[House Report 106-889]
[From the U.S. Government Publishing Office]



106th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     106-889

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



 
      NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING 
                           ESTABLISHMENT ACT

                                _______
                                

 September 26, 2000.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

  Mr. Bliley, from the Committee on Commerce, submitted the following

                              R E P O R T

                             together with

                            ADDITIONAL VIEWS

                        [To accompany H.R. 1795]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Commerce, to whom was referred the bill 
(H.R. 1795) to amend the Public Health Service Act to establish 
the National Institute of Biomedical Imaging and Engineering, 
having considered the same, report favorably thereon with 
amendments and recommend that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     2
Purpose and Summary..............................................     4
Background and Need for Legislation..............................     4
Hearings.........................................................     5
Committee Consideration..........................................     5
Committee Votes..................................................     5
Committee Oversight Findings.....................................     6
Committee on Government Reform Oversight Findings................     6
New Budget Authority, Entitlement Authority, and Tax Expenditures     6
Committee Cost Estimate..........................................     6
Congressional Budget Office Estimate.............................     6
Federal Mandates Statement.......................................     7
Advisory Committee Statement.....................................     7
Constitutional Authority Statement...............................     7
Applicability to Legislative Branch..............................     7
Section-by-Section Analysis of the Legislation...................     7
Changes in Existing Law Made by the Bill, as Reported............     8
Additional Views.................................................    11

                               Amendment

    The amendments are as follows:
    Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``National Institute of Biomedical 
Imaging and Bioengineering Establishment Act''.

SEC. 2. FINDINGS.

    The Congress makes the following findings:
          (1) Basic research in imaging, bioengineering, computer 
        science, informatics, and related fields is critical to 
        improving health care but is fundamentally different from the 
        research in molecular biology on which the current national 
        research institutes at the National Institutes of Health 
        (``NIH'') are based. To ensure the development of new 
        techniques and technologies for the 21st century, these 
        disciplines therefore require an identity and research home at 
        the NIH that is independent of the existing institute 
        structure.
          (2) Advances based on medical research promise new, more 
        effective treatments for a wide variety of diseases, but the 
        development of new, noninvasiveimaging techniques for earlier 
detection and diagnosis of disease is essential to take full advantage 
of such new treatments and to promote the general improvement of health 
care.
          (3) The development of advanced genetic and molecular imaging 
        techniques is necessary to continue the current rapid pace of 
        discovery in molecular biology.
          (4) Advances in telemedicine, and teleradiology in 
        particular, are increasingly important in the delivery of high 
        quality, reliable medical care to rural citizens and other 
        underserved populations. To fulfill the promise of telemedicine 
        and related technologies fully, a structure is needed at the 
        NIH to support basic research focused on the acquisition, 
        transmission, processing, and optimal display of images.
          (5) A number of Federal departments and agencies support 
        imaging and engineering research with potential medical 
        applications, but a central coordinating body, preferably 
        housed at the NIH, is needed to coordinate these disparate 
        efforts and facilitate the transfer of technologies with 
        medical applications.
          (6) Several breakthrough imaging technologies, including 
        magnetic resonance imaging (``MRI'') and computed tomography 
        (``CT''), have been developed primarily abroad, in large part 
        because of the absence of a home at the NIH for basic research 
        in imaging and related fields. The establishment of a central 
        focus for imaging and bioengineering research at the NIH would 
        promote both scientific advance and U.S. economic development.
          (7) At a time when a consensus exists to add significant 
        resources to the NIH in coming years, it is appropriate to 
        modernize the structure of the NIH to ensure that research 
        dollars are expended more effectively and efficiently and that 
        the fields of medical science that have contributed the most to 
        the detection, diagnosis, and treatment of disease in recent 
        years receive appropriate emphasis.
          (8) The establishment of a National Institute of Biomedical 
        Imaging and Bioengineering at the NIH would accelerate the 
        development of new technologies with clinical and research 
        applications, improve coordination and efficiency at the NIH 
        and throughout the Federal government, reduce duplication and 
        waste, lay the foundation for a new medical information age, 
        promote economic development, and provide a structure to train 
        the young researchers who will make the pathbreaking 
        discoveries of the next century.

