```

[House Report 110-889]
[From the U.S. Government Publishing Office]

110th Congress                                                   Report
  2d Session             HOUSE OF REPRESENTATIVES               110-889

======================================================================
 
          BREAST CANCER AND ENVIRONMENTAL RESEARCH ACT OF 2008

                                _______
                                

 September 25, 2008.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

 Mr. Dingell, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 1157]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 1157) to amend the Public Health Service Act to 
authorize the Director of the National Institute of 
Environmental Health Sciences to make grants for the 
development and operation of research centers regarding 
environmental factors that may be related to the etiology of 
breast cancer, having considered the same, report favorably 
thereon with an amendment and recommend that the bill as 
amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     2
Purpose and Summary..............................................     3
Background and Need for Legislation..............................     3
Hearings.........................................................     6
Committee Consideration..........................................     6
Committee Votes..................................................     6
Committee Oversight Findings.....................................     6
Statement of General Performance Goals and Objectives............     6
New Budget Authority, Entitlement Authority, and Tax Expenditures     6
Earmarks and Tax and Tariff Benefits.............................     7
Committee Cost Estimate..........................................     7
Congressional Budget Office Estimate.............................     7
Federal Mandates Statement.......................................     7
Advisory Committee Statement.....................................     7
Constitutional Authority Statement...............................     7
Applicability to Legislative Branch..............................     7
Section-by-Section Analysis of the Legislation...................     7
Changes in Existing Law Made by the Bill, as Reported............    10

                               Amendment

  The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Breast Cancer and Environmental 
Research Act of 2008''.

SEC. 2. EXPANDING COLLABORATIVE RESEARCH ON BREAST CANCER AND THE 
                    ENVIRONMENT.

  (a) In General.--Subpart 1 of part C of title IV of the Public Health 
Service Act (42 U.S.C. 285 et seq.) is amended by adding at the end the 
following:

``SEC. 417F. INTERAGENCY BREAST CANCER AND ENVIRONMENTAL RESEARCH 
                    COORDINATING COMMITTEE.

  ``(a) Interagency Breast Cancer and Environmental Research 
Coordinating Committee.--
          ``(1) Establishment.--Not later than 6 months after the date 
        of the enactment of this section, the Secretary shall establish 
        a committee, to be known as the Interagency Breast Cancer and 
        Environmental Research Coordinating Committee (in this section 
        referred to as the `Committee').
          ``(2) Duties.--The Committee shall--
                  ``(A) share and coordinate information on existing 
                research activities, and make recommendations to the 
                National Institutes of Health and other Federal 
                agencies regarding how to improve existing research 
                programs, that are related to breast cancer research;
                  ``(B) develop a comprehensive strategy and advise the 
                National Institutes of Health and other Federal 
                agencies in the solicitation of proposals for 
                collaborative, multidisciplinary research, including 
                proposals to evaluate environmental and genomic factors 
                that may be related to the etiology of breast cancer 
                that would--
                          ``(i) result in innovative approaches to 
                        study emerging scientific opportunities or 
                        eliminate knowledge gaps in research to improve 
                        the research portfolio;
                          ``(ii) outline key research questions, 
                        methodologies, and knowledge gaps;
                          ``(iii) expand the number of research 
                        proposals that involve collaboration between 2 
                        or more national research institutes or 
                        national centers, including proposals for 
                        Common Fund research described in section 
                        402(b)(7) to improve the research portfolio; 
                        and
                          ``(iv) expand the number of collaborative, 
                        multidisciplinary, and multi-institutional 
                        research grants;
                  ``(C) develop a summary of advances in breast cancer 
                research supported or conducted by Federal agencies 
                relevant to the diagnosis, prevention, and treatment of 
                cancer and other diseases and disorders; and
                  ``(D) not later than 2 years after the date of the 
                establishment of the Committee, make recommendations to 
                the Secretary--
                          ``(i) regarding any appropriate changes to 
                        research activities, including recommendations 
                        to improve the research portfolio of the 
                        National Institutes of Health to ensure that 
                        scientifically-based strategic planning is 
                        implemented in support of research priorities 
                        that impact breast cancer research activities;
                          ``(ii) to ensure that the activities of the 
                        National Institutes of Health and other Federal 
                        agencies, including the Department of Defense, 
                        are free of unnecessary duplication of effort;
                          ``(iii) regarding public participation in 
                        decisions relating to breast cancer research to 
                        increase the involvement of patient advocacy 
                        and community organizations representing a 
                        broad geographical area;
                          ``(iv) on how best to disseminate information 
                        on breast cancer research progress; and
                          ``(v) on how to expand partnerships between 
                        public entities, including Federal agencies, 
                        and private entities to expand collaborative, 
                        cross-cutting research.
