[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5397 Introduced in House (IH)]








109th CONGRESS
  2d Session
                                H. R. 5397

 To amend the Public Health Service Act to establish grant programs to 
provide for education and outreach on newborn screening and coordinated 
followup care once newborn screening has been conducted, to reauthorize 
 programs under part A of title XI of such Act, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 16, 2006

    Ms. Roybal-Allard (for herself and Mr. Simpson) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act to establish grant programs to 
provide for education and outreach on newborn screening and coordinated 
followup care once newborn screening has been conducted, to reauthorize 
 programs under part A of title XI of such Act, 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.

    This Act may be cited as the ``Newborn Screening Saves Lives Act of 
2006''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Currently, it is possible to test for more than 30 
        disorders through newborn screening.
            (2) There is a lack of uniform newborn screening throughout 
        the United States. While a newborn with a debilitating 
        condition may receive screening, early detection, and treatment 
        in 1 location, in another location the condition may go 
        undetected and result in catastrophic consequences.
            (3) Each year more than 4,000,000 babies are screened by 
        State and private laboratories to detect conditions that may 
        threaten their long-term health.
            (4) There are more than 2,000 babies born every year in the 
        United States with detectable and treatable disorders that go 
        unscreened through newborn screening.

SEC. 3. AMENDMENT TO TITLE III OF THE PUBLIC HEALTH SERVICE ACT.

    Part Q of title III of the Public Health Service Act (42 U.S.C. 
280h et seq.) is amended by adding at the end the following:

``SEC. 399AA. NEWBORN SCREENING.