SEC. 3. ESTABLISHMENT OF NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND 
                    BIOENGINEERING.

  (a) In General.--Part C of title IV of the Public Health Service Act 
(42 U.S.C. 285 et seq.) is amended by adding at the end the following 
subpart:

      ``Subpart 18--National Institute of Biomedical Imaging and 
                             Bioengineering

                       ``purpose of the institute
  ``Sec. 464z. (a) The general purpose of the National Institute of 
Biomedical Imaging and Bioengineering (in this section referred to as 
the `Institute') is the conduct and support of research, training, the 
dissemination of health information, and other programs with respect to 
biomedical imaging, biomedical engineering, and associated technologies 
and modalities with biomedical applications (in this section referred 
to as `biomedical imaging and bioengineering').
  ``(b)(1) The Director of the Institute, with the advice of the 
Institute's advisory council, shall establish a National Biomedical 
Imaging and Bioengineering Program (in this section referred to as the 
`Program').
  ``(2) Activities under the Program shall include the following with 
respect to biomedical imaging and bioengineering:
          ``(A) Research into the development of new techniques and 
        devices.
          ``(B) Related research in physics, engineering, mathematics, 
        computer science, and other disciplines.
          ``(C) Technology assessments and outcomes studies to evaluate 
        the effectiveness of biologics, materials, processes, devices, 
        procedures, and informatics.
          ``(D) Research in screening for diseases and disorders.
          ``(E) The advancement of existing imaging and bioengineering 
        modalities, including imaging, biomaterials, and informatics.
          ``(F) The development of target-specific agents to enhance 
        images and to identify and delineate disease.
          ``(G) The development of advanced engineering and imaging 
        technologies and techniques for research from the molecular and 
        genetic to the whole organ and body levels.
          ``(H) The development of new techniques and devices for more 
        effective interventional procedures (such as image-guided 
        interventions).
  ``(3)(A) With respect to the Program, the Director of the Institute 
shall prepare and transmit to the Secretary and the Director of NIH a 
plan to initiate, expand, intensify, and coordinate activities of the 
Institute with respect to biomedical imaging and bioengineering. The 
plan shall include such comments and recommendations as the Director of 
the Institute determines appropriate. The Director of the Institute 
shall periodically review and revise the plan and shall transmit any 
revisions of the plan to the Secretary and the Director of NIH.
  ``(B) The plan under subparagraph (A) shall include the 
recommendations of the Director of the Institute with respect to the 
following:
          ``(i) Where appropriate, the consolidation of programs of the 
        National Institutes of Health for the express purpose of 
        enhancing support of activities regarding basic biomedical 
        imaging and bioengineering research.
          ``(ii) The coordination of the activities of the Institute 
        with related activities of the other agencies of the National 
        Institutes of Health and with related activities of other 
        Federal agencies.
  ``(c) The establishment under section 406 of an advisory council for 
the Institute is subject to the following:
          ``(1) The number of members appointed by the Secretary shall 
        be 12.
          ``(2) Of such members--
                  ``(A) 6 members shall be scientists, engineers, 
                physicians, and other health professionals who 
