H. Rept. 109-687 - 109th Congress (2005-2006)

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House Report 109-687 - NATIONAL INSTITUTES OF HEALTH REFORM ACT OF 2006

[House Report 109-687]
[From the U.S. Government Publishing Office]



109th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     109-687

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



 
            NATIONAL INSTITUTES OF HEALTH REFORM ACT OF 2006

                                _______
                                

 September 26, 2006.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

    Mr. Barton of Texas, from the Committee on Energy and Commerce, 
                        submitted the following

                              R E P O R T

                             together with

                            ADDITIONAL VIEWS

                        [To accompany H.R. 6164]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 6164) to amend title IV of the Public Health 
Service Act to revise and extend the authorities of the 
National Institutes of Health, 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..............................................     2
Background and Need for Legislation..............................     2
Hearings.........................................................     5
Committee Consideration..........................................     6
Committee Votes..................................................     6
Committee Oversight Findings.....................................    12
Statement of General Performance Goals and Objectives............    12
New Budget Authority, Entitlement Authority, and Tax Expenditures    12
Earmark..........................................................    12
Committee Cost Estimate..........................................    12
Congressional Budget Office Estimate.............................    12
Federal Mandates Statement.......................................    14
Advisory Committee Statement.....................................    14
Constitutional Authority Statement...............................    14
Applicability to Legislative Branch..............................    14
Section-by-Section Analysis of the Legislation...................    14
Changes in Existing Law Made by the Bill, as Reported............    27
Additional Views.................................................    76

                          Purpose and Summary

    The purpose of H.R. 6164 is to reauthorize the National 
Institutes of Health.

                  Background and Need for Legislation

    The National Institutes of Health (NIH) is the Federal 
government's principal medical research agency. Its mission is 
to advance research in pursuit of fundamental knowledge that 
will lead to better health outcomes for all. Funding for the 
NIH represents nearly half of the discretionary budget of the 
Department of Health and Human Services.
    The last reauthorization of the NIH occurred 13 years ago, 
when the ``National Institutes of Health Revitalization Act of 
1993'' was signed into law (P.L. 103-43), authorizing several 
NIH research programs for fiscal years 1994-1996. In 1996, the 
Senate passed S. 1897, the ``National Institutes of Health 
Revitalization Act of 1996,'' but the House did not take 
action. Beginning in fiscal year 1999, Congress committed to 
doubling the budget of the NIH over a five-year period in the 
absence of an existing authorization.
    In the 108th Congress, more than 100 bills were introduced 
in the House of Representatives to change some function of the 
NIH. Many of the bills introduced focused on a specific 
disease, disorder, or adverse health condition. Often the bill 
sponsors indicated that the need for such legislation was to 
direct NIH to do more in the respective area of research. 
However, without a comprehensive reporting system to accurately 
evaluate the level and degree of effort in these areas at NIH, 
the Committee on Energy and Commerce was left with an 
impossible task of determining how to prioritize research 
activities throughout the 27 research institutes and centers. 
Furthermore, several of the proposals demanded that NIH 
establish research programs that promoted multidisciplinary 
research and greater collaboration between the 27 institutes 
and centers. However, the current budget allocations for the 
NIH, determined largely by institute and center status, do not 
accurately reflect the level of trans-NIH research that is 
currently underway at the agency. Trans-NIH research activities 
are generally referred to as important areas of emerging 
scientific opportunities, rising public health challenges, or 
knowledge gaps that would benefit from additional research 
where such research involves the responsibilities of more than 
one institute or center.
    The diverse research portfolios of the 27 research 
institutes and centers that make up the NIH are designed both 
to meet public health needs and to embrace scientific 
opportunities. Although the Administration has authority to 
establish and abolish research institutes and centers, Congress 
is largely responsible for the creation of new institutes and 
centers. For more than two decades, evaluations of the NIH have 
highlighted that the proliferation of institutes and centers is 
a problematic trend for the agency. In 1984, when the NIH 
consisted of 17 research institutes (which included research 
bureaus), the Institute of Medicine (IOM) was asked to review 
the organizational structure of the NIH (``Responding to Health 
Needs and Scientific Opportunity: The Organizational Structure 
of the National Institutes of Health,'' Institute of Medicine 
Report, October 16, 1984).
    The IOM reported the following:

The [IOM] committee believes that NIH is now at a stage where 
there should be a presumption against additions at the 
institute level because such changes:
          (1) fragment the scientific effort and diminish 
        effective communication with key scientists in other 
        institutes;
          (2) add to the burden and difficulty of effective 
        program coordination by the NIH Director and his top 
        staff, and
          (3) add to the administrative costs without ensuring 
        increased appropriations.

    Dr. Harold Varmus, Director of the NIH from 1993 through 
1999, wrote the following in an article published in Science 
magazine in March 2001 (``Proliferation of National Institutes 
of Health,'' Science, Volume 291, March 9, 2001):

Many people with influence in Washington view the National 
Institutes of Health as ``the jewel in the crown of the federal 
government.'' Such praise has helped to enhance the value--the 
number of carats--in this jewel, especially over the past few 
years. But considerably less attention has been given to its 
shape than its price. New facets are being added without much 
thought to overall design, providing a superficial sparkle that 
may be pleasing to the few, but threatening to the functional 
integrity of the entire gem. With too many surfaces of 
different sizes, the organization may soon become less able to 
take advantage of its extraordinary budget increase and more 
difficult to manage responsibly. Those who care about the NIH 
need to think about its form and propose some solutions before 
the structure becomes even more fragmented and harder to fix.

    In an interview published in the January 2004 edition of 
Health Affairs, Current NIH Director Dr. Zerhouni discusses the 
difficulties of managing the vast research portfolio of the NIH 
(``Twenty-Seven Fingers Without A Palm Is Not A Hand: A 
Conversation With Elias Zerhouni,'' Health Affairs, January 8, 
2004).
    He stated as follows:

Over the years the NIH has had what I call a structural 
approach to portfolio management. Anytime there was a need and 
a vocal constituency, and Congress agrees, a structure was 
added to the NIH. That structure would get an appropriation 
that would grow in lockstep with all of the other structures. 
The problem here is that no one cares for the entire 
institution except the director .  .  . at the end of the day 
we need a new way to manage the portfolio, and that's what I 
call functional portfolio management. The director needs the 
ability to merge the fourteen different tracking systems that 
have developed to record and code what the NIH does .  .  . We 
need to be able to plan across NIH. We need some funds in 
common. If you have twenty-seven fingers out there with no 
palm, you don't have a hand.

    The National Academy of Sciences in July 2003 once again 
reported on the organizational design of the National 
Institutes of Health. In the report, ``Enhancing the Vitality 
of the National Institutes of Health: Organizational Change to 
Meet New Challenges,'' the IOM committee recommended a series 
of changes at the NIH, including strengthening the Office of 
the Director, expanding trans-NIH strategic planning and 
funding, and improving data collection systems. These changes 
require authorizing legislation.
    In response to the IOM suggestion that there is need for 
public process when considering proposed changes in the number 
of NIH institutes and centers, the National Institutes of 
Health Reform Act of 2006 creates a formal, public process to 
review the structural organizational design of the agency every 
seven years. A ``scientific management review'' group comprised 
of institute and center directors and other scientific experts 
would evaluate the structural design of the existing institutes 
and centers at the NIH, and proposed new institutes, and 
recommend necessary restructuring plans. After a series of 
statutorily required public meetings, the scientific management 
review board is to issue its first report to Congress within 18 
months of the date of enactment of the National Institutes of 
Health Reform Act of 2006. If a recommendation is made 
regarding organizational authorities, the NIH official 
responsible for overseeing the change must initiate the public 
process toward making the change within 100 days, and the 
change is to be fully implemented within a three-year period. 
Should the Director of NIH object to a recommendation, he may 
submit within 90 days a report to Congress outlining the 
reasons for not implementing the recommendation.
    The National Institutes of Health Reform Act of 2006 
responds to the IOM recommendation to enhance and increase 
trans-NIH strategic planning and funding by requiring the 
Director, through the Division of Program Coordination, 
Planning, and Strategic Initiatives, to identify research that 
is important to the advancement of biomedical science and 
involves the responsibilities of more than one institute or 
center. The National Institutes of Health Reform Act of 2006 
establishes a ``common fund'' to provide a permanent funding 
mechanism for trans-NIH research projects identified through 
the Division. The common fund would be a reserve account that 
may be competitively drawn down by institutes, centers, and 
independent investigators to advance trans-NIH research.
    The IOM report clearly stated the need to strengthen the 
Office of the Director and create a Director's special project 
program. Additionally, in response to the IOM's recommendation 
to establish a process for creating new Office of the Director 
offices and programs, the National Institutes of Health Reform 
Act of 2006 would permit the Director, with the approval of the 
Secretary of Health and Human Services, to reorganize the 
offices within the Office of the Director. The Division of 
Program Coordination, Planning, and Strategic Initiatives would 
house the existing offices to better coordinate trans-NIH 
research activities. The Director of NIH would also be able to 
establish demonstration programs that award grants, contracts, 
or engage in other transactions for high-impact, cutting edge 
research.
    The IOM report includes strong recommendations to 
standardize data and information management systems. The 
National Institutes of Health Reform Act of 2006 achieves that 
goal by creating a new, comprehensive electronic reporting 
system that would, for the first time, catalogue all of the 
research activities of the NIH in a standardized format. 
Instead of thousands of pages of reports from each of the 
individual research institutes and centers, the NIH Director 
will compile biennially a report that comprehensively lays out 
the strategic plans and research activities of the agency. 
Increased transparency of NIH research activities would 
highlight areas of ongoing research to improve research 
portfolio management, provide greater accountability of 
research dollars, and spur creative thinking about new 
scientific approaches.
    The National Institutes of Health Reform Act of 2006 
provides NIH with the management tools to better evaluate the 
research portfolio of the agency, encourage greater research 
collaboration between national research institutes and centers, 
and make necessary changes, including structural changes, to 
ensure that NIH research addresses current scientific 
opportunities and public health burdens.

                                Hearings

    The Subcommittee on Health held a hearing on ``Setting the 
Path for Reauthorization: Improving Portfolio management at the 
NIH'' on March 17, 2005. The Subcommittee received testimony 
from: Elias A. Zerhouni, M.D., Director, National Institutes of 
Health.
    The House Energy and Commerce Committee held a hearing on 
``Legislation to Reauthorize the National Institutes of 
Health'' on July 19, 2005. The Committee received testimony 
from: Elias A. Zerhouni, M.D., Director, National Institutes of 
Health.
    The Subcommittee on Oversight and Investigations held a 
hearing on ``Human Tissue Samples: NIH Research Policies and 
Practices'' on June 13, 2006. The Subcommittee received 
testimony from: Dr. Susan Molchan, Program Director, AD 
Neuroimaging Initiative, Neuroscience and Neuropsychology of 
Aging Program, National Institute on Aging.
    The Subcommittee on Oversight and Investigations held a 
hearing on ``Human Tissue Samples: NIH Research Policies and 
Practices'' on June 14, 2006. The Subcommittee received 
testimony from: Dr. Thomas Insel, Director of the National 
Institute of Mental Health (NIMH), accompanied by (1) Dr. 
Donald Rosenstein, Acting Clinical Director, National Institute 
of Mental Health, National Institutes of Health; (2) William 
Fitzsimmons, Executive Officer; National Institute of Mental 
Health, National Institutes of Health; and (3) Suzanne Winfeld, 
Technology Transfer Officer, National Institute of Mental 
Health, National Institutes of Health; Dr. David L. Friedman, 
formerly with Pfizer, Inc.; Dr. Trey Sunderland, Chief of the 
Geriatric Psychiatry Branch, National Institute of Mental 
Health, National Institutes of Health; Karen Putnam, formerly 
with the Geriatric Psychiatry Branch, National Institute of 
Mental Health, National Institutes of Health; and Dr. Michael 
Gottesman, Deputy Director for Intramural Research, National 
Institutes of Health.
    The Subcommittee on Oversight and Investigations held a 
hearing on ``Continuing Ethics and Mangement Concerns at NIH 
and the Public Health Service Commissioned Corps'' on September 
13, 2006. The Subcommittee received testimony from: The 
Honorable John Agwunobi, Assistant Secretary for Health, U.S. 
Department of Health and Human Services; Dr. Raynard Kington, 
Deputy Director, National Institutes of Health; Dr. John 
Niederhuber, Director, National Cancer Institute; Dr. Thomas R. 
Insel, Director, National Institute of Mental Health, National 
Institutes of Health; and Mr. William Fitzsimmons, Executive 
Officer, National Institute of Mental Health, National 
Institutes of Health.
    The House Energy and Commerce Committee held a hearing on 
``Improving NIH Management and Operation: A Legislative Hearing 
on the NIH Reform Act of 2006'' on September 19, 2006. The 
Committee received testimony from: Dr. Edward D. Miller, Chief 
Executive Officer, Johns Hopkins Medicine; Dr. Robert H. Eckel, 
Professor, Department of Physiology and Biophysics, University 
of Colorado Health Sciences Center, on behalf of the American 
Heart Association; Dr. Leo T. Furcht, President, Federation of 
American Societies for Experimental Biology (FASEB); Dr. 
Darrell G. Kirch, President, Association of American Medical 
Colleges (AAMC); and Dr. Elias A. Zerhouni, Director, National 
Institutes of Health.

                        Committee Consideration

    On Wednesday, September 20, 2006, the Full Committee met in 
open markup session and ordered a Committee Print entitled the 
National Institutes of Health Reform Act of 2006 favorably 
reported to the House, amended, by a record vote of 42 yeas and 
1 nay, a quorum being present. A request by Mr. Barton to allow 
a report to be filed on a bill to be introduced by Mr. Barton, 
and that the actions of the Committee be deemed as actions on 
that bill, was agreed to by unanimous consent.

                            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. The 
following are the recorded votes taken on amendments offered to 
the measure, including the names of those Members voting for 
and against. A motion by Mr. Barton to order the Committee 
Print entitled the National Institutes of Health Reform Act of 
2006 favorably reported to the House, amended, was agreed to by 
a record vote of 42 yeas and 1 nay.


                      Committee Oversight Findings

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

         Statement of General Performance Goals and Objectives

    The National Institutes of Health Reform Act of 2006 amends 
Title IV of the Public Health Service Act to revise and extend 
the authorities of the National Institutes of Health.

   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. 
6164, the National Institutes of Health Reform Act of 2006, 
would result in no new or increased budget authority, 
entitlement authority, or tax expenditures or revenues.

                                Earmark

    In compliance with H. Res. 1000 as passed the House of 
Representatives on September 14, 2006, the Committee finds that 
H.R. 6164, the National Institutes of Health Reform Act of 
2006, contains no earmarks.

                        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:

                                                September 25, 2006.
Hon. Joe Barton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for the National Institutes 
of Health Reform Act of 2006.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Tom Bradley.
            Sincerely,
                                          Donald B. Marron,
                                                   Acting Director.
    Enclosure.

National Institutes of Health Reform Act of 2006

    Summary: The National Institutes of Health Reform Act would 
authorize appropriations for the activities of the National 
Institutes of Health (NIH) of $29.7 billion for fiscal year 
2007, $31.2 billion for fiscal year 2008, and $32.8 billion for 
fiscal year 2009. Assuming appropriation of the specified 
amounts, CBO estimates that implementing the bill would cost 
about $8.6 billion in 2007 and about $90 billion over the 2007-
2011 period. Enacting the bill would not affect direct spending 
or receipts.
    The bill contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act (UMRA) 
and would impose no costs on state, local, or tribal 
governments.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of the bill is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                                  By fiscal year, in millions of dollars--
                                                           -----------------------------------------------------
                                                              2006     2007     2008     2009     2010     2011
----------------------------------------------------------------------------------------------------------------
                                        SPENDING SUBJECT TO APPROPRIATION

NIH Spending Under Current Law:
    Budget Authority \1\..................................   28,310        0        0        0        0        0
    Estimated Outlays.....................................   27,549   19,927    5,122    1,841      404       11
Proposed Changes:
    Authorization Level...................................        0   29,748   31,235   32,797        0        0
    Estimated Outlays.....................................        0    8,574   24,561   29,117   22,007    5,455
NIH Spending Under the Bill:
    Authorization Level \1\...............................   28,310   29,748   31,235   32,797        0        0
    Estimated Outlays.....................................   27,549   28,501   29,683   30,958   22,411   5,466
----------------------------------------------------------------------------------------------------------------
\1\ The 2006 level is the amount appropriated for that year.

    Basis of Estimate: Title IV of the Public Health Service 
Act contains nearly 50 provisions that established the 
responsibilities of the National Institutes of Health and 
authorized the appropriation of funds to carry out those 
responsibilities. Nearly all of those authorizations have 
expired. The bill would:
           Strike all of those authorizations of 
        appropriations (without terminating the authority of 
        the NIH to conduct the activities funded by those 
        appropriations);
           Authorize all of the national research 
        institutes and national centers that currently make up 
        the the NIH; and
           Authorize the appropriation of specified 
        amounts for fiscal years 2007 through 2009 to conduct 
        the activities of the NIH ($29.7 billion for 2007, 
        rising to $32.8 billion for 2009).
    Assuming the appropriation of the specified amounts, and 
based on historical patterns of spending by the NIH, CBO 
estimates that implementing the bill would cost about $8.6 
billion in fiscal year 2007 and about $90 billion over the 
2007-2011 period.
    The bill would require the Secretary of Health and Human 
Services to establish a board that would review the 
organizational structure of the NIH and recommend modifications 
to that structure. NIH would be required to implement the 
board's recommendations unless the Director of NIH submits to 
the Congress a report objecting to a change.
    The bill would require the allocation of part of the 
appropriated amounts to a ``common fund'' for research that 
involves the collaboration of two or more institutes of the 
NIH. In 2007, the allocation to the common fund would be 5 
percent of the amount appropriated for NIH (about $1.5 billion, 
assuming appropriation of the authorized amount). By 
comparison, 1.2 percent (about $330 million) of the 
appropriation for 2006 is earmarked for similar collaborative 
research activities. That allocation would increase in 
subsequent years by half of any increase in the amount 
appropriated for NIH. CBO expects that change would not have a 
significant effect on the average rate of spending by the NIH.
    The bill also would require the Director of NIH to submit 
biennial reports to the Congress on the state of biomedical 
research and on the activities supported by NIH and to 
establish an electronic database to track research activities 
and grants.
    Intergovernmental and private-sector impact: The bill 
contains no intergovernmental or private-sector mandates as 
defined in UMRA and would impose no costs on state, local, or 
tribal governments.
    Estimate prepared by: Federal Costs: Tom Bradley. Impact on 
State, Local, and Tribal Governments: Leo Lex. Impact on the 
Private Sector: Paige Shevlin.
    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; table of contents

    This section provides the short title of the bill, the 
``National Institutes of Health Reform Act of 2006,'' and a 
table of contents.

