[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3743 Introduced in Senate (IS)]








109th CONGRESS
  2d Session
                                S. 3743

  To amend the Public Health Service Act to improve newborn screening 
                  activities, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 26, 2006

Mrs. Clinton (for herself and Mr. Allen) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To amend the Public Health Service Act to improve newborn screening 
                  activities, and for other purposes.

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

SECTION 1. SHORT TITLE.

    (a) Short Title.--This Act may be cited as the ``Screening for 
Health of Infants and Newborns Act'' or the ``SHINE Act''.

SEC. 2. PURPOSES.

    The purposes of this Act are the following:
            (1) To ensure the health and quality of life of all 
        newborns in the United States by enhancing the capacity to 
        screen for heritable diseases. This enhanced capacity will 
        assist the States in making progress toward the following 
        goals:
                    (A) All babies born in hospitals in the United 
                States and the territories of the United States should 
                have access to, and be screened for, certain core 
                conditions.
                    (B) Appropriate newborn screening evaluations 
                should be conducted for all newborns to allow 
                appropriate referrals and provisions for early medical 
                intervention.
                    (C) Newborn screening data collection should be 
                standardized, and conditions detected by newborn 
                screening should be tracked and monitored.
                    (D) Information on newborn screening and conditions 
                for which a patient can be screened should be readily 
                accessible, current, and understandable to both health 
                care providers and parents. Information should include 
                the following:
                            (i) A component for rehabilitation, 
                        medical, and early intervention options that 
                        ensure linkage to any new and existing national 
                        or State system of intervention.
                            (ii) Rehabilitative services for newborns 
                        with the conditions.
                    (E) Newborn screening should be expanded to include 
                more conditions, and additional newborn screening tests 
                should be developed to enhance the health of newborns.
            (2) To expand newborn screening, and improve systems to 
        make newborn screening more efficient and effective, by 
        authorizing--
                    (A) statewide newborn screening and medical 
                evaluation systems and intervention programs;
                    (B) technical assistance;
                    (C) national demonstration grant programs; and
                    (D) interagency collaborations between the 
                appropriate Federal agencies, including the Agency for 
                Healthcare Research and Quality, Centers for Disease 
                Control and Prevention, Food and Drug Administration, 
                Health Resources and Services Administration, and 
                National Institutes of Health.

SEC. 3. NEWBORN SCREENING GUIDELINES AND GRANT PROGRAMS.

    Part A of title XI of the Public Health Service Act (42 U.S.C. 
300b-1 et seq.) is amended by adding at the end the following:

``SEC. 1112. RECOMMENDED GUIDELINES FOR NEWBORN SCREENING AND DATA 
              COLLECTION; MONITORING AND EVALUATION.