                represent disciplines in biomedical imaging and 
                bioengineering and who are not officers or employees of 
                the United States; and
                  ``(B) 6 members shall be scientists, engineers, 
                physicians, and other health professionals who 
                represent other disciplines and are knowledgeable about 
                the applications of biomedical imaging and 
                bioengineering in medicine, and who are not officers or 
                employees of the United States.
          ``(3) In addition to the ex officio members specified in 
        section 406(b)(2), the ex officio members of the advisory 
        council shall include the Director of the Centers for Disease 
        Control and Prevention, the Director of the National Science 
        Foundation, and the Director of the National Institute of 
        Standards and Technology (or the designees of such officers).
  ``(d)(1) Subject to paragraph (2), for the purpose of carrying out 
this section:
          ``(A) For fiscal year 2001, there is authorized to be 
        appropriated an amount equal to the amount obligated by the 
        National Institutes of Health during fiscal year 2000 for 
        biomedical imaging and bioengineering, except that such amount 
        shall be adjusted to offset any inflation occurring after 
        October 1, 1999.
          ``(B) For each of the fiscal years 2002 and 2003, there is 
        authorized to be appropriated an amount equal to the amount 
        appropriated under subparagraph (A) for fiscal year 2001, 
        except that such amount shall be adjusted for the fiscal year 
        involved to offset any inflation occurring after October 1, 
        2000.
  ``(2) The authorization of appropriations for a fiscal year under 
paragraph (1) is hereby reduced by the amount of any appropriation made 
for such year for the conduct or support by any other national research 
institute of any program with respect to biomedical imaging and 
bioengineering.''.
  (b) Use of Existing Resources.--In providing for the establishment of 
the National Institute of Biomedical Imaging and Bioengineering 
pursuant to the amendment made by subsection (a), the Director of the 
National Institutes of Health (referred to in this subsection as 
``NIH'')--
          (1) may transfer to the National Institute of Biomedical 
        Imaging and Bioengineering such personnel of NIH as the 
        Director determines to be appropriate;
          (2) may, for quarters for such Institute, utilize such 
        facilities of NIH as the Director determines to be appropriate; 
        and
          (3) may obtain administrative support for the Institute from 
        the other agencies of NIH, including the other national 
        research institutes.
  (c) Construction of Facilities.--None of the provisions of this Act 
or the amendments made by the Act may be construed as authorizing the 
construction of facilities, or the acquisition of land, for purposes of 
the establishment or operation of the National Institute of Biomedical 
Imaging and Bioengineering.
  (d) Date Certain for Establishment of Advisory Council.--Not later 
than 90 days after the effective date of this Act under section 4, the 
Secretary of Health and Human Services shall complete the establishment 
of an advisory council for the National Institute of Biomedical Imaging 
and Bioengineering in accordance with section 406 of the Public Health 
Service Act and in accordance with section 464z of such Act (as added 
by subsection (a) of this section).
  (e) Conforming Amendment.--Section 401(b)(1) of the Public Health 
Service Act (42 U.S.C. 281(b)(1)) is amended by adding at the end the 
following subparagraph:
          ``(R) The National Institute of Biomedical Imaging and 
        Bioengineering.''.

