[House Report 106-1002]
[From the U.S. Government Publishing Office]
106th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 106-1002
======================================================================
CLINICAL RESEARCH ENHANCEMENT ACT OF 1999
_______
October 25, 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
[To accompany H.R. 1798]
[Including cost estimate of the Congressional Budget Office]
The Committee on Commerce, to whom was referred the bill
(H.R. 1798) to amend the Public Health Service Act to provide
additional support for and to expand clinical research
programs, and for other purposes, having considered the same,
report favorably thereon without amendment and recommend that
the bill do pass.
Contents
Page
Purpose and Summary.............................................. 1
Background and Need for Legislation.............................. 2
Hearings......................................................... 2
Committee Consideration.......................................... 2
Committee Votes.................................................. 3
Committee Oversight Findings..................................... 3
Committee on Government Reform Oversight Findings................ 3
New Budget Authority, Entitlement Authority, and Tax Expenditures 3
Committee Cost Estimate.......................................... 3
Congressional Budget Office Estimate............................. 3
Federal Mandates Statement....................................... 3
Advisory Committee Statement..................................... 5
Constitutional Authority Statement............................... 5
Applicability to Legislative Branch.............................. 5
Section-by-Section Analysis of the Legislation................... 5
Changes in Existing Law Made by the Bill, as Reported............ 7
Purpose and Summary
H.R. 1798, the Clinical Research Enhancement Act, requires
the Director of the National Institutes of Health (NIH) to
support and expand programs to revitalize the Nation's clinical
research capacity. The bill accomplishes this objective by:
establishing new career development awards for clinical
investigators; establishing awards for mid-career investigators
who are studying the potential clinical application of a basic
scientific discovery; expanding the existing intramural loan
repayment program so that it will be available to clinical
investigators in academic medical centers around the country;
establishing tuition/stipend grants for individuals
participating in advanced degree programs in clinical
investigation; authorizing the underfunded NIH General Clinical
Research Centers program in law; and, improving the peer review
process for clinical research grants.
Background and Need for Legislation
The Nation's medical research enterprise seems poised to
make even greater contributions to humanity's health and well-
being in the coming years. However, there appears to be a
defect in the structure of the country's medical research
edifice which must be repaired. This defect is evidenced by the
decline in the market of physicians dedicated to clinical
research.
The gradual decline in the Nation's clinical research
capacity is not a new phenomenon. Former National Institutes of
Health Director James Wyngaarden first called attention to it
some 20 years ago in a paper entitled, ``The Clinical
Investigator as an Endangered Species.'' In recent years, the
problem has also been highlighted by the Institute of Medicine
of the National Academy of Sciences, the NIH Director's
Advisory Panel on Clinical Research, the Association of
American Medical Colleges, and the American Medical
Association. These organizations have all concluded that the
Nation's clinical research capacity is in decline and
recommended, in several reports, immediate action to correct
this problem.
In the past, the Nation's academic medical centers were
able to more adequately support clinical research from patient
care revenues. However, due to various cost containment
pressures, this internal funding has been severely curtailed
and often eliminated. Despite substantial increases in NIH
spending, the number of young physicians applying for their
first NIH grant decreased by 30 percent over the past five
years.
Obstacles to clinical research slow progress in medicine,
thereby delaying discoveries of new approaches to the
prevention or treatment of disease. Furthermore, a weakened
clinical research effort also delays the development of new
products and erodes the United States' international
competitive edge in biomedical science.
Hearings
The Committee on Commerce has not held hearings on the
legislation.
Committee Consideration
On September 26, 2000, the Subcommittee on Health and
Environment was discharged from the further consideration of
H.R. 1798. On September 26, 2000, the Full Committee met in
open markup session and approved H.R. 1798, without amendment,
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. 1798 reported.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee held an oversight
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.
1798, the Clinical Research Enhancement Act of 1999, 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, October 19, 2000.
Hon. Tom Bliley,
Chairman, Committee on Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 1798, the Clinical
Research Enhancement Act of 2000.
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. 1798--Clinical Research Enhancement Act of 1999
Summary: H.R. 1798 would authorize the National Institutes
of Health (NIH) to provide grants to establish clinical
research centers, fund clinical researchers and clinical
research projects, and support students pursuing master's
doctoral degrees in clinical research.
The bill also would increase the numbers of scholarships
under the Public Health Service Act, and would modify a loan
repayment program. Under the current program, health
professionals from disadvantaged backgrounds working at the NIH
agree to conduct clinical research in return for an agreement
that the federal government will repay up to $35,000 of the
principal and interest of educational loans for each year of
service. The bill would expand the eligibility of who could
qualify for loans and the sites at which these individuals
could be employed. It would also require that at least half of
the loan repayment contracts involve individuals from
disadvantaged backgrounds. The program is currently paid out of
appropriated funds and would continue to be operated in such a
way under H.R. 1798.