    ``(a) Recommended Guidelines for Newborn Screening and Data 
Collection.--
            ``(1) In general.--The Director of the Centers for Disease 
        Control and Prevention (referred to in this section as the 
        `Director'), in collaboration with the Associate Administrator 
        of the Maternal and Child Health Bureau of the Health Resources 
        and Services Administration and the Advisory Committee on 
        Heritable Disorders and Genetic Diseases in Newborns and 
        Children (referred to in this section as the `Advisory 
        Committee'), shall develop specific guidelines that the States 
        may follow in reporting newborn screening data, as requested by 
        the Advisory Committee, from newborn screening tests, including 
        the screening tests for the core conditions designated by the 
        Newborn Screening Expert Group convened by the American College 
        of Medical Genetics, as commissioned by the Health Resources 
        and Services Administration.
            ``(2) Guidelines.--The guidelines developed under paragraph 
        (1) shall include--
                    ``(A) standardizing the case definitions and names 
                of the disorders for which newborn screening tests are 
                performed and the definitions of performance measures 
                used to evaluate such tests so that performance 
                criteria and outcomes among all States may be 
                evaluated;
                    ``(B) establishing procedures for standardized 
                newborn screening data collection and reporting; and
                    ``(C) ensuring that tests and technologies used by 
                each State meet established standards for detecting and 
                reporting positive screening results.
            ``(3) Implementation.--The Director shall submit the 
        guidelines described in this subsection to the Secretary. Not 
        later than 90 days after receiving the guidelines, the 
        Secretary, in consultation with the Director, the Administrator 
        of the Health Resources and Services Administration (referred 
        to in this section as the `Administrator'), and the Assistant 
        Administrator of the Maternal and Child Health Bureau, shall 
        implement such guidelines.
            ``(4) Annual report.--Not later than 2 years after the date 
        of enactment of the Screening for Health of Infants and 
        Newborns Act, and each year thereafter, the Advisory Committee 
        shall--
                    ``(A) publish an annual report on newborn screening 
                guidelines in the United States;
                    ``(B) submit such report to the appropriate 
                committees of Congress, the Secretary, and the State 
                departments of health; and
                    ``(C) disseminate such report on as wide a basis as 
                practicable.
    ``(b) Recommended Guidelines for Monitoring, Evaluation, and 
Surveillance of Newborn Screening.--
            ``(1) In general.--
                    ``(A) Development.--The Secretary, acting through 
                the Administrator and in consultation with the Director 
                and the Advisory Committee, shall develop guidelines 
                to--
                            ``(i) monitor and evaluate newborn 
                        screening activities, including diagnosis, 
                        screening, follow-up, and treatment activities, 
                        in the United States; and
                            ``(ii) coordinate the results of 
                        surveillance activities in order to enhance 
                        monitoring of newborn diseases.
                    ``(B) Duties.--In carrying out this paragraph, the 
                Administrator, in consultation with the Advisory 
                Committee and the Director, shall collaborate with non-
                Governmental organizations, such as the Joint 
                Commission on Accreditation of Hospital Organizations, 
                laboratories certified by the Clinical Laboratory 
                Improvement Amendment (referred to in the part as 
                `CLIA'), and the Association of Public Health 
                Laboratories to ensure effective monitoring and 
                evaluation of newborn screening activities.
            ``(2) Implementation.--Not later than 90 days after the 
        development of the guidelines under paragraph (1), the 
        Secretary, in consultation with the Director, the 
        Administrator, and the Assistant Administrator of the Maternal 
        and Child Health Bureau, shall implement such guidelines.
    ``(c) Surveillance and Identification Research.--The Secretary, 
acting through the Director and the National Center on Birth Defects 
and Developmental Disabilities, and in consultation with the 
Administrator and Advisory Committee, shall develop a surveillance 
system for newborn screening. The system shall use the standardized 
procedures and guidelines developed under subsection (b) for data 
management and tracking program effectiveness and costs, in order to--
            ``(1) ensure quality monitoring of newborn screening and 
        medical evaluation systems and intervention programs;
            ``(2) provide technical assistance on data collection and 
        management;
            ``(3) study the cost and effectiveness of newborn screening 
        and medical evaluation systems and intervention programs 
        conducted by State-based programs in order to answer issues of 
        importance to national and State policymakers; and
            ``(4) identify the causes of, and risk factors for, 
        heritable disorders.
    ``(d) Advisory Committee Meetings.--The Advisory Committee shall 
meet not less than annually to--
            ``(1) assess the implementation of the guidelines and 
        surveillance activities developed under this section;
            ``(2) advise the Secretary with respect to--
                    ``(A) such guidelines; and
                    ``(B) monitoring and evaluating newborn screening 
                and surveillance activities;
            ``(3) consider ways to ensure that States attain the 
        capacity to screen for the core conditions described in 
        subsection (a)(1), and include in such consideration the 
        results of the demonstration projects funded under section 
        1115; and
            ``(4) consider any addition to the list of the core 
        conditions described in subsection (a)(1), and include in such 
        consideration the results of the demonstration projects funded 
        under section 1116.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section--
            ``(1) $10,000,000 for fiscal year 2007; and
            ``(2) such sums as necessary for fiscal year 2008 through 
        2011.

``SEC. 1113. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION.