SEC. 4. EFFECTIVE DATE.

  This Act takes effect October 1, 2000, or upon the date of the 
enactment of this Act, whichever occurs later.

  Amend the title so as to read:

      A bill to amend the Public Health Service Act to 
establish the National Institute of Biomedical Imaging and 
Bioengineering.

                          Purpose and Summary

    H.R. 1795 amends the Public Health Service Act to provide 
for the establishment of the National Institute of Biomedical 
Imaging and Bioengineering. Specifically, the bill requires the 
Director of the Institute to establish a National Biomedical 
Imaging and Bioengineering Program which must include research 
and related technology assessments and development in 
biomedical imaging and engineering. The Director, with respect 
to this program, must prepare and transmit to the Secretary of 
Health and Human Services and the Director of the National 
Institutes of Health (NIH) a plan to initiate, expand, 
intensify, and coordinate Institute biomedical imaging and 
bioengineering activities. H.R. 1795 also requires the 
consolidation and coordination of Institute biomedical imaging 
and bioengineering research and related activities with those 
of the NIH and other Federal agencies and the establishment of 
an Institute advisory council. The bill authorizes 
appropriations for the Institute for FY 2000 through 2002; and 
provides for the transfer of appropriate NIH personnel and 
research facilities for Institute activities.

                  Background and Need for Legislation

    Breakthroughs in imaging such as magnetic resonance imaging 
(MRI) and computed tomography (CT) have revolutionized the 
practice of medicine in the past quarter century, but those 
technologies are currently inadequate in diagnosing some 
diseases. The potential for advancement is unlimited and all 
efforts to increase the rate of further developments will 
simultaneously increase improvements in the quality of health 
care. Breakthroughs in imaging have allowed physicians to 
eliminate many surgeries, including exploratory surgery, and to 
diagnose diseases at earlier stages of development, when 
treatment is most effective. Because of advances in imaging, 
patients receive more effective treatment, avoid painful, 
expensive, and often dangerous surgical procedures, and live 
longer.
    The National Institutes of Health itself has recognized the 
importance of this discipline by designating imaging as one of 
the top four research priorities at the National Cancer 
Institute. That designation is a positive and important step, 
but the Committee believes that NIH's focus on imaging research 
should be broadened beyond cancer, and that a new institute at 
NIH is required to do it.
    The Committee has heard testimony that the current 
structure of NIH makes research efforts harder. Research 
authority resides in the institutes. As a result, the success 
of imaging research proposals was ultimately dependent on the 
ability of imaging researchers to convince one or more of the 
institutes--institutes whose primary missions and priorities 
are in areas other than imaging--to divert funds from their 
main activities. This sometimes requires artificially tailoring 
proposals to create the appearance of disease or organ specific 
research.
    H.R. 1795 will modernize the structure of NIH to focus on 
the exciting area of biomedical imaging and bioengineering 
without the limitations of the current structure of institutes.

                                Hearings

    The Subcommittee on Health and Environment held a hearing 
on H.R. 1795 on September 13, 2000. The Subcommittee received 
testimony from: R. Nick Bryan, Professor and Chairman of 
Radiology, Hospital of University of Pennsylvania; N. Reed 
Dunnick, Professor and Chair, Department of Radiology, 
University of Michigan Health System; and Dr. Bruce J. Hillman, 
Professor and Chair, Department of Radiology, University of 
Virginia.

                        Committee Consideration

    On September 14, 2000, the Subcommittee on Health and 
Environment was discharged from the further consideration of 
H.R. 1795. On September 14, 2000, the Committee on Commerce met 
in open markup session and approved H.R. 1795 for Full 
Committee consideration, as amended, by a voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no record votes taken in connection with ordering 
H.R. 1795 reported. A motion by Mr. Bliley to order H.R. 1795 
reported to the House, with an amendment, was agreed to by a 
voice vote.
    The following amendment was agreed to by a voice vote:
    An amendment by Mr. Burr, No. 1, changing the word 
``engineering'' to ``bioengineering'' wherever it appeared.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee held a legislative 
hearing and made findings that are reflected in this report.

           Committee on Government Reform Oversight Findings

    Pursuant to clause 3(c)(4) of rule XIII of the Rules of the 
House of Representatives, no oversight findings have been 
submitted to the Committee by the Committee on Government 
Reform.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
1795, The National Institute of Biomedical Imaging and 
Bioengineering Establishment Act, would result in no new or 
increased budget authority, entitlement authority, or tax 
expenditures or revenues.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                Washington, DC, September 21, 2000.
Hon. Tom Bliley,
Chairman, Committee on Commerce,
U.S. House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 1795, the National 
Institute of Biomedical Imaging and Bioengineering 
Establishment Act.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Christopher 
J. Topoleski.
            Sincerely,
                                          Barry B. Anderson
                                    (For Dan L. Crippen, Director).
    Enclosure.