          ``(3) Rule of construction.--For the purposes of the 
        Committee, when focusing on research to evaluate environmental 
        and genomic factors that may be related to the etiology of 
        breast cancer, nothing in this section shall be construed to 
        restrict the Secretary from including other forms of cancer, as 
        appropriate, when doing so may advance research in breast 
        cancer or advance research in other forms of cancer.
          ``(4) Membership.--
                  ``(A) In general.--The Committee shall be composed of 
                the following voting members:
                          ``(i) Not more than 7 voting Federal 
                        representatives as follows:
                                  ``(I) The Director of the Centers for 
                                Disease Control and Prevention.
                                  ``(II) The Director of the National 
                                Institutes of Health and the directors 
                                of such national research institutes 
                                and national centers (which may include 
                                the National Institute of Environmental 
                                Health Sciences) as the Secretary 
                                determines appropriate.
                                  ``(III) One representative from the 
                                National Cancer Institute Board of 
                                Scientific Advisors, appointed by the 
                                Director of the National Cancer 
                                Institute.
                                  ``(IV) The heads of such other 
                                agencies of the Department of Health 
                                and Human Services as the Secretary 
                                determines appropriate.
                                  ``(V) Representatives of other 
                                Federal agencies that conduct or 
                                support cancer research, including the 
                                Department of Defense.
                          ``(ii) 12 additional voting members appointed 
                        under subparagraph (B).
                  ``(B) Additional members.--The Committee shall 
                include additional voting members appointed by the 
                Secretary as follows:
                          ``(i) 6 members shall be appointed from among 
                        scientists, physicians, and other health 
                        professionals, who--
                                  ``(I) are not officers or employees 
                                of the United States;
                                  ``(II) represent multiple 
                                disciplines, including clinical, basic, 
                                and public health sciences;
                                  ``(III) represent different 
                                geographical regions of the United 
                                States;
                                  ``(IV) are from practice settings, 
                                academia, or other research settings; 
                                and
                                  ``(V) are experienced in scientific 
                                peer review process.
                          ``(ii) 6 members shall be appointed from 
                        members of the general public, who represent 
                        individuals with breast cancer.
                  ``(C) Nonvoting members.--The Committee shall include 
                such nonvoting members as the Secretary determines to 
                be appropriate.
          ``(5) Chairperson.--The voting members of the Committee shall 
        select a chairperson from among such members. The selection of 
        a chairperson shall be subject to the approval of the Director 
        of NIH.
          ``(6) Meetings.--The Committee shall meet at the call of the 
        chairperson of the Committee or upon the request of the 
        Director of NIH, but in no case less often than once each year.
  ``(b) Review.--The Secretary shall review the necessity of the 
Committee in calendar year 2011 and, thereafter, at least once every 2 
years.''.
  (b) Authorization of Appropriations.--For the purpose of carrying out 
research activities under title IV of the Public Health Service Act, 
including section 417F of such Act as added by subsection (a), there 
are authorized to be appropriated $40,000,000 for each of fiscal years 
2009 through 2012. Amounts authorized to be appropriated under the 
preceding sentence shall be in addition to amounts otherwise authorized 
to be appropriated for such purpose under section 402A of the Public 
Health Service Act (42 U.S.C. 282a).

                          Purpose and Summary

    The purpose of H.R. 1157, the Breast Cancer and 
Environmental Research Act of 2007, is to amend the Public 
Health Service Act to authorize the Secretary of Health and 
Human Services to establish an Interagency Breast Cancer and 
Environmental Research Coordinating Committee.

                  Background and Need for Legislation

    Breast cancer is the second most common type of cancer 
among women in the United States. In the United States, a 
woman's lifetime risk of breast cancer increased steadily and 
dramatically over the course of the 20th century. Between 1973 
and 1998, breast cancer incidence rates in the United States 
increased by more than 40 percent. Today, a woman's lifetime 
risk of breast cancer is one in eight. In 2008, the National 
Cancer Institute (NCI) estimates that 182,460 women and 1,990 
men will be diagnosed with breast cancer and 40,480 women and 
450 men will die as a result of breast cancer.
