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[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1858 Reported in Senate (RS)]

                                                       Calendar No. 522
110th CONGRESS
  1st Session
                                S. 1858

 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 SENATE OF THE UNITED STATES

                             July 23, 2007

Mr. Dodd (for himself, Mr. Hatch, Mrs. Clinton, Mr. Kennedy, Mr. Bond, 
 Mrs. Murray, Ms. Collins, Mr. Inouye, Ms. Cantwell, Mr. Sanders, Mr. 
Johnson, Mr. Whitehouse, Mr. Brown, Mr. Durbin, Mr. Lugar, Mr. Cardin, 
  Mrs. Lincoln, Mr. Casey, Mr. Harkin, Ms. Mikulski, and Mr. Coleman) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

                            December 5, 2007

               Reported by Mr. Kennedy, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Newborn Screening Saves 
Lives Act of 2007''.</DELETED>

<DELETED>SEC. 2. FINDINGS.</DELETED>

<DELETED>    Congress finds the following:</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (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.</DELETED>
        <DELETED>    (5) Currently only 11 States and the District of 
        Columbia require infants to be screened for all 29 of these 
        recommended disorders.</DELETED>
        <DELETED>    (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.</DELETED>

<DELETED>SEC. 3. AMENDMENT TO TITLE III OF THE PUBLIC HEALTH SERVICE 
              ACT.</DELETED>

<DELETED>    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:</DELETED>

<DELETED>``SEC. 399Z-1. NEWBORN SCREENING.</DELETED>

<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) education in newborn screening; 
        and</DELETED>
        <DELETED>    ``(2) training in--</DELETED>
                <DELETED>    ``(A) relevant and new technologies in 
                newborn screening; and</DELETED>
                <DELETED>    ``(B) congenital, genetic, and metabolic 
                disorders.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(c) Selection of Grant Recipients.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Approval factors.--</DELETED>
                <DELETED>    ``(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--
                </DELETED>
                        <DELETED>    ``(i) will use grant funds only 
                        for the purposes specified in the approved 
                        application and in accordance with the 
                        requirements of this section; and</DELETED>
                        <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(B) Existing programs.--Prior to 
                awarding a grant under this section, the Secretary 
                shall--</DELETED>
                        <DELETED>    ``(i) conduct an assessment of 
                        existing educational resources and training 
                        programs with respect to newborn screening; 
                        and</DELETED>
                        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) continuing medical education programs for 
        health care professionals and newborn screening laboratory 
        personnel in newborn screening;</DELETED>
        <DELETED>    ``(2) education, technical assistance, and 
        training on new discoveries in newborn screening and the use of 
        any related technology;</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(4) models to communicate effectively with 
        parents and families about--</DELETED>
                <DELETED>    ``(A) the process and benefits of newborn 
                screening and the meaning of screening results, 
                including the possibility of false positive 
                findings;</DELETED>
                <DELETED>    ``(B) how to use information gathered from 
                newborn screening;</DELETED>
                <DELETED>    ``(C) the right of refusal of newborn 
                screening, if applicable; and</DELETED>
                <DELETED>    ``(D) the potential need for followup care 
                after newborns are screened;</DELETED>
        <DELETED>    ``(5) information and resources on coordinated 
        systems of followup care after newborns are screened;</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(7) information on additional newborn screening 
        that may not be required by the State, but that may be 
        available from other sources; and</DELETED>
        <DELETED>    ``(8) other items to carry out the purpose 
        described in subsection (a)(1) as determined appropriate by the 
        Secretary.</DELETED>
<DELETED>    ``(f) Reports to Congress.--</DELETED>
        <DELETED>    ``(1) In general.--Subject to paragraph (2), the 
        Secretary shall submit to the relevant committees of Congress 
        reports--</DELETED>
                <DELETED>    ``(A) evaluating the effectiveness and the 
                impact of the grants awarded under this section--
                </DELETED>
                        <DELETED>    ``(i) in promoting newborn 
                        screening education, resources, and training 
                        for health care professionals;</DELETED>
                        <DELETED>    ``(ii) on the successful diagnosis 
                        and treatment of congenital, genetic, and 
                        metabolic disorders; and</DELETED>
                        <DELETED>    ``(iii) on the continued 
                        development of coordinated systems of followup 
                        care after newborns are screened;</DELETED>
                <DELETED>    ``(B) describing and evaluating the 
                effectiveness of the activities carried out with grant 
                funds received under this section; and</DELETED>
                <DELETED>    ``(C) that include recommendations for 
                Federal, State, and local actions to support--
                </DELETED>
                        <DELETED>    ``(i) education and training in 
                        newborn screening; and</DELETED>
                        <DELETED>    ``(ii) followup care after 
                        newborns are screened.</DELETED>
        <DELETED>    ``(2) Timing of reports.--The Secretary shall 
        submit--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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.</DELETED>
<DELETED>    ``(g) Definition of Eligible Entity.--In this section, the 
term `eligible entity' means--</DELETED>
        <DELETED>    ``(1) a State or a political subdivision of a 
        State;</DELETED>
        <DELETED>    ``(2) a consortium of 2 or more States or 
        political subdivisions of States;</DELETED>
        <DELETED>    ``(3) a territory;</DELETED>
        <DELETED>    ``(4) an Indian tribe or a hospital or outpatient 
        health care facility of the Indian Health Service; or</DELETED>
        <DELETED>    ``(5) other entities with appropriate expertise in 
        newborn screening, as determined by the Secretary.</DELETED>
<DELETED>    ``(h) Authorization of Appropriations.--There are 
authorized to be appropriated to carry out this section--</DELETED>
        <DELETED>    ``(1) $5,000,000 for fiscal year 2008; 
        and</DELETED>
        <DELETED>    ``(2) such sums as may be necessary for each of 
        fiscal years 2009 through 2012.''.</DELETED>

