's Child Development and Behavior Branch supports 
research on the cognitive, social, and emotional development of 
children from newborns to adolescents. We are concerned that NICHD has 
received a below-average share of NIH's budget increases in the past 
few years; what this conveys, whether intended or not, is that 
children's issues have lower priority in health research. We hope you 
will send a strong counter-message this year, and allow NICHD to 
enhance its child development portfolio. We ask the Committee to 
allocate the necessary resources in fiscal year 2002 to allow NICHD to 
fulfill its mission in these areas.
    On a related topic, NICHD has been supporting the Study of Early 
Child Care and Youth Development, the most comprehensive study to date 
of child care experiences and characteristics and developmental 
outcomes. NICHD is now sharing the rich body of data from the study 
with other qualified researchers in order to allow an even greater 
number of researchers to explore issues around child care, including 
those that may affect child development. We ask the Committee to 
support this study and NICHD's data-sharing initiative.
    NIH Office of Behavioral and Social Sciences Research (OBSSR).--We 
ask the Committee to welcome Raynard Kington as the new director of 
OBSSR, and to encourage him, as he contributes his expertise to NIH's 
``Health Disparities'' initiative, to ensure that the full spectrum of 
behavioral and social science research be brought to bear on this 
important topic as well as on the other initiatives that are within 
OBSSR's purview.
    Communication Disorders, Visual Perception, Diabetes, Brain and 
Behavior.--Although space doesn't permit me to describe fully some of 
the other behavioral science activities across NIH, I want to note the 
impressive behavioral science work being done in such areas as 
communication disorders, visual perception, diabetes, and brain 
research, all of which merits the encouragement and support of this 
Committee. We ask that in fiscal year 2002, support be given to 
expanding the behavioral science research and training programs at 
institutes where this important work is being done.
    This concludes my testimony--I would be pleased to answer your 
questions or provide additional information.
                                 ______
                                 

    Prepared Statement of the American Society of Clinical Oncology

    The American Society of Clinical Oncology (ASCO) represents more 
than 16,000 physicians involved in cancer research and treatment. ASCO 
is the leading voice among medical professional societies concerning 
issues of cancer clinical research. The Society is pleased to have the 
opportunity to comment on fiscal year 2002 appropriations for the 
National Institutes of Health (NIH) and the National Cancer Institute 
(NCI), as well as other issues related to the missions of NIH and NCI. 
These matters are of great importance to clinical researchers, 
physicians, and their patients.

            FISCAL YEAR 2002 APPROPRIATIONS FOR NIH AND NCI
    ASCO applauds the commitment of this Subcommittee and the 
outstanding leadership of Chairman Arlen Specter and Ranking Member Tom 
Harkin to doubling the budget for NIH between 1999 and 2003. This 
panel's commitment has been essential to ensuring predictability and 
stability in NIH funding and allowing scientists to pursue exciting new 
research endeavors. We believe the biomedical research effort of this 
country is so strong largely because of the unwavering support of 
Congress.
    As you know, sustaining progress toward the goal of doubling the 
NIH budget by 2003 requires a funding boost of 16.5 percent in 2002. We 
greatly appreciate the budget amendment sponsored by the Chairman and 
Ranking Member to achieve this effort. We strongly support a 16.5 
percent increase for NIH and will work with you toward that goal.
    In addition, we recommend that funding for NCI be enhanced in 
accordance with the Institute's plan and budget proposal for fiscal 
year 2002 ( the ``Bypass Budget''). As directed by Congress in the 
National Cancer Act of 1971, each year the NCI delivers a ``bypass'' 
budget directly to the President. This process was implemented to 
ensure that the President and Congress directly receive NCI's 
scientific recommendations on the best way to appropriate funds to 
build on research successes, support the cancer research workforce, and 
ensure that recent discoveries are translated into improved patient 
care. For fiscal year 2002, the NCI recommends funding of $5.03 
billion, an increase of $1.27 billion. Funding NCI at this level will 
allow the Institute to fund promising and innovative investigator-
initiated research proposals and facilitate research that capitalizes 
on important advances in molecular biology. ASCO believes the bypass 
budget includes a persuasive rationale for boosting the NCI budget to 
$5.03 billion, and we urge the Subcommittee to begin the new millennium 
by implementing this carefully considered budget proposal.

                 FUNDING FOR CLINICAL TRIALS OPERATION
    If promising basic research advances are to have meaning for 
Americans, they must be translated into medical practice. This 
translation process can only be accomplished through clinical research. 
NCI provides essential support for cancer clinical research. NCI-
sponsored trials represent at least half of all cancer trials. 
Unfortunately, NCI does not provide adequate funding to support the 
grants they award. ASCO funded three surveys in September 1998 to 
examine (1) oncologists' experiences and perceptions associated with 
clinical trial participation; (2) pharmaceutical industry participation 
in clinical trials; and (3) the costs associated with conducting 
clinical trials. The surveys indicated that physicians prefer to 
participate in NCI trials, especially those conducted through the 
cooperative cancer groups. They report that these trials are 
exceptionally well designed, respond to the critical goals of oncology, 
and are intellectually challenging. Participating in these trials, 
however, amounts to an act of good will, since physicians lose money on 
every NCI trial they conduct.
    Conducting a clinical trial requires tremendous resources for a 
physician practice. These resources include trained research nurses and 
data managers and the computer equipment needed to compile and analyze 
the data. In fact, it takes 15 separate activities to enroll patients 
and conduct a clinical trial. The most time-consuming of these 
activities include recruiting patients, seeing patients in the 
physician's office, and completing forms. Overall, 200 hours of work 
are required to see one patient through the clinical trial process. Our 
1998 survey found that the average cost to enroll a patient in a 
clinical trial is $2,000 per patient. Current NCI reimbursement is 
$1,500 per patient.
    Our ability to find better cancer treatments and improved 
understanding of this dreadful disease are inextricably linked to a 
thriving clinical research network. Without proper reimbursement, 
physicians will be pressed to devote less time to clinical research--
especially with the pressure that managed care is placing on practices 
to seek higher reimbursements. If trials are adequately funded and 
supported, we could shorten the length of time it takes to complete 
patient accrual--thus quickening the time it takes to complete research 
and improve patient care. We will not reap the full rewards of our 
increased investment in NIH and NCI unless we provide adequate support 
to the physicians who are conducting clinical trials.

                    CLINICAL RESEARCH STUDY SECTION
    Investigator-initiated clinical research proposals have not fared 
well historically at NIH because they have been reviewed by basic 
researchers who are not well versed in patient-oriented research. ASCO 
has maintained that allowing the proportion of reviewers for such 
patient-oriented research proposals to be dominated by basic 
researchers is inequitable, a position endorsed by several blue ribbon 
panels charged with oversight of the NIH peer review process. 
Furthermore, physician scientists' success in obtaining NIH funding for 
investigator-initiated research has a significant impact on their 
willingness to remain in the field, according to reports. Therefore, 
the research review process has a significant impact on today's 
clinical research and on the future of patient care.
    ASCO has previously brought the issue of peer review of cancer 
clinical research to the attention of this Subcommittee, and the panel 
has supported efforts to improve the grants evaluation process. As a 
result of Subcommittee directives to the NIH, the Center for Scientific 
Review (CSR) appointed a special emphasis panel (SEP) to review 
clinical oncology research proposals. The Clinical Oncology (CONC) SEP 
is composed of clinical researchers who have the expertise and 
experience to evaluate cancer clinical research proposals. We are 
pleased that a number of clinical oncologists sit on the CONC SEP, and 
reports on its work have been positive. We are also pleased that CSR is 
currently in the process of making the CONC SEP into a permanent study 
section. We believe this will result in a system of fair and informed 
review of clinical oncology research.
    Through this transition and the larger CSR transformation of the 
Integrative Review Group (IRG) system, we remain chiefly concerned that 
clinical oncology research proposals are reviewed by committee members 
with expertise in patient-oriented research. External NIH advisors have 
consistently recommended that NIH avoid a review process where basic 
researchers dominate the review of patient-oriented research proposals. 
A majority of the membership of panels reviewing clinical research 
should have experience in reviewing and/or conducting patient-oriented 
research. ASCO urges the Subcommittee to renew its directive to NIH 
officials to maintain a peer review system that has researchers with 
patient-oriented research expertise making up the majority of 
researchers reviewing cancer clinical research proposals. The 
Subcommittee's involvement will be particularly timely, as CSR is 
currently in the process of appointing steering committees and study 
teams to begin work on organizing the Oncological Sciences IRG in the 
coming months. ASCO believes that a rigorous peer review system is 
fundamental to a strong clinical research effort.

                        CLINICAL TRIALS COVERAGE
    ASCO has worked for several years for enactment of the Medicare 
Cancer Clinical Trials Coverage Act, which would require Medicare to 
reimburse the routine patient care costs for those enrolled in cancer 
clinical trials. We are pleased that President Clinton responded to our 
decade-long legislative effort by issuing an Executive Memorandum last 
year that provides Medicare coverage of the routine patient care costs 
of those enrolled in trials. The new Medicare policy lays the 
groundwork for increasing seniors' participation in clinical trials--
thereby improving their access to state-of-the-art care and speeding 
the translation of research discoveries into effective patient 
treatments.
    We are continuing our work to ensure that enrollees of private-
sector health plans have access to this same quality cancer care. We 
have been actively involved in efforts to ensure clinical trials 
coverage provisions in the Patients' Bill of Rights. Although coverage 
for routine patient care costs is not technically a matter for this 
Subcommittee, assurance of such coverage is critical to the efficiency 
of the research enterprise and is therefore surely a concern for this 
panel. Only if treatments can be tested in clinical trials can clinical 
researchers determine their effectiveness. If reimbursement denials or 
the fear of such denials slow accrual to clinical trials, this will 
adversely affect the ability of researchers to answer questions about 
new treatments. ASCO believes it is absolutely necessary that barriers 
to enrollment in clinical trials, including possible reimbursement 
uncertainties or denials, be eliminated.
    ASCO appreciates the opportunity to submit its views on NIH funding 
and clinical research. On behalf of oncologists and their patients, we 
urge Congress to continue its strong support of NIH. We also recommend 
that special attention be paid to the clinical research enterprise to 
ensure that basic research findings are promptly brought to the patient 
bedside.
                                 ______
                                 

  Prepared Statement of the American Society of Clinical Pathologists

    The United States is approaching a serious shortage of medical 
laboratory personnel. The vacancy rates for seven of ten key laboratory 
medicine positions is at an all time high.
    Vacancy rates for cytotechnologists, the professionals who 
interpret cellular material such as Pap smears, and histotechnologists, 
the individuals who prepare tissue specimens, are at a disturbing high 
of over 20 percent. This is a cause for immediate concern as some 
laboratories will not have the appropriate personnel available to 
evaluate Pap smears or prepare biopsies.
    The American Society of Clinical Pathologists' Board of Registry, 
in conjunction with MORPACE International, Inc., Detroit, conducts a 
biennial wage and vacancy survey of 2,500 medical laboratory managers. 
The survey measures the vacancy rates for 10 medical laboratory 
positions, and compares and contrasts these data with that from 1988, 
1990, 1992, 1994, 1996, and 1998 studies. The data for 2000 was 
published in March 2001, and this statement gives a glimpse of what was 
found.
    Vacancy rates for cytotechnologists in the northeast average 45 
percent, 16.7 percent for the east north central, and 33.3 percent for 
the far west. Rural areas average a 20 percent vacancy rate for 
cytotechnologists, and large cities a rather surprising 28.3 percent 
rate.
    Private reference laboratories have an average vacancy rate of 20 
percent for histotechnologists, and hospitals have a 37.7 percent 
shortage of the same profession. The west south central region of the 
country has a 73.7 percent vacancy rate for histotechnologists, and the 
south central Atlantic states have an average vacancy rate of 16.7 
percent.
    By comparison, the vacancy rate for medical technologists will not 
appear to be of concern, but it too is reason for concern. Medical 
technologist vacancy rate averages 11.1 percent, but rural areas show 
21.1 percent vacancy and hospitals with 100-299 beds have a rate of 
17.6 percent.

                      MEDICAL LABORATORY PROGRAMS
    One of the logical solutions to this vacancy rate problem is to 
train more students; however, the number of programs are decreasing.
    According to the ``Health Professions Education Directory'' 
published by the American Medical Association, the number of medical 
technology programs decreased from 383 in 1994 to 273 in 1999. The 
number of graduates in medical technology has similarly decreased from 
3563 in 1994 to 2491 in 1999, a 30 percent decline in five years.

                               ASSESSMENT
    There are several reasons why the vacancy rate is increasing and 
the number of program enrollees is decreasing. A number of available 
positions are outside the traditional clinical laboratory. Some program 
directors have reported that graduates are gaining employment in 
laboratory information systems companies, ``dot.coms,'' and 
corporations that manufacture or distribute diagnostic reagents, 
supplies or equipment. With limited resources, hospitals have merged, 
thus decreasing the availability of training sites for medical 
laboratory programs. Some programs have responded by increasing access 
to other laboratory training sites, such as forensics laboratories, 
blood centers, physician offices, and outpatient clinics. Yet, with 
these shifts, the continued demand for laboratory services is real and 
is expected to grow.
    In Pennsylvania, according to the Bureau of the Census, the 
population is projected to grow by 3 percent by 2020, and the 
population over age 65 is projected to grow by 24 percent in the same 
time period. In Iowa, the population is projected to grow by 4 percent 
by 2020, and the population over age 65 is projected to grow by 37 
percent in the same time period.
    Given the country's aging population, the number and complexity of 
biopsy specimens and the use of molecular techniques will likely 
increase during the next decade. Laboratory professionals who entered 
the workforce in the 1960s and 1970s will be retiring soon. Also, the 
threat of bioterrorism calls for trained laboratory professionals to 
respond. The laboratory-allied health workforce will need to be able to 
react accordingly with appropriate numbers of trained and educated 
personnel.

                               SOLUTIONS
    There are solutions to these problems. There are grants available 
to help attract laboratory professionals to the field, especially 
minorities and individuals in rural and underserved communities. The 
Allied Health Project Grants program, administered by the Health 
Resources and Services Administration, has been successful in 
effectively attracting new allied health professionals into the 
laboratory field.
    For example, the University of Nebraska Medical Center established 
medical technology education sites in four communities in rural 
Nebraska, including a student laboratory in central Nebraska, under an 
Allied Health Project Grant. As of 1999, of 69 graduates, 99 percent 
took their first job in a rural community, and 74 percent took their 
first job in rural Nebraska.
    The grants are also designed to create successful minority 
recruiting and retention programs for medical technologists. This was 
the focus of a University of Maryland, Baltimore project initiated by 
allied health grant funding in 1991. Through utilizing a four phase 
design, which begins with career awareness activities for elementary 
and middle school students, this model provides a continuum of 
activities that progressively focuses on identifying, retaining, and 
advancing interested students to the completion of a baccalaureate 
degree. Because of this program, the University of Maryland, Baltimore 
has attained a current 70 percent minority medical technology student 
enrollment at a majority institution, and an average 89 percent student 
retention rate, placing it among the highest in the country. 95 percent 
of the graduates of this program receive immediate placement.
    Most allied health grant projects continue after federal funding 
ends, making them a long-lasting, worthwhile investment in the future 
of allied health.
    While allied health professionals comprise more than 60 percent of 
the entire health care work force, and number more than 3 million 
individuals, the attention paid to these health professionals is rather 
small. Allied health professionals are involved in the prevention, 
identification, monitoring, and evaluation of diseases, disabilities 
and disorders. The Allied Health Project Grants program is a relatively 
small step in assuring that funding is available to attract allied 
health professionals to the professions and to underserved communities, 
but, given the critical shortages mentioned, it needs to be taken quite 
seriously.
    We respectfully request funding for the Allied Health Project 
Grants in the amount of $21 million.
    The American Society of Clinical Pathologists (ASCP) is a nonprofit 
medical specialty society organized for educational and scientific 
purposes. Its 75,000 members include board certified pathologists, 
other physicians, clinical scientists, and certified technologists and 
technicians. These professionals recognize the Society as the principal 
source of continuing education in pathology and as the leading 
organization for the certification of laboratory personnel. ASCP's 
certifying board registers more than 150,000 laboratory professionals 
annually.
    Thank you for this opportunity to submit written testimony for 
inclusion in the hearing record.
                                 ______
                                 

      Prepared Statement of the American Society for Microbiology

    The American Society for Microbiology (ASM) gratefully acknowledges 
Congress' increased support for the Centers for Disease Control and 
Prevention (CDC), particularly for the CDC's National Center for 
Infectious Diseases (NCID), which supports programs to address emerging 
and drug resistant infectious diseases, public health infrastructure, 
bioterrorism preparedness and food safety. The CDC is the primary 
agency responsible for guarding the public's health, including 
protecting the nation against potentially life threatening infectious 
diseases. The ASM appreciates Congressional recognition for CDC's role 
in responding to the threats of emerging infectious diseases and 
encourages Congress to maintain and renew that support.
    The ASM endorses the recommendation of the CDC Coalition to 
increase the overall CDC budget to $5 billion in fiscal year 2002 to 
provide additional new resources for CDC programs focused on national 
and global health and security. The CDC is called upon constantly to 
identify, control, and prevent outbreaks of disease here and abroad. 
For the past fifty years, members of the CDC's Epidemic Intelligence 
Service have helped solve microbial mysteries, such as the recent 
outbreaks of Legionnaire's disease at a Cleveland automotive plant and 
the unexpected arrival in New York of West Nile encephalitis. Despite 
this nation's successes against certain diseases, our public health 
system continues to be at risk from both new and re-emerging infectious 
diseases, from threats of bioterrorism and antibiotic resistant 
pathogens, and from an aging public health infrastructure. These areas 
are of particular concern to the ASM, which represents more than 42,000 
members from a broad spectrum of microbiology-related professions, 
including microbiologists who work in biomedical, clinical, public 
health, and industrial laboratories.
    Prevention strategies promoted by the CDC promise significant 
rewards in the form of improved public health. Likewise, strong 
financial support for the CDC will give Americans both a healthier 
society and cost-saving benefits. The multi-billion-dollar cost of 
microbial diseases in this country alarms all of us. Foodborne diseases 
alone cost the national health care system more than $3 billion per 
year, added to annual lost productivity estimated at $8 billion. On a 
global scale, the CDC's participation in eradication campaigns like 
that against polio also promises high returns: the United States would 
save more than $230 million annually in vaccine costs, and worldwide 
the estimated savings would exceed $1.5 billion. Investment in a 
stronger CDC undoubtedly will yield measurable positive results in the 
form of disease identification and control, helping to fulfill the 
CDC's vision of a healthier 21st Century. Investment in CDC will also 
enhance national and global security, both economic and political. For 
these reasons, the ASM asks Congress to respond aggressively to threats 
from infectious diseases with generous support of the Centers for 
Disease Control and Prevention.
infectious diseases--threats to national and global health and security
    Microbial pathogens and the diseases they cause persist as a 
leading cause of death worldwide and in the United States. In today's 
global society, it is possible for a new disease to spread 
internationally within days, perhaps hours. It is alarming to realize 
that infectious diseases would cause even more deaths in this country 
if it were not for a persistent federal assault against these 
pathogens.
    The CDC's vision for the 21st Century is ``healthy people in a 
healthy world--through prevention.'' Toward this goal, the CDC launched 
a nationwide effort to protect the public from infectious diseases that 
includes surveillance and response, applied research, infrastructure 
and training, and prevention and control. In 1998 the CDC developed a 
comprehensive plan, ``Preventing Infectious Diseases: A Strategy for 
the 21st Century,'' listing a sobering array of new and re-emerging 
infectious diseases and the obstacles that make stopping these diseases 
so difficult. Last year, Congress passed the Public Health Threats and 
Emergencies Act to strengthen the public health infrastructure in the 
areas of antimicrobial resistance, bioterrorism and major infectious 
disease outbreaks.
    New and re-emerging infectious diseases pose unique challenges to 
the CDC in its role as the nation's prevention agency. More than 35 new 
infectious diseases have been identified since 1973, among them those 
caused by HIV, E. coli O157:H7, and airborne Ebola virus. The ever-
changing threats posed by infectious diseases demonstrate the 
importance of a public health infrastructure capable of rapid and 
accurate disease identification and prevention anywhere in the United 
States or abroad. On-call CDC personnel consistently assist local and 
state health departments across the United States in identifying 
outbreaks due to such emergent microorganisms as the West Nile virus.
    First described in New York State in 1999, West Nile encephalitis 
spread to a wider area during the summer of 2000, carried by mosquitoes 
and underscoring the need to rebuild our capability to deal with 
vector-borne diseases. The CDC's response illustrates its four-pronged 
approach--surveillance and response; applied research; infrastructure 
and training; and prevention and control--to protect the public against 
infectious diseases. The agency developed a national electronic 
surveillance system (ArboNet) to track the virus in humans, birds, 
mosquitoes and horses. It also helped develop rapid laboratory tests to 
detect the presence of the virus, as well as a DNA vaccine that thus 
far looks promising in animal studies. Funding to 49 state and local 
health departments and related training sessions and educational 
materials enhanced the public health system's chance of stopping the 
virus. To prevent spread of the virus, the CDC formulated a large-scale 
emergency plan for mosquito control in affected areas.
    A similar multifaceted CDC program is in place against hepatitis C 
viral infection (HCV), a relatively recent problem in the United 
States. HCV is the most common chronic bloodborne viral infection in 
the United States, where it has infected more than 4 million people, 
nearly 75 percent of whom remain chronically infected. Persistent 
infection often leads to serious medical conditions, possibly cirrhosis 
or liver cancer; in fact, an estimated 40 to 60 percent of chronic 
liver disease is due to this virus. The CDC supports a national survey 
of blood collection centers and hospital transfusion services to 
determine the progress of notifying transfusion recipients who received 
blood from donors who later tested positive for HCV, works with state 
and local health departments to coordinate activities including viral 
hepatitis education and counseling, testing, referral, surveillance and 
vaccination efforts, and coordinates the Hepatitis C Public Information 
Campaign. CDC will continue to fund new studies to monitor the 
transmission of HCV among various populations, enhance support for 
state and local health department programs, and develop and provide 
training to healthcare professionals.
    New infectious diseases are not the only menace to public health. 
Historic killers such as malaria and influenza continue to challenge 
national and global health systems. Of all the emerging and re-emerging 
infections, influenza has the greatest potential to cause catastrophic 
morbidity, mortality, and social disruption both locally and globally. 
Three pandemics in the past century were grim reminders of how 
dangerous influenza can be. The CDC actively supports influenza 
surveillance in other countries, to monitor for variant viruses that 
may cause new pandemics. Agency mathematical models suggest that an 
influenza pandemic could result in a five-fold increase in U.S. deaths, 
compared with non-pandemic years. In a typical year, the disease causes 
an average of 20,000 deaths in the United States, along with more than 
110,000 hospitalizations. Each year brings new influenza viruses and 
fears of even more serious U.S. epidemics, during which up to 40,000 
deaths and 200,000 hospitalizations can occur. The CDC counters such 
persistent problems with long-term, year-round surveillance both in the 
United States and in countries known to be sources of new viruses. As 
with other diseases, the agency also works to improve individual 
states' ability to respond to epidemics and to strengthen the 
international network of laboratories and personnel able to identify 
outbreaks. Recognized as a global leader in responding to any disease 
outbreak, the CDC must be provided with sufficient resources to improve 
its readiness for any future pandemic.
    Antibiotic resistance in pathogens and the threat of bioterrorism 
have further complicated the current global infectious disease crisis, 
forcing health officials to rethink our approach to both old and new 
infectious disease. Overuse of antibiotics contributes to a rising 
incidence of microbial mutants resistant to the traditional 
therapeutic-of-choice. In some areas of the United States, more than 30 
percent of pneumococci resist penicillin, a drug once effective against 
virtually all pneumococcal pneumonia and meningitis. More than 90 
percent of strains of Staphylococcus aureus in U.S. hospitals are 
resistant to penicillin; these strains now are spreading into the 
general community. Other common infections, such as gonorrhea and 
salmonella, also are becoming more difficult to treat. The cost of 
resistant diseases is significant: the U.S. health care system spends 
an estimated $1.3 billion, annually, on the treatment of nosocomial 
infections caused by resistant organisms. It normally costs $2,000 to 
treat a patient for tuberculosis in this country, but if the tubercle 
strain is resistant, that cost may be inflated 100 times.
    On January 18, the Department of Health and Human Services released 
its plan to combat antimicrobial resistance, to be led by the CDC, the 
Food and Drug Administration (FDA) and the National Institutes of 
Health. The plan, which provides a blueprint for coordinated federal 
action, has four components--surveillance, prevention and control, 
research, and product development. CDC personnel and collaborators will 
work with state health departments and others to coordinate and improve 
surveillance methodologies. The CDC already has begun preparation of 
clinical guidelines for health professionals on the best use of 
antimicrobials and on infection control practices, to prevent the 
spread of drug resistance. With the FDA and the U.S. Department of 
Agriculture, the CDC is monitoring resistant nosocomial infections in 
300 hospitals in 15 states. This program complements the CDC's National 
Nosocomial Infection Surveillance System (NNISS) already in place, a 
prototype system for preventing adverse health care events. An 
estimated 44,000 to 98,000 Americans die each year from preventable 
medical errors, which include nosocomial infection. In the past decade, 
hospitals participating in the NNISS have had a 30 percent decline in 
targeted infections.
    Substantial funding and flexibility is needed to enable CDC to 
fully implement the goals set forth in its strategic and comprehensive 
plan against emerging and re-emerging infectious diseases. The ASM 
recommends an additional $120 million in fiscal year 2002 to achieve 
such goals as improving the detection and prevention of emerging 
pathogens, communicating among all levels of government health 
agencies, and integrating laboratory science with on-site epidemiology.

                 BIOTERRORISM PREPAREDNESS AND RESPONSE
    Unfortunately, emerging infectious diseases and drug-resistant 
pathogens could also be used in terrorist attacks. The CDC considers 
bioterrorism as part of its mission against emerging infectious 
diseases here and abroad. It is worrisome that there is no guarantee 
that the nation's current public health infrastructure could adequately 
respond to a bioterrorist event. CDC has joined other federal agencies 
in implementing new programs and expanding others to include 
counterterrorism capabilities.
    To diminish our vulnerability to such attacks, the CDC will 
continue to focus its attention on laboratory capabilities at CDC and 
at State and local health department levels; on the development and 
implementation of rapid diagnostic tests for biological agents; on 
surveillance activities with hospitals, health clinics, private and 
commercial laboratories, as well as with veterinary and agriculture 
partners; on electronic communication capacity at the local level with 
the Health Alert Network (HAN) and the National Electronic Data 
Surveillance System (NEDSS), designed to collect, analyze and interpret 
health-related data in a timely and efficient manner; and on public 
health preparedness and readiness activities such as the education and 
training of both public and private health care personnel, 
firefighters, police officers and emergency medical technicians.
    In fiscal year 2002, ASM recommends that Congress provide an 
additional $100 million for CDC to continue and expand these activities 
to respond to the threat of bioterrorism.

                        BUILDINGS AND FACILITIES
    In protecting American health and safety, the CDC puts science into 
action, shares vital information, and creates partnerships with public 
and private groups concerned with public health. But unless the CDC's 
buildings and physical infrastructure receive more funding from 
Congress, its ability to respond to disease anywhere, anytime, could be 
seriously undermined. The expansion of CDC's responsibilities around 
the world and in the United States has stretched thin the agency's 
infrastructure. CDC buildings in Atlanta cannot house the current staff 
and about half of that workforce labors in nearly two dozen leased 
offices around Atlanta. Much of CDC's laboratory equipment is outdated. 
According to the agency, at present 70 percent of its infectious 
disease scientists and all of its parasitology and environmental health 
specialists work in highly inadequate and potentially hazardous 
laboratories. Last year the CDC began a phased 10-year improvement of 
its Atlanta facilities. As a result, phase I of the infectious disease 
laboratory was completed and opened, and phase II will be completed 
this fall. In addition, the emerging infectious disease laboratory is 
currently being designed and construction has begun on parasitology and 
environmental health laboratories. The ASM appreciates Congress' 
attention to CDC's physical infrastructure needs and urges an 
additional $175 million in fiscal year 2002, for the construction of 
the emerging infectious disease laboratory, the design for the 
environmental toxicology laboratory and routine maintenance projects 
nationwide.
    Thank you for the opportunity to submit ASM's recommendations for 
the hearing record of the House Appropriations Subcommittee on Labor, 
Health and Human Services, and Education, for the CDC's fiscal year 
2002 appropriation.
                                 ______
                                 

      Prepared Statement of the American Society for Microbiology

    The American Society for Microbiology (ASM) appreciates the 
continued bipartisan support of Congress for the National Institutes of 
Health (NIH). Through generous appropriations over the past years, 
Congress has brought biomedical research to the forefront of the 
national agenda and recognized the NIH's pivotal position in serving 
the American public through the support of biomedical research. 
Increased support for NIH not only helps to ensure the continued 
leadership of the United States in biomedical research, but it will 
also allow the United States to address the global health issues in 
infectious diseases that currently threaten national security.
    The ASM commends President Bush's proposal for a record $2.8 
billion increase for the NIH in fiscal year 2002. This proposed 
increase is a major step toward meeting the bipartisan goal set by 
Congress of doubling the NIH budget by fiscal year 2003, enabling the 
Institutes to take greater advantage of the many recent significant 
discoveries affecting human health.
    Within the past few years we have seen exponential advances in 
knowledge in the biomedical sciences. The landmark advances of decoding 
the human genome and sequencing over 30 bacterial genomes, discovering 
new treatments for AIDS, and developing vaccines that can prevent 
meningitis and ear infections in children are only a few of the many 
accomplishments that have set the stage for an even more explosive 
growth in the benefits derived from NIH research.
    The opportunities for substantial return on investment in 
biomedical research have never been greater, and it is essential that 
the NIH be supported at a level to take full advantage of promising 
existing and new areas of basic and clinical research. According to a 
report of the Joint Economic Committee, public investment in NIH yields 
returns to the economy of 25 percent to 40 percent per year. The 
development of the Hemophilus influenzae vaccine to prevent meningitis 
in children, for example, has saved an estimated $400 million yearly in 
treatment and long-term care costs.
    At the same time, we are being challenged by emerging and existing 
infectious diseases, increasing resistance to antibiotics, and 
accumulating evidence pointing to an infectious cause for many chronic 
diseases, such as arthritis, heart disease, and some forms of cancer. 
In addition, each year the cost of illness in the United States totals 
an estimated $3 trillion in health care and lost productivity, 
representing 31 percent of the gross domestic product. The entire NIH 
budget equals less than 1 percent of this annual health-related burden 
on the national economy.
    The ASM, therefore, joins with the Ad Hoc Group for Medical 
Research in endorsing an fiscal year 2002 budget increase of $3.4 
billion (16.5 percent) for NIH to ensure we reach the goal of doubling 
the NIH budget by fiscal year 2003. Such an increase will also enable 
the NIH to increase the total number of research project grants it 
supports, thereby pursuing a greater number of scientific 
opportunities, and to expand training programs, ensuring an adequate 
scientific workforce that can translate research discoveries into 
significant patient care advances.

              PUBLIC HEALTH NEEDS AND INFECTIOUS DISEASES
    Past investments in medical research clearly have benefited both 
the United States and the world in terms of improved health care and 
increased understanding of disease. However, the ASM is concerned about 
the continuing onslaught of infectious diseases, a threat directly 
confronted by NIH-sponsored research. In the United States, infectious 
diseases remain a leading cause of death, with five of the top ten 
killers related to infection (pneumonia, AIDS, chronic liver disease, 
chronic obstructive lung disease and cancer). The estimated annual cost 
of infectious disease in this country exceeds $120 billion. Worldwide, 
infections account for more than 13 million deaths each year, 
potentially undermining both the political and the economic security of 
nations. Seven of the 20 leading causes of global death and disability 
are infectious diseases.
    We can expect previously unknown infectious diseases--as well as 
old diseases with renewed virulence--to continue to imperil public 
health. Microbial diseases that appeared just in the last 25 years 
include legionnaires' disease, HIV/AIDS, Lyme disease, human cases 
linked to mad cow disease, airborne Ebola virus infection, and toxic 
shock syndrome. Medical researchers have identified nearly 40 new 
disease agents since 1973, some capable of massive destruction. In 
1998, HIV/AIDS was the fourth leading cause of death worldwide, 
responsible for an estimated 2.3 million deaths that year. In the 
United States, pathogens such as hantavirus from rodents, the West Nile 
virus, and last year's new hemorrhagic fever virus (the Whitewater 
Arroyo virus) appeared during the past decade without warning, claiming 
human lives and placing new demands on our health care system. A 
recently described hepatitis virus, type C, infects almost 4 million 
Americans. Although numbers of new infections have decreased due to 
better public health efforts, about 9,000 die from HCV each year and 
many more may develop chronic liver disease. HCV is the leading cause 
of liver cancer and one of the major reasons for liver transplants.
    In recent years there has been a resurgence of several long-time 
enemies of public health, historic diseases revitalized by acquired 
antibiotic resistance and expedited by global travel and commerce. 
Increasingly resistant to traditional therapeutics, malaria continues 
to ravage the world's populations, killing an estimated 1.1 million 
each year and infecting 275 million new victims. In response to such 
alarming statistics, the NIH is leading a multilateral initiative 
against malaria, hoping to maximize research against the disease in 
Africa. Another long-time threat, tuberculosis kills about 2 million 
people each year and persists as the eighth leading cause of death 
worldwide, with fully one-third of the global population infected with 
the tubercle bacterium. Once treated effectively with drug regimens, 
bacteria causing tuberculosis are developing multiple drug resistance. 
Not just a problem in developing countries, this more-virulent form of 
tuberculosis has now spread to several larger American cities, a 
disturbing trend in a health care system where antibiotics have become 
the second most commonly prescribed category of drugs.
    Other pathogens, such as salmonella, Staphylococcus aureus, 
enterococci, and the gonorrhea bacterium, are similarly acquiring drug 
resistance, becoming more serious problems in our nation's hospitals. 
More than 90 percent of S. aureus found in U.S. hospitals are now 
resistant to penicillin and beta-lactam antibiotics, for example. In 
intensive care units, nearly one-third of hospital-acquired nosocomial 
infections are resistant to the preferred antibiotic treatment. 
Nosocomial infections caused by just six of the most common kinds of 
resistant bacteria cost the United States at least $1.3 billion 
annually. In response, the NIH, CDC and FDA just released the 
Antimicrobial Resistance Action Plan, a comprehensive, 
multidisciplinary collaboration with private and public groups to 
include surveillance, prevention and control, research, and product 
development. NIH will lead the research component, towards new 
information and technologies and support of clinical studies.
    Among newly recognized infectious agents are those now believed 
linked to chronic disorders heretofore attributed solely to 
environmental or lifestyle factors, thus further complicating our 
efforts to improve the public's health. This new concept of infectious 
diseases will force a reassessment of chronic disease--one example of 
how NIH's focus will change in a new era of medical research. Medical 
experts estimate that infectious agents cause 16 to 20 percent of all 
cancers, and may be the underlying causes of common chronic diseases 
such as diabetes, multiple sclerosis, chronic lung conditions, and 
coronary artery disease. Specific infectious agents already have been 
indicted in certain conditions: for instance, Helicobacter pylori in 
peptic ulcers and Borrelia burgdorferi in some forms of arthritis and 
brain disorders. With advances in genomics, it now is possible to 
identify non-human genetic material in human diseased tissues, making 
this new field of medical research feasible. Investment of research 
dollars promises high returns, as suggested by estimates that more than 
50 percent of stomach and cervical cancers could be avoided by 
preventing their suspected infectious disease etiologies.
    Not only must the NIH focus on infectious diseases in this country, 
it also must address the cumulative burden of disease worldwide. 
Infectious disease agents easily cross national boundaries, creating a 
global health interdependence that impacts the health, economics and 
foreign policy of the United States. Infectious disease has become a 
national security issue, as we become tightly connected to the rest of 
the world physically, commercially and culturally. High incidence of 
mortality and disability can intensify social and political instability 
in countries where the U.S. has significant economic and political 
investments. Infectious diseases also raise the possibility of 
bioterrorism through deliberate spread of dangerous microorganisms. The 
NIH, through its research on diseases that primarily affect other 
countries--such as malaria and cholera--accepts a responsibility 
towards fighting global infectious disease. The ASM urges Congress to 
recognize the NIH's role in national security when determining the 
fiscal year 2002 budget.

        THE NEED FOR BASIC MICROBIOLOGY RESEARCH AND NIH FUNDING
    Scientific knowledge of microbes and their link with larger life 
has expanded exponentially in the last half of the 20th century. 
Scientists studying microbes discovered that DNA was the genetic 
material of life. Many believe that the future of humankind depends on 
our ability to understand microbes and how they work and to take 
advantage of their abilities to solve some of humanity's most difficult 
problems, including the prevention and treatment of infectious 
diseases.
    The path of scientific investigation will shift in the coming 
decades, with new funding needed for a broader scientific base that 
will require much more multidisciplinary research. Genomics is just one 
aspect of the increasingly complex research enterprise needed to combat 
the diseases that afflict humankind. Conquering disease requires 
additional emphasis on environment and infectious disease. In 
particular the physiologies of organisms, that is the actual 
functioning of organisms from microbes to humans, requires 
multidisciplinary inputs. Institutes like the National Institute of 
Environmental Health Sciences need to do more in areas such as the 
environmental reservoirs and transport of pathogens so that we can 
understand the epidemiology of many environmentally borne infectious 
diseases and act judiciously to prevent them. Studies on the 
interactions of genetics, environment, and infectious diseases is 
critical for preventing and treating many human diseases.
    Immediate attention is needed to reverse the decline in the field 
of microbial physiology or we risk losing ground in medical and 
environmental research and discovery. The once flourishing field of 
basic (prokaryotic) microbiology is no longer receiving sufficient 
attention. The decline in funding devoted by the NIH to bacterial 
physiology is compounded by the limited budgetary growth of other 
agencies, such as the National Science Foundation, to support the basic 
cellular biological studies of prokaryotes. Given that an understanding 
of bacterial physiology is a critical underpinning to overall cellular 
studies that are key to the advancement of the broader life and 
biomedical sciences, the NIH would be well served by coordinating with 
other agencies to ensure the adequacy of funding for bacterial 
physiology. This would be an important step for overcoming the shortage 
of qualified scientists with training in bacterial physiology to fill 
the employment opportunities available in biotechnology and biomedical 
research laboratories The ASM recommends that NIH recommit itself to 
rebuilding support for this critical area and to take steps such as 
training grants and requests for proposals to increase the number of 
laboratories, institutions, and scientists working in this area.
    The ASM emphasizes the importance of providing increased support 
for the basic, untargeted research in the biomedical sciences supported 
by the National Institutes of General Medical Sciences (NIGMS), which 
provides the fundamental underpinning for all the disease-oriented 
research done by other NIH Institutes. If we are to sustain the 
momentum of NIH research in the future--and to build upon the notable 
advances made in recent years--it is important to recognize that basic 
and clinical research both are indivisible segments of successful 
medical science. Basic science is at the heart of what the NIH and 
research institutions do best. Basic research is the engine that drives 
scientific creativity and productivity making sustained funding for new 
research projects a particularly critical issue when deciding the 
fiscal year 2002 budget. There must be a high-quality continuum of not 
only new projects, but new scientist training programs, to keep 
American medical science of the future as vigorous as it is today. We 
also need more physician-investigators trained to translate discoveries 
into patient care and lives saved.

                   REQUIREMENTS FOR TODAY'S RESEARCH
    Technological innovation may become the most visible hallmark of 
research in the 21st century, but it is just one aspect of an 
increasingly complex and expensive system needed to combat infectious 
diseases and other threats to national and global health. It is 
essential that financial support of the NIH includes sufficient funds 
for all facets of the research process, whether state-of-the-art DNA 
sequencing equipment or increased stipends for scientists-in-training.
    New pathways to medical discoveries rely upon a complicated, 
interlocking framework of scientific infrastructure, which needs to be 
updated with an infusion of federal funding. Skilled personnel and 
premier research facilities are the foundation of U.S. research and 
make medical advances happen. The more the research landscape changes, 
the more researchers must have expertise outside the traditional 
boundaries of their disciplines, and research facilities must make this 
cross-pollination possible. The fields of bioinformatics, imaging, and 
computer science will repeatedly meld with biology and chemistry. These 
scientific cross-currents will require new and creative training 
programs to produce interdisciplinary scientists, as well as greater 
financial incentives to retain the best of these at federal research 
centers.

                      RESEARCH STEWARDSHIP FUNDING
    The management and support budget of the NIH is decreasing as a 
percentage of the agency's entire budget, a trend that negatively 
affects the best administration of federal research dollars. This 
deficiency undermines the strength of the NIH and its promise to the 
American public to improve health and well-being.

                           ECONOMIC BENEFITS
    Medical advances in the past have directly minimized the cost of 
specific diseases. The United States spent a total of $32 million over 
10 years to support the global smallpox campaign. Economists estimate 
that, every 2\1/2\ months since the world was declared smallpox-free in 
1977, the entire $32 million has been recouped in health cost savings. 
The ongoing anti-polio campaign promises similar results: The United 
States will save more than $230 million annually in vaccine costs, 
while globally, the annual savings is expected to exceed $1.5 billion. 
At the NIH's National Institute of Allergy and Infectious Diseases, 
research costing $31.8 million produced the hepatitis B vaccine, saving 
our health care system an estimated $73.7 million to $146.6 million 
each year. But the price of illness in this country will grow if we are 
not prepared to confront all new and costly diseases, such as 
antibiotic-resistant infections and the inevitable yet-unknown 
pathogens. The NIH, and specifically, the National Institute of Allergy 
and Infectious Diseases (NIAID), is at the center of a national mission 
to stop these diseases, a mission that must be adequately funded in the 
fiscal year 2002 budget.
    The American Society for Microbiology, the largest single life 
science society with over 42,000 scientists, appreciates the 
opportunity to provide these recommendations to the Senate Subcommittee 
on Labor, Health and Human Services and Education Appropriations and 
stands ready to assist the Subcommittee in any way possible.
                                 ______
                                 

  Prepared Statement of the American Society of Tropical Medicine and 
                                Hygiene

    The American Society of Tropical Medicine and Hygiene (ASTMH) 
appreciates the opportunity to submit testimony to present our views on 
fiscal year 2002 funding priorities to the Subcommittee.
    The ASTMH is a professional society of 3,500 researchers and 
practitioners dedicated to the prevention and treatment of infectious 
and tropical diseases. The collective expertise of our members is in 
the areas of basic science, medicine, vector control, epidemiology, and 
public health.
    The staggering burden of tropical and infectious diseases confronts 
us on a daily basis. Poor health and the spread of infectious disease 
across borders have profound effects on the social and economic 
development and stability of nations around the globe. With the 
enormous volume of travel and trade today, and with the expanded 
deployment of American troops, infectious diseases can affect 
populations around the globe within 24 hours. The globalization of 
infectious disease has brought an increased realization that infectious 
diseases represent not only a humanitarian concern but also a bona fide 
threat to the health and national security of the United States.
    Now more than ever, we must be vigilant in our efforts to control 
and eradicate infectious diseases. In this new millennium, we must 
marshal the efforts of government, industry, international 
organizations and private foundations if we are to protect our national 
security against biological and chemical attacks and protect Americans 
against infectious diseases and antimicrobial resistance. Tuberculosis 
(TB) and malaria are renewed threats because they are becoming 
increasingly drug resistant. Monitoring, preventing, and controlling 
antimicrobial resistance requires sustained effort, commitment, and 
collaboration among public and private sectors, with support and 
leadership from the Federal Government.

                  NATIONAL INSTITUTES OF HEALTH (NIH)
    The Society thanks the Subcommittee for your strong leadership in 
the area of biomedical research and for pursuing budget increases that 
will effectively double the NIH budget by fiscal year 2003. Investments 
in NIH have led to an explosion of knowledge that promises to advance 
our understanding of the biological basis of disease and unlock new 
strategies for disease prevention, diagnosis, treatment, and cures. 
Congress responded to these opportunities by pursuing, in a bipartisan 
fashion, an effort to double the NIH budget over the five-year period 
of fiscal year 1999 to fiscal year 2003--and we are now over halfway to 
that goal. The ASTMH joins the Ad Hoc Group for Biomedical Research 
Funding in urging you to maintain support for the Congressional 
campaign to double the NIH budget. We seek your support for an 
appropriation of $23.7 billion for NIH in fiscal year 2002. This $3.4 
billion (16.5 percent) increase represents the fourth step toward the 
bipartisan goal of doubling the NIH by fiscal year 2003, and will allow 
promising research avenues to be pursued, including the development of 
new vaccines and drug therapies for diseases such as malaria, TB, 
dengue fever, cholera and other diarrheal diseases, HIV/AIDS, and a 
myriad of other viral bacterial, fungal, and parasitic disease agents.
    As a result of the increased funding of the NIH, new scientific and 
research opportunities are being pursued that hold the potential to 
prevent and control tropical and infectious diseases around the world. 
Infectious diseases are the second leading cause of death worldwide, 
accounting for over 13 million deaths (25 percent of all deaths 
worldwide in 1999). Twenty well-known diseases--including TB, malaria, 
and cholera--have reemerged or spread geographically since 1973, often 
in more virulent and drug-resistant forms. At least 30 previously 
unknown disease agents have been identified in this period--including 
HIV, Ebola, and hepatitis C--for which no cures are available.
    Additional support for clinical research is needed to take 
advantage of existing opportunities and develop new approaches to 
accelerate efforts to develop vaccines and drug therapies for HIV/AIDS, 
malaria, TB, and hepatitis C. Emerging scientific opportunities and 
recent developments in infectious disease research include sequencing 
the human genome and recombinant DNA technologies for developing new 
vaccines, such as the very successful vaccines against hepatitis B that 
are now given to all children in the United States. Although it will be 
a great challenge, we are optimistic that similar such vaccines can be 
developed against the big three global killers: AIDS, TB, and malaria.

     NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)
    The National Institute of Allergy and Infectious Diseases (NIAID) 
is the third largest institute at the NIH, with a fiscal year 2001 
budget of more than $2 billion, a 15 percent increase from fiscal year 
2000. During the past 15 years three factors have prompted NIAID to 
grow significantly: the emergence of HIV/AIDS in the early 1980s; 
results from basic research that are now driving new approaches to 
solving clinical and public health problems; and the realization that 
infectious diseases will continue to emerge unpredictably and at times 
explosively. There are several important on-going issues relating to 
NIAID's research efforts in tropical and infectious diseases that we 
would like to highlight.
    Acquired Immunodeficiency Syndrome (AIDS).--In the United States, 
an estimated 271,000 people are living with HIV, and the rate of the 
new HIV infections, approximately 40,000 per year, continues at an 
unacceptably high level. NIAID-supported basic research identified the 
HIV protease enzyme as a target for antiviral drugs, which led to the 
development of very potent protease inhibitors, that have prolonged and 
improved the quality of life for many HIV-infected people. However, 
effective, low-cost tools for HIV prevention, such as a vaccine and 
affordable drug therapies, are needed urgently to bring the HIV 
epidemic under control.
    Tuberculosis (TB).--TB is the eighth leading cause of death 
worldwide. One-third of the world's population has latent TB, 
constituting a huge reservoir from which active TB can surface. 
Moreover, multidrug-resistant TB is an increasing problem.
    Malaria.--Malaria has been undergoing a global resurgence in recent 
years, partially related to drug resistance, with 275 million cases 
occurring annually, and a death toll estimated at 1 to 2 million, 
primarily children.
    Hepatitis.--Hepatitis (liver inflammation) can be caused by several 
viruses. The most common are hepatitis A, a food- and water-borne 
infection that is a particular risk for travelers, and hepatitis B and 
hepatitis C, both of which are blood-borne. We now have excellent 
vaccines for hepatitis A and B, but none for hepatitis C, which kills 
about 9,000 Americans annually.
    Emerging Infections.--There are numerous emerging infectious agents 
among the viruses, bacteria, protozoa, and fungi that make up the 
microbial world. Because the frequency of world travel makes the United 
States part of a global community, diseases that emerge in foreign 
countries are also health threats in the United States.
    The Society commends the NIH and NIAID for their continued 
leadership and focus on tropical and infectious diseases. We urge the 
Subcommittee to strongly support efforts of the NIAID to develop new 
and improved methods for treating illness, controlling outbreaks, and 
preventing epidemics that continue to challenge global health.
    Tropical Medicine Research Centers.--The NIH's tropical disease 
research program is funded primarily by the NIAID. This year marks the 
tenth anniversary of the International Centers for Tropical Disease 
Research network, established by NIAID to build new and strengthen 
established partnerships between U.S. scientists and investigators from 
tropical disease endemic areas; NIAID and other government agencies 
with interests in tropical disease research; and academic scientists 
and private industry, to encourage translational and collaborative 
research. The Society strongly urges that the Committee express its 
continued support for these unique research opportunities.

                   FOGARTY INTERNATIONAL CENTER (FIC)
    The Fogarty International Center (FIC) is a unique component of NIH 
with a mandate to support training in biomedical research on behalf of 
the developing nations of the world. The ASTMH wishes to acknowledge 
the significant contributions of the FIC in overall support of tropical 
disease research, and their efforts to train scientists in molecular 
biology and molecular epidemiology techniques of relevance to 
developing countries in which research collaborations will be 
conducted. The new training program in clinical investigation is a 
necessary component of new NIH initiatives such as the HIV Prevention 
and Vaccine Trials Networks and other expanding human research programs 
in the developing world. The Society supports training local 
investigators as an investment in the research itself.

                      TRAINING/CAREER DEVELOPMENTS
    It is clear to those of us who have devoted our careers to fighting 
tropical and infectious diseases that we need to attract the best and 
brightest young students and trainees to our field if we are to take 
full advantage of advances in science and technology and to make 
progress in the global war against infectious diseases. NIAID and the 
Fogarty International Center have taken the lead with initiatives for 
training students and young scientists and clinicians in tropical 
medicine and international health. However, compared to the need, there 
remains a shortage of training opportunities and especially support for 
junior researchers at the point in their training when they must choose 
between more mainstream careers in clinical medicine or other areas or 
research, or the sometimes more challenging path of tropical medicine 
and infectious disease research. We urge you to consider additional 
support for training and career development programs, which we feel are 
most successful when they are integrated with research funding.

            CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
    The ASTMH appreciates the Subcommittee's past support for the CDC's 
infectious diseases program and requests your continued support for 
these critically important public health initiatives. Increased funding 
will help support the development of a national electronic disease 
surveillance network that will enable State and local health 
departments to respond to infectious disease outbreaks and share 
information about infectious disease emergencies and trends. We also 
urge you to continue to fund the CDC's efforts to control global 
malaria.

                               CONCLUSION
    In the 21st Century we must aggressively pursue the battle against 
tropical and infectious diseases, which undoubtedly will intensify in 
the years ahead. We must have adequate surveillance systems and modern 
infrastructure, coupled with scientific expertise in both basic and 
clinical research, if we are to develop the tools necessary to rapidly 
respond to, and control, the threats posed by tropical infectious 
diseases. We stand at the threshold of an exciting new era of medical 
progress, exemplified by the recent completion of the sequencing of the 
human genome. Opportunities for new treatments, diagnostics, cures, and 
preventive measures have never been greater. We must also be prepared 
to confront the new challenges that will lie ahead. The path of 
progress will be different in the coming era, as the demand increases 
for a broader science base, more interdisciplinary research, and 
improved technology.

                                REQUEST
    The Society greatly appreciates your support for our nation's 
investment in infectious disease research, control, and prevention 
activities. We urge you to continue your efforts to double the NIH 
budget over the next five years and towards this end we support an 
appropriation of $23.7 billion for the NIH in fiscal year 2002, with a 
corresponding increase for NIAID. We also request that the Committee 
support increased funding for the CDC's infectious disease activities.
    The Society of Tropical Medicine and Hygiene appreciates the 
opportunity to express our views and for your consideration of these 
requests.
                                 ______
                                 

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

    Good morning. My name is Julie Rish McCord. I am an infection 
control nurse for North Mississippi Medical Center, in Tupelo, 
Mississippi. I am here today representing the Association for 
Professionals in Infection Control and Epidemiology (APIC). APIC is a 
non-profit organization representing nearly 12,000 infection control 
professionals who work across the continuum of health care.
    APIC has long been a strong proponent of science-based programs 
designed to protect patients and health care workers, such as those of 
the Centers for Disease Control and Prevention (CDC). We are extremely 
concerned, however, about regulations that are not based upon sound 
science and are unnecessary and costly to implement. Specifically, I am 
referring to the proposed OSHA rule to prevent occupational exposure to 
tuberculosis (TB).
    OSHA's proposed requirements would place additional burdens on 
health care providers while failing to add protection for health care 
workers. We are in dire need of Congressional assistance in opposing 
this proposed rule. We greatly appreciate the efforts of Congressman 
Roger Wicker, who, at our request, sponsored language in the fiscal 
year 2000 appropriations bill calling for an independent study of the 
proposed rule by the Institute of Medicine (IOM). This study culminated 
in the publication of the report, ``Tuberculosis in the Workplace,'' 
issued by the IOM on January 16, 2001. We would like to highlight seven 
of the report's major findings.
    One: health care workers as a group are not at increased risk;
    Two: the primary risk to health care, correctional, and other 
workers now comes from patients, inmates or clients with unsuspected, 
undiagnosed infectious TB. There is no regulatory standard that could 
ever address this risk, since TB is not even suspected in these 
patients;
    Three: CDC guidelines for the prevention of occupational exposure 
to TB have been implemented, as appropriate, and are working;
    Four: OSHA overstated the risks to health care workers by using 
out-dated information and data from outbreaks to craft a proposed rule 
that is unnecessary and would be ineffective and costly;
    Five: OSHA vastly overestimated the benefit that could be derived 
from implementation of its proposed rule;
    Six: A respiratory protection program should be tailored to the 
level of risk within a facility; and
    Seven: the proposed rule will not allow the necessary flexibility 
for organizations to adopt the TB control measures that are most 
appropriate to the level of risk facing their individual workers.
    The report states, ``. . . if an OSHA standard follows the 1997 
proposed rule it may not offer sufficient flexibility for organizations 
to adopt control measures appropriate for the level of risk facing 
workers. To the extent that an OSHA standard inflexibly extends 
requirements to institutions that are at negligible risk of 
occupational transmission of M. tuberculosis, the standard is unlikely 
to benefit workers at the same time that it would impose significant 
costs and administrative burdens on covered organizations and absorb 
institutional resources that could be applied to other, potentially 
more beneficial uses.''
    With this information, Congress should take further and stronger 
action to ensure that this rule, which will be virtually ineffective 
and overly burdensome to facilities, is not issued.
    I bring this message to you on behalf of my professional 
organization, but I am also speaking to you today as someone who has 
had direct experience with TB disease. My mother was diagnosed with TB 
in the 1950s. In the years that followed, my family and I stood by her 
side as she experienced many complications as a direct result of TB, 
which contributed to her death in 1995. I can tell you from first-hand 
experience that TB is a truly devastating disease. APIC cares very much 
about protecting health care workers (including ourselves) from TB. 
While the intention behind this rule may be sincere, it does not 
address the area of true risk.
    There is no doubt that in the late 1980s, the public health 
infrastructure and health care facilities were not prepared for the 
devastating combination of HIV/AIDS and TB, but the incidence of TB in 
the U.S. is now at its lowest level ever recorded. TB is a public 
health issue, not a facility-specific issue. Health care workers are 
already protected from patients with known or suspected TB. In fact, 
the rate of TB in health care workers is lower than the rate among the 
general population.
    TB is a public health issue because it is in our communities and 
largely undetected. People with active TB disease, who go undetected, 
pose a risk to others until they are identified, isolated and treated. 
Strengthening our public health programs will allow us to target 
prevention and treatment programs to high-risk populations--
particularly immigrants--provide directly observed therapy, and 
thoroughly investigate all cases for spread to contacts.
    With regard to this regulation, I would like to make one final 
point, as someone who has lost a family member to the complications of 
TB. If I believed for one moment that this rule would prevent people 
from contracting this terrible disease, I assure you, I would not be 
testifying before you today. The OSHA TB rule will offer no added 
protection for workers and will be logistically and financially 
burdensome for facilities nationwide. We would appreciate your 
assistance in halting the issuance of a final rule.
    Infection control professionals nationwide wish to thank this 
subcommittee for its long-standing support of the Centers for Disease 
Control and Prevention (CDC), particularly with regard to funding for 
infectious disease programs. Through its efforts and expertise, the CDC 
has been instrumental in national as well as international efforts to 
control the incidence and spread of infectious disease. Since the CDC 
is the primary entity responsible for safeguarding the public's health, 
it is imperative that it be granted adequate resources to perform this 
monumental task. APIC recommends an fiscal year 2002 funding level of 
$5 billion and we hope that the subcommittee will take this into 
consideration during the appropriations process.
    APIC believes that the CDC needs more resources in order to 
adequately address infection prevention and control at both the 
national and international levels. Infectious disease is the leading 
cause of death worldwide and a significant cause of death here in the 
United States. APIC members, many of whom work on the front lines in 
infection control and in public health capacities, recognize the urgent 
need for enhanced prevention measures as well as increased 
surveillance.
    In recent decades, significant progress has been made in the 
prevention and control of many infectious diseases. Today, our efforts 
are confounded, despite our many accomplishments. Changes in human 
behavior, alterations to the environment, deterioration of our public 
health infrastructure, widespread antibiotic usage, and dramatic 
increases in international commerce and travel are factors contributing 
to the proliferation of drug resistance and new and resurgent 
microorganisms.
    For this reason, APIC also strongly supports full funding of Public 
Law 106-505, the Public Health Improvement Act, which includes 
authorization language to address public health emergencies such as 
antimicrobial resistance and bioterrorism. We are requesting:
  --$4 million through fiscal year 2006, to enhance surveillance 
        networks throughout our public health system;
  --$95 million through 2006 to establish competitive grants to address 
        core public health capacity needs to best identify, monitor, 
        and respond to public health threats;
  --$180 million for fiscal year 2002, through 2010, for new facilities 
        construction and renovating existing facilities at the CDC; and
  --$40 million through fiscal year 2006, to establish an Antimicrobial 
        Resistance Task Force, and to establish competitive grants and 
        demonstration programs to conduct research and development for 
        new antimicrobial drugs and diagnostics.
    Federal funding would enhance surveillance sites, strengthen 
epidemiological and laboratory response capabilities and support 
efforts to address emerging infectious disease on a global level. We 
are hopeful that the committee will recognize the absolute necessity of 
this program and provide the highest possible level of funding.
    Thank you for your attention to these concerns.
                                 ______
                                 

 Prepared Statement of the Association of Minority Health Professions 
                                Schools

    Mr. Chairman, thank you for the opportunity to present the views of 
the Association of Minority Health Professions Schools (AMHPS). I am 
Ronny B. Lancaster, Senior Vice President for Management and Policy at 
Morehouse School of Medicine, and President of AMHPS.
    AMHPS is an organization which represents twelve (12) historically 
black health professions schools in the country. Combined, our 
institutions have graduated 50 percent of African-American physicians 
and dentists, 60 percent of all the nation's African-American 
pharmacists, and 75 percent of the African-American veterinarians.
    Mr. Chairman, historically black health professions institutions 
are addressing a pressing national need in carrying out their mission 
of training minorities in the health professions. While African-
Americans represent approximately 15 percent of the U.S. population, 
only 2-3 percent of the nation's health professions workforce is 
African-American. Studies have demonstrated that when African Americans 
and other minorities are trained in minority institutions, they are 
much more likely to: (1) serve in medically underserved areas, (2) care 
for minorities, and (3) accept patients who are Medicaid dependent or 
otherwise poor. This is important Mr. Chairman because the gap in 
health status between our nation's minority and majority populations 
continues to widen due in part to the lack of access to quality health 
care services in minority communities. As a result, we believe it is 
imperative that the federal commitment to training African Americans 
and other minorities in the health professions remains strong.
    In spite of our proven success in training health professionals, 
and the important contribution these professionals make, our 
institutions continue to face a financial struggle inherent to our 
mission. The financial challenges facing the majority of our students 
affect our institutions in numerous ways. For example, we are unable to 
depend on tuition as a means by which to respond to any discontinuation 
of federal support. Moreover, the patient populations served by the 
AMHPS institutions are overwhelmingly poor. As a result, our 
institutions cannot rely on patient care income at a time when the 
average medical school gets 40-60 percent of its operating revenue from 
health care services.
    Mr. Chairman, due to the many challenges facing our institutions, 
AMHPS was very pleased that the Department of Heath and Human Services 
made reducing the health status gap between our nation's minority and 
majority populations a top priority in fiscal year 2001. We look 
forward to continuing to work with all agencies of the Public Health 
Service in fiscal year 2002 to make additional progress toward the goal 
of eliminating all health status disparities by 2010.
    Mr. Chairman, before I present AMHPS's appropriations 
recommendations for fiscal year 2002, I would like to state for the 
record that these programs represent, quite frankly, the difference 
between keeping the doors open or closed at many of our nation's 
minority health professions institutions.

 FISCAL YEAR 2002 RECOMMENDATIONS FOR FEDERAL PROGRAMS OF INTEREST TO 
                                 AMHPS
National Institutes of Health
    Mr. Chairman, I would like to take this opportunity to thank you 
for your support of the establishment of the National Center for 
Minority Health and Health Disparities at NIH last year. As you know, 
ethnic minorities and medically underserved populations suffer 
disproportionately from virtually every major form of disease. Despite 
this longstanding public health problem, the former Office of Research 
on Minority Health at NIH had neither the authority nor the resources 
to adequately address the challenges in this country with respect to 
health status disparities.
    The new National Center and its leadership now have the authority 
to:
  --Directly support biomedical research, training, and information 
        dissemination focused on eliminating health status disparities.
  --Serve in a leadership capacity in developing a comprehensive plan 
        for minority health research at NIH.
  --Participate as an equal when NIH institute and center directors 
        meet to determine research policy.
  --Establish and support research programs at health professions 
        institutions that are studying diseases which 
        disproportionately impact ethnic minority and medically 
        underserved populations.
    On behalf of the minority health community, I would like to commend 
the subcommittee for appropriating $130 million for the National Center 
in fiscal year 2001. Given the immense public health challenge of 
eliminating health status disparities in this country by 2010, AMHPS is 
recommending that the National Center receive an appropriation of $200 
million in fiscal year 2002. In addition, AMHPS strongly supports the 
goal of doubling the NIH budget by fiscal year 2003 and joins with the 
Ad Hoc Group for Medical Research Funding in recommending a 16.5 
percent increase ($3.4 billion) for NIH in fiscal year 2002.
Research Centers at Minority Institutions
    The Research Centers at Minority Institutions program (RCMI) at the 
National Center for Research Resources has a long and distinguished 
record of helping our institutions develop the research infrastructure 
necessary to be leaders in the area of health disparities research. 
Although NIH has received unprecedented budget increases in recent 
years, funding for the RCMI program has not increased by the same rate. 
Therefore, AMHPS recommends that funding for this important program 
grow at the same rate as NIH overall in fiscal year 2002.
Animal Research Facilities Improvements
    Minority health professions institutions have identified a pressing 
need to upgrade our animal research facilities in order to remain 
competitive in the field of biomedical research. We are grateful for 
the subcommittee's support last year of our ``animal facilities 
improvement initiative'' and are pleased to report that a majority of 
our institutions are working with NCRR to upgrade their animal care 
infrastructure.
    To continue this important initiative we urge the subcommittee to 
provide an adequate level of funding within the Developing and 
Improving Institutional Animal Resources program at NCRR to assist the 
remaining schools in improving their animal facilities.
Extramural Facilities Construction
    The minority health professions community thanks the subcommittee 
for its support of NCRR's Extramural Facility Construction program over 
the past two years. It is critical that our nation's research 
infrastructure remain strong if we are to take full advantage of the 
historic increases in biomedical research funding that the Congress has 
provided to NIH.
    Under legislation passed last year, the authorization level for the 
Extramural Facility Construction program was increased from $150 
million to $250 million. Moreover, the new law maintains the 25 percent 
set-aside for Institutions of Emerging Excellence (many of which are 
minority institutions) for funding up to $50 million and allows the 
NCRR director to waive the matching requirement.
    Current funding for the Extramural Facility Construction program at 
NCRR is $75 million. AMHPS encourages the subcommittee to continue its 
strong support for this program in fiscal year 2002 by increasing its 
appropriation by the same percentage as NIH overall.
Research Infrastructure Development
    Mr. Chairman, as we review the priorities of our member 
institutions with respect to NIH, clearly most of our needs relate to 
institutional infrastructure, and those programs which help our schools 
enhance their capabilities to compete for research funding on a level 
playing field. Now that these programs are in place, we believe there 
should be an effort to coordinate these infrastructure development 
programs so our schools can work with NIH to approach them on a 
comprehensive, rather than on a piece-meal basis. It would seem more 
efficient for NIH to work with our schools to collaborate on our 
infrastructure needs, and coordinate efforts to help us build our 
infrastructure.
Strengthening Historically Black Graduate Institutions--Department of 
        Education
    The Department of Education's Strengthening Historically Black 
Graduate Institutions program (Title III, Part B, Section 326) is 
extremely important to AMHPS institutions. The funding from this 
program is used to enhance educational capabilities, establish and 
strengthen program development offices, initiate endowment campaigns, 
and support numerous other institutional development activities.
    Mr. Chairman, we applaud the subcommittee's leadership in securing 
a funding level of $45 million (an increase of $14 million) in fiscal 
year 2001 for this vital program. For fiscal year 2002, AMHPS 
recommends an appropriation of $60 million to continue the vital 
support that this program provides to historically black graduate 
institutions.
Health Professions Training for Diversity at the Health Resources and 
        Services Administration
    The health professions programs supported by this subcommittee are 
the only federal initiatives designed to address the longstanding 
under-representation of minority individuals in health careers. HRSA's 
Minority Centers of Excellence, Health Careers Opportunity Program, and 
Scholarships for Disadvantaged Students, support those institutions 
with a historic mission and commitment to increasing the number of 
minorities in the health professions.
    Mr. Chairman, our schools and students greatly appreciate the 
consistent support of this subcommittee for these important programs 
and recommend the following funding levels for fiscal year 2002:
  --$40 million for Centers of Excellence (an increase of $9.4 million 
        over fiscal year 2001).
  --$40 million for the Health Careers and Opportunities Program (an 
        increase of $7.2 million over fiscal year 2001).
  --$50 million for the Scholarships for Disadvantaged Students program 
        (an increase of $5.5 million over fiscal year 2001).
    Finally, we are working with HRSA and Bureau of Health Professions 
leaders to ensure that the COE and HCOP programs continue to focus on 
providing support to minority serving institutions. Recently proposed 
changes to the eligibility criteria for COE, and the process for 
awarding HCOP grants, have raised some concerns in the HBCU community. 
We look forward to working with the subcommittee to ensure that these 
programs continue to benefit those institutions with the greatest need.
HHS Office of Minority Health
    The HHS Office of Minority Health (OMH) plays a critical role in 
ensuring that all Public Health Service agencies focus appropriate 
resources on improving the health of our nation's minority citizens. 
Although their task is daunting, progress has been made thanks to the 
leadership of OMH.
    OMH has helped our institutions directly by supporting a 
comprehensive study on how our schools can better compete as health 
care providers and educational entities in the age of managed care. 
Moreover, we are working to develop a partnership with OMH in support 
of AMHPS's Annual Symposium on Careers in the Biomedical Sciences. This 
unique event brings together over 1,000 minority and other high school 
and college students each year to expose them to career and educational 
opportunities in the health sciences. Many believe that this is the 
best program of its type in the country.
    To continue the important mission of the Office of Minority Health, 
we are recommending a funding level of $60 million in fiscal year 2002 
(an increase of $11 million over fiscal year 2001).
Centers for Disease Control and Prevention
    Minority populations of many ethnic backgrounds are at an increased 
risk of suffering from low birth weight, infectious disease, sexually 
transmitted diseases, tuberculosis, and other chronic disorders.
    The Centers for Disease Control and Prevention has taken a 
leadership role in combating these problems through its various health 
status disparities initiatives. Because of the proximity of minority 
health professions institutions to disadvantaged, medically underserved 
communities, our institutions frequently partner with CDC in support of 
community based, prevention and control initiatives. We encourage the 
subcommittee to provide CDC with an overall appropriation of $5 billion 
in fiscal year 2002 (an increase of $1.1 billion over fiscal year 
2001).
    Mr. Chairman, once again, thank you and this subcommittee for your 
longstanding support of these very important programs. I appreciate the 
opportunity to present the views of the Association of Minority Health 
Professions Schools.
                                 ______
                                 

          Prepared Statement of Babyland Family Services, Inc.

    Mr. Chairman: On behalf of Babyland Family Services, Inc. I 
appreciate the opportunity to submit this written testimony to you on 
three important initiatives: (1) a Pediatric Health Center; (2) an 
Education Technology project; and (3) a Family Violence and Child Abuse 
Initiative.
    Babyland provides child care and early childhood education services 
for 750 children (0 to five years old) at eight child care centers and 
provides emergency shelter and family support services to 750 other at-
risk and low-income children and families. Babyland is currently 
Newark's Early Head Start grantee (serving children 0 to 3 years old, 
pregnant teenagers, young fathers and families living with HIV/AIDS) 
and has a partnership with the Newark Public Schools to provide Abbott 
preschool services to over 250 children. The agency has an extensive 
partnership with the New Jersey Department of Human Services for the 
provision of child welfare, family violence and child care services. 
Babyland is a leader in Newark for the promotion of accredited child 
care centers and has been recognized by The Annie E. Casey Foundation 
as a model child and family development organization through its 2001 
Families Count Honors Program.
    Babyland is a lead agency for the United Way's Success By 6 
Initiative and the State's Family and Children Early Education Services 
(FACES) Initiative which, combined, provides early childhood support 
services to 2,000 children and over 20 other child care agencies and 
schools. Finally, Babyland and Passaic Beth Israel Hospital have 
partnered to implement the Pediatric Asthma Reduction Effort (PARE), 
which is funded by the Robert Wood Johnson Foundation to develop a 
model pediatric asthma education and management program for children in 
Newark and Passaic.

THE BABYLAND PEDIATRIC HEALTH CENTER: WHERE HEALTHY BEGINNINGS LEAD TO 
                            BRIGHTER FUTURES
    Babyland is seeking $1 million for the rehabilitation or 
construction of a Pediatric Health Center. Babyland is in a unique 
position, as the lead agency for several collaborative initiatives that 
promote the development of young children under six years old, to 
launch a pediatric health initiative that will prevent and manage 
childhood illnesses in Newark. As part of the agency's new multipurpose 
building, this federal funding will enable the agency to include a 
pediatric and family health center that will directly provide basic 
health services to over 1,000 families and provide health education, 
assessments, screening and follow-up services to 2,000 families with 
children under six years old. In addition to the pediatric and family 
health center, the new multipurpose building will include a child care 
center for 137 children (0 to 5 years old), a computer technology 
center, an employment training and placement center and family resource 
center. The new health center will particularly focus on increasing 
immunizations, screening for lead poisoning, asthma management, 
preventive dental care services, nutrition, prenatal care, home safety, 
parent education and child development, HIV/AIDS prevention and other 
preventive health education.
    In partnership with over 20 child care agencies, elementary schools 
and local health care providers, Babyland will develop a coordinated 
community-based approach for residents to gain access to health care 
services. Increased access to health care services will be achieved 
through the following methods: training for over 50 Abbott Family 
Workers who provide case management services for 2,000 preschoolers; 
parent-to-parent workshops that will be part of a series of parent and 
health education workshops; and creative grass-roots efforts that will 
encourage families to utilize the health center's resources. Community 
outreach workers, parents, nurses and a team of other health 
professionals will provide health outreach, education and services. 
Services will be coordinated with the Newark Department of Health, the 
Newark Public Schools and other local health care service providers.
    Matching Funds.--$1 million capital funding from the following: The 
Annie E. Casey Foundation ($500,000 unrestricted award) and $500,000 
from a lender. Operating funds will come from the United Way and the 
State of New Jersey. Other potential funders could include previous 
health-related supporters such as the Robert Wood Johnson Foundation 
and the Healthcare Foundation of New Jersey.

   THE NEWARK PROJECT: A SOLUTION TO THE DIGITAL DIVIDE AMONG URBAN 
                                FAMILIES
    The purpose of this initiative is to serve as a model educational 
program that closes the digital divide among minority inner city 
children and families. This technological network links center and 
home-based child care centers and schools; community resources and 
service providers; educational, economic and resource information 
sources; training centers and administrative offices. The establishment 
of this network will be a model for educating urban children and serve 
as a conduit for comprehensive family support services.
    The focus of this initiative is to establish the telecommunications 
linkages necessary for the educational development of 1,000 preschool 
and school-age children and to provide computer and technology training 
for 2,000 parents, teachers, family service workers and entry-level 
employees. As a result, this initiative will strengthen children's 
educational skills; promote the self-sufficiency of and enhance the 
educational skills of parents; enable the agency to better track child 
and family needs in order to enhance client services; and link the 
community to local and national resource centers.
    Computer technology is transforming the economic and social 
landscape of this country by offering information and educational 
opportunities for individual growth and community development. Inner-
city children and residents are inadequately prepared to take advantage 
of these growth opportunities. If the gap in information technology--
the digital divide--is not bridged, a large segment of society will be 
further polarized and left without the tools needed for full 
participation in society.
    This technology initiative will assist clients who have no other 
tangible means of becoming computer literate and of acquiring the 
requisite skills necessary to be informed and self-sufficient.
Specific Provisions
  --Technology Center, as part of a new multi-purpose community 
        resource and education center, that will provide distance 
        learning, online and network linkages to educational 
        institutions and community resources, professional development 
        and training in basic and advanced computer and technology 
        skills for low-income parents, neighborhood residents and 
        entry-level employees.
  --Technology hardware and software (technical assistance, network 
        installation and expansion, wiring, modems, printers etc.) for 
        children, parents and residents, and teaching/social service 
        staff in classrooms, homes, family resource centers and safe 
        havens.
  --Technology Training, Curriculum Development and Professional 
        Development for children, parents and residents, educational 
        and social services staff, as well as local, State, national 
        and international community-based family service providers.
The initiative will benefit the following
  --Children at nine child care centers (850 preschoolers) and 400 
        school-age children (charter school and after school/summer 
        enrichment programs) at six centers and schools.
  --Parents and family members (2,000) at 14 Babyland sites with links 
        to community resources;
  --Agency Staff (300), including teachers and family service workers, 
        for client tracking purposes; training and professional 
        development; and access to community resources to be provided 
        through workstations, wireless technology and/or palm pilots.
  --Parents and children in the home for educational instruction and 
        support, economic and resource information, links to other 
        parents and teachers, parenting education (child and family 
        health, child behavior and development, cultural sensitivity, 
        etc.) and professional education (ex. Certifications, GED, 
        etc.).
  --Family day care homes with links to community resources, 
        professional education, BFS child care centers and other child 
        and family resource centers.
  --Child and family service providers, throughout Newark, New Jersey, 
        the nation and South Africa, who will receive training in 
        child, family and community development.
Key Outcomes
  --Enhanced early childhood development and education for children 
        (three to 13 years old).
  --Enhanced ability of inner city residents, especially low-income 
        parents and teenagers, to learn computer and technology skills.
  --Enhanced tracking of 1,500 children in center- and home-based child 
        care facilities; teenage parents; victims of domestic violence; 
        homeless families; and children in foster care.
  --Enhanced delivery of professional development of teaching and 
        family service staff.
  --Enhance the provision and delivery of parent education programs.
  --Enhanced delivery of clinical and therapeutic services to parents 
        and children.
  --Enhanced ability to fulfill State and Federal reporting 
        requirements and to provide community development consultation 
        to local, State, national and international family service 
        providers.
    This project received an allocation of $723,000 in the last fiscal 
year. But in order for the system to be fully operational and 
implemented for the entire target clientele population, an additional 
allocation of $2 million is being sought.

                             MEN FOR PEACE
    Babyland is seeking $500,000 under the Administration on Children 
and Families Community Services Block Grant to integrate its family 
violence and child abuse prevention and crisis intervention services in 
order to develop a comprehensive program for 500 children and families. 
Key components of the initiative will include: Intensive family 
reunification and permanency planning for children in foster care; 
counseling for male batterers; parent education; mental health 
counseling; substance abuse counseling; and specialized services for 
at-risk men.
    Babyland currently provides prevention and crisis intervention 
services for 500 abused and neglected children (under five years old) 
and 200 battered women. The agency provides foster care services for 
nearly 300 children (siblings and infants, or boarder babies). Babyland 
is also a lead agency for the Responsible Fatherhood Initiative, which 
utilizes a collaboration of several support service agencies to mentor 
young men who have substance abuse problems.
    This project will enable the agency to integrate and build 
components of its prevention and intervention services that emphasize 
the utilization of men--fathers and male role models--toward the 
reduction of child abuse and domestic violence. This initiative will 
draw upon the strengths of specially trained male role models in 
providing mentorship and parent education for young fathers, counseling 
for batterers and men at risk of abuse or violence as well as outreach 
to fathers with children in foster care. The project will employ 
innovative methods to engage and educate young men and fathers as well 
as comprehensive support services that will promote self-sufficiency 
and family development.
    Matching Funds--$500,000 from the United Way of Essex and West 
Hudson and the NJ State Department of Human Services
    Thank you for your consideration.
                                 ______
                                 

            Prepared Statement of Canavan Research Illinois

    Dear Mr. Chairman: Thank you for hearing my testimony explaining 
why orphan diseases, and Canavan disease in particular, are in 
desperate need of Government funding for medical research.
    Because neurodegenerative diseases are all related, there will be 
gains in medical science that reach far beyond these rare diseases. 
Research for Canavan disease will have a spill over effect, and 
ultimately help millions of Americans.
    I can personally attest to the impact that Canavan disease has on 
the family it affects. Canavan disease develops in early childhood and 
is 100 percent fatal. Canavan disease (CD) is progressive; our children 
lose motor skills until eventually they can no longer even breath or 
swallow. As parents, we are forced to become full time caregivers and 
fundraisers, which puts a tremendous burden on the family, both 
emotionally and financially.
    When I found out that my precious little baby, Max, would die I 
thought that was the end of the world. But, if anything could possibly 
be worse, it was when I realized that in addition to living with this 
disease my family and I would also have to financially support medical 
research in order to give Max a chance. Due to the lack of funding from 
our Government, we the parents of dying children, have worked 
tirelessly raising money to pay for research that may help our children 
enjoy a better quality of life, and possibly live longer.
    While there are approximately ten families who actively raise money 
for research, it is simply not enough to sustain our effort. For 
example, my family has been aggressively fundraising for over three 
years and founded a charity, Canavan Research Illinois. We have raised 
just under a quarter of a million dollars. Though this may sound like a 
lot of money, even when combined with funds from other Canavan 
foundations, it does not compare to the astronomical costs of both 
research and clinical trials. Orchestrating a safety trial is both time 
consuming and costly. Together, families affected by Canavan disease 
have raised over two and a half million dollars in five years, but we 
will need seven million dollars over the next three years to continue 
the research that we have started.
    I have dedicated my life to working towards finding a cure for 
Canavan disease. My husband, Michael, Max, and I live on one moderate 
income, so I can work full time as an unpaid volunteer for the public 
charity I co-founded. I have chosen this path because I believe a cure 
can be found; it is just a matter time, and money. However, as the 
mother of a very sick little boy there are many other demands on my 
time. Max goes to school and therapy everyday, so I spend a great deal 
of time in our van shuttling him from place to place. The time required 
to be a full time caregiver for a profoundly handicapped child with 
multiple disabilities is in itself a full time job. This is why I am 
asking for your help. Help us find a cure, but also help us fund a 
cure!
    Medical research is too expensive to be funded solely by private 
donations. We can no longer do it. We have exhausted our resources. Our 
friends and family have generously donated money when they have been 
asked, but this has decreased over time. We are out of resources, and 
our children are losing precious time. Science cannot move ahead if it 
is only supported by dinner dances, raffles, auctions, and donations 
from friends. I get extremely discouraged when I work forty to fifty 
hours a week fundraising to save my baby and then hear from our 
privately funded researcher that we are out of money, again. This means 
we are out of hope. I have worked too hard to stop now. So I am 
pleading with you, Mr. Chairman that in addition to granting additional 
funds to the NIH, that you encourage them to make a concerted effort to 
look at granting more research funds towards medical interventions for 
the young children afflicted with Canavan disease. The children who are 
dying now deserve a chance.
    While Canavan disease is rare, and may require millions of dollars 
for medical research, the beneficiaries of this research are not 
limited to the Canavan children. There are many related diseases that 
will benefit from this research including: Alzheimer's, ALS, 
Parkinson's, MS, Spinal Cord Injury, and Stroke.
    Canavan disease is a very good model for neurodegenerative disease. 
It is caused by a single mutated gene, which has been identified. The 
defective gene in Canavan children is responsible for making one 
enzyme, which also has been identified. If the doctors and scientists 
had the funds necessary to expand our understanding of CD, we would be 
able to develop a treatment or cure for it and apply this knowledge to 
the other neurodegenerative diseases.
    If you look at all the related diseases it is clear that research 
in one area, will spill over and help research in another. But the 
millions of dollars necessary for this to happen have simply never been 
granted to the Canavan researchers who are working on treatments that 
are ready to be used in human clinical trials. Testing mice and rats 
for ten years will not help the people who are dying today. Because 
there is no funding for the disease my son was born with, he does not 
have access to any treatment.
    I believe that every American is entitled to have access to some 
course of medical treatment. The little children dying of Canavan 
disease deserve a chance. Without Government funding they will not have 
that chance. Many of these children are already medical pioneers and 
have undergone experimental therapies to try and improve their lives, 
and the lives of children in generations to come but, sadly this will 
come to an end. The financial burden of supporting medical research is 
too much for the friends and family of a dying child. Without 
Government grants that will be used towards medical interventions for 
the people who need help now, the science we have all so vigorously 
supported will come to a screeching halt, and our children will die.
    We need research dollars now. Our children are running out of time, 
along with the other people who suffer from degenerative brain 
diseases. We cannot do this alone! The millions of dollars necessary to 
treat and cure Canavan disease will ultimately help millions of people.
    Thank you for receiving my testimony.
                                 ______
                                 

 Prepared Statement of the National Jewish Medical and Research Center

    Mr. Chairman and Members of the Subcommittee, thank you for your 
support last year and the opportunity to present this testimony 
regarding the National Jewish Medical and Research Center's proposal to 
build an integrated Center for Environmental Health Research and 
Service (CEHRS). This Center will, under one roof, support research and 
provide clinical services for patients with respiratory and immune 
diseases with the mission of controlling or eradicating environmental 
and occupational illness in the Rocky Mountain Region. It will serve as 
a regional resource and national model for the delivery of 
environmental clinical health services, conduct both basic and field 
research on environmental illness, and ``translate'' new knowledge, to 
better inform the public and help guide rational environmental policy 
by government, at both regional and national levels.
    National Jewish Medical and Research Center is known worldwide for 
the diagnosis and treatment of patients with environmental, 
respiratory, immune and allergic disorders, and for groundbreaking 
medical research. For the past 20 years, this century-old nonsectarian, 
nonprofit medical center has earned an international reputation for its 
treatment of environmental illness and for research leading to the 
detection and prevention of environmental disorders including asthma, 
berylliosis, tuberculosis, and building-related illnesses.
    With funding from Federal agencies including the NIEHS, NHLBI, 
NIAID, EPA, DOE, and CDC/NIOSH, as well as foundations and private 
industry, National Jewish has become one of the leaders in the field of 
environmental health. National Jewish is deeply committed to providing 
accessible, affordable and high quality care for environmentally and 
occupationally exposed individuals, to consulting for government and 
industries in the region and nationally, and to educating medical 
professionals and the public on matters of environmental risk and 
health.
    Our nation faces a significant challenge for the 21st century--how 
to safeguard the health of the American public from environmental 
hazards. We are faced with the reality that many Americans, 
particularly the working poor, blue collar middle class, minorities, 
children and the elderly, are exposed daily to environmental toxins 
that may cause major lung, heart, immune and allergic diseases, 
disability and untimely death. We must find ways to better diagnose, 
treat and, most importantly, prevent environmental disease. In 
addition, federal agencies and corporations face the daunting task of 
cleaning up environmental ``sins of the past''--without unduly 
endangering the health of today's hazardous waste workers and the 
members of communities that surround them.
    The State of Colorado has historically been medically underserved, 
in environmental health services, with fewer than 40 medical 
practitioners in Colorado who are board certified to practice 
environmental and occupational health. While the Division of 
Environmental and Occupational Health Sciences at National Jewish 
provides consultation to industry, agriculture, community groups, and 
labor, its services are outstripped by the regional need for expertise. 
National Jewish is forced to turn away many patients and groups who 
have environmental concerns because of physical and staffing 
limitations at the Center. These needs range from community groups 
seeking advice on the hazards of radioactivity and of metal-
contaminated soil, to industries needing help in the control of lead 
poisoning and biological hazard exposures, to regional agencies seeking 
aid in the investigation of disease outbreaks caused by airborne molds 
or tuberculosis-like organisms.
    National Jewish is uniquely positioned in the Rocky Mountain region 
to serve as a model health care institution for implementing innovative 
environmental health programs that reduce the risk of respiratory and 
immune system disease. Regionally and nationally, the diseases that are 
treated at National Jewish Medical and Research Center are on the rise, 
including asthma, diseases due to environmental tobacco smoke, 
building-related respiratory and allergic illnesses. National Jewish 
Medical and Research Center specializes in helping both small and large 
regional employers address practical issues of toxic exposure 
assessment, exposure control, medical management of occupational 
illness, and remediation. Employees and their employers, while aiming 
to make the workplace safer and more productive, often lack enough 
information about the toxic effects of airborne chemicals, metals, and 
organic matter that produce disability. Recent studies show that 1 in 
10 hospital admissions is related to a workplace injury or exposure. 
More than half of all patients seen in general medicine clinics in the 
central U.S. report past or ongoing exposure to one or more known 
toxin.
    The solutions to these environmental health dilemmas are to prevent 
exposures from causing disease and, if environmental exposures have 
already occurred, to detect disease earlier and to develop more 
effective treatments for disease.
    National Jewish can best increase our effectiveness by housing 
these major activities in a single, dedicated location. The CEHRS will 
be a showcase for the application of the most advanced environmental 
science and directly to the prevention of disease in groups of 
Americans at environmental risk. By showing how a multidisciplinary 
approach can help eradicate environmental respiratory and allergic 
diseases, our Center will be a model for other centers around the 
country who may address other forms of environmental illness, such as 
those linked to skin disease, neurologic disorders, liver disease, and 
cancer. National Jewish Medical and Research Center believes that by 
maintaining a tight focus of both clinical care and research in an area 
of great need--the respiratory and immune systems--its Center will be 
able to deliver long term solutions to the most important forms of 
environmental disease.
    The CEHRS will meet this need by integrating the following existing 
and new program components in the new Center:
    The Clinic for Environmental and Occupational Health Care.--A 
combined adult and pediatric outpatient clinical practice staffed by 
experienced environmental and occupational health physicians and nurses 
who diagnose and treat environmental disorders. Annually, this clinical 
group screens and evaluates more than 2,000 patients with suspected 
environmental or occupational lung and allergic disorders.
    The Environmental Disease Prevention and Research Service.--A 
multidisciplinary team of physicians, researchers, epidemiologists, 
industrial hygienists, and health educators, who conduct practical 
research aimed at ``real life'' problems solving by measuring airborne 
exposures to toxins and implementing innovative programs that detect 
the effects of chemicals in individuals and in the air. The goal is to 
devise practical, cost-effective solutions to reducing risks of cancer, 
lung fibrosis, and allergic lung disease.
    The Environmental Away-Team Consultation Service.--A mobile 
consultation service staffed by a team of environmental and 
occupational health experts who go anywhere in the country to measure 
environmental exposures, monitor for disease, and advise industrial and 
agricultural employers, labor, and private citizens on the management 
and control of environmental hazards. This service has gone on-site to 
more than 20 states.
    The Respiratory Protection Program.--A mobile service that helps 
individuals and corporations to educate and provide appropriate types 
of masks for people being potentially exposed to airborne hazards. 
Firefighters, hazardous waste workers, municipal employees, and others 
who encounter potentially lethal exposures to highly toxic materials 
call on this service.
    The Environmental Education/Community Outreach Service.--A risk 
communication service that utilizes the internet as well as more 
traditional educational approaches to deliver up-to-date, balanced, 
practical environmental information to civic groups, labor, industry, 
and local and federal government agencies.
    The Occupational and Environmental Medicine Training Program.--
Based at National Jewish and the Department of Preventive Medicine and 
Biometrics at the University of Colorado School of Medicine, this is 
the only training program for environmental medicine in the state of 
Colorado.
    The Environmental Toxicology Section.--A research unit dedicated to 
understanding oxidative stress which is a natural process that produces 
disease when undesirable oxidant gases or dusts are inhaled, causing 
inflammation.
    The Environmental Immunology Laboratory.--A research unit dedicated 
to understanding how environmental toxins cause allergic diseases.
    National Jewish is the only academic research facility in Colorado 
that provides clinical care for patients with suspected environmental 
or occupational illnesses. Patients from the region as well as from all 
50 states come to National Jewish Medical and Research Center for 
medical diagnosis and care. Patients receive superior care without 
regard to their ability to pay. Each year $7 to $10 million of free or 
heavily subsidized care is provided.
    National Jewish was recently ranked as the best hospital in the 
nation for excellence in treating respiratory diseases in U.S. New and 
World Report's ``America's Best Hospitals.'' American Health magazine 
termed National Jewish one of the finest U.S. hospitals in allergy, 
immunology and pulmonology for both adult and pediatric patients. The 
Institute for Science and medicine rated National Jewish among the top 
10 independent biomedical research institutions--of any kind--in the 
world, and the only one that also provides patient care. It was ranked 
as one of the three most influential research institutions for 
immunology and as the number one private immunology research 
institution in the world.
    Partnerships with governmental agencies.--In addition to conducting 
research directly funded by several agencies, National Jewish faculty 
provide advice and consultation to local, regional and Federal 
Government offices, including: the Colorado Department of Health and 
the Environment, the Governor's Air Toxics Science Advisory Committee, 
the U.S. DOE Beryllium Standards Advisory Committee, oversight Boards 
for Hanford Reservation in Washington State, the Nevada Test Site, and 
Los Alamos National Laboratories, the EPA air pollution research 
advisory panel, and the OSHA Metalworking Fluids Standards Advisory 
Committee, and both CDC/NIOSH and NIH research advisory committees.
    Partnership with community health organizations.--Faculty members 
conduct community outreach, speaking at local hospitals on 
environmental health. Three of our faculty have served as presidents of 
the Rocky Mountain Academy for Environmental and Occupational Medicine, 
the regional society for all physicians practicing in this field.
    Partnership with regional industry and labor.--National Jewish has 
helped organize and conduct medical education and medical surveillance 
programs for many regional industries, helping them to protect 
employees from hazards in the workplace.
    National Jewish proposes to continue the public/private partnership 
with the Federal Government by the establishment of the ``Center for 
Environmental Health Research and Service.'' This partnership will 
cover the cost of the construction of a new, 113,000 square foot, 
state-of-the-art facility which will house research in the fields of 
asthma, inflammation, immunology, and environmental medicine. These 
basic and clinical/translational research programs address issues that 
are central to the mission of the Center for Environmental Health 
Research and Services. The new research facility will be closely 
integrated with the clinical care, outpatient services, and training 
programs that our Center for Environmental Health Research and Services 
uses to translate research to improve clinical services for patients 
with respiratory and immune diseases such as asthma, lung fibrosis, 
tuberculosis, and other lung and skin disorders which often stem from 
environmental and occupational hazards.
    The total cost of the proposed facility and equipment is $39 
million. Since fiscal year 1999, National Jewish has received a total 
of $3.75 million from the Labor, Health and Human Services, and 
Education Appropriations Bill under HRSA to carry out the initial 
phases for the construction of the CEHRS and has privately raised $29 
million. National Jewish seeks $5.25 million in HRSA follow-on funding 
in fiscal year 2002 to complete the balance of the construction 
request.
                                 ______
                                 

         Prepared Statement of the Children's Heart Foundation

    Mr. Chairman and Distinguished Subcommittee Members: On behalf of 
The Children's Heart Foundation and all who are suffering with 
congenital heart defects we enter this testimony for consideration at 
the fiscal year 2002 budget hearing. The Children's Heart Foundation 
formally requests to be allowed to testify before the subcommittee 
during hearings on appropriations for fiscal year 2002 to the National 
Institutes of Health.
    According to the NIH Guide: PEDIATRIC DISEASE CLINICAL RESEARCH 
NETWORK (release date May 24, 2000); about 32,000 babies are born each 
year in the U.S. with congenital cardiovascular malformations (CCVM). 
CCVM is considered the most common or number one birth defect and a 
leading cause of death in infants. CCVM occurs at least three times 
more often than childhood cancers and significantly more often than 
pediatric AIDS. The mortality rate for these children may be as high as 
fifty percent, depending on the condition.
    The financial and social impacts on families are staggering. Many 
children who survive infancy are forced into a life of dependency on 
medications, medical procedures, and repeated open-heart surgeries. 
Parents of these children will struggle with high medical costs and low 
productivity when critical care is needed or when the child dies. This 
trauma can throw a family into emotional and financial devastation. In 
1992 nearly $500 million was spent to pay for 44,000 hospitalized 
children who were under fifteen years old.
    Because so few of these children live long enough to have children 
of their own, it has been difficult to carry out genetic studies of 
CCVM. However researchers have now come to the conclusion that most 
CCVM occurrences are caused by genetic deflects. According to 
information provided by the NHL&BI, the direct cause for at leapt eight 
different structural heart defects may be genetic.
    While we at The Children's Heart Foundation applaud the genetic 
studies that have been ongoing at the NIH, we also realize that 
clinical studies on procedures and methods of treatment are vital to 
the future of patients suffering with congenital heart defects. For 
this reason we urge this distinguished committee to encourage the NHLBI 
to support more clinical research related to congenital heart defects.
    In the next few pages we will present the stories of some of the 
families who have lived with these life-threatening conditions. One of 
these families has lost the battle while others still live with the 
daily difficulties that accompany their illness. Please accept these 
testimonies and the request to testify before this committee under the 
auspices of The Children's Heart Foundation.

                                 ANDREA
    My name is Andrea Piwowar. Twenty-three years ago, I was born with 
several congenital heart defects. I was diagnosed with tricuspid 
atresia with transposition of the great arteries and a large 
ventricular septal defect associated with pulmonary hypertension and an 
absent pulmonary valve.
    When I was three months old, I had a banding of the pulmonary 
artery. In January of 1982, I had a modified Fontan, a surgical 
procedure that makes it possible for blood to enter the lungs without 
being pumped in by the right ventricle. This is achieved by connecting 
the pulmonary artery directly to the right atrium. In my situation, 
since I had transposition of the great arteries and a ventricular 
septal defect along with tricuspid atresia, the underlying need for the 
Fontan procedure, the surgeon corrected the transposition and closed 
the hole between the two atria.
    Seven months following the modified Fontan, I had a stroke. In 
December of the same year, I had yet another stroke. It was thought 
that clots were forming in the pulmonary stump; therefore, after the 
second stroke, I was operated on again and the pulmonary stump was 
removed. The doctors could not find where the clots came from. As a 
result of the strokes, which occurred after my corrective heart 
operations, I have both orthopedic and speech impairments and require 
the use of an electric wheelchair for mobility purposes.
    Throughout my childhood, my parents fought for the appropriate 
accommodations to be made in the school systems and for my right to be 
in classes with able-bodied children. I felt likes was necessary for me 
to work harder on class assignments just so I could keep up with the 
class. I also felt that I had to prove myself to my teachers. I am 
proud to say I am now an Indiana University/graduate.
    Like other patients who have had the Fontan operation, I am 
beginning to see some of its side effects. Within two years, I have had 
atrial fibrillation three times, each time requiring a cardio version 
to get back into normal rhythm. I also have an enlarged atrium, which 
is causing my blood return to become sluggish. My first bout with 
atrial fibrillation occurred during the week of college midterms. I 
thought it might have been something that I had brought on myself from 
stress, but I later found out in the hospital that it was a side effect 
from the Fontan procedure.
    No one had informed me of any possible side effects of the Fontan. 
Only by speaking with my cardiologist and reading personal experiences 
of other Fontan patients I am beginning to understand more about the 
side effects; however, I have yet to understand why some people with 
congenital heart defects have strokes while others do not. No one can 
explain why I had two strokes after the Modified Fontan operation.
    It is my hope that as more congenital heart research is performed, 
researchers may discover why some people are more prone to having a 
stroke than others and find a way to prevent them from occurring.

                                  SAM
    My name is Teresa Taylor from Skokie, Illinois and I would like to 
address this committee on behalf of all the children born with 
congenital heart defects, those surviving, and in honor of those that 
have lost their lives including my son, Sam.
    My son Sam and countless others that have died prematurely are not 
forgotten but remembered. And to be a constant reminder for the need 
for additional federal funding for research on congenital heart 
defects.
    Sam was born with hypo plastic left heart syndrome. In other words, 
his left side of his heart was underdeveloped. The left side of the 
heart is the main pumping chamber of the heart and pumps blood to the 
rest of the body.
    The devastation over our son's condition has caused us great sorrow 
and pain. We knew very little in 1993 of his birth defect. There was 
little that we could do except listen to the doctors' prognosis and go 
along with the treatment they suggested. In 1993, the options for Sam 
were immediate open-heart surgery or wait for a heart transplant. We 
opted to place Sam on a heart transplant list. We were told that Sam 
would probably get a heart within the next 6-9 weeks. We did not 
receive a heart when we had thought. The heart for Sam came when he was 
5 months old. He lived in the hospital his whole life on a ventilator. 
I would not call this life support but assistance so that his heart and 
lungs would not flood up with blood while he waited for a heart. Sam 
died two weeks after transplantation. He died due to lung and hospital 
related infections. Because Sam waited only two days short of the 
longest wait for an infant heart doctors did not know what to expect of 
his outcome. Today doctors know that an infant and most likely any 
patient waiting for a heart transplant cannot survive as long as Sam 
did on a ventilator. Because of Sam, doctors know that it is critical 
to find better ways to manage a patient waiting for a heart transplant 
and open-heart surgery. Today at Children's Memorial Hospital in 
Chicago, doctors have perfected open-heart surgery that would have been 
used on Sam instead of transplantation (the procedure is called 
Norwood). Research helped in this matter and patients like Sam helped 
them in their research. Sam and other children paid with their lives to 
help doctors understand congenital heart defects and find ways to 
better manage and treat their condition.
    I have heard countless stories subsequent to our son's death. 
Stories of survivors with the same condition Sam was born with. These 
children are living today because of research in congenital heart 
defects.

                                JESSICA
    My name is Jessica Cowin and I am 16 years old. I have had five 
heart surgeries since I was four days old because I was born with a 
hypo plastic left heart. A hypo plastic left heart is a heart that has 
no left side; in other words I had no pump. At four days and 18 months 
the doctors performed closed heart surgeries on me. At five years and 
13 years, I had open-heart surgeries. All of these surgeries worked, 
for a while, but my heart began to fail in the last two years. The 
doctors and my parents agreed that I needed a heart transplant. It was 
very scary to think that the doctors were going to put someone else's 
heart inside of me, but if I wanted to live longer that's what I had to 
do.
    On September 25, 1999, my mother got a phone call from the 
Children's Memorial Hospital in Chicago (where I have had all of my 
surgeries), saying that they had a heart for me. It has been two months 
since my transplant and even though I am on a lot of medication I 
already feel better. Before the transplant I had no energy and got sick 
more often than other children. I have missed a lot of school in the 
past three years and I missed my friends, too.
    Without the research for congenital heart defects, I would not be 
here today. I was born in 1983 at Children's Memorial Hospital. At that 
time they were not even doing heart transplants there. They started 
doing transplants in 1988, when I was 5 years old. I have personally 
benefited from the research of all of my five surgeries.
                                 ______
                                 

           Prepared Statement of the City of Miami Beach, FL

    Mr. Chairman: On behalf of the City of Miami Beach, Florida, I 
appreciate the opportunity to submit written testimony on an extremely 
important program the City has undertaken to serve its elderly 
community both now and in the future. The City is seeking $500,000 in 
fiscal year 2002 appropriations through the Administration on Aging for 
the City's Elder Ready Community Pilot Initiative. We believe that this 
pilot project can serve as a national model for aging services programs 
as the nation's population continues to age.

                 ELDER READY COMMUNITY PILOT INITIATIVE
    The Elder Affairs Office is part of the Housing Division of the 
City of Miami Beach, a public entity. The office assists the elder 
population in obtaining appropriate services through its information 
and referral service. Staff also identifies and coordinates services 
available in the community and serves as a liaison with other 
governmental and community based organizations. In addition, the Elder 
Services Initiative includes a needs and assessment that identifies 
programs that will enhance senior life on Miami Beach.
    As you may know, the City of Miami Beach has traditionally been a 
destination for retirees. Over the last decade, the City has been 
revitalized as a tourist destination and as a business center 
attracting a younger resident population. At the same time, from 1990 
to 2000, the population group ages 44 to 65 has increased from 19.4 
percent to 23.2 percent of the City's total population. A key component 
of the Elder Services Initiative is the Elder Ready Communities 
Initiative that was developed by the Florida Department of Elder 
Affairs and was officially announced during Older Americans Month, May 
2000. It seeks to enhance recognition of both the value of elders to 
Florida's communities and the need to plan for the accelerated 
demographic changes over the next ten years as the ``baby boomer'' 
generation reaches seniority. In order to seek the designation of the 
City as an Elder Ready Community, the Elder Affairs Office requests 
direct funding through the to undertake a comprehensive assessment of 
its elder community in regard to housing, transportation, city 
infrastructure, the business community and the availability of 
services.
    The City of Miami Beach estimates that the cost of implementing an 
Elder Ready Pilot Program will be $500,000. The City has currently 
allocated an annual budget of $65,000 in general funds for its Elder 
Affairs Programs. In addition, the City has committed fiscal year 2000/
2001 Community Development Block Grant funds in the amount of $90,000 
and $65,000 in general funds to local providers of services to the 
elder community.
    At this time, the City of Miami Beach is not receiving funding for 
this pilot program from any other Federal agency.
    Florida is at the forefront of elder related issues that will 
greatly impact the rest of the country during the next decade. Florida 
has the largest proportion of elders of any state in the nation and all 
projections indicate that this will continue to be the case for the 
foreseeable future. The Florida Department of Elder Affairs leads the 
country in its creation of the Elder Ready Communities Initiative. The 
findings of this pilot project could be replicated in other 
municipalities across the country as the population continues to age. 
Through research, surveys and the ongoing commitment of the community, 
new and innovative systems can be implemented for the health and 
vitality of the entire City as well as for the rest of the country.
    We hope you will find this critically important pilot project 
worthy of your support.
    Thank you for your consideration.
                                 ______
                                 

              Prepared Statement of the City of Newark, NJ

    Dear Mr. Chairman: The City of Newark, NJ hereby submits for the 
record, testimony regarding three innovative projects that are of great 
importance to the State of New Jersey's largest City. The projects 
described below each address an aspect of the needs of Newark's low 
income population. They are: (1) the Emergency Medical Services 
Demonstration Project, (2) the Children's Health Care Services and 
Outreach Center and (3) Babyland Family Services-A Solution to the 
Digital Divide among Urban Families.
  newark coordinated emergency medical services demonstration project
    The objective of Newark's Coordinated EMS Demonstration Project is 
to develop a coordinated model for a City-wide system for efficient 
patient transportation and emergency services utilization, tracking and 
billing. Funding is requested to assist in the design and 
implementation of a system which will assure transportation of patients 
to the appropriate specialty hospital or other medical facility. The 
system will include a billing and service allocation component to 
reduce inefficiencies and deter fraud, waste and abuse. The system will 
be coordinated with the City's 911 integrated dispatch, to insure the 
timely transfer of calls and delivery of services. The City's dispatch 
center handles over 300,000 calls for service per year, and must 
efficiently channel calls for medical service to the EMS system in a 
manner that allows for tracking of services while transferring 
operational responsibility. Over 100,000 calls for service per year go 
to the Emergency Medical Services system in Newark.
    Currently, the City of Newark contracts with the University of 
Medicine and Dentistry of New Jersey (UMDNJ), through University 
Hospital, to provide a complete system of dedicated 911 emergency 
medical services. These services include: basic life support units 
integrated with advanced life support services, emergency treatment and 
transportation to local area hospitals as defined in an Approved. 
Hospitals for Patient Transport policy, heavy rescue and vehicle 
extrication, and service as the lead agency in response to mass 
casualty incidents within the City. UMDNJ provides centralized medical 
dispatch communications per NJ State requirements, and the interface 
with City E911 services is crucial to both efficient and effective 
dispatching, as well as to securing appropriate and adequate 
reimbursement for services.
    The combination of an increase in the number of calls for service, 
tremendous advances in available technology, and pressures on the 
billing system present both a challenge and an opportunity for a unique 
demonstration project. The City of Newark's Police Computer Aided 
Dispatch system is the central point for 911 emergency calls, and calls 
to it for medical assistance are transferred to UMDNJ. However, calls 
for assistance can also be placed directly to the emergency medical 
assistance provider. There is no integrated system which can track all 
calls, the disposition of them, and ultimately, the payment for them. 
The reimbursements paid by the City, Medicaid, Medicare, the State's 
Charity Care system, and managed care providers do not cover the cost 
of capital expenditure for system upgrades. Further, the integration of 
the City's E911 system with the UMDNJ system cannot currently be funded 
through municipal sources, due to other needs and demands. The City is 
now unable to track and verify EMS services and billing to residents 
and/or third parties for which it is responsible. Therefore, an 
allocation of $5 million is requested to establish a much needed 
demonstration project for an integrated system for coordinated delivery 
of emergency medical services.