    One of the hopeful messages from cancer research generally 
is that many cases of cancer are linked to environmental causes 
and, in principle, can be prevented. Cancer develops over 
several years and has many causes. Numerous factors both inside 
and outside the body contribute to the development of cancer. 
In this context, scientists refer to everything outside the 
body that interacts with humans as the ``environment.'' 
Exposure to a wide variety of natural and man-made substances 
in the environment accounts for at least two-thirds of all the 
cases of cancer in the United States. These environmental 
factors include lifestyle choices such as cigarette smoking, 
excessive alcohol consumption, poor diet, lack of exercise, and 
excessive sunlight exposure. Other factors include exposure to 
certain medical drugs, hormones, radiation, viruses, bacteria, 
and environmental chemicals that may be present in the air, 
water, food, and workplace.
    Environmental factors such as viruses, sunlight, and 
chemicals interact with cells throughout our lives. Mechanisms 
to repair damage to our genes and healthy lifestyle choices 
(wearing protective clothing for sun exposure or not smoking) 
help to protect us from harmful exposures. Over time, however, 
substances in the environment may cause gene alterations, which 
accumulate inside our cells. While many alterations have no 
effect on a person's health, permanent changes in certain genes 
can lead to cancer. The chance that an individual will develop 
cancer in response to a particular environmental agent depends 
on several interacting factors: how long and how often a person 
is exposed to a particular substance, his/her exposure to other 
agents, genetic factors, diet, lifestyle, health, age, and 
gender.
    Because of the complex interplay of many factors and the 
lack of conclusive evidence about the links between cancer and 
environmental factors, it is not currently possible to predict 
whether a specific environmental exposure will cause a 
particular person to develop cancer. It is known that certain 
genetic and environmental factors increase the risk of 
developing cancer, but it is not known exactly which 
combination of factors is responsible for a person's specific 
cancer.
    With respect to environmental effects on breast cancer, 
research has varied widely. Some studies have linked alcohol 
consumption to an increased risk of the most common type of 
breast cancer. Other studies have suggested that infants 
exposed to butyl benzyl phthalate (BBP), a chemical additive 
used in pipes, vinyl floor tiles, carpet-backing, and other 
household items may affect mammary gland development and 
perhaps increase the susceptibility to breast cancer. 
Researchers have also found that bisphenol A, a chemical found 
in some plastic food and drink packaging, including baby 
bottles, may be tied to early puberty and prostate and breast 
cancer. Other research has shown that hormone replacement 
therapy may increase breast cancer risk. Breast cancer is a 
complex disease that occurs in an environmentally complex 
world. While it is generally believed that environmental 
factors play some role in the development of breast cancer, the 
full extent of that role is not yet understood.
    In addition to studying environmental impacts, the recently 
completed Human Genome Project is providing an entirely new 
avenue of research opportunities to better understand why some 
women are more likely to develop breast cancer than others. 
Understanding the relevance of genetic markers and potential 
predisposition to developing breast cancer are also critically 
important areas of cancer research that need to be further 
explored. The Cancer Genome Atlas project is one of several 
genomic research programs that could help to identify how 
environmental factors may or may not impact the development of 
breast cancer.
    Currently, there are several sources of Federal funding for 
research on the links between breast cancer and the 
environment. The National Institute of Environmental Health 
Sciences (NIEHS) and NCI have partnered to support a network of 
research centers in which multidisciplinary teams of 
scientists, clinicians, and breast cancer advocates work 
collaboratively on a unique set of scientific questions. The 
focus is on the interaction of chemical, physical, biological, 
and social factors in the environment with genetic factors to 
cause breast cancer. The network is working towards integrating 
histologic, pathologic, cellular, and sub-cellular changes that 
occur in normal mammary gland tissue across the lifespan along 
with comparisons to exposure-induced changes. The seven-year 
study began in September 2003 with a $5 million per year 
budget.
    In addition, the Department of Defense (DOD) has a 
federally-funded Breast Cancer Research Program (BCRP). Since 
its inception in 1992, the BCRP has funded research targeted 
toward the program's vision to eradicate breast cancer. 