Section 2. Organization of the National Institutes of Health

    Section 2 strikes and replaces Section 401 of the Public 
Health Service Act (PHSA), which describes the organizational 
structure of the National Institutes of Health (NIH). The list 
includes the names of the 24 national research institutes and 
centers in existence. In addition, the section recognizes any 
other national center that, as an agency separate from any 
national research institutes, was established within the NIH as 
of the day before the date of enactment of the Act. The 
Committee recognizes these centers to include the Center for 
Scientific Review, the Center for Information Technology, and 
the NIH Clinical Center, thereby totaling 27 national research 
institutes and centers.
    Section 2 establishes within the Office of the Director, a 
Division of Program Coordination, Planning, and Strategic 
Initiatives (Division). The Division includes the Office of 
AIDS Research, the Office of Research on Women's Health, the 
Office of Behavioral and Social Sciences Research, the Office 
of Disease Prevention, the Office of Dietary Supplements, the 
Office of Rare Diseases, and any other office designated by the 
Director. The section clarifies that each office included in 
the Division shall continue to carry out the authorities that 
were in effect for the office before the date of enactment of 
the Act, and as determined appropriate by the Director of NIH, 
to support the work of the Division with respect to its 
authorities.
    Section 2 states that the total number of national research 
institutes and centers at the NIH may not exceed 27. The 
Committee intends for this number to include the 24 national 
research institutes and centers listed by name in the Act, as 
well as the Center for Scientific Review, the Center for 
Information Technology, and the NIH Clinical Center at the NIH. 
The Committee recognizes that changes in scientific 
opportunities and public health burdens may necessitate the 
addition of a new institute or center to manage research 
activities at the agency properly. However, for nearly two 
decades, evaluations of the NIH by the Institute of Medicine 
and others have highlighted that the proliferation of 
institutes and centers is a problematic trend for the agency. 
The Committee expects that if the Director of the NIH, or the 
Scientific Management Review Board (as described below) 
determines that a new national research institute or center is 
needed, that existing research institute and center structures 
will be consolidated or eliminated, to comply with this 
provision.
    Section 2 also clarifies when and what notification 
requirements that must occur before structural reforms can be 
implemented at the NIH. Under current law, Section 401 of the 
PHSA permits the Secretary to reorganize the institutes and 
centers with notice to Congress. Section 2 authorizes the 
Director to makes organizational changes if the overall mission 
of the NIH, or the management and operation of programs and 
activities conducted or supported by NIH would be more 
efficiently carried out under the reorganization. Section 2 
authorizes the Director to reorganize the institutes and 
centers subject to three requirements: (1) approval of the 
Secretary; (2) a public process, carried out by regulations; 
and (3) notice to Congress. The Director, with the approval of 
the Secretary, and after a series of public hearings, may 
reorganize the offices within the Office of the Director. In 
addition, the director of an institute or center may, with the 
approval of the Director of NIH, and after a series of public 
hearings, reorganize the divisions, centers, or other 
administrative units within an institute or center. A 
reorganization of a national research institute or center, an 
office within the Office of the Director, or a division or 
other unit located within a national research institute or 
center, may not be implemented before the expiration of 90 days 
after the Secretary submits written notice of the 
reorganization to the Committee on Energy and Commerce of the 
House of Representative and the Committee on Health, Education, 
Labor, and Pensions of the Senate.
    Section 2 establishes a new advisory council, to be known 
as the ``Scientific Management Review Board,'' to review the 
organizational design of the NIH periodically. The Scientific 
Management Review Board (Board) must convene at least once 
every seven years to determine whether and to what extent the 
organizational authorities provided to the Secretary, Director 
of NIH, and national research institute and center directors 
should be used; and issue a report providing recommendations 
for changes that should be made to the organizational design of 
the agency. In fulfilling these responsibilities, the Board 
must: (1) review all programs of the NIH to determine their 
progress and cost-effectiveness, and allocation of resources 
with respect to the programs; (2) determine what are pending 
scientific opportunities and public health needs that the NIH 
should focus on; and (3) include proposals for organizational 
change. With respect to proposals for organizational change, 
the Board must analyze the budgetary and operational 
consequences of the proposed changes, estimate the level of 
resources needed to implement the proposed changes, and make a 
recommendation for the allocation of resources throughout NIH 
if the change were to be fully implemented. The Committee notes 
several Congressional proposals for organizational changes to 
NIH, including, for example, the possible creation of an 
institute for arthritis, rehabilitation research, and a center 
for translating NIH research into new products. The Scientific 
Management Review Board should carefully consider all of these 
proposals as part of its deliberations.
    To fulfill its responsibilities, the Board must consult 
with the directors of the national research institutes and 
centers, other scientific leaders within NIH, advisory councils 
of the national research institutes and centers, organizations 
representing the scientific community, and organizations 
representing patients.
    The membership of the Board may not exceed 21 individuals, 
all of whom shall be voting members with equal weight. The 
board will include the Director of NIH, at least 9 officials 
representing national research institutes and centers, 
individuals representing the interest of public or private 
institutes of higher education that have historically received 
funds from NIH, and individuals representing the interest of 
private entities that have received funds from NIH or that have 
broad expertise regarding how the NIH functions. With the 
exception of the Director of NIH, the Secretary makes 
appointments for the remaining 20 individuals who will serve on 
the Board. The Secretary also selects who will chair the Board, 
and may select the Director of NIH to serve in this capacity.
    The Board must meet at the call of the chair or upon the 
request of the Director of NIH, but may not meet fewer than 
five times before issuing a report required at least once every 
seven years. The Board must also hold a series of forums, 
involving both the scientific community and patient advocate 
organizations, to seek input and suggestions on changes to the 
structure of NIH. The Director must post a summary of the 
meetings on the Internet site of the NIH to inform the public 
of the discussions. Members of the Board may be compensated in 
the same manner as other NIH advisory councils, as outlined in 
section 406 of the PHSA.
    The Board must submit a report to the Committee on Energy 
and Commerce of the House of Representatives, the Committee on 
Health, Education, Labor, and Pensions of the Senate, the 
Secretary, and officials with organizational authorities within 
the NIH. The report must be posted on the Internet site of the 
NIH. The first report must be completed no later than 18 months 
after the date of enactment of the Act.
    Once the Board has submitted its report, an official who 
has organizational authorities must begin to execute the change 
no later than 100 days after the report is submitted, and shall 
fully implement the change within a three-year period. The 
Director of NIH may object to the entirety of a recommended 
organizational change or to an aspect of the recommended 
change. A change does not have to be implemented if the 
Director of NIH submits a subsequent report to Congress within 
90 days after the Board submits its report on recommendations.
    Section 2 makes technical and conforming changes to reflect 
that the National Center for Human Genome Research is now the 
National Human Genome Research Institute.

Section 3. Authority of Director of NIH

    Section 3 amends Section 402 of the PHSA, which outlines 
the authorities of the Director of NIH. In addition to existing 
authorities, Section 3 delineates several new authorities to 
improve agency coordination and collaboration. Specifically, 
the Director, in consultation with the heads of the national 
research institutes and centers, is responsible for program 
coordination, including conducting priority setting reviews, to 
ensure that the research portfolio of the NIH is balanced and 
free of unnecessary, duplicative research. The Committee is 
concerned that the NIH cannot track accurately the research 
activities between the national research institutes and 
centers. For example, both the National Cancer Institute and 
the National Heart, Lung, and Blood Institute conduct research 
on lung cancer. There is nothing in current law that prohibits 
the two research institutes from conducting and supporting the 
unnecessarily redundant or duplicative research experiments. 
The Committee recognizes that science demands duplication to 
verify results. However, the Committee is concerned that at 
some point, duplication may be counterproductive and an 
inefficient use of taxpayer dollars given the numerous research 
opportunities that demand attention. When evaluating the 
research portfolio of the NIH, the Director of NIH should work 
with the national research institute and center directors to 
ensure that all of the priorities of the NIH can be 
accomplished as efficiently as possible with the resources 
available.
    Section 3 requires the Director of NIH to assemble accurate 
data to be used to assess research priorities, including 
information to evaluate scientific opportunity, public health 
burdens, and progress in reducing health disparities. For 
example, the Committee believes that all research conducted or 
supported by NIH should include both males and females, except 
when it is scientifically inappropriate, using sex as a 
variable when appropriate. This includes research on human or 
animal subjects and material derived from the research, 
clinical research, and publications resulting from such 
research. With respect to reducing health disparities, the 
Director of NIH, when evaluating the research portfolio, must 
identify the activities conducted by NIH that make progress in 
reducing health disparities, so that this information may be 
used to assess the research priorities of the agency better. 
Compiling accurate data with respect to health disparities 
should be a critical function that the Director of NIH fulfills 
in coordination with the Director for the National Center for 
Minority Health and Health Disparities.
    The Director shall also ensure that scientifically based 
strategic planning is implemented in support of research 
priorities as determined by the institutes and centers. The 
Director shall also ensure that the resources of NIH are 
sufficiently allocated for research projects identified in 
strategic plans.
    Section 3 outlines the authorities of the Division of 
Program Coordination, Planning, and Strategic Initiatives 
(Division) as established in Section 2 of the Act. The 
Director, acting through the Division, must identify research 
that represents important areas of emerging scientific 
opportunities, rising public health challenges, or knowledge 
gaps that deserve special emphasis and would benefit from 
research that involves collaboration between two or more 
national research institutes and centers, or would otherwise 
benefit from strategic coordination and planning. The Committee 
recognizes research resources, such as the databases and 
research networks for training translational and clinical 
researchers, as an activity that may be supported by the common 
fund.
    The Director may allocate funds set aside in a ``common 
fund,'' under Section 4 of the Act, to the national research 
institutes and centers for conducting and supporting research 
that is identified. The Committee expects that research 
conducted or supported through the common fund will be subject 
to the same peer review standards as research conducted or 
supported through the national research institutes and centers. 
The Director of NIH may assign additional functions to the 
Division. The Division must report on its activities in the 
biennial report required in Section 5 of the Act.
    With respect to research supported through the common fund, 
the Director must require that proposals include milestones and 
goals for the research and timeframes for funding of the 
research. The Director must also ensure appropriate 
consideration of proposals for which the principal investigator 
is an individual who has not previously served as the principal 
investigator of research conducted or supported by the NIH. The 
Committee is concerned that young investigators are given a 
fair opportunity to make significant contributions within their 
areas of expertise and that they are provided with the 
incentive to be the future driving force of innovation and new 
discoveries. The Committee recognizes the existing Clinical 
Transformation Science Awards program as an activity that may 
receive common fund support, especially as it may assist first 
time young investigator applicants.
    To reflect the growing trend in interdisciplinary science, 
the Committee expects that the common fund will provide an 
avenue to fund meritorious research that requires the 
collaboration of several national research institutes and 
centers. For example, the Institute of Medicine reported in 
2006 that to better understand premature birth, a 
multidisciplinary research approach is needed. Several other 
areas of public health concern, such as spinal cord injuries 
and rehabilitation, mental health, Parkinson's disease, and 
autism, also require multidisciplinary research approaches that 
involve the responsibilities of several research institutes and 
centers.
    Section 3 requires the Director of NIH, in coordination 
with the heads of the national research institutes and centers, 
to ensure that the institutes and centers preserve an emphasis 
on investigator-initiated research project grants, including 
projects funded by the common fund; and, when appropriate, 
maximize investigator-initiated research project grants in the 
annual research portfolios. The Committee encourages NIH to 
consider taking the steps necessary to allow principal 
investigators the opportunity to communicate to the agency 
whether their research involves trans-NIH research in order to 
possibly allow the respective investigators' research to be 
considered for funding through the common fund.
    Section 3 requires that the Director of NIH ensure that 
research conducted or supported by the NIH is subject to review 
in accordance with Section 492 of the PHSA, and specifically 
Section 492(a)(2) of the PHSA, which requires appropriate 
advisory council review before research proposals are funded. 
The Committee is concerned that some national research 
institutes and centers may not be complying fully with 
statutory requirements that demand advisory council review of 
grant applications.
    Section 3 requires that the Director approve the 
establishment of all centers of excellence recommended by the 
national research institutes, other than the centers already 
recognized under Section 414. The Committee is concerned that, 
over the past decade, the number of centers of excellence to 
conduct research on specific diseases, disorders, or other 
adverse health conditions, has grown without proper evaluation 
to determine if indeed these centers are the most efficient use 
of taxpayer dollars to accomplish the research priorities of 
the NIH. The Institute of Medicine reported in 2004 that 
centers of excellence represent nearly 9 percent of the overall 
NIH budget. The Committee is requiring the Director of NIH to 
approve any new center of excellence so that NIH may accurately 
track the number of centers of excellence it funds and the 
research activities completed.
    Section 3 also refines the authorities of the Director of 
NIH to establish a Director's Discretionary Fund to reserve 
funds to provide for research on matters that have not received 
significant funding relative to other matters, to respond to 
new issues and scientific emergencies, and to act on research 
opportunities of high priority. The Committee expects that the 
Director's transfer authority may be used to augment this 
account, in addition to any funds appropriated in a fiscal 
year, to be used at the Director's discretion.
    The Director may, subject to appropriations Acts, collect 
and retain registration fees obtained from third parties to 
defray expenses for scientific, educational, and research-
related conferences.
    Section 3 establishes a new advisory council to be known as 
the Council of Councils (Council) for the purpose of advising 
the Director on matter related to the responsibilities of the 
Division, including making recommendations with respect to the 
conduct and support of research identified by the Division 
through the common fund. The Committee designed the Council to 
be similar to the existing advisory councils in the national 
research institutes and centers that provide recommendations 
regarding what research to conduct and support and help set 
priorities for the national research institutes and centers.
    The membership of the Council may not exceed 27 members 
selected by the Director of NIH, with approval by the 
Secretary. In selecting the members of the Council, the 
Director must ensure that the members represent a broad range 
of disciplines and perspectives, and must include at all times 
at least one representative from each national research 
institute whose budget is substantial relative to a majority of 
the other institutes. The Committee recognizes at this time 
these institutes to be the National Cancer Institute, the 
National Heart, Lung, and Blood Institute, and the National 
Institute of Allergy and Infectious Diseases. The Director must 
maintain an updated list of individuals who have been nominated 
to serve on the Council. With respect to nominations from each 
national research institute and center, three individuals shall 
be nominated by the head of the institute or center; at least 
two must be scientists, and one other representing the general 
public; four shall be a leader in the field of public policy, 
law, health policy, economics, or management. In addition, each 
office within the Division of Program Coordination, Planning, 
and Strategic Initiatives shall nominate one person.
    The Committee expects the Council to be a rotating body 
that will grant representation to every institute and center 
that comprises the NIH at some point in time. The Committee 
expects that national research institutes and centers with 
budgets that are substantially less than the majority of others 
will have an opportunity to serve on the Council of Councils. 
The Act requires that a term of service is six years for a 
member of the Council. The initial terms of service are: nine 
members serving for six years, nine members for four years, and 
nine members for two years. The Director may appoint a member 
to fill a position if there is a vacancy, but only for the 
remainder of the term or until a successor is replaced.
    Section 3 amends Section 492A(a)(2) of the PHSA by 
requiring that a majority of the voting members of the 
appropriate advisory council within the national research 
institutes and centers recommend approval of a research 
proposal before it may receive funding. The Committee is very 
concerned that the two-tier peer review system is followed 
completely, given that NIH leaders consistently note that the 
peer review system is the hallmark of NIH success. It has been 
brought to the Committee's attention that past Cancer Center 
Support Grant (CCSG) recipients receiving a National Cancer 
Institute (NCI) ``priority score'' were not awarded funds 
consistent with NCI recommended levels. The Committee would 
like information on whether or not appropriate consideration 
has been given to the scores received by potential grant 
applications through the CCSG program, and the respective 
budgetary allocations that correspond with this program.
    Section 3 clarifies that the new authorities of the 
Director may not be construed as affecting the specific 
authorities of the institutes and centers that were in effect 
on the date of enactment of the bill.

Section 4. Authorization of appropriations

    Section 4 creates a new section 402A of the PHSA.
            ``Section 402A. Authorization of Appropriations.''
    New Section 402A authorizes appropriations for the overall 
NIH budget for the fiscal year 2007 through fiscal year 2009 
period. For fiscal year 2007, $29,747,874,000 is authorized; 
for fiscal year 2008, $31,235,268,000; and for fiscal year 
2009, $32,797,032,000.
    New Section 402A also authorizes appropriations for the 
Office of the Director for the fiscal year 2007 through 2009 
period, within the overall appropriation for the NIH. For 
fiscal year 2007, $1 billion; for fiscal year 2008, 
$1,050,000,000; and for fiscal year 2009, $1,102,500,000.
    New Section 402A establishes a ``common fund'' to provide a 
permanent funding mechanism for trans-NIH research projects 
identified through the Division of Program Coordination, 
Planning, and Strategic Initiatives. The amount reserved in the 
common fund for a fiscal year is equal to the sum of the base 
amount and any additional allocation as determined through 
appropriations. The amount reserved by the Director of NIH for 
a fiscal year may not exceed 5 percent of the total NIH budget. 
This restriction does not apply after an evaluation and 
recommendations are submitted to Congress in the first year 
that the common fund represents 5 percent of the total NIH 
budget. The percentage reservation for the common fund may not 
be less than the previous fiscal year, and may not fall below 5 
percent after the first fiscal year that the common fund 
represents 5 percent of the total amount appropriated.
    The base amount for the common fund for fiscal year 2007 is 
the amount reserved by the Director of NIH for fiscal year 2006 
for trans-NIH research. The Committee has identified several 
initiatives at NIH that meet this criteria, including, but not 
limited to, the Director's Roadmap initiative, the 
neurosciences blueprint, and the obesity initiative. In 
addition, the Committee recognizes Clinical Transformation 
Science Awards as an important use of common fund dollars. The 
base amount for the common fund in fiscal year 2008 and each 
subsequent fiscal year is the amount of the common fund 
reserved for the preceding fiscal year.
    The additional amount that is reserved in the common fund 
represents 50 percent of the amount appropriated that exceeds 
the appropriation for the preceding fiscal year. The new 
funding percentage set aside may be adjusted for a fiscal year 
after the submission of an evaluation and recommendations to 
Congress with respect to the common fund.
    An evaluation of the common fund must be conducted during 
the six month period following the end of the first fiscal year 
when the common fund equals 5 percent of the total NIH budget. 
The Director of NIH, in consultation with the Council of 
Councils, must submit recommendations to Congress for changes 
to the amount of the reservation for the common fund. The 
Committee strongly recommends that when the Director and the 
Council of Councils evaluate the program, the Director include 
in the report to Congress an evaluation of various levels of 
funding for the common fund. This report should discuss whether 
or not the common fund should be less than 5 percent of the 
total NIH budget at any point in time, and how the common fund 
could potentially grow to the level recommended by the 
Institute of Medicine of 10 to 15 percent of the total NIH 
budget. The evaluation should include information on research 
activities funded by the common fund, as is required in the 
biennial report as described in Section 5 of the Act.
    New Section 402A, beginning in fiscal year 2008, national 
research institutes and centers may only receive funding 
increases above the fiscal year 2006 baseline if they report on 
the level of trans-NIH activities that the Institute or Center 
has engaged in during the previous fiscal year. This amount may 
include projects funded through the common fund. Not later than 
January 1, 2008, and each subsequent January 1st thereafter, 
the head of each national research institute or center must 
submit to the Director a report, which the Director of NIH is 
required to verify the accuracy. The Secretary of HHS will then 
submit a report to Congress identifying the percentage of funds 
made available by each national research institute or center 
for the previous fiscal year for conducting trans-NIH research. 
At the request of a national research institute or center, the 
Director of NIH may waive this requirement if the Director of 
NIH determines that the condition is inconsistent with the 
mission of the institute or center. The Committee also 
recognizes that there may be collaborative work between 
national research institutes and centers that may not be fully 
demonstrated in budgetary data, such as planning meetings, 
conferences, and casual communication. The heads of national 
research institutes and centers should highlight the major 
time-consuming activities that fall under this category.
    New Section 402A authorizes transfer authority for the 
Director of NIH at 1 percent, however, the Director may not 
decrease any appropriation account by more than 1 percent. The 
Committee notes that this is the same level that is currently 
permitted in annual appropriations legislation.
    New Section 402A strikes statutory authorization of 
appropriations line items that are expired or have never 
received a direct appropriation. The elimination of other 
authorizations of appropriations, however, may not be construed 
as terminating the authority of the Federal Agency involved to 
carry out the program. The Committee notes that Title III of 
the PHSA grants the Secretary of HHS broad authority to conduct 
research on a variety of issues, regardless of disease-specific 
research directives that Congress has approved over the years. 
The Committee firmly believes that, in order to avoid political 
micromanagement of the agency, NIH needs to improve the 
transparency of research activities and findings.