       NEWARK CHILDREN'S HEALTH CARE SERVICES AND OUTREACH CENTER
    The objective of the Newark Children's Health Care Services and 
Outreach Center is to positively impact on the health of Newark's 
children through the development of a coordinated health care system 
that will allow the City to bring health care services to the 
community. The Children's Health Care Services and Outreach Center will 
provide a coordinated approach to offering health and social services 
to uninsured/underinsured pregnant women and children between the ages 
of 0 through 5. The City's Department of Health and Human Services will 
partner with other community organizations and hospitals to provide a 
full spectrum of health, social services and mental health services. At 
minimum, the Center will provide services that include, pre-conception 
counseling, early pregnancy testing, pre-natal care, substance abuse 
counseling and referral services, family counseling, pediatric practice 
with related services including WIC, immunization, nutritional 
counseling and case management services. Health education will be 
offered to develop parenting skills and managing households.
    Through the use of focus groups, the DHHS will assess and re-
evaluate Newark residents' use of existing services. Focus groups will 
be conducted to analyze barriers to services and residents utilization 
rates. Based upon the analysis, the DHHS will design the Children's 
Health Services and Outreach Center as a consumer friendly service 
center.
    The City of Newark has been designated by the Centers for Disease 
Control and Prevention as a pocket of need for children. An analysis of 
trends in the City of Newark reveals that one-fifth of Newark resident 
births in 1996 were to teenage mothers (under age 20). Teenage mothers 
have accounted for 1 in 5 Newark resident births from 1989 through 
1996. Over one-half of Newark resident women who delivered in 1996 
began pre-natal care in the first trimester of pregnancy. In contrast 
three fourths of all New Jersey mothers giving birth in 1996 began pre-
natal care in the first trimester. Since 1989 the percentage of Newark 
mothers receiving pre-natal care in the first trimester has generally 
declined for all age groups. In fact, the rate of mothers giving birth 
in 1996 who received no pre-natal care was six times as high for Newark 
(8.3 percent) as for the State as a whole (1.3 percent). By race, 
nearly 12 percent of black mothers in Newark and 3 percent of white 
mothers received no pre-natal care.
    In 1996 the number of Newark resident infant deaths 80, a 14.3 
percent increase over the 70 infant deaths in 1995. Notwithstanding 
this one year increase, the number of resident infant deaths in Newark 
decreased from a high of 189 deaths in 1989 to the current level. Neo-
natal deaths have been increasing over the past 8 years, from 52 
percent of the total infant deaths in 1989 to 58 percent in 1996. The 
leading cause of death for infants in Newark in 1996 is low birth-
weight. The second leading causes of death were congenital anomalies 
and sudden infant death syndrome.
    Other ailments that affect the health of Newark children include 
pulmonary dysfunctions such as asthma and lead poisoning. As of 
December 31, 1998, Newark had a caseload of 1,613 children under age 
six with blood lead levels over 20 ug/dL. In 1998 an average of 25 
percent of nearly 2,000 children tested had blood lead levels over 20 
ug/dL.
    In addition to services available at the Center, there will be an 
outreach team that will provide Newark residents with a mechanism that 
will link them to all services currently provided within the City of 
Newark, and that are identified through the focus groups. Teams will be 
assigned to identified neighborhoods, and will be comprised of a Public 
Health Nurse, Social Worker and Outreach worker. The teams will be 
responsible for visiting Newark children as well as older residents and 
assessing health and service needs. Working in coordination with 
neighborhood community based organizations, city-wide faith based 
agencies and area hospitals, citizens will be provided with referrals 
for care and services. There will be specific emphasis on reaching 
young mothers and their children who have not been previously involved 
with the health care system and available services.
    Through the centralization of services, we believe that we can 
increase access to the array of health and social services needed by 
Newark residents to raise healthy children. The City seeks $2.5 million 
from the Centers for Disease Control (CDC) to support this initiative.

                     BABYLAND FAMILY SERVICES, INC.
   THE NEWARK PROJECT: A SOLUTION TO THE DIGITAL DIVIDE AMONG URBAN 
                                FAMILIES
    The purpose of this initiative is to serve as a model educational 
program that closes the ``digital divide'' among minority inner city 
children and families. This technological network links center and 
home-based child care centers and schools; community resources and 
service providers; educational, economic and resource information 
sources; training centers and administrative offices. The establishment 
of this network will be a model for educating urban children and serve 
as a conduit for comprehensive family support services.
    The focus of this initiative is to establish the telecommunications 
linkages necessary for the educational development of 1,000 preschool 
and school-age children and to provide computer and technology training 
for 2,000 parents, teachers, family service workers and entry-level 
employees. As a result, this initiative will strengthen children's 
educational skills; promote the self-sufficiency of and enhance the 
educational skills of parents; enable the agency to better track child 
and family needs in order to enhance client services; and link the 
community to local and national resource centers.
    Background: Computer technology is transforming the economic and 
social landscape of this country by offering information and 
educational opportunities for individual growth and community 
development. Inner-city children and residents are inadequately 
prepared to take advantage of these growth opportunities. If the gap in 
information technology--the digital divide--is not bridged, a large 
segment of society will be further polarized and left without the tools 
needed for full participation in society.
    Babyland has been a major non-profit child and family service 
organization in Newark, New Jersey for over 33 years and currently 
provides comprehensive child and family development services to 1,500 
at-risk children and their families each year. BFS programs provide a 
continuum of educational services to individual children from infancy 
to 18 years old (including teenage mothers and young fathers) as well 
as multiple support services for family members. The agency is able to 
build extensive relationships with families and to provide follow-up 
care. As a result, Babyland is in a unique position to launch and 
oversee a major computer and technology initiative that will provide 
extensive training and technology support for individual families. This 
technology initiative will assist clients who have no other tangible 
means of becoming computer literate and of acquiring the requisite 
skills necessary to be informed and self-sufficient.
Specific Provisions
  --Technology Center, as part of a new multi-purpose community 
        resource and education center, that will provide distance 
        learning, online and network linkages to educational 
        institutions and community resources, professional development 
        and training in basic and advanced computer and technology 
        skills for low-income parents, neighborhood residents and 
        entry-level employees.
  --Technology hardware and software (technical assistance, network 
        installation and expansion, wiring, modems, printers etc.) for 
        children, parents and residents, and teaching/social service 
        staff in classrooms, homes, family resource centers and safe 
        havens.
  --Technology Training, Curriculum Development and Professional 
        Development for children, parents and residents, educational 
        and social services staff, as well as local, State, national 
        and international community-based family service providers.
The initiative will benefit the following
  --Children at nine child care centers (850 preschoolers) and 400 
        school-age children (charter school and after school/summer 
        enrichment programs) at six centers and schools.
  --Parents and family members (2,000) at 14 Babyland sites with links 
        to community resources;
  --Agency Staff (300), including teachers and family service workers, 
        for client tracking purposes; training and professional 
        development; and access to community resources to be provided 
        through workstations, wireless technology and/or palm pilots.
  --Parents and children in the home for educational instruction and 
        support, economic and resource information, links to other 
        parents and teachers, parenting education (child and family 
        health, child behavior and development, cultural sensitivity, 
        etc) and professional education (ex. Certifications, GED, 
        etc.).
  --Family day care homes with links to community resources, 
        professional education, BFS child care centers and other child 
        and family resource centers.
  --Child and family service providers, throughout Newark, New Jersey, 
        the nation and South Africa, who will receive training in 
        child, family and community development.
Key Outcomes
  --Enhanced early childhood development and education for children 
        (three to 13 years old).
  --Enhanced ability of inner city residents, especially low-income 
        parents and teenagers, to learn computer and technology skills.
  --Enhanced tracking of 1,500 children in center- and home-based child 
        care facilities; teenage parents; victims of domestic violence; 
        homeless families; and children in foster care.
  --Enhanced delivery of professional development of teaching and 
        family service staff.
  --Enhance the provision and delivery of parent education programs.
  --Enhanced delivery of clinical and therapeutic services to parents 
        and children.
  --Enhanced ability to fulfill State and Federal reporting 
        requirements and to provide community development consultation 
        to local, State, national and international family service 
        providers.
    This project received an allocation of $723,000 in the last fiscal 
year. But in order for the system to be fully operational and 
implemented for the entire target clientele population, an additional 
allocation of $2 million is being sought.
    The City of Newark wishes to express its deep appreciation to this 
Committee for permitting the presentation of these important projects. 
Your positive response for Newark's request for support will have a 
positive impact on the health and well-being of Newark's citizens.
                                 ______
                                 

           Prepared Statement of Mississippi State University

    Mr. Chairman and Members of the Subcommittee, thank you for the 
opportunity to submit this testimony regarding the National Institutes 
of Health Institutional Development Award (IDeA) program. I am Dr. 
Robert Altenkirch, and I am Vice-President for Research at Mississippi 
State University. I also serve as EPSCoR State Project Director in 
Mississippi. I submit this testimony on behalf of the Coalition of 
EPSCoR States.\1\
---------------------------------------------------------------------------
    \1\ Alabama, Alaska, Arkansas, Idaho, Kansas, Kentucky, Louisiana, 
Maine, Mississippi, Montana, Nebraska, Nevada, North Dakota, Oklahoma, 
Puerto Rico, South Carolina, South Dakota, Vermont, West Virginia, and 
Wyoming.
---------------------------------------------------------------------------
    I would like first to express my gratitude to Senator Cochran for 
his strong support of the IDeA program and the related Experimental 
Programs to Stimulate Competitive Research (EPSCoR) in other federal 
agencies. Senator Cochran has been a strong advocate of IDeA because he 
understands the importance of enhancing our nation's biomedical 
research infrastructure by building the research capacity of 
Mississippi and the other IDeA states. We Mississippians greatly 
appreciate his leadership on IDeA and a whole host of issues important 
to Mississippi. We are proud to have him represent us in the United 
States Senate.
    IDeA was authorized by the 1993 NIH Revitalization Act (Public Law 
103-43). IDeA works to improve our nation's biomedical research 
capacity by enhancing the capability of states that have not yet 
substantially participated in the NIH's research endeavors. The NIH has 
identified the following states as eligible for IDeA funding: Alaska, 
Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, 
Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, 
North Dakota, Oklahoma, Rhode Island, South Dakota, South Carolina, 
Vermont, West Virginia, Wyoming and the Commonwealth of Puerto Rico. 
IDeA acknowledges that nearly one-half of the states do not have an 
adequate R&D infrastructure in the biomedical sciences. Clearly this is 
not in the long-term best interest of our nation.
    IDeA is important, Mr. Chairman, because NIH research funds are 
extremely concentrated geographically. The 24 states that participate 
in IDeA received just 5.3 percent of NIH research funding over the 
fiscal year 1994-fiscal year 2000 period, while the top state alone 
received nearly three times that amount. The five most successful 
states combined received 48 percent of NIH funding over the same 
period.
    For example, according to data compiled by the Social Science 
Research Center at Mississippi State University, Mississippi received 
$20 million in NIH research funding in fiscal year 1999, compared with 
a national average of nearly $250 million per state. Alaska received 
just $2 million, Idaho received $3 million, and New Hampshire received 
$50.3 million--all a fraction of the national average.
    Our country has embarked on a great endeavor: to increase 
substantially the NIH research budget--possibly even doubling research 
funding over the next five to seven years. Many scientists and Members 
of Congress support this worthy goal, and I applaud this important 
effort.
    While I strongly support efforts to increase biomedical research 
funding, I think it crucial that all regions of the country participate 
in this effort--not just existing centers of excellence in a small 
handful of states. If we are to double research funding we need to 
enhance our research capacity by including a greater portion of the 
country in our research endeavors. Every region of the country has 
talent to contribute to our nation's biomedical research efforts--and 
every region of the country should have the opportunity to nurture and 
develop their talent pool into individuals and centers that can compete 
successfully for NIH funding and develop the biomedical R&D base across 
our nation.
    The 24 IDeA states have fine research institutions that are home to 
many talented researchers. The institutions and researchers in these 24 
states should play a significant role in our nation's effort to expand 
research capacity; they are crucial to any serious effort to improve 
our nation's ability to treat, cure and prevent disease.
    Mr. Chairman, the Congress provided the NIH with $20.3 billion in 
fiscal year 2001--an increase of $2.5 billion or 14 percent above the 
fiscal year 2000 level. It is the largest increase that NIH has ever 
received, and I understand the NIH could receive an increase this year 
as well. Mr. Chairman, the Subcommittee was helpful last year in 
providing IDeA with an increase, and we sincerely appreciate the 
Subcommittee's support. While last year's appropriation for IDeA is 
definitely a step in the right direction, we believe IDeA should be 
funded at $200 million or more.
    We ask you to provide $200 million for IDeA in fiscal year 2002--a 
small fraction of the likely NIH increase. Building the research 
capability of the 24 IDeA states is crucial toward the goal of 
increasing and enhancing our nation's research capability. On behalf of 
the Coalition of EPSCoR States, I thank the Subcommittee for the 
opportunity to submit this testimony.
                                 ______
                                 

         Prepared Statement of the Coalition for Health Funding

    Mr. Chairman, the Coalition for Health Funding is pleased to 
provide the Subcommittee with testimony recommending fiscal year 2002 
funding levels for the agencies and programs of the Public Health 
Service. Since 1970, the Coalition's member organizations, representing 
40 million health care professionals, researchers, lay volunteers, 
patients and families, have been advocating for adequate resources for 
the agencies and programs within the Public Health Service. The 
Coalition for Health Funding is the nation's oldest, most broadly based 
alliance focused on the breadth of discretionary health spending.
    The Coalition sincerely appreciates the strong and continued 
support that the Subcommittee has given to health discretionary 
programs in the past. The Coalition recognizes the considerable funding 
limitations that the Subcommittee is likely to face in fiscal year 
2002, but the Coalition urges you to seize every opportunity, as the 
process moves forward, to fund increases for critical public health 
programs.
    On the cusp of the second year of the 21st Century, the nation, and 
the world, are at an unprecedented nexus of great promise and potential 
disaster. If we devote adequate resources to research opportunities at 
the National Institutes of Health we have the potential to advance our 
understanding of the biological basis of disease and unlock new 
strategies for disease prevention, diagnosis, treatment and cures. But 
we will not fully reap that potential for all Americans if we do not 
also invest in the other agencies and programs of the U.S. Public 
Health Service. We will not fully reap our investment in biomedical and 
behavioral research if we do not also invest in a strong public health 
infrastructure at the local, state, and federal level; translate 
biomedical and behavioral research into community-based prevention 
strategies; provide needed services for medically underserved 
populations; assure a well-distributed health and public health 
workforce in adequate numbers; and develop and translate the most cost-
effective implementation of biomedical and behavioral research into 
medical practice. If we do not also do these things we risk disaster in 
the form of soaring medical care costs as the cohort of baby boomers 
ages with a host of preventable chronic diseases and there are not 
enough nurses, and other essential health care personnel, to care for 
them. We risk disaster if we do not continue to strengthen our 
seriously weakened public health infrastructure at the local, state and 
federal levels to prepare for a bioterrorist attack, a major outbreak 
of infectious disease such as the world experienced in the 1918 with 
pandemic flu, and to curb rapidly growing resistance to antibiotics 
used to treat serious bacterial infections. We risk disaster if we do 
not continue to try to meet growing demand for basic health and medical 
care services, particularly for mothers and children. A community is 
only as healthy as its weakest members. Failure to fully immunize 
children, adolescents, and vulnerable adults puts everyone at risk. 
Failure to respond to the health, mental health, and substance abuse 
needs of millions of uninsured Americans undermines the health of our 
workforce and undermines the health of our economy.
    These are the major public health challenges ahead in the 21st 
Century. To address them and reap the potential of enormous positive 
returns requires adequate investment across the continuum of public 
health activity. The coalition's members recognize that no one 
component of the public health continuum can be effective in achieving 
the overall goal of improved health outcomes without the strong support 
of the components.
    Each year, the Coalition for Health Funding works with other health 
alliances to determine an appropriate level of federal support for all 
health discretionary programs. For fiscal year 2002 the Coalition is 
recommending $44.2 billion be provided to address the nation's needs in 
the areas of biomedical, behavioral, and health services research; 
disease prevention and health promotion; health services for medically 
underserved populations; health professions education; and substance 
abuse and mental health services. The Coalition's recommendation also 
includes funding for the Indian Health Service and the Food and Drug 
Administration, which are not within the jurisdiction of this 
Subcommittee, but are important agencies within the U.S. Public Health 
Service. The Coalition appreciates that these funding levels, 20 
percent over fiscal year 2001, may appear excessive, but they reflect 
both the professional judgment within the various agencies as well as 
our own members' assessment of community and national need. The 
Coalition presents these recommendations to the Subcommittee in the 
hope that it will view them as important targets for optimal health 
outcomes.
    The following is a partial list of the Coalition's findings and 
recommendations; the attached table provides the Coalition's 
recommendations for all the public health agencies:

                  NATIONAL INSTITUTES OF HEALTH (NIH)
    The Coalition supports an additional $3.4 billion in funding for 
NIH in fiscal year 2002, for a total of $23.7 billion, as the fourth 
installment toward doubling the NIH budget by 2003. But in recognition 
of the difficulty in achieving this goal, the Coalition cautions that 
this increase must not come at the expense of other public health 
programs.
    The Coalition recognizes the critical importance of the research 
conducted at the NIH and that increases provided in fiscal year 1999, 
2000, and 2001 must be continued in order to fully reap our investment. 
Three main reasons for continuing on the path to doubling the NIH 
budget include the many research challenges still confronting us, the 
burgeoning scientific opportunities that are now available in this 
post-genomic world, and the large economic benefits that accrue as we 
make progress against diseases. Examples of past investments in NIH 
research that have yielded important benefits include identifying a 
gene that contributes to susceptibility to type 2 diabetes, developing 
a vaccine to nearly eliminate infections caused by Haemophilus 
influenzae type b, using magnetic resonance imaging (MRI) measurements 
to predict who will get Alzheimer's disease, making landmark strides in 
the diagnosis and treatment of depression and schizophrenia, uncovering 
a hormone involved in the onset of osteoporosis, and growing 
replacement heart valves in the laboratory.
    The Coalition appreciates that medical research is a vision not a 
precise blueprint. It must be flexible enough to respond to society's 
changing health care needs and dynamic enough to open the way to ever 
more promising frontiers of fundamental research. Scientific 
discoveries are the result of a series of incremental steps that pave 
the way for future breakthroughs. This process needs sustained support. 
With it, and support for other public health partners, we will be ready 
to meet the challenges of the future.

            CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
    The Coalition for Health Funding recommends an overall funding 
level of $5 billion for CDC in fiscal year 2002. The Coalition believes 
this is the amount needed to enable CDC to carry out its vital mission 
of disease prevention and health promotion.
    The Coalition is very pleased that Congress provided $181 million 
in fiscal year 2001 to continue the process of re-building the nation's 
seriously eroded public health infrastructure in order to prepare for 
bioterrorism. The Coalition notes that landmark legislation passed last 
year, the Public Health Threats and Emergencies Act, builds on the 
three years of bioterrorism funding, to further strengthen public 
health infrastructure at all levels of government, but particularly the 
local and state levels. The Act authorizes $524 million in fiscal year 
2002 to address three major threats: bioterrorism, antimicrobial 
resistance and major infectious disease outbreaks. The Coalition urges 
the Subcommittee to provide full funding for this critical effort; 
strengthening basic public health capacity also lays a foundation for 
addressing all disease and disabling conditions.
    CDC administers many programs that utilize the research findings of 
the National Institutes of Health, and other public health agencies and 
programs, to develop community-based strategies to prevent disease and 
disabling conditions and promote improved health. Programs needing 
increases include those addressing chronic and environmental diseases 
such as cardiovascular diseases, diabetes, cancer, and asthma. This 
program line received a substantial, 40 percent increase in fiscal year 
2001, but because there are over 40 separate programs included, some 
received significant increases, others small increases, and some no 
increases. Chronic diseases combined constitute the nation's most 
costly health problem, but we still do not reach all states with 
adequate funding to implement cost-saving and life-enhancing prevention 
efforts.
    In the area of infectious diseases, the Coalition believes that 
significant increases are needed to enable CDC to fully implement its 
comprehensive plan, `` Preventing Emerging Infectious Diseases: A 
Strategy for the 21st Century.'' In today's global society, it is 
possible for a new disease to spread internationally within days, 
perhaps hours. Since 1973, more than 35 new infectious diseases have 
been identified, including E. coli 0157:H7, airborne Ebola virus, and 
West Nile virus. Serious challenges lie ahead as these newly emerging 
and re-emerging diseases are identified, while at the same time, multi-
drug resistant organisms, such as Staphylococcus aureus, proliferate. 
More than 90 percent of strains of Staphylococcus aureus in U.S. 
hospitals are resistant to penicillin. In some areas of the United 
States, more than 30 percent of the pneumococci resist penicillin, a 
drug once effective against almost all pneumococcal pneumonia and 
meningitis.
    Increases are also needed for prevention of HIV transmission, which 
is receiving new focus within CDC. Prevention of HIV transmission is 
our best defense against the AIDS epidemic that has already killed over 
400,000 U.S. citizens and is devastating the populations of nations 
around the globe. There are 40,000 new infections every year with one-
half occurring in individuals under the age of 25.
    Elimination of TB and STDs, especially syphilis, are now within our 
grasp. These welcome opportunities, if adequately funded now, will save 
millions in annual health care costs in the future.
    Finally, also in the area of infectious diseases, significant 
increases are needed for immunization. An important IOM report on 
immunizations published last year entitled, Calling the Shots, stated 
that unstable funding for state immunization programs threatens 
coverage for specific populations and age groups. The report 
recommended an increase of $75 million for CDC's operations/
infrastructure state grant program. Congress provided $42.5 million of 
this increase in fiscal year 2001; the full increase is needed in 
fiscal year 2002. In addition, significant increases are also needed 
for the domestic vaccine purchase program to meet the costs of the 
newly recommended pneumococcal conjugate vaccine, as well as the costs 
of expanding vaccines to the 1 million two-year-olds that are not fully 
vaccinated, and to adolescents and adults. Finally, increases are also 
needed for CDC's global immunization program.
    In response to legislation enacted last year, CDC has created a new 
Center on Birth Defects and Developmental Disabilities. This exciting, 
strengthened focus on many preventable diseases and disabling 
conditions, as well as on improving the lives of those who live with 
disabilities, also needs new resources.
    The Preventive Health and Health Services Block Grant is the only 
source of flexible funding to enable state public health officials to 
achieve Healthy People 2010 goals, address health gaps in discretionary 
funding, and respond to unexpected crises such as the emergence of West 
Nile Virus. The Block Grant was cut nearly $15 million (10 percent) in 
fiscal year 2000 to $135 million and level funded in fiscal year 2001. 
State health officials are requesting a 50 percent increase in the 
Prevention Block Grant for fiscal year 2002.
    Prevention Centers and Prevention Research, important programs in 
the nation's foremost health prevention agency, should receive 
significant increases reflecting their importance. Prevention research 
is mentioned as a priority area in President Bush's February budget 
blueprint.
    Other important programs needing increases are: the National Center 
for Health Statistics, NIOSH; health disparities demonstration 
research; and injury control.

          HEALTH RESOURCES AND SERVICES ADMINISTRATION (HRSA)
    The Coalition for Health Funding recommends an overall funding 
level of $6.7 billion for HRSA in fiscal year 2002. This is the total 
funding level that the Coalition believes is needed to provide adequate 
resources for the important programs that HRSA administers that address 
access to needed medical and health care services for medically 
underserved populations.
    The Coalition is pleased that the President has expressed his 
support for the effort to double funding for the Consolidated Health 
Centers program over the next five years. Last year, Congress provided 
the first down payment on this goal bringing the current funding levels 
to $1.169 billion. The Coalition for Health Funding supports a second 
down payment in fiscal year 2002 to help reach the goal of building 
1,200 new health center sites and doubling the patient capacity of the 
entire health center program over the next five years.
    The Coalition's recommendation also includes increases for the 
programs of the Ryan White CARE Act. HIV/AIDS is an extremely serious 
epidemic facing Americans and people throughout the world. The programs 
of the Ryan White CARE Act target needed health care, and other support 
services, including expensive drug therapies, to Americans suffering 
from HIV/AIDS.
    The Coalition supports an increase for the Title X family planning 
program in fiscal year 2002. This funding would support 4,600 family 
planning clinics across the United States. It would pay for 
comprehensive services including screenings for cancer, HIV, and other 
diseases as well as contraception, and teen pregnancy prevention 
including educational activities that encourage young people to 
postpone sexuality.
    Preliminary information indicates the President's budget may cut 
funding for Graduate Medical Education for free-standing children's 
teaching hospitals which was a new initiative in fiscal year 2000, and 
received $235 million in funding in fiscal year 2001. This important 
program that trains physicians that provide direct care for children, 
needs to continue, and needs increased, not decreased, funding. The 
Coalition also supports increased funding for the Children's Emergency 
Medical Services program which ensures that emergency care provided for 
children is appropriate for their specific needs, and funding at the 
authorized level for HRSA's new trauma care program.
    The Coalition is disappointed that the Maternal and Child Health 
Block Grant has been level funded for the past several years at $710 
million. This program provides comprehensive, preventive care for 
mothers and young children, as well as an array of coordinated services 
for children with special needs. MCH programs are facing increased 
demands for services due largely to two trends: continued growth in the 
numbers of uninsured that is outpacing targeted efforts, such as the 
Child Health Insurance Program, to cover them; as more eligible 
children for CHIP are identified, often by MCH outreach efforts, more 
children are identified as needing MCH services. This increased demand, 
and the findings of a recent Institute of Medicine report entitled, 
From Neurons to Neighborhoods, which concludes that new science about 
early childhood development demonstrates urgent need to expand the kind 
of services that the MCH Block Grant provides, the Coalition believes 
this program should be funded at its fully authorized amount in fiscal 
year 2002.
    The Coalition is also very disappointed that the President's budget 
blueprint proposes to cut the Health Professions and Nursing Education 
Programs. These programs provide support to students, programs, 
departments and institutions to improve the racial and ethnic 
diversity, accessibility, and quality of the health and public 
healthffff workforce. In particular, these programs help meet the 
health care delivery needs of over 2,800 Health Professions Shortage 
Areas in this country, at times serving as the only source of health 
care in many rural and disadvantaged communities. The Coalition 
believes this program needs increased, not reduced, funding in fiscal 
year 2002.
    The Coalition sincerely appreciates this opportunity to provide its 
fiscal year 2002 funding recommendations to the Subcommittee for the 
agencies and programs of the U.S. Public Health Service. The 
Coalition's recommendations for all of the public health agencies is 
provided in the accompanying table. The Coalition, and its member 
organizations, look forward to working with the Subcommittee in the 
weeks ahead to improve the health of all Americans.

                                          DISCRETIONARY HEALTH PROGRAMS
                                          [B.A. in millions of Dollars]
----------------------------------------------------------------------------------------------------------------
                                                           Fiscal year
                                                --------------------------------
                                                      2001          2002 CHF       Difference        Percent
                                                  appropriation  recommendation
----------------------------------------------------------------------------------------------------------------
CDC............................................          $3,868          $5,000          +$1.1b            +29
NIH............................................           20.3b           23.7b           +3.4b            +16.7
HRSA...........................................           5,557           6,700           +1.1b            +20
SAMSHA.........................................           2,958           4,057           +1.1b            +37
AHRQ...........................................             270             400           +130m            +48
FDA............................................           1,217           1,399           +182m            +15
IHS............................................           2,598           2,848           +250m             +9
OPHS...........................................             165             181            +16m             +9
                                                ----------------------------------------------------------------
      Total Public Health......................          36,933          44,285          +7,352            +20
----------------------------------------------------------------------------------------------------------------

                                 ______
                                 

     Prepared Statement of the Coalition of Northeastern Governors

    The Coalition of Northeastern Governors (CONEG) is pleased to 
provide testimony for the record to the Senate Appropriations 
Subcommittee on Labor, Health and Human Services, Education and Related 
Agencies as it considers fiscal year 2002 and advance fiscal year 2003 
appropriations for the Low Income Home Energy Assistance Program 
(LIHEAP). The CONEG Governors appreciate the support provided by the 
Subcommittee in maintaining this important program, and urge the 
Subcommittee to increase funding for both fiscal year 2002 and advance 
funding for fiscal year 2003 to the full authorized level. In addition, 
we are requesting that the full authorized funding authority be 
provided for each year to allow for the release of emergency funds for 
unforeseen circumstances, such as price spikes in natural gas or 
heating oil, severe weather and other potential emergencies.
    During the current fiscal year, LIHEAP has played an essential role 
in making home energy affordable for the region's very low-income 
households--the elderly and disabled on fixed incomes, families with 
young children, and those making the difficult transition from welfare 
to work. Two-thirds of the region's LIHEAP recipients have annual 
incomes of less than $8,000 per year. For many of these households, 
annual income is not sufficient to pay high winter heating bills, even 
in periods of economic growth. Many low-income residents are forced to 
choose between heating their homes or purchasing food or vital 
medications.
    The recent rise in winter heating fuel prices has hit these 
vulnerable citizens especially hard. Price volatility adversely affects 
the low-income households who, without disposable income to purchase 
fuels off-season, typically enter the market when demand and price are 
high. The percentage of household income spent on energy by low-income 
residents can be significant. Program funds are targeted to those 
households with high energy burdens, averaging 18 percent of household 
income--compared with 6.7 percent for all households.
    This increase in the price of home heating fuels has created a 
heightened demand on the states' LIHEAP programs. The projected need 
far outweighs the available funding. States in the region have seen 
increases as high as 33 percent in their regular caseloads as well as 
significant increases in requests for emergency assistance from those 
households in imminent danger of a fuel service cut-off.
    The $600 million in LIHEAP contingency funding provided by Congress 
in the fiscal year 2000 supplemental appropriations bill was essential 
in ensuring that low-income households could heat their homes this 
winter, and the states are deeply appreciative of Congress' action. 
Even with these contingency funds, the program currently serves less 
than 20 percent of citizens who qualify for LIHEAP assistance. While 
there will always be true crises that call for emergency funding, an 
increase in the regular LIHEAP appropriation for fiscal years 2002 and 
2003 to the full authorized amount will enable the states to more fully 
implement cost-effective measures to meet the continuing energy needs 
of the region's most vulnerable citizens.
    State LIHEAP programs could stabilize heating fuel prices for low-
income households and expand the reach of limited program funds if an 
agency could achieve some form of price protection through contracting 
with retailers on a fixed or ceiling price basis when heating oil 
prices are most attractive. Today, these ``pre-buys'' are difficult to 
do, since the programs face the constraints of limited or no funds to 
carry forward to a new heating season, and the new funds are not 
available until October 1 of each year. A federal appropriation, and 
advance funding, to the full authorized level would allow states to 
manage the program resources in a manner to better take advantage of 
retail contracts.
    As you know, the fiscal year 2001 Labor, HHS and Education 
appropriations bill did not contain advance fiscal year 2002 funds for 
LIHEAP. Enactment of advance funding is vital to the states' program 
planning activities for the coming heating season. In the Northeast, 
where the heating season begins in early October, states generally 
spend up to 70 percent of the LIHEAP funds during the first two 
quarters of the fiscal year. States must be prepared to begin their 
LIHEAP program as soon as the new fiscal year starts. Advance funding 
permits them to do this, even when Congress has not yet enacted the 
Labor, HHS and Education appropriations bill for the new fiscal year.
    Our states have aggressively planned for a colder winter and higher 
heating fuel prices. LIHEAP programs opened early and states undertook 
aggressive outreach campaigns urging customers to conserve energy and 
explore fuel price protection options. States have designed their 
LIHEAP programs to make the most efficient use of funds by coordinating 
with weatherization and leveraging programs. In cooperation with 
federal officials and the winter fuels industry, CONEG conducted a 
winter fuels emergency simulation exercise to ensure that our states, 
federal agencies and the industry will be prepared to anticipate and 
effectively manage winter fuel supply emergencies which may arise.
    These preparedness activities, while critical, cannot fully shield 
our lowest-income citizens from the impacts of higher heating fuel 
prices. Your support for increased LIHEAP appropriations to the full 
authorized level and the enactment of advance appropriations is 
urgently needed to enable our states to help mitigate the potential 
life-threatening emergencies and economic hardship that confront the 
region's most vulnerable citizens.
    We thank the Subcommittee for this opportunity to share the views 
of the Coalition of Northeastern Governors, and we stand ready to 
provide you with any additional information on the importance of the 
Low Income Home Energy Assistance Program to the Northeast.
                                 ______
                                 

   Prepared Statement of College on Problems of Drug Dependence, Inc.

    Thank you Mr. Chairman and Members of the Subcommittee for the 
opportunity to present written testimony for the record. My name is 
Charles Schuster and in addition to being a Professor of Psychiatry and 
Behavioral Neuroscience and Director of the Wayne State University 
Addiction Research Institute, I am the President of the College on 
Problems of Drug Dependence (CPDD). The CPDD, formerly the Committee on 
Problems of Drug Dependence, has been in existence since 1929 and is 
the longest standing group in the United States addressing problems of 
drug dependence and abuse. From 1929 until 1976, the CPDD was 
associated with the National Academy of Sciences, National Research 
Council. Now the CPDD functions as an independent organization with 
over 600 members representing all of the scientific disciplines and 
medical specialties concerned with understanding the etiology and 
consequences of drug abuse and based upon this understanding the 
development of effective prevention and treatment interventions.
    As part of its function the CPDD serves as an interface among 
governmental, industrial and academic communities maintaining liaisons 
with regulatory and research agencies as well as educational, 
treatment, and prevention facilities in the drug abuse field. CPDD also 
serves as a collaborating center for the World Health Organizations 
Drug Abuse Advisory Committee and members of the CPDD Board of 
Directors have served as an Expert Advisory Group to the Office of 
National Drug Control Policy.
    Since 1938, a major focus of the CPDD's activities has been its 
sponsorship of an annual scientific meeting. This conference serves as 
a forum bringing together basic scientists, clinical investigators from 
industry, academia, and government. Representatives of regulatory 
agencies and other policy makers, as well as scientists and 
professionals in a number of diverse disciplines interested in the 
biochemical, behavioral, and public health aspects of drug dependence 
participate. This year I am pleased to note the Center for Substance 
Abuse Treatment/SAMSHA has supported the participation of community 
treatment practitioners. This support will enable us to bridge the gap 
between academic researchers and drug abuse treatment practitioners to 
facilitate the application of new science-based treatment and 
prevention interventions in community treatment programs.
    The National Institute on Drug Abuse/NIH is a governmental 
organization that is very important to CPDD because it supports the 
overwhelming majority of the scientific research on the biopsychosocial 
problems associated with drug abuse and dependence. These research 
efforts are rapidly increasing our knowledge about the etiology and 
consequences of drug abuse and providing a science base for the 
development of more effective prevention and treatment interventions. 
There are a number of areas of NIDA sponsored research ranging from the 
basic to the applied that are making a difference. However, time 
permits me to mention only a few of these today.

                             NEUROTOXICITY
    Many years ago my colleagues and I at the University of Chicago 
reported that high doses of methamphetamine (speed, crack) causes 
irreversible damage to dopaminergic and serotonergic neurons in the 
brains of laboratory animals. Although this uniform finding across 
diverse-animal species suggests that similar effects would be found in 
humans it is important to firmly establish this conclusion. Today, 
using modern techniques for the non-invasive study of the human brain 
(Positron Emission Tomography, functional Magnetic Resonance Imaging 
and Magnetic Resonance Spectroscopy) is allowing NIDA sponsored 
researchers to explore this premise and definitive answers are 
imminent. In addition, NIDA sponsored research is currently using these 
imaging techniques to determine the type of brain changes that take 
place when drug abusers are exposed to high doses of other drugs such 
as cocaine, MDMA (Ecstasy) and heroin, whether these changes are 
irreversible and their functional consequences. The recent emergence of 
the problems of teen-age abuse of MDMA and other ``Club Drugs'' 
exemplifies the ever-changing challenges which face the NIDA.

                   BEHAVIORAL TREATMENT INTERVENTIONS
    Such basic knowledge informs and improves efforts to develop 
treatments of drug dependence. Treatments of all varieties and various 
combinations are important for promoting abstinence for the drug abuser 
and dependent patients. Behavioral treatments are one area of many 
where NIDA has been very successful and effective in adding to our 
``treatment toolbox''. Behavioral treatments emphasize that treatment 
must address multiple factors in an individual's life that support drug 
use and rearrange them so that they support abstinence. Such successful 
treatments have shown that teaching skills, supporting change, and 
providing incentives can produce both immediate and long lasting 
abstinence in the drug-dependent patient. NIDA sponsored researchers 
are applying these important innovations to an ever increasing array of 
conditions and patients. Among the most important of these is the 
pregnant addict. Behavioral treatments that promote abstinence in 
pregnant mothers not only help the mother, but prevent a plethora of 
problems in the developing baby. Such efforts show the success of 
developing treatments and exemplify the broad impact they can have not 
only today but also in tomorrow's generation.

    NATIONAL DRUG ABUSE TREATMENT CLINICAL TRIALS NETWORK (NIDA-CTN)
    Developing successful treatments are important, but so is the 
dissemination and utilization of those treatments. Over the past two 
years NIDA has established a network of 14 university-based research 
centers, each of which are affiliated with 5-10 community treatment 
programs (CTP's). Behavioral and pharmacological treatments, alone and 
in combination which have been shown to be efficacious in NIDA 
sponsored controlled clinical trials will be evaluated for their 
``usefulness'' in these CTP's. Those that are found to be useful will 
be disseminated to treatment programs throughout the United States. In 
this way the NIDA-CTN will facilitate the utilization of the most 
effective treatments for all those seeking to overcome their drug 
dependence problems. If funding is available, we understand that NIDA 
plans on expanding this system to have an even greater impact on the 
quality of drug abuse treatment available throughout the country. The 
College urges you to support funding for NIDA at $991.7 million in the 
fiscal year 2002 Labor, Health and Human Services Appropriation Bill, 
which represents a 27.0 percent increase over current funding.
    This increase will allow for the expansion of the CTN while at the 
same time providing the necessary funding for research which will lead 
to the development of new treatment interventions that the CTN will 
evaluate.
    The members of the College on Problems of Drug dependence want to 
thank this Subcommittee for your steadfast support of the NIH in 
general and the National Institute on Drug Abuse in particular. We 
believe that the federal governmental investment in drug abuse research 
is extremely wise. Every individual in this country is effected either 
directly or indirectly by the problems associated with drug abuse. 
Economists estimate that drug abuse costs our society over $100 billion 
dollars each year. But dollars cannot portray the tragedies that drug 
abuse cause for the individual, their families and the communities in 
which they live.
    I have seen the tragic consequences of my son's involvement with 
the criminal justice system because of his illicit drug use. The good 
news is that research has shown that drug abuse can be prevented and 
effectively treated. Clearly there is room for improvement in our 
ability to prevent and treat the problems of drug abuse/dependence. 
This is why additional research is needed. Basic research to better 
delineate the social and biological factors that make some young people 
vulnerable to the addictive properties of drugs of abuse. A thorough 
understanding of these etiological risk factors for drug dependence 
will make it possible to improve our prevention efforts especially for 
those who are most vulnerable for addiction. Basic research is 
essential for understanding what changes in the brain take place in the 
transition from sporadic abuse of drugs to the compulsive use 
characterizing drug dependence. This knowledge will help us to target 
the brain neurochemical systems that must be treated with medications 
if we are to reverse the addiction process.
    Finally, basic research is needed to delineate the long term 
neurotoxic consequences of exposure to drugs of abuse so that we can 
develop therapies to assist individuals so afflicted to function 
optimally. Hopefully the insights provided by this basic research will 
lead clinical researchers in the development of new effective 
pharmacological and behavioral interventions for the treatment of all 
forms of substance abuse/dependence. Research has already shown that 
currently available empirically based prevention and treatment is the 
most cost-effective means of curbing drug abuse. Clearly supporting 
research that will further improve our ability to prevent and treat the 
problems of drug abuse will pay handsome dividends both financially and 
for the morale of our country. CPDD therefore asks this Subcommittee to 
seriously consider funding NIDA at $991.7 million for fiscal year 2002. 
We recognize that there are many competing demands for federal funds 
but strongly believe that this area is of the highest priority.
    It must also be stated that the membership of the College on 
Problem of Drug Dependence is concerned about the adequacy of funding 
for drug abuse prevention and treatment services. We therefore request 
that you provide increased funding for the Center for Substance Abuse 
Prevention and the Center for Substance Abuse Treatment to insure that 
they are able to provide the support necessary to provide all of our 
citizens the very best services possible.
    Thank you for the opportunity to present the views of the 
membership of the College on Problems of Drug Dependence to this 
Subcommittee.
                                 ______
                                 

      Prepared Statement of Community Medical Centers, Fresno, CA

    Mr. Chairman and Members of the Subcommittee: My name is Dr. Philip 
Hinton and I am Chief Executive Officer of Community Medical Centers in 
Fresno, California. Community Medical Centers is a not-for-profit, 
locally owned healthcare corporation that is committed to improving the 
health of the community. I am pleased to provide the subcommittee with 
a request for assistance in securing federal monies for a critical 
project in the Central San Joaquin Valley that would improve healthcare 
delivery to the growing Hispanic and minority populations by creating a 
network of clinics accessible to the rural areas. These populations in 
the five county area of Fresno, Madera, Tulare, Kings and Mariposa face 
some of the most devastating and worst health outcomes in the state of 
California and in the nation:
  --the third highest asthma mortality rate in the nation;
  --the highest rates of teen pregnancy in the state;
  --the highest incidence of diabetes among the Hispanic population
  --late or no prenatal care for pregnant women
  --greater likelihood for newborns to be of low birth weight than the 
        rest of the state
  --some of the lowest immunization rates in the nation (62 percent at 
        age 2 versus 79 percent nationally)
  --the highest rates of syphilis in the state.
    These health outcomes are not acceptable and yet they exist because 
of the following reasons:
Limited access to care
  --Low ratio of primary care providers to population. Fresno County 
        has 178 physicians/100,000 population vs. 235/100,000 in the 
        state.
  --Virtually no specialist care located in rural areas
  --Isolation of rural communities from urban areas and poor public 
        transportation.
Financial constraints
  --Many people are without health insurance
  --Accessing healthcare in the urban areas results in a day's lost 
        wages
  --Lack of childcare providers means that patients must bring their 
        entire family with them when they visit the clinic.
Educational issues concerning health
  --Lack of understanding of preventive care
  --Cultural barriers to addressing health issues before they become 
        acute crisis
Language barriers
  --Over 100 languages are spoken in the area
    Coupled with high unemployment rates that are twice the state and 
three times the national average, and adults and children living below 
the poverty line hovering at 25 percent and 32 percent respectively, 
the statistics and indicators point to the need for aggressive action 
to address the tremendous health care needs of the population in this 
five county area.
    Community Medical Centers proposes to address this health situation 
with a pilot project to improve the health of farm workers and 
residents of the rural communities who make up 41 percent of the 
population of the region.
    Community Medical Centers has proposed developing a collaborative 
network that will include local healthcare providers, Federally 
Qualified Health Centers, county health and human services agencies, 
local hospitals, dentists, schools, churches and local communities. The 
network will work to aggressively deliver both preventive and primary 
health care to the people of the five county region. The new Regional 
Health Center on the campus of the Regional Medical Center in downtown 
Fresno will be the center for coordinating these activities. The new 
Regional Health Center is just one component of a more comprehensive, 
$210 million medical complex that will also include a new facility to 
house Level I burn and trauma services, emergency services, in-patient 
surgery, cardiac services and intensive care beds as well as a 
University of California San Francisco (UCSF) Medical Education and 
Research Center to house the teaching program. The Regional Health 
Center will deliver primary and specialty care, offer easy access to 
higher level care in an inpatient and outpatient setting, and access 
the faculty and residents of the UCSF-Fresno Medical Education Program.
    This $35 million project will:
  --Improve access to the rural areas by partnering with existing 
        centers and local healthcare providers to provide access for 
        all patients and utilize and coordinate mobile health care 
        units to go into the areas that are under-served. In addition, 
        provide trained bilingual personnel to qualify people for 
        health care programs and educate them about preventive care.
  --Focus on preventive care and high prevalence diseases by offering 
        asthma education and management programs; early diagnosis, 
        dietary and medical management of diabetes; teen pregnancy 
        prevention programs; prenatal care; screenings for cancer, 
        diabetes and high blood pressure; and dental and mental health 
        services.
  --Result in a healthier community by providing primary care to a 
        significant portion of the population and reducing their 
        dependency on hospital emergency rooms for these services; 
        improve people's quality of life and health thereby reducing 
        hospital admissions for asthma, diabetes, hypertension and 
        complications associated with these diseases; reduce the number 
        of premature births.
  --Realize significant savings in medical costs by focusing on the 
        health needs of the population and emphasizing prevention and 
        disease management as opposed to depending on hospitalization 
        for primary care. We predict a 20 percent decrease in emergency 
        room visits and hospitalization that would result in a 
        significant savings of $18 million per year.
    The human statistics point to the need to address this situation 
now before it progresses to a crisis. Community Medical Centers is 
working with the County of Fresno to contribute $17.5 million of state 
and local monies toward this pilot project. These monies, coupled with 
an additional $17.5 million from the federal government, would provide 
key funding support and ensure completion of this critical health care 
initiative facing our community.
    We have identified the HHS Health, Resources and Services 
Administration (HRSA) Buildings and Facilities earmark in the fiscal 
year 2002 appropriation bill for Labor/HHS/Education as a source of 
funds. We understand that this program is specifically designated for 
buildings and facilities, and we request your assistance in securing as 
much of the needed $17.5 million as possible through this program 
account for the Regional Health Center to be housed on the downtown 
campus in Fresno. This past year, we were pleased to be the recipients 
of $851,000 of Federal support for this project. The funding was 
provided by the fiscal year 2001 Department of Health and Human 
Services Appropriation Act (Public Law 106-554).
    We appreciate your attention to this matter, and we hope that you 
will favorably consider our request to improve healthcare delivery to 
the Central San Joaquin Valley in California.
                                 ______
                                 

      Prepared Statement of the Council of State and Territorial 
                            Epidemiologists

     FULL FUNDING FOR THE PUBLIC HEALTH THREATS AND EMERGENCIES ACT
    The Public Health Threats and Emergencies Act (PHTEA) is landmark 
legislation that was signed into law on November 13, 2000. The PHTEA 
builds on three years of funding, provided by Congress, to prepare the 
nation for bioterrorist attacks by strengthening the nation's public 
health system at the local, state and federal level. The PHTEA was 
introduced after a series of bipartisan Congressional forums, Committee 
hearings and a GAO report all of which established that our public 
health system is not prepared to detect or respond effectively to 
significant public health threats, including major outbreaks of 
infectious disease, pathogens resistant to antimicrobial agents, and 
acts of bioterrorism. CSTE contributed to the development of the PHTEA 
at every phase, and strongly supports funding the Act at the authorized 
level of $534 million.
    The PHTEA has four major components as follows: (1) $100 million 
for building public health capacity with this amount expected to rise 
in future years; (2) $40 million for antimicrobial resistance; (3) $215 
million for Bioterrorism preparedness; and (4) $180 million for CDC's 
facilities renovations. I will focus commentary on two components, 
building public health capacity and bioterrorism preparedness.
    Building Public Health Capacity by Strengthening Infrastructure.--
The Public Health Capacities provision of PHTEA has three main 
sections. Section 319A requires the Secretary of HHS, by November, 
2001, to establish reasonable capacities, including needed personnel or 
workforce, that are appropriate for effective response to major public 
health threats. These capacities would include, for instance, the 
ability of a state or local health department to: recognize the 
clinical signs and epidemiological signs of significant outbreaks of 
infectious disease; identify the disease-causing pathogens rapidly; 
organize and implement an effective medical response for those infected 
and prevention measures for those in danger of exposure; and 
communicate relevant information about the threat rapidly to other 
health departments, the CDC and to the provider community. Section 319B 
requires the Secretary, by November, 2001, to award grants to states to 
perform an evaluation of the extent to which state and local health 
departments can achieve the needed capacities. Finally, Section 319C 
provides grants to state and local health departments to address the 
identified gaps in their capacities--again with a focus on building 
capacity to identify, detect, monitor and respond to threats to the 
public health. Funds for filling gaps in capacities can be used to 
train public health personnel; develop, enhance, coordinate or improve 
participation in an electronic network for rapid disease information 
dissemination; develop plans for responding to public health 
emergencies coordinated with all levels of government; and enhance 
laboratory capacity and facilities.
    Part of public health capacity building reflects CSTE's efforts, 
since 1994, to develop a comprehensive, state-based National Public 
Health Surveillance System (NPHSS). Congress has begun to support 
components of this system through the Health Alert Network (HAN) and 
the National Electronic Disease Surveillance System (NEDSS). However, 
there are other components that address the need for flexible, 
coordinated, and efficient surveillance (or health tracking) systems 
and that define the methods of surveillance in a changing health 
environment. These issues are discussed more thoroughly in the NPHSS 
section below.
    Bioterrorism Preparedness.--For the past three years, Congress has 
provided funding specifically to address the greatest public health 
threat of all--bioterrorism. The PHTEA provides a more coherent 
framework for addressing this very real threat, one that experts 
believe will happen, it is just a matter of when. Some national 
security officials believe the United States will experience a major 
bioterrorist incident within the current decade.
    The PHTEA ensures federal coordination of bioterrorism preparedness 
by creating interdepartmental task forces and working groups. Grants 
are made available to state and local health departments, but also to 
hospitals, clinics and primary care facilities, for the following 
purposes: (a) training of health care professionals and public health 
personnel to recognize the symptoms and epidemiological characteristics 
of exposure to a potential bioweapon; (b) rapid and accurate 
identification of potential bioweapons; (c) coordinating medical care 
for individuals exposed to bioweapons; (d) facilitating and 
coordinating rapid communication of data generated from a bioterrorist 
attack between national, state, and local health agencies and health 
care providers.

        BUILDING THE NATIONAL PUBLIC HEALTH SURVEILLANCE SYSTEM
    Epidemiologists working in public health agencies are responsible 
for monitoring trends in health and devising prevention programs that 
enable the entire community to be healthy. The science of epidemiology 
and surveillance, or health tracking, provide the basis for appropriate 
public health practice. Public health assessment includes surveillance, 
epidemiologic studies, program monitoring of diseases, risk factors for 
disease, health hazards, and preventive actions. Surveillance enables 
public health officials to:
  --Recognize outbreaks and intervene to prevent additional cases;
  --Identify priority health problems/needs so that resources can be 
        appropriately allocated;
  --Identify high-risk communities and groups to effectively target 
        programs;
  --Monitor the effectiveness of public health programs; and
  --Identify issues that need further scientific study to devise 
        preventive strategies.
    These core activities of public health agencies are critical to the 
success of public health efforts, but have historically had no stable 
funding source and are often the first to suffer in state funding 
cutbacks. Funding restrictions in categorical federal programs have 
also contributed to a fragmented approach to surveillance at the state 
and local level. CSTE recommends that all federal funding for public 
health programs recognize and adequately fund epidemiology, assessment 
and surveillance as core required activities for public health 
programs. States should also be given flexibility to combine and 
integrate categorical funds for this purpose. This will help build the 
National Public Health Surveillance System (NPHSS) which CSTE 
conceptualized and has been advocating for among its various local, 
state, and federal partners.
    In addition to support for core public health surveillance, CSTE 
supports the establishment of a national electronic public health 
surveillance, or health tracking, system that encompasses development 
of standards and criteria from which all programmatic surveillance 
systems would be built. CSTE views this overarching electronic system 
(NEDSS) as an important component of a National Public Health 
Surveillance System. Several CDC programs have well-developed 
surveillance systems that meet the needs of the program, but are not 
easily linked to increase the body of knowledge of the public's health. 
There is critical need for an over-arching model for integrated public 
health surveillance that assumes collaboration and integration of data 
collection efforts and use of surveillance resources across program and 
Center lines both at the federal and state levels. More effective 
integration of surveillance and health information systems could 
increase the power of public health agencies to make effective use of 
available information as economically as possible. In practical terms, 
an integrated health tracking system allows the detection and 
monitoring of infectious disease outbreaks and environmental hazards 
that involve more than one local or state jurisdiction such as the 
recent West Nile Fever outbreak.
    Most importantly, a comprehensive, integrated, electronic 
surveillance, or health tracking, system present in every state and 
operational at the local, state and national level is the nation's best 
defense against a serious bioterrorism threat. It is a critical 
component of public health infrastructure that will significantly 
strengthen core public health capacity.
    For the past two years, Congress has provided specific resources to 
begin implementing the National Electronic Disease Surveillance, or 
Health Tracking, System (NEDSS). In fiscal year 2000, $20 million was 
provided for this project at CDC and, in fiscal year 2001, $35 million, 
but since $5 million of this was earmarked for specific projects only 
$30 million was provided to CDC to continue building NEDSS nationally. 
Currently, under the fiscal year 2000 extramural grants, the first 
round to date, all 50 states have received some NEDSS funding with 42 
states receiving Assessment and Planning grants averaging $86,000; 12 
states receiving Element Development grants averaging $315,000 and two 
states, New York and Oregon, receiving Charter Site grants averaging 
$1,113,000 each. It is important to note that fully 35 states applied 
for Element Development grants, which include features such as web 
browser-based data entry, HL 7 messaging, and integrated data 
repository, but in large part due to resource constraints, only 12 
received funding. Similarly, CDC received 12 Charter Site applications, 
but only had resources to fund two. Clearly more resources are needed 
to help states build a national electronic health tracking system. CSTE 
strongly supports $50 million in fiscal year 2002 for the NEDSS project 
as a critical public health capacity building component as provided 
within the Public Health Threats and Emergencies Act.

    INCREASED SUPPORT FOR STATE CONDUCTED HIV CASE SURVEILLANCE, OR 
                                TRACKING
    HIV case surveillance, or tracking, is a critical defense against 
the spread of AIDS, but currently depends on under-funded state and 
local health departments where funding for on-going AIDS surveillance 
(tracking) has been level or declining for several years. CDC estimates 
200,000 250,000 persons are living with HIV (not AIDS) in non-HIV 
reporting states. Several recent developments have intensified the need 
for increased support for state and local health departments to conduct 
appropriate HIV case surveillance: (1) in December, 1999, CDC issued 
HIV case surveillance guidelines, but no additional funds were provided 
to states despite the fact that HIV case surveillance costs twice as 
much as AIDS surveillance; (2) the newly re-authorized Ryan White CARE 
Act (Public Law 106-345) includes new provisions that that seek to 
include HIV data in the formula that determines how many Federal 
resources each state will receive; (3) the September, 2000 Institute of 
Medicine report, ``No Time To Lose: Getting More from HIV Prevention,'' 
recommended that sentinel surveillance also be expanded to provide 
additional information on HIV incidence. None of these important 
recommendations and developments can be responded to without additional 
resources for states.
    For the 2000 and 2001 grant cycle for state cooperative agreements 
with CDC to conduct HIV surveillance, states requested twice the amount 
than they were awarded--a 40 percent gap in funding at a time when the 
need for HIV case surveillance data is intensifying and its benefit as 
a tool to target prevention efforts and reduce transmission of the 
disease is clear. CSTE strongly supports a $45 million increase in 
fiscal year 2002 to strengthen state and local health department HIV 
surveillance (tracking) systems.

  ADDRESSING IDENTIFIED STATE AND LOCAL ENVIRONMENTAL HEALTH CAPACITY 
                              DEFICIENCIES
    CSTE concurs with the Pew Environmental Health Commission's 
findings and supports their recommendations to commit significant 
national resources to enhance the National Public Health Surveillance 
System (NPHSS) so that, in addition to the ongoing efforts to monitor 
infectious diseases, the public health community can begin to track all 
chronic diseases and conditions like asthma, birth defects, and various 
forms of cancer. To advance the understanding of environmental disease, 
the NPHSS needs to include an ability to investigate disease links to 
environmental exposures. Much of the NPHSS will need to be based in 
state and local health departments where the data is generated, but 
allow aggregation for national assessment of progress toward the 2010 
Healthy People goals. However, a comprehensive data system is not 
enough. Sufficient public health expertise capacity must also be 
present to interpret data, evaluate environmental health problems, and 
advance solutions. Both data collection and timely local response are a 
fundamental duty of state government, but experience has shown value-
added benefits from federal partnerships. The scope of environmental 
public health activities is broad, ranging from assurance of the 
quality and integrity of public food, water and waste disposal systems 
to protecting the environment from manmade pollutants.
    As a down payment on implementation of a nationwide health tracking 
system which will include chronic disease and its link to environmental 
exposures, CSTE urges Congress to provide an additional $20 million in 
fiscal year 2002 to expand environmental health capabilities within 
state health departments. Two agencies provide the bulk of the federal 
support for state environmental public health: the Agency for Toxic 
Substances and Disease Registry (ATSDR) and the National Center for 
Environmental Health (NCEH); both are administered by CDC. The Pew 
Commission has called for merging ATSDR and the NCEH under HHS at the 
CDC. ATSDR provided nearly $9 million in fiscal year 2001 to 28 states 
to assess environmental threats to communities. This program focus 
needs additional funding to reach all states, and provide each state 
with sufficient support.
    The NCEH has been unable to provide core support for state 
environmental public health, but does provide substantial technical and 
laboratory assistance and categorical support to address issues such as 
childhood lead poisoning and emerging environmental threats such as 
asthma. CSTE urges the Subcommittee to increase support for CDC's 
asthma program from its current funding level of $25 million to $50 
million. In spite of significant advances in the diagnosis and 
treatment of asthma, an improved understanding of the environmental 
triggers of asthma attacks, the health burden of asthma in the United 
States is increasing at epidemic proportions. Asthma affects more than 
14 million Americans, of which five million are children. Over 5000 
persons died from asthma in 1995, and asthma accounts for nearly 
500,000 hospitalizations each year. The health care costs associated 
with asthma exceeded six billion dollars in 1990, and is currently $11 
billion. Experts predict that those costs could climb to more than $18 
billion by the year 2020.
    Asthma control and prevention requires a long term, multifaceted 
approach that includes patient education, surveillance, and control 
programs. These programs have not been available due to a lack of 
resources at the state level. CDC's asthma program needs increased 
funding.

   RESTORING AND INCREASING FUNDING FOR THE PREVENTIVE HEALTH/HEALTH 
                          SERVICES BLOCK GRANT
    This program was cut $15 million in fiscal year 2000, a ten percent 
reduction, and level funded in fiscal year 2001. State health officials 
have indicated that $210 million is needed to enable them to respond to 
identified health problems that gaps in discretionary program funding 
prevent them from addressing, and unexpected health crises, such as 
West Nile Virus, or an environmental hazard. The PHHS Block Grant 
provides the only source of flexible funding for state health 
departments to address health problems they have specifically targeted 
under Healthy People 2010 goals, such as cardiovascular diseases and 
injury, but do not have sufficient, or sufficiently flexible, 
discretionary funds, to reach specified goals. In addition, up to five 
percent of total Prevention Block Grant funding is used to support 
basic public health activities including routine epidemiological 
surveillance, or health tracking. It seems contradictory to the public 
health community to support bioterrorism preparedness including 
building epidemiological capacity in state and local health departments 
and then threaten the net positive effect of this support by cutting 
the block grant funding ten percent and then locking in the cut through 
level funding.

       SUPPORT FOR THE BEHAVIORAL RISK FACTOR SURVEILLANCE SYSTEM
    The Behavioral Risk Factor Surveillance System (BRFSS) is an 
essential component of an overarching public health surveillance, or 
tracking, system. It the only source of state level behavioral data, 
but is used at every level of government to inform intervention 
programs, policy decisions and budget direction for chronic and other 
diseases. It is the source of data for 24 of the 73 chronic disease 
indicators, six areas of the Healthy People 2010 leading health 
indicators and serves as the core source of surveillance, or health 
tracking, for multiple public health programs across the entire CDC. 
The BRFSS is currently in its 17th year of operation and is the largest 
continuous telephone survey in the world. It is flexible, timely and 
allows for state-to-state and state-to-nation comparisons of data. The 
BRFSS is able to address emerging health issues and fewer resources are 
required to run BRFSS than is required to run in-person interviews. The 
state-based telephone surveys are used to monitor health behaviors and 
knowledge regarding tobacco use, physical inactivity, poor diet, 
alcohol use, violence, risky sexual behaviors, and lack of preventive 
services (i.e. screening and immunizations).
    In spite of all the data that BRFSS provides and the role these 
data play in the development of intervention programs and policy 
decisions, CDC funding for BRFSS is discretionary and averages $62,000 
per state. Although states support a majority of the costs of BRFSS 
data collection, few are able to analyze and translate the data into 
long-term disease prevention and control programs and policies due to a 
lack of resources.
    Current funding for BRFSS is $1.9 million. CSTE believes that BRFSS 
should be a discrete line item in the CDC budget and that funding 
should be doubled to $3.8 million in fiscal year 2002 to ensure 
adequate funding for all states.
    The Council of State and Territorial Epidemiologists appreciates 
the opportunity to provide its fiscal year 2002 funding recommendations 
to the Subcommittee. Our members look forward to working with the 
Subcommittee to strengthen these areas of public health activity that 
CSTE believes are so critical to enhancing and protecting the health of 
the American public.
                                 ______
                                 

  Prepared Statement of the Crohn's and Colitis Foundation of America

                              INTRODUCTION
    Mr. Chairman, thank you for the opportunity to submit testimony on 
behalf of the Crohn's & Colitis Foundation of America (CCFA). CCFA is a 
non-profit, voluntary organization dedicated to finding the cure for 
Crohn's disease and ulcerative colitis. Throughout its 34 year history, 
CCFA has sponsored basic and clinical research of the highest quality. 
The Foundation also offers a wide range of educational programs for 
patients and healthcare professionals, and provides support services to 
assist people in coping with these chronic intestinal diseases.
    My name is Jean Kouris, I live in Berea, Ohio, a suburb of 
Cleveland, and I am honored to represent the people of this country who 
suffer from Crohn's disease and ulcerative colitis. These are serious 
diseases that affect the gastrointestinal (GI) tract. Because they 
behave similarly, Crohn's and colitis are known as inflammatory bowel 
disease, or IBD. They can cause severe diarrhea, cramping abdominal 
pain, fever, and rectal bleeding. Complications of IBD can include 
arthritis, osteoporosis, anemia, liver disease, and colon cancer. 
Crohn's and colitis are not fatal, but they can be devastating. We do 
not know their cause, and we have no cure.
    I am all too familiar with these diseases because my son Nathan is 
one of the up to one million Americans who suffer from IBD. Nathan has 
the dubious distinction of being among the youngest of children 
diagnosed with Crohn's disease. And while his age at diagnosis is 
unusual, the manifestation and course of the disease itself has not 
been. His nine short years have been a study in endurance, 
determination, the healing power of medicine and the healing power of 
prayer.
    When Nathan was about seven weeks old, I arrived to pick him up at 
the end of a workday. The sitter told me that he had cried inconsolably 
for most of the day, drawing his legs up as if he was in pain. 
``There's something wrong with your baby,'' she said. The dutiful 
first-time mother, I took him to see the pediatrician that evening. 
Admittedly he was smiling and happy on my lap in her office, and her 
explanation was that some babies just had a harder time separating from 
their mothers when they went back to work.
    Shortly thereafter, when he started passing bloody stools, I was 
told this was fairly common, and to put him on a ``lactose-free'' diet. 
By age six months he had been referred to a pediatric 
gastroenterologist, who put him on medication and scheduled him for a 
colonoscopy. When the biopsy results came back I was told that he had 
something ``not usually seen in babies this age.''
    Over the next few months Nathan's condition continued to 
deteriorate, and I became increasingly disenchanted with this 
particular physician. I first saw the words Crohn's disease when I 
picked up Nathan's biopsy results to take to another doctor for a 
second opinion. While waiting for the day of the appointment, Nathan, 
who was now eleven months old and otherwise developing normally, became 
so weak he could not stand up.
    Three months later Nathan was put on ``total parenteral nutrition'' 
(TPN). TPN is a special liquid food mixture administered intravenously. 
Around this time, I remember saying to the doctor ``I'm afraid he's 
going to die,'' and she responded ``I'm not saying he won't, but right 
now we're a million miles away from that.'' That was the right thing 
for her to say to me as a mother, but I learned later that she had 
cried privately, afraid too that he would not make it.
    For the next nine months I kept a bag packed, at the ready to head 
for the hospital if one of his twice-daily temperature readings was 
elevated. That was a trip I made too many times to count, as Nathan 
spent more than 90 days in the hospital during that time.
    We have endured the comments of unknowing strangers, like the woman 
who referred to him as ``a baby on a leash'' and one who scolded my 
husband for ``overfeeding that poor child.'' The reality was that he 
was seriously malnourished, but so bloated from the TPN and steroids 
that his eyes had become mere slits.
    I took pictures, as every baby book should have the full complement 
of about a million and a half photos before age two. I took pictures of 
Nathan in the hospital, Nathan with his favorite nurses, Nathan pulling 
the TPN pack in a little red wagon, Nathan bare-chested with the 
Broviac showing. I took pictures because he was a charming child, 
always smiling and happy, a fun-loving baby who effervesced with a joy 
for life.
    Nathan is nine now. He has achieved a measure of medical stability, 
and last summer, for the first time in his life, he actually went three 
months between doctor visits! He plays baseball and football, and takes 
piano and horseback riding lessons. He collects Poke-mon and does all 
the things most nine-year-old kids do.
    I know that throughout his life he will have good times and not so 
good times. But Nathan has the spirit of a warrior and that's what 
helps him get through the difficult days. I also know that a cure is 
possible. I envision a world without Crohn's disease and ulcerative 
colitis. I hope you do too.
    If we are to find the cause of, and cure for IBD, we must 
investigate all of the exciting possibilities that are being made known 
to us. To take advantage of these opportunities, CCFA has developed 
long-standing partnerships with NIH--specifically the National 
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the 
National Institute of Allergy and Infectious Diseases (NIAID)--and the 
Centers for Disease Control and Prevention (CDC).

                  RECOMMENDATIONS FOR FISCAL YEAR 2002
                     NATIONAL INSTITUTES OF HEALTH
    Mr Chairman, together with NIAID, NIDDK supports the majority of 
IBD research at NIH. We were pleased that the Committee again last year 
recognized CCFA's IBD research agenda, entitled ``Challenges in 
Inflammatory Bowel Disease,'' in its report.
    Although we have made significant progress in recent years in the 
fight against Crohn's disease and ulcerative colitis, IBD remains among 
the most challenging disorders affecting the digestive tract. IBD 
patients and their families are pinning their hopes for a better life 
on medical advancements made through NIH and CCFA sponsored research. 
For this reason, CCFA supports the goal of the doubling the NIH budget 
by fiscal year 2002 and joins with the Ad Hoc Group for Medical 
Research Funding in recommending a 16.5 percent increase for NIDDK, 
NIAID, and NIH overall in fiscal year 2002. Moreover, the CCFA 
encourages the subcommittee to increase IBD research funding within 
NIDDK and NIAID at the same rate as NIH overall.
    Throughout its 30-year existence, CCFA has recognized the 
importance of working closely with NIH. A primary principal of the 
Foundation's research program is to provide investigators with seed 
money to generate enough preliminary data to compete for NIH grants. 
And indeed, at last count, 40 of 57 IBD researchers funded through 
NIDDK and NIAID were former CCFA grant recipients.
    Some of the most promising IBD research by the NIH has focused on 
translating findings from studies conducted on animal models to humans 
with IBD. These animal models have enabled researchers to form the 
current hypothesis that Crohn's disease and ulcerative colitis are 
caused by a malfunctioning immune system, wherein components of the 
patient's immune system overreact to normal intestinal bacteria.
    We know that people are susceptible to this malfunction because of 
their genetic makeup but further research is necessary to determine 
which bacteria are responsible, how these bacteria interact with the 
intestine's immune system, and which immune system components are 
involved.
    Mr. Chairman, I am pleased to report that due in part to CCFA's 
Basic Research Agenda and our partnerships with NIDDK and NIAID, 
research findings are being translated with greater speed into new 
therapies for IBD patients. According to an industry report, the total 
sales of pharmacological therapies to treat IBD is expected to increase 
to nearly $1 billion in 2008, and the most dramatic increase will be in 
the sale of biologic therapies that target various proteins in the 
immune system.
    By working together we have begun to alleviate the intense pain 
suffered by people with IBD, but there is a great deal more that needs 
to be accomplished. Our progress thus far gives us tremendous hope for 
the future, however, the study of new and promising research pathways 
depends upon increased federal funding for IBD research at NIH.
    Finally, CCFA is excited by NIDDK's recent announcement that Dr. 
Stephen James, a leading IBD researcher, has joined the institute as 
the deputy director of its Digestive Diseases and Nutrition Division. 
We look forward to working with Dr. James in the search for improved 
clinical therapies, and a cure for IBD.

               CENTERS FOR DISEASE CONTROL AND PREVENTION
IBD Surveillance Program
    Mr. Chairman, as I have mentioned previously, CCFA estimates that 
``up to one million'' people in the United States suffer from IBD. 
Unfortunately, we do not have an exact number: Due to the complicated 
nature of these diseases, patients may remain undiagnosed or 
misdiagnosed for several years. Given the recent advancements in 
treatment for these diseases and the increased risk that IBD patients 
have for developing colorectal cancer, CCFA is pleased that the 
Committee again last year recommended that CDC initiate a nationwide 
surveillance and epidemiological program with respect to IBD.
    CCFA believes that generating improved epidemiological information 
on the IBD population is essential if we are to provide our patient 
community with the best possible care. We look forward to working with 
CDC this year on a comprehensive IBD epidemiological program. We ask 
that the subcommittee continue to support this important initiative in 
fiscal year 2002.
Colorectal Cancer Prevention
    Finally, Mr. Chairman, in addition to coping with either Crohn's 
disease or ulcerative colitis, many IBD patients are at high risk for 
developing colorectal cancer. As you may know, colorectal cancer is the 
third most commonly diagnosed cancer for both men and women in the 
United States and the second leading cause of cancer-related deaths. 
Because people who have suffered from IBD for more than eight years are 
susceptible to this disease, CCFA has a long history of actively 
promoting the benefits of colorectal cancer screening.
    Although colorectal cancer is almost entirely curable when detected 
early, studies have shown a tremendous need to: (1) inform the public 
about the availability and advisability of screening and (2) educate 
healthcare providers about screening guidelines. CDC's National 
Colorectal Cancer Roundtable is actively working to address these 
challenges by partnering with organizations like CCFA to implement a 
national public awareness campaign emphasizing the importance of 
screening and early detection. CCFA encourages the subcommittee to 
provide CDC with $15 million in fiscal year 2002 (an increase of $6 
million over fiscal year 2001) for this vital campaign.

          IBD RESEARCH AND SURVEILLANCE COORDINATING COMMITTEE
    Mr. Chairman, because NIH and CDC are engaged in numerous research 
and public health activities related to IBD, CCFA recommends that the 
Department of Health and Human Services establish an Inflammatory Bowel 
Disease Research and Surveillance Coordinating Committee to ensure that 
the Federal government has a focused and coordinated plan for 
addressing IBD.
    CCFA recommends that the Coordinating Committee be comprised of 
representatives from NIDDK, NIAID, the National Institute of Child 
Health and Human Development, CDC and other Public Health Service 
agencies as appropriate. The Committee would be charged with developing 
and implementing a comprehensive IBD strategy in collaboration with the 
IBD community. We ask that the subcommittee join us in supporting the 
establishment of a Coordinating Committee in fiscal year 2002.
    Mr. Chairman, thank you for the opportunity to present the views of 
the Crohn's and Colitis Foundation of America.
                                 ______
                                 

         Prepared Statement of the Cure for Lymphoma Foundation

                              INTRODUCTION
    It is my pleasure to submit this statement regarding funding for 
the National Institutes of Health (NIH) in fiscal year 2002 and 
priorities for lymphoma research. I am a volunteer representing the 
Cure For Lymphoma Foundation (CFL), a non-profit organization that 
funds research on Hodgkin's disease and Non-Hodgkin's lymphoma (NHL); 
provides educational materials and support services to individuals with 
lymphoma and their families; and engages in advocacy activities to 
advance a cure and improve the quality of care for those with lymphoma.
    In November 1997, two weeks before my 38th birthday, I was 
diagnosed with follicular non-Hodgkin's lymphoma, an indolent cancer 
with a life-expectancy of seven to ten years. At that time, I was 
advised that because this disease was incurable, the best treatment 
strategy would be to ``watch and wait'' or defer treatment until I 
experienced further progression of my disease. As the mother of two 
young children, receiving this diagnosis and treatment recommendation 
certainly sharpened my focus on the disease and the advances in the 
treatment of lymphoma. During the next two years, I became involved in 
the activities of CFL and became an amateur researcher monitoring each 
and every advancement in lymphoma research and treatment. I felt one of 
my strongest contributions to CFL could be participating in public 
policy activities, attempting at every opportunity to create the very 
best climate for lymphoma research.
    By November of 1999, my disease had progressed to the point where 
treatment became necessary and I participated in a clinical trial of a 
vaccine for the treatment of lymphoma but achieved only a brief 
remission. Currently, I am preparing to enroll in a second clinical 
trial, this time hoping to secure a longer remission through a 
combination therapy using monoclonal antibodies. It is my hope, in this 
statement, to convey both the exciting opportunities for lymphoma 
research and the sense of urgency that must be brought to this research 
and its funding. Those of us living with lymphoma will accept no less.

                         INCIDENCE OF LYMPHOMA
    The Director of the National Cancer Institute (NCI) proudly 
reported this year that the incidence of most cancers is declining. 
This achievement is to be applauded. However, the situation for 
lymphoma is different. Since the 1970's, incidence rates for NHL have 
increased dramatically, making it one of the fastest rising cancers in 
the United States. The number of persons diagnosed with NHL has doubled 
since the 1970's, and NHL is the second rising cancer in incidence and 
death rates in the United States. The reasons for the increased 
incidence of NHL are not understood. This is a matter that deserves 
more attention, and CFL recommends a coordinated and aggressive 
research enterprise directed toward strengthening our understanding of 
the reasons for the increase in incidence of lymphoma.

              LYMPHOMA RESEARCH ADVANCES AND OPPORTUNITIES
    The nation's investment in basic research has deepened our 
understanding of lymphoma and contributed to enhancements in treatment, 
with many more therapeutic improvements expected. These advances 
include:
  --Use of genetic analysis techniques to identify subpopulations of 
        lymphoma patients who respond more favorably to chemotherapy. 
        NCI-sponsored researchers have developed a lymphochip, which 
        utilizes microarray technology and has allowed researchers to 
        identify two subtypes of B-cell lymphoma. This discovery has 
        significant implications, because further development and 
        commercialization of the lymphochip will allow physicians to 
        accurately diagnose patients and predict whether they may be 
        effectively treated with chemotherapy or not, depending on 
        their lymphoma subtype.
  --Advances in immunology that have led to the development of a 
        monoclonal antibody for the treatment of indolent B-cell NHL 
        and may be the first of a group of therapies that use the 
        body's own immune system to fight cancer.
  --Cancer vaccines that employ immunotherapy to rally the body's 
        defense against the diseases are currently being tested in 
        trials across the country.
  --New therapies combining different modalities, such as immune 
        therapy and radiation, to fight the disease.
        progress review group on leukemia, lymphoma, and myeloma
    The NCI recently convened a meeting of extramural scientists, 
physicians, and advocates in a Leukemia, Lymphoma, and Myeloma Progress 
Review Group (LLM-PRG) that analyzed the current NCI portfolio of 
research on blood-related cancers and opportunities and barriers to 
research on these cancers. The report of the LLM-PRG is not yet 
complete, but a preliminary draft summarizing the work of the advisory 
panel captures the wealth of research opportunities that are available 
to researchers on blood-related cancers and identifies strategies for 
capitalizing on all those research avenues. We believe the unique 
contribution of the LLM-PRG may be proposals for innovative cooperative 
public-private sector research and development endeavors, and we 
applaud the willingness of the group to consider aggressive research 
strategies and structures.
    Because advances in the treatment of blood-related cancers often 
provide insights into the treatment of all other cancers, the LLM-PRG 
report should be of particular importance not only to NCI but also to 
the Congress.
               fiscal year 2002 recommendations from cfl
    CFL believes this is a critically important moment in lymphoma 
research which must be maximized by an appropriate federal response. 
CFL recommendations are listed below.
  --Congress should sustain progress toward doubling the NIH budget in 
        the five-year period from fiscal year 1999 to fiscal year 2003. 
        We applaud the commitment of the Congress in providing 
        substantial increases in funding for NIH in fiscal year 1999, 
        2000, and 2001 and urge that you provide an increase of 16.5 
        percent in fiscal year 2002. A boost of this magnitude is 
        necessary to ensure that the five-year goal can be met.
  --The Subcommittee should include language in its report that 
        requires NCI to respond to the recommendations of the LLM-PRG 
        when it appears before the Subcommittee to defend its fiscal 
        year 2003 budget. CFL believes the LLM-PRG report may make a 
        special contribution in identifying opportunities for public-
        private sector cooperation, and NCI should be directed to pay 
        particular attention to these recommendations and its ability 
        to implement collaborative programs of this sort.
  --The Subcommittee should also include language in its report that 
        requires NCI and the National Institute of Environmental Health 
        Sciences to coordinate their investigations of the possible 
        links between environmental exposures to toxins and the 
        development of lymphoma.
  --The Centers for Disease Control and Prevention (CDC) should be 
        directed to enter into discussions with lymphoma researchers 
        regarding the collection of lymphoma incidence and survival 
        data through the CDC cancer registries program. In order to aid 
        the lymphoma research effort, CDC cancer registries should 
        collect lymphoma data by subtype.
                                 ______
                                 

     Prepared Statement of the Digestive Disease National Coalition

    Mr. Chairman, thank you for the opportunity to submit testimony 
regarding fiscal year 2002 appropriations for the National Institutes 
of Health and the Centers for Disease Control and Prevention. before 
you today. I am Dr. Maurice Cerulli, a practicing gastroenterologist 
and Chief of Gastroenterology at The Brooklyn Hospital Center and 
president of the Digestive Disease National Coalition (DDNC). Founded 
in 1978, the DDNC is a voluntary organization comprised of 25 
professional and patient organizations concerned with the many disease 
of the digestive tract. The Coalition has as its goal a desire to 
improve the health of the millions of Americans suffering from both 
acute and chronic digestive disorders.
    Mr. Chairman, the social and economic impact of digestive disease 
is enormous. Digestive disorders afflict approximately 62 million 
Americans, resulting in 50 million visits to physicians, 10 million 
hospitalization, 230 million days of restricted activity, and nearly 
200, deaths annually. The total cost associated with digestive diseases 
has been conservatively estimated at $60 billion a year.
    On behalf of the DDNC, I would like to thank the subcommittee for 
its past support of digestive disease research and prevention programs 
at the NIH and CDC. With respect to the coming fiscal year, the DDNC 
joins the Ad Hoc Group for Medical Research Funding in recommending a 
16.5 percent increase for the National Institute of Diabetes and 
Digestive and Kidney Disease (NIDDK), the National Institute of Allergy 
and Infectious Diseases (NIAID) and the NIH overall. These increases 
will keep on track, for the final 2 years, the initiative to double the 
NIH budget over a 5 year period.

             SPECIFIC RECOMMENDATIONS FOR FISCAL YEAR 2002
    Inflammatory Bowel Disease.--Up to one million people in the United 
States suffer from Crohn's disease and ulcerative colitis, collectively 
known as inflammatory bowel disease (IBD). These are serious diseases 
that affect the gastrointestinal tract causing bleeding, diarrhea, 
abdominal pain and fever. Complications of IBD can include anemia, 
ulcers of the skin, eye disease, colon cancer, liver disease, 
arthritis, and osteoporosis. Crohn's disease and ulcerative colitis are 
not usually fatal, but they can be devastating. We do not know the 
cause, and we have no cure.
    In recent years we have made significant progress in the fight 
against IBD. In 1998, the FDA approved the first drug ever specifically 
for Crohn's disease. The DDNC encourages the subcommittee to continue 
its support of IBD research at NIDDK and NIAID at a level commensurate 
with the overall increase for each institute.
    Given the recent advancements in treatment for these diseases and 
the increased risk that IBD patients have for developing colorectal 
cancer, the DDNC believes that generating improved epidemiological 
information on the IBD population is essential if we are to provide 
patients with the best possible care. Therefore, the DDNC, and its 
member organization the Crohn's and Colitis Foundation of America, 
encourage the CDC to initiate a nationwide IBD surveillance and 
epidemiological program in fiscal year 2002.
    Endoscopic Research.--There continues to be tremendous potential 
for the development of new diagnostic and therapeutic procedures for 
gastrointestinal disorders. Without surgery, using endoscopes, we can 
find bleeding ulcers and stop the bleeding; we can take out stones that 
are blocking the bile duct; and we can cut out colon polyps to prevent 
colorectal cancer. The Clinical Outcomes Research Initiative (CORI) 
program is allowing us to link more than 50 centers around the country 
to assess the outcomes of endoscopic therapies. The gastroenterology 
community looks forward to working with the NIDDK to expand its 
endoscopic research program and we encourage the subcommittee to 
support this important effort.
    Hepatitis C: a Looming Threat to Health.--It is estimated that 4 
million Americans are infected with the Hepatitis C Virus (HCV). 
Unfortunately the majority of infected individuals are unaware that 
they have contracted the disease. In 1997, more than 10,000 people died 
from hepatitis C and the CDC estimates that the death rate will triple 
by 2010 unless there is additional research, education and effective 
public healthy interventions. Moreover, liver failure from HCV now 
accounts for more than half of all the liver transplants performed in 
the United States and is the leading cause of liver cancer.
    The DDNC joins with the liver disease community in recommending an 
increase of $15 million in fiscal year 2002 for CDC's Hepatitis C 
Prevention Strategy program. This new funding will expand the number of 
states with CDC sponsored hepatitis C prevention coordinators from 16 
to 50. In addition, we recommend an appropriation of $40 million (an 
increase of $17 million over fiscal year 2001) for CDC's Prevention 
Research Centers program.
    Finally, Surgeon General David Satcher drafted a ``Dear Citizen'' 
letter last year warning American about the silent epidemic of HCV. The 
letter provided important educational information on HCV as well as 
action people can take to determine whether or not they are infected. 
The DDNC encourages the subcommittee to work with the Surgeon General's 
office in fiscal year 2002 to facilitate the distribution of this 
important correspondence to all Americans.
    Pancreatic Cancer.--Last year, an estimated 28,300 in the United 
States were found to have pancreatic cancer and approximately 28, 200 
died from the disease. Pancreatic cancer is the fourth leading cause of 
cancer death in men and women. Only 2 out of 10 patients will live one 
year after the cancer is found and only a very few will survive five 
years. Although we do not know exactly what causes pancreatic cancer, 
several risk factors linked to the disease have been identified:
  --Age: Most people are over 60 years old when the cancer is found;
  --Sex: Men have pancreatic cancer more often than women;
  --Race: African Americans are more likely to develop pancreatic 
        cancer than are white or Asian Americans;
  --Smoking
  --Diet: Increased red meat and fats
  --Diabetes
    The National Cancer Institute has established a Pancreatic Cancer 
Progress Review Group charged with developing a detailed research 
agenda for the disease. The DDNC encourages the subcommittee to provide 
an increase for pancreatic cancer research at a level commensurate with 
the overall percentage increase for NCI.
    Colorectal Cancer Prevention.--Colorectal cancer is the third most 
commonly diagnosed cancer for both men and women in the United States 
and the second leading cause of cancer-related deaths. Colorectal 
cancer affects men and women equally. Although colorectal cancer is 
preventable and curable when polyps are detected early, a General 
Accounting Office report issued in March 2000 documented that less than 
10 percent of Medicare beneficiaries have been screened for colorectal 
cancer. This report revealed a tremendous need to: (1) inform the 
public about the availability and advisability of screening; (2) 
educate health care providers about colorectal cancer screening 
guidelines.
    CDC's National Colorectal Cancer Screening Awareness Program is 
addressing these needs by partnering with organizations like the DDNC 
and its coalition partners (AGA, ASGE, ACG, UOA) to develop an advocacy 
agenda emphasizing the value of early detection. The digestive disease 
community hopes that this relatively new program will do for colorectal 
cancer screening rates what the CDC's Breast and Cervical Cancer 
Screening Program has done for mammography and Pap smear screening 
compliance.
    The DDNC has seen first-hand the ambitious agenda that CDC and its 
partners have developed to reduce the incidence of colorectal caner. We 
are convinced that we can make a significant impact on screening rates 
across the country if given adequate resources. Therefore, the 
Coalition encourages the subcommittee to provide CDC with $15 million 
in fiscal year 2002 (an increase of $6 million over last year) for this 
important program.
    Mr. Chairman, thanks to support provided by this subcommittee in 
past years the NIDDK has been able to make important advances in the 
understanding and treatment of digestive diseases and improve the 
quality of life of many digestive disease patients.
    One digestive disease that concerns us greatly is irritable bowel 
syndrome (IBS) a disorder that affects an estimated 35 million 
Americans. Many people with IBS suffer in silence, unable to speak 
about the disease even to their family members. The medical community 
has been slow in recognizing IBS as a legitimate disease and the burden 
of illness associated with it. Patients often see several doctors 
before they are given an accurate diagnosis.
    Once a diagnosis of IBS is made, medical management is limited 
because the medical community still does not understand the physiologic 
mechanism of the disease. Living with IBS is a challenge. Trying to 
learn how to manage the symptoms is not easy.
    There is a loss of spontaneity when symptoms may intrude at any 
time. Plans made often need to be changed. IBS is unpredictable. One 
can wake up in the morning feeling fine and within a short time 
encounter abdominal cramping to the point of being doubled over in pain 
and unable to function.
    The unpredictable bowel symptoms may make it next to impossible to 
leave home. It is difficult to ease pain that may repeatedly occur 
periodically throughout the day. One becomes reluctant to eat for fear 
that just eating a meal will trigger symptoms all over again. IBS has a 
broad and significant impact on a person's quality of life. It strikes 
individuals from all walks of life and results in a significant toll of 
human suffering and disability.
    While there is much we don't understand about the causes and 
treatment of IBS, we do know that IBS is a chronic complex of symptoms 
affecting as many as one in five adults. In addition;
  --It is reported more by women than men.
  --It is the most common gastrointestinal diagnosis 
        amonggastroenterology practices in the United States.
  --It is a leading cause of worker absenteeism in the United States.
  --It costs the U.S. health care system an estimated $8 billion 
        annually.
    Mr. Chairman, much more can still be done to address the needs of 
the nearly 35 million Americans suffering from irritable bowel syndrome 
and other functional gastrointestinal disorders. We understand the 
challenging budgetary constraints that this subcommittee is operating 
under, yet we hope you will carefully consider the tremendous benefits 
to be gained by supporting a strong research and education program for 
irritable bowel syndrome at NIH and CDC. Mr. Chairman, on behalf of the 
millions of digestive disease sufferers, we appreciate your 
consideration of the views of the Digestive Disease National Coalition.
                                 ______
                                 

           Prepared Statement of the Doris Day Animal League

    Mr. Chairman and members of the Subcommittee on Labor, Health and 
Human Services, Education and Related Agencies Appropriations, thank 
you for the opportunity to submit testimony on behalf of the 300,000 
members and supporters of the Doris Day Animal League requesting 
appropriations for the National Institute of Environmental Health 
Sciences' (NIEHS) National Toxicology Program Interagency Center for 
the Evaluation of Alternative Toxicological Test Methods (NICEATM) for 
Interagency Coordinating Committee for the Validation of Alternative 
Methods (ICCVAM) activities for fiscal year 2002. This entity, ICCVAM, 
was permanently authorized in 2000.

                           FUNCTION OF ICCVAM
    The ICCVAM performs an invaluable function for regulatory agencies, 
industry, public health, and animal protection organizations by 
assessing the validation of new, revised and alternative toxicological 
test methods that have interagency application. After appropriate 
independent peer review of the test method, the ICCVAM recommends the 
test to the federal regulatory agencies that regulate the particular 
endpoint the test measures. In turn, the federal agencies maintain 
their authority to incorporate the validated test method as appropriate 
for the agencies' regulatory mandates. This streamlined approach to 
assessment of validation of new, revised and alternative test methods 
has reduced the regulatory burden of individual agencies, provided a 
``one-stop shop'' for industry, animal protection, public health and 
environmental advocates for consideration of methods and set uniform 
criteria for what constitutes a validated test method. In addition, 
from the perspective of animal protection advocates, ICCVAM can serve 
to appropriately assess test methods that can refine, reduce and 
replace the use of animals in toxicological testing. This function will 
provide credibility to the argument that scientifically validated 
alternative test methods, which refine, reduce or replace animals, 
should be expeditiously integrated into federal toxicological 
regulations, requirements and recommendations.

                           HISTORY OF ICCVAM
    The ICCVAM is currently composed of representatives from the 
relevant federal regulatory and research agencies. It was created from 
an initial mandate in the NIH Revitalization Act of 1993 for the NIEHS 
to ``(a) establish criteria for the validation and regulatory 
acceptance of alternative testing methods, and (b) recommend a process 
through which scientifically validated alternative methods can be 
accepted for regulatory use.'' In 1994, NIEHS established the ad hoc 
ICCVAM to write a report that would recommend criteria and processes 
for validation and regulatory acceptance of toxicological testing 
methods that would be useful to federal agencies and the scientific 
community. Through a series of public meetings, interested stakeholders 
and agency representatives from all 14 regulatory and research 
agencies, developed the NIH Publication No. 97-3981, ``Validation and 
Regulatory Acceptance of Toxicological Test Methods.'' This report has 
become the sound science guide for consideration of new, revised and 
alternative test methods by the federal agencies and interested 
stakeholders.
    After publication of the report, the ad hoc ICCVAM moved to 
standing status under the NIEHS' NICEATM. Representatives from federal 
regulatory and research agencies and their programs have continued to 
meet, with advice from the NICEATM's Advisory Committee and independent 
peer review committees, to assess the validation of new, revised and 
alternative toxicological methods. Since then, two methods have 
undergone rigorous assessment and are deemed scientifically valid and 
acceptable. The first method, Corrositex, is a replacement for animal-
based dermal corrosivity tests for some chemicals. The second, the 
Local Lymph Node Assay, is a reduction and refinement of an animal test 
for the skin irritation endpoint. The open public comment process, 
input by interested stakeholders and the continued commitment by the 
federal agencies has led to ICCVAM's success. It has resulted in a more 
coordinated review process for rigorous scientific assessment of the 
validation of new, revised and alternative test methods.

                       REQUEST FOR APPROPRIATIONS
    On December 19, 2000, the ``ICCVAM Authorization Act'' which makes 
the entity a permanent standing committee, was signed into Public Law 
No. 106-545. For the past few years, the NIEHS has provided 
approximately $1 million per fiscal year to the NICEATM for ICCVAM's 
activities. In order to ensure that federal regulatory agencies and 
their stakeholders benefit from the work of the ICCVAM, it is important 
to fund it at an appropriate level. I respectfully urge the 
Subcommittee to support an appropriation for the NIEHS's NICEATM for 
ICCVAM's activities at $3 million for fiscal year 2002. This 
appropriation request includes all FTEs, funding for independent peer 
review assessment of test methods and meetings of the ICCVAM and other 
activities as deemed appropriate by the Director of the NIEHS.

                 REQUEST FOR COMMITTEE REPORT LANGUAGE
    I also respectfully request the Subcommittee consider the following 
report language for the Senate Labor, Health and Human Services, 
Education and Related Agencies Appropriations bill:
    ``The Committee supports the assessment of scientific validation of 
new, revised and alternative toxicological test methods by the ICCVAM. 
The Committee directs the regulatory and research agencies, including 
the National Institute of Environmental Health Sciences, Food and Drug 
Administration and Environmental Protection Agency, to use the 
expertise and credibility of the ICCVAM for these assessments to 
streamline their individual consideration of new, revised and 
alternative toxicological test methods. The Committee also urges the 
federal regulatory and research agencies to incorporate scientifically 
validated new, revised and alternative test methods into their 
regulations, requirements and recommendations in an expeditious 
manner.''
    Thank you for the opportunity to submit this request on behalf of 
the Doris Day Animal League.
                                 ______
                                 

     Prepared Statement of the Dystonia Medical Research Foundation

    Chairman Specter, thank you for the opportunity to describe for the 
Subcommittee how dystonia has affected our lives and our 
recommendations for fiscal year 2002 federal funding of dystonia 
research.
    My name is Rosalie Lewis, president of the Dystonia Medical 
Research Foundation. Three of my four sons have dystonia, and my fourth 
son is a carrier of the DYT1 gene which is responsible for generalized 
dystonia that begins in childhood. As there is no cure for dystonia, 
and only in the past thirty years has research given way to treatments 
other than brain surgery, my sons have had some benefit from oral 
medication and botulinum toxic injections. Although we are fortunate to 
have these treatments available, the various drugs have significant 
cognitive side-effects.
    Dystonia is a neurological movement disorder characterized by 
involuntary muscle contractions and postures. There are several 
different types of dystonia, including: focal dystonias, affecting 
specific parts of the body, such as the arms, legs, neck, jaw, eyes, 
vocal cords; and generalized dystonia, affecting many parts of the body 
at the same time. Some forms of dystonia are genetic and others are 
caused by injury or illness. Dystonia does not affect a person's 
consciousness or intellect, but is a chronic and progressive physical 
disorder for which, at this time, there is no cure. We believe that 
some form of dystonia affects about 300,000 people in North America.
    In the past few decades, dystonia researchers have made several 
exciting scientific advancements and have been able to rapidly turn 
laboratory and clinical research into diagnostic examinations and 
treatment procedures, directly benefitting those affected. Genetics, in 
particular, is opening up new understanding into the cause and 
pathophysiology of the disorder. Thus far, 12 dystonia related genes 
have been identified. In 1997, the DYT1 gene for childhood onset 
dystonia was identified, and we now have a genetic test available for 
this particular type of dystonia.

                    RESEARCH, AWARENESS, AND SUPPORT
    It is an exciting time to be involved in dystonia research and 
awareness. Researchers are becoming more interested in movement 
disorders and dystonia at the National Institutes of Health (NIH), and 
research is yielding promising clues for better understanding and 
management of this disorder.
    One way the Dystonia Foundation has advocated for more research on 
dystonia, is by funding ``seed'' grants to researchers. Thus far, the 
Dystonia Foundation has funded 338 grants, and 3 fellowships, totaling 
more than $17 million. Due to our advocacy there is a growing number of 
talented researchers dedicated to understanding the biochemistry of 
dystonia, genetic causes, new therapeutics and the ramifications of an 
epidemiology study.
    Another primary goal of the Dystonia Foundation is education of 
both lay and medical audiences. Every year the Foundation conducts 
several medical workshops and regional symposiums to present, discuss, 
and disseminate comprehensive medical and research data on dystonia. In 
January, 2001 NINDS co-sponsored a genetics and animal models meeting, 
designed to involve not only prominent researchers but inviting junior 
investigators to participate in the discussions. Additionally, in 
October 1996, the NIH was one of our co-sponsors for an international 
medical symposium, which featured 60 papers on dystonia and 125 
representatives from 24 countries. Our next major international 
symposium is scheduled for September, where again we anticipate NINDS 
to co-sponsor the meeting.
    Since 1995, over 3,000 educational medical videos have been 
distributed to hospitals, medical and nursing schools, and at medical 
conventions. Now, we have a children's video to increase public 
awareness of this devastating disorder. Media awareness is conducted 
throughout the year, and especially during Dystonia Awareness Week, 
observed nationwide from October 14 through 20, 2001.
    The Dystonia Foundation has over 200 chapters, support groups, and 
area contacts across North America. In addition, there are 15 
international chairpersons whose mission is to increase awareness, 
children's advocacy, development, extension, the Internet, leadership, 
medical education, an on-line news group, and symposiums. Furthermore, 
patient symposiums are held regionally to provide the latest 
information to dystonia patients and others interested in the disorder. 
Last year we held over eight regional symposiums reaching approximately 
2,000 affected families.

             DYSTONIA AND THE NATIONAL INSTITUTES OF HEALTH
    The Dystonia Medical Research Foundation recommends an increase to 
$23.7 billion or 16.5 percent for NIH overall, and a 16.5 percent 
increase for NINDS and NIDCD or $1.37 billion and $350 million 
respectively. This increase reflects a request to double the NIH budget 
in five years. However, we request that this increase for NIH does not 
come at the expense of other Public Health Service agencies.
    Dystonia is the third most common movement disorder after 
Parkinson's and tremor, and effects six times more people than better 
known disorders such as Huntington's, muscular dystrophy and ALS or Lou 
Gehrig's Disease. We ask that NINDS fund dystonia-specific extramural 
research at the same level that it supports research for other 
neurological movement disorders.
    We urge the Subcommittee to recommend that NINDS provide the 
necessary funding for extramural research and a large scale dystonia 
epidemiological study and increase its efforts to educate the public 
and medical community about dystonia though cosponsorship of workshops 
and seminars. We also encourage the Subcommittee to support NIDCD in 
its efforts to revamp its strategic planning process by implementing a 
Strategic Planning Group which will help NIDCD as they: consider 
applications for high program priority; develop program announcements 
and requests for applications; and develop new research areas in the 
Intramural Research Program.
    The ultimate goal of the Dystonia Foundation is a cure for 
dystonia. Until that goal is realized, we are hungry for any knowledge 
about the nature of dystonia and for more effective treatments with 
fewer side-effects. We have amassed many exceptional and diligent 
researchers, committed to our goal, and our top priority is funding 
their very important research. But the Foundation cannot do it alone. 
We need federal support through NIH, NINDS, and NIDCD to continue to 
fund good research and eliminate this debilitating disease.
    I would like to introduce Mr. Peter Cohen.
    Thank you Rosalie, my name is Peter Cohen and I have dystonia. 
Because of this neurological disorder, I have difficulty walking, 
standing, writing, and driving a car, just to mention a few daily 
activities I can't take for granted. Dystonia affected me first when I 
was a teenager, I developed muscle spasm and tremors. By my late 
twenties it became increasingly difficult to walk, my neck would turn 
involuntarily, and the tremors had spread to much of my body.
    As these physical changes worsened over time, dystonia began to 
affect my professional and personal life. It became virtually 
impossible for me to read, write, type or sit in a comfortable working 
position, and I was forced to give up a successful career as an 
attorney. Furthermore, it became increasingly difficult to be in social 
situations. I felt physically and emotionally awkward because of the 
challenges presented by dystonia. I started isolating myself because I 
was ashamed of my appearance.
    For the past couple of years I have tried to move beyond this 
shame. I look forward to a day when there is a cure for this 
debilitating disorder and I can fully participate in life.
    Thank you Peter, Chairman Specter, we ask that you aggressively 
support medical research, specifically for movement disorders and brain 
research. By doing so, you are doing a tremendous service for myself 
and my family, for Peter, and to the hundreds of thousands of people 
and families affected by dystonia.
    Thank you very much.

                THE DYSTONIA MEDICAL RESEARCH FOUNDATION
    The Dystonia Medical Research Foundation was founded 25 years ago 
and has been a membership-driven organization since 1993. Since its 
inception, the goals of the Foundation have remained the same: to 
advance research for more effective treatments of dystonia and 
ultimately a cure; to promote awareness and education; and support the 
needs and well being of affected individuals and their families.
                                 ______
                                 

                   Prepared Statement of Easter Seals

    Easter Seals is a national nonprofit service organization dedicated 
to helping children and adults with disabilities achieve independence. 
Collectively, Easter Seals assists more than one million people 
annually through a national network of 105 affiliates. Easter Seals 
appreciates the opportunity to report on the success of ``Early 
Childhood Development Project for the Mississippi Delta Region (Delta 
Project),'' and to recommend that $1.6 million be allocated in fiscal 
2002 to conduct the project's fifth and final year.
    To date, the Delta Project has provided essential services to 7,000 
children with disabilities who would otherwise have gone without needed 
evaluation and therapy services. Hundreds of Delta families have 
received counseling, training, and support that helps parents 
understand and promote their child's development. Delta Project staff 
have provided technical assistance and training to hundreds of child 
care workers, early intervention and health department professionals, 
teachers, therapists, doctors, and others to enhance competencies for 
better helping children with disabilities develop and learn. The Delta 
Project is committed to building lasting local capacity for improved 
service to children with disabilities and associated developmental and 
educational results. Delta project activities are conducted 
collaboratively with state and local health and education agencies and 
other providers, and do not duplicate or supplant available services.

                   DELTA PROJECT RATIONALE AND DESIGN
    Children with disabilities in the Mississippi Delta are not 
receiving the appropriate early intervention and education services 
that they need to maximize development and learning. Proportionately 
lower family incomes, fewer public resources, shortages of pediatric 
personnel and specialized services, and inadequate support systems for 
families and staff are among the factors contributing to this 
situation. Geographic isolation, caused by wide dispersal of residents 
and community resources, poor roads, and lack of transportation, make 
it difficult for families to access services locally and out-of-region, 
and impede the ability of service providers to be available as needed. 
As a result, increased attention and supports are needed to promote 
more effective implementation of the Individuals with Disabilities 
Education Act (IDEA) in Delta communities, as well as other rural areas 
across the country.
    The Delta Project is demonstrating strategies for building local 
capacity to improve early intervention and education services and 
enhance developmental and educational results for children with 
disabilities in the Delta regions of Arkansas, Louisiana and 
Mississippi. It offers a nationally-significant, replicable model for 
overcoming chronic gaps in local services and addressing parental and 
personnel preparation needs.
    The Delta Project was officially launched in October 1998, with 
significant project activities appearing in targeted Delta communities 
in Arkansas, Louisiana and Mississippi in January 1999. Project 
implementation is occurring in phases, reflecting annual appropriations 
and U.S. Department of Education funding cycles. To date, Congress has 
approved a total of $3.725 million for this five-year initiative. A 
final appropriation of $1.6 million is recommended for fiscal 2002, to 
enable Easter Seals to provide full-scale services, training, and 
technical assistance in 45 Delta counties and parishes, and to report 
overall project findings. No further requests to earmark Education 
Department funds for this initiative will be made after 2002. To the 
extent necessary, Easter Seals will sustain needed capacity-building 
efforts using existing public and private funds.
    The Delta Project is bringing needed expertise, technical 
assistance, and support to local families, educators and service 
providers, and community decision-makers that are currently lacking in 
the Delta. Major goals of the Delta Project are:
  --Improve child find activities.
  --Improve the quality and availability of appropriate early 
        intervention and childhood development services for Delta 
        region children with disabilities.
  --Increase parent information and skills to better promote child 
        development and learning.
  --Increase the capacity of local educators and service providers to 
        better serve children with disabilities and their families.
  --Increase the ability of community decision-makers to create 
        solutions to improve access to appropriate services for 
        children with disabilities.
    The Delta Project achieves these goals through collaboration with 
state and local health and education personnel, parents of children 
with disabilities, and local decision-makers, by:
  --providing training and technical assistance to teachers, other 
        education personnel, public health practitioners, child care 
        workers and others to elevate their skills and ease in 
        assisting children with disabilities and families;
  --providing training and support to families with children with 
        disabilities to promote increased understanding of child 
        development and parent-child activities that advance child 
        development and learning;
  --facilitating collaboration and problem-solving among local 
        agencies, community resources and decision-makers to improve 
        services and results for children with disabilities; and,
  --offering short-term, otherwise unavailable evaluation and essential 
        services for children with disabilities.

