[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3825 Introduced in House (IH)]







110th CONGRESS
  1st Session
                                H. R. 3825

 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

                            October 15, 2007

  Ms. Roybal-Allard (for herself, Mr. Simpson, Mr. Reynolds, and Mr. 
   Waxman) 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 
2007''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Each year more than 4,000,000 babies born in the United 
        States are screened by State and private laboratories to detect 
        some conditions that may threaten their long-term health.
            (2) However, there is a lack of uniformity in the number of 
        conditions for which newborns are screened throughout the 
        United States. While a newborn may be screened and treated for 
        a debilitating condition in one State, in another State, the 
        condition may go undetected and result in permanent disability 
        or even death.
            (3) Approximately 4,000 infants born each year are 
        diagnosed with these detectable and treatable disorders. If 
        diagnosed early, these conditions can be successfully managed 
        or treated to prevent severe and often lifelong health 
        consequences.
            (4) In 2004, the American College of Medical Genetics 
        (ACMG) completed a report commissioned by the Department of 
        Health and Human Services which recommended that every baby 
        born in the United States be screened for 29 specific 
        disorders, including certain metabolic conditions and hearing 
        deficiencies.
            (5) Currently only 11 States and the District of Columbia 
        require infants to be screened for all 29 of these recommended 
        disorders.
            (6) Continuity, especially during a public health 
        emergency, plays a critical role in the screening, diagnosis, 
        referral, and treatment of these disorders. Currently there is 
        no national contingency plan for maintaining continuity of 
        newborn screening systems following a public health emergency.

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. 399Z-1. NEWBORN SCREENING.

    ``(a) Authorization of Grant Programs.--From funds appropriated 
under subsection (h), the Secretary, acting through the Administrator 
of the Health Resources and Services Administration (referred to in 
this section as the `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--
            ``(1) education in newborn screening; and
            ``(2) training in--
                    ``(A) relevant and new technologies in newborn 
                screening; and
                    ``(B) 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 
                        with respect to newborn screening; and
                            ``(ii) take all necessary steps to minimize 
                        the duplication of the resources and programs 
                        described in clause (i) and ensure that funding 
                        under this section will supplement, not 
                        supplant, existing funding for such activities.
    ``(d) Coordination.--The Secretary shall take all necessary steps 
to coordinate programs funded with grants received under this section 
and to coordinate with existing newborn screening activities.
    ``(e) Use of Grant Funds.--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--
            ``(1) continuing medical education programs for health care 
        professionals and newborn screening laboratory personnel in 
        newborn screening;
            ``(2) education, technical assistance, and training on new 
        discoveries in newborn screening and the use of any related 
        technology;
            ``(3) 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;
            ``(4) models to communicate effectively with parents and 
        families about--
                    ``(A) the process and benefits of newborn screening 
                and the meaning of screening results, including the 
                possibility of false positive findings;
                    ``(B) how to use information gathered from newborn 
                screening;
                    ``(C) the right of refusal of newborn screening, if 
                applicable; and
                    ``(D) the potential need for followup care after 
                newborns are screened;
            ``(5) information and resources on coordinated systems of 
        followup care after newborns are screened;
            ``(6) 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;
            ``(7) information on additional newborn screening that may 
        not be required by the State, but that may be available from 
        other sources; and
            ``(8) other items to carry out the purpose described in 
        subsection (a)(1) as determined appropriate by the Secretary.
    ``(f) Reports to Congress.--
            ``(1) In general.--Subject to paragraph (2), the Secretary 
        shall submit to the relevant committees of Congress reports--
                    ``(A) evaluating the effectiveness and the impact 
                of the grants awarded under this section--
                            ``(i) in promoting newborn screening 
                        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, 
                State, and local 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) other entities 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) $5,000,000 for fiscal year 2008; and
            ``(2) such sums as may be necessary for each of fiscal 
        years 2009 through 2012.''.

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 
        ``$15,000,000 for fiscal year 2008 and such sums as may be 
        necessary for each of the fiscal years 2009 through 2012.''.

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 2008 
and such sums as may be necessary for each of the fiscal years 2009 
through 2012.''.