Section 5. Reports

    Section 5 amends the PHSA to create a new Section 402B.
            ``Section 402B. Electronic Coding of Grants and 
                    Activities.''
    New Section 402B requires the Secretary of HHS, acting 
through the Director of NIH, to establish an electronic system 
to uniformly code research grants and activities throughout the 
NIH. The electronic coding system must be searchable by a 
variety of codes, such as the type of research grant, the 
research entity managing the grant, and the public health area 
interest. When permissible, the Director must provide 
information on relevant literature and patents that are 
associated with research activities of the NIH. The Committee 
has listened to stakeholder concerns about NIH's current open 
access policy with respect to making published literature 
available online. The Committee will continue to monitor the 
open access policies adopted by the NIH, including the 
management of the program and the participation levels of 
scientific journals.
    Section 5 amends Section 403 of PHSA to require the 
Director of NIH to submit biennially a report to Congress. The 
report must include an assessment of the state of biomedical 
research, a description of the activities conducted or 
supported by the NIH, classification and justification for the 
priorities established by the agencies, including a strategic 
plan and recommendations for future research initiatives to be 
carried out by the Division of Program Coordination, Planning, 
and Strategic Initiatives.
    The report must include a catalogue of all the research 
activities of the agencies. The catalogue must include (1) 
epidemiological studies and longitudinal studies; (2) disease 
registries, information clearinghouses, and other data systems; 
(3) public education and information campaigns; (4) training 
activities; (5) clinical trials, including a breakdown by 
demographic variables and other appropriate categories; and (6) 
translational research activities. The Committee directs the 
NIH to create a new, comprehensive electronic reporting system 
that will, for the first time, catalogue all of the research 
activities of the NIH in a standardized format. The Committee 
expects to receive from the NIH Director a report that 
comprehensively lays out the strategic plans and research 
activities of the agency, instead of thousands of pages of 
reports from each of the individual research Institutes and 
Centers. The Committee strongly believes that increased 
transparency of NIH research activities will highlight areas of 
ongoing research to improve research portfolio management, 
provide greater accountability of research dollars, and spur 
creative thinking about new scientific approaches. The 
Committee does not expect, nor does it encourage, the NIH to 
submit a 1,000+ page report; however, the Committee does expect 
that the research activities are catalogued in an 
electronically accessible database, searchable by the variety 
of new codes to meet the criteria outlined in the Act.
    With respect to reporting on training activities, the 
Committee requests that the Director accurately identify the 
institutions that receive training awards, as well as provide a 
breakdown of appropriate variables to analyze the disbursement 
of awards, including, but not limited to, race, ethnicity, and 
gender.
    The catalogue must also identify the agency or agencies 
involved, state whether the activity was carried out directly 
by the agencies or was supported by the agencies and describe 
to what extent the agency was involved, and identify whether 
the specific activity was carried out through a center of 
excellence. The Committee believes this information is critical 
in determining the overall level of intramural and extramural 
activities supported through the NIH. It has been brought to 
the Committee's attention that centers of excellence may 
shelter researchers who may not be as competitive if they were 
applying for research support through another avenue, or unduly 
emphasize research that should not be a high priority for NIH 
based on current scientific opportunities and public health 
burdens. Information on the type of research supported by 
centers of excellence will highlight the efficiency of these 
programs.
    The report must also include a summary of the research 
activities throughout NIH, organized by the following 
categories: cancer; neurosciences; life stages, human 
development, and rehabilitation; organ systems and autoimmune 
diseases; genomics; molecular biology and basic science; 
technology development; chronic diseases, including pain and 
palliative care; infectious diseases and bioterrorism; health 
disparities; and any other additional categories as the 
Director determines to be appropriate. For example, the 
Director may choose to include a separate subsection under the 
category of neurosciences for stroke, and a separate subsection 
under organ systems for heart disease, two of the leading 
causes of death in America.
    With respect to research activities on specific diseases, 
disorders, or other adverse health conditions, the Director 
must present information in a standardized format, identify the 
actual dollar amounts obligated for such activities, and 
include plans for research on specific diseases, disorders, and 
conditions, including statements of objectives regarding the 
research, the means for achieving the objectives, and a date by 
which the objectives are expected to be achieved, and 
justifications for revisions to the plans. The Committee does 
not expect that the NIH develop all at once a report on 3,000+ 
diseases, disorders, and adverse health conditions in the same 
standardized format. The Committee does demand, however, that 
from this point forward, when NIH disseminates information 
regarding research activities with respect to a disease, 
disorder, or adverse health condition, that the information be 
formatted in a standardized format. For example, the Committee 
is interested in learning more about the research activities 
with respect to diseases such as Cystic Fibrosis, rare 
diseases, arthritis, Chronic Obstructive Pulmonary Disease, 
Idiopathic Pulmonary Fibrosis, chronic kidney diseases, and 
Charcot Marie Tooth disease. The Committee is also interested 
in learning more about prevention methods using microbicides 
and studies of routine scheduled Cesarean delivery procedures 
versus attempted vaginal childbirth. The Committee is 
interested in better understanding what research is underway at 
NIH to address the adverse health conditions of those impacted 
by the terrorist attacks on September 11, 2001. The Committee 
would like to know more about the research underway at NIH with 
respect to prosthetics for soldiers whose limbs have been 
amputated as a result of combat, and related illnesses 
experienced by those individuals due to amputations. The 
Director should also include in the report information about 
population research activities and advances.
    Section 5 permits the Director to submit additional reports 
to Congress as he determines appropriate.
    Section 5 amends the PHSA by creating a new Section 403A.
            ``Section 403A. Annual Reporting to Increase Interagency 
                    Collaboration and Coordination.''
    New Section 403A requires the Director of NIH to submit a 
report on an annual basis to the Secretary of HHS describing 
the activities involving collaboration between NIH and the 
other agencies of the Department of Health and Human Services. 
This information is important to better tracking not only 
patient safety initiatives, but also agency efforts to reduce 
health disparities. Specifically, the Committee recognizes the 
positive impact that the NIH can have by collaborating across 
the institutes and centers and with the Centers for Disease 
Control, Agency for Healthcare Research and Quality, and other 
HHS agencies to improve the delivery of care for the nation's 
patients by increasing quality, eliminating duplication, and 
reducing the unnecessary costs caused by infections, medical, 
and medication errors. The Committee encourages NIH to include 
detailed information that describes how long the agency has 
collaborated on the projects listed in the report, the total 
level of funding to date, the total contribution of NIH funding 
to the project, and a list of all major meetings between the 
agencies. It is also critically important for NIH and the Food 
and Drug Administration to collaborate on new research 
initiatives to help speed the development and approval of 
lifesaving drugs and biologics. Other agency collaborations, 
such as the provision included in the Medicare Prescription 
Drug and Modernization Act of 2003 that directed the Agency for 
Healthcare Research and Quality to conduct systematic reviews 
of existing evidence on drugs and other treatments that treat 
the same condition should be included in the report. The 
Committee requests that the report include public education 
campaigns, epidemiological studies and longitudinal studies, 
disease registries, and information clearinghouses that the NIH 
coordinates with the Centers for Disease Control and 
Prevention, including detailed information about NIH funding 
for the activities.
    New Section 403A requires the Director of NIH to submit to 
the Commissioner of the Food and Drug Administration on an 
annual basis a report that identifies each clinical trial that 
is registered during the calendar year in the databank of 
information established under Section 402(j) of the PHSA.
    Section 5 amends the PHSA by creating a new Section 403B.
            ``Section 403B. Annual Reporting to Prevent Fraud and 
                    Abuse.''
    New Section 403B requires the Director of NIH submit to 
Congress on an annual basis a report that describes how the NIH 
stores and tracks human tissue samples.
    New Section 403B requires the Director of NIH to submit to 
the Inspector General of the Department of HHS, the Secretary, 
the Committee on Energy and Commerce of the House of 
Representatives, and the Committee on Health, Education, Labor, 
and Pensions of the Senate, a report summarizing the activities 
of the NIH relating to whistleblower complaints, including the 
agency involved, the status of the complaint, and the 
resolution of the complaint to date. The Director of NIH is 
also required to submit a report that identifies the number of 
experts and consultants whose services are obtained by the NIH.
    New Section 403B strikes all other statutory reporting 
requirements that are either expired or are duplicative given 
the new comprehensive reporting system. The Committee, however, 
expects NIH to submit reports that are already underway, and 
near completion, such as the report required by Section 4923 of 
Public Law 105-33.

Section 6. Certain demonstration projects

    Section 6 authorizes the Director of NIH to conduct two 
distinct demonstration programs with funds appropriated through 
the Office of the Director.
    The first demonstration program, ``Bridging the Sciences,'' 
permits the Secretary of HHS, acting through the Director of 
NIH, in consultation with the Director of the National Science 
Foundation, the Secretary of Energy, and other agencies, to 
award grants for demonstration projects for biomedical research 
at the interface between the biological, behavioral, and social 
sciences with the physical, chemical, mathematical, and 
computational sciences. The Secretary must establish goals, 
priorities, and methods of evaluation for the research. A grant 
must be peer reviewed, as required under Section 492 of the 
PHSA, and an advisory council must complete the review. The 
Committee recognizes that research projects eligible under this 
demonstration program may require a more diverse group of peer 
reviewers than are currently available through NIH's 
traditional peer review process, and encourages the agencies 
involved to organize appropriate advisory councils to properly 
review the applicants.
    The second demonstration program, ``High Risk, High Reward 
Research,'' permits the Director of NIH to allocate funds for 
the national research institutes and centers to award grants, 
contracts, or engage in other transactions, for high-impact, 
cutting edge research that fosters scientific creativity and 
increases fundamental biological understanding leading to the 
prevention, diagnosis, and treatment of diseases and disorders. 
In addition to funds allocated by the Director, the head of a 
national research institute or center may conduct or support 
similar research with funds appropriated to the institute or 
center, if the institute or center gives notice to the Director 
of NIH beforehand and submits a report to the Director of NIH 
on an annual basis regarding the activities.
    The Director of NIH must give special consideration to 
coordinating activities with national research institutes whose 
budgets are substantial relative to a majority of the other 
institutes. The Committee recognizes that high risk, high 
reward research, similar to the Defense Advanced Research 
Projects Agency initiatives at the Department of Defense, could 
be quite expensive to conduct. Therefore the Committee 
encourages the Director of NIH to maximize funds for this 
demonstration project by coordinating with institutes and 
centers with substantial budgets. In addition, the Director of 
NIH or the head of a national research or institute should seek 
to facilitate partnerships between public and private entities. 
The Director of NIH or the head of a national research 
institute or center must also coordinate with the Foundation 
for the National Institutes of Health. The Committee expects 
coordination with the Foundation for the National Institutes of 
Health for the sole purpose of drawing down additional research 
dollars to operate the demonstration program. All grants must 
be peer reviewed.
    The Director of NIH must conduct an evaluation of both 
demonstration projects and submit a report to Congress on the 
results no later than the end of fiscal year 2009.

Section 7. Foundation for the National Institutes of Health

    Section 7 amends Section 499 of the Public Health Service 
Act, the statute governing the National Foundation for the 
National Institutes of Health (Foundation), and makes technical 
corrections and grants increased flexibility in the amounts of 
Federal funding and support services. Most significantly, these 
corrections clarify membership in the Foundation's board of 
directors and assure that the Foundation receives funds from 
the National Institutes of Health (NIH) to support the 
Foundation's administrative and operating expenses.

Section 8. Applicability

    Section 8 clarifies that the amendments made by the bill 
apply only with respect to amounts appropriated for fiscal year 
2007 or subsequent fiscal years.

         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 III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

           *       *       *       *       *       *       *



Part M--National Program of Cancer Registries

           *       *       *       *       *       *       *



SEC. 399E. STUDY IN CERTAIN STATES TO DETERMINE THE FACTORS 
                    CONTRIBUTING TO THE ELEVATED BREAST CANCER 
                    MORTALITY RATES.

  (a)  * * *

           *       *       *       *       *       *       *

  [(e) Report.--Not later than September 30, 1999, the 
Secretary shall complete the study required in subsection (a) 
and submit to the Committee on Energy and Commerce of the House 
of Representatives, and to the Committee on Labor and Human 
Resources of -the Senate, a report describing the findings and 
recommendations made as a result of the study.]

           *       *       *       *       *       *       *


                 TITLE IV--NATIONAL RESEARCH INSTITUTES


                 Part A--National Institutes of Health


           [ORGANIZATION OF THE NATIONAL INSTITUTES OF HEALTH

  [Sec. 401. (a) The National Institutes of Health is an agency 
of the Service.
  [(b)(1) The following national research institutes are 
agencies of the National Institutes of Health:
          [(A) The National Cancer Institute.
          [(B) The National Heart, Lung, and Blood Institute.
          [(C) The National Institute of Diabetes and Digestive 
        and Kidney Diseases.
          [(D) The National Institute of Arthritis and 
        Musculoskeletal and Skin Diseases.
          [(E) The National Institute on Aging.
          [(F) The National Institute of Allergy and Infectious 
        Diseases.
          [(G) The National Institute of Child Health and Human 
        Development.
          [(H) The National Institute of Dental and 
        Craniofacial Research.
          [(I) The National Eye Institute.
          [(J) The National Institute of Neurological Disorders 
        and Stroke.
          [(K) The National Institute of General Medical 
        Sciences.
          [(L) The National Institute of Environmental Health 
        Sciences.
          [(M) The National Institute on Deafness and Other 
        Communication Disorders.
          [(N) The National Institute on Alcohol Abuse and 
        Alcoholism.
          [(O) The National Institute on Drug Abuse.
          [(P) The National Institute of Mental Health.
          [(Q) The National Institute of Nursing Research.
          [(R) The National Institute of Biomedical Imaging and 
        Bioengineering.
  [(2) The following entities are agencies of the National 
Institutes of Health:
          [(A) The National Library of Medicine.
          [(B) The National Center for Research Resources.
          [(C) The John E. Fogarty International Center for 
        Advanced Study in the Health Sciences.
          [(D) The National Center for Human Genome Research.
          [(E) The Office of Dietary Supplements.
          [(F) The National Center for Complementary and 
        Alternative Medicine.
          [(G) The National Center on Minority Health and 
        Health Disparities.
  [(c)(1) The Secretary may establish in the National 
Institutes of Health one or more additional national research 
institutes to conduct and support research, training, health 
information, and other programs with respect to any particular 
disease or groups of diseases or any other aspect of human 
health if--
          [(A) the Secretary determines that an additional 
        institute is necessary to carry out such activities; 
        and
          [(B) the additional institute is not established 
        before the expiration of 180 days after the Secretary 
        has provided the Committee on Energy and Commerce of 
        the House of Representatives and the Committee on Labor 
        and Human Resources of the Senate written notice of the 
        determination made under subparagraph (A) with respect 
        to the institute.
  [(2) The Secretary may reorganize the functions of any 
national research institute and may abolish any national 
research institute if the Secretary determines that the 
institute is no longer required. A reorganization or abolition 
may not take effect under this paragraph before the expiration 
of 180 days after the Secretary has provided the Committee on 
Energy and Commerce of the House of Representatives and the 
Committee on Labor and Human Resources of the Senate written 
notice of the reorganization or abolition.
  [(d) For purposes of this title, the term ``national research 
institute'' means a national research institute listed in 
subsection (b) or established under subsection (c). A reference 
to the National Institutes of Health includes its agencies.]

SEC. 401. ORGANIZATION OF NATIONAL INSTITUTES OF HEALTH.