Assuming the appropriation of the necessary amounts, CBO
estimates that implementing H.R. 1798 would cost $53 million in
2001 and $814 million over the 2001-2005 period, assuming
annual adjustments for inflation for the activities without
specified authorization levels. The five-year total would be
$783 million if such inflation adjustments are not made. The
legislation would not affect direct spending or receipts;
therefore, pay-as-you-go procedures would not apply.
H.R. 1798 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA).
To the extent that public and university hospital conduct
clinical research eligible for grant assistance under the bill,
those entities may receive additional funding.
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 1798 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-----------------------------------------------
2000 2001 2002 2003 2004 2005
----------------------------------------------------------------------------------------------------------------
SPENDING SUBJECT TO APPROPRIATION
Spending Under Current Law:
Estimated Authorization Level\1\............................ 229 0 0 0 0 0
Estimated Outlays........................................... 201 156 90 23 11 11
Proposed Changes\2\:
Estimated Authorization Level............................... 0 230 236 242 249 256
Estimated Outlays........................................... 0 53 123 196 212 230
Spending Under H.R. 3250:
Estimated Authorization Level............................... 229 230 236 242 249 256
Estimated Outlays........................................... 201 209 214 218 224 240
----------------------------------------------------------------------------------------------------------------
\1\ The 2000 level is the amount appropriated for that year for the agencies that would be affected by H.R.
1798.
\2\ The amounts shown reflect adjustments for anticipated inflation for those activities for which the bill
would authorize such sums as necessary. Without such inflation adjustments, the five-year changes in
authorization levels would total $1.15 billion (instead of $1.21 billion) and the changes in outlays would
total $783 million (instead of $814 million).
Basis of estimate: The bill authorizes several grant
programs to support clinical research that NIH already
operates. It also increases the number of national research
service awards under section 487(a)(1)(C) of the Public Health
Service Act form 50 to 100 awards. The bill would also expand
the criteria under which an individual could enter into a loan
repayment contract with the federal government under section
487E of the Public Health Service Act. Under current law, only
individuals from disadvantaged backgrounds employed by the NIH
may qualify for loan repayment. The bill would expand the
program to all individuals in a clinical research training
position, with a requirement that half of the contracts must be
to individuals from disadvantaged backgrounds.
Many of the grants, scholarships, and loan repayment
contracts that would be authorized by H.R. 1798 are currently
conducted within the NIH, and are reflected in the estimated
changes to both budget authority and outlays. The estimates of
changes in budget authority and outlays of the proposal reflect
the incremental cost of the increase in National Service Awards
and the expansion of the loan repayment program.
Pay-as-you-go considerations: None.
Intergovernmental and private-sector impact: H.R. 1798
contains no intergovernmental or private-sector mandates as
defined in the UMRA. To the extent that public and university
hospital conduct clinical research eligible for grant
assistance under the bill, those entities may receive
additional funding.
Estimate prepared by: Federal Costs: Christopher J.
Topoleski. Impact on State, Local, and Tribal Governments: Leo
Lex. Impact on the Private Sector: Jennifer Bullard Bowman.
Estimate 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
This section provides the short title of the bill, the
``Clinical Research Enhancement Act.''
Section 2. Findings and purpose
Section 2 describes the role of clinical research in
medical discovery, summarizes the factors that have weakened
clinical research programs in recent years, and highlights the
extent to which the National Institutes of Health has reduced
funding for the General Clinical Research Centers as a
percentage of overall NIH spending.
Section 3. Increasing the involvement of the NIH in clinical research
Section 3 requires the NIH Director to undertake activities
to enhance clinical research including: (1) implementing the
recommendations of an NIH study group on peer review; (2)
establishing an intramural clinical research fellowship program
and a continuing education program at NIH; (3) working in
cooperation with Institute/Center/Division directors at NIH to
expand resources available to meet the needs of the clinical
research community; and, (4) establishing peer review
mechanisms for the new awards and the intramural fellowship
authorized by the bill.
Section 4. General clinical research centers
Section 4 amends part B of title IV of the Public Health
Service Act to add two new sections. Section 409C authorizes
the General Clinical Research Centers in law and authorizes
such sums as may be necessary for each fiscal year.
Section 409D authorizes the Director of the National Center
for Research Resources (NCRR) within NIH to provide support for
three clinical research awards: (1) the Mentored Patient-
Oriented Research Career Development Awards; (2) the Mid-Career
Investigator Award in Patient-Oriented Research; and, (3) the
Graduate Training in Clinical Investigation Award. Section 409D
also requires the NCRR director to: (1) make these awards to
support career development and research projects ``at general
clinical research centers or at other institutions that have
the infrastructure and resources deemed appropriate for
conducting patient-oriented research''; and, (2) collaborate or
consult with other NIH Institute Directors in making these
awards. This section also authorizes such sums as may be
necessary for the three awards.