H.R. 1795--National Institute of Biomedical Imaging and Bioengineering 
        Establishment Act

    H.R. 1795 would establish the National Institute of 
Biomedical Imaging and Bioengineering, a new institute within 
the National Institutes of Health (NIH), for the purpose of 
encouraging research into noninvasive forms of diagnosis and 
treatment. The bill would require the institute to coordinate 
and consolidate biomedical imaging and bioengineering research 
activities with those of other NIH agencies and other federal 
agencies. Additionally, H.R. 1795 would establish an advisory 
council for the institute.
    The bill would authorize the appropriation of the amounts 
appropriated in previous years for the activities that would be 
consolidated in the new institute, adjusted for inflation. The 
bill would authorize the transfer of personnel, facilities, and 
administrative support from existing institutes within the NIH 
into the newly established institute. CBO cannot estimate the 
budget authority necessary for implementing H.R. 1795 at this 
time. However, because the bill would not affect direct 
spending or receipts, pay-as-you-go procedures would not apply.
    H.R. 1795 continues no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act and 
would not affect the budgets of state, local, or tribal 
governments.
    The CBO staff contact is Christopher J. Topoleski. This 
estimate was approved by Peter H. Fontaine, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
Article I, section 8, clause 3, which grants Congress the power 
to regulate commerce with foreign nations, among the several 
States, and with the Indian tribes.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 of H.R. 1795 provides the short title of the Act, 
the ``National Institute of Biomedical Imaging and 
Bioengineering Establishment Act.''

Section 2. Findings

    Section 2 provides findings on the importance of biomedical 
imaging and bioengineering and the need for an institute at the 
NIH.

Section 3. Establishment of National Institute of Biomedical Imaging 
        and Bioengineering

    Section 3 amends part C of title IV of the Public Health 
Service Act (42 U.S.C. Sec. 285 et seq.) to create a National 
Institute of Biomedical Imaging and Bioengineering at the NIH. 
The Director of the new Institute shall establish a program on 
biomedical imaging and bioengineering which includes research, 
technology assessment, and development of new techniques. The 
Secretary of the Health and Human Services shall also establish 
an advisory council for the Institute.

Section 4. Effective date

    Section 4 establishes the effective date as the date of 
enactment.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (new matter is 
printed in italics and existing law in which no change is 
proposed is shown in roman):

                       PUBLIC HEALTH SERVICE ACT

           *       *       *       *       *       *       *



                 TITLE IV--NATIONAL RESEARCH INSTITUTES


                 Part A--National Institutes of Health


           organization of the national institutes of health

  Sec. 401. (a)  * * *
  (b)(1) The following national research institutes are 
agencies of the National Institutes of Health:
          (A)  * * *

           *       *       *       *       *       *       *

          (R) The National Institute of Biomedical Imaging and 
        Bioengineering.