  (a) Relation to Public Health Service.--The National 
Institutes of Health is an agency of the Service.
  (b) National Research Institutes and National Centers.--The 
following agencies of the National Institutes of Health are 
national research institutes or national centers:
          (1) The National Cancer Institute.
          (2) The National Heart, Lung, and Blood Institute.
          (3) The National Institute of Diabetes and Digestive 
        and Kidney Diseases.
          (4) The National Institute of Arthritis and 
        Musculoskeletal and Skin Diseases.
          (5) The National Institute on Aging.
          (6) The National Institute of Allergy and Infectious 
        Diseases.
          (7) The National Institute of Child Health and Human 
        Development.
          (8) The National Institute of Dental and Craniofacial 
        Research.
          (9) The National Eye Institute.
          (10) The National Institute of Neurological Disorders 
        and Stroke.
          (11) The National Institute on Deafness and Other 
        Communication Disorders.
          (12) The National Institute on Alcohol Abuse and 
        Alcoholism.
          (13) The National Institute on Drug Abuse.
          (14) The National Institute of Mental Health.
          (15) The National Institute of General Medical 
        Sciences.
          (16) The National Institute of Environmental Health 
        Sciences.
          (17) The National Institute of Nursing Research.
          (18) The National Institute of Biomedical Imaging and 
        Bioengineering.
          (19) The National Human Genome Research Institute.
          (20) The National Library of Medicine.
          (21) The National Center for Research Resources.
          (22) The John E. Fogarty International Center for 
        Advanced Study in the Health Sciences.
          (23) The National Center for Complementary and 
        Alternative Medicine.
          (24) The National Center on Minority Health and 
        Health Disparities.
          (25) Any other national center that, as an agency 
        separate from any national research institute, was 
        established within the National Institutes of Health as 
        of the day before the date of the enactment of the 
        National Institutes of Health Reform Act of 2006.
  (c) Division of Program Coordination, Planning, and Strategic 
Initiatives.--
          (1) In general.--Within the Office of the Director of 
        the National Institutes of Health, there shall be a 
        Division of Program Coordination, Planning, and 
        Strategic Initiatives (referred to in this subsection 
        as the ``Division'').
          (2) Offices within division.--
                  (A) Offices.--The following offices are 
                within the Division: The Office of AIDS 
                Research, the Office of Research on Women's 
                Health, the Office of Behavioral and Social 
                Sciences Research, the Office of Disease 
                Prevention, the Office of Dietary Supplements, 
                the Office of Rare Diseases, and any other 
                office located within the Office of the 
                Director of NIH as of the day before the date 
                of the enactment of the National Institutes of 
                Health Reform Act of 2006. In addition to such 
                offices, the Director of NIH may establish 
                within the Division such additional offices or 
                other administrative units as the Director 
                determines to be appropriate.
                  (B) Authorities.--Each office in the 
                Division--
                          (i) shall continue to carry out the 
                        authorities that were in effect for the 
                        office before the date of enactment 
                        referred to in subparagraph (A); and
                          (ii) shall, as determined appropriate 
                        by the Director of NIH, support the 
                        Division with respect to the 
                        authorities described in section 
                        402(b)(7).
  (d) Organization.--
          (1) Number of institutes and centers.--In the 
        National Institutes of Health, the number of national 
        research institutes and national centers may not exceed 
        a total of 27, including any such institutes or centers 
        established under authority of paragraph (2) or under 
        authority of this title as in effect on the day before 
        the date of the enactment ofthe National Institutes of 
        Health Reform Act of 2006.
          (2) Reorganization of institutes and centers.--
                  (A) In general.--Notwithstanding subsection 
                (b), and subject to paragraph (1), the Director 
                of NIH may, with the approval of the Secretary, 
                reorganize the national research institutes and 
                the national centers, including the addition, 
                removal, or transfer of functions of such 
                institutes and centers, and the establishment 
                or termination of such institutes and centers, 
                if the Director determines that the overall 
                mission of the National Institutes of Health, 
                or the management and operation of programs and 
                activities conducted or supported by the 
                National Institutes of Health, would be more 
                efficiently carried out under such a 
                reorganization.
                  (B) Administrative unit.--For purposes of 
                paragraph (1), an administrative unit within 
                the National Institutes of Health that is 
                established under authority of subparagraph (A) 
                shall be considered a national research 
                institute or a national center, without regard 
                to whether the administrative unit is 
                designated by the Director of NIH as such an 
                institute or center.
                  (C) Public process.--Any reorganization under 
                subparagraph (A) shall be carried out by 
                regulation in accordance with the procedures 
                for substantive rules under section 553 of 
                title 5, United States Code.
          (3) Reorganization of office of director.--
        Notwithstanding subsection (c), the Director of NIH 
        may, after a series of public hearings, and with the 
        approval of the Secretary, reorganize the offices 
        within the Office of the Director, including the 
        addition, removal, or transfer of functions of such 
        offices, and the establishment or termination of such 
        offices, if the Director determines that the overall 
        management and operation of programs and activities 
        conducted or supported by such offices would be more 
        efficiently carried out under such a reorganization.
          (4) Internal reorganization of institutes and 
        centers.--Notwithstanding any conflicting provisions of 
        this title, the director of a national research 
        institute or a national center may, after a series of 
        public hearings and with the approval of the Director 
        of NIH, reorganize the divisions, centers, or other 
        administrative units within such institute or center, 
        including the addition, removal, or transfer of 
        functions of such units, and the establishment or 
        termination of such units, if the director of such 
        institute or center determines that the overall 
        management and operation of programs and activities 
        conducted or supported by such divisions, centers, or 
        other units would be more efficiently carried out under 
        such a reorganization.
          (5) Notice to congress; effective date.--A 
        reorganization under paragraph (2), (3), or (4) may not 
        take effect before the expiration of 90 days after the 
        Secretary submits to the Committee on Energy and 
        Commerce of the House of Representatives and the 
        Committee on Health, Education, Labor, and Pensions of 
        the Senate written notice of the reorganization.
  (e) Scientific Management Review Board for Periodic 
Organizational Reviews.--
          (1) In general.--Not later than 60 days after the 
        date of the enactment of the National Institutes of 
        Health Reform Act of 2006, the Secretary shall 
        establish an advisory council within the National 
        Institutes of Health to be known as the Scientific 
        Management Review Board (referred to in this subsection 
        as the ``Board'').
          (2) Duties.--
                  (A) Reports on organizational issues.--The 
                Board shall provide advice to the appropriate 
                officials under subsection (d) regarding the 
                use of the authorities established in 
                paragraphs (2), (3), and (4) of such subsection 
                to reorganize the National Institutes of Health 
                (referred to in this subsection as 
                ``organizational authorities''). Not less 
                frequently than once each 7 years, the Board 
                shall--
                          (i) determine whether and to what 
                        extent the organizational authorities 
                        should be used; and
                          (ii) issue a report providing the 
                        recommendations of the Board regarding 
                        the use of the authorities and the 
                        reasons underlying the recommendations.
                  (B) Certain responsibilities regarding 
                reports.--The activities of the Board with 
                respect to a report under subparagraph (A) 
                shall include the following:
                          (i) Reviewing all programs of the 
                        National Institutes of Health (referred 
                        to in this subsection as ``NIH'') in 
                        order to determine the progress and 
                        cost-effectiveness of such programs and 
                        the allocation among the programs of 
                        the resources of NIH.
                          (ii) Determining pending scientific 
                        opportunities, and public health needs, 
                        with respect to research within the 
                        jurisdiction of NIH.
                          (iii) For any proposal for 
                        organizational changes to which the 
                        Board gives significant consideration 
                        as a possible recommendation in such 
                        report--
                                  (I) analyzing the budgetary 
                                and operational consequences of 
                                the proposed changes;
                                  (II) estimating the level of 
                                resources needed to implement 
                                the proposed changes; and
                                  (III) assuming the proposed 
                                changes will be made and making 
                                a recommendation for the 
                                allocation of the resources of 
                                NIH among the national research 
                                institutes and national 
                                centers.
                  (C) Consultation.--In carrying out 
                subparagraph (A), the Board shall consult 
                with--
                          (i) the heads of national research 
                        institutes and national centers whose 
                        directors are not members of the Board;
                          (ii) other scientific leaders who are 
                        officers or employees of NIH and are 
                        not members of the Board;
                          (iii) advisory councils of the 
                        national research institutes and 
                        national centers;
                          (iv) organizations representing the 
                        scientific community; and
                          (v) organizations representing 
                        patients.
          (3) Composition of board.--The membership of the 
        Board may not exceed 21 individuals, all of whom shall 
        be voting members. The Board shall be composed of the 
        following:
                  (A) The Director of NIH, who shall be a 
                permanent member on an ex officio basis.
                  (B) Not fewer than 9 officials who are 
                directors of national research institutes or 
                national centers. The Secretary shall designate 
                such officials for membership and shall ensure 
                that the group of officials so designated 
                includes directors of--
                          (i) national research institutes 
                        whose budgets are substantial relative 
                        to a majority of the other institutes;
                          (ii) national research institutes 
                        whose budgets are small relative to a 
                        majority of the other institutes;
                          (iii) national research institutes 
                        that have been in existence for a 
                        substantial period of time without 
                        significant organizational change under 
                        subsection (d);
                          (iv) as applicable, national research 
                        institutes that have undergone 
                        significant organization changes under 
                        such subsection, or that have been 
                        established under such subsection, 
                        other than national research institutes 
                        for which such changes have been in 
                        place for a substantial period of time; 
                        and
                          (v) national centers.
                  (C) Members appointed by the Secretary from 
                among individuals who are not officers or 
                employees of the United States. Such members 
                shall include--
                          (i) individuals representing the 
                        interests of public or private 
                        institutions of higher education that 
                        have historically received funds from 
                        NIH to conduct research; and
                          (ii) individuals representing the 
                        interests of private entities that have 
                        received funds from NIH to conduct 
                        research or that have broad expertise 
                        regarding how the National Institutes 
                        of Health functions, exclusive of 
                        private entities to which clause (i) 
                        applies.
          (4) Chair.--The Chair of the Board shall be selected 
        by the Secretary from among the appointed members of 
        the Board, except that the Secretary may select the 
        Director of NIH as the Chair. The term of office of the 
        Chair shall be 2 years.
          (5) Meetings.--
                  (A) In general.--The Board shall meet at the 
                call of the Chair or upon the request of the 
                Director of NIH, but not fewer than 5 times 
                with respect to issuing any particular report 
                under paragraph (2)(A). The location of the 
                meetings of the Board is subject to the 
                approval of the Director of NIH.
                  (B) Particular forums.--Of the meetings held 
                under subparagraph (A) with respect to a report 
                under paragraph (2)(A)--
                          (i) one or more shall be directed 
                        toward the scientific community to 
                        address scientific needs and 
                        opportunities related to proposals for 
                        organizational changes under subsection 
                        (d), or as the case may be, related to 
                        a proposal that no such changes be 
                        made; and
                          (ii) one or more shall be directed 
                        toward consumer organizations to 
                        address the needs and opportunities of 
                        patients and their families with 
                        respect to proposals referred to in 
                        clause (i).
                  (C) Availability of information from 
                forums.--For each meeting under subparagraph 
                (B), the Director of NIH shall post on the 
                Internet site of the National Institutes of 
                Health a summary of the proceedings.
          (6) Compensation; term of office.--The provisions of 
        subsections (b)(4) and (c) of section 406 apply with 
        respect to the Board to the same extent and in the same 
        manner as such provisions apply with respect to an 
        advisory council referred to in such subsections, 
        except that the reference in such subsection (c) to 4 
        years regarding the term of an appointed member is 
        deemed to be a reference to 5 years.
          (7) Reports.--
                  (A) Recommendations for changes.--Each report 
                under paragraph (2)(A) shall be submitted to--
                          (i) the Committee on Energy and 
                        Commerce within the House of 
                        Representatives;
                          (ii) the Committee on Health, 
                        Education, Labor, and Pensions within 
                        the Senate;
                          (iii) the Secretary; and
                          (iv) officials with organizational 
                        authorities, other than any such 
                        official who served as a member of the 
                        Board with respect to the report 
                        involved.
                  (B) Availability to public.--The Director of 
                NIH shall post each report under paragraph (2) 
                on the Internet site of the National Institutes 
                of Health.
                  (C) Report on board activities.--Not later 
                than 18 months after the date of the enactment 
                of the National Institutes of Health Reform Act 
                of 2006, the Board shall submit to the 
                committees specified in subparagraph (A) a 
                report describing the activities of the Board.
  (f) Organizational Changes Per Recommendation of Scientific 
Management Review Board.--
          (1) In general.--With respect to an official who has 
        organizational authorities within the meaning of 
        subsection (e)(2)(A), if a recommendation to the 
        official for an organizational change is made in a 
        report under such subsection, the official shall, 
        except as provided in paragraph (2) of this subsection, 
        make the change in accordance with the following:
                  (A) Not later than 100 days after the report 
                is submitted under subsection (e)(7)(A), the 
                official shall initiate the applicable public 
                process required in subsection (d) toward 
                making the change.
                  (B) The change shall be fully implemented not 
                later than the expiration of the 3-year period 
                beginning on the date on which such process is 
                initiated.
          (2) Objection by director of nih.--
                  (A) In general.--Paragraph (1) does not apply 
                to a recommendation for an organizational 
                change made in a report under subsection 
                (e)(2)(A) if, not later than 90 days after the 
                report is submitted under subsection (e)(7)(A), 
                the Director of NIH submits to the committees 
                specified in such subsection a report providing 
                that the Director objects to the change, which 
                report includes the reasons underlying the 
                objection.
                  (B) Scope of objection.--For purposes of 
                subparagraph (A), an objection by the Director 
                of NIH may be made to the entirety of a 
                recommended organizational change or to 1 or 
                more aspects of the change. Any aspect of a 
                change not objected to by the Director in a 
                report under subparagraph (A) shall be 
                implemented in accordance with paragraph (1).
  (g) Definitions.--For purposes of this title:
          (1) The term ``Director of NIH'' means the Director 
        of the National Institutes of Health.
          (2) The terms ``national research institute'' and 
        ``national center'' mean an agency of the National 
        Institutes of Health that is--
                  (A) listed in subsection (b) and not 
                terminated under subsection (d)(2)(A); or
                  (B) established by the Director of NIH under 
                such subsection.
  (h) References to NIH.--For purposes of this title, a 
reference to the National Institutes of Health includes its 
agencies.

              APPOINTMENT AND AUTHORITY OF DIRECTOR OF NIH

  Sec. 402. (a) The National Institutes of Health shall be 
headed by the [Director of the National Institutes of Health 
(hereafter in this title referred to as the ``Director of 
NIH'') who shall] Director of NIH who shall be appointed by the 
President by and with the advice and consent of the Senate. The 
Director of NIH shall perform functions as provided under 
subsection (b) and as the Secretary may otherwise prescribe.
  (b) In carrying out the purposes of section 301, the 
Secretary, acting through the Director of NIH--
          [(1) shall be responsible for the overall direction 
        of the National Institutes of Health and for the 
        establishment and implementation of general policies 
        respecting the management and operation of programs and 
        activities within the National Institutes of Health;
          [(2) shall coordinate and oversee the operation of 
        the national research institutes and administrative 
        entities within the National Institutes of Health;
          [(3) shall assure that research at or supported by 
        the National Institutes of Health is subject to review 
        in accordance with section 492;]
          (1) shall be responsible for the overall direction of 
        the National Institutes of Health and for the 
        establishment and implementation of general policies 
        respecting the management and operation of programs and 
        activities within the National Institutes of Health;
          (2) shall coordinate and oversee the operation of the 
        national research institutes, national centers, and 
        administrative entities within the National Institutes 
        of Health;
          (3) shall, in consultation with the heads of the 
        national research institutes and national centers, be 
        responsible for program coordination across the 
        national research institutes and national centers, 
        including conducting priority-setting reviews, to 
        ensure that the research portfolio of the National 
        Institutes of Health is balanced and free of 
        unnecessary, duplicative research, and takes advantage 
        of collaborative, cross-cutting research;
          (4) shall assemble accurate data to be used to assess 
        research priorities, including information to better 
        evaluate scientific opportunity, public health burdens, 
        and progress in reducing health disparities;
          (5) shall ensure that scientifically based strategic 
        planning is implemented in support of research 
        priorities as determined by the agencies of the 
        National Institutes of Health;
          (6) shall ensure that the resources of the National 
        Institutes of Health are sufficiently allocated for 
        research projects identified in strategic plans;
          (7)(A) shall, through the Division of Program 
        Coordination, Planning, and Strategic Initiatives--
                  (i) identify research that represents 
                important areas of emerging scientific 
                opportunities, rising public health challenges, 
                or knowledge gaps that deserve special emphasis 
                and would benefit from conducting or supporting 
                additional research that involves collaboration 
                between 2 or more national research institutes 
                or national centers, or would otherwise benefit 
                from strategic coordination and planning;
                  (ii) include information on such research in 
                reports under section 403; and
                  (iii) in the case of such research supported 
                with funds referred to in subparagraph (B)--
                          (I) require as appropriate that 
                        proposals include milestones and goals 
                        for the research;
                          (II) require that the proposals 
                        include timeframes for funding of the 
                        research; and
                          (III) ensure appropriate 
                        consideration of proposals for which 
                        the principal investigator is an 
                        individual who has not previously 
                        served as the principal investigator of 
                        research conducted or supported by the 
                        National Institutes of Health;
          (B) may, with respect to funds reserved under section 
        402A(c)(1) for the Common Fund, allocate such funds to 
        the national research institutes and national centers 
        for conducting and supporting research that is 
        identified under subparagraph (A); and
          (C) may assign additional functions to the Division 
        in support of responsibilities identified in 
        subparagraph (A), as determined appropriate by the 
        Director;
          (8) shall, in coordination with the heads of the 
        national research institutes and national centers, 
        ensure that such institutes and centers--
                  (A) preserve an emphasis on investigator-
                initiated research project grants, including 
                with respect to research involving 
                collaboration between 2 or more such institutes 
                or centers; and
                  (B) when appropriate, maximize investigator-
                initiated research project grants in their 
                annual research portfolios;
          (9) shall ensure that research conducted or supported 
        by the National Institutes of Health is subject to 
        review in accordance with section 492 and that, after 
        such review, the research is reviewed in accordance 
        with section 492A(a)(2) by the appropriate advisory 
        council under section 406 before the research proposals 
        are approved for funding;
          (10) shall approve the establishment of all centers 
        of excellence recommended by the national research 
        institutes, other than centers recognized under section 
        414;
          (11) shall oversee research training for all of the 
        national research institutes and National Research 
        Service Awards in accordance with section 487;
          (12) may, from funds appropriated under section 
        402A(b), reserve funds to provide for research on 
        matters that have not received significant funding 
        relative to other matters, to respond to new issues and 
        scientific emergencies, and to act on research 
        opportunities of high priority;
          (13) may, subject to appropriations Acts, collect and 
        retain registration fees obtained from third parties to 
        defray expenses for scientific, educational, and 
        research-related conferences;
          [(4)] (14) for the national research institutes and 
        administrative entities within the National Institutes 
        of Health--
                  (A)  * * *

           *       *       *       *       *       *       *

          [(5)] (15) may secure resources for research 
        conducted by or through the National Institutes of 
        Health;
          [(6)] (16) may, without regard to the provisions of 
        title 5, United States Code, governing appointments in 
        the competitive service, and without regard to the 
        provisions of chapter 51 and subchapter III of chapter 
        53 of such title relating to classification and General 
        Schedule pay rates, establish such technical and 
        scientific peer review groups and scientific program 
        advisory committees as are needed to carry out the 
        requirements of this title and appoint and pay the 
        members of such groups, except that officers and 
        employees of the United States shall not receive 
        additional compensation for service as members of such 
        groups;
          [(7)] (17) may secure for the National Institutes of 
        Health consultation services and advice of persons from 
        the United States or abroad;
          [(8)] (18) may use, with their consent, the services, 
        equipment, personnel, information, and facilities of 
        other Federal, State, or local public agencies, with or 
        without reimbursement therefor;
          [(9)] (19) may, for purposes of study, admit and 
        treat at facilities of the National Institutes of 
        Health individuals not otherwise eligible for such 
        treatment;
          [(10)] (20) may accept voluntary and uncompensated 
        services;
          [(11)] (21) may perform such other administrative 
        functions as the Secretary determines are needed to 
        effectively carry out this title; and
          [(12) after consultation with the Director of the 
        Office of Research on Women's Health, shall ensure that 
        resources of the National Institutes of Health are 
        sufficiently allocated for projects of research on 
        women's health that are identified under section 
        486(b);
          [(13) may conduct and support research training--
                  [(A) for which fellowship support is not 
                provided under section 487; and
                  [(B) which does not consist of residency 
                training of physicians or other health 
                professionals; and]
          [(14)] (22) may appoint physicians, dentists, and 
        other health care professionals, subject to the 
        provisions of title 5, United States Code, relating to 
        appointments and classifications in the competitive 
        service, and may compensate such professionals subject 
        to the provisions of chapter 74 of title 38, United 
        States Code.
The Federal Advisory Committee Act shall not apply to the 
duration of a peer review group appointed under [paragraph (6)] 
paragraph (16). The members of such a group shall be 
individuals who by virtue of their training or experience are 
eminently qualified to perform the review functions of such 
group. Not more than one-fourth of the members of any such 
group shall be officers or employees of the United States.

           *       *       *       *       *       *       *

  [(i)(1) There is established a fund, consisting of amounts 
appropriated under paragraph (3) and made available for the 
fund, for use by the Director of NIH to carry out the 
activities authorized in this Act for the National Institutes 
of Health. The purposes for which such fund may be expended 
include--
          [(A) providing for research on matters that have not 
        received significant funding relative to other matters, 
        responding to new issues and scientific emergencies, 
        and acting on research opportunities of high priority;
          [(B) supporting research that is not exclusively 
        within the authority of any single agency of such 
        Institutes; and
          [(C) purchasing or renting equipment and quarters for 
        activities of such Institutes.
  [(2) Not later than February 10 of each fiscal year, the 
Secretary shall submit to the Committee on Energy and Commerce 
of the House of Representatives, and to the Committee on Labor 
and Human Resources of the Senate, a report describing the 
activities undertaken and expenditures made under this section 
during the preceding fiscal year. The report may contain such 
comments of the Secretary regarding this section as the 
Secretary determines to be appropriate.
  [(3) For the purpose of carrying out this subsection, there 
are authorized to be appropriated $25,000,000 for fiscal year 
1994, and such sums as may be necessary for each of the fiscal 
years 1995 and 1996.]
  [(j)] (i)(1)(A) [The Secretary, acting through the Director 
of NIH, shall establish, maintain, and operate a data bank of 
information on clinical trials for drugs for serious or life-
threatening diseases and conditions (in this subsection 
referred to as the ``data bank'').] The activities of the data 
bank shall be integrated and coordinated with related 
activities of other agencies of the Department of Health and 
Human Services, and to the extent practicable, coordinated with 
other data banks containing similar information.
  (B) The Secretary shall establish the data bank after 
consultation with the Commissioner of Food and Drugs, the 
directors of the appropriate agencies of the National 
Institutes of Health (including the National Library of 
Medicine), and the Director of the Centers for Disease Control 
and Prevention.
  (2) In carrying out paragraph (1), the Secretary shall 
collect, catalog, store, and disseminate the information 
described in such paragraph. The Secretary shall disseminate 
such information through information systems, which shall 
include toll-free telephone communications, available to 
individuals with serious or life-threatening diseases and 
conditions, to other members of the public, to health care 
providers, and to researchers.
  (3) The data bank shall include the following:
          (A) A registry of clinical trials (whether federally 
        or privately funded) of experimental treatments for 
        serious or life-threatening diseases and conditions 
        under regulations promulgated pursuant to section 
        505(i) of the Federal Food, Drug, and Cosmetic Act, 
        which provides a description of the purpose of each 
        experimental drug, either with the consent of the 
        protocol sponsor, or when a trial to test effectiveness 
        begins. Information provided shall consist of 
        eligibility criteria for participation in the clinical 
        trials, a description of the location of trial sites, 
        and a point of contact for those wanting to enroll in 
        the trial, and shall be in a form that can be readily 
        understood by members of the public. Such information 
        shall be forwarded to the data bank by the sponsor of 
        the trial not later than 21 days after the approval of 
        the protocol.
          (B) Information pertaining to experimental treatments 
        for serious or life-threatening diseases and conditions 
        that may be available--
                  (i) under a treatment investigational new 
                drug application that has been submitted to the 
                Secretary under section 561(c) of the Federal 
                Food, Drug, and Cosmetic Act; or
                  (ii) as a Group C cancer drug (as defined by 
                the National Cancer Institute).
        The data bank may also include information pertaining 
        to the results of clinical trials of such treatments, 
        with the consent of the sponsor, including information 
        concerning potential toxicities or adverse effects 
        associated with the use or administration of such 
        experimental treatments.
  (4) The data bank shall not include information relating to 
an investigation if the sponsor has provided a detailed 
certification to the Secretary that disclosure of such 
information would substantially interfere with the timely 
enrollment of subjects in the investigation, unless the 
Secretary, after the receipt of the certification, provides the 
sponsor with a detailed written determination that such 
disclosure would not substantially interfere with such 
enrollment.
  (5) For the purpose of carrying out this subsection, there 
are authorized to be appropriated such sums as may be 
necessary. Fees collected under section 736 of the Federal 
Food, Drug, and Cosmetic Act shall not be used in carrying out 
this subsection.
  [(k)] (j)(1) The Director of NIH may establish a program to 
provide day care services for the employees of the National 
Institutes of Health similar to those services provided by 
other Federal agencies (including the availability of day care 
service on a 24-hour-a-day basis).
  (2) Any day care provider at the National Institutes of 
Health shall establish a sliding scale of fees that takes into 
consideration the income and needs of the employee.
  (3) For purposes regarding the provision of day care 
services, the Director of NIH may enter into rental or lease 
purchase agreements.
  (k) Council of Councils.--
          (1) Establishment.--The Director of NIH shall 
        establish within the Office of the Director an advisory 
        council to be known as the ``Council of Councils'' 
        (referred to in this subsection as the ``Council'') for 
        the purpose of advising the Director on matters related 
        to the policies and activities of the Division of 
        Program Coordination, Planning, and Strategic 
        Initiatives, including making recommendations with 
        respect to the conduct and support of research 
        described in subsection (b)(7).
          (2) Membership.--
                  (A) In general.--The Council shall be 
                composed of 27 members selected by the Director 
                of NIH with approval from the Secretary from 
                among the list of nominees under subparagraph 
                (C).
                  (B) Certain requirements.--In selecting the 
                members of the Council, the Director of NIH 
                shall ensure--
                          (i) the representation of a broad 
                        range of disciplines and perspectives; 
                        and
                          (ii) the ongoing inclusion of at 
                        least 1 representative from each 
                        national research institute whose 
                        budget is substantial relative to a 
                        majority of the other institutes.
                  (C) Nomination.--The Director of NIH shall 
                maintain an updated list of individuals who 
                have been nominated to serve on the Council, 
                which list shall consist of the following:
                          (i) For each national research 
                        institute and national center, 3 
                        individuals nominated by the head of 
                        such institute or center from among the 
                        members of the advisory council of the 
                        institute or center, of which--
                                  (I) two shall be scientists; 
                                and
                                  (II) one shall be from the 
                                general public or shall be a 
                                leader in the field of public 
                                policy, law, health policy, 
                                economics, or management.
                          (ii) For each office within the 
                        Division of Program Coordination, 
                        Planning, and Strategic Initiatives, 1 
                        individual nominated by the head of 
                        such office.
          (3) Terms.--
                  (A) In general.--The term of service for a 
                member of the Council shall be 6 years, except 
                as provided in subparagraphs (B) and (C).
                  (B) Terms of initial appointees.--Of the 
                initial members selected for the Council, the 
                Director of NIH shall designate--
                          (i) nine for a term of 6 years;
                          (ii) nine for a term of 4 years; and
                          (iii) nine for a term of 2 years.
                  (C) Vacancies.--Any member appointed to fill 
                a vacancy occurring before the expiration of 
                the term for which the member's predecessor was 
                appointed shall be appointed only for the 
                remainder of that term. A member may serve 
                after the expiration of that member's term 
                until a successor has taken office.
  [(l) The Director of NIH shall carry out the program 
established in part F of title XII (relating to interagency 
research on trauma).]

SEC. 402A. AUTHORIZATION OF APPROPRIATIONS.

  (a) In General.--For the purpose of carrying out this title, 
there are authorized to be appropriated--
          (1) $29,747,874,000 for fiscal year 2007;
          (2) $31,235,268,000 for fiscal year 2008; and
          (3) $32,797,032,000 for fiscal year 2009.
  (b) Office of the Director.--Of the amount authorized to be 
appropriated under subsection (a) for a fiscal year, there are 
authorized to be appropriated for programs and activities under 
this title carried out through the Office of the Director of 
NIH the following amount, as applicable to the fiscal year:
          (1) $1,000,000,000 for fiscal year 2007.
          (2) $1,050,000,000 for fiscal year 2008.
          (3) $1,102,500,000 for fiscal year 2009.
  (c) Trans-NIH Research.--
          (1) Common fund.--
                  (A) Annual reservation of amounts.--Of the 
                total amount appropriated under subsection (a) 
                for fiscal year 2007 or any subsequent fiscal 
                year, the Director of NIH shall reserve the 
                applicable amount under subparagraph (B) for 
                allocations under section 402(b)(7)(B) 
                (relating to research identified by the 
                Division of Program Coordination, Planning, and 
                Strategic Initiatives), which reservations 
                shall constitute an account to be known as the 
                Common Fund.
                  (B) Amount of reservation.--Subject to 
                subparagraph (C), the amount reserved by the 
                Director of NIH under subparagraph (A) for a 
                fiscal year shall be the sum of--
                          (i) the base amount determined under 
                        subparagraph (D); and
                          (ii) any additional amount determined 
                        under subparagraph (E).
                Amounts reserved under the preceding sentence 
                shall remain available until expended.
                  (C) Maximum reservation.--
                          (i) In general.--The amount reserved 
                        by the Director of NIH under 
                        subparagraph (A) for a fiscal year 
                        shall not exceed 5 percent of the total 
                        amount appropriated under subsection 
                        (a) for such fiscal year, subject to 
                        clause (ii).
                          (ii) Applicability.--Clause (i) may 
                        not apply with respect to any fiscal 
                        year beginning after the submission of 
                        recommendations under subparagraph (F).
                          (iii) Preservation of reservation.--
                        For any fiscal year following the first 
                        fiscal year for which the percentage 
                        that applies for purposes of clause (i) 
                        is 5 percent, the reservation under 
                        subparagraph (A) for the fiscal year 
                        involved may not be less than 5 percent 
                        of the total amount appropriated under 
                        subsection (a) for such fiscal year. 
                        For fiscal year 2008 and each 
                        subsequent fiscal year, the percentage 
                        constituted by the reservation under 
                        subparagraph (A) relative to the total 
                        amount appropriated under subsection 
                        (a) for the fiscal year involved may 
                        not be less than the percentage 
                        constituted by the reservation under 
                        such subparagraph for the preceding 
                        fiscal year relative to the total 
                        amount appropriated under subsection 
                        (a) for such preceding fiscal year.
                  (D) Base amount.--The base amount referred to 
                in subparagraph (B)(i) for a fiscal year is--
                          (i) for fiscal year 2007, the amount 
                        reserved by the Director of NIH for 
                        fiscal year 2006 for research described 
                        in section 402(b)(7)(A)(i); and
                          (ii) for fiscal year 2008 and each 
                        subsequent fiscal year, the amount 
                        reserved under subparagraph (A) for the 
                        preceding fiscal year.
                  (E) Additional amount corresponding to 
                increases in appropriations.--The additional 
                amount referred to in subparagraph (B)(ii) is 
                50 percent of the amount by which the total 
                amount appropriated under subsection (a) for 
                the fiscal year involved exceeds the total 
                amount appropriated under such subsection for 
                the preceding fiscal year, except that for any 
                fiscal year beginning after the submission of 
                recommendations under subparagraph (F), such 
                percentage may be adjusted by the Director of 
                NIH, and such percentage shall be adjusted by 
                the Director to the extent necessary for 
                compliance with subparagraph (C)(iii).
                  (F) Evaluation.--During the 6-month period 
                following the end of the first fiscal year for 
                which the amount reserved by the Director of 
                NIH under subparagraph (A) is equal to 5 
                percent of the total amount appropriated under 
                subsection (a) for such fiscal year, the 
                Secretary, acting through the Director of NIH, 
                in consultation with the advisory council 
                established under section 402(k), shall submit 
                recommendations to the Congress for changes to 
                the amount of the reservation under 
                subparagraph (A).
          (2) Trans-nih research reporting.--
                  (A) Limitation.--With respect to the total 
                amount appropriated under subsection (a) for 
                fiscal year 2008 or any subsequent fiscal year, 
                if the head of a national research institute or 
                national center fails to submit the report 
                required by subparagraph (B) for the preceding 
                fiscal year, the amount made available for the 
                institute or center for the fiscal year 
                involved may not exceed the amount made 
                available for the institute or center for 
                fiscal year 2006.
                  (B) Reporting.--Not later than January 1, 
                2008, and each January 1st thereafter--
                          (i) the head of each national 
                        research institute or national center 
                        shall submit to the Director of NIH a 
                        report on the amount made available by 
                        the institute or center for conducting 
                        or supporting research that involves 
                        collaboration between the institute or 
                        center and 1 or more other national 
                        research institutes or national 
                        centers; and
                          (ii) the Secretary shall submit a 
                        report to the Congress identifying the 
                        percentage of funds made available by 
                        each national research institute and 
                        national center with respect to such 
                        fiscal year for conducting or 
                        supporting research described in clause 
                        (i).
                  (C) Determination.--For purposes of 
                determining the amount or percentage of funds 
                to be reported under subparagraph (B), any 
                amounts made available to an institute or 
                center under section 402(b)(7)(B) shall be 
                included.
                  (D) Verification of amounts.--Upon receipt of 
                each report submitted under subparagraph 
                (B)(i), the Director of NIH shall review and 
                verify the accuracy of the amounts specified in 
                the report.
                  (E) Waiver.--At the request of any national 
                research institute or national center, the 
                Director of NIH may waive the application of 
                this paragraph to such institute or center if 
                the Director finds that the conduct or support 
                of research described in subparagraph (B)(i) is 
                inconsistent with the mission of such institute 
                or center.
  (d) Transfer Authority.--Of the total amount appropriated 
under subsection (a) for a fiscal year, the Director of NIH may 
(in addition to the reservation under (c)(1) for such year) 
transfer not more than 1 percent for programs or activities 
that are authorized in this title and identified by the 
Director to receive funds pursuant to this subsection. In 
making such transfers, the Director may not decrease any 
appropriation account under subsection (a) by more than 1 
percent.
  (e) Rule of Construction.--This section may not be construed 
as affecting the authorities of the Director of NIH under 
section 401.

                       [report of director of nih

  [Sec. 403. The Secretary shall transmit to the President and 
to the Congress a biennial report which shall be prepared by 
the Director of NIH and which shall consist of--
          [(1) a description of the activities carried out by 
        and through the National Institutes of Health and the 
        policies respecting the programs of the National 
        Institutes of Health and such recommendations 
        respecting such policies as the Secretary considers 
        appropriate;
          [(2) a description of the activities undertaken to 
        improve grants and contracting accountability and 
        technical and scientific peer review procedures of the 
        National Institutes of Health and the national research 
        institutes;
          [(3) the reports made by the Associate Director for 
        Prevention under section 402(f) during the period for 
        which the biennial report is prepared;
          [(4) a description of the health related behavioral 
        research that has been supported by the National 
        Institutes of Health in the preceding 2-year period, 
        and a description of any plans for future activity in 
        such area; and
          [(5) the biennial reports of the Directors of each of 
        the national research institutes, the Director of the 
        Division of Research Resources, and the Director of the 
        National Center for Nursing Research.
The first report under this section shall be submitted not 
later than July 1, 1986, and shall relate to the fiscal year 
ending September 30, 1985. The next report shall be submitted 
not later than December 30, 1988, and shall relate to the two-
fiscal-year period ending on the preceding September 30. Each 
subsequent report shall be submitted not later than 90 days 
after the end of the two-fiscal-year period for which the 
report is to be submitted.]

SEC. 402B. ELECTRONIC CODING OF GRANTS AND ACTIVITIES.

  The Secretary, acting through the Director of NIH, shall 
establish an electronic system to uniformly code research 
grants and activities of the Office of the Director and of all 
the national research institutes and national centers. The 
electronic system shall be searchable by a variety of codes, 
such as the type of research grant, the research entity 
managing the grant, and the public health area of interest. 
When permissible, the Secretary, acting through the Director of 
NIH, shall provide information on relevant literature and 
patents that are associated with research activities of the 
National Institutes of Health.

SEC. 403. BIENNIAL REPORTS OF DIRECTOR OF NIH.

  (a) In General.--The Director of NIH shall submit directly to 
the Congress on a biennial basis a report in accordance with 
this section. The first report shall be submitted not later 
than 1 year after the date of the enactment of the National 
Institutes of Health Reform Act of 2006. Each such report shall 
include the following information:
          (1) An assessment of the state of biomedical and 
        behavioral research.
          (2) A description of the activities conducted or 
        supported by the agencies of the National Institutes of 
        Health and policies respecting the programs of such 
        agencies.
          (3) Classification and justification for the 
        priorities established by the agencies, including a 
        strategic plan and recommendations for future research 
        initiatives to be carried out under section 402(b)(7) 
        through the Division of Program Coordination, Planning, 
        and Strategic Initiatives.
          (4) A catalog of all the research activities of the 
        agencies, prepared in accordance with the following:
                  (A) The catalog shall, for each such 
                activity--
                          (i) identify the agency or agencies 
                        involved;
                          (ii) state whether the activity was 
                        carried out directly by the agencies or 
                        was supported by the agencies and 
                        describe to what extent the agency was 
                        involved; and
                          (iii) identify whether the activity 
                        was carried out through a center of 
                        excellence.
                  (B) In the case of clinical research, the 
                catalog shall, as appropriate, identify study 
                populations by demographic variables and other 
                variables that contribute to research on health 
                disparities.
                  (C) Research activities listed in the catalog 
                shall include the following:
                          (i) Epidemiological studies and 
                        longitudinal studies.
                          (ii) Disease registries, information 
                        clearinghouses, and other data systems.
                          (iii) Public education and 
                        information campaigns.
                          (iv) Training activities, including 
                        National Research Service Awards and a 
                        breakdown by demographic variables and 
                        other appropriate categories.
                          (v) Clinical trials, including a 
                        breakdown of participation by study 
                        populations and demographic variables 
                        and such other information as may be 
                        necessary to demonstrate compliance 
                        with section 492B (regarding inclusion 
                        of women and minorities in clinical 
                        research).
                          (vi) Translational research 
                        activities with other agencies of the 
                        Public Health Service.
          (5) A summary of the research activities throughout 
        the agencies, which summary shall be organized by the 
        following categories:
                  (A) Cancer.
                  (B) Neurosciences.
                  (C) Life stages, human development, and 
                rehabilitation.
                  (D) Organ systems.
                  (E) Autoimmune diseases.
                  (F) Genomics.
                  (G) Molecular biology and basic science.
                  (H) Technology development.
                  (I) Chronic diseases, including pain and 
                palliative care.
                  (J) Infectious diseases and bioterrorism.
                  (K) Health disparities.
                  (L) Such additional categories as the 
                Director determines to be appropriate.
  (b) Requirement Regarding Disease-Specific Research 
Activities.--In a report under subsection (a), the Director of 
NIH, when reporting on research activities relating to a 
specific disease, disorder, or other adverse health condition, 
shall--
          (1) present information in a standardized format;
          (2) identify the actual dollar amounts obligated for 
        such activities; and
          (3) include a plan for research on the specific 
        disease, disorder, or other adverse health condition, 
        including a statement of objectives regarding the 
        research, the means for achieving the objectives, a 
        date by which the objectives are expected to be 
        achieved, and justifications for revisions to the plan.
  (c) Additional Reports.--In addition to reports required by 
subsections (a) and (b), the Director of NIH may submit to the 
Congress such additional reports as the Director determines to 
be appropriate.

SEC. 403A. ANNUAL REPORTING TO INCREASE INTERAGENCY COLLABORATION AND 
                    COORDINATION.

  (a) Collaboration With Other HHS Agencies.--On an annual 
basis, the Director of NIH shall submit to the Secretary a 
report on the activities of the National Institutes of Health 
involving collaboration with other agencies of the Department 
of Health and Human Services.
  (b) Clinical Trials.--Each calendar year, the Director of NIH 
shall submit to the Commissioner of Food and Drugs a report 
that identifies each clinical trial that is registered during 
such calendar year in the databank of information established 
under section 402(j).
  (c) Human Tissue Samples.--On an annual basis, the Director 
of NIH shall submit to the Congress a report that describes how 
the National Institutes of Health and its agencies store and 
track human tissue samples.
  (d) First Report.--The first report under subsections (a), 
(b), and (c) shall be submitted not later than 1 year after the 
date of the enactment of the National Institutes of Health 
Reform Act of 2006.

SEC. 403B. ANNUAL REPORTING TO PREVENT FRAUD AND ABUSE.

  (a) Whistleblower Complaints.--
          (1) In general.--On an annual basis, the Director of 
        NIH shall submit to the Inspector General of the 
        Department of Health and Human Services, the Secretary, 
        the Committee on Energy and Commerce of the House of 
        Representatives, and the Committee on Health, 
        Education, Labor, and Pensions of the Senate a report 
        summarizing the activities of the National Institutes 
        of Health relating to whistleblower complaints.
          (2) Contents.--For each whistleblower complaint 
        pending during the year for which a report is submitted 
        under this subsection, the report shall identify the 
        following:
                  (A) Each agency of the National Institutes of 
                Health involved.
                  (B) The status of the complaint.
                  (C) The resolution of the complaint to date.
  (b) Experts and Consultants.--On an annual basis, the 
Director of NIH shall submit to the Inspector General of the 
Department of Health and Human Services, the Secretary, the 
Committee on Energy and Commerce of the House of 
Representatives, and the Committee on Health, Education, Labor, 
and Pensions of the Senate a report that--
          (1) identifies the number of experts and consultants, 
        including any special consultants, whose services are 
        obtained by the National Institutes of Health or its 
        agencies;
          (2) specifies whether such services were obtained 
        under section 207(f), section 402(d), or other 
        authority;
          (3) describes the qualifications of such experts and 
        consultants;
          (4) describes the need for hiring such experts and 
        consultants; and
          (5) if such experts and consultants make financial 
        disclosures to the National Institutes of Health or any 
        of its agencies, specifies the income, gifts, assets, 
        and liabilities so disclosed.
  (c) First Report.--The first report under subsections (a) and 
(b) shall be submitted not later than 1 year after the date of 
the enactment of the National Institutes of Health Reform Act 
of 2006.

                                  DES

  Sec. [403A] 403C. (a)  * * *

           *       *       *       *       *       *       *

  [(e) In addition to any other authorization of appropriations 
available for the purpose of carrying out this section, there 
are authorized to be appropriated for such purpose such sums as 
may be necessary for each of the fiscal years 1993 through 
2003.]

           *       *       *       *       *       *       *


                     CHILDREN'S VACCINE INITIATIVE

  Sec. 404B. (a)  * * *

           *       *       *       *       *       *       *

  [(c) Authorization of Appropriations.--In addition to any 
other amounts authorized to be appropriated for activities of 
the type described in this section, there are authorized to be 
appropriated to carry out this section $20,000,000 for fiscal 
year 1994, and such sums as may be necessary for each of the 
fiscal years 1995 and 1996.]

           *       *       *       *       *       *       *


SEC. 404E. MUSCULAR DYSTROPHY; INITIATIVE THROUGH DIRECTOR OF NATIONAL 
                    INSTITUTES OF HEALTH.

  (a)  * * *
  (b) Centers of Excellence.--
          (1)  * * *

           *       *       *       *       *       *       *

          [(3) Coordination of centers; reports.--The Director 
        of NIH--
                  [(A) shall, as appropriate, provide for the 
                coordination of information among centers under 
                paragraph (1) and ensure regular communication 
                between such centers; and
                  [(B) shall require the periodic preparation 
                of reports on the activities of the centers and 
                the submission of the reports to the Director.]
          (3) Coordination of centers.--The Director of NIH 
        shall, as appropriate, provide for the coordination of 
        information among centers under paragraph (1) and 
        ensure regular communication between such centers.

           *       *       *       *       *       *       *

  [(f) Reports to Congress.--The Coordinating Committee shall 
biennially submit to the Committee on Energy and Commerce of 
the House of Representatives, and the Committee on Health, 
Education, Labor, and Pensions of the Senate, a report that 
describes the research, education, and other activities on 
muscular dystrophy being conducted or supported through the 
Department of Health and Human Services. Each such report shall 
include the following:
          [(1) The plan under subsection (e)(1) (or revisions 
        to the plan, as the case may be).
          [(2) Provisions specifying the amounts expended by 
        the Department of Health and Human Services with 
        respect to various forms of muscular dystrophy, 
        including Duchenne, myotonic, FSHD and other forms of 
        muscular dystrophy.
          [(3) Provisions identifying particular projects or 
        types of projects that should in the future be 
        considered by the national research institutes or other 
        entities in the field of research on all muscular 
        dystrophies.]
  [(g)] (f) Public Input.--The Secretary shall, under 
subsection (a)(1), provide for a means through which the public 
can obtain information on the existing and planned programs and 
activities of the Department of Health and Human Services with 
respect to various forms of muscular dystrophy and through 
which the Secretary can receive comments from the public 
regarding such programs and activities.
  [(h) 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 of fiscal 
years 2002 through 2006. The authorization of appropriations 
established in the preceding sentence is in addition to any 
other authorization of appropriations that is available for 
conducting or supporting through the National Institutes of 
Health research and other activities with respect to muscular 
dystrophy.]

                        OFFICE OF RARE DISEASES

  Sec. 404F. (a)  * * *
  (b) Duties.--
          (1) In general.--The Director of the Office shall 
        carry out the following:
                  (A)  * * *

           *       *       *       *       *       *       *

                  [(F) The Director shall biennially prepare a 
                report that describes the research and 
                education activities on rare diseases being 
                conducted or supported through the national 
                research institutes and centers, and that 
                identifies particular projects or types of 
                projects that should in the future be conducted 
                or supported by the national research 
                institutes and centers or other entities in the 
                field of research on rare diseases.
                  [(G) The Director shall prepare the NIH 
                Director's annual report to Congress on rare 
                disease research conducted by or supported 
                through the national research institutes and 
                centers.]

           *       *       *       *       *       *       *

  [(d) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as already have been appropriated for 
fiscal year 2002, and $4,000,000 for each of the fiscal years 
2003 through 2006.]

              RARE DISEASE REGIONAL CENTERS OF EXCELLENCE

  Sec. 404G. (a)  * * *
  [(e) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as already have been appropriated for 
fiscal year 2002, and $20,000,000 for each of the fiscal years 
2003 through 2006.]

Part B--General Provisions Respecting National Research Institutes

           *       *       *       *       *       *       *


                            [BIENNIAL REPORT

  [Sec. 407. The Director of each national research institute, 
after consultation with the advisory council for the institute, 
shall prepare for inclusion in the biennial report made under 
section 403 a biennial report which shall consist of a 
description of the activities of the institute and program 
policies of the Director of the institute in the fiscal years 
respecting which the report is prepared. The Director of each 
national research institute may prepare such additional reports 
as the Director determines appropriate. The Director of each 
national research institute shall provide the advisory council 
for the institute an opportunity for the submission of the 
written comments referred to in section 406(g).]

