79–006

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

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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, noninvasive

imaging 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’).

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‘‘(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’’)—

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(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

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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.

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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 imagVerDate 11-MAY-2000 02:08 Sep 28, 2000 Jkt 079006 PO 00000 Frm 00006 Fmt 6659 Sfmt 6602 E:\HR\OC\HR889.XXX pfrm07 PsN: HR889
7

ing 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.

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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. § 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’’).

9

(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

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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.

* * * * * * *

(11)

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

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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.

Æ