                DELTA PROJECT STATUS & RECENT ACTIVITIES
    Although Easter Seals is seeking final year funding for the Delta 
Project in fiscal 2002, the project is programmatically at its mid-
point in terms of implementation and capacity building effect. A 
summary of significant accomplishments and selected activities during 
the past six months (October 1, 2000 to March 31, 2001) follows.
    Over the past two and one-half years, the Delta Project has proven 
an effective catalyst for necessary change in Delta communities. 
Significant accomplishments include:
  --Dramatically enhanced child find efforts through capacity building 
        with Head Start agencies, child care providers, physicians, 
        local health departments and other service agencies. For 
        example, in East Carroll Parish, Louisiana, these efforts 
        resulted in the identification and referral of ten children 
        with developmental delays for services. This may not seem 
        noteworthy until contrasted with previous years during which no 
        children with developmental needs were found, despite the birth 
        of hundreds of children annually in an at-risk environment of 
        crushing poverty, teen pregnancy, and inadequate pre-natal 
        care. In Bolivar County, Mississippi, project staff 
        collaborated with Head Start to screen 282 preschool children 
        for developmental delay and other needs, of whom 49 were 
        referred for additional testing.
  --Substantial increase in access to early intervention services in 
        the Delta because of developmental screenings, evaluations, and 
        short-term therapy services provided by Project staff. A total 
        of 438 children received short-term therapy services from 
        project staff across the three-state region. It is important to 
        note that these services meet not only the immediate needs of 
        specific children, but also address personnel and parent needs 
        as well. In Arkansas, for example, the majority of children 
        were referred by school personnel triggering direct service to 
        children, accompanied by consultation on classroom programming, 
        behavioral issues, and augmentative communications needs. In 
        many instances, parents were included in these consultations.
  --Increased competency of nearly 400 Delta health and education 
        professionals to better understand and serve children with 
        disabilities through participation in 15 project training 
        sessions that addressed topics of greatest concern. For 
        example, two tri-state training conferences were held in Little 
        Rock; ``Communication Development with Autistic Spectrum 
        Disorder,'' held in October 2000 and ``Managing Children's 
        Behavior in a Positive, Developmentally Appropriate Way'' in 
        February 2001. A workshop was held in Greenville, Mississippi 
        in late march 2001 entitled ``Sensory Processing: From 
        Definition to Intervention,'' which was attended by 53 
        professionals and paraprofessionals from the three-state Delta 
        region.
  --Higher level of knowledge and skills development among Delta 
        parents due to project training and support. For example, three 
        parent workshops on Early Brain Development were conducted in 
        Morehouse and Richland Parishes, Louisiana, that helped 47 
        parents understand early brain development and its relevance to 
        their child's abilities and needs. In Arkansas, project staff 
        helped hundreds of families, including 40 parents who received 
        individualized consultations on developmental milestones, home 
        activities to enhance development, positioning techniques, 
        feeding strategies, and effective use of assistive technology.
  --Greatly increased awareness of child development needs and services 
        in the Delta through distribution of materials, participation 
        in agency initiatives, presentations, and use of the media. For 
        example, the project developed and distributed 2,881 copies of 
        a basic child development letter titled ``Is Your Child on 
        Track,'' which helps parents, personnel, and others to better 
        understand child development milestones, recognize potential 
        delays, and to facilitate evaluations, as appropriate. Delta 
        project staff regularly contribute to health and education 
        agency decision-making, such as First Connections in Arkansas, 
        Children's Coalition in Louisiana, and First Steps in 
        Mississippi, and Interagency Coordinating Committees in all 
        three states. Community contacts with faith groups, community 
        groups and the media are a regular part of Delta Project 
        outreach.
    The Delta Project is fully operational in 45 counties and parishes, 
representing the entire area originally targeted based on need, as 
follows:
  --Arkansas.--Arkansas, Ashley, Bradley, Chicot, Crittenden, Cross, 
        Desha, Drew, Lee, Lincoln, Mississippi, Monroe, Phillips, 
        Poinsett, and St. Francis.
  --Louisiana.--Avoyelles, Catahoula, Concordia, East Carroll, East 
        Feliciana, Franklin, Livingston, Point Coupee, Madison, Monroe, 
        Richland, St. Helena, Tensas, West Carroll, and West Feliciana.
  --Mississippi.--Adams, Bolivar, Coahoma, Claborne, De Soto, 
        Humphreys, Issaquena, Jefferson, Leflore, Sunflower, Sharkey, 
        Tunica, Warren, Washington, and Wilkerson.
    Note.--Project staff are currently conducting a comprehensive needs 
assessment in parishes and counties listed in italics. Planning and 
coordination services will be available in these targeted areas this 
fiscal year, and full project services will be implemented beginning 
October 2001.
    Project offices are located in Little Rock, AR, Monroe, LA, 
Covington, LA, and Greenville, MS. Easter Seals Arkansas based in 
Little Rock serves as project headquarters, coordinating project 
services in Arkansas and overseeing region-wide training, technical 
assistance, evaluation, and reporting activities.
    Highlights for the period, by state, characterize the Delta 
Project's fundamental and lasting contribution to addressing chronic 
needs at the local and national levels.
    In Arkansas, selected accomplishments during the past six months 
include:
  --Educated 30 mothers attending a Lee County WIC (Women, Infants and 
        Children) Clinic about developmental milestones and potential 
        indications of developmental delay, and guidance on accessing 
        needed services.
  --Assessed 81 children for developmental delay, with one-third being 
        referred to the early intervention program.
  --Initiated 171 contacts with social, health, educational, parenting, 
        and therapy providers in the Delta to enhance child find 
        efforts; 27 contacts were with physicians and 85 visits were 
        made to Head Start and community child care centers.
  --Participated in health fairs in Monroe and Desha counties and 
        provided information to about 375 people on child development 
        and early intervention.
  --Surveyed 772 therapists in the three-state Delta region regarding 
        practices and attitudes on delivering school-based therapy 
        services in the classroom (inclusionary) versus on a ``pull-out 
        basis. Therapists generally favored services outside of the 
        classroom, while administrators and teachers supported an 
        inclusionary approach.
    In Louisiana, selected accomplishments during the past six months 
include:
  --Boosted child find results in chronically underserved areas, with 
        40 percent of the children assessed by project staff referred 
        to the early intervention program.
  --Met with LSU Shreveport medical staff address concerns that 
        children referred to ChildNet for early intervention services 
        after medical treatment were not entering the system or 
        accessing needed services. Project staff worked out a solution, 
        whereby project staff will facilitate the referral process 
        between LSU and ChildNet and support ChildNet in reducing 
        service delays.
  --Collaborated with Child Search Coordinators to identify and address 
        barriers to raising awareness among parents regarding the 
        benefits of early intervention.
    In Mississippi, selected accomplishments during the past six months 
include:
  --Established a collaborative relationship with the Delta Area Health 
        Education Centers and Delta Medical Society to schedule 
        presentations by project staff and disseminate project 
        information.
  --Moved project office from Jackson to Greenville to better access 
        and support local early intervention and education systems 
        serving children with disabilities.
  --Aided development of a proposal by Part C leadership to increase 
        Medicaid payment for early intervention services that has been 
        submitted to the governor for review.
  --Scheduled regional training conferences for therapists, teachers, 
        and parents to be held in Greenville, MS in spring 2001 on 
        sensory processing, inclusion or intrusion, and therapeutic 
        interventions.
    Detailed information on Delta Project activities and findings are 
described in a mid-year report to the U.S. Department of Education, 
submitted May 2001.
    Delta Project accomplishments and outcomes are evaluated by the 
University of Alabama's Civitan International Research Center, based in 
Birmingham, Alabama. The Civitan International Research Center is a 
University-Affiliate Program with research and evaluation expertise in 
early childhood development and programs serving children with 
disabilities in the Mississippi Delta Region. Civitan conducts an 
independent evaluation of the Delta Project, including site visits, 
throughout the year. During the past six months, evaluation staff 
conducted project site visits in Arkansas on January 30-31, 2001; in 
Mississippi on February 22-23, 2001; and Louisiana on March 8-9, 2001. 
Civitan reports its findings to the U.S. Department of Education on a 
semi-annual and annual basis. Easter Seals is pleased that evaluation 
findings to date are favorable.
    Easter Seals greatly appreciates the Subcommittee's strong support 
for initiating and continuing the ``Early Childhood Development Project 
for the Mississippi Delta Region.'' The Delta Project is beginning to 
have a dramatic, positive, and lasting impact in Arkansas, Louisiana, 
and Mississippi. It is generating valuable lessons and techniques for 
use in underserved areas throughout the country. Investment of $1.6 
million in fiscal 2002 will support final year operations in the three-
state region, evaluation and reporting, and the dissemination of 
findings and recommendations. Proposed statutory and report language 
for fiscal 2002 is attached for your information and use. Thank you for 
supporting the Delta Project.
  early childhood development project for the mississippi delta region
    The following statutory and report language is proposed for use in 
the fiscal 2002 Appropriations Bill for Labor-HHS-Education for the 
U.S. Department of Education, Office of Special Education and 
Rehabilitative Services, Special Education programs IDEA Research and 
Innovation.

             FISCAL 2002 APPROPRIATIONS STATUTORY LANGUAGE
    ``Of the funds provided, $1,600,000 shall be available for Easter 
Seals Arkansas ``Early Childhood Development Project for the 
Mississippi Delta Region.''

      REPORT LANGUAGE TO ACCOMPANY FISCAL 2002 APPROPRIATIONS BILL
    ``The Committee continues to be concerned about unmet needs among 
children with disabilities in rural areas, particularly the Mississippi 
River Delta, and the lack of adequate support in these areas for 
parents, school personnel, child care staff, and health providers to 
overcome chronic barriers to effective local service delivery. The bill 
addresses these concerns by providing $1,600,000 to continue the Early 
Childhood Development Project for the Mississippi River Delta Region to 
be carried out by Easter Seals Arkansas in Arkansas, Louisiana and 
Mississippi. The Committee recognizes that this multi-year project 
provides unduplicated early intervention and early childhood services 
to children with disabilities ages birth through twelve years, assists 
parents, and builds lasting local capacity to better provide and 
coordinate such services to maximize developmental and educational 
results. Valuable solutions generated by this project will be available 
for replication across rural America.''

                                                           DELTA PROJECT--SUMMARY OF SERVICES
                                                            [October 1, 2000-March 31, 2001]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   Arkansas                    Louisiana                  Mississippi
                                         ------------------------------------------------------------------------------------     Total     Total Number
                                            Number of                   Number of                   Number of                   Children      of Visits
                                            Children      Number of     Children      Number of     Children      Number of     Seen For     For Period
                                              Seen         Visits         Seen         Visits         Seen         Visits        Period
--------------------------------------------------------------------------------------------------------------------------------------------------------
Evaluations.............................            42            52            15            15            11            31            68            92
Consultations...........................            29            29             3             3  ............  ............            32            32
Screenings..............................            32             1  ............  ............           282  ............           314             1
Therapy:
    OT..................................  ............  ............            13           137  ............  ............            13           137
    PT..................................  ............  ............  ............  ............             1             4             1  ............
    SLP.................................  ............  ............            20           203  ............  ............            20           203
    Other...............................  ............  ............             4            54  ............  ............             4            54
                                         ---------------------------------------------------------------------------------------------------------------
      Total.............................           103            82            41           412           294            35           438           529
                                         ---------------------------------------------------------------------------------------------------------------
                                            Number of     Number of     Number of     Number of     Number of     Number of       Total         Total
                                           Individuals    Trainings    Individuals    Trainings    Individuals    Trainings      Trained      Trainings
                                             Trained      Conducted      Trained      Conducted       Seen        Conducted                   Conducted
                                         ---------------------------------------------------------------------------------------------------------------
Inservice...............................           205             9           126             5            53             1           384            15
Parent Training/Consultations...........            38            42           114           114            15            35           167           191
                                         ---------------------------------------------------------------------------------------------------------------
      Total.............................           243            51           240           119            68            36           551           206
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                 ______
                                 

             Prepared Statement of the Epilepsy Foundation

    The Epilepsy Foundation is the national voluntary organization that 
works for people affected by seizures through research, education, 
advocacy and service. Founded in 1968, its national office is based in 
Landover, Maryland. The national office and its network of more than 60 
affiliates across the country provide many direct services to 
individuals and families, including: community education; employment 
assistance; recreation; professional education conferences; assisted 
living; and case management and counseling.
    The Epilepsy Foundation supports medical research to find better 
treatment and an eventual cure for epilepsy, and works with federal 
government agencies and Congress to advance the interests of people 
with epilepsy.
    Epilepsy is a neurological condition characterized by recurrent, 
unprovoked seizures. At least 2.3 million people currently have 
epilepsy; the number of people affected by epilepsy, family members, 
teachers, care givers, employers is an exponentially far larger number. 
A recent CDC study in Texas found 1.8 percent of adults had been 
diagnosed with epilepsy or seizures. Approximately 181,000 new cases of 
epilepsy occur each year; 10 percent of all Americans will experience 
seizures in their lifetimes.

                      MEDICAL RESEARCH ADVANCEMENT
    The Epilepsy Foundation actively supports the efforts of Congress 
to double funding for the National Institutes of Health. We are pleased 
that NIH maintains strong bi-partisan support and has enjoyed 
significant increases in funding. These investments in our nation's 
health are paying dividends. In the last decade considerable progress 
has been made in identifying genes associated with epilepsy and in 
developing medications, devices and surgical treatments.
    Almost a year ago, participants in a historic scientific conference 
predicted that prevention and a cure for epilepsy are only a generation 
away. Now the scientific community is working on next steps and ways to 
measure progress toward those goals. The conference, ``Curing Epilepsy: 
Focus on the Future'', was sponsored by the National Institute for 
Neurological Disorders and Stroke (NINDS), which is the primary federal 
sponsor of epilepsy medical research. The Epilepsy Foundation was one 
of the co-sponsors. NINDS, together with scientific experts have 
developed a set of benchmarks and priorities to guide future research.
    Specifically, the conference and the benchmarks look at how 
epilepsy begins, ways of identifying people at risk and how to develop 
treatments that will prevent epilepsy in those people as well as 
continuing the search for new therapies, free of side effects, to 
prevent seizures. Clearly there are significant opportunities for 
advancements in epilepsy research.

                         THE IMPACT OF SEIZURES
    Despite this progress and hope for the future, epilepsy remains a 
chronic condition that usually requires a lifetime of medical 
treatment. As many as 44 percent of people with epilepsy continue to 
have seizures despite treatment; 56 percent have early or delayed 
seizure control with treatment. Currently, there is no cure for 
epilepsy.
    A recent cost study estimates that the cost of epilepsy, focussed 
on its most narrow measures, the direct medical costs, and the indirect 
costs as identified by the impact on earning and home production, is 
$12.5 billion annually.
    The consequences of seizures continue to be severe and life 
altering, even among people with well-controlled seizures. Their impact 
spans employability, income levels, education, marriage, fertility, 
life expectancy and life style. The Texas study showed high levels of 
pain, anxiety, poor health, depression, and fatigue among adults living 
in the community, to the degree that their quality of life was 
negatively affected about 40 percent of the time.
    Twenty five percent of all people with epilepsy are unemployed; 
among those who are partially or poorly controlled, unemployment 
approaches 50 percent. Marriage and fertility rates are reduced in 
people with epilepsy, there is an increased risk of brain damage and 
increased mortality and stigma remains a fact of life for too many 
people fueling discrimination and isolation from the mainstream of 
life.
    Children with epilepsy are at special risk of learning 
difficulties. Studies have documented deficits in language, visual-
spatial function, problem solving, and adaptive behaviors, even in the 
absence of co-morbidity. Children with epilepsy have unique 
difficulties when compared to those with other chronic illnesses such 
as asthma and diabetes; achievement scores are lower, there are 
problems with self-concept, depression, and behavior. These studies 
demonstrate the critical importance of early recognition and treatment, 
as well as the often unanticipated consequences that a diagnosis of 
epilepsy can have.

               RESEARCH AND PUBLIC HEALTH RECOMMENDATIONS
    The Epilepsy Foundation supports the doubling of the NIH budget. We 
expect that the NINDS will update Congress and the epilepsy community 
on the progress being made to implement the recommendations from the 
conference entitled ``Curing Epilepsy: Focus on the Future.'' 
Continuing to invest in basic and clinical research is crucial to 
meeting our goal of preventing and curing epilepsy. However much more 
needs to be done to address the impact of epilepsy and to improve the 
quality of life of those living with the disorder. Experts agree that 
timely recognition of seizures and effective treatment can reduce the 
risk of subsequent brain damage, as well as disability and mortality 
from injuries incurred during a seizure and from recurring seizures.
    In 1993 Congress recognized this need and directed the Centers for 
Disease Control and Prevention (CDC) to develop an epilepsy program 
within the National Center for Chronic Disease Prevention and Health 
Promotion. As a result, the CDC initiated a number of activities 
including a public health campaign geared toward teen awareness and 
education, a project with the Agency for Healthcare Research and 
Quality to develop provider education materials and surveillance and 
prevention research activities to better analyze trends in access to 
care, levels of care and other demographic variables.
    In 2000, Congress expanded the program by passing the Children's 
Health Act of 2000. The goals for this program include progress in 
research, epidemeology and surveillance, early detection, improved 
treatment, public education and expansion of interventions to support 
people with epilepsy and their families in their communities. The 
Children's Health Act of 2000 also authorized a new program within the 
Health Resources and Services Administration. HRSA is directed to 
create grants to improve access to health and other services regarding 
seizures; and to gear projects toward encouraging early detection and 
treatment for those living in medically underserved areas.
    This agenda is much larger than current resources for the program. 
In fiscal year 2001, Congress appropriated $4 million for the CDC 
epilepsy program. Additional resources will be needed in order to 
expand the reach of the program into local communities and to fulfill 
the legislative intent.

                  FISCAL 2002 FUNDING RECOMMENDATIONS
    Epilepsy research funded by the National Institute of Neurological 
Disorders and Stroke is vital to continuing the fight against epilepsy. 
The promise of future breakthroughs in epilepsy research can only be 
achieved by increased funding for epilepsy research and prevention 
programs. The Foundation urges Congress to increase the federal 
commitment to epilepsy research by allocating sufficient funding for 
the NINDS, the Centers for Disease Control and the Health Resources 
Services Administration.
  --Epilepsy Program at the Centers for Disease Control and 
        Prevention.--The Epilepsy Foundation supports a $3 million 
        dollar increase in funding for the CDC epilepsy program.
  --Health Resources and Services Administration.--The Epilepsy 
        Foundation supports an initial investment of $3 million in 
        order to create demonstration projects to improve access to 
        health care for people with epilepsy.
  --Doubling the National Institutes of Health Budget.--The Epilepsy 
        Foundation supports the efforts to double the funding for the 
        NIH, particularly the National Institute of Neurological 
        Disorders and Stroke (NINDS). In keeping with this effort, we 
        support an increase to $1,370.6 million for NINDS in fiscal 
        year 2002. The Foundation urges Congress to support a major 
        expansion of epilepsy research within NINDS. In 1999, NINDS 
        spent $74 million on epilepsy research. We are seeking a 
        commitment to double that amount by fiscal year 2005.
    Thank you for the opportunity to submit testimony to the 
Subcommittee. We look forward to working with you in the 107th 
Congress.
                                 ______
                                 

   Prepared Statement of the Facioscapulohumeral Muscular Dystrophy 
                                Society

    Mr. Chairman, it is a great pleasure to submit this testimony to 
you today.
    My name is Daniel Paul Perez, of Lexington, Massachusetts, and I am 
testifying today as President & Chief Executive Officer (CEO) of the 
Facioscapulohumeral Muscular Dystrophy Society (FSH Society, Inc.) and 
as an individual who has this devastating disorder.
    We are excited to report that during the past several months, the 
National Institutes of Health (NIH) have announced a series of 
initiatives to accelerate research on Facioscapulohumeral Muscular 
Dystrophy (FSHD). For the first time since its inception, the NIH has 
requested grant applications whose purpose is to explore and develop 
research that will broaden the base of knowledge on FSHD. We are 
indebted to you, Senator Arlen Specter, as well as Representative John 
Porter, Chairman U.S. House of Representatives Subcommittee on Labor, 
HHS, Education and Related Agencies, formerly of U.S. House of 
Representatives, as well as the directors and staff of the National 
Institute of Neurological Disorders and Stroke (NINDS) and the National 
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 
the NIH for this progress.
    The FacioScapuloHumeral (FSH) Society, incorporated in 1991, solely 
addresses specific issues and needs regarding facioscapulohumeral 
muscular dystrophy (FSHD). We provide public awareness of FSHD by 
providing information, referral, education, and advocacy on FSHD. 
Additionally, the FSH Society offers assistance and support to 
patients, families, physicians, and other professionals. The Society 
publishes a newsletter with information about advances in research, 
political action effecting FSHD research and profiles of people with 
FSHD. We have awarded $650,000 in grants toward the prevention, cause 
and treatment of FSHD for research projects, post-doctoral and research 
fellowships and provided training support to institutions and 
fellowships to individuals in the field of FSHD research worldwide. The 
FSH Society promotes collaborative research and collects and 
disseminates research information. The Society organizes and sponsors 
annual international and national scientific meetings on FSHD as well 
as annual international and national patient network day meetings.
    FSHD is a neuromuscular disorder that is inherited genetically and 
has an estimated frequency of one in twenty thousand (1/20,000). FSHD 
affects 12,500-37,500 persons in the United States. The major 
consequence of inheriting this disease is that of a clinically 
unpredictable and progressive and severe loss of skeletal muscle, with 
the usual pattern of initial noticeable weakness of facial, scapular 
and upper arm muscles and subsequent developing weaknesses of other 
skeletal muscles. Retinal and cochlear disease can often be associated 
with FSHD although the pathogenesis and causative relationship to FSHD 
remains completely unknown. FSHD wastes the skeletal muscles and 
gradually but surely brings weakness and reduced mobility. Many with 
FSHD are severely physically disabled and spend the last 30 years of 
their lives in a wheelchair. The toll and cost of FSHD physically, 
emotionally and financially is enormous. FSHD is a life long disease 
that has an enormous cost-of-disease burden and is a life sentence for 
the innocent patient and involved persons and their children and 
grandchildren as well.
    We are in an unprecedented time with the publication of the entire 
human genome sequence. We have spent an enormous amount of money in 
genomic research that is coming to fruition and we hope to begin to 
realize the payoff for this investment. However, this chapter is not 
closed and we are not done with understanding FSHD. FSHD is a complex 
and difficult disease and the mechanism of this disease is tightly 
bound to the next steps for genome research. FSHD is an enormously rich 
disease to study with its involvement in telomeres, repeats, 
chromosomal ``cross-talk'', new protein and DNA models for 
transcription of the genome, and many other new areas outlined for 
investigation by the entire genome community as critical areas for the 
next steps to understanding how the human genome and physiome works. 
FSHD may well be the only human disease that can be used as a model for 
the next generation of novel genomic inquiry.
    A decade of progress in FSHD has led to the discovery of a novel 
genetic phenomena of crossover of subtelomeric DNA between chromosomes 
(4 and 10) in both normal individuals and diseased individuals and to 
the discovery that facioscapulohumeral muscular dystrophy may be the 
only human disease caused by a deletion-mutation causing a position 
effect variegation (PEV). PEV causes DNA in one part of the genome to 
affect DNA in other parts of the genome. In FSHD, DNA at the very end 
of the chromosome (telomere) interferes with DNA upstream towards the 
center (proximal) of the chromosome. Despite remarkable genetic insight 
and immense progress by a small team of scientists worldwide, the 
nature of the gene product(s) remain enigmatic and the biochemical 
mechanism and cause of this common muscle disease remains absolutely 
unknown and elusive.
    FSHD, in particular, and muscular dystrophy in general appear to be 
of little interest to the pharmaceutical industry, biotechnology 
industry and Wall Street. No privately or publicly owned company is 
currently pursuing FSHD research. Unlike Alzheimer's, Parkinson's 
disease or breast cancer with hundreds of millions of research dollars 
from the NIH supplemented by the enormous investments from the 
pharmaceutical and biotechnology sector, FSHD has nowhere to go in the 
private sector. We rely totally on NIH funding and that of voluntary 
health organizations which raise research funds from the public, to 
advance knowledge in this field.
    Neuromuscular and muscle disease has one of the highest cost-of-
disease burdens in the U.S. economy. Yet, of $20.5 billion annually 
given to NIH, approximately $19 million is spent on all muscular 
dystrophy research and, of that amount, conservatively $450,000 is 
currently being spent on the third most prevalent and third largest 
dystrophy, FSHD. Clearly, the muscular dystrophies are significantly 
under-funded by NIH. In last year's testimony, we reported the NIH had 
not responded to the past three years of House and Senate Reports 
accompanying the appropriations bill Language. We are pleased to report 
a very different picture this year.
    The FSH Society with the NINDS, the NIAMS and the and the NIH 
Office of Rare Diseases (ORD) held ``The 3rd International Conference 
on the Cause and Treatment of FSHD'' on Monday, May 8, 2000. The 
research community, the clinical community, the observers and the NIH 
related experts agreed that it was a truly outstanding, top-rate and 
excellent meeting. We successfully assembled the leading FSHD 
researchers from all over the world at the NIH in Bethesda, Maryland 
where they shared their findings with each other and the NIH. The 
Directors and Staff at the NIH developed an excellent program to aid in 
the development of a portfolio for FSHD. The Research Planning 
Conference held Tuesday, May 9, 2000 generated a multitude of ideas on 
how to move forward on the FSHD agenda.
    The May 9, 2000 baseline of recommendations by expert scientific 
panel on FSHD for evaluating priorities is as follows and to date the 
NIH is beginning to accomplish the sixteen items listed in this set. 
Recommendations for future directions, organized by topic, are listed 
as follows:
    A. Molecular Processes; 1. Characterize the molecular pathogenesis 
of FSHD; elucidate the role of the repeats associated with the disease 
as well as what causes their deletion; 2. Determine the relationship 
between repeat length and its effect on the degree to which disease is 
manifested (penetrance); 3. Determine the gene sequence and whether the 
repeats are acting as suppressors or insulating units; 4. Clarify how 
similarity of regions on chromosomes 4 and 10 may relate to FSHD.
    B. Tissue Changes; 5. Characterize changes in muscle as the disease 
develops; 6. Determine basis of differential involvement of muscles; 7. 
Explore the role of inflammation in FSHD; 8. Study properties of muscle 
cells derived from affected tissue.
    C. Possible Therapies; 9. It was speculated that it may become 
possible to repair the disease locus by selected and targeted addition 
of 3.3 kb repeats to the disease locus on chromosome 4; 10. The 
modification of cultured FSHD regenerative muscle cells that would 
reverse their higher sensitivity to oxidative stress. Such cultured 
cells, with better ability to respond to oxidative stress, might then 
be used for treatment of patients.
    D. Population Based Studies; 11. Establish patient registries and 
recruit additional families for study; 12. Determine if a nonstandard 
locus produces FSHD.
    E. Resources; 13. Create new animal models; 14. Facilitate use of 
differential gene and protein expression techniques; 15. Promote 
development and use of non-invasive imaging techniques; 16. Enhance 
formation of clinical and basic research consortia.
    Each year anew the FSH Society defines, at the request of the 
entire international and global molecular genetics and clinical 
research community, the most crucial issues in FSHD research today and 
in the coming several years--these following nine areas represent the 
majority of efforts to be made given recent advances in technology, 
science and understanding of FSHD.
    A. An International clinical and molecular data (resource) base. 
Although a complicated issue for several reasons (homogeneity of 
clinical and genetic data, access etc.), presence of such a facility 
should greatly improve; 1. our insight in the natural history, and 
genotype-phenotype relationships as support for patient counseling and 
management; 2. the availability of biological material (DNA, cell 
lines, muscle biopsies etc.) for research purposes; the design of 
(homogeneous) clinical trials.
    B. Non-chromosome 4q families; large enough to allow linkage 
analysis and gene isolation. Identification of a second FSHD gene 
should greatly facilitate the identification of crucial (rate-limiting) 
molecular pathways. This might help direct our thinking on (gene) 
therapy.
    C. Large scale profiling of thousands of components to identify 
molecular pathways leading to FSHD and targets amenable for 
intervention. Attention should be given to; 1. RNA (transciptomics). 
RNA reflects the steady-state transcription situation, but might be 
only a meager reflection of the true (patho)biology. This work is 
ongoing in several centers; 2. Protein (proteomics). The protein 
components reflect the real biological executive situation. Proteomics 
is much more complicated than transcriptomics, but may give much more 
information; 3. Metabolites (metabolomics). In the near future, we will 
have technologies at our disposal to identify and quantify metabolites, 
the individual steps (substrates) of metabolic pathways. These 
compounds may crucially determine the actual pathology and phenotype.
    D. Cellular and animal models. It is very likely that the 
generation of cellular and animal models will be pivotal, not only for 
the generation of therapeutic means, but also to help identifying the 
molecular basis of FSHD itself. In all likelihood, several approaches 
have to be followed; 1. Transgenic mouse models. Two different 
approaches can be envisaged: models for individual candidate genes, 
identified in the chromosome 4q region or elsewhere and general models 
in which large genomic regions of chromosome 4q and chromosome 10q, 
including the telomeres are transferred and integrated, preferably at 
mouse telomeres. These latter models will approximate the human 
situation and allow studies on the cause and consequences of the inter- 
and intra-chromosomal interactions and rearrangements in relation to 
FSHD; 2. Other animal models. For specific questions on position 
effects variegation etc., simpler models, like Drosophilia, and yeast 
may be very useful.
    E. Chromatin structure in and adjacent to the region where the FSHD 
deletions occur. Including; 1. factors predisposing to illegitimate 
recombination; 2. abnormally expressed genes in FSHD.
    F. Better understanding of abnormalities of the small blood vessels 
of the retina at the back of the eye in FSHD patients. Including; 1. 
why children with a more severe or even sporadic form of FSHD are more 
likely to develop this symptomatic form of retinal disease; 2. an 
unidentified additional genetic peculiarity which renders some FSH 
individuals peculiarly susceptible to symptomatic retinal disease; 3. 
whether retinal, cochlear and skeletal muscle abnormalities in FSH 
represent different effects of the same mutation or otherwise are the 
results of abnormalities of adjacent genes; 4. the possibility that 
such pleitropic effects are mediated by inflammation and/or 
``environmental'' factors.
    G. Clinical, molecular genetic study and genotype/phenotype 
correlation of facioscapulohumeral muscular dystrophy phenotype and 
facioscapuloperoneal muscular dystrophy phenotype.
    H. Clinical trials. It is likely that new clinical trials will be 
launched on basis of hints in other (muscular) disorders. Access to 
well characterized (e.g. with respect to clinical phenotype and genetic 
constitution) patients cohorts is crucial for proper evaluation.
    I. Molecular pathway based therapy. Increasing insight in the 
molecular pathways of FSHD, already available and hopefully even more 
so in the near future, will form the rationale for novel treatment 
strategies. It is difficult to predict whether these efforts will be 
DNA-based or pharmacological. In any case, such experimental approaches 
have to be developed in (transgenic) animal models; another argument 
for investing in versatile models.
    The NIH has the tremendous capacity to quickly enhance research in 
the above project areas through its intramural and extramural research 
programs. The FSH Society and Congress have been repeatedly informed 
that the NIAMS has invested considerable resources into the newly 
formed Laboratory of Physical Biology (LPB) at the NIAMS to strengthen 
its intramural program on muscle diseases and in FSHD muscular 
dystrophy research. The LPB mission is to study of biological systems 
using leading-edge physical approaches, and muscle contraction, 
regulation, structure, and function. The NINDS also has a considerable 
resource to offer with its intramural research staff and programs. 
Additionally, the NINDS and NIAMS staff are currently consulting with 
members of the extramural community to build a research portfolio on 
FSHD. This year should bring a concerted effort by the NIH NINDS/NIAMS, 
the National Institute for Human Genome Research (NIGHR) and its NIH 
Intramural Sequencing Center (NISC) to accelerate extramural research 
by offering and bridging intramural resources with the extramural 
community of researchers and clinicians thereby making the above 
research viable. The NIH has begun to make great progress in its 
extramural programs covering FSHD and the immediate proactive inclusion 
of intramural resources and programs will help rapidly accelerate 
solutions and understanding of FSHD.
    On November 8, 2000, the first of the three major announcements was 
made by NIH as ``Exploratory Research on Facioscapulohumeral Muscular 
Dystrophy''. On December 11, 2000, the second announcement was made on 
the establishment of a National Patient Registry at the University of 
Rochester Medical School for FSHD and Myotonic muscular dystrophy. On 
January 4, 2001, the third announcement was made for a three year 
program ``Therapeutic and Pathogenic Approaches for the Muscular 
Dystrophies.''
    We are delighted with these steps towards finding solutions for 
FSHD. We note with cautious optimism that the NIH has begun the process 
to establish a portfolio in the causes and treatment of FSHD as called 
for in the past three years of House and Senate Report Language. 
However, we are only beginning the process. Difficult work lies ahead 
involving establishing population databases, developing research 
resources such as a mouse model, understanding the molecular process, 
understanding tissue changes, the development and clinical trials of 
possible therapies and population based studies.
    Mr. Chairman, we are watching with interest the response of the 
scientific community to the announcements of NIH referenced above. We 
are concerned that, despite these announcements, the exciting 
scientific questions about this disease and progress in genomics and 
the tremendous need of patients for therapies, that the response of the 
scientific community will be less than optimal. We hope we are wrong. 
We are concerned that there is not an attitude of confidence that FSHD, 
muscular dystrophy or muscle biology is of significant importance at 
NIH over the long term to justify the investment by researchers in this 
field. After all it has taken the FSH Society since 1994 to encourage 
Congress and NIH to move this far, we feel the Committee should 
consider earmarking funding in this area sufficient to encourage 
researchers to make a commitment to pursue this difficult and often 
frustrating area of investigation.
    We request that the Committee consider earmarking an amount of not 
less than fifteen (15) million dollars for FSHD research.
    The men, women and children who live with the daily consequences of 
this devastating disease are your friends, neighbors, fellow taxpayers 
and contributors to the American way of life. With an historic 88 
percent employment rate and an average educational achievement level of 
14 years, we personally bear our burden of the health care costs and 
training expenses to prepare for and maintain financial and personal 
independence. We appeal to you today to take our hard earned tax 
dollars commensurate with our numbers and valuable contributions to 
American Society and we urge the United States Government to allocate a 
proportion of our tax burden toward research on FSHD.
    Mr. Chairman, we trust your judgement on the matter before us. 
Please remember, we need your help to ensure that the sun is rising on 
FSHD and all other muscular dystrophies.
    Mr. Chairman, again, thank you for providing this opportunity to 
testify before your Subcommittee.
                                 ______
                                 

  Prepared Statement of the Foundation for Ichthyosis & Related Skin 
                                 Types

    Mr. Chairman and members of the Subcommittee: The Foundation for 
Ichthyosis & Related Skin Types (F.I.R.S.T.) wishes to thank the 
members of this subcommittee for your past support of the National 
Institutes of Health (NIH) and the National Institute of Arthritis, 
Musculoskeletal and Skin Diseases (NIAMS). We appreciate the 
opportunity to provide written testimony regarding funding for skin 
disease research and the budget for NIAMS. F.I.R.S.T. is requesting 
that the budget for the NIH/NIAMS be increased by 16.5 percent, which 
will keep the NIH on track to doubling the budget by fiscal year 2003.
    In 1992 a member of F.I.R.S.T. testified before this committee 
regarding the need for a national registry for ichthyosis and related 
disorders. Today, as a direct result of your interest and support, we 
have the National Registry for Ichthyosis and Related Disorders. The 
Registry's funding was just renewed for another four years and was 
expanded to include molecular diagnosis. The registry helps generate 
researcher interest in ichthyosis, and provides investigators with an 
essential tool--a pool of affected individuals with a confirmed 
clinical diagnosis. The availability of this pool of information 
results in significant savings in research time and dollars, which 
would have normally been spent identifying eligible patient 
populations.
    F.I.R.S.T. is a voluntary organization dedicated to providing 
support, information, education and advocacy for individuals and 
families affected by ichthyosis. F.I.R.S.T. supports research into 
causes, treatment and a cure for ichthyosis.
    Ichthyosis is a family of genetic skin diseases characterized by 
dry, thickened, scaling skin. These diseases are caused by genetic 
defects that are usually the result of genetic inheritance. Currently, 
there is no cure for ichthyosis, and there are no truly effective 
treatments.
    Some forms of ichthyosis cause the skin to be very fragile and 
blister easily. Scaling and flaking are continuous. The skin is tight 
and cracked. The palms and soles can be thick, making something as 
simple as holding a pencil or as natural as walking difficult and 
painful. Overheating is dangerous and infections are a constant threat.
    Our children are sometimes hospitalized for infections. Simple 
medical procedures are complicated. Days and activities are planned 
around skin care. Stares and questions from strangers are common. While 
the physical aspects of ichthyosis are obvious, the blows to ones self-
esteem can be even more damaging. Currently, ichthyosis is a life-long 
battle. Hopefully, this will change in the future.
    We recognize this Subcommittee's strong history of bipartisan 
support for medical research funding and the NIH. Recently new genes 
have been discovered for several types of ichthyosis and related skin 
types. Darier's disease, although not strictly an ichthyosis, was found 
to be caused by mutations involving the ATP2A2 gene. Another ATPase 
gene, ATP2C1, encoding another calcium pump was found this year to be 
the cause of Hailey-Hailey disease. Patients with this condition have 
more problems with blistering, but lesser problems with scaly skin than 
patients with Darier's disease.
    Two new genetic defects affecting the synthesis of cholesterol have 
now been linked to ichthyosis. The affected enzymes, sterol 4 
demethylase and sterol 7,8 isomerase, were first shown to cause 
ichthyosis-like conditions in laboratory mice. Cholesterol is an 
essential component of the plasma membrane that surrounds each cell, 
and also of the membranes lying between the cells of the stratum 
corneum. In these outer skin layers, cholesterol acts to prevent too 
much evaporative loss of water from the interior of the body to the 
drier atmosphere. Subsequently, several patients with the Conradi-
Hunermann-Happle syndrome, a condition that affects only females and 
causes an ichthyosiform erythroderma in a swirling pattern during 
infancy, along with abnormalities affecting the eye, bones and other 
tissues, have mutations in the gene for sterol 7,8 isomerase. And 
patients with CHILD syndrome, a condition also only affecting females 
in a pattern of abnormalities but is limited to only one side of the 
body, have had mutations affecting the sterol 4 demethylase in some 
cases and the sterol 7,8 isomerase in others.
    Several new causes of palmar plantar keratoderma (PPK) (thickened 
outer skin mostly restricted to palms and soles) were identified this 
past year. Striate PPK (bands of thickened skin along the digits) was 
linked to mutations affecting two proteins, desmoglein I and 
desmoplakin, that are constituents of desmosomes. Papillon Lefevre 
syndrome is a palmar plantar keratoderma with severe periodontitis 
(inflammation of the gums). This condition was found to be due 
deficiency of a protease (enzyme that digests proteins), Cathepsin. The 
last of the genetic breakthroughs this past year were the 
identification of connexin gene mutations in two scaling skin 
disorders. One of the skin diseases caused by a connexin mutation 
(connexin 31 protein, encoded by the gap junction protein beta-3 gene) 
is Erythrokeratodermia vanablis. Not all patients with EKV have been 
found to have mutations in this gene, implying that other genes may 
cause the same disease pattern. Also patients with different mutations 
in this same gene do not have skin disease, but instead are deaf. 
Mutations affecting another connexin, Connexin 26, also cause deafness 
and some of these patients, in addition to deafness, have Vohwinkel's 
PPK.
    We are excited about this progress, and about the current research 
into gene therapy. We are hopeful about the possibility for an 
effective treatment or cure on the horizon, but at this point it is 
still just hope. We continue to be frustrated by the lack of effective 
treatment options.
    Three years ago, this country embarked on a commitment to double 
the National Institutes of Health (NIH) budget in five years. 
F.I.R.S.T. requests that funding to the NIH continually be increased to 
stay on track with that plan. It is very important to support this 
initiative because the NIH is where most of the country's important 
research originates. Research that involves any new discovery for any 
skin disease is beneficial to all skin diseases. Since skin diseases 
are so closely related, eventually these advancements will filter 
across the board and possibly lead to discoveries in our particular 
disease, ichthyosis. It is critical for fundamental research to be 
continued as well. Even though each particular skin disease group wants 
their particular disease to be the focus of increased research, it is 
difficult to study any of these diseases if the basic function of skin 
cells is not mastered.
    Last year, Congress passed the Clinical Enhancement Act to provide 
a loan repayment program for medical school graduates. F.I.R.S.T. asks 
that funding for this program be supported and increased.
    Young doctors are faced with enormous medical school loans after 
graduation. Because of this debt, many young doctors choose professions 
that provide higher salaries, which will help them reduce their debt 
quicker. By supporting and increasing funding for the Clinical 
Enhancement Act, this program will become stronger and encourage young 
doctors to choose a career path in research. F.I.R.S.T. also requests 
that federal appropriators support funding for a workshop to study and 
record the current yearly medical costs related to skin diseases in 
this country.
    If the NIH is to unlock the mysteries of disease, translate the 
recent research discoveries into new treatments for the bedside, it is 
necessary that the appropriation for the NIH be a sizable, sustained 
and stable effort. We hope that you will keep the faith with your 
constituents, and provide the needed funds to the NIH.
    On behalf of our members, those with ichthyosis and their families, 
we thank this Congressional Subcommittee for their time and attention.
                                 ______
                                 

       Prepared Statement of Families of Spinal Muscular Atrophy

    Mr. Chairman and members of the Senate Appropriations Subcommittee 
on Labor, HHS, Education and Related Agencies, Families of Spinal 
Muscular Atrophy wishes to thank you for this opportunity to submit 
written testimony for the record.
    Mr. Chairman and Members of the Subcommittee, let me begin by 
asking a question, what would you do if you were told your 10-week-old 
son or daughter would not live to see his/her second birthday? Or, if 
your child were beginning to walk, and then for some reason, unknown to 
you, regressed to only crawling then eventually only sitting? For 
families who have a child diagnosed with Spinal Muscular Atrophy these 
are not hypothetical questions, these are real situations faced 
everyday.
    Spinal Muscular Atrophy (SMA) is the number one genetic killer of 
children under the age of two. SMA is a vicious, debilitating genetic 
disease that affects individuals indiscriminately and is more 
widespread than anyone realizes. One in every forty people carries the 
gene that causes SMA and one in every 6,000 babies is born with SMA. 
Due to the various forms of SMA, the disease onset can be at any age.
    SMA is a neuromuscular disease that affects the anterior horn 
cells. Through great collaborative effort the scientific field has 
identified the gene that causes SMA as well as determined the missing 
protein and are well on their way to replacing it. By replacing this 
missing protein it is hopeful that the disease will be eradicated and 
that some damage might be repaired. With this knowledge and additional 
National Institutes of Health (NIH) funding through the National 
Institute of Neurological Disease and Stroke (NINDS), this information 
will not only lead to a cure for SMA, but will also open doors through 
this new technology to be used for other motor neuron and neuromuscular 
diseases.
    Families of S.M.A is a 100 percent volunteer organization whose 
mission is to fund research, support families and create awareness. 
Through the efforts of Families of S.M.A. scientists from all over the 
world meet once a year to discuss and share the progress made in 
research. Most recently we have asked that NINDS explore areas of 
promising research, which were identified at the 2000 Families of SMA 
International Workshop. This includes the development of a SMA basic 
and clinical research portfolio through all available mechanisms, as 
appropriate, including clinical trails of drug compounds capable of 
activating SMN2 expression.
    We wish to thank NINDS for their support in the Multi-Center 
Creatine Study, but the continued development of a SMA research 
portfolio is critical. In the very near future SMA will be involved in 
drug development and/or stem cell therapy or gene replacement therapy. 
The participation of NINDS in this endeavor is most important. We ask 
the committee to encourage NINDS to explore areas which will be 
identified at the 2001 Families of S.M.A. International Workshop which 
is being held in June.
    Mr. Chairman, on behalf of all the individuals suffering from the 
various forms of SMA, thank you for your continued, strong leadership 
for the bipartisan effort to double the NIH budget over five years. 
Providing the NIH with a $3.4 billion increase in funding this year is 
critical to individuals with SMA.
    Thank you.

             FACT SHEET ABOUT SPINAL MUSCULAR ATROPHY (SMA)
The Disease
    Spinal muscular atrophy (SMA), the number one genetic killer of 
children under the age of two, is a group of inherited and often fatal 
diseases that destroys the nerves controlling voluntary muscle 
movement, which affects crawling, walking, head and neck control, and 
even swallowing.
Who is Affected
    SMA is one of the most prevalent genetic disorders.
  --One in every 6,000 babies is born with SMA. Of children diagnosed 
        before age two, 50 percent will die before their second 
        birthday.
  --SMA can strike anyone of any age, race or gender.
  --One in every 40 people carries the gene that causes SMA. The child 
        of two carriers has a one in four chance of developing SMA.
Types of SMA
  --Type I, or Werdnig-Hoffman Disease, is the most severe form of SMA. 
        Children with Type I tend to be weak and lack motor 
        development, rendering movement difficult. Children afflicted 
        with Type I cannot sit unaided and have trouble breathing, 
        sucking and swallowing. Type I SMA strikes infants between 
        birth and six months.
  --Type II, is slightly less severe. Type II patients may be able to 
        sit unaided or even stand with support and usually do not 
        suffer from feeding and swallowing difficulties. However, they 
        are at increased risk for complications from respiratory 
        infections. Type II SMA affects infants between seven and 
        eighteen months old.
  --Type III, also known as Kugelbert-Welander Disease, is the least 
        deadly form of childhood-onset SMA. Type III patients are able 
        to stand, but weakness is prevalent and tends to eventually 
        sentence its victims to a wheelchair. Type III SMA strikes 
        children after the age of eighteen months, but can surface even 
        in adulthood.
  --Type IV, is the adult form of the disease in which symptoms tend to 
        begin after age 35. Symptoms usually begin in the hands, feet 
        and tongue, and spread to other areas of the body.
  --Adult Onset X-Linked SMA, also known as Kennedy's Syndrome or 
        Bulbo-Spinal Muscular Atrophy, occurs only in men. Facial and 
        tongue muscles are noticeably affected. Like all forms of SMA, 
        the course of the disease is variable, but in general tends to 
        progress slowly.
    SMA does not affect sensation and intellectual activity in 
patients. It commonly is observed that patients with SMA are unusually 
bright and sociable.
Testing
    Prenatal counseling is available to couples who are carriers of SMA 
or who have lost a child to SMA.
                                 ______
                                 

      Prepared Statement of the Hepatitis Foundation International

    Chairman Specter and members of the Committee. I am Thelma King 
Thiel, Chairman and Chief Executive Officer of the Hepatitis Foundation 
International (HFI), representing the Board of Directors and members of 
425 patient support groups across the nation, the majority of whom 
suffer from chronic viral hepatitis.
    We commend the Committee for allocating initial funds that have 
enabled CDC to make tremendous strides in efforts to understand 
hepatitis and to control it through universal immunization and 
education programs.
    Although all five types of viral hepatitis are preventable, we are 
currently dealing with an ``epidemic of discovery'', people who are 
already infected with the hepatitis C virus because of lack of 
information about transmission, appropriate vaccines and effective 
treatments to stop the spread to others. Hepatitis B has been eclipsed 
by hepatitis C even though we have effective tools to eradicate 
hepatitis B. Lack of funds and integrated prevention activities 
contribute to the ongoing transmission of hepatitis B that claims 5,000 
lives each year. If high risk individuals who attended STD clinics, or 
those who have been incarcerated had been vaccinated against hepatitis 
B in the early 1980s when the vaccine was approved, we would not be 
dealing with the large numbers of individuals who are chronically 
infected and in need of liver transplants today. It is time to make a 
major investment in immunization and preventive education to bring 
these diseases under control. All newborns, young children, young 
adults, and especially those who participate in high-risk behaviors 
must be a priority for immunization initiatives. We need to provide 
effective preventive education in our elementary and secondary schools 
to help children avoid the ravages of health problems resulting from 
viral hepatitis infection.
    The Hepatitis Foundation International has worked closely with the 
Centers for Disease Control and Prevention through cooperative 
agreements in addition to contributing private funds for specific 
projects. HFI provided significant independent support and co-sponsored 
the Hepatitis C Teleconference for healthcare providers in 1997. 
Collaboration with CDC has enabled the Foundation to develop and 
distribute thousands of award winning videos and innovative, effective 
educational materials nationwide dealing with liver wellness, hepatitis 
and substance abuse prevention. Many of these items are available in 
several languages. Teachers, healthcare providers, public health 
officials, personnel in corrections and juvenile detention centers, 
governmental and non-governmental agencies all need these tools. 
Funding is needed to duplicate and distribute many more to those on the 
front line in the battle against hepatitis and substance abuse.
    Prevention can save lives today. We need to train health care 
professionals in effective communication and counseling techniques. We 
need public awareness campaigns to alert individuals to assess their 
own risk behaviors. We need to motivate them to seek medical advice . . 
. to encourage them to be immunized against hepatitis A and B . . . and 
to stop drinking any alcohol if they have participated in risky 
behaviors that may have exposed them to hepatitis C.
    Mechanisms are in place to provide screening, referral services, 
medical management, counseling, and prevention education for those who 
have HIV/AIDS. Funds must be made available to expand all of these 
services, including immunization, to those who are infected by 
hepatitis viruses.
    HFI recommends an increase of $15 million for further 
implementation of CDC's Hepatitis C Prevention Strategy. This increase 
will further the development of state-based prevention programs by 
increasing the number of state health departments with CDC funded 
coordinators from 16 to 51 covering each state and by implementing 
demonstration projects to evaluate ways to integrate hepatitis C and 
hepatitis B prevention efforts into existing public health programs. 
HFI recommends that $10 million be added to CDC's budget to train and 
maintain hepatitis coordinators in every state to implement prevention 
and management strategies.
    The CDC Prevention Research Centers Program plays a critical role 
in reducing the human and economic costs of disease. CDC should be 
commended for its decision to fund the most meritorious applications in 
the fiscal year 2001 competition, regardless of geographic location of 
the applicants with respect to other Prevention Research Centers. 
Preventive education is cost effective. CDC estimates that for every $1 
spent on school-based drug and alcohol, tobacco, and sexuality 
education, $14 are saved in avoided health care costs.
    CDC currently funds 24 prevention research centers at schools of 
public health and schools of medicine across the country. An additional 
two centers will be selected using a portion of the $23 million the 
Congress dedicated to the program in fiscal year 2001. However, core 
funding for prevention centers has been decreasing since this program 
was first funded in 1986 from an average of $800,000 per center to 
$580,000 in fiscal year 2000.
    In order to continue to build this flagship CDC extramural research 
program, HFI requests Congress to increase the core funding to $40 
million for Prevention Research Centers in fiscal year 2002.
    Past investment in NIH has led to an explosion of knowledge that 
has advanced understanding of the biological basis of disease and 
development of strategies for disease prevention diagnosis, treatment, 
and cures. Countless medical advances have resulted in a direct benefit 
to the lives of all Americans. NIH-supported scientists remain our best 
hope for sustaining the momentum in the pursuit of scientific 
opportunities and new health challenges. Research studies to learn why 
some HCV infected individuals resolve their infection spontaneously may 
prove to be life saving information for many who are currently 
infected. The answer may provide a cure for others.
    To achieve the proposed doubling of the NIH budget over the five-
year period from fiscal year 1999 to fiscal year 2003, the Hepatitis 
Foundation International joins with Congress and the new Administration 
in supporting an appropriation of $23.7 billion for NIH in fiscal year 
2002 representing a 16.5 percent increase. HFI also recommends a 
comparable increase of 16.5 percent in hepatitis research funding at 
the National Institute of Diabetes and Digestive and Kidney Diseases 
and the National Institute of Allergy and Infectious Diseases. An 
additional $4 million is needed to extend and expand the HALT-C to 
study the pathogenesis and treatment of hepatitis C and to understand 
why some patients respond to treatment and others do not.
    A significant portion of increases for these Institutes should be 
earmarked to conduct studies among groups of patients that have been 
neglected in overall research initiatives. They include:
  --African Americans--to identify reason why they do not respond to 
        antiviral agents in the treatment of chronic hepatitis C.
  --Children and Adolescents--Pediatric liver research lacks 
        appropriate funding to address the many diseases, including 
        viral hepatitis, that affect children.
  --Renal Dialysis Patients--Many are HCV infected and outcomes of 
        treatment need more investigation.
  --HIV/HCV Positive Patients--Co-infections need special investigation
  --Hemophilia Patients--Co-infection with HIV needs further study.
    Victims of hepatitis suffer emotionally as well as physically. They 
experience discrimination in employment, strained personal 
relationships and severe depression when treatments fail to control 
their illness as well as during their treatment. We look forward to 
working in collaboration with CDC, NIH, health departments and other 
voluntary organizations to bring viral hepatitis under control.
    I would be happy to answer any questions you may have. Thank you 
for providing this opportunity to present our testimony.
                                 ______
                                 

     Prepared Statement of the Humane Society of the United States

    We appreciate the opportunity to provide testimony to the Labor, 
Health and Human Services, and Education Subcommittee on two funding 
items of great importance to The Humane Society of the United States 
(HSUS) and its 7.7 million supporters nationwide. As the largest animal 
protection organization in the country, The HSUS urges the Committee to 
address these priority issues in the fiscal year 2002 budget:
  --$6 million for planning and construction to launch the national 
        chimpanzee sanctuary system authorized by Public Law 106-551;
  --$3 million to expand the work of the Interagency Coordinating 
        Committee for the Validation of Alternative Methods (ICCVAM), 
        authorized by Public Law 106-545, coupled with Committee Report 
        language encouraging federal agencies to avail themselves of 
        ICCVAM's expertise and efficient review process.

                         CHIMPANZEE SANCTUARIES
    We are very pleased that Congress last year enacted H.R. 3514 
(Public Law 106-551), the Chimpanzee Health Improvement, Maintenance, 
and Protection Act, which authorized up to $30 million to establish and 
operate a federal chimpanzee sanctuary system for chimpanzees no longer 
used in medical research. Introduced by Senators Bob Smith (R-NH) and 
Richard Durbin (D-IL) and Representative Jim Greenwood (R-PA), this 
legislation earned the bipartisan support of 24 cosponsors in the 
Senate and 143 cosponsors in the House. It had the endorsement of more 
than 100 scientists, many of whom are renowned experts in the field of 
chimpanzee research. The legislation was approved by unanimous voice 
vote in both chambers and was signed into law on December 20, 2000.
    This common-sense statute is designed to help animals who are 
deemed by the Secretary of Health and Human Services to be ``surplus'' 
for medical research, but who are still being warehoused in expensive 
federally-supported laboratory cages. As determined by the 
Congressional Budget Office (CBO), the sanctuaries envisioned by this 
law will provide a much higher quality of life for these animals. They 
will also serve American taxpayers well, by saving millions of dollars 
over the course of the next several years ($4 million annually, after 
initial construction costs). These savings are primarily due to the 
fact that sanctuary facilities, which offer a more naturalistic 
environment and opportunities for social interaction, can be built and 
operated at significantly lower cost than laboratory facilities. 
Housing chimpanzees in sanctuaries is estimated to cost $8-$15 per day 
per animal, compared to the $20-$30 per day per animal that the federal 
government currently spends to house them in lab cages. In addition, 
the statute creates a public-private partnership, requiring private 
sector matching dollars to complement the federal government's share 
(the private match is 10 percent of construction costs and 25 percent 
of operating costs).
    The statute follows the recommendations of a National Research 
Council (NRC) report commissioned by the National Institutes of Health 
(NIH) and released in 1997, ``Chimpanzees in Research: Strategies for 
Their Ethical Care, Management, and Use.'' In 1986, NIH launched an 
initiative to breed chimpanzees--mistakenly thought to be useful models 
for AIDS research--creating a surplus of several hundred chimpanzees 
who are no longer used in medical research. According to the NRC 
report, the government is spending more than $7 million annually on 
maintenance of chimpanzees. The report recommends a breeding moratorium 
and opposes euthanasia of chimpanzees as a means of population control, 
noting that ``[s]ome of the best and most caring members of the support 
staff, such as veterinarians and technicians would, for personal and 
emotional reasons, find it impossible to function effectively in an 
atmosphere in which euthanasia is a general policy, and might resign.'' 
The report also specifically recommends: ``The concept of sanctuaries 
capable of providing for the long-term care and well-being of 
chimpanzees that are no longer needed for research and breeding should 
become an integral component of the strategic plan to achieve the best 
and most cost-effective solutions to the current dilemma.''
    To implement this law in a timely and efficient way, we 
respectfully request that the Committee direct NIH to allocate $6 
million in fiscal year 2002 for planning and construction of the 
national chimpanzee sanctuary system. In recognition of budget 
constraints, this requested funding level falls well below the $11 
million outlays that CBO projected for the first year of the system. 
But we believe it is enough to ensure that implementation will move 
forward quickly, so that the chimpanzees and taxpayers can begin to 
benefit as Congress intended.

 INTERAGENCY COORDINATING COMMITTEE FOR THE VALIDATION OF ALTERNATIVE 
                            METHODS (ICCVAM)
    We are also very pleased that Congress enacted H.R. 4281 (Public 
Law 106-545) last year by unanimous voice vote in both chambers. This 
legislation, introduced by Senator Mike DeWine (R-OH) and 
Representatives Ken Calvert (R-CA) and Tom Lantos (D-CA), earned the 
bipartisan support of 5 Senate cosponsors and 73 House cosponsors, and 
was signed into law on December 19, 2000. This statute strengthens and 
makes permanent the Interagency Coordinating Committee for the 
Validation of Alternative Methods (ICCVAM). We hope the statute will 
increase acceptance of more animal-friendly test methods by 
streamlining the process by which these methods are validated and 
easing institutional barriers within federal agencies that discourage 
their use.
    ICCVAM performs an invaluable function for regulatory agencies, 
industry, public health, and animal protection organizations by 
assessing the validation of new, revised and alternative toxicological 
test methods that have interagency application--including methods that 
replace, reduce, and refine the use of animals in testing. After 
appropriate independent peer review of a test method, ICCVAM provides 
its assessment of the test to the federal agencies that regulate the 
particular endpoint that the test measures. In turn, the federal 
agencies maintain their authority to incorporate the validated test 
method as appropriate for the agencies' regulatory mandates. This 
streamlined approach to assessment of validation of new, revised and 
alternative test methods has reduced the regulatory burden of 
individual agencies, provided ``one-stop shopping'' for industry, 
animal protection, public health and environmental advocates to 
consider test methods, and set uniform criteria for what constitutes a 
validated test method.
    ICCVAM arose from an initial mandate in the NIH Revitalization Act 
of 1993 for the National Institute of Environmental Health Sciences 
(NIEHS) to ``(a) establish criteria for the validation and regulatory 
acceptance of alternative testing methods, and (b) recommend a process 
through which scientifically validated alternative methods can be 
accepted for regulatory use.'' In 1994, NIEHS established an ad hoc 
ICCVAM to write a report that would recommend criteria and processes 
for validation and regulatory acceptance of toxicological testing 
methods that would be useful to federal agencies and the scientific 
community. Through a series of public meetings, interested stakeholders 
and agency representatives from 14 regulatory and research agencies 
developed NIH Publication No. 97-3981, ``Validation and Regulatory 
Acceptance of Toxicological Test Methods.'' This report has become the 
``sound science'' guide for consideration of new, revised and 
alternative test methods by the federal agencies and interested 
stakeholders. After publication of the report, the ad hoc ICCVAM moved 
to standing status under the NIEHS' National Toxicology Program 
Interagency Center for the Evaluation of Alternative Toxicological 
Methods (NICEATM). Representatives from federal regulatory and research 
agencies have continued to meet, with advice from NICEATM's Advisory 
Committee and independent peer review committees, to assess the 
validation of new, revised and alternative toxicological test methods.
    Since then, two methods have undergone rigorous assessment and been 
deemed scientifically valid and acceptable. The first method, 
Corrositex, is a replacement for animal-based dermal corrosivity tests 
for some chemicals. The second, the Local Lymph Node Assay, is a 
reduction and refinement of an animal test for the skin irritation 
endpoint.
    The open public comment process, input by interested stakeholders, 
and the continued commitment by various federal agencies have led to 
ICCVAM's success so far. Now, with enactment of Public Law 106-545, 
ICCVAM is poised to accomplish even more in terms of streamlining the 
validation of other new, revised and alternative test methods. For the 
past few years, NIEHS has provided approximately $1 million annually to 
NICEATM for ICCVAM activities. In order to ensure that federal 
regulatory agencies and their stakeholders can more fully benefit from 
the work of ICCVAM, we respectfully urge the Committee to direct NIEHS 
to allocate $3 million for ICCVAM activities in fiscal year 2002. 
Funding at this level will cover FTEs, independent peer review 
assessment of test methods, meeting expenses, and other activities as 
deemed appropriate by the Director of the NIEHS. In addition, we 
respectfully request inclusion of the following Committee Report 
language:

    ``The Committee directs that $3 million from the National Institute 
of Environmental Health Sciences budget be allocated to the National 
Toxicology Program's Interagency Center for the Evaluation of 
Alternative Toxicological Test Methods for Interagency Coordinating 
Committee for the Validation of Alternative Methods (ICCVAM) activities 
during fiscal year 2002. The Committee supports the assessment of 
scientific validation of new, revised and alternative toxicological 
test methods by the ICCVAM. The Committee directs the regulatory and 
research agencies, including, but not limited to, the National 
Institute of Environmental Health Sciences, Food and Drug 
Administration and Environmental Protection Agency, to use the 
expertise and credibility of the ICCVAM for these assessments to 
streamline their individual consideration of new, revised and 
alternative toxicological test methods. The Committee also urges the 
federal regulatory and research agencies to incorporate scientifically 
validated new, revised and alternative test methods into their 
regulations, requirements and recommendations in an expeditious 
manner.''

    Again, we appreciate the opportunity to share our views and 
priorities for the Labor, Health and Human Services, and Education 
Appropriation Act of fiscal year 2002. We hope the Committee will be 
able to accommodate these two requests affecting animals across the 
United States. Thank you for your consideration.
                                 ______
                                 

   Prepared Statement of the Huntington's Disease Society of America

                       SUMMARY OF RECOMMENDATIONS
    The Huntington's Disease Society of America (``HDSA'') urges 
Congress to increase funding for medical research on neurodegenerative 
diseases and disorders, especially Huntington's Disease (``HD''), 
through budgetary increases to the National Institutes of Health 
(``NIH'').
    Specifically, HSDA encourages Congress to provide at least a 16.5 
percent increase over fiscal year 2001 for NIH, raising the funding 
levels from $20.3 billion to $23.7 billion, as recommended by the Ad 
Hoc Group for Medical Research Funding. Within NIH, HDSA recommends at 
least a commensurate increase for the National Institute of 
Neurological Disorders and Stroke (``NINDS''), the National Institute 
of Mental Health (``NIMH''), and the National Institute on Aging 
(``NIA''), each of which support a modest portfolio of HD research. 
These increases would allow for further research on the diagnosis, 
treatment and cure for HD, a debilitating and devastating 
neurodegenerative disease.

                HUNTINGTON'S DISEASE SOCIETY OF AMERICA
    HDSA is a national voluntary non-profit health organization 
dedicated to finding a cure for Huntington's Disease while providing 
services and support for those living with HD and their families. 
Founded in 1967, HDSA promotes and supports both basic and clinical HD 
research, aids families throughout the continuum of HD, and educates 
the public and healthcare professionals about HD.
    Private donations coupled with the tireless fundraising efforts of 
HDSA chapters around the country make the HDSA Research Grants program 
possible. These grants help innovative research projects develop 
sufficiently to attract funding from other sources, particularly the 
NIH, which do not provide funds for projects in their early stages of 
development.

                          HUNTINGTON'S DISEASE
    HD is an inherited degenerative brain disorder that results in the 
loss of both mental faculties and physical control. It is caused by the 
mutation of a single gene. The disease afflicts approximately 30,000 
Americans, while 150,000-200,000 Americans are at-risk of inheriting it 
from a parent. Each child of a parent with the HD gene has a 50/50 
chance of inheriting the disease. Every person who inherits the HD gene 
will eventually develop the disease. HD does not skip generations; if 
one does not inherit the gene, one cannot pass it on. HD affects as 
many people as Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's 
disease) or Cystic Fibrosis.
    Symptoms of HD may affect cognitive ability or mobility and include 
depression, mood swings, forgetfulness, clumsiness, involuntary 
twitching and lack of coordination. As the disease progresses, 
concentration and short-term memory diminish and involuntary movements 
of the head, trunk and limbs increase. Walking, speaking and swallowing 
abilities deteriorate. Eventually the person is unable to care for him 
or herself. Death often results from complications such as choking, 
infection or heart failure.
    The costs to society are both direct and indirect, and include 
medical expenses, loss of productivity in the workplace by patients and 
caregivers (oftentimes spouses or children), disability claims, and 
long-term care expenses. On an annual basis, the direct and indirect 
costs of HD to society total over $2 billion.

                        RESEARCH RECOMMENDATIONS
    Once thought of as a rare disease, HD is now considered to be one 
of the more common hereditary diseases. Although HD is classified as a 
more common hereditary disease, researchers have yet to discover an 
effective treatment to slow the progression of HD or a cure for this 
deadly disease. Over the past decade, there have been breakthroughs in 
HD research and researchers continue to aggressively build upon these 
advancements. The outlook for treating and curing HD has never been 
more promising.
    In 1993, researchers identified the gene that causes HD. Such a 
discovery has made possible a predictive test for HD. Individuals at-
risk for HD can now find out whether they carry the gene before 
symptoms arise. This discovery has been a springboard for laboratory 
research. It has led to the creation of a mouse model of Huntington's 
Disease, referred to as a ``transgenic'' mouse. The HD gene is inserted 
into mouse DNA, thus causing the mouse to develop HD symptoms. Using 
transgenic mouse models, researchers have identified and characterized 
pathogenic hallmarks; the aberrant events that occur in the brain cells 
of the subjects with HD.
    In an effort to transform basic research data and determine how it 
can be applied to treat or cure HD in humans, clinical trials must be 
established. Patients with HD and their families are desperately 
depending on the positive outcomes of these clinical trials to improve 
their quality of life. However, prior to commencement of clinical 
trials, researchers must employ the technology of high throughput 
screens for drug development. This technique rapidly tests a very large 
number of compounds to see if they have a desired positive effect. 
Compounds that have a positive effect then go through more research to 
determine if they could become a viable drug therapy for human clinical 
trials.
    HDSA appreciates the commitment that Congress has made to double 
the NIH budget by fiscal year 2003. Medical research endeavors and 
America's patients are benefiting tremendously from this five-year 
effort. This initiative will pay dividends for decades to come. 
However, despite the fact that HD is considered one of the more common 
hereditary disease, the NIH Office of Budget estimates that only one-
third of 1 percent of NIH's sizeable $20.3 billion budget will be 
dedicated to HD research in fiscal year 2001. The level of NIH 
resources allocated to HD research is inadequate, especially 
considering the recent substantial increases in the NIH budget. NIH 
must elevate the priority level of HD research.
    HDSA recommends that Congress urge the NINDS, NIMH, and NIA to 
increase RO1 funding for HD and other neurodegeneration research by 15 
percent for fiscal year 2002. Using such an increase in resources, 
researchers will develop more models of HD, including fruit fly models 
and worm models, and will test compounds and genes which may ameliorate 
or prevent HD. Additionally, researchers hope to target the aberrant 
events that occur in brain cells of subjects with HD and test 
approaches to prevent or mitigate these adverse occurrences.
    HD serves as a prototype disease caused by the mutation of a single 
gene. Therefore, advances made in the understanding and treatment of HD 
will increase scientists' ability to derive the mechanism and 
therapeutic approaches for several similar diseases, including 
Alzheimer's Disease, ALS and Parkinson's Disease.

                               CONCLUSION
    HD continues to take a huge emotional and financial toll on 
America's families. HDSA appreciates Congress' commitment to biomedical 
research and to the NIH in recent years. However, more effort is 
needed. Congress must maintain the momentum, and in some cases, devote 
even more resources. HDSA is grateful for the opportunity to present 
its views on fiscal year 2002 appropriations. Please contact Barbara 
Boyle, HDSA National Executive Director/CEO, at (212) 242-1968, if you 
have further questions.
                                 ______
                                 

         Prepared Statement of the Immune Deficiency Foundation

    Mr. Chairman, thank you for the opportunity to submit testimony on 
primary immune deficiency disorders and the need for continued research 
and education on these diseases.
    Primary immune deficiency diseases are inherited disorders in which 
parts of the body's immune system are missing or do not function 
properly. The World Health Organization has identified more than 70 
different primary immunodeficiency diseases. These disorders are very 
under diagnosed, but we believe that more than 45,000 Americans, of all 
races, ages, and gender. Fortunately, most primary immune deficient 
patients, once diagnosed, are able to maintain their health through 
infusions of a pooled plasma derivative known as intravenous 
immuneglobulin (IGIV) every three to four weeks for the rest of their 
life. However, if primary immunodeficiency diseases are not properly 
diagnosed and treated, they can lead to serious illness and early 
death.
    The Immune Deficiency Foundation (IDF) is the national non-profit, 
charitable organization dedicated to improving the health of primary 
immune deficient patients through research and education. Headquartered 
in Towson, Maryland, IDF was founded in 1980 by a group of parents of 
primary immune deficient children who wanted to focus attention on the 
needs of primary immune deficient patients, physicians, and 
researchers.
    IDF provides a wide variety of patient and family services, medical 
research and education, and advocacy for issues related to these 
diseases. Specifically, the Foundation acts as an information 
clearinghouse for newly diagnosed patients and provides these 
individuals with an opportunity to interact with other primary immune 
deficient patients and families. Oftentimes, the most reassuring call a 
parent of a newly-diagnosed child will make is not to a doctor or 
hospital, but to one of our local patient representatives with his or 
her own children playing loudly in the backyard. This opportunity to 
speak directly and frankly to another parent in a similar situation 
often is the first chance to seek support and results in a level of 
comfort that with proper treatment their child can grow up with a near-
normal life.
    The foundation is also active in medical research to try to better 
define and diagnose these diseases. While we search for these longer-
term answers, we are also looking to improve current treatment options 
for patients as well as improve understanding of these diseases within 
the medical community. Because primary immune deficiency is a rare 
disease, we focus on providing educational opportunities such as 
visiting professorships and grand rounds for physicians and medical 
students who might otherwise not be exposed to this knowledge. The 
foundation is also working through an NIH grant that I will discuss in 
more detail later to help better identify the range and occurrence of 
these diseases.
    Finally, IDF has a very active public policy program that focus on 
blood safety issues, patient reimbursement for treatment, and advancing 
scientific knowledge regarding primary immune deficiency diseases.
    Mr. Chairman, I am both a patient, a physician, and the newly 
elected Chairman of the IDF Board of Trustees. My case is 
representative of a typical immune deficient patient. I was diagnosed 
with Common Variable Immunodeficiency 10 years ago, following years of 
repeated infections, which were unresponsive to antibiotics, and 
undiagnosed by numerous physicians who happened to be colleagues of 
mine. This led to numerous unsuccessful surgeries resulting in 
permanent lung and sinus damage. Prior to my diagnosis, a day was 
considered successful if I had enough energy to get out of bed. 
Following appropriate diagnosis and treatment with IGIV, I was able to 
return to my medical practice and developed a new lease on life.
    In my testimony, I would like to highlight three areas of 
importance to the IDF and the primary immune deficiency community we 
represent: (1) National Primary Immune Deficiency Surveillance Program. 
(2) Primary Immune Deficiency Research at the National Institutes of 
Health. (3) Primary Immune Deficiency Registries at the National 
Institute of Allergy and Infectious Diseases.

        NATIONAL PRIMARY IMMUNE DEFICIENCY SURVEILLANCE PROGRAM
    Mr. Chairman, because primary immune deficient patients are the 
only patient population that require life-long infusions of IGIV to 
maintain their health, the Immune Deficiency Foundation has been 
working to establish a national surveillance study of this group to 
evaluate the short and long term effects of IGIV use. The establishment 
of this surveillance initiative is vitally important because although 
primary immune patients have been treated with IGIV for over 20 years, 
a prospective study on adverse events associated with its use has not 
been performed.
    IDF's surveillance program would provide valuable epidemiological 
data on the potential risks of IGIV therapy, and conditions which might 
predispose patients to adverse events. In addition, this initiative 
would benefit other IGIV users by serving as an early warning system 
should study participants be exposed to new and emerging pathogens.
    IDF's proposed surveillance study would focus on the following:
  --Identifying and characterizing adverse events
  --Determining their prevalence and incidence
  --Determining whether there are specific risk factors for adverse 
        events such as: (1) Certain primary immunodeficient diseases 
        (e.g., Common Variable Immunodeficiency vs. X-Linked 
        Agammaglobulinemia); (2) Pre-existing medical conditions (e.g., 
        renal and/or cardiac disease); and (3) More common with some 
        preparations than with others (e.g., different brands and 
        different formulations).
    Mr. Chairman, IDF has been working with the plasma fractionation 
industry, the Food and Drug Administration, and the Centers for Disease 
Control and Prevention to establish this new surveillance program, and 
we are grateful for the subcommittee's support of this partnership last 
year as we developed the details of this project. Now that the program 
is nearing the end of the planning stage, we ask that you continue to 
support this important public health initiative by encouraging CDC to 
work with us again in fiscal year 2002. Moreover, we ask that you 
encourage the National Institutes of Health to support this effort as 
well.
primary immune deficiency research at the national institutes of health
    Mr. Chairman, I would like to take this opportunity to thank the 
subcommittee for its longstanding support of biomedical research at the 
National Institutes of Health. IDF remains committed to the goal of the 
doubling the NIH budget by fiscal year 2003. Specifically, IDF 
encourages the subcommittee to continue its support of primary immune 
deficiency research at the National Institute of Allergy and Infectious 
Diseases (NIAID), the National Institute of Child Health and Human 
Development (NICHD), and the National Cancer Institute (NCI).
    In recent years, NIAID sponsored research has shed new light on the 
genetics of primary immunodeficiencies. NIAID investigators are using 
this information to develop new gene-based therapies for many primary 
immune disorders. This cutting-edge research has given patients hope 
that improved therapies, and eventually a cure, for these diseases may 
be on the horizon. Primary immune deficiency research also benefits 
people suffering from other disorders, such as autoimmune diseases and 
cancer, due to its acute focus on the functions of the immune system.
    Recognizing the promise that biomedical research holds for 
improving the quality of life for primary immune deficient patients, 
IDF joins with the Ad Hoc Group for Medical Research in recommending a 
16.5 percent increase for NIAID, NICHD and NCI in fiscal year 2002.

         PRIMARY IMMUNE DEFICIENCY CLINICAL REGISTRIES PROGRAM
    Mr. Chairman, since 1997, IDF has contracted with NIAID to 
construct and maintain registries of 8 primary immunodeficiency 
diseases including, Chronic Granulomatous Disease, Common Variable 
Immunodeficiency, DiGeorge Anomaly, Hyper IgM Syndrome, Leukocyte 
Adhesion Defect, Severe Combined Immunodeficiency, Wiskott-Aldrich 
Syndrome, and X-Linked Agammaglobulinemia. The goal of these registries 
is to assemble a comprehensive clinical picture of each disorder, 
including estimates of disease prevalence, clinical course, and 
complications.
    This data is an invaluable resource for physicians conducting basic 
research on these disorders. For example, information from one registry 
(chronic granulamatous) is being used by four institutions to examine 
six different questions relating to various aspects of the disease. 
Further expansion of these registries is essential if we are to 
increase our understanding of additional primary immune deficiency 
disorders. IDF appreciates the subcommittee's longstanding support of 
the NIAID/IDF clinical registries partnership and encourages you to 
continue to support these important programs in fiscal year 2002.
    Mr. Chairman, thank you once again for the opportunity to present 
the views of the Immune Deficiency Foundation.
                                 ______
                                 

  Prepared Statement of the Infectious Diseases Society of America's 
                                 (IDSA)

    IDSA appreciates the opportunity to provide testimony to the Senate 
Appropriations Subcommittee on Labor, Health and Human Services, and 
Education concerning fiscal year 2002 funding for the Centers for 
Disease Control and Prevention (CDC), the National Institutes of Health 
(NIH)--particularly the National Institute of Allergy and Infectious 
Diseases (NIAID), the Office of AIDS Research (OAR) and the Fogarty 
International Center (FIC)--and for the Health Resources Services 
Administration (HRSA).
    IDSA represents more than 6,000 physicians and scientists devoted 
to patient care, education, research, and community health planning in 
infectious diseases. Our members share a common focus on the 
epidemiology, diagnosis, prevention, investigation and treatment of 
infectious diseases. The discipline of infectious diseases is a 
subspecialty of both internal medicine and pediatrics, typically 
involving a two-to-three year fellowship and then board certification. 
Infectious diseases physicians care for patients with serious 
infections, including persons with HIV/AIDS, meningitis, heart valve 
infections, severe bone, joint or wound infections, and those with 
cancer or transplants who have life-threatening infections caused by 
unusual organisms. IDSA is the principal organization representing 
infectious diseases physicians.
    Infectious diseases are the second leading cause of death and the 
leading cause of disability-adjusted life years worldwide (one 
disability-adjusted life year is one lost year of healthy life) and the 
third leading cause of death in the United States. The World Health 
Organization estimates that 1,500 people die each hour from an 
infectious disease. Diseases, such as AIDS, hepatitis, tuberculosis, 
malaria and pneumonia, as well as new and emerging infectious diseases, 
continue to cause unfathomable human suffering in this country and 
around the world. The real and potential implications on human lives 
and the escalating costs of health care in this country is staggering. 
CDC reports that should an influenza pandemic occur in the United 
States today with the ferocity of past ones, it would cause an 
estimated 89,000 to 207,000 deaths, 314,000-734,000 hospitalizations; 
and the economic impact would range from $71 billion to $167 billion.
    Earlier predictions of the elimination of infectious diseases did 
not take into account changes in demographics and human behaviors and 
the extraordinary ability of microbes to adapt, evolve, and develop 
resistance to drugs. More than 35 newly emerging infectious diseases 
were identified between 1973 and 1999, and new infectious disease 
threats continue to be identified. The continual evolution of emerging 
and reemerging diseases, particularly the acceleration of the HIV/AIDS 
pandemic in developing countries, will heighten the global impact of 
infectious diseases in this century.
    But the story is not all bleak. Advances made over the past century 
in infectious diseases treatment, prevention and research, particularly 
related to vaccines' development, and infection control have 
demonstrated the many benefits that biomedical research and public 
health may have in bringing these diseases under control. As the 
physicians who care for patients with serious and often life-
threatening infections and as researchers who study drug resistance and 
are involved in development of new and better antimicrobial agents, our 
goal is to ensure that patients have access to state-of-the-art care 
and that the care provided is the most clinically appropriate for each 
patient.
    We strongly believe that today's investment in infectious diseases 
prevention, treatment, and research will pay significant dividends in 
the future to the American people in dramatically reduced health care 
costs and improved quality of life for millions. As such, the Society 
has strongly advocated for appropriate funding for biomedical research, 
public health and infrastructure building. And, as infectious diseases 
do not recognize nor respect arbitrarily determined national borders, 
IDSA also adamantly supports United States' leadership in funding 
international collaborative efforts to fight transmission of infectious 
diseases through international research and infrastructure building in 
lesser-resourced countries.

                     NATIONAL INSTITUTES OF HEALTH
    It is unlikely that we can overestimate the importance that the 
National Institutes of Health have had in advancing the continuum of 
disease knowledge now available. NIH is largely responsible for 
orchestrating current efforts in scientific discovery and for training 
future scientific leaders. The National Institutes of Allergy and 
Infectious Diseases (NIAID), NIH's Office of AIDS Research (OAR) and 
the John E. Fogarty International Center (FIC) are largely responsible 
for fulfilling those goals in the field of infectious diseases in the 
United States and around the world. NIAID-, OAR- and FIC-sponsored 
research and training in the areas of HIV/AIDS, sexually transmitted 
diseases, tuberculosis, malaria, new and emerging infectious diseases, 
antimicrobial resistance and genomics will significantly and favorable 
impact the health of millions of Americans and people of all countries.
    We applaud Congress' and the Administration's commitment to 
increase support for NIH's programs and to double its budget by 2005. 
We can think of no more important investment than for the basic and 
clinical research that NIAID, OAR and FIC sponsors and conducts. We 
would note that, although the FIC's budget has increased substantially 
over the past several years reaching $50 million in fiscal year 2001, 
this amount is a small fraction of what is necessary to carry out the 
increasingly important international research and training that FIC 
supports around the world. Thus, we recommend that you closely review 
FIC's budget with an eye toward providing a significant increase in 
funding for the Center in fiscal year 2002.

               CENTERS FOR DISEASE CONTROL AND PREVENTION
    CDC is the nation's prevention agency. Its important mission is to 
translate health information, including the results of NIH-sponsored 
research, into prevention programs that are effective in the diversity 
of our nation's communities. They do their work in partnership with 
state and local public health providers and other Federal agencies. CDC 
programs make public health work around the nation.
    Increased surveillance and response, applied research, 
infrastructure building and training and prevention and control efforts 
are all necessary if we are to meet the challenges that infectious 
diseases will create in the years to come. CDC's Strategic Plan 
Preventing Emerging Infectious Diseases: A Strategy for the 21st 
Century continues to build domestic and global capacity for recognizing 
and responding to infectious diseases. Providing health departments 
with resources for building epidemiology and laboratory capacity has 
dramatically improved our ability to identify, investigate, and rapidly 
implement control measures in outbreak situations (such as with West 
Nile in the eastern United States and E.Coli, Salmonella and Listeria 
in other parts of the country).
    Both NIH and CDC's work are inextricably linked. And, while we 
strongly support the Administration's proposed funding for NIH, we 
maintain that Congress' and the Administration's commitment to CDC must 
not waiver. Increased funding for NIH must not be appropriated at the 
expense of CDC and/or other public health programs. Thus, we support 
increased funding to enable CDC to implement the activities envisioned 
in its Strategic Plan. It is our best professional judgment, given the 
many unmet public health needs and missed prevention opportunities, 
that CDC funding should be increased to $5 billion, a $1.2 billion 
increase over fiscal year 2001 levels, to permit the agency to 
adequately fulfill its mission.
    Moreover, the ever-evolving complexity of CDC's budget structure 
and the increased practice by Congress to dedicate particular funds for 
specific projects is a cause of great concern to the public health 
community and fiscal planners. A Pricewaterhouse/Coopers study has 
determined that CDC's budget structure is particularly inflexible and 
that this may have negative implications for public health. The General 
Accounting Office has concurred with these findings. We ask that 
Congress review this analysis and act accordingly to afford CDC the 
flexibility to effectively and efficiently carry out its public health 
mission.

              HEALTH RESOURCES AND SERVICES ADMINISTRATION
    Programs administered through the Health Resources and Services 
Administration serve as vital components of the nation's health care 
safety net. From funding for health professionals' training to 
resources for community health centers and HIV/AIDS services, HRSA 
funding provides vital resources that translate into health care for 
underserved and disenfranchised populations. Of particular interest to 
IDSA is funding for the Ryan White CARE Act, a program that funds 
medical care, drug therapy for HIV disease and HIV-related 
opportunistic infections, and ancillary services for uninsured and 
underinsured individuals, as well as training for health care 
providers. IDSA urges the Subcommittee to support generous funding for 
all Titles of the Ryan White Care Act so that biomedical and clinical 
research may benefit all Americans living with HIV disease.

                    SIGNIFICANT FUNDING NEEDS EXIST
    Now, we would like to highlight a few specific public health and 
research areas where increased funding is needed.
Antimicrobial resistance
    In the United States and around the world, many important human 
infections are becoming increasingly resistant to the antimicrobial 
drugs used to treat them. For example, CDC reports that in some areas 
of the United States, more than 30 percent of infections with 
pneumococci, the most common cause of bacterial pneumonia and 
meningitis, are no longer susceptible to penicillin. In the 1970s, all 
were susceptible. Moreover, nearly 30 percent of the bacteria that most 
frequently cause infections acquired in hospital intensive care units 
are resistant to the preferred antibiotic.
    We must respond to the persistent problem of antimicrobial 
resistance by increasing research efforts, creating surveillance 
systems and developing strategies to ensure that newly developed and 
existing drugs are used effectively. An interagency task force, co-
chaired by CDC, the Food and Drug Administration and NIH recently 
released ``A Public Health Action Plan to Combat Antimicrobial 
Resistance''. The Plan outlines a number of surveillance, prevention 
and control, research, and product development action items. Increased 
funding is necessary to permit these agencies to move quickly to 
implement these critical action items. We also support full funding to 
implement the Public Health Improvement Act that was enacted last year.
Food safety
    According to CDC, food-borne diseases cause approximately 76 
million illnesses, 325,000 hospitalizations, and 5,000 deaths in the 
United States each year. Hospital costs for these illnesses are 
estimated at more than $3 billion per year. Costs from lost 
productivity are estimated at $8 billion per year.
    Through the National Food Safety Initiative, Congress has supported 
increased funding over the past several years, which has enabled the 
Department of Health and Human Services (HHS) and U.S. Department of 
Agriculture (USDA) to move aggressively to reduce the impact of food-
borne illness in this country. CDC, USDA, and FDA have developed and 
implemented critical, new research, surveillance, education and 
prevention efforts, under this initiative. We encourage Congress to 
continue to lead the way in this effort by increasing funding for the 
Food Safety Initiative.
Bioterrorism
    The nation's public health infrastructure is not adequate to detect 
and respond to a bioterrorism event in this country. The potential for 
such an event increases with each passing day. Timely response to a 
bioterrorism event will absolutely depend upon a sound monitoring 
system at the community level. Such a system will require strong 
support for state and local public health infrastructure, particularly 
adequately equipped and staffed laboratories, and support as well for a 
program that cuts across all centers and programs at CDC. To this end, 
increased funding is needed to implement the activities authorized last 
year through the Public Health Improvement Act. Only through sufficient 
funding for assessments of local capacities to respond to an event, 
infrastructure development and training, vaccine research and 
development at NIH and coordinated response efforts across governments 
and health care organizations will we be able to anticipate problems, 
prioritize resources, and intervene effectively.
Vaccines and immunization
    Immunizations are among the greatest public health achievements of 
the 20th Century. With the advent of vaccines for chickenpox, measles, 
whooping cough, polio, pneumococcal disease, hepatitis B, influenza and 
other infectious diseases, thousands of lives have been saved and 
disability and suffering averted with incredible cost savings achieved. 
Despite generally high coverage levels in the United States, pockets of 
under-immunized children, adolescents and adults remain at increased 
risk for contracting and transmitting vaccine preventable diseases. The 
global picture is much more ominous.
    Additional funding is needed to shore up the nation's immunization 
infrastructure. In an Institute of Medicine report released last year, 
entitled Calling the Shots, experts agreed that unstable funding for 
state immunization programs threatens coverage for specific populations 
and age groups. In addition, according to CDC, immunization costs for 
more than 12 million Americans are not covered by public or private 
health insurance programs. This is shocking given the level of 
importance to public health and the demonstrated cost-effectiveness 
that have been realized as a result of the establishment of the 
National Immunization Program (NIP). Increased funding is critical to 
ensure that every individual may have access to appropriate vaccines.
    Sufficient funding for CDC's programs to eliminate measles in the 
Western Hemisphere and to eradicate polio worldwide also is critical. 
The benefits of these programs are not limited to other countries; in 
the United States alone, the eradication of polio would result in a 
yearly cost savings of $230 million.
    Finally, new vaccines' research and development will help us to 
prevent populations from becoming infected in the first place. 
Researchers at NIAID are working to develop vaccines for tuberculosis, 
HIV and Streptococcus pneumoniae, the leading cause of morbidity and 
mortality in infants and young children worldwide. NIH-sponsored 
research has proven successful in the past, most notably with the 
development of vaccines against Haemophilus influenzae type b (Hib) a 
bacterium that can lead to life-threatening meningitis and pneumonia in 
young children. Thanks to the work of NIH researchers, this vaccine 
reduced the number of cases of invasive Hib disease by 97 percent from 
1987 to 1997. In order to repeat this success with other diseases, we 
urge your continued support for vaccine research and development.
HIV/AIDS
    A comprehensive funding strategy through NIH's Office of AIDS 
Research, CDC's prevention programs and HRSA's primary care services is 
the only appropriate response to the HIV/AIDS epidemic. Increased 
funding for AIDS through the Office of AIDS Research is critical. 
Through the research that it supports, the Office of AIDS Research 
holds the most promise for saving and improving many lives through the 
development of improved treatments for people living with HIV/AIDS and 
the development of an HIV/AIDS vaccine. CDC plays a key role in the 
fight against the spread of HIV/AIDS. With 40,000 new cases of HIV 
being diagnosed each year, this is no time for complacency. We strongly 
encourage increased investment in CDC's HIV/AIDS programs. These 
include the HIV/AIDS surveillance program that tracks the disease and 
informs the development of national and local prevention efforts; 
funding of community-based programs that design and implement 
prevention programs targeted at their communities; and the variety of 
programs funded through the Congressional Black Caucus (CBC). The CBC 
programs deserve special attention given the alarming increase of HIV/
AIDS in minority communities. To adequately support these and other 
important programs, CDC funding for HIV/AIDS programs should be 
increased substantially. The Ryan White CARE Act administered under 
HRSA is the heart of the federal response to HIV/AIDS care. Generous 
funding for all titles of the CARE Act are necessary to maintain the 
significant reductions in HIV-related morbidity and mortality we have 
enjoyed in recent years.
    Finally, IDSA strongly supports HHS' global AIDS efforts. 
Substantial increases are warranted for new research, treatment and 
prevention strategies, and public health infrastructure building in 
lesser-resourced countries. Our Society supports a robust and 
comprehensive U.S. response to the global HIV/AIDS pandemic. We will be 
advocating for increased funding in other federal budget accounts as 
well.
    Thank you again for the opportunity to provide IDSA's views on 
these important matters to the subcommittee. Please let us know if you 
require any additional information.
                                 ______
                                 

            Prepared Statement of the Joslin Diabetes Center

    Mr. Chairman and Members of the Subcommittee, I appreciate the 
opportunity to appear before you to present Joslin Diabetes Center's 
proposal to improve the access to and quality of health care for people 
with obesity and type 2 diabetes and to reduce costs and increase 
savings for these health care outlays by establishing a new paradigm 
for the prevention and treatment of obesity and type 2 diabetes.
    Obesity is a major risk factor for the development of type 2 
diabetes and insulin resistance and a major cause of morbidity and 
mortality in the Unites States:
  --1 in every 2 Americans is overweight and the prevalence of obesity 
        has increased 57 percent in the last 10 years.
  --Obesity disproportionately affects minorities--60 percent of 
        African-American, Mexican-American, and Native-American women 
        meet the criteria for being overweight and between 33-37 
        percent are obese.
  --Obesity in children and adolescents is increasing at an alarming 
        rate, leading to the occurrence of type 2 diabetes in these 
        groups.
    Equally foreboding for the future well-being of our country, the 
startling rise in obesity is driving an emerging epidemic of diabetes 
in the United States:
  --Diabetes in the United States increased by 6 percent in 1999.
  --Over 90 percent of diabetes is type 2 (adult-onset), and 90 percent 
        of people with type 2 are obese.
  --The Centers for Disease Control and Prevention reported that 
        diabetes increased 33 percent nationally to 6.5 percent between 
        1990 and 1998.
  --The rise in diabetes costs increased across all age groups but was 
        most profound--about 70 percent--among people ages 30-39.
  -- For the rapidly expanding over-50 age group, the incidence of 
        diabetes approaches 20 percent, and diabetes and its 
        complications comprise 25 percent of Medicare costs.
    Obesity is a risk factor for:
  --Diabetes
  --Cardiovascular disease--heart attack, stroke
  --High blood pressure
  --Sleep apnea
  --Uterine cancer
  --Breast cancer
  --Colon cancer
  --Gall bladder disease
    With over 50 percent of the population obese, these risk factors 
underscore why this serious problem is emerging as an epidemic.
    As the world's largest and most comprehensive independent diabetes 
research and patient care institution, Joslin Diabetes Center proposes 
the development of a pilot program to prevent and treat obesity and 
type 2 diabetes. Over 80 percent of people with type 2 diabetes would 
be ``cured'' if they could lose 10-20 pounds of weight. Unfortunately, 
90 percent of these people with type 2 diabetes cannot successfully 
lose weight because obesity is a medical problem and not a moral fault.
    To address the growing epidemic of obesity and type 2 diabetes, 
Joslin Diabetes Center would like to share technology, methods and 
experience through the development of a pilot demonstration project for 
the prevention and treatment of obesity and type 2 diabetes:
  --To adapt Joslin's state-of-the-art Diabetes Outpatient Intensive 
        Treatment Program for different ethnic, economic, social and 
        age population groups.
  --To demonstrate the effective long-term benefits of Joslin's 
        Intensive Treatment and telemedicine protocols.
  --To evaluate clinical strategies for prevention and treatment of 
        obesity including the application of our growing knowledge of 
        molecular mechanisms that increase appetite and of the role of 
        leptin in obesity.
  --To analyze different diets of people with type 2 diabetes.
  --To advance Joslin's applied research results in the development of 
        preferences for alternative food choices and lifestyles and 
        community-level and school interventions to prevent obesity and 
        the onset of diabetes.
    Joslin's pilot project would demonstrate significantly improved 
prevention and treatment of obesity and type 2 diabetes, resulting in 
reduced costs, improved patient access and quality of life.
    Specifically, we propose to initiate a pilot project of detection, 
prevention, and care of obesity and type 2 diabetes for a three-year 
period, utilizing training and validation exercises derived from 
Joslin's expertise and telemedicine infrastructure. The cost would be 
$3.6 million annually.
    Through its Diabetes Outpatient Intensive Treatment Program, Joslin 
applies a new approach towards patients with diabetes. This approach 
focuses on two major areas: improving clinical outcomes in a practical, 
resource-efficient manner. Clinical outcomes have demonstrated improved 
metabolic control (and thus fewer long-term complications) and reduced 
patient stress resulting from having to treat their diabetes. The 
Program is focused on individual flexibility and was developed in a way 
to be more efficient in utilization of both patient resources and 
health-care resources.
    Rather than rely on continued intensive involvement of health care 
providers throughout a patient's lifetime, we put the patient through a 
short, intensive course of training which not only leads to an 
immediate improvement in their metabolic control, but gives the patient 
the foundation to take care of themselves in the future. The Program 
also reduces the patient's diabetes-related stress by training the 
patients to care for their own diabetes, seeking other professional 
input when needed. This is more appealing to the patient, more 
efficient in the use of resources in the long-term, and produces good 
results.
    With the proposed pilot project, Joslin is in the process of 
developing an alternative Outpatient Intensive Treatment Program for 
people with obesity and type 2 diabetes. The pilot project will 
establish and validate appropriate criteria, protocols and outcome 
guidelines for different ethnic, economic, social and age population 
groups.
    Utilizing Joslin's JVN telemedicine infrastructure, Joslin Diabetes 
Center will design and develop a modularized medical outcomes-based 
Telemedicine Diabetes Intensive Treatment Program to provide a web-
based Comprehensive Diabetes Management System. Integrating Joslin's 
JVN telemedicine infrastructure as a component of the CDC can link 
health care practitioners with the National Diabetes Education Program, 
targeting the segment of the population that suffers from the epidemic 
explosion of obesity and diabetes complications. Adaptation of Joslin's 
JVN system for treating obesity and type 2 diabetes can measurably 
improve patient access, compliance, education and motivation to further 
increase effective long-term individual and society health benefits.
    Ongoing research at Joslin addresses how complex molecular 
mechanisms regulate body weight (hormones that control eating and 
appetite), how the fat cell functions as an endocrine cell, how leptin 
signaling the brain affects eating, and how fat interacts with the beta 
cell to cause diabetes. Resulting new clinical strategies for 
prevention and treatment of obesity and diabetes complications will be 
incorporated as a component of the pilot project.
    The three-year demonstration pilot will additionally provide the 
opportunity to broaden the clinical applications of promising bariatric 
surgery and medical therapy protocols for alleviating obesity and 
resulting diabetes complications. Evaluation of strategies for the 
prevention and treatment of obesity and type 2 diabetes will analyze 
long-term effects of gastric by-pass (bariatric) surgery, including 
clinical evaluation of people with gastric bypass surgery and the 
clinical evaluation of medical therapies to further refine Joslin's new 
paradigm of intensive treatment of obesity and type 2 diabetes.
    The demonstration project will train health care providers, e.g. 
nurse educators and physicians, from and for different ethnic, 
economic, social and age population groups. Concurrently, Joslin will 
provide curriculum-based patient and provider education modules.
    The proposed pilot project will demonstrate significantly improved 
detection, prevention and care techniques for obesity and type 2 
diabetes, resulting in overall reduced costs, improved patient access, 
and improved quality of life. Furthermore, this demonstration of 
Joslin's new paradigm for obesity and type 2 diabetes health care will 
provide better clinical understanding and expertise, which can be 
effectively extended to benefit all people living with type 2 diabetes.
    Thank you for this opportunity to appear before you today. I would 
be pleased to answer any questions you might have.
                                 ______
                                 

    Prepared Statement of the Juvenile Diabetes Research Foundation 
                             International

Brayton James DiPietro
    Before I begin, I would like to thank the Senate Appropriations 
Subcommittee on Labor, Health and Human Services, Education and Related 
Agencies for giving me the opportunity to share my story. My name is 
Brayton DiPietro and I am pleased to testify on behalf of the Juvenile 
Diabetes Research Foundation. I am in the eighth grade at St. Paul's 
Grade School in North Canton, Ohio. I also have diabetes and was 
diagnosed just after my eleventh birthday. I will be fifteen this June, 
so this summer will mark four years that I have had the disease.
    I broke my leg on December 15 while sledding in my backyard. The 
doctors were unable to use any rods or pins in setting my break because 
people with diabetes run a high risk of infection. We also heal slower. 
For a person with diabetes, the entire process would have taken about 
one fourth as long.
    Many people believe that the life of an individual with diabetes 
doesn't change dramatically once diagnosed. I am here to tell you that 
that is not true. Three or four times a day, I have to check my blood 
sugar by pricking my finger and give myself an injection of insulin. I 
have to think about every single thing that I eat and when I eat it. As 
a teenager, it won't surprise you that I would love to sleep in on a 
Saturday morning. However, if I do that it would throw of my blood 
sugar levels and it could take several days to get back on course.
    Those, of course, are the good days. When I have the flu, I have to 
check my blood sugar constantly and my urine for ketones to make sure 
that I don't go into Ketoacidosis, a condition that could be fatal in 
less than 24 hours. When I play baseball, I have to check my blood 
sugar level every other inning to make sure I am maintaining proper 
blood sugar levels. Even taking these precautions, I have experienced 
loss of vision, dizziness, and general disorientation during a game.
    I don't really know what I am going to be yet when I grow up. I 
know that I can't be a pilot for the Navy because of my diabetes. Can 
you imagine what would happen if I blacked out in a combat situation?
    I have approximately 6,000 finger pricks plus an equal amount of 
insulin injections in the past four years. That doesn't even count 
regular drawing of blood tests at the doctor's office. While I wait for 
a cure, which I know will happen if you continue to generously support 
medical research at the National Health Institute and help ensure that 
juvenile diabetes research is adequately funded, the best thing that I 
can do is to continue to take proper care of myself, remain 
disciplined, and try to lead as normal a life as possible.
    Back in Canton, I heard a lot about the not so good things that 
happen in Washington these days. I am really glad to have the 
opportunity to be part of a good thing that is happening in Washington. 
Your subcommittee's leadership in doubling the NIH budget by 2003 could 
allow me to live a fuller and healthier life. Thank you.
Steven DiPietro
    Brayton's story is not unique. In one form or another, it is shared 
by each of the 16 million Americans who have diabetes. In addition to 
its personal burden, diabetes carries an extraordinary price tag--one 
in four Medicare dollars are attributable to individuals with diabetes, 
and the disease costs our nation more than $100 billion annually. If we 
could cure diabetes it could both solve the Medicare solvency problem 
and be a major boost to our economy!
    As you may imagine, I am very proud of my son, who I witness each 
day persevere through his daunting, daily regimen of living with 
diabetes. I do my share in fighting juvenile diabetes by volunteering 
with my local chapter of the Juvenile Diabetes Research Foundation, 
where I currently serve as Board President. I am pleased that through 
our local walks, galas, and special events, JDRF will be able this year 
to allocate $120 million for juvenile diabetes research.
    However, we can't do it alone. This is why your continued support 
for the bipartisan effort to double the NIH budget over five years and 
provide the NIH with a $3.4 billion increase in funding this year is 
critical to individuals with diabetes.
    Last year, researchers announced that seven individuals with 
diabetes had been ``cured'' of the disease following the successful 
transplantation of insulin-producing cells. In my mind, the question is 
no longer whether we will cure diabetes, but when will it happen. Your 
support for doubling the NIH budget will make this happen sooner, and 
my family, and the millions of others who have diabetes want to thank 
you for making their hopes and dreams possible.
                                 ______
                                 

          Prepared Statement of the Kennedy Krieger Institute

    Mr. Chairman, Members of the Committee, the Kennedy Krieger 
Institute in Baltimore, Maryland appreciates the opportunity to present 
its views on a number of important programs supported by the U.S. 
Department of Education; the National Institutes of Health and the 
Health Resources and Services Administration at the U.S. Department of 
Health and Human Services.
    We would like to highlight the efforts of three federal agencies 
under your jurisdiction and the important work that they do to 
strengthen the capacity of programs, such as the Kennedy Krieger 
Institute, to make progress in the important areas of education and 
health.

                     THE KENNEDY KRIEGER INSTITUTE
    The Kennedy Krieger Institute is an independent research 
institution located adjacent to Johns Hopkins University. The mission 
of the Institute is to focus solely on disorders related to the brain 
and central nervous system. Brain related disorders effect one in four 
adults and one in ten children at a cost to society of $400 billion per 
year. The overall goal of research at the Kennedy Krieger Institute is 
to understand the developing central nervous system through the study 
of relationships between genes, the brain and human behavior. Although 
the Institute has special expertise with regard to children, the 
research scope includes studies of changes in the brain and the central 
nervous system across the lifespan. The Kennedy Krieger Institute is a 
comprehensive resource for children with disabilities, recognized as a 
research facility and training center for health care professionals 
from around the world. The Institute treats a wide array of children 
with neurological diseases including, but not limited to, Down 
syndrome; attention deficit hyperactivity disorder; lead poisoning, 
autism; cerebral palsy; genetic and metabolic disorders, like fragile X 
syndrome, neurofibromatosis, tay sachs disease, tourette syndrome; 
spina bifida; degenerative brain disorders; mental retardation; and 
many others. Our Institute integrates cutting edge neurobiological and 
behavioral research efforts into a comprehensive program which includes 
inpatient and day treatment services; outpatient services; home and 
community services; and school programs for children with disorders of 
the brain. The Institute is well-known for its strong interdisciplinary 
research and care in many fields including medicine, psychology, 
education, physical and occupational therapy, audiology, speech and 
language therapy, social work, child development, nutrition and 
nursing.