           *       *       *       *       *       *       *


 RESEARCH ON OSTEOPOROSIS, PAGET'S DISEASE, AND RELATED BONE DISORDERS

  Sec. 409A. (a)  * * *
  [(d) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated $40,000,000 for fiscal year 1994, and such sums as 
may be necessary for each of the fiscal years 1995 through 
2003.]

           *       *       *       *       *       *       *


                          PARKINSON'S DISEASE

  Sec. 409B. (a) In General.--The Director of NIH shall 
establish a program for the conduct and support of research and 
training with respect to Parkinson's disease (subject to the 
extent of amounts appropriated [under subsection (e)] to carry 
out this section).

           *       *       *       *       *       *       *

  [(e) Authorization of Appropriations.--For the purpose of 
carrying out this section and section 301 and title IV of the 
Public Health Service Act with respect to research focused on 
Parkinson's disease, there are authorized to be appropriated up 
to $100,000,000 for fiscal year 1998, and such sums as may be 
necessary for each of the fiscal years 1999 and 2000.]

EXPANSION, INTENSIFICATION, AND COORDINATION OF ACTIVITIES OF NATIONAL 
        INSTITUTES OF HEALTH WITH RESPECT TO RESEARCH ON AUTISM

  Sec. 409C. (a)  * * *
  (b) Centers of Excellence.--
          (1)  * * *

           *       *       *       *       *       *       *

          [(4) Coordination of centers; reports.--The Director 
        shall, as appropriate, provide for the coordination of 
        information among centers under paragraph (1) and 
        ensure regular communication between such centers, and 
        may require the periodic preparation of reports on the 
        activities of the centers and the submission of the 
        reports to the Director.]
          [(5)] (4) Organization of centers.--Each center under 
        paragraph (1) shall use the facilities of a single 
        institution, or be formed from a consortium of 
        cooperating institutions, meeting such requirements as 
        may be prescribed by the Director.
          [(6)] (5) Number of centers; duration of support.--
                  (A)  * * *

           *       *       *       *       *       *       *

  [(e) Funding.--There are authorized to be appropriated such 
sums as may be necessary to carry out this section. Amounts 
appropriated under this subsection are in addition to any other 
amounts appropriated for such purpose.]

                     PEDIATRIC RESEARCH INITIATIVE

  Sec. 409D. (a)  * * *

           *       *       *       *       *       *       *

  [(d) Authorization.--For the purpose of carrying out this 
section, there are authorized to be appropriated $50,000,000 
for fiscal year 2001, and such sums as may be necessary for 
each of the fiscal years 2002 through 2005.]
  [(e)] (d) Transfer of Funds.--The Director of NIH may 
transfer amounts appropriated under this section to any of the 
Institutes for a fiscal year to carry out the purposes of the 
Initiative under this section.

SEC. 409E. AUTOIMMUNE DISEASES.

  (a)  * * *

           *       *       *       *       *       *       *

  [(d) Reports to Congress.--The Coordinating Committee under 
subsection (b)(1) shall biennially submit to the Committee on 
Commerce of the House of Representatives, and the Committee on 
Health, Education, Labor and Pensions of the Senate, a report 
that describes the research, education, and other activities on 
autoimmune diseases being conducted or supported through the 
national research institutes, and that in addition includes the 
following:
          [(1) The plan under subsection (c)(1) (or revisions 
        to the plan, as the case may be).
          [(2) Provisions specifying the amounts expended by 
        the National Institutes of Health with respect to each 
        of the autoimmune diseases included in the plan.
          [(3) Provisions identifying particular projects or 
        types of projects that should in the future be 
        considered by the national research institutes or other 
        entities in the field of research on autoimmune 
        diseases.
  [(e) 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 of the 
fiscal years 2001 through 2005. The authorization of 
appropriations established in the preceding sentence is in 
addition to any other authorization of appropriations that is 
available for conducting or supporting through the National 
Institutes of Health research and other activities with respect 
to autoimmune diseases.]

                      MUSCULAR DYSTROPHY RESEARCH

  Sec. 409F. (a)  * * *

           *       *       *       *       *       *       *

  [(c) Authorization of Appropriations.--There are authorized 
to be appropriated such sums as may be necessary to carry out 
this section for each of the fiscal years 2001 through 2005. 
Amounts appropriated under this subsection shall be in addition 
to any other amounts appropriated for such purpose.]

           *       *       *       *       *       *       *


SEC. 409H. ENHANCEMENT AWARDS.

  (a) Mentored Patient-Oriented Research Career Development 
Awards.--
          (1)  * * *

           *       *       *       *       *       *       *

          [(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)  * * *

           *       *       *       *       *       *       *

          [(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)  * * *

           *       *       *       *       *       *       *

          [(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.]
  (d) Clinical Research Curriculum Awards.--
          (1)  * * *

           *       *       *       *       *       *       *

          [(4) 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.]

SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

  (a)  * * *

           *       *       *       *       *       *       *

  [(d) Authorization of Appropriations.--
          [(1) In general.--There are authorized to be 
        appropriated to carry out this section--
                  [(A) $200,000,000 for fiscal year 2002; and
                  [(B) such sums as are necessary for each of 
                the five succeeding fiscal years.
          [(2) Availability.--Any amount appropriated under 
        paragraph (1) shall remain available to carry out this 
        section until expended.]

           *       *       *       *       *       *       *


  Part C--Specific Provisions Respecting National Research Institutes

Subpart 1--National Cancer Institute

           *       *       *       *       *       *       *


                    [AUTHORIZATION OF APPROPRIATIONS

  [Sec. 417B. (a) Activities Generally.--For the purpose of 
carrying out this subpart, there are authorized to be 
appropriated $2,728,000,000 for fiscal year 1994, and such sums 
as may be necessary for each of the fiscal years 1995 and 1996.
  [(b) Breast Cancer and Gynecological Cancers.--
          [(1) Breast cancer.--
                  [(A) For the purpose of carrying out 
                subparagraph (A) of section 417(c)(1), there 
                are authorized to be appropriated $225,000,000 
                for fiscal year 1994, and such sums as may be 
                necessary for each of the fiscal years 1995 
                through 2003. Such authorizations of 
                appropriations are in addition to the 
                authorizations of appropriations established in 
                subsection (a) with respect to such purpose.
                  [(B) For the purpose of carrying out 
                subparagraphs (B) through (E) of section 
                417(c)(1), there are authorized to be 
                appropriated $100,000,000 for fiscal year 1994, 
                and such sums as may be necessary for each of 
                the fiscal years 1995 through 2003. Such 
                authorizations of appropriations are in 
                addition to the authorizations of 
                appropriations established in subsection (a) 
                with respect to such purpose.
          [(2) Other cancers.--For the purpose of carrying out 
        subsection (d) of section 417, there are authorized to 
        be appropriated $75,000,000 for fiscal year 1994, and 
        such sums as are necessary for each of the fiscal years 
        1995 through 2003. Such authorizations of 
        appropriations are in addition to the authorizations of 
        appropriations established in subsection (a) with 
        respect to such purpose.
  [(c) Prostate Cancer.--For the purpose of carrying out 
section 417A, there are authorized to be appropriated 
$72,000,000 for fiscal year 1994, and such sums as may be 
necessary for each of the fiscal years 1995 through 2004. Such 
authorizations of appropriations are in addition to the 
authorizations of appropriations established in subsection (a) 
with respect to such purpose.
  [(d) Allocation Regarding Cancer Control.--
          [(1) In general.--Of the amounts appropriated for the 
        National Cancer Institute for a fiscal year, the 
        Director of the Institute shall make available not less 
        than the applicable percentage specified in paragraph 
        (2) for carrying out the cancer control activities 
        authorized in section 412 and for which budget 
        estimates are made under section 413(b)(9) for the 
        fiscal year.
          [(2) Applicable percentage.--The percentage referred 
        to in paragraph (1) is--
                  [(A) 7 percent, in the case of fiscal year 
                1994;
                  [(B) 9 percent, in the case of fiscal year 
                1995; and
                  [(C) 10 percent, in the case of fiscal year 
                1996 and each subsequent fiscal year.]

SEC. 417C. GRANTS FOR EDUCATION, PREVENTION, AND EARLY DETECTION OF 
                    RADIOGENIC CANCERS AND DISEASES.

  (a)  * * *

           *       *       *       *       *       *       *

  [(f) Report to Congress.--Beginning on October 1 of the year 
following the date on which amounts are first appropriated to 
carry out this section and annually on each October 1 
thereafter, the Secretary shall submit a report to the 
Committee on the Judiciary and the Committee on Health, 
Education, Labor, and Pensions of the Senate and to the 
Committee on the Judiciary and the Committee on Commerce of the 
House of Representatives. Each report shall summarize the 
expenditures and programs funded under this section as the 
Secretary determines to be appropriate.
  [(g) Authorization of Appropriations.--There are authorized 
to be appropriated for the purpose of carrying out this section 
$20,000,000 for fiscal year 1999 and such sums as may be 
necessary for each of the fiscal years 2000 through 2009.]

SEC. 417D. RESEARCH, INFORMATION, AND EDUCATION WITH RESPECT TO BLOOD 
                    CANCER.

  (a) Joe Moakley Research Excellence Program.--
          (1)  * * *

           *       *       *       *       *       *       *

          [(3) Authorization of appropriations.--For the 
        purpose of carrying out this subsection, there is 
        authorized to be appropriated such sums as may be 
        necessary for fiscal year 2002 and each subsequent 
        fiscal year. Such authorizations of appropriations are 
        in addition to other authorizations of appropriations 
        that are available for such purpose.]
  (b) Geraldine Ferraro Cancer Education Program.--
          (1)  * * *

           *       *       *       *       *       *       *

          [(3) Authorization of appropriations.--For the 
        purpose of carrying out this subsection, there is 
        authorized to be appropriated such sums as may be 
        necessary for fiscal year 2002 and each subsequent 
        fiscal year. Such authorizations of appropriations are 
        in addition to other authorizations of appropriations 
        that are available for such purpose.]

Subpart 2--National Heart, Lung, and Blood Institute

           *       *       *       *       *       *       *


    HEART ATTACK, STROKE, AND OTHER CARDIOVASCULAR DISEASES IN WOMEN

  Sec. 424A. (a)  * * *

           *       *       *       *       *       *       *

  [(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 of the 
fiscal years 1999 through 2003. The authorization of 
appropriations established in the preceding sentence is in 
addition to any other authorization of appropriation that is 
available for such purpose.]

               COORDINATION OF FEDERAL ASTHMA ACTIVITIES

  Sec. 424B (a) In General.--The Director of Institute shall, 
through the National Asthma Education Prevention Program 
Coordinating Committee--
          (1) identify all Federal programs that carry out 
        asthma-related activities; and
          (2) develop, in consultation with appropriate Federal 
        agencies and professional and voluntary health 
        organizations, a Federal plan for responding to 
        asthma[; and].
          [(3) not later than 12 months after the date of the 
        enactment of the Children's Health Act of 2000, submit 
        recommendations to the appropriate committees of the 
        Congress on ways to strengthen and improve the 
        coordination of asthma-related activities of the 
        Federal Government.]

           *       *       *       *       *       *       *

  [(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 of the 
fiscal years 2001 through 2005.]

                    [AUTHORIZATION OF APPROPRIATIONS

  [Sec. 425. For the purpose of carrying out this subpart, 
there are authorized to be appropriated $1,500,000,000 for 
fiscal year 1994, and such sums as may be necessary for each of 
the fiscal years 1995 and 1996.]

  Subpart 3--National Institute of Diabetes and Digestive and Kidney 
Diseases

           *       *       *       *       *       *       *


                  INTERAGENCY COORDINATING COMMITTEES

  Sec. 429. (a)  * * *

           *       *       *       *       *       *       *

  [(c) Each Committee shall prepare an annual report for--
          [(1) the Secretary;
          [(2) the Director of NIH; and
          [(3) the Advisory Board established under section 430 
        for the diseases for which the Committee was 
        established,
detailing the work of the Committee in carrying out paragraphs 
(1) and (2) of subsection (a) in the fiscal year for which the 
report was prepared. Such report shall be submitted not later 
than 120 days after the end of each fiscal year.
  [(d) In each annual report prepared by the Diabetes Mellitus 
Interagency Coordinating Committee pursuant to subsection (c), 
the Committee shall include an assessment of the Federal 
activities and programs related to pancreatic islet cell 
transplantation. Such assessment shall, at a minimum, address 
the following:
          [(1) The adequacy of Federal funding for taking 
        advantage of scientific opportunities relating to 
        pancreatic islet cell transplantation.
          [(2) Current policies and regulations affecting the 
        supply of pancreata for islet cell transplantation.
          [(3) The effect of xenotransplantation on advancing 
        pancreatic islet cell transplantation.
          [(4) The effect of United Network for Organ Sharing 
        policies regarding pancreas retrieval and islet cell 
        transplantation.
          [(5) The existing mechanisms to collect and 
        coordinate outcomes data from existing islet cell 
        transplantation trials.
          [(6) Implementation of multiagency clinical 
        investigations of pancreatic islet cell 
        transplantation.
          [(7) Recommendations for such legislation and 
        administrative actions as the Committee considers 
        appropriate to increase the supply of pancreata 
        available for islet cell transplantation.]

           *       *       *       *       *       *       *


                           JUVENILE DIABETES

  Sec. 434A. (a)  * * *

           *       *       *       *       *       *       *

  [(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 of the 
fiscal years 2001 through 2005.]

Subpart 4--National Institute of Arthritis and Musculoskeletal and Skin 
Diseases

           *       *       *       *       *       *       *


                                 LUPUS

  Sec. 441A. (a)  * * *

           *       *       *       *       *       *       *

  [(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 of the 
fiscal years 2001 through 2003.]

                             ADVISORY BOARD

  Sec. 442. (a)  * * *

           *       *       *       *       *       *       *

  [(j) The Advisory Board shall prepare an annual report for 
the Secretary which--
          [(1) describes the Advisory Board's activities in the 
        fiscal year for which the report is made;
          [(2) describes and evaluates the progress made in 
        such fiscal year in research, treatment, education, and 
        training with respect to arthritis, musculoskeletal 
        diseases, and skin diseases;
          [(3) summarizes and analyzes expenditures made by the 
        Federal Government for activities respecting such 
        diseases in such fiscal year for which the report is 
        made;
          [(4) contains the Advisory Board's recommendations 
        (if any) for changes in the plan prepared under section 
        436(a); and
          [(5) contains recommendations for expanding the 
        Institute's funding of research directly applicable to 
        the cause, diagnosis, early detection, prevention, 
        control, and treatment of, and rehabilitation of 
        children with arthritis and musculoskeletal diseases.]
  [(k)] (j) The National Arthritis Advisory Board in existence 
on the date of enactment of the Health Research Extension Act 
of 1985 shall terminate upon the appointment of a successor 
Board under subsection (a). The Secretary shall make 
appointments to the Advisory Board established under subsection 
(a) before the expiration of 90 days after such date. The 
members of the Board in existence on such date may be 
appointed, in accordance with subsections (b) and (d), to the 
Advisory Board established under subsection (a).

               JUVENILE ARTHRITIS AND RELATED CONDITIONS

  Sec. 442A. (a)  * * *

           *       *       *       *       *       *       *

  [(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 of the 
fiscal years 2001 through 2005.]

Subpart 5--National Institute on Aging

           *       *       *       *       *       *       *


                    AGING PROCESSES REGARDING WOMEN

  Sec. 445H. [(a)] The Director of the Institute, in addition 
to other special functions specified in section 444 and in 
cooperation with the Directors of the other national research 
institutes and agencies of the National Institutes of Health, 
shall conduct research into the aging processes of women, with 
particular emphasis given to the effects of menopause and the 
physiological and behavioral changes occurring during the 
transition from pre- to post-menopause, and into the diagnosis, 
disorders, and complications related to aging and loss of 
ovarian hormones in women.
  [(b) For the purpose of carrying out this section, there are 
authorized to be appropriated such sums as may be necessary for 
each of the fiscal years 1999 through 2003. The authorization 
of appropriations established in the preceding sentence is in 
addition to any other authorization of appropriation that is 
available for such purpose.]

SEC. 445I. ALZHEIMER'S CLINICAL RESEARCH AND TRAINING AWARDS.

  (a)  * * *

           *       *       *       *       *       *       *

  [(d) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated $2,250,000 for fiscal year 2001, and such sums as 
may be necessary for each of fiscal years 2002 through 2005.

                    [AUTHORIZATION OF APPROPRIATIONS

  [Sec. 445J. For the purpose of carrying out this subpart, 
there are authorized to be appropriated $500,000,000 for fiscal 
year 1994, and such sums as may be necessary for each of the 
fiscal years 1995 and 1996.]

Subpart 6--National Institute of Allergy and Infectious Diseases

           *       *       *       *       *       *       *


         RESEARCH AND RESEARCH TRAINING REGARDING TUBERCULOSIS

  Sec. 447A. [(a)] In carrying out section 446, the Director of 
the Institute shall conduct or support research and research 
training regarding the cause, diagnosis, early detection, 
prevention and treatment of tuberculosis.
  [(b) For the purpose of carrying out subsection (a), there 
are authorized to be appropriated $50,000,000 for fiscal year 
1994, and such sums as may be necessary for each of the fiscal 
years 1995 through 1998. Such authorization is in addition to 
any other authorization of appropriations that is available for 
such purpose.]

SEC. 447B. SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH AND TRAINING 
                    AWARDS.

  (a)  * * *

           *       *       *       *       *       *       *

  [(d) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated $2,250,000 for fiscal year 2001, and such sums as 
may be necessary for each of fiscal years 2002 through 2005.]

Subpart 7--National Institute of Child Health and Human Development

           *       *       *       *       *       *       *


     RESEARCH CENTERS WITH RESPECT TO CONTRACEPTION AND INFERTILITY

  Sec. 452A. (a)  * * *

           *       *       *       *       *       *       *

  [(g) For the purpose of carrying out this section, there are 
authorized to be appropriated $30,000,000 for fiscal year 1994, 
and such sums as may be necessary for each of the fiscal years 
1995 and 1996.]

           *       *       *       *       *       *       *


                               FRAGILE X

  Sec. 452E. (a)  * * *
  (b) Research Centers.--
          (1)  * * *

           *       *       *       *       *       *       *

          [(7) 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 of the fiscal years 2001 through 
        2005.]

             INVESTMENT IN TOMORROW'S PEDIATRIC RESEARCHERS

  Sec. 452G. [(a) Enhanced Support.--]In order to ensure the 
future supply of researchers dedicated to the care and research 
needs of children, the Director of the Institute, after 
consultation with the Administrator of the Health Resources and 
Services Administration, shall support activities to provide 
for--
          (1) an increase in the number and size of 
        institutional training grants to institutions 
        supporting pediatric training; and
          (2) an increase in the number of career development 
        awards for health professionals who intend to build 
        careers in pediatric basic and clinical research.
  [(b) Authorization.--For the purpose of carrying out 
subsection (a), there are authorized to be appropriated such 
sums as may be necessary for each of the fiscal years 2001 
through 2005.]

           *       *       *       *       *       *       *


Subpart 12--National Institute of Environmental Health Sciences

           *       *       *       *       *       *       *


   NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS 
                             ADVISORY BOARD

  Sec. 464D. (a)  * * *

           *       *       *       *       *       *       *

  [(j) The Advisory Board shall prepare an annual report for 
the Secretary which--
          [(1) describes the Advisory Board's activities in the 
        fiscal year for which the report is made;
          [(2) describes and evaluates the progress made in 
        such fiscal year in research, treatment, education, and 
        training with respect to the deafness and other 
        communication disorders;
          [(3) summarizes and analyzes expenditures made by the 
        Federal Government for activities respecting such 
        disorders in such fiscal year; and
          [(4) contains the Advisory Board's recommendations 
        (if any) for changes in the plan prepared under section 
        464A(a).]

                   INTERAGENCY COORDINATING COMMITTEE

  Sec. 464E. (a)  * * *

           *       *       *       *       *       *       *

  [(e) Not later than 120 days after the end of each fiscal 
year, the Coordinating Committee shall prepare and transmit to 
the Secretary, the Director of NIH, the Director of the 
Institute, and the advisory council for the Institute a report 
detailing the activities of the Committee in such fiscal year 
in carrying out subsection (b).]

           *       *       *       *       *       *       *


     Subpart 14--National Institute on Alcohol Abuse and Alcoholism

                          PURPOSE OF INSTITUTE

  Sec. 464H. (a)  * * *

           *       *       *       *       *       *       *

  [(d) Funding.--
          [(1) Authorization of appropriations.--For the 
        purpose of carrying out this subpart, there are 
        authorized to be appropriated $300,000,000 for fiscal 
        year 1993, and such sums as may be necessary for fiscal 
        year 1994.
          [(2) Allocation for health services research.--Of the 
        amounts appropriated under paragraph (1) for a fiscal 
        year, the Director shall obligate not less than 15 
        percent to carry out health services research relating 
        to alcohol abuse and alcoholism.]

