‘‘(5) a nongovernmental organization with ap-
propriate expertise in newborn screening, as deter-
mined by the Secretary. 
‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this sec-
tion— 
‘‘(1) $15,000,000 for fiscal year 2007; and 
‘‘(2) such sums as may be necessary for each 
of fiscal years 2008 through 2011.’’. 
SEC. 4. IMPROVED NEWBORN AND CHILD SCREENING FOR 
HERITABLE DISORDERS. 
Section 1109 of the Public Health Service Act (42 
U.S.C. 300b–8) is amended— 
(1) in subsection (c)(2)— 
(A) in subparagraph (E), by striking 
‘‘and’’ after the semicolon; 
(B) by redesignating subparagraph (F) as 
subparagraph (G); and 
(C) by inserting after subparagraph (E) 
the following: 
‘‘(F) an assurance that the entity has 
adopted and implemented, is in the process of 
adopting and implementing, or will use grant 
amounts received under this section to adopt 
and implement the guidelines and recommenda-
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tions 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 new-
born for the heritable disorders recommended 
by the Advisory Committee and adopted by the 
Secretary and the reporting of results; and’’; 
and 
(2) in subsection (i), by striking ‘‘such sums’’ 
and all that follows through the period at the end 
and inserting ‘‘$25,000,000 for fiscal year 2007 and 
such sums as may be necessary for each of the fiscal 
years 2008 through 2011.’’. 
SEC. 5. EVALUATING THE EFFECTIVENESS OF NEWBORN- 
AND CHILD-SCREENING PROGRAMS. 
Section 1110 of the Public Health Service Act (42 
U.S.C. 300b–9) is amended by adding at the end the fol-
lowing: 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
$5,000,000 for fiscal year 2007 and such sums as may 
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be necessary for each of the fiscal years 2008 through 
2011.’’. 
SEC. 6. ADVISORY COMMITTEE ON HERITABLE DISORDERS 
IN NEWBORNS AND CHILDREN. 
Section 1111 of the Public Health Service Act (42 
U.S.C. 300b–10) is amended— 
(1) in subsection (b)— 
(A) by redesignating paragraph (3) as 
paragraph (5); 
(B) in paragraph (2), by striking ‘‘and’’ 
after the semicolon; 
(C) by inserting after paragraph (2) the 
following: 
‘‘(3) recommend a uniform screening panel for 
newborn screening programs that includes the heri-
table disorders for which all newborns should be 
screened, including secondary conditions that may be 
identified as a result of the laboratory methods used 
for screening; 
‘‘(4) develop a model decision-matrix for new-
born screening program expansion, and periodically 
update the recommended uniform screening panel 
described in paragraph (3) based on such decision- 
matrix; and’’; and 
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(D) in paragraph (5) (as redesignated by 
subparagraph (A)), by striking the period at the 
end and inserting ‘‘, including recommenda-
tions, advice, or information dealing with— 
‘‘(A) followup activities, including those 
necessary to achieve rapid diagnosis in the 
short term, and those that ascertain long-term 
case management outcomes and appropriate ac-
cess to related services; 
‘‘(B) diagnostic and other technology used 
in screening; 
‘‘(C) the availability and reporting of test-
ing for conditions for which there is no existing 
treatment; 
‘‘(D) minimum standards and related poli-
cies and procedures for State newborn screen-
ing programs; 
‘‘(E) quality assurance, oversight, and 
evaluation of State newborn screening pro-
grams; 
‘‘(F) data collection for assessment of new-
born screening programs; 
‘‘(G) public and provider awareness and 
education; 
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‘‘(H) language and terminology used by 
State newborn screening programs; 
‘‘(I) confirmatory testing and verification 
of positive results; and 
‘‘(J) harmonization of laboratory defini-
tions for results that are within the expected 
range and results that are outside of the ex-
pected range.’’; and 
(2) 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 recommenda-
tion pursuant to this section, the Secretary shall 
adopt or reject such recommendation. 
‘‘(2) PENDING RECOMMENDATIONS.—The Sec-
retary 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 2006 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 Advi-
sory Committee pursuant to this subsection, includ-
ing the justification for the determination. 
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‘‘(e) CONTINUATION
OF
OPERATION
OF
COM-
MITTEE.—Notwithstanding section 14 of the Federal Ad-
visory Committee Act (5 U.S.C. App.), the Advisory Com-
mittee shall continue to operate during the 5-year period 
beginning on the date of enactment of the Newborn 
Screening Saves Lives Act of 2006.’’. 
