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






                                                 Union Calendar No. 352
110th CONGRESS
  2d Session
                                H. R. 3825

                          [Report No. 110-570]

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 15, 2007

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

                             April 8, 2008

Additional sponsors: Mrs. McCarthy of New York, Ms. Baldwin, Mr. Rush, 
Ms. Matsui, Mr. Rothman, Ms. Eshoo, Mr. Pearce, Mr. Towns, Mr. Ramstad, 
   Mr. Schiff, Ms. Schakowsky, Mr. Spratt, Mr. Fattah, Mr. Gordon of 
  Tennessee, Mr. McNulty, Mr. Pastor, Mr. Larson of Connecticut, Mr. 
  Arcuri, Mr. Hinojosa, Mr. Cohen, Mr. Langevin, Mr. Abercrombie, Ms. 
 DeGette, Mr. Higgins, Mr. Shays, Mr. Engel, Mr. Gene Green of Texas, 
   Mrs. Tauscher, Mr. Allen, Mr. Grijalva, Mr. Gonzalez, Ms. Herseth 
Sandlin, Mr. Sires, Mr. Boucher, Mrs. Capps, Mr. Baca, Mrs. Napolitano, 
  Mr. Ortiz, Mr. Salazar, Mr. Lampson, Ms. Solis, Ms. Velazquez, Mr. 
Rodriguez, Mr. Cardoza, Mr. Becerra, Mr. Stark, Ms. Loretta Sanchez of 
   California, Mr. Cuellar, Mr. Gutierrez, Mr. Serrano, Ms. Linda T. 
Sanchez of California, Ms. DeLauro, Mrs. Lowey, Ms. Lee, Mr. Jackson of 
   Illinois, Mr. Kennedy, Mr. Honda, Mr. Ryan of Ohio, Ms. Wasserman 
  Schultz, Ms. Berkley, Ms. Richardson, Mr. Hastings of Florida, Mr. 
Hinchey, Mr. Berry, Mr. Duncan, Mr. Burgess, Mr. Fossella, Ms. Pryce of 
Ohio, Mrs. Capito, Mr. McHugh, Mr. Johnson of Georgia, Mr. Filner, Mr. 
  Davis of Illinois, Ms. Granger, Mr. Tim Murphy of Pennsylvania, Ms. 
         Hirono, Mr. Moore of Kansas, and Mr. Lewis of Georgia

                             April 8, 2008

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
[For text of introduced bill, see copy of bill as introduced on October 
                               15, 2007]

_______________________________________________________________________

                                 A BILL


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

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Newborn Screening Saves Lives Act of 
2008''.

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 are authorized to be 
appropriated--
            ``(1) to provide grants for the purpose of carrying out 
        activities under subsection (a)(1), $15,000,000 for fiscal year 
        2009, $15,187,500 for fiscal year 2010, $15,375,000 for fiscal 
        year 2011, $15,562,500 for fiscal year 2012, and $15,750,000 
        for fiscal year 2013; and
            ``(2) to provide grants for the purpose of carrying out 
        activities under paragraphs (2), (3), and (4) of subsection 
        (a), $15,000,000 for fiscal year 2009, $15,187,500 for fiscal 
        year 2010, $15,375,000 for fiscal year 2011, $15,562,500 for 
        fiscal year 2012, and $15,750,000 for fiscal year 2013.''.

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 2009, 
$5,062,500 for fiscal year 2010, $5,125,000 for fiscal year 2011, 
$5,187,500 for fiscal year 2012, and $5,250,000 for fiscal year 
2013.''.

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), respectively;
                    (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 2008 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 2008, 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 2008.
    ``(g) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, $1,000,000 for fiscal year 
2009, $1,012,500 for fiscal year 2010, $1,025,000 for fiscal year 2011, 
$1,037,500 for fiscal year 2012, and $1,050,000 for fiscal year 
2013.''.

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 2008; 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 
2009, $2,531,250 for fiscal year 2010, $2,562,500 for fiscal year 2011, 
$2,593,750 for fiscal year 2012, and $2,625,000 for fiscal year 
2013.''.

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 2009, $5,062,500 for fiscal year 2010, $5,125,000 for 
fiscal year 2011, $5,187,500 for fiscal year 2012, and $5,250,000 for 
fiscal year 2013.

``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 2009, $1,012,500 for fiscal year 2010, $1,025,000 for 
fiscal year 2011, $1,037,500 for fiscal year 2012, and $1,050,000 for 
fiscal year 2013.''.

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, 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.''.
                                                 Union Calendar No. 352

110th CONGRESS

  2d Session

                               H. R. 3825

                          [Report No. 110-570]

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                             April 8, 2008

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed