To amend the Public Health Service Act to combat autism through research, screening, intervention and education.

April 19, 2005

Mr. SANTORUM (for himself and Mr. DODD) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

To amend the Public Health Service Act to combat autism through research, screening, intervention and education.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the `Combating Autism Act of 2005'.

SEC. 2. ACTIVITIES TO IMPROVE AUTISM-RELATED RESEARCH AND FUNDING.

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

`PART J--AUTISM-RELATED ACTIVITIES

`SEC. 499A. AUTHORITY OF THE DIRECTOR OF THE NATIONAL INSTITUTES OF HEALTH RELATING TO AUTISM.

`(a) Identifying Total Expenditures on Autism Spectrum Disorders- The Director of NIH, in coordination with the National Institute of Mental Health and other institutes of the National Institutes of Health, shall identify the total amount of expenditures, both intramural and extramural, by the National Institutes of Health for autism spectrum disorders for fiscal year 2005.

`(b) Budget for Autism Research and Coordination of Activities and Programs- The Director of NIH, based on the strategic plan developed under subsection (c), shall--

`(1) develop and oversee the implementation of a scientifically justified budget for research on autism spectrum disorders at the National Institutes of Health;

`(2) coordinate all research activities and programs on autism spectrum disorders at the institutes, centers, and divisions of the National Institutes of Health; and

`(3) evaluate all such activities and programs.

`(c) Strategic Plan for Autism Research-

`(1) IN GENERAL- The Director of NIH shall develop and oversee the implementation of a comprehensive, long-range plan for the conduct and support of research on autism spectrum disorders by the institutes, centers, and divisions of the National Institutes of Health.

`(2) REQUIREMENTS- The plan developed under paragraph (1) shall--

`(A) be updated on an annual basis;

`(B) be based on the research recommendations contained in the Autism Research Roadmap and Matrix of the Interagency Autism Coordinating Committee;

`(C) determine and establish priorities among critical scientific questions related to autism spectrum disorders;

`(D) based on the priorities established under subparagraph (C), specify the short and long-range objectives to be achieved, and estimate the resources needed to achieve these objectives;

`(E) evaluate the sufficiency of existing research programs on autism spectrum disorders to meet the objectives specified under subparagraph (D), and establish objectives, timelines, and criteria for evaluating future research programs; and

`(F) make recommendations for changes to existing research programs on autism spectrum disorders.

`(d) Budgetary Authority-

`(1) IN GENERAL- The Director of NIH shall--

`(A) in accordance with the strategic plan developed under subsection (c), annually prepare and submit to Congress a scientifically justified budget estimate for research on autism spectrum disorders to be conducted within the agencies of the National Institutes of Health, which shall include the amount of funds that will be required for--

`(i) the continued funding of ongoing discretionary program initiatives at the institutes, centers, and divisions of the National Institutes of Health; and

`(ii) the funding of new and complementary program initiatives.

`(B) receive all research funds for autism spectrum disorders described in subparagraph (A), and allocate those funds to the institutes, centers, and divisions of the National Institutes of Health.

`(2) EFFECTIVE DATE- Paragraph (1)(B) shall become effective in the fiscal year following the submission of the autism budget described in paragraph (1)(A).

`(e) Evaluation and Report-

`(1) EVALUATION- The Director of NIH shall evaluate the effect of this section on the planning and coordination of research programs on autism spectrum disorders at the institutes, centers, and divisions of the National Institutes of Health, and the extent to which funding mandated under this section has followed the recommendation of the strategic plan developed under subsection (c).

`(2) REPORT- Not later than 1 year after the date of enactment of this section, the Director of NIH shall prepare and submit to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate, a report based on the evaluation described in paragraph (1).

`SEC. 499B. EXPANSION, INTENSIFICATION, AND COORDINATION OF ACTIVITIES OF NATIONAL INSTITUTES OF HEALTH WITH RESPECT TO RESEARCH ON AUTISM.

`(a) In General-

`(1) EXPANSION OF ACTIVITIES- The Director of NIH shall expand, intensify, and coordinate the activities of the National Institutes of Health with respect to research on autism.

`(2) ADMINISTRATION OF PROGRAM; COORDINATION AMONG AGENCIES- The Director of NIH shall carry out this section acting through the Director of the National Institute of Mental Health and in collaboration with the National Institute of Child Health and Human Development, the National Institute of Neurological Disorders and Stroke, the National Institute of Environmental Health Sciences, the National Institute on Deafness and Other Communication Disorders, and any other agencies that the Director determines appropriate.

`(b) Centers of Excellence-

`(1) IN GENERAL- In carrying out subsection (a)(1), the Director of NIH shall award grants and contracts to public or nonprofit private entities to pay all or part of the cost of planning, establishing, improving, and providing basic operating support for centers of excellence regarding research on autism.

`(2) RESEARCH- Each center of excellence that receives funding under paragraph (1) shall conduct basic and clinical research into autism. Such research--

`(A) shall be conducted in the fields of developmental neurobiology, genetics, and psychopharmacology, and, beginning on July 1, 2008, immunology, endocrinology, gastroenterology, and toxicology; and

`(B) should include--

`(i) investigations into the cause, diagnosis, early detection, prevention, control, treatment, and cure of autism; and

`(ii) research on high-risk infant siblings.

`(3) SERVICES FOR PATIENTS-

`(A) IN GENERAL- A center of excellence that receives funding under paragraph (1) may expend amounts provided under a grant or contract under such paragraph to carry out a program to make individuals aware of opportunities to participate as subjects in research conducted by the centers.

`(B) REFERRALS AND COSTS- A program carried out under subparagraph (A) may, in accordance with such criteria as the Director of NIH may establish, provide to the subjects described in such subparagraph, referrals for health and other services, and such patient care costs as are required for research.

`(C) AVAILABILITY AND ACCESS- The extent to which a center of excellence that receives funding under paragraph (1) can demonstrate availability and access to clinical services shall be considered by the Director of NIH in decisions about awarding grants or contracts to applicants that meet the scientific criteria for funding under this section.

`(4) COORDINATION OF CENTERS OF EXCELLENCE-

`(A) IN GENERAL- The Director of NIH shall, as appropriate, provide for the coordination of information among centers of excellence that receive funding under paragraph (1) and centers of excellence that receive funding under section 463C, and ensure regular communication between such centers.

`(B) PERIODIC REPORTS- The Director of NIH may require the periodic preparation of reports on the activities of the centers described in subparagraph (A) and the submission of such reports to the Director.

`(C) COLLECTION AND STORAGE OF DATA- The Director of NIH shall establish and fund mechanisms and entities for collecting, storing, and coordinating data collected by the centers referred to in subparagraph (A) and data generated from public and private research partnerships.

`(5) ORGANIZATION- Each center of excellence that receives funding 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 of NIH.

`(6) NUMBER AND DURATION-

`(A) IN GENERAL- The Director shall provide for the establishment of not less than 10 centers under paragraph (1).

`(B) DURATION- A grant or contract awarded under paragraph (1) shall not exceed a period of 5 years. Such period may be extended for 1 or more additional periods not exceeding 5 years if the operations of the center of excellence involved have been reviewed by an appropriate technical and scientific peer review group established by the Director of NIH and the group has recommended to the Director that such period should be extended.

`(C) FACILITATION OF RESEARCH-

`(i) ESTABLISHMENT OF PROGRAM- The Director of NIH shall establish a program under which samples of tissues and genetic and other biological materials that are of use in research on autism are donated, collected, preserved, and made available for such research.

`(ii) ACCEPTED SCIENTIFIC STANDARDS- The program established under clause (i) shall be carried out in accordance with accepted scientific and medical standards for the donation, collection, and preservation of such samples, and shall be conducted so that the tissues and other materials saved, as well as any database compiled from such tissues and materials, are available to researchers at a reasonable cost.

`(D) PUBLIC INPUT- In carrying out this section, the Director of NIH shall provide for a means through which the public can obtain information on the existing and planned programs and activities of the National Institutes of Health with respect to autism and through which the Director can receive comments from the public regarding such programs and activities.

