[Congressional Record Volume 153, Number 191 (Thursday, December 13, 2007)]
[Senate]
[Pages S15572-S15576]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




               NEWBORN SCREENING SAVES LIVES ACT OF 2007

  Mr. HARKIN. Mr. President, I ask unanimous consent that the Senate 
proceed to the immediate consideration of Calendar No. 522, S. 1858.
  The PRESIDING OFFICER. The clerk will report the bill by title.
  The legislative clerk read as follows:

       A bill (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.

  There being no objection, the Senate proceeded to consider the bill, 
which had been reported from the Committee on Health, Education, Labor 
and Pensions, with an amendment to strike all after the enacting clause 
and insert in lieu thereof the following:

     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

[[Page S15573]]

     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.

[[Page S15574]]

       ``(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.''.
  Mr. HARKIN. I ask unanimous consent that the amendment at the desk be 
considered and agreed to, the committee reported substitute, as 
amended, be agreed to, the bill as amended be read a third time, 
passed, the motion to reconsider be laid on the table, and any 
statements be printed in the Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment (No. 3852) was agreed to.
  (The amendment is printed in today's Record under ``Text of 
Amendments.'')
  The committee amendment in the nature of a substitute, as amended, 
was agreed to.
  The bill (S. 1858), as amended, was ordered to be engrossed for a 
third reading, was read the third time, and passed, as follows:

                                S. 1858

       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. IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE 
                   DISORDER.

       Section 1109 of the Public Health Service Act (42 U.S.C. 
     300b-8) is amended--

[[Page S15575]]

       (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'';
       (D) 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, the Interagency Coordinating 
     Committee established under Section 1114, 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:

[[Page S15576]]

     ``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. INTERAGENCY COORDINATING COMMITTEE ON NEWBORN 
                   AND CHILD SCREENING.

       ``(a) Purpose.--It is the purpose of this section to--
       ``(1) assess existing activities and infrastructure, 
     including activities on birth defects and developmental 
     disabilities authorized under section 317C, in order to make 
     recommendations for programs to collect, analyze, and make 
     available data on the heritable disorders recommended by the 
     Advisory Committee on Heritable Disorders in Newborns and 
     Children under section 1111, including data on the incidence 
     and prevalence of, as well as poor health outcomes resulting 
     from, such disorders; and
       ``(2) make recommendations for the establishment of 
     regional centers for the conduct of applied epidemiological 
     research on effective interventions to promote the prevention 
     of poor health outcomes resulting from such disorders as well 
     as providing information and education to the public on such 
     effective interventions.
       ``(b) Establishment.--The Secretary shall establish an 
     Interagency Coordinating Committee on Newborn and Child 
     Screening (referred to in this section as the `Interagency 
     Coordinating Committee') to carry out the purpose of this 
     section.
       ``(c) Composition.--The Interagency Coordinating Committee 
     shall be composed of the Director of the Centers for Disease 
     Control and Prevention, the Administrator, the Director of 
     the Agency for Healthcare Research and Quality, and the 
     Director of the National Institutes of Health, or their 
     designees.
       ``(d) Activities.--The Interagency Coordinating Committee 
     shall--
       ``(1) report to the Secretary and the appropriate 
     committees of Congress on its recommendations related to the 
     purpose described in subsection (a); and
       ``(2) carry out other activities determined appropriate by 
     the Secretary.
       ``(e) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated $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. 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.''.




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