    [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

                                   __________

             Printed for the use of the Committee on Appropriations

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