Recognizing that the war against breast cancer must be fought 
on multiple fronts, the DOD BCRP developed a multidisciplinary 
research portfolio that encompasses a wide spectrum of 
prevention, detection, diagnosis, and treatment research 
projects. The BCRP specifically avoids duplication of research 
funded by other Federal agencies. Research awards are made 
using a two-tier review process composed of peer and 
programmatic review. An important element in the BCRP is its 
partnership with scientists and consumers, who participate 
during both levels of review. Peer review evaluates the 
scientific merit of the research proposals, and programmatic 
review determines the relevance of proposals to the BCRP vision 
and goals. The Integration Panel, comprised of scientists and 
consumers, makes final funding recommendations and provides 
guidance on the BCRP's investment strategies. The program's 
initial success encouraged Congress to appropriate additional 
funds to the BCRP in subsequent years, totaling $1.96 billion 
through FY 2006. These funds have supported 4,894 awards.

                                Hearings

    The Subcommittee on Health held a legislative hearing in 
connection with the bill reported by the Committee. This 
hearing was held on May 21, 2008, and was entitled ``H.R. 1157, 
Breast Cancer and Environmental Research Act of 2007, and H.R. 
758, Breast Cancer Patient Protection Act of 2007.''
    The Subcommittee on Health heard the testimony of three 
panels. The witnesses on the first panel were: Deborah Winn, 
Ph.D., Director, Epidemiology and Genetics Research Program, 
Division of Cancer Control and Population Sciences, National 
Cancer Institute, National Institutes of Health.
    The witnesses on the second panel were: Ms. Fran Visco, 
President, National Breast Cancer Coalition; Ms. Sheryl Crow, 
Singer-Songwriter and breast cancer advocate; and H. Kim 
Lyerly, M.D., Director and George Barth Geller Professor of 
Research in Cancer, Duke Comprehensive Cancer Center, Duke 
University Medical Center.
    The witnesses on the third panel were: Kristen Zarfos, 
M.D., F.A.C.S., St. Francis Hospital, Hartford, CT; and Ms. 
Alva Williams.

                        Committee Consideration

    On Tuesday, September 23, 2008, the full Committee met in 
open markup session and ordered H.R. 1157 favorably reported to 
the House, amended, by a voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. No 
record votes were taken on amendments or in connection with 
ordering H.R. 1157 reported to the House. A motion by Mr. 
Dingell to order H.R. 1157 favorably reported to the House, 
amended, was agreed to by a voice vote.

                      Committee Oversight Findings

    Regarding clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Subcommittee on Health held a 
legislative hearing on H.R. 1157, and the oversight findings of 
the Committee regarding the bill are reflected in this report.

         Statement of General Performance Goals and Objectives

    The objective of H.R. 1157 is to amend the Public Health 
Service Act to require the Secretary of HHS to establish an 
Interagency Breast Cancer and Environmental Research 
Coordinating Committee and to authorize $40,000,000 for each of 
fiscal years 2009 through 2012 for the purpose of carrying out 
research activities under title IV of the Public Health Service 
Act, including provisions added by this legislation.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Regarding compliance with clause 3(c)(2) of rule XIII of 
the Rules of the House of Representatives, the Committee finds 
that H.R. 1157 would result in no new or increased budget 
authority, entitlement authority, or tax expenditures or 
revenues.

                  Earmarks and Tax and Tariff Benefits

    Regarding compliance with clause 9 of rule XXI of the Rules 
of the House of Representatives, H.R. 1157 does not contain any 
congressional earmarks, limited tax benefits, or limited tariff 
benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate on H.R. 
1157 prepared by the Director of the Congressional Budget 
Office pursuant to section 402 of the Congressional Budget Act 
of 1974.

                  Congressional Budget Office Estimate

    Regarding clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, a cost estimate on H.R. 1157 by the 
Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974 was not available at the time 
of the filing of this report.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates regarding H.R. 1157 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 would be created by H.R. 
1157.

                   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 H.R. 1157 is provided in the 
provisions of Article I, section 8, clause 1, that relate to 
expending funds to provide for the general welfare of the 
United States.

                  Applicability to Legislative Branch

    The Committee finds that H.R. 1157 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 of 1995.

             Section-by-Section Analysis of the Legislation

Section 1. Short title

    Section 1 establishes the short title of the bill as the 
Breast Cancer and Environmental Research Act of 2008.