<DELETED>SEC. 4. IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE 
              DISORDERS.</DELETED>

<DELETED>    Section 1109 of the Public Health Service Act (42 U.S.C. 
300b-8) is amended--</DELETED>
        <DELETED>    (1) in subsection (c)(2)--</DELETED>
                <DELETED>    (A) in subparagraph (E), by striking 
                ``and'' after the semicolon;</DELETED>
                <DELETED>    (B) by redesignating subparagraph (F) as 
                subparagraph (G); and</DELETED>
                <DELETED>    (C) by inserting after subparagraph (E) 
                the following:</DELETED>
                <DELETED>    ``(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</DELETED>
        <DELETED>    (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.''.</DELETED>

<DELETED>SEC. 5. EVALUATING THE EFFECTIVENESS OF NEWBORN- AND CHILD-
              SCREENING PROGRAMS.</DELETED>

<DELETED>    Section 1110 of the Public Health Service Act (42 U.S.C. 
300b-9) is amended by adding at the end the following:</DELETED>
<DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 6. ADVISORY COMMITTEE ON HERITABLE DISORDERS IN NEWBORNS 
              AND CHILDREN.</DELETED>

<DELETED>    Section 1111 of the Public Health Service Act (42 U.S.C. 
300b-10) is amended--</DELETED>
        <DELETED>    (1) in subsection (b)--</DELETED>
                <DELETED>    (A) in paragraph (1), by inserting ``and 
                grants awarded under section 399Z-1'' before the 
                semicolon;</DELETED>
                <DELETED>    (B) by redesignating paragraph (3) as 
                paragraph (6);</DELETED>
                <DELETED>    (C) in paragraph (2), by striking ``and'' 
                after the semicolon;</DELETED>
                <DELETED>    (D) by inserting after paragraph (2) the 
                following:</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(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'';</DELETED>
                <DELETED>    (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--</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(B) implementation, monitoring, and 
                evaluation of newborn screening activities, including 
                diagnosis, screening, follow-up, and treatment 
                activities;</DELETED>
                <DELETED>    ``(C) diagnostic and other technology used 
                in screening;</DELETED>
                <DELETED>    ``(D) the availability and reporting of 
                testing for conditions for which there is no existing 
                treatment;</DELETED>
                <DELETED>    ``(E) conditions not included in the 
                recommended uniform screening panel that are treatable 
                with Food and Drug Administration-approved 
                products;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(H) public and provider awareness and 
                education;</DELETED>
                <DELETED>    ``(I) the cost and effectiveness of 
                newborn screening and medical evaluation systems and 
                intervention programs conducted by State-based 
                programs;</DELETED>
                <DELETED>    ``(J) identification of the causes of, and 
                risk factors for heritable disorders; and</DELETED>
                <DELETED>    ``(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</DELETED>
        <DELETED>    (2) in subsection (c)(2)--</DELETED>
                <DELETED>    (A) by redesignating subparagraphs (E), 
                (F) and (G) as subparagraphs (F), (H), and 
                (I);</DELETED>
                <DELETED>    (B) by inserting after subparagraph (D) 
                the following:</DELETED>
                <DELETED>    ``(E) the Commissioner of the Food and 
                Drug Administration;''; and</DELETED>
                <DELETED>    (C) by inserting after subparagraph (F), 
                as so redesignated, the following:</DELETED>
                <DELETED>    ``(G) individuals with expertise in ethics 
                who have worked and published material in the area of 
                newborn screening;''; and</DELETED>
        <DELETED>    (3) by adding at the end the following:</DELETED>
<DELETED>    ``(d) Decision on Recommendations.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) publish a report on peer-reviewed newborn 
        screening guidelines in the United States;</DELETED>
        <DELETED>    ``(2) submit such report to the appropriate 
        committees of Congress, the Secretary, and the State 
        departments of health; and</DELETED>
        <DELETED>    ``(3) disseminate such report on as wide a basis 
        as practicable, including through posting on the internet 
        clearinghouse established under section 1112.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(g) Authorization of Appropriations.--There are 
authorized to be appropriated to carry out this section--</DELETED>
        <DELETED>    ``(1) $1,000,000 for fiscal year 2008; 
        and</DELETED>
        <DELETED>    ``(2) such sums as may be necessary for each of 
        the fiscal years 2009 through 2012.''.</DELETED>