                      BASIC AND CLINICAL RESEARCH
    The Board of Directors, the researchers, health professionals and 
patients and families at the Kennedy Krieger Institute are all very 
grateful for the support that this Committee has provided to the NIH 
over the past several years. The resources that Congress has 
appropriated have enabled the research community to grasp research 
opportunities that a decade ago we could not even have dreamed 
possible. This is making an incredible difference in the lives of the 
children that we treat.
    We are currently experiencing an unprecedented appreciation of the 
benefits to health and life quality that can result from biomedical and 
behavioral research. Of particular note is the most welcome present and 
predicted increase in public sector funding for basic research and the 
dramatic, if not explosive, private sector investment in biology. With 
such appreciation and tangible support comes the responsibility to 
organize the scientific enterprise so as to produce effective 
interventions. And, our challenges are many.
    Many children with developmental disabilities and neurological 
diseases display severe behavior problems. The mission of our basic and 
clinical research, clinical care, and educational programs is to 
improve the quality of life for these children and their families 
through a variety of mechanisms including:
  --providing advanced and comprehensive treatment services;
  --promoting the widespread dissemination of effective interventions; 
        and
  --improving treatment technologies through basic and clinical 
        research.
    With that said, we support treatment and research initiatives 
including but not limited to behavior programs, pediatric feeding 
disorders, neuroimaging, basic and clinical research efforts and 
training.
    The National Institute of Child Health and Human Development 
(NICHD) and the National Institute of Neurological Diseases and Stroke 
support a number of important initiatives with regard to brain biology; 
neurobehavioral assessment and protocol development; translation 
studies related to cognition pathways of learning disorders from a 
developmental perspective; molecular sciences to further understand the 
molecular basis of many developmental disabilities; brain mapping; and 
other basic and clinical programs which are at the core of the programs 
conducted at the Kennedy Krieger Institute. Further, the National 
Center for Research Resources (NCRR) supports important neuroimaging 
studies for neuroscience, metabolic, behavioral, and other research. 
The Kennedy Krieger Institute receives funding from the NCRR for our 
neurobehavior research unit through a subcontract from the Johns 
Hopkins University General Clinical Research Center (GCRC). The support 
we receive is used to conduct studies related to functional imaging. We 
believe it is important for the Committee to consider an NIH National 
Imaging Network for Clinical Research that will enable NCRR to provide 
the resources to create links between the GCRC to the imaging center. 
This sort of infrastructure would be vitally important to facilitate 
and integrate research networks.
    Clearly, multiple programs supported by the National Institutes of 
Health (NIH) enrich our capacity to address important basic and 
clinical research issues in the population that we serve. The work of 
this Committee ensuring a sustained commitment to these programs has 
enabled institutions, such as ours, to move forward at unprecedented 
speed. To that end, we urge the Committee to continue its efforts in 
support of the NIH.
    Request.--The Kennedy Krieger Institute endorses the recommendation 
of the Ad Hoc Group for Medical Research Funding for fiscal year 2002 
which recommends a $3.4 billion, or 16.5 percent, increase that will 
result in a total NIH budget of $23.7 billion in fiscal year 2002. This 
funding level is necessary to continue the congressional campaign to 
double the budget of the NIH by 2003.

                               EDUCATION
    Our approach to severe behavioral problems in many children with 
developmental disabilities and severe behavior problems is multi-
focused. The Severe Behavior Program provides comprehensive diagnostic 
evaluations, parent training and school consultative services. The 
linkage to the child's school and school district is imperative to 
develop and effectively implement effective strategies to deal with the 
behavioral problems many of our patients present with. This initiative 
is complemented by inpatient and outpatient behavioral management 
services for children who display severe destruction behavior.
    The Kennedy Krieger Institute's Lower and Middle Schools, 
recipients of the US Department of Education's National Blue Ribbon 
Awards in 1996 and 1997, respectively, are recognized models in special 
education. Their track record includes: innovative models of education 
based upon current scientific understanding of brain functioning; 
creative integration of technology in the classroom; comprehensive 
curriculum tailored to unique needs of the student; and training in the 
field of special education.
    Employment data for all youth in the United States are a national 
concern. Fewer students are graduating from high school adequately 
prepared to enter post-secondary program or secure competitive 
employment. Of particular concern are youth with disabilities, who are 
consistently less successful than their non-disabled peers. It has been 
estimated that 70 percent of individuals with disabilities are either 
unemployed or underemployed.
    The Kennedy Krieger high school program, which opened in September, 
1999, provides a comprehensive approach to school-to-work transition 
for youth with serious learning, emotional, neurological, and 
developmental disabilities. The school-to-work curriculum at our Career 
and Technology High School is unique in that it will be the only 
program in the state to make career training the foundation of, and not 
merely a supplement to, the school's core curriculum. All of the 
students that attend the Kennedy Krieger Career and Technology High 
School demonstrate a serious disability, and 50 percent of these 
students come from families supported by federally-funded programs for 
children and families living below the poverty level. As the school's 
student population grows from the current enrollment of 125 to 200 
students, it is anticipated that the percentage of students living 
below poverty will remain current if not increase.
    Drawing on the most current educational, work-readiness, and 
industry standards, the high school staff develop partnerships with 
business and community groups to develop a state-of-the-art model that 
will result in economically and personally rewarding employment for 
youth with disabilities. The Career and Technology High School will 
take students challenged by severe learning, emotional, traumatic brain 
injury, and developmental disabilities and provide a school-to-work 
instructional model that addresses the needs of students with serious 
disabilities who have the potential to undertake meaningful employment. 
Students will graduate with the knowledge and work and social 
experience they will need for successful postsecondary employment in a 
specific career clusters including: Information Technologies; 
Hospitality; Tourism Construction and Manufacturing; Business and 
Finance; Arts and Graphics; and Communications. Programs supported by 
the Department of Education, including the Technology Innovation 
Challenge Grant program are critical to enable cutting edge programs 
such as our to fully develop our capacity to create model systems which 
can be applied nationwide. The strong support that this Committee has 
provided to these programs in the past have been a worthwhile 
investment and we urge your continued strong support.
    Request.--The Kennedy Krieger Institute respectfully requests $2 
million in program funding from the Department of Education's 
Technology Innovation Challenge Grant program to support the expansion 
of a dynamic performance-based curricula and instructional delivery 
options utilizing distance learning that connects educational and 
research programs. Students, teachers, parents, and other professionals 
will receive support through instructional software, performance 
databases, access to the Internet, and opportunities for self-directed 
learning.

                   MARCUS INSTITUTE, ATLANTA GEORGIA
    The Kennedy Krieger Institute has embarked upon a collaboration and 
formal fiscal affiliation with the Marcus Institute, located in 
Atlanta, Georgia, to establish a national network of developmental 
services for children with disorders of the brain and their families. 
The foremost goal of this national initiative is to rally support and 
spearhead unified advocacy for individuals with developmental 
disabilities and severe and challenging behaviors so that they can 
experience a greater quality of life and participate as fully as 
possible in family, school, and community life.
    Currently, the Marcus Institute is housed in leased space within a 
professional office park--a location woefully inadequate for the 
programs and specialized services provided to the severely disabled 
children served by the Institute. We are in the process of developing 
an 80,000 square foot facility near the Emory University campus and the 
Centers for Disease Control and Prevention. The new facility will allow 
the Institute to expand upon its mission to encourage and facilitate 
advanced research, training, and programming for children and 
adolescents with developmental disabilities and severe and challenging 
behaviors through the further refinement and expansion of the Marcus 
Behavior Center. This behavior center of excellence is devoted to 
providing the most advanced clinical treatments, training, and research 
so that services for the families of children with severe and 
challenging behavior are as effective and as comprehensive as possible.
    The new Marcus Institute will include a school with a student 
population of approximately 50 children. The school will work with 
those children with the most acute emotional, behavioral, and 
psychological challenges to continue their educational process while 
receiving our specialized services and avoid additional difficulties 
when they return to their community school. The Marcus Institute school 
is designed continue their education while they are here, rather than 
permanently removing them from their community school.
    Since 1993, the Marcus Institute has provided clinical services to 
more than 14,000 individuals, conducted research, and provided 
education and training programs. These services have been provided by 
developmental pediatricians, psychiatrists, behavioral, clinical and 
neuro-psychologists, neurologists, geneticists, nurses, physical, 
occupational, and speech therapists, social workers, special educators, 
and family support personnel.
    The Marcus Institute in Atlanta and Kennedy Krieger Institute (KKI) 
in Baltimore have developed a partnership in which programmatic, 
research, and training expertise is shared to provide community-based 
treatments for children with developmental disabilities who display the 
most severe forms of behavior disorders, including aggression, self-
injurious behavior, and pediatric feeding disorders. These behaviors 
pose a substantial risk to the individual(s), family members, and other 
care providers. Without appropriate treatment, these children are at 
substantial risk for health problems (and even death) and for lifelong 
placement in residential programs, which often costs $100,000 or more 
per year and millions of dollars over the individual's lifetime. The 
behavior programs at the KKI have been in existence for over 20 years. 
All children who receive these services show clear improvement and over 
80 percent meet their primary discharge goals (compared with less than 
2 percent for traditional outpatient mental health services).
    The Marcus and Kennedy Krieger programs are unique not only in 
terms of their success levels, but also because the effectiveness of 
the treatment protocols used have been documented through systematic 
program evaluation data and through formal research studies published 
in refereed journals. The Marcus Behavior Center currently provides a 
continuum of consultative, outpatient, educational, and day treatment 
services for children with severe behavior disorders. Those with the 
most severe problems are seen in our intensive day treatment programs. 
Young children (usually below age 6) are admitted to the Feeding Day 
Treatment Program if they display behaviors such as food refusal or 
food selectivity (eating one or only a few foods) that necessitate 
medical interventions (e.g., gastrostomy tubes) to prevent malnutrition 
or death. School-aged children (ages 3 to 21) are admitted to the 
Severe Behavior Day Treatment Program if they have developmental 
disabilities and display severe self-injurious behavior (SIB), 
aggression, or property destruction that poses a significant risk to 
self, others, or the environment, which cannot be safely managed or 
effectively treated in a less intensive program.
    Less severe cases are served through our outpatient and 
consultative programs, whereas the most severe cases are served through 
our day treatment programs. For example, SIB consists of repetitive 
motor responses that produce physical harm to the individual who 
displays the behavior. Typical forms of SIB include head banging, self-
biting, head hitting, body hitting, scratching, eye poking, pica, and 
ear poking. SIB is extremely rare among individuals of normal 
intellectual functioning. It is seen in approximately 6 percent to 16 
percent of individuals with mental retardation and autism.
    As part of our collaborative effort, the Kennedy Krieger Institute 
is working with the Marcus Institute, the United States Congress, and 
State and local officials in Georgia as we establish this state-of-the-
art facility in Atlanta.
    Request.--We respectfully request $5 million in fiscal year 2002 
funding through the Health Resources and Services Administration (HRSA) 
Construction account to provide assistance with the construction of a 
new, state-of-the-art health facility for the Marcus Institute. The 
Marcus Institute was created as a result of a generous donation by 
Bernie and Billie Marcus. It is known as a nationally recognized center 
for excellence for the provision of coordinated and comprehensive 
services for children and adolescents with developmental disabilities 
and severe and challenging behaviors. Our goal is to publicize any 
Federal grant to leverage additional dollars throughout the private 
sector. Funding at the $5 million level would provide 20 percent of the 
total cost of the campus.

                               CONCLUSION
    The Kennedy Krieger respectfully requests the support of the 
Committee through the allocation of fiscal year 2002 funds for the 
following.
    1. A continued commitment to the congressional campaign to double 
the NIH budget by 2003 by providing a $3.4 billion, or 16.5 percent, 
increase for NIH in fiscal year 2002, as advocated by the Ad Hoc Group 
for Biomedical Research funding. The continued investment in NIH will 
support a number of important research initiatives including brain 
biology, neurobehavioral assessment, and molecular sciences to further 
understand the molecular basis of many developmental disabilities.
    2. The Kennedy Krieger Institute respectfully requests $2 million 
in program funding from the Department of Education's Technology 
Innovation Challenge Grant program to support the expansion of a 
dynamic performance-based curricula and instructional delivery options 
utilizing distance learning that connect experiences between school and 
the workplace. This investment will permit severely disabled students 
to receive support through instructional software, performance 
databases, access to the Internet, and opportunities for self-directed 
learning.
    3. We respectfully request $5 million through the Health Resources 
and Services Administration (HRSA) Construction account to provide 
assistance with the construction of a new, state-of-the-art health 
facility for the Marcus Institute in Atlanta Georgia. It is known as a 
nationally recognized center for excellence for the provision of 
coordinated and comprehensive services for children and adolescents 
with developmental disabilities and severe and challenging behaviors.
    The Kennedy Krieger Institute thanks you for the opportunity to 
present our views.
                                 ______
                                 

     Prepared Statement of the Drug and Alcohol Service Providers 
                      Organization of Pennsylvania

    My name is Deb Beck and I am the President of the Drug and Alcohol 
Service Providers Organization of Pennsylvania (DASPOP), a statewide 
coalition of drug and alcohol prevention and treatment programs, 
practitioners, employee assistance programs, and drug and alcohol 
associations representing more than 365 organizations, programs and 
clinics, over 3,000 certified addiction professionals, 1,200 student 
assistance professionals, and 400 prevention specialists. Thank you for 
this opportunity to submit testimony in support of increased fiscal 
year 2002 funding for alcohol and drug treatment, prevention, and 
research programs in the Departments of Health and Human Services and 
Education.
    Today I am representing the views of DASPOP, the State Associations 
of Addiction Services, which is composed of 27 state-based associations 
of treatment and prevention providers in 26 states, and the Legal 
Action Center, a non-profit law and policy firm that represents 
individuals in recovery from and struggling with alcohol and drug 
problems and AIDS.
    Thank you, Mr. Chairman and members of the subcommittee, for last 
year's increases for alcohol and drug treatment, prevention, and 
research programs and your refusal to cut funding for these services. 
Funding is even more important in light of the recent sharp increases 
in ecstasy use among our youth and in marijuana use among young adults 
age 18 to 25. President Bush has recognized the need for expansion of 
these services through his campaign proposals for large increases in 
funding and his encouragement of even greater participation by faith-
based organizations that meet appropriate standards. We urge the 
Congress to dramatically expand funding for the full continuum of drug 
and alcohol treatment, prevention, and effectiveness. Providing strong 
support for alcohol and drug treatment, prevention, and research is 
essential to maintaining and improving the health and well being of our 
nation. These programs save lives and money by decreasing alcohol and 
drug use, crime, health care costs, AIDS and welfare dependence, and by 
increasing employment.

             TREATMENT AND PREVENTION NEEDS IN PENNSYLVANIA
    Pennsylvania programs have been leaders in developing effective 
alcohol and drug treatment programs for women, youth, criminal justice 
offenders, and other under-served populations. However, despite the 
success of these programs, we are faced with a capacity crisis that 
needs attention. The annual waiting list for alcohol and drug treatment 
services in Pennsylvania is approximately 49,000 individuals, yet these 
individuals represent only a small portion of the actual number of 
persons in need of treatment services. And in spite of last year's 
increases for the Substance Abuse Prevention and Treatment (SAPT) Block 
Grant, this year in Pennsylvania we are expecting that waiting list to 
continue to grow as pressure on public treatment funds increases. Some 
factors that place a strain on these funds include:
  --Reduced Medicaid Coverage.--Many individuals with alcohol and drug 
        problems have lost their Medicaid coverage which helped to pay 
        for their alcohol and drug treatment. Some individuals lost 
        their coverage due to changes in Pennsylvania law, while others 
        lost Medicaid coverage because of changes in federal law which 
        made individuals with a primary diagnosis of alcoholism or drug 
        dependence ineligible for SSI and Medicaid. These changes in 
        eligibility have created a funding shortfall of more than $80 
        million.
  --Reduced General Support Funding.--Fewer individuals are eligible 
        for Medicaid coverage that pays for general health care 
        services. When individuals without Medicaid enter alcohol and 
        drug treatment and require medical care, alcohol and drug 
        treatment programs pay for the cost of the client's medical 
        care by using general support funds that are not specifically 
        earmarked for alcohol and drug treatment. This reduction in 
        general support funding results in programs relying more 
        heavily on funds dedicated expressly to treatment to provide 
        alcohol and drug treatment services. These dedicated funds 
        include the SAPT Block Grant.
  --Lack of Managed Care Coverage.--Commercial managed care companies 
        frequently deny coverage for alcohol and drug treatment, 
        forcing individuals and families to seek treatment in the 
        publicly funded alcohol and drug treatment system.
  --Increase in Purity of Heroin and Cocaine.--In the last few years 
        heroin has returned to popularity due in large part to the 
        increased purity of the substance. This allows drug users that 
        were fearful of injecting chemicals into their bodies to either 
        smoke or snort the drug. In the past, the average purity of 
        heroin was between 1 and 10 percent. Now authorities are 
        noticing the percentage as high as 98 percent in Pennsylvania 
        compared to a national average of 35 percent. There has also 
        been a significant increase in the purity of cocaine, the most 
        commonly used drug in Pennsylvania, with an average purity as 
        high as 80 to 90 percent. The substantial increase in the 
        purity of these drugs has put a severe strain on the public 
        drug treatment system, as users of these purer drugs are more 
        likely to quickly become addicts in need of treatment.
    This increase in demand for treatment services, coupled with 
funding and benefit reductions, places even more pressure on the SAPT 
Block Grant to provide support for alcohol and drug treatment services. 
Increased fiscal year 2002 funding, especially for the SAPT Block 
Grant, is necessary in order for Pennsylvania to expand access to 
alcohol and drug treatment services, which save both lives and money.
    Pennsylvania also has developed effective community-based 
prevention services that reduce the onset of alcohol and drug use among 
youth and other vulnerable populations. However, decreasing Safe and 
Drug Free Schools State Grants program funding will adversely impact 
many of these programs, requiring cuts in prevention services for 
youth. Increasing funding for effective, community-based alcohol and 
drug prevention programs is critical, especially in light of the recent 
sharp increases in drug use among middle-school youth. The State Grants 
program in the Safe and Drug Free Schools and Communities Act is a 
vital resource for these services.

                            RECOMMENDATIONS
    For providers to supply these essential services in Pennsylvania 
and throughout the nation, we need your support. We urge Congress to 
adopt the following increases in fiscal year 2002 funding for alcohol 
and drug treatment, prevention, and research programs in the Substance 
Abuse and Mental Health Services Administration (SAMHSA), Department of 
Education, and National Institutes of Health. These are wise 
investments that will provide desperately needed services in 
communities across the country:
  --$2.0 billion for the Substance Abuse Prevention and Treatment Block 
        Grant to continue closing the treatment and prevention gap.
  --$350 million for the Center for Substance Abuse Treatment (CSAT) 
        and $350 million for the Center for Substance Abuse Prevention 
        (CSAP), including CSAP's High Risk Youth program, to expand 
        Targeted Capacity Expansion programs that provide targeted, gap 
        filling services and infrastructure tailored to address 
        specific and emerging drug epidemics and/or underserved 
        populations, and to support the continued translation of 
        research into best practice through Knowledge Development and 
        Application programs.
  --$694 million for the Safe and Drug Free Schools and Communities Act 
        program, with the increased funding ($50 million) allocated to 
        the State Grants program to support local, community-based 
        prevention initiatives.
  --$341 million for research at the National Institute on Alcohol 
        Abuse and Alcoholism (NIAAA) and $991 million for research at 
        the National Institute on Drug Abuse (NIDA).

 TREATMENT AND PREVENTION REDUCE ALCOHOL AND DRUG USE AND HAVE PUBLIC 
                                SUPPORT
    Numerous studies have demonstrated the effectiveness of treatment 
and prevention in reducing alcohol and drug use. As stated above, the 
National Treatment Improvement Evaluation Study (NTIES) evaluated 
CSAT's demonstration programs and found sustained reductions in drug 
use. Drug use declined by 51 percent for crack, 55 percent for cocaine, 
47 percent for heroin, and 50 percent for marijuana for the 5,700 
clients studied one year after completing treatment. NTIES also found a 
78 percent decrease in violent crime, 19 percent increase in 
employment, and 11 percent decrease in welfare dependence. Prevention 
has also been shown to be effective in reducing use. A recent study, 
conducted by the University of Washington's Washington Kids Count 
project, clearly demonstrates that the level of peer substance use in 
middle schools has a substantial impact on the academic performance of 
students across the state. The study found that on average, students 
whose peers had little or no involvement with drinking or drugs scored 
18 points higher in the reading portion of the Washington Assessment of 
Student Learning (WASL) test and 45 points higher on the math section.
    Prevention and treatment have been repeatedly shown to be cost-
effective. The Office of National Drug Control Policy estimates that 
drug abuse and addiction cost this country at least $277 billion per 
year in deaths, medical emergencies, spread of infectious diseases, 
crime, homelessness, lost productivity, and other social costs. 
Expanded access to treatment and prevention would decrease this cost. A 
1994 California study found that each $1 invested in drug and alcohol 
treatment and prevention saves taxpayers $7. These reductions in 
taxpayer costs were attributed to savings in criminal justice costs (22 
percent), victim losses (40 percent), theft losses (69 percent), and 
health care costs (23 percent).
    The public recognizes the value of treatment and prevention 
services. A 2000 survey found that 84 percent of poll respondents 
believed that at least half of the funding available to fight the drug 
problem in local communities should be spent on prevention, education, 
and treatment. Police have echoed the public's support for treatment. 
In a 1996 survey, police chiefs from around the country ranked drug 
abuse as the most serious problem in their communities and identified 
the shortage of treatment programs as the most serious limitation in 
their ability to address drug problems successfully.

              CLOSING THE TREATMENT GAP IN OUR COMMUNITIES
    Access to alcohol and drug treatment does not meet the current need 
for services. While between 13 million and 16 million people need 
treatment for alcohol and drug problems in any given year, only 3 
million, or 20 percent receive treatment.
    The need for treatment will only become greater in the future. A 
1999 analysis of data from the National Household Survey on Drug Abuse 
(NHSDA) projected that the need for future treatment is expected to 
increase 57 percent because of increased marijuana first use and 
problems among the aging cohort of drug abusers who first started using 
illicit drugs during the 1970s.

          INCREASED INVESTMENT IN PREVENTION PROGRAMS REQUIRED
    To reduce the trend of increased alcohol and drug use by youth, 
especially middle-school aged youth, Congress must increase its 
investment in community-based prevention programs. A 1998 study found 
that drug use jumps 300 percent in the first year after elementary 
school. Furthermore, according to data from the Monitoring the Future 
Study, ecstasy use has significantly increased in 2000 among all 
students, with a 45 percent increase in use among 8th graders.
    To effectively address this important problem, every adolescent 
should have access to alcohol and drug prevention services, but this is 
not the case nationwide. Providing universal access to effective 
community and school-based prevention services requires increased 
funding.

 DRUG AND ALCOHOL TREATMENT, PREVENTION, AND RESEARCH FUNDING MUST BE 
                                EXPANDED
Substance Abuse Prevention and Treatment Block Grant--SAMHSA/CSAT
    The majority of SAMHSA's funding for drug and alcohol treatment and 
prevention is sent directly to states through the Substance Abuse Block 
Grant. The Block Grant is the primary source of federal funding for 
alcohol and drug treatment and prevention services, accounting for over 
40 percent of public funding for these services nationwide.
    To help meet the pressing need for treatment and prevention 
services, we urge Congress to fund the Block Grant at $2.0 billion for 
an overall increase of $335 million of fiscal year 2002 funding.
SAMHSA/CSAT & CSAP--Balancing the Knowledge Development Application 
        Program with the Need to Target Services to Underserved 
        Populations and Emerging Drug Epidemics
    Funding at the Centers for Substance Abuse Treatment and Prevention 
should be directed toward two major activities: services capacity 
expansion for populations at high risk or which have increased need for 
treatment and prevention services and Knowledge Development and 
Application (KDA). Targeting service funding allows CSAT and CSAP to 
meet the evolving needs of communities by providing targeted, gap 
filling services and infrastructure tailored to address specific and 
emerging drug epidemics and/or underserved populations (e.g., 
methamphetamine, heroin, designer drugs, adolescents, specific racial 
and ethnic groups, exoffenders, homeless persons, and women on 
welfare.)
    Investment in the application of research findings is also a key 
Federal responsibility, and CSAT and CSAP, as the lead Federal agencies 
in treatment and prevention, are singularly equipped to translate 
research findings into best practices for treatment and prevention 
programs.
    For fiscal year 2002 we urge Congress to appropriate $350 million 
each for CSAT and CSAP, a $94 million increase for CSAT and a $175 
million increase for CSAP.
Safe and Drug Free Schools and Communities Act--Department of Education
    Research has demonstrated that school-based prevention programs 
that focus on personal and refusal skills development can significantly 
reduce alcohol and drug use. The Safe and Drug Free Schools program 
also provides critical intervention services by supporting student 
assistance programs that refer students who are beginning to use 
alcohol and drugs to appropriate services. These early intervention 
programs, which have no other source of federal funding, are critical 
to reaching youth at high risk early.
    For fiscal year 2002 we urge Congress to appropriate $694 million 
for the Safe and Drug Free Schools and Communities Act program, a $50 
million increase over fiscal year 2001, with the entire increase be 
directed into the States Grants program which supports local community 
prevention programs.
    We also ask that Congress keep the funding for the Safe and Drug 
Free Schools and Communities Act program separate from the 21st Century 
Program. The combination of these two programs would dilute funding 
directed toward drug and alcohol prevention efforts.
Basic Research--NIH/NIAAA & NIDA
    Research into the causes, costs, and ``cures'' of alcoholism and 
drug dependence is an important component of our field's continuum. 
This past year NIDA and NIAAA have been making great strides in 
research relative to alcohol and drug dependence. These breakthroughs 
have demonstrated that alcoholism and drug dependence research hones 
our knowledge about addiction and improves our ability to treat and 
prevent it.
    To expand our knowledge of addiction and how best to treat and 
prevent it, we urge Congress to appropriate $341 million for NIAAA, a 
$79 million increase, and $991 million for NIDA, a $211 million 
increase.

                               CONCLUSION
    Alcoholism and drug dependence continue to be among our Nation's 
most serious and costly public health problems. The programs I have 
discussed this afternoon are the first line of defense to protect our 
children from developing drug and alcohol problems, as well as the 
funding source of last resort to treat Americans who have already 
developed these problems. As a society, we must strengthen these 
programs. Thank you.
                                 ______
                                 

   Prepared Statement of the Lovelace Respiratory Research Institute 
                                 (LRRI)

    It is proposed that the Department of Health and Human Services 
(DHHS) through its constituent agencies, support the renovation of the 
LRRI clinical facilities and purchase of necessary equipment to support 
LRRI maintain its high research and clinical standards, better provide 
appropriate data security.
    LRRI has committed to a building campaign using $10 million in 
private funds to improve its laboratory facilities and equipment. 
LRRI's clinical study facility is in need of renovation to better 
accommodate the thousands of outpatients recruited for these studies 
and to better maintain security of their patient information. LRRI 
requests $2 million to help renovate this facility.

                             PROJECT IMPACT
    LRRI, as a private non-profit research institute, places top 
priority on its ability to translate its basic science findings from 
animal models, into protocols designed to evaluate new approaches for 
treating respiratory disease. These protocols lead to new innovative 
techniques and approaches to health care.
    LRRI conducts clinical studies requiring the recruitment of 
thousands of patients that provide the basis for making the link 
between genetic and cellular defects and clinical disease presentation 
and demographic characteristics. Currently, LRRI is conducting 
population-based genetic studies in:
  --Chronic obstructive pulmonary diseases (COPD),
  --Early detectors for lung cancer,
  --Pulmonary fibrosis, and
  --Mechanisms of asthma and other lung diseases in Hispanic and Native 
        American children
    Two events have greatly enhanced the ability to better understand 
the mechanisms of human disease in communities. One is the dramatic 
advance in molecular and cellular biology over the last 10 years, 
especially in human genetics. The other is the ability to collect and 
process data using advance computer systems and statistical techniques. 
This process called ``molecular epidemiology'' makes the link between 
genetic and cellular defects and clinical disease. LRRI has formed 
collaborations with national and local a private health providers to 
collect and manage patient data to carry out their ``molecular 
epidemiological'' studies. These partners include, the:
  --Lovelace Health Systems (LHS),
  --Albuquerque Veterans Administration Medical Center (VA),
  --University of New Mexico School of Medicine (UNM), and the
  --University of Miami School of Medicine (UMSM).
    Given the nature of the clinical studies performed, LRRI's facility 
requires security mechanisms well beyond those of ordinary medical 
clinics. As one can well imagine, this facility is the repository of 
very sensitive personal data, including that linked to an individual's 
DNA. To carry out this responsibility for privacy and confidentiality, 
there is a need to renovate the facilities and equipment necessary to 
be physically and electronically impenetrable to all but those who have 
specific and authorized access.
    The existing 8,000 sq. ft. facility was constructed in the 1950's 
and requires renovation and upgrades to provide a suitable, efficient, 
functional and secure facility. The proposed project would require 
reconfigured space, upgrades to meet current fire and safety codes, new 
interior finishes, new plumbing, upgraded electrical and a new heating, 
ventilation and air conditioning system.
    The current clinical trials facility is occupied in part by other 
LRRI functions. Some of these functions will need to be relocated to 
provide the required additional space for the clinical studies. 
Unfinished space is being made available in the new research facility 
included as part of the $10 million LRRI campaign. The proposed project 
will include the completion of 8,000 square feet of the unfinished 
space for this purpose.
    Accordingly, to meet this responsibility and to improve LRRI's 
ability to conduct its clinical studies, we respectfully request $2 
million. The responsible Federal agency is the Health Resources and 
Services Administration (HRSA).
                                 ______
                                 

Prepared Statement of the Lymphoma Research Foundation of America, Inc.

    Chairman Specter, Ranking Member Harkin and esteemed members of the 
Subcommittee, thank you for this opportunity to present written 
testimony before you on behalf of the over 600,000 Americans living 
with lymphoma and on behalf of the Lymphoma Research Foundation of 
America (LRFA). LRFA is the foremost national nonprofit organization 
dedicated to funding lymphoma research and providing information, 
education and support to lymphoma patients and their loved ones.
    The organization was founded in 1991 by Ellen Glesby Cohen, whose 
own experience battling non-Hodgkin's lymphoma led her to fully 
appreciate the pressing need for better, safer cancer treatments. To 
date, LRFA has awarded $3 million in support of 93 lymphoma research 
projects. Tragically, Ms. Cohen's battle with lymphoma ended in August 
of last year.
    Lymphoma is a cancer that originates in and affects the body's 
immune system. Lymphoma occurs when cells that normally fight infection 
abnormally multiply and form tumors. Lymphoma strikes men, women and 
children of all ages, races and socio-economic backgrounds.
    Three years ago, after a routine physical, my doctor told me that 
he was concerned about my white blood cell count. It had been high for 
a while, and he feared that I might have a form of cancer called 
Chronic Lymphocytic Leukemia (CLL). He calmed me by saying that people 
sometimes lived up to ten years with CLL without treatment, and 
referred me to an oncologist at Mayo Clinic for further evaluation.
    After several days of testing at Mayo, the oncologist told me that 
I had a disease called Mantle Cell Lymphoma not CLL. I remember vividly 
that he could not look me in the eye when he told me there were no 
known effective treatments for it. I asked him how long I had to live. 
He said that I was in the last stage of the disease, that lymphoma was 
in every organ of my body, and I could have as little as six to 18 
months to live.
    Stunned, my wife and I felt lost. We knew nothing about lymphoma. 
That evening we walked to a bookstore and started to read. We learned 
that lymphoma is a cancer of the lymphatic system, a part of our immune 
system, and that there are two main types of lymphoma, Hodgkin's 
lymphoma, also known as Hodgkin's Disease, and non-Hodgkin's lymphoma 
(NHL). We learned that about 80 percent of people diagnosed with 
Hodgkin's disease, with treatment, survive for at least five years.
    The prognosis is quite varied for non-Hodgkin's lymphomas, the 
category I am in, for NHL is a more complex group of cancers. There are 
more than 30 subtypes of non-Hodgkin's lymphoma that range from slow 
growing, or indolent, to highly aggressive. Some non-Hodgkin's 
lymphomas are considered curable. The majority are not curable, but are 
treatable. With mine, we discovered that statistically, whether you 
treat it or not, you live the same amount of time. In the complexity 
that I have described lays our challenge. No one knows what causes 
lymphoma.
    According to ``Cancer Facts & Figures'' published by the American 
Cancer Society (ACS), the number of newly diagnosed cases of lymphoid 
malignancies in 2001 is estimated to be 89,600 with a 50 percent 
average mortality rate for all lymphomas. The ACS also reports that the 
diagnostic incidence of non-Hodgkin's lymphoma has risen a dramatic 80 
percent over the last 20 years, making it the second most rapidly 
rising cancer by rate of incidence in the United States. Furthermore, 
lymphoma is the second leading cause of cancer-related deaths. An 
astonishing 60 percent of all childhood malignancies are lymphomas, or 
their cousin, leukemia. According to the National Cancer Institute 
(NCI), lymphoma represents the third most frequent type of cancer in 
the under 20-age group. Within these statistics, Mr. Chairman, is an 
urgent human cry for leadership and focus.
    Since receiving my diagnosis three years ago, I have been struck by 
the almost academic pace of lymphoma research. The scientists and 
researchers involved in developing diagnostic and treatment approaches 
have excellent skills. The federal budget for cancer research has been 
increasing, but progress has been too slow, and there is a notable lack 
of urgency. To address this situation, Mr. Chairman, the Lymphoma 
Research Foundation of America supports the campaign of doubling the 
budget of the National Institutes of Health (NIH) by the year 2003.
    The National Cancer Institute (NCI) is in the process of completing 
a Progress Review Group, or PRG, on lymphoma, leukemia, and myeloma. 
One purpose of the PRG is to identify the overlaps in research and 
where gaps exist. As a participant in the PRG Roundtable meeting 
consisting of scientists, clinicians, industry, patient advocates and 
federal agencies, it was obvious that cross-disciplinary and multi-
institutional research collaboration is needed. This would enable 
researchers to better communicate research results and to share 
resources, reagents, and patients. Ultimately, it would result in 
quickening the pace of the research itself. The PRG report produced by 
this process is designed to create a national prioritized research 
agenda for lymphoma and other hematological cancers. But we believe 
that the recommendations alone will not bring about needed change 
rapidly enough. Therefore, we request that a budget plan accompany the 
report.
    In addition, because of the link between lymphoma and 
environmental, bacterial, and viral factors, we request the National 
Institute on Environmental Health Sciences (NIEHS) to report to 
Congress on the current state of its research portfolio on lymphoma and 
hematological cancers. For fiscal year 2002, we request the Centers for 
Disease Control and Prevention (CDC) to expand its support in 
investigating the possible environmental causes of lymphoma and 
increase its data collection on lymphoma to provide accurate statistics 
on the disease. Both NIEHS and CDC must also be encouraged to 
collaborate with NCI and the NIH to avoid overlap in their research.
    Lymphoma is one of the most difficult cancers to diagnose. Indeed, 
too many people are already in advanced stages of the disease when they 
receive a diagnosis. Many people are also misdiagnosed, like I was, as 
to the type of lymphoma they have. As a result of the highly complex 
nature of the disease and the many different types of lymphoma, we 
request an outreach campaign by the CDC to educate clinicians and the 
general public on the symptoms associated with lymphoma and methods to 
better diagnose this complicated cancer. As you are well aware, early 
detection and early treatment of cancer increase one's chance of 
survival.
    I do not believe that the situation for those of us living with 
lymphoma has to be bleak. As evidenced by exciting discoveries 
resulting from the human genome project, advances in science and 
technology have brought us to the brink of an explosion in our 
understanding of the basic science of human malignancies. We have also 
entered into one of the most exciting periods in lymphoma research as 
more targeted, nontoxic therapies that attempt to modify the 
immunologic and genetic abnormalities of lymphomas are developed, such 
as vaccines, antisense compounds and gene therapy. Newer technologies 
will eventually allow physicians to predict more reliably a patient's 
response to treatment and to customize treatment strategies.
    I am a beneficiary of this progress. I am currently participating 
in a clinical trial at the NCI that involves treatment with a vaccine 
made from my own cancer cells. But I am one of only 20 participants, 
and even if successful, this treatment will take many, many years to 
reach the thousands who need it.
    Many scientists believe that lymphoma, because of its cellular 
biology and metastatic presentation, is the perfect malignancy in which 
to explore new avenues of treatment. Exciting discoveries resulting 
from lymphoma research, such as monoclonal antibodies, have the 
potential to benefit many other cancers, including those of the breast, 
prostate, colon and lung. But the technologies and novel therapies I 
described above are still early in their development and have to 
surmount considerable obstacles before they become available to treat 
patients. There is still a critical need for more innovative research 
and collaborative efforts before our goal of more effective, safer 
treatments, and ultimately, cures for lymphoma and other cancers can be 
achieved. And that is why I am asking you today to continue to increase 
your support of lymphoma research and to further the extraordinary 
research opportunities and momentum created by this moment.
    Lymphoma is the only cancer with an increasing mortality rate, in 
contrast to the decreasing mortality rates of many other cancers. I do 
not believe that we should consider this statistic as something beyond 
our control, and therefore, tragic but acceptable. In 1998, LRFA 
founder, Ellen Glesby Cohen, testified before this subcommittee. At 
that time, approximately 800 people per week died of lymphoma. This 
year, about 1,000 people per week will die. It is my hope that this 
subcommittee will provide the leadership and means to reverse these 
trends.
    Thank you for the opportunity to present written testimony and 
share my story with you.
                                 ______
                                 

     Prepared Statement of the Medicare Payment Advisory Commission

    The Medicare Payment Advisory Commission (MedPAC) requests a budget 
appropriation of $8,250,000 for fiscal year 2002: the same amount as 
fiscal year 2001, plus $250,000 to cover the costs of an anticipated 
mandatory office relocation. This level of funding will enable the 
Commission to complete the range of reports assigned to it by the 
Congress under recent legislation, as well as to provide technical 
support on Medicare policies to congressional committees and staff. 
This testimony will discuss MedPAC's statutory mandate, our work in 
fulfillment of that mandate during fiscal years 2000 and 2001, the work 
we have planned in fiscal year 2002, and the resources we will need to 
pursue that work.

                          LEGISLATIVE MANDATE
    The Congress established MedPAC in the Balance Budget Act of 1997 
(BBA) as an independent legislative agency to provide analysis of and 
recommendations on policies affecting the Medicare program. The 
Commission consists of 17 Commissioners appointed to three-year terms 
by the Comptroller General. By law, Commissioners are appointed to 
represent diverse points of view, including those of health care 
providers, payers, consumers, and employers, and to bring expertise in 
health economics and biomedical and health services research. (See 
Table 1 for a listing of the Commission's members and their 
affiliations).
    The Commission is assisted in its work by an executive director and 
professional research and administrative staff. Our professional staff 
have expertise in health economics, statistics, public policy, public 
health, hospital administration, medicine, and law. When specialized 
data or expertise are needed, the Commission also contracts with 
government agencies, trade associations, and private research firms.
    Within its broad mandate, MedPAC is directed by law to consider 
specific issues relating to the Medicare program. We are charged with 
considering:
  --Medicare payment, risk adjustment, risk selection, quality of care, 
        access to care, and other major issues relating to the 
        implementation and development of the Medicare+Choice program;
  --methods to determine and update payments for different types of 
        health services under the traditional fee-for-service Medicare 
        program;
  --the impact of payment policies on access to and quality of care for 
        beneficiaries in the traditional program;
  --the effect of Medicare payment policies on the broader health care 
        system; and
  --the effect of developments outside the program on Medicare.
    The law directs the Commission to make recommendations to the 
Congress on Medicare's payment policies by March 1 of each year. MedPAC 
also must submit a report to the Congress addressing other issues 
relating to the Medicare program by June 15 of each year. In addition, 
the Commission is required to comment on reports submitted by the 
Secretary of Health and Human Services to the Congress. Finally, MedPAC 
must submit additional reports on specific topics of interest at the 
direction of the Congress. Eighteen reports were assigned to the 
Commission under the Balanced Budget Refinement Act of 1999 (BBRA), and 
an additional 11 under the Medicare, Medicaid, and the SCHIP Benefits 
Improvement and Protection Act of 2000 (BIPA).
    The Commission meets about eight times a year to review analyses 
presented by staff and to develop and discuss its recommendations. 
These meetings are open to the public, with time routinely provided for 
public comment.

           ACCOMPLISHMENTS DURING FISCAL YEARS 2000 AND 2001
    MedPAC fulfills its mandate to assist the Congress in improving 
Medicare policy in a number of ways:
  --reports to the Congress required by our authorizing legislation or 
        by other laws,
  --formal testimony before the authorizing Committees of the House and 
        the Senate,
  --formal comments to the Secretary of Health and Human Services on 
        proposed regulations, and
  --technical analyses and briefings by Commission staff for 
        congressional staff.
Statutorily required reports
    The Commission submitted its March 2001 report to the Congress on 
time. This report contained the Commission's recommendations concerning 
Medicare payment policy issues and presented supporting analyses and 
reasoning behind the Commission's views. The report addressed the 
following areas:
  --evaluating Medicare's payment policies,
  --updating payments for physician services and for care provided in 
        hospital outpatient departments,
  --accounting for new technology in hospital prospective payment 
        systems (PPS),
  --developing input-price indexes for all health care settings,
  --financial performance and inpatient payment issues for PPS 
        hospitals,
  --prospective payment for post-acute care,
  --reconciling Medicare+Choice payments and fee-for-service spending,
  --end-stage renal disease payment policies in traditional Medicare,
  --reducing beneficiary coinsurance under the hospital outpatient 
        prospective payment system, and
  --treatment of the initial residency period in Medicare's direct 
        graduate medical education payments.
    The Commission will submit its second mandated report for the year 
on June 15, 2001. This report focuses on the Commission's examination 
of issues affecting the Medicare program in rural areas. The June 
report will include the following topics:
  --overview of rural markets and Medicare,
  --rural beneficiaries' access to care,
  --prospective payment for hospitals in rural areas,
  --home health payment issues,
  --prospective payment systems for outpatient hospital services,
  --Medicare+Choice in rural areas, and
  --quality of care issues for rural beneficiaries.
    This report will address several issues MedPAC was directed to 
study under the BBRA, including:
  --the appropriateness of prospective payment for home health agencies 
        in rural areas,
  --the adequacy of Medicare's payment provisions for rural providers,
  --the appropriateness of prospective payment for rural psychiatric 
        hospitals, and
  --the appropriateness of applying the prospective payment system for 
        hospital outpatient departments to certain rural hospitals.
    The June report will also include MedPAC's review of the 
sustainable growth rate and conversion factor for physician services, 
as required by the Congress.
    The BBRA required that MedPAC review several policies in 
Medicare+Choice and on Medicare payment for post-surgical recovery care 
centers. In November 2000, MedPAC fulfilled these requirements by 
submitting three reports to the Congress: ``Medical Savings Accounts 
and the Medicare Program, Improving Risk-adjustment in Medicare, and 
Medicare Payment for Post-surgical Recovery Care Centers.'' In May 
2001, the Commission will submit reports as required under the BBRA on 
Medicare payment for clinical training of non-physician health 
professionals in hospitals and on payment for skilled nursing 
facilities in Alaska and Hawaii.
    During the next fiscal year, Commission staff will continue to 
prepare and distribute other reports containing information from its 
analyses and research requested by the Congress or initiated on its 
own. Some of these reports will result from analyses undertaken by the 
Commission staff; others will contain findings from research and 
analyses conducted under external research contracts.
Testimony
    During fiscal years 2000 and 2001, the chair of the Commission 
testified before the House Committee on Ways and Means, Subcommittee on 
Health and the House Committee on Commerce. Her testimony before the 
Ways and Means Subcommittee focused on the impact of the BBA on 
patients, providers and Medicare+Choice plans and her testimony before 
the Commerce Committee addressed the impact of the BBA on patients and 
providers. During this period, the executive director testified before 
the House Committee on Commerce and the Senate Committee on Finance. 
The executive director's testimony before the Commerce Committee 
addressed accounting for new technology in the hospital prospective 
payment system. Before the Finance Committee he addressed issues 
surrounding the Medicare+Choice program.
    In addition, the Commission expects to provide further testimony on 
subjects related to its expertise during fiscal year 2002. Members of 
the Commission and staff will continue to provide briefings, technical 
advice, and other support to members of the Congress and their staff. 
The Commission also works with the Health Care Financing Administration 
(HCFA) and a number of private sector groups concerning Medicare 
payment for facility and physician's services and Medicare+Choice, as 
well as broader changes in health care financing and delivery.
Comments on proposed regulations
    Since enactment of the BBA, the Commission has closely monitored 
implementation of the law by the Secretary and has commented on 
proposed rules and interim final regulations. Although MedPAC is not 
required by law to comment on proposed regulations, we do so in cases 
where we feel that the Congress benefits from having an independent 
assessment. Further, making comments as the regulations are developed 
provides the Congress (and the Secretary) with more timely advice than 
we can provide in our March or June reports. In fiscal year 2000, 
MedPAC submitted formal comments on the Secretary's proposal for the 
prospective payment system for home health services.

                              FUTURE WORK
    Our priorities for the upcoming fiscal year include working on our 
two mandated reports, focusing on access and quality of care, 
continuing our work on Medicare in rural areas, and examining the 
regulatory complexity of the Medicare program. We also will continue to 
monitor the impact of changes in payment for ambulatory care services 
including hospital outpatient department and physicians, evaluate 
payment policies for post-acute care, and examine issues in 
Medicare+Choice.
    Other topics the Commission will pursue were defined by the 
Congress under the BBRA and the BIPA. These include payments to 
Medicare+Choice plans, appropriate quality standards, skilled nursing 
facility payment, use of and payment for physician services, examining 
the use of consumer coalitions in marketing of Medicare+Choice plans, 
access to and use of the hospice benefit, Medicare coverage of services 
provided by certain allied health providers, the shortage of 
geriatricians, and the implications of the hospital-specific cap on 
residents in Medicare's graduate medical education payments. The 
Commission further anticipates that the Congress will continue to seek 
its advice and analytic help in monitoring implementation of the 
Medicare provisions of the BBA, the BBRA, and the BIPA, and the 
Congress continues work on legislation affecting the Medicare program.
    MedPAC's staff is beginning to develop research projects on these 
and other topics. Commissioners will meet in July to discuss which 
projects should be given emphasis and we will discuss our analytic 
agenda at our public meetings.

                         APPROPRIATIONS REQUEST
    As noted above, MedPAC is requesting $8,250,000 for fiscal year 
2002, the same amount as fiscal year 2001, plus $250,000 to cover the 
costs of an anticipated mandatory office relocation. We propose to 
allocate a large portion of the requested funds to external research 
contracts to support the numerous reports request by the Congress (see 
Table 2).
    We also plan to target funding towards salaries and benefits in an 
effort to achieve the staff size needed to fulfill our responsibilities 
and to provide the maximum support to Congress. Although, the 
Commission continued to experience staff turnover during fiscal year 
2001 through aggressive recruiting we have attracted several highly 
qualified individuals. Despite a tight labor market for health policy 
analysts--particularly senior people with extensive knowledge of the 
Medicare program--we hope to be fully staffed at the beginning of 
fiscal 2002 to allow us to fully respond to the many responsibilities 
given to us by the Congress.

 TABLE 1.--MEMBERS OF THE MEDICARE PAYMENT ADVISORY COMMISSION AND THEIR
                              AFFILIATIONS
------------------------------------------------------------------------
                  Member                             Affiliation
------------------------------------------------------------------------
Gail R. Wilensky, Ph.D., Chair, Bethesda,   Project HOPE, Center for
 MD.                                         Health Affairs
Joseph P. Newhouse, Ph.D., Vice Chair,      Harvard University
 Boston, MA.
Beatrice Braun, M.D., Spring Hill, FL.....  American Association of
                                             Retired Persons
Autry O.V. ``Pete'' DeBusk, Powell, TN....  DeRoyal
Glenn M. Hackbarth, J.D., Bend, OR........  Independent consultant
Spencer Johnson, Lansing, MI..............  Michigan Health and Hospital
                                             Association
Floyd D. Loop, M.D., Cleveland, OH........  The Cleveland Clinic
                                             Foundation
Alan R. Nelson, M.D., Washington, DC......  American College of
                                             Physicians--American
                                             Society of Internal
                                             Medicine
Janet G. Newport, Santa Ana, CA...........  PacifiCare Health Systems
Carol Raphael, New York, NY...............  Visiting Nurse Service of
                                             New York
Robert D. Reischauer, Ph.D., Washington,    The Urban Institute
 DC.
Alice Rosenblatt, F.S.A., M.A.A.A.,         Wellpoint Health Networks
 Thousand Oaks, CA.
John W. Rowe, M.D., Hartford, CT..........  Aetna US Healthcare
David A. Smith, Washington, DC............  AFL-CIO
Ray E. Stowers, D.O., Tulsa, OK...........  Oklahoma State University--
                                             College of Osteopathic
                                             Medicine
Mary K. Wakefield, Ph.D., Fairfax, VA.....  George Mason University
------------------------------------------------------------------------


    TABLE 2.--BUDGET AUTHORITY, MEDICARE PAYMENT ADVISORY COMMISSION
                        [In thousands of dollars]
------------------------------------------------------------------------
                                   Fiscal year
                             ----------------------              Fiscal
    Object classification        2002                 Change   year 2002
                                actual   2001 plan              request
------------------------------------------------------------------------
Salaries:...................
    Full-time staff.........     $2,439     $2,911  .........     $2,911
    Commissioners...........        152        182  .........        182
                             -------------------------------------------
      Subtotal..............      2,591      3,093  .........      3,093
                             ===========================================
Benefits....................        631        760  .........        760
                             ===========================================
Travel:.....................
    Staff...................         37         31  .........         31
    Commissioners...........         77        100  .........        100
                             -------------------------------------------
      Subtotal..............        109        131  .........        131
                             ===========================================
Standard level user charges.        349        355  .........        355
Mainframe computer..........        941        755  .........        755
Telephone...................         56         50  .........         50
Postage.....................         53         90  .........         90
                             -------------------------------------------
      Subtotal..............      1,050        895  .........        895
                             ===========================================
Printing and reproduction...        160        250       -$32        218
Computer programming........        870        900  .........        900
Research contracts..........        590      1,230        -30      1,200
Commercial contracts........        222        230       +250        480
Government contracts........          1          1          0          1
GSA support.................         60         66         +2         68
                             -------------------------------------------
      Subtotal..............      1,743      2,427       +222      2,649
                             ===========================================
Supplies....................         38         38  .........         38
Publications................         34         33  .........         33
                             -------------------------------------------
      Subtotal..............         72         71  .........         71
                             ===========================================
Equipment and furnishings...         23         18        +60         78
                             ===========================================
Lapsing.....................        230  .........  .........  .........
                             ===========================================
      Total.................      7,015      8,000       +250      8,250
------------------------------------------------------------------------
Note.--Numbers may not add to totals because of rounding.

                                 ______
                                 

     Prepared Statement of the Medical Library Association and the 
           Association of Academic Health Sciences Libraries

                              INTRODUCTION
    Mr. Chairman, thank you for the opportunity to submit testimony on 
behalf of the Medical Library Association (MLA) and the Association of 
Academic Health Sciences Libraries (AAHSL) regarding the fiscal year 
2002 budget for the National Library of Medicine (NLM). I am Marianne 
Comegys, associate professor of medical library science at the 
Louisiana State University Health Sciences Library in Shreveport, La.
    MLA is a professional organization, headquartered in Chicago, 
representing over 4,000 individuals and 1,200 institutions involved in 
the management and dissemination of biomedical information to support 
patient care, education and research. In 1998, the organization 
celebrated its 100th anniversary.
    AAHSL, is comprised of the directors of libraries of 142 accredited 
United States and Canadian medical schools belonging to the Association 
of American Medical Colleges. Together, MLA and AAHSL address health 
information issues and legislative matters of importance to the medical 
library community through a joint legislative task force.
    Mr. Chairman, the National Library of Medicine, on the campus of 
the National Institutes of Health in Bethesda, Maryland, is the world's 
largest medical library. The Library collects materials in all areas of 
biomedicine and health care, as well as works on biomedical aspects of 
technology, the humanities, and the physical, life, and social 
sciences. The collections stand at 5.8 million items--books, journals, 
technical reports, manuscripts, microfilms, photographs and images. 
Housed within the Library is one of the world's finest medical history 
collections of old and rare medical works. The Library's collection may 
be accessed in the reading room or requested on interlibrary loan. NLM 
is a national resource for all U.S. health science libraries through a 
National Network of Libraries of Medicine.
    On behalf of the medical library community, I would like to thank 
the subcommittee for its leadership in securing a 15 percent increase 
for NLM in fiscal year 2001. With respect to the Library's budget for 
the coming fiscal year, I would like to touch briefly on four issues; 
(1) NLM's basic services, (2) NLM's outreach and telemedicine 
activities, (3) NLM's PubMed Central and clinical trials databases, (4) 
and NLM's facilities needs.

                  THE GROWING DEMAND FOR NLM SERVICES
    Mr. Chairman, it is a tribute to NLM that the demand for its 
services continues to steadily increase each year. An average of 250 
million Internet searches (30 percent from the general public) are 
performed annually on NLM's MEDLINE database, which provides access to 
the world's most up to date health care information. Moreover; medical 
libraries, academic health centers, hospitals, community health 
centers, veterans health care facilities, and private physicians rely 
heavily on NLM and its National Network of Libraries of Medicine to 
deliver quality health care everyday.
    NLM also plays a critical role in maintaining the integrity of the 
world's largest collection of medical books and journals. Increasingly, 
this information is in digital form, and NLM, as a national library 
responsible for preserving the scholarly record of biomedicine, is 
developing a strategy for selecting, organizing, and ensuring permanent 
access to digital information. Regardless of the format in which the 
materials are received, ensuring their availability for future 
generations remains the highest priority of the Library.
    Mr. Chairman, simply stated, NLM is a national treasure. I can tell 
you that without NLM our nation's medical libraries would be unable to 
provide the type of information services that our nation's health care 
providers, educators, researchers and patients have come to expect.
    Recognizing the invaluable role that NLM plays in our health care 
delivery system, the Medical Library Association and the Association of 
Academic Health Sciences Libraries join with the Ad Hoc Group for 
Medical Research Funding in recommending a 16.5 percent increase for 
NLM and NIH overall in fiscal year 2002.

               NLM'S OUTREACH AND TELEMEDICINE ACTIVITIES
Outreach and Education
    NLM's outreach programs are of particular interest to both MLA and 
AAHSL. These activities, designed to educate medical librarians, health 
care professionals and the general public about NLM's services, are an 
essential part of the Library's mission.
    The need for enhanced outreach activities has grown significantly 
in recent years following NLM's decision to make its MEDLINE database 
available for free over the World Wide Web. The Library has taken a 
leadership role in promoting educational outreach aimed at public 
libraries, secondary schools, senior centers and other consumer-based 
settings. We were pleased that the Committee again last year recognized 
the need for NLM to coordinate its outreach activities with the medical 
library community.
    Mr. Chairman, we applaud the success of NLM's outreach initiatives 
and look forward to continuing our work with the Library again in 
fiscal year 2002 on these important programs.
Telemedicine
    Mr. Chairman, telemedicine continues to hold great promise for 
dramatically increasing the delivery of health care to underserved 
communities across the country and throughout the world. NLM has 
sponsored over 50 telemedicine related projects in recent years, 
including 21 multi-year projects located in various rural and urban 
medically underserved communities. These sites serve as models for:
  --Evaluating the impact of telemedicine on cost, quality, and access 
        to health care;
  --Assessing various approaches to ensuring the confidentiality of 
        health data transmitted via electronic networks;
  --Testing emerging health data standards.
    Mr. Chairman, it is clear that telemedicine will play a major role 
in the delivery of health care in the 21st Century. Medical librarians 
and health information specialists have an important role to play in 
supporting this revolutionary approach to health care and we encourage 
Congress and NLM to continue their strong support of telemedicine in 
our nation's medically underserved areas.

                PUBMED CENTRAL /CLINICAL TRIALS DATABASE
    The medical library community applauds NLM for its leadership in 
establishing PubMed Central, an online repository for life science 
articles introduced in early 2000. PubMed Central evolved from an 
electronic publishing concept proposed by former NIH Director Dr. 
Harold Varmus. The site houses articles from the Proceedings of the 
National Academy of Sciences, the American Society for Cell Biology's 
journal Molecular Biology of the Cell, and other publications.
    This new online resource will significantly increase access to 
biomedical information by health care professionals, students, 
researchers and the general public. The medical library community 
believes that health sciences librarians have a key role to play in the 
further development of PubMed Central. Because of the high level of 
expertise health information specialists have in the organization, 
collection, and dissemination of medical literature, we believe our 
community can assist NLM in issues related to copyright, fair use, and 
information classification on the PubMed Central site. We look forward 
to collaborating with the Library as this exciting new project 
continues to unfold this year.
    Mr. Chairman, I also want to comment on another relatively new 
service offered by NLM--its clinical trails database 
(Clinicaltrials.gov). This listing of some 5,200 federal and privately 
funded trials for serious or life-threatening diseases was launched in 
February of 2000. This free service is currently logging more than 2 
million page hits a month and is an invaluable resource to patients and 
families interested in participating in cutting edge treatments for 
serious illnesses. The medical library community congratulates NLM for 
its leadership in creating
    ClinicalTrials.gov and looks forward to assisting the Library in 
anyway possible to advance this important initiative. This database is 
a nice compliment to NLM's extremely successful consumer web-site 
MEDLINEplus, which now covers over 450 health topics.

                         NLM'S FACILITIES NEEDS
    Mr. Chairman, over the past two decades NLM has assumed several 
major new responsibilities particularly in the areas of biotechnology, 
health services research, high performance computing, and consumer 
health. As a result, the Library has had tremendous growth in its basic 
functions related to the acquisition, organization, and preservation of 
an ever-expanding body of biomedical literature.
    This increase in the volume of biomedical information as well as 
Library personnel (NLM currently houses over 1,100 people in building 
built to accommodate 650) has resulted in a serious shortage of space 
at the Library. In addition, the National Center for Biotechnology 
Information at NLM builds sophisticated data management tools for 
processing and analyzing enormous amounts of genetic information 
critical to advancing the Human Genome Project.
    In order for NLM to continue its mission as the world's premier 
biomedical library, a new facility is urgently needed. The NLM Board of 
Regents has assigned the highest priority to supporting the acquisition 
of a new facility. The medical library community is pleased that 
Congress last year appropriated the necessary architectural and 
engineering funds for facility expansion at NLM. We encourage the 
subcommittee to continue to provide the resources necessary to acquire 
a new facility and to support the Library's health information 
programs.
    Mr. Chairman, thank you once again for the opportunity to present 
the views of the medical library community.
                                 ______
                                 

             Prepared Statement of The Mended Hearts, Inc.

    I am Robert H. Gelenter, the legal representative for the Mended 
Hearts Inc, a national heart disease patient support group of 25,000 
members across the country. We visit patients in about 450 hospitals 
throughout the United States. I have been appointed by the group to 
assist in this lobbying effort--a volunteer position.
    More than 25 years ago, I was diagnosed with a rare heart disease. 
After having severe chest pains and trouble breathing for more than two 
years, I was diagnosed with hypertrophic cardiomyopathy, a disease in 
which the heart enlarges. The heart muscle eventually thickens so much 
that it can't pump blood effectively and does not grow in the normal 
parallel patterns. More than 35 percent of young athletes who die 
suddenly die from this disease. But, it affects men and women of all 
ages. It is sudden and one of the things known about this disease is 
sudden cardiac death. There is no cure for this disease. Medication may 
work and there is surgery that may or may not alleviate the pain. If 
that doesn't work a patient may need a heart transplant, yet spare 
organs are scarce. The doctor who made my diagnosis was trained at the 
National Heart, Lung, and Blood Institute of the National Institutes of 
Health.
    Initially, I received several medications which allowed me to 
engage in most activities. But, some activities, such as walking up 
hills, gave me problems like shortness of breath and severe chest 
pains. But, generally I could function normally. However, after about 
10 years, the discomfort was increasing, and it became apparent that I 
was in serious trouble. I could not walk sixty feet without having to 
stop to catch my breath. Sometimes the pain was so great that I would 
almost double over in the middle of the street. My wife told me that my 
face would become gray. The perspiration would pour off by body. If I 
was lucky I could find a chair to sit on. The quality of my life had 
deteriorated so drastically that I knew I needed some treatment.
    Finally in 1988, I went to Georgetown University Medical Center for 
an angiogram--the gold standard for diagnosing heart problems. The 
cardiologist who performed the angiogram told me that he had bad news 
and worse news. The bad news was that I had a 95 percent blockage in my 
left anterior descending heart artery--the so-called ``widow makers 
spot.'' The worse news was that I had a major chance of having a major 
heart attack with a less than a 5 percent chance of surviving that 
heart attack because of the hypertrophic cardiomyopathy. At this point, 
my wife was quietly crying and I was perspiring profusely. Since 
Georgetown University Medical Center did not have the expertise to 
operate on me, they called the NIH to see if they would accept me as a 
patient. I was sent home pending notice from the NIH.
    My parents begged me to go to New York or San Francisco for second 
opinions. But, I knew that I had run out of alternatives. No matter 
what the result, I needed treatment and I needed it immediately.
    I was accepted by the NIH. After entering the National Heart, Lung, 
and Blood Institute on February 6th, I was operated on February 11th, 
1988. No matter how trite the expression--that was the first day of the 
rest of my life. The surgery, considered drastic and rare, is still 
considered the gold standard throughout the world for the treatment of 
hypertrophic cardiomyopathy. The Murrow Procedure, in honor of the 
creator, was developed and improved at the NIH.
    Although this surgery is no longer performed at the National Heart, 
Lung, and Blood Institute, there is another experimental ongoing 
protocol in which the same effect is being attempted by using alcohol 
to deaden the excessive heart tissue.
    Now, I am on medication for the rest of my life. My condition is 
progressive. Five years ago, I was fitted with a pacemaker to insure 
that my heart beats at the correct rate. I am 100 percent dependent on 
this pacemaker. Without the pacemaker, there are times when my normal 
heart beat is so slow that I would die.
    I am eternally grateful to the physicians funded by the National 
Heart, Lung, and Blood Institute, particularly to Dr. MacIntosh and his 
staff, for the gift of life. Because of this marvelous research 
supported by the NHLBI, I have lived 13 years pain free. I have seen 
two children graduate from college and three grandchildren born, I have 
shared these years with a wonderful wife. I have been able to work at 
my profession--an attorney at law.
    I have had the gift of life restored to me. So to express my 
gratitude for that gift, I visit patients recovering from heart 
episodes at two hospitals, Washington Hospital Center and Washington 
Adventist Hospital.
    I ask for a doubling of the fiscal year 1998 National Heart, Lung, 
and Blood Institute budget by fiscal year 2003. As the fourth increment 
toward reaching that goal, I advocate a fiscal year 2002 appropriation 
of $2.679 billion for the NHLBI, including $1.650 billion for its heart 
disease and stroke-related budget.
    My experience is the proof that the research supported by the 
Institute benefits not just the patients at the NIH Clinical Center, 
but throughout the United States. The benefits go worldwide as well.
    Heart attack, stroke and other cardiovascular diseases remain the 
No. 1 killer and major cause of disability of men and women in the 
United States. Nearly 41 percent of people who die in the United States 
die from cardiovascular diseases. This year, nearly 950,000 Americans 
will die from cardiovascular diseases, including more than 150,000 
under the age of 65.
                                 ______
                                 

            Prepared Statement of Miami Children's Hospital

    In recognition of the indispensable role that independent 
children's hospitals, like Miami Children's Hospital, play in 
children's health, I urge you to continue the commitment to the 
Children's Hospital Graduate Medical Education (``GME'') program by 
calling for and supporting full funding this year.
    As President and Chief Executive Officer of Miami Children's 
Hospital, I am very concerned about the cut in funding the 
Administration is proposing for the GME program this year. The 
Children's Hospital Graduate Medical Education program provides funding 
to about 60 independent children's hospitals that were left out of a 
GME financing system that depends on Medicare. Children's hospitals do 
not qualify for Medicare GME support which leaves a gap of $285 million 
annually. As you know, Congress passed legislation in 1999 to address 
this inequity. The $235 million authorized last year takes a big step 
in the right direction to reaching the $285 million goal. Achieving an 
appropriation of $285 million this fiscal year will make an essential 
investment in the children's hospitals' missions as centers of 
education and research, and regional centers of excellence.
    Instead of moving towards that goal, the Administration has 
announced that the President's budget will propose a 15 percent cut, an 
equivalent of $35 million, for GME payments to children's hospitals. 
Independent children's hospitals make up only one percent of all 
hospitals, train thirty percent of pediatricians, fifty percent of 
specialists, and a larger portion of pediatric researchers. Despite 
these significant contributions, the survival of these institutions is 
contingent upon reaching the $285 million goal and thus closing the 
gap.
    I look forward to your continued support for GME funding.
    Miami Children's Hospital (MCH) hereby submits for the record, 
testimony regarding the need to develop a significant Ambulatory Care 
Center at Miami Children's Hospital.
    Miami Children's Hospital is a private, non-profit entity that 
offers a full range of services from birth to age 21 with primary care 
pediatrics as the cornerstone. Also, MCH is the largest provider of 
Pediatric Orthopedics in Miami Dade County. By percentage of net 
revenue, Miami Children's Hospital is the largest Medicaid provider for 
children in the state of Florida. The services include preventive 
medicine, the only children's hospital in Florida with such a 
department, and the most sophisticated medical and surgical tertiary 
care.
    Miami Children's Hospital is South Florida's only independent, 
free-standing licensed specialty hospital exclusively for children. Our 
mission to provide excellent family centered health care has helped us 
pave the way to our continuing success. Some of the success along our 
path include: being the only children's hospital in Florida to 
successfully separate conjoined twins; it is the leading child 
neurological facility in the region. Furthermore, MCH houses the only 
pediatric cardiac intensive care unit in the Southeastern United 
States. It is one of only 10 centers nationwide selected to participate 
in the clinical trial of CardioSEAL, a revolutionary closure device to 
be used in treating children with atrial septal defects. It was 
successfully completed in its first clinical trial.
    The Hospital is also very pleased to have been ranked first in 
Florida, second in Southeast and tied 14th in the country as top 
hospital by Child Magazine. This recognition highlights our dedication 
to pediatric excellence and focuses on the outstanding work taking 
place in South Florida. For example, MCH is the first hospital in the 
state of Florida to have pediatric Extra Corporeal Membrane Oxygenation 
(ECMO) available. This procedure allows children born with certain 
system failures, such as renal or cardio-pulmonary, to have an 
effective oxygenation of blood while recovering. In addition, Miami 
Children's Hospital has been the first in the United States and in the 
international arena in spearheading many procedures. For instance, it 
was the first in the United States to perform a tracheal transplant. It 
was first in the Southeastern United States to perform a tracheal 
transplant. It was first in the Southeastern United States in 
performing reconstructive surgery for brachial plexus injuries as well 
as in repairing Pectus Excavatus (sunken chest). MCH also performed the 
world's first extracardiac Fontan operation that did not require 
cardiopulmonary bypass, i.e., the need of heart lung machine, and the 
world's first endoscopic ventricular thrombectomy, i.e., removal of 
cardiac clot without surgery. It also led the world's first conference 
on minimally invasive surgery for congenital heart disease and hosted 
the first Youth Leadership Conference on Health. MCH is also credited 
with developing the first international medical teleconference in 
pediatrics. It was first in the United States and the Americas to use 
the Helex Septal Occluder to treat atrial septal device (ASD), a common 
heart defect.
    Miami Children's Hospital is dedicated to the development of 
technology that will be less invasive to children. Always at the 
forefront of cutting-edge technology, most recently, MCH created a 
pediatric brain tumor center. The cornerstone of the new center will be 
a powerful new tool for treating brain cancer: an interoperative 
magnetic resonance imaging (MRI) unit that can be rolled into the 
operating room to provide surgeons with real-time scans of the child's 
brain. The resulting accuracy will bring new levels of confidence to 
parents and doctors that all of the tumor has been removed.
    The demand for pediatric care services has grown enormously, 
especially in Miami Dade County, since MCH is the only hospital 
exclusively for children in the region and indeed in South Florida. To 
meet these growing needs, we are presently engaged in the construction 
of a new Ambulatory Care Center that will serve to meet the needs of a 
growing population of our patients. The three story Ambulatory Care 
Building would provide patient services for the following pediatric 
specialties: Orthopedics, Rheumatology, Urology, Nephrology, Urodynamic 
Laboratory, Enuresis Center, Dermatology, Neurosciences, Behavioral 
Health, and Pediatric Dentistry. Our goal to meet the growing demand 
for children's services helped create the Miami Children's Hospital Dan 
Marino Center in South Florida. An extension of MCH, it is an 
integrated neuro developmental center specializing in the diagnosis and 
treatment of children at risk for developmental and psychological 
problems.
    Even with such innovative technologies and procedures, MCH still 
finds itself unable to meet the growing needs of children. Miami 
Children's Hospital treats more than 185,000 children each year. The 
Hospital is faced with severe waiting list challenges, for certain 
services (i.e. child neurological services) the wait can be up to six 
weeks or more. The Hospital has for two decades made investments 
through its own services, as well as through community-based 
contributions.
    A major component of Miami Children's Hospital is its mission and 
commitment to early intervention and preventive medicine. Miami 
Children's Hospital's mission is on track to become a leading pediatric 
preventive medicine institute in the United States. For example, Miami 
Children's Hospital has established mobile pediatric health vans called 
the ``Health-on-Wheels'' program to reach underserved and disadvantaged 
areas. Since September 1995, two 40-foot, mobile Health-on-Wheels 
vehicles carrying state-of-the-art medical and dental facilities, in 
the hands of board-certified pediatricians, pediatric nurse 
practitioners, nurse assistants and paramedics, have served over 22,000 
children in Dade and Monroe counties. As of 1998, the Program has 
administered 13,510 immunizations, 4,129 tuberculosis screens and 8,721 
hearing and vision tests. Of the 14,000 children evaluated, 11 percent 
were diagnosed with an acute medical condition.
    The Hospital has a state-of-the-art critical care transport service 
for patients in need of specialty care using ground ambulance, 
helicopter or fixed-wing aircraft called ``LifeFlight''. The helicopter 
is one-of-a-kind in that it can transport two patients, travel up to a 
200 mile radius and is configured with state-of-the art medical 
technology. LifeFlight is used in conjunction with other transportation 
to bring patients from Florida, as well as world-wide to the Hospital.
    Miami Children's Hospital has excellent clinical services, medical 
research and a comprehensive teaching program for doctors, nurses and 
medical specialists. The Hospital has eliminated the need to send 
Florida's children elsewhere to get the medical attention they so 
desperately need. Additionally, Miami Children's Hospital offers array 
of services that draw children world-wide to the Hospital. Programs 
that have been established at Miami Children's Hospital can be used in 
other parts of the United States.
    Moreover, area hospitals are sending their patients to Miami 
Children's Hospital because of its focus on early intervention and 
treatment, especially given their specialization in developmental 
disabilities, as well as the use of the Hospital's expansive imaging 
equipment. There is no need to send Florida's children elsewhere to get 
the medical attention they so desperately need.
    As you know, funding to improve health care services and access to 
health care facilities for children has been a priority for Congress. 
Therefore, we would appreciate any assistance you may be able to render 
to ensure that children in need of special care receive the quality 
care they deserve, by including $4 million for the Miami Children's 
Hospital Ambulatory Care Center in the fiscal year 2002 Labor, Health 
and Human Services, and Education Appropriations Bill.
    The estimated cost of construction for the entire Ambulatory Care 
Center is $13.2 million. We are requesting that approximately $4 
million dollars of this cost be funded by the federal government, 
possibly through the Health Resources and Services Administration's 
Facilities account. The balance of the funding for the project will be 
supported as follows: one-third through philanthropic contributions via 
the Miami Children's Hospital Foundation and one-third through 
operating money generated by the hospital.
    Miami Children's Hospital wishes to express its deep appreciation 
to this Committee for permitting us to submit this presentation on 
Miami Children's Hospital's Ambulatory Care Center. Your positive 
response for Miami Children's Hospital's request for support will have 
a positive impact on the health and well-being of our children in need.
    Thank you.
                                 ______
                                 

  Prepared Statement of the Mississippi Department of Rehabilitation 
                                Services

    Thank you for the opportunity to present testimony for the record 
on an issue vital to Americans with disabilities--the need for adequate 
funding for every state's vocational rehabilitation program.
    Established in 1920, the Public Vocational Rehabilitation Program 
(VR) is the cornerstone of our nation's commitment to people with 
disabilities toward becoming economically independent. Last year, the 
vocational rehabilitation program assisted 235,000 Americans with 
disabilities to go to work. The combined income of these 235,000 
individuals during their first year of employment was a staggering $3.1 
billion. Vocational Rehabilitation works!
    However, the current federal funding formula threatens to slam shut 
the door of opportunity for a vast number of these citizens. While a 
mandatory cost-of-living adjustment applies to the entire program, a 
different formula prescribed in the Rehabilitation Act (as amended by 
the Workforce Investment Act of 1998) applies to how funds are 
allocated to the states. For example, while the national program has 
received annual two to three percent cost-of-living (COLA) increases 
from Congress during the past eight years, many states have gotten less 
than the COLA during each of those years. Specifically, in Federal 
fiscal year 2000, 22 states (including Mississippi) received less than 
the 1.24 percent COLA increase, and six actually received fewer dollars 
during Federal fiscal year 2000 than in Federal fiscal year 1999. A 
majority of states--29 in all--received less than the Federal fiscal 
year 2001 COLA of 2.6 percent provided in the Congressional 
appropriation. Unless the formula is fixed, more will follow.
    Compounding this problem is the fiscal pressure exerted on the 
vocational rehabilitation program. For example:
  --The success of the Individuals with Disabilities Education Act 
        (IDEA) means that more young adults than ever before are 
        entering the vocational rehabilitation program for post-
        secondary training leading to employment.
  --Post-secondary tuition has skyrocketed to 200-300 percent above any 
        COLA increase.
  --Medical costs are inflating at an alarming rate and will continue 
        to do so.
  --The use of assistive technology (such as computerized wheelchairs) 
        in the rehabilitation of Americans with disabilities involves 
        significant expense.
  --Because of Welfare-to-Work, the Ticket to Work/Workforce Incentives 
        Improvement Act and the Workforce Investment Act, a large pool 
        of previously unemployed adults is now entering the workforce.
    Americans with disabilities have high expectations for the future. 
They're becoming better educated and eagerly expect to work in 
competitive, skilled jobs. As a nation, we have an obligation to ensure 
that every citizen is able to attain the dignity that comes with 
employment and self-reliance.
    With the projected Consumer Price Index (CPI) for Federal fiscal 
year 2002 at 3.4 percent, and without some language to hold states 
harmless from the application formula, more than 20 states will fall 
short of this CPI and thousands of Americans with disabilities won't 
receive the services they need to go to work.
    It was never the intent of Congress that any state should receive 
less than a COLA increase. On behalf of Americans with disabilities, I 
respectfully request that:
  --the attached ``Amendment for Appropriations for Vocational 
        Rehabilitation'' language be adopted;
  --every state receive ``hold harmless'' protection at the actual 
        percentage of the cost-of-living increase so that no state 
        loses federal dollars, as happened during fiscal year 2000;
  --an additional appropriation of $19.1 million be made to the 
        vocational rehabilitation program to remedy the COLA problem; 
        and
  --each state receive a 5 percent increase in new federal funds (above 
        the COLA) to meet the increasing demands upon its vocational 
        rehabilitation program.
    The very future of Americans with disabilities is at stake. Thank 
you for this opportunity to express my concerns and solutions.
                                 ______
                                 

    Prepared Statement of the National Alliance to End Homelessness

    The National Alliance to End Homelessness is a national membership 
organization with nearly 2,000 members around the country. Most are 
local nonprofit community-based and faith-based organizations that are 
doing the hands-on work to end homelessness for families and 
individuals. As our name implies, our primary focus is ending 
homelessness, not simply making it easier to manage. There is nothing 
inevitable about homelessness in the United States. We know more about 
homelessness and how to address it than we ever have before. We know 
what program models are effective for what kinds of people. It remains 
only to bring these solutions to a scale commensurate with the problem, 
and to focus them on bringing homelessness to an end.
    It is our contention that an end to homelessness is a goal that we 
can achieve by the end of the decade. To do so we need to pursue four 
lines of attack simultaneously. We must:
  --Plan for outcomes
  --Close the front door in to homelessness
  --Open the back door out of homelessness and in to housing
  --Build the infrastructure.

                         PLANNING FOR OUTCOMES
    We have an extensive system for dealing with homelessness. Too 
often, however, this system focuses only on managing the problem and 
not on a permanent solution. To change this focus we need to be sure we 
have accurate information on who homeless people are, how they become 
homeless, and what works to allow them to secure and stay in housing. 
Most homeless people have some contact with mainstream social services 
programs; indeed, a 1996 study funded by the Interagency Council on the 
Homeless found that 62 percent of currently homeless people in 
families, and 22 percent of those single, were receiving some type of 
income-based government assistance.
    Recommendation: Encourage all programs to collect information about 
housing status among those the program serves.--Over the past few years 
this subcommittee has encouraged agencies that oversee large 
``mainstream'' (i.e. not homeless-targeted) programs to pay attention 
to the amount of homelessness among the populations they serve. This 
has led to important work by the agencies involved, to examine ways to 
make these programs more conscious of housing stability as an end to be 
achieved. More remains to be done, and the subcommittee should continue 
its diligence in this regard. State agencies administering TANF, and 
recipients of substance abuse and mental health block grants should, at 
a minimum, be required to monitor and report on clients' housing 
status, as the success of their programs depends greatly on housing 
stability.
    Recommendation: Encourage TANF, Foster Care and Substance Abuse and 
Mental Health block grant reporting agencies to include a description 
of preventing and ending homelessness in their annual State plans.--
Many homeless people come from these systems of care. The homeless 
assistance system, while it provides temporary housing services for 
people while they are homeless, can not stop the flow of people 
entering its doors. Rather, the mainstream programs should be aware of 
the integral role they play in preventing and ending homelessness.
    Recommendation: Require recipients of PATH, GBHI, and Healthcare 
for the Homeless program funds to implement and participate in homeless 
management information systems.--Many communities are implementing 
``homeless management information systems'', and some have integrated 
data collection across systems of service (i.e. shelters, criminal 
justice, psychiatric facilities). Recipients of HUD targeted homeless 
funds are required to collect data on homelessness in order to prevent 
duplicate counting of homeless persons, and to analyze their patterns 
of use of assistance. PATH, GBHI and Healthcare for the Homeless 
grantees should also be collecting the data necessary to properly serve 
the homeless population, and therefore more effectively expend limited 
resources.

               CLOSING THE FRONT DOOR IN TO HOMELESSNESS
    We need to hold government-funded systems accountable for, at the 
very least, ensuring that the Americans they serve do not become 
homeless. We must treat homelessness among people with mental illness 
as sign that the mental health system needs improvement; homelessness 
among former foster children as a similar sign for the child protection 
system; homelessness among people with addiction disorders for the 
substance abuse treatment system.
    Recommendation: No tolerance for discharge into homelessness from 
residentially-based programs in HHS.--No system of care should be 
discharging people into homelessness. The homeless assistance system is 
not large, or well-funded, enough to accommodate people being shifted 
out of other systems of care, nor should it be. We need to make 
mainstream systems more accountable in order to close the front door 
into homelessness. Some localities--after recognizing the cost shifting 
occurring between various publicly-funded institutions--have started to 
implement discharge planning as requisite and/or part of performance 
goals. Every locality should be required to follow suit.

       OPENING THE BACK DOOR OUT OF HOMELESSNESS AND INTO HOUSING
    Most people who become homeless find housing on their own in 
relatively short order. We need to speed up that process, and prevent 
disruptions during the period of homelessness. A minority, however, 
remains homeless for a long time. Among this group, disabilities are 
prevalent, including mental illness, substance addiction, and HIV/AIDS. 
Most of the chronically homeless, therefore, are already being served 
by, or are eligible for, services funded by the Department of Health 
and Human Services.
    This subcommittee's work can have a huge impact on efforts to 
rehouse people who are chronically homeless and chronically ill. 
Besides housing, they need treatment and services:
  --Outreach, particularly to long-term homeless people with mental 
        health and substance abuse problems, to ensure that they make 
        use of the services that are available.
  --Short-term treatment in a residential setting aimed at stabilizing 
        these individuals and transitioning them into permanent 
        housing.
  --Treatment and long-term aftercare linked with permanent housing, 
        creating permanent supportive housing, a powerful model that 
        improves the lives of long-term homeless people while saving 
        public money that would otherwise be spent on hospital 
        emergency rooms, emergency detoxification, acute mental health 
        care, shelters and jails.
  --Help with employment, as soon as homeless people are stabilized in 
        a residential setting.
  --Case management to ensure that all services are available.
  --Preparing people with few skills for success, once their housing 
        situation has been stabilized.
  --Assistance, particularly with children, to avoid disruption of 
        family life during times of homelessness.
    These services are especially urgent given the Department of 
Housing and Urban Development's emphasis on funding the housing, not 
the services, associated with homeless assistance programs. 30 percent 
of the funds in the HUD homeless programs is reserved for permanent 
housing. This is a unique opportunity to build infrastructure in 
communities to move the most disabled and chronically homeless people 
out of homelessness. But these same housing projects need services in 
order to be successful.
    Recommendation: Appropriate $100 million for the Grants for the 
Benefit of Homeless Individuals program.--This program, first 
authorized in 1992, has the potential to fill the most gaping hole in 
the system of supports for chronically homeless people--the lack of 
effective substance abuse treatment services. The program would provide 
competitive grants from the Substance Abuse and Mental Health Services 
Administration to local agencies, to provide specific services for 
homeless people with addictive disorders and/or mental illnesses. Last 
year the Committee appropriated $10 million for substance abuse 
treatment for homeless people. An expansion of this program would 
supplement the funds committed for housing by HUD, and greatly increase 
program success.
    Recommendation: Appropriate $75 million for Projects for Assistance 
in Transition from Homelessness.--PATH provides formula grants to each 
state for outreach, case management and treatment for homeless people 
with severe mental illnesses, including those with a dual diagnosis of 
mental illness and drug or alcohol addiction. PATH is ideal for funding 
outreach and case management, allowing people with severe mental 
illness to be brought into the system of care, their treatment 
stabilized, and services to continue once they are permanently housed.
    Recommendation: Provide $172 million for Health Care for the 
Homeless (through a $2 billion appropriation for Consolidated Health 
Centers).--Health Care for the Homeless is part of the Consolidated 
Health Centers line item in the budget for the Health Resource Services 
Administration. The program funds clinics that specialize in the unique 
treatment challenges presented by people who are homeless, often for 
long periods of time. Clinics provide primary care, as well as 
diagnostic, preventive, emergency medical, pharmaceutical, addiction, 
and mental health services. They also conduct intensive outreach and 
case management, linking patients to housing, income and 
transportation. HCH projects are ideal to provide outreach and to 
stabilize the worst-off homeless people.
    Recommendation: Appropriate $120 million for the Runaway and 
Homeless Youth Programs.--The Administration for Children and Families 
within HHS operates coordinated competitive grant programs addressing 
the problems of homeless and runaway youth. Runaway and Homeless Youth 
programs support cost-effective, community-based services that protect 
youth from the harms of life on the streets and either reunify them 
safely with family or find alternative placements. RHYP ends 
homelessness by engaging in outreach, and quickly rehouses as many 
homeless youth as possible. For others, it provides services that will 
prepare them to enter adulthood housed.

                        BUILD THE INFRASTRUCTURE
    In addition to initiatives that focus on homelessness, bringing 
homelessness to an end will require larger systemic reforms to improve 
the incomes of the poorest Americans, to make housing more affordable, 
and to make services widely available to those who need them. This 
subcommittee's efforts in areas such as child care, education and 
employment are critical in this regard.
    Recommendation: Appropriate $1.4 billion for the Low-Income Home 
Energy Assistance Program.--Inability to pay for utilities is second 
only to inability to pay rent as an economic cause of homelessness. 
LIHEAP has for many years proven an effective program with bipartisan 
support, designed to help low-income people afford these charges and 
avoid homelessness. We encourage Congress to provide adequate funding 
for this important program.
                                 ______
                                 

Prepared Statement of the National Alliance for Eye and Vision Research 
                 and the Foundation Fighting Blindness

    The National Alliance for Eye and Vision Research (NAEVR) and the 
Foundation Fighting Blindness are pleased to have the opportunity to 
submit their views to the Subcommittee. NAEVR is a nonprofit advocacy 
coalition of 37 eye research organizations dedicated to expanding our 
national capacity to address eye and vision research opportunities. The 
Foundation Fighting Blindness is a non-profit research foundation 
dedicated to finding treatments and cures for retinal degenerative 
diseases such as retinitis pigmentosa, macular degeneration and Usher 
syndrome. These blinding eye diseases affect over 6 million Americans 
of every age and ethnicity. The Foundation Fighting Blindness supports 
17 interdisciplinary research centers and over 150 targeted grant 
programs around the country.
    We would like to begin by thanking the Subcommittee for your 
continuing commitment to biomedical research supported by the National 
Institutes of Health (NIH) and the National Eye Institute (NEI). 
Congress has been tremendously supportive of pushing the frontiers of 
medical research through support of the NIH. We know that you have many 
difficult decisions with regard to funding priorities in your 
Appropriations Bill and we appreciate the strong support that you have 
provided NIH. With this funding, NEI supported researchers have 
developed several promising experimental treatments with the potential 
to halt vision loss and restore sight for millions of Americans. We are 
now at a turning point. Clinical trials testing a number of new 
treatments are within our grasp. To advance these promising treatments 
to clinical trials requires even greater financial commitment from 
organizations like The Foundation Fighting Blindness and the federal 
government. Currently, only a fraction of the research needed to make 
treatments and cures a reality is funded.

                    FISCAL YEAR 2002 FUNDING REQUEST
    We urge your continued commitment to the congressional campaign to 
double the NIH budget by fiscal year 2003. We strongly support the 
recommendation of the Ad Hoc Group for Biomedical Research Funding 
calling for a $3.4 billion, or 16.5 percent, increase for NIH in fiscal 
year 2002. This request represents the necessary funding level to 
maintain the course towards the NIH doubling effort.
    Within the context of the NIH budget, the National Alliance for Eye 
and Vision Research and the Foundation Fighting Blindness request your 
support for a budget of $620 million for the NEI in fiscal year 2002. 
This funding level represents a $109.4 million, or 21 percent, increase 
above the current year budget. This level of funding for eye and vision 
research is called for as a result of previous disparities, which have 
disadvantaged NEI in the NIH priority setting and funding allocation 
process. Historically, the NEI ranks among the lowest Institutes 
relative to the percentage increase in funding provided by the 
Congress.
    A fiscal year 2002 budget of $620 million also reflects the 
professional judgment of the vision research community as the funding 
necessary to continue ongoing research initiatives and pursue new 
scientific opportunities that have resulted from the nation's 
investment in eye and vision research. We would like to discuss some of 
the exciting research opportunities that will be pursued with this 
level of investment to assure you that an investment in eye and vision 
research will be a wise and cost-effective investment.
    Genetics and Gene Therapy.--Ongoing genetic studies are revealing 
the normal function of genes and how those functions are impaired when 
genes mutate which in turn will provide essential insight into many 
types of vision dysfunction. Gene therapy holds great potential as a 
therapeutic strategy to halt the progression of many forms of blinding 
eye diseases, including macular degeneration, retinitis pigmentosa, and 
glaucoma. Gene therapy has already proven to be successful in 
preventing vision loss and restoring sight in rodent models of 
retinitis pigmentosa.
    Tissue and Cell Transplantation.--NEI-sponsored scientists are 
determining whether transplanting healthy cells into the retina might 
lead to new treatments for people with blinding eye diseases, such as 
diabetic retinopathy, glaucoma and age-related macular degeneration--
the leading cause of blindness in the United States.
    Drug Therapy.--A new therapeutic drug developed may be important in 
treating blindness in human caused by diabetic retinopathy or macular 
degeneration. Vessels that grow abnormally in the eyes can leak fluid 
or blood, causing rapid and severe vision loss. This new drug, PKC 412, 
blocks new abnormal vessel growth and has no apparent adverse effects 
on normal vessels. More tests are needed to determine whether the drug 
is a viable, effective alternative in the treatment of diabetic 
retinopathy.
    Neurodegeneration Research.--Research on neurodegeneration and the 
rescue and regeneration of neural cells is an area of tremendous 
opportunity with application to many neurological diseases and 
conditions, and to cases of traumatic injury, including:
  --Rescue of Photoreceptors in Retinal Degenerative Diseases: A number 
        of research advances now support the development of strategies 
        for preventing or slowing down photoreceptor degeneration in 
        retinal degenerative diseases. There are numerous opportunities 
        for basic research in this area, as well as opportunities for 
        translating these research advances to patient care. A number 
        of approaches show promise, including the use of growth 
        factors, transplantation, and molecular and genetic 
        technologies.
  --Survival of Retinal Ganglion Cells: Retinal ganglion cells (RGCs) 
        can be studied in culture conditions, providing a special 
        opportunity for investigating signaling mechanisms that 
        normally promote survival and how these mechanisms are altered 
        by injury.
    Protection of Nerve Cells in Glaucoma--Researchers have found 
elevated levels of nitric oxide synthase in the optic nerve heads from 
human eyes with glaucoma and animal models of glaucoma. By 
pharmacologically inhibiting the production of nitric oxide in these 
animals, scientists found that axons of the optic nerve were protected 
from neurodegeneration. NEI-supported scientists are also conducting 
research to improve the understanding of the nature and course of 
glaucoma, incorporating studies of co-morbidity, natural history, and 
genetics with special emphasis on Hispanic, Native American, and 
African-American populations.
    Resources for Research on the Visual System.--In order to better 
understand the molecular and genetic basis for diseases of the eye and 
disorders of vision, it is essential that research be conducted to 
identify and sequence genes that are expressed in the visual system. 
There are a number of projects which could be pursued much more 
aggressively with additional NEI funding. This genetic information will 
be collected from ocular tissues that are qualitatively and 
quantitatively representative of the genes expressed in the visual 
system and optimized to detect rare or unique sequences. It is 
anticipated that this catalogue of genes expressed in the visual system 
will be publicly available in an easily accessible and retrievable 
format to facilitate research on eye diseases with the goal of 
improving treatment or preventing their occurrence.
    Control of Angiogenesis.--Diseases that affect the retinal blood 
vessels are among the major causes of visual disability and blindness 
in this country. These include diabetic retinopathy, retinopathy of 
prematurity, neovascular glaucoma, and age-related macular degeneration 
in which the proliferation of abnormal new blood vessels can result in 
the rapid and irreversible loss of vision. Scientists have discovered 
that inhibitors of certain growth factors and enzymes are ideal 
candidates for the treatment of these diseases.
    Bioengineering and Advanced Instrumentation.--NEI is pursuing the 
development of advanced assistive devices for the visually impaired, 
adaptive optics and other imaging techniques to improve non-invasive 
examination of ocular tissues for both research and disease diagnosis, 
instruments to analyze the biomechanics of the eye, and instruments to 
analyze visual performance. NEI is continuing research on the further 
development of laser-targeted dye delivery systems which could 
revolutionize the visualization of blood vessels in the retina and the 
treatment of eye disorders; and optical coherence tomography and 
confocal scanning laser polarimetry for quantitative measurements of 
the retinal nerve fiber layer.
    Clinical Research and Health Disparities.--Research in this area 
will enhance our understanding of glaucoma, diabetic retinopathy, and 
myopia incorporating studies of comorbidity, natural history, and 
genetics with special emphasis on populations at increased risk. For 
example, rates of blindness from glaucoma are six times higher in 
African-Americans than in Caucasians, however age-related macular 
degeneration is rare for African-Americans as compared to Caucasians.
    Low Vision.--A related area of concern is low vision, or vision 
impairment which is not correctable by glasses or contact lenses. As 
many as 12 million Americans suffer from visual impairments which 
affect their ability to read, drive, work, and perform many everyday 
activities we all take for granted. The most common eye diseases which 
cause visual impairment in adults are AMD, cataract, glaucoma, diabetic 
retinopathy, and optic nerve atrophy. Even more serious are the eye 
diseases which cause visual impairment in children. These include 
retinopathy of prematurity, cortical visual impairment, and coloboma. 
Low vision in children often affects their development and results in 
the need for special education, vocational training, and social 
services throughout their lives. The cost of these impairments is more 
than $22 billion each year.
    Under the auspices of the National Eye Health Education Program 
(NEHEP), NEI has developed and is initiating a program directed at low 
vision in order to increase public awareness about visual impairment 
and the impact it has on everyday life. The Low Vision Traveling 
Exhibit will be displayed in shopping malls around the country during 
the next five years and was recently launched in Birmingham. Alabama. 
The program provides information about low vision services and the 
devices which are currently available to assist those with visual 
impairments. This effort is directed at those suffering from visual 
impairments and also to medical professionals, eye care specialists, 
managed care organizations, and family members. NAEVR supports this 
public education partnership and urges the Committee to support it as 
well.
    By the year 2030, the NEI estimates that the elderly population in 
the United States will double and more than 66 million Americans will 
be at risk for blinding eye diseases. If we do not make significant 
investments in vision research, we will have both an economic and 
health care crisis in this country, given our nation's demographics. 
With increased support for the NEI, we can make treatments for many 
vision diseases and disorders happen within our lifetime.
    Conclusion.--Mr. Chairman, the members of the National Alliance for 
Eye and Vision Research and the Foundation Fighting Blindness are 
supportive of an increased research focus on eye and vision disorders 
that improves the quality of life for all Americans by allowing 
individuals to remain independent and lead productive, fulfilling 
lives. We urge the Subcommittee to provide a total NEI budget of $620 
million, or a 21 percent increase in fiscal year 2002. In this new 
millennium we must ensure that we are doing our best to find ways to 
prevent and treat eye and vision disorders, and are providing quality 
eye care services and devices for those who are already suffering from 
visual impairment.
    Thank you for allowing the National Alliance for Eye and Vision 
Research and the Foundation Fighting Blindness to present their views.
                                 ______
                                 

     Prepared Statement of the National Alopecia Areata Foundation

    Chairman Specter and Members of the Senate Appropriations 
Subcommittee on Labor, Health and Human Services, Education and Related 
Agencies, I am Vicki Kalabokes, Chief Executive Officer of the National 
Alopecia Areata Foundation (NAAF) for the past fourteen years. Before I 
begin my testimony, I would first like to express to you my deep 
gratitude for the Congress' on-going bipartisan support of research at 
the National Institutes of Health (NIH), and most particularly for 
their recent support of increased funding, via passage of the 
Children's Public Health Act of 2000, for autoimmune disease research-
research that might not otherwise have been funded.
    As a non-profit voluntary health agency, the National Alopecia 
Areata Foundation is the largest organization in the nation dedicated 
to supporting research and finding a cure or acceptable treatment for 
alopecia areata, a common but mysterious and unpredictable autoimmune 
skin disease resulting in hair loss. The Foundation also provides 
emotional support for those with the disease through a publication 
program, an annual conference, and support groups. The support groups 
provide information and direction to thousands of people with alopecia 
areata. As a lay organization and the nationwide center for those 
affected by alopecia areata, the Foundation is often the first place, 
outside of the medical community, that a person turns to for help and 
information. Frequently people call who are scared, misinformed, and 
afraid. The support groups provide a forum to reach out to others, 
solve common problems and grow.
    The National Alopecia Areata Foundation receives no federal grants 
or subgrants, nor do we receive federal contracts or subcontracts. The 
Foundation is also a member of, and the past headquarters for, the 
Coalition of Patient Advocates for Skin Disease Research (CPA-SDR). The 
Coalition, which operates as a voluntary organization and as such 
receives no public or private money, provides an umbrella to over 25 
``lay'' skin groups. These groups represent millions of people who 
suffer from a wide range of skin diseases. We work together for two 
reasons. First, to provide information to others about why research is 
needed. And secondly, so that we may push for a wide ranging research 
agenda. Recent research has demonstrated that diseases such as alopecia 
areata, lupus, vitiligo and others are the result of a malfunctioning 
immune system. When the key is found to one of our diseases, then it is 
very likely that many of the other diseases represented in the 
Coalition will be cured. By working together we can and will make a 
difference.
    Alopecia areata is an autoimmune skin disease that strikes over 4.5 
million Americans. It results in the loss of hair. For the fortunate 
few it is a quarter-size patch that can be easily covered, for many 
others it is the loss of every hair follicle on their entire body. For 
over half of the people with alopecia areata, it starts between the 
ages of 5 and 9. It strikes members of all ages and ethnic groups; 
males and females are equally affected. The loss of hair has several 
types of impacts. Hair provides significant protection for the body. 
The loss of eyelashes or nasal hairs means that even the simple acts of 
opening and closing one's eyes, or breathing in or out, cannot keep 
dust or foreign particles away. These natural physical acts become a 
very difficult process.
    However, alopecia is not simply a physical problem, it has 
surprisingly serious psychological consequences. For many people, when 
they first discover their hair falling out they are devastated. They 
think that they are the only ones in the world with the disease. 
Frequently when they go to their doctors they discover that even their 
physicians have little idea of what is happening, why it is happening, 
or even if others suffer from it. For some, treatment options stop at 
that point, while for others, they begin the long process of finding 
someone who knows something about the condition.
    Unfortunately in our society the lack of information is not the 
only problem. Frequently people with alopecia arata believe that they 
are vulnerable to the stares and grimaces of those around them. People 
have lost their jobs. A noted news anchor lost his on-air job because 
he was suddenly perceived as being unappealing. This lack of being 
appealing (either real or perceived) causes many people to lose 
confidence in themselves and they begin to withdraw from society.
    Recently, the Foundation received a call from a young woman who was 
denied the ability to take her GRE (Graduate Record Examination) simply 
because she arrived to take the test wearing a head covering. She was 
sternly reprimanded and, without prior notification, was informed that 
absolutely no hats or head coverings were allowed to be worn while 
taking the exam. Her choice was either to remove her scarf and suddenly 
expose her completely bald scalp, or to leave the room immediately and 
forfeit taking the test. And in Washington D.C., a young child was 
deprived of taking a school field trip simply because others feared his 
hair loss was contagious. In the recent past, two parents called about 
their children. These two girls, one 12 and the other 14 at the time, 
were in the process of losing their hair. They stayed inside their 
homes, fearing that going outside would lead to harassment, cruel 
stares, and not-being accepted as normal. Sadly in this image-conscious 
society, this is so often the case. It seems to be hardest on the 
children, who are routinely teased and even shunted into special 
education classes.
    Fortunately, there are people who can help, and in many of our 
support groups people learn how they can help themselves both 
cosmetically and psychologically. They learn that they are not alone 
and that they can do something about their sense of vulnerability and 
isolation. But the real solution will be when we find a cure for 
alopecia areata.
    Over the past fifteen years the Foundation has raised and provided 
nearly $2.5 million for research studies. Our privately funded research 
grants have been studying the mechanisms of hair biology; the genetics 
and functioning of the immune system; the etiology, genetics, clinical 
presentation and therapies of alopecia areata, and the development of 
non-human research studies looking for the cause of and treatments for 
alopecia areata. One of NAAF's recent grant awards resulted in the 
scientific demonstration that alopecia areata is indeed an autoimmune 
disease. In addition, an association exists between alopecia areata and 
numerous other autoimmune diseases such as vitiligo, thyroiditis, 
Addison's Disease, Type I diabetes, and others. Obviously the potential 
benefit from cross-over research is enormous.
    Part of our research program is to continue to work with the 
National Institute of Arthritis and Musculoskeletal and Skin Diseases 
(NIAMS) to create a research agenda. In September 2000, NIAMS announced 
the awarding of a disease registry on alopecia areata, a watershed 
event in the history of alopecia areata research. This award of more 
than $2.7 Million over five years will establish a research registry 
consisting of five sites across the United States. This commitment by 
NIAMS to the advancement of alopecia areata research creates an 
enormous opportunity to further basic, clinical, and translational 
studies in alopecia areata. It will provide an essential resource for 
all investigators interested in studying alopecia areata and will 
stimulate opportunities for additional research support from federal 
and private sources. The monies from this grant will not go to NAAF, 
but directly to the institutions of the investigators overseeing the 
research at these five centers.
    In 1990, 1994, and 1998, NIAMS and NAAF conducted three 
international research workshops on what is known about alopecia 
areata. One of the many results from these joint programs was that 
NIAMS funded a significant study on the structure of the disease. 
Another result was the discovery of animals with alopecia-thus NAAF was 
able to support the first non-human host of the disease. Recent genetic 
studies have revealed unique markers (HLA or histocompatibility 
leukocyte antigens) on the surface of white blood cells in those with 
alopecia areata, strongly suggesting the existence of both 
susceptibility as well as severity genes. These findings are very 
similar to what has been noted in HLA marker groups of those with other 
autoimmune diseases.
    We are now planning the Fourth International Research Workshop on 
Alopecia Areata in 2002 in conjunction with NIAMS. This symposium, as 
with the earlier meetings, will bring researchers, clinicians, and 
patients together from around the world to study what progress has been 
made and how new studies should be structured. The convening authority 
of NIAMS is critical for this sharing of knowledge.
    Working together in this unique private-public partnership is a 
significant step towards finding a cure. We hope to continue this 
relationship with NIAMS providing limited funds for critical studies, 
while we continue to work to support the research effort as well. With 
this partnership we have been able to sharpen the research agenda so 
that we are looking at questions that are building on a wider and more 
informed base of knowledge.
    The National Alopecia Areata Foundation asks that you continue to 
support NIAMS by increasing the overall budget of the National 
Institutes of Health (NIH). The NAAF believes that we must sustain the 
current level of increased commitment to the NIH. The NAAF joins the Ad 
Hoc Group for Medical Research Funding, the NIAMS Coalition, and the 
Coalition of Patient Advocates for Skin Disease Research in asking 
Congress to support a 16.5 percent ($3.4 Billion) increase in the 
budget of the NIH for fiscal year 2002. This increase would allow us to 
get back on track to continue the bipartisan effort to double the NIH 
budget by fiscal year 2003--a sentiment shared by the President, the 
Congress and the American people.
    Funding biomedical research through the NIH is today's investment 
in America's future. The economic burden in the United States for 
musculoskeletal and skin diseases is staggering. The annual cost for 
medical care and lost wages resulting from skin diseases alone is 
estimated to be $22.3 Billion, affecting over 65 million Americans. The 
research for these diseases falls under the umbrella of NIAMS and 
today's technology, like never before, has enabled us to understand, 
treat and ultimately cure many of these devastating, chronic skin 
diseases. Support for the NIH, and therefore NIAMS, is particularly 
instrumental in unlocking the genetic mysteries of autoimmune skin 
diseases such as alopecia areata.
    Again, we are asking for an increase of 16.5 percent or $3.4 
Billion. This increase would allow NIAMS to increase its ability to 
continue to fund more research projects and support more programs that 
will help these 65 million Americans who are impacted by skin diseases. 
We also believe that work done in any of the disease areas represented 
by the Coalition of Patient Advocates for Skin Disease Research, will 
have a profound impact on the lives of the millions of those who suffer 
from one or more of the diseases that NIAMS is charged with 
investigating. We also believe that when a cure is found for any of 
these diseases that there is a good chance that it will help in finding 
a cure for many of the other skin diseases.
    Again, thank you for your past support of medical research funding. 
Thank you so very much for your time and concern.
                                 ______
                                 

Prepared Statement of the National Association of Anorexia Nervosa and 
                          Associated Disorders

    When a young woman starves to death in the midst of plenty; when a 
young woman despairs of hope in trying to cope with a deadly illness at 
age 32 after struggling to survive for 17 years; and when thousands of 
people all across America strive to live, but are victims of insurance 
discrimination, assistance and guidance are desperately needed. All of 
these are recent documented cases of eating disorders. eating disorders 
is the major illness in our nation which receives totally inadequate 
support or funding.
    Eating disorders are rampant in our society and have reached 
epidemic levels. All segments of society, young and old, rich and poor, 
both sexes and all races are impacted by eating disorders. These 
illnesses, which include anorexia nervosa, bulimia and binge eating 
disorders, ravage the lives of more than 8 million people in the United 
States including seven million women and young girls. An estimated 6 
percent of the individuals with severe eating disorders will die; a 
higher mortality rate than for any other mental illness. For those who 
remain ill the constant thoughts of food, weight, body and behaviors 
distort body image and their thought processes to the degree that their 
lives are centered in a kind of hell rather than in living.
    Although eating disorders are so prevalent in society, neither the 
federal government nor most states in the nation have adequate programs 
or services to combat anorexia nervosa, bulimia or binge eating. There 
are few programs to prevent or educate children and youths about eating 
disorders in schools and colleges. Resources that public health 
agencies and schools devote to the prevention of eating disorders are 
negligible in comparison to the resources and attention that they give 
to the prevention of other serious health problems such as drug and 
alcohol abuse. At all levels, federal, state and local, a significant 
commitment must be made to the prevention of these life-destroying 
illnesses.
    Children and adolescents are a critical target of these prevention 
programs as eighty-six percent of individuals with eating disorders 
report the age of onset by 20 years. Of these 43 percent were between 
16-20 years; 33 percent between 11-15 years; 10 percent 10 years and 
younger. Shockingly eating disorders have been found in children as 
young as 5 years of age. Something must be done to save these children.
    We request that a minimum of $10,000,000 be appropriated for the 
development and implementation of comprehensive education and 
prevention programs that promote healthy notions about emotional 
development of self, nutrition, body development and growth through 
educational wellness for all of America's school-aged children and 
early identification of those at risk for eating disorders. The need 
for the request is substantial as ANAD estimates that twelve percent of 
high school students and ten to twenty percent of college students 
suffer from an eating disorder.
    Founded in Illinois in 1976, ANAD is the first national health 
organization of its kind. Dedicated to education, awareness, prevention 
and alleviating the effects of eating disorders, ANAD helps victims and 
their families by providing hotline counseling, support groups, 
referrals to health care professionals, information packets and 
newsletters, along with education/prevention programs. The services are 
offered free of charge and the programs developed are low cost. ANAD 
also undertakes and encourages research, fights insurance 
discrimination and dangerous advertising, and organizes advocacy 
campaigns to protect potential victims of eating disorders. Prevention 
and education about eating disorders are pivotal to ANAD's mission. 
Each year our outreach programs touch the lives of tens of thousands of 
people.
    The causes of eating disorders are varied and have not been 
thoroughly delineated, however issues of identity and self-esteem and 
other psychological problems often underlie eating disorders. Societal 
and cultural influences emphasize thinness and work simultaneously with 
media and advertising campaigns to continually reinforce the message to 
be thin. Unrealistic self-images often result. Individuals feel 
vulnerable and powerless in relationship to the world at large and 
eating disorders provide the illusion of being in charge of one aspect 
of their lives, food.
    Education and prevention programs which teach children the skills 
needed to cope with the emotional complexities of life in a positive 
and life and self affirming way are crucial. ANAD's theme of ``Accept 
Yourself, Accept Others'' encourages people to make healthy choices, 
build self-esteem and lead to healthier living practices. Teaching 
proper nutrition alone is not enough as evidenced by a statement a 
dietitian with an eating disorder once made. ``Through my training, I 
can teach anyone the right diet for any condition . . . as to myself 
none of that applies to me.''
    Prevention programs and support services need not be expensive to 
be effective as proven by ANAD's many successful programs and services. 
Implementation of these programs will ultimately lead to an enormous 
financial savings as it will reduce the number of victims who will need 
expensive and lengthy medical and psychiatric care required to treat 
serious eating disorders. In monetary terms the cost savings will be 
enormous and in human costs, the savings will be immeasurable.
    We also request the Senate to increase current funding by an 
additional $10,000,000 for research into the causes and treatment of 
eating disorders, and research evaluating the effectiveness of 
different prevention, treatment and self-help support strategies. By 
elucidating the causes of eating disorders the specific at-risk 
population can be identified and helped prior to the life-destroying 
effects of the illnesses taking hold on their lives. Deciphering the 
role of genetics in determining who is at-risk for these disorders 
would also be valuable in prevention and treatment of eating disorders. 
This funding is essential to the development of truly effective 
prevention programs and treatment strategies.
    Furthermore, improving patients' access to quality, affordable 
treatment through insurance reform and parity bills is vital. High 
quality treatment is available, however many victims of eating 
disorders are unable to access this treatment due to restrictions 
placed on them by insurance companies. Concurrent medical and 
psychological services are often necessary when treating people 
suffering from eating disorders. Often, because eating disorders are 
treated solely as a mental illness, patients are both denied the 
medical treatment that they require and are subjected to the extremely 
low caps on benefits for treatment of mental illness.
    Action must be taken to change the uphill battle that victims of 
eating disorders face when confronting insurance needs. On the 
legislative front, proposals for insurance reform and health care 
reform must ensure that patients with eating disorders can receive 
reimbursement for both medical and mental health care. Government 
funded mental health centers should be encouraged to develop 
multidisciplinary approaches to the treatment of eating disorders.
    We ask the Senate to help safeguard the rights of people with 
eating disorders through reforms of the health care and insurance 
systems. We also ask the members of this subcommittee and the Senate to 
enact legislation that provides funding aimed at preventing another 
generation of youth from developing eating disorders. This legislation 
would also fund research into the causes of eating disorders which 
would in turn strengthen the effectiveness of eating disorder treatment 
protocols.
    Thank you.
                                 ______
                                 

 Prepared Statement of the National Association of Children's Hospitals

    Mr. Chairman and Members of the Subcommittee, my name is Dr. Robert 
Felter, and I am the Chairman of Pediatrics and Medical Director at Tod 
Children's Hospital in Youngstown, Ohio.
    I submit this testimony on behalf of the National Association of 
Children's Hospitals in Alexandria, VA, in support of the Children's 
Hospitals' Graduate Medical Education (GME) program in the Health 
Resources and Services Administration. On behalf of the nation's nearly 
60 independent children's teaching hospitals, I urge you to continue to 
provide adequate funding for Children's Hospitals' GME so that these 
institutions will have the resources to continue to train and educate 
the nation's pediatric workforce.