    ``(a) Clearinghouse.--The Secretary shall direct the Maternal and 
Child Health Bureau of the Health Resources and Services 
Administration, working through the Regional Genetic and Newborn 
Screening Collaborative Groups of such Bureau, the National 
Coordinating Center, and the National Newborn Screening and Genetic 
Resource Center, to collaborate with the Director of the Centers for 
Disease Control and Prevention and the National Library of Medicine of 
the National Institutes of Health to establish and maintain a central 
clearinghouse of current educational and family support and services 
information, materials, resources, research, and data on newborn 
screening to--
            ``(1) enable parents and family members of newborns, health 
        professionals, industry representatives, and other members of 
        the public to increase their awareness, knowledge, and 
        understanding of newborn screening;
            ``(2) increase awareness, knowledge, and understanding of 
        newborn diseases and screening services for individuals wishing 
        to have children and expectant families; and
            ``(3) develop and maintain current data on quality 
        indicators to measure performance of newborn screening 
        entities, such as false-positive rates and other quality 
        indicators as determined by the Advisory Committee described 
        under section 1112.
    ``(b) Internet Availability.--The Health Resources and Services 
Administration shall ensure that the clearinghouse described under 
subsection (a)--
            ``(1) is available on the Internet;
            ``(2) includes an interactive forum;
            ``(3) is updated on a regular basis, but not less than 
        quarterly; and
            ``(4) provides--
                    ``(A) links to Government-sponsored, nonprofit, and 
                other websites of laboratories that have demonstrated 
                expertise in newborn screening that supply research-
                based information on newborn screening tests currently 
                available throughout the United States;
                    ``(B) information about newborn conditions and 
                screening services available in each State, including 
                the ability of infants to obtain additional 
                comprehensive screening services that may not be 
                required in the State where the infant is born, from 
                CLIA-certified laboratories for disorders;
                    ``(C) current research on both treatable and not-
                yet treatable conditions for which newborn screening 
                tests are available;
                    ``(D) information about newborn diseases and 
                screening services available in each State; and
                    ``(E) other relevant information as determined 
                appropriate by the Secretary.
    ``(c) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section--
            ``(1) $5,000,000 for fiscal year 2007; and
            ``(2) such sums as necessary for fiscal years 2008 through 
        2011.

``SEC. 1114. INTERAGENCY GRANT REVIEW PANEL.

    ``(a) Definition of SHINE Grant Program.--In this section, the term 
`Screening for Health of Infants and Newborns grant program' or `SHINE 
grant program' means any grant program under section 1115 or 1116.
    ``(b) Review Panel.--The Secretary shall appoint an Interagency 
Grant Review Panel to review grant applications and provide oversight 
of the SHINE grant program.
    ``(c) Membership.--The Secretary shall ensure that the Interagency 
Grant Review Panel includes representation from all appropriate Federal 
agencies, including the Agency for Healthcare Research and Quality, the 
Centers for Disease Control and Prevention, the Food and Drug 
Administration, the Health Resources and Services Administration, and 
the National Institutes of Health.
    ``(d) Duties.--
            ``(1) Duties of the secretary.--After the last day of the 
        application period for a SHINE grant program, the Secretary 
        shall forward the grant applications received for the program 
        to the Interagency Grant Review Panel.
            ``(2) Duties of the interagency grant review panel.--
                    ``(A) Selection of grant recipients.--Upon receipt 
                of the grant applications for a SHINE grant program 
                from the Secretary, the Interagency Grant Review Panel 
                shall review the applications for grants under the 
                program and shall select, on a competitive basis, all 
                of the grant recipients for the program and the amount 
                of each grant award.
                    ``(B) Submission of grant recipients.--The 
                Interagency Grant Review Panel shall submit the list of 
                award recipients for grants under a SHINE grant program 
                to the Secretary at a time determined by the Secretary, 
                but not later than 90 days after the last day of the 
                application period for a grant under such program.
                    ``(C) Oversight of grants.--The Interagency Grant 
                Review Panel shall provide oversight of the programs 
                and activities funded by grants under a SHINE grant 
                program, and shall report to the Secretary on the 
                program and activities as the Secretary or the Panel 
                determines necessary.

``SEC. 1115. CAPACITY GRANT PROGRAM.