           *       *       *       *       *       *       *


              Subpart 15--National Institute on Drug Abuse

                          PURPOSE OF INSTITUTE

  Sec. 464L. (a)  * * *

           *       *       *       *       *       *       *

  [(d) Funding.--
          [(1) Authorization of appropriations.--For the 
        purpose of carrying out this subpart, other than 
        section 464P, there are authorized to be appropriated 
        $440,000,000 for fiscal year 1993, and such sums as may 
        be necessary for fiscal year 1994.
          [(2) Allocation for health services research.--Of the 
        amounts appropriated under paragraph (1) for a fiscal 
        year, the Director shall obligate not less than 15 
        percent to carry out health services research relating 
        to drug abuse.]

           *       *       *       *       *       *       *


                      DRUG ABUSE RESEARCH CENTERS

  Sec. 464N. (a)  * * *

           *       *       *       *       *       *       *

  (c) Drug Abuse and Addiction Research.--
          (1)  * * *

           *       *       *       *       *       *       *

          [(4) Authorization of appropriations.--
                  [(A) In general.--There are authorized to be 
                appropriated to carry out this subsection such 
                sums as may be necessary for each fiscal year.
                  [(B) Supplement not supplant.--Amounts 
                appropriated pursuant to the authorization of 
                appropriations in subparagraph (A) for a fiscal 
                year shall supplement and not supplant any 
                other amounts appropriated in such fiscal year 
                for research on drug abuse and addiction.]

           *       *       *       *       *       *       *


                     MEDICATION DEVELOPMENT PROGRAM

  Sec. 464P. (a)  * * *

           *       *       *       *       *       *       *

  [(e) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated $85,000,000 for fiscal year 1993, and $95,000,000 
for fiscal year 1994.]

            Subpart 16--National Institute of Mental Health

                          PURPOSE OF INSTITUTE

  Sec. 464R. (a)  * * *

           *       *       *       *       *       *       *

  [(f) Funding.--
          [(1) Authorization of appropriations.--For the 
        purpose of carrying out this subpart, there are 
        authorized to be appropriated $675,000,000 for fiscal 
        year 1993, and such sums as may be necessary for fiscal 
        year 1994.
          [(2) Allocation for health services research.--Of the 
        amounts appropriated under paragraph (1) for a fiscal 
        year, the Director shall obligate not less than 15 
        percent to carry out health services research relating 
        to mental health.]

           *       *       *       *       *       *       *


                 OFFICE OF RURAL MENTAL HEALTH RESEARCH

  Sec. 464T. (a)  * * *

           *       *       *       *       *       *       *

  [(e) Report to Congress.--Not later than February 1, 1993, 
and each fiscal year thereafter, the Director shall submit to 
the Subcommittee on Health and the Environment of the Committee 
on Energy and Commerce (of the House of Representatives), and 
to the Committee on Labor and Human Resources (of the Senate), 
a report describing the activities of the Office during the 
preceding fiscal year, including a summary of the activities of 
demonstration projects and a summary of evaluations of the 
projects.]

           *       *       *       *       *       *       *


Subpart 17--National Institute of Nursing Research

           *       *       *       *       *       *       *


                        PURPOSE OF THE INSTITUTE

  Sec. 464z. (a)  * * *

           *       *       *       *       *       *       *

  [(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.]

  Subpart [3--National Center for Human Genome Research] 19--National 
                    Human Genome Research Institute

                   PURPOSE OF THE [CENTER] INSTITUTE

  Sec. [485B] 464z-1. (a) The general purpose of the [National 
Center for Human Genome Research] National Human Genome 
Research Institute (in this subpart referred to as the 
``[Center] Institute'') is to characterize the structure and 
function of the human genome, including the mapping and 
sequencing of individual genes. Such purpose includes--
          (1)  * * *

           *       *       *       *       *       *       *

  (b) The Director of the [Center] Institute may conduct and 
support research training--
          (1)  * * *

           *       *       *       *       *       *       *

  (c)(1) Except as provided in paragraph (2), of the amounts 
appropriated to carry out subsection (a) for a fiscal year, the 
Director of the [Center] Institute shall make available not 
less than 5 percent for carrying out paragraph (6) of such 
subsection.
  (2) With respect to providing funds under subsection (a)(6) 
for proposals to address the ethical issues associated with the 
genome project, paragraph (1) shall not apply for a fiscal year 
if the Director of the [Center] Institute certifies to the 
Committee on Energy and Commerce of the House of 
Representatives, and to the Committee on Labor and Human 
Resources of the Senate, that the Director has determined that 
an insufficient number of such proposals meet the applicable 
requirements of sections 491 and 492.

                  Part D--National Library of Medicine

Subpart 1--General Provisions

           *       *       *       *       *       *       *


                           LIBRARY FACILITIES

  Sec. 467. [There are authorized to be appropriated amounts 
sufficient for the erection and equipment of suitable and 
adequate buildings and facilities for use of the Library.] The 
Administrator of General Services may acquire, by purchase, 
condemnation, donation, or otherwise, a suitable site or sites, 
selected by the Secretary in accordance with the direction of 
the Board, for [such buildings and facilities] suitable and 
adequate buildings and facilities for use of the Library and to 
erect thereon, furnish, and equip such buildings and 
facilities. [The amounts authorized to be appropriated by this 
section include] Amounts appropriated to carry out this section 
may be used for the cost of preparation of drawings and 
specifications, supervision of construction, and other 
administrative expenses incident to the work. The Administrator 
of General Services shall prepare the plans and specifications, 
make all necessary contracts, and supervise construction.

                    [AUTHORIZATION OF APPROPRIATIONS

  [Sec. 468. (a) For the purpose of carrying out this part, 
there are authorized to be appropriated $150,000,000 for fiscal 
year 1994, and such sums as may be necessary for each of the 
fiscal years 1995 and 1996.
  [(b) Amounts appropriated under subsection (a) and made 
available for grants or contracts under any of sections 472 
through 476 shall remain available until the end of the fiscal 
year following the fiscal year for which the amounts were 
appropriated.]

           *       *       *       *       *       *       *


                     Part E--Other Agencies of NIH

           Subpart 1--National Center for Research Resources

SEC. 481A. BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES.

  (a)  * * *

           *       *       *       *       *       *       *

  (c) Requirements for Grants.--
          (1)  * * *
          (2) Institutions of emerging excellence.--From the 
        amount appropriated [under subsection (i)(1)] to carry 
        out this section for a fiscal year up to $50,000,000, 
        the Director of the Center shall make available 25 
        percent of such amount, and from the amount 
        appropriated [under such subsection] to carry out this 
        section for a fiscal year that is over $50,000,000, the 
        Director of the Center shall make available up to 25 
        percent of such amount, for grants under subsection (a) 
        to applicants that in addition to meeting the 
        requirements established in paragraph (1), have 
        demonstrated emerging excellence in biomedical or 
        behavioral research, as follows:
                  (A)  * * *

           *       *       *       *       *       *       *

  [(h) Report to Congress.--The Director of the Center shall 
prepare and submit to the appropriate committees of Congress a 
biennial report concerning the status of the biomedical and 
behavioral research facilities and the availability and 
condition of technologically sophisticated laboratory equipment 
in the United States. Such reports shall be developed in 
concert with the report prepared by the National Science 
Foundation on the needs of research facilities of universities 
as required under section 108 of the National Science 
Foundation Authorization Act for Fiscal Year 1986 (42 U.S.C. 
1886).
  [(i) Authorization of Appropriations.--
          [(1) Center.--For the purpose of carrying out this 
        section with respect to the Center, there are 
        authorized to be appropriated $250,000,000 for fiscal 
        year 2001, and such sums as may be necessary for each 
        of the fiscal years 2002 and 2003.
          [(2) National institute of allergy and infectious 
        diseases.--For the purpose of carrying out this section 
        with respect to the National Institute of Allergy and 
        Infectious Diseases, there are authorized to be 
        appropriated such sums as may be necessary for each of 
        the fiscal years 2004 and 2005.]

       CONSTRUCTION OF REGIONAL CENTERS FOR RESEARCH ON PRIMATES

  Sec. 481B. (a) With respect to activities carried out by the 
National Center for Research Resources to support regional 
centers for research on primates, the Director of NIH may, for 
each of the fiscal years 1994 through 1996, reserve from the 
amounts appropriated [under section 481A(h)] to carry out 
section 481A up to $2,500,000 for the purpose of making awards 
of grants and contracts to public or nonprofit private entities 
to construct, renovate, or otherwise improve such regional 
centers. The reservation of such amounts for any fiscal year is 
subject to the availability of qualified applicants for such 
awards.

           *       *       *       *       *       *       *


[SEC. 481C. 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 National Institutes of Health 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.]

           *       *       *       *       *       *       *


                Subpart 4--Office of Dietary Supplements

SEC. 485C. DIETARY SUPPLEMENTS.

  (a)  * * *

           *       *       *       *       *       *       *

  [(e) Authorization of Appropriations.--There are authorized 
to be appropriated to carry out this section $5,000,000 for 
fiscal year 1994 and such sums as may be necessary for each 
subsequent fiscal year.]

           *       *       *       *       *       *       *


  Subpart 6--National Center on Minority Health and Health Disparities

SEC. 485E. PURPOSE OF CENTER.

  (a)  * * *

           *       *       *       *       *       *       *

  [(k) Annual Report.--The Director of the Center shall prepare 
an annual report on the activities carried out or to be carried 
out by the Center, and shall submit each such report to the 
Committee on Health, Education, Labor, and Pensions of the 
Senate, the Committee on Commerce of the House of 
Representatives, the Secretary, and the Director of NIH. With 
respect to the fiscal year involved, the report shall--
          [(1) describe and evaluate the progress made in 
        health disparities research conducted or supported by 
        the national research institutes;
          [(2) summarize and analyze expenditures made for 
        activities with respect to health disparities research 
        conducted or supported by the National Institutes of 
        Health;
          [(3) include a separate statement applying the 
        requirements of paragraphs (1) and (2) specifically to 
        minority health disparities research; and
          [(4) contain such recommendations as the Director 
        considers appropriate.
  [(l) Authorization of Appropriations.--For the purpose of 
carrying out this subpart, there are authorized to be 
appropriated $100,000,000 for fiscal year 2001, and such sums 
as may be necessary for each of the fiscal years 2002 through 
2005. Such authorization of appropriations is in addition to 
other authorizations of appropriations that are available for 
the conduct and support of minority health disparities research 
or other health disparities research by the agencies of the 
National Institutes of Health.]

SEC. 485F. CENTERS OF EXCELLENCE FOR RESEARCH EDUCATION AND TRAINING.

  (a)  * * *

           *       *       *       *       *       *       *

  [(h) Authorization of Appropriations.--For the purpose of 
making grants under subsection (a), there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2001 through 2005.]

SEC. 485G. LOAN REPAYMENT PROGRAM FOR MINORITY HEALTH DISPARITIES 
                    RESEARCH.

  (a)  * * *

           *       *       *       *       *       *       *

  [(e) Funding.--
          [(1) 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 of the fiscal years 2001 through 
        2005.
          [(2) Availability of appropriations.--Amounts 
        available for carrying out this section shall remain 
        available until the expiration of the second fiscal 
        year beginning after the fiscal year for which the 
        amounts were made available.]

SEC. 485H. GENERAL PROVISIONS REGARDING THE CENTER.

  [(a) Administrative Support for Center.--The Secretary,] The 
Secretary, acting through the Director of the National 
Institutes of Health, shall provide administrative support and 
support services to the Director of the Center and shall ensure 
that such support takes maximum advantage of existing 
administrative structures at the agencies of the National 
Institutes of Health.
  [(b) Evaluation and Report.--
          [(1) Evaluation.--Not later than 5 years after the 
        date of the enactment of this subpart, the Secretary 
        shall conduct an evaluation to--
                  [(A) determine the effect of this subpart on 
                the planning and coordination of health 
                disparities research programs at the agencies 
                of the National Institutes of Health;
                  [(B) evaluate the extent to which this 
                subpart has eliminated the duplication of 
                administrative resources among such Institutes, 
                centers and divisions; and
                  [(C) provide, to the extent determined by the 
                Secretary to be appropriate, recommendations 
                concerning future legislative modifications 
                with respect to this subpart, for both minority 
                health disparities research and other health 
                disparities research.
          [(2) Minority health disparities research.--The 
        evaluation under paragraph (1) shall include a separate 
        statement that applies subparagraphs (A) and (B) of 
        such paragraph to minority health disparities research.
          [(3) Report.--Not later than 1 year after the date on 
        which the evaluation is commenced under paragraph (1), 
        the Secretary shall prepare and submit to the Committee 
        on Health, Education, Labor, and Pensions of the 
        Senate, and the Committee on Commerce of the House of 
        Representatives, a report concerning the results of 
        such evaluation.]

           *       *       *       *       *       *       *


                      Part G--Awards and Training

          Ruth L. Kirschstein National Research Service Awards

  Sec. 487. (a)  * * *

           *       *       *       *       *       *       *

  [(d) For the purpose of carrying out this section, there are 
authorized to be appropriated $400,000,000 for fiscal year 
1994, and such sums as may be necessary for each of the fiscal 
years 1995 and 1996. Of the amounts appropriated under this 
subsection--
          [(1) not less than 15 percent shall be made available 
        for payments under Ruth L. Kirschstein National 
        Research Service Awards provided by the Secretary under 
        subsection (a)(1)(A);
          [(2) not less than 50 percent shall be made available 
        for grants under subsection (a)(1)(B) for Ruth L. 
        Kirschstein National Research Service Awards;
          [(3) 1 percent shall be made available to the 
        Secretary, acting through the Administrator of the 
        Health Resources and Services Administration, for 
        payments under Ruth L. Kirschstein National Research 
        Service Awards which (A) are made to individuals 
        affiliated with entities which have received grants or 
        contracts under section 747, 748, or 749, and (B) are 
        for research in primary medical care; and 1 percent 
        shall be made available for payments under Ruth L. 
        Kirschstein National Research Service Awards made for 
        health services research by the Agency for Health Care 
        Policy and Research under section 304(a); and
          [(4) not more than 4 percent may be obligated for 
        Ruth L. Kirschstein National Research Service Awards 
        for periods of three months or less.]

  LOAN REPAYMENT PROGRAM FOR RESEARCH WITH RESPECT TO ACQUIRED IMMUNE 
                          DEFICIENCY SYNDROME

  Sec. 487A. (a)  * * *

           *       *       *       *       *       *       *

  [(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 of the 
fiscal years 1994 through 2001.]

           *       *       *       *       *       *       *


SEC. 487F. LOAN REPAYMENT PROGRAM REGARDING CLINICAL RESEARCHERS.

  (a)  * * *

           *       *       *       *       *       *       *

  [(c) Funding.--
          [(1) 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.
          [(2) Availability.--Amounts appropriated for carrying 
        out this section shall remain available until the 
        expiration of the second fiscal year beginning after 
        the fiscal year for which the amounts were made 
        available.]

           *       *       *       *       *       *       *


Part H--General Provisions

           *       *       *       *       *       *       *


   CERTAIN PROVISIONS REGARDING REVIEW AND APPROVAL OF PROPOSALS FOR 
                                RESEARCH

  Sec. 492A. (a) Review as Precondition to Research.--
          (1)  * * *
          (2) Peer review.--In the case of any proposal for the 
        National Institutes of Health to conduct or support 
        research, the Secretary may not approve or fund any 
        proposal that is subject to technical and scientific 
        peer review under section 492 unless the proposal has 
        undergone such review in accordance with such section 
        and has been recommended for approval by a majority of 
        the members of the entity conducting such review, and 
        unless a majority of the voting members of the 
        appropriate advisory council under section 406, or as 
        applicable, of the advisory council under section 
        402(k), has recommended the proposal for approval.

           *       *       *       *       *       *       *


                 RESEARCH ON PUBLIC HEALTH EMERGENCIES

  Sec. 494. [(a) If the Secretary] If the Secretary determines, 
after consultation with the Director of NIH, the Commissioner 
of the Food and Drug Administration, or the Director of the 
Centers for Disease Control and Prevention, that a disease or 
disorder constitutes a public health emergency, the Secretary, 
acting through the Director of NIH--
          (1)  * * *

           *       *       *       *       *       *       *

  [(b) Not later than 90 days after the end of a fiscal year, 
the Secretary shall report to the Committee on Energy and 
Commerce of the House of Representatives and the Committee on 
Labor and Human Resources of the Senate on actions taken under 
subsection (a) in such fiscal year.]

           *       *       *       *       *       *       *


        PART I--FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH

SEC. 499. ESTABLISHMENT AND DUTIES OF FOUNDATION.

  (a)  * * *

           *       *       *       *       *       *       *

  (d) Board of Directors.--
          (1) Composition.--
                  (A)  * * *

           *       *       *       *       *       *       *

                  (D)(i)  * * *
                  [(ii) Upon the appointment of the members of 
                the Board under clause (i)(II), the terms of 
                service of the ex officio members of the Board 
                as members of the Board shall terminate.]
                  (ii) Upon the appointment of the appointed 
                members of the Board under clause (i)(II), the 
                terms of service as members of the Board of the 
                ex officio members of the Board described in 
                clauses (i) and (ii) of subparagraph (B) shall 
                terminate. The ex officio members of the Board 
                described in clauses (iii) and (iv) of 
                subparagraph (B) shall continue to serve as ex 
                officio members of the Board.

           *       *       *       *       *       *       *

                  (G) The Board may, through amendments to the 
                bylaws of the Foundation, provide that the 
                number of appointed members of the Board shall 
                be greater than the number specified in 
                subparagraph (C).

           *       *       *       *       *       *       *

          (3) Terms and vacancies.--
                  (A)  * * *
                  [(B) Any vacancy in the membership of the 
                Board shall be filled in the manner in which 
                the original position was made and shall not 
                affect the power of the remaining members to 
                execute the duties of the Board.]
                  (B) Any vacancy in the membership of the 
                appointed members of the Board shall be filled 
                in accordance with the bylaws of the Foundation 
                established in accordance with paragraph (6), 
                and shall not affect the power of the remaining 
                appointed members to execute the duties of the 
                Board.

           *       *       *       *       *       *       *

          (5) Meetings and quorum.--A majority of the appointed 
        members of the Board shall constitute a quorum for 
        purposes of conducting the business of the Board.

           *       *       *       *       *       *       *

  (j) General Provisions.--
          (1)  * * *
          (2) Financial conflicts of interest.--Any individual 
        who is an officer, employee, or member of the Board of 
        the Foundation may not (in accordance with policies and 
        requirements developed under subsection 
        [(d)(2)(B)(i)(II)] (d)(6)) personally or substantially 
        participate in the consideration or determination by 
        the Foundation of any matter that would directly or 
        predictably affect any financial interest of the 
        individual or a relative (as such term is defined in 
        section 109(16) of the Ethics in Government Act of 
        1978) of the individual, of any business organization 
        or other entity, or of which the individual is an 
        officer or employee, or is negotiating for employment, 
        or in which the individual has any other financial 
        interest.

           *       *       *       *       *       *       *

          (4) Reports.--
                  (A) Not later than 5 months following the end 
                of each fiscal year, the Foundation shall 
                publish a report describing the activities of 
                the Foundation during the preceding fiscal 
                year. Each such report shall include for the 
                fiscal year involved a comprehensive statement 
                of the operations, activities, financial 
                condition, and accomplishments of the 
                Foundation, including an accounting of the use 
                of amounts transferred under subsection (l).

           *       *       *       *       *       *       *

                  [(C) The Foundation shall make copies of each 
                report submitted under subparagraph (A) 
                available for public inspection, and shall upon 
                request provide a copy of the report to any 
                individual for a charge not exceeding the cost 
                of providing the copy.]
                  (C) The Foundation shall make copies of each 
                report submitted under subparagraph (A) 
                available--
                          (i) for public inspection, and shall 
                        upon request provide a copy of the 
                        report to any individual for a charge 
                        that shall not exceed the cost of 
                        providing the copy; and
                          (ii) to the appropriate committees of 
                        Congress.

           *       *       *       *       *       *       *

          (10) Transfer of funds.--The Foundation may transfer 
        funds to the National Institutes [of Health.] of Health 
        and the National Institutes of Health may accept 
        transfers of funds from the Foundation. Any funds 
        transferred under this paragraph shall be subject to 
        all Federal limitations relating to federally-funded 
        research.