                               BACKGROUND
    The National Association of Children's Hospitals or ``N.A.C.H.'' is 
a not-for-profit trade association, representing more than 100 
children's hospitals across the country. Its members include 
independent acute care children's hospitals such as Tod Children's 
Hospital, as well as children's hospitals in Akron, Cincinnati, 
Cleveland, Columbus and Dayton; acute care children's hospitals 
organized within larger medical centers, such as Kosair Children's 
Hospital in Louisville, KY; and children's specialty and rehabilitation 
hospitals, such as the Hospital for Sick Children in Washington, DC.
    N.A.C.H. seeks to serve its member hospitals' ability to fulfill 
their four-fold missions of clinical care, education, research, and 
advocacy devoted to the health and well-being of children. Children's 
hospitals are regional and national centers of excellence for children 
with serious and complex conditions. They are centers of biomedical and 
health services research for children, and they serve as the major 
training grounds for future pediatric researchers, as well as a 
significant number of our children's doctors. These institutions are 
advocates for the public health of children, and they are essential to 
the health care safety net for children of low-income families.
    While they account for less than 1 percent of all hospitals, the 
independent children's hospitals train nearly 30 percent of all 
pediatricians and nearly half of all pediatric specialists, and they 
are the major producers of future pediatric researchers.
    Independent children's teaching hospitals are experiencing very 
serious financial challenges that affect their ability to sustain their 
missions. In addition to the challenges of covering the costs of their 
academic programs, they include challenges in covering the higher costs 
of sicker patients in a price competitive marketplace, meeting the 
costs of uncovered services such as child protection services and 
poison control centers, and assuming the costs of devoting a large 
portion of their patient care to children from low-income families.
    On average, independent acute care children's hospitals devote 
nearly half of their patient care to children who are assisted by 
Medicaid or are uninsured. They devote more than 75 percent of their 
care for children with one or more chronic or congenital conditions. 
For children with rare and complex conditions, independent children's 
hospitals often provide the majority of care in their region or even 
nationwide.
    Left unresolved, children's hospitals' financial challenges will 
seriously affect not only their academic programs of education and 
research but also their clinical care missions as safety net providers 
and centers of excellence. In fact, their roles as safety net providers 
and centers of excellence are made possible in part by their having 
strong academic programs.

                            ISSUE OF CONCERN
    The issue of concern to NACH, which brings me here today, is that 
independent children's hospitals have faced serious financial burdens 
and competitive disadvantages in recent years, because they receive 
virtually no GME support through Medicare--the only source of 
significant and stable GME support available to teaching hospitals. 
Because children's hospitals do not care for the elderly, they have few 
(if any) Medicare patients and thus receive less than 0.5 percent or 1/
200th of the federal Medicare GME support provided to other teaching 
hospitals.
    In recent years, while the Medicare program was spending about $7 
billion annually on GME programs at over 1,000 teaching hospitals 
across the nation, children's hospitals received less than $2 million 
in federal support for their continuing education programs. The Lewin 
Group, an independent health policy analysis firm, calculated in 1998 
that independent children's teaching hospitals should receive 
approximately $285 million in federal GME support for nearly 60 
institutions to achieve parity with the financial compensation provided 
through Medicare for GME support to other teaching hospitals.
    In the absence of any movement towards broader GME financing 
reform, Congress enacted the Children's Hospitals' GME discretionary 
grant program to address the existing inequity and ensure that these 
institutions could receive equitable federal support to sustain their 
teaching programs. The pediatric community, including the American 
Academy of Pediatrics, Association of Medical School Pediatric 
Department Chairs, and others, recognize the critical importance of the 
GME programs of the independent children's teaching hospitals, not only 
to the future of the individuals hospitals and their essential services 
but also to the future of the nation's pediatric workforce and 
pediatric research overall.
    In fact, after three years of work assessing the needs of pediatric 
education in the next decades, the leadership of the pediatric 
education community last year issued 34 recommendations, including a 
recommendation for equitable GME support for independent children's 
teaching hospitals. The Future of Pediatric II (FOPE II) Task Force 
said: ``Pediatric residents and fellows at freestanding children's 
hospitals should receive the same level of federal support as those 
trained elsewhere.''

                         CONGRESSIONAL RESPONSE
    The 106th Congress recognized the pressing need to provide 
independent children's teaching hospitals with the same federal support 
for their teaching programs that they provide to all other teaching 
hospitals through Medicare by taking action on two fronts:
    First, Congress has both authorized and reauthorized the program. 
In November 1999, with broad bipartisan support, Congress authorized 
$285 million for the Children's Hospitals' GME Program in fiscal year 
2001 as part of the ``Healthcare Research and Quality Act of 1999.'' In 
September 2000, Congress reauthorized the program through fiscal year 
2005 at ``such sums as necessary'' as part of the ``Children's Health 
Act of 2000.'' Congress passed both the authorization and 
reauthorization bills by unanimous consent.
    Second, and more importantly, Congress appropriated $235 million 
for Children's Hospitals' GME in the Fiscal 2001 Labor/HHS/Education 
Appropriations bill as a specific line-item within the Health Resources 
and Services Administration (HRSA) account. Last year's funding was a 
significant increase over the fiscal year 2000 funding of $40 million--
an initial funding level provided for the program before it was 
authorized.
    The $40 million appropriated in Fiscal 2000 was distributed through 
HRSA to 57 children's hospitals according to a formula based on the 
number and type of full-time equivalent (FTE) residents trained, as 
well as the complexity of care and intensity of teaching the hospitals 
provide. HRSA will soon be finalizing the process of distributing $235 
million in Fiscal 2001 funding to children's hospitals to cover a 
higher percentage of the costs associated with their GME programs.

                   IMPACT ON TOD CHILDREN'S HOSPITAL
    Tod Children's Hospital, which is part of Forum Health, is a 97 
bed-facility that serves as a regional referral center, delivering care 
to children in northeastern Ohio and western Pennsylvania, with more 
than 30 subspecialties and a number of specialized programs, such as a 
children's emergency center and a pediatric inpatient cancer unit. We 
serve all children, devoting more than 60 percent of our care to 
children who are assisted by Medicaid or uninsured.
    Tod Children's Hospital also is a teaching hospital, training 27 
resident FTEs, including 24 in pediatrics and three in medicine and 
pediatrics. Despite the small size of our training program, it has an 
enormous impact on the availability and quality of health care for 
children in the Youngstown area. The majority of our residents go on to 
practice in Ohio, and in the last six years, more than 40 percent went 
on to practice in Youngstown. Today, 50 percent of pediatricians 
practicing in Youngstown were trained at our hospital.
    Youngstown is an economically depressed community, which makes it 
hard to attract strong, clinical talent to come to and stay in our 
area. Without our training program, the pediatric workforce of 
Youngstown would be seriously affected. And without our training 
program, our ability to maintain a children's hospital and its 
substantial contribution to the quality of care for all of the children 
of our region would also be seriously challenged.
    Clinical care and residency training go hand in hand. A strong 
training program contributes to a strong clinical program, and a strong 
clinical program contributes to a strong training program. Our hospital 
spends more than $2 million to cover the direct costs of our GME 
program, which represents a major expense for our institution. As a 
consequence, every year our hospital faces difficult financial 
tradeoffs as we struggle to balance our commitments to training and 
clinical care. Even with the GME funding our hospital received as a 
result of the fiscal year 2000 appropriation, Tod Children's could not 
sustain is residency training program without cutting our family-based 
HIV clinic serving infected children and their mothers and scaling back 
our child-life program. These kinds of financial decisions are not easy 
to make. However, with equitable GME support from the federal 
government--comparable to what other teaching hospitals receive--our 
hospitals will be able to cover the added costs that result from their 
teaching missions while being able to provide other important programs 
and services that affect the health and well being of the children of 
our region.
    The significant increase in funding we project to receive from the 
fiscal year 2001 appropriation is absolutely vital to our residency 
training program, our hospital, and our community. Without it, the 
future of our training program will be in jeopardy, and that in turn 
will put in jeopardy the long-term future of our children's hospital 
and the health of the children of our community.
    With such a major impact on a small institution like Tod Children's 
and our community, you can imagine the magnitude of the impact that 
Children's Hospitals' GME funding will have on much larger institutions 
and their regions--Children's Hospital Boston with 238 resident FTEs, 
Children's Hospital of Michigan with 160 resident FTEs in Detroit, or 
Children's Hospital Medical Center in Cincinnati with 153 resident 
FTEs.

                            FISCAL 2002 NEED
    I am here to impress upon you that adequate funding for Children's 
Hospitals' GME is an ongoing need. Our institutions continue to train 
new pediatric residents and researchers every year. While we have 
appreciated very much the Congressional support--particularly with the 
funding provided in Fiscal 2001--we have received, the teaching mission 
carried out by children's hospitals will not end this year. Now, we 
seek to achieve full parity with other teaching hospitals for federal 
GME support, which will require the full authorization of $285 million 
for Fiscal 2002.
    In order to make children's health a top priority for our country, 
Congress should appropriate the fully authorized funding level of $285 
million for Children's Hospitals' GME in Fiscal 2002. These funds will 
ensure that independent children's hospitals receive the resources 
necessary to continue to train and educate the nation's pediatric 
workforce and sustain their core missions, including clinical care and 
research.
    Support for a strong investment in GME at independent children's 
teaching hospitals is consistent with the repeated concern the 
Subcommittee has expressed for the health and well being of our 
nation's children--through education, health, and social welfare 
programs. It also is consistent with the Subcommittee's repeated 
emphasis on the importance of enhanced investment in the National 
Institutes of Health (NIH) overall, and in NIH support for pediatric 
research in particular, for which we are very grateful.
    Finally, support for this program is a strong investment in cost 
effective health care. Please remember that prevention is the core of 
pediatrics. We train every pediatrician to specialize first in primary 
and preventive health care, which maximizes children's long-term health 
and reduces the long-term cost of their care, not only as children but 
also as adults. As a result, it's an investment in the future health of 
everyone. The children we care for today may be only 25 percent of our 
population; but tomorrow, they will be 100 percent of all adults.
                                 ______
                                 

    Prepared Statement of the National Association of Developmental 
                         Disabilities Councils

    The National Association of Developmental Disabilities Councils is 
a national organization representing Developmental Disabilities 
Councils in thirty-nine states and territories. Combined with the 
Councils represented by the Consortium of Developmental Disabilities 
Councils, there are a total of 55 Councils--one in each State, the 
District of Columbia, and the territories of American Samoa, the 
Commonwealth of the Northern Marianas Islands, Guam and Puerto Rico. 
NADDC provides leadership to member Councils to support their work for 
change on behalf of individuals with developmental disabilities and 
their families. On the national level we support policies that enhance 
the quality of life for all people with developmental disabilities--
individuals who experience a severe, chronic disability which occurs 
before the age of 22 and results in substantial functional limitation 
in three or more areas of major life activity (self-care; receptive and 
expressive language; learning; mobility; self-direction; capacity for 
independent living; and economic self-sufficiency).
    Council activities are authorized through the Developmental 
Disabilities Assistance and Bill of Rights Act (Public Law 106-402). 
The ``DD Act'' was originally enacted in 1963 as the Mental Retardation 
Facilities and Construction Act in response to the need for 
alternatives to large institutions. It has been expanded to meet the 
growing needs for community supports with each subsequent 
reauthorization. In addition to the State Councils on Developmental 
Disabilities (Part B of the Act), the Act also provides authority for 
funding in each State and territory for a statewide Protection and 
Advocacy System and a University Center for Excellence in Developmental 
Disabilities Education, Research and Service (formerly the University 
Affiliated Programs).
    The Governor in each State and territory appoints members of State 
Councils. Sixty percent of the Council membership must be people with 
significant disabilities and their family members. The rest are state 
agency administrators, private providers, and members of the community. 
Together this group develops and implements a statewide plan which lays 
out activities to enhance the lives of people with developmental 
disabilities through a variety of systemic change, capacity building 
and advocacy activities. The Councils' plans promote a comprehensive 
system of services and supports designed to increase the independence, 
productivity, inclusion, integration and self-determination of 
individuals with developmental disabilities. Federal funding for these 
activities is administered by an agency also designated by the 
Governor.
    Flexible systems based on individual empowerment and self-
determination that require partnerships between the professional and 
the consumers have proven to be the key ingredients for the successful 
promotion of the goals expressed in the DD Act. Unfortunately, systems 
change is difficult and state systems for developmental disabilities 
were designed years ago to ``treat'' rather than partner with the 
individual receiving the service. The Councils have a key role to play 
in bringing changes about in ways that can positively impact 
individuals with developmental disabilities.
    To assist States, the Act lists a number of ``areas of emphasis'' 
for Council activities. Councils can choose to work on issues related 
to quality assurance, childcare, housing, transportation, recreation, 
education, employment, health, and formal and informal community 
supports. They are required to strengthen, support and expand 
opportunities for individuals with developmental disabilities to 
receive and provide leadership training and to work in coalitions. They 
are also free to establish priorities outside of those prescribed in 
the Act to meet the unique needs of individuals with developmental 
disabilities in their own State or territory.
    While Councils are not service providers, one of the ways that we 
are able to advance change is through direct support of best practice 
activities. One of the more recognized activities of the State Councils 
are grants to public and private agencies that support system change 
projects, demonstrating at the local level that there is a better way 
to provide services to individuals with disabilities. Because there are 
too few quality community services for people with developmental 
disabilities, the Councils have taken on the responsibility of 
assisting grantees seek new State, local, and private sector funds to 
support these activities. Preliminary data for fiscal year 2000 
indicates that in this way Councils helped leverage far more in state, 
local and private funds for services and supports than the taxpayer 
invested in the four DD programs combined at the Federal level.
    DD Council work goes far beyond service system improvement into new 
areas of community development that improve the lives of everyone--
including people who do not have disabilities. Realizing that people 
are best protected and included in their communities if their lives are 
intertwined with families, neighbors, friends and co-workers, DD 
Councils also work on community and economic development so that all 
citizens share in the resources communities have to offer. It is clear 
that if we want people with disabilities to have competitive jobs and 
life-long careers, we must invest in the economic vitality of our 
communities: poverty-stricken communities result in poverty for people 
with disabilities. If we want people with disabilities to live safe and 
healthy lives, we must invest in affordable housing initiatives for 
them and their neighbors: slums and homelessness are bad for everyone. 
If we want children with disabilities to attend school with their non-
disabled peers and become productive, civic-minded adults, there must 
be quality education for all children. If we want people with 
disabilities to be included in our communities, we must have 
communities that appreciate and believe in the equality of all people.
    For all of these reasons, Councils are viewed as invaluable change 
agents in the States and have made a significant difference in the 
lives of individuals and their families across the nation. Best 
practices promoted by Councils have resulted in, among other 
accomplishments, strong early childhood programs; improvements in 
school services; access to real, inclusive jobs through supported 
employment; small business ownership; training and empowerment of self-
advocates; means to address the crisis in the shortage of qualified 
direct care professionals; home ownership; accessible transportation 
systems; appropriate community activities for individuals with 
developmental disabilities as they become older; and tremendously 
important supports for families so they can remain healthy and intact. 
In keeping with changing times, Councils across the country are now 
called on to address burgeoning community waiting lists; to plan for 
the huge demands that will be placed on services by the aging baby boom 
generation--including the loss of a large percentage of the service 
provider population as they reach retirement; and to face the 
challenges of abuse and neglect in a wide range of settings.
    A sampling of activities across the country should be helpful in 
understanding the importance of the Developmental Disabilities Councils 
in each State. To give the big picture would take volumes, but the 
following provides a glimpse into some of the State Councils list of 
achievements.
  --The DD Council in Ohio developed a self-determination initiative 
        that has proven so successful that it has been adopted by the 
        State Department and has spread to 30 out of the 88 counties. 
        This effort continues to grow through the State, resulting in 
        more control for individuals with developmental disabilities 
        over their own lives.
  --Through a grant with Very Special Arts of Idaho (VSAI) the Idaho 
        Council is assessing the accessibility of arts, leisure, and 
        recreational facilities and programs across the state.
  --In Iowa the DD Council working in coalition with other like-valued 
        groups was successful securing all of the state's Tobacco 
        Settlement Fund ($55 million) for purposes related to health 
        care and the needs of children, adults and families, with a 
        strong focus on special needs.
  --One hundred and sixty individuals with developmental disabilities 
        in Mississippi became employed in their communities as a result 
        of the DD Council's activities in that state. One hundred and 
        fifty eight businesses employment people with developmental 
        disabilities, and 630 people were trained in the Person 
        Centered Planning process.
  --Housing shortage issues are tackled head-on by a number of 
        Councils. One initiative in New York uses a low income housing 
        tax credit designed to encourage private sector investment in 
        the production of low-income housing. The program allows the 
        owner/developer of a qualified property a dollar-for-dollar 
        credit claimed over an extended period of time to equal an 
        established share of the property's construction costs.
  --The Maryland Council has led a statewide, cross-disability 
        initiative to expand homeownership opportunities to low-income 
        people with significant disabilities. This work has resulted in 
        the state's commitment of $8.2 million in mortgage funds. The 
        program received a HUD ``Best Practice'' award in 1999.
  --In North Dakota public transit services, when available, are not 
        fully accessible. Thanks to start-up funding provided by the DD 
        Council, the cities of Mandan and Bismarck have been able to 
        address transportation needs for people with disabilities in 
        these cities by combining formerly fragmented and autonomous 
        transit programs into a consolidated, accessible community-wide 
        public transportation system. Without access to this system 
        riders with disabilities would not be able to realize 
        employment ambitions, shop for necessities, achieve 
        independence or experience general community involvement and 
        participation.
  --The South Carolina DD Council is active in developing and 
        monitoring a universal newborn hearing screening program 
        required on all newborns in the State. The program is designed 
        to detect hearing impairments in infants. With early detection 
        and intervention children are more likely to experience normal 
        language development.
  --The Community Self-Employment Program in Arkansas resulted in a 
        number of new entrepreneurs in the state--business owners who 
        experience a disability. The project was designed to provide 
        loans to assist and support individuals in ownership and 
        operation of their own business. Businesses included include 
        Web-site designing, a concession business, a recycle shop for 
        computers and business machines, legal abstracting, Web 
        marketing, and a pizza store.
  --The DD Council has a long history of leading systems change efforts 
        in Hawaii. Among its accomplishments are the closure of Waimano 
        Training School and Hospital, the state institution for people 
        with mental retardation, and the successful integration of 
        those residents into the community. The Council also played a 
        key role in the development of state legislation that created 
        the nation's first statute codifying self-determination for 
        persons with developmental disabilities (Act 133, 1998).
  --With an initial start-up grant in 1996 of $124,000.00 for the Home 
        of Your Own Program, the Nevada DD Council has leveraged more 
        than $3 million in non-HOYO funding to provide first time home 
        ownership to 51 Nevadans with disabilities. Through a 
        partnership with Accessible Space, Inc. and the Office of 
        Community Based Services, the Council with initial funding of 
        $250,000.00 has leveraged over $24 million in HUD funding to 
        build 4 affordable, accessible assisted living apartment 
        buildings for Nevadans with severe disabilities and has HUD 
        funding approved to build 2 more such apartments.
  --The New Hampshire Council has done significant work in voter 
        access, giving rise to national attention to voter access 
        issues through work with state and national election officials. 
        The Council published and widely disseminated a voter manual. 
        The Council in New Hampshire has also taken the lead in work 
        incentives activities in their state. They have facilitated a 
        statewide effort to coordinate the integration of three federal 
        grants to implement the Workforce Investment Act and other 
        employment initiatives with the Governor's Task Force on 
        Employment and Economic Opportunities.
    Every Council has to set priorities identified at the State level 
and hard choices have to be made. Unfortunately, there are many more 
critically needed infrastructure activities than DD Councils alone can 
generate funds to address. In our public testimony last year we listed 
some of these needs. Regrettably, they have not changed.
  --Direct Care Staff--The need for additional direct care staff 
        continues to be at a crisis level in most of our communities. 
        We cannot train front line personnel rapidly enough. We know 
        that properly trained staff on the day-to-day firing line can 
        spot abuse and neglect and take immediate action to stop such 
        incidents and prevent any repetition. High turnover rates and 
        poor compensation are significant challenges to our services 
        system. If these issues are not addressed, we will see 
        individuals with developmental disabilities lose their newfound 
        independence.
  --Inclusive Child Care--There is a well-documented shortage of 
        quality childcare for working parents. This is an even more 
        serious problem for parents of children with disabilities who 
        do not want their children segregated from their non-disabled 
        peers--for parents who want their children in childcare 
        settings that welcome all children.
  --Transportation System Redesign--One of the major blockades for 
        individuals with disabilities who wish to work but who require 
        special transportation accommodations is the lack of such 
        accommodations. The lack of affordable, accessible 
        transportation is often identified as the single most constant 
        problem faced by individuals with developmental disabilities in 
        achieving employment and community life.
    These are examples of some of the issues that remain largely 
untouched by Council advocacy due to the lack of funding. This list 
will grow as the Councils take on the new activities Congress included 
for the DD Councils in the Act last year. The law now includes a role 
for the Councils in addressing issues of: (1) aging parents of adult 
sons and daughters with developmental disabilities; (2) waiting lists; 
(3) abuse and neglect; (4) inappropriate restraints; (5) development of 
person-centered quality assurance systems; and (6) increased emphasis 
on self-advocacy.
    There are high expectations of Councils in every State, and DD 
Councils have demonstrated that they get results and are a bargain for 
the federal tax dollar. DD Councils are taking a significant next step 
to build communities that work for everyone, including people with 
developmental disabilities, in addition to their work to improve the 
service system. Because they do not provide services and can act 
independently of the service system, the voice of the DD Council has 
proven to be critical in each State and territory to the lives of 
people with developmental disabilities and their families.
    Unfortunately, the current reach of the State Councils is far 
smaller than it could be, given adequate funding. The two tables 
appended to this statement reflect a seven-year funding history for the 
DD Councils. It is notable that funding was cut by 8 percent in fiscal 
year 1995 and has yet to return to the fiscal year 1995 level. Councils 
are not able to keep pace with the growing needs in every State. With 
the fiscal year 2001 Federal investment in Council activities of $67.8 
million, the smallest 14 states receive $420,000 and the average 
allocation is less than $1 million, far less than needed keep pace with 
the cost of living, let alone to fulfill the promises of the DD Act, 
including the requirements added in the recent reauthorization. The 
lack of adequate funding has made it difficult to advance the 
independence and inclusion of individuals with significant disabilities 
in every State.
    To remedy this shortfall, the National Association of Developmental 
Disabilities Councils (NADDC) urgently recommends an appropriation of 
$85 million for DD Councils. This represents a restoration of the 
fiscal year 1995 cut, CBO cost of living percentage increases for the 
past 5 years, and an additional $3 million for new requirements. Our 
sister programs, Protection and Advocacy Systems and University 
Affiliated Programs have also languished since 1995 with insufficient 
funding and NADDC recommends $35 million for P&As and $28.5 for UAPs. 
For Projects of National Significance, the only national research and 
development program targeted especially to individuals with 
developmental disabilities, including the Family Support Program, we 
recommend $16 million. This totals $164.5 million the DD Act programs 
need to keep up the momentum and to launch the necessary changes in the 
new century.
                                 ______
                                 

          Prepared Statement of the National AHEC Organization

    Mr. Chairman, and members of the subcommittee, I am pleased to 
present testimony on behalf of the National AHEC Organization.
    I am Project Director at the Northeastern Ohio AHEC, located in 
Rootstown, and a member of the National AHEC organization. We are a 
professional organization representing the Area Health Education 
Centers (AHECs) and Health Education and Training Centers (HETCs). 
Together, we seek to further the AHEC mission; to enhance access to 
quality health care, particularly primary care and preventative care, 
by improving the supply and distribution of health care professionals 
through community and academic/educational partnerships. Health 
Education and Training Centers (HETCs) have a similar mission to AHECs, 
but are unique in their focus on public health matters associated with 
areas found along our nation's border with Mexico, the State of 
Florida, and other extremely underserved areas within our country.

                             WHAT AHECS DO
    Since our inception almost thirty years ago, AHECs, in partnership 
with local/state/federal initiatives and educational institutions, have 
provided clinical training opportunities to health professions and 
nursing students in underserved communities and have extended the 
resources of academic health centers to these locations. Currently, 
there are 40 AHEC programs and more than 160 AHEC centers.
    AHEC programs concentrate on four areas:
  --Developing health care recruitment/preparation programs in 
        underserved areas for underrepresented and disadvantaged 
        students. These efforts provide hands on science and math 
        instruction and exposure to local health professionals. Not 
        only is this an educational opportunity, but an encouragement 
        for young people to enter health professions careers.
  --Oversee the community based training of primary care health 
        professions students and residents in health professions 
        shortage areas. AHECs are pioneers in the effort to train 
        residents in a community based setting. The contribution of 
        this type of training is immense to the healthcare workforce. 
        It allows for individuals to complete their education in the 
        locale they will serve. In 1998, AHECs provided community based 
        training to approximately 15,000 health professions students in 
        underserved areas.
  --Provide information, support, and technical assistance to health 
        care professionals to ensure an opportunity for continuing 
        education. In 1999, AHECs provided Continuing Education 
        Programs for 174,425 participants.
  --Promote healthy lifestyles in a manner which is appropriate to 
        specific community and population needs.
    AHEC's play a vital role in integrating community needs, 
educational resources, and health professionals. An example of this 
effort is the Canton Area Regional Health Education Network, an AHEC 
Center, which operates a primary care project in partnership with the 
Kent State College of Nursing. Primary health care nurse practitioners, 
medical students, and allied health students provide a broad range of 
care; screening for disease, education, and follow-up care, to migrant 
workers. Initially, this was limited to adults, but has since expanded 
to include immunizations and primary care for children, as well as 
women's health services.

       THE ROLE OF HEALTH EDUCATION AND TRAINING CENTERS (HETCS)
    The HETC programs are a subset of the National AHEC program, 
created with the purpose of improving the number and placement of 
health professionals along the border between the United States and 
Mexico, the State of Florida, and other areas of extraordinary need. 
Like AHECs, the cooperation between faculty, students, and communities 
serve as the base for HETC development.
    In the state of Kentucky, in one year, over 6,000 disadvantaged 
students were involved in programs focusing on healthy lifestyles, 
violence prevention, and dental health. This was achieved through 
partnerships among local schools, community centers, Boy's and Girl's 
Clubs, and HETCs.

               JUSTIFICATION FOR FUNDING RECOMMENDATIONS
    Mr. Chairman, I respectfully ask the Subcommittee to support our 
recommendations of increasing the funding for the health professions 
and nursing education programs under Title VII and Title VIII of the 
Public Health Service Act to at least $440 million. This is consistent 
with the funding level recommended by the Health Professions/Nursing 
Education Coalition.
    A 20 percent increase for the AHEC and HETC programs is needed for 
fiscal year 2002. Last year, no new AHEC programs were started. To 
enable AHEC programs to expand service to states that currently have no 
program and strive towards completing a 50 state network, additional 
funding is crucial. AHEC programs have a multitude of responsibilities, 
from recruitment of minority and disadvantaged students into health 
professions careers, to enhancing the quality of the health care 
workforce through telecommunications training, telemedicine, distance 
learning, and providing health career experience to K-16 students.
    HETCs provide training experiences for health professions students 
and local providers at sites of severe underservice to improve access 
to health care, diversity and cultural competence of the healthcare 
workforce. One out of five U.S. citizens live in a border HETC county. 
Within these areas, only 62 primary care physicians per 100,000 reside 
in border counties compared to 105 per 100,000 nationally. To help 
alleviate this situation, each HETC project supports at least one 
training and education program for physicians and one for nurses so 
that a portion of the clinical training for students is in the service 
area.
    Mr. Chairman, thank you for the opportunity to present the views of 
the National AHEC Organization. We look forward to working with you and 
your staff. I would be happy to answer any questions that you or your 
colleagues may have.
                                 ______
                                 

     Prepared Statement of the National Center for Victims of Crime

    The National Center for Victims of Crime is the nation's leading 
nonprofit advocacy and resource organization serving victims of all 
crime. Since its founding in 1985, the National Center has worked with 
nearly 10,000 public and private non-profit organizations and agencies 
across the country, and has provided information, support, and 
technical assistance to hundreds of thousands of victims, victim 
service providers, allied professionals, and advocates.
    One of the highlights of the Violence Against Women Act of 2000 
(VAWA II) was the increased resources to support rape prevention and 
education. This money funds the rape crisis centers nationwide that 
provide support, counseling, community outreach, and education 
activities that are the nation's best hope for making inroads against 
this terrible crime.
    While advocates cheered to see the increase as part of VAWA II, the 
President's fiscal year 2002 Budget proposes retaining the previous 
funding levels. Rather than the $80 million authorized, the 
Administration proposes funding this important program at $45 million. 
We call on this Subcommittee to fully fund this important program.

                    THE IMPORTANCE OF RAPE EDUCATION
    The incidence of sexual assault in this country remains high; 
despite an overall drop in crime rates, there was a 20 percent increase 
in rapes, and a 33.3 percent increase in sexual assaults in 1999.\1\ 
Rape prevention and education efforts are key to ending sexual 
violence, by changing attitudes about rape and ending the isolation of 
victims.
---------------------------------------------------------------------------
    \1\ Rennison, Callie M. (August 2000). Criminal Victimization 1999: 
Changes 1998-99 with Trends 1993-99. Washington, D.C.: Bureau of 
Justice Statistics, U.S. Department of Justice, Table 1.
---------------------------------------------------------------------------
    In the National Center's 1992 landmark study, ``Rape in America: A 
Report to the Nation,'' sexual assault victims were asked about the 
extent to which they were concerned about issues specific to their 
personal rape experiences. Rape victims reported that they were 
concerned about:
  --her family knowing about the assault (71 percent);
  --people outside her family knowing she had been sexually assaulted 
        (68 percent); and
  --people thinking it was her fault or that she was responsible (69 
        percent).\2\
---------------------------------------------------------------------------
    \2\ National Victim Center & Crime Victims Research and Treatment 
Center. (1992). Rape in America: A Report to the Nation. Arlington, VA: 
National Victim Center. P. 4.
---------------------------------------------------------------------------
    This combination of concerns may explain why so few rape victims 
report their assaults. The Rape Prevention and Education Grants 
represent the best opportunity for change.
    Rape education changes attitudes; it is a direct response to the 
problem of victim blaming which allows sexual violence to fester. 
Victims blame themselves: ``If only I hadn't . . .'' Their friends and 
family often judge them: ``Why didn't she . . .?'' It is only by 
education that victims will stop blaming themselves and society will 
stop blaming the victims. It is only through education that blame can 
be shifted back where it belongs: to the offender.
    When that happens, victims will be more willing to reach out to the 
services they need. Indeed, rape crisis centers around the country 
report that following public awareness and education activities, more 
victims come forward to seek help. This serves as a concrete indication 
of the importance of such education and outreach efforts.

            THE CONNECTION BETWEEN EDUCATION AND PREVENTION
    Education about rape can prevent rape. As young people become aware 
of the frequency of acquaintance rape, they broaden their efforts to 
protect themselves from merely locking doors against strangers to 
taking precautions with those they know. Education is also key to 
reducing drug-facilitated sexual assault. As detection and prosecution 
remains difficult, the best means to reduce such crimes is prevention 
through education. Through education and public awareness efforts, 
young people can learn to reduce their risk, and understand the warning 
signs that they or a friend may have ingested Rohypnol, GHB, or other 
drugs commonly used to facilitate sexual assault.
    As noted above, education also fosters requests for assistance. 
This, in turn, leads to prevention of future assaults by reducing 
repeat victimization. In 1998, the Canada Solicitor General found that 
sexual assault victims are thirty-five times more likely to be re-
assaulted than individuals who were never assaulted.\3\ As education 
prompts victims to seek services, they will get the support to reduce 
their likelihood of revictimization. As one rape crisis director 
recently stated, ``We have the opportunity in rape crisis agencies to 
explain to [victims] their risks and offer support to help them 
decrease their vulnerability in a blameless manner.'' Thus, there is a 
direct connection between rape education and rape prevention.
---------------------------------------------------------------------------
    \3\ Canada Solicitor Genera. (1998). Multiple victimization 
(Canadian Urban Victimization Survey Bulletin No. 10). Ottawa: Ministry 
of the Solicitor General.
---------------------------------------------------------------------------

                          PURPOSES OF FUNDING
    As newly expanded under the Violence Against Women Act of 2000,\4\ 
rape prevention and education money can be used for:
---------------------------------------------------------------------------
    \4\ Part of the Victims of Trafficking and Violence Protection Act 
of 2000 (H.R. 3244).
---------------------------------------------------------------------------
  --educational seminars;
  --operation of hotlines;
  --training programs for professionals;
  --preparation of informational material;
  --education and training programs for students and campus personnel 
        designed to reduce the incidence of sexual assault at colleges 
        and universities;
  --education and training to increase awareness about drug-facilitated 
        sexual assault; and
  --other efforts to increase awareness about, or to help prevent, 
        sexual assault, including efforts to increase awareness in 
        underserved communities and awareness among individuals with 
        disabilities.
    These are important efforts, that deserve to be fully funded. The 
lack of such full funding directly impacts the ability of state and 
local organizations to reduce rape in America.
    From its conversations with sexual assault coalitions nationwide, 
the National Center has learned of the dire need that exists for these 
prevention and education funds. As examples:
  --Approximately one out of six sexual assault programs in the 
        National Center's referral database does not have a 24-hour 
        toll-free hotline. In some states, there is no hotline, and for 
        centers that cover large geographic areas, calling the center 
        may cost the victim and be reflected on the victim's phone 
        bill, violating her confidentiality.
  --In Alabama, less than half of the 15 rape crisis centers have a 
        full-time outreach staff member. None of the programs have 
        translated materials, and only two have a bilingual staff 
        member.
  --Arkansas has no statewide sexual assault hotline, and no translated 
        materials or translators in sexual assault programs.
  --In California, of 92 rape crisis centers, only 25 have translated 
        materials.
  --Of Georgia's 21 rape crisis centers, only four have translated 
        materials and 4 have a bilingual staff member. Furthermore, 
        while the state has a law mandating sexual assault education in 
        the schools, 50 counties have no rape crisis program to provide 
        this education, and the programs that do exist consistently 
        turn away requests for presentations due to lack of staff.
  --Mississippi has nine rape crisis centers, but because of a lack of 
        funds, two-thirds have no community outreach program. The state 
        coalition has received requests to provide training regarding 
        drug-facilitated sexual assault, but has not had the money to 
        develop such training.
  --Ohio estimates that of its 40 rape crisis centers, only four have 
        translated materials, and only six have a bi-lingual staff 
        member.
  --The Pennsylvania Coalition Against Rape reports that 25 counties do 
        not have access to a full-time rape crisis education staff 
        member. Moreover, in the last year, rape crisis centers have 
        turned down over 7,000 requests for programs/presentations, 
        largely due to a lack of staff and volunteers. As a result 
        between 129,000 and 206,000 persons were not served.
  --Of the 10 rape crisis centers in Utah, only one has translated 
        materials. None have bilingual staff. Only half have 24-hour 
        hotlines. Three of the programs have no full-time education 
        staff member. The Utah Coalition Against Sexual Assault reports 
        they are only reaching 50 percent of the junior high and high 
        school students in the state through their education efforts.
  --In Wisconsin, only three of the state's 38 rape crisis centers have 
        a full-time community educator. Between one-half and two-thirds 
        of the centers have only one staff member.
    When Congress increased the authorization for the Rape Prevention 
and Education Grants as part of VAWA II, it recognized the importance 
of this program in reducing sexual victimization. The National Center 
calls on Congress to honor its commitment to women by providing full 
funding for the Rape Prevention and Education Grant Program for fiscal 
year 2002.
    For more information, contact Susan Howley, public policy director, 
National Center for Victims of Crime, at (703) 276-2880.
                                 ______
                                 

   Prepared Statement of the National Coalition for Heart and Stroke 
                                Research

    My name is Jack Owen Wood. I solicit your support for more 
aggressive federal funding for research into prevention and treatment 
of the sister diseases, stroke and heart disease. Strokes and heart 
attacks are occurring at an alarming rate.
    I am representing the National Coalition for Heart and Stroke 
Research. The coalition consists of 14 organizations representing more 
than 5 million volunteers and members united in support for increased 
funding for heart and stroke research. Members of the Coalition 
include: American Academy of Neurology; American Academy of Physical 
Medicine and Rehabilitation; American Association of Neurological 
Surgeons; American College of Cardiology; American Heart Association; 
Americans for Medical Progress Congress of Neurological Surgeons; 
American Neurological Association; Association of Black Cardiologists; 
Citizens for Public Action on Blood Pressure and Cholesterol, Inc.; 
Mended Hearts, Inc.; North American Society of Pacing and 
Electrophysiology; Stroke Connection, Inc.; and the National Stroke 
Association.
    I will deal primarily with one man's personal experience with 
stroke and its functional and financial costs--my own. I have only the 
use of my right arm.
    I was born in 1937, raised in Vicksburg, Mississippi, earned an 
engineering degree at Mississippi State University and currently reside 
in Port Orchard, Washington.
    I worked for the Boeing Company in Seattle, am a former Director of 
the Washington State Energy Office, served as Director of Cost and 
Revenue Analysis and as the Forcasting Manager for a major Northwest 
Area Natural Gas Utility until May 1, 1995.
    On May 1, 1995, at the age of 57, I was stricken and severely 
disabled by my stroke. Two years later I experienced a triple bypass 
heart operation. You might say I've ``been there and done that'' for 
both major cardiovascular diseases. So you see, I am an expert.
    Last year I was offered an exciting and rewarding volunteer 
opportunity. I was asked to lead the ``JACK WOOD STROKE VICTOR TOUR'' 
for the American Heart Association.
    The JACK WOOD STROKE VICTOR TOUR was a 5-state lobbying tour. 
Through it I tried to meet personally with every Northwest 
Congressional representative on his or her home turf (in Alaska, Idaho, 
Montana, Oregon and Washington). In each meeting I was joined by local 
people, stroke survivors and their families and medical professionals. 
I told my story and asked them to join the Congressional Heart and 
Stroke Coalition and to support increased federal heart and stroke 
research funding.
    I am proud to say I traveled to 18 communities and meet personally 
with 28 members of our delegation or their staff. Nearly half of our 
congressional delegation is now members of the Congressional Heart and 
Stroke Coalition.
    One of the most powerful memories for me was the frequency in which 
Members of Congress or staff members related their personal experience 
with stroke. One member I spoke to lost both parents to stroke. I 
suspect many of you have stories too.
    I realize your interest is greater than the physical impact of my 
stroke. Your concern must include the financial impact, not only on me, 
but on our country from increased health care costs and lost 
productivity and its many implications.
    I have confronted the difficult and painful task of calculating 
that cost to me. Besides being a man whose stroke took his ability to 
pick up and play with his grandchildren, his livelihood, and marriage, 
I remain a statistician at heart. I couldn't resist calculating and 
telling that part of my story. But please remember my story is not 
dissimilar to that of many of the 4.5 million stroke survivors in the 
United States. Many of whom were stricken in their prime earning years. 
Who in a matter of moments, seemingly without warning, are transformed 
from a contributor and provider to a receiver and patient.
    My full analysis is on the final page of my written testimony. 
Allow me to highlight three figures that I feel sum up my data and 
should be important to you. I estimate that my stroke at age 57:
  --Reduced my earnings before retirement age 65 by over $600,000.
  --Subsequently, the cost to the federal government in lost income and 
        other taxes, early Medicare payments and Social Security 
        disability payments is over $320,000.
  --My HMO spent approximately $150,000 to respond to and treat my 
        stroke.
  --One man, over one million dollars.
    About 600,000 Americans will suffer a stroke this year costing this 
nation an estimated $45 billion in medical expenses and lost 
productivity.
    Earlier I described a stroke as occurring seemingly without 
warning. All too often as in my case, people either don't know or 
ignore the signs of a stroke, even one in progress. When my stroke hit 
I denied it. It took me two days after my stroke to acknowledge it and 
seek help. Because of research into new treatments, we now have t-PA, 
which if administered within 3 hours of the onset of stroke symptoms, 
can dramatically reduce the damage of certain kinds of strokes. Had I 
recognized and acknowledged my stroke, gone to a hospital with a 
neurologist on staff and had there been tPA, the impact of my stroke 
most certainly would have been lessened.
    What is even more painful to me is that my impending stroke could 
have been detected. Unfortunately, we need to create easier and less 
expensive diagnostic techniques so that effective diagnostics can be 
given routinely as part of regular health exams. And they must be 
covered through insurance.
    I am not asking for your sympathy. Instead, please think of me as 
two of the ghosts in the famous Dickens' story. Please don't 
misunderstand, I'm not casting you as Scrooge. See me as both the 
ghosts of things past and things yet to be. I too am here to tell you, 
the future, which I represent, needs not be. It is largely up to you.
    I hope my story and estimate of the cost of my stroke convinces you 
that taking on stroke and heart disease through increased research, 
leading to better prevention, diagnosis and treatment is fiscally 
responsible. The human and financial costs are astronomical.
    Thank you for your past support of research and recent decision to 
eliminate (at least for now) restrictions on reimbursement for 
rehabilitation services, essential to those who have experienced a 
stroke. Please continue and broaden that support.
                                 ______
                                 
         Prepared Statement of the National Fuel Funds Network

                              INTRODUCTION
    The National Fuel Funds Network thanks the members of the 
Subcommittee for the opportunity to submit this testimony. We thank the 
Chairman and other subcommittee members for your efforts in securing 
$1.86 billion in sorely needed energy assistance funding for fiscal 
year 2000.
    The National Fuel Funds Network (NFFN) supports funding for the 
Low-Income Home Energy Assistance Program (LIHEAP) in the amount of $2 
billion in regular funds plus $300 million in emergency funds, the 
maximum amount authorized for fiscal year 2002. NFFN also supports 
advance funding in the amount of $2 billion for fiscal year 2003. The 
Network also supports the Bingamin amendment to the bankruptcy reform 
bill, which authorizes $3.4 billion for LIHEAP.
    The NFFN is a membership organization comprised of over 200 dues-
paying representatives of private fuel and energy assistance funds, 
community action agencies, social service organizations, utility 
companies, local and Tribal governments, trade associations and private 
citizens. Our member organizations are located in 44 states and the 
District of Columbia.
    The NFFN members raise private contributions in their local 
communities or states to assist people with low incomes to pay home 
energy bills. Fuel funds range from small church organizations that 
distribute hundreds of dollars in a single neighborhood to large 
independent organizations that distribute millions of dollars across a 
state. Fuel funds may be a division of a large social service agency, 
or a local utility or energy company may operate them. Some Indian 
tribes maintain fuel funds to supplement LIHEAP programs. Since our 
first steering committee meeting in 1984, the NFFN and its member 
organizations have put into action a commitment to help people of 
limited means, due to chronic poverty and temporary misfortune or 
illness, meet their basic energy needs.
    Whatever their form, all fuel funds raise and distribute private 
sector monies, and they all, inevitably, discover that the resources 
they manage and the resources provided by LIHEAP are inadequate. 
Therefore, fuel funds are becoming increasingly involved in attempting 
to locate or direct even more financial resources to help the poor meet 
their energy needs.
    Nationally, fuel funds assist almost 1.8 million households to make 
heating and cooling bill assistance payments of over $102 million this 
year. These payments, while vitally needed, are quite small in 
comparison to the $1.86 billion in fiscal year 2000 LIHEAP funding.
    During the 1990's there was a consistent demand for energy 
assistance funding despite the fact it was one of the warmest winter 
decades on record. The households assisted during this period were 
among the poorest of the poor with average household incomes of less 
than $8,000 per year in most states for a family size of 2.6.
    A 1999 NFFN survey revealed that many fuel fund managers reported 
an increase in their energy assistance caseloads due in part to the 
1996 Welfare to Work legislation.
    Fuel Funds have worked vigorously to raise private non-federal 
funds to assist needy households during the last decade, raising $74 
million in 1994, $88 million in 1998 and an estimated $100 million this 
winter.
    Despite these valiant efforts, the amount of funds raised by fuel 
funds is very small compared to federal LIHEAP funds of $1.86 billion 
for his winter.
    The current 2000/2001 winter has highlighted the need for not only 
continued but increased LIHEAP funding.

                     IMPACT OF RISING ENERGY PRICES
    The increases in energy costs this winter, especially natural gas 
has greatly increased the energy burden i.e. the ratio of energy costs 
to household income borne by poor households. As you know, natural gas 
prices this winter have averaged, at times, three to four times the 
prices paid last year. In addition, the weather across most of the 
country this winter was not only considerably colder than last winter, 
but colder than normal, with records set in some areas.
    The combination of colder weather and dramatically higher energy 
costs have imposed an unbearable energy burden on the poor.
    A December 2000 study by Economic Opportunities Studies estimated 
the energy burden for poor households this winter would be 19 percent 
for households with incomes of 125 percent of poverty and 14 percent 
for households at 60 percent of the average of the states' median 
incomes compared to 3.2 percent for middle-income households not 
eligible for assistance.
    The above energy burdens were based on a projected natural gas 
price increase of 40 percent above the 1999-2000 winter. Current 
estimates indicate natural gas prices will average 60 percent more 
above last winter, thus imposing an even greater burden on the poor.
    Moreover, by the time the heating season and cut off moratoria 
ended, millions of households faced utility cutoffs because of 
arrearages amassed during the winter. Indeed, a recent National Energy 
Assistance Directors Association study tallies 3.6 million households 
in only eighteen states.

                     FUEL FUNDS RESPONSE TO CRISIS
    Fuel Funds, in response to the above escalations in energy costs 
and colder weather have aggressively stepped up their fundraising and 
service delivery efforts.
    For example, the Victorine Q. Adams Fuel fund in Baltimore City 
anticipates servicing 50 percent more households this winter compared 
to last winter or 3,000 vs. 2,000 respectively.
    The Dollar-Help program in St. Louis has increased its fundraising 
from about $550,000 two years ago to an estimated $800,000 this winter 
and will serve about 2,500 households this winter as compared to 2,000 
in 1999.
    KeySpan Energy recently announced a $3 million in grants to fuel 
funds serving New York City, Long Island and New England. Entergy--New 
Orleans donated $1 million to two fuel funds in that city.
    NFFN estimates contributions to fuel funds are up at least $12 
million this year for a total of $100 million vs. $88 million raised in 
1998-99.
    Local and state governments have also increased their funding of 
energy assistance in their jurisdictions.
    In Ohio Governor Taft committed $2.5 million in state funds for 
energy assistance and challenged the state's utilities to match the 
state's commitment. In response, Columbia Gas of Ohio formed the 
Columbia Energy Assistance Fund with $3.5 million, Dominion East Ohio 
Gas expanded the People Helping People Fund with a $1 million 
contribution and Cinergy expanded its Heatshare program from $100,000 
to $500,000.
    Some cities have used a portion of their increased Gross Receipts 
tax revenues to fund energy assistance efforts through Community Action 
Agencies and fuel funds.
    In the city of St. Louis, the Board of Aldermen and the Mayor 
appropriated $1.13 million for energy assistance. In western Missouri, 
several cities either reduced their Gross Receipts taxes or donated a 
portion for energy assistance.
    The above efforts, while worthy of praise are small when compared 
to the LIHEAP funding for this winter of $1.86 billion. Therefore, it 
is clear that the most ambitious private efforts cannot replace LIHEAP. 
These private efforts, when used in partnership with LIHEAP serve as a 
very helpful safety net supplement to the very needy.
    Most states have experienced dramatic increases in applications for 
assistance this winter as a result of the severe weather and energy 
cost increases. Many of the agencies responsible for delivering 
assistance are experiencing large backlogs due to a shortage of modern 
computers and electronic capability such as e-mail.
    Approximately half way through the 2000-2001 heating season in 
Colorado, more than 49,585 households have been approved for energy 
assistance through the LIHEAP program. This number exceeds the caseload 
of 48,417 households served during the entire 6 month heating season in 
1999-2000. Applications for assistance set records exceeding the number 
of applications ever to have been accepted by the state administered 
federally and privately funded LIHEAP program.
    Privately funded non-profits, charities and faith-based 
organizations have also seen caseloads up by more than 50 percent from 
last year serving in excess of an additional 10,000 households not 
currently served by LIHEAP.
    Call volumes to my agency, Colorado Energy Assistance Foundation 
show astronomical increases rising from approximately 25 calls a day in 
January and February to recorded levels of 543 calls per day. Averages 
are running in the neighborhood of 270 calls per day.
    To ease the problem of backlogs and to avoid the non-delivery of 
sorely needed help, NFFN recommends the use of a portion of LIHEAP 
appropriation for the purchase of new sorely needed delivery equipment.
    The summer of 1995, with its oppressive heat and loss of lives 
taught us that energy assistance is a year around issue and the need 
for LIHEAP funding is almost constant.
    As evidenced by this winter, the volatility in energy prices 
experienced this winter, as well as cold weather can wreak havoc on the 
lives of the poor.
    In St. Louis, for example some lenders are offering to refinance 
mortgages for people to pay increased heating bills.

                               CONCLUSION
    In conclusion, NFFN strongly supports and urges the approval of a 
fiscal year 2002 LIHEAP appropriation of $2.3 billion, $2 billion in 
regular funding and $300 million in emergency funds. We also urge the 
Subcommittee to provide advance appropriations for fiscal year 2003 at 
the same level. State and Tribal agencies need advance funding to 
insure stability and continuity. This holds especially true in a time 
of volatile home energy prices.
    Fuel Funds will continue their efforts to serve as a helpful safety 
net supplement to LIHEAP but cannot in any way replace the vital role 
LIHEAP plays in the lives of the poorest of our neighbors.
    NFFN is grateful for this opportunity to submit testimony the 
Subcommittee.
                                 ______
                                 

  Prepared Statement of the National Indian Child Welfare Association

    The National Indian Child Welfare Association appreciates the 
opportunity to submit testimony regarding fiscal year 2002 funding 
child welfare and mental health programs that serve our most precious 
resource--our children. Our comments will focus on the need for mental 
health services for Indian children and for research and services 
related to abuse and neglect of Indian children. Specifically, we need 
increased resources and/improved access to the following DHHS programs:
    (1) Substance Abuse and Mental Health Services Administration 
(SAMHSA) programs:
  --Knowledge, Development and Application category--Circles of Care 
        tribal children's mental health grant program
  --Comprehensive Community Mental Health Services for Children and 
        their Families grant program--funding for tribal children's 
        mental health service sites.
    (2) Administration for Children and Families (ACF) Office of Child 
Abuse and Neglect under the Child Abuse Prevention and Treatment Act 
(CAPTA) programs:
  --National Clearinghouse for Child Abuse and Neglect Information and
  --Child Abuse Research and Demonstration.
    (3) There are barriers to funding services for Indian children, 
especially in the Foster Care and Adoption Assistance programs, the 
Mental Health Block Grant, and the Child Abuse Prevention and Treatment 
Act state grants.
    The National Indian Child Welfare Association (NICWA).--NICWA, 
headquartered in Portland, Oregon, provides a broad range of services 
to tribes, Indian organizations, and state and federal agencies that 
serve Indian children and families throughout the United States. These 
services are not direct client services such as counseling or case 
management. Rather, they are services that strengthen the programs that 
serve Indian children and families. Our services include: (1) 
professional training for tribal and urban Indian child welfare and 
mental health professionals; (2) technical assistance to improve child 
welfare and mental health programs that serve Indian children; and, (3) 
activities to promote improved public policy for Indian children and 
families. In addition to maintaining a strong network in Indian country 
by working closely with the National Congress of American Indians and 
tribal governments across the nation, we have established mutually 
beneficial partnerships with organizations including the Federation of 
Families for Children's Mental Health, the Child Welfare League of 
America, and Casey Family Programs.
    Program.--Circles of Care tribal grantees under the budget category 
of Knowledge, Development and Application (last year for this 3-year 
grant program is fiscal year 2001).
    Fiscal year 2001 Enacted.--$2.4 million (approximately $0.7 million 
was reserved for the Circles of Care grant program).
    DHHS Division.--Substance Abuse and Mental Health Services 
Administration.
    Recommendation.--$3 million, with $1.1 million for the Circles of 
Care projects
    Justification.--The Circles of Care projects utilize the most 
current and innovate thinking in delivering Indian children's mental 
health services. The current nine Indian community grantees, which base 
their efforts in ``a system of care'' model, are engaging local 
communities in partnerships and capacity building for children's mental 
health services. Within the field of children's mental health, a system 
of care is a formal collaboration of the family and community members, 
professional and other organizations committed to enhancing the lives 
of emotionally disturbed children and their families.
    All of the Circle of Care Indian projects are subject to rigorous 
external evaluation which helps determine the feasibility of project 
designs and also the potential for successful replication in other 
communities.
    Historically, American Indians/Alaska Natives have had little 
access to mental health services, and funding from Indian Health 
Service for this purpose has been minimal. Funding planning efforts is 
critical to the successful building of systems of care for American 
Indian/Alaska Native children with severe emotional disturbances. We 
ask Congress to provide additional planning grants so that other tribes 
and urban Indian organizations can enter into partnerships with Indian 
and non-Indian agencies to develop community-based mental health 
programs.
    The Circles of Care programs are demonstrating that careful 
planning combined with community partnerships can make a positive 
difference in helping children with severe emotional disturbances and 
their families.
    Program.--Comprehensive Community Mental Health Services for 
Children and their Families grant program (tribal service site 
funding).
    Fiscal year 2001 Enacted.--Approximately $91.7 million.
    DHHS Division.--Substance Abuse and Mental Health Services 
Administration.
    Recommendation.--Recommend (1) reserve 10 percent of the total 
allocation to this program for tribal applicants and (2) exempt Indian 
tribes and organizations from population limits used to allocate these 
grant funds.
    Justification.--Developing systems of care for Indian children 
with, or at risk of, emotional and behavioral disorders has been 
initiated through the Children's Mental Health Services tribal service 
grantees. To date, seven tribal sites have received grant awards. 
Information and descriptions of the most ``promising practices'' of the 
full range of the mental health services are being documented in the 
Promising Practices monograph series. The monograph devoted to the 
Native American grantees was released in June 2000. This monograph 
poignantly illustrates the success of community-based systems of care 
when American Indian communities are afforded the advantages of 
designing systems tailored to their specific needs.
    Focusing on cultural and family strengths, parent and community 
involvement, and ongoing service evaluation, the service sites yield 
rich information useful to Indian and non-Indian providers. Substantive 
data gathering is an integral part of tracking the success and 
challenges of implementing new systems of care in Indian country. The 
verbal reports of parents and children enrolled in some of the 
project's systems of care suggest a high rate of success and 
demonstrate high consumer satisfaction by parents and children. A 10 
percent allocation would enable funding of additional sites that are in 
desperate need for children-specific mental health services.
    The formula for funding grantees only allows a specified number 
people to be served within a given state. If a state becomes a grantee 
it would almost automatically exclude any American Indian/Alaska Native 
tribes from being awarded a grant in that same state even though they 
would be serving different populations and using a different service 
delivery system. Many states have numerous tribes in rural areas with 
small populations. We believe that the program should fund tribes in a 
way that honors the government-to-government relationships. An 
allocation of dollars to these Native populations that is unrestricted 
by state populations addresses the inordinately high index of need for 
mental health services of American Indian/Alaska Native children.
    Program.--National Clearinghouse for Child Abuse and Neglect 
Information, Child Abuse Research and Demonstration.
    Fiscal year 2001 Enacted.--$33 million (no portion of these funds 
are reserved for a Tribal grant program, but Tribes receive services 
from the clearinghouse as well as a few discretionary grants).
    DHHS Division.--Office of Child Abuse and Neglect.
    Recommendation.--Recommend an allocation of at least $2 million to 
support research, information services and demonstration projects in 
American Indian communities.
    Justification.--Beginning with the passage of the Indian Child 
Welfare Act in 1978, tribes began in earnest to reclaim their 
responsibility for the protection of tribal children (Canby, 1998). 
Today almost every tribe in the nation provides some form of child 
welfare services to their children, and approximately two-thirds are 
directly involved in the investigation of cases of child abuse and/or 
neglect (Earle, 2000). Efforts to address the problems of abuse/neglect 
of Indian children living on tribal lands are hampered by the fact that 
no one knows how widespread the abuse/neglect of Native children really 
is. Although there are various sources of data for the rates of abuse/
neglect of Indian children, the accuracy of these data is suspect not 
only due to problems of definition and limited scope but to the 
inability to collect accurate data on the known cases of child abuse/
neglect.
    U.S. Bureau of Justice statistics for 1995 reported a per capita 
rate of one substantiated report of a child victim of abuse or neglect 
for every 30 American Indian children aged 14 or younger. This compares 
to one report for every 58 children of any race, approximately half the 
rate for Native children. It was the highest rate of abuse or neglect 
reported for any ethnic group. In addition, American Indians and Asians 
were the only racial/ethnic groups to experience increases in the rate 
of abuse or neglect of children under age 15 from 1992 to 1995 (Dept. 
of Justice, 1999). Data from the National Child Abuse and Neglect Data 
System (NCANDS) show that, for child maltreatment victimization rates 
by race and ethnicity in 1998 (40 states reporting), the rate for 
Native children was 19.8 cases per 1000 children. This compares to a 
rate of 3.8 for Asians/Pacific Islanders, 8.5 for Whites, and 10.6 for 
Hispanics (U.S. Dept. of Health and Human Services, Children's Bureau, 
2000). Tribes and policy makers desperately need research on the extent 
of the problem and information about how to combat child about in their 
communities.

   STATUTORY AND REGULATORY BARRIERS TO FUNDING SERVICES FOR INDIAN 
                                CHILDREN
    While we recognize this Committee does not have the authority to 
amend language in the authorizing statutes, we feel it is important 
that the Committee be aware of the disparity in access to federal 
funding that exists for Indian children. Therefore, we are providing 
information on key programs that have the potential to fund services 
for Indian children under tribal jurisdiction, but contain significant 
barriers. The appropriations for these programs, however, do fall under 
the purview of this Subcommittee.
    Program.--Foster Care and Adoption Assistance (Title IV-E of the 
Social Security Act).
    Fiscal year 2001 ENACTED.--Entitlement funding $5 billion (foster 
care) and $1.2 billion (adoption assistance).
    DHHS Division.--Children's Bureau under the ACF.
    Recommendation.--Support legislation (to be introduced in the 
Senate in March) to include tribal governments as eligible for direct 
reimbursement for Title IV-E services they provide to eligible Indian 
children under their jurisdiction and care. We point out that the 
American Public Human Services Association, the organization of state 
social service agencies, has recently formally endorsed the provision 
of direct funding to tribes under the IV-E statute.
    Justification.--While Congress intended for the Title IV-E program 
to serve all eligible children in the United States, Indian children 
under the jurisdiction of a tribal government and living on tribal 
lands do not have an entitlement to this important program afforded 
other children. The statute provides services only for income-eligible 
children placed by states and public agencies with which states have 
agreements. While approximately 70 tribes have been able to forge 
agreements with a state to access Title IV-E funds, the vast majority 
of tribes have no access. In those states where agreements exist, 
tribes often receive only a portion of the funding available overall to 
support foster care and adoption related services. With no stable 
source of foster care and adoption assistance funding, tribes have 
struggled to provide the same level of protection and permanency that 
other children are guaranteed under this federal program. By enacting 
the soon to be introduced legislation in the Senate that would add 
tribes to Title IV-E, the federal government can provide a higher level 
of security and permanence for Indian children than would be found in 
any other federal funding source.
    Program.--Mental Health Performance Partnership Block Grant.
    Fiscal year 2001 Enacted.--$420 million.
    DHHS Division.--Substance Abuse and Mental Health Services 
Administration
    Recommendation.--We recommend the authorizing statute be amended to 
provide tribal governments direct access to the Mental Health Block 
Grant. We recommend that 3 percent of the overall appropriation be 
reserved for direct allocation to tribal governments. To fund this 
recommendation without impacting state allocations, we also recommend 
increasing the overall level of appropriation by 3 percent. The 
specific allocation for individual tribes could be based on a formula 
that would be similar to the one used for the allocation of tribal 
funds from the Child Care and Developmental Block Grant. This formula 
provides a base amount of funding for every tribe, in addition to a per 
capita amount based on the tribe's population.
    Justification.--Tribal governments do not have access to the Mental 
Health Performance Partnerships Block Grant and therefore miss out on 
funding opportunities to support mental health services for both Indian 
adults and children. These monies are distributed by formula to state 
and territorial governments, but not to tribal governments. 
Additionally, tribes and tribal organizations are eligible applicants 
for only some of the discretionary mental health grants under the 
Substance Abuse and Mental Health Administration. Mental health block 
grants not only can address immediate mental health needs, but also 
support long-term capacity building for tribes and the communities they 
represent.
    Program.--Promoting Safe and Stable Families Act (Title IV-B , 
Subpart 2 of the Social Security Act).
    Fiscal year 2001 Enacted.--$305 million capped entitlement.
    DHHS Division.--Children's Bureau under ACF.
    Recommendation.--Amend the authorizing legislation to increase the 
amount of reserved funds for tribal governments from 1 percent to 3 
percent of the overall appropriation. Current levels of funding and the 
statutory language only allow 66 tribal grantees to be eligible to 
receive funding under this program.
    Justification.--This program is part of an overall federal system 
of child welfare funding designed to support a more comprehensive array 
of program services in child welfare. Title IV-B, Subpart 2 helps 
promote services to prevent the removal of children from their homes, 
reunify them with their families after removal when possible and 
provide services to support adoption when return to the home is not 
possible. As an indicator of need, Indian children in the United States 
are placed in substitute care at a much higher rate than is the average 
for all other children in the nation. 12.5 out of every 1,000 Indian 
children are placed in substitute care, compared to 6.9 out of every 
1,000 children from all races (Child Welfare League of America, 1996, 
with 34 states reporting substitute care data). This funding has been a 
good fit for tribes who have been eligible to receive grants. However, 
with only a small portion of the total number of federally recognized 
tribes eligible, the program has had little impact on the overall need 
for these services in tribal communities across the United States. One 
of the primary purposes of the program was to stimulate systems change, 
a goal that is definitely needed in child welfare, but again, the small 
amount of funding and restricted eligibility has made it very difficult 
to create and sustain any meaningful change for tribal governments.
    Program.--State grants under the Child Abuse Prevention and 
Treatment Act (CAPTA).
    Fiscal year 2001 Enacted.--$21 million.
    DHHS Division.--Office of Child Abuse and Neglect.
    Recommendation.--We recommend that the authorizing statute be 
amended to provide tribal governments direct grants for child abuse 
prevention and treatment programs. Tribes receive no funding under the 
state grants.
    Justification.--Given sharply increasing reports of maltreatment, 
(Greenfeld and Smith, 1999) prevention programming must be expanded in 
American Indian communities. While Indian people have a heritage for 
child protection, we also have a growing problem with child abuse and 
neglect. If we are to survive as nations, we must turn this around. It 
is essential that Tribes build the capacity to conduct comprehensive 
child abuse and neglect prevention and treatment programs. National 
attention on this topic is needed. It is our belief that direct tribal 
grants under CAPTA will be helpful in shaping future of our children.
                                 ______
                                 

        Prepared Statement of the National Latex Allergy Network

    On behalf of the National Latex Allergy Network (formerly ELASTIC 
Inc.), a nonprofit voluntary health organization, and the 2.3 million 
Americans estimated to be sensitized to natural rubber latex. I would 
like to thank Senator Specter, Ranking Member Senator Harkin, and 
Members of the Subcommittee for the opportunity to provide written 
testimony.
    We are respectfully requesting that the Senate subcommittee 
allocate federal funds to facilitate and advance research in the area 
of latex allergy. Scientists from all over the country are working very 
hard to help the growing number of people who are becoming sensitized 
to latex. There is a critical need for financial support in all areas 
of research, including pathophysiology, existing and unknown causative 
factors, occupational asthma, diagnostics, immunotherapy, product and 
environmental safety standards, treatment standards and prevention 
strategies.
    Increased use of latex, most notably, latex gloves, to prevent 
infectious diseases has been followed by an increase in the number of 
people affected by latex allergy. In 1991, the FDA issued a medical 
alert in response to growing reports of allergic reactions by patients 
to latex-containing medical devices. At this same time the CDC was 
investigating clusters of anaphylactic reactions among young patients 
undergoing treatment at various children's hospitals across the 
country.
    The explosion of anaphylaxis and serious allergic reactions to 
latex gloves and other medical equipment shocked physicians, 
researchers and regulatory government agencies because, quite simply, 
prior to the mid-1980's, latex allergy was virtually unheard of.
    Latex, or more accurately, natural rubber latex, is harvested from 
the Brazilian rubber tree found in Africa and Southeast Asia. The 
culprits are certain allergenic proteins retained in varying amounts in 
finished products such as gloves, medical equipment, balloons, condoms 
and toys. With the exception of medical gloves and other medical 
devices, there are no regulations for content labeling or warnings.
    How a product is made determines the amount of latex allergens 
retained in the finished item. Currently, there are no federal 
regulations that limit the amount of allergenic proteins in finished 
products. The FDA Center for Medical Devices and Radiological Health is 
in the process of finalizing recommendations for maximum levels of 
extractable protein and powder per glove for medical exam and surgeon's 
gloves. This has been a lengthy effort and applies only to the medical 
gloves regulated by this agency.
    A joint statement of the American Academy of Allergy, Asthma & 
Immunology and the American College of Allergy, Asthma & Immunology 
published in 1997 defines latex allergy as an IgE-mediated latex 
allergy that results from cumulative exposure of susceptible 
individuals to natural latex rubber proteins (allergens) and identify 
medical gloves and equipment as the largest single source of exposure 
to these potent allergens. Exposure to bio-available latex allergens is 
by direct contact with an offending device or by inhalation of 
allergens carried by cornstarch powder with which most powdered gloves 
are coated. The clinical manifestations of latex allergy range from 
mild contact urticaria to fatal anaphylaxis.
    Latex allergy, an IgE-mediated reaction to proteins retained in 
finished natural rubber latex products, has emerged in the 1990s as one 
of the most pervasive problems in medicine, affecting both patients and 
health care providers. ``Latex allergy has resulted in death, 
progressive asthma, severe food allergy from cross-reactivity, and 
disability of health care professionals with the accompanied loss of 
self-esteem and income as a result of their inability to work in their 
chosen profession.'' (Kelly KJ, Walsh-Kelly CM--Latex allergy: A 
patient and health care system emergency. J Emerg Nursing Dec 1998 
24;6:539-545)
    While similar to peanut, stinging insects and drug allergies in the 
risk for life-threatening anaphylaxis, latex allergy is unique in that 
the latex gloves and other medical products used in emergency 
situations to save a life could cause a fatal anaphylactic reaction.
    Since the early 1990s, the FDA has received over 2,000 adverse 
event reports describing allergic reactions to medical gloves 
containing natural rubber latex. These reports relate both to patients 
and users of natural rubber latex products. These reports include 16 
deaths, 5 caused by latex gloves.
    While working as a general dentist, I had never heard of latex 
allergy, let alone had any inkling of the enormous burden it would 
impose on my family, the dilemma it would pose for my health care 
providers and the debilitating effect it would have on my health. That 
is, not before the summer of 1994 when I was diagnosed with latex 
allergy and asthma caused by the latex gloves I wore everyday and the 
``second-hand latex'' from the latex-laden powdered gloves everyone in 
the office used.
    Nor did I think that something so innocuous that I would lose my 
practice and become so chronically ill those even day-to-day activities 
would be nearly if not totally impossible. Who would have thought the 
very products we used everyday as health care providers would end my 
career in dentistry and impose an enormous physical, emotional and 
financial burden on my family?
    Latex glove use has spilled over to non-medical settings, so much 
so that a Philadelphia nurse and latex allergy prevention advocate has 
developed a new spin on an old nursery rhyme. ``Butcher, baker, 
beautician, thief, mechanic, chef, fire chief . . . the common 
denominator here is routine latex glove use! The list of occupations 
also wearing gloves for barrier protection includes; farmers, produce 
pickers, factory workers, restaurant and food service workers, day care 
workers, dog groomers, landscapers, painters, toll collectors, auto 
factory workers as well as florists, housekeeping and janitorial 
service workers, students for science, art and shop classes.
    Latex allergy develops primarily because of repeat exposure to 
significant levels of allergenic proteins retained in finished products 
made from natural rubber latex (NRL), in particular latex gloves and 
other medical equipment that contact mucosal tissues.
    The transfer of allergenic latex proteins from glove surfaces to 
food products has been scientifically documented resulting in an often 
hidden source of latex exposure for consumers. Disposable latex gloves, 
commonly utilized by food handlers, are a source of indirect food 
additives violating Section 402(a)(1) of the FDA Food Regulations which 
state: ``A food is illegal (adulterated) if it bears or contains an 
added poisonous or deleterious (harmful) substance which may render it 
injurious to health.''
    Health risks to consumers and workers associated with latex glove 
use in all aspects of food service--from farm to table. As stated in 
the 1999 Food Code Annex 3 3-3-4.15; 3-304.15--Gloves, Use Limitation--
``Natural rubber latex gloves have been reported to cause allergic 
reactions in some individuals who wear latex gloves during food 
preparation, and even in individuals eating food prepared by food 
employees wearing latex gloves (refer to Annex 2 for this section).'' 
The FDA is currently evaluating safety issues associated with latex 
glove use in the food industry.
    Avoidance of latex allergens is presently the only method to 
prevent reactions, latex-related asthma and latex sensitization. 
Commonplace use of medical and non-medical latex gloves as well as 
hundreds of other products encountered in daily life makes this task 
extremely difficult. Ironically, the prevalence of latex in gloves and 
other life-saving equipment used by first responders, emergency medical 
service providers, emergency rooms and hospitals, has resulted in a 
critical public health crisis--access to safe emergency and routine 
health care for the growing number of latex allergic patients.
    Mr. Chairman, I thank you again for the opportunity to provide the 
Committee with information about this newly emerged disease, latex 
allergy. Government agencies are working hard to provide product and 
environmental standards and guidelines. Federal funding for medical 
research would provide the thousands of families affected by latex 
allergy a source of hope for universal access to safe health care, safe 
school and work environments and especially hope for a cure. Please 
help us advance and expedite treatment and a cure for latex allergy by 
providing funding for research.
                                 ______
                                 
        Prepared Statement of the National Down Syndrome Society
    Chairman Stevens, Members of the Committee: The National Down 
Syndrome Society is pleased to submit written testimony in support of 
improved health care for individuals with mental retardation, including 
people with Down syndrome.

                 NATIONAL DOWN SYNDROME SOCIETY (NDSS)
    The National Down Syndrome Society represents more than 350,000 
individuals with Down syndrome who live in the United States, their 
families, friends and professionals who serve them. The National Down 
Syndrome Society was established in 1979 to ensure that all people with 
Down syndrome have the opportunity to achieve their full potential in 
community life. Since that time, NDSS has become the largest non-
governmental supporter of Down syndrome research in the United States. 
Today, NDSS continues to increase public awareness about Down syndrome 
and discover its underlying causes through research.
    Under the leadership of a Board of Directors, Scientific Advisory 
Board, Clinical Advisory Board, Affiliate Advisory Board and Self-
Advocate Advisory Board, NDSS distributes timely and informative 
materials, supports activities of local parent support groups, sponsors 
conferences and scientific symposia and undertakes major advocacy 
efforts--all to help improve lives of people with Down syndrome.
    More than 125 parent support groups and related member 
organizations comprise the NDSS Affiliate Program. The NDSS affiliate 
members form the grassroots structure of the organization and represent 
thousands of individuals with Down syndrome and their families from 
around the country.

                             DOWN SYNDROME
    Down syndrome is the most commonly occurring chromosomal 
abnormality, occurring in approximately one in every 800 to 1,000 live 
births. There are approximately 6,000 people born with Down syndrome in 
the United States each year and thousands more impacted by this genetic 
condition. Most people with Down syndrome have some degree of mental 
retardation, usually in the mild to moderate range.
    Children with Down syndrome are at increased risk for certain 
health problems. Congenital heart defects (50 percent), endocrine 
problems (10 percent), neurological conditions (10-20 percent), 
increased susceptibility to infection, respiratory problems, obstructed 
digestive tracts and childhood leukemia occur with greater frequency 
among children who have Down syndrome. Adults with Down syndrome are at 
a significantly increased risk for Alzheimer's disease (25 percent), 
dental problems, thyroid concerns, musculoskeletal problems and 
depression. These, of course, do not include the many other kinds of 
health care problems that everyone in the population is susceptible to.
    Today, the average life expectancy of individuals with Down 
syndrome is approximately 55 years, with many living even longer. As 
this population ages, the need for access to adequate health care and 
for well-trained professionals to address these needs, becomes even 
more critical.

           HEALTH CARE PROBLEMS FOR PEOPLE WITH DOWN SYNDROME
    While advances in medicine have rendered most of these health 
problems treatable, some people with Down syndrome do not have access 
to necessary care. NDSS has identified the following major health care 
issues, based on speaking to many of our constituents:
  --Physicians and health care professionals not adequately trained to 
        meet the medical and health care needs specific to individuals 
        with Down syndrome.
  --Access to health care and surgical procedures being denied to 
        individuals with Down syndrome based on discrimination and 
        attitudes, rather than medical necessity.
  --People being denied health insurance on the basis of Down syndrome 
        being considered a ``preexisting condition.''
    These problems with the current systems as they relate to 
individuals with Down syndrome represent just some of the issues we 
hear.

                             THE CHALLENGE
    Throughout the years, NDSS has heard hundreds of stories from 
parents about insensitive attitudes on the part of health care 
professionals, whether in presenting a diagnosis of Down syndrome or in 
treatment, as well as professionals being inadequately prepared with 
the necessary information and resources to work with their child. NDSS 
has also been contacted by numerous physicians, nurses, social workers, 
genetic counselors and others seeking information and resources that 
will help them to better care for their patients who have Down 
syndrome. There is very limited training available for health care 
professionals on how to address the specific needs of people with Down 
syndrome.
    There are many resources available, such as the Down Syndrome 
Health Care Guidelines, which are critical in helping to ensure that 
adequate attention is paid to particular health care concerns. The 
challenge has been getting these resources into the hands of those who 
need it the most. NDSS works closely with the Down Syndrome Medical 
Interest Group, comprised of more than 150 physicians and clinicians 
worldwide who have an interest in working with this population, to 
share information and develop resources that will improve the quality 
of life for individuals with Down syndrome.
    Attached is a summary of Down Syndrome Health Care Guidelines, 
based on Health Care Guidelines for Individuals with Down Syndrome: 
1999 Revision (Down Syndrome Preventive Medical Check List), published 
in Down Syndrome Quarterly (Volume 4, Number 3, September, 1999, pp. 1-
16).

                               CONCLUSION
    The opportunities today for individuals with Down syndrome and 
mental retardation have never been greater, thanks to the commitment 
and dedication of many legislators, organizations, families and 
agencies. In the past 25 years alone, groundbreaking legislation has 
lead to de-institutionalization, inclusion in schools and a no-
tolerance attitude towards discrimination against people with 
disabilities. Now that the laws are in place and the opportunities to 
succeed available, we owe it to people with mental retardation to 
ensure they are healthy enough to take advantage of all that is 
available.
    We appreciate your taking the time to read our testimony, and 
applaud you for your interest in helping to improve health care for 
people with mental retardation. Please do not hesitate to contact us if 
we may be of any assistance to you in your efforts.
  Attachment I--Addressing the Health Care Needs of People With Down 
                                Syndrome
    The National Down Syndrome has been dedicated to improving health 
care for individuals with Down syndrome since its inception in 1979. 
Under the direction of a Science Advisory Board and Clinical Advisory 
Board comprised of distinguished, world-renowned experts on Down 
syndrome-related issues, NDSS has developed programs and resources to 
address these needs.
    Science Scholar Award Program.--Each year NDSS awards research 
grants to promising postdoctoral scientists who have demonstrated 
extraordinary skill and achievement in seeking a better understanding 
of Down syndrome. Since 1983, more than twenty researchers have 
received this prestigious salary grant.
    Research Partnership.--NDSS, the National Institute of Child Health 
and Human Development and the National Institute of Neurological 
Disorders and Stroke are engaged in a $3.9 million partnership to 
further Down syndrome research. The funding goes to organizations and 
individual researchers studying Down syndrome-specific cognition, 
behavior and related therapies. The $3.9 million partnership represents 
the most funding ever earmarked for Down syndrome research.
    International Down Syndrome Research Conference.--In an effort to 
increase communication among the world's most distinguished scientists 
working in fields related to Down syndrome, NDSS hosts international 
scientific conferences on relevant research topics. The proceedings of 
these conferences are published and distributed worldwide.
    Educational Services.--The NDSS Information and Referral Center 
responds to over 25,000 requests annually via E-mail and toll-free 
hotline. A large percentage of these requests are related to health 
care issues. NDSS has developed and disseminated a Clinical Care 
Booklet series to educate parents and professionals about some of the 
most commonly occurring health care problems, including the Heart, the 
Endocrine System, Neurology, Alternative Therapies, Speech and 
Language, and others.
    Changing Lives: Down Syndrome & the Health Care Professional 
Program.--This new program, still in the pilot phase, is being 
developed to support health care professionals in the delivery of 
appropriate care and to help children with Down syndrome get the 
healthy start they deserve. The program aims to educate health care 
professionals in the community about Down syndrome and how best to 
treat and diagnose these patients; educate health care professionals on 
the medical and developmental needs a baby with Down syndrome may have 
and the best care practices to address these needs; provide health care 
professionals with materials and resources to share with new and 
expectant parents of children with Down syndrome; and raise the 
awareness of health care professionals of how attitudes and beliefs 
affect the experience of raising a child with Down syndrome.

 Attachment II--NDSS Science Advisory Board and Clinical Advisory Board

                         SCIENCE ADVISORY BOARD
    David Patterson, Ph.D., Chair, Eleanor Roosevelt Cancer Research 
Institute, CO; Terry J. Hassold, Ph.D., Department of Genetics, Case 
Western Reserve University, OH; Julie R. Korenberg, Ph.D., M.D., 
Department of Pediatrics, Cedars-Sinai Medical Center, CA; Ira T. Lott, 
M.D., Department of Pediatrics, Irvine Medical Center, CA; and Lynn 
Nadel, Ph.D., Department of Psychology, University of Arizona, AZ.

                        CLINICAL ADVISORY BOARD
    William I. Cohen, M.D., Chair, Down Syndrome Center of Western PA, 
Children's Hospital of Pittsburgh, PA; Joan E. Guthrie Medlen, R.D., 
Disability Solutions, OR; Jon F. Miller, Ph.D., Waisman Mental 
Retardation Center, University of Wisconsin-Madison, WI; Bonnie 
Patterson, M.D., Cincinnati Center for Developmental Disorders, 
University of Cincinnati, OH; Richard A. Villa, Ed.D., Bayridge 
Consortium, Inc., CA; Leslie Walker-Hirsch, M.Ed., Moonstone Group, NY; 
and Patricia C. Winders, PT, Down Syndrome Clinic, Kennedy Krieger 
Institute, MD.

    Attachment III--Summary of Down Syndrome Health Care Guidelines

    (Based on Health Care Guidelines for Individuals with Down 
Syndrome: 1999 Revision, Down Syndrome Preventive Medical Check List, 
published in Down Syndrome Quarterly, Volume 4, Number 3, September, 
1999, pp. 1-16)

                DOWN SYNDROME--NEONATAL (BIRTH-1 MONTH)
    Review parental concerns. Chromosomal karyotype; genetic 
counseling, if necessary.
    If vomiting or absence of stools, check for gastrointestinal tract 
blockage (duodenal web or atresia, or Hirschsprung disease).
    Evaluation by a pediatric cardiologist including echocardiogram. 
Subacute bacterial endocarditis prophylaxis--SBE, in susceptible 
children with cardiac disease.
    Exam for plethora, thrombocytopenia.
    Review feeding history to ensure adequate caloric intake.
    Thyroid function test--check on results of state-mandated screening 
at birth.
    Auditory brainstem response (ABR) or otoacoustic emission (OAE) 
test to assess congenital sensorineural hearing (at birth or 3 months).
    Pediatric ophthalmological evaluation (by 6 months) for screening 
purposes.
    Discuss Early Intervention (infant stimulation) and refer for 
enrollment in local program.
    Refer to local DS parent group for family support and resources, as 
indicated. Refer to NDSS.

                  DOWN SYNDROME--INFANT (1-12 MONTHS)
    General neurological, neuromotor, and musculoskeletal examination.
    TSH and T4--Thyroid Function Test (at 6 & 12 months).
    Evaluation by a pediatric cardiologist including echocardiogram, if 
not done at birth.
    Consider progressive pulmonary hypertension in patients with a VSD 
or atrioventricular septal defect who are having little or no symptoms 
of heart failure.
    Subacute bacterial endocarditis prophylaxis--SBE (as indicated).
    Well Child Care--immunizations.
    Feeding consult, especially if constipated. Consider Hirschsprung 
disease.
    Auditory brainstem response (ABR) or otoacoustic emission (OAE) 
test to assess congenital sensorineural hearing (by 3 months if not 
performed previously or if results are suspicious).
    Ear, nose and throat exam (as needed), especially if suspicious of 
otitis media.
    Vision exam (by 6 months & annually), earlier if nystagmus, 
strabismus or poor vision.
    Discuss early intervention and refer for enrollment in local 
program (if not done yet).
    Application for SSI, depending on family income; consider estate 
planning/custody arrangements; continue family support.

                 DOWN SYNDROME--CHILDHOOD (1-12 YEARS)
    TSH and T4--Thyroid Function Test (annually).
    Echocardiogram by a pediatric cardiologist if not done previously.
    Behavioral Auditory Testing (every 6 months until age 3, annually 
thereafter).
    Lateral cervical spine x-rays (neutral view, flexion, extension) to 
rule out atlanto-axial instability. Radiologist to measure atlanto-dens 
distance and neural canal width (at 3-5 years, then as needed).
    General pediatric and neurological exam including evaluation for 
signs of spinal cord compression: deep tendon reflexes, gait, Babinski 
sign.
    Use Down syndrome growth charts and head circumference charts, as 
well as growth charts for typically developing children.
    Eye examination (annually, or more often as indicated).
    Screen for celiac disease IgA antiendomysium antibodies and total 
IgA (between 2-3 years).
    Question about obstructive sleep apnea; ear, nose and throat exam 
(ENT) (as needed).
    Dental Exam (2 years; follow up exams every 6 months after). Twice 
daily teeth brushing.
    Reinforce need for subacute bacterial endocarditis prophylaxis 
(SBE) for cardiac problems (as indicated).
    Brief vulvar exam for girls.
    Well Child Care--immunizations; administer pneumococcal vaccine (2 
years).
    Well balanced, high fiber diet. Regular exercise program.
    Evaluation by a speech and language pathologist to maximize 
language development and verbal communication.
    Review parental concerns; current level of functioning; monitor for 
behavior problems.
    Complete educational assessment annually, as part of Individualized 
Family Service Plan (IFSP) for child from birth to 3 years of age, or 
Individualized Educational Plan (IEP) from age 4 until the end of 
formal schooling.
    Continue speech therapy and physical therapy (as needed).

                DOWN SYNDROME--ADOLESCENCE (12-18 YEARS)
    TSH and T4--Thyroid Function Test (annually).
    Auditory Testing (annually).
    Cervical spine x-ray, if required by Special Olympics.
    Monitor for obstructive airway disease and sleep apnea.
    General physical and neurological examination (check for atlanto-
axial dislocation).
    Eye examination (annually).
    Dental Exams (every 6 months). Twice daily teeth brushing.
    Monitor for obesity by plotting height for weight on the growth 
charts for typical children.
    Clinical evaluation of the heart to rule out mitral/aortic valve 
problems. Echocardiogram (ECHO) as indicated by clinical findings.
    Reinforce the need for subacute bacterial endocarditis prophylaxis 
(SBE) in susceptible adolescents.
    Adolescent medicine consult for puberty/sexuality issues; health, 
abuse prevention and sexuality education. Pelvic exam (only if sexually 
active).
    Low calorie, high fiber diet; regular exercise program.
    Smoking, drug and alcohol education.
    Psychoeducational evaluations (every two years), for Individualized 
Educational Plan (IEP).
    Begin functional transition planning (age 16 years).
    Consider enrollment for SSI depending on family income; monitor 
independent functioning.
    Update estate planning and custody arrangements; discuss plans for 
alternative long-term living arrangements such as community living 
arrangements.

                DOWN SYNDROME--ADULTHOOD (OVER 18 YEARS)
    TSH and T4--Thyroid Function Test (annually).
    Auditory testing (every 2 years).
    Cervical spine x-rays as needed for Special Olympics participation 
(or as indicated).
    Opthalmologic examination, looking especially for keratoconus and 
cataracts (every 2 years).
    Dental Exam (every 6 months). Twice daily teeth brushing.
    Clinical evaluation of the heart to rule out mitral/aortic valve 
problems. Echocardiogram (ECHO) as indicated by clinical exam.
    Reinforce need for subacute bacterial endocarditis prophylaxis 
(SBE) in susceptible adults with cardiac disease.
    Baseline Mammography at 40 years. Follow up every other year until 
50 years, then annually.
    Pap smear and pelvic exam (every 1-3 years following the age of 
first intercourse). If not sexually active, single-finger bimanual 
examination with finger-directed cytology exam. If unable to perform, 
screen pelvic ultrasound (every 2-3 years). Breast exam (annually).
    General physical/neurological exam (atlanto-axial dislocation); 
routine adult health care.
    Clinical evaluation for sleep apnea.
    Low calorie, high fiber diet. Regular exercise. Monitor for 
obesity.
    Health, abuse prevention & sexuality education.
    Smoking, drug and alcohol education.
    Clinical evaluation of functional abilities (consider accelerated 
aging); monitor loss of independent living skills.
    Neurological referral for early symptoms of dementia (decline in 
function, memory loss, ataxia, seizures and incontinence of urine and/
or stool).
    Monitor for behavioral/emotional changes, mental health. Psych 
Referral (as needed).
    Continue speech and language therapy, as indicated.
    Discuss plans for programming/vocational opportunities at age 21 or 
end of formal schooling.
    Discuss alternative long-term living arrangements; estate planning/
custody arrangements.
                                 ______
                                 

          Prepared Statement of the National Marfan Foundation

    Chairman Specter and members of the Committee, the members of the 
National Marfan Foundation (NMF) thank you for the opportunity to 
provide written testimony in support of the budget of the National 
Institutes of Health (NIH) and the National Institute of Arthritis, 
Musculosketetal and Skin Diseases (NIAMS). This is the first year that 
the NMF is submitting written testimony on its own. We have been 
previously included in the written and spoken testimony of the 
Coalition for Heritable Disorders of Connective Tissue (CHDCT). We 
would first like to express our gratitude of the Committee's ongoing 
support of NIH research, and most particularly their support for 
increased funding for research on rare and genetic disorders--research 
that might not otherwise have been funded.
    The NMF believes that we must sustain the current level of 
commitment to the NIH. The NMF joins the Ad Hoc Group for Medical 
Research Funding, the Coalition of Heritable Disorders of Connective 
Tissue, the NIAMS Coalition, and the Coalition of Patient Advocates for 
Skin Disease Research in asking that Congress support a 16.5 percent 
increase in the budget of the NIH for fiscal year 2002. This increase 
would allow us to get back on track the bipartisan effort to double the 
NIH budget by fiscal year 2003--a sentiment shared by the President, 
the Congress and the American people.
    The Marfan syndrome is a potentially fatal, relatively rare genetic 
disorder of the connective tissue. The NMF requests the establishment 
and support of Scientific Research Centers for Marfan Syndrome and 
Related Disorders which will allow these centers to gather significant 
numbers of Marfan affected people to investigate clinical therapies, 
which in the case of a rare and multi-system disorder, are the only way 
to compile enough individuals to establish well-controlled clinical 
studies. This can bring about a comprehensive understanding of the 
clinical burden of this syndrome and help to predict manifestations of 
the disease before they occur. In addition, the recruitment of 
geneticists, molecular and cell biologists who can contribute their 
expertise to a common problem, serve to coordinate basic research and 
enable these studies to be translated rapidly into advances in patient 
care. The goal of establishing Scientific Research Centers for the 
Marfan Syndrome and Related Disorders can only be accomplished through 
the available mechanisms of the National Institutes of Health.
    The NMF represents people affected with the Marfan syndrome. 
Voluntary health organizations such as ours consistently hear the 
frustrations, confusion and despair of people who deal with the daily 
medical issues associated with genetic disorders. In multi-systemic 
disorders such as Marfan syndrome, numerous physicians in specialties 
such as cardiology and cardiovascular surgery, orthopedics, 
ophthalmology, respiratory/pulmonary, neurology, and genetics must be 
consulted to manage the manifestations of this syndrome. The families 
are distraught from the overwhelming emotional turmoil of dealing with 
so many doctors and the fear of losing 2 their life at an early age, 
not to mention the tremendous monetary burden. These circumstances are 
multiplied many times over since this genetic disorder can affect more 
than one family member and more than one generation.
    It is estimated that a quarter of a million people in the United 
States are affected by the Marfan syndrome and relate disorders. The 
Marfan syndrome is a potentially fatal, genetic disorder of the 
connective tissue. The Marfan syndrome is a multi-system disorder 
because the connective tissue is essentially the glue and the 
scaffolding of the body, and manifests itself in the heart, eyes, 
skeleton and blood vessels. Individuals with the Marfan syndrome are 
uncharacteristically tall, with arms, legs, toes and fingers that are 
disproportionately long and thin. Typically, patients also have poorly 
developed muscles and abnormally curved spines.
    The life-threatening aspect of this disorder is the weakening of 
the aorta, the largest artery that supplies blood to the heart. In the 
Marfan syndrome, the abnormalities in the connective tissue place a 
great deal of stress on the aortic artery and significantly weaken the 
walls of this most important blood vessel. Tears form in the walls of 
the aorta and death can only be prevented by surgical intervention. 
There is no simple diagnosis for the Marfan syndrome. Many patients who 
present in emergency rooms fail to receive life-saving treatments. For 
example Jonathon Larson, the Tony awardwinning playwright of the hit 
Broadway musical ``Rent'', died at the age of 35 after being 
misdiagnosed by two different hospital emergency rooms. In addition, 
communities across this country often are faced with the premature 
death of a future basketball star or athlete, because parents, coaches, 
and physicians failed to realize that their height, a tremendous asset 
on the basketball court or other athletic arena was in reality a sign 
of the Marfan syndrome. This was unfortunately the case for Flo Hyman, 
the captain of the 1984 U.S. Olympic Women's Volleyball Team. She was 
not diagnosed with the Marfan syndrome until after her death from 
aortic dissection at the age of 31 on the volleyball court. Similar 
scenarios are noted in many cases. A woman who lost a brother, a sister 
and a son to the Marfan syndrome remembers how she learned about the 
disorder, ``It was the first day of school for my three excited sons 
and the bus was just minutes from arriving. Suddenly my son fell to the 
ground in convulsions and extreme pain. It took the hospital 28 hours 
to determine the problema four-foot long tear in his aorta . . .'' It 
is stories such as these that move us to advocate for this Committee's 
support for increased research funding. Research is the only hope for 
Marfan-affected individuals.
    To this day ignorance still exists on how to adequately diagnose 
the Marfan syndrome. Many people die at a young age in the emergency 
room with a ruptured aorta because these people were never diagnosed. 
One of the main problems is that there is no simple diagnostic test for 
this multi-system disorder. Because most features of the Marfan 
syndrome progress with age, the diagnosis is often more obvious in 
older persons however, this can turn out to be deadly. Furthermore, 
those persons who are considered to be candidates of this syndrome but 
cannot get a precise diagnosis must also continually monitor themselves 
since the 3 symptoms manifest over time. Research is desperately needed 
in this area. Development of a rapid molecular diagnostic test could 
save thousand of lives.
    Research into the basic mechanisms of the Marfan syndrome has borne 
fruit. In 1991, scientists discovered the cause of the Marfan syndrome, 
an alteration of the gene that encodes the protein fibrillin-1. 
Although this important finding did not lead us directly to a cure, it 
has allowed scientists to focus their research to look for answers to 
more specific questions. More research is needed to determine how this 
mutant gene actually produces the change in human biology that leads to 
this disease and is responsible for variability within the syndrome 
from mild to extremely severe cases. Additional basic research in 
molecular studies will also help us to fully investigate the 
interaction of the fibrillin-1 gene product with other molecules in the 
extracellular matrix to better understand pathogenesis of this disease. 
The use of this knowledge to develop a genetic manipulation strategy to 
eventually cure this disease is becoming technically feasible but is 
years away. In the meantime, more immediate issues need to be dealt 
with.
    Clinical research is needed to identify strategies and therapies 
for reducing aortic enlargement, to determine the optimal time for 
surgical intervention and to predict risk for aortic dissection. This 
is extremely important to save lives as noted in a recent letter to the 
NMF. A young woman writes ``My cousin's 17 year-old daughter died with 
a ruptured aortic aneurysm. She knew she had Marfan syndrome and had 
echocardiograms every six months. Her aorta was not large enough for 
surgery but she must have not read the book, because she died anyway. 
She had an echocardiogram just six weeks before she died.'' It is 
stories such as these that alert us to the fact that much more research 
is needed in this most crucial area. It is imperative to determine what 
are the clinical features and presentations of acute aortic dissection 
in Marfan patients and how is this different from non-Marfan patients.
    Clinical research can also offer more solutions to be used 
immediately to alleviate some of the pain and disabling effects such as 
curvature of the spine, dislocated lenses in the eye, and abnormalities 
in the heart valves. Clinical research of treatments for back pain due 
to scoliosis and more specifically for dural ectasia, the enlargement 
of the membrane that surrounds the brain and spinal cord, are 
desperately needed to reduce the amount of pain and suffering endured 
by Marfan-affected individuals.
    Funding biomedical research through the NIH is today's investment 
in America's future. The technology and the science are available to 
understand and ultimately cure or eradicate many of these devastating 
genetic disorders. Support for the NIH is especially crucial to 
unlocking the mysteries of rare diseases, such as the Marfan syndrome. 
We need your support.
                                 ______
                                 

         Prepared Statement of the National Medical Association

    Mr. Chairman and members of the Subcommittee, thank you for the 
opportunity to present the views of the National Medical Association 
(NMA). I am Dr. Rodney Hood, President of the NMA, and a practicing 
internist in San Diego, CA.
    I am very pleased to have the opportunity to submit NMA's fiscal 
year 2002 appropriations priorities to this Subcommittee. Established 
in 1895, the National Medical Association is the Nation's largest and 
oldest professional, educational and scientific organization 
representing the interests of more than 26,000 African American 
physicians and their patients, as well as nearly 100 state and local 
societies. As such, the NMA has been committed to improving the health 
status and outcomes of minority and disadvantaged people for more than 
105 years. And while the Association has focused primarily on health 
issues related to African Americans and medically underserved 
populations, NMA's principles, goals and initiatives benefit all 
people.
    As the leading force for parity and justice in medicine and the 
elimination of disparities in health, the NMA's primary goals include 
improving the health status and health outcomes of minorities. In our 
quest to improve healthcare, we have promoted the increased 
representation of African Americans and other underrepresented 
minorities in the health professions; the integration of hospitals and 
universities; the protection of the rights of our patients involved 
in--and increased participation in--biomedical research and the 
promotion of increased access to health care services for all 
Americans.
    In recent years, there have been considerable discussions about 
eliminating the health disparities that pervade our nation's minority 
populations, to the extent that there are now national initiatives to 
close the gap. In order to understand the critical need to provide 
increased federal funding for programs established to address the 
health status of African Americans and other medically underserved 
populations, it is important to know that centuries of discrimination 
against African Americans have left us with a complicated legacy of 
poor health outcomes, illness, disease and death that are widespread 
and pervasive. This is what authors W. Michael Byrd, M.D., M.P.H. and 
Linda A. Clayton, M.D., M.P.H. call the Slave Health Deficit. The 
programs supported by this Subcommittee are critical to the elimination 
of health disparities. NMA looks forward to working closely with the 
Subcommittee and relevant federal agencies to ensure that the 
tremendous advances made through biomedical research, health 
professions training and community based public health and disease 
control are equally available to all Americans, particularly those who 
have not fully benefited from these advances.

   SUPPORT THE DEVELOPMENT OF A HEALTH POLICY AND RESEARCH INSTITUTE
    Recently, NMA joined the Office of the U.S. Surgeon General and the 
American Public Health Association, in partnership with the nation's 
leading health providers and business leaders, to issue a Call to the 
Nation to Eliminate Racial and Ethnic Health Disparities. In response 
to this challenge, the National Medical Association urges Congress to 
provide $1 million to support the development and implementation of a 
Health Policy and Research Institute focused on achieving health parity 
for African Americans. NMA is concerned that historic and current data 
points to a modern-day form of ``health care racial profiling'' that 
must be addressed if we are ever going to achieve parity in health 
care. Recent studies are confirming what minority--particularly African 
American--physicians, health professionals and caregivers have known 
for years: there are significant disparities in the quality of 
healthcare provided to minority patients across this nation. In 
addition, there are disparities in training and professional 
advancement opportunities for minority medical students and professors 
of medicine; and in opportunities for equitable participation by 
minority physicians in the managed care system. NMA strongly believes 
that without achieving parity in the health status of African 
Americans, who experience disproportionate rates of disease, morbidity 
and mortality, the goals of the U.S. Surgeon General's Healthy People 
2010 Initiative will remain unattainable.

     NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES, NIH
    Mr. Chairman, the disparate health status experienced by African 
Americans and other minorities is a serious problem that threatens to 
increase in complexity as the Nation, with its growing minority 
population, proceeds through the 21st century. The long-term prognosis 
for the elimination of health disparities among minorities is largely 
dependent upon a strong federal commitment to biomedical research and 
research training. However, in order to fully realize the benefits of 
scientific investigation, research and research training, much more 
needs to be done by the National Institutes of Health (NIH) and policy 
makers to ensure that those who are suffering disproportionately, with 
chronic and debilitating diseases, are able to share in these advances.
    NMA is pleased that Congress supported the elevation of the Office 
of Research on Minority Health at NIH to Center status, during the 
107th Congress. This effort is critical to the Nation's ability to 
effectively address the disproportionate cancer, and other disease, 
mortality rates that exist among minorities and the underserved. This 
Center will enable NIH to ensure that research targeted towards 
minorities is carefully and strategically coordinated across the 
Institutes and provide increased support for important minority focused 
biomedical research projects. Additionally, the Center will help NIH to 
address the, often systematic, oversight of minorities in clinical 
trials.
    NMA supports fiscal year 2002 budget increase of $3.4 billion (16.5 
percent above the fiscal year 2001 funding level), for the National 
Institutes of Health, to keep us on the path toward doubling the NIH 
budget by fiscal year 2003. NMA sincerely hopes that as increased 
funding is made available to NIH, Congress will provide adequate 
funding specifically targeted towards programs to improve the status of 
minority health. NMA recommends that the National Center for Minority 
Health and Health Disparities be funded at a level adequate to support 
the Center's expanded agenda as well as the broadened populations it 
serves.
    Funded at an estimated $130 million, in fiscal year 2001, more than 
$90 million of the Center's budget is identified to support specific, 
longitudinal research efforts and programs. That provides very little 
latitude with which the Center can sufficiently support new or expanded 
functions, such as Research Endowments, Centers of Excellence and the 
Loan Repayment program.
    Now that there is a greater recognition of the need to make 
improving the health status of minority Americans a national priority, 
the NMA is asking this Subcommittee to make the same commitment to 
minority health research.

 HEALTH PROFESSIONS TRAINING THROUGH THE HEALTH RESOURCES AND SERVICES 
                         ADMINISTRATION (HRSA)
    The NMA strongly urges the Subcommittee to substantially provide 
increased funding for Health Professions Training Programs at HRSA and 
supports the Health Professions and Nursing Education Coalition's 
recommendation of at least $440 million for Title VII and VIII, of the 
Public Health Service Act, in fiscal year 2002. Each one of the Health 
Professions Training Programs, including the Training for Diversity 
Programs, impact minorities, and other Americans, who reside in Health 
Professions Shortage Areas (HPSA's) where there are shortages of both 
primary care and specialist physicians. Funding cuts to these programs 
will negatively impact the ability of minorities to pursue careers in 
health, as well as the patients who benefit from their training.
    Nearly all of the Health Professions Training Programs fund a 
variety of programs that are essential for students and institutions 
that work to improve the racial and ethnic diversity of the health 
professions workforce. These programs ensure that all Americans, 
regardless of their race or geographic location, have access to quality 
health care services. Narrowing the health status gap that exists 
between minorities and non-minorities is a national priority. Thus, 
increasing the numbers of minorities in the health professions training 
pipeline, as well as those serving in the health professions, is 
absolutely critical to accomplishing this goal.
    Numerous responsible studies demonstrate that, historically, 
African Americans and other minorities are more likely than their non-
minority counterparts to serve in medically underserved areas. However, 
while African-Americans represent approximately 12 percent of the U.S. 
population, they represent only 2-3 percent of the Nation's medical 
professionals.
    Mr. Chairman, this Subcommittee has always been a strong supporter 
of the Health Professions Training Programs. Your continued support is 
vital to ensuring that bright, capable minority students who want to 
pursue careers in the health professions have that opportunity, despite 
the looming financial burdens and matriculation challenges. We 
appreciate and recognize all that you have done for health professions 
training in the past and urge you to be even more ardent supporters in 
fiscal year 2002.

DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS) RACIAL AND ETHNIC HEALTH 
                         DISPARITIES INITIATIVE
    The National Medical Association strongly supports increased 
funding for the DHHS initiative to reduce racial and ethnic disparities 
in health [Racial and Ethnic Approaches to Community Health (REACH) 
Initiative]. Studies clearly indicate that there is a connection 
between race and ethnicity and the growing health disparities and 
disease burden among African Americans and other underserved racial and 
ethnic minorities. With the Nation's changing demographics, it is 
anticipated that minorities will comprise nearly 50 percent of the 
United States population during the 21st Century. Increased support of 
this initiative is critical to the future health of this nation and its 
workforce.
    Currently funded at $35 million, the REACH Initiative must be 
funded at a level that will allow the CDC, in collaboration with OMH 
and other appropriate federal agencies, to intensify its efforts to 
eliminate health disparities by funding additional communities for 
Phase I planning grants, Phase II comprehensive grants, training 
activities under national and regional minority organizations, expanded 
and enhanced technical assistance, research on social and behavioral 
determinants, distance-based training, effective health interventions 
and targeted health outcomes.
    Additionally, in recognition of the strengths that national/multi-
geographical minority organizations can provide this program, NMA urges 
the Committee to request that DHHS include such organizations among the 
entities that are eligible to compete for funding without preventing 
other applicants from receiving these grants. Such organizations often 
have the capacity to influence communities through coalitions and 
collaborative relationships that have already been established and 
provide essential support to local organizations that may lack the 
infrastructure needed to implement the full scale of programmatic 
activities required for this important program.
    The REACH Initiative is critical to enhancing efforts geared 
towards disease prevention, health promotion and the delivery of care 
to racial and ethnic minorities. Adequate support of this critical 
program will enable us to gain a better understanding of the 
relationship between race and ethnicity and health status, thereby 
giving us tools that will help us to eliminate health disparities. The 
development of close working relationships with minority communities is 
critical to ensuring that programmatic implementation strategies and 
activities, such as data collection, are culturally sensitive and 
appropriate.

   DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS) OFFICE OF MINORITY 
                              HEALTH (OMH)
    NMA was pleased that, for fiscal year 2001, Congress provided $50 
million in funding for the Office of Minority Health. However, given 
the additional demands the DHHS Health Disparities Initiative has 
placed on this office, such funding remains inadequate to meet the 
programmatic needs of the Office. NMA strongly supports providing 
adequate funding for OMH to ensure continued support for the Office's 
current programs as well as the expansion of its critical efforts. 
Significantly more support is needed to allow OMH to accomplish the 
goals established by the Health Disparities Initiative.

                    STUDY ON ETHNIC BIAS IN MEDICINE
    Mr. Chairman, during fiscal year 2000, Congress commissioned an 
Institute of Medicine (IOM) Study on ``Ethnic Bias in Medicine.'' This 
study will help provide a clear understanding of the extent to which 
ethnic bias is ingrained in the practice of medicine and the education 
of health professions students. Such knowledge is absolutely essential 
to the effort to eliminate health disparities by 2010. NMA recommends 
the Subcommittee request that the Institute of Medicine report back to 
the Committee regarding the findings and recommendations of the study, 
upon its completion, and urges the Committee to convene a hearing to 
address this important study.

                HEALTH CARE INITIATIVE FOR THE UNINSURED
    In order to provide medical care to the estimated 46 million 
uninsured Americans, physicians and other health care providers, who 
provide this care, must often waive payment or provide care on a 
reduced basis to the uninsured. In fact, studies show that minority 
physicians provide disproportionate levels of care for the uninsured. 
At the same time, the number of uninsured workers has increased and 
changes in managed care have led to reduced Medicaid revenues. The NMA 
is concerned about ensuring that uninsured Americans receive health 
care coverage and that physicians are able to receive an equitable 
reimbursement for their services. Therefore, we strongly urge the 
Subcommittee to provide adequate support for this much-needed 
initiative to strengthen health services for uninsured workers. This 
initiative will provide grants, over five years, to strengthen the 
ability of public and private entities, in 100 communities, to provide 
comprehensive care and coordinate health care for uninsured workers.

                      MINORITY HIV/AIDS INITIATIVE
    While new treatment therapies have led to the recent decline in 
HIV/AIDS death rates, African Americans continue to die from this 
disease at disproportionate rates. In fact, recent data from the 
Centers for Disease Control and Prevention shows that AIDS is the 
number one killer of African American men between the ages of 25 and 44 
and the second leading cause of death among African American women of 
the same age. And, while Blacks and Hispanics accounted for 65 percent 
of AIDS cases, estimates indicate that by the year 2005, Blacks will 
account for 60 percent of all AIDS cases.
    Mr. Chairman, the data paints a clear picture of the devastation 
HIV/AIDS has brought to minority communities. The NMA thanks the 
Committee for its support of the Minority HIV/AIDS initiative during 
the fiscal year 2001 funding cycle and recommends full funding in 
fiscal year 2002 funding for this critical initiative to address HIV/
AIDS across the nation's racial and ethnic minority communities. The 
Minority AIDS initiative is in the early stages of implementation. 
Funding for this program needs to be increased to a level that will 
sustain and expand its current efforts. This program's infrastructure 
and capacity to address disparities in AIDS must be strengthened.

                          HEALTHY PEOPLE 2010
    The National Medical Association views the Healthy People 2010 
initiative as one of great importance. Healthy People 2010 is to be 
commended for making the health objectives identical for all Americans, 
rather than having different (generally lower) targets for minorities 
as was the case for the Healthy People 2000 initiative. The NMA 
strongly believes that all health status targets should be the same for 
all Americans. We urge the Subcommittee to continue to provide the 
necessary resources to the Department of Health and Human Services to 
fund this important initiative.

                               IN CLOSING
    Mr. Chairman, thank you for the opportunity to present the views of 
the National Medical Association. I am pleased to respond to any 
questions that you have. Our Association looks forward to working with 
this Subcommittee to address the challenges we have outlined for you 
today.
                                 ______
                                 

          Prepared Statement of the National MPS Society Inc.

    Mr. Chairman and members of the Subcommittee: My name is Les 
Sheaffer, I serve on the Board of Directors of the National MPS Society 
and chair the Committee on Federal Legislation. My daughter Brittany is 
8 years old and is suffering with MPS III. I have submitted this 
testimony to express the views of the National MPS Society regarding 
the budget of the National Institutes of Health.
    I wish to offer my thanks to Chairman Specter and the members of 
the Subcommittee for their continued support for genetic and biomedical 
research through the National Institutes of Health.
    The Mucopolysaccharidosis disorders are relatively rare genetically 
determined disorders caused by the body's inability to produce certain 
enzymes. The lack of production of these vital enzymes results in the 
interruption of the usual breakdown of specific normal molecules, which 
are then stored in every cell in the body. Storage causes progressive 
damage including respiratory system, bones, internal organs, nervous 
system and brain damage. The most profound effect of these disorders is 
the poor quality of life these children eventually endure and a 
drastically shortened life span. These disorders manifest themselves in 
children sometimes at birth and develop more rapidly with age as cells 
become more damaged by storage.
    The MPS disorders are inherited when both parents are carriers of a 
recessive gene that causes enzyme deficiency in the child. The parents 
maintain a 1 in 4 chance of producing a MPS child with each pregnancy. 
The exception is MPSII in which the mother may be the carrier and 
normally only boys are affected. The occurrence of MPS in the general 
population is believed to be 1 in 25,000 births.
    There are eight types of MPS disorders; Huler Syndrome MPS IH, 
Scheie Syndrome MPS IS, Huler/Scheie Syndrome MPS IHS, Hunter Syndrome 
MPS II, Sanfilippo Syndrome MPS III, Morquio Syndrome MPS IV, 
Maroteaux-Lamy Syndrome MPSVI, and Sly Syndrome MPS VII. All MPS 
disorders result in some combination of the affects listed above.
    NIH funded research is a cornerstone component in the effort to 
develop treatments for these deadly diseases. The grants funded by NIH 
have resulted in a great deal of important information that is integral 
in the quest for viable treatments for the MPS disorders. There is no 
question that NIH appropriations for genetic and biomedical research 
are truly an investment of federal funds.
    NIH supported grants relating to MPS over the past few years have 
included: bone marrow therapy, animal models, gene therapy, enzyme 
therapy, molecular studies, stem cell research and other studies. 
Through the support of the NIDDK, NINDS and NICHD these projects are 
contributing to a better understanding of MPS disorders as well as 
narrowing down possible viable treatment options for MPS. There is 
still much work to be done, with adequate funding this important work 
can continue.
    The 14.2 percent increase for NIH in the fiscal year 2001 
appropriations bill will continue to provide the essential federal 
funds for future advancements. I truly hope that this commitment 
continues to hold the highest priority.
    Expanded research in MPS disorders is a goal of our organization 
however we understand the value of basic and clinical research leading 
to advances in treatments for all disease sufferers. It is also my view 
that legislation and funding for programs supporting pediatric research 
grant programs, collaborative research in NIH institutes, increased 
access to clinical trials, training of pediatric research professionals 
and multidisciplinary research and other enhancements will contribute 
to conquering many crippling diseases.
    The National MPS Society represents hundreds of children with MPS 
and their families across the United States. The support of Congress 
for genetic and biomedical research is greatly appreciated, without 
this support we could not hope to find treatments for MPS and the many 
other disorders that plague thousands of American children.
                                 ______
                                 

     Prepared Statement of the National Multiple Sclerosis Society

    Mr. Chairman and distinguished members of the subcommittee, we 
appreciate the opportunity to submit written testimony on behalf of the 
National Multiple Sclerosis Society. The Society is the world's largest 
private voluntary health agency devoted to the concerns of all those 
affected by MS. Throughout the Society's 55-year history, our number 
one priority has been research to understand MS and apply this 
knowledge to the development of new treatments and a cure. Our current 
annual budget for research is nearly $30 million. This represents the 
largest privately funded program of basic, applied and clinical 
research and training related to multiple sclerosis in the world.
    In this statement, we wish to emphasize the importance of NIH basic 
and clinical research to all people with chronic illnesses and 
disabilities and highlight our solid working relationship with NIH. 
Indeed, NIH and the National MS Society collaborate to further 
biomedical research and to end the devastating effects of MS. The most 
recent example is the first-ever collaborative research effort between 
the NIH and the National MS Society, supporting a multi-year research 
effort on gender and sex-based differences between men and women with 
MS and other autoimmune diseases. This effort, focused primarily at the 
NIAID, serves as an outstanding model for future collaborations between 
the Society and NIH, which we welcome and look forward to.
    MS is a progressive, degenerative and disabling disease of the 
central nervous system, unpredictable in its course, and devastating in 
its effects. It affects a third of a million Americans and their 
families, friends and employers. It can cause spasticity, tremor, 
abnormal fatigue, bladder and bowel dysfunction, cognitive problems, 
visual problems, mobility impairment, and in the worst cases, complete 
paralysis and blindness. The disease usually is diagnosed between the 
ages of 20 and 40--but is life long. Many people with MS live thirty 
years or more with constant unpredictability and progressive 
disability. MS affects more than twice as many women as men, can result 
in loss of employment and loss of a place in society and the community. 
Recent studies sponsored by the National MS Society show that the 
annual direct and indirect cost of the disease for each affected 
individual as a result of MS averages $44,000--and the total cost can 
exceed $2.6 million over an individual's lifetime. For all people with 
MS in the United States, the annual cost exceeds $13 billion. Ending 
the devastating effects of this unpredictable disease is completely 
dependent upon the discovery of safe and effective treatments that halt 
progression of the disease and reverse its symptoms.

     RECENT INSTITUTE OF MEDICINE REVIEW OF CURRENT KNOWLEDGE OF MS
    In April 1999, the National MS Society's Board of Directors 
commissioned the National Academy of Sciences/Institute of Medicine 
(IOM) to undertake a strategic analysis of the current state of 
knowledge of multiple sclerosis and to evaluate strategies for future 
productive basic and clinical research. The Board commissioned the $1.2 
million study in the hope it would identify promising areas of research 
and other strategies that had not previously been exploited, not just 
for the National MS Society, but for all agencies and pharmaceutical 
companies engaged in the battle against MS around the world.
    The IOM assembled a committee of 14 independent scientists and 
physicians from basic and clinical academic research and from industry, 
with expertise in many different fields of science and medicine. Over 
the course of 18 months, the committee reviewed the therapeutic 
frontiers and quality of life issues, and sought comments from 45 
outside consultants. A draft report was prepared, and was reviewed by 
experts from outside the MS Society.
    While underscoring the quality of current MS research worldwide and 
the progress that has been made, the committee made 18 recommendations 
that fall into three categories: research on the cause, course and 
treatment of MS; disease adaptation and management; and building and 
supporting the MS research ``enterprise'' (the training and 
infrastructure to attract and keep the best minds focused on the 
problem of MS). Many are strategies already being employed through 
existing research programs at the National MS Society as well as 
through research programs related to MS supported by government 
agencies, including NIH, and other MS societies around the world.
    Recommendations for Research on Causes, Course, and Treatments:
  --Research the pathological changes underlying the natural course of 
        MS.
  --Investigate how nerve cells are damaged, how that damage can be 
        prevented, and role of glial cells (such as oligodendrocytes 
        and astrocytes) in damage and repair.
  --Identify the genes that make people susceptible to developing MS.
  --Search for a possible pathogen or pathogens that trigger MS.
  --Exploit the power of neuroimaging technology (such as MRI and 
        related technologies).
  --Continue to investigate the immune system events that lead to MS.
  --Develop animal models that better reflect the features of MS.
  --Find strategies to protect and repair neurons and oligodendrocytes, 
        including research into stem cells.
  --Investigate more effective ways to manage troubling symptoms of MS.
  --Research the effectiveness of combination therapies.
  --Develop better strategies to gain the most scientific value from 
        clinical trials.
    Recommendations on Disease Adaptation and Management:
  --Develop better tools for assessing the health status of individuals 
        with MS to increase the reliability and power of clinical 
        trials and to improve individual patient care.
  --Find ways to improve the ability of those with MS to function and 
        adapt, and determine the most pressing needs of people with MS.
    Recommendations on Building and Supporting the MS Research 
Enterprise:
  --Recruit new researchers to work in MS, including those from allied 
        fields.
  --Stimulate collaborations between scientists from different 
        disciplines.
  --Stimulate large-scale, expensive, collaborative studies.
  --Increase cross-disciplinary research on ``quality of life'' issues.
  --Organize research to more rapidly assess claims for new candidate 
        MS pathogens.
    The National MS Society's Research Programs Advisory Committee is 
thoroughly reviewing the report and will, for our own programs, 
prioritize the recommendations that have been made, taking into account 
work already being done, and develop strategies for implementing new 
programs, where appropriate.
    To help disseminate the study's results and plan for the future, 
the National MS Society also has asked the NAS/IOM to host, at the 
Society's expense, a conference in April 2001 that will bring together 
organizations from around the world that fund MS research. The aim is 
to maximize the dissemination of information in the IOM report, to 
stimulate discussion about important strategies that might be 
implemented, and to foster collaborations, where possible, in support 
of MS research. NIH program officers involved in institutes that 
support work related to MS will be in attendance, and it will be an 
opportunity to work toward a coherent, inter-organizational effort to 
further MS research.
    While the IOM study will be an important reference point for the 
development of future strategies in MS research, it also clearly 
illustrates, through the example of MS, the need to continue the course 
of doubling NIH funding over five years (fiscal years 1999-2003).
  --MS is an extremely complex disease with no known pathogen or known 
        determinants of its severity and course, and as a consequence, 
        increased understanding of the cause and treatments require 
        research on many fronts. MS is not alone in this regard. 
        Neurological diseases are among the most difficult to study. 
        Although beneficial therapies have been developed in the last 
        decades for Parkinsons's disease, Epilepsy, and more recently 
        for Alzheimers' disease, there is still no cure for any of the 
        degenerative neurological diseases.
  --Advances, such as improved ability to create images of the living 
        brain and spinal cord, new understanding of the brain's 
        capacity for repair, and the overall accelerated pace of new 
        discoveries about the cellular machinery of the brain, have 
        renewed the optimism of many investigators about the 
        possibility of developing effective therapeutic strategies for 
        MS and other disorders.
  --On the horizon are important new therapeutic strategies: gene 
        therapy, stem cell transplantation and neuroprotection. Much 
        needs to be done in these areas, but progress in understanding 
        and treating virtually all degenerative neurological diseases 
        depends on our ability to capitalize on such new research 
        dimensions.

THE NATIONAL MULTIPLE SCLEROSIS SOCIETY AND THE NATIONAL INSTITUTES OF 
                                 HEALTH
National Institute of Neurological Disorders and Stroke
    The National MS Society has had a long and productive relationship 
with NIH, particularly with the National Institute of Neurological 
Disorders and Stroke (NINDS). Our founder, Ms. Sylvia Lawry, who passed 
away on February 24, 2001, helped spearhead the effort that led to the 
creation of what is now the NINDS at NIH in 1950 when President Truman 
signed the bill into law that established the former National Institute 
for Neurological Diseases and Blindness. Since then, the Society has 
had a very positive working relationship with the institute--a vital 
link for us since NINDS currently is responsible for approximately 75 
percent of the MS-related research at NIH.
    The Society works with NINDS to coordinate grant funding. In cases 
where scientists seek support for projects from both NINDS and the 
Society, we have had fruitful negotiations with the agency to assure 
appropriate levels of funding, without overlapping support.
    Intramural scientists from NINDS serve on our scientific advisory 
committees and help the Society make our research project decisions. 
These outstanding scientist/physicians dedicate their volunteer time to 
help the Society make its research funding decisions, and to help 
ensure that the work of the Society and that of relevant parts of NIH 
are in concert, and not in opposition.
National Institute of Allergy and Infectious Diseases
    While MS is a neurological disease, the root problem in MS is 
dysfunction of the immune system. Therefore, the Society fosters close 
working relationships with the primary institute charged with studies 
of the immune system, the National Institute of Allergy and Infectious 
Diseases (NIAID). NIAID funds about 25 percent of the MS-related 
research at NIH. The Society benefits from a variety of interactions 
with NIAID. We have participated in the NIH Autoimmune Disease 
Coordinating Committee that is assessing federal and non-federal 
support of autoimmune disease research and is charged with plotting a 
dynamic future research plan.
    But perhaps the most significant aspect of our relationship with 
NIAID is the first-ever collaborative initiative to fund research on 
``Sex-based Differences in the Immune Response.'' This collaboration 
extends the reach of the Society's targeted research initiative on 
gender differences in MS by encouraging basic and clinical 
investigation of sex differences in the immune response in MS and 
related diseases; forging new collaborations to address existing gaps; 
providing wider visibility of the problem and opportunities; and 
ensuring increased support for high quality and relevant research.
  --The objectives are to identify and define differences in immune 
        response between males and females to increase understanding 
        and treatment of immune-based diseases such as MS.
  --The Society and NIAID will co-fund research projects relevant to 
        MS, but the program also will fund projects related to other 
        autoimmune diseases.
  --Over the course of this agreement, up to $20 million could be spent 
        on this initiative, of which the Society plans to contribute up 
        to $4 million.
  --A Request for Applications (RFA) has been released, and the 
        deadline is August 2001.

                      NIH FUNDING RECOMMENDATIONS
    NIH plays the major role in maintaining our country's preeminence 
in biotechnology and provides worldwide leadership in health research 
and discovery. The National MS Society recognizes that new discoveries 
and breakthroughs could come from any area of biomedical research and 
could apply to the primary concern of our members: finding new 
treatments and eventually a cure for MS. Therefore we encourage 
Congress to focus on NIH as a whole and on agencies of particular 
relevance to our concern, knowing that a well-funded federal research 
enterprise will be of great public benefit.
    We would like to express our sincere appreciation, Mr. Chairman, 
for the work this subcommittee has done in the past to promote 
biomedical research funding. The National Multiple Sclerosis Society 
believes that in order to take advantage of current opportunities in 
biomedical and rehabilitation research, Congress must increase funding 
at NIH by 16.5 percent for fiscal year 2002. This would keep us on 
track, and bring us another year closer, to our goal of doubling the 
NIH budget over the five-year period fiscal years 1999-2003. In order 
to pursue cutting edge research, the Society recommends that this 
translate into parallel increases of 16.5 percent each for the National 
Institute of Neurological Disorders and Stroke and the National 
Institute of Allergy and Infectious Diseases, the primary institutes 
that conduct nearly all of the MS-related research at NIH.

                          NEUROSCIENCE CENTER
    Last year, Congress approved $47.3 million in funding to begin the 
construction of the John Edward Porter Neuroscience Center at NIH. This 
year, the National MS Society asks that Congress provide $26 million to 
complete Phase I and $10.6 million to start Phase II of construction. 
The Center will emphasize important cross cutting themes such as 
neurodegeneration, regeneration and repair of neurons, neurogenetics 
and pain research. Last year's funding for the Center was incorporated 
into the NIH Building and Facilities budget, and did not affect funding 
for research. Likewise, second-year funding for the Center should come 
out of the same budget. Funding for the Porter Neuroscience Center 
would continue to increase the pace of discovery in all areas of 
neuroscience and help translate laboratory discoveries into new and 
effective treatments.

                                SUMMARY
    The National MS Society recognizes that new discoveries and 
breakthrough findings could come from almost any area of biomedical 
research and could apply to the primary concern of our members: finding 
a cure for MS. NIH plays the major role in maintaining our country's 
preeminence in the biotechnology industry and provides world-wide 
leadership in health research and discovery. We thus encourage Congress 
to focus on NIH as a whole, and on agencies of particular relevance to 
our concern, knowing that a well-funded federal research enterprise 
will benefit all of us.
    Increasing funding at NIH by 16.5 percent will fulfill our fourth 
annual objective in the five-year effort to double the biomedical 
research budget at NIH. We also recommend parallel increases for the 
two institutes that conduct or fund the majority of MS-related research 
at NIH: NINDS and NIAID. In addition, in order to take advantage of 
potential discoveries in all areas of neuroscience and help translate 
these discoveries into new and effective treatments for patients, we 
recommend funding the completion of the John Edward Porter Neuroscience 
Center at NIH. These priorities represent an extraordinarily good use 
of federal resources that will yield important biomedical and economic 
benefits.
                                 ______
                                 

 Prepared Statement of the National Neurofibromatosis Foundation, Inc.

    The National Neurofibromatosis Foundation, Inc. (NNFF) is an 
organization dedicated to improving the health and well-being of 
individuals and families affected by neurofibromatosis otherwise known 
as ``NF.'' The Foundation is the oldest and by far largest NF 
organization in the world. I have been privileged to serve as its 
President since 1986 and currently serve also as Chairman of the 
International Neurofibromatosis Association.
    NF is a neurological disorder that causes a variety of problems 
including learning disabilities, skeletal abnormalities, disfigurement, 
deafness, blindness, loss of limbs, and brain, spinal, and dermal 
tumors. It also can be fatal. NF does not discriminate. It is found in 
every racial and ethnic group throughout the world and affects both 
sexes equally.
    Neurofibromatosis is a surprisingly common genetic disorder of the 
nervous system which causes tumors to grow along nerves anywhere on or 
in the body. In fact, NF is the most common neurological disorder 
caused by a single gene. NF is more prevalent than Cystic Fibrosis, 
hereditary muscular dystrophy, Huntington's Disease, and Tay Sachs 
combined.
  --Two distinct forms of NF exist. NF1 is the more familiar form of 
        the disorder and occurs in one out of every 4,000 births. At 
        least 100,000 Americans of both sexes and all races have the 
        NF1 gene defect. NF2, which generally involves more severe 
        symptoms, occurs in one out of every 40,000 births.
  --Symptoms of both forms of NF vary greatly but can include curvature 
        of the spine, enlarged heads, congenital bone defects, 
        blindness, loss of limbs, and tumors of the optic nerves, the 
        brain, and the spinal cord, as well as the vestibular nerves 
        which may cause deafness.
  --Recent advances in NF research have linked the disorder to cancer, 
        brain tumors, heart disease, and learning disabilities. In 
        particular, NF causes learning disabilities at about four to 
        five times the frequency found in the general population.
    There is still no way to prevent NF and there is no known cure. But 
prior federal funding has helped lead to important advances. 
Researchers are hopeful that a cure can be found in the next 10-15 
years and believe that this timeframe possibly could be cut in half if 
more research dollars are made available. The potential that NF 
research holds for cancer, developmental disorders, and learning 
disabilities is significant for the more than 100,000,000 Americans 
with these medical problems.
    I am pleased and proud that NF research has been recognized as a 
model for ``Managing Science.'' It represents an effective partnership 
between public agencies, most notably the U.S. Congress and the 
National Institutes of Health (NIH), private organizations and The 
National Neurofibromatosis Foundation, Inc., and scientists and 
clinical researchers in the field who have achieved tremendous progress 
by their collaboration. NF also has a particularly strong and committed 
grassroots network of individuals affected by NF and their families who 
are united in a common purpose to promote research and decrease the 
impact of neurofibromatosis.
    NF research has been so productive that scientists have moved from 
cloning the NF gene to the start of clinical trials within a single 
decade. Despite these successes, there is still a long way to go to 
find a cure. The next steps in the neurofibromatosis research agenda 
include continuing work in basic research, preparing comprehensive 
natural history studies for NF, and maintaining the all-important 
process of clinical trials with innovative approaches. With these goals 
in mind, our first priority continues to be directing limited resources 
to support research activities that will lead to better understanding, 
diagnosis, and treatment of neurofibromatosis, and an enhanced quality 
of life for persons with the disorder.
    Congress and the Administration have demonstrated their commitment 
to scientific advances in this field with funding and directives for 
improved coordination at the National Institutes of Health. Funds have 
been appropriated since fiscal year 1996 as part of the Congressionally 
Directed Medical Research Programs (CDMRP) in the Department of Defense 
(DOD) to support neurofibromatosis research by making grants available 
to NF scientists worldwide through a meticulous peer review process. 
CDMRP is a unique partnership among the public, Congress, and DOD to 
mobilize resources and identify untapped opportunities for research 
that will shape the future of health care in areas of tremendous need 
including women's health, osteoporosis, and prostate, breast, and 
ovarian cancer. It is a remarkable testament to the leadership of our 
Armed Services. We have requested that a total of $25,000,000 be 
appropriated in fiscal year 2002 under the Medical Advanced Technology 
account of the DOD Research, Development, Test, and Evaluation budget 
of the U.S. Army for neurofibromatosis research.
    CDMRP is the largest single source of funding for NF1 and NF2 
research in the world. But the support that we have received from other 
sources is also of great importance to the future well-being of 
individuals and families with NF. In its fiscal year 2000 
appropriations bill this Subcommittee added language which expressed to 
the NIH the commitment of the full Committee and of the Congress to 
accelerate research to find a cure for NF. NF research has wide-ranging 
impact beyond neurofibromatosis. It has linked the disease to cancer, 
brain tumors, and developmental disorders. NF research has also 
documented the involvement of neurofibromatosis in heart valve 
formation which may lead to new opportunities and understanding of the 
genetic and environmental causes of heart disease. It has demonstrated 
significant promise to uncovering a molecular basis for cognitive 
impairment and will have broad application to learning disabilities in 
the general population. This Subcommittee has recognized that the wide 
variety of symptoms of NF and the significant potential that NF 
research has for other very large patient populations demands the 
continued integration of neurofibromatosis research with the basic and 
clinical research goals of NIH.
    Today, I'm asking that you continue to provide clear directives to 
the National Institutes of Health to express the continuing commitment 
of the Congress to NF research conducted at NIH, and to ensure that the 
level of funding to find a cure for thousands of individuals with 
neurofibromatosis continues to grow every year. NF has been a 
tremendous research success story for all of those who have invested in 
it.
    Mr. Chairman and Members of the Subcommittee, on behalf of The 
National Neurofibromatosis Foundation, Inc., as well as the thousands 
of children and adults with NF, I thank you for your support.
    The National Neurofibromatosis Foundation, Inc., a non-profit 
organization, is the leading resource on NF. NNFF's primary goals are:
  --To promote and drive research to find the cause(s) and cure for NF;
  --To provide support to patients and their families;
  --To promote public awareness and understanding of NF; and
  --To promote the development of and patient access to high quality 
        medical care for patients and their families.
                                 ______
                                 

   Prepared Statement of the National Organization for Rare Disorders

    Mr. Chairman and members of the Appropriations Subcommittee on 
Labor, HHS, Education and Related Agencies, thank you for allowing the 
National Organization for Rare Disorders (NORD) to submit testimony 
regarding funding for the National Institutes of Health (NIH). We want 
to express our deep appreciation for all the Subcommittee has done to 
ensure increased funding for biomedical research--research that has 
been used to reduce suffering and save lives.
    The rare disease community is asking that the Office of Rare 
Diseases at the National Institutes of Health (NIH) be adequately 
funded to ensure that ALL Americans, not just a select few, have access 
to the incredible work being done at the NIH. Today, only ten cents for 
each and every person suffering with a rare disease or disorder is 
allocated to the ORD. We are asking for a mere $1 for each man, woman 
and child who must sometimes wait years for a diagnosis--$25 million to 
``uncover new knowledge that will lead to better health for everyone.'' 
\1\ We are also asking that ORD be given permanent status to allow for 
a diagnostic and research center, and to expand the authority of the 
office because it does not currently have a permanent line item in the 
NIH budget.
---------------------------------------------------------------------------
    \1\ Scientific Opportunities and Public Needs, National Institutes 
of Health, 1998.
---------------------------------------------------------------------------
    NORD is a federation of approximately 140 voluntary health 
organizations and over 70,000 individual patients, healthcare providers 
and clinical researchers dedicated to helping people with rare 
``orphan'' diseases. An orphan disease is defined by statute as any 
disease or condition impacting less than 200,000 Americans.\2\ It makes 
no difference whether you are male or female, rich or poor, young or 
old, white, African-American, Latino, Asian or American Indian. These 
diseases affect everyone.
---------------------------------------------------------------------------
    \2\ The Orphan Drug Act, Public Law 97-414, January 4, 1983.
---------------------------------------------------------------------------
    Rare ``orphan'' diseases include such better known diseases as 
Sickle Cell anemia, Tay-Sachs disease, Hemophilia, Fanconi's anemia, 
Tourette Syndrome, Lou Gehrig's disease, scleroderma, etc. It also 
includes obscure diseases such as Landau Kleffner Syndrome, Wilson's 
Disease, mastocytosis, Canavan disease, and fibrodysplasia osssificans 
progressiva (FOP). In a recent article by Thomas Maeder in the Red 
Herring, FOP is described ``as one of the strangest and rarest diseases 
of all, with about 125 patients in the United States.'' The body 
mysteriously ``transforms its muscles, tendons, and ligaments into bone 
. . .'' Internal organs are not affected and so patients can live 
normal life spans unless they ``die from complications secondary to 
their immobility, like pneumonia, falls, or choking on aspirated 
food.'' \3\
---------------------------------------------------------------------------
    \3\ Red Herring, Adopting Orphan Diseases, by Thomas Maeder, 
January 16, 2001, p. 130.
---------------------------------------------------------------------------
    Our commitment to those 125 FOP patients and the estimated 25 
million other people suffering with the approximately 6,000 often 
debilitating and devastating diseases is the identification, treatment 
and cure of rare disorders. Approximately 5,000 of those conditions are 
genetic diseases. In fact, no research is being pursued for most of 
them. You can imagine the frustration many of these people feel knowing 
that no one is willing or able to conduct vitally needed clinical 
studies to develop new treatments or cures.
    The mission of the National Institutes of Health is to ``uncover 
new knowledge that will lead to better health for everyone.'' \4\ Yet, 
millions are being left behind simply because they lack the knowledge 
or vast resources available to many larger disease groups that allow 
them to exploit the resources of the NIH. In fact, the National 
Commission on Orphan Diseases (DHHS, 1989) estimated that only 30 
percent of the 25 million patients suffering with rare diseases receive 
a diagnosis in three to five years after the onset of symptoms. That 
works out to about 7.5 million patients who are shuffled from 
specialist to specialist, year after year. Fifteen percent, or 3.7 
million people, wait seven years or more. Those statistics are both 
frightening and unacceptable.
---------------------------------------------------------------------------
    \4\ Ibid.
---------------------------------------------------------------------------
    To help fill that void, the Office of Rare Diseases at the NIH was 
created in 1993. Its mission is to:
  --Stimulate and coordinate research on rare diseases
  --Compile and provide information on rare diseases to patients and 
        their families, as well as researchers and physicians 
        interested in conducting clinical research
  --Co-fund with NIH Institutes and other organizations approximately 
        50 scientific workshops a year costing between $35,000 and 
        $75,000 each to
    --Stimulate research where none exists
    --Establish research priorities
    --Develop collaborative research protocols
    --Encourage the exchange of ideas among investigators, voluntary 
            patient support groups and NIH Institute staff to stimulate 
            new research, and finally
    --Take advantage of scientific opportunities
  --Develop and maintain the Rare Disease Clinical Research Database 
        describing over 1,600 research protocols.
  --Develop and maintain the Medical Genetics and Rare Disorders 
        subfile of the Combined Health Information Database (CHID)
  --Provide information collected from voluntary patient support 
        organizations
  --Coordinate and provide liaison for the NIH with federal and non-
        federal national and international organizations concerned with 
        rare disease research and treatment of rare diseases.
  --Identify current needs in the coordination of rare disease research 
        in cooperation with voluntary health organizations, research 
        investigators and the pharmaceutical and biotech industries
  --Bridge the gap between basic and translational research
  --Discover opportunities to increase research resources
  --Develop novel methods of research planning, coordination and 
        collaboration
    This small office, funded with little more than $2.2 million for 
the 2001 fiscal year, is the only central government resource available 
to 25 million people. When you do the math, that $2.2 million works out 
to be less than ten cents for each and every American suffering with a 
rare disease. And while the entire NIH is enjoying increases of 14 
percent and more, the ORD has seen increases of little more than three 
percent.
    We ask today that this Subcommittee consider the creation of one 
intramural research and diagnostic center for the study of rare 
diseases. The center should conduct research on rare diseases and 
conditions; take advantage of emerging research opportunities; and, 
augment NIH Institutes' research for neglected rare diseases.
    We also ask that the responsibilities of the ORD be extended to 
include:
  --Oversight of the intramural research and diagnostic center for the 
        study of rare diseases
  --Recruitment of qualified academic scientists to participate in the 
        grant review process for rare disease research proposals
  --Support of grants for clinical pilot studies
  --Collaboration with industry to develop gene vectors for gene 
        therapy experiments
  --Expansion of existing programs to provide support for 100 
        scientific workshops and symposia annually, and
  --Development and maintenance of a central clearinghouse for rare and 
        genetic disease information, written in understandable language 
        for use by patients and their families.
    Because rare disease patients are particularly impacted by the cost 
of diagnosis, treatment and ancillary support services that can reduce 
a family to poverty, and because patients must often travel long 
distances to academic hospitals to see the few specialists who work on 
their particular disease, we also ask that this Committee consider the 
creation of four regional extramural diagnostic and research centers to 
expand patient outreach activities and facilitate the development of 
post-doctoral training fellowships.
    Mr. Chairman and members of this Subcommittee, we deeply appreciate 
Congress' commitment to increase research funding for the NIH by 50 
percent over the next five years because many have benefited from the 
groundbreaking work already being done today. But we respectfully 
request that you appropriate a minimum of $25 million to the Office of 
Rare Diseases for the coming fiscal year to help the 25 million 
Americans who look to you and all members of Congress for help.
    Appropriating just one dollar for each rare disease patient in 
America who is suffering with a rare disease, rather than the current 
funding level of less than ten cents, is a win-win situation. Patients 
win when their symptoms are alleviated or cured. Families win when 
their loved ones no longer suffer. Society, as a whole, wins when 
patients are able to return to school or work to become productive tax-
paying citizens. Pharmaceutical and biotechnology companies win when 
they are able to develop new therapeutic products. The scientific 
community wins when the knowledge they gain can be applied to more 
prevalent diseases. And, finally, the government wins when the drain on 
healthcare dollars is minimized.
    I would like to leave you with a quote from Thomas Maeder's 
article--``Yet even if the worries of the few were laid aside, and one 
cared only about bringing the biggest benefits to the greatest number 
of people, it would still make sense to study rare diseases. We 
understand health through the observation of illness, and the more 
illnesses we survey, the more we are likely to learn.'' \5\
---------------------------------------------------------------------------
    \5\ Thomas Maeder, p. 128.
---------------------------------------------------------------------------
    Again, thank you for your continuing commitment to the National 
Institutes of Health and your recognition today of the unmet needs of 
those who suffer with rare ``orphan'' diseases.

                          SUPPORTING DOCUMENTS

     NATIONAL INSTITUTES OF HEALTH, APPROPRIATIONS--FISCAL YEAR 2001
                        [in thousands of dollars]
------------------------------------------------------------------------
                                     FY 2000      FY 2001      Percent
  Institute, Center, or Division     Estimate    Conference     Change
------------------------------------------------------------------------
Cancer...........................    3,310,992    3,757,242         13.5
Heart, Lung, and Blood...........    2,026,006    2,299,866         13.5
Dental and Craniofacial Research.      269,129      306,448         13.9
Diabetes and Digestive and Kidney    1,141,176    1,303,385         14.2
 Diseases........................
Neurological Disorders and Stroke    1,029,528    1,176,482         14.3
Allergy and Infectious Disease...    1,776,571    2,043,208         15.0
General Medical Sciences.........    1,353,660    1,535,823         13.5
Child Health and Human                 859,079      976,455         13.7
 Development.....................
Eye..............................      450,007      510,611         13.5
Environmental Health Sciences....      442,596      502,549         13.5
Aging............................      687,717      786,039         14.3
Arthritis and Musculoskeletal and      349,407      396,687         13.5
 Skin Diseases...................
Deafness and Other Communication       263,606      300,581         14.0
 Disorders.......................
Mental Health....................      974,470    1,107,028         13.6
Drug Abuse.......................      687,232      781,327         13.7
Alcohol Abuse and Alcoholism.....      293,173      340,678         16.2
Nursing Research.................       89,521      104,370         16.6
Human Genome Research............      335,792      382,384         13.9
Research Resources...............      674,913      817,475         21.1
Complementary and Alternative           68,997       89,211         29.3
 Medicine........................
Fogarty International Center.....       43,319       50,514         16.6
Library of Medicine..............      215,154      246,801         14.7
Office of the Director...........      281,941     213,5812        -24.2
National Center on Minority        ...........      130,200          N/A
 Health and Health Disparities...
Buildings and Facilities.........     165,3501      153,790         -7.0
                                  --------------------------------------
    Total........................   17,789,336   20,312,735         14.2
Office of Rare Diseases..........        2,070        2,153         3.8
------------------------------------------------------------------------
\1\ Includes $40 million in advance funding from the previous year.
\2\ The Office of the Director shows a significant loss in fiscal year
  2001 due to the carve-out of funds for the newly established National
  Center for Minority Health and Health Disparities.

  
  
                                 ______
                                 

        Prepared Statement of the National Psoriasis Foundation

    Mr. Chairman and Members of the Appropriations Subcommittee: Thank 
you for allowing the National Psoriasis Foundation (NPF) this 
opportunity to present written testimony to the committee on the 
subject of NIH appropriations, particularly as regards skin disease 
research conducted through the National Institute of Arthritis and 
Musculoskeletal and Skin Diseases (NIAMS).
    We write to urge the committee to approve an allocation for NIAMS 
of $462.2 million for fiscal year 2002, an increase of 16.5 percent 
over current funding levels. This increase would further the commitment 
to double the NIH budget in five years and critically increase the 
ability of our nation's scientists to uncover the secrets of diseases 
such as psoriasis and psoriatic arthritis.
    We make this request on behalf of more than 7 million American men, 
women and children with psoriasis and psoriatic arthritis--chronic, 
debilitating genetic skin and joint diseases. Psoriasis is a common 
disease that affects one person in forty, and yet it is a disease 
without a cure and without universally effective treatments. Until a 
cure or more effective treatments are found, millions of people with 
psoriasis face a lifetime fighting this disease, which costs our nation 
billions of dollars annually and, immeasurably, in the tragic emotional 
and physical toll psoriasis can take on its victims.
    Children.--I am 10 years old, and I have psoriasis. It really 
itches a lot, and I can't do gym at school because it cracks open and 
it hurts really bad. I look at it and I cry. . . .
    Teenagers.--There are many times when I look at myself in the 
mirror and just cry because I look so bad. I haven't gone swimming for 
years now. . . .
    I live in the South, and I wear long sleeves and pants even in the 
summer to hide my psoriasis. My best friends have never seen my legs, 
I'm too ashamed. . . .
    The Elderly.--My medicines are so expensive, I often can't get my 
prescriptions filled. Psoriasis has taken such a toll on my life. Many 
times I've had to stand in the shower to soak my clothes of off my 
skin.
  --More than three billion dollars are spent annually on psoriasis 
        treatment.
  --Each year psoriasis patients make approximately 2.4 million visits 
        to dermatologists.
  --Each year several hundred people with debilitating psoriasis are 
        granted disability by the Social Security Administration.
  --One person in five with psoriasis has disease that interferes with 
        their ability to perform everyday tasks, including employment 
        and childcare.
    Psoriasis is chronic, unpredictable and often unrelenting. 
Treatments may be successful for only relatively short periods of time 
for only some people. The thick, red, scaly patches on any or all parts 
of the body can limit daily activities and interfere with physical, 
occupational and psychological functions. Skin affected by psoriasis 
may itch, burn, sting and easily bleed. Physically, psoriasis can range 
in severity from mild to disabling. Three-quarters of a million of the 
people diagnosed with psoriasis are under the age of ten.
    As many as 20-30 percent of people with psoriasis--more than one 
million people--also suffer from an associated arthritic condition, 
psoriatic arthritis. Psoriatic arthritis can cause significant 
disability, disfigurement and impairment of quality of life. The 
occupational impact of psoriasis and psoriatic arthritis not only poses 
a significant economic burden for this nation but also a significant 
hardship for the person with psoriasis.
    Moderate-to-severe psoriasis, which affects as many as 2 million 
American men, women and children, dramatically inhibits a person's 
ability to maintain a normal, healthy, active lifestyle. Plaques on 
large areas of their skin may restrict their movement and the pain and 
itching often disrupts their sleep and their ability to work. Psoriasis 
on the palms of the hands or the soles of the feet can be disabling, 
preventing people from grasping a pen, holding their child, walking or 
standing.
    These people have psoriasis that cannot be controlled by simple 
topical treatments. To manage their disease they require expensive, 
inconvenient phototherapy (ultraviolet radiation) treatments in a 
doctor's office, or oral systemic medications that put the patient at 
risk of serious side effects. Some types of psoriasis require 
hospitalization and can even be life threatening.
    Emotionally, psoriasis can be devastating. The social rejection and 
physical suffering of psoriasis can lead people to suicide. Many 
psoriasis sufferers struggle throughout their lives with pain, 
embarrassment, and shattered self-image.
    Like diabetes, arthritis and heart disease, psoriasis requires 
lifelong treatment. Indeed, a recent survey shows that 48 percent of 
Americans would actually prefer to have heart disease, asthma or 
diabetes, all of which are life threatening, instead of psoriasis. 
Unlike diabetes or heart disease, however, psoriasis is not a top 
priority for many researchers or pharmaceutical companies. But thanks 
to focus and funding provided by NIAMS, recent research has identified 
several possible sites for the genes that may cause this inherited 
condition. Scientists tell us that a real cure for psoriasis will come 
from these critical genetics studies.
    Other research has begun to pinpoint the autoimmune component of 
the disease, providing valuable targets for drug development. Many of 
the same autoimmune processes that researchers have discovered at work 
in diseases such as rheumatoid arthritis and Crohn's disease are also 
active in psoriasis. For instance, researchers are now finding that 
testing new therapies in psoriasis can be an effective way to determine 
both if a new drug is safe and effective for psoriasis, and also if it 
may work in these other diseases. This research must be aggressively 
supported, as research in one disease will very likely benefit others.
    Effective treatments and a cure for psoriasis are within reach. 
Sufficient funding will enable medical science to find a cure for this 
chronic, costly and devastating disease. This not only will benefit the 
7 million American children and adults now suffering with this chronic 
disease, but also will help the 200,000 people who are diagnosed each 
year with new cases of psoriasis.
    Better treatments or a cure for psoriasis will result in savings 
both to the public and the government in treatment costs, lost workdays 
and Social Security disability claims. Beyond these valuable dollar 
measurements, an increase in federal spending for such biomedical 
research will directly result in an immeasurable improvement in the 
quality of life for these millions of affected Americans.
    Therefore, on behalf of the members of the National Psoriasis 
Foundation, and the 7 million Americans with psoriasis, we again 
strongly urge you to approve $462.2 million for NIAMS, an increase of 
16.5 percent over current funding levels for fiscal year 2002. This 
increase will have significant health and socioeconomic benefits for 
the millions of Americans who are affected by psoriasis and by other 
diseases under the purview of NIAMS.
    Thank you for your time and your support.
                                 ______
                                 

          Prepared Statement of the National Sleep Foundation

    Mr. Chairman, distinguished Members of the Subcommittee, thank you 
for allowing me to submit testimony for the hearing record on behalf of 
the National Sleep Foundation. I am the Medical Director for the Center 
for Sleep Disorders at Doctor's Hospital in Massillon, Ohio. Since 
1994, I have also been a coordinator for the Wake Up America Coalition 
focusing on reducing drowsy driving crashes in Ohio.
    The National Sleep Foundation (NSF) is an independent, non-profit 
organization. NSF works with thousands of sleep experts, patients, and 
drowsy driving victims throughout the country to prevent health and 
safety problems related to fatigue and untreated sleep disorders. The 
Foundation's interest in the Subcommittee's work is based on NSF's 
relationship with the Centers for Disease Control and Prevention (CDC), 
and specifically with the National Institute on Occupational Safety and 
Heath (NIOSH) and the National Center for Injury Prevention and Control 
(NCIPC). NSF is asking the Subcommittee to consider providing an 
additional $1.5 million in fiscal year 2002 funding between NIOSH and 
NCIPC to address sleep deprivation and fatigue-related injury in this 
country.

                        SLEEP AND PUBLIC HEALTH
    We recognize the many competing priorities that the Subcommittee 
must consider as it writes the appropriations legislation for fiscal 
year 2002. At first glance, sleep and fatigue issues may not appear to 
be an immediate concern to the nation's health and safety. However, all 
you need to do is stop and ask yourself, how do I perform when I am 
tired? Have I ever driven while drowsy? Do I know someone with a sleep 
disorder? Can a child learn when they can't stay awake in class? As a 
sleep physician, I can tell you first-hand that insufficient sleep and 
sleep disorders have a profound impact on millions of people's lives.
    Sleep represents a third of every person's life, and it has a 
tremendous impact on how we live, function, perform, and think during 
the other two-thirds of their lives. Sleep is as vital as the air we 
breathe and the food we eat, yet for many, it is last on the ``to do 
list.'' Too many of us forget that lack of adequate, restful slumber 
has serious consequences at home, in the workplace, at school, and on 
the highway. Tragically, drowsy driving claims more than 1,500 lives 
and accounts for at least 100,000 crashes in the United States every 
year. Untreated sleep disorders and sleep deprivation contribute to 
accidents, impaired work productivity, academic performance, reduced 
quality of life, poor health, and even death.

                FATIGUE AND PREVENTABLE DEATH AND INJURY
    We know that tens of thousands of lives are endangered, if not 
lost, each year because of fatigue. Some of them are high profile. For 
instance, fatigue was cited in disasters such as the Exxon Valdez oil 
spill in 1989, and the commercial airline crash in Little Rock, 
Arkansas in 1999. Some of the losses do not make the evening news, but 
they are tragic just the same. Just last year, nine Boy Scouts and two 
Troop leaders from New Kensington, Pennsylvania, were hurt when their 
van flipped over after the driver simply fell asleep at the wheel when 
coming back from a camping trip. People who don't drive automobiles are 
not immune from the danger. In 1998, a 6-year-old Kirkwood, 
Pennsylvania, Amish girl was killed on Route 896 in Bart Township after 
a driver fell asleep and smashed into the back of a buggy in which she 
was riding. These crashes, along with workplace accidents, happen every 
day throughout America. The tragedy is that these accidents are 
eminently preventable.
    Fatigue or sleep deprivation is an impairment, comparable in effect 
to alcohol and drugs. New research tells us that a person who has been 
awake for 24 consecutive hours demonstrates the same impairment to 
judgment and reaction time as an adult who is legally drunk with a 
blood alcohol concentration of 0.10 percent. Furthermore, people do not 
realize that alcohol interacts with sleep deprivation to form a deadly 
combination. An adult with only four or five hours of sleep may think 
he or she is drinking responsibly when they have one or two drinks 
after work, but in this case, what he or she does not know can kill 
them or someone else. Like drugs and alcohol, fatigue needs to be 
addressed as a public health issue.

          RAISING AWARENESS ON SLEEP AND FATIGUE IMPLICATIONS
    The National Sleep Foundation has worked with volunteers like 
myself for the last decade to raise awareness, have people diagnosed 
and treated, and minimize fatigue-related injuries. NSF, in cooperation 
with many partners, has successfully mounted state programs in New 
York, Arkansas, California, Washington, Oregon, and Idaho that target 
fatigue-related injuries. In New York, NSF worked with state and 
federal agencies and other partners to launch the nation's first 
statewide public information and injury prevention program related to 
the dangers of sleep deprivation. In March, NSF worked with over 80 
diverse national organizations, state and federal agencies and more 
than 350 sleep centers to hold a National Sleep Awareness Week, prior 
to Daylight Saving Time, when Americans lose a precious hour of sleep. 
This comprehensive, award-winning public education campaign, now in its 
fourth year, generates tremendous public awareness of how good sleep 
contributes to health, safety, and productivity.
    While public awareness is desperately needed, a strong federal 
partner with the expertise and ability to disseminate tested and proven 
education, training, and injury prevention programs to communities like 
New Kensington and Bart Township are needed even more. The CDC is the 
partner that NSF and public health officials need to help us address 
the comprehensive and complex health and safety problems related to 
sleep issues.
    The problem is complex and far-reaching. Complex in that, while 
there are many unanswered questions about the relationship between 
sleep, rest, and physical performance, the sleep research community has 
established that sufficient sleep is not optional. The costs are as 
immediate a disabling farm equipment accident and as debilitating as 
mental disorders, seemingly unassociated with sleep patterns. Far-
reaching in that the NSF has identified several significant steps we 
need to take in the public health field. Public education, physician 
and police training, school-based programs, workplace safety--these are 
some of the obvious program pieces that the Foundation sees a need to 
initiate.
    We have data telling us that lack of sleep affects the nation on 
many different levels--from the airline pilot in the skies to the child 
in the classroom, from the solider in battle to our farmers in the 
field. But this research does no good if we cannot translate it into 
education and injury prevention programs for the general public. We 
believe that the CDC can and should play a vital role, working with the 
sleep community, to address these problems by developing a Sleep Action 
Plan that would set national priorities around sleep issues in public 
health and safety. The proposed plan would better identify the specific 
public health problems associated with sleep and sleep deprivation, 
gather the relevant data to inform policy decisions, and recommend 
policy direction and plans for implementation.

                     AWARENESS IN MEDICAL COMMUNITY
    The National Institutes of Health estimates that more than 40 
million Americans suffer from chronic sleep disorders, and millions of 
others suffer intermittent sleep problems related to other medical 
problems like depression, diabetes, Parkinson's Disease, arthritis, and 
cancer. The overwhelming majority of these people are undiagnosed and 
untreated due to a lack of public understanding of symptoms and the 
training of physicians in medical schools. A Foundation survey found 58 
million Americans report suffering excessive daytime sleepiness at 
levels that interfere with day-to-day activities.
    We believe increasing awareness on the role of sleep and the 
prevalence of sleep disorders in the medical community is a crucial 
element of addressing the problem. One example of how a physician 
education initiative can make a difference in people's lives is from 
Walla Walla, Washington. Several primary care physicians in Walla 
Walla, Washington, were trained to look for and recognize symptoms of 
sleep apnea, one of the more common and subtly debilitating sleep 
disorders. With this training, physicians were able to diagnose and 
ultimately recommend treatment to hundreds of people for sleep apnea 
and other sleep disorders. A control group of physicians without 
specific training only diagnosed a tiny fraction of these cases. The 
moral of the story is not that there are many people with sleep 
disorders in Walla Walla, but that countless Americans needlessly 
suffer from sleep disorders. These people are one step away from 
serious tragedy because their physicians have not been provided with 
the training they need to diagnose and treat them. Accurate data from 
the health care community along with additional training would show the 
extent of the problem and allow us to target physicians who are on the 
front lines of our health care system to tackle this problem before it 
gets further out of hand.
    The lack of knowledge evident in Walla Walla prior to the 
community-based intervention by sleep physicians was confirmed in a 
recent study by the National Sleep Foundation. The NSF released data in 
January 2001 that indicated that while 98 percent of primary care 
physicians believe that questions about a patient's sleep should be 
part of a routine checkup, only half of the doctors stated that they 
ever asked such questions. Maybe more telling is that most physicians 
admitted that their colleagues were likely to only talk about sleep if 
the patient initiated the conversation.

                       VULNERABLE SUB-POPULATIONS
    One of the largest groups affected by fatigue is young adults. 
Twenty years of research shows us that older adolescents require about 
nine hours of sleep a night to maintain proper alertness during the 
day. Sleep specialists also indicate that during puberty, a shift in 
the biological clock occurs, making it difficult for teenagers to get 
to sleep before 10 p.m. In fact, studies have found that the average 
high school student does not go to bed until midnight. This pervasive 
sleepiness creates what is called a ``sleep debt,'' which profoundly 
affects health, safety, productivity, and learning abilities and makes 
teens the largest at-risk group for fall-asleep car crashes. Evidence 
tells us that America's ``sleep debt'' is on the rise, but we, as a 
nation, lack the basic resources to address this problem.
    Another sub-population at risk for sleep loss is overweight 
children. As the Members of the Subcommittee may know, America's 
children are more obese than ever. The CDC has stated that this health 
issue is reaching epidemic proportions. As a result of this alarming 
weight gain, my colleagues and I are seeing more and more children 
developing obstructive sleep apnea at younger ages. Left untreated, 
sleep apnea leads to higher healthcare utilization and is associated 
with cardiovascular disease, diabetes, stroke, depression, and other 
very serious medical conditions. People with untreated sleep apnea also 
have up to a seven times greater risk of falling asleep behind the 
wheel of an automobile.

                                SUMMARY
    Current CDC resources within the National Center for Injury 
Prevention and Control and the National Institute on Occupational 
Safety and Health are allocated for other projects that are of equal 
importance to the country. It is with this recognition that we ask the 
Subcommittee to increase the overall budget at NCIPC and NIOSH by $1.5 
million to allow CDC to act as the coordinating body for the 
development and implementation of the five-year Sleep Action Plan. This 
plan will allow the NSF, CDC, and other federal agencies to develop and 
distribute accurate, medically sound information and programs to local 
communities. This information, coupled with training for those involved 
with public health and safety at the state level, will begin to turn 
the tide of injuries, health problems, and costs associated with 
sleepiness and sleep disorders. We are ready and willing to take up 
this challenge, but we need your help.
    Thank you for consideration of this request.
                                 ______
                                 

             Prepared Statement of the NephCure Foundation

              SUMMARY OF FISCAL YEAR 2002 RECOMMENDATIONS
    Continue the effort to double funding for the National Institutes 
of Health by providing an increase of 16.5 percent, to $23.7 billion 
for fiscal year 2002. Increase funding for the National Institute of 
Diabetes and Digestive and Kidney Diseases (NIDDK) by 16.5 percent to 
$1,518,443,525 for fiscal year 2002.
    Prioritize glomerular injury research at NIDDK (including clinical 
trials), raise professional and public awareness about glomerular 
injury, and encourage more aggressive scientific attention to all 
kidney diseases.
    Urge NIDDK to develop programs to attract talented researchers to 
the field of glomerular injury.
    Mr. Chairman, and members of the subcommittee, I am pleased to 
present testimony on behalf of the NephCure Foundation (NCF).
    We are a relatively new, non-profit organization with a mission of 
supporting research and public awareness on glomerular injury, which is 
related to the filtering mechanism of the kidney. I serve as president 
of the foundation, and have a son, who has had a glomerular disease 
since he was eleven months old. Although he is now 24 years old and in 
remission, eighty percent of those in his situation lose their kidneys 
or their life by the age of five.
What is glomerular injury?
    Mr. Chairman, each kidney contains about one million tiny filtering 
units called nephrons. Nephrons are the key to the kidney's filtering 
function, processing a constant flow of waste-laden blood, sorting out 
the vital fluids, from the toxic and unnecessary elements.
    When someone suffers from a glomerular disease, this vital process 
is impaired. In some instances, an individual will lose protein and 
sometimes red blood cells in the urine, have high cholesterol levels, 
and experience severe swelling in the body from too much fluid. 
Incidence of this disruptive Nephrotic Syndrome is increasing, and this 
perplexes physicians who cannot identify the cause or cure.
    Sometimes damage occurs to the nephrons, specifically, scarring of 
the glomeruli, which are microscopic capillaries in the nephron. The 
severe form of this glomerular injury is Focal Segmental 
Glomerulosclerosis (FSGS). Presently, there is no treatment to reverse 
this damage. FSGS can lead to end stage renal disease--total, or near 
total, permanent kidney failure. Costly dialysis treatments become 
necessary and kidney transplants may be required for severe cases.
The Toll of Glomerular Injury
    Glomerular injury affects tens of thousands of patients in the 
nation, most of them young. While it is unclear exactly how many 
Americans are impacted, the incidence of glomerular injury is on the 
rise. Severe forms of glomerular injury are costly to diagnose and 
treat, and at this time the only relief for these patients is with 
heavy medication, usually steroids, which have strong and unpleasant 
side effects and only work for about 30 percent of patients.
    Problems of misdiagnosis often occur with glomerular injury. Most 
patients and parents have stories about the unusual length of time 
between the first symptoms and diagnosis. The early signs of glomerular 
injury, swollen eyelids, are often mistaken for allergic reactions. 
Health care professionals don't appear to be fully knowledgeable about 
this disease.
    The physical changes, extreme swelling of the face and body, can 
adversely affect all aspects of a young person's life. With a stronger 
commitment to research and educational awareness, suffering can be 
minimalized and hopefully eliminated.
There is hope for scientific breakthroughs
    At a meeting co-sponsored by the NephCure Foundation, preeminent 
scientists from around the world have shared their findings about the 
podocyte, a major filtering cell, with tentacle-like feet. The 
relationship between the podocyte and the glomerulus may be a key to 
understanding glomerular injury.
    Recently, researchers have discovered certain molecules that are 
essential to the podocyte's function. As this becomes better 
understood, scientists are hopeful of finding better ways to treat 
glomerular diseases, and prevent their progression to more grave 
conditions.
    This spring, NIDDK will begin to establish clinical trials, which 
will test various treatments for hundreds of FSGS patients. But there 
is a need for more funds to strengthen the basic science behind these 
studies. Researchers need to study tissue and fluids from those 
patients to advance their knowledge of the molecular causes of FSGS.
What needs to be done?
    Respectfully, Mr. Chairman, the NephCure Foundation urges this 
subcommittee to:
  --Continue the support for doubling the National Institutes of Health 
        (NIH) and the National Institute of Diabetes and Digestive and 
        Kidney Diseases (NIDDK).
  --Provide the funding and recommendations for the National Institute 
        of Diabetes and Digestive and Kidney Diseases to aggressively 
        pursue a scientific program which will advance research into 
        glomerular injury, conduct clinical trials, raise public 
        awareness, and recruit talented scientists to this field of 
        research.
    Thank you for the opportunity to appear before you today.
    Mr. Chairman, we hoped to have Melanie Stewart here to testify 
today, but her health would not allow her to be here. Her father, Brad 
Stewart, will read Melanie's statement.
    My name is Melanie Stewart. I'm 13 years old and have had FSGS 
since I was six. Until a year ago I spent most of my life in the 
hospital or hooked up to a dialysis machine for 8 hours every day. My 
kidneys finally died last year, so my dad gave me one of his. I've done 
my best to keep it by taking 20 pills a day, fighting off infections, 
hemorrhages, and a blood clot in my heart. The kidney my Dad gave me is 
failing.
    There are thousands of kids just like me who would like a chance at 
a normal life. For all of us, I'm asking for your help in finding a 
cure for this disease.
    Thank you for listening.
                                 ______
                                 

               Prepared Statement of New York University

    On behalf of New York University, I appreciate the opportunity to 
speak in support of public investment in basic research and, in 
particular, to salute the National Institutes of Health, whose funding 
of biomedical and biological research is so important to the health and 
well being of our nation.
    The NIH has benefited in recent years from significant budget 
increases that have enabled important new NIH initiatives and funded 
path breaking research conducted by both NIH as well as university-
based researchers. NIH supports established as well as junior 
investigators, funds research as well as facilities and 
instrumentation, and shapes emerging areas of biomedical research. NIH 
funding is critical both for its direct support of research, as well as 
its indirect impact in enabling extramural (university-based) 
researchers to attract additional funding from other federal agencies, 
private foundations, and industry for research and science 
infrastructure. We at NYU applaud the national goal of doubling the NIH 
budget to $30 billion by 2003, and urge Congress and this Committee to 
support that proposal. A strong NIH is absolutely essential to meet the 
new challenges in biology, biomedicine, and health care.
    At New York University, NIH funding has supported leading-edge 
research across a range of areas from molecular genetics of plants to 
computer modeling of DNA structures to neural visual pathways to 
language comprehension. I would like today to underscore biomedical 
genomics, an important and pervasive area of contemporary biomedical 
research that is a very important priority for NIH and is, as well, an 
area in which NYU is well-positioned to make major contributions.
    The implications of the NIH National Genome Project for America 
cannot be overstated. Its scope of investigations and applications 
encompasses every living thing--humans, animals, and plants--and has 
the potential to revolutionize disease diagnostics and therapy, 
agricultural applications, environmental conservation, and indeed, our 
most cherished notions of life.

                          ADVANCES IN GENOMICS
    The genome is the recipe or blueprint for life. During the last 
decade--and particularly, during the last few weeks alone--the 
unraveling of the genetic code has opened up a vast range of new 
opportunities for evolutionary and developmental biologists, 
neurobiologists and chemists to understand what genes are, what they 
do, and how they do it. Genomics is revolutionizing biology and is 
dramatically changing the way we characterize and address biological 
questions. As a field which straddles biology, chemistry, and 
mathematics, genomics is growing extraordinarily rapidly and 
transforming these disciplines, as well as the social and behavioral 
sciences.
    In its first stage, the revolution in genomics was characterized by 
a period of intensive development of techniques to analyze DNA, first 
in simple models, like yeast, bacteria, the worm, and the fruitfly, 
then in the mouse, and now in humans. The structure and function of 
genes are similar in these models, making comparisons useful. The 
second phase was characterized by the use of these tools to address 
whatever biological question was most easily approached, given the 
state of technique development. It may be described as structural 
genomics--which comprises the mapping and sequencing of genomes and is 
mainly driven by technology. The scientific community is now poised to 
enter the third phase of the genomics revolution in which investigators 
bring perspectives from other fields, like immunology, genetics, and 
neurobiology to pursue investigations that are driven by hypothesis 
rather than technique. This third phase is generally termed functional 
genomics and uses the map and sequence information already collected to 
infer the function of genes. Functional genomics integrates basic and 
clinical science: the strategy is to exploit genomics approaches to 
address the relationship between the genes identified in model 
organisms--like the worm, or the fruitfly--and the genes responsible 
for human disease states.
    At New York University, we think the key issues facing genomics 
today are how to translate the enormous quantities of gene sequence 
data into knowledge of gene function. The answers lie, we believe, in 
comparative functional genomics, an approach that looks for the 
occurrence of the same genes in different species that share certain 
structures or functions, and provides a powerful method for 
understanding the function of particular genes. Comparative functional 
genomics uses two primary modes of analysis: (1) identifying what has 
been conserved over long evolutionary distances, and (2) determining 
crucial differences that distinguish two closely related species. This 
focus can provide the key to understanding the genetic basis of disease 
states that are dependent on numerous genes and to unraveling the 
complex regulatory networks for crucial biological functions.

                    STRENGTHS AT NEW YORK UNIVERSITY
    New York University and other major research institutions are 
poised to make important contributions to the next phase of genomics 
research.
    Studies in comparative functional genomics, the thrust of NYU 
research, is necessarily multidisciplinary, and indeed, involves 
multiple institutions. This approach synergizes medically related 
research programs, such as those at the NYU School of Medicine and its 
affiliated Mount Sinai School of Medicine, with basic science research 
programs such as those at NYU's Faculty of Arts and Science. This 
approach recognizes that an essential feature of emerging genomics 
studies is an intimate tie of biology to computer science. The mass of 
data involved in genomics strains computational capacity and analytic 
tools. This has spawned a new scientific discipline, bioinformatics, 
whose focus is developing entirely new algorithms for large-scale 
database management, alignments, pattern recognition and data 
processing for application to genomic sequences. Accordingly, genomics 
studies at NYU are essentially rooted in computational investigations 
at its Courant Institute of Mathematical Sciences.
    NYU has substantial strengths in areas important to genomics, 
including evolutionary biology, neurobiology, developmental genetics 
and applied mathematics research, imaging and computation, and extends 
this expertise through active collaboration and formal affiliations 
with premier metropolitan area institutions, including The New York 
Botanical Garden, which houses the world's largest collections of well-
characterized specimens from the plant kingdom, and Cold Spring Harbor 
Laboratory, one of the world's centers for molecular biology and 
genomics research. NYU Medical School has outstanding programs in 
developmental genetics, molecular neurobiology, pathogenesis and 
structural biology. And Mount Sinai Medical School has an 
internationally acclaimed program in human genetics and has begun to 
use genomics approaches to identify the origins of human genetic 
disorders. The multidisciplinary perspective that characterizes 
genomics--particularly comparative functional genomics--requires this 
kind of concentration of strengths in biological, neurobiological, and 
computational sciences, and established frameworks for 
interdisciplinary and interschool collaboration.
    The nation's largest private university, with 13 schools and over 
49,000 students, NYU is a leading center of scholarship, teaching and 
research. It is one of 29 private institutions constituting the 
distinguished Association of American Universities, and is consistently 
among the top U.S. universities in funds received from foundations and 
federal sources. NYU encompasses a pre-eminent science faculty and 
generates substantial external funding from federal and state agencies 
as well as the private sector. These investigations have attracted 
millions of federal dollars from the NIH, NSF, ONR, and EPA. In 
addition, NYU has received major funding from the most prestigious 
private foundations supporting the sciences, including the Howard 
Hughes Medical Institute, the W. M. Keck Foundation, the Alfred M. 
Sloan Foundation, and the Beatrice and Samuel A. Seaver Foundation. 
Faculty members have, as individuals, won prestigious awards, including 
HHMI Investigator, NSF Presidential Faculty Fellow, NIH Merit Awardee, 
McKnight Foundation Scholar in Neuroscience, and MacArthur ``Genius'' 
Fellow.

              RESEARCH APPLICATIONS AND NATIONAL BENEFITS
    Concentrated studies in comparative functional genomics can be a 
major resource for the research and development activities of academic 
organizations and commercial firms; can provide a strong framework for 
direct and indirect economic development in vital, high-tech 
industries; and can offer benefits to our citizens from improved health 
care, and technology development. Further investment in state-of-the-
art equipment, and in facilities where computer scientists, physical 
chemists, and geneticists can readily interact with each other is 
essential for the development of this field.
    Advances in Biomedical and Other Research Fields.--The 
understanding of the human genome is a field which is particularly 
fertile with applications to cell biology, embryology, developmental 
biology, study of cancers and many other heritable diseases, 
immunology, endocrinology, neurology, and population genetics. Genomics 
brings together laboratory scientists in all these fields with formerly 
unrelated disciplines, and can stimulate expansion in key directions in 
genetics, physical chemistry, evolutionary studies, and diagnostics. 
Functional genomics research has created a need for information 
processing structures that efficiently compare multiple strands of DNA, 
each represented by thousands of kilobytes of data, and allow groups of 
strands to be represented graphically in a way that highlights their 
common elements and differences. These research challenges overlap with 
the fields of machine vision, robotics, and combinatorial mathematics. 
As an example, computer scientists at NYU are working closely with 
molecular geneticists and business entrepreneurs to develop a library 
of genomics software tools. Some of these tools are already being 
considered by medical researchers for use in diagnosing tumors, which 
have a genetic structure different from healthy tissue.
    Biomedical Applications for National Health Needs.--An investment 
in genomics research will have a heavy payoff in the nation's well-
being by advancing the frontiers of knowledge, finding new cures and 
treatments for diseases, and helping to develop new diagnostic 
technologies. For example, it is known that heart cells dying from 
oxygen deprivation cause heart attacks. It is also known that mice are 
usually more susceptible to low-oxygen heart attacks than humans. The 
hearts of certain breeds of mice, such as the high-altitude deer mouse, 
have the surprising genetic capability to adjust themselves to endure 
oxygen deprivation. Studies conducted by genomics researchers at NYU 
are focused on isolating the gene that allows this adaptation and 
considering the implications for heart attack prevention. Clinical 
applications like this hold enormous promise to revolutionize medicine 
and our understanding of both normal development and disease. Genomics 
research may lead to lifesaving technologies for diagnosis, prevention, 
and cure of diseases and disorders such as diabetes, heart disease, 
cancer and infectious disease. In particular, genomics science has the 
potential to revolutionize the development of mass screening tests for 
genetic disorders, ultimately making it possible to identify the 
hereditary contribution to common diseases, predict individual 
responses to drug intervention, and design drugs that are customized 
for individual use.
    Economic Development.--In a now familiar dynamic of university-
centered economic growth, industry draws on the faculty's 
entrepreneurial energies, their expertise in training the personnel 
needed to staff high-technology firms, and the fundamental scientific 
research that can translate into practical applications. High-tech 
firms spring up near a research university and, in turn, attract or 
spin off additional high-tech firms in the same or related fields. The 
interaction of scientists across firms makes the spread of information 
quicker and the development of projects more rapid. Initial firms and 
newer firms share a growing pool of highly trained personnel. The 
expansion of the skilled labor pool makes hiring easier; the existence 
of the pool attracts still more firms. Once a core of high-tech 
industries locates in an area, venture capitalists identify that area 
as promising. The flow of capital--a key ingredient for high-technology 
growth--increases. Once the process of agglomeration begins, it can be 
expected to grow on itself and become self-reinforcing.
    University funded genomics studies have the potential to identify 
and characterize genes of scientific and economic importance in 
pharmaceutics, biotechnology, industrial processing, and agrigenomics, 
including those directly applicable to human health and well-being. New 
data about the function of genes has widespread commercial 
applications, including, the development of novel human and veterinary 
therapeutics and diagnostics; the generation of data to provide better 
management of patient care, such that medicine becomes more 
``customized'' as it becomes possible to determine which individuals 
will benefit from which therapies; and agricultural applications, 
including the development of crops with improved characteristics such 
as resistance to herbicides, lack of moisture, and other adverse 
conditions, or improved growth capabilities.
    R&D investment in genomics is already energizing bio-technology, 
pharmaceutical, biomedicine, agbiotech, computer software, and 
engineering enterprises. As the genomics research base expands, there 
is likely to be a generation of new commercializable technologies. 
Genomics studies will meet critical needs of existing companies for 
basic research leading to developments in pharmaceuticals, industrial 
processing, and bioinformatics, specifically, large scale functional 
genomics studies to validate genetic targets and bioinformatics studies 
to guide drug discovery efforts. Genomics research is also likely to 
spawn the growth of new companies, including bioinformatics and 
software companies and genomics platform companies that generate 
specific genomic data for product development.
    Research and development funding for genomics will also spur job 
growth. Academic R&D, although itself not directed towards specific 
commercial application, provides the focus for attracting industry and 
serving as a base for commercial spin-offs. A conservative 
approximation that uses state employment multipliers maintained by the 
U.S. Commerce Department's Bureau of Economic Analysis points to 
immediate employment impacts of academic R&D. The BEA calculates that 
each $1 million in R&D grants supports roughly 34.5 full and part time 
jobs \1\ directly within the university and indirectly outside the 
university as the university's expenditures ripple through the local 
and state economy.
---------------------------------------------------------------------------
    \1\ The multiplier is for 1995 and is based on 1987 benchmark 
input-output accounts for the U.S. economy and 1994 regional data, 
adjusted for 1995 inflation. See the latest (March 1997) edition of the 
BEA publication Regional Multipliers: A User Handbook for the Regional 
Input-Output Modeling System (RIMS II). These multipliers are 
frequently used in studies of the economic impacts of individual 
universities and colleges.
---------------------------------------------------------------------------
    Investment in genomic science is a strategic and efficient vehicle 
for advancing fundamental studies in a wide variety of scientific 
fields, facilitating biomedical applications that can greatly enhance 
the public welfare, and energizing existing and new industries. The 
commitment of this committee to support the National Institutes of 
Health and its genomic initiative is greatly appreciated. We urge 
Congress to continue its commitment to doubling the NIH budget. We 
firmly believe that a federal investment in these and other biomedical 
research fields repays itself many times over.
                                 ______
                                 

            Prepared Statement of James and Margaret Nyeholt

    Dear Mr. Chairman: Thank you for allowing us to testify as to why 
orphan diseases--particularly Canavan disease--desperately need 
government funding for medical research. Canavan disease is a model 
disease for other neurodegenerative diseases such as Alzheimer's, 
Parkinson's, MS, and ALS. Medical breakthroughs against Canavan disease 
have the potential to also benefit so many Americans suffering from 
other debilitating neurological diseases. In the case of Canavan 
disease, we are dealing with a 100 percent fatal illness that affects 
children. Most Canavan children do not survive their 10th birthday.
    When our precious grandson (Max Randell) was diagnosed with Canavan 
disease (CD) at 4 months old, our lives were forever changed. We sat in 
a room with our daughter and son-in-law as our family was told that our 
darling Max would disintegrate before our eyes. We were told that Max 
had a fatal progressive brain disorder affecting the formation of 
myelin or white matter of the brain. We learned that the childhood 
victims of CD were among the most profoundly disabled people in the 
world. We sat in horror as the doctors went on to tell us that because 
CD is progressive, the children eventually lose all motor function, 
becoming blind, paralyzed, and require feeding tubes. Canavan 
children's brains slowly dissolve into a spongy mass, and even the most 
elementary signals cannot reach their destination. As respiration slows 
to the point where the lungs can longer function, they usually succumb 
to a common illness such as pneumonia. We were also told that there was 
no treatment or cure for this devastating illness.
    We decided to fight back against this disease. Without government 
help, our family has tirelessly fundraised for the past three years to 
fund groundbreaking medical research for clinical interventions against 
Canavan disease. During the course of the past three years, we have 
formed a public charity devoted to finding a treatment and cure to give 
these children a chance. We know there is hope, as our grandson 
participated in an experimental therapy (solely supported through 
fundraising efforts) where four out of fifteen children produced new 
myelin. These remarkable results were confirmed by MRI's and additional 
follow-up tests. Max is one of these children, and we have personally 
witnessed his gaining vision (his whole world opened up) and the great 
improvements in his quality of life. These improvements are now fading 
and we are desperately fundraising to support another trial. We need 
our government's help to fund research to give these children a chance 
at the life they so deserve.
    The Canavan children love life; they are very loving and social 
children, although they are trapped in bodies that can respond only in 
very limited ways. These children are fighters and we are fighting for 
them, however without government help, by granting additional funds to 
the NIH (with encouragement to grant more research funds towards 
medical interventions for the children battling CD) we cannot move 
forward.
    We are in our late fifties. We have spent much of our retirement 
savings to help to save Max and the Canavan children, and we are 
exhausted and reaching out to our government for help. Both of us have 
worked all of our lives, never asking for any type of government help. 
We both work full time, and are devoted parents and grandparents. Most 
evenings we are up until 2 AM writing fundraising letters to support 
medical research to treat and cure Canavan disease. Over the past two 
years, Jim has lost a kidney due to Kidney Cancer, yet we still devote 
endless time to trying to save these precious children. We are fueled 
by our love for our grandson (and the other Canavan victims we have 
met), as well as the knowledge that advancements against Canavan 
disease will truly aid in developing treatments for other 
neurodegenerative diseases.
    Medical research is overwhelmingly expensive to be solely funded by 
private donations. Mr. Chairman, we are hopeful that (coupled with 
granting additional funds to the NIH) you will also encourage them to 
make an effort to grant more research funds towards therapeutic medical 
interventions for the little victims of Canavan disease. Without 
government grants we cannot raise the millions of dollars necessary to 
continue to support crucial medical research. The Canavan children are 
running out of time. By helping us to save these children's lives, 
millions of other Americans suffering from degenerative brain diseases 
also stand to benefit from this promising research.
                                 ______
                                 

              Prepared Statement of Dr. Christina O'Connor

    My name is Dr. Christina O'Connor from Lake Bluff, Illinois. 
Dentistry has been my pursuit and profession for over half of my life. 
I have become latex allergic by wearing latex gloves in my dental 
practice. I started working in dental offices during high school and 
college. After graduating from Loyola University with a degree in 
psychology, I earned a Certificate in Dental Hygiene at Loyola 
University and began to work as a dental hygienist. While in a 
community outreach program in Newfoundland, Canada, as a hygienist, 
working with poor children, I knew I could do more to help people as a 
dentist. I decided to go to dental school. I graduated from Loyola 
Dental School in 1985 and completed a general dentistry residency and 
fellowship program at Northwestern Memorial Hospital Dental Center. 
Later, I became an Assistant Clinical Professor in Dentistry at 
Northwestern Memorial Hospital Dental Center where I practiced until 
1994. In addition to dental patient care, I was an infection control 
officer.
    During my early years of practice, AIDS emerged as a national 
health problem. The Center for Disease Control mandated universal 
precautions to protect the practitioner and the patient from blood-
borne pathogens. The use of latex gloves, glasses, and masks as well as 
protective clothing, became the standard of care. Dentists all over the 
country washed and gloved their hands between every patient. In the 
dental center where I practiced, latex gloves were snapping off and on 
constantly as dentists, hygienists, and dental assistants moved from 
patient to patient.
    I noticed blister-like formations on the backs of my hand when I 
used latex gloves. My hands were always red, and a rash would appear 
within 24-hours of wearing latex gloves. The rash forced me to change 
to non-latex gloves. Even though I had no direct contact with latex, I 
developed labored breathing, wheezing, itchy swollen eyes, and asthma 
when others used powdered latex gloves in my presence. My shortness of 
breath, coughing, and labored breathing lasted for several hours after 
work. I needed inhaled bronchodilators to help me to breathe.
    I was forced to retire in June of 1997 when a leading latex 
allergist diagnosed me as having Type I Ig-E cell-mediated latex 
allergy after a skin prick test for latex allergy was performed. The 
allergist explained that the skin rashes experienced earlier were 
evidence of a Type IV allergy to latex. He explained that continued 
exposure to airborne latex from powdered gloves even after I stopped 
using latex gloves myself, caused the conversion to Type I (immediate 
hypersensitivity) latex allergy. My choices were very limited. I was to 
avoid latex and its dust to save my life. With a deep sense of loss, I 
retired from my dental profession.
    Today, I know I am not alone. There is an epidemic of latex allergy 
emerging. Scientific literature estimates the prevalence of latex 
allergy among healthcare workers to be between 8 percent to 17 percent, 
and between 1 percent to 6 percent in the general population. One study 
sponsored by the American Dental Association Health Foundation 
estimated average prevalence among dental professionals to be 6.2 
percent based on a health-screening program in 1994 and 1995. The 
American Dental Association has not released latex allergy data from 
this study for the subsequent years 1996, 1997, 1998, and 1999 so it is 
difficult to ascertain whether the prevalence is increasing or 
declining among this group of dental professionals. The American Dental 
Association refuses to disclose this current prevalence data on latex 
allergy.
    Today, I know powdered latex gloves produce ``secondhand latex 
exposure'' similar to the secondhand smoke phenomena seen in the 
tobacco industry. The Food and Drug Administration in 1997 issued a 
report on glove powder stating that the latex protein can bind with 
glove powder and become airborne causing respiratory allergic reactions 
in latex allergic individuals and ``may represent an important agent 
sensitizing non-allergic individuals.'' An article in the Journal of 
the American Medical Association in 1997 stated: ``Since the 
institution of universal precautions, latex glove protein has emerged 
as a major allergen in health care facilities. Airborne exposure of 
health care workers to latex protein allergens may be increased by the 
use of powdered gloves compared with non-powdered gloves.''
    The National Institute for Occupational Safety and Health Alert in 
1997 and the Occupational Safety and Health Administration Technical 
Information Bulletin in 1999 on latex allergy have sought to shed light 
on this emerging health problem and to offer preventive strategies in 
the workplace. The American College of Allergy, Asthma, and Immunology 
launched a nationwide campaign to educate healthcare workers and other 
high-risk groups like spina bifida patients, individuals who have had 
multiple surgical or medical procedures, to the risk inherent in latex.
    The Allergy Report from the American Academy of Allergy, Asthma, 
and Immunology of March 2000 reported: ``The increasing prevalence of 
latex allergy is related to more frequent use of latex gloves resulting 
from universal precautions and changes in the manufacturing process.'' 
The Allergy Report also stated: ``During the past five years, 
increasing evidence has accumulated that latex allergy has become a 
major occupational health problem, which has become epidemic in scope 
among highly exposed healthcare workers, and in others with significant 
occupational exposure.'' With all of these people affected with latex 
allergy, there are still many questions left unanswered. We need 
research for all areas of latex allergy including its prevention, 
immune mechanism, disease progression, and the long-term outcome of 
latex allergic patients.
    Latex allergy is a life long, life threatening condition. The 
biggest risk is anaphylactic shock--a life threatening condition 
resulting in hives, severe swelling of the eyes, mouth, lips, and 
tongue as well as difficulty breathing, severe chest tightness, and 
potentially, respiratory failure. Since 1989, the Food and Drug 
Administration has received reports of 15 deaths due to latex enema 
cuffs. During the past ten years, the Food and Drug Administration has 
received over 2,000 reports of adverse events involving latex gloves. 
Five deaths were included in these reports, in addition to the fifteen 
deaths previously reported. There is no treatment, no cure for latex 
allergy.
    I live a life of avoidance. All I can do is avoid all latex 
products that may be inhaled, ingested, or touched. This presents a 
sizable challenge for all latex allergic patients and me since there 
are over 40,000 products that contain natural rubber latex. I avoid 
paramedics, hospitals, doctor's offices, and dental offices that use 
latex gloves and latex medical equipment. An accidental or inadvertent 
exposure with latex can push me into anaphylactic shock so I carry with 
me two epinephrine injectable pens, latex-free gloves and latex free 
emergency medical equipment. A hospital emergency room or an ambulance 
where latex gloves have been used can be a real threat to me. In my 
community, police officers and paramedics arrive on an emergency scene 
already wearing latex gloves.
    Access to safe medical care is impossible for the latex allergic 
patient when latex gloves and latex medical equipment are all that is 
available. There is no time in an emergency medical situation to 
determine whether a patient is latex allergic. There are safe and 
affordable latex alternatives that offer protection from blood-borne 
pathogens for the patient and the healthcare deliverer. Latex-free 
products should be the standard of care for the emergency medical 
service, fire fighters, and law enforcement.
    I want to ask for your help in financial support for awareness, for 
education, and for research into all aspects of latex allergy. Research 
is desperately needed to formulate a multi-disciplinary approach to 
latex allergy prevention involving hospitals, public health 
departments, emergency medical systems, government regulatory agencies, 
and manufacturers. Research is desperately needed to develop treatment 
models for those who suffer from this emerging public health problem. 
Finally, research is desperately needed to determine the best means of 
educating employers and employees to phase out latex gloves from work 
settings and tasks that do not involve contact with infectious 
material. There is widespread and indiscriminate use of latex gloves in 
non-medical industries such as food handlers, daycare workers, auto 
mechanics, housekeeping personnel, and hair stylists.
                                 ______
                                 

    Prepared Statement of the Pancreatic Cancer Action Network, Inc.

    Mr. Chairman and Members of the Subcommittee. My name is Paula Kim, 
I am the Co-Founder & Chairman of the Board of the Pancreatic Cancer 
Action Network or ``PanCAN''. In March of 1998, my father died from 
pancreatic cancer--a mere 75 days after diagnosis. Watching the 
devastation of this disease first hand, and encountering a severe lack 
of information, scientific progress and advocacy support, sparked my 
desire in 1999 to co-found PanCAN. PanCAN is a non-profit organization 
and the first and only national patient based advocacy group for 
pancreatic cancer. Our staff of three is also fueled by grass roots 
volunteers across the country focused on creating awareness and 
eradicating pancreatic cancer.

                               BACKGROUND
    Increased emphasis on and awareness about pancreatic cancer is a 
good idea for several reasons. First, there is currently no early 
detection method for pancreatic cancer. Second, treatment options are 
severely limited and generally palliative. The term ``palliative'' is 
what doctors say when they try to make someone comfortable while he or 
she is dying from a disease. Third, there is an extreme shortage of 
trained investigators working specifically on pancreatic cancer 
research.
    Pancreatic cancer is one of the most aggressive cancers and has one 
of the lowest survival rates among all cancers. Pancreatic cancer is 
the 4th leading cause of cancer death for men and women in this 
country. About 29,000 Americans are diagnosed with it each year, and 
nearly the same number die each year from this horrible disease. The 
incidence of the disease among African Americans remains 
disproportionately high. The typical pancreatic cancer patient has 
vague symptoms, presents with metastatic disease and has a life 
expectancy of less than one year following diagnosis.
    Our nation's experience in dealing with AIDS, breast cancer and 
prostate cancer has shown us that a focused effort and targeted funding 
can have an enormous impact on combating a specific disease. Pancreatic 
cancer has not attracted much interest because so many of the people 
most familiar with it are in cemeteries and because the research 
funding has been the lowest funded per mortality of all major cancers.
    These facts, along with the recently completed National Cancer 
Institute (NCI) Progress Review Group Report for Pancreatic Cancer, 
clearly identify the overdue and desperate need to accomplish the 
following: develop Centers of Excellence, recruit and train 
investigators, develop public and professional education about the 
disease, support research that identifies new methods of detecting and 
treating pancreatic cancer, and provide patient support and information 
services.
    On behalf of PanCAN and the thousands of pancreatic cancer victims 
and their loved ones, I summon your help and seek to impress upon you 
that ongoing emphasis and action is needed to address the magnitude and 
urgency of this disease. In order for the research community to make 
progress on battling pancreatic cancer, we must first get them to the 
starting line. Your consideration of our recommendations will help 
facilitate this process, and we are extremely grateful for your 
support.

                         FISCAL YEAR 2002 NEED
    For fiscal year 2002, we urge your support in promoting the 
specific actions with the following Federal agencies:
National Cancer Institute
    We commend the National Cancer Institute (NCI) for its report on 
the Pancreatic Cancer Progress Review Group. This report is an agenda 
for action to attack pancreatic cancer. Pancreatic cancer is the 4th 
leading cause of cancer death for men and women.
    However, we remain concerned that while there are over 29,000 new 
cases of pancreatic cancer each year, 28,900 people die each year from 
this disease. It is one of the most fatal forms of cancer but is one of 
the lowest funding priorities at NCI. We seek your support to direct 
the NCI to develop, and present to the Congress within six months, a 
professional judgment budget in line with the NCI Progress Review Group 
for pancreatic cancer research for fiscal year 2003-fiscal year 2008. 
In addition, we seek your support to direct the NCI to develop an 
initiative for the awareness of pancreatic cancer that includes both 
scientific and lay materials to disseminate, thus helping to increase 
public and research awareness about this tragic disease. Also, we would 
request that NCI consult closely with the research community, 
clinicians, patient advocacy groups and Congress in the preparation of 
this report.
National Institute of Diabetes & Digestive & Kidney Diseases
    We seek your support to urge the National Institute of Diabetes and 
Digestive and Kidney Diseases (NIDDK) to collaborate with the National 
Cancer Institute on mutual research areas and awareness programs for 
the scientific and lay communities. We specifically seek your support 
in directing the NIDDK to establish translational research activities 
to understand the inter-relationships of pancreatitis, diabetes, and 
pancreas cancer.
Centers for Disease Control and Prevention
    We seek your support to encourage the Centers for Disease Control 
(CDC) to work with the National Cancer Institute to determine possible 
areas of collaboration in epidemiology, translational research, and 
awareness and registry programs. We would further request that you 
direct the CDC to report back to you on initiatives in these areas when 
they testify before Congress next year.
    It would be most beneficial if the CDC would also plan and 
implement awareness programs for orphan cancers for patients and 
community oncologists. Patients diagnosed with these cancers, such as 
esophageal, kidney, liver, multiple myeloma, pancreatic, and stomach, 
currently have lowest life expectancy rates of all diagnosed cancers, 
yet community oncologists generally lack specific knowledge about these 
malignancies. We suggest that the CDC develop comprehensive community 
oncologist education programs to help doctors better identify orphan 
cancer symptoms and make more accurate, timely diagnoses.
    Because pancreatic cancer adversely affect ethnic minorities and 
the medically underserved, we suggest that the CDC to determine the 
feasibility of integrating hematological (leukemia, lymphoma, multiple 
myeloma), digestive system (liver, pancreatic), and genitourinary 
(kidney, genital) cancers screening and awareness programs into 
existing activities.
    Lastly, we would encourage the CDC registries program to establish, 
along with the states, high-risk registries for the digestive cancers 
(liver, pancreatic) and other cancers with significantly low survival 
rates following diagnosis.

                            CLOSING REMARKS
    Mr. Chairman and Senators on the Subcommittee, thank your for 
allowing me this opportunity to outline specific action steps which our 
Federal agencies may take to further increase the awareness about 
pancreatic cancer and accelerate efforts to eradicate this terrible 
disease. I have attached draft legislative language for your 
consideration so that the recommendations outlined above may be 
incorporated in the Fiscal 2002 Labor/HHS/Education Appropriations 
report.
    Best wishes and good health to each of you.
                                 ______
                                 

 Prepared Statement of the People for the Ethical Treatment of Animals

    Chairman Specter and Members of the Subcommittee: People for the 
Ethical Treatment of Animals (PETA) is the world's largest animal 
rights organization, with more than 700,000 members. We greatly 
appreciate this opportunity to submit testimony regarding fiscal year 
2002 appropriations for the National Institutes of Health. Our 
testimony will focus on nicotine experiments on animals.
    Studies on human beings have documented the effects of smoking on 
disease processes, organ systems, longevity, and other health issues. 
Conducting nicotine experiments on animals is duplicative, meaningless, 
and wasteful.
    We would like to request that the subcommittee include report 
language ensuring that no funds under the appropriations act shall be 
used for nicotine or tobacco experiments on non-human animals.
    In fiscal year 1996, the National Institutes of Health funded 123 
grants totaling $28,099,418 for research primarily concerned with 
cigarette smoke or nicotine. Forty percent of these grants (49 of the 
123) involved non-human animals. As you know, funding is limited for 
medical research and health programs. Why waste American tax dollars on 
nicotine experiments on animals when those funds could be much better 
spent on prevention programs, public education, or clinical studies?

   CURRENT AND ONGOING NICOTINE EXPERIMENTS ON ANIMALS FUNDED BY THE 
                     NATIONAL INSTITUTES OF HEALTH
Pregnancy studies
    In his abstract entitled, ``Fetal nicotine exposure effect on 
primate lung,'' researcher Eliot R. Spindel writes, ``The deleterious 
effects of maternal smoking during pregnancy are all too well 
established,'' including ``overwhelming evidence that smoking during 
pregnancy directly and adversely affects lung development.''
    However, ``overwhelming evidence'' did not stop Spindel from 
applying for and receiving a four-year grant from the National 
Institute of Child Health and Human Development to conduct nicotine 
experiments on pregnant rhesus monkeys. In order to ``characterize the 
effects of chronic exposure to low levels of nicotine throughout 
pregnancy on lung development and subsequent pulmonary function,'' 
pregnant monkeys were given doses of nicotine ``consistent with that of 
smokers.'' Afterwards, the infants' lungs were examined to determine 
the effects of chronic nicotine exposure on lung development and 
function.
    Spindel hopes that his study will ``provide an important tool in 
smoking control and will begin to better explain the link between 
maternal smoking and altered neonatal respiratory function,'' despite 
the fact that evidence already in existence has failed to alter the 
``unfortunate prevalence of smoking during pregnancy.''
    Eliot Spindel is with the Oregon Regional Primate Research Center 
in Beaverton, Ore. His project started in February of 1999 and is 
scheduled to conclude in January 2004. (Source: NIH Computer Retrieval 
Information on Scientific Projects, June 2000.)
    The public health message that can be gleaned from this 
experiment--that pregnant women should not smoke--was already well 
established before these experiments began. From a public health 
standpoint, it is difficult to avoid the conclusion that these 
experiments are, at best, costly and trivial. Experiments like these 
are frightening, stressful, and ultimately fatal for the animals 
involved. If helping human babies is our goal, such experiments should 
be replaced with aggressive public health measures.
Addiction studies
    In his abstract entitled, ``Stress induced reinstatement of 
nicotine-seeking behavior,'' James D. Valentine writes, ``Many believe 
that stressful life events can contribute to drug use in humans, and, 
recently, animal models have been developed for studying this 
phenomenon.''
    According to Valentine, ``exposure to unavoidable stressors can 
dramatically affect drug-seeking behavior, including relapse to drug-
seeking in drug-free animals.'' While a variety of ``drugs of abuse'' 
have been used to examine this phenomenon, the ``effect of unavoidable 
stress on nicotine-seeking behavior has yet to be examined.''
    As a result, Valentine applied for and received a grant from the 
National Institute on Drug Abuse to, ``determine if exposure to 
unavoidable stress will reinstate nicotine-seeking behavior in rats.''
    Valentine is with the Minneapolis Medical Research Foundation, Inc. 
His project started in July of 1998 and was scheduled to conclude in 
June 1999. (Source: NIH Computer Retrieval Information on Scientific 
Projects, June 2000.)
    ``Unavoidable stressors'' as mentioned above can involve a wide 
variety of obstacles, dangers, and painful experiences which the 
animals are forced to endure before they are killed. Stressors in past 
nicotine experiments have included:
  --placing animals on a hot plate heated to 126 degrees F;
  --starvation until between 15 and 20 percent of the animal's body 
        weight is lost;
  --placing an animal in a large, deep tank filled with a paint and 
        water mixture (so that the animal cannot see what is beneath 
        him). The animal's task is to struggle to find a clear 
        Plexiglas ``escape platform'' below the surface on which he can 
        stand to keep his head above the liquid.
    One has to question the value of Valentine's experiment, as it has 
already been well established that nicotine is a highly addictive 
substance, and there is little doubt that rats would seek it just as 
they do cocaine, heroin, and other highly addictive substances. It 
would have been more helpful to society if this money had been used to 
create addiction treatment programs for people for whom stress has 
already ``reinstated nicotine-seeking behavior.''
Other examples
    Here are two more examples of the numerous grants that NIH has 
bestowed for nicotine experiments on animals.
    A grant of $183,628 in 1996 was given to Hakan W. Sundell at 
Vanderbilt University to use nonsedated, mechanically ventilated lambs 
to see if ventilation effects of nicotine exposure relate to SIDS in 
humans. (This grant was given despite our knowledge that maternal 
smoking accounts for about 30 percent of all SIDS cases.)
    A grant of $152,166 in 1996 was given to Leonard L. Howell at Emory 
University to see how caffeine and nicotine interact in rhesus monkeys. 
Again, clinical studies of human beings who smoke and use caffeine 
would be far more relevant.

                                SUMMARY
    Nicotine experiments on animals cause immeasurable suffering and 
divert funds from efforts that benefit human health, such as aggressive 
prevention, education, and addiction treatment programs.
    Please include language in the report accompanying the fiscal year 
2002 Labor-HHS-Education Appropriations bill stating that none of the 
funds under this appropriations act shall be used for nicotine or 
tobacco experiments on non-human animals.
    If you do not feel that that would be possible, please consider 
including the following stipulations in the report:
    If any of the funds under this appropriations act are to be used 
for nicotine or tobacco experiments on non-human animals, the following 
criteria must be met before the experiments can begin:
  --The secretary or administrator of the agency responsible for 
        conducting the experiment shall provide a report to Congress 
        with the following information:
    --the purpose of the experiment and a description of its 
            anticipated benefits to human health;
    --the number and species of animals required;
    --the source from which the animal(s) will be procured;
    --an explanation of why the number of animals cannot be reduced;
    --a detailed description of what procedures the animal(s) will 
            undergo;
    --a rating (none, mild, moderate, or severe) and detailed 
            description of the pain and distress that the animal(s) 
            will experience;
    --a statement of whether or not analgesics or other painkillers 
            will be used (and if not, an explanation of why not);
    --a description of all elements in the experiment considered to be 
            stressors to the animal(s);
    --an explanation of what will happen to the animal(s) after the 
            experiment is completed;
    --a list of all databases that were searched to ensure that the 
            experiment is not replicating any experiment(s) that has/
            have already been performed;
    --a statement that, in the opinion of the secretary or 
            administrator, there is no possible way that the topic of 
            the experiment could be researched without using live 
            animals, and an explanation of why this is, including an 
            explanation of why this experiment would be more relevant 
            to human health effects than human clinical studies or 
            epidemiological studies would be;
    --a description of any non-animal research methods that are 
            currently under development which may be a viable 
            alternative to the experiment, and an explanation of why 
            the experiment cannot be postponed until that non-animal 
            method becomes available for use;
  --this report shall be published in the Federal Register for a 60-day 
        period during which the public may submit comments;
  --this report, along with all public comments submitted during the 
        aforementioned 60-day period, shall be reviewed by the House 
        Appropriations Committee and by the Senate Appropriations 
        Committee. After reviewing the report and the public comments, 
        a two-thirds majority in each committee must vote to approve 
        the use of funds for the experiment.
    If the above three criteria are not met, the funds may not be used 
for the experiment.
    Without these stipulations, tax dollars will continue to be wasted 
on duplicative, meaningless experiments that cause animals to suffer 
and that do nothing to benefit human health.
    Thank you for your consideration of our request.
                                 ______
                                 

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

    Thank you, Mr. Chairman for this opportunity to present the 
position of the Population Association of America (PAA) and the 
Association of Population Centers (APC) to the Subcommittee on Labor, 
Health and Human Services and Education on fiscal year 2002 funding for 
the National Institutes of Health (NIH), specifically the National 
Institute on Aging (NIA), and the National Institute of Child Health 
and Human Development (NICHD). You are a long-standing friend of both 
organizations. We are grateful to you for your recognition and support 
of demographic research.
    As you know, PAA is a scientific and educational society of 
professionals working in demographic research. APC is a consortium of 
30 leading American population research centers. In addition to their 
academic roles, members of both organizations provide federal, state 
and local government agencies, as well as private sector institutions, 
with data and research to guide decision-making. Two population 
research centers are based in Pennsylvania--one in Philadelphia and one 
in State College.
    Demographic research covers many issues important to our nation, 
such as retirement, health disparities, disability and long term care, 
child care, immigration, labor force participation, worker retraining, 
family formation and dissolution, and population forecasting. The 
United States is undergoing far-reaching shifts in its demographic 
composition and distribution. Such changes are not always recognized or 
understood until they confront society with new and immediate needs--
often requiring federal and state expenditures. Incorporating 
demographic, social and behavioral research into long term policy 
discussions allow such changes to be tracked and anticipated in a 
manner that promotes more coherent and efficient planning and policy 
implementation.
    The National Institute of Child Health and Human Development 
(NICHD) and the National Institute on Aging (NIA) provide primary 
support for demographic research at NIH. We would like to take this 
opportunity to share with you information concerning the implications 
of an aging population, the effects of welfare reform on children and 
families, immigration, fatherhood and adolescent health.

        NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
    NICHD has a well-established and successful population research 
program. NICHD is currently funded at $977 million with approximately 
$74.5 million of that budget dedicated to research funded through the 
Demographic and Behavioral Sciences Branch in fiscal year 2000. Among 
the many areas of demographic research supported by NICHD are families 
and household composition; marriage and family change; fertility and 
family planning; teen pregnancy; mortality; HIV prevention; and 
population movement, distribution and composition. NICHD also funds a 
highly regarded population research centers program. Population 
research centers provide a critical core of professionals who conduct 
research in a cost-effective manner. Further, the centers' training 
programs are an essential source of population scientists who bring 
fresh perspectives, ideas and improved methodologies to demographic 
research.
    NICHD-supported demographic research provides important, ongoing 
information critical to policymakers. We are pleased to provide 
information in this testimony that focuses on the Fatherhood 
Initiative, the effects of welfare reform on children and families, 
profiles of immigrants, and adolescent health.
Fatherhood
    In the past, males were often overlooked in research that focused 
on family formation and functioning. NICHD, in conjunction with the 
Federal Interagency Forum on Child and Family Statistics and the 
National Center on Fathers and Families, launched a Fatherhood 
Initiative to review the capacity of the federal statistical system to 
conceptualize, measure and gather information from men about how they 
became fathers and how they provide economic and emotional support to 
their children.
    Among the results of this effort are the inclusion of men in the 
National Survey of Family Growth and the development of a father's 
component in the Early Childhood Longitudinal Survey and the inclusion 
of basic research on fathers in the Early Head Start Research and 
Evaluation Project. NICHD is also supporting research to understand 
factors leading to stable unions among unmarried fathers and mothers.
    The roles fathers play in the lives of their children are strongly 
affected by the father's relationship to the mother: the access of 
fathers to their children is highest when parents are living together. 
The Fragile Families Study has found that unmarried fathers are 
generally engaged with their children at birth and aspire to be good 
fathers, contrary to popular myth. Additionally, in cases of divorce, a 
NICHD funded research has shown that many fathers have enormous desire 
to maintain contact with their children, and with intervention can 
continue to be major influences in the lives of their children.
Welfare Reform Effects on Children and Families
    The 1996 welfare reform act and the subsequent changes in the 
welfare programs of nearly every state constitute the greatest shift in 
social policy for low-income families with children since the Social 
Security Act of 1935. Since the passage of welfare reform legislation, 
welfare caseloads nationwide have dropped dramatically, yet we know 
very little about how these changes affect these children and families. 
NICHD supports a wide range of research that examines how communities, 
families and children are interrelated and adapting to changes in 
social policy.
    The Fragile Families and Child-Well Being Study started collecting 
data in 2000 and will continue through 2004. Initial waves of data will 
inform research on prenatal care, mother-father relationships, 
expectations about fathers' rights and responsibilities, attitudes 
toward marriage, social support and knowledge of local policies and 
community resources. The Three Cities Study of Welfare Reform and the 
Well-Being of Children studies the effects of the 1996 Welfare Reform 
bill on children in three cities, Boston, San Antonio, and Chicago, 
over the period 1999-2002.
Research on Immigration
    Understanding the trends in immigration and the characteristics of 
immigrants is vital for making informed policy decisions. NICHD, the 
Immigration and Naturalization Service (INS), the National Science 
Foundation (NSF), and the National Institute on Aging (NIA) have 
cooperatively funded a New Immigrant Survey Pilot Study (NIP). This 
study will provide immediate policy relevant information on immigrants 
in the U.S. and serve as the foundation for long-term research on 
immigrants.
    Much of the conventional wisdom on immigrants has been repudiated 
in recent NICHD supported studies. For example, legal immigrants are 
better schooled, on average, than the native born; the proportion with 
postgraduate education is almost three times larger than among the 
native born, at the same time, there is also a substantial group 
without a high school education. Overall, however, the quality of legal 
immigrants entering the U.S. is improving. Influenced by changes in 
immigration laws and changing economic conditions, the skill 
composition of immigrants to the U.S. has risen.
Adolescent Health
    Our knowledge of adolescent health has been greatly enhanced by the 
National Longitudinal Study of Adolescent Health (Add Health), a 
comprehensive study, begun in 1994, of adolescent health and well-being 
funded by NICHD and 17 other federal agencies. This study provides 
information that is valuable to parents, educators, researchers and 
policy makers.
    One of the key findings from the Add Health study is that ``family-
connectedness'' plays a central role in protecting adolescent health: 
adolescents who feel loved and cared for by their parents and are 
satisfied with their family relationships are least likely to smoke, 
drink or use illegal drugs; least likely to become sexually active at a 
young age; least likely to be emotionally distressed or contemplate 
suicide; and least likely to engage in violence.
Family and Child Well-Being Research Network
    We would also like to bring you up-to-date on NICHD's Family and 
Child Well-Being Research Network--an interdisciplinary data system 
focusing on child- and family-related research that relies on cross-
agency cooperation. The network is comprised of scientists from nine 
universities collaboratively working with federal officials from NICHD, 
the Office of the Assistant Secretary for Health, of the Department of 
Health and Human Services (HHS), the Administration of Children and 
Families of HHS, the Census Bureau and the Department of Education. 
This network currently addresses a variety of questions about the 
interrelations between parent characteristics, family structure and 
organization, neighborhood attributes and different forms of social 
support. The network is committed to increasing the visibility of basic 
research findings to those involved in formulating public policy. 
Projects such as the Family and Child Well-Being Research Network 
perform the important task of helping synthesize research into sensible 
policy solutions.
    The Network, in cooperation with federal statistical agencies and 
the research community developed a comprehensive set of indicators of 
child well-being. The information from these indices are compiled 
annually in the report ``America's Children: Key National Indicators of 
Well Being.'' This report provides a much improved information base 
that summarizes the changes in the overall well-being of American 
children and families on an annual basis.

                   NATIONAL INSTITUTE ON AGING (NIA)
    The NIA also has a well established and widely respected 
demographic research program, which provides crucial information on the 
implications of an aging of the American population for our country. 
Currently, the NIA is funded at $786 million, with approximately $115 
million of that budget dedicated to the Behavioral and Social Research 
Program--training, career development, and demographic, economic and 
epidemiological research in fiscal year 2000. As the U.S. population 
ages and Congress contemplates sweeping changes in Medicare and Social 
Security, the demography of the elderly steadily becomes more 
important. The NIA has a strong history of supporting the collection of 
data, which allows demographers to study questions of concern to 
policymakers. Chief among these is the NIA-supported studies, the 
Health and Retirement Study (HRS). You have been a solid supporter of 
this important prospective panel study since its inception in the early 
1990s, Mr. Chairman, and we would like to express our gratitude for 
your support.
Health and Retirement Study (HRS)
    The Health and Retirement Study (HRS) was launched in 1992 with 
baseline interviews for a representative sample of persons born between 
1931 and 1941. These respondents were interviewed again in 1994, 1996 
and 1998. Last year HRS completed its most recent round of data 
collection, HRS2000 and even now is preparing to go back into the field 
in 2002.
    In 1993, the HRS was augmented by the AHEAD (Asset and Health 
Dynamics of the Oldest-Old) which sampled the cohorts born before 1924, 
individuals who are the oldest-old segment of our population with high 
rates of chronic disease, disability, and health care costs. The older 
AHEAD respondents were interviewed in 1995, 1998 and 2000. In 1998, 
samples of two other cohorts were added, those born between 1924 and 
1930, the so-called children of the Depression, and those born between 
1942 and 1947, or the ``early baby-boomer cohort''. With the addition 
of these cohorts, HRS is nationally representative of the population 
over age 50. Since 1998, the entire study is referred to as the HRS.
    The original HRS focused on mid-life work and health dynamics. 
Biennial data are now available for all respondents on health, 
disability, work, health insurance, pensions and retirement plans, and 
transfers of time and financial help across generations of the family. 
The HRS has been used by NIA-supported researchers to explore issues 
related to health, work and retirement; mid-life savings and the 
prospects for late-life economic security; cognitive changes, health 
insurance coverage, and use of health care services. Data provided by 
very old respondents has been useful for studying how families 
redistribute their resources across generations, and how these flows 
interact with public sector transfers. These data inform policy 
decisions on initiatives such as Medicare/Medicaid coverage for long-
term care and prescription drug benefits.
Health Status and Health Care
    We have long known that Americans are living longer than ever 
before, and new research shows that older Americans are living better 
as well. A recent NIA funded study showed that while memory problems 
increase with age, fewer seniors were identified as having significant 
memory or cognitive problems in 1998 than in 1993. Both men and women 
experienced improvements over the past decade and marked improvements 
were seen in those over 80. These preliminary findings suggest that 
severe cognitive impairment in the senior population has declined over 
time. This study follows earlier studies which demonstrated a similar 
decline in the rates of physical disability among the senior 
population.
    The majority of Americans over age 65 rates their health as good or 
excellent and report being satisfied with the health care they receive, 
still, many seniors face chronic health conditions or disabilities and 
utilize home care to help meet their needs. While most home care is 
still provided informally and free of charge by family and friends, 
recent trends have shown a decline in the use of informal home care as 
the sole means of help and an increase in the use of combined formal or 
paid assistance and informal help. The 1990s saw dramatic increases in 
paid home health care for older Americans. There are however a number 
of disparities in home care assistance. Research has found that on 
average, disabled women receive significantly fewer hours of informal 
care than disabled men, and the dominant provider is a child rather 
than the spouse, as it is for men.
Federal Forum on Aging Related Statistics
    Finally, PAA and APC are interested in and support the current 
efforts to strengthen the Federal Interagency Forum on Aging-Related 
Statistics. The NIA leads the forum, which is a consortium of nine 
federal agencies working together to improve the quality and usefulness 
of data on older Americans. The forum is an example of NIA's interest 
in supporting NIH's innovative endeavor of streamlining federal 
databases, making data accessible to the business community as well as 
academic researchers. Only by allying these two groups can the data 
produced by the federal government be brought to bear on the real 
problems of older Americans.

                               CONCLUSION
    PAA and APC would like to thank you for the opportunity to present 
this information. Demographic data and research are important tools for 
policymakers that can both save public funds and promote more informed 
decision-making. If this vital research is to continue producing 
relevant and timely information, adequate funding and Congressional 
support are needed.
    The Population Association of America and the Association 
Population Centers support an increase in the range of 15 percent to 
sustain the momentum of demographic research in the National Institutes 
of Health as part of the broadly based support to continue five year 
process of doubling of NIH's by 2003. PAA and APC continue to support 
an even distribution of any increase in funding for NIH among the 
institutes.
                                 ______
                                 

      Prepared Statement of the Pulmonary Hypertension Association

                              INTRODUCTION
    Mr. Chairman, thank you for the opportunity to submit written 
testimony regarding fiscal year 2002 appropriations for the National 
Institutes of Health (NIH) and the Centers for Disease Control and 
Prevention (CDC).
    I am Linda Carr, president of the Pulmonary Hypertension 
Association (PHA). Pulmonary hypertension is a rare disorder of the 
lung in which the pressure in the pulmonary arteries (the blood vessels 
in the lungs) rises above normal levels and may become life 
threatening. Symptoms of pulmonary hypertension include shortness of 
breath with minimal exertion, fatigue, chest pain, dizzy spells and 
fainting. When pulmonary hypertension occurs in the absence of a known 
cause, it is referred to as primary pulmonary hypertension (PPH). This 
term should not be construed to mean that because it has a single name 
it is a single disease. There are likely many unknown causes of PPH.
    Secondary pulmonary hypertension (SPH) means the cause is known. 
Common causes of SPH are the breathing disorders emphysema and 
bronchitis. Other less frequent causes are the inflammatory or collagen 
vascular diseases such as scleroderma, CREST syndrome or systemic lupus 
erythematosus (SLE). Congenital heart diseases that cause shunting of 
extra blood through the lungs like ventricular and atrial septal 
defects, chronic pulmonary thromboembolism (old blood clots in the 
pulmonary artery), HIV infection, liver disease and diet drugs like 
fenfluramine and dexfenfluramine are also causes of pulmonary 
hypertension.
    Pulmonary hypertension is frequently misdiagnosed and has often 
progressed to late stage by the time it is accurately diagnosed. 
Pulmonary hypertension has been historically chronic and incurable with 
a poor survival rate. However, new treatments are available which have 
significantly improved prognosis. Recent data indicate that the length 
of survival is continuing to improve, with some patients able to manage 
the disorder for 15 to 20 years or longer.
    As PHA's new president, I come to this role standing on the 
shoulders of giants. Ten years ago when three women with PH founded 
this organization, there were less than 50 diagnosed cases of this 
disease. It's not that PH wasn't there, so much as it was--for the most 
part--unknown, even in the medical community.
    Today, PHA includes:
  --Over 3,600 patients, care givers and medical professionals
  --An international network of over 50 support groups
  --An active and growing patient hotline
  --An new and fast-growing research fund
  --A host of numerous electronic and print publications
Centers for Disease Control and Prevention
    PHA applauds the subcommittee for its leadership in encouraging CDC 
to initiate a professional and public PH awareness campaign in the 
fiscal year 2001 Labor, Health and Human Services, and Education (L-
HHS) conference report. Currently, we are working with officials from 
the CDC to establish this important program that will better inform 
health care professionals and the general public about PH, its 
symptoms, and treatment options. The following is a description of the 
specific initiatives we hope to launch in collaboration with CDC:
    (1) Increasing awareness and understanding of PH among primary care 
physicians is critically important, because these practitioners are 
usually the first point of contact for PH patients. If the primary care 
doctor misses the symptoms, then the chance for early diagnosis depends 
upon the intuition and persistence of the patient. They have a chance, 
if they aggressively pursue diagnosis by trained and aware specialists. 
If they are not aggressive, or if they are in a health plan that 
requires their general practitioner to prescribe the referral, they are 
more likely to go undiagnosed until it is too late to control their 
illness.
    We are in the process of developing and implementing several 
targeted strategies for reaching these providers, including:
  --Written and video diagnostic tools for placement on the Internet.
  --A postcard mailing to be sent to all primary care physicians, 
        medical schools and medical centers in the United States 
        drawing attention to the new web resources.
  --A simplified and visually attractive version of the proper 
        diagnostic procedures, which will be sent in a second mailing 
        to all primary care physicians, medical schools and medical 
        centers in the United States.
  --Advertising in publications general practitioners are likely to 
        read. The emphasis will be the urgency and ease of early 
        diagnosis and the ease of accessing diagnostic tools via the 
        Internet.
  --A CD-ROM that explains pulmonary hypertension from a variety of 
        angles. We would like to make 100,000 of these available to the 
        medical community and patients through our web site on an as 
        requested basis and at conferences and through targeted 
        mailings.
    (2) Due to the advancements in treatment for PH, it is important 
that we also focus on educating cardiologists and pulmonologists. Our 
strategies for reaching cardiovascular specialists include:
  --Publication of the first Pulmonary Hypertension Journal focused on 
        educating a wider population of doctors on issues related to 
        the diagnosis and treatment of the illness.
  --Placement of additional detailed information on the illness on the 
        web. The PH Journal and other publications will promote this 
        availability.
  --Expansion of PHA's international conference on pulmonary 
        hypertension (the largest PH conference in the world).
  --Expansion of PHA's Pulmonary Hypertension Resource Network. This 
        program is focused on increasing awareness of PH among nurses 
        through peer education.
    (3) Finally, PHA is committed to increasing PH awareness among the 
general public through the development of the following initiatives:
  --A series of 10, 15 and 30 second public service announcements on 
        PH. These PSAs will be in both audio and video form.
  --A PH media relations manual.
  --An organ donation awareness campaign (unfortunately, many PH 
        patients die before finding a suitable organ donor).
  --Expansion of PHA's web-site.
    We look forward to working with CDC to implement these and other 
initiatives aimed at increasing awareness of PH in the United States 
and throughout the world. For fiscal year 2002, we encourage the 
subcommittee to continue to support the important mission of the CDC 
with an overall appropriation of $5 billion (an increase of $1.1 
billion over fiscal year 2001) Moreover, we urge you to provide $1 
million (level funded from fiscal year 2001) within CDC's 
Cardiovascular Disease program (a division of CDC's Chronic Disease 
Prevention program) for the continuation of the PH public and 
professional awareness initiative.
National Heart, Lung and Blood Institute
    Mr. Chairman, PHA commends the leadership of the National Heart, 
Lung and Blood Institute (NHLBI) for its support PH research. Just last 
year, two separate groups of scientists funded by NHLBI simultaneously 
identified a genetic mutation associated with primary pulmonary 
hypertension.
    The two groups, independently reported that defects in the BMPR2 
gene, which regulates growth and development of the lung, are 
associated with PPH. The defects in the gene lead to the abnormal 
proliferation of cells in the lung characteristic of PPH.
    Although both studies suggest that only one gene is involved in 
PPH, neither group identified the defects in BMPR2 as the sole cause of 
PPH. In addition, since many people without a known family history of 
PPH get the disease, both groups suggested that other factors may 
interfere with control of tissue growth. Now that we have pinpointed a 
gene, we can focus on learning how it works. Hopefully, that 
information will enable researchers to devise better treatments and 
perhaps eventually a preventive therapy or cure.
    Mr. Chairman, PHA would like to thank you and the subcommittee for 
your leadership in support of funding for the National Institutes of 
Health. Moreover, we would like to thank the subcommittee for the 
inclusion of committee recommendations on PH research at NHLBI in the 
fiscal year 2002 Senate L-HHS report. For fiscal year 2002, PHA joins 
with the Ad Hoc Group for Medical Research Funding in supporting a 16.5 
percent increase for NHLBI. Finally, we request that the subcommittee 
provide $25 million in fiscal year 2002 for PH research at the 
institute to enhance basic research, gene therapy and clinical trails 
of promising new therapies.

                               CONCLUSION
    Mr. Chairman, once again thank you for the opportunity to present 
the views of the Pulmonary Hypertension Association. We look forward to 
continuing to work with you and the subcommittee to improve the lives 
of pulmonary hypertension patients. If you have any questions or would 
like additional information please do not hesitate to contact me or the 
PHA National Office in Silver Spring, Maryland (301) 565-3004.
                                 ______
                                 

        Prepared Statement of the Research Society on Alcoholism

    The Research Society on Alcoholism appreciates the opportunity to 
present its views about the importance of alcohol research within our 
nation's priorities for health and improving the quality of life. The 
Research Society on Alcoholism is a professional society of over 1,200 
members who are committed to understanding and intervening in the 
negative consequences of alcohol through basic research, clinical 
protocols and epidemiological studies.
    The cost of alcohol abuse and dependence on American society and 
individual lives is staggering. The cost to the nation is estimated at 
approximately $185 billion annually. Not only are the fiscal costs real 
and powerful, but alcohol misuse is costly in other ways as well. 
Specifically, it is associated with 50 percent of all homicides, 40 
percent of all motor vehicle fatalities, 30 percent of all suicides and 
30 percent of all accidental deaths. Furthermore, the cost to 
productive life is astounding. A recent review of estimates of 
Disability--Adjusted Life Years (a means of estimating loss in 
productive daily living) indicates that alcohol abuse and dependence is 
the fifth leading cause of lost life-years in the United States. It 
follows conditions which are not unrelated from alcohol abuse and 
dependence such as ischemic heart disease, traffic collisions, certain 
cancers and HIV/AIDS. For some subgroups, such as the American Indians 
with whom I work, the costs associated with alcohol misuse may be even 
higher and may be directly linked to some of the major health problems 
in this group such as hypertension and diabetes.
    Despite, or perhaps because of, the widespread impact and effects 
of alcohol, it has been impossible to identify a single cause or 
solution to alcohol's negative consequences. There is no doubt that 
alcohol abuse and dependence are affected by a number of factors 
including genetic risk, socio-cultural characteristics, psychiatric and 
general health co-morbidity and individual differences in the acute and 
chronic effects of alcohol. The only hope for better understanding and 
thus more effective education, prevention, intervention, treatment and 
long-term recovery is through research.
    The Research Society on Alcoholism wants to thank the Congress, and 
this Committee in particular, for the strong support the National 
Institute on Alcohol Abuse and Alcoholism (NIAAA) received in current 
fiscal year. Because of this committee's historic support of the growth 
of biomedical research, and the investment in NIAAA more specifically, 
the alcohol research community has made tremendous strides in 
clarifying many of the factors which we now know contribute to risk to 
alcoholism and the overall negative consequences of alcohol abuse and 
dependence. Specifically, because of this support we have seen 
significant advances in disentangling the genetic influence and role of 
family history in alcohol dependence, we have begun to identify the 
critical components of effective treatment, and we have begun to 
explore effective integrated treatments for those who suffer from the 
most severe forms of the disease. Given our scientific understanding of 
alcoholism only a few decades ago, this is truly remarkable progress.
    While recognizing these advances, we believe the need to continue 
the effort and national commitment to this issue. The leadership of the 
Research Society on Alcoholism has framed a set of priorities which, if 
adequately supported, will move the field significantly forward in all 
areas of NIH priority.
    Specifically, we strive to more accurately evaluate risk for 
alcohol dependence and measure the effectiveness of early education and 
primary prevention efforts. In regard to treatment, we are moving 
toward a systematic evaluation of integrated treatments which engage 
more traditional therapies, the use of pharmacotherapies (such as 
naltrexone) and the use of support and self-help groups. This focus 
does not imply that all alcoholics require this level of treatment, but 
it is important that we develop more effective treatments and develop 
means of identifying those who are most in need of these interventions. 
Newer pharmacotherapies are now available which significantly decrease 
drinking and increase sobriety while still newer medications (e.g., 
acamprosate; now under study) appear to reduce craving and thus enhance 
the newly recovering person's ability to sustain abstinence.
    Technology has its place in these identified priorities, as well. 
Imaging and computerized testing will provide the means for 
understanding the underlying brain systems and enable a more standard 
assessment across research protocols. Relatedly, the developing imaging 
techniques will facilitate our understanding of ``craving'' and provide 
the means for its characterization as the ``brain event'' that it is.
    Basic studies of alcohol metabolism with specific subgroups 
continues to be a critical area for study. Additionally, neuroimaging 
studies including brain electrophysiology, positron emission tomography 
and developing technologies will shed light on new ways of 
conceptualizing the disease process of alcohol dependence and 
facilitate the distinction between alcohol abuse and dependence.
    The Human Genome project as well as the Consortium on the Genetics 
of Alcoholism Study (the latter funded by NIAAA) have turned our 
nation's attention to the role of genes and the possibility of 
discovery. Alcoholism will not easily lend itself to a simple genetic 
application. It can, however, be better described, the subtypes better 
identified and the differential risk for various interactions between 
alcohol and other medical disorders better clarified through these 
technologies.
    Finally, we endorse the concern regarding health disparities as it 
is experienced in the research of substance abuse and dependence. We 
know that there appears to be an increased risk within certain ethnic/
racial groups, however, it is unclear why this risk exists and whether 
or not the risk applies to all members of the group. For example, the 
Indian Health Service estimates that the age-adjusted alcoholism 
mortality rate for American Indians is 63 percent higher than the rate 
for all other races in the U.S. Initial studies with other racial 
groups have identified specific strengths and vulnerabilities which are 
important to further explore if we are to address the needs of all 
Americans.
    Recommendations.--Given the costs of alcohol abuse/dependence as 
well as the significant advances over the past decade, we believe that 
the continued support of NIH and NIAAA are imperative to our nation's 
quality of life. Consistent with the Ad Hoc Committee for Biomedical 
Research Funding, the Research Society on Alcoholism is urging that 
Congress support a $3.4 billion, or 16.5 percent, increase for NIH in 
fiscal year 2002 to maintain the congressional campaign to double the 
NIH budget by 2003. Within this funding level, the RSA requests a $79.4 
million, or 23 percent, increase to NIAAA for fiscal year 2002; this 
increase would bring the total NIAAA budget to $420 million. This 
request represents the professional judgement of the alcohol research 
community and is justified on the basis of the historic under funding 
of NIAAA, significant advances in recent years, and the promise of 
opportunity in the present.
    The Research Society on Alcoholism thanks you for the opportunity 
to present our views.
                                 ______
                                 

               Prepared Statement of Rotary International

    Chairman Specter, Senator Harkin, members of the Subcommittee, 
thank you for this opportunity to testify on behalf of Rotary 
International in support of the polio eradication activities of the 
U.S. Centers for Disease Control and Prevention. The effort to 
eradicate polio has been likened to a race--a race to reach the last 
child. As in any race, discipline, commitment, and endurance are 
indispensable elements of success. This race requires the discipline to 
remain focused on the task at hand. We cannot allow ourselves to become 
complacent as we approach the finish line. Though we sense victory is 
near, a single misstep could jeopardize all we have accomplished. This 
race requires the commitment to make the sacrifices necessary to 
achieve success. The major partners in the global polio eradication 
effort have joined with national governments around the world in an 
unprecedented demonstration of commitment to this historic public 
health goal. As the initiative runs its course, total victory can only 
be guaranteed through continued and unwavering commitment to the goal 
of a polio-free world. This race requires the endurance necessary to 
maintain our current activities. We cannot allow the great distance we 
have traveled to diminish our resolve. Though we may be weary from a 
race that has now lasted years, our adversary is weakening. The victory 
over polio is closer than ever!
    I would like to take this opportunity to thank you Chairman 
Specter, Senator Harkin, and members of the Subcommittee for your 
tremendous commitment to this effort. Without your support of the CDC's 
polio eradication activities, the battle against polio would be 
impossible.
    The global eradication strategy is working. In 1985, when Rotary 
began its PolioPlus Program, 125 nations around the world were polio-
endemic. At the end of 2000, only 20 countries remained polio-endemic. 
The Western Hemisphere has now been polio-free since 1991, and the 
Western Pacific region was certified polio-free in October of 2000. 
Europe will be the next block of countries to be certified polio-free 
with the rest of the world anticipated to be certified polio-free not 
later than 2005. Today polio is confined only to Sub-Saharan Africa, 
parts of the Middle East, and South Asia (Exhibit A).
    Thanks to the polio eradication efforts over the last decade, more 
than three million children who might have been polio victims are 
walking and playing normally. Tens of thousands of public health 
workers have been trained to investigate cases of acute flaccid 
paralysis and manage immunization programs. Cold chain, transport and 
communications systems for immunization have been strengthened. A 
network of 148 polio laboratories has been established.
    Significant challenges lie before us. Continued political 
commitment is essential in polio endemic countries, to support the 
acceleration of eradication activities, and in donor countries, so that 
the necessary human and financial resources are made available to 
polio-endemic countries. Access to children is needed, particularly in 
countries affected by conflict. Truces must be negotiated if National 
Immunization Days (NIDS) are to proceed in these countries. Polio-free 
countries must maintain high levels of routine polio immunization and 
surveillance. The continued leadership of the United States is critical 
if we are to overcome these challenges.
    Rotary International is a global association of more than 29,000 
Rotary clubs, with a membership of over 1.1 million business and 
professional leaders in 163 countries. In the United States today there 
are some 7,500 Rotary clubs with over 380,000 members. All of our clubs 
work to promote humanitarian service, high ethical standards in all 
vocations, and international understanding.
    In the United States, Rotary has formed the USA Coalition for the 
Eradication of Polio, a group of committed child health advocates that 
includes Rotary, the March of Dimes Birth Defects Foundation, the 
American Academy of Pediatrics, the Task Force for Child Survival and 
Development, and the U.S. Fund for UNICEF. These organizations join us 
in expressing our gratitude to you for your staunch support of the 
international program to eradicate polio. Over the past several years, 
you have steadily increased your appropriation for the polio 
eradication activities of the Centers for Disease Control, and for 
fiscal year 2001 you appropriated a total of $91.4 million for the 
CDC's overseas polio eradication efforts. This investment has made the 
United States the leader among donor nations in the drive to eradicate 
this crippling disease.

                    FISCAL YEAR 2002 BUDGET REQUEST
    For fiscal year 2002, we respectfully request that you provide 
$106.4 million for the targeted polio eradication efforts of the 
Centers for Disease Control and Prevention, a $15 million increase from 
the fiscal year 2001 funding level. This $15 million increase is 
necessary to respond to the rising cost of oral polio vaccine, which 
has increased to as much as $.096 from $.072 per dose. In addition, we 
must continue to meet the enormous costs of eradicating polio in its 
final stronghold--sub-Saharan Africa. The underdeveloped and conflict-
torn countries of Africa represent the greatest challenges to the 
success of the global Polio Eradication Initiative. This appropriation 
will allow the CDC to help African nations accelerate polio eradication 
activities, improve surveillance for polio and other diseases, and 
support peace-building cease-fires for National Immunization Days. 
Without the additional $15 million, we may not be able to purchase 
sufficient levels of oral polio vaccine, prolonging the need to 
continue expensive NIDs and routine immunization worldwide. The time 
for the final assault against polio is now.

  ERADICATING POLIO WILL SAVE THE UNITED STATES AT LEAST $230 MILLION 
                                ANNUALLY
    In 1998 the Chairman of the House Committee on International 
Relations commissioned the General Accounting Office to investigate the 
soundness of WHO cost estimates for the eradication or elimination of 
seven infectious diseases. The United States was a major force behind 
the successful eradication of the smallpox virus, and the GAO concluded 
that the eradication of smallpox has saved the United States some $17 
billion to date. Even greater benefits will result from the eradication 
of polio.
    Although polio-free since 1979, the United States' public and 
private sectors currently spend at least $230 million annually to 
protect its newborns against the threat of importation of the 
poliovirus, in addition to its investment in international polio 
eradication. Globally, over $1.5 billion U.S. dollars are spent 
annually to immunize children against polio. This figure does not even 
include the cost of treatment and rehabilitation of polio victims, nor 
the immeasurable toll in human suffering which polio exacts from its 
victims and their families. Once polio is eradicated and immunization 
against it can be discontinued, tremendous resources will be unfettered 
to focus on other health priorities.

           PROGRESS IN THE GLOBAL PROGRAM TO ERADICATE POLIO
    Thanks to your leadership in appropriating funds, the international 
effort to eradicate polio has made tremendous progress.
  --Since the global initiative began in 1988, more than 3 million 
        children in the developing world, who otherwise would have 
        become paralyzed with polio, are walking because they have been 
        immunized.
  --The number of polio cases has fallen from an estimated 350,000 in 
        1988--of which 35,000 were reported--to approximately 3,500 
        reported cases in 2000 (Exhibit B). More than 180 countries are 
        polio-free, including 4 of the 5 most populous countries in the 
        world (China, U.S., Indonesia and Brazil).
  --Almost 2 billion children worldwide have been immunized during NIDs 
        in the last 5 years, including 150 million in a single day in 
        India.
  --Approximately 3,500 confirmed polio cases were reported to WHO for 
        2000. As a result of routine polio immunization, NIDs and 
        house-to-house mopping-up activities, there has been a 99 
        percent decline in reported polio cases since 1998.
  --Of the three types of wild poliovirus, Type 2 has not been seen 
        since October of 1999, and appears to have been eradicated.
  --All polio-endemic countries in the world have conducted NIDs. The 
        achievement of successful NIDs and implementation of APF 
        surveillance in Somalia and Sudan shows that polio eradication 
        strategies can be implemented even in countries affected by 
        civil unrest.

    THE ROLE OF THE U.S. CENTERS FOR DISEASE CONTROL AND PREVENTION
    Rotary commends the CDC for its leadership in the global polio 
eradication effort, and greatly appreciates your Subcommittee's support 
of the CDC's polio eradication activities. For 2001, you appropriated a 
total of $91.4 million for the CDC's global polio eradication 
activities. Because of Congress' unprecedented support, in 2001 the CDC 
is:
  --Supporting the international assignment of more than 110 long-term 
        epidemiologists, virologists, and technical officers to assist 
        the World Health Organization and polio-endemic countries to 
        implement polio eradication strategies, and 16 technical staff 
        to assist UNICEF and polio-endemic countries. This includes 30 
        CDC staff provided directly on assignment to WHO and UNICEF.
  --Providing nearly $50 million to UNICEF for approximately 530 
        million doses of polio vaccine and $9 million for operational 
        costs for NIDs in some 60 countries in Asia, Eastern Europe, 
        the Middle East and Africa. A 33 percent increase in polio 
        vaccine costs in 2001 has reduced the number of doses that can 
        be procured with CDC funds. Many of these NIDs would not take 
        place without the assurance of the CDC's support.
  --Providing over $13 million to WHO for surveillance, technical staff 
        and NIDs' operational costs, primarily in Africa. As successful 
        NIDs take place, surveillance has emerged as a critical need to 
        determine where polio cases are continuing to occur. Good 
        surveillance can save resources by eliminating the need for 
        extensive immunization campaigns if it is determined that polio 
        circulation is limited to a specific locale.
  --Training virologists from all over the world in advanced poliovirus 
        research and public health laboratory support. The CDC's 
        Atlanta laboratories serve as a global reference center and 
        training facility.
  --Providing the largest volume of both operational (poliovirus 
        isolation) and technologically sophisticated (genetic 
        sequencing of polio viruses) lab support to the 148 
        laboratories of the global polio laboratory network. CDC has 
        the leading specialized polio reference lab in the world.
  --Serving as the primary technical support agency to WHO on 
        scientific and programmatic issues regarding: (1) laboratory 
        containment of wild poliovirus stocks following polio 
        eradication, and (2) when and how to stop polio vaccination 
        worldwide following global certification of polio eradication 
        in 2005.

                  OTHER BENEFITS OF POLIO ERADICATION
    Increased political and financial support for childhood 
immunization has many documented long-term benefits. Polio eradication 
is helping countries to develop public health and disease surveillance 
systems useful in the control of other vaccine-preventable infectious 
diseases. Already, much of Latin America is free of measles, due in 
part to improvements in the public health infrastructure implemented 
during the war on polio. The disease surveillance system--the network 
of laboratories and trained personnel built up during the Polio 
Eradication Initiative--is now being used to track measles, Chagas, 
neonatal tetanus, and other deadly infectious diseases. NIDs have been 
used as an opportunity to give children essential vitamin A, as well as 
polio vaccine. The campaign to eliminate polio from communities has led 
to increased public awareness of the benefits of immunization, creating 
a ``culture of immunization'' and resulting in increased usage of 
primary health care and higher immunization rates for other vaccines. 
It has improved public health communications and taught nations 
important lessons about vaccine storage and distribution, and the 
logistics of organizing nation-wide health programs. Additionally, the 
unprecedented cooperation between the public and private sectors serves 
as a model for other public health initiatives. Polio eradication is 
the most cost-effective public health investment, as its benefits 
accrue forever. The world will begin to ``break even'' on its 
investment in polio eradication only two years after the virus has been 
vanquished.

        RESOURCES NEEDED TO FINISH THE JOB OF POLIO ERADICATION
    The World Health Organization estimates that $1 billion is needed 
from donors for the period 2001-2005 to help polio-endemic countries 
carry out the polio eradication strategy. Of this total approximately 
$550 million has been committed, leaving a funding gap of approximately 
$450 million. In the Americas, some 80 percent of the cost of polio 
eradication efforts were borne by the national governments themselves. 
However, as the battle against polio is taken to the poorest, least-
developed nations on earth, and those in the midst of civil conflict, 
many of the remaining polio-endemic nations can contribute only a small 
percentage of the needed funds. In some countries, up to 100 percent of 
the NID and other polio eradication costs must be met by external donor 
sources. We are asking that the United States continue to take the 
leadership role in meeting this funding gap.
    The United States' commitment to polio eradication has stimulated 
other countries to increase their support (Exhibit C). Belgium, Canada, 
Germany, and Italy are among those countries that have followed 
America's lead and made special grants for the global Polio Eradication 
Initiative. Japan has also expanded its support to polio eradication 
efforts in Africa. Germany has made major grants that will help India 
eradicate polio. In 1999 the United Kingdom announced two grants 
totaling U.S. $94.6 million for polio eradication efforts in India and 
Africa. In the last year, the Netherlands has committed nearly $50 
million for global polio eradication. The Dutch Government pledged $8.4 
million for surveillance in India, Pakistan and the Democratic Republic 
of the Congo, followed by a year-end allocation of $40 million for 
surveillance in 2000.
    By the time polio has been eradicated, Rotary International expects 
to have expended approximately $500 million on the effort--the largest 
private contribution to a public health initiative ever. Of this, $402 
million has already been allocated for polio vaccine, operational 
costs, laboratory surveillance, cold chain, training and social 
mobilization in 122 countries. More importantly, we have mobilized tens 
of thousands of Rotarians to work together with their national 
ministries of health, UNICEF and WHO, and with health providers at the 
grassroots level in thousands of communities.
    Your discipline, commitment and endurance have brought us to the 
brink of victory in the great race against this ancient scourge. Polio 
cripples and kills. It deprives our children of the capacity to run, 
walk and play. Other great health crises loom on the horizon. The work 
you have done and that which we ask you to continue will ensure that 
today's children possess the strength and vitality to run the race on 
behalf of future generations.
    Thank you for this opportunity to present written testimony.
    
    
    
    
    
    
                                 ______
                                 

       Prepared Statement of the Scleroderma Research Foundation

    The Scleroderma Research Foundation appreciates the opportunity to 
submit this written statement urging Congress to provide increased 
federal support to the National Institutes of Health (NIH) for the 
aggressive pursuit of basic research programs on scleroderma.
    The Scleroderma Research Foundation has, on its own, mobilized and 
developed a high quality scientific and medical research program 
dedicated to the pursuit of a cure for scleroderma, all without 
government support. The advances made by the Scleroderma Research 
Foundation have led to the identification of several key areas of 
investigation that could further focus the path to a cure, if only the 
research receives the support it deserves. As this progress has 
developed, significant government help has been sorely lacking. A 
commitment from Congress and the NIH is needed to leverage and build 
upon the key advances that have been achieved, and to bring us closer 
to saving lives.
    We ask for a commitment by Congress to provide concentrated federal 
support at the NIH to aggressively pursue basic research programs on 
scleroderma. A goal of $10 million annually would constitute a minute 
portion of total health research spending, yet would more than double 
the current available funds for scleroderma research. More important, 
this level of funding would support needed advances in the current 
state of knowledge in the field.
    The Scleroderma Research Foundation also calls for an appropriation 
of $23.7 billion for the NIH in fiscal year 2002. This 16.5 percent 
increase represents the fourth step toward doubling the NIH budget by 
fiscal year 2003. This continued growth will allow the NIH to realize 
the promise of new technologies and better meet the challenges of 
improving the health of the nation's people.
    Scleroderma is a serious, but overlooked and under-funded disease. 
It is conservatively estimated to afflict at least 350,000 Americans 
(many organizations estimate as many as 750,000 scleroderma patients in 
the United States, given recent advances in diagnostics). More than 80 
percent of scleroderma patients are women, between the ages of 30 and 
50, but scleroderma is also a disease that strikes--and kills--children 
and men. Yet, the NIH is projected to fund scleroderma research this 
year at only $4.74 million.
    Scleroderma is a chronic, degenerative disorder that leads to 
vascular deterioration, tissue loss, and fibrosis in the body's 
connective tissue. There are different types of scleroderma, but even 
in the disease's limited forms, scleroderma can be disfiguring, 
debilitating, and painful. In its most serious form, systemic 
sclerosis, the disease causes severe damage and serious complications 
for the body's digestive, respiratory, circulatory, and immune systems. 
Almost 70 percent of patients with systemic sclerosis die in less than 
seven years after their initial diagnosis.
    A diagnosis of scleroderma is all the more chilling for patients 
when they learn there are no effective treatments for the vast majority 
of cases and no cure for the disease. Scleroderma has a particularly 
complex phenotype affecting different organs. The failure of a long 
list of medications in scleroderma patients points to the critical need 
for basic scientific research to unlock the mysteries of this disease.
    When the Foundation was created in 1987 there were no diagnostic 
tools for scleroderma, and research on the disease was almost 
nonexistent. In a little over a decade, the Scleroderma Research 
Foundation has successfully met the challenge of raising pivotal funds, 
brought together top scientists to direct and execute cutting edge, 
basic research programs and targeted the most direct approach to 
finding a cure for scleroderma. The $5 million invested in research by 
the Scleroderma Research Foundation has all come from private sources, 
especially scleroderma patients, their friends, families and 
supporters.
    The Foundation's research programs have made critical discoveries 
in the three major areas of pathogenesis of scleroderma: the immune 
system, blood vessels, and extracellular matrix.
  --Autoantibodies have been found that are unique to scleroderma 
        patients and are not found in other autoimmune diseases. 
        Further research is needed to understand why and how these 
        antibodies form.
  --The study of blood vessel pathology has identified key receptors 
        that mediate the vascular hypersensitivity known as Raynaud's 
        phenomenon, a primary feature of scleroderma and a precursor to 
        extensive vascular damage.
  --Hardening of the skin, or fibrosis, is another prominent feature of 
        scleroderma. Investigators have identified a decrease in an 
        inhibitory molecule that may explain the mechanisms leading to 
        excessive hardening of the skin.
  --New genetics studies have been initiated to determine if there are 
        host factors that can influence the onset of scleroderma. 
        Advances in genetics present new opportunities for scleroderma 
        research, including the development of scleroderma genotypes 
        and the search for genetic mutations or aberrations.
    These discoveries point the way to future investigations that 
cannot be carried by the Scleroderma Research Foundation alone. We have 
made significant progress, but have far to go in understanding this 
disease. We have made enough progress, however, to know that 
scleroderma is a solvable problem. The Scleroderma Research Foundation 
has been successful in bringing together the appropriate scientists in 
specialized fields. The advances in molecular and cellular sciences 
have created tremendous potential, compared to ten years ago, for 
discovering the triggers of this disease. Today, the right people and 
technologies are in place to cure scleroderma. Your partnership is 
needed to secure the necessary resources to get the job done and start 
saving lives.
    Thank you for providing the opportunity to present this statement. 
The Scleroderma Research Foundation welcomes any questions or requests 
for further information.
                                 ______
                                 

    Prepared Statement of the National Task Force to End Sexual and 
                    Domestic Violence Against Women

    The Sexual Assault, Rape and Incest Issues Committee of the 
National Task Force to End Sexual and Domestic Violence Against Women 
urges the Senate Appropriations Committee, Labor, Health, and Human 
Services, Education Subcommittee to appropriate the $80 million for 
Rape Prevention and Education Grants authorized under the Victims of 
Trafficking and Violence Protection Act of 2000, specifically:
    Title IV--Strengthening Education and Training to Combat Violence 
Against Women
    Sec. 1401 Rape prevention and education.
    Congress made a commitment by passing the Violence Against Women 
Act of 2000 to provide increased resources to sexual assault service 
providers and to continue and expand rape prevention programs. FULL 
FUNDING OF THIS GRANT PROGRAM IS CRITICAL TO CONTINUING THIS IMPORTANT 
WORK.
    The funds authorized under the Act are used for prevention and 
education programs for the following:
  --Educational seminars
  --Operation of hotlines
  --Training programs for professionals
  --Preparation of informational material
  --Education and training programs for students and campus personnel 
        designed to reduce the incidence of sexual assault at colleges 
        and universities
  --Education to increase awareness about drugs used to facilitate 
        rapes or sexual assaults
  --Prevention/education efforts targeting underserved communities and 
        individuals with disabilities
    Rape Prevention and Education funding also supports the National 
Sexual Violence Resource Center, a project of the Pennsylvania 
Coalition Against Rape. The Center is a clearinghouse of information 
and resources related to all facets of sexual violence, including 
stranger and non-stranger rape, drug-facilitated rape, statutory rape, 
sexual harassment and child sexual abuse. The Center collects and 
facilitates resource-sharing among organizations across the country. 
Every month, the Center receives over 100 requests for information from 
state and territorial sexual assault coalitions, local rape crisis 
centers, government entities, allied national organizations and the 
media.
    Sexual violence is a critical social epidemic confronting our 
Nation:
    An estimated 302,100 women and 92,700 men are forcibly raped each 
year in the United States (Tjaden, Patricia and Thoennes, Nancy, 
November 1998).
    13.3 percent of college women indicated that they had been forced 
to have sex in dating situation (Johnson, I., Sigler, R., 2000. 
``Forced Sexual Intercourse Among Intimates'').
    In a 1998 study of which school students, over half of all males 
and 42 percent of all females believed that sometimes it is 
``acceptable for a male to hold a female down and physically force her 
to engage in intercourse'' (Warshaw, 1998).
    The majority of rapes nationwide are perpetrated against young 
women and girls. Full funding of the Rape Prevention and Education 
grants is an indispensable tool for keeping women and girls safe from 
sexual violence. Thank you for giving us the opportunity to present our 
perspective.
                                 ______
                                 

        Prepared Statement of the Sjogren's Syndrome Foundation

                           SJOGREN'S SYNDROME
    Sjogren's (SHOW-grins) syndrome is one of the most common 
autoimmune disorders, striking 4 million Americans. Ninety percent are 
women, and most are middle aged and older when diagnosed. However, 
Sjogren's crosses all ages, ethnic groups, and socioeconomic 
boundaries. Anyone can have this disease. There is no cure and few 
treatments beyond palliative measures, yet the suffering and disability 
is tremendous, and the potential consequences serious.
    In Sjogren's, the immune system turns against one's own body. 
Moisture-producing glands are primary targets, resulting in hallmark 
symptoms of dry eyes and dry mouth. These symptoms alone can be 
devastating. If not treated, dry eyes can lead to corneal ulcers and 
abrasions and potential blindness. Untreated dry mouth can lead to 
rampant cavities and loss of teeth. Once teeth are lost, those with 
Sjogren's have few options--dentures often don't work in a mouth that's 
dry and susceptible to infection. Problems with swallowing, digestion, 
and reflux are also common in Sjogren's.
    But Sjogren's syndrome is not confined to symptoms of dryness. 
Sjogren's can affect any organ in the body, including the skin, lungs, 
pancreas, and liver, endocrine glands, and gastrointestinal, vascular, 
nervous, and urinary and reproductive systems. Autoimmune thyroid and 
autoimmune liver disease are not uncommon in one who has Sjogren's. 
Sjogren's can cause debilitating joint and muscle pain and fatigue, and 
maternal antibodies associated with Sjogren's can cause heartblock in 
babies of mothers who have the disease. Finally, Sjogren's can result 
in lymphoproliferative disorders, or lymphoma, there being a 44 times 
higher rate of non-Hodgkins lymphoma in those who have Sjogren's.

            WHAT IS IT LIKE TO LIVE WITH SJOGREN'S SYNDROME
    A Sjogren's syndrome patient, Kim Vaughn, wants to tell you what 
it's like for her to live with the disease. She writes:
    ``I'm a model, a former Mrs. Georgia America, and the mother of two 
energetic boys. I'm a wife, a daughter, a sister. But what I know you 
can't see if you were to look at me is that I have a disease called 
Sjogren's syndrome. This disease has not only affected my life, but it 
has affected the lives of every member of my family.
    Sjogren's syndrome is an autoimmune disease. While it can affect 
any organ in the body, it targets the moisture producing glands. Can 
you imagine your eyes being constantly dry because you can't produce 
tears? Can you imagine what it's like not to have saliva, so that you 
can't eat many common foods? Can you imagine being so exhausted every 
night that you collapse at 8:00 p.m.? It's hard enough to raise two 
boisterous boys with a normal energy level.
    I live with pain.--Joint and muscle pain are a big part of 
Sjogren's syndrome. I know it's hard for people to understand the 
impact of pain and fatigue, and it might seem minor to have dry eyes 
and dry mouth, but these symptoms are devastating. To have your eyes 
and mouth dry all the time, be susceptible to infection, always have to 
carry and use moisturizing eyedrops and drinking water wherever I go . 
. . these things greatly affect quality of life.
    I live with fear.--Will I be one of the 5 percent with Sjogren's 
who gets lymphoma and leaves a wonderful husband and kids behind, 
because this disease doesn't seem urgent or important enough? Because 
my symptoms can't be seen? When I was pregnant, I had to worry if my 
child would have fetal heartblock because of my Sjogren's. Would I have 
the energy to take care of an infant, to nurture a baby from infancy to 
adulthood? Are my children genetically susceptible to this disease?
    I was one of the lucky ones because I was diagnosed quickly--it 
only took a year and a half. Sjogren's might be a common autoimmune 
disease, but most women suffer for years before being diagnosed. When 
we're finally diagnosed, there's not much to be done for it but treat 
the symptoms, many times ineffectively or only for a little while. Why?
    The Sjogren's Syndrome Foundation greatly appreciates your 
continued support of federally funded medical research. Please help us 
to take advantage, now, of the escalating breakthroughs in medical 
research to unlock the mysteries of autoimmunity--particularly the 
mysteries of Sjogren's syndrome.''

                            QUALITY OF LIFE
    Quality of life might be hard to measure, but it is critical to 
one's well-being, to the ability to live a full life without 
potentially crippling psychological and physical anguish and affecting 
employment and enjoyment of life.
    Quality of life is surely compromised when one is frequently in 
pain and suffers from severe fatigue, spends hours in doctors' offices 
and undergoing testing, and when one faces fear of complications. Other 
quality-of-life issues include having one's eyes and mouth hurt all the 
time and succumb to infection, not always being able to focus clearly, 
swallow easily, go out to eat, or talk for long periods or take a walk 
because one's throat and mouth get dry quickly. The incidence of 
depression increases when quality of life diminishes.
    Most of the palliative treatments to which patient Kim Vaughn 
refers are over-the-counter medications, which are not reimbursable by 
insurance. This creates an additional financial burden on those who 
suffer from Sjogren's syndrome. High costs of medical testing, frequent 
doctors' visits to a range of specialists, and prescription 
medications, might or might not be largely covered by insurance. Those 
who are chronically ill face lifetime insurance caps and often find 
work options reduced.
    Let's take a look at the impact of just one of the common symptoms 
of Sjogren's--dry eye: A year 2000 study by Dr. David Sullivan of The 
Schepens Eye Research Institute, Harvard Medical School, found that 
more than 37 percent of employed dry eye patients say their symptoms 
interfered with their work and more than 60 percent say symptoms 
interfered with leisure activities. The same 60 percent say their 
lifestyle has been adversely affected, and of these, more than 40 
percent suffer from depression. Some 40-45 million Americans, most of 
them women, have dry eye, and the numbers double from those in their 
50s to those 75 and older.

                              THE NUMBERS
    Autoimmunity is a huge problem. Autoimmune diseases make up the 
third largest disease category in the United States, affecting 5 
percent of the population, and include some 70 to 80 diseases, many of 
which overlap and share symptoms. Sjogren's syndrome is one of the most 
prevalent.
    The numbers of those with Sjogren's syndrome are probably higher 
than scientists estimate. It is often unrecognized and, thus, 
underdiagnosed and misdiagnosed. Among the reasons--the disease crosses 
many medical specialties, symptoms often seem unrelated, and Sjogren's 
can mimic or co-exist with other autoimmune organ-specific disorders. 
Dryness might be attributed incorrectly to the aging process. Other 
complaints of fever, joint and muscle pain, and fatigue, and the waxing 
and waning of symptoms are sometimes seen as insignificant to 
physicians not well informed about Sjogren's syndrome. It often takes 
years of seeking help before a diagnosis is made; a recent national 
health study showed an average of 6.3 years from onset of symptoms to 
diagnosis. Add to this the fact that the baby-boomer generation is now 
entering the age of high risk for Sjogren's, and the number of patients 
will surely increase.

                         RESEARCH OPPORTUNITIES
    Scientists still do not know the cause of Sjogren's syndrome, but 
recent developments have taken us a step closer to understanding the 
disease and finding new treatments. For example, inflammatory 
infiltrates have long been believed to cause decreased tears and saliva 
in Sjogren's, but new research shows there might be a very different 
reason. The glands that produce moisture might, in fact, be rendered 
dysfunctional by specific autoantibodies, antibodies that target one's 
own self. These antibodies targeting muscarinic receptors have been 
found to cause dry eyes and mouth in animal models. Similar antibodies 
have been implicated in other Sjogren's complications, such as fetal 
heartblock in babies born to mothers with Sjogren's.
    Other new developments will enhance both clinical and basic 
Sjogren's research. The first is an agreement by an international 
committee of scientists working to develop standards for defining the 
disease, an effort organized and supported by the Sjogren's Syndrome 
Foundation.
    Second is the potential for a registry on Sjogren's and inclusion 
of Sjogren's in a database on autoimmunity. NIDCR is looking into the 
possibility of starting a database specifically on Sjogren's, and NIAMS 
and NIAID already fund one for autoimmune disease, but Sjogren's was 
not originally included. They are now working with us on ways to do 
just that. If Sjogren's is included in databases, we'll be better able 
to understand the genetics of Sjogren's and autoimmune diseases and 
other aspects of autoimmunity.
    We're in a new information age, and it's time we gathered data that 
will answer the critical need for epidemiological studies on Sjogren's. 
We have no statistics!
    Finally, as an NIDCR scientific workshop held last fall on 
Sjogren's demonstrates, we can inspire groups of scientists from around 
the world to work together, develop the means to share research, and 
expand our base of knowledge.
    There's a wonderful Sjogren's Syndrome Clinic housed at NIDCR, and 
indeed, most of the research on Sjogren's is being done at the dental 
and eye institutes. Sjogren's syndrome crosses many specialties and 
encompasses systemic manifestations, and because of that, we would like 
to see NIAMS and NIAID become more actively involved in this disease.
    We rely on the National Institutes of Health (NIH) to help educate 
physicians and the public. Our foundation and the NIDCR co-hosted a 
continuing education conference for healthcare providers this fall--the 
first one ever at NIH. NIDCR held a scientific workshop at the same 
time, and NIAMS published its first information booklet on Sjogren's 
this year. These are wonderful, but these are only firsts. We MUST 
continue and expand these initiatives.
    We're seeing an explosion in medical and scientific opportunity 
right now. We have incredible opportunities ranging from immunology to 
cell biology, from drug development to genetic engineering, through 
which genetic makeup might eventually be changed to actually block 
autoimmune disease. The human genome project opens up new avenues for 
discovering the genetic links in autoimmune disease. We have 
unprecedented opportunities for research in the areas of 
immunomodulation, gene therapy, and creation of artificial glands. We 
MUST take advantage of this.

            NATIONAL INSTITUTES OF HEALTH AND APPROPRIATIONS
    Sjogren's syndrome is one of the most prevalent autoimmune 
diseases. Yet, astonishingly, the prevalence does not match the low 
dollar figure spent on research and education.
    Sjogren's syndrome ranks ninth when we compare the number of 
extramural grants at the National Institutes of Health (NIH) for 
autoimmune disease. There are twice as many clinical trials for lupus, 
another autoimmune disease, as are being done for Sjogren's syndrome, 
but Sjogren's affects twice as many people.
    The most recent figures available from the NIH Autoimmune Diseases 
Coordinating Committee show that out of an approximately $18 billion 
budget for NIH, $398 million was allocated for autoimmunity. Yet 
autoimmunity is the third largest disease category in the U.S. Of the 
total amount for autoimmunity, over 90 percent went to just three 
autoimmune diseases--rheumatoid arthritis, juvenile diabetes, and 
multiple sclerosis. Lupus received the next largest amount, leaving 
about $45 million for 76 other autoimmune disorders, including 
Sjogren's syndrome.
    We ask your committee as it works on the next Appropriations bill, 
to add the words ``Sjogren's syndrome'' any time another autoimmune 
disease is mentioned by name. Sjogren's is one of the most prevalent 
autoimmune diseases, is an ideal scientific model, and yet over and 
over again it is left out.
    We are working to change the visibility of and attention for 
Sjogren's syndrome, and we hope after our testimony, you, as members of 
the Subcommittee on Labor, Health and Human Services, Education and 
Related Agencies, will recognize the importance of this disease.
    We applaud you for supporting medical research at the NIH and 
working towards doubling the NIH budget over 5 years. We applaud you 
for your support and allocation of dollars for autoimmunity. We are 
grateful for your support of the NIH Autoimmune Diseases Coordinating 
Committee. Finally, we urge you to consider research costs not just in 
dollars, but the human cost, the tremendous burden of disease on 
families, and especially the specific burden of a prevalent and 
devastating disease--Sjogren's syndrome.

  HOW CAN THE SENATE APPROPRIATIONS SUBCOMMITTEE ON LABOR, HEALTH AND 
          HUMAN SERVICES, EDUCATION, AND RELATED AGENCIES HELP
    A first and important step by Congress was establishing the 
Autoimmune Diseases Coordinating Committee at the National Institutes 
of Health. But we would like to see NIAMS and NIAID take on a larger 
role in the many systemic aspects of this disease.
    We ask that NIAMS and NIAID recognize that research in Sjogren's 
syndrome is part of their mission and should be included in their 
portfolio of grants.
                                 ______
                                 

    Prepared Statement of the Sudden Infant Death Syndrome Alliance

    Chairman Specter, thank you for the opportunity to address this 
subcommittee and explain what Sudden Infant Death Syndrome and the 
importance of federal funding for SIDS programs and research means to 
me. My wife and I lost our son Chandler in 1997, and we are compelled 
to do everything and anything possible to ensure no one has to suffer 
the loss of a child again. Mr. Chairman, we need your help, your 
commitment, and your support to help solve the mystery that is SIDS.
    Despite the fact that SIDS cases have been documented for years, 
organized scientific research into SIDS only began in the mid 1970's. 
Three decades later scientists are now beginning to make significant 
progress in unraveling the enigma of SIDS. For instance, we now know 
that in many SIDS related deaths there is an abnormality in a region of 
the brain which is thought to control heart and lung functions. In 
these cases, this irregularity may have hampered normal respiratory 
activity, and while not the sole cause of SIDS, it may have contributed 
to a larger respiratory problem leading to death.
    As a direct result of SIDS research and the ``Back to Sleep'' 
educational and awareness campaign, SIDS deaths have been reduced by 38 
percent since 1992, concurrent with the increase in awareness regarding 
infants being placed on their backs to sleep-leading to the greatest 
decline in infant mortality rates in over 20 years.
    However, our research and educational campaign is far from 
finished. Each year more than 3,000 infants in the United States die 
from SIDS and it continues to be the number one cause of death for 
children between one month and one year of age. SIDS is a major 
component of the United States infant mortality rate. In spite of this 
fact, we do not yet understand the causes of SIDS nor do we possess a 
guaranteed method for its prevention.
    The primary federal agency responsible for conducting SIDS research 
and the ``Back to Sleep'' public awareness campaign is the National 
Institute of Child Health and Human Development (NICHD) at the National 
Institutes of Health. In addition to federal funding of SIDS research, 
there are other federal agencies involved in the SIDS effort. Since 
1975, the Maternal and Child Health Bureau (MCHB) within the Health 
Resources and Services Administration (HRSA) has supported specific 
programs for SIDS family counseling and for public and professional 
education about SIDS. The Centers for Disease Control and Prevention 
(CDC) has established a standardized death scene investigation protocol 
for SIDS incidents. Additionally an Interagency Panel on SIDS has been 
established, which includes: NIH, HRSA, CDC, Indian Health Services, 
Food and Drug Administration, U.S. Consumer Products Safety Commission, 
Department of Defense, Administration for Children and Families, and 
the Department of Justice to help coordinate all federally funded SIDS 
activities.
    The SIDS Alliance is grateful for the Subcommittee's past support 
of SIDS activities, especially the support of NICHD. We urge you again 
to provide the additional funding necessary for the second year of the 
third Five Year SIDS Research Plan to ensure that NICHD can continue to 
address critical SIDS research initiatives. Specifically the SIDS 
Alliance is supporting a funding increase to $23.7 billion or 16.5 
percent for NIH overall, and a 16.5 percent increase for NICHD to 
$1.137 billion. We ask that the increases for NIH do not come at the 
expense of other Public Health Service Agencies. Further research is 
essential to find the reasons for, and means of preventing the tragedy 
of SIDS.
    I urge the Subcommittee to support SIDS educational, awareness, and 
counseling activities that take place at the MCHB, and the death scene 
investigation protocol demonstration projects at the CDC. These 
programs are a vital ``flip-side'' to the good research that NICHD 
does. Without prevention awareness, counseling, and standardized 
investigation procedures, good research does not translate into 
meaningful advances for SIDS victims and their families.

             HIGHLIGHTS OF FEDERALLY FUNDED SIDS ACTIVITIES
National Institute of Child Health and Human Development (NICHD)
    Childcare has become increasingly important in the social fabric of 
the United States, so have child care centers and homes. To address 
this issue the NICHD has initiated the ``Back to Sleep Child Care 
Project,'' sending publications and other ``Back to Sleep'' materials 
to over 280,000 child care centers and licensed homes throughout the 
United States. Response to these mailings has been overwhelming, 
resulting in a 20 percent increase in the volume of requests for Back 
to Sleep materials.
    Studies on the risk factors for SIDS among African American and 
American Indian populations conducted in collaboration with the CDC and 
the Indian Health Service have yielded valuable information for 
targeted interventions to reduce infant mortality in these communities. 
SIDS among minority populations continues to be a top priority for the 
NICHD. Surveys show that the proportion of African Americans placing 
their infants to sleep on their stomachs continues to decrease, 
however, African Americans are still twice as likely to place infants 
on their stomachs as compared to other populations. Discussion groups 
are underway in African American communities across the country to 
assess the ``Back to Sleep'' campaign message, and to improve message 
delivery. In addition, during fiscal year 2001, the NICHD established 
new initiatives on health disparities in minority populations. SIDS and 
related fetal and infant deaths are part of the initiatives targeted at 
eliminating health disparities in infant mortality.
    A new component of the ``Back to Sleep'' campaign focusing on 
reducing SIDS among African American was launched in late 1999. The 
goal is to develop and implement a community-based initiative. The 
National Black Child Development Institute (NBCDI) joined with the 
NICHD, the campaign sponsors, and several other organizations in the 
outreach initiative. A culturally appropriate resource kit, which 
includes a training guide, has been developed, and the first national 
training workshops have been held. Plans for fiscal year 2002 include 
training at the local level through affiliate African American 
organizations, and regional infant mortality summits. In addition, 
discussions have begun for a community partnership campaign targeted to 
reducing SIDS among American Indians in fiscal year 2002.
    The mechanism of SIDS is still unknown; there are no clinical or 
biologic tests to identify a newborn at high risk of succumbing to 
SIDS; and more work is needed to increase the implementation of ``Back 
to Sleep'' among all caregivers and in communities with high rates of 
infant death. To address and focus its efforts on these challenges, the 
NICHD is in the process of developing and implementing its third SIDS 
Research Five-Year Plan. Meetings regarding various aspects of the 
five-year plan have been held throughout the past two years and are 
expected to continue. The plan will be divided into five parts: 
Introduction, Etiology/Pathogenesis, Prognostics/Diagnostics, 
Prevention, and Health Disparities. A draft of the Introduction and the 
Etiology/Pathogenesis section will be open for public comment on the 
web during the month of March 2001. The remainder of the draft plan 
will be on the web for public comment in April.
    Plans for research initiatives in fiscal year 2002 include (1) 
continued research on mechanisms of pathogenesis through studies in 
animal models, postmortem tissue, and high-risk infants. This includes 
a prospective study to define a battery of physiologic and genetic 
markers that will predict SIDS and to determine whether SIDS is part of 
a larger family of autonomic nervous system disorders; (2) analysis of 
epidemiological and physiological data collected during the second five 
year research plan to improve our understanding of environmental and 
intrinsic risk factors; (3) a community-linked health disparities 
initiative to investigate related aspects of mortality from late fetal 
life through early childhood; (4) improve risk reduction and efficacy 
of ``Back to Sleep'' through continued research, monitoring, and 
outreach in at risk communities.
Maternal and Child Health Bureau (MCHB)
    The MCHB supports a number of SIDS and Other Infant Death related 
services and programs, including the following activities:
  --National SIDS Resource Center, a major source of current 
        information about SIDS.
  --Maternal and Child Health Service Block Grant (MCH), which grants 
        funds to states providing a range of services to SIDS families. 
        Block grant funds support activities like: contact families 
        immediately after death, discussion of autopsy results with the 
        family, and support and counseling through the first year of 
        bereavement. Unfortunately, in many jurisdictions across the 
        country, funds for these services have been decreased or 
        eliminated due to budgetary difficulties.
  --Field training and curriculum to health care providers for case 
        management of families who have experienced an infant death, 
        and the development of model programs, particularly for the 
        underserved and minorities. Demonstration grants have been 
        established in four states to target services for specific 
        populations: California, Massachusetts, Missouri, and New York.
  --National SIDS & Infant Death Program Support Center to address SIDS 
        service issues at the federal level on an ongoing basis. The 
        SIDS Alliance was chosen to run this center, which opened in 
        1999, and has experienced notable success.
Centers for Disease Control and Prevention (CDC)
    To develop a better statistical figure on SIDS cases, Congress 
recommended in 1993 the establishment of a standard death scene 
protocol to offset discrepancies on unexplained infant deaths between 
states. It was hoped that this protocol would be adopted by states not 
only for statistical measure, but to help avoid awkward and emotionally 
charged misunderstandings at the death scene. In 1996, CDC published 
the protocol, and since that time several states have adopted the 
standard. It is SIDSA's long term goal to ensure that all states fully 
adopt the protocol. To help realize this goal, SIDSA would like CDC to 
heed Congress' recommendations for the past two years and implement 
demonstration projects that follow these guidelines in several 
communities nationwide. We would also encourage CDC to implement a 
nationwide survey to measure how many locales have implemented the 
protocol independently and to analyze the results thus far.
    In conclusion, we are all too painfully aware that SIDS has 
historically been a mystery, leaving in its wake devastated families 
and bewildered physicians. Not only have there been no answers on the 
cause of SIDS, but there have been no answers on how to effectively 
prevent its occurrence. Today we are beginning to find some of the 
answers on cause and prevention, and therefore reduce the risk of SIDS. 
Because of the ``unknown'', however, babies are still vulnerable even 
when parents and care givers take the cautionary steps to prevent SIDS 
deaths. This tragedy will continue if research efforts are stalled or 
halted, especially when we are at the point where so much progress has 
been made. Now is the time for a re-energized effort against this 
tragic syndrome.
    On behalf of the thousands of families who have been devastated by 
the loss of a baby to SIDS, and the millions of concerned and 
frightened parents, we ask for your support, and thank you again for 
allowing us to present this testimony. If you have any questions, 
please do not hesitate to contact us.
                                 ______
                                 

          Prepared Statement of the Trust for America's Health

    Mr. Chairman, and members of the Committee, I wish to provide a 
real perspective on our nation's ability to respond to health 
emergencies like the pediatric leukemia cluster in Fallon, Nevada and 
health concerns related to multiple sclerosis in Wellington, Ohio.
    My name is Dr. Shelley Hearne and I serve as the executive director 
of the Trust for America's Health--a new nonprofit health advocacy 
organization taking action to prevent disease and protect the health 
and safety of our communities. I am very proud to have former Governor 
Lowell Weicker, Representative Louis Stokes, and Chairman John Porter 
along with many other national leaders in public health serve on our 
Advisory Council.
    By way of background, I am an environmental health scientist--
serving for almost twenty years in government, non-profits, and as a 
faculty member of the Johns Hopkins School of Public Health. Most 
recently, I was the executive director of the Pew Environmental Health 
Commission.
    Let me be candid. Our public health service is falling short in its 
duty to watch over the safety and health of Americans, particularly 
when it comes to chronic diseases that may be associated with 
environmental factors.
    Chronic diseases such as cancer, asthma, Parkinson's, birth defects 
and diabetes are responsible for 7 out of 10 deaths in this country. 
More than a third of our population, over 100 million men, women and 
children, suffer from chronic disease. By 2020, studies estimate that 
chronic disease will strike 134 million Americans and cost $1 trillion 
a year. And the Centers for Disease Control and Prevention (the 
``CDC'') estimates that 70 percent are preventable.
    Despite the human and financial toll of chronic diseases on our 
country, we have no national approach to track these diseases and 
respond effectively to cluster crises. Our federal, state, and local 
agencies only coordinate tracking and responding to infectious diseases 
such as polio, yellow fever and typhoid--diseases that a national 
tracking and response system helped to eradicate back in the late 
1800s.
    Let me give you some examples of chronic disease clusters and 
concerns from around the country and the problems we face in responding 
to them.
    In Fallon, Nevada, twelve children have been stricken with an acute 
form of leukemia since 1997. This occurrence rate is higher than the 
expected average of this disease in a town the size of Fallon. 
Residents as well as health officials suspect that this cancer may be 
linked to environmental factors such as a high level of naturally-
occurring arsenic in the water or possibly an infectious virus.
    In my home state of New Jersey, between 1993-1997, parents in Brick 
Township identified 53 cases of autism out of 6000 children between the 
ages of 3 and 10 years. For years, parents complained to politicians 
and health officials about a feared autism cluster in their community. 
Health agencies are still trying to determine if this is a problem.
    And in Wellington, Ohio, 25 citizens have been diagnosed with 
multiple sclerosis (MS) in a town of 4,200. This rate is higher than 
the national average based on recent studies. Residents worry about the 
toxic exposures from a local iron foundry and the nearby landfill.
    In each case, our public health officials lacked the disease 
occurrence data, personnel, training, and lab capacity to detect these 
health emergencies and respond to them.
    Many chronic diseases are preventable, and each of the above 
mentioned clusters and health concerns might have been a preventable 
tragedy. But, because we have no coordinated national tracking of 
chronic disease, we are unable to identify disease clusters and respond 
quickly to these health emergencies. As a result, we are hamstringing 
our scientists from finding solutions and effectively taking action--
regardless if it's childhood leukemia in Fallon or multiple sclerosis 
in Ohio.
    Let me describe the existing status of our fractured state health 
tracking networks.
  --Even though studies have shown that birth defects are the number 
        one cause of infant mortality, 17 states do not track birth 
        defects--Pennsylvania, Ohio, Mississippi, New Hampshire, 
        Louisiana, Vermont, Rhode Island, Indiana, Minnesota, South 
        Dakota, North Dakota, Wyoming, Montana, Idaho, Nevada, Oregon, 
        and Washington.
  --Only eight states and the District of Columbia track developmental 
        diseases such as cerebral palsy, autism and mental retardation 
        even though the National Academy of Science estimates that 25 
        percent of these diseases in children are caused by 
        environmental factors--California, Kentucky, Mississippi, 
        Nebraska, New Jersey, North Carolina, South Carolina, and South 
        Dakota.
  --Even though studies have shown autoimmune diseases like Lupus to be 
        increasing, only four states report tracking this disease--
        Arizona, Massachusetts, New Mexico, and South Dakota.
  --For years most states did not track cancer. Tracking began in the 
        early 1990's when the CDC allocated money to the states to 
        start cancer registries. Uniform standards for the state cancer 
        tracking networks were just established in 1997.
  --More than half of the states do not track asthma even though 
        studies have shown that asthma attacks are the number one cause 
        of school absenteeism and that asthma has increased 75 percent 
        between 1980 and 1994.
    The Pew Environmental Health Commission based out of the Johns 
Hopkins School of Public Health studied ways to strengthen our nation's 
public health defenses and proposed creating a Nationwide Health 
Tracking Network.
    The Nationwide Health Tracking Network consists of five components:
    Coordinating essential data collection systems.--The first 
component builds on existing health and environmental data collection 
systems and establishes data collection systems where they do not 
exist. The Network would coordinate with the local, state and federal 
health agencies to collect this critical data.
    In all fifty states, the Network would track:
  --Asthma and other respiratory diseases;
  --Developmental diseases such as autism, cerebral palsy, and mental 
        retardation;
  --Neurological diseases such as Alzheimer's, multiple sclerosis, and 
        Parkinson's;
  --Birth defects; and
  --Cancers, especially in children.
    The Network also would track exposures to:
  --Heavy metals such as mercury and lead;
  --Pesticides such as organophosphates and carbamates;
  --Air contaminants such as toluene and carbamates;
  --Organic compounds such as PCB's and dioxins; and
  --Drinking water contaminants, including pathogens.
    Developing an Early Warning System.--The second component is an 
Early Warning System that would immediately alert communities to health 
emergencies such as lead, pesticide and mercury poisonings. The 
existing system of local health officials, hospitals and poison centers 
that alert our communities to outbreaks like food illness and the West 
Nile virus would also warn our communities about these health 
emergencies.
    Creating Rapid Response Teams.--The third component consists of 
improving our response time to identified disease clusters and other 
health emergencies. The Network would coordinate federal, state and 
local health officials into Rapid Response Teams to quickly investigate 
these health emergencies, providing the teams with the trained 
personnel and necessary equipment.
    Addressing unique local health problems.--The fourth component is a 
pilot program consisting of twenty regional programs that would 
investigate local disease clusters and emergencies outside of the 
Network. These programs would alert the public and health officials to 
new developing disease clusters. These pilots programs also would serve 
as possible tracking models to be included in the Network.
    Creating community and academic partnerships.--The fifth component 
creates relationships with our communities and with regional academic 
centers. Community relationships would ensure that the tracking data is 
accessible and useful on a local level. The academic partners would 
assist with training the workforce, analyzing data, and developing 
links between the tracking results and preventative measures.
    [The background and basis for this Network and other Commission 
findings are also available on the website at http://
healthyamericans.org or http://health-track.org]
    This Network would provide our communities, scientists, doctors, 
hospitals and public health officials with the missing data on where 
chronic diseases are occurring and whom they are striking. This basic, 
but yet critical, information would enable us to develop effective 
prevention strategies to protect the health of our citizens.
    Data from the Network will also allow us to spend our limited 
research dollars more effectively by identifying which chronic diseases 
are increasing and where they are clustering. We have doubled our 
research dollars in the National Institutes of Health, yet these 
scientists do not have the most basic information about how often and 
where chronic disease occurs. Without a Network, our scientists will 
remain in the dark, unable to develop effective prevention strategies.
    Developing prevention strategies for chronic diseases is critical 
to reducing the $325 billion our country spends on these diseases. In 
less than fifteen years, the cost of chronic disease is expected to 
rise to $1 trillion. The estimated cost of the Network is about $275 
million or less than 1 dollar per every man, woman and child. This is 
the most cost effective use of tax dollars today--investing in ways to 
prevent the leading and most costly diseases in this country.
    The public strongly supports the concept of nationwide tracking. A 
recent public opinion poll by Princeton Survey Research Associates 
revealed that nine out of ten (89 percent) registered voters support 
the creation of a national health tracking system. The American public 
is so concerned about this issue that 63 percent feel that public 
health spending is more important than cutting taxes. Seven out of ten 
registered voters (73 percent) feel that public health spending is more 
important than spending on a national missile defense system.
    Over thirty key health organizations have endorsed the Network, 
ranging from Aetna US Health Care to the American Heart Association to 
the Association of State and Territorial Health Officers.
    The American Chemistry Council supports the concept, noting ``. . . 
data generated by a national tracking program can shift the focus from 
debate and speculation about disease trends to intervention and 
prevention based on scientific evidence.''
    Most local health departments face declining funding, inadequate 
training for staff, limited or no laboratory access, and outdated 
information systems. The CDC, the Agency for Toxic Substances and 
Disease Registry (the ``ATSDR'') and other federal agencies have not 
been able to adequately help our local health departments. For 
instance, most states do not have a chronic disease investigator. 
Recently in Fallon Nevada neither the CDC nor the ATSDR could give 
Nevada written guidance, standards or protocols on how to investigate 
their childhood cancer cluster. Our federal health agencies have never 
developed a concrete response program to these growing disease cluster 
demands.
    We are concerned that the Administration's proposed budget 
recommends severe cuts for the nation's chronic disease prevention 
programs. Overall, the Administration is recommending $109,000,000 cut 
from last years budget for the CDC, most of it coming from the National 
Center for Chronic Disease Prevention and Health Promotion. We need to 
be going in the exact opposite direction. Health defense should be the 
country's number one commitment.
    In order for us to identify clusters before they grow, we must take 
rapid action. The CDC must be given the direct mandate to aggressively 
respond to communities' concerns like those in Fallon and Wellington 
with modern tools and health tracking. And Congress must prioritize 
$275 million per year--just a tenth of one percent of the overall 
spending of health care dollars in this country.
    Without this type of investment, we will only watch asthma, certain 
cancers and other chronic disease rates continue to raise. There will 
be many more Fallons. And that will be the greatest tragedy of all.
                                 ______
                                 

  Prepared Statement of the United Fresh Fruit & Vegetable Association

    United Fresh Fruit & Vegetable Association appreciates the 
opportunity to testify in strong support of increased funding for 
nutrition, physical activity, and obesity at the Centers for Disease 
Control and Prevention (CDC). As the national trade organization 
representing the views of producers, wholesalers, distributors, brokers 
and processors of fresh fruits and vegetables, United has worked 
aggressively for many years to enhance federal programs and policies to 
address the staggering costs associated with poor diets and physical 
inactivity.
    According to the U.S. Department of Health & Human Services (HHS), 
unhealthy eating habits and physical inactivity are now the nation's 
second leading actual cause of death and are primary factors in the 
skyrocketing rates of obesity and number of overweight persons. 
Unhealthy eating and physical inactivity are also major causes of heart 
disease, cancer, stroke, diabetes, high blood pressure, and 
osteoporosis. In fact, HHS estimates that unhealthy eating and 
inactivity contribute to between 310,000 and 580,000 deaths each year, 
13 times more than gun-related deaths and 20 times higher than deaths 
due to illicit drug use.
    The costs of diseases caused by unhealthy diets and physical 
inactivity are enormous. Annual costs related to cancer, coronary heart 
disease, obesity, diabetes, stroke and osteoporosis now total nearly 
$550 billion. For Medicare patients alone, the Health Care Financing 
Administration (HCFA) estimates that coronary heart disease costs 
taxpayers $9.8 billion per year and strokes cost an additional $3.7 
billion. Furthermore, when assessing the costs of diet related diseases 
only, the U.S. Department of Agriculture (USDA) has estimated that 
healthier diets could prevent at least $71 billion per year in medical 
costs, lost productivity, and lost lives. It is important to note that 
this estimate only takes into account diet-related coronary heart 
disease, stroke, cancer and diabetes and not other diet-related 
diseases.
    It is obvious that the challenges faced by today's healthcare 
delivery system have changed enormously, and over the past century, the 
leading causes of death have shifted from infectious to chronic 
diseases. These diseases are expensive to treat; and many of them 
cannot be cured so they require years of expensive treatments.
    The CDC has stated that of the 30-year increase in life expectancy 
between 1900 and 1999, only five years can be attributed to curative 
medicine, and the remaining 25 years of the increase represent advances 
in public health and preventive measures. However, today's health care 
system is still geared almost exclusively toward treatment of disease. 
Despite the proven success of preventive medicine, spending by state 
and federal governments averaged $1,390 per person per year for disease 
treatment and only $1.21 per person per year for preventive measures. 
We are not advocating that these numbers should be reversed. We are, 
however, recommending that the United States begin to make sound 
investments in preventive measures for the well-being of all Americans. 
A modest investment in programs that can change diet and activity 
patterns can prevent enormous long-term spending on treatment in the 
future.
    Leading health experts have asserted their firm belief in the 
benefits of a nutritious diet and physical activity. The National 
Academy of Sciences (NAS), CDC, USDA, Surgeon General, and others have 
affirmed that Americans must change their diets and become more 
physically active if the rates of illness and premature death are to be 
reduced.
    With research documenting health benefits of increased fruit and 
vegetable consumption and increased exercise to reduce the risk of 
cancer and numerous other serious illnesses including heart disease, 
stroke, obesity and high blood pressure, we support aggressive action 
to further these important health messages. For example, studies show 
that people who eat five or more servings of fruits and vegetables each 
day have one-half the cancer risk of those who eat fewer than two 
servings. In the area of physical activity, it is documented that a 
regimen of at least 30-45 minutes of brisk walking, bicycling, or even 
working around the house or yard will further reduce risks of chronic 
illness including coronary heart disease, hypertension, colon cancer, 
and diabetes.
    However, only one in four Americans consume five or more servings 
of fruits and vegetables per day and children ages six to 12 are eating 
only two-and-a-half servings of fruits and vegetables a day, half of 
the minimum amount recommended by national guidelines. In the area of 
physical activity, research indicates that 60 percent--well over half 
of Americans are not regularly active. Worse yet, 25 percent of 
Americans are not active at all. With such statistics and limited 
funding available for federal campaigns to change these behaviors, poor 
diets, physical inactivity and obesity will soon be the number one 
cause of preventable deaths and avoidable health care costs.
    Current trends document this assumption with at least one-third of 
all cancer, 20-to-40 percent of heart attack and stroke, and as much as 
80 percent of Type 2 diabetes being diet-related, and the diet- and 
exercise-attributable costs of these four conditions nationally are 
comparable to tobacco. Additionally, obesity which is a primary marker 
of poor eating and exercise habits, has been declared an epidemic by 
CDC. This country desperately needs to attack the problem of poor diet 
and physical inactivity with an initiative of similar scope and 
duration to that mounted against tobacco over the last decade. The 
longer we wait to start, the harder it will be to reverse, and the more 
we will pay as health care becomes more expensive.
    To reverse these dangerous trends and begin to elevate this issue 
at the federal level, United Fresh Fruit & Vegetable Association 
supports multi-year appropriations totaling $350 million for CDC to 
expand and build upon ongoing national and state intervention 
initiatives within the Division of Nutrition and Physical Activity. 
This funding level will allow CDC to implement a national coordinated 
nutrition and physical activity plan in every state and a corresponding 
national media education strategy. Only through such aggressive funding 
increases will CDC in coordination with state departments of health be 
able to put in place a national strategy that encourages healthy eating 
and increased physical activity that is supported by coordinated 
communications efforts at the federal level. Presently, nutrition and 
physical activity are the only major chronic disease risk factors 
without dedicated funding for state intervention programs. While some 
states do have programs in place for obesity prevention, nutrition and 
physical activity, these efforts will remain very limited and 
ineffective without substantial federal funding. The expertise of the 
CDC in the implementation of effective intervention strategies, health 
communications, education, and prevention research will enhance the 
success of state-based efforts by providing states with additional 
federal resources to leverage their efforts and ensure the 
implementation of best practices.
    We are well aware of budget constraints facing the Committee. 
However, we strongly encourage the Committee to carefully examine the 
need to take aggressive action to implement a national coordinated 
nutrition and physical activity strategy to address the staggering 
costs of chronic diseases. When you look at the costs associated with 
heart disease, cancer, diabetes, stroke, high blood pressure, and 
osteoporosis which total $405 billion a year, we think that $350 
million is a very small investment to make in the future health of our 
nation.
    We look forward to working with the Committee on this critical 
issue and hope that this request can be accommodated to the maximum 
extent possible during the coming fiscal year. Thank you for your time 
and consideration.
                                 ______
                                 

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

    The University of Medicine and Dentistry of New Jersey (UMDNJ) is 
the largest public, freestanding health sciences university in the 
nation. Our statewide system is located on five academic campuses and 
consists of eight schools (3 medical, a dental, nursing, public health, 
health related professions and a graduate school of biomedical 
sciences). UMDNJ also comprises a University-owned acute care hospital, 
three core teaching hospitals, an integrated behavioral health care 
delivery system, a statewide system for managed care and affiliations 
with more than 200 health care and educational institutions across the 
state. No other institution in the nation possesses the resources that 
match our scope in higher education, research, health care delivery, 
and community service initiatives with federal, state and local 
government entities.
    The University's priority projects are statewide in scope and 
include collaborations both within the University system and with our 
academic and health care partners. Our mission is focused on building 
``Centers of Excellence'' that will expand our research, enhance our 
educational programs and provide access to quality health care services 
for all New Jerseyans. Our projects also underscore UMDNJ's commitment 
to eliminating racial disparities in health care delivery, which is why 
our first priority initiative is the Institute for the Elimination of 
Health Disparities.
    The Federal Government has identified striking disparities in the 
overall health and life expectancy of racial and ethnic populations in 
the United States. Despite dramatic improvements in health care, 
disparities still exist among racial and ethnic groups. In recognition 
of the importance of health disparities to the health of all citizens, 
UMDNJ supports the efforts of the federal government in a number of 
initiatives aimed at eliminating health disparities.
    UMDNJ has long been recognized for its leadership in providing 
educational opportunities and health care services to under-represented 
communities throughout our state. We are a leader in minority student 
education, minority faculty recruitment and patient care services to 
minority populations through our core and affiliated hospitals, clinics 
and community-based programs.
    UMDNJ is developing an Institute for the Elimination of Health 
Disparities that will have statewide impact. The mission of the 
Institute is to eliminate health disparities through training minority 
health care providers, improving research on minority health, 
increasing the number of minority scientists and improving outcomes in 
health service delivery to minority populations.
    The Institute is based in Newark, the largest city in New Jersey 
with a diverse population, socio-economic status and special health 
care needs. Newark is also home to UMDNJ-University Hospital, a Level I 
Trauma Center and the state's only public safety net hospital serving 
the largest number of indigent patients. In addition to Newark, the 
Institute will provide services in our host communities of Camden and 
New Brunswick, which also have large diverse populations.
    Leadership of the Institute is provided by the UMDNJ-School of 
Public Health in partnership with all schools of the University and 
with our Centers of Excellence including the Cancer Institute of New 
Jersey; the Environmental and Occupational Health Sciences Institute; 
the National Pediatric & Family HIV Resource Center; the Hispanic 
Center of Excellence, the Minority Oral Health Research Center; the 
Chandler Health Center (a Federally Qualified Health Center); and the 
Center for Healthy Families and Cultural Diversity. The Institute will 
also collaborate with state, county, city, community and private 
organizations to extend its visibility and outreach.
    The Federal Government has identified six broad areas that 
disproportionately affect racial and ethnic populations including 
infant mortality, cancer, cardiovascular disease, diabetes, HIV/AIDS 
and childhood immunization. The Institute will focus its research, 
training and education programs on initiatives related to these areas, 
and will work to implement other programs that will improve overall 
health outcomes.
    UMDNJ is ideally positioned to lead New Jersey's efforts to 
eliminate racial and ethnic health disparities. We are requesting $5 
million over 5 years to carry out the mission of the Institute for the 
Elimination of Health Disparities on behalf of the citizens of New 
Jersey and the nation.
    Our second priority is the Cancer Institute of New Jersey.
    The Cancer Institute of New Jersey was established in 1990 with a 
$10 million capital grant from the federal government. Over the past 
decade, CINJ has grown to become one of the nation's most successful 
cancer institutes and New Jersey's only NCI-designated clinical cancer 
center. New Jersey has been especially devastated by cancer where 
incidence and mortality rates are high compared to national averages. 
Since it opened its doors, CINJ is successfully fulfilling its mission 
through innovative advances in research and patient care. CINJ's basic 
and clinical research are conducted in collaboration with its clinical 
partners and other academic institutions, community physicians and 
health care professionals. CINJ's provider network of 20 hospitals 
stretches across the state and services reach people in every county in 
New Jersey.

                     CANCER INSTITUTE OF NEW JERSEY
    One of CINJ's significant accomplishments is the creation of the 
Dean and Betty Gallo Prostate Cancer Center established with funding 
from the federal government. The Center honors the late Congressman 
Dean Gallo, who succumbed to prostate cancer in 1994. The Gallo 
Prostate Cancer Center has garnered $9 million in federal 
appropriations over the past 3 years and is the state's only 
specialized prostate health resource located at an NCI-designated 
cancer center.
    Because African-American males are 2.5 times more likely to die 
from prostate cancer than white males, the Gallo Prostate Cancer Center 
has partnered with the 100 Black Men of New Jersey organization to 
offer prostate cancer screenings in minority communities throughout the 
state. A major goal of the Gallo Prostate Cancer Center is to expand 
its educational awareness and health screenings to every county in New 
Jersey.
    Additional resources are needed to accelerate the Gallo Center's 
promising research and to expand its services to the community through 
education and prevention programs. This expansion is hindered by a 
critical lack of space in CINJ's New Brunswick facility. Constructed in 
1996 to accommodate 16,000 patient visits, CINJ is now seeing 37,000 
patients per year with more than 3,000 new patients seeking care. Based 
on this rate of growth, CINJ anticipates between 50,000 to 60,000 
patient visits per year and 5,000 new patients by the year 2003.
    UMDNJ has responded to this need for additional space by approving 
the construction of a 120,000 square foot addition to CINJ's New 
Brunswick facility. This new space will house the Gallo Prostate Cancer 
Center as well as provide more space for the treatment of other types 
of cancer, research, teaching and support staff. We have commitments of 
$16 million toward the construction cost of approximately $30 million 
and request $10 million in federal participation to expand the Cancer 
Institute of New Jersey facility to house the Gallo Prostate Cancer 
Center.
    Another priority initiative is the Child Health Institute of New 
Jersey.
    The UMDNJ-Robert Wood Johnson Medical School has developed the 
Child Health Institute of New Jersey as a comprehensive biomedical 
research center focused on the health and wellness of children. The 
Child Health Institute (CHI) has garnered close to $5 million in 
federal funds over the past two years and has been awarded a $1.9 
million facility grant from the National Center for Research Resources 
of the NIH in fiscal year 2000. The CHI has received $27 million from 
private foundations, corporations and individuals, as well as from the 
state and federal government, to construct a 100,000 square foot 
research facility in New Brunswick, NJ. The CHI will grow the current 
research funding base of the Robert Wood Johnson Medical School and 
strengthen research efforts with clinical departments at the Robert 
Wood Johnson University Hospital, especially those involved with the 
new Children's Hospital.
    The Child Health Institute will focus research on molecular 
genetics that direct development of human growth and function. Research 
will serve as the basis for new treatments, therapies and cures for 
devastating and debilitating childhood syndromes. Scientists will 
direct efforts toward the environmental, genetic and cellular causes of 
diseases in infants and children in a quest to prevent, treat and cure 
these diseases. Some of the disorders that warrant immediate attention 
include asthma, muscular dystrophy, diabetes, birth defects and neuro-
developmental disorders including autism and spina bifida.
    Currently, the Child Health Institute serves as the hub for the New 
Jersey Governor's Council on Autism at UMDNJ. The Council distributes 
grants from the State to improve the treatment of autistic children, to 
educate families and physicians and to investigate causes and possible 
cures for autism. The Child Health Institute represents the best hope 
for a sustained campaign against childhood diseases and disorders and 
provides a unique opportunity to support the health and welfare of this 
generation and to protect the health of future generations.
    Basic science is the key to the future of medicine. As scientists 
unravel the human genetic code, the impact on America's health is 
enormous. We are at the brink of discovering which genes cause birth 
defects and the root causes for disease so that prevention and cures 
can be realized.
    The Child Health Institute has the expertise and the infrastructure 
in place to achieve major breakthroughs and discoveries that will lead 
to improvements and cures in childhood diseases.
    We request $5 million in federal participation to cap the 
development of the Child Health Institute of New Jersey.
    UMDNJ is committed to scientific research that will benefit the 
elderly as well as children. That is why our next priority is the 
Geriatric Research Center.
    The Center for Aging at the UMDNJ-School of Osteopathic Medicine 
(SOM) is an inter-disciplinary center of excellence in geriatric 
education, clinical care and research. The Center is nationally 
recognized as a leader in quality care for older individuals through an 
array of services in the field of aging. Attracting more researchers to 
the Center is critical to achieving national prominence as a Geriatric 
Research Center of Excellence. The research programs of the Center will 
focus on the cellular, biochemical and physiological basis of aging. 
Research will be directed at the genetic determinants of both aging and 
diseases common in the elderly. The Research Center will build on 
existing programs in nutrition, protein loss, injury, Alzheimer's 
disease to expand basic science research programs in support of the 
established clinical and educational programs at the Center for Aging. 
A major drawback is the critical lack of dedicated research space to 
expand the Center's research laboratories. We seek $5 million in 
capital and program funds to support dedicated space for the Geriatric 
Research Center at the Center for Aging at SOM.
    Our final priority is to implement a statewide medical response 
system to respond to catastrophic emergencies as an integral component 
of the UMDNJ-Center for BioDefense in New Jersey.
    UMDNJ has established a Center for BioDefense which achieved $3 
million in federal funding over the past two years. That funding is 
focused on scientific research to understand and identify infectious 
biological organisms in order to develop treatments for victims of 
bioterrorist attacks.
    New Jersey is the most densely populated state in the nation with 
more than 8 million residents. New Jersey is home to a myriad of high 
technology companies and the national headquarters of leading-edge 
pharmaceutical, radiological and chemical industries. As such, New 
Jersey is a prime target for terrorist attacks which employ weapons of 
mass destruction including biological and chemical attacks. Successful 
mitigation of these events requires a proactive, coordinated effort in 
planning, training, monitoring and response.
    A significant component of the UMDNJ-Center for BioDefense is our 
expertise in education and training concerning chemical and biological 
weapons. While emergency medical technicians and paramedics maintain 
state certification requirements, this does not include continued 
education in incident command, EMS mass casualty response training, and 
hazardous material training.
    The UMDNJ Center for BioDefense will use the expertise at UMDNJ-
University Hospital, the state's Level I Trauma Center, and University 
Emergency Medical Services (EMS) to provide statewide leadership in 
training of EMS, first responders and other health professionals and to 
coordinate a standard regional response to incidents involving weapons 
of mass destruction, bioterrorism or public health threats. The 
Incident Support and Operational Planning (ISOP) team will be 
responsible for training, coordinated communications and response. The 
unit would also provide technical expertise to assist communities in 
the development of emergency plans and procedures.
    The team will track and disseminate statewide hospital bed status 
through technology at University Hospital's Regional Emergency Medical 
Communications System dispatch center. Improvements to the system would 
include implementing a secure internet-based tracking system, upgrading 
the existing radio system to integrate with the New Jersey State 
Police, the Office of Emergency Management, and the Departments of 
Health and Transportation, as well as implementing an alert network to 
provide public health agencies with information on potential public 
health threats. We request funding of $2 million for the Center of 
BioDefense to assist our efforts to develop a statewide Medical 
Response System that will strengthen New Jersey's ability to respond to 
bioterrorism.
    Thank you again for your past support and for the opportunity to 
present testimony of the University of Medicine and Dentistry of New 
Jersey (UMDNJ) on its priority initiatives in cancer, children's 
health, geriatrics, biodefense and the elimination of racial and ethnic 
health disparities.
                                 ______
                                 

               Prepared Statement of Dr. William H. Lippy

    I would like to express my support for increased funding of 
Universal Newborn Hearing Screening (UNHS) programs through the Health 
Resources and Services Administration (HRSA) and the Centers for 
Disease Control (CDC). President Bush's proposed budget for fiscal year 
2002 cut appropriations for these programs, despite the fact that 
deafness is the most common birth defect in the United States.
    Each year 12,000 babies--one in 300--are born with some type of 
hearing impairment. Technologies such as hearing aids and cochlear 
implants can alleviate the symptoms of deafness, although these 
interventions must be made within the first 24 months of life in order 
to ensure full learning capabilities and language development.
    Currently, only 32 states have enacted some type of newborn 
screening legislation and less than half of all infants are screened 
for hearing impairment at birth. As a result, deafness is not 
identified in children until age 30 months, on average, in the United 
States. Special education costs an additional $420,000 per deaf child 
by high school graduation, and the combined expenses of deaf education 
and lost productivity result in average lifetime costs of over $1 
million per deaf individual. Newborn hearing screenings average $15-50 
in price.
    In fiscal year 2001, $8 million was appropriated to HRSA for UNHS, 
and approximately $6 million was appropriated to CDC. In order to 
sustain the grants of those states that already receive funding and 
increase the number of participating states, however, $10 million must 
be appropriated to both HRSA and CDC specifically for UNHS in fiscal 
year 2002.
    I appreciate your attention to this critical issue and request a 
response to my inquiry.
                                 ______
                                 

  Prepared Statement of the University of Miami, Coral Gables, Florida

    Mr. Chairman and Members of the Subcommittee: I appreciate the 
opportunity to appear before you today on behalf of my colleagues at 
the University of Miami School of Medicine.
    The University of Miami, a private university founded in 1925, has 
grown to become a major research and educational institution with 
strong collaborations and affiliations nationally and internationally. 
The University consists of 14 schools and colleges with 2,341 faculty 
and 13,715 undergraduate and graduate students, with facilities located 
on five campuses. According to the latest National Science Foundation 
survey, ``Federally Funded Research and Development Expenditures,'' the 
University ranks 40th nationally and 18th of all private universities 
with medical schools. Annual expenditures in support of sponsored 
programs exceeded $194 million during the fiscal year ending May 31, 
2000.
    The School of Medicine was established in 1952, and was the first 
accredited medical school in the State of Florida. It has over 1,000 
faculty members as well as a large research, administrative, and 
support staff. In addition to 619 students enrolled for the M.D. 
degree, the School of Medicine offers a variety of graduate programs 
with over 350 enrolled students. With its community partner, Jackson 
Memorial Hospital, it comprises the second largest medical center in 
the United States and is recognized for its excellence in research, 
teaching, and community service. The University of Miami/Jackson 
Memorial Medical Center complex occupies 67 acres and combines 
facilities in three hospitals, an affiliated Veterans Administration 
Hospital, the Diabetes Research Institute, the Sylvester Comprehensive 
Cancer Center, the Bascom Palmer Eye Institute, and numerous other 
facilities. Sponsored program expenditures during the past fiscal year 
exceeded $142 million. NIH statistics for fiscal year 1999 rank the 
School of Medicine as 42nd among the 123 medical schools receiving 
funding, with over $59 million committed to our programs. There is an 
additional $5 million in annual NIH funding at our other campuses. U.S. 
physicians rank our teaching hospital in the top 10 percent of all 
teaching hospitals in the nation.
    One of the major objectives of the School of Medicine's research 
programs is to promote interdisciplinary collaboration and 
translational research. Basic scientists and clinicians interact 
regularly through structured programs and disease-oriented conferences. 
These have resulted in innovative research and, more importantly, the 
translation of our basic laboratory findings to the clinical setting. 
The University has invested its own funds in numerous projects and 
facilities dedicated to advancing this objective.
    In this regard, the University of Miami respectfully requests the 
Subcommittee to allocate funding that assists in understanding the 
incidence and causes of disease among particularly vulnerable 
populations--children, women, the elderly and ethnic minorities, and 
especially among African-American, Hispanic, and Native American 
populations.

                                HIV/AIDS
    Miami and the surrounding South Florida region continue to show 
strong population growth with an unparalleled ethnic diversity. The 
incidence of HIV and HTLV infections among this population group is 
high and requires continuous health support. In turn, this patient 
population offers a unique opportunity and challenge for the 
understanding of disease pathogenesis caused by HIV/HTLV, including the 
progression to neoplasia and immunodeficiency.
    Investigators at the University of Miami School of Medicine have 
played important roles in helping to understand and resolve the HIV/
AIDS crisis locally, nationally and internationally. In addition to 
studies in the United States, we have collaborative HIV programs in the 
Dominican Republic, Zambia, China, and India. Examples of significant 
seminal research studies conducted at the University of Miami produced 
the following findings: AZT protection of newborns from maternal/fetal 
transmission of HIV; transmission of HIV through sharing of needles by 
drug abusers, discovered here, led to initiatives in interrupting this 
route of transmission; and the effectiveness of the combination of Ifn-
a with AZT for the treatment of AIDS related lymphomas was elucidated 
here recently.
    The strong clinical, epidemiological and behavioral research 
programs at the University continue to attract a high level of 
competitive funding from the NIH, as evidence of their vitality and 
strength. However, it has become clear in the research community that 
further progress in limiting HIV/HTLV morbidity and mortality requires 
a broader understanding of HIV/HTLV pathogenesis. It is evident that 
the changes during disease onset and progression, both in the virus and 
in the immune system of the host, are complex and far from understood. 
It also is clear that a deeper insight into the virus-host relationship 
is the only way by which further progress can be made. Some 
institutions have significant NIH funding for HIV/AIDS research in 
clinical trials and epidemiological studies; however, with modest 
funded laboratory research programs.
    We ask that the Committee provide resources to support programs 
through the Health Resources and Services Administration that allow for 
the enhancement of facilities and equipment that bolster HIV/AIDS basic 
research and treatment facilities and equipment especially for 
children, and particularly in entities with recognized excellent 
epidemiological and clinical programs.

                 MINORITY RESPIRATORY DISEASE RESEARCH
    Vulnerable populations in the United States, especially those 
located in major metropolitan areas, are experiencing a much higher and 
more severe level of respiratory disease. Diseases such as asthma, and 
smoking related diseases such as lung cancer and emphysema, are rising 
at unprecedented rates. To address these critical issues, unique 
partnerships that bring together existing national research assets that 
can focus on developing new treatments and preventative strategies 
designed to have the maximum impact on vulnerable groups, which include 
children, women, the elderly and African-American, Hispanic, and Native 
American populations.
    Respiratory diseases including asthma, chronic bronchitis, 
emphysema, and lung cancer are a growing problem in the United States 
and worldwide. While mortality from most chronic diseases such as heart 
disease and cancer has substantially declined over the last few 
decades, deaths from respiratory diseases have increased and are 
projected to continue to increase over the next decade. Although many 
respiratory diseases are attributable to smoking, asthma, which most 
commonly afflicts young non-smokers, has also had a remarkable increase 
in incidence and mortality. Respiratory diseases occur most commonly 
among children and the elderly, and also tend to have the most impact 
on these vulnerable populations. Population-based surveys have 
suggested that most of the increase in respiratory disease has occurred 
among minority populations and children. Also, at equivalent levels of 
environmental exposure, women are more susceptible to developing 
respiratory disease than men.
    It is not clear why there has been an increase in respiratory 
disease. Most respiratory diseases are the consequence of complex 
interactions between environmental exposures and individual 
susceptibility factors. The pathway from environmental exposure to the 
diagnosis of respiratory disease may be affected by multiple factors at 
every step that confound or modify the exposure-disease relationship. 
The complexity of this system makes it difficult to identify causal 
relationships or to interpret the significance of these relationships 
when they are found.
    For example, several studies have suggested that exposures that 
result from crowded inner-city conditions could be responsible for the 
increased incidence of asthma in African-American children; however, 
others have suggested that a lack of exposure to common environmental 
pathogens could result in the immune system hyper-reactivity that 
characterizes asthma. However, without a complete understanding and 
inventory of environmental exposures, it is impossible to know what 
contribution inheritance has had to the increased incidence of disease, 
or how potential new therapies targeted at immune-system defects will 
help.
    Without a multidisciplinary approach, it is unlikely that 
researchers ever will be able to identify the true causes of this 
increase in respiratory illness, much less design effective solutions. 
To conquer this problem, it is essential that the resources and talents 
of scientists from a broad spectrum of disciplines work cooperatively, 
and that the mechanisms of respiratory disease in a variety of regions 
and ethnic groups be carefully examined.
    We urge the Committee to support initiatives through the CDC and 
Public Health Emergency Fund that will advance long-term organized 
community-based health utilization studies, especially those that 
examine the growing incidence of respiratory disease among minority 
populations. State-of-the-art collaborations with recognized partners 
that have traditional affiliations with minority populations and that 
will allow the use of innovative research techniques will help 
elucidate the significance of specific causative factors across 
different populations in the affected communities, and beyond.

                      THE ELDERLY AND ELDER ABUSE
    Demographic reports unequivocally document the fact that the 
fastest growing segment of the U.S. population is those over the age of 
65 years, especially the ``elderly'' elderly, over the age of 80 years. 
Florida is in the unique position of having the fastest growing elderly 
population, and South Florida, in particular, of having to deal with 
the cultural diversity of that population. With the increasing 
probability of longer life spans, come increasing problems related to 
chronic diseases and fewer social and economic resources. Elderly 
individuals are particularly vulnerable and require more medical, 
legal, and social interventions as well as greater dependence on family 
caregiving where possible. In response to the needs of older Americans 
the necessity to develop extensive and integrated services is critical. 
These services range from assessments of competency and functional 
capacity and guardianship, to the end of life decision making, to long 
term care issues, elder abuse, to resource allocation and the economic 
impact on the aging population and their families.
    Though not all encompassing, the importance of education and 
research in this arena will have significant impact on shaping public 
policies and on practical approaches to assist the medical and legal 
fields, including law enforcement, the judiciary, and policy makers.
    We urge the Committee to provide funding through the Administration 
on Aging and the Health Care Financing Administration for programs and 
projects that address the specific issues of importance to the aging 
population, including: abuse and neglect, management models for unique 
care requirements, a focus on the role of families and caregivers, end-
of-life care, mental capacity, and research ethics. We would envision 
programs and projects that would involve collaborations between 
university schools of medicine and law and clinicians and researchers 
in related university departments and in community agencies.
    Mr. Chairman, we understand how difficult a year this will be for 
you and the Subcommittee. However, my colleagues and I at the 
University of Miami respectfully request that you give serious 
consideration to providing support for initiatives that assist in 
understanding the incidence and causes of disease among particularly 
vulnerable populations--children, women, the elderly, and ethnic 
minorities, and especially among African-American, Hispanic, and Native 
American populations. Vital initiatives in these areas all have great 
implications and will provide exceptional benefits to the well being of 
the nation.
    Thank you for allowing me to appear here today.
                                 ______
                                 

                   RELATED AGENCIES/GENERAL TESTIMONY

         Prepared Statement of the American Library Association

    The American Library Association appreciates the opportunity to 
present testimony for the record in support of appropriations for 
library programs through the Library Services and Technology Act, 
administered by the Institute of Museum and Library Services.
    We thank the Subcommittee and you as Chairman for your strong 
support for libraries in the past and ask for that support again for 
appropriations for fiscal year 2002.
    All Americans benefit from the small, but critical, Federal role 
that assists libraries to foster an informed citizenry in the service 
of democracy. Federal support for libraries is concentrated on two key 
national goals: outreach to those for whom library service requires 
extra effort or special materials, (such as individuals with 
disabilities); and, mechanisms to identify, preserve and share library 
and information resources across institutional or governmental 
boundaries through technology. The Federal role has traditionally 
focused on areas which require incentive funding for activities that 
libraries have difficulty initiating independently, which involve 
coordinated interstate and intrastate efforts, or which benefit from a 
national policy initiative.
    The library community is capable of astonishing creativity and 
expertise in support of national goals such as revitalizing the 
economy, having children start school ready to learn, and developing 
literate, informed adults. Oftentimes, one of the few sources of 
funding for innovation available to libraries is Federal funding. It is 
estimated that library programs generate some $3 to $4 dollars for 
every Federal dollar invested.
    President Bush has said on many occasions in discussing his new 
education proposals that ``we must leave no child behind.'' America's 
libraries believe that we can also afford to leave no reader behind. 
That statement also includes pre-readers such as very young children, 
those learning to read, young adult and adult learners. That is why we 
feel so strongly that library programs need additional Federal funding.
    Within the overarching theme of ``Leaving No Reader Behind,'' our 
specific recommendations for fiscal year 2002 are guided by three basic 
priorities, I am sure you share our vision that:
  --We need to ensure equitable access and participation of our 
        nation's readers to library activities and opportunities in 
        their communities. Gaps in access exist not only in rural 
        areas, but also in cities that lack an advanced 
        telecommunications infrastructure.
  --We need to support our libraries' continuing efforts to keep pace 
        with the rapidly changing information technology environment. 
        Indeed some of our libraries are at the forefront of the web-
        based revolution, but many others need to accelerate their 
        initiatives.
  --We need to recognize the important contributions that libraries 
        make to the social, civic, and educational health of their 
        communities. Like many schools, libraries often serve as the 
        hubs of their communities and provide important services, 
        training in technology and opportunities for life-long 
        learning, particularly in traditionally under-served areas.