<DELETED>SEC. 7. INFORMATION CLEARINGHOUSE.</DELETED>

<DELETED>    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:</DELETED>

<DELETED>``SEC. 1112. CLEARINGHOUSE OF NEWBORN SCREENING 
              INFORMATION.</DELETED>

<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(2) increase awareness, knowledge, and 
        understanding of newborn diseases and screening services for 
        individuals wanting to have children and expectant families; 
        and</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(b) Internet Availability.--The Secretary, acting 
through the Administrator, shall ensure that the clearinghouse 
described under subsection (a)--</DELETED>
        <DELETED>    ``(1) is available on the Internet;</DELETED>
        <DELETED>    ``(2) includes an interactive forum;</DELETED>
        <DELETED>    ``(3) is updated on a regular basis, but not less 
        than quarterly; and</DELETED>
        <DELETED>    ``(4) provides--</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(C) current research on both treatable 
                and not-yet treatable conditions for which newborn 
                screening tests are available;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(E) other relevant information as 
                determined appropriate by the Secretary.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(d) Authorization of Appropriations.--There are 
authorized to be appropriated to carry out this section--</DELETED>
        <DELETED>    ``(1) $2,500,000 for fiscal year 2008; 
        and</DELETED>
        <DELETED>    ``(2) such sums as may be necessary for each of 
        the fiscal years 2009 through 2012.''.</DELETED>

<DELETED>SEC. 8. LABORATORY QUALITY AND SURVEILLANCE.</DELETED>

<DELETED>    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:</DELETED>

<DELETED>``SEC. 1113. LABORATORY QUALITY.</DELETED>

<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(2) population-based pilot testing for new 
        screening tools for evaluating use on a mass scale.</DELETED>
<DELETED>    ``(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.</DELETED>

<DELETED>``SEC. 1114. SURVEILLANCE PROGRAMS FOR HERITABLE DISORDERS 
              SCREENING.</DELETED>

<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(3) to provide information and education to the 
        public on effective interventions for the prevention of poor 
        health outcomes resulting from such disorders; and</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(b) Grants and Contracts.--</DELETED>
        <DELETED>    ``(1) In general.--In carrying out subsection (a), 
        the Secretary may make grants to and enter into contracts with 
        public and nonprofit private entities.</DELETED>
        <DELETED>    ``(2) Supplies and services in lieu of award 
        funds.--</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(c) Reports to Congress.--</DELETED>
        <DELETED>    ``(1) In general.--Subject to paragraph (2), the 
        Secretary shall submit to the relevant committees of Congress 
        reports--</DELETED>
                <DELETED>    ``(A) containing information under 
                paragraph (1) that is specific to various racial, 
                ethnic, and socioeconomic groups;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(C) describing the activities carried 
                out under this section;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(E) containing a summary of 
                recommendations from all heritable disorders research 
                conferences sponsored by the Centers for Disease 
                Control and Prevention; and</DELETED>
                <DELETED>    ``(F) containing any recommendations of 
                the Secretary regarding this section.</DELETED>
        <DELETED>    ``(2) Timing of reports.--The Secretary shall 
        submit--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(e) Coordination.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 9. GRANTS.</DELETED>