    ``(a) Authorization of Grant Programs.--
            ``(1) Grants to assist health care professionals.--From 
        funds appropriated under subsection (h), the Secretary, acting 
        through the Associate Administrator of the Maternal and Child 
        Health Bureau of the Health Resources and Services 
        Administration (referred to in this section as the `Associate 
        Administrator') and in consultation with the Advisory Committee 
        on Heritable Disorders in Newborns and Children (referred to in 
        this section as the `Advisory Committee'), shall award grants 
        to eligible entities to enable such entities to assist in 
        providing health care professionals and newborn screening 
        laboratory personnel with--
                    ``(A) education in newborn screening; and
                    ``(B) training in--
                            ``(i) relevant and new technologies in 
                        newborn screening; and
                            ``(ii) congenital, genetic, and metabolic 
                        disorders.
            ``(2) Grants to assist families.--
                    ``(A) In general.--From funds appropriated under 
                subsection (h), the Secretary, acting through the 
                Associate Administrator and in consultation with the 
                Advisory Committee, shall award grants to eligible 
                entities to enable such entities to develop and deliver 
                educational programs about newborn screening to 
                parents, families, and patient advocacy and support 
                groups. The educational materials accompanying such 
                educational programs shall be provided at appropriate 
                literacy levels.
                    ``(B) Awareness of the availability of programs.--
                To the extent practicable, the Secretary shall make 
                relevant health care providers aware of the 
                availability of the educational programs supported 
                pursuant to subparagraph (A).
            ``(3) Grants for quality newborn screening followup.--From 
        funds appropriated under subsection (h), the Secretary, acting 
        through the Associate Administrator and in consultation with 
        the Advisory Committee, shall award grants to eligible entities 
        to enable such entities to establish, maintain, and operate a 
        system to assess and coordinate treatment relating to 
        congenital, genetic, and metabolic disorders.
    ``(b) Application.--An eligible entity that desires to receive a 
grant under this section shall submit an application to the Secretary 
at such time, in such manner, and accompanied by such information as 
the Secretary may require.
    ``(c) Selection of Grant Recipients.--
            ``(1) In general.--Not later than 120 days after receiving 
        an application under subsection (b), the Secretary, after 
        considering the approval factors under paragraph (2), shall 
        determine whether to award the eligible entity a grant under 
        this section.
            ``(2) Approval factors.--
                    ``(A) Requirements for approval.--An application 
                submitted under subsection (b) may not be approved by 
                the Secretary unless the application contains 
                assurances that the eligible entity--
                            ``(i) will use grant funds only for the 
                        purposes specified in the approved application 
                        and in accordance with the requirements of this 
                        section; and
                            ``(ii) will establish such fiscal control 
                        and fund accounting procedures as may be 
                        necessary to assure proper disbursement and 
                        accounting of Federal funds paid to the 
                        eligible entity under the grant.
                    ``(B) Existing programs.--Prior to awarding a grant 
                under this section, the Secretary shall--
                            ``(i) conduct an assessment of existing 
                        educational resources and training programs and 
                        coordinated systems of followup care with 
                        respect to newborn screening; and
                            ``(ii) take all necessary steps to minimize 
                        the duplication of the resources and programs 
                        described in clause (i).
    ``(d) Coordination.--The Secretary shall take all necessary steps 
to coordinate programs funded with grants received under this section.
    ``(e) Use of Grant Funds.--
            ``(1) Grants to assist health care professionals.--An 
        eligible entity that receives a grant under subsection (a)(1) 
        may use the grant funds to work with appropriate medical 
        schools, nursing schools, schools of public health, schools of 
        genetic counseling, internal education programs in State 
        agencies, nongovernmental organizations, and professional 
        organizations and societies to develop and deliver education 
        and training programs that include--
                    ``(A) continuing medical education programs for 
                health care professionals and newborn screening 
                laboratory personnel in newborn screening;
                    ``(B) education, technical assistance, and training 
                on new discoveries in newborn screening and the use of 
                any related technology;
                    ``(C) models to evaluate the prevalence of, and 
                assess and communicate the risks of, congenital 
                conditions, including the prevalence and risk of some 
                of these conditions based on family history;
                    ``(D) models to communicate effectively with 
                parents and families about--
                            ``(i) the process and benefits of newborn 
                        screening;
                            ``(ii) how to use information gathered from 
                        newborn screening;
                            ``(iii) the meaning of screening results, 
                        including the possibility of false positive 
                        findings;
                            ``(iv) the right of refusal of newborn 
                        screening, if applicable; and
                            ``(v) the potential need for followup care 
                        after newborns are screened;
                    ``(E) information and resources on coordinated 
                systems of followup care after newborns are screened;
                    ``(F) information on the disorders for which States 
                require and offer newborn screening and options for 
                newborn screening relating to conditions in addition to 
                such disorders;
                    ``(G) information on additional newborn screening 
                that may not be required by the State, but that may be 
                available from other sources; and
                    ``(H) other items to carry out the purpose 
                described in subsection (a)(1) as determined 
                appropriate by the Secretary.
            ``(2) Grants to assist families.--An eligible entity that 
        receives a grant under subsection (a)(2) may use the grant 
        funds to develop and deliver to parents, families, and patient 
        advocacy and support groups, educational programs about newborn 
        screening that include information on--
                    ``(A) what newborn screening is;
                    ``(B) how newborn screening is performed;
                    ``(C) who performs newborn screening;
                    ``(D) where newborn screening is performed;
                    ``(E) the disorders for which the State requires 
                newborns to be screened;
                    ``(F) different options for newborn screening for 
                disorders other than those included by the State in the 
                mandated newborn screening program;
                    ``(G) the meaning of various screening results, 
                including the possibility of false positive and false 
                negative findings;
                    ``(H) the prevalence and risk of newborn disorders, 
                including the increased risk of disorders that may stem 
                from family history;
                    ``(I) coordinated systems of followup care after 
                newborns are screened; and
                    ``(J) other items to carry out the purpose 
                described in subsection (a)(2) as determined 
                appropriate by the Secretary.
            ``(3) Grants for quality newborn screening followup.--An 
        eligible entity that receives a grant under subsection (a)(3) 
        shall use the grant funds to--
                    ``(A) expand on existing procedures and systems, 
                where appropriate and available, for the timely 
                reporting of newborn screening results to individuals, 
                families, primary care physicians, and subspecialists 
                in congenital, genetic, and metabolic disorders;
                    ``(B) coordinate ongoing followup treatment with 
                individuals, families, primary care physicians, and 
                subspecialists in congenital, genetic, and metabolic 
                disorders after a newborn receives an indication of the 
                presence or increased risk of a disorder on a screening 
                test;
                    ``(C) ensure the seamless integration of 
                confirmatory testing, tertiary care medical services, 
                comprehensive genetic services including genetic 
                counseling, and information about access to developing 
                therapies by participation in approved clinical trials 
                involving the primary health care of the infant;
                    ``(D) analyze data, if appropriate and available, 
                collected from newborn screenings to identify 
                populations at risk for disorders affecting newborns, 
                examine and respond to health concerns, recognize and 
                address relevant environmental, behavioral, 
                socioeconomic, demographic, and other relevant risk 
                factors; and
                    ``(E) carry out such other activities as the 
                Secretary may determine necessary.
    ``(f) Reports to Congress.--
            ``(1) In general.--Subject to paragraph (2), the Secretary 
        shall submit to the appropriate committees of Congress 
        reports--
                    ``(A) evaluating the effectiveness and the impact 
                of the grants awarded under this section--
                            ``(i) in promoting newborn screening--
                                    ``(I) education and resources for 
                                families; and
                                    ``(II) education, resources, and 
                                training for health care professionals;
                            ``(ii) on the successful diagnosis and 
                        treatment of congenital, genetic, and metabolic 
                        disorders; and
                            ``(iii) on the continued development of 
                        coordinated systems of followup care after 
                        newborns are screened;
                    ``(B) describing and evaluating the effectiveness 
                of the activities carried out with grant funds received 
                under this section; and
                    ``(C) that include recommendations for Federal 
                actions to support--
                            ``(i) education and training in newborn 
                        screening; and
                            ``(ii) followup care after newborns are 
                        screened.
            ``(2) Timing of reports.--The Secretary shall submit--
                    ``(A) an interim report that includes the 
                information described in paragraph (1), not later than 
                30 months after the date on which the first grant funds 
                are awarded under this section; and
                    ``(B) a subsequent report that includes the 
                information described in paragraph (1), not later than 
                60 months after the date on which the first grant funds 
                are awarded under this section.
    ``(g) Definition of Eligible Entity.--In this section, the term 
`eligible entity' means--
            ``(1) a State or a political subdivision of a State;
            ``(2) a consortium of 2 or more States or political 
        subdivisions of States;
            ``(3) a territory;
            ``(4) an Indian tribe or a hospital or outpatient health 
        care facility of the Indian Health Service; or
            ``(5) a nongovernmental organization with appropriate 
        expertise in newborn screening, as determined by the Secretary.
    ``(h) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section--
            ``(1) $15,000,000 for fiscal year 2007; and
            ``(2) such sums as may be necessary for each of fiscal 
        years 2008 through 2011.''.

