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Text of the Breast Cancer and Environmental Research Act of 2006

This bill was introduced on June 28, 2006, in a previous session of Congress, but was not enacted. The text of the bill below is as of Jul 24, 2006 (Reported by Senate Committee).

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II

Calendar No. 530

109th CONGRESS

2d Session

S. 757

[Report No. 109–290]

IN THE SENATE OF THE UNITED STATES

April 11, 2005

(for himself, Mr. Reid, Mr. Talent, Mrs. Clinton, Mr. Hatch, Ms. Cantwell, Mr. Allen, Ms. Collins, Mr. Grassley, Mr. Corzine, Mr. Harkin, Mrs. Murray, Mr. Bingaman, Mr. Kennedy, Mr. Cochran, Mr. DeWine, Mr. Warner, Mr. Coleman, Mr. Lautenberg, Mr. Dayton, Mr. Biden, Mr. Voinovich, Mr. Johnson, Mr. McCain, Mrs. Feinstein, Mr. Smith, Ms. Mikulski, Mr. Reed, Mr. Feingold, Mr. Sarbanes, Mr. Lieberman, Mr. Kohl, Mr. Schumer, Mr. Sununu, Mrs. Hutchison, Ms. Murkowski, Ms. Stabenow, Mr. Carper, Mr. Specter, Mr. Kerry, Mr. Jeffords, Ms. Landrieu, Mr. Dodd, Mrs. Lincoln, Mrs. Boxer, Mr. Bayh, Mr. Dorgan, Mr. Pryor, Mr. Hagel, Mr. Bennett, Mr. Conrad, Ms. Snowe, Mr. Leahy, Mr. Vitter, Mr. Salazar, Mr. Wyden, Mr. Lugar, Mr. Graham, Mr. Domenici, Mr. Cornyn, Mr. Baucus, Mrs. Dole, Mr. Menendez, Mr. Santorum, Mr. Burns, Mr. Kyl, and Mr. Nelson of Florida) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

July 24, 2006

Reported by , with an amendment

Strike out all after the enacting clause and insert the part printed in italic

A BILL

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.

1.

Short title

This Act may be cited as the Breast Cancer and Environmental Research Act of 2005.

2.

Findings

The Congress finds as follows:

(1)

Breast cancer is the second leading cause of cancer deaths among American women.

(2)

More women in the United States are living with breast cancer than any other cancer (excluding skin cancer). Approximately 3,000,000 women in the United States are living with breast cancer, about 2,000,000 of which have been diagnosed and an estimated 1,000,000 who do not yet know that they have the disease.

(3)

Breast cancer is the most commonly diagnosed cancer among women in the United States and worldwide (excluding skin cancer). In 2005, it is estimated that 269,730 new cases of breast cancer will be diagnosed among women in the United States, 211,240 invasive breast cancers and 58,490 cases of ductal carcinoma in situ (DCIS).

(4)

Approximately 40,410 women in the United States will die from the disease in 2005. Breast cancer is the leading cause of cancer death for women in the United States between the ages of 20 and 59, and the leading cause of cancer death for women worldwide.

(5)

A woman who lives into her 80s in the United States has a 1 in 7 chance of developing invasive breast cancer in her lifetime. This risk was 1 in 11 in 1975. In 2005, a new case of breast cancer will be diagnosed every 2 minutes and a woman will die from breast cancer every 13 minutes.

(6)

All women are at risk for breast cancer. About 90 percent of women who develop breast cancer do not have a family history of the disease.

(7)

The National Action Plan on Breast Cancer, a public private partnership, has recognized the importance of expanding the scope and breadth of biomedical, epidemiological, and behavioral research activities related to the etiology of breast cancer and the role of the environment.

(8)

To date, there has been only a limited research investment to expand the scope or coordinate efforts across disciplines or work with the community to study the role of the environment in the development of breast cancer.