Section 2. Expanding collaborative research on breast cancer and the 
        environment

    Section 2 amends subpart 1 of part C of title IV of the 
Public Health Service Act (PHSA) to add a new section which 
requires the Secretary of HHS to establish a committee, to be 
known as the Interagency Breast Cancer and Environmental 
Research Coordinating Committee.
    Section 2 sets forth requirements for the composition of 
the Coordinating Committee and directs that the Coordinating 
Committee shall be composed of voting and nonvoting members. 
The voting members of the Coordinating Committee shall select a 
chairperson from among the members, subject to the approval of 
the Director of NIH. The Coordinating Committee is required to 
meet at the call of the chairperson or upon the request of the 
Director of NIH, but at least once annually.
    Section 2 establishes the duties of the Coordinating 
Committee to include sharing and coordinating information on 
existing research activities, and making recommendations to NIH 
and other Federal agencies regarding how to improve existing 
research programs that are related to breast cancer research. 
Another required duty of the Coordinating Committee is to 
develop a summary of advances in breast cancer research 
supported or conducted by Federal agencies relevant to the 
diagnosis, prevention, and treatment of cancer and other 
diseases and disorders.
    In addition, section 2 directs the Coordinating Committee 
to develop a comprehensive strategy and advise NIH and other 
Federal agencies in the solicitation of proposals for 
collaborative, multidisciplinary research. Such research shall 
focus on proposals to evaluate environmental and genomic 
factors that may be related to the etiology of breast cancer 
that would: (1) result in innovative approaches to study 
emerging scientific opportunities or eliminate knowledge gaps 
in research to improve the research portfolio; (2) outline key 
research questions, methodologies, and knowledge gaps; (3) 
expand the number of research proposals that involve 
collaboration between two or more national research institutes 
or centers, including proposals for Common Fund research to 
improve the research portfolio; and (4) expand the number of 
collaborative, multidisciplinary, and multi-institutional 
research grants.
    Section 2 also requires that the Coordinating Committee 
make recommendations to the Secretary regarding any appropriate 
changes to research activities, including recommendations on 
how to improve the research portfolio of NIH to ensure that 
scientifically-based strategic planning is implemented in 
support of research priorities that impact breast cancer and 
environmental research activities. The Coordinating Committee 
must also make recommendations to the Secretary regarding 
public participation in decisions relating to breast cancer and 
environmental research to increase the involvement of patient 
advocacy and community organizations representing a broad 
geographical area.
    In addition, the Coordinating Committee must make 
recommendations on how: (1) to ensure that NIH and other 
Federal agencies, including the Department of Defense, are free 
of unnecessary duplication of effort; (2) to disseminate 
information on progress related to breast cancer and 
environmental research; and (3) to expand partnerships between 
public and private entities to expand collaborative, cross-
cutting research, particularly related to the study of breast 
cancer and the environment. All recommendations required by 
this section must be made to the Secretary not later than two 
years after the establishment of the Coordinating Committee.
    Section 2 provides that, for the purposes of the 
Coordinating Committee, when focusing on research to evaluate 
environmental and genomic factors that may be related to the 
etiology of breast cancer, nothing in this legislation shall be 
construed to restrict the Secretary from including other forms 
of cancer, as appropriate, when doing so may advance research 
in breast cancer or advance research in other forms of cancer.
    The Committee believes that this clarification is necessary 
because of the complex interplay in the field of cancer 
research and science. While the focus of the Coordinating 
Committee is intended to be on breast cancer and environmental 
research, the Committee recognizes that oftentimes knowledge 
and advances in one field of cancer research can have important 
implications and relevance to other fields of cancer research. 
For example, scientists using a three-dimensional cell culture 
system have identified a mechanism by which dormant, metastatic 
tumor cells can begin growing again after long periods of 
inactivity. The new findings indicate that the switch from 
dormancy to proliferative, metastatic growth may be regulated, 
in part, through signaling from the surrounding 
microenvironment, which leads to changes in the skeletal 
architecture of dormant tumor cells. Targeting this mechanism 
may also provide strategies for inhibiting the switch from 
dormancy to proliferation. The results of this study by NCI 
scientists and their collaborators, appeared in the August 1, 
2008, issue of ``Cancer Research'' and has broad implications 
for all forms of cancer research.