`(c) Authorization of Appropriations- There is authorized to be appropriated to carry out this section, $30,000,000 for each of fiscal years 2007 through 2011. Amounts appropriated under this subsection shall be in addition to any other amounts appropriated for such purpose.

`SEC. 499C. COLLABORATIVE PROGRAMS OF EXCELLENCE IN AUTISM.

`(a) In General- The Director of NIH, acting through the Director of the National Institute of Child Health and Human Development and the Director of the National Institute on Deafness and Other Disorders, shall award grants and contracts to public or nonprofit private entities to pay all or part of the cost of planning, establishing, improving, and providing basic operating support for the Collaborative Programs of Excellence in Autism.

`(b) Research- Each program established under subsection (a) shall conduct basic and clinical research into autism. Such program--

`(1) shall conduct research in the fields of developmental neurobiology, genetics, and psychopharmacology, and, beginning July 1, 2008, in the fields of immunology, endocrinology, gastroenterology, and toxicology; and

`(2) should conduct--

`(A) investigations into the cause, diagnosis, early detection, prevention, control, treatment, and cure of autism; and

`(B) research on high-risk infant siblings.

`(c) Coordination of Programs-

`(1) IN GENERAL- The Director of NIH shall, as appropriate, provide for the coordination of information among programs established under subsection (a), and centers of excellence that receive funding under section 463C and 499B, and ensure regular communication between such centers.

`(2) PERIODIC REPORTS- The Director of NIH may require the periodic preparation of reports on the activities of the programs described in paragraph (1) and the submission of such reports to the Director.

`(3) COLLECTION AND STORAGE OF DATA- The Director of NIH shall establish and fund mechanisms and entities for collecting, storing, and coordinating data collected by the programs referred to in paragraph (1) and data generated from public and private research partnerships.

`(d) Organization- Each program that receives funding under subsection (a) 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 of NIH.

`(e) Number and Duration-

`(1) IN GENERAL- The Director shall provide for the establishment of not less than 10 programs under paragraph (1).

`(2) DURATION- A grant or contract awarded under subsection (a) shall not exceed a period of 5 years. Such period may be extended for 1 or more additional periods not exceeding 5 years if the operations of the program involved have been reviewed by an appropriate technical and scientific peer review group established by the Director of NIH and the group has recommended to the Director that such period should be extended.

`(f) Authorization of Appropriations- There is authorized to be appropriated to carry out this section, $14,000,000 for each of fiscal years 2007 through 2011. Amounts appropriated under this subsection shall be in addition to any other amounts appropriated for such purpose.'.

SEC. 3. DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RESEARCH PROGRAM.

Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by adding at the end thereof the following:

`PART R--PROGRAMS RELATING TO AUTISM

`SEC. 399AA. DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RESEARCH PROGRAM.

`(a) National Autism and Pervasive Developmental Disabilities Surveillance Program-

`(1) IN GENERAL- The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants and cooperative agreements to eligible entities for the collection, analysis, and reporting of epidemiological data on autism and pervasive developmental disabilities. In making such awards, the Secretary may provide direct technical assistance in lieu of cash.

`(2) ELIGIBILITY- To be eligible to receive a grant or cooperative agreement under paragraph (1), an entity shall be a public or nonprofit private entity (including a health department of a State or political subdivisions of a State, a university, or any other educational institution), and submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.

`(b) Centers of Excellence in Autism and Pervasive Developmental Disabilities Epidemiology-

`(1) IN GENERAL- The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish not less than 6 regional centers of excellence in autism and pervasive developmental disabilities epidemiology for the purpose of collecting and analyzing information on the number, incidence, incidence trend over time, correlates, and causes of autism and related developmental disabilities.

`(2) RECIPIENTS OF AWARDS- Each center of excellence under paragraph (1) shall be established and operated through the awarding of grants or cooperative agreements to public or nonprofit private entities that conduct research, including health departments of States and political subdivisions of States, and universities and other educational entities.

`(3) REQUIREMENTS- To be eligible to receive a grant or cooperative agreement under paragraph (2), an entity shall submit to the Secretary an application containing such agreements and information as the Secretary may require, including an agreement that the center to be established shall operate in accordance with the following:

`(A) The center will collect, analyze, and report autism and pervasive developmental disabilities data according to guidelines prescribed by the Director of the Centers for Disease Control and Prevention, after consultation with relevant State and local public health officials, private sector developmental disability researchers, and advocates for those with developmental disabilities.

`(B) The center will assist with the development and coordination of State autism and pervasive developmental disabilities surveillance efforts within a region.

`(C) The center will identify eligible cases and controls through its surveillance systems and conduct research into factors which may cause or increase the risk of autism and related developmental disabilities.

`(D) The center will develop or extend an area of special research expertise (including genetics, environmental exposure to contaminants, immunology, and other relevant research specialty areas).

`(c) Clearinghouse- The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall carry out the following:

`(1) ESTABLISHMENT- The Secretary shall establish a clearinghouse within the Centers for Disease Control and Prevention for the collection and storage of data generated from the monitoring programs established under this part and part J of title IV. Through the clearinghouse, such Centers shall serve as the coordinating agency for autism and pervasive developmental disabilities surveillance activities. The functions of such clearinghouse shall include facilitating the coordination of research and policy development relating to the epidemiology of autism and other pervasive developmental disabilities.

`(2) FEDERAL RESPONSE- The Secretary shall coordinate the Federal response to requests for assistance from State health department officials regarding potential or alleged autism or developmental disability clusters.

`(3) FACILITATION OF RESEARCH- The Secretary shall provide for the establishment of a program under which samples of tissues and genetic and other biological materials that are of use in research on autism are donated, collected, preserved, and made available for such research. Such program shall be carried out in accordance with accepted scientific and medical standards for the donation, collection, and preservation of such samples, and shall be conducted so that the tissues and other materials saved, as well as any database compiled from such tissues and materials, are available to researchers at a reasonable cost.

`(4) COORDINATION- The Centers for Disease Control and Prevention shall coordinate research and surveillance activities of such Centers with the National Institutes of Health, other appropriate Federal agencies, and interested nonprofit private entities, in a manner consistent with the research recommendations contained in the Autism Research Roadmap and Matrix of the Interagency Autism Coordinating Committee, which shall be updated as determined appropriate by the Secretary.

`(d) State- In this part, the term `State' means each of the several States, the District of Columbia, the Commonwealth of Puerto Rico, American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, the Virgin Islands, and the Trust Territory of the Pacific Islands.

`(e) Authorization of Appropriations- There is authorized to be appropriated to carry out this section, $12,000,000 for each of fiscal years 2007 through 2011.

`SEC. 399BB. INFORMATION AND EDUCATION RELATING TO AUTISM.

`(a) In General- The Secretary shall establish and implement a program to provide information and education on autism and its risk factors to health professionals and the general public, including information and education on advances in the diagnosis and treatment of autism and training and continuing education through programs for scientists, physicians, and other health professionals who provide care for patients with autism. The program shall place special emphasis on early identification of autism and those at risk for autism and prompt referral for appropriate services.

`(b) Stipends- The Secretary may use amounts made available under this section to provide stipends for health professionals who are enrolled in training programs under this section.

`(c) Authorization of Appropriations- There is authorized to be appropriated to carry out this section, $10,000,000 for each of fiscal years 2007 through 2011.

`SEC. 399CC. INTERAGENCY AUTISM COORDINATING COMMITTEE.

`(a) Establishment- The Secretary shall establish a committee to be known as the `Autism Coordinating Committee' (in this section referred to as the `Committee') to coordinate all efforts within the Department of Health and Human Services concerning autism, including activities carried out through the National Institutes of Health and the Centers for Disease Control and Prevention under the amendments made by the National Autism Research Act.

`(b) Membership-

`(1) IN GENERAL- The Committee shall be composed of--

`(A) the Director of the Centers for Disease Control and Prevention;

`(B) the Directors of such national research institutes of the National Institutes of Health as the Secretary determines appropriate;

`(C) the heads of such other agencies as the Secretary determines appropriate; and

`(D) the additional members appointed under paragraph (2) (if any).