           *       *       *       *       *       *       *

  [(l) Funding.--
          [(1) Authorization of appropriations.--For the 
        purpose of carrying out this part, there is authorized 
        to be appropriated an aggregate $500,000 for each 
        fiscal year.
          [(2) Limitation regarding other funds.--Amounts 
        appropriated under any provision of law other than 
        paragraph (1) may not be expended to establish or 
        operate the Foundation.]

           *       *       *       *       *       *       *


  TITLE XI--GENETIC DISEASES, HEMOPHILIA PROGRAMS, AND SUDDEN INFANT 
DEATH SYNDROME

           *       *       *       *       *       *       *


                  Part B--Sudden Infant Death Syndrome

       sudden infant death syndrome research and research reports

  Sec. 1122. [(a) From the sums] From the sums appropriated to 
the National Institute of Child Health and Human Development, 
the Secretary shall assure that there are applied to research 
of the type described in subparagraphs (A) and (B) of 
subsection (b)(1) of this section such amounts each year as 
will be adequate, given the leads and findings then available 
from such research, in order to make maximum feasible progress 
toward identification of infants at risk of sudden infant death 
syndrome and prevention of sudden infant death syndrome.
  [(b)(1) Not later than ninety days after the close of the 
fiscal year ending September 30, 1979, and of each fiscal year 
thereafter, the Secretary shall report to the Committees on 
Appropriations of the Senate and the House of Representatives, 
the Committee on Labor and Human Resources of the Senate, and 
the Committee on Energy and Commerce of the House of 
Representatives specific information for such fiscal year on--
          [(A) the (i) number of applications approved by the 
        Secretary in the fiscal year reported on for grants and 
        contracts under this Act for research which relates 
        specifically to sudden infant death syndrome, (ii) 
        total amount requested under such applications, (iii) 
        number of such applications for which funds were 
        provided in such fiscal year, and (iv) total amount of 
        such funds; and
          [(B) the (i) number of applications approved by the 
        Secretary in such fiscal year for grants and contracts 
        under this Act for research which relates generally to 
        sudden infant death syndrome, including high-risk 
        pregnancy and high-risk infancy research which directly 
        relates to sudden infant death syndrome, (ii) 
        relationship of the high-risk pregnancy and high-risk 
        infancy research to sudden infant death syndrome, (iii) 
        total amount requested under such applications, (iv) 
        number of such applications for which funds were 
        provided in such fiscal year, and (v) total amount of 
        such funds.
  [(2) Each report submitted under paragraph (1) of this 
subsection shall--
          [(A) contain a summary of the findings of intramural 
        and extramural research supported by the National 
        Institute of Child Health and Human Development 
        relating to sudden infant death syndrome as described 
        in subparagraphs (A) and (B) of such paragraph (1), and 
        the plan of such Institute for taking maximum advantage 
        of such research leads and findings; and
          [(B) provide an estimate of the need for additional 
        funds over each of the next five fiscal years for 
        grants and contracts under this Act for research 
        activities described in such subparagraphs.
  [(c) Within five days after the Budget is transmitted by the 
President to the Congress for each fiscal year after fiscal 
year 1980, the Secretary shall transmit to the Committees on 
Appropriations of the Senate and the House of Representatives, 
the Committee on Labor and Human Resources of the Senate, and 
the Committee on Energy and Commerce of the House of 
Representatives an estimate of the amounts requested for the 
National Institute of Child Health and Human Development and 
any other Institutes of the National Institutes of Health, 
respectively, for research relating to sudden infant death 
syndrome as described in subparagraphs (A) and (B) of 
subsection (b)(1) of this section, and a comparison of such 
amounts with the amounts requested for the preceding fiscal 
year.]

   TITLE XXIII--RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY 
                                SYNDROME

              Part A--Administration of Research Programs

[SEC. 2301.  REQUIREMENT OF ANNUAL COMPREHENSIVE REPORT ON ALL 
                    EXPENDITURES BY SECRETARY WITH RESPECT TO ACQUIRED 
                    IMMUNE DEFICIENCY SYNDROME.

  [(a) In General.--Not later than December 1 of each fiscal 
year, the Secretary shall prepare and submit to the Congress a 
report on the expenditures by the Secretary of amounts 
appropriated for the preceding fiscal year with respect to 
acquired immune deficiency syndrome.
  [(b) Inclusion of Certain Information.--The report required 
in subsection (a) shall, with respect to acquired immune 
deficiency syndrome, include--
          [(1) for each program, project, or activity with 
        respect to such syndrome, a specification of the amount 
        obligated by each office and agency of the Department 
        of Health and Human Services;
          [(2) a summary description of each such program, 
        project, or activity;
          [(3) a list of such programs, projects, or activities 
        that are directed towards members of minority groups;
          [(4) a description of the extent to which programs, 
        projects, and activities described in paragraph (3) 
        have been coordinated between the Director of the 
        Office of Minority Health and the Director of the 
        Centers for Disease Control and Prevention;
          [(5) a summary of the progress made by each such 
        program, project, or activity with respect to the 
        prevention and control of acquired immune deficiency 
        syndrome;
          [(6) a summary of the evaluations conducted under 
        this title; and
          [(7) any report required in this Act to be submitted 
        to the Secretary for inclusion in the report required 
        in subsection (a).]

           *       *       *       *       *       *       *


                    Part D--Office of AIDS Research

Subpart I--Interagency Coordination of Activities

           *       *       *       *       *       *       *


SEC. 2354. ADDITIONAL AUTHORITIES.

  (a)  * * *
  [(b) Report to Secretary.--The Director of the Office shall 
each fiscal year prepare and submit to the Secretary, for 
inclusion in the comprehensive report required in section 
2301(a), a report--
          [(1) describing and evaluating the progress made in 
        such fiscal year in research, treatment, and training 
        with respect to acquired immune deficiency syndrome 
        conducted or supported by the Institutes;
          [(2) summarizing and analyzing expenditures made in 
        such fiscal year for activities with respect to 
        acquired immune deficiency syndrome conducted or 
        supported by the National Institutes of Health; and
          [(3) containing such recommendations as the Director 
        considers appropriate.]
  [(c)] (b) Projects for Cooperation Among Public and Private 
Health Entities.--In carrying out subsection (a), the Director 
of the Office shall establish projects to promote cooperation 
among Federal agencies, State, local, and regional public 
health agencies, and private entities, in research concerning 
the diagnosis, prevention, and treatment of acquired immune 
deficiency syndrome.

                Subpart II--Emergency Discretionary Fund

SEC. 2356. EMERGENCY DISCRETIONARY FUND.

  (a)  * * *

           *       *       *       *       *       *       *

  [(e) Report to Congress.--Not later than February 1 of each 
fiscal year, the Director of the Office shall submit to the 
Committee on Energy and Commerce of the House of 
Representatives, and to the Committee on Labor and Human 
Resources of the Senate, a report on the identified sets of 
AIDS activities carried out during the preceding fiscal year 
with amounts in the Fund. The report shall provide a 
description of each such set of activities and an explanation 
of the reasons underlying the use of the Fund for the set.]
  [(f)] (e) Definitions.--For purposes of this section:
          (1)  * * *

           *       *       *       *       *       *       *

  [(g)] (f) Funding.--
          (1)  * * *

           *       *       *       *       *       *       *


                    Subpart III--General Provisions

SEC. 2359. GENERAL PROVISIONS REGARDING THE OFFICE.

  (a)  * * *
  [(b) Evaluation and Report.--
          [(1) Evaluation.--Not later than 5 years] (b) 
        Evaluation.--Not later than 5 years after the date of 
        the enactment of National Institutes of Health 
        Revitalization Act of 1993, the Secretary shall conduct 
        an evaluation to--
          [(A)] (1) determine the effect of this section on the 
        planning and coordination of the AIDS research programs 
        at the institutes, centers and divisions of the 
        National Institutes of Health;
          [(B)] (2) evaluate the extent to which this part has 
        eliminated the duplication of administrative resources 
        among such Institutes, centers and divisions; and
          [(C)] (3) provide recommendations concerning future 
        alterations with respect to this part.
          [(2) Report.--Not later than 1 year after the date on 
        which the evaluation is commenced under paragraph (1), 
        the Secretary shall prepare and submit to the Committee 
        on Labor and Human Resources of the Senate, and the 
        Committee on Energy and Commerce of the House of 
        Representatives, a report concerning the results of 
        such evaluation.]

           *       *       *       *       *       *       *

                              ----------                              


                    SECTION 7 OF THE ORPHAN DRUG ACT

          ANALYSIS OF THYROID CANCER; ACTIONS BY THE SECRETARY

  Sec. 7. (a) In carrying out section 301 of the Public Health 
Service Act, the Secretary of Health and Human Services shall--
          (1) * * *
          (2) conduct scientific research and prepare analyses 
        necessary to develop valid and credible methods to 
        estimate the thyroid doses of Iodine 131 that are 
        received by individuals from nuclear bomb fallout; and
          (3) conduct scientific research and prepare analyses 
        necessary to develop valid and credible assessments of 
        the exposure to Iodine 131 that the American people 
        received from the Nevada atmospheric nuclear bomb 
        tests[; and].
          [(4) prepare and transmit to the Congress within one 
        year after the date of enactment of this Act a report 
        with respect to the activities conducted in carrying 
        out paragraphs (1), (2), and (3).]
  (b)(1) * * *
  (3) The tables specified in paragraph (1) and the formulas 
specified in paragraph (2) shall be devised from the best 
available data that are most applicable to the United States, 
and shall be devised in accordance with the best available 
scientific procedures and expertise. [The Secretary of Health 
and Human Services shall update these tables and formulas every 
four years, or whenever he deems it necessary to insure that 
they continue to represent the best available scientific data 
and expertise.]
                              ----------                              


      HOME HEALTH CARE AND ALZHEIMER'S DISEASE AMENDMENTS OF 1990



           *       *       *       *       *       *       *
TITLE III--TASK FORCE ON AGING RESEARCH

           *       *       *       *       *       *       *


[SEC. 304. REPORTS.

  [(a) In General.--Not later than 1 year after the date of the 
enactment of this Act, and annually thereafter, the Task Force 
shall prepare and submit to the Secretary, and to the Committee 
on Energy and Commerce of the House of Representatives and the 
Committee on Labor and Human Resources of the Senate, a report 
providing the recommendations required in section 301(b).
  [(b) Availability to Public.--The Task Force may make 
available to the public copies of the reports required in 
subsection (a).]

SEC. [305] 304. DEFINITIONS.

  For purposes of this title:
          (1) * * *

           *       *       *       *       *       *       *


SEC. [306] 305. AUTHORIZATION OF APPROPRIATIONS.

  For the purpose of carrying out this title, there are 
authorized to be appropriated such sums as may be necessary for 
each of the fiscal years 1991 through 1993.

           *       *       *       *       *       *       *

                              ----------                              


            SECTION 4923 OF THE BALANCED BUDGET ACT OF 1997

SEC. 4923. REPORT ON DIABETES GRANT PROGRAMS.

  (a) * * *
  [(b) Reports.--The Secretary shall submit to the appropriate 
committees of Congress--
          [(1) an interim report on the evaluation conducted 
        under subsection (a) not later than January 1, 2000, 
        and
          [(2) a final report on such evaluation not later than 
        January 1, 2007.]
                              ----------                              


                     CHILDREN'S HEALTH ACT OF 2000



           *       *       *       *       *       *       *
                     DIVISION A--CHILDREN'S HEALTH

TITLE I--AUTISM

           *       *       *       *       *       *       *


[SEC. 105. REPORT TO CONGRESS.

  [Not later than January 1, 2001, and each January 1 
thereafter, the Secretary shall prepare and submit to the 
appropriate committees of Congress, a report concerning the 
implementation of this title and the amendments made by this 
title.]

           *       *       *       *       *       *       *


TITLE X--PEDIATRIC RESEARCH INITIATIVE

           *       *       *       *       *       *       *


SEC. 1004. LONG-TERM CHILD DEVELOPMENT STUDY.

  (a) * * *

           *       *       *       *       *       *       *

  [(d) Report.--Beginning not later than 3 years after the date 
of the enactment of this Act, and periodically thereafter for 
the duration of the study under this section, the Director of 
the National Institute of Child Health and Human Development 
shall prepare and submit to the appropriate committees of 
Congress a report on the implementation and findings made under 
the planning and feasibility study conducted under this 
section.]

           *       *       *       *       *       *       *


DIVISION B--YOUTH DRUG AND MENTAL HEALTH SERVICES

           *       *       *       *       *       *       *


TITLE XXXVI--METHAMPHETAMINE AND OTHER CONTROLLED SUBSTANCES

           *       *       *       *       *       *       *


PART III--ABUSE PREVENTION AND TREATMENT

           *       *       *       *       *       *       *


[SEC. 3633. STUDY OF METHAMPHETAMINE TREATMENT.

  [(a) Study.--
          [(1) Requirement.--The Secretary of Health and Human 
        Services shall, in consultation with the National 
        Institute on Drug Abuse, conduct a study on the 
        development of medications for the treatment of 
        addiction to amphetamine and methamphetamine.
          [(2) Report.--Not later than 9 months after the date 
        of the enactment of this Act, the Secretary shall 
        submit to the Committees on the Judiciary of the Senate 
        and House of Representatives a report on the results of 
        the study conducted under paragraph (1).
  [(b) Authorization of Appropriations.--There are hereby 
authorized to be appropriated for the Department of Health and 
Human Services for fiscal year 2000 such sums as may be 
necessary to meet the requirements of subsection (a).]

           *       *       *       *       *       *       *

                              ----------                              


SECTION 105 OF THE MINORITY HEALTH AND HEALTH DISPARITIES RESEARCH AND 
                         EDUCATION ACT OF 2000

[SEC. 105. REPORT REGARDING RESOURCES OF NATIONAL INSTITUTES OF HEALTH 
                    DEDICATED TO MINORITY AND OTHER HEALTH DISPARITIES 
                    RESEARCH.

  [Not later than December 1, 2003, the Director of the 
National Center on Minority Health and Health Disparities 
(established by the amendment made by section 101(a)), after 
consultation with the advisory council for such Center, shall 
submit to the Congress, the Secretary of Health and Human 
Services, and the Director of the National Institutes of Health 
a report that provides the following:
          [(1) Recommendations for the methodology that should 
        be used to determine the extent of the resources of the 
        National Institutes of Health that are dedicated to 
        minority health disparities research and other health 
        disparities research, including determining the amount 
        of funds that are used to conduct and support such 
        research. With respect to such methodology, the report 
        shall address any discrepancies between the methodology 
        used by such Institutes as of the date of the enactment 
        of this Act and the methodology used by the Institute 
        of Medicine as of such date.
          [(2) A determination of whether and to what extent, 
        relative to fiscal year 1999, there has been an 
        increase in the level of resources of the National 
        Institutes of Health that are dedicated to minority 
        health disparities research, including the amount of 
        funds used to conduct and support such research. The 
        report shall include provisions describing whether and 
        to what extent there have been increases in the number 
        and amount of awards to minority serving institutions.]
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SECTION 6 OF THE MUSCULAR DYSTROPHY COMMUNITY ASSISTANCE, RESEARCH AND 
                      EDUCATION AMENDMENTS OF 2001

[SEC. 6. REPORT TO CONGRESS.

  [Not later than January 1, 2003, and each January 1 
thereafter, the Secretary shall prepare and submit to the 
appropriate committees of Congress, a report concerning the 
implementation of this Act and the amendments made by this 
Act.]
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                      RESEARCH REVIEW ACT OF 2004



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[SEC. 3. EPIDEMIOLOGICAL STUDY REPORT.

  [(a) In General.--The Secretary, acting through the Director 
of the Centers for Disease Control and Prevention, shall 
prepare a report outlining the epidemiological studies 
currently under way at such Centers, future planned studies, 
the criteria involved in determining what epidemiological 
studies to conduct, defer, or suspend, and the scope of those 
studies, including with respect to the inflammatory bowel 
disease epidemiological study. The report shall include a 
description of the activities the Centers for Disease Control 
and Prevention undertakes to establish partnerships with 
research and patient advocacy communities to expand 
epidemiological studies.
  [(b) Report.--Not later than May 1, 2005, the Secretary shall 
submit the report under subsection (a) to the Committee on 
Energy and Commerce of the House of Representatives and to the 
Committee on Health, Education, Labor, and Pensions of the 
Senate.]

SEC. [4] 3. STUDY BY GOVERNMENT ACCOUNTABILITY OFFICE ON MEDICARE AND 
                    MEDICAID COVERAGE STANDARDS.

  (a) * * *

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SEC. [5] 4. STUDY BY GOVERNMENT ACCOUNTABILITY OFFICE INVOLVING 
                    DISABILITY INSURANCE.

  (a) * * *

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ADDITIONAL VIEWS OF REPRESENTATIVES EDWARD MARKEY, JOHN DINGELL, HENRY 
  WAXMAN, RICK BOUCHER, EDOLPHUS TOWNS, FRANK PALLONE, SHERROD BROWN, 
ANNA ESHOO, BART STUPAK, ELIOT ENGEL, ALBERT WYNN, GENE GREEN, DIANA DE 
   GETTE, LOIS CAPPS, THOMAS ALLEN, JAN SCHAKOWSKY, HILDA SOLIS, JAY 
                         INSLEE, TAMMY BALDWIN

    The National Institutes of Health is our country's premier 
research institution. It embodies our hopes for treating or 
curing debilitating diseases like heart disease, Alzheimer's, 
cystic fibrosis, diabetes, cancer and so many other illnesses 
that American families battle every day. It also our best hope 
for containing the health care costs of the Baby Boomers. If we 
don't act now, the chronic disease epidemic and its economic 
costs will skyrocket over the next 25 years. We must invest in 
research today that will yield the cures tomorrow.
    We are concerned that the 5% authorization level included 
in this legislation sets a cap on the funding available for NIH 
for the duration of the authorization. Further this 5% increase 
will barely keep up with the high rate of inflation. Biomedical 
inflation, as measured by the Biomedical Research and 
Development Price Index (BRDPI), is generally 3-4 percent per 
year. In some years it is even as high as 5-10%. In a year in 
which biomedical inflation is over 5%, this bill would 
authorize a real cut to NIH.
    We have already seen the impact on research when the NIH 
budget fails to account for increases in inflation. Since 2003, 
NIH has lost 11 percent of its research funding when adjusted 
for inflation. Already this has done significant damage to 
NIH's ability to support cutting edge research and encourage 
new investigators. The impact has been so significant that even 
top-tier researchers with established track records of 
publishing in top journals are struggling to get funding for 
their research.
    In committee, we supported an amendment offered by Mr. 
Markey to ensure that the bill authorized a real 5% increase in 
NIH funding above the rate of inflation. This amendment was 
endorsed by numerous research and patient advocacy 
organizations including, AIDS Action, The AIDS Institute, AIDS 
Vaccine Advocacy Coalition (AVAC), The Alliance for Aging 
Research, The Alliance for Microbicide Development, The 
Alzheimer's Foundation of America, American Psychological 
Association, amfAR, The Foundation for AIDS Research, Beth 
Israel Deaconess Medical Center, Boston Medical Center, Boston 
University School of Medicine, Brigham and Women's Hospital, 
Cambridge Health Alliance, Caritas Carney Hospital, Caritas St. 
Elizabeth's Medical Center, Children's Hospital Boston, 
Consortium of Social Science Associations, The Cystic Fibrosis 
Foundation, Dana Farber Cancer Institute, Drug Development 
Committee of the AIDS Treatment Advocacy Campaign (ATAC), 
Elizabeth Glaser Pediatric AIDS foundation, Faulkner Hospital, 
The Friends of the National Institute on Aging, Harvard 
University, Lahey Clinic Medical Center, Massachusetts Eye and 
Ear Infirmary, Massachusetts General Hospital, National AIDS 
Treatment Advocacy Project (NATAP), The New England Council, 
The Schepens Eye Research Institute, Treatment Action Group 
(TAG), Tufts New England Medical Center.
    Although the amendment was rejected on a party-line vote, 
we continue to believe that Congress should provide at least 5 
percent annual increases in NIH funding above the level of 
biomedical inflation, so that NIH can maintain and expand its 
life-saving research.

                                   Edward J. Markey.
                                   Rick Boucher.
                                   Henry A. Waxman.
                                   Edolphus Towns.
                                   Gene Green.
                                   Sherrod Brown.
                                   Eliot L. Engel.
                                   Bart Stupak.
                                   Tammy Baldwin.
                                   Jan Schakowsky.
                                   Tom Allen.
                                   Diana DeGette.
                                   Hilda L. Solis.
                                   Lois Capps.
                                   Anna Eshoo.
                                   Jay Inslee.
                                   Frank Pallone, Jr.
                                   John D. Dingell.
                                   Albert R. Wynn.