Section 5. Clinical research assistance
Section 5 modifies section 487(a)(1)(C) of the Public
Health Service Act, a program to provide loan repayment for
clinical researchers from disadvantaged backgrounds who serve
as employees of the National Institutes of Health. Section 5
eliminates the statutory requirement that all loan repayment
recipients must be from disadvantaged backgrounds and
substitutes language requiring that not less than 50% of
recipients have such backgrounds. Section 5 also eliminates the
statutory requirement that recipients must be NIH employees and
substitutes language qualifying individuals in a ``clinical
research training position,'' defined as ``an individual
serving in a general clinical research center or in clinical
research at the National Institutes of Health or a physician
receiving a clinical research career enhancement award, or a
graduate training in clinical investigation award.'' Finally,
section 5 also authorizes such sums as may be necessary for the
loan repayment program.
Section 6. Definition
This section defines clinical research as patient oriented
clinical research conducted with human subjects, or research on
the causes and consequences of disease in human populations
involving material of human origin (such as tissue specimens
and cognitive phenomena) for which an investigator or colleague
directly interacts with human subjects in an outpatient or
inpatient setting to clarify a problem in human physiology,
pathophysiology, or disease; or epidemiologic or behavioral
studies, outcomes research, or health services research, or
developing new technologies or therapeutic interventions.
Section 7. Oversight by General Accounting Office
Section 7 requires the Comptroller General of the United
States to submit to Congress within 18 months of the date of
enactment of the bill a report describing the extent to which
the NIH has complied with the provisions of the legislation.
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 (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, 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
* * * * * * *
appointment and authority of director of nih
Sec. 402. (a) * * *
* * * * * * *
(m)(1) The Director of NIH shall undertake activities to
support and expand the involvement of the National Institutes
of Health in clinical research.
(2) In carrying out paragraph (1), the Director of NIH
shall--
(A) implement the recommendations of the Division of
Research Grants Clinical Research Study Group and other
recommendations for enhancing clinical research, where
applicable; and
(B) establish an intramural clinical research
fellowship program and a continuing education clinical
research training program at NIH.
(3) The Director of NIH, in cooperation with the Directors of
the Institutes, Centers, and Divisions of the National
Institutes of Health, shall support and expand the resources
available for the diverse needs of the clinical research
community, including inpatient, outpatient, and critical care
clinical research.
(4) The Director of NIH shall establish peer review
mechanisms to evaluate applications for--
(A) Mentored Patient-Oriented Research Career
Development Awards;
(B) Mid-Career Investigator Awards in Patient-
Oriented Research;
(C) graduate training in clinical investigation
awards;
(D) intramural clinical research fellowships.
Such review mechanisms shall include individuals who are
exceptionally qualified to appraise the merits of potential
clinical research training and research grant proposals.
* * * * * * *
Part B--General Provisions Respecting National Research Institutes
* * * * * * *
definitions
Sec. 409. [For purposes] (a) Health Service Research.--For
purposes of this title, the term ``health services research''
means research endeavors that study the impact of the
organization, financing and management of health services on
the quality, cost, access to and outcomes of care. Such term
does not include research on the efficacy of services to
prevent, diagnose, or treat medical conditions.
(b) Clinical Research.--As used in this title, the term
``clinical research'' means patient oriented clinical research
conducted with human subjects, or research on the causes and
consequences of disease in human populations involving material
of human origin (such as tissue specimens and cognitive
phenomena) for which an investigator or colleague directly
interacts with human subjects in an outpatient or inpatient
setting to clarify a problem in human physiology,
pathophysiology, or disease; or epidemiologic or behavioral
studies, outcomes research, or health services research, or
developing new technologies or therapeutic interventions.
* * * * * * *
SEC. 409C. GENERAL CLINICAL RESEARCH CENTERS.
(a) Grants.--The Director of the National Center for Research
Resources shall award grants for the establishment of general
clinical research centers to provide the infrastructure for
clinical research including clinical research training and
career enhancement. Such centers shall support clinical studies
and career development in all settings of the hospital or
academic medical center involved.
(b) Activities.--In carrying out subsection (a), the Director
of NIH shall expand the activities of the general clinical
research centers through the increased use of
telecommunications and telemedicine initiatives.
(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each fiscal
year.
SEC. 409D. ENHANCEMENT AWARDS.
(a) Mentored Patient-Oriented Research Career Development
Awards.--
(1) In general.--The Director of the National Center
for Research Resources shall make grants (to be
referred to as ``Mentored Patient-Oriented Research
Career Development Awards'') to support individual
careers in clinical research at general clinical
research centers or at other institutions that have the
infrastructure and resources deemed appropriate for
conducting patient-oriented clinical research. The
Director of the National Center for Research Resources
shall, where practicable, collaborate or consult with
other Institute Directors in making awards under this
subsection.