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) in paragraph (1), by inserting ``and grants 
                awarded under section 399Z-1'' before the semicolon;
                    (B) by redesignating paragraph (3) as paragraph 
                (6);
                    (C) in paragraph (2), by striking ``and'' after the 
                semicolon;
                    (D) by inserting after paragraph (2) the following:
            ``(3) make systematic evidence-based and peer-reviewed 
        recommendations that include 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, as appropriate, based on such 
        decision-matrix;
            ``(5) consider ways to ensure that States attain the 
        capacity to screen for the conditions described in paragraph 
        (3), and include in such consideration the results of grant 
        funding under section 1109; and'';
                    (E) in paragraph (6) (as so redesignated by 
                subparagraph (A)), by striking the period at the end 
                and inserting ``, which may include 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) implementation, monitoring, and evaluation of 
                newborn screening activities, including diagnosis, 
                screening, follow-up, and treatment activities;
                    ``(C) diagnostic and other technology used in 
                screening;
                    ``(D) the availability and reporting of testing for 
                conditions for which there is no existing treatment;
                    ``(E) conditions not included in the recommended 
                uniform screening panel that are treatable with Food 
                and Drug Administration-approved products;
                    ``(F) minimum standards and related policies and 
                procedures used by State newborn screening programs, 
                such as language and terminology used by State newborn 
                screening programs to include standardization of case 
                definitions and names of disorders for which newborn 
                screening tests are performed;
                    ``(G) quality assurance, oversight, and evaluation 
                of State newborn screening programs, including ensuring 
                that tests and technologies used by each State meet 
                established standards for detecting and reporting 
                positive screening results;
                    ``(H) public and provider awareness and education;
                    ``(I) the cost and effectiveness of newborn 
                screening and medical evaluation systems and 
                intervention programs conducted by State-based 
                programs;
                    ``(J) identification of the causes of, and risk 
                factors for heritable disorders; and
                    ``(K) coordination of surveillance activities, 
                including standardized data collection and reporting, 
                harmonization of laboratory definitions for heritable 
                disorders and testing results, and confirmatory testing 
                and verification of positive results, in order to 
                assess and enhance monitoring of newborn diseases.''; 
                and
            (2) in subsection (c)(2)--
                    (A) by redesignating subparagraphs (E), (F) and (G) 
                as subparagraphs (F), (H), and (I);
                    (B) by inserting after subparagraph (D) the 
                following:
                    ``(E) the Commissioner of the Food and Drug 
                Administration;''; and
                    (C) by inserting after subparagraph (F), as so 
                redesignated, the following:
                    ``(G) individuals with expertise in ethics who have 
                worked and published material in the area of newborn 
                screening;''; and
            (3) 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 2007 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) Annual Report.--Not later than 2 years after the date of 
enactment of the Newborn Screening Saves Lives Act of 2007, and each 
fiscal year thereafter, the Advisory Committee shall--
            ``(1) publish a report on peer-reviewed newborn screening 
        guidelines in the United States;
            ``(2) submit such report to the appropriate committees of 
        Congress, the Secretary, and the State departments of health; 
        and
            ``(3) disseminate such report on as wide a basis as 
        practicable, including through posting on the internet 
        clearinghouse established under section 1112.
    ``(f) 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 2007.
    ``(g) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section--
            ``(1) $1,000,000 for fiscal year 2008; and
            ``(2) such sums as may be necessary for each of the fiscal 
        years 2009 through 2012.''.

SEC. 7. INFORMATION CLEARINGHOUSE.

    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. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION.

    ``(a) In General.--The Secretary, acting through the Administrator 
of the Health Resources and Services Administration (referred to in 
this part as the `Administrator'), in consultation with the Director of 
the Centers for Disease Control and Prevention and the Director of the 
National Institutes of Health, shall 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 wanting 
        to have children and expectant families; and
            ``(3) develop and maintain current data on quality 
        indicators to measure performance of newborn screening, such as 
        false-positive rates and other quality indicators as determined 
        by the Advisory Committee under section 1111.
    ``(b) Internet Availability.--The Secretary, acting through the 
Administrator, 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, non-profit, 
                and other Internet websites of laboratories as 
                determined appropriate by the Secretary 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 from 
                laboratories certified under subpart 2 of part F of 
                title III, including information about supplemental 
                screening that is available but not required, in the 
                State where the infant is born;
                    ``(C) current research on both treatable and not-
                yet treatable conditions for which newborn screening 
                tests are available;
                    ``(D) the availability of Federal funding for 
                newborn and child screening for heritable disorders 
                including grants authorized under the Newborn Screening 
                Saves Lives Act of 2007; and
                    ``(E) other relevant information as determined 
                appropriate by the Secretary.
    ``(c) Nonduplication.--In developing the clearinghouse under this 
section, the Secretary shall ensure that such clearinghouse minimizes 
duplication and supplements, not supplants, existing information 
sharing efforts.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section--
            ``(1) $2,500,000 for fiscal year 2008; and
            ``(2) such sums as may be necessary for each of the fiscal 
        years 2009 through 2012.''.

SEC. 8. LABORATORY QUALITY AND SURVEILLANCE.

    Part A of title XI of the Public Health Service Act (42 U.S.C. 
300b-1 et seq.), as amended by section 7, is further amended by adding 
at the end the following:

``SEC. 1113. 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 2008 and such sums as may be necessary for each of the 
fiscal years 2009 through 2012.