`(2) ADDITIONAL MEMBERS- If determined appropriate by the Secretary, the Secretary may appoint to the Committee--

`(A) individuals with autism or other pervasive developmental disorders;

`(B) parents or legal guardians of individuals with autism or other pervasive developmental disorders;

`(C) representatives of leading autism research and service organizations; and

`(D) representatives of other governmental agencies that serve children with autism such as the Department of Education.

`(c) Administrative Support; Terms of Services; Other Provisions- The following shall apply with respect to the Committee:

`(1) The Committee shall receive necessary and appropriate administrative support from the Secretary.

`(2) Members of the Committee appointed under subsection (b)(2)(A) shall serve for a term of 3 years, and may serve for an unlimited number of terms if reappointed.

`(3) The Committee shall meet not less than 2 times each year.

`SEC. 399DD. SCREENING, DIAGNOSIS, AND TREATMENT OF AUTISM; MEDICAL CARE FOR INDIVIDUALS WITH AUTISM.

`(a) Statewide Autism Screening, Diagnosis, and Intervention Programs and Systems-

`(1) IN GENERAL- The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall award grants or cooperative agreements to eligible entities to develop statewide autism screening, diagnosis, and intervention programs and systems for the purposes described in paragraph (2).

`(2) PURPOSES- The purposes described in this paragraph are the following:

`(A) To develop and monitor the efficacy of statewide autism screening, diagnosis, and intervention programs and systems, ensuring that all children are screened for autism before their second birthday, and that children at risk for autism receive appropriate services as early as possible. Intervention includes referral to schools and agencies, including community, consumer, and parent-based agencies, and organizations and other programs mandated by part C of the Individuals with Disabilities Education Act, which offer programs specifically designed to meet the unique needs of children with autism.

`(B) To collect data on statewide autism screening, diagnosis, and intervention programs and systems that can be used for applied research, program evaluation, and policy development.

`(C) To provide comprehensive medical care for individuals with autism through evidence-based practices, with specific attention to medical conditions that may be associated with autism, and to disseminate information on the medical care of individuals with autism to health professionals and the general public. In carrying out the program under this paragraph, a grant shall be awarded to a national organization that will establish and support regional centers of clinical excellence to provide medical care to individuals with autism and promote research aimed at improving the treatment of such individuals, and that will build a shared national medical database to record the results of treatments and studies at the regional centers.

`(3) SET ASIDE OF FUNDS- From amounts appropriated under subsection (e), the Secretary shall set-aside not less than $4,000,000 for each of fiscal years 2007 through 2011 to carry out activities described in paragraph (2)(C).

`(b) Technical Assistance, Data Management, and Applied Research- The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award grants or cooperative agreements to provide technical assistance to State agencies to conduct applied research related to autism screening, diagnosis, and intervention programs and systems. In carrying out this section the Secretary shall develop standardized procedures for data management and program effectiveness and costs, including procedures--

`(1) to ensure quality monitoring of autism screening, diagnosis, and intervention programs and systems;

`(2) to provide technical assistance on data collection and management;

`(3) to study the costs and effectiveness of autism screening, diagnosis, and intervention programs and systems conducted by State-based programs in order to address issues of importance to State and national policymakers;

`(4) to identify the causes and risk factors for autism;

`(5) to study the effectiveness of autism screening, diagnosis, and intervention programs and systems by assessing the intellectual and social development, cognitive status, and language skills of children with autism at school age; and

`(6) to promote the sharing of data regarding autism with State-based birth defects and developmental disabilities monitoring programs and environmental discharge monitoring programs of the Environmental Protection Agency for the purpose of identifying previously unknown causes of and risk factors for autism.

`(c) Coordination and Collaboration-

`(1) IN GENERAL- In carrying out programs under this section, the Administrator of the Health Resources and Services Administration, the Director of the Centers for Disease Control and Prevention, and the Director of the National Institutes of Health shall collaborate and consult with--

`(A) other Federal, State and local agencies, including those responsible for early intervention services pursuant to title XIX of the Social Security Act (particularly the Medicaid Early and Periodic Screening, Diagnosis and Treatment Program), title XXI of the Social Security Act (State Children's Health Insurance Program), title V of the Social Security Act (Maternal and Child Health Block Grant Program), and part C of the Individuals with Disabilities Education Act;

`(B) consumer groups of, and that serve, individuals with autism and their families;

`(C) appropriate national medical and other health and education specialty organizations;

`(D) individuals with autism and their families;

`(E) other qualified personnel who possess the specialized knowledge, skills, and attributes needed to serve autistic children and their families; and

`(F) related commercial industries.