           *       *       *       *       *       *       *


Part C--Specific Provisions Respecting National Research Institutes

           *       *       *       *       *       *       *


Subpart 18--National Institute of Biomedical Imaging and Bioengineering


                        purpose of the institute


  Sec. 464z. (a) The general purpose of the National Institute 
of Biomedical Imaging and Bioengineering (in this section 
referred to as the ``Institute'') is the conduct and support of 
research, training, the dissemination of health information, 
and other programs with respect to biomedical imaging, 
biomedical engineering, and associated technologies and 
modalities with biomedical applications (in this section 
referred to as ``biomedical imaging and bioengineering'').
  (b)(1) The Director of the Institute, with the advice of the 
Institute's advisory council, shall establish a National 
Biomedical Imaging and Bioengineering Program (in this section 
referred to as the ``Program'').
  (2) Activities under the Program shall include the following 
with respect to biomedical imaging and bioengineering:
          (A) Research into the development of new techniques 
        and devices.
          (B) Related research in physics, engineering, 
        mathematics, computer science, and other disciplines.
          (C) Technology assessments and outcomes studies to 
        evaluate the effectiveness of biologics, materials, 
        processes, devices, procedures, and informatics.
          (D) Research in screening for diseases and disorders.
          (E) The advancement of existing imaging and 
        bioengineering modalities, including imaging, 
        biomaterials, and informatics.
          (F) The development of target-specific agents to 
        enhance images and to identify and delineate disease.
          (G) The development of advanced engineering and 
        imaging technologies and techniques for research from 
        the molecular and genetic to the whole organ and body 
        levels.
          (H) The development of new techniques and devices for 
        more effective interventional procedures (such as 
        image-guided interventions).
  (3)(A) With respect to the Program, the Director of the 
Institute shall prepare and transmit to the Secretary and the 
Director of NIH a plan to initiate, expand, intensify, and 
coordinate activities of the Institute with respect to 
biomedical imaging and bioengineering. The plan shall include 
such comments and recommendations as the Director of the 
Institute determines appropriate. The Director of the Institute 
shall periodically review and revise the plan and shall 
transmit any revisions of the plan to the Secretary and the 
Director of NIH.
  (B) The plan under subparagraph (A) shall include the 
recommendations of the Director of the Institute with respect 
to the following:
          (i) Where appropriate, the consolidation of programs 
        of the National Institutes of Health for the express 
        purpose of enhancing support of activities regarding 
        basic biomedical imaging and bioengineering research.
          (ii) The coordination of the activities of the 
        Institute with related activities of the other agencies 
        of the National Institutes of Health and with related 
        activities of other Federal agencies.
  (c) The establishment under section 406 of an advisory 
council for the Institute is subject to the following:
          (1) The number of members appointed by the Secretary 
        shall be 12.
          (2) Of such members--
                  (A) 6 members shall be scientists, engineers, 
                physicians, and other health professionals who 
                represent disciplines in biomedical imaging and 
                bioengineering and who are not officers or 
                employees of the United States; and
                  (B) 6 members shall be scientists, engineers, 
                physicians, and other health professionals who 
                represent other disciplines and are 
                knowledgeable about the applications of 
                biomedical imaging and bioengineering in 
                medicine, and who are not officers or employees 
                of the United States.
          (3) In addition to the ex officio members specified 
        in section 406(b)(2), the ex officio members of the 
        advisory council shall include the Director of the 
        Centers for Disease Control and Prevention, the 
        Director of the National Science Foundation, and the 
        Director of the National Institute of Standards and 
        Technology (or the designees of such officers).
  (d)(1) Subject to paragraph (2), for the purpose of carrying 
out this section:
          (A) For fiscal year 2001, there is authorized to be 
        appropriated an amount equal to the amount obligated by 
        the National Institutes of Health during fiscal year 
        2000 for biomedical imaging and bioengineering, except 
        that such amount shall be adjusted to offset any 
        inflation occurring after October 1, 1999.
          (B) For each of the fiscal years 2002 and 2003, there 
        is authorized to be appropriated an amount equal to the 
        amount appropriated under subparagraph (A) for fiscal 
        year 2001, except that such amount shall be adjusted 
        for the fiscal year involved to offset any inflation 
        occurring after October 1, 2000.
  (2) The authorization of appropriations for a fiscal year 
under paragraph (1) is hereby reduced by the amount of any 
appropriation made for such year for the conduct or support by 
any other national research institute of any program with 
respect to biomedical imaging and bioengineering.

           *       *       *       *       *       *       *


                            ADDITIONAL VIEWS

    During the markup on this bill, I raised several questions 
about the costs and duplication associated with the creation of 
a new institute. At my request, staff followed up with the 
Department, and Secretary Shalala responded with the attached 
letter dated September 25, 2000. This letter concludes that 
``the newly created Office of Bioengineering, Bioimaging, and 
Bioinformatics in the Office of Director, NIH, ensures the most 
effective and efficient deployment of resources to foster 
research in this area.'' We should consider carefully whether 
this legislation, with its requirement of what Secretary 
Shalala notes is ``an expensive administrative structure, for 
which additional resources would be required,'' is a prudent 
and timely exercise, particularly in light of the new office 
being established.
                                                   John D. Dingell.