(9)

In 2003, the National Institute of Environmental Health Sciences awarded grants to four research centers to begin to study the prenatal-to-adult environmental exposures that may predispose a woman to breast cancer. The currently funded research is examining the mammary tissue in animals and young girls and study the subjects’ life exposures to environmental, nutritional, and social factors that impact menarche. Early menarche, beginning menstruation before the age of 12, has been shown to increase breast cancer risk later in life.

(10)

The National Cancer Institute and the National Institute of Environmental Health Sciences have paired together to make those four centers possible. The two institutes work well together, combining their respective areas of expertise to the best advantage of the research.

(11)

In order to take full advantage of the tremendous potential for avenues of prevention, the Federal investment in the role of the environment and the development of breast cancer should be expanded. The research conducted at the four centers, while critically important, is one small facet of the many issues that must be addressed in order to gauge the link between environmental factors and breast cancer.

(12)

In order to understand the effect of chemicals and radiation on the development of cancer, multi-generational, prospective studies are probably required.

3.

National Institute of Environmental Health Sciences; awards for development and operation of research centers regarding environmental factors related to breast cancer

Subpart 12 of part C of title IV of the Public Health Service Act (42 U.S.C. 285l et seq.) is amended by adding at the end the following section:

463C.

Research centers regarding environmental factors related to breast cancer

(a)

In general

The Director of the Institute, based on recommendations from the Breast Cancer and Environmental Research Panel established under subsection (b) (referred to in this section as the Panel) shall make grants, after a process of peer review and programmatic review, to public or nonprofit private entities for the development and operation of not more than 8 centers for the purpose of conducting multidisciplinary and multi-institutional research on environmental factors that may be related to the etiology of breast cancer. Each such center shall be known as a Breast Cancer and Environmental Research Center of Excellence.

(b)

Breast Cancer and Environmental Research Panel

(1)

Establishment

The Secretary shall establish in the Institute of Environmental Health Sciences a Breast Cancer and Environmental Research Panel.

(2)

Composition

The Panel shall be composed of—

(A)

9 members to be appointed by the Secretary, of which—

(i)

six members shall be appointed from among 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 or academia or other research settings; and

(V)

are experienced in biomedical review; and

(ii)

three members shall be appointed from the general public who are representatives of individuals who have had breast cancer and who represent a constituency; and

(B)

such nonvoting, ex officio members as the Secretary determines to be appropriate.

(3)

Chairperson

The members of the Panel appointed under paragraph (2)(A) shall select a chairperson from among such members.

(4)

Meetings

The Panel shall meet at the call of the chairperson or upon the request of the Director, but in no case less often than once each year.

(5)

Duties

The Panel shall—

(A)

oversee the peer review process for the awarding of grants under subsection (a) and conduct the programmatic review under such subsection;

(B)

make recommendations with respect to the funding criteria and mechanisms under which amounts will be allocated under this section; and

(C)

make final programmatic recommendations with respect to grants under this section.

(c)

Collaboration with community

Each center under subsection (a) shall establish and maintain ongoing collaborations with community organizations in the geographic area served by the center, including those that represent women with breast cancer.

(d)

Coordination of centers; reports

The Director of the Institute shall, as appropriate, provide for the coordination of information among centers under subsection (a) 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.

(e)

Required consortium

Each center under subsection (a) shall be formed from a consortium of cooperating institutions, meeting such requirements as may be prescribed by the Director of the Institute. Each center shall require collaboration among highly accomplished scientists, other health professionals and advocates of diverse backgrounds from various areas of expertise.

(f)

Duration of support

Support of a center under subsection (a) may be for a period not exceeding 5 years. Such period may be extended for one or more additional periods not exceeding 5 years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director of the Institute and if such group has recommended to the Director that such period should be extended.

(g)

Geographic distribution of centers

The Director of the Institute shall, to the extent practicable, provide for an equitable geographical distribution of centers under this section.