`(2) POLICY DEVELOPMENT- The Administrator of the Health Resources and Services Administration, the Director of the Centers for Disease Control and Prevention, and the Director of the National Institutes of Health shall coordinate and collaborate on recommendations for policy development at the Federal and State levels and with the private sector, including consumer, medical, and other health and education professional-based organizations, with respect to autism screening, diagnosis, and intervention programs and systems.

`(3) STATE EARLY DETECTION, DIAGNOSIS, AND INTERVENTION PROGRAMS AND SYSTEMS- The Administrator of the Health Resources and Services Administration and the Director of the Centers for Disease Control and Prevention shall coordinate and collaborate in assisting States to establish autism screening, diagnosis, and intervention programs and systems under subsection (a) and to develop a data collection system under subsection (b).

`(d) Physician Reimbursement for Development Screening- To make developmental screening more readily available, the Secretary, acting through the Administrator of the Centers for Medicare & Medicaid Services, shall assign a relative value unit to the diagnostic code for developmental screening.

`(e) Authorization of Appropriations- There is authorized to be appropriated--

`(1) to carry out subsection (a), $75,000,000 for each of fiscal years 2007 through 2011; and

`(2) to carry out subsection (b), $25,000,000 for each of fiscal years 2007 through 2011.

`SEC. 399EE. ANNUAL REPORT ON AUTISM.

`(a) In General- Not later than January 1, 2006, and each January 1 thereafter, the Secretary shall prepare and submit to the appropriate committees of Congress, a report concerning the implementation of this part and part J of title IV.

`(b) Contents- The report, utilizing uniform reporting methods and procedures, shall--

`(1) provide the dollar amount that each institute of the National Institutes of Health expended on autism research in the year for which the report was prepared; and

`(2) detail the progress and success of the National Institutes of Health in implementing and funding the recommendations contained in the Autism Research Roadmap and Matrix of the Interagency Autism Coordinating Committee.'.

SEC. 4. ENVIRONMENTAL HEALTH RESEARCH PROGRAMS.

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:

`SEC. 463C. ENVIRONMENTAL HEALTH RESEARCH PROGRAMS.

`(a) Centers of Excellence- The Director of NIH, acting through the Director of the Institute, shall awards grants and contracts to public or nonprofit private entities to pay all or part of the cost of planning, establishing, improving, and providing basic operating support for centers of excellence regarding environmental health and autism.

`(b) Research- Each center of excellence under subsection (a) shall conduct basic and clinical research into possible environmental causes of and risk factors for autism and the mechanisms by which they may lead to autism, and the developmental effects of environmental agents that may be associated with autism.

`(c) Coordination; Reports- The Director of NIH shall, as appropriate, provide for the coordination of information among centers of excellence established under subsection (a) and section 499B and ensure regular communication between such centers. The Director may require the periodic preparation of reports on the activities of the centers and the submission of such reports to the Director. The Director shall establish and fund mechanisms and entities for collecting, storing, and coordinating data collected by the centers established under this section and data generated from public and private research partnerships.

`(d) Organization- Each center of excellence under subsection (a) 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 of NIH.

`(e) Number of Centers; Duration-

`(1) IN GENERAL- The Director shall provide for the establishment of not less than 3 centers under subsection (a).

`(A) DURATION- A grant or contract awarded under subsection (a) shall not exceed a period of 5 years. Such period may be extended for 1 or more additional periods not exceeding 5 years if the operations of the center of excellence involved have been reviewed by an appropriate technical and scientific peer review group established by the Director of NIH and the group has recommended to the Director that such period should be extended.

`(f) Authorization of Appropriations- There is authorized to be appropriated to carry out this section, $6,000,000 for each of fiscal years 2007 through 2011.'.

END