SEC. 4. IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE DISORDERS.

    Section 1109 of the Public Health Service Act (42 U.S.C. 300b-8) is 
amended--
            (1) in subsection (c)(2)--
                    (A) in subparagraph (E), by striking ``and'' after 
                the semicolon;
                    (B) by redesignating subparagraph (F) as 
                subparagraph (G); and
                    (C) by inserting after subparagraph (E) the 
                following:
                    ``(F) an assurance that the entity has adopted and 
                implemented, is in the process of adopting and 
                implementing, or will use grant amounts received under 
                this section to adopt and implement the guidelines and 
                recommendations of the Advisory Committee on Heritable 
                Disorders in Newborns and Children established under 
                section 1111 (referred to in this section as the 
                `Advisory Committee') that are adopted by the Secretary 
                and in effect at the time the grant is awarded or 
                renewed under this section, which shall include the 
                screening of each newborn for the heritable disorders 
                recommended by the Advisory Committee and adopted by 
                the Secretary and the reporting of results; and''; and
            (2) in subsection (i), by striking ``such sums'' and all 
        that follows through the period at the end and inserting 
        ``$25,000,000 for fiscal year 2007 and such sums as may be 
        necessary for each of the fiscal years 2008 through 2011.''.

SEC. 5. EVALUATING THE EFFECTIVENESS OF NEWBORN- AND CHILD-SCREENING 
              PROGRAMS.

    Section 1110 of the Public Health Service Act (42 U.S.C. 300b-9) is 
amended by adding at the end the following:
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $5,000,000 for fiscal year 2007 
and such sums as may be necessary for each of the fiscal years 2008 
through 2011.''.