                The Secretary of Health and Human Services,
                                Washington, DC, September 25, 2000.
Hon. John D. Dingell,
Committee on Commerce, U.S. House of Representatives, Washington, DC.
    Dear Representative Dingell: On September 14, the Committee 
on Commerce marked up and ordered reported H.R. 1795, which 
would establish a new National Institute of Biomedical Imaging 
and Bioengineering at the National Institutes of Health (NIH). 
During the markup, you raised questions about the impact of the 
legislation on the operations of NIH. I am writing in response 
a request made by your staff to address these concerns.
    NIH invests heavily in this promising field of research. 
The majority of its Institutes and Centers (ICs) have 
significant research efforts underway in bioimaging and 
bioengineering. We believe that the application of imaging 
techniques to scientific questions about health and disease is 
part of the basic mission of NIH. We further believe it is 
imperative that the ICs maintain their support for imaging and 
engineering projects that are informed by compelling biological 
questions.
    The discovery of new imaging modalities and approaches is 
being fostered in this collaborative environment, since the 
engineers and physicists are constantly being challenged by 
their biologist/clinician colleagues to develop new approaches 
to studying the body. A critical mass of engineers and 
physicists is present in many of these programs, providing the 
necessary technical and theoretical insight to develop advances 
in the biological sciences. There are many examples in the 
various ICs of this synergy leading to significant discoveries.
    Three Institutes--the National Institute of Neurological 
Disorders and Stroke, the National Institute of Mental Health, 
and the National Institute on Aging--are using bioimaging 
advances to evaluate cognition. The National Heart, Lung and 
Blood Institute is collaborating with other Government as well 
as private sector researchers to develop new cardiac magnetic 
resonance imaging and ultrasound techniques. The National 
Cancer Institute is developing new, more sensitive diagnostic 
and treatment tools using bioimaging techniques to detect and 
cure malignancies that heretofore have been recalcitrant to 
current interventions.
    These are but a few examples of the tremendous amount of 
research being conducted within the ICs, where collaborations 
among scientists, physicists, and engineers are essential to 
developing new technologies.
    The establishment of another NIH Institute would require an 
expensive administrative structure, for which additional 
resources would be required, so as not to rob the existing NIH 
ICs of their expertise and funds. While this Department and NIH 
are thoroughly committed to this rich and exciting research 
area, we have concluded that the newly created Office of 
Bioengineering, Bioimaging, and Bioinformatics in the Office of 
the Director, NIH, ensures the most effective and efficient 
deployment of resources to foster research in this area. The 
mission of the Office, for which a director is now being 
recruited, is to provide a focus for biomedical engineering, 
bioimaging, and biomedical computational science among the ICs 
and other Federal agencies. The Office will develop programs 
aimed at fostering basic understanding and new collaborations 
among the biological, medical, engineering, physical, and 
computational scientists and among the various ICs. The purpose 
of the Office is to develop effective research strategies while 
maintaining the core of the research at the individual ICs that 
have the necessary expertise to ask the appropriate questions 
and conduct the best research. In sum, we have carefully 
considered various approaches and are convinced that at this 
time a new Office, rather than a new Institute with its 
attendant organizational layers and administrative costs, 
offers the best and most practical opportunity to exploit the 
many potentials of this critical research. Experience with the 
new Office will contribute to the evaluation of the need for a 
separate Institute for bioengineering and bioimaging at NIH.
    I would be delighted to answer any further questions that 
you may have regarding bioimaging and bioengineering research 
at NIH, and I look forward to working with you as you consider 
legislation that would enhance our research efforts. An 
identical letter on this subject has been sent to Chairman 
Bliley.
    The Office of Management and Budget has advised that there 
is no objection to the transmittal of this letter from the 
standpoint of the Administration's program.
            Sincerely,
                                                  Donna E. Shalala.

                                  
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