(2) Applications.--An application for a grant under
this subsection shall be submitted by an individual
scientist at such time as the Director may require.
(3) Authorization of appropriations.--For the purpose
of carrying out this subsection, there are authorized
to be appropriated such sums as may be necessary for
each fiscal year.
(b) Mid-Career Investigator Awards in Patient-Oriented
Research.--
(1) In general.--The Director of the National Center
for Research Resources shall make grants (to be
referred to as ``Mid-Career Investigator Awards in
Patient-Oriented Research'') to support individual
clinical research projects at general clinical research
centers or at other institutions that have the
infrastructure and resources deemed appropriate for
conducting patient-oriented clinical research. The
Director of the National Center for Research Resources
shall, where practicable, collaborate or consult with
other Institute Directors in making awards under this
subsection.
(2) Applications.--An application for a grant under
this subsection shall be submitted by an individual
scientist at such time as the Director requires.
(3) Authorization of appropriations.--For the purpose
of carrying out this subsection, there are authorized
to be appropriated such sums as may be necessary for
each fiscal year.
(c) Graduate Training in Clinical Investigation Award.--
(1) In general.--The Director of the National Center
for Research Resources shall make grants (to be
referred to as ``graduate training in clinical
investigation awards'') to support individuals pursuing
master's or doctoral degrees in clinical investigation.
(2) Applications.--An application for a grant under
this subsection shall be submitted by an individual
scientist at such time as the Director may require.
(3) Limitations.--Grants shall be for terms of 2
years or more and will provide stipend, tuition, and
institutional support for individual advanced degree
programs in clinical investigation.
(4) Definition.--As used in this subsection, the term
``advanced degree programs in clinical investigation''
means programs that award a master's or Ph.D. degree
after 2 or more years of training in areas such as the
following:
(A) Analytical methods, biostatistics, and
study design.
(B) Principles of clinical pharmacology and
pharmacokinetics.
(C) Clinical epidemiology.
(D) Computer data management and medical
informatics.
(E) Ethical and regulatory issues.
(F) Biomedical writing.
(5) Authorization of appropriations.--For the purpose
of carrying out this subsection, there are authorized
to be appropriated such sums as may be necessary for
each fiscal year.
* * * * * * *
Part G--Awards and Training
national research service awards
Sec. 487. (a)(1) The Secretary shall--
(A) * * *
* * * * * * *
(C) provide contracts for scholarships and loan
repayments in accordance with sections 487D and 487E,
subject to providing not more than an aggregate [50]
100 such contracts during the fiscal years 1994 through
1996.
* * * * * * *
loan repayment program regarding clinical researchers [from
disadvantaged backgrounds]
Sec. 487E.(a) Implementation of Program.--
(1) In general.--Subject to section 487(a)(1)(C), the
Secretary, acting through the Director of NIH may,
subject to paragraph (2), carry out a program of
entering into contracts with appropriately qualified
health professionals [who are from disadvantaged
backgrounds] under which such health professionals
agree to conduct clinical research [as employees of the
National Institutes of Health] as part of a clinical
research training position in consideration of the
Federal Government agreeing to pay, for each year of
such service, not more than $35,000 of the principal
and interest of the educational loans of the health
professionals.
* * * * * * *
[(3) Applicability of certain provisions regarding
obligated service.--Except to the extent inconsistent
with this section, the provisions of sections 338B,
338C and 338E shall apply to the program established in
paragraph (1) to the same extent and in the same manner
as such provisions apply to the National Health Service
Corps Loan Repayment Program established in section
338B.]
(3) Applicability of certain provisions regarding
obligated service.--With respect to the National Health
Service Corps Loan Repayment Program established under
subpart III of part D of title III, the provisions of
such subpart shall, except as inconsistent with this
section, apply to the program established in this
section in the same manner and to the same extent as
such provisions apply to such loan repayment program.
(b) Availability of Authorization of Appropriations.--
[Amounts]
(1) In general.--Amounts appropriated for a fiscal
year for contracts under subsection (a) shall remain
available until the expiration of the second fiscal
year beginning after the fiscal year for which the
amounts were appropriated.
(2) Disadvantaged backgrounds set-aside.--In carrying
out this section, the Secretary shall ensure that not
less than 50 percent of the contracts involve those
appropriately qualified health professionals who are
from disadvantaged backgrounds.
(c) Definition.--As used in subsection (a)(1), the term
``clinical research training position'' means an individual
serving in a general clinical research center or in clinical
research at the National Institutes of Health, or a physician
receiving a clinical research career enhancement award, or a
graduate training in clinical investigation award.
(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each fiscal
year.
* * * * * * *