SEC. 6. ADVISORY COMMITTEE ON HERITABLE DISORDERS IN NEWBORNS AND 
              CHILDREN.

    Section 1111 of the Public Health Service Act (42 U.S.C. 300b-10) 
is amended--
            (1) in subsection (b)--
                    (A) by redesignating paragraph (3) as paragraph 
                (5);
                    (B) in paragraph (2), by striking ``and'' after the 
                semicolon;
                    (C) by inserting after paragraph (2) the following:
            ``(3) recommend a uniform screening panel for newborn 
        screening programs that includes the heritable disorders for 
        which all newborns should be screened, including secondary 
        conditions that may be identified as a result of the laboratory 
        methods used for screening;
            ``(4) develop a model decision-matrix for newborn screening 
        program expansion, and periodically update the recommended 
        uniform screening panel described in paragraph (3) based on 
        such decision-matrix; and''; and
                    (D) in paragraph (5) (as redesignated by 
                subparagraph (A)), by striking the period at the end 
                and inserting ``, including recommendations, advice, or 
                information dealing with--
                    ``(A) followup activities, including those 
                necessary to achieve rapid diagnosis in the short term, 
                and those that ascertain long-term case management 
                outcomes and appropriate access to related services;
                    ``(B) diagnostic and other technology used in 
                screening;
                    ``(C) the availability and reporting of testing for 
                conditions for which there is no existing treatment;
                    ``(D) minimum standards and related policies and 
                procedures for State newborn screening programs;
                    ``(E) quality assurance, oversight, and evaluation 
                of State newborn screening programs;
                    ``(F) data collection for assessment of newborn 
                screening programs;
                    ``(G) public and provider awareness and education;
                    ``(H) language and terminology used by State 
                newborn screening programs;
                    ``(I) confirmatory testing and verification of 
                positive results; and
                    ``(J) harmonization of laboratory definitions for 
                results that are within the expected range and results 
                that are outside of the expected range.''; and
            (2) by adding at the end the following:
    ``(d) Decision on Recommendations.--
            ``(1) In general.--Not later than 180 days after the 
        Advisory Committee issues a recommendation pursuant to this 
        section, the Secretary shall adopt or reject such 
        recommendation.
            ``(2) Pending recommendations.--The Secretary shall adopt 
        or reject any recommendation issued by the Advisory Committee 
        that is pending on the date of enactment of the Newborn 
        Screening Saves Lives Act of 2006 by not later than 180 days 
        after the date of enactment of such Act.
            ``(3) Determinations to be made public.--The Secretary 
        shall publicize any determination on adopting or rejecting a 
        recommendation of the Advisory Committee pursuant to this 
        subsection, including the justification for the determination.
    ``(e) Continuation of Operation of Committee.--Notwithstanding 
section 14 of the Federal Advisory Committee Act (5 U.S.C. App.), the 
Advisory Committee shall continue to operate during the 5-year period 
beginning on the date of enactment of the Newborn Screening Saves Lives 
Act of 2006.''.

SEC. 7. LABORATORY QUALITY AND SURVEILLANCE.

    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. LABORATORY QUALITY.

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention and in consultation with 
the Advisory Committee on Heritable Disorders in Newborns and Children 
established under section 1111, shall provide for--
            ``(1) quality assurance for laboratories involved in 
        screening newborns and children for heritable disorders, 
        including quality assurance for newborn-screening tests, 
        performance evaluation services, and technical assistance and 
        technology transfer to newborn screening laboratories to ensure 
        analytic validity and utility of screening tests; and
            ``(2) population-based pilot testing for new screening 
        tools for evaluating use on a mass scale.
    ``(b) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $5,000,000 
for fiscal year 2007 and such sums as may be necessary for each of the 
fiscal years 2008 through 2011.

``SEC. 1113. SURVEILLANCE PROGRAMS FOR HERITABLE DISORDERS SCREENING.