SEC. 7. LABORATORY QUALITY AND SURVEILLANCE. 
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. LABORATORY QUALITY. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director of the Centers for Disease Control and Pre-
vention and in consultation with the Advisory Committee 
on Heritable Disorders in Newborns and Children estab-
lished under section 1111, shall provide for— 
‘‘(1) quality assurance for laboratories involved 
in screening newborns and children for heritable dis-
orders, including quality assurance for newborn- 
screening tests, performance evaluation services, and 
technical assistance and technology transfer to new-
born screening laboratories to ensure analytic valid-
ity and utility of screening tests; and 
‘‘(2) population-based pilot testing for new 
screening tools for evaluating use on a mass scale. 
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‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
to be appropriated $5,000,000 for fiscal year 2007 and 
such sums as may be necessary for each of the fiscal years 
2008 through 2011. 
‘‘SEC. 1113. SURVEILLANCE PROGRAMS FOR HERITABLE 
DISORDERS SCREENING. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director of the Centers for Disease Control and Pre-
vention, shall carry out programs— 
‘‘(1) to collect, analyze, and make available data 
on the heritable disorders recommended by the Advi-
sory Committee on Heritable Disorders in Newborns 
and Children established under section 1111, includ-
ing data on the causes of such disorders and on the 
incidence and prevalence of such disorders; 
‘‘(2) to operate regional centers for the conduct 
of applied epidemiological research on the prevention 
of such disorders; 
‘‘(3) to provide information and education to 
the public on the prevention of such disorders; and 
‘‘(4) to conduct research on and to promote the 
prevention of such disorders, and secondary health 
conditions among individuals with such disorders. 
‘‘(b) GRANTS AND CONTRACTS.— 
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‘‘(1) IN GENERAL.—In carrying out subsection 
(a), the Secretary may make grants to and enter 
into contracts with public and nonprofit private enti-
ties. 
‘‘(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, sub-
ject to subparagraph (B), provide supplies, 
equipment, and services for the purpose of aid-
ing the recipient in carrying out the purposes 
for which the award is made and, for such pur-
poses, may detail to the recipient any officer or 
employee of the Department of Health and 
Human Services. 
‘‘(B) REDUCTION.—With respect to a re-
quest described in subparagraph (A), the Sec-
retary 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 Sec-
retary shall, for the payment of expenses in-
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curred 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) BIENNIAL REPORT.—Not later than February 
1 of fiscal year 2007 and of every second such year there-
after, the Secretary shall submit to the Committee on En-
ergy and Commerce of the House of Representatives, and 
the Committee on Health, Education, Labor, and Pen-
sions of the Senate, a report that, with respect to the pre-
ceding 2 fiscal years— 
‘‘(1) contains information regarding the inci-
dence and prevalence of heritable disorders and the 
health status of individuals with such disorders and 
the extent to which such disorders have contributed 
to the incidence and prevalence of infant mortality 
and affected quality of life; 
‘‘(2) contains information under paragraph (1) 
that is specific to various racial and ethnic groups 
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(including Hispanics, non-Hispanic whites, Blacks, 
Native Americans, and Asian Americans); 
‘‘(3) contains an assessment of the extent to 
which various approaches of preventing heritable dis-
orders and secondary health conditions among indi-
viduals with such disorders have been effective; 
‘‘(4) describes the activities carried out under 
this section; 
‘‘(5) contains information on the incidence and 
prevalence of individuals living with heritable dis-
orders, information on the health status of individ-
uals with such disorders, information on any health 
disparities experienced by such individuals, and rec-
ommendations for improving the health and wellness 
and quality of life of such individuals; 
‘‘(6) contains a summary of recommendations 
from all heritable disorders research conferences 
sponsored by the Centers for Disease Control and 
Prevention; and 
‘‘(7) contains any recommendations of the Sec-
retary regarding this section. 
‘‘(d) APPLICABILITY OF PRIVACY LAWS.—The provi-
sions 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 
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the data and information that is collected under this sec-
tion. 
‘‘(e) COORDINATION.— 
‘‘(1) IN GENERAL.—In carrying out this sec-
tion, the Secretary shall coordinate, to the extent 
practicable, programs under this section with pro-
grams 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 dem-
onstrate the ability to coordinate activities under a 
grant or contract made under this section with exist-
ing birth defects surveillance activities. 
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
to be appropriated $15,000,000 for fiscal year 2007 and 
such sums as may be necessary for each of the fiscal years 
2008 through 2011.’’. 
Æ 
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