    ``(a) In General.--The Secretary shall award grants, in conjunction 
with the Interagency Grant Review Panel established under section 1114, 
to eligible entities for demonstration projects that increase the 
capacity of a State to screen for all of the core conditions designated 
by the Advisory Committee described under section 1112. Such grants 
shall be made on a competitive basis.
    ``(b) Eligibility.--To be eligible to receive a grant under this 
section, an entity shall--
            ``(1) submit to the Secretary an application at such time, 
        in such manner, and containing such information as the 
        Secretary may require;
            ``(2) be a public or private organization, including an 
        academic research center, medical center, physician group, 
        newborn screening program, or CLIA-certified laboratory with 
        expertise in newborn metabolic screening;
            ``(3) provide assurance that such organization will work in 
        consultation with the appropriate State department of health;
            ``(4) have the capacity to perform the core newborn 
        screening tests described in subsection (a) and to collect and 
        report data on the costs, benefits, and effectiveness of such 
        tests, in consultation with the appropriate State department of 
        health and in accordance with the guidelines implemented under 
        section 1112;
            ``(5) demonstrate sustainability of such activities based 
        on the outcomes of the demonstration project; and
            ``(6) if applicable, submit to the Secretary a plan for 
        follow-up, diagnosis, and treatment of those infants who test 
        positive on newborn screening tests developed under this 
        section.
    ``(c) Report to Secretary and Interagency Panel.--An organization 
that receives a grant under this section shall, on an annual basis, 
submit to the Secretary and the Interagency Grant Review Panel 
established under section 1114 a report that describes the activities 
conducted pursuant to such grant and the outcomes of such activities.
    ``(d) Evaluation and Results.--The Secretary shall--
            ``(1) evaluate the demonstration projects funded under this 
        section; and
            ``(2) on an annual basis--
                    ``(A) publish and disseminate the results of such 
                evaluation on as wide a basis as is practicable; and
                    ``(B) submit to the appropriate committees of 
                Congress the results of such evaluation.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section--
            ``(1) $10,000,000 for fiscal year 2007; and
            ``(2) such sums as necessary for fiscal years 2008 through 
        2011.

``SEC. 1116. HUNTER KELLY GRANT PROGRAM.

    ``(a) Additional Newborn Screening Tests Grants.--
            ``(1) In general.--The Secretary shall award grants (to be 
        known as Hunter Kelly Newborn Screening grants), in conjunction 
        with the Interagency Grant Review Panel established under 
        section 1114, to eligible entities to carry out demonstration 
        projects that develop screening tests for additional newborn 
        conditions, such as tests for Krabbe disease and Insulin 
        Dependent Diabetes Mellitus, or develop multiple markers to 
        increase the specificity of newborn screening tests. Such 
        grants shall be made on a competitive basis.
            ``(2) Additional newborn condition.--For purposes of this 
        subsection, the term `additional newborn condition' means any 
        condition that is not one of the core conditions designated by 
        the Advisory Committee described under section 1112.
    ``(b) Eligibility.--To be eligible to receive a grant under this 
section, an entity shall--
            ``(1) submit to the Secretary an application at such time, 
        in such manner, and containing such information as the 
        Secretary may require;
            ``(2) be a public or private organization including, an 
        academic research center, medical center, physician group, 
        newborn screening program, or CLIA-certified laboratory with 
        expertise in newborn metabolic screening;
            ``(3) provide assurance that such entity will work in 
        consultation with the appropriate State department of health;
            ``(4) submit to the Secretary a strategic plan for 
        performing additional newborn screening tests and for 
        collecting and reporting data on the costs, benefits, and 
        effectiveness of such tests, in consultation with the 
        appropriate State department of health;
            ``(5) demonstrate sustainability of such activities based 
        on the outcomes of the demonstration project;
            ``(6) provide assurance that the entity will develop 
        newborn screening tests that are not currently performed in the 
        State in which the entity is located; and
            ``(7) if applicable, submit to the Secretary a plan for 
        short- and long-term follow-up, diagnosis, and treatment of 
        those infants who test positive on newborn screening tests 
        developed under this section.
    ``(c) Report to Secretary and Interagency Panel.--An organization 
that receives a grant under this section shall, on an annual basis, 
submit to the Secretary and the Interagency Grant Review Panel 
established under section 1114 a report that describes the activities 
conducted pursuant to such grant and the outcomes of such activities.
    ``(d) Evaluation and Results.--The Secretary shall--
            ``(1) evaluate the demonstration projects funded under this 
        section; and
            ``(2) on an annual basis--
                    ``(A) publish and disseminate the results of such 
                evaluation on as wide a basis as is practicable; and
                    ``(B) submit to the appropriate committees of 
                Congress the results of such evaluation.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section--
            ``(1) $30,000,000 for fiscal year 2007; and
            ``(2) such sums as necessary for fiscal years 2008 through 
        2011.

``SEC. 1117. PRIVACY PROTECTIONS.

    ``Except to the extent inconsistent with this part, the provision 
of information pursuant to sections 1112 through 1116, and any 
subsequent transfer of such information in accordance with those 
sections, are subject to any requirement that would otherwise apply 
under the regulations promulgated pursuant to section 264(c) of the 
Health Insurance Portability and Accountability Act of 1996.''.
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