(h)

Innovative approaches

Each center under subsection (a) shall use innovative approaches to study unexplored or under-explored areas of the environment and breast cancer.

(i)

Authorization of appropriations

For the purpose of carrying out this section, there is authorized to be appropriated $30,000,000 for each of the fiscal years 2006 through 2011. Such authorization is in addition to any other authorization of appropriations that is available for such purpose.

.

1.

Short title

This Act may be cited as the Breast Cancer and Environmental Research Act of 2006.

2.

National Institutes of Health; awards for development and operation of research centers regarding environmental factors related to breast cancer

Part A of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by adding at the end the following:

404H.

Research centers regarding environmental factors related to breast cancer

(a)

In general

The Secretary, acting through the Director of NIH, based on recommendations from the Breast Cancer and Environmental Research Panel established under subsection (b) (referred to in this section as the Panel), shall make grants to public or nonprofit private entities for the development and operation of collaborative, multi-institutional centers for the purpose of conducting multidisciplinary and multi-institutional research on environmental factors that may be related to the etiology of breast cancer. Each such center shall be known as a Breast Cancer and Environmental Research Center of Excellence.

(b)

Breast Cancer and Environmental Research Panel

(1)

Establishment

The Secretary shall establish within the National Institutes of Health a Breast Cancer and Environmental Research Panel.

(2)

Composition

The Panel shall be composed of—

(A)

9 members to be appointed by the Secretary, of which—

(i)

six members shall be appointed from among 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 peer review; and

(ii)

three members shall be appointed from the general public who are representatives of individuals who have had breast cancer and who represent a constituency; and

(B)

such nonvoting, ex officio members as the Secretary determines to be appropriate.

(3)

Chairperson

The members of the Panel appointed under paragraph (2)(A) shall select a chairperson from among such members.

(4)

Meetings

The Panel shall meet at the call of the chairperson or upon the request of the Director of NIH, but in no case less often than once each year.

(5)

Duties

The Panel shall—

(A)

develop a comprehensive strategy concerning collaborative centers that would—

(i)

result in innovative approaches to study unexplored or underexplored areas of the environment and breast cancer;

(ii)

outline key research questions, methodologies, and knowledge gaps concerning environmental factors that may be related to the etiology of breast cancer;

(iii)

outline key issues concerning environmental factors that may be related to the etiology of breast cancer; and

(iv)

result in an overall strategy to address environmental factors related to breast cancer;

(B)

make recommendations to the Secretary with respect to the mechanisms, peer review criteria, and allocations under this section;

(C)

assist in the overall program evaluation; and

(D)

make recommendations for the dissemination of information on program process.

(c)

Collaboration with community

Each center under subsection (a) shall include community organizations in the geographic area served by the center, including those that represent women with breast cancer, as integral collaborators involved at all levels of the decision-making and research in such center.

(d)

Coordination of centers; reports

The Director of NIH shall, as appropriate, provide for the coordination of information among centers under subsection (a) 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.

(e)

Required consortium

Each center under subsection (a) shall be formed from a consortium of cooperating institutions and community groups, meeting such requirements as may be prescribed by the Director of NIH. Each center shall require collaboration among highly accomplished scientists, other health professionals and advocates of diverse backgrounds from various areas of expertise.

(f)

Duration of support

Support of a center under subsection (a) may be for a period not exceeding 5 years. Such period may be extended for one or more additional periods not exceeding 5 years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director of NIH and if such group has recommended to the Director that such period be extended.

(g)

Geographic distribution of centers

The Director of NIH shall, to the extent practicable, provide for an equitable geographical distribution of centers under this section.

(h)

Authorization of appropriations

For the purpose of carrying out this section, there is authorized to be appropriated $30,000,000 for each of the fiscal years 2007 through 2012. Such authorization is in addition to any other authorization of appropriations that is available for such purpose.

.

July 24, 2006

Reported with an amendment