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, and for other purposes.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Newborn Screening Saves Lives Act of 
2004''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Currently, it is possible to test for at least 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 one 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 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 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 State health department 
        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.--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.
            ``(3) Grants for 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, 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 State health department 
                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 what a newborn should be 
                screened for and when and where that screening should 
                take place;
                    ``(D) models to evaluate the prevalence of, and 
                assess and communicate the risks of, newborn disorders, 
                including the prevalence and risk of certain newborn 
                disorders based on family history;
                    ``(E) 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 rate of false positives;
                            ``(iv) the right of refusal of newborn 
                        screening; and
                            ``(v) the potential need for followup care 
                        after newborns are screened;
                    ``(F) information and resources on coordinated 
                systems of followup care after newborns are screened;
                    ``(G) 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;
                    ``(H) information on supplemental newborn screening 
                that the States do not require and offer but that 
                parents may want; and
                    ``(I) 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 is newborn screening;
                    ``(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 rate of false positives;
                    ``(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 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 2005; and
            ``(2) such sums as may be necessary for each of fiscal 
        years 2006 through 2009.''.

Summary: Newborn Screening Saves Lives Act of 2004 - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Associate Administrator of the Maternal and Child Health Bureau of the Health Resources and Services Administration, to awards grants to eligible entities to: (1) provide education and training in newborn screening and congenital, genetic, and metabolic disorders to health care professionals and State health department laboratory personnel; (2) develop educational programs about newborn screening for parents, families, and parents advocacy and support groups; and (3) establish, maintain, and operate a system to assess and coordinate treatment relating to congenital, genetic, and metabolic disorders.