<DELETED>    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:</DELETED>

<DELETED>``SEC. 1115. GRANTS.</DELETED>

<DELETED>    ``(a) Authorization of Grant Program.--</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(B) enable such entities to establish, 
                maintain, and operate a system to assess and coordinate 
                treatment relating to congenital, genetic, and 
                metabolic disorders.</DELETED>
        <DELETED>    ``(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).</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(c) Selection of Grant Recipients.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(2) Approval factors.--</DELETED>
                <DELETED>    ``(A) Requirements.--An application 
                submitted under subsection (b) may not be approved by 
                the Secretary unless the application contains 
                assurances that the eligible entity--</DELETED>
                        <DELETED>    ``(i) will use grant funds only 
                        for the purposes specified in the approved 
                        application and in accordance with the 
                        requirements of this section; and</DELETED>
                        <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(B) Existing programs.--Prior to 
                awarding a grant under this section, the Secretary 
                shall--</DELETED>
                        <DELETED>    ``(i) conduct an assessment of 
                        existing educational resources and training 
                        programs and coordinated systems of followup 
                        care with respect to newborn screening; 
                        and</DELETED>
                        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(e) Use of Grant Funds.--</DELETED>
        <DELETED>    ``(1) In general.--An eligible entity that 
        receives a grant under this section may use the grant funds--
        </DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(i) what newborn screening is 
                        and how it is performed;</DELETED>
                        <DELETED>    ``(ii) who performs newborn 
                        screening;</DELETED>
                        <DELETED>    ``(iii) where newborn screening is 
                        performed;</DELETED>
                        <DELETED>    ``(iv) the disorders for which the 
                        State requires newborns to be 
                        screened;</DELETED>
                        <DELETED>    ``(v) different options for 
                        newborn screening for disorders other than 
                        those included by the State in the mandated 
                        newborn screening program;</DELETED>
                        <DELETED>    ``(vi) the meaning of various 
                        screening results, including the possibility of 
                        false positive and false negative 
                        findings;</DELETED>
                        <DELETED>    ``(vii) the prevalence and risk of 
                        newborn disorders, including the increased risk 
                        of disorders that may stem from family 
                        history;</DELETED>
                        <DELETED>    ``(viii) coordinated systems of 
                        followup care after newborns are screened; 
                        and</DELETED>
                        <DELETED>    ``(ix) other items to carry out 
                        the purpose described in subsection (a)(1) as 
                        determined appropriate by the Secretary; 
                        and</DELETED>
                <DELETED>    ``(B) for purposes of grants under 
                subsection (a)(1)(B), to--</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(v) collect, analyze and report 
                        data on the costs, benefits and effectiveness 
                        of such tests; and</DELETED>
                        <DELETED>    ``(vi) carry out such other 
                        activities as the Secretary may determine 
                        necessary.</DELETED>
<DELETED>    ``(f) Reports to Congress.--</DELETED>
        <DELETED>    ``(1) In general.--Subject to paragraph (2), the 
        Secretary shall submit to the relevant committees of Congress 
        reports--</DELETED>
                <DELETED>    ``(A) evaluating the effectiveness and the 
                impact of the grants awarded under this section--
                </DELETED>
                        <DELETED>    ``(i) in promoting newborn 
                        screening--</DELETED>
                                <DELETED>    ``(I) education and 
                                resources for families; and</DELETED>
                                <DELETED>    ``(II) education, 
                                resources, and training for health care 
                                professionals;</DELETED>
                        <DELETED>    ``(ii) on the successful diagnosis 
                        and treatment of congenital, genetic, and 
                        metabolic disorders; and</DELETED>
                        <DELETED>    ``(iii) on the continued 
                        development of coordinated systems of followup 
                        care after newborns are screened;</DELETED>
                <DELETED>    ``(B) describing and evaluating the 
                effectiveness of the activities carried out with grant 
                funds received under this section; and</DELETED>
                <DELETED>    ``(C) that include recommendations for 
                Federal, State, and local actions to support--
                </DELETED>
                        <DELETED>    ``(i) education and training in 
                        newborn screening; and</DELETED>
                        <DELETED>    ``(ii) followup care after 
                        newborns are screened.</DELETED>
        <DELETED>    ``(2) Timing of reports.--The Secretary shall 
        submit--</DELETED>
                <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(g) Eligible Entity.--In this section, the term 
`eligible entity' means--</DELETED>
        <DELETED>    ``(1) a State or a political subdivision of a 
        State;</DELETED>
        <DELETED>    ``(2) a consortium of 2 or more States or 
        political subdivisions of States;</DELETED>
        <DELETED>    ``(3) a territory;</DELETED>
        <DELETED>    ``(4) an Indian tribe or a hospital or outpatient 
        health care facility of the Indian Health Service; or</DELETED>
        <DELETED>    ``(5) other entities with appropriate expertise in 
        newborn screening, as determined by the Secretary.</DELETED>
<DELETED>    ``(h) Authorization of Appropriations.--There is 
authorized to be appropriated to carry out this section--</DELETED>
        <DELETED>    ``(1) $10,000,000 for fiscal year 2008; 
        and</DELETED>
        <DELETED>    ``(2) such sums as may be necessary for each of 
        fiscal years 2009 through 2012.''.</DELETED>