    This discovery was not born out of research focused 
specifically on breast cancer and the environment, but rather 
it was born out of basic science research focused on 
understanding how tumors grow. This type of research, though 
not explicitly focused on breast cancer and the environment, 
does have a direct impact on the understanding of the etiology 
of breast cancer. An NIH press release stated, ``The recurrence 
of breast cancer often follows a long latent period in which 
there are no signs of cancer, and metastases may not become 
clinically apparent until many years after removal of the 
primary tumor and follow-up therapy. According to NCI's Jeffrey 
E. Green, M.D., one of the lead researchers of this study, 
``Recent evidence suggests that, in many cases, tumor cells 
have already seeded metastatic sites even when the primary 
tumor is diagnosed at an early stage.'' Approximately 30 
percent of breast cancer patients diagnosed with early-stage 
disease have been found to have breast cancer cells in their 
bone marrow. However, these cells seem to exist primarily as 
micrometastases that do not manifest themselves clinically in 
any way.''
    Another example of how knowledge and advances in one field 
of cancer research can have important implications and 
relevance to other fields of cancer research, such as breast 
cancer, pertains to cancer stem cells. Many cancer researchers 
believe that the most promising frontier is in the area of 
cancer stem cells. The hypothesis is that cancers grow from 
cancer stem cells. When a stem cell divides, it produces two 
unequal cells--one stem cell, and one that multiplies into 
cells that are required by its organ. Most cancer therapies 
target all cells in a tumor as the same, and the function and 
origin of these cancer stem cells is not fully understood. A 
researcher studying AML (leukemia) was one of the first to 
advance this theory. The theory was then tested in breast 
cancer cells--and brain, prostate, colon, pancreas, and ovary 
cells. Theses stem cell studies might not naturally fall under 
a heading of breast cancer research, but clearly could be 
critical to understanding how and why tumor cells multiply.
    Because of examples like these, it is the Committee's view 
that, while the focus of the Coordinating Committee is breast 
cancer and environmental research, this should not be 
interpreted in a way that would preclude the Committee from 
taking into account the important role of basic science 
research in advancing environmental and genomic research that 
may be related to the etiology of breast cancer.
    Beginning in calendar year 2011, section 2 requires the 
Secretary of HHS to review the necessity of the Committee at 
least once every two years.
    Finally, section 2 authorizes $40 million to be 
appropriated for each of fiscal years 2009 through 2012, for 
purposes of carrying out research activities under title IV of 
the PHSA, including provisions added by this legislation. This 
is intended to be in addition to amounts otherwise authorized 
to be appropriated for title IV of the PHSA.

         Changes in Existing Law Made by the Bill, as Reported

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

                       PUBLIC HEALTH SERVICE ACT

           *       *       *       *       *       *       *
TITLE IV--NATIONAL RESEARCH INSTITUTES

           *       *       *       *       *       *       *

  Part C--Specific Provisions Respecting National Research Institutes

Subpart 1--National Cancer Institute

           *       *       *       *       *       *       *

SEC. 417F. INTERAGENCY BREAST CANCER AND ENVIRONMENTAL RESEARCH 
                    COORDINATING COMMITTEE.

  (a) Interagency Breast Cancer and Environmental Research 
Coordinating Committee.--
          (1) Establishment.--Not later than 6 months after the 
        date of the enactment of this section, the Secretary 
        shall establish a committee, to be known as the 
        Interagency Breast Cancer and Environmental Research 
        Coordinating Committee (in this section referred to as 
        the `Committee').