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, shall carry out 
programs--
            ``(1) to collect, analyze, and make available data on the 
        heritable disorders recommended by the Advisory Committee on 
        Heritable Disorders in Newborns and Children established under 
        section 1111, including data on the causes of such disorders 
        and on the incidence and prevalence of such disorders;
            ``(2) to operate regional centers for the conduct of 
        applied epidemiological research on the prevention of such 
        disorders;
            ``(3) to provide information and education to the public on 
        the prevention of such disorders; and
            ``(4) to conduct research on and to promote the prevention 
        of such disorders, and secondary health conditions among 
        individuals with such disorders.
    ``(b) Grants and Contracts.--
            ``(1) In general.--In carrying out subsection (a), the 
        Secretary may make grants to and enter into contracts with 
        public and nonprofit private entities.
            ``(2) Supplies and services in lieu of award funds.--
                    ``(A) In general.--Upon the request of a recipient 
                of an award of a grant or contract under paragraph (1), 
                the Secretary may, subject to subparagraph (B), provide 
                supplies, equipment, and services for the purpose of 
                aiding the recipient in carrying out the purposes for 
                which the award is made and, for such purposes, may 
                detail to the recipient any officer or employee of the 
                Department of Health and Human Services.
                    ``(B) Reduction.--With respect to a request 
                described in subparagraph (A), the Secretary shall 
                reduce the amount of payments under the award involved 
                by an amount equal to the costs of detailing personnel 
                and the fair market value of any supplies, equipment, 
                or services provided by the Secretary. The Secretary 
                shall, for the payment of expenses incurred in 
                complying with such request, expend the amounts 
                withheld.
            ``(3) Application for award.--The Secretary may make an 
        award of a grant or contract under paragraph (1) only if an 
        application for the award is submitted to the Secretary and the 
        application is in such form, is made in such manner, and 
        contains such agreements, assurances, and information as the 
        Secretary determines to be necessary to carry out the purposes 
        for which the award is to be made.
    ``(c) Biennial Report.--Not later than February 1 of fiscal year 
2007 and of every second such year thereafter, the Secretary shall 
submit to the Committee on Energy and Commerce of the House of 
Representatives, and the Committee on Health, Education, Labor, and 
Pensions of the Senate, a report that, with respect to the preceding 2 
fiscal years--
            ``(1) contains information regarding the incidence and 
        prevalence of heritable disorders and the health status of 
        individuals with such disorders and the extent to which such 
        disorders have contributed to the incidence and prevalence of 
        infant mortality and affected quality of life;
            ``(2) contains information under paragraph (1) that is 
        specific to various racial and ethnic groups (including 
        Hispanics, non-Hispanic whites, Blacks, Native Americans, and 
        Asian Americans);
            ``(3) contains an assessment of the extent to which various 
        approaches of preventing heritable disorders and secondary 
        health conditions among individuals with such disorders have 
        been effective;
            ``(4) describes the activities carried out under this 
        section;
            ``(5) contains information on the incidence and prevalence 
        of individuals living with heritable disorders, information on 
        the health status of individuals with such disorders, 
        information on any health disparities experienced by such 
        individuals, and recommendations for improving the health and 
        wellness and quality of life of such individuals;
            ``(6) contains a summary of recommendations from all 
        heritable disorders research conferences sponsored by the 
        Centers for Disease Control and Prevention; and
            ``(7) contains any recommendations of the Secretary 
        regarding this section.
    ``(d) Applicability of Privacy Laws.--The provisions of this 
section shall be subject to the requirements of section 552a of title 
5, United States Code. All Federal laws relating to the privacy of 
information shall apply to the data and information that is collected 
under this section.
    ``(e) Coordination.--
            ``(1) In general.--In carrying out this section, the 
        Secretary shall coordinate, to the extent practicable, programs 
        under this section with programs on birth defects and 
        developmental disabilities authorized under section 317C.
            ``(2) Priority in grants and contracts.--In making grants 
        and contracts under this section, the Secretary shall give 
        priority to entities that demonstrate the ability to coordinate 
        activities under a grant or contract made under this section 
        with existing birth defects surveillance activities.
    ``(f) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $15,000,000 
for fiscal year 2007 and such sums as may be necessary for each of the 
fiscal years 2008 through 2011.''.
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