             THE LIBRARY SERVICES AND TECHNOLOGY ACT (LSTA)
    I am please to convey ALA's deep appreciation to the Subcommittee 
for the support it has provided in the past for libraries and Federal 
library programs, particularly your support of the Library Services and 
Technology Act (LSTA) state grant program; library services to Native 
Americans; and the national leadership grants program.

      FISCAL YEAR 2002 FUNDING REQUEST: $350 MILLION FOR LIBRARIES
    The library community has collaborated on developing a draft for 
the reauthorization of the Library Services and Technology Act and will 
be working with the House and Senate authorizing committees this year 
on the reauthorization. The current authorization expires at the end of 
fiscal year 2002. We are seeking to increase the authorization level to 
$500 million. As you know, this represents a significant expansion in 
the Federal government's commitment to the support of our nation's 
libraries. Today we request your support for fiscal year 2002 for a 
down-payment of $350 million for library programs authorized under the 
Library Services and Technology Act.
    Libraries are making great strides in preparing for and introducing 
technology to their users. With this increase more libraries could 
expand their services to include technology training and access to the 
world wide web for their users.
    It would also enable libraries to provide additional badly needed 
services to underserved populations in their communities. These 
outreach efforts can pay off in terms of literacy programs that enable 
students to achieve success in education and programs for families who 
may not have used libraries before. Library programs for young children 
encourage pre-reading skill development and stimulate a love of 
reading, but only if funds are available for these programs.
    It is important to note that funding for the State grant program 
for libraries has not increased significantly in recent years. In 
fiscal year 1997 it was $136,369,000; in fiscal year 2001 it is 
$148,939,000. Library services are not keeping pace with the increases 
in populations in most States.
    In fiscal year 2001, the total distributed to states was 
$148,939,000 and of that, Pennsylvania received $5,964,319. The state 
library has already received requests for over $6,892,604, and expects 
at least requests for $3 million more in the second round of grant 
requests in the fall. An increase in state distribution to $350,000,000 
would bring Pennsylvania dollars up to roughly $11 million. This 
doubling of funds could enable more outreach to Pennsylvania's rural 
areas, more attention to technology, and more resource sharing for all 
libraries, school, academic and public in Pennsylvania. State libraries 
always report that the requests for funds are double and sometimes 
triple the amount actually awarded.

   $400 MILLION FOR TITLE VI--INNOVATIVE EDUCATION PROGRAM STRATEGIES
    We also ask that you fund the Elementary and Secondary Education 
Act Title VI block grant at least at the $400 million level. We 
appreciate your support of Title VI, particularly since it is the only 
current funding possibility for school libraries. As you know, school 
library materials are only one option of many in the block grant and 
less and less of the funds are being used for school library materials.
    As a result, many school libraries have old, outdated and 
inaccurate material on their shelves. In research done in Alaska, 
Pennsylvania and Colorado, it was found that a good school library 
media program is an excellent predictor of improved student 
achievement. That is why we feel it is so important to provide adequate 
funding for school libraries.

                21ST CENTURY COMMUNITY LEARNING CENTERS
    We support funding for the 21st Century Community Learning Centers 
program. School library media centers have the potential to be after-
school learning centers. If properly equipped and adequately staffed by 
professional library media specialists, school library media centers 
are a perfect place for after school learning. Currently, public 
libraries as part of a consortium also can function as after school 
learning centers. Many places, particularly in large urban areas like 
Chicago, Baltimore, New York and Miami, perform that service, however, 
the bulk of the grants are used by schools. We support initiatives to 
allow public libraries and other community organizations to be the lead 
agency.

                          IMPACT OF LIBRARIES
    No public institution maximizes a modest amount of federal funds to 
greater public benefit than libraries. Libraries are efficient users of 
federal dollars. Funds are leveraged to attract other dollars; to 
demonstrate new and innovative methods of providing service; and to 
bring new users into the library for learning, literacy and the 
information needed for more productive daily living.

                        IMPORTANCE OF TECHNOLOGY
    Both school and public libraries have made great strides towards 
the goal of full Internet access. However, effective public access is 
far from complete. We believe that the E-rate telecommunications 
discounts are critical to our nation's libraries. The library community 
believes that this program must be continued in its current form. The 
first three years of this E-rate fund have created the stimulus for 
more schools and libraries to connect to the Internet, particularly in 
areas where the discounts have been the greatest. The progress has been 
immense and needs to continue. Over 95 percent of public libraries 
offer Internet access to their patrons.
    Moving the program from its fund status to one supported by the 
appropriations process would be difficult and likely result in a strain 
on other important education programs and a reduction of the amount 
available. Telecommunications providers like BellSouth are so 
enthusiastic about the program that they are providing training to help 
schools and libraries apply. Please do not disrupt this program--it 
works.
    Federal funding supports the continuing investment libraries must 
make in computer hardware and software, electronic content and training 
for staff and the public. An increase in LSTA program funding to the 
$350 million level would allow more of the 16,047 library outlets to 
connect to the Internet and begin to provide training and information 
access services to families, adult learners, the small business sector 
and all in the community who need access. Sixty-five percent of all 
households use public library services each year, according to data 
from the National Center for Education Statistics.
                                 ______
                                 

   Prepared Statement of the National Association of State Workforce 
                                Agencies

                      BUILDING A STRONG WORKFORCE
    The members of the National Association of State Workforce Agencies 
are the state leaders responsible for building and overseeing workforce 
development activities through the administration of a one-stop center 
infrastructure and the implementation of workforce-related programs. 
These programs include labor exchange activities, Internet job 
matching, unemployment insurance administration, labor market 
information services, veterans' employment services, job training and 
welfare-to-work programs. Several critical components of this publicly 
administered workforce development system--unemployment insurance, 
employment services and labor market information programs--are financed 
through taxes on employers. Thus, a strong connection to the needs of 
the private sector business community is critical to the continued 
viability of the workforce development system.
    The primary emphasis of current workforce development efforts in 
the states is the connection of employers with job seekers. In each of 
the states, the workforce development system plays a vital role in the 
success of the local economy by providing services that build a 
stronger workforce, enhance employee skills, and promote economic 
development by helping attract and retain large and small businesses.
    In addition, with implementation of the Workforce Investment Act of 
1998 (WIA), the new workforce development infrastructure being 
developed in each of the states strives to address the changing needs 
of the new economy by empowering individuals to make appropriate job 
choices including enhancing their skills through training 
opportunities. At the core of this new paradigm is understanding the 
needs of business in the new economy and preparing workers who can 
immediately contribute to the health of a company and allow economic 
growth to continue.
    As state workforce officials strive to marshal the resources within 
a state and build this much needed system capacity, their role has 
become even more important as they serve as:
  --Leaders and change agents in creating a workforce vision and 
        implementing new services and opportunities for businesses and 
        workers;
  --Partners with various federal, state and local officials who each 
        share responsibility for the new workforce development system;
  --Overseers of a customer-driven system that focuses on the needs of 
        employers and job seekers;
  --Supporters of the one-stop center system who work closely with 
        local planners in developing service delivery systems that 
        match customer wants and needs; and
  --Facilitators of systems integration so that services can be 
        provided seamlessly.
    While providing leadership and building strong workforce investment 
systems, state administrators are facing two unique challenges which 
come as a result of economic forces and highlight the need for adequate 
workforce system funding. The first is company ``churning,'' where 
American workers with low skills are displaced while job growth is 
occurring in high skills industries, and the second is the pending 
economic slowdown that might turn into a recession.
    With these two factors as a backdrop, I want to outline the 
important need to increase funding for (1) unemployment insurance 
administration to ensure the economic safety net for workers is strong 
enough to withstand an economic slowdown, (2) the employment service as 
the cornerstone of one-stop center systems and the connection between 
employers and job seekers, (3) WIA training and labor market 
information to assist customers with market-based solutions to their 
employment needs, (4) incumbent worker training to assist with business 
and employer needs in the changing economy, and (5) veterans' 
employment and training. These funding improvements, along with the 
system improvements that are occurring, can support employers and 
workers who are hardest hit by emerging economic changes.

                            FIRMS ``CHURN''
    The aggregate economy has seen the largest boom in history, with 
economic expansion running into its ninth year in 2000. The 
unemployment rate fell for seven straight years, from 7.5 percent in 
1992 to 4.1 percent in 1999. An unemployment rate of 4.1 percent was 
the lowest level in 30 years. After accounting for inflation, median 
weekly earnings of full-time wage and salary workers increased last 
year, marking a third consecutive year of gains in real earnings.
    Yet, workforce system builders have seen unique challenges during 
the good economic times as firms ``churn'' employees. In a recent 
survey, the American Management Association found that 36 percent of 
the approximately 2,000 companies contacted created new jobs at the 
same time that they cut existing jobs.
    The demand for skilled labor has forced employers to adapt quickly. 
Companies that once engaged in employee retraining or waited for 
employees to leave voluntarily find that the quickest alternative is to 
replace these workers with new employees who have skill sets currently 
in demand. This leaves the workforce development system with the large 
challenge of retooling a whole set of workers with outdated skills, 
while serving employers with large gaps in their workforce due to a 
lack of qualified workers.
    To solve this problem, the workforce development system is actively 
engaged in assisting employers with the skills training that workers 
need to keep updated on new technologies and new workplace production 
methods. Workers must adapt to new technologies in order to remain 
competitive in the labor market. An important partner in this effort is 
the education community, and in many areas of the country, the 
workforce development system and the community college system have 
developed programs that assist workers with on-the-job training and 
skills retraining.
    Technology is playing an ever-increasing role in productivity gains 
made by businesses and the way workers conduct their jobs. Technology 
is also becoming a critical tool for job seekers and employers looking 
to hire. The Internet allows job seekers to sift through a whole host 
of jobs at their convenience, while employers can post jobs and also 
search through resumes. State workforce agency administrators are 
proponents of using technology to assist employers and job seekers in 
making more informed decisions and have implemented job matching and 
other workforce technology into service delivery systems.

                         AN ECONOMIC SLOWDOWN?
    Recent news headlines point to a coming economic slowdown. While it 
is not known to what extent the economy will contract, what is known is 
that the growth rate of recent years is not sustainable. This means 
that unemployment will grow and workers will lose jobs, even in the 
high tech sector. Efforts at preparing for a slowdown, and even a 
potential recession, have been undertaken during the past year. For 
example, the states are providing leadership in efforts to strengthen 
and improve administration of unemployment insurance and the employment 
service system.

             UNEMPLOYMENT INSURANCE AND EMPLOYMENT SERVICES
    Last year, representatives from the states, United States 
Department of Labor, business and labor met to craft a package of 
reforms that included, among other things, repeal of the Federal 
Unemployment Tax Act (FUTA) 0.2 percent surtax and unemployment 
insurance and employment services administrative funding improvements.
    A hearing was held last September before the House Ways and Means 
Subcommittee on Human Resources. Because of the short legislative 
timeframe and the intense budget negotiations that lasted into fiscal 
year 2001, no further action on unemployment insurance and employment 
services reform was taken in the 106th Congress.
    Because a number of governors have expressed support for this 
reform, as well as a number of state business organizations, it is our 
intent to work on a bill this year. Meanwhile, until the long-term 
structural changes are enacted, states are struggling in the short-term 
to maintain an essential infrastructure for the unemployment insurance 
and employment service system that meet the needs of businesses and 
workers.
    These issues get to the core of the success of the nationwide one-
stop center system. If unemployment insurance and employment services 
continue to be neglected, then the essential ``job connection'' that 
has successfully moved unemployed and dislocated workers into 
meaningful employment and assisted single mothers on welfare with job 
skills and job attachment will be lost. States are now closing offices 
in local communities and reducing staff--substantially decreasing 
needed services to employers and job seekers. We urge the Congress to 
fund fiscal year 2002 unemployment insurance at $2.65 billion, which 
reflects need based on workload.
    We also urge the Congress to fund the Employment Service State 
Allotments at $933 million and Reemployment Services at $35 million. 
Our request for Employment Service State Allotments represents the 
current appropriation of $761.7 million plus the amount that state 
legislatures have funded--$135,033,684--through state appropriations, 
plus a four-percent growth allowance. It is a travesty that state 
legislatures must essentially double tax employers to provide needed 
employment services while FUTA taxes are building excessive balances in 
the unemployment trust fund.
    It is also disheartening that Congress does not provide adequate 
funds for a program that yields measurable cost savings. A recent study 
of the public labor exchange in Washington and Oregon indicates that 
direct placement services conducted through the public employment 
service return as much as two dollars for every one dollar spent. This 
is a result of reduced unemployment insurance payments as unemployed 
job seekers gain quicker reentry into the labor market. In addition, 
the employment service assists employers by filling job vacancies more 
quickly, enhancing companies' productivity.
    This study of Washington and Oregon validates a broader study 
conducted in 1999 that found similar results:
  --Job search assistance participants found a new job more quickly and 
        the duration of unemployment insurance benefit payments was 
        reduced.
  --Savings to the government averaged two dollars for every one dollar 
        spent.
  --Shorter job searches did not lead to jobs that paid less.
    We urge you to address funding shortfalls for the unemployment 
insurance and employment service system.

                        WORKFORCE INVESTMENT ACT
    In 1998, Congress passed the Workforce Investment Act, the first 
major reform of the nation's job training system in over 15 years. It 
was designed to replace the patchwork federal system that developed 
over the last sixty years with a locally designed and driven system to 
improve the quality of the workforce, enhance the productivity and 
competitiveness of the nation and reduce welfare dependency. The 
Workforce Investment Act took effect on July 1, 2000. It passed by a 
wide bipartisan majority, in part because it was designed to permit 
communities and states to build a workforce investment system that 
respects individual choices, reflects local conditions, and results in 
increased employment, retention, and earnings of participants, and 
increases occupational skills attained by participants.
    The Workforce Investment Act redesigned the nation's workforce 
development system to:
  --Streamline multiple employment and training programs into an 
        integrated one-stop center system, simplifying access to 
        services for job seekers and employers.
  --Empower individuals to get the services and skills they need to 
        improve their employment opportunities through qualified 
        training programs of their choosing.
  --Increase accountability of states, localities and training 
        providers for their performance based on job placement rates, 
        earnings, retention in employment, skill gains, and credentials 
        earned.
  --Involve local elected officials and the private sector in business-
        led boards for the local areas focusing on strategic planning, 
        policy development and local oversight.
  --Allow state and local flexibility to implement innovative and 
        comprehensive workforce investment systems to meet the needs of 
        their communities.
  --Improve youth programs by creating Youth Councils that are linked 
        more closely to local labor market needs and the community.
    Partnerships at all levels--local, state and federal--and across 
the system are the hallmark of the new workforce investment system. All 
levels are required to coordinate and collaborate with agencies and 
entities that have not been a part of the traditional workforce 
development system. Accountability and responsibility for outcomes at 
all levels of the system now exist, with each level having unique and 
integral roles and responsibilities.
    The goal of the Workforce Investment Act is to provide employment 
and training services in a one-stop environment. Under the former job 
training program, the Job Training Partnership Act, training was 
limited to eligible populations. Under the new law, no eligibility 
criteria exist, and services are universal. We recognize that, in the 
first year of implementation, spending on training services is low. 
However, the only way to address the growing skills gap between 
employers' needs and workers' skills is through training. We support a 
fiscal year 2002 appropriation of $988 million for Adult Training, 
$1.147 billion for Youth Training, and $1.1653 billion for Dislocated 
Worker Assistance that is essentially a current services budget for WIA 
programs with a four-percent increase over fiscal year 2001 levels.

                    KEEPING WORKERS ATTACHED TO JOBS
    In addition to providing basic employment and training services, we 
strongly believe that the workforce system must assist incumbent 
workers as they upgrade their skills and keep their individual 
portfolios viable, while at the same time meeting their company's 
evolving labor needs. We support $30 million in Workforce Investment 
Act funds for incumbent worker training. Our competitive advantage in 
the world economy rests in large measure on upgrading our workers' 
skills.

                        LABOR MARKET INFORMATION
    Providing labor market statistics for use by job seekers and 
employers at the local level, rather than just on the national and 
state level, is a new service expectation. In order to provide more 
localized information as well as program performance information, 
considerable enhancements to statistical programs and information 
systems are needed. These enhancements will pay off as local labor 
market needs will be more accurately assessed and employment programs 
can be tailored to meet the needs of local employers. Therefore we 
support a four-percent increase for the Bureau of Labor Statistics for 
a total appropriation of $213 million, and a continued investment in 
One-Stop/ALMIS dollars of $150 million. We also ask that report 
language contained in last year's appropriation for One-Stop/ALMIS be 
included as bill language in this year's appropriation bill.
    The bill language we request reads, ``One-Stop/ALMIS funds will be 
used to support infrastructure upgrades at the state level for one-stop 
center system operations, labor market information, and integrated 
services to employers and job seeker customers.'' This will ensure that 
the dollars go to the states, where infrastructure needs are most 
critical.

                    MEETING COMMITMENTS TO VETERANS
    Our society recognizes the important contribution that veterans 
have made, and Congress has taken that recognition and turned it into a 
commitment. Title 38 of the U.S. Code includes provisions for special 
employment services for veterans. Priority is given to disabled and 
Vietnam era veterans, through the Disabled Veterans Outreach Program 
(DVOP) and the Local Veterans Employment Representative (LVER) program, 
which are administered by state workforce agencies. DVOPs and LVERs 
also serve our veterans population by helping to ensure a smooth 
transition for people moving from military service into the civilian 
workforce.
    Title 38 provides formulas to determine DVOP and LVER staffing 
levels. Since 1990, appropriations for DVOPs and LVERs have not 
supported the number of positions authorized by the statutory formulas. 
We strongly encourage support for funding at the statutorily-authorized 
levels of $121 million for the DVOP program and $102 million for the 
LVER program. This will help us follow-through on our commitment to the 
men and women who have served valiantly in the military both in times 
of war and peace.

                               CONCLUSION
    I do believe we are making significant strides in building the 
workforce investment system in each of the states. With a potential 
slowing of the economy, we cannot afford to wait any longer for the 
improvements that need to be made so that families can be served with 
their workforce development needs. With additional investments by 
Congress, I know that we are prepared to help those citizens needing 
job placement or skills training assistance and those businesses 
looking for good, solid workers who can improve their economic 
prospects. Thank you for your interest and support.
                                 ______
                                 

      Prepared Statement of the National Treasury Employees Union

    Chairman Specter, Members of the Subcommittee: My name is Colleen 
M. Kelley and I am the National President of the National Treasury 
Employees Union (NTEU). On behalf of the 150,000 federal employees NTEU 
represents, thank you for permitting NTEU to share our views concerning 
the fiscal year 2002 budget.
    NTEU represents employees in a number of HHS agencies including the 
Health Resources and Services Administration, Indian Health Service, 
Substance Abuse and Mental Health Services Administration, Agency for 
Healthcare Research and Quality, Administration for Children and 
Families, Administration on Aging, Office of the Secretary, Office for 
Civil Rights, Program Support Center and the National Center for Health 
Statistics. NTEU also represents employees in the Social Security 
Administration's Office of Hearings and Appeals.
    As the Chairman knows, funding remains severely constrained at 
federal agencies, leaving agencies with insufficient resources to 
complete their missions or adequately reward their employees. Funding 
shortfalls have resulted in hiring restrictions and delayed and 
canceled employee training, making it difficult for employees to do the 
best job possible. Moreover, with federal salaries continuing to lag 
well behind similar private sector salaries, agencies have been unable 
to hire or keep the expertise they need.
    In fact, the looming crisis in the federal government recently 
caused the General Accounting Office to place human capital management 
on its High Risk List. The GAO stressed that federal employees are 
assets to be valued, not costs to be cut. Adequate and stable agency 
funding coupled with appropriate pay, benefits and incentives are the 
keys to insuring that the federal government continues to attract and 
retain the right federal employees.
    With surpluses predicted for the immediate future, the opportunity 
exists to provide adequate resources to federal agencies. Doing so will 
enable federal employees to carry out their agencies' missions to the 
best of their abilities and provide first class service to agency 
customers. Unfortunately, the President's budget calls for an average 4 
percent increase in discretionary agency funding, an amount clearly 
inadequate to address the crisis the federal government faces and move 
human capital management off the high risk list. If there is room in 
the federal budget for a tax cut in excess of $1 trillion, clearly 
there is room to adequately fund federal agencies.
    The Administration's fiscal year 2002 budget request for program 
management at the Health Resources and Services Administration (HRSA) 
is $154 million. Although this figure represents a $9 million increase 
over program management funding for fiscal year 2001, the budget also 
calls for a reduction of 24 FTE in the next fiscal year. I think this 
shows quite clearly how inadequate the proposed $9 million increase is. 
HRSA's goal is to bring health care services to some of our neediest 
populations, including those in underserved rural communities, people 
living with HIV/AIDS, and those who are uninsured. HRSA provides 
essential services that are desperately in need of expansion; they 
cannot accomplish their mission with fewer employees and inadequate 
resources.
    The employees represented by NTEU at the Agency for Healthcare 
Research and Quality (AHRQ) strive to improve the quality of patient 
care in our health care system. This agency's goal is to both cut the 
number of medical errors and explore ways to better use research to 
improve medical care in our country. The Administration's fiscal year 
2002 budget proposal calls for $3 million for program support at the 
AHRQ, the same amount the agency received in fiscal year 2001. AHRQ 
will not be able to continue its mission and maintain its current staff 
without additional funding.
    Likewise, the Administration's budget proposes no increase in 
funding for program management at the Substance Abuse and Mental Health 
Services Administration (SAMHSA). This agency is at the forefront of 
efforts to provide early intervention programs designed to discourage 
young people from using drugs. SAMHSA also plays a critical role in 
insuring that mental health and drug abuse services are widely 
available to populations that would otherwise receive no services. If 
SAMHSA is to adequately respond to the substance abuse and mental 
health needs in this country, they will require an increase in funding. 
In fiscal year 2001 the agency received $67 million and 632 FTE. The 
President's budget freezes the agency at an identical, and 
insufficient, level for fiscal year 2002.
    Under the President's budget, the Indian Health Service (IHS) is 
slated to receive $2.9 billion for its health services programs in 
fiscal year 2002. This budget request reflects a small increase of $151 
million over the fiscal year 2001 level of $2.8 billion which NTEU 
believes fails to recognize and value the important work this agency 
does in improving health care for the millions of American Indians and 
Alaska Natives. A substantial increase is warranted here as well.
    The fiscal year 2002 budget request for federal administration at 
the Administration for Children and Families (ACF) is $182 million, an 
$8 million increase over fiscal year 2001 funding. As the Chairman 
knows, ACF is one of the government's premiere agencies for promoting 
the health and welfare of America's children. Programs under its 
jurisdiction include Head Start as well as projects that promote and 
support child care, foster care and adoption efforts. The 2002 budget 
request would severely hamper ACF's ability to continue to provide 
quality services. It envisions permitting the agency to hire no more 
than 15 additional staff in the next fiscal year, a number that does 
not reflect the importance these employees play in overseeing the 
critical Head Start Program. Funding restrictions in past years have 
already hampered ACF's ability to fulfill its mission and I urge the 
Subcommittee to provide additional fiscal year 2002 funding over and 
above the President's request.
    For fiscal year 2002, $18 million is requested for program 
administration at the Administration on Aging (AoA), a $1 million 
increase over the agency's fiscal year 2001 funding level. America's 
elderly population continues to grow and helping older Americans remain 
independent and productive is one of the key goals of AoA. The 
employees of AoA operate nutrition programs and are active in the 
Alzheimer's programs. To continue and expand its work, the AoA, too, 
requires funding increases that reflect its critical mission.
    NTEU also represents employees in the Office of the Secretary of 
HHS. The President's budget request for departmental management is $450 
million for fiscal year 2002, an increase of $68 million over fiscal 
year 2001 funding levels that will allow the agency to hire an 
additional 107 FTE. As you know, the employees in the Office of the 
Secretary help support those activities associated with the overall 
operation of the department and NTEU hopes the Subcommittee will 
support this proposed increase.
    The President's budget request for the Office for Civil Rights 
(OCR) for Fiscal 2002 is $32 million, an increase of $4 million over 
the fiscal year 2001 funding level. HHS's Office for Civil Rights 
enforces the Nation's civil rights statutes that prohibit 
discrimination in social service programs. Moreover, OCR plays a 
central role in efforts to prohibit discrimination against individuals 
with disabilities in programs under HHS's purview. In past years, the 
funding levels OCR has received have not reflected OCR's critical 
mission and NTEU urges the Subcommittee to provide the maximum possible 
increase to OCR in fiscal year 2002.
    For the National Center for Health Statistics (NCHS), the 
Administration has requested $127 million for fiscal year 2002, an 
increase of $5 million over the fiscal year 2001 level. One of NCHS's 
primary responsibilities is to follow changes in health and health 
care, assess the effectiveness of health care programs and identify 
health and disease patterns and risk factors in our country. The NCHS 
deserves the maximum possible allocation for fiscal year 2002.
    As the name implies, the Department's Program Support Center (PSC) 
provides support services to HHS and other agencies. These services 
include efforts in three areas, including human resources, financial 
management and administrative operations. For fiscal year 2002, the 
Administration has recommended a funding level of $308 million for PSC, 
a small increase over the division's fiscal year 2001 budget that NTEU 
hopes can be increased during Subcommittee deliberations.
    NTEU also represents employees in the Office of Hearings and 
Appeals (OHA), and as I have brought to this Committee's attention in 
past years, OHA is again the subject of reorganization. The latest, the 
Hearing Process Improvement (HPI) plan, is not working.
    As you know, disability claimants who have been found ineligible 
for disability benefits are entitled to a timely and fair hearing of 
their cases at the OHA level. In 1995, the Social Security 
Administration began an innovative program called the Senior Attorney 
Program, which, in every respect, was a resounding success. The 
agency's experienced staff attorneys were given the authority to decide 
and issue fully favorable decisions--without the time and expense of a 
full hearing--in those cases where the evidence clearly identified an 
individual as disabled. It materially improved both the quality and 
timeliness of service provided to the public. Despite the success of 
the Senior Attorney Program, the Hearing Process Improvement Plan 
eliminates it, largely due to opposition from Administrative Law 
Judges.
    From 1995 until it was canceled in 2000, nearly 230,000 Senior 
Attorney decisions were issued. It is noteworthy that the SSA Appeals 
Council found no significant difference in the accuracy of Senior 
Attorney decisions vs. full, on the record decisions made by the 
agency's Administrative Law Judges. Moreover, these Senior Attorney 
decisions helped reduce the backlog of cases at OHA to 311,000 by 
September of 1999. That backlog is now on the rise.
    The average processing time for a case favorably decided by a 
Senior Attorney was approximately 105 days. This was at a time when 
processing time for cases at OHA took approximately 386 days--more than 
a full year. Senior Attorney decisions helped deserving claimants 
receive their benefits in a more timely fashion while simultaneously 
not wasting valuable agency resources.
    Since the Senior Attorney Program was terminated, the backlog of 
cases has risen at an alarming rate with almost 390,000 cases awaiting 
processing today. Without the Senior Attorney Program these cases will 
wait about 314 days to be processed. Even worse, the situation is 
expected to continue to deteriorate. There can be no significant 
reduction in the case backlog or case processing time without reviving 
this program. The Senior Attorney Program can help the agency address 
these problems with current resources and stem the decline in the 
quality of services nationwide. It does so without hiring new 
Administrative Law Judges and staff and it presents an immediate 
solution to a worsening problem. I urge you to question the agency 
concerning this matter as soon as possible.
    Thank you again for permitting NTEU to share our views on the needs 
of the agencies within the jurisdiction of your Subcommittee.
                                 ______
                                 

      Prepared Statement of the American Public Power Association

    The American Public Power Association (APPA) is the service 
organization representing the interests of the more than 2,000 
municipal and other state and locally owned utilities throughout the 
United States. Collectively, public power utilities deliver electric 
energy to one of every eight U.S. electric consumers (about 40 million 
people) serving some of the nation's largest cities. The majority of 
APPA's member systems are located in small and medium-sized communities 
in every state except Hawaii. APPA member systems appreciate the 
opportunity to submit this statement in support of fiscal year 2002 
appropriations for the Low-Income Home Energy Assistance Program 
(LIHEAP).
    APPA urges the Committee to support LIHEAP at its maximum funding 
level of $2 billion in fiscal year 2002. APPA also supports a minimum 
of $300 million in emergency funds in fiscal year 2002 and supports a 
funding level of at least $2 billion in advanced funding for fiscal 
year 2003. In addition, APPA supports the numerous amendments being 
considered in the Senate to increase the current $2 billion funding 
authorization level of LIHEAP. Because the majority of LIHEAP monies 
are needed during a short period of time in the winter months, advanced 
funding for LIHEAP is critical in enabling states to effectively plan 
for and administer the program. Moreover, a severe winter, escalating 
home heating oil prices in the Midwest and Northeast and higher than 
expected utility bills in California have depleted fiscal year 2001 
emergency funds and highlight the important role LIHEAP plays for the 
elderly and working poor during winter months and for all consumers 
when energy prices are volatile.
    Funding cuts since LIHEAP's reauthorization in fiscal year 1995 
have forced a tightening of eligibility standards and, in some cases, 
significant reductions in benefit levels. According to the National 
Energy Assistance Directors' Association (NEADA), the primary 
educational and policy organization for state LIHEAP directors, the 
number of recipients has been cut by over one million households during 
the recent past and average benefits have declined by about 10 percent. 
Prior to the dramatic reduction in LIHEAP funding in fiscal year 1995, 
the program was serving 20 percent of the eligible population, with 
one-half of the recipients being elderly or disabled Americans living 
on fixed incomes. Without the assistance provided by LIHEAP, many would 
be forced to choose between paying their home energy bill or purchasing 
other necessities of life, such as food.
    As the debate over restructuring of the electric utility industry 
and the issue of providing and funding ``public benefits'' programs 
continues, some have stated their belief that electric utilities should 
assume the entire burden of energy assistance for low income customers 
as a cost of doing business. As these restructuring efforts take place 
at both the federal and state levels, the risks become greater that 
bills for residential customers, especially those with low incomes, 
will increase as retail markets are opened to competition. This 
prophesy has come true for consumers across America this winter as we 
witness price spikes in all areas of fuel production, including natural 
gas, home heating oil and electricity. The need for full funding of 
LIHEAP remains critical in ensuring that all those in need of energy 
assistance receive help. APPA believes that any public benefits 
programs should not replace or supersede existing programs, such as 
LIHEAP, that are funded by federal appropriations.
    APPA is proud of the commitment that its members have made to their 
low-income customers. Many public power systems have low-income energy 
assistance programs based on community resources and needs. APPA 
continues to remind its members of how important it is to have in place 
a well designed low-income customer assistance program, in tandem with 
energy efficiency and weatherization programs, that can help consumers 
hold down their energy bills and lower their requirements for 
assistance.
    In addition, the impact of welfare reform on energy assistance is 
just beginning to be felt and LIHEAP is likely to play an important 
role in the transition. Persons leaving the public assistance rolls are 
entering lower paying jobs and continue to be confronted with large 
energy bills. These families remain at risk.
    LIHEAP is one of the outstanding examples of a successful state-
operated program. The requirements imposed by the federal government 
are minimal and most important decisions are left to grantees.
    APPA urges this Subcommittee's favorable consideration of fiscal 
year 2002 funding for LIHEAP. Again, thank you for this opportunity to 
present our views.
                                 ______
                                 

 Prepared Statement of the Association of America's Public Television 
                                Stations

    The Association of America's Public Television Stations submits 
this testimony to the appropriations subcommittee on Labor Health and 
Human Services, Education and Related Agencies. APTS, on behalf of the 
nation's 354 local public television stations, urges the committee to 
support funding for the Corporation for Public Broadcasting and the 
Ready to Learn and TeacherLine projects within the Department of 
Education.
    This year APTS is asking Congress to fund the Corporation for 
Public Broadcasting in fiscal year 2004 at $395 million. This modest 
$30 million increase will help pay for increases in system support such 
as royalties and copyright fees as well as funds to support projects to 
develop new content for our increased educational services and 
programming. Most significantly, this request would mean an average 
increase of $90,000 per station in the form of Community Service 
Grants. Eighty nine percent of CPB's funding goes to local public 
television and radio stations in the form of CSGs, which are the seed 
money for local operations. These federal funds are leveraged an 
average of six fold to raise non-federal funds to enable local stations 
to serve their local communities.
    APTS thanks the committee for its generous past support and for 
acknowledging the special needs of public broadcasting in the form of 
advanced appropriations. The advance funding provision for CPB allows 
public broadcasting and local stations a predictable source of support 
that can be applied to research and development. It also provides the 
important lead time needed to leverage other funding sources necessary 
to bring programs to the air.
    Public television also requests that the subcommittee provide 
funding for the Ready to Learn program at $24 million and the 
TeacherLine project at $8.5 million in fiscal year 2002. Both of these 
programs are administered through the Department of Education. The 
Ready to Learn program provides funding for the development and 
production of the highest quality children's educational programming. 
It also assists local stations in their outreach efforts to train 
teachers, parents and day care providers to effectively use these 
programs to teach young children. TeacherLine is an online professional 
development initiative that helps teachers improve their teaching 
skills in core subject areas.
    Public broadcasting is also seeking equipment funds for the 
federally mandated conversion to digital through the Public 
Telecommunications Facilities Program (PTFP) within NTIA at the 
Department of Commerce.

                     COMMITMENT IN THE DIGITAL AGE
    Public broadcasters historically have been the leaders in using new 
technologies for education and public service. The nation's public 
television stations stand ready to make an historic commitment to all 
Americans to provide near universal access to wireless, high-speed data 
for education. Specifically, public television stations will commit the 
equivalent of one multicast digital channel--a daily average of 4.5 
megabits per second (Mbps), among the highest data rates available--for 
formal early childhood, K-12, and post-secondary education, as well as 
workforce training and professional development. This digital capacity 
is conservatively valued at $2.4 billion per year.

           HARNESSING DIGITAL TECHNOLOGY TO SERVE THE PUBLIC
    With roots going back to the earliest days of radio and television, 
America's public broadcasters have played a unique role in a media 
industry that is otherwise built on consumer advertising and mass 
market entertainment. Since the 1960s, publicly funded noncommercial 
television has provided a clear alternative to commercial television, 
focusing on education and culture, public affairs and the performing 
arts.
    While the proliferation of television channels has been driven by 
market demands, public television's core mission has not and will not 
change in a digital world. We will build on our track record of 
providing the best programming and services to educate and enlighten 
audiences. We also will continue to be leaders in using new technology 
for the public interest. From satellite delivery of broadcast signals, 
to the development of stereo broadcasting; from closed captioning and 
descriptive video services, to video streaming and cutting edge 
interactive television trials, public broadcasters have been inventors, 
innovators and blenders of technologies to serve the public.
    Public television is committed to use digital technologies to 
transform the way we learn--by providing the American public with 
educational services anytime anywhere. That means how they want them, 
when they want them and where they want them--in homes, schools, 
childcare facilities, and workplaces across America.

   MULTICAST DIGITAL SERVICES--UNLOCKING PUBLIC TELEVISION'S PUBLIC 
                            SERVICE MISSION
    Since receiving their digital channels, public television stations 
have been engaged in systemwide and station level planning. In 1997, 
public broadcasting put forward a comprehensive plan for its digital 
conversion to the Administration and Congress. We set four broad 
systemwide goals for the use of digital technology--goals that are 
founded on fully utilizing the multicasting capability of the digital 
technology to expand and enhance services.
    To make the full complement of Ready to Learn services available to 
every child, parent and caregiver in America.--The PBS Ready to Learn 
Service is currently meeting two national education goals: it teaches 
basic reading skills and it helps prepare more children for school 
success. Its 133 participating stations cover over 94 percent of the 
country. In the past three years, RTL public television stations have 
trained 370,000 parents and 250,000 teachers and caregivers, affecting 
approximately 6 million children.
    To expand the reach of public television's K-12 educational 
programs and services by making them universally available to all 
schools and home schoolers.--70 percent of public television licensees 
provide K-12 programming in math, science, arts and humanities. These 
services are enhanced by:
  --PBS TeacherSource, an online K-12 teacher resource with online 
        lesson plans, teacher guides and activities, correlated to more 
        than 90 national and state standards; and,
  --PBS Teacherline, online modules to enhance the learning and 
        teaching of K-12 mathematics and other core subjects.
    To increase the reach of post secondary telecourses so that they 
are universally available to all adult learners.--Collectively, public 
television stations are the largest source of post-secondary 
telecourses in the nation. PBS Adult Learning Service (ALS) supports 
station-college partnerships that offer distance learning credit-
bearing telecourses, enrolling more than 500,000 students in 1999-2000. 
GED on TV has enabled more than two million adults in five years to 
earn their high school equivalency from home. The estimated positive 
economic impact of these more productive workers exceeds $12 billion.
    To expand our commitment to serving the unserved and underserved 
populations in our country, those who because of economic, geographic, 
physical, cultural or language barriers have been left behind by the 
commercial marketplace.--Public Broadcasting has pioneered the 
development of open and closed captioning for the deaf and descriptive 
video services and reading services for the blind or visually impaired. 
Stations like WYBE, Philadelphia and WNVC, Fairfax provide programming 
in multiple languages serving a variety of different ethnic cultures.
    Local public television stations throughout the country have turned 
those systemwide goals into concrete and very bold and exciting service 
plans tailored to their local communities. APTS maintains an 
interactive clearinghouse of stations' plans for digital services. Our 
data show that virtually every public television station in the country 
has developed digital service plans to meet these and other goals. The 
centerpiece of virtually every plan is the delivery of multicast 
services with a strong focus on education.
  --In exchange for federal financial support and favorable cable must 
        carry regulations, the nation's public television stations 
        stand ready to commit an average daily rate of 4.5 megabits per 
        second (approximately one channel) of their digital spectrum to 
        education. The value of this capacity is conservatively 
        estimated at $2.4 billion per year
  --Three out of every four PTV stations plan to carry at least two 
        formal education multicast services.
  --Approximately 85 percent of PTV stations plan to multicast a 
        children's channel; 78 percent intend to broadcast university-
        level or post-secondary telecourses; and 66 percent plan to 
        multicast an instructional programming channel for students in 
        grades K-12.
  --Others plan to multicast channels that focus on local public 
        affairs, teacher training, foreign language programming, and 
        programming aimed at minority and under-served audiences.
   ptv digital service plans--creating local solutions for national 
    priorities realizing national educational goals on a local level
    While public television stations plan to deliver one or more formal 
educational multicast channel, the specific educational services are 
tailored to meet local community needs.
    Florida public television stations have promised the state 
legislature that they will collectively devote a multicasting stream to 
the Florida Knowledge Network in return for digital funding. This 
statewide educational network will serve as a teacher training 
resource, linking Florida's classrooms with direct access to the 
highest quality programming, electronic field trips, and distance 
learning.
    New York's public television stations plan to dedicate one of their 
multicast streams to an educational service called the Empire State 
Channel. Developed with the state Department of Education, the Empire 
State Channel will feature teacher training, vocational instruction and 
public affairs programming.
  providing unserved and underserved with access to digital technology
    Today, public television stations, through their nationwide system 
of transmitters and translators, serve 99 percent of American 
households with an over-the-air analog signal. Public television 
stations that serve rural communities with a network of analog 
translators are ideally positioned to bring the benefits of broadband 
digital services to the most rural and remote areas of this country.
    KAET in Phoenix plans to partner with KUAT in Tucson to dedicate 
one or two multicasting channels to feeding math, science, geography 
and other educational programming to 300 schools throughout the 
geographically diverse state. Directed by the stations and funded by 
the state Department of Education and Arizona State University, 
programming will relate directly to course materials, and teacher 
training will be accompanied by curriculum guides, instructional 
materials, and planning booklets that can be downloaded to computers in 
the classrooms. These services are intended to reach students in the 
farthest corners of Arizona, students who are unable to be linked via 
telephone and fiber optic lines.
    KNME in Albuquerque is considering leasing part of its digital 
spectrum to the New Mexico Department of Education to facilitate the 
delivery of educational materials to the state's K-12 schools. The 
station will position itself as the state's virtual classroom, 
providing curricular support and teacher training opportunities for 
viewers separated by hundreds of miles. This arrangement would allow 
the Department of Education to help with the costs of digital 
conversion.
    Public television stations also plan to use the multicast 
capability to serve populations under-served because of cultural, 
language or economic barriers.
    KBDI in Denver plans to launch a Latino Initiative Channel. This 
channel would feature programming for Denver's Spanish-speaking and 
bilingual community and will emphasize news, public affairs, and social 
and cultural events. Potential partners include local community service 
organizations, schools, commercial Spanish-language broadcasters, and 
public service agencies.
    WNYE in Brooklyn and WYBE in Philadelphia plan to provide multicast 
foreign language and international channels to serve the international 
residents in their respective cities. The WNYE multicast channel will 
feature programming in at least 12 different languages, including 
Japanese, Chinese, Italian, Greek, Polish, and Eastern European 
languages.
  partnering with local institutions to solve local community problems
    A key characteristic of public television's digital planning is 
localism. In an age of increasing media consolidation, public 
television stations remain the only locally owned, locally operated 
television service in many communities. Consequently, several PTV 
stations are planning ``local'' channels, focusing on specific 
community needs.
    Vermont Public Television plans a Vermont Public Service Channel, 
which would provide regular coverage of the state legislature, 
important legislative committee hearings and other statehouse-related 
programs, as well as local government town meetings and debates. 
Additional programming might include call-in programs with the Vermont 
congressional delegation, travel and tourism information, and other 
local news and public affairs programming.
    The federal government must play its historic leadership role in 
underwriting a portion of public broadcasting's digital transition. The 
government's failure to make this investment will have direct 
consequences. Millions of Americans may be deprived of the enormous 
educational promise of digital television. Many of the smaller and 
rural stations may be unable to make the transition at all.
    The public broadcasting industry has updated its costs for the 
digital transition. Balancing reductions for the stations currently on 
the air against additions for increased costs, public broadcasters 
estimate the total costs of conversion for both television and radio at 
$1.8 billion.

                               CONCLUSION
    For more than 30 years Congress has invested wisely in public 
broadcasting. We now have a strong system of public television stations 
that reaches 99 percent of American households, giving viewers tools to 
improve and enrich their lives. The public service promise of new 
digital technology is enormous:
  --for children to provide a dedicated stream of nonviolent, 
        educational and entertaining programs, commercial-free and 
        free-of-charge;
  --for parents and schools to better educate children;
  --for colleges and universities to reach out beyond their campus 
        walls;
  --for students of all ages to have access to lifelong learning;
  --for under-served audiences whose income, geography, culture or 
        disability threatens to cut them off from the digital promise;
  --for citizens who feel alienated from their local, state or federal 
        governments; and
  --for public service organizations seeking to build a sense of civic 
        connection and commitment.
    Realizing this potential and remaining a viable service provider in 
the digital age is fully dependent on a federal investment to ensure 
access to all digital services. Public television stands ready with 
service plans, matching state and local grants, and community-based 
content partners to fully utilize this technology for public service.
    Funding for the Corporation for Public Broadcasting and through the 
Ready to Learn and TeacherLine programs at the Department of Education 
will provide essential financial assistance to stations in order to 
meet their digital service goals.
                                 ______
                                 

       Prepared Statement of the Motion Picture & Television Fund

    Funding is requested by the Motion Picture & Television Fund 
(MPTF), Woodland Hills, California, in fiscal year 2002 appropriations, 
for an ``Eden Alternative'' demonstration project.
    Nursing homes and assisted living facilities play a critical role 
in the delivery of care to older people with chronic needs. It is 
expected that over half of the people who turned 65 in 1990 will enter 
such a facility before they die. Too often the stay is characterized by 
feelings of helplessness, loneliness and boredom. It is presumed, but 
untested, that these ultimately add to the cost of care because of an 
increase in hospitalizations, medical problems, and the use of 
psychotropic drugs. Any program that can reduce the frequency of those 
problems would have major implications through a reduction of Federal 
expenditures for health programs, including Medicare and Medicaid.
    The Eden Alternative is an innovative approach which was developed 
as a way to improve the quality of life of nursing home and assisted 
living residents. This approach seeks to overcome the problems of 
helplessness, loneliness, and boredom. It is intended to improve 
quality of life and decrease medical problems and expense through 
changes in the physical, psycho-social, and staffing environments. 
MPTF, by this proposed demonstration project, seeks to validate that 
improvement in both health outcomes and medical cost reductions can be 
achieved by implementing the ``Eden Alternative'' concept in its 
nursing home and assisted living community. A demonstration project of 
this type can serve as a model for other similar community based 
facilities nationwide.
    The Federal Government and the Congress have a significant interest 
and responsibility in the quality of life and access to long term care 
by its older adults. This responsibility is particularly relevant when 
in the near future the aging baby-boom generation will substantially 
increase the number of United States citizens in retirement. By the 
year 2030, all baby-boomers will be over 65 years old, with the oldest 
nearing age 85. Twenty percent of the total United States population 
will be elderly in thirty years, compared with 13 percent today, 20 
percent of all those over 85 years old will be residing in nursing 
homes. Since most, if not all, of these nursing home residents will be 
on Medicare, the nationwide impact of a program which significantly 
reduces medical costs should be a priority item of interest and 
responsibility.
    The Eden Alternative offers a paradigm shift that seeks to 
transform the concept of institutional care. A central tenet is that 
the environment should help maximize individual potential for personal 
growth by offering variety, vibrancy and spontaneity. This approach 
includes homelike furnishings, regular interaction with children and 
young adults, resident responsibility for the care of companion animals 
and plants, and flexibility in residents' daily activities to encourage 
spontaneity. Perhaps most important is staff development which 
facilitates the replacement of top down bureaucratic authority with 
decision making that is closest to the resident, whenever possible. 
Staff needs to be provided with the necessary training, skills and 
information, in order to assume responsibility for the improved social 
and medical outcomes. The change in surroundings results in an enhanced 
sense of self, a higher quality of life, and a relief from the problems 
that frequently affect nursing home and assisted living residents.
    In addition to a plethora of environmental changes, the Eden 
Alternative also promotes substantive changes in management philosophy 
and style and organizational culture. Management principles include:
  --Replacing top down bureaucratic authority with decision making that 
        is closest to the consumer whenever possible. This includes 
        empowering residents and those who provide the most direct care 
        and transforming the roles of staff to family-like companions 
        rather than medical care providers.
  --Encouraging leadership that embraces change which is focused on 
        improving residents' quality of life. To support necessary 
        changes in the physical and work environment, leaders assume 
        the role of coaches. Leaders and staff are encouraged to reward 
        appropriate risk-taking, promote fundamental fairness, and 
        recognize that mistakes are part of change.
  --Organizing work through self-directed work teams in contrast to 
        hierarchy and strict departmental lines. To ensure informed 
        decision making, team members are provided with necessary 
        information, resources, training and skills, knowledge, and a 
        supportive environment. Thus empowered, teams are responsible 
        for making decisions about how to meet their goals including 
        scheduling and organizing their work.
    These innovations are believed to create a more desirable 
environment for residents and staff and to result in improved health 
status for residents. In addition to the relief of boredom and 
helplessness that afflicts residents, preliminary work suggests that 
such an enriched habitat improves residents' quality of life and leads 
to such related benefits as reducing prescription mediation use; 
reduced incidence of infections, skin breakdowns, and falls; less 
depression; and improved sense of well being and control. Studies have 
also suggested that an enriched environment positively affects staff, 
resulting in less absenteeism, reduced turnover, and higher levels of 
job satisfaction.
    MPTF goals for this project are two-fold: (1) Implement the 
environmental and staff changes necessary to achieve the life style 
envisioned by the Eden Alternative (including programmatic changes and 
staff training); and (2) Measure and report on specific parameters 
related to quality of life and decreased medical resource consumption. 
These parameters would include the use of psychotropic drugs, the 
presence of skin ulcers, falls, and hospitalizations. In addition, 
national data on specific outcomes in nursing homes has been collected 
for several years. Our experience will be compared to these national 
benchmarks. We believe that this demonstration project will confirm 
significant financial savings for our residents and that these savings 
will be applicable to Medicare and Medicaid if this effort is adopted 
nationally. Once confirmed, we would share our experience and teach 
other organizations how to effectively implement the operating 
principles of the Eden Alternative.
    MPTF is an 80-year old non-profit health and social service 
organization which serves the Southern California entertainment 
community. Among our services are a 195 bed long-term care facility and 
a retirement community (independent and assisted living) of 120. In the 
first quarter of 2002, we will be opening additional retirement housing 
with a capacity of 95. Our residents are admitted regardless of their 
ability to pay. It is because of our history of providing the highest 
quality of life in the most cost-effective way possible that we seek 
support for this transition in our care model.
                                 ______
                                 

Prepared Statement of the National Federation of Community Broadcasters

    Thank you for the opportunity to submit testimony to this 
Subcommittee regarding the appropriation for the Corporation for Public 
Broadcasting (CPB). As the President and CEO of the National Federation 
of Community Broadcasters I speak on behalf of 150 community radio 
stations across the country. NFCB is the sole national organization 
representing this group of stations which provide service in the 
smallest communities of this country as well as the largest 
metropolitan areas. Nearly half of our members are rural stations and 
half are minority controlled stations.
    In summary, the points we wish to make to this Subcommittee are 
that NFCB:
  --Requests $395 million CPB for fiscal year 2004, a $30 million 
        increase over fiscal year 2004 funding;
  --Requests that advance funding for CPB is maintained to preserve 
        journalistic integrity and facilitate planning and local 
        fundraising by public broadcasters;
  --Requests report language to ensure that CPB utilizes digital funds 
        it receives for radio as well as television needs;
  --Supports CPB activities in facilitating programming services to 
        Latino and Native American radio stations;
  --Supports CPB's efforts to help public radio stations utilize new 
        distribution technologies and requests that the Subcommittee 
        ensure that these technologies are available to all public 
        radio services and not just the ones with the greatest 
        resources.
    Community radio fully supports $365 million for the Corporation for 
Public Broadcasting in fiscal year 2004.--Federal support distributed 
through the CPB is an essential resource for rural stations and for 
those stations serving minority communities. These stations provide 
critical, life-saving information to their listeners. Yet they are 
often in communities with very small populations and limited economic 
bases so that the ability of the community to financially support the 
station is insufficient without federal funds.
    In larger towns and cities, sustaining grants from CPB enable 
community radio stations to provide a reliable source of noncommercial 
programming about the communities themselves. Local programming is an 
increasingly rare commodity in a nation that is dominated by national 
program services and concentrated ownership of the media.
    For the past 25 years, CPB appropriations have been enacted two 
years in advance. We are grateful for Senators Spector and Steven's 
comments in support of continuing the advance appropriations. This 
insulation has allowed pubic broadcasting to grow into a respected, 
independent, national resource that leverages its federal support with 
significant local funds. Knowing what funding will be available in 
advance has allowed local stations to plan for programming and 
community service and to explore additional non-governmental support to 
augment the federal funds. Most importantly, the insulation that 
forward-funding provides ``go[es] a long way toward eliminating both 
the risk of and the appearance of undue interference with and control 
of public broadcasting.''--House Report 94-245.
    In the last two years, CPB has increased support to rural stations 
and committed resources to helping public radio take advantage of new 
technologies such as the internet and satellite radio. We commend these 
activities which we feel provide better service to the American people, 
but want to be sure that the smaller stations with more limited 
resources are not left out of this technological transition. We ask 
that the Subcommittee include language in the appropriation that will 
ensure that funds are available to help the entire public radio system 
utilize the new technologies, particularly rural and minority stations.
    NFCB commends CPB for the leadership it has shown in supporting and 
fostering the programming services to Latino stations and to Native 
American stations. Satelite Radio Bilingue provides 24 hours of 
programming to stations across the United States and Puerto Rico 
addressing issues of particular interest to the Latino population. In 
the same way, American Indian Radio on Satellite (AIROS) is 
distributing programming for the Native American stations, arguably the 
fastest growing groups of stations. There are now over 30 stations 
controlled by and serving Native Americans, primarily on Indian 
reservations.
    CPB plays a very important role for the public and community radio 
system. They are the convener of discussions on critical issues facing 
us as a system. They support research so that we have a better 
understanding of how we are serving listeners. And they provide funding 
to programming, new ventures, expansion to new listeners, and projects 
that improve the efficiency of the system. This is particularly 
important at a time when there are so many changes in the radio and 
media environment with new distribution technologies and media 
consolidation.
    Finally, community radio supports funding for conversion to digital 
broadcasting by public radio and television.--While public television's 
needs are more immediate, the Federal Communications Commission is now 
in the process of identifying a standard for digital radio 
transmission. We expect that there will be funds available for radio 
conversion as well as television conversion. More immediately, the 
television conversion process is already having an impact on public 
radio stations. As television stations increase the space they need on 
their towers to accommodate both analog and digital signals, radio 
stations that rent space on TV towers are losing their leases and being 
forced to move to other towers--sometimes with very short notice. This 
situation will only get worse over the next year as we approach the FCC 
deadline for television conversion. We would like to see emergency 
funding to help public radio stations who lose their tower space do the 
necessary engineering studies and move to new tower locations.
    We appreciate Congress' direction to CPB that it utilize its 
digital conversion fund for both radio and television and ask that you 
ensure that the funds are used for both media. Congress stated, with 
regard to fiscal year 2001 digital conversion funds:

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

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

    Prepared Statement of the National Minority Public Broadcasting 
                               Consortia

    The National Minority Public Broadcasting Consortia (Minority 
Consortia) submits this statement on the fiscal year 2004 appropriation 
for the Corporation for Public Broadcasting (CPB). Our primary missions 
are to bring a significant amount of programming from our communities 
into the mainstream of PBS and public broadcasting. In summary, we ask 
the Committee to:
  --Reject the Administration's proposal to end forward funding of the 
        Corporation for Public Broadcasting
  --Recommend at least $395 million for CPB for fiscal year 2004, a $30 
        million increase over fiscal year 2003
  --Encourage CPB to increase its efforts for diverse programming with 
        commensurate increases for minority programming and the 
        Minority Consortia
  --Support the Administration's request of $20 million for digital 
        conversion
    The National Minority Public Broadcasting Consortia consists of the 
National Asian American Telecommunications Association, the National 
Black Programming Consortium, Native American Public 
Telecommunications, Pacific Islanders in Communications and the Latino 
Public Broadcasting Project
    Forward Funding.--We strongly oppose the Administration's proposal 
that the advance funding for CPB be eliminated, a proposal that would 
stop CPB funding for two years. We were pleased to see the colloquy on 
the Senate floor April 6 between Senators Stevens and Specter 
concerning this issue, and we support any efforts to continue the 
practice of two years forward funding for CPB. Reasons to continue 
forward funding for CPB include:
  --The production of programming for public broadcasting usually takes 
        several years and substantial lead time is needed for planning.
  --Public broadcasting programs are supported by multiple funding 
        sources, and two years advance knowledge of the amount of 
        federal funding allows CPB to better leverage its federal funds 
        to bring in other sources of revenue.
  --The Minority Consortia administers a significant amount of CPB 
        programming monies, and elimination of forward funding would 
        negatively affect our organizations' planning and fundraising 
        activities.
    CPB Appropriation.--We support a fiscal year 2004 federal 
appropriation for CPB of at least $395 million. This would be a 
reasonable, albeit modest, contribution toward our national treasure of 
public broadcasting. The debate of the past several years regarding 
public television and public radio has highlighted the great esteem in 
which they are held.
    Public broadcasting, including PBS and NPR, is particularly 
important for minority and ethnic communities. While there is a niche 
in the commercial broadcast and cable world for quality programming 
about our communities and our concerns, it is in the public 
broadcasting industry where minority communities and producers are more 
able to bring quality programming for national audiences. Additionally, 
public television and radio is universally available.
    Digital Conversion Assistance.--We support the Administration's 
request for $20 million for digital conversion funding for CPB. We also 
urge Congress to enact the necessary authorizing legislation so that 
these funds can be distributed.
    With stations able to broadcast on multiple channels, there will be 
a need for a tremendous amount of new, quality public broadcasting 
programming. There are costs involved in the conversion which go beyond 
the significant equipment and hardware needs of stations. It will also 
take additional money to produce programming for digital broadcast. All 
producers will face these new, higher costs.
    Part of the equation in bringing more high quality diverse 
programming to public broadcasting is that independent producers be 
able to transition to digital production. Federal funding for digital 
conversion should include assistance for independent producers.
    The Minority Consortia works closely with CPB. We value our 
relationship with President Coonrod and the CPB staff and appreciate 
the financial and technical assistance provided to us by that 
organization. We do not doubt CPB's commitment to increasing the 
diversity of programming on public television and radio but also 
believe they can do more with the resources at hand. The oft-stated 
commitment of CPB and Congress for increased multicultural programming 
combined with four years of funding increases make this an ideal time 
for significant progress.
    Thank you for your consideration of our recommendations. We see new 
opportunities to increase diversity in programming, production, 
audience, and employment in the new media environment, and thank you 
for your long time support of our work on behalf of our communities.
                                 ______
                                 

            Prepared Statement of the National Public Radio

                              INTRODUCTION
    Thank you for the opportunity to submit a statement for the hearing 
record on behalf of National Public Radio (NPR) and the hundreds of 
public radio stations that air NPR programming across the country. 
Public radio offers diverse perspectives by airing a combination of 
local and national public affairs and cultural programming, funded by 
local and national sources, both public and private. Public 
broadcasting raises nearly 85 percent of its funding from non-federal 
sources, yet it requires help from federal sources to fully achieve its 
programming mission.
    Public broadcasters seek a $395 million appropriation for CPB in 
fiscal year 2004 (for the past quarter century, CPB has received 
appropriations two years in advance).--The CPB was established in 1967 
to provide federal support to stations. A $395 million funding level 
for the annual CPB appropriation would provide an additional $6.7 
million for radio over last year. Of that $6.7 million, $5.2 million 
would be available for local public radio stations to keep pace with 
technological changes and to produce and to acquire content for a 
number of technological platforms and, $1.5 million would allow CPB to 
fund 10-15 new radio production projects in fiscal year 2004.
    Public broadcasters urge the Subcommittee to maintain advance 
appropriations for CPB.--The Administration and the House and Senate 
budget resolutions have proposed to eliminate this long-standing 
practice that preserves freedom of expression, affords program managers 
more lead time to plan and organize activities, and provides seed money 
for raising non-federal money.
    Public broadcasters support the Bush Administration's request for 
$20 million in fiscal year 2002 for local stations' transition to 
digital technology.--The estimated cost for digital radio is $116 
million for transmission only, excluding production equipment.
    Thank you for your commitment to our nation's public broadcasters, 
and the citizens and communities they serve.

               A COMMITMENT TO LOCAL AND NATIONAL SERVICE
    Public radio stations are committed to serving their local 
communities for philosophical, geographical and financial reasons.
    Philosophically, non-profit public radio stations' missions are to 
serve their local communities with a variety of programs and 
perspectives. For instance, the mission of WDUQ-FM in Pittsburgh, PA 
states, ``WDUQ is a noncommercial, educational public radio station 
licensed to Duquesne University. As a steward of this license, WDUQ 
serves Duquesne, listeners and the community with high quality 
programming and services to inform, educate, enlighten and entertain.''
    As a result of these guiding missions, many public radio stations 
provide listeners with more than headlines and traffic reports by 
building local news departments that produce in-depth reports on 
community issues. Moreover, stations air national and international 
programming that connects listeners to broader sources of ideas, 
cultures and events.
    Geographically, stations are licensed locally and make all 
significant operational and programming decisions. In fact, stations 
are often the only locally owned media outlets in their communities. 
NPR Members include stations licensed to communities, local school 
boards and other local institutions, and private and public colleges 
and universities. Specifically, 78 of NPR's Member licensees are local 
communities (including several Native American tribes). In addition, 8 
are school boards, 11 are state entities, 27 are private universities, 
and 146 are state universities.
    Public broadcasting has been a grassroots movement, joining diverse 
regions and viewpoints around a common purpose of community service and 
education. Because public radio's foundation was built by and is 
maintained by local decision-makers and listeners, this local nature 
preserves accountability to the people in the listening community.
    This support is also reflected in the personal support dedicated by 
listeners and viewers to their local stations. For instance, according 
to CPB, replacing the work that volunteers contribute to public 
television stations would require nearly an eight percent increase in 
full-time staff, and for public radio more than a 14 percent increase.
    Financially, public broadcasters are part of a successful public-
private partnership. Nearly 85 percent of public radio's funding comes 
from non-federal sources. Stations are supported by a variety of 
sources, including government, foundations, businesses and listeners. 
Currently, local stations' listeners generally provide the largest 
percentage of funding (approximately one third) for local stations.
    Nevertheless, federal money is crucial because it helps public 
radio stations plan, produce, acquire and air programs that attract 
these non-federal funding sources. CPB funding acts as ``seed money'', 
raising $6 of non-federal money for every $1 of federal funding.
    A statutory formula governs all federal appropriations distributed 
through CPB. Public television receives 75 percent of the CPB 
appropriation while radio receives 25 percent. 93 percent of the radio 
designated federal money goes directly to local communities. The other 
7 percent of radio funds remain at CPB to support national radio 
programming, which is awarded on a competitive basis. This money is 
essential to support the unrivaled services public radio stations bring 
to their communities.

                     ADVANCE APPROPRIATION FOR CPB
    President Bush's budget document calls for a series of reforms to 
the federal budget process, one of which is targeted on the ``abusive'' 
use of advance appropriations for short-term budgeting purposes rather 
than for ``advanced appropriations enacted for programmatic . . .'' The 
President's policy of limiting advance appropriations is reflected in 
the House and Senate budget resolutions. This cap will effectively 
preclude any advance appropriation to CPB for fiscal year 2004.
    During the April 6, 2001 Senate debate of the budget resolution, 
however, Senate Appropriations Committee Chairman Ted Stevens (R-AK) 
and Senate Labor/HHS Appropriations Subcommittee Chairman Arlen Specter 
(R-PA) expressed their concerns regarding the elimination of CPB's 
advance appropriations. NPR and its Member stations sincerely thank 
these two Senators and strongly support this effort to maintain advance 
funding for CPB.
    Advance funding preserves journalistic integrity by insulating CPB 
from reactions to programming decisions. Advance appropriations also 
afford program managers more lead-time to plan and organize their 
activities. Moreover, advance appropriations provide seed money for 
raising non-federal funding. Ordinarily, the decision to advance fund a 
program is driven by a desire to insulate that program from the 
uncertainties surrounding the annual appropriations process, such as 
delays in enacting appropriations. Legislative history shows that it 
was this reasoning that led Congress--backed by the recommendations of 
three presidents--to place CPB on an advance appropriation basis 
beginning in 1976. In fact, in 1975, President Ford sent a five-year 
reauthorization to Congress with a five-year advance funding provision. 
Subsequently in 1976, the Congress, in a bipartisan vote, established a 
three-year funding practice with two-year advance appropriations that 
has supported CPB ever since (Public Law 94-439).

                        DIGITAL RADIO CONVERSION
    Like our friends in public television, NPR and its member stations 
are excited about the possibilities of digital service and ``new 
media.'' Public radio supports President Bush's budget proposal that 
earmarks $20 million in fiscal year 2002 for CPB to help facilitate 
public radio and television's transition to digital broadcasting. The 
estimated cost for digital radio is $116 million for transmission only, 
excluding production equipment.
    Digital radio transmission technology is poised to deliver near 
compact-disc-quality sound free of interference to listeners. Digital 
production and transmission conversion will enable public radio 
stations to produce and deliver programming using a far more efficient 
process than currently exists. It may allow listeners and users to 
experience a variety of new services such as the ability to search 
program formats, scan selective programs and read music lyrics and song 
titles.
    U.S. broadcasters are developing a digital technology that works in 
the existing AM and FM radio bands named In-Band, On-Channel or 
``IBOC.'' The Federal Communications Commission (FCC) initiated a 
digital audio broadcasting, or ``DAB,'' rulemaking in November 1999, 
placing a high priority on preserving spectrum. IBOC DAB achieves 
spectrum preservation by combining digital and analog signals within 
the same AM or FM radio channel, thereby avoiding the need for 
additional spectrum.
    The National Radio Systems Committee (NRSC) will independently test 
IBOC DAB in the Summer 2001. At some point after evaluation of the 
additional testing, the NRSC is expected to make a recommendation to 
the FCC on the selection of a standard. The FCC is awaiting this 
industry recommendation before it endorses a digital transmission 
standard.

        NATIONAL SUPPORT FOR LOCAL EFFORTS: CPB FUNDED PROGRAMS
    The majority of CPB dollars go to local stations to help sponsor 
community outreach activities, create local programming and purchase 
national programming from a diverse set of content producers. The 
following are a few of the many examples of the local and national 
programming that are supported in part by CPB funding:
    KSKA-FM in Anchorage, AK.--Produces Community Forum. Host Robert 
Howk and his guests discuss community issues and take listener calls 
during this live, call-in broadcast. The station also partners with 
other Alaskan public radio stations to produce and broadcast Alaska 
Edition, an award-winning daily radio magazine. It is an hour-long mix 
of news, interviews, music and commentaries written, produced and 
hosted by Alaskans for Alaskans.
    KPBS in San Diego, CA.--Partnered with the California League of 
Women in the last election season to offer voters personalized election 
information. Along with locally produced news stories, the feature 
contained a sample ballot with candidate profiles, proposition 
information, links to voter registration and polling place information. 
Users could create their own portfolio of election information and 
stories that interested them.
    WOI Radio in Ames, IA.--Partners with St. John's Lutheran Church 
Foundation, Essman/Associates to produce St. John's Forum, a series 
devoted to promoting civil discourse on ethical questions and other 
issues facing Iowans. Beginning its third season on WOI Radio, The 
Forum is recorded before a live audience at WOI's studios in the Iowa 
State University Learning Connection in downtown Des Moines.
    WFPL-FM in Louisville, KY.--Broadcasts Louisville Forums, 
programming that helps Louisville citizens learn about local issues and 
ideas from people in the community. WFPL-FM broadcasts presentations at 
the Downtown Rotary Club, the Louisville Forum, the University of 
Louisville, the Louisville Free Public Library and other local venues. 
The station also produces State of Affairs, a program offering 
substantive discussion with an inquisitive host, informed guests and 
thoughtful callers covering topics as diverse as politics and economic 
development, to social issues, religion and arts.
    New Hampshire Public Radio.--Produces Front Porch with John 
Walters, a program dedicated to hearing from the Granite State's most 
interesting people with a unique, creative approach to their work or 
their life.
    KNPR-FM in Las Vegas, NV.--Produces The Las Vegas I Remember, a 
series devoted to the history of Las Vegas and Nevada told by those who 
lived it. For instance, the program featured members of three of Las 
Vegas' founding families. Another program examined the history of Las 
Vegas after the building of the Hoover Dam.
    WVIA-FM in Scranton, PA.--Broadcasts performances of artists who 
perform and record in the magnificent space of St. Stephen's Pro-
Cathedral in Wilkes-Barre. Past performances have included organists, 
choral groups and chamber music. The station also produces Art Scene, a 
unique program bringing attention to the area's cultural events through 
interviews, reviews and commentaries on films, books, jazz, and 
classical music.
    KERA-FM in Dallas, TX.--Airs The People's Agenda, a call-in show 
exploring issues of public concern such as work, family, transportation 
and crime. The show defines problems from the public's perspective, 
examining how citizens are addressing local matters.
    WXPR-FM in Rhinelander, WI.--Produces nearly a dozen programs such 
as Northwoods Cafe, a mix of music from traditional, new and ethnic 
folk music, as well as world music to some blues, cajun and zydeco 
music.
    NPR's.--Morning Edition is the premier national/local program on 
public radio, with 10 million weekly listeners. The program is designed 
to encourage local stations' news departments to report on community 
news and events by inserting these stories into the national feed.
    NPR's.--Lost & Found Sound is a collection of stories that 
chronicles, reflects, and celebrates the changing sounds of this 
century. Stories explore American life through sound--endangered 
sounds, shifting accents, vanishing voices, the merging of languages, 
the music of new technologies, and the soundscape of the streets.
    NPR.--Distributes Latino USA, a national, English-language news and 
culture program produced from a Latino perspective. It is a production 
partnership of KUT Radio and the Center for Mexican American Studies at 
The University of Texas at Austin.

                               CONCLUSION
    Survey after survey finds that public broadcasting is valued and 
supported enthusiastically by leaders of both political parties and by 
Americans from all regions and walks of life. According to Roper Starch 
Worldwide, a leading global marketing research and consulting firm, 
public television and public radio are among the top five choices for 
government services that provide excellent or good value for the tax 
dollar.
    Please support a $395 million appropriation for CPB for fiscal year 
2004 and maintain advance appropriations for CPB. Moreover, please 
support $20 million for public radio and television's digital 
transition that is contained in the President's budget.
    NPR is a private, nonprofit corporation that produces and 
distributes award-winning programming such as Morning Edition, All 
Things Considered, Performance Today, and Car Talk. NPR is also a 
membership organization. NPR Member stations are independent entities, 
licensed to a variety of non-profit organizations, local communities, 
colleges, universities and other institutions. Public radio stations 
independently select and produce community-appropriate programming that 
best serve their listening areas rather than having these decisions 
made by a centralized conglomerate.


       LIST OF WITNESSES, COMMUNICATIONS, AND PREPARED STATEMENTS

                              ----------                              
                                                                   Page

Alexander, David C., president, Auburn Engineers, Inc............   169
    Prepared statement...........................................   170
Alexander, Hon. Duane, M.D., Director, National Institute of 
  Child Health and Human Development, National Institutes of 
  Health, Department of Health and Human Services, prepared 
  statement......................................................   300
Alpha One Foundation, prepared statement.........................   442
American Academy of:
    Family Physicians, prepared statement........................   450
    Physician Assistants, prepared statement.....................   454
American Association of:
    Geriatric Psychiatry, prepared statement.....................   457
    Colleges of Nursing, prepared statement......................   464
    Colleges of Osteopathic Medicine, prepared statement.........   468
    Colleges of Pharmacy, prepared statement.....................   470
    Immunologists, prepared statement............................   462
    Pharmaceutical Scientists, prepared statement................   471
American:
    College of Cardiology, prepared statement....................   472
    Council on Education Coalition for International Education, 
      prepared statement.........................................   424
    Dental Hygienists' Association, prepared statement...........   475
    Gastrotenterological Association, prepared statement.........   482
    Health Care Association, prepared statement..................    25
    Heart Association, prepared statement........................   485
    Indian Higher Education Consortium, prepared statement.......   417
    Library Association, prepared statement......................   684
    Lung Association (ALA), prepared statement...................   478
    Museum of Natural History, prepared statement................   420
    Psychological Society, prepared statement....................   489
    Public Power Association, prepared statement.................   693
    Society for Microbiology, prepared statements..............498, 501
    Society of Clinical Oncology, prepared statement.............   494
    Society of Clinical Pathologists, prepared statement.........   496
    Society of Tropical Medicine and Hygiene, prepared statement.   504
    Thoracic Society (ATS), prepared statement...................   478
Association for Professionals in Infection Control and 
  Epidemiology, Inc., prepared statement.........................   507
Association of:
    Academic Health Sciences Libraries, prepared statement.......   588
    America's Public Television Stations, prepared statement.....   694
    Minority Health Professions Schools, prepared statement......   508
    Schools of Public Health, prepared statement.................   444

Babyland Family Services, Inc., prepared statement...............   511
Barondess, Dr. Jeremiah A., chairman, panel on Musculoskelatal 
  Disorders and the Workplace, and president of the New York 
  Academy of Medicine............................................   118
    Prepared statement...........................................   120
Battey, Dr. James F., Jr., Director, National Institute on 
  Deafness and Other Communication Disorders, National Institutes 
  of Health, Department of Health and Human Services, prepared 
  statement......................................................   302
Bigos, Dr. Stanley, Professor of Orthopedics, University of 
  Washington.....................................................    79
    Prepared statement...........................................    81
Bonacum, Doug, director, Patient Safety, Kaiser Permanente.......   182
    Prepared statement...........................................   184
Burton, Dr. Kim, director, Spinal Research Unit, University of 
  Hudderfield, United Kingdom....................................   114
    Prepared statement...........................................   116
Bushnell Center for the Performing Arts, prepared statement......   422
Byrd, Hon. Robert C., U.S. Senator from West Virginia, questions 
  submitted by...................................................   289

Canavan Research Illinois, prepared statement....................   514
Carper, Senator Thomas R., amendment proposed by.................   280
Cassman, Dr. Marvin, Ph.D., Director, National Institute of 
  General Medical Sciences, National Institutes of Health, 
  Department of Health and Human Services, prepared statement....   305
Chao, Hon. Elaine L., Secretary of Labor, Office of the 
  Secretary, Department of Labor................................68, 201
    Letter from..................................................    26
    Prepared statements.........................................69, 206
    Summary statement............................................   203
Children's Heart Foundation, prepared statement..................   518
City of:
    Miami Beach, FL, prepared statement..........................   520
    Newark, NJ, prepared statement...............................   520
Coalition for Health Funding, prepared statement.................   525
Coalition of Northeastern Governors, prepared statement..........   528
Cochran, Hon. Thad, U.S. Senator from Montana:
    Opening statement............................................   379
    Question submitted by........................................   249
College on Problems of Drug Dependence, Inc., prepared statement.   530
Collins, Dr. Francis S., M.D., Ph.D., Director, National Human 
  Genome Research Institute, National Institutes of Health, 
  Department of Health and Human Services, prepared statement....   307
Colonial Williamsburg Foundation, prepared statement.............   427
Community Medical Centers, Fresno, CA, prepared statement........   532
Council of State and Territorial Epidemiologists, prepared 
  statement......................................................   533
Craig, Hon. Larry E., U.S. Senator from Idaho, question submitted 
  by.............................................................   283
Crohn's and Colitis Foundation of America, prepared statement....   537
Crownpoint Institute of Technology, prepared statement...........   439
Cure for Lymphoma Foundation, prepared statement.................   540

Dean, Hon. Donna J., Ph.D., Acting Director, National Institute 
  of Biomedical Imaging and Bioengineering, National Institutes 
  of Health, Department of Health and Human Services, prepared 
  statement......................................................   311
Derebery, Dr. Jane, vice president of Medical Affairs, Concentra 
  Medical Services...............................................   136
    Prepared statement...........................................   137
Digestive Disease National Coalition, prepared statement.........   541
Doris Day Animal League, prepared statement......................   544
Drug and Alcohol Service Providers Organization of Pennsylvania, 
  prepared statement.............................................   578
Dystonia Medical Research Foundation, prepared statement.........   545

Easter Seals, prepared statement.................................   547
Eberhardt, Heidi, international trade specialist.................   107
    Prepared statement...........................................   109
Epilepsy Foundation, prepared statement..........................   552
Evanoff, Dr. Bradley, assistant professor of medicine, Washington 
  University School of Medicine..................................    97
    Prepared statement...........................................    99

Facioscapulohumeral Muscular Dystrophy Society, prepared 
  statement......................................................   553
Families of Spinal Muscular Atrophy, prepared statement..........   559
Fauci, Dr. Anthony S., Director, National Institute of Allergy 
  and Infectious Diseases, National Institutes of Health, 
  Department of Health and Human Services........................   293
    Prepared statement...........................................   313
Feinstein, Hon. Dianne, U.S. Senator from California, questions 
  submitted
  by.............................................................   291
Fellner, Baruch A. Esq., Partner, Gibson, Dunn & Crutcher, LL1, 76, 196
    Prepared statement...........................................    78
Ficca, Stephen A., Associate Director for Research Services, 
  National Institutes of Health, Department of Health and Human 
  Services, prepared statement...................................   316
Florida State University, prepared statement.....................   430
Foundation for Ichthyosis & Related Skin Types, prepared 
  statement......................................................   557
Frumin, Eric, director, Safety and Health, Union of Needle Trades 
  Industrial and Textile Employees...............................   175
    Prepared statement...........................................   177

Gordis, Hon. Enoch, M.D., Director, National Institute on Alcohol 
  Abuse and Alcoholism, National Institutes of Health, Department 
  of Health and Human Services, prepared statement...............   318
Grady, Dr. Patricia A., Director, National Institute of Nursing 
  Research, National Institutes of Health, Department of Health 
  and Human Services, prepared statement.........................   321

Hadler, Dr. Nortin M., professor of Medicine and Microbiology/
  Immunology, University of North Carolina, Chapel Hill..........    83
    Prepared statement...........................................    85
Harkin, Hon. Tom, U.S. Senator from Iowa:
    Opening statements......................................28, 66, 252
    Prepared statements....................................... 202, 390
    Questions submitted by............................59, 238, 284, 404
Hepatitis Foundation International, prepared statement...........   560
Hodes, Dr. Richard J., Director, National Institute on Aging, 
  National Institutes of Health, Department of Health and Human 
  Services.......................................................   293
    Prepared statement...........................................   324
Hollings, Hon. Ernest F., U.S. Senator from South Carolina, 
  questions submitted by.........................................   407
Humane Society of the United States, prepared statement..........   562
Huntington's Disease Society of America, prepared statement......   564
Hutchison, Hon. Kay Bailey, a U.S. Senator from Texas, questions 
  submitted by...................................................   408
Hyman, Hon. Steven E., M.D., Director, National Institute of 
  Mental Health, National Institutes of Health, Department of 
  Health and Human Services, prepared statement..................   329

Immune Deficiency Foundation, prepared statement.................   565
Infectious Diseases Society of America's (IDSA), prepared 
  statement......................................................   567

Joslin Diabetes Center, prepared statement.......................   571
Juvenile Diabetes Research Foundation International, prepared 
  statement......................................................   573

Katz, Dr. Stephen I., Director, National Institute of Arthritis 
  and Musculoskeletal and Skin Diseases, National Institutes of 
  Health, Department of Health and Human Services................   293
    Prepared statement...........................................   332
Kennedy Krieger Institute, prepared statement....................   574
Keusch, Gerald T., M.D., Director, John E. Fogarty International 
  Center for Advanced Study in the Health Sciences, National 
  Institutes of Health, Department of Health and Human Services, 
  prepared statement.............................................   334
Kirschstein, Hon. Ruth L., M.D., Acting Director, National 
  Institutes of Health, Department of Health and Human Services..   293
    Prepared statement...........................................   296
    Summary statement............................................   295
Klausner, Dr. Richard D., Director, National Cancer Institute, 
  National Institutes of Health, Department of Health and Human 
  Services.......................................................   293
    Prepared statement...........................................   337

Landrieu, Hon. Mary L., U.S. Senator from Louisiana:
    Opening statement............................................   112
    Questions submitted by.......................................   287
Lenfant, Dr. Claude, Director, National Heart, Lung and Blood 
  Institute, National Institutes of Health, Department of Health 
  and Human Services.............................................   293
    Prepared statement...........................................   340
Leshner, Alan I., Ph.D., Director, National Institute on Drug 
  Abuse, National Institutes of Health, Department of Health and 
  Human Services, prepared statement.............................   345
Lindberg, Dr. Donald A.B., Director, National Library of 
  Medicine, National Institutes of Health, Department of Health 
  and Human Services, prepared statement.........................   343
Lippy, Dr. William H., prepared statement........................   681
Lovelace Respiratory Research Institute (LRRI), prepared 
  statement......................................................   581
LPA, Inc., prepared statement....................................    20
Lymphoma Research Foundation of America, Inc., prepared statement   582

Maddox, Dr. Yvonne T., Acting Deputy Director, Office of the 
  Director, National Institutes of Health, Department of Health 
  and Human Services, prepared statement.........................   348
McLaughlin, Dr. Jack A., Acting Director, National Eye Institute, 
  National Institutes of Health, Department of Health and Human 
  Services.......................................................   293
    Prepared statement...........................................   351
McMullen, James, Deputy Assistant Secretary, Budget, Department 
  of
  Labor..........................................................   201
Medical Library Association, prepared statement..................   588
Medicare Payment Advisory Commission, prepared statement.........   584
Miami Children's Hospital, prepared statement....................   592
Mirer, Dr. Franklin E., director, Health and Safety, United Auto 
  Workers........................................................   150
    Prepared statement...........................................   151
Mississippi:
    Department of Rehabilitation Services, prepared statement....   594
    State University, prepared statement.........................   523
Motion Picture & Television Fund, prepared statement.............   697
Murray, Hon. Patty, U.S. Senator from Washington, questions 
  submitted by...................................................   246

National:
    AHEC Organization, prepared statement........................   609
    Alliance for Eye and Vision Research and the Foundation 
      Fighting Blindness, prepared statement.....................   597
    Alliance to End Homelessness, prepared statement.............   595
    Alopecia Areata Foundation, prepared statement...............   599
    Association of Anorexia Nervosa and Associated Disorders, 
      prepared statement.........................................   602
    Association of Children's Hospitals, prepared statement......   603
    Association of Developmental Disabilities Councils, prepared 
      statement..................................................   606
    Association of State Workforce Agencies, prepared statement..   687
    Center for Victims of Crime, prepared statement..............   611
    Coalition for Heart and Stroke Research, prepared statement..   613
    Down Syndrome Society, prepared statement....................   622
    Federation of Community Broadcasters, prepared statement.....   698
    Fuel Funds Network, prepared statement.......................   614
    Indian Child Welfare Association, prepared statement.........   616
    Jewish Medical and Research Center, prepared statement.......   515
    Latex Allergy Network, prepared statement....................   620
    Marfan Foundation, prepared statement........................   626
    Medical Association, prepared statement......................   628
    Military Family Association, Inc., prepared statement........   432
    Minority Public Broadcasting Consortia, prepared statement...   700
    MPS Society Inc., prepared statement.........................   631
    Multiple Sclerosis Society, prepared statement...............   632
    Neurofibromatosis Foundation, Inc., prepared statement.......   636
    Organization for Rare Disorders, prepared statement..........   637
    Psoriasis Foundation, prepared statement.....................   641
    Public Radio, prepared statement.............................   701
    Sleep Foundation, prepared statement.........................   642
    Task Force to End Sexual and Domestic Violence Against Women, 
      prepared statement.........................................   668
    Treasury Employees Union, prepared statement.................   690
NephCure Foundation, prepared statement..........................   645
New York University, prepared statement..........................   646
Nowell, Jacqueline, director, Safety and Health, United Food and 
  Commercial Workers International Union.........................   189
    Prepared statement...........................................   190
Nyeholt, James and Margaret, prepared statement..................   649

O'Connor, Dr. Christina, prepared statement......................   650
Olden, Hon. Kenneth, Director, National Institute of 
  Environmental Health Sciences, National Institutes of Health, 
  Department of Health and Human Services, prepared statement....   353

Paige, Dr. Roderick R., Secretary of Education, Office of the 
  Secretary, Department of Education.............................   251
    Prepared statement...........................................   262
    Summary statement............................................   255
Pancreatic Cancer Action Network, Inc., prepared statement.......   652
Penn, Dr. Audrey S., Acting Director, National Institute of 
  Neurological Disorders and Stroke, National Institutes of 
  Health, Department of Health and Human Services................   293
    Prepared statement...........................................   356
People for the Ethical Treatment of Animals, prepared statement..   653
Population Association of America and the Association of 
  Population Centers, prepared statement.........................   656
Pulmonary Hypertension Association, prepared statement...........   659
Punnett, Dr. Laura, professor, Department of Work Environment, 
  University of Massachusetts Lowell.............................   139
    Prepared statement...........................................   141

Reid, Hon. Harry, U.S. Senator from Nevada:
    Prepared statement...........................................   266
    Questions submitted by......................................63, 287
Research Society on Alcoholism, prepared statement...............   661
Rhinehart, Lynn, American Federation of Labor-Congress of 
  Industrial Organizations.......................................     3
    Prepared statement...........................................    22
Rotary International, prepared statement.........................   663
Ruffin, John, Ph.D., Director, National Center on Minority Health 
  and Health Disparities, National Institutes of Health, 
  Department of Health and Human Services, prepared statement....   359

Scleroderma Research Foundation, prepared statement..............   667
Seminario, Peg, director, Department of Occupational Safety and 
  Health, AFL-CIO...............................................88, 197
    Prepared statement...........................................    89
Sjogren's Syndrome Foundation, prepared statement................   669
Skelly, Thomas P., Director, Budget Service, Department of 
  Education......................................................   251
Sparlin, Dean, Esq., Gibson, Dunn & Crutcher, LLP................   165
    Prepared statement...........................................   167
Specter, Hon. Arlen, U.S. Senator from Pennsylvania:
    Opening statements.........................1, 27, 65, 201, 251, 293
    Questions submitted by............................54, 229, 280, 394
Spiegel, Dr. Allen M., National Institute of Diabetes and 
  Digestive and Kidney Diseases, National Institutes of Health, 
  Department of Health and Human Services........................   293
    Prepared statement...........................................   364
Stevens, Hon. Ted, U.S. Senator from Alaska:
    Opening statement............................................    30
    Questions submitted by.................................58, 245, 401
Straus, Stephen E., M.D., Director, National Center for 
  Complementary and Alternative Medicine, National Institutes of 
  Health, Department of Health and Human Services, prepared 
  statement......................................................   362
Sudden Infant Death Syndrome Alliance, prepared statement........   672

Tabak, Lawrence A., Director, National Institute of Dental and 
  Craniofacial Research, National Institutes of Health, 
  Department of Health and Human Services, prepared statement....   367
The Mended Hearts, Inc., prepared statement......................   590
Thompson, Hon. Tommy G., Secretary, Office of the Secretary, 
  Department of Health and Human Services........................    27
    Prepared statement...........................................    32
    Summary statement............................................    31
Trust for America's Health, prepared statement...................   674

U.S. Senators and House Members, copy of letter sent to..........    25
United:
    Fresh Fruit & Vegetable Association, prepared statement......   677
    Tribes Technical College, prepared statement.................   435
University of:
    Cincinnati, prepared statement...............................   448
    Medicine and Dentistry of New Jersey, prepared statement.....   678
    Miami, Coral Gables, Florida, prepared statement.............   682
    Tulsa, prepared statement....................................   438

Vaitukaitis, Dr. Judith L., Director, National Center for 
  Research Resources, National Institutes of Health, Department 
  of Health and Human Services, prepared statement...............   371
Whitescarver, Jack, Ph.D., Acting Director, Office of AIDS 
  Research, National Institutes of Health, Department of Health 
  and Human Services, prepared statement.........................   374
Wood, Jerri, legislative chairman, Local 7800, Communication 
  Workers of America.............................................   192
    Prepared statement...........................................   194
Woodward, Joseph M., Associate Solicitor of Labor, Occupational 
  Safety and Health Administration, Department of Labor.......... 3, 68


                             SUBJECT INDEX

                              ----------                              

                               ERGONOMICS

                                                                   Page

Application of ergonomics, what are the tangible benefits to?....   172
Approach.........................................................   120
Congress, questions posed by, answers to.........................   130
Congressional Review Act to rescind ergonomics regulation, AHCA 
  praises use of.................................................    25
Considerations, additional.......................................   129
CRA, Department activities since.................................    71
Credentials and qualifications...................................   170
Data collection and reporting systems, the need for..............   122
Dimensions of the problem........................................   121
Dissent..........................................................   122
    Panel response to............................................   134
Does ergonomics work?............................................   171
Epidemiologic evidence since 1997................................   143
Epidemiology, summary of.........................................   147
Ergonomic:
    Interventions, the effectiveness of..........................   104
    Programs are technically feasible and are cost-effective, 
      actual industrial experience shows that....................   177
    Sues in the health care workplace, addressing................   184
    Standard, adequate scientific and clinical basis exists to 
      support....................................................   100
    Standard, refutation of some common arguments against........   106
    Trends in applied............................................   173
    Why failed...................................................    71
Evidence, patterns of............................................   126
Exposure--response relationships.................................   145
Impetus..........................................................   120
Industry misrepresentations about costs, history of..............   180
Injuries, cost of................................................   181
Literature reviews...............................................   145
Musculoskeletal disorders:
    Epidemiology in 1997, NIOSH review of........................   142
    The importance of early recognition and appropriate treatment 
      of.........................................................   101
    And the workplace--low back and upper extremities............   123
    The toll of, on workers and the economy is great.............    91
OSHA ergonomics standard:
    National Academy of Sciences/Institute of Medicine report 
      supports...................................................    22
    Needed to protect workers from musculoskeletal disorders.....    93
Panel:
    Charge, composition, and approach............................   125
    Composition..................................................   120
Principles.......................................................    72
Psychosocial factors and MSDs....................................   146
Recommendations..................................................   128
Research agenda..................................................   122
Scientific evidence in support of an ergonomics standard is 
  extensive and strong...........................................    92
Timeline.........................................................    70
Truth, the first casualty of war is the..........................   177
What's next?.....................................................    73
Work factors and musculoskeletal disorders, relationship among...   121
Work-related musculoskeletal disorders are the Nation's leading 
  job safety problem.............................................    90
Workplace interventions, the value of............................   121

                        DEPARTMENT OF EDUCATION

                        Office of the Secretary

Achievement:
    Creating a culture of........................................   258
    Gap, closing the.............................................   263
Additional committee questions...................................   280
American history instruction support.............................   289
Annual testing, cost of..........................................   279
Campus crime.....................................................   275
Choices, empowering parents with.................................   264
Clery Act implementation.........................................   281
College:
    Education, access to a.......................................   284
    Persistence in...............................................   283
    Population, growth in........................................   283
Community Learning Centers, 21st Century.........................   282
Debate reform and principles of reform, not budget...............   260
Dropout problem, addressing the..................................   287
Education 302(b) congressional budget allocation.................   254
Education budget:
    Issues.......................................................   251
    Strategic review of..........................................   253
Education change:
    Guiding principles of........................................   259
    Principles of................................................   260
Elementary and secondary proposals, other key....................   265
Elementary School Counseling Demonstration Program...............   284
ESEA:
    Reauthorization..............................................   259
    Spending and 4th grade math achievement......................   257
        Reading achievement......................................   257
Excellence:
    Education must be nationwide.................................   255
    Requires change..............................................   255
Expanding flexibility and reducing bureaucracy...................   264
Failing schools--cumulative effect of achievement gaps...........   260
Federal:
    ESEA investment and student achievement......................   258
    Role and school construction.................................   267
Fellowships, GAANN and Javits....................................   286
Funding:
    Class-size reduction.........................................   290
    For special education and IDEA reauthorization...............   277
    School construction........................................267, 269
        Renovation...............................................   253
    Special education............................................   252
Higher education, unmet need and access to.......................   282
Houston:
    Independent school system....................................   259
    School system reforms and public opinion.....................   262
Impact aid construction..........................................   271
Leveraging Federal funds--school construction in Iowa............   270
Math and science budget support..................................   285
NAEP testing results--4th grade reading scores...................   255
Pell Grant Program costs.........................................   289
Postsecondary education..........................................   265
President's proposal and use of school construction funds........   277
Reading performance, flat........................................   256
Reform and results, budget increases to be tied to...............   275
Reform, education funds for......................................   281
School renovation grants--guidance for implementation............   281
Shortages, special education teacher.............................   284
Tax cut package and education funding............................   253
Teacher:
    Fund and class size reduction, flexible......................   268
    Retention and recruitment grants.............................   288
Teaching:
    American History Grant Program...............................   290
    Transition to................................................   288
Testing and accountability.......................................   279
Title I:
    Allocations--use of updated data.............................   291
    Budget request...............................................   287
    Hold-harmless................................................   291
    ``Shortfall''................................................   291
    State Grants Program, Assistive Technology Act...............   285
TRIO programs..................................................283, 289
Vocational education programs support............................   286
Vouchers:
    Private school...............................................   280
    School choice................................................   274
Youth violence...................................................   280

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                     National Institutes of Health

Additional committee questions...................................   393
Adolescents:
    Factors influencing obesity in...............................   322
    Reducing HIV and AIDS among..................................   301
Adult stem cell experiment.......................................   381
Aging, biology of................................................   326
AIDS:
    Comprehensive research plan and budget.......................   375
    Research, Office of..........................................   349
Alcohol:
    Is unique....................................................   318
    Research, advances in........................................   319
Alcoholism, neuroscience holds the key to behaviors of...........   319
Alzheimer's disease:
    Conquering...................................................   324
    Patients, improving daily living for.........................   321
    Research.....................................................   383
Autism research..................................................   301
Basic science, beyond............................................   320
Behavior.........................................................   342
Bioengineering, bioimaging, and bioinformatics...................   372
Biomedical research infrastructure...............................   405
Bone biology and bone diseases...................................   333
Botanicals.......................................................   363
Budget summary, fiscal year 2002.................................   318
Budgetary increases..............................................   415
CAM interventions, mechanisms of.................................   362
Canavan's research...............................................   401
Cancer...........................................................   363
    Trends.......................................................   337
Capacity building programs, other................................   361
Centers of Excellence Program....................................   361
Children:
    Research in..................................................   332
    To grow, improving the environment for.......................   301
Cholesterol guidelines, new......................................   397
Chronic:
    Infectious diseases: Dental caries and periodontal diseases..   369
    Pain and temporomandibular disorders, new methods needed to 
      treat......................................................   370
Clinical Research Career Development programs....................   400
Clinical:
    Research: Taking basic discoveries into medical practice.....   298
    Trials, including child mental disorder studies..............   331
Congenital cardiovascular malformations..........................   340
Diabetes.........................................................   365
Diagnosis........................................................   338
Disease:
    And disability, reducing.....................................   325
    New preventive strategies against............................   372
Drug:
    Abuse prevention, science-based principles for...............   347
    Problems, responding to ever-emerging new....................   346
Embryonic stem cell potential....................................   382
End-of-life/palliative care research.............................   322
End-stage renal disease and polycystic kidney disease............   367
Environmental susceptibility genes, search for...................   355
Ethical, legal, and social implications..........................   311
External influences..............................................   342
Fundamental question, new technology to help answer a............   300
Funding collaboration............................................   408
Gene:
    And the environment..........................................   354
    Expression...................................................   309
Generation of researchers, developing a new......................   313
Genetic:
    And genomics.................................................   341
    Research is key to understanding craniofacial disorders......   369
    Variability, exposure, and disease association...............   355
Genome sequences of non-human species............................   308
Genomic:
    And genetic medicine.......................................297, 371
    Science, centers of excellence in............................   310
Global health:
    Challenges in................................................   335
    Emerging infectious diseases.................................   314
Government Performance and Results Act.....318, 321, 343, 348, 353, 370
Grant submissions:
    Quality of science in........................................   415
    Success rate for.............................................   415
Health:
    And disease, understanding...................................   341
    Disease and stroke, trans-agency conference..................
    Disparities.................................298, 307, 332, 364, 373
    Education and communication..................................   353
    Information dissemination.................................... 361on
                                                                    395
Hepatitis C and other chronic liver diseases.....................   366
HIV infection, investigating the oral cavity's contribution to 
  defending the body against.....................................   370
HIV/AIDS.........................................................   314
Human:
    Genetic variation............................................   309
    Genome sequence, finishing the...............................   308
Immune-mediated diseases.........................................   315
Inflammatory bowel disease and other digestive diseases..........   367
Information dissemination........................................   416
Infrastructure and enabling technologies.........................   298
Initiatives:
    Fiscal year 2002.............................................   336
    New and expanded.............................................   322
Integrative medicine and research training.......................   364
International collaborations by institutes.......................   409
Investments, return on...........................................   398
Islet:
    Inadequate supply of.........................................   384
    Transplants in type 1 diabetes...............................   384
John Edward Porter Neuroscience Research Center..................   331
Learning, behavioral interventions to improve....................   301
Loan Repayment Program...........................................   361
Low vision.......................................................   407
Mandate, broadening the..........................................   344
Mental:
    And general medical disorders, co-occurring..................   329
    Disorder phenotypes, animal models can provide...............   330
    Disorders are enormously disabling...........................   329
    Illness research, molecular genetics tools benefit...........   330
Meritorious research.............................................   400
Molecular targets: A new era in the discovery and development of 
  preventive and therapeutic agents for cancer...................   338
Mood disorders, strategic research planning targets..............   329
Muscle biology and muscle diseases...............................   333
National drug abuse treatment clinical trials network............   346
NCCAM success rate...............................................   406
NDRI expansion...................................................   394
Neurological:
    Diseases, progress and promise in............................   357
    Disorders, the burden of.....................................   356
Neuroscience portfolio sets stage for new treatments.............   347
NIAID, overview of...............................................   313
NIBIB, new technologies in.......................................   399
NIDA'S comprehensive portfolio...................................   345
NIH institutes and centers, leveraging resources with the........   359
NINDS stroke strategic plan......................................   394
Nursing research, building the capacity to do....................   323
OD activities, other.............................................   350
Pancreatic cancer................................................   404
Pandemic, the exploding..........................................   374
Population morbidity and mortality rates.........................   398
Practice at the community level, translating research findings 
  into...........................................................   321
President's request, amount of...................................   343
Prion:
    NIH support of...............................................   404
    Research.....................................................   404
Priority:
    Basic science................................................   376
    International research.......................................   376
    Prevention research..........................................   375
    Racial and ethnic minorities.................................   376
    Treatment research...........................................   376
    Vaccine research.............................................   375
Promise, mission of..............................................   312
Protein structure, function, and interaction.....................   310
Public health and public safety approaches, blending.............   348
Quality of life for all Americans, reducing oral health 
  disparities to improve.........................................   368
Research:
    Behavioral and social........................................   326
    Capacity.....................................................   373
    Cataract.....................................................   352
    Corneal disease..............................................   351
    Creates new materials for replacing and restoring damaged 
      tissues....................................................   369
    Directions, identifying productive new.......................   312
    Early detection..............................................   338
    Endowment Program............................................   361
    Glaucoma.....................................................   352
    Grant portfolio, an independent..............................   360
    Initiatives, recent..........................................   306
    Mission, role in the.........................................   316
    Project grants...............................................   399
    Retinal disease..............................................   351
    Strabismus, amblyopia, and visual processing.................   352
    Training.....................................................   306
    Training and career development..............................   373
Retinal degenerative diseases....................................   407
Science:
    Advances.....................................................   344
    Leads our national discourse.................................   348
Sickle cell disease..............................................   340
SIDS, new collaborations to eliminate racial disparities in......   300
Skin biology and skin diseases...................................   333
Stem cell........................................................   400
    Funding......................................................   405
    In vision research, use of...................................   385
    Research.....................................................   384
The Office of:
    Behavioral and Social Sciences Research......................   349
    Disease Prevention...........................................   350
    Research on Women's Health...................................   349
Toxicity/carcinogenicity, assessment of..........................   354
Treatments and prevention, promise for new.......................   310
United States, the evolving epidemic in the......................   374
Urologic diseases................................................   367
Vaccine development..............................................   316
Variant..........................................................   401
vCJD:
    And prion infected beef......................................   404
    On the rise?.................................................   402
    Research, role of NIH in.....................................   402
Viral similarities...............................................   403
Visual impairment and its rehabilitation.........................   352
What is NINDS doing to move toward cures?........................   358
Women's health...................................................   302

                        Office of the Secretary

                                                                     27
Additional committee questions...................................    54
Alternative medicines............................................    48
America's children and families, increasing support for..........    33
Budget proposal, President's fiscal year 2002....................    60
Center for Mental Health Services................................    60
Child care.......................................................43, 46
    Development block grant......................................    57
Child support reform.............................................    52
Children with mental retardation, special health needs of........    58
Chronic disease tracking system..................................    63
Community:
    Attendant services and supports..............................    62
    Health centers...............................................56, 61
Disease control prevention, centers for..........................    39
Faith-based initiatives..........................................48, 54
Family planning..................................................    51
Federal mental health funding....................................    59
Foster care......................................................45, 47
Head Start.......................................................    57
Health care......................................................    44
Infrastructure and reforming management, investing in............    36
Medicaid program.................................................    50
Medicare and expanding access to quality health care, improving..    35
National Health Service Corps....................................    61
Nursing:
    Home initiative..............................................    53
    Shortage.....................................................42, 46
Nutrition programs...............................................    50
Obesity rates....................................................    49
Real Choice Systems Change grants................................    62
Ryan White programs..............................................    57
SCHIP............................................................    44
Scientific and health care quality research, enhancing...........    34
Stem cell research...............................................    40
Strong and healthy America, working together to build a..........    39
Tobacco, regulation of, by FDA...................................    41
    Advertisements...............................................    41
Youth violence...................................................47, 57

                          DEPARTMENT OF LABOR

                        Office of the Secretary

Additional committee questions...................................   229
Advance appropriation............................................   208
Asbestos, exposure of miners to, in Libby, Montana...............   246
Bureau of International Labor Affairs (ILAB).....................   240
Caregivers, shortage of..........................................   248
Companionship services...........................................   229
Coordination, one-stop...........................................   233
Disability employment policy.....................................   207
Employment and training programs.................................   206
Energy Employees Occupational Illness Compensation Program Act 
  (EEOICPA)...............................................208, 238, 247
ERGO II..........................................................   244
Fair Labor Standards Act (FLSA)..................................   242
Federal Employees' Compensation Act surcharge....................   209
Funding level, fiscal year 2002..................................   234
Government Performance and Results Act...........................   209
Grant accountability.............................................   209
Harwood grants...................................................   230
Health care professionals, immigration of........................   249
Information technology...........................................   208
    Cross-cut budget.............................................   231
Injuries, underreporting of......................................   243
International labor affairs......................................   208
Labor statistics.................................................   208
Long-term care givers, legislation for...........................   249
Mass layoffs.....................................................   246
Migrant and Seasonal Farmworker Housing Program..................   249
Office of the 21st Century Workforce.............................   230
OSHA:
    Enforcement budget...........................................   244
    Ergonomists..................................................   243
    MSHA and ESA staff reductions................................   231
    Standards....................................................   244
Pension and Welfare Benefits Administration......................   241
Pension distributions, lump sum..................................   242
Personal protective equipment....................................   241
Staffing shortages...............................................   240
The Treasury, funds reverting to.................................   235
Trade Adjustment Assistance (TAA)/North American Free Trade 
  Agreement-Transitional Adjustment Assistance (NAFTA-TAA).......   209
Training needs, State flexibility for............................   235
Transitional Living Program......................................   230
Unemployment insurance...........................................   208
Unspent funds listed by State and by grant.......................   235
Veterans' Employment and Training Service........................   208
WIA budget request reductions....................................   245
    Disparity in.................................................   241
Women's Bureau equal pay.........................................   247
Worker layoffs...................................................   233
Worker protection/compliance assistance..........................   207
Workforce programs, cuts in......................................   232
Youth programs...................................................   248
    Additional funding...........................................   234


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