``SEC. 1114. SURVEILLANCE PROGRAMS FOR HERITABLE DISORDERS SCREENING.

    ``(a) In General.--The Secretary, acting through an Interagency 
Group consisting of the Director of the Agency for Healthcare Research 
and Quality, the Director of the Centers for Disease Control and 
Prevention, the Administrator, and the Director of the National 
Institutes of Health, shall build upon existing activities and 
infrastructure to 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 incidence and prevalence 
        of, as well as poor health outcomes resulting from, such 
        disorders;
            ``(2) to operate regional centers for the conduct of 
        applied epidemiological research on effective interventions for 
        such disorders for the prevention of poor health outcomes;
            ``(3) to provide information and education to the public on 
        effective interventions for the prevention of poor health 
        outcomes resulting from such disorders; and
            ``(4) to conduct research on and to promote the prevention 
        of poor health outcomes resulting from 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) Reports to Congress.--
            ``(1) In general.--Subject to paragraph (2), the Secretary 
        shall submit to the relevant committees of Congress reports--
                    ``(A) containing information under paragraph (1) 
                that is specific to various racial, ethnic, and 
                socioeconomic groups;
                    ``(B) containing 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;
                    ``(C) describing the activities carried out under 
                this section;
                    ``(D) containing information on the incidence and 
                prevalence of individuals living with heritable 
                disorders, information on the health status of 
                individuals with such disorders including the extent to 
                which such disorders have contributed to the incidence 
                and prevalence of infant mortality, information on any 
                health disparities experienced by such individuals, and 
                recommendations for improving the health and wellness 
                and quality of life of such individuals;
                    ``(E) containing a summary of recommendations from 
                all heritable disorders research conferences sponsored 
                by the Centers for Disease Control and Prevention; and
                    ``(F) containing any recommendations of the 
                Secretary regarding this section.
            ``(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.
    ``(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 2008 and such sums as may be necessary for each of the 
fiscal years 2009 through 2012.''.

SEC. 9. GRANTS.

    Part A of title XI of the Public Health Service Act (42 U.S.C. 
300b-1 et seq.), as amended by section 8, is further amended by adding 
at the end the following:

``SEC. 1115. GRANTS.

    ``(a) Authorization of Grant Program.--
            ``(1) In general.--From funds appropriated under subsection 
        (h), the Secretary, acting through the Administrator and in 
        consultation with the Advisory Committee, shall award grants to 
        eligible entities to--
                    ``(A) enable such entities to develop and deliver 
                educational programs about newborn screening to 
                parents, families, and patient advocacy and support 
                groups, such educational materials accompanying such 
                educational programs to be provided at appropriate 
                literacy levels; and
                    ``(B) enable such entities to establish, maintain, 
                and operate a system to assess and coordinate treatment 
                relating to congenital, genetic, and metabolic 
                disorders.
            ``(2) 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 paragraph (1).
    ``(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.--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) and ensure that funding 
                        under this section will supplement, not 
                        supplant, existing funding for such activities.
    ``(d) Coordination.--The Secretary shall take all necessary steps 
to coordinate programs funded with grants received under this section 
and to coordinate with existing newborn screening activities.
    ``(e) Use of Grant Funds.--
            ``(1) In general.--An eligible entity that receives a grant 
        under this section may use the grant funds--
                    ``(A) for purposes of grants under subsection 
                (a)(1)(A), to develop and deliver to parents, families, 
                and patient advocacy and support groups, educational 
                programs about newborn screening that include 
                information on--
                            ``(i) what newborn screening is and how it 
                        is performed;
                            ``(ii) who performs newborn screening;
                            ``(iii) where newborn screening is 
                        performed;
                            ``(iv) the disorders for which the State 
                        requires newborns to be screened;
                            ``(v) different options for newborn 
                        screening for disorders other than those 
                        included by the State in the mandated newborn 
                        screening program;
                            ``(vi) the meaning of various screening 
                        results, including the possibility of false 
                        positive and false negative findings;
                            ``(vii) the prevalence and risk of newborn 
                        disorders, including the increased risk of 
                        disorders that may stem from family history;
                            ``(viii) coordinated systems of followup 
                        care after newborns are screened; and
                            ``(ix) other items to carry out the purpose 
                        described in subsection (a)(1) as determined 
                        appropriate by the Secretary; and
                    ``(B) for purposes of grants under subsection 
                (a)(1)(B), to--
                            ``(i) 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 appropriate subspecialists such 
                        as in congenital, genetic, and metabolic 
                        disorders;
                            ``(ii) coordinate ongoing followup 
                        treatment with individuals, families, primary 
                        care physicians, and appropriate subspecialists 
                        such as 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;
                            ``(iii) ensure the seamless integration of 
                        confirmatory testing, tertiary care medical 
                        services, comprehensive genetic services 
                        including genetic counseling, and information 
                        about Food and Drug Administration-approved 
                        treatments as well as access to developing 
                        therapies by participation in approved clinical 
                        trials involving the primary health care of the 
                        infant;
                            ``(iv) 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;
                            ``(v) collect, analyze and report data on 
                        the costs, benefits and effectiveness of such 
                        tests; and
                            ``(vi) 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 relevant 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, 
                State, and local 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
                            ``(i) 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) 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) other entities with appropriate expertise in newborn 
        screening, as determined by the Secretary.
    ``(h) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section--
            ``(1) $10,000,000 for fiscal year 2008; and
            ``(2) such sums as may be necessary for each of fiscal 
        years 2009 through 2012.''.

SEC. 10. CONTINGENCY PLANNING.

    Part A of title XI of the Public Health Service Act (42 U.S.C. 
300b-1 et seq.), as amended by section 9, is further amended by adding 
at the end the following:

``SEC. 1116. NATIONAL CONTINGENCY PLAN FOR NEWBORN SCREENING.

    ``(a) In General.--Not later than 180 days after the date of 
enactment of this section, the Secretary, acting through the Director 
of the Centers for Disease Control and Prevention and in consultation 
with the Administrator and State departments of health (or related 
agencies), shall develop a national contingency plan for newborn 
screening for use by a State, region, or consortia of States in the 
event of a public health emergency.
    ``(b) Contents.--The contingency plan developed under subsection 
(a) shall include a plan for--
            ``(1) the collection and transport of specimens;
            ``(2) the shipment of specimens to State newborn screening 
        laboratories;
            ``(3) the processing of specimens;
            ``(4) the reporting of screening results to physicians and 
        families;
            ``(5) the diagnostic confirmation of positive screening 
        results;
            ``(6) ensuring the availability of treatment and management 
        resources;
            ``(7) educating families about newborn screening; and
            ``(8) carrying out other activities determined appropriate 
        by the Secretary.

``SEC. 1117. HUNTER KELLY RESEARCH PROGRAM.

    ``(a) Additional Newborn Screening Tests Grants.--
            ``(1) In general.--The Secretary, in conjunction with the 
        Director of the National Institutes of Health and taking into 
        consideration the recommendations of the Advisory Committee, 
        shall establish a research program (to be known as `Hunter 
        Kelly Newborn Screening Research Program') by expanding, 
        carrying out, and coordinating research in--
                    ``(A) identifying, developing, and testing the most 
                promising new screening technologies, in order to 
                improve already existing screening tests, which may 
                include tests for Krabbe Disease and Insulin Dependent 
                Diabetes Mellitus, and Turner Syndrome, increase the 
                specificity of newborn screening, and expand the number 
                of conditions for which screening tests are available;
                    ``(B) experimental treatments and disease 
                management strategies for additional newborn 
                conditions, and other genetic, metabolic, hormonal and/
                or functional conditions that can be detected through 
                newborn screening for which treatment is not yet 
                available; and
                    ``(C) other activities that would improve newborn 
                screening, as identified by the Director.
            ``(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.
    ``(b) Funding.--In carrying out the research program under this 
section, the Secretary and the Director shall ensure that entities 
receiving funding through the program will provide assurances, as 
practicable, that such entities will work in consultation with the 
appropriate State departments of health, and, as practicable, focus 
their research on screening technology not currently performed in the 
States in which the entities are located, and the conditions on the 
uniform screening panel (or the standard test existing on the uniform 
screening panel).
    ``(c) Monitoring and Results.--The Director shall--
            ``(1) monitor and report on the activities resulting from 
        any funding distributed under this section; and
            ``(2) on an annual basis--
                    ``(A) publish and disseminate the results of such 
                monitoring on as wide a basis as is practicable, which 
                may include incorporation of these results in other 
                newborn screening reports and posting on the Internet 
                Clearinghouse established under section 1112;
                    ``(B) submit to the relevant committees of Congress 
                the results of such evaluation, which may include 
                incorporation of such results in other newborn 
                screening reports being submitted to Congress.
    ``(d) Nonduplication.--In carrying out programs under this section, 
the Secretary shall minimize duplication and supplement, not supplant, 
existing efforts of the type carried out under this section.
    ``(e) Peer Review.--Nothing in this section shall be construed to 
interfere with the scientific peer-review process at the National 
Institutes of Health.
    ``(f) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section--
            ``(1) $7,000,000 for fiscal year 2008; and
            ``(2) such sums as may be necessary for fiscal years 2009 
        through 2012.''.
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