<DELETED>SEC. 10. CONTINGENCY PLANNING.</DELETED>

<DELETED>    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:</DELETED>

<DELETED>``SEC. 1116. NATIONAL CONTINGENCY PLAN FOR NEWBORN 
              SCREENING.</DELETED>

<DELETED>    ``(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.</DELETED>
<DELETED>    ``(b) Contents.--The contingency plan developed under 
subsection (a) shall include a plan for--</DELETED>
        <DELETED>    ``(1) the collection and transport of 
        specimens;</DELETED>
        <DELETED>    ``(2) the shipment of specimens to State newborn 
        screening laboratories;</DELETED>
        <DELETED>    ``(3) the processing of specimens;</DELETED>
        <DELETED>    ``(4) the reporting of screening results to 
        physicians and families;</DELETED>
        <DELETED>    ``(5) the diagnostic confirmation of positive 
        screening results;</DELETED>
        <DELETED>    ``(6) ensuring the availability of treatment and 
        management resources;</DELETED>
        <DELETED>    ``(7) educating families about newborn screening; 
        and</DELETED>
        <DELETED>    ``(8) carrying out other activities determined 
        appropriate by the Secretary.</DELETED>

<DELETED>``SEC. 1117. HUNTER KELLY RESEARCH PROGRAM.</DELETED>

<DELETED>    ``(a) Additional Newborn Screening Tests Grants.--
</DELETED>
        <DELETED>    ``(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--
        </DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(C) other activities that would improve 
                newborn screening, as identified by the 
                Director.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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).</DELETED>
<DELETED>    ``(c) Monitoring and Results.--The Director shall--
</DELETED>
        <DELETED>    ``(1) monitor and report on the activities 
        resulting from any funding distributed under this section; 
        and</DELETED>
        <DELETED>    ``(2) on an annual basis--</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(e) Peer Review.--Nothing in this section shall be 
construed to interfere with the scientific peer-review process at the 
National Institutes of Health.</DELETED>
<DELETED>    ``(f) Authorization of Appropriations.--There are 
authorized to be appropriated to carry out this section--</DELETED>
        <DELETED>    ``(1) $7,000,000 for fiscal year 2008; 
        and</DELETED>
        <DELETED>    ``(2) such sums as may be necessary for fiscal 
        years 2009 through 2012.''.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Newborn Screening Saves Lives Act of 
2007''.

SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE DISORDER.

    Section 1109 of the Public Health Service Act (42 U.S.C. 300b-8) is 
amended--
            (1) by striking subsections (a), (b), and (c) and inserting 
        the following:
    ``(a) Authorization of Grant Program.--From amounts appropriated 
under subsection (j), 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--
            ``(1) to enhance, improve or expand the ability of State 
        and local public health agencies to provide screening, 
        counseling, or health care services to newborns and children 
        having or at risk for heritable disorders;
            ``(2) to assist in providing health care professionals and 
        newborn screening laboratory personnel with education in 
        newborn screening and training in relevant and new technologies 
        in newborn screening and congenital, genetic, and metabolic 
        disorders;
            ``(3) to develop and deliver educational programs (at 
        appropriate literacy levels) about newborn screening 
        counseling, testing, follow-up, treatment, and specialty 
        services to parents, families, and patient advocacy and support 
        groups; and
            ``(4) to establish, maintain, and operate a system to 
        assess and coordinate treatment relating to congenital, 
        genetic, and metabolic disorders
    ``(b) 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) a health facility or program operated by or pursuant 
        to a contract with or grant from the Indian Health Service; or
            ``(5) any other entity with appropriate expertise in 
        newborn screening, as determined by the Secretary.
    ``(c) Approval Factors.--An application submitted for a grant under 
subsection (a)(1) shall not be approved by the Secretary unless the 
application contains assurances that the eligible entity has adopted 
and implemented, is in the process of adopting and implementing, or 
will use amounts received under such grant to adopt and implement the 
guidelines and recommendations of 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.'';
            (2) by redesignating subsections (d) through (i) as 
        subsections (e) through (j), respectively;
            (3) by inserting after subsection (c), the following:
    ``(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.''; and
            (4) by striking subsection (j) (as so redesignated) and 
        inserting the following:
    ``(j) Authorization of Appropriations.--There is authorized to be 
appropriated--
            ``(1) to provide grants for the purpose of carrying 
        activities under section (a)(1), $15,000,000 for fiscal year 
        2008; $15,187,500 for fiscal year 2009, $15,375,000 for fiscal 
        year 2010, $15,562,500 for fiscal year 2011, and $15,750,000 
        for fiscal year 2012; and
            ``(2) to provide grant for the purpose of carrying out 
        activities under paragraphs (2), (3), and (4) of subsection 
        (a), $15,000,000 for fiscal year 2008, $15,187,500 for fiscal 
        year 2009, $15,375,000 for fiscal year 2010, $15,562,500 for 
        fiscal year 2011, and $15,750,000 for fiscal year 2012.''.