          (2) Duties.--The Committee shall--
                  (A) share and coordinate information on 
                existing research activities, and make 
                recommendations to the National Institutes of 
                Health and other Federal agencies regarding how 
                to improve existing research programs, that are 
                related to breast cancer research;
                  (B) develop a comprehensive strategy and 
                advise the National Institutes of Health and 
                other Federal agencies in the solicitation of 
                proposals for collaborative, multidisciplinary 
                research, including proposals to evaluate 
                environmental and genomic factors that may be 
                related to the etiology of breast cancer that 
                would--
                          (i) result in innovative approaches 
                        to study emerging scientific 
                        opportunities or eliminate knowledge 
                        gaps in research to improve the 
                        research portfolio;
                          (ii) outline key research questions, 
                        methodologies, and knowledge gaps;
                          (iii) expand the number of research 
                        proposals that involve collaboration 
                        between 2 or more national research 
                        institutes or national centers, 
                        including proposals for Common Fund 
                        research described in section 402(b)(7) 
                        to improve the research portfolio; and
                          (iv) expand the number of 
                        collaborative, multidisciplinary, and 
                        multi-institutional research grants;
                  (C) develop a summary of advances in breast 
                cancer research supported or conducted by 
                Federal agencies relevant to the diagnosis, 
                prevention, and treatment of cancer and other 
                diseases and disorders; and
                  (D) not later than 2 years after the date of 
                the establishment of the Committee, make 
                recommendations to the Secretary--
                          (i) regarding any appropriate changes 
                        to research activities, including 
                        recommendations to improve the research 
                        portfolio of the National Institutes of 
                        Health to ensure that scientifically-
                        based strategic planning is implemented 
                        in support of research priorities that 
                        impact breast cancer research 
                        activities;
                          (ii) to ensure that the activities of 
                        the National Institutes of Health and 
                        other Federal agencies, including the 
                        Department of Defense, are free of 
                        unnecessary duplication of effort;
                          (iii) regarding public participation 
                        in decisions relating to breast cancer 
                        research to increase the involvement of 
                        patient advocacy and community 
                        organizations representing a broad 
                        geographical area;
                          (iv) on how best to disseminate 
                        information on breast cancer research 
                        progress; and
                          (v) on how to expand partnerships 
                        between public entities, including 
                        Federal agencies, and private entities 
                        to expand collaborative, cross-cutting 
                        research.
          (3) Rule of construction.--For the purposes of the 
        Committee, when focusing on research to evaluate 
        environmental and genomic factors that may be related 
        to the etiology of breast cancer, nothing in this 
        section shall be construed to restrict the Secretary 
        from including other forms of cancer, as appropriate, 
        when doing so may advance research in breast cancer or 
        advance research in other forms of cancer.
          (4) Membership.--
                  (A) In general.--The Committee shall be 
                composed of the following voting members:
                          (i) Not more than 7 voting Federal 
                        representatives as follows:
                                  (I) The Director of the 
                                Centers for Disease Control and 
                                Prevention.
                                  (II) The Director of the 
                                National Institutes of Health 
                                and the directors of such 
                                national research institutes 
                                and national centers (which may 
                                include the National Institute 
                                of Environmental Health 
                                Sciences) as the Secretary 
                                determines appropriate.
                                  (III) One representative from 
                                the National Cancer Institute 
                                Board of Scientific Advisors, 
                                appointed by the Director of 
                                the National Cancer Institute.
                                  (IV) The heads of such other 
                                agencies of the Department of 
                                Health and Human Services as 
                                the Secretary determines 
                                appropriate.
                                  (V) Representatives of other 
                                Federal agencies that conduct 
                                or support cancer research, 
                                including the Department of 
                                Defense.
                          (ii) 12 additional voting members 
                        appointed under subparagraph (B).
                  (B) Additional members.--The Committee shall 
                include additional voting members appointed by 
                the Secretary as follows:
                          (i) 6 members shall be appointed from 
                        among scientists, physicians, and other 
                        health professionals, who--
                                  (I) are not officers or 
                                employees of the United States;
                                  (II) represent multiple 
                                disciplines, including 
                                clinical, basic, and public 
                                health sciences;
                                  (III) represent different 
                                geographical regions of the 
                                United States;
                                  (IV) are from practice 
                                settings, academia, or other 
                                research settings; and
                                  (V) are experienced in 
                                scientific peer review process.
                          (ii) 6 members shall be appointed 
                        from members of the general public, who 
                        represent individuals with breast 
                        cancer.
                  (C) Nonvoting members.--The Committee shall 
                include such nonvoting members as the Secretary 
                determines to be appropriate.
          (5) Chairperson.--The voting members of the Committee 
        shall select a chairperson from among such members. The 
        selection of a chairperson shall be subject to the 
        approval of the Director of NIH.
          (6) Meetings.--The Committee shall meet at the call 
        of the chairperson of the Committee or upon the request 
        of the Director of NIH, but in no case less often than 
        once each year.
  (b) Review.--The Secretary shall review the necessity of the 
Committee in calendar year 2011 and, thereafter, at least once 
every 2 years.

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