[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.

           *       *       *       *       *       *       *


                                  
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