SEC. 3. 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, 
$5,062,500 for fiscal year 2009, $5,125,000 for fiscal year 2010, 
$5,187,500 for fiscal year 2011, and $5,250,000 for fiscal year 
2012.''.

SEC. 4. 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 
                (6);
                    (B) in paragraph (2), by striking ``and'' after the 
                semicolon;
                    (C) by inserting after paragraph (2) the following:
            ``(3) make systematic evidence-based and peer-reviewed 
        recommendations that include the heritable disorders that have 
        the potential to significantly impact public health 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 
        expansion, including an evaluation of the potential public 
        health impact of such expansion, and periodically update the 
        recommended uniform screening panel, as appropriate, based on 
        such decision-matrix;
            ``(5) consider ways to ensure that all 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) follow-up 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 or other safe 
                and effective treatments, as determined by scientific 
                evidence and peer review;
                    ``(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, public 
                health impacts 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 and 
                infectious diseases 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 3 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, including follow-up and treatment, 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, $1,000,000 for fiscal year 
2008, $1,012,500 for fiscal year 2009, $1,025,000 for fiscal year 2010, 
$1,037,500 for fiscal year 2011, and $1,050,000 for fiscal year 
2012.''.

SEC. 5. 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 expectant 
        individuals and families; and
            ``(3) 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 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, $2,500,000 for fiscal year 
2008, $2,531,250 for fiscal year 2009, $2,562,500 for fiscal year 2010, 
$2,593,750 for fiscal year 2011, and $2,625,000 for fiscal year 
2012.''.

SEC. 6. 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 5, 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) appropriate quality control and other performance 
        test materials to evaluate the performance of new screening 
        tools.
    ``(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, $5,062,500 for fiscal year 2009, $5,125,000 for 
fiscal year 2010, $5,187,500 for fiscal year 2011, and $5,250,000 for 
fiscal year 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 identify 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 or 
                the National Institutes of Health; 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) 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.
    ``(e) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $15,000,000 
for fiscal year 2008, $15,187,500 for fiscal year 2009, $15,375,000 for 
fiscal year 2010, $15,562,500 for fiscal year 2011, and $15,750,000 for 
fiscal year 2012.''.

SEC. 7. 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 6, is further amended by adding 
at the end the following:

``SEC. 1115. 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. 1116. HUNTER KELLY RESEARCH PROGRAM.

    ``(a) Newborn Screening Activities.--
            ``(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, 
        may continue carrying out, coordinating, and expanding research 
        in newborn screening (to be known as `Hunter Kelly Newborn 
        Screening Research Program') including--
                    ``(A) identifying, developing, and testing the most 
                promising new screening technologies, in order to 
                improve already existing screening tests, 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 recommended by 
        the Advisory Committee and adopted by the Secretary.
    ``(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) Reports.--The Director is encouraged to include information 
about the activities carried out under this section in the biennial 
report required under section 403 of the National Institutes of Health 
Reform Act of 2006. If such information is included, the Director shall 
make such information available to be included on the Internet 
Clearinghouse established under section 1112.
    ``(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.''.
                                                       Calendar No. 522

110th CONGRESS

  1st Session

                                S. 1858

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                            December 5, 2007